DC Medical Malpractice & Patient Safety Blog

Medical providers, insurance companies and well-informed medical consumers know that drugs, devices and treatments aren’t considered best-practice—or even credible—unless and until research has been conducted, the results reviewed by scientific peers and the results published in a reputable journal.

So how was it, health reporter Martha Rosenberg asks on KevinMd.com, that blockbuster drugs such as Vioxx (an arthritis drug withdrawn from the market in 2004 because of heart risks) and Baycol (a cholesterol drug withdrawn in 2001 because of muscle degeneration) were deemed safe, and that their benefits outweighed their risks?

These, and many others, Rosenberg writes, passed peer muster after journal reports were published that were written by drug companies or their hired writing hands. Gee, if you’ve spent millions developing a drug and you’re given license to appraise its effectiveness and safety, wouldn’t you make sure the story had a happy ending?

We regularly write about drug company conflicts of interest, and Rosenberg’s post adds to this stinky body of “knowledge.”

“Scratch the surface of many blockbuster drugs that went on to be discredited, or even withdrawn as risks emerged,” she writes, “and an elaborate ‘publication plan’ emerges, developed by the drug company’s marketing firm. For example, at least 50 articles promoting hormone replacement drugs like Prempro were planted in medical journals by Pfizer’s (then Wyeth) marketing firm DesignWrite…” You can read that document, courtesy of the University of California, San Francisco’s Drug Industry Document Archive.

One of DesignWrite’s articles published in the Journal of Women’s Health was called “Is There an Association Between Hormone Replacement Therapy and Breast Cancer?” The answer was “no.” Another DesignWrite offering appeared in the Archives of Internal Medicine, “The Role of Hormone Replacement Therapy in the Prevention of Postmenopausal Heart Disease.”A third, also from DesignWrite, in the Archives of Internal Medicine, championed “The Role of Hormone Therapy in the Prevention of Alzheimer’s disease.”

Rosenberg calls the marketing firm’s so-called science “egregiously flawed.” Hormone therapy has a demonstrable association with breast cancer, heart disease and Alzheimer’s. Still, the papers have not been retracted from the journals, two of which are published by the American Medical Association.

Parke-Davis/Pfizer also engaged in planned research plants with regard to its anti-seizure drug Neurontin. It wanted to expand the drug’s use to people suffering from migraines, bipolar disorder and other problems for which it had not been given FDA approval. Such “off-label” uses are the prerogative of practitioners, but manufacturers are not allowed to promote them for any use not approved by the FDA.

We wrote about the unethical use of fake Neurontin trials a couple of years ago in our blog, “The Difference Between Pharmaceutical Research and Marketing Blurs Yet Again.” Rosenberg notes that within a three-year period, Parke-Davis planted 13 ghostwritten articles in medical journals promoting off-label uses for Neurontin, and made 43,000 reprints from one for dissemination by its sales representatives.

“Researching, writing and submitting papers to medical journals — and reworking and finessing them if accepted — is a demanding, time consuming job which drug companies have made into pay dirt. … ‘publication plans’ for their products —elaborate grids with the names of journals where papers have run, are slated to run, have been submitted and have been resubmitted, the marketing firms apparently not taking ‘no’ for answer. Do the journals know they are part of such machinations?” Rosenberg asks.

Not only is iffy science given cred by these journals, the stench of conflict grows stronger when you realize that journals make money off such dreck when they license reprint rights for drug company promotion.

Several years ago, when it came to light that some researchers were subsidized by companies whose products they were testing, journals loudly announced they were raising their standards, scrutinizing submissions and adding disclaimers to address even the appearance of conflicts of interest. But, says Rosenberg, “Often the disclosures are relegated to a barely readable paragraph linking authors identified by initials, not names, to 60 or more drug companies. Worse, the disclosures don’t appear in abstract databases like PubMed but are hidden behind a financial firewall available only to paid subscribers who have access to the full articles.”

So if John Q. Public wants to read a full study, he must shell out a meaningful amount. And that’s for only one journal.

Rosenberg is not optimistic that this status quo can be changed any time soon. The problem, of course, is that it’s just too lucrative for both journals and drug companies to stop scratching each others’ backs at the cost of patient safety.

She highlights a well-established class of drugs called TNF blockers that includes Humira, Remicide, Enbrel and Cimzia. They treat various forms of arthritis formerly considered fairly rare, but promoted to “under-diagnosed” by their manufacturers in the hope of enlarging their market to people with a tenuous, at best, connection to them.

She warns consumers about taking their planted “quizzes” to encourage self-diagnosis, and practitioners about ghostwritten journal stories that minimize the drugs’ dangerous side effects, including suppression of the immune system.

As Rosenberg writes, “Recently, research by drug industry-funded authors has appeared in medical journals to dispel data linking TNF blockers to increasing incidences of hospitalizations, malignancies, cardiovascular events and Herpes zoster. Looks like another publication plan.”

And another strike against patient safety.

The proliferation of lawsuits over adverse events associated with invasive medical devices including metal-on-metal hip implants and transvaginal surgical mesh speak to a recent call by Consumers Union to strengthen the testing requirements for high-risk implants.

Consumers Union, as described by AboutLawsuits.com, is the lobbying arm of Consumer Reports. Last month, it sent a letter to the FDA urging it to require full research and testing under the agency’s premarket approval (PMA) process for Class III implantable devices.

The FDA has three classes of medical devices categorizing approximately 1,700 different generic types. Each type of device is classified, according to the agency, “based on the level of control necessary to assure the safety and effectiveness of the device.”

Class I devices require the least amount of regulatory intervention, and Class III, such as the hip and mesh implants, the most. For Class III devices, PMA is required unless there’s a substantially similar product already on the market. If so, newer versions of it get what’s known as a 510(k), or fast-track exemption, excusing it from all the testing required of the earliest device.

As reported on AboutLawsuits, many fast-tracked Class III devices are quite dissimilar from the originally approved device they are based on. Often, they are marketed as using new techniques and new designs “at the very same time the FDA is approving them for being identical enough to an existing device so as not to warrant clinical trials.”

Many 510(k) devices now on the market weren’t clinically tested before the 510(k) program or PMA process existed. So potentially dangerous new devices, notes AboutLawsuits, are given “grandfathered” approval without warranting it. A Consumer Reports investigative study that we wrote about last year concluded that most medical devices being implanted in U.S. patients have not been tested.

Thousands of people, the Consumer Union letter says, have suffered severe and debilitating injuries from implants that weren’t thoroughly evaluated by the FDA, and the agency should reclassify all high-risk implantable medical devices to require that those receiving PMA undergo clinical trials to prove that they are safe and effective.

FDA action seems to prove this case: In January, the agency issued a safety warning about metal-on-metal hip implants that said they have “unique risks” including soft tissue damage and other problems. (See our blog about a large damages award to a patient who learned this sad truth.)

Transvaginal mesh also should fall under this scrutiny, the Consumers Union letter said, because it has been known to puncture organs and cause autoimmune disorders. And it, too, was the subject of an FDA warning and a subsequent letter to manufacturers ordering additional studies to evaluate their risks.

According to AboutLawsuits, “many manufacturers have decided to cease commercialization of their products, hoping to avoid the need for testing that many believe should have been done before the devices were ever sold in the United States.”

If you want to report or research adverse events associated with medical devices, visit the FDA’s MedWatch site. For additional guidance on informing yourself about medical devices, and protecting against their risks, see our blog “Protecting Yourself from Dangerous Medical Devices.”

No one would ever describe “surgery” as a walk in the park, but if being operated on resolves a problem or makes it less bad, it can be worth the risk, trouble and discomfort. But what if you undergo surgery to resolve a problem you never had?

According to a preliminary paper presented earlier this month at the annual meeting of the American Association for Cancer Research, nearly 1 in 10 people having this surgery in fact have a benign disease; that is, they had surgery unnecessarily. About 2 in 100 of the patients with the benign condition died in the hospital after the lung surgery.

A couple of factors contribute to this troubling and wasteful medical “care.” One big one is a screening test that seems to indicate the presence of cancer, but in fact is a false positive. Last year we wrote about the abundance of this kind of misdiagnosis in lung cancer screenings.

The study was reported on MedPageToday. Although the average rate of benign lung disease is high, rates vary widely from state to state—Vermont registered the lowest (1.3%), and Hawaii had the highest (25%). And women were somewhat more likely to have the benign condition than men—9.8% to 8.5%.

The study was inspired by the National Lung Screening Test, which showed in 2010 that CT scans were superior to chest X-rays to reduce deaths from lung cancer, and which boosted the profile of the diagnostic scans.

But nearly 1 in 4 lung surgeries in that study resulted in a diagnosis of benign disease.

The new study relied on data from a single year for more than 25,000 patients who had surgery for known or suspected lung cancer. It examined the geographical variations for patterns that might inform a best-practice approach for successful screenings—those that find cancers without unacceptable rates of false-positives.

One reason there’s so much variation among the different states might be simply a matter of local standards of care. Patients in some places go into surgery much faster after a suspicious test than in other places. Speed, suggested the authors, might cause more errors.

Some places have higher incidents of certain disorders that might complicate things. One, for example, is histoplasmosis, a fungal infection found in humid areas. It can cause an imaging result that looks like it might be lung cancer.

Now, the researchers are studying data from several years to see if the rate of benign disease changes over a longer period of time. They’re also focusing on associations between benign disease rates and the prevalence of disease-causing fungi by region.

They’re trying to tease out the difference between the cultural practices of certain areas that would lead to higher rates of benign disease versus actual differences in the incidence of it from place to place.

Once you can tell the difference between a false-positive caused by hasty or misinformed medical practices from those caused by, say, an environmental organism, you can hone your screening recommendations to people who would benefit most.

Dr. Louis Weiner, who was not involved in the study, is affiliated with Lombardi Comprehensive Cancer Center at Georgetown University. His analysis? "This is information and information doesn't become powerful until you can convert it into knowledge."

If your doctor prescribes a screening test, ask:

• What are the possible benefits?


• What are the possible harms?


• How often do harms occur?


• Are there alternative tests?

For a long time, women were advised to get annual pap smears, especially if they had ever been diagnosed with HPV (human papillomavirus), a common sexually transmitted disease. Now, says the American Society for Colposcopy and Cervical Pathology, longer intervals are recommended—every five years for women 30 to 64, and those screenings should include both HPV and cervical cell anomalies (cytology).

The guidelines were published in the journal Obstetrics and Gynecology.

An accompanying editorial raised the same concerns of over-PSA testing: "In a move toward safety, the guidelines discourage intensive evaluation and treatment of women ages 21 to 24 years who have minimally abnormal cytology, a group at low risk of cancer but with a substantial risk of harm."

Sometimes, like prostate cancer, cervical lesions often regress on their own, without aggressive treatment.

The guideline, as described on MedPageToday.com, advised women who have tested negative for HPV and positive for atypical squamous cells of undetermined significant (ASCUS) to be screened for cytology and HPV at three-year intervals. ASCUS is the most common abnormal test result, but it isn’t usually associated with HPV and, as MedPageToday said, “carries low risk for invasive disease.”

For women with ASCUS who haven’t been tested for HPV, screening should be more frequent initially—once a year—but after a negative test it can be repeated at three-year intervals.

Women older than 65 with ASCUS, however, should be screened annually.

Positive results from a Pap test can fall into several different pathologies, some requiring more frequent follow-up than others. So, as always, individual diagnoses determine individual screening guidelines. But, in general, Pap tests needn’t be repeated as frequently as once thought.

Adopting that practice, however, is challenging because, as noted in another study reported on MedPageToday, “Most physicians wanted female patients to undergo cervical cancer screening more frequently than recommended under published guidelines, …”

That was the conclusion of a government survey of physicians published in JAMA Internal Medicine. As many as 8 in 10 doctors surveyed said they would recommend women with normal Pap tests and negative HPV tests be rescreened in three, instead of the now-recommended five, years.

In an accompanying editorial headlined “Swimming Upstream,” Dr. Michael LeFevre said that the study results show that "doing less" in medicine remains challenging for doctors even if scientific evidence indicates that approach is best for most patients.

"It is important to acknowledge that getting physicians to do less testing and patients to accept less testing in many clinical situations is like swimming upstream; it is hard,” said LeFevre. “The forces to do more rather than less, particularly for 'early detection' of asymptomatic disease, are powerful."

Our cultural belief that medicine does only good is the culprit here. But it seems to us that when you’re a doctor, you’re obliged to let science, not momentum, be your guide.

LeFevre believes that "some overuse of diagnostic testing in general and screening specifically" is the result of doctors worrying that if they don’t test they leave themselves open to charges of malpractice. And that lawsuits claiming excessive testing are not a compensating concern. This continuing refrain doesn’t get any truer by virtue of repetition.

He also explains that the fee-for-service payment model encourages overtesting because it means a bigger paycheck. Again, when the profit motive, not science, is your guide, the patient pays, figuratively and literally.

We agree with LeFevre’s conclusion that although screening tests will benefit some patients, "blind adherence to doing more whenever there is a possibility of good, no matter how remote that possibility is or how much harm is done in the process, should not be our approach."

If you have been screened for prostate or cervical cancer, or HPV, and your doctor advises rescreening more frequently than these guidelines, find out why. Know your test results, and what they mean.

The value of two regular common screening tests—for prostate and cervical cancers—were called into question earlier this month by yet more professional medical associations. Today we'll report on prostate cancer screening with the PSA test. Tomorrow: Pap tests for cervical cancer.

A statement issued by the clinical guidelines committee of American College of Physicians (ACP) said, “The potential harms of PSA testing outweigh the benefits for most men, such that testing should occur only after a careful discussion between physician and patient …”

Readers of this blog are familiar with the evolving awareness of potential harms from the prostate specific antigen (PSA) test. Although one life is saved for every 1,000 people screened over a 10-year period, more than 100 of those same 1,000 men will produce suspicious results when there is either no cancer or a cancer that is growing so slowly (or not at all) as to produce no threat.

For most men, a positive test means having a biopsy, whose risks include pain, fever, bleeding, infection and hospitalization. If cancer is detected, 9 in 10 men will have surgery and/or radiation even when the tumors are not life-threatening. Their side effects include impotence, urinary incontinence and blood clots.

"ACP recommends that clinicians should not screen for prostate cancer using the prostate-specific antigen test in patients who do not express a clear preference for screening," the panel said.

As explained on MedPageToday.com, the guideline statement is a melding of recent recommendations issued by other groups, including the American College of Preventive Medicine (ACPM), American Cancer Society (ACS), American Urological Association (AUA) and the U.S. Preventive Services Task Force (USPSTF).

The USPSTF doesn’t recommend routine PSA screening, but for men who choose to have the test, it advises that they being fully informed of the benefits and harms.

"Studies have shown,” said the ACP statement, “that up to one-third of men screened for prostate cancer were unaware that they were being tested, and many men who were aware that they were tested do not receive an adequate discussion of the benefits and harms of screening."

The ACP panel says doctors should address these issues with every patient:

• PSA testing is controversial.


• PSA tests can detect prostate cancer, but for most men, the harms outweigh the benefits.


• Relatively few prostate cancers prove to be aggressive and cause death; most are likely to be slow-growing and nonfatal.


• Most men who are not screened do not develop prostate cancer and die of other causes.


• Men who choose to be tested are much more likely to have prostate cancer diagnoses compared with men who decline to be screened.


• PSA tests do not distinguish between serious and nonserious cancers.


• At most, PSA testing prevents one prostate cancer death per 1,000 men screened after 11 years of follow-up.


• Screening can lead to many potential harms, some of them serious (including unnecessary biopsies and surgery).


• PSA testing can "open the door to more testing and treatment that a man may not actually want and that may actually harm him."


• Ongoing studies will provide more information about PSA testing, and recommendations might change.

Men at high risk—those with a family history of prostate cancer, smokers, the obese, African Americans, those older than 65—also should engage in the shared decision, said the ACP. The panel said there’s a lack of evidence that screening high-risk patients changes outcomes appreciably as compared with screening average-risk men.

Guidelines for how often women should get pap tests, which are used to detect cervical cancer, were updated this month as well. More on that in our next blog.

Computed tomography (CT) is a scan of internal organs that creates cross-section images using X-rays. It’s a very popular kid on the medical technology block:

• Between 1980 and 2007, the number of CT scans performed in the U.S. increased from 3 million to 70 million.


• An estimated 29,000 future cancers, according to a National Cancer Institute study, will be related to scans done in 2007 alone.


• An estimated 1 in 3 imaging exams do not help the patient nor contribute to better outcomes.

We’ve also discussed the fact that a lot of patients are unaware that a CT scan involves radiation, or that radiation can be harmful. Brayer notes that a new study from the University of Washington shows that 1 in 3 people did not know that a CT scan exposed them to radiation, and those who did underestimated the amount of radiation it delivered.

“A CT scan,” Brayer writes, “delivers a mega-dose of radiation, as much as 500 times that of a conventional X-ray.”

The more scans you have, the higher your risk. Radiation risk is cumulative.

Brayer explains a medical situation called “incidentalomas”; that’s when you get, say, an X-ray for a suspected case of pneumonia that also shows something that can’t be explained. So the radiologist might recommend a follow-up CT scan to diagnose that, and you’re on your way to possibly unnecessary—and dangerous—overexposure to radiation.

A better approach taken by Brayer and other clinicians not under spell of “more more more” is to weigh the risks of getting the additional scan with its possible benefits. That often leads clear thinkers, who know that “defensive medicine” (when doctors overprescribe tests in order not to be accused of missing something) is misguided, to address the infection now and repeat the chest X-ray in a few months to see if the unknown spot remains.

Brayer applauds the ability of CT technology, but encourages everyone to understand it better. Her advice:

• If a doctor orders a CT scan for a child, the parent should ask the technician to use pediatric-appropriate settings. (Children are especially vulnerable to the risks of excess radiation.)


• Do not let a doctor or facility repeat a scan that was done recently (for example, if you get second opinions or are seen at a different place). All scans can be electronically shared.


• Ask if a “low-dose” scan is appropriate.


• Avoid using the emergency department for health care—your chances of getting a CT scan for a variety of complaints are extremely high. (See our blog, “Emergency Use of CT Scans Soars.”) The overworked ER doc wants to cover all possibilities, even those that have low probability, in the least amount of time—bingo! Order a CT scan.


• Ask “How could the test result change my (or my child’s care), if at all?”


• Ask, “Can you recommend an alternative, such as an ultrasound or MRI, that doesn’t involve radiation?”

The story begins in 2011, when a young Florida man died of brain inflammation from an unknown cause, and organs from his body were transplanted into four recipients. Fifteen months later, a Maryland man died of rabies, and now it turns out to have come from the transplanted kidney he got from the Florida donor. The question now is, could anything have been done to prevent this tragic outcome?

The Centers for Disease Control and Prevention just confirmed the link after DNA testing matched the disease in the two victims. The recipient received his transplant at Walter Reed National Medical Center in Bethesda, Maryland and just died at the Veterans Hospital in Washington, DC.

Organ donation officials stress that rabies is extremely rare -- you can count the number of human deaths in the United States each year on one hand. The other problem is that there is no simple test that can be done quickly enough to get an answer while the organ being transplanted is still viable.

But why would anyone take organs from a donor who died of a mysterious brain infection like encephalitis, as this donor did?

Even that question has no easy answers.

A takeout by Betsy McKay in the Wall Street Journal reports that symptoms of encephalitis can be hard to distinguish from other causes. This is according to Dr. Michael Green, chair of the disease transmission advisory committee for the United Network for Organ Sharing. Dr. Green, a professor of pediatrics and surgery at the University of Pittsburgh School of Medicine, told Ms. McKay:

"If you knew someone had encephalitis, the recommendation would be to be extremely cautious before using any organs. The problem is identifying everyone who has encephalitis."

The Journal report said that seven disease transmissions are reported for every 5,000 donations, and death is very rare.

The other three recipients of organs from the infected donor are being treated and are reportedly doing okay.

UNOS is urging closer scrutiny of potential organ donors for encephalitis, which it says has been underecognized in donors but is highly transmissible.

Two treatments are proven to lengthen the lives of women with ovarian cancer, but only 1 in 3 patients gets them, according to a new study. It's no mystery why. The old rule for better health care -- experience, experience, experience -- is proven out again.

Ovarian cancer is a bone-scary diagnosis because of its dismal prognosis. But the understandable fright causes many women to make illogical moves when they reach out for care: First, they often look to a familiar face for treatment, such as the obstetrician who birthed their children (who usually is qualified on paper to take out ovaries, but lacks big-time experience with ovarian cancer). Second, they think they have to get surgery in a matter of days, not weeks, and that leads them to grab onto whatever surgeon can see them first.

These are mistakes that can shorten lives. The two treatments that are shown to lengthen life of ovarian cancer patients are:

* Debulking surgery.

* Chemotherapy delivered directly to the inside of the abdomen, called intraperitoneal (IP) chemo.

The best advice for women with a new diagnosis of ovarian cancer is to get to a "center of excellence" for cancer treatment, and to make sure the surgery is done by a gynecologic oncologist. That's a gynecologist with extra training in women's cancers of the reproductive organs.

Also, make sure the surgeon does ovarian debulking surgeries at least about once a month, or a dozen times a year. The operation often takes six or more hours, and it's necessary to have a surgeon with the skill, experience and meticulous patience to take out all visible signs of the cancer from inside the lower abdomen.

The seeds of cancer are scattered like Rice Krispies, and the best result is for those women who get all visible cancer removed by the surgeon, and then get the pelvis washed out with IP chemo.

Read more about this in a takeout in the New York Times by Denise Grady.

Both conscientious medical practitioners and consumer health-care watchdogs were gratified last month when a professional group deemed nearly 100 medical procedures, tests and therapies overused and frequently unnecessary.

Medical care in the U.S. has long functioned under a more-is-more principle that is not only expensive and wasteful of resources, but often causes patient harm from false positives (when a test indicates disease when there is none), uncomfortable additional procedures, possible infection and unnecessary worry. Things are changing, however because of the pressures of health-care reform, a growing population of older patients and the awareness that practicing defensive medicine (doctors over-prescribing tests and procedures to protect against claims of malpractice) is misguided and doesn’t work.

As widely reported, including in the Los Angeles Times, last month the American Board of Internal Medicine (ABIM) issued the list of practices that undermine health care and contribute to runaway costs. They include:

• early elective caesarean deliveries;


• CT scans for head injuries in children;


• annual Pap test for middle-aged women.

Although individual circumstances might make these practices reasonable and appropriate, for most people they should not be routine.

The ABIM has been down this path before through its foundation, whose mission is to advance medical professionalism into clinical policy and practice through collaboration with consumer organizations, patients, insurers and policy makers. Its Choosing Wisely campaign, which encourages physicians and patients to communicate in an effort to reduce overuse of tests and procedures and make effective choices about their care.

As The Times reports, the U.S. spends more than $2.5 trillion a year on health care; that’s more than $8,000 per person, and 2 1/2 times as much as the average spent by other industrialized, affluent nations.

We spend more because hospital and doctor fees are higher here than other countries. But the cost is higher also because U.S. practitioners perform far more tests and elective procedures. They order nearly twice as many CT and MRI exams, do more knee replacements and deliver more babies by caesarean section.

Yes, the U.S. has some of the highest cancer survival rates in the world, but in comparison with other countries, we fall short in other areas, including caring for children with asthma and adults with lung disorders, for example.

The fact that more isn’t necessarily more was demonstrated last year by the Institute of Medicine (IOM), which estimated that nearly one-third of annual health-care expenditures were wasteful, or $750 billion a year.

"Millions of Americans are increasingly realizing that when it comes to health care, more is not necessarily better," Dr. Christine K. Cassel, president of the ABIM Foundation, told The Times.

Many health-care reform advocates blame the fee-for-service business model for much overuse in health care. When someone is paid for every procedure, he or she is more likely to recommend it.

The question remains: Will this rising awareness of overdoing it change the treatment default from always doing to sometimes waiting? When diseases can be fatal, when families are pressuring the doctor to everything he or she can, a conservative approach, even if wise, can seem heartless and wrong.

Never mind that the U.S. Preventive Services Task Force has been clear about the dicey value of breast and prostate cancer screenings, noting that they often do more harm than good. Many patient advocates have objected to its pronouncements, and some congressional representatives called what it promoted as a best medical practice rationing.

The broad coalition of medical societies involved in the last call to action included the American Academy of Pediatrics, the American Academy of Ophthalmology, the American College of Obstetricians and Gynecologists and the Society of Thoracic Surgeons. Other supporters include Consumer Reports, the AARP and the National Business Group on Health.

The New York Times’ venerable health columnist Jane Brody recently wrote about the advisability of the annual physical checkup. It’s a topic we’ve covered, too, reaching mostly the same conclusion: In most cases, an annual doctor examination is a poor use of time, money and medical resources.

As Brody points out, trying to figure out if a routine checkup is a good idea is more important than ever, because next year, the Affordable Care Act (“Obamacare”) will enable about 30 million more people to be insured. Many of them will be eligible for an annual exam that insurance plans must cover. That’s a lot of potential demand on a resource stretched pretty thin.

So who should get a checkup? And how often?

According to one of Brody’s sources, about 44.4 million adults get preventive exams every year. If every U.S. adult got one, 145 million more visits would occur every year, and gobble up almost half of all the time primary care doctors spend with patients. And you think the health-care system is slow, inefficient and frustrating now?

No one within or outside of the medical community disputes the wisdom of regular checkups for babies, children and pregnant women. No one disputes the wisdom of exams that include specific screenings for certain populations, such as Pap smears for women. But, as Brody says, “Among physicians, researchers and insurers, there is an ongoing debate as to whether regular checkups really reduce the chances of becoming seriously ill or dying of an illness that would have been treatable had it been detected sooner.”

Those who vote “no” point to a growing number of studies that fail to find a benefit that outweighs the risk that they’ll do more harm by finding something abnormal that, if it had never been discovered, would never have done harm. Something can be technically "abnormal" without being threatening or even, sometimes, interesting.

But the default behavior by too many practitioners is to conduct extra tests. This causes the patient distress, expense and, sometimes, medical complication.

One of Brody’s examples was provided by a physician who told the tale of Brian Mulroney, former prime minister of Canada. He had a physical in 2005 that included a CT scan. It showed two small lumps in his lungs. He underwent surgery to find out what they were, after which he developed an inflamed pancreas that forced him into the intensive care unit. He was in the hospital six weeks, and readmitted a month later to remove a cyst caused by the inflammation of his pancreas.

Oh, and the lung lumps were benign.

Of course, the question arises: What if the lumps had been cancerous? Wouldn’t the initial scan and all the unpleasant consequences of it have been worth it in order to be able to treat the cancer?

“The question of benefits versus risks from routine exams,” Brody writes, “can be answered only by well-designed scientific research.”

One recent study cited in her story was conducted at the Nordic Cochrane Center in Copenhagen, Denmark.

Researchers analyzed 14 clinical trials of routine checkups that followed participants for as long as 22 years. The team found that healthy people who got routine checkups got no benefit in terms of the risk of death or serious illness compared with compared with people who did not.

And as we’ve said in this blog repeatedly, the researchers concluded that many routine exams involve specific screening tests whose value hasn’t been studied adequately. The possible harms of such routine tests, they said, are “overdiagnosis, overtreatment, distress or injury from invasive follow-up tests, distress due to false positive test results [a test that shows the existence of a potential problem when there isn’t one], false reassurance due to false negative test results [tests that don’t show a problem when there is one], adverse psychosocial effects due to labeling and difficulties with getting insurance.”

Among a general population—that is, the subjects weren’t chosen because they did or didn’t have certain risk factors of medical problems—the Danish team simply didn’t find that having a checkup reduced the possibility of dying any more than not having one. Nor did they find any reduction in cardiovascular problems and cancer—the causes of death most likely to be influenced by health checkups.

But a regular doctor appointment can be useful, Brody says, noting that many doctors welcome an annual visit even when their patients don’t have a medical issue because it’s good for the relationship—it helps alert them to changes in patients’ lives that can affect health. And doctors can use that time to encourage patients to get needed immunizations and other health care, such as eye and dental exams that have proven benefits with almost no risk.

So what’s a person to do if she wants to monitor her health without overdoing it?

Brody has three pieces of advice:

1. Whenever you visit the doctor for any reason, have your blood pressure checked and get blood tests if the ones in your medical record are older than a year.

2. Remain current on immunizations—flu shots, tetanus, shingles, etc. (If you don’t know which vaccinations you should have, ask. Some are recommended for certain age groups or if you have certain risk factors.) Get the screening tests specifically recommended for your profile—age, gender, risk factors, family and personal medical history.

3. Some symptoms require attention. If you develop unexplained pain, shortness of breath, digestive problems, a lump, a skin lesion that doesn’t heal, or unusual fatigue or depression, call your doctor. If the problem is diagnosed and treated, ask when you should feel relief. If that time has come, and you’re not feeling better, seek further help.

See our newsletter on vaccine shots worth getting, and other screening tests that are a smart idea.

“The medical arena, like society at large, is permeated with self-interest,” says Dr. Michael Kirsch writing on MDWhistleblower, a website whose name pretty much tells you where he’s coming from.

Like us, he’s a big supporter of comparative effectiveness research, which means comparing different treatments for a given illness and compiling a body of knowledge from which doctors and patients can choose the best option for a given case. And in the case of colonoscopy, an invasive procedure whose benefits vs. risk we’ve addressed before, this expert has a boatload of doubt.

As described by Gary Schwitzer on HealthNewsReview.org, Kirsch’s essay “Is Colonoscopy the Best Colon Cancer Screening Test?” manages to address “medical conflicts of interest, comparative effectiveness research, the medical arms race, medical marketing and more,” all within a few hundred words.

Kirsch starts by describing the absolute adoration his profession has for the latest medical tool or technology, and how this lust is ripe for conflict of interest. “In medicine, every heath care reform, new medicine, new medical device or revised medical guideline is at some constituency’s expense,” he says. “Recognizing and dismantling conflicts of interests is one of our greatest challenges and threats. “

Practitioners and medical facilities love new medical developments not only for their therapeutic potential, but because they can be used to market somebody’s practice or hospital. “Large medical institutions will spend mightily for the latest high-tech robotic laser shooting burger-flipping tumor ray gun, even if (especially if) the competitor across the street already has one,” Kirsch writes. That, he says, is a “model of overtesting and overtreatment,” and leads to a “culture of excess.”

In the case of his field, gastroenterology, Kirsch is clear. Age 50, he says, is when “we pounce upon you to scour your colon to remove cancers-in-waiting. While we champion this test, and sincerely believe in its worth, it is not ideal.”

If the benefit is possible diagnosis of potential cancer, here, according to Kirsch, are some drawbacks:

• the pre-colonoscopy cathartic cocktail;


• anxiety;


• discomfort (it’s not always painless);


• cost;


• risk of complications (like a perforated bowel);


• high rate of negative results;


• loss of a day’s wages;


• the need for a driver to bring you home.

Unlike a colonoscopy, which involves inserting a probe in the rectum and snaking up through the bowel, a CAT scan is not invasive—it takes pictures (cross-section X-rays) while the patient lies motionless on the table.

Right now, colonoscopy is winning the match because patients who choose the CAT scan option still have to swallow that gacky laxative before the test, and if polyps are discovered, they can’t be removed—patients have to undergo another treatment. So colonoscopy has the advantage now because nearly all polyps discovered can be removed during the test.

But, Kirsch writes, “If radiologists perfect the technique of performing a CAT colonography without any required laxatives, then the scales may tip in their favor.”

And he believes that both colonoscopy and CAT colonography will lose favor while he’s still practicing medicine. “Colonoscopy,” he suggests, “will still be performed, but only when some kinder and gentler screening test indicates that an individual has a high probability of harboring polyps. It will no longer be wielded in a buckshot fashion. The number of colonoscopies being performed will be decimated.”

“When that happens,” he concludes with refreshing honesty, “it will not be good news for the Kirsch family. But, it will be greater good news for everyone else’s family.”

File this one in our ongoing series about miscommunication between doctors and patients. This time the subject is radiation and how little most patients know about it.

Last week we posted an item about how doctors sometimes mislead, even lie, to their patients when discussing the risks and benefits of certain treatments or mistakes they might have made.

A research letter recently published in the Archives of Internal Medicine, concluded that many patients undergoing diagnostic imaging don’t understand that it often involves radiation. And that the risks of radiation might be more than they think.

The researchers analyzed the use of CT and SPECT scans. CT (computed tomography) scans create cross-section images of the body using X-rays. Depending on the test, they can involve injecting a contrast dye to illuminate certain areas of the body. SPECT (single-photon emission computerized tomography) scans are a more specific test using nuclear images—the radioactive dye and a special camera create 3-D pictures of how certain organs are functioning. An X-ray can show bone and tissue structure, but a SPECT scan shows how blood flows to a certain organ.

The risks of any kind of CT scan include allergic reactions to the dye, and exposure to radiation. According to the National Institutes of Health, CT scans expose you to a lot more radiation than regular X-rays, and having several of either over time might increase your risk for cancer. To learn more, see our backgrounder on radiation overdose injuries.

The amount of radiation you receive during a CT scan depends on the body part being tested. According to the Health Physics Society, a nonprofit scientific professional organization devoted to the science and practice of radiation safety, and composed of some 5,500 scientists, physicians, engineers and lawyers, the averages for certain CT scans are:

• head—2.0 mSv


• chest—7.0 mSv


• abdomen/pelvis—10.0 mSv


• whole body—10.2mSv

The dose from a standard chest X-ray (two views, front and side) is 0.1 mSv. That means a chest CT scan with 7.0 mSv's has the same X-ray dose as 70 chest X-rays.

Some other authoritative resources say certain scans use more radiation. The Associated Radiologists of New Jersey say some chest or abdominal scans can approach 18 mSv.

The designation mSv is an abbreviation for millisieverts, the scientific unit of measurement for radiation dose (commonly referred to as “effective dose”). The average exposure from background radiation (originating not from tests or, for example, airport security screenings, but the natural environment), is about 3 mSv per year; more if you live at high elevation.

So a single abdominal CT scan exposes you to three to six times the amount of radiation you otherwise would be exposed to in a year.

Researchers surveyed several hundred randomly selected, nonurgent outpatients at a major academic medical center for most of 2011. They asked 16 questions to assess patient knowledge and perceptions about health risks and benefits from CT or cardiac SPECT. One question asked if the scan they were about to undergo exposed their body to radiation. Only if patients responded “yes” were they instructed to continue answering five additional questions assessing their knowledge and perceptions of radiation.

One-third of all patients did not know that the scan exposed their body to radiation. Of the 154 patients who did, nearly half said their health-care provider had informed them of the radiation.

Nearly 7 in 10 respondents said their health-care provider was their main source of health information. About half had heard nothing in the media over the past year about radiation from medical imaging. Two-thirds believed that their scan was definitely necessary; half believed the results would help them feel better, and nearly as many believed the test would enable them to live longer. Only 3 in 100 reported thinking about radiation before their scan.

Nine in 10 patients said that it was important to be informed of imaging risks, and more than 8 in 10 said that the health-care provider who ordered the scan explained the reason(s) for it.

When the patients were asked to compare radiation from their scan with a year’s worth of background radiation, 85 in 100 underestimated the amount of radiation. Even more than that said they weren’t worried about scan radiation. Only 5 in 100 believed that scan radiation would increase their lifetime risk of cancer, and 95 in 100 said it was more important to figure out what might be wrong than to worry about scan radiation.

As the researchers wrote, “A well-informed patient has an understanding of radiation dose and potential health risks of radiation prior to imaging. When combined with an understanding of benefits, patients are well positioned to assess the risk-benefit ratio and participate in shared decision-making.”

Why are patients so ill-informed? Many health-care providers, the researchers suggested, have little knowledge themselves about radiation, so they’re not equipped to educate their patients. And because radiation is difficult to explain and comprehend, some patients might be unable to grasp the whole picture during a short clinical visit.

Because so many people appear to be unaware of scan radiation, and because those who are appear to have an inaccurate sense of it, it’s important that if your doctor suggests such a diagnostic test, you be assured that it’s necessary and that the diagnostic benefit is greater than the risks. And always understand that a test is not a treatment. CT scans find a problem, they don’t solve it.

Here's a good website from the American Society of Radiation Technologists that lets you calculate your X-ray exposure and risk from various types of imaging studies.

With all the political angst over the future of Medicare and how to fund it, we have to ask: Why not start with eliminating the redundancies -- the repeats on tests when no repeat is needed?

A new study published in the Archives of Internal Medicine suggests that Medicare patients frequently undergo repeated diagnostic tests. The researchers called such repetitive interventions a “major determinant” in the ability to contain health-care costs.

“We examined repetitive testing for six commonly performed diagnostic tests in which repeat testing is not routinely anticipated,” they wrote. “Although we expected a certain fraction of examinations to be repeated, we were struck by the magnitude of that fraction: one-third to one-half of these tests are repeated within a three-year period. This finding raises the question whether some physicians are routinely repeating diagnostic tests.”

Nearly three-quarters of a million older adults with fee-for-service Medicare coverage were studied. Within three years, the tests and their repeat numbers out of 100 Medicare patients were:

• echocardiography (heart), 55;


• imaging stress tests (heart), 44;


• pulmonary function tests (lungs), 49;


• chest computed tomography, 46;


• cystoscopies (bladder), 41;


• upper endoscopies (digestive tract), 35.

So nearly half (or more) of Medicare patients who had heart, chest, stomach or bladder tests had them again within three years. And the average time between repeat testing was four to 14 months.

Two different heart tests were analyzed. Echocardiography is an ultrasound of the heart, and is less invasive than imaging, or nuclear stress test, which tracks radioactive dye through the bloodstream to create the image while the patient works out on a treadmill or stationary bike, and again at rest.

As noted on Reuters, such procedures usually aren't supposed to be repeated routinely. And the routine use of some (echocardiography, stress tests) are specifically contraindicated.

As Reuters makes clear, the tests studied are for diagnostic purposes; that is, they’re generally performed on people with symptoms to help doctors make a diagnosis, then decide how to treat the problem. They cost from about $200 to more than $1,000.

As the lead research told Reuters, "Either these patients continually develop new problems or there are doctors who routinely repeat tests. … The fact is, we are paid more to do more."

Cost is not the only factor in having unnecessary tests; overuse can reduce the time available for practitioners to see new patients. As many Medicare beneficiaries are aware, it can be difficult already to find a doctor who accepts new Medicare patients. And as we’ve previously noted, unnecessary tests can lead to unnecessary and possibly complicating treatment for conditions that are harmless or relatively so.

As the researchers concluded, “Although the tests themselves pose little risk, repeat testing is a major risk factor for incidental detection and overdiagnosis

In an editorial accompanying the research study, Dr. Jerome P. Kassirer of Tufts University School of Medicine and Dr. Arnold Milstein of Stanford University School of Medicine wrote that “After decades of attention to unsustainable growth in health spending and its degradation of worker wages, employer economic vitality, state educational funding and fiscal integrity, it is discouraging to contemplate the fresh evidence … of our failure to curb waste of health care resources.”

To address unnecessary redundancies, the commentators suggest implementing peer-designed electronic systems to coordinate clinical information and eliminating incentives for fee-for-service procedures. The former would communicate a patient’s history more efficiently and the latter would pull the plug on the notion that more treatment means better treatment.

“No matter what future payment system is implemented,” wrote Kassirer and Milstein, “intercession in clinical decision making will be required to protect patients from too many tests and from too few tests. We have not come close to getting it right.”

If your doctor has prescribed a diagnostic test, either for the first time or especially as a repeat procedure, ask why; ask what would happen if you didn’t have the test, what it might show and what treatments might be prescribed for those hypothetical results.

You can also visit Choosing Wisely, an initiative to help providers and patients communicate better with the aim of more efficient delivery of health-care services. The site, produced by nine medical professional organizations, identifies procedures patients should question and discuss.

Another study examining the benefits and risks of routine mammograms has confirmed earlier concerns that, in many cases the tests at best complicate the assessment of breast health and at worst pose significant harm for people whose results show the presence of a small mass.

Writing in the New England Journal of Medicine, the researchers conclude that, “Despite substantial increases in the number of cases of early-stage breast cancer detected, screening mammography has only marginally reduced the rate at which women present with advanced cancer. Although it is not certain which women have been affected, the imbalance suggests that there is substantial overdiagnosis, accounting for nearly a third of all newly diagnosed breast cancers, and that screening is having, at best, only a small effect on the rate of death from breast cancer.”

Although many members of the medical community—radiologists and the American Cancer Society—continue to support regular mammograms for all women 40 and older, it seems that, absent a higher risk for the disease, most women needn’t have the regular screenings. And those who do might benefit more from “watchful waiting” than aggressive treatment for small tumors.

Women at higher risk are those with a family history of breast cancer, those who have genetic mutations known as BRCA1/BRCA2 and those with dense breasts. “Watchful waiting” is monitoring something identified on a screening test that may or may not become dangerous.

Readers of this blog are familiar with the to-and-fro surrounding the wisdom of people at low risk of having both mammograms and prostate tests. The new study says that approximately one-third of the tumors found in routine mammograms probably won’t develop into cancer.

The researchers say that the tests are overused and that improving survival rates from breast cancer are mostly the result of better treatment, not of discovering small tumors earlier through imaging.

The researchers “estimated that breast cancer was overdiagnosed (i.e., tumors were detected on screening that would never have led to clinical symptoms) in 1.3 million U.S. women in the past 30 years. We estimated that in 2008, breast cancer was overdiagnosed in more than 70,000 women; this accounted for 31% of all breast cancers diagnosed.”

As explained on NPR, this means that although mammography is good at catching early tumors, it isn't catching many advanced breast cancers. Some early tumors never progress to malignancy; they resolve on their own.

So the harm of “overdiagnosis”—treating something that doesn’t need to be treated—is not just the fear that a positive test indicates a probability for cancer, but the risk of false positives that lead to additional tests with their own risks, such as radiation exposure and infection from biopsies. Not to mention the additional cost.

The new study looked at 30 years of breast cancer data.

One breast imaging specialist interviewed by NPR said, "What my friends … want to know is, 'Should I have a screening mammogram?' And ... this kind of study sometimes raises more questions than it answers."

A breast surgeon who acknowledges that women might be hopelessly, frustratingly confused about regular screening says it depends on the individual’s medical profile. Women at lower risk might forgo frequent screening, and everyone—women and their doctors—should accept that not all diagnosed breast cancers should be treated to the max.

She used the example of ductal carcinoma in situ (DCIS), when the abnormal cells haven’t spread beyond the milk ducts. It’s often treated with surgery, hormones and radiation, when the patient might do just as well with watchful waiting.

The best way to disperse the fog surrounding the question of whether or not to have regular mammograms is knowledge and communication: Know your family’s medical history, know your own anatomy, know all the risks and rewards of screening and have frank discussions with your doctor. If he or she is unwilling to engage, it’s time to see someone else.

Health journalist/watchdog Gary Schwitzer is among our heroes, and here’s another reason why. In a recent post on his HealthNewsReview.org, he championed the efforts of British physician/writer Margaret McCartney, who introduced a new resource for patients seeking information about their care.

“Private health screening tests are oversold and under-explained,” she wrote in a British newspaper that Schwitzer quoted. “Health screening can cause more harm than it prevents, so companies have a duty to provide full information to customers.”

With that, she described PrivateHealthScreening.org, explaining that frustration and anger led her and a few doctor colleagues to establish the website to share information about screening tests and help people direct their thinking in making decisions whether or not to have them.

McCartney reported that one of this group of doctors, a neurologist, went to his local church for something called a Life Line Screening. He paid $230 for the test. In a story he published later in BMJ (British Medical Journal), he asked: “Why is this nonsense tolerated or allowed?” (See our recent post about commercial come-ons for medical screenings.)

Although the “ask first, test later” sentiment and its productive result were forged in Britain, U.S. consumers can benefit from the online service. As the site explains, “We are a group of doctors who are concerned about the safety and the ethics of private screening tests. We are worried that the companies who charge you for these tests are not giving consumers full and fair information about them.”

The site links to pages explaining their concerns, as well as to a page offering examples of misleading advertising, doctor and patient commentary and stories about screening offers and their results. Its Evidence Bank link provides a host of authoritative, scientific analyses of a wide range of specific screening tests for head and toe and everything in between.

The ongoing outbreak of spinal infections -- with so far five patients dead and 30 with serious meningitis infections in six states, including Maryland and Virginia -- shows the antiquated regulatory system for drugs that are compounded by a pharmacy.

All the injected steroid drugs that have sickened and killed patients came from a pharmacy in Massachusetts that was "compounding" the drugs: in other words, mixing different drugs together and essentially manufacturing a new drug. The drugs were contaminated with a common fungus known as aspergillus. When injected into patients' spines for chronic pain, the patients got a fungal infection of the meninges, the lining of the spinal cord and brain.

The Food and Drug Administration closely regulates the manufacture of drugs by regular manufacturers. But the pharmacies that essentially manufacture drugs are in a regulatory shadowland. They are allowed to engage in the ancient art of "compounding" on the theory that they are making customized products for individual patients. But some have enough volume, like the pharmacy in Massachusetts that sold its contaminated injection drug across the entire eastern U.S., that they really should be treated as any other manufacturer.

The New York Times has a good story explaining this regulatory gap that endangers patients who unknowingly receive these compounded drugs.

The gatekeepers are the pain management doctors and pain clinics that order these drugs. I have spoken with pain management specialists who tell me they would never dream of buying drugs from any except an established manufacturer. But big clinics and hospitals can sometimes save money by buying from the compounding pharmacies. And patients never know what they're getting.

It's a scary proposition that needs new oversight from drug safety agencies. In the meantime, if you're a chronic pain patient who gets these injections, ask your doctor what source he is using.

Check our website for an article on other ways that patients can get infections in hospitals and clinics, which has links to prevention techniques.

In what’s becoming a pattern of late, another cancer screening test has been deemed overused and unnecessary by the U.S. Preventive Services Task Force (USPSTF). The independent group of experts in prevention and evidence-based medicine has determined that tests for screening healthy women for ovarian cancer are more harmful than beneficial, and should not be routinely performed.

The screenings involve a blood test to detect the presence of substances linked to cancer and ultrasound scans that examine the ovaries. The USPSTF concluded that not only do they set off many false alarms (false-positives), they don’t lower the death rate from the disease.

If this sounds familiar to you, it’s probably because the same body has concluded the same thing recently about screenings for prostate and breast cancers. And several months ago, our blog “Medical Boards Advise Fewer Tests for Many Patients” discussed how the medical community enumerated 45 procedures whose routine use should be limited.

“There is no existing method of screening for ovarian cancer that is effective in reducing deaths,” Dr. Virginia A. Moyer, chairwoman of the expert USPSTF, told the New York Times last week. “In fact, a high percentage of women who undergo screening experience false-positive test results and consequently may be subjected to unnecessary harms, such as major surgery.”

The panel made clear that the advice to decline these screening applies only to healthy women with an average risk of ovarian cancer. For some people, such as those with suspicious symptoms, family history of the disease or who have certain genetic markers, the potential benefit to screening can outweigh the potential harm.

The panel’s research was published in the Annals of Internal Medicine, and, as The Times points out, its conclusions are based on medical evidence, not cost. And this isn’t the panel’s first such warning: It’s reaffirming its own advice from 2004.

“Although the task force has sometimes drawn fire in the past,” The Times noted, “particularly with its stand on mammograms, it has plenty of support in this case. Other medical groups, including the American Cancer Society and the American Congress of Obstetricians and Gynecologists, have for years been discouraging tests to screen for ovarian cancer.”

But some doctors still advise patients to have the screenings, and many patients ask for it in the hope test can detect the presence of disease early enough to save their lives. “We are fueled by hope,” Moyer told The Times. “It’s such a terrible disease. Almost everyone knows somebody’s who’s had it, and that means somebody who’s died of it. You get the feeling you should do anything possible to avoid that situation, but it’s easy to forget that what you do to avoid it can make matters worse.”

Ovarian cancer usually is fatal, and, from the time of diagnosis, quickly—by the time it’s diagnosed, usually it’s quite advanced. According to the American Cancer Society, more than 22,000 women will be diagnosed this year, and 15,500 will die.

The panel found a recent, large study particularly persuasive: As published last year in The Journal of the American Medical Association (JAMA) half of more than 78,000 women ages 55 to 74 were screened and half were not. Screening was ultrasound exams and blood tests for elevated levels of a factor called CA-125, which can be a sign of ovarian cancer.

The death rate from ovarian cancer, after 11 to 13 years, was the same for both groups.

Among the screened subjects, nearly 1 in 10 had false-positive results. More than 1,000 of those women had surgery, usually to remove one or both ovaries. After the surgeries it was clear that they had been unnecessary. And at least 15 in 100 of the surgical subjects experienced at least one serious complication, such as blood clots, infections or surgical injuries to other organs.

To find one case of ovarian cancer, 20 women had to undergo surgery.

Screening is not definitive—or, clearly, often even helpful; CA-125 can be elevated, as The Times explains, by conditions other than cancer, and ultrasound can reveal ovarian disorders that aren’t threatening but also indistinguishable from cancer unless surgery is performed to remove it.

Reader comments to The Times’ story, as might be expected, confirmed both the wisdom of the panel’s recommendation, and the personal experience of individuals who got screened and were grateful they did.

One commenter who identified himself as a cancer professor said, “Pretty much any adult has at least one, probably multiple cancerous tumors somewhere in their body. Scary but true. The large majority of them won't ever grow much, and something else will kill you long before it will. With bad luck one of yours will be aggressive and make itself known. Remember, most tumors have probably been growing in your body for many years,…”

“Now enter new, much more sensitive screening technologies, both imaging and biochemical. Guess what? We start removing all of those little tumors that will never kill you. Sure, some of them might kill you. But statistically you are more likely to get screwed up and die from surgery/chemo/radiation than you are the small chance that we detected the tumor earlier. It's all odds. Psychologically it may make you feel better to be doing something, but every shred of medical evidence argues that it is better to avoid a procedure unless that procedure is PROVEN to have a substantial benefit…”

“Just because you can find a tumor doesn't mean you should remove it. There are a lot of great new targeted drugs coming out, and we're starting to tailor them to the genotype of tumors. That's the ticket.”

If you’re in good health and don’t have any of the risk factors, the best advice doctors have for women concerned about ovarian cancer is to pay attention to first-warning symptoms. Contact your doctor if you have:

• persistent bloating;


• pelvic or abdominal pain;


• a feeling of fullness early when you eat; and/or


• the need to urinate frequently.

We’ve all seen, heard or read the pitch: “Get a bone density screening this weekend!” a typical radio promo might say. Such offers might be extended by churches, pharmacies, fitness clubs and shopping malls in conjunction with companies that provide the technology. Local hospitals, academic medical centers and physician groups are often advertising sponsors, lending them a sense of credibility.

Such direct consumer marketing of medical procedures offers convenience and lower cost than those prescribed by a clinician. But, as regular readers of this blog would know, just as there is no such thing as a free—or cheap—lunch, there is no such thing as a risk-free medical screening.

Some routine screenings are unquestionably good and relatively low tech. Checks for hypertension (blood pressure), dyslipidemia (abnormal cholesterol or blood fats), diabetes and tobacco use—combined with lifestyle modification and medications—can prevent more than half of all heart attacks and strokes, according to a recent article published in the Annals of Internal Medicine.

But, write Drs. Erik A. Wallace, John H. Schumann, and Steven E. Weinberger, “[T]he increasing availability of direct-to-consumer screening tests is undermining physician efforts to provide high-quality, cost-conscious screening services to patients through shared decision making.”

They’re particularly concerned about the misapplication of technology—using hi-tech equipment such as ultrasonography to assess carotid arteries for blockage, for example. Physicians and medical facilities like these tools (and often feel the need to use them liberally to justify their cost), and many patients believe they’re getting a higher level of care with fancy tools. But, as the writers point out, their widespread use contributes to substantial increases in health-care costs.

And, the writers warn, “When screenings are provided in a church and sponsored by a trusted medical organization, consumers may have a false sense of trust in the quality and appropriateness of services provided. Consumers are generally unaware of the potential harms of screening.”

They note that when the screening tests are purchased and performed, the tech companies tell consumers to share any “abnormal” result with their personal doctors. As we’ve discussed, and the journal writers reinforce, most of these tests are not medically indicated in the first place; their questionable use is not disclosed to consumers; and there is no discussion about the possibility of consequences or additional costs.

The harms of unnecessary screening, as we regularly remind, include:

• unnecessary worry and emotional upheaval;


• false positives (the indication of a problem when there isn’t one) that often lead to invasive, uncomfortable, additional testing that can bring complications such as infection, impaired function, loss of work time … and expense.

Advocates of the generous use of screening technology like to promote the idea that someone who knows he has a disease or shows a predisposition to disease is more likely to make lifestyle changes that benefit his health.

That’s fiction. “[E]vidence does not support this hypothesis,” say the journal authors.

They cite the example that although patients who smoke and are interested in quitting have a high incidence of atherosclerosis (narrowing of the carotid artery), people whose carotid ultrasonography results are abnormal are no more likely to quit smoking than those with normal results or those who did not have the test. And the U.S. Preventive Services Task Force recommends against screening the general adult population for atherosclerosis, thanks to a fair certainty that there is no net benefit.

Commercial medical screening is just a Pollyanna way of getting consumers to sample something merchants would like to sell them in perpetuity. From their standpoint, it’s best not to muddy the “information is powerful” message with reality.

That reality, the journal writers say, is that claims such as, “the ultrasound screenings we offer can help save your life” are coercive, unsubstantiated, misleading statements that escape the regulatory control imposed when pharmaceutical companies try to sell drugs directly to consumers. Those companies are required to disclose the potential risks of taking a medication, which is why the possible side effects listed ad nauseum in their TV commercials often take more time than the drug pitch.

When the mobile ultrasonography screening van stops at your local library in the hope of testing the health of your carotid arteries, the journal authors believe, it, too, should “be obligated to disclose from published guidelines the recommended indications and benefits of testing, as well as the potential risks and harms.”

It’s a question not only of patient safety, but ethics. The writers say that:

• Companies offering such screening tests should fully inform customers of the potential risks of positive or negative screening test results before the test is performed.


• Medical organizations, hospitals and physicians should refrain from sponsoring health screenings with commercial companies that offer unproven or harmful testing because it represents a conflict of interest.

You cannot make an informed choice about your medical care if you don’t have all the information. And, despite their claims that screening gives you information you need, direct-to-consumer screening operations give you only half the story.

Few health problems are as frustrating as back pain. Americans spend an estimated $73 billion every year seeking relief from their aching backs, and any disorder as common and intractable as that is ripe for abuse.

We’ve written about the less-is-more approach to back surgery, a notion recently reinforced by a study published in the Archives of Internal Medicine.

As part of an initiative of the National Physicians Alliance, a project called “Promoting Good Stewardship in Clinical Practice” compiled the top 5 activities in primary care for which changes in clinical practice could lead to higher-quality care and better use of resources. Included in those five recommendations was “Don't do imaging for low back pain within the first six weeks unless red flags are present.”

According to the American Academy of Family Physicians, those flags include a history of trauma, fever, incontinence, unexplained weight loss, cancer, long-term steroid use, and intense localized pain. And even then, the first treatment usually consists of nonsteroidal anti-inflammatory agents or acetaminophen and a gradual return to usual activities.

The stewardship project reviewed medical literature, guidelines and commentaries about the benefits and risks of routine imaging, such as MRI and CT scan, in low back pain. It also assessed the cost of spine imaging using data from the National Ambulatory Medical Care Survey. One high-quality review focused on outcomes in patients with low back pain and found no significant difference in pain or function between patients who got immediate lumbar spine imaging versus less aggressive care.

Plus, the data documented certain harms from such early imaging, including patient “labeling.” Anyone can have an anatomical abnormality that shows up on a screening test but that, in fact, has nothing to do with the reason the person went to the doctor in the first place. That’s labeling, and it prejudices future diagnoses and care, prompting unneeded follow-up tests for minor findings, exposure to radiation, unnecessary surgery and significant cost.

“Routine imaging should not be pursued in acute low back pain,” was the project’s categoric conclusion. “Not imaging patients with acute low back pain will reduce harms and costs, without affecting clinical outcomes.”

Writing in the September newsletter of his Patient Safety America movement, John James, a Ph.D. scientist, applauds this conclusion. He advises anyone who shares his back-pain experience to question any medical provider who advises an imaging test as a first-response to diagnosing and alleviating pain. It’s difficult to do nothing, but sometimes that’s the best medicine. And the best use of health-care resources.

One-third of Medicare patients with low back pain receive diagnostic imaging within a month of the initial complaint, James reports. The use of MRI imaging for low back pain in Medicare patients increased more than 300 percent in the decade from 1994 to 2005. That doesn’t signify too many people lifting boxes improperly as much as it does inflated treatment for a common malady.

James notes that, according to the stewardship project, if no scanning were done because medical recommendations were being followed, $140 million would be saved. And if unnecessary MRI and CT scanning were eliminated, the additional savings would be $160 million. And that doesn’t even include the additional costs associated with unnecessary surgery.

“As a patient,” James writes, “you have a critical role in helping physicians with good stewardship. If a physician suggests that you wait for your acute back pain to resolve before he makes images of your back, then go along with that recommendation. In the process, you might be avoiding some potentially harmful treatments.”

And be careful, he adds, about the potential for overusing pain medication.

To learn more about the risks of back and spine surgery, read our backgrounder.

Hospital patients yearn most of all to shed the label of patient and go home. But the day of discharge carries some special dangers for last-minute testing, according to a new study. The takeaway lesson: Don't let the joy of new freedom cloud your watchfulness as you're on the way home.

The study published in the Archives of Internal Medicine showed that tests ordered on the last day of a hospital stay account for nearly half of all test results that are not reviewed. They also represent a larger proportion of abnormal test results.

We've written previously about the need to manage a complete transition from hospital to home. (See our post, “Safely Handling the Transition from Hospital to Home.”)

Because patients are deemed ready to go home, most tests ordered on the day of discharge are unlikely to change care and many aren’t even necessary. But, the researchers wrote, “if an important test result is required to guide care at discharge, providers need to figure out a process to ensure follow-up.”

Timing is key: Tests requested early in a hospital stay are more likely to be reviewed than those requested later. “Tests ordered on the day of discharge have a very limited chance of being reviewed,” researchers concluded.

More than 20 in 100 tests ordered on the day of discharge were not followed up, compared with not quite 2 in 100 tests ordered on other days. In addition, day-of-discharge tests were more likely to show abnormal results--nearly 15 in 100 of all unreviewed tests at discharge were abnormal, but of those given on the day of discharge, 65 in 100 were abnormal.

As the researchers noted, 1 in 5 patients experiences an adverse event during the transition from hospital to home, and 6 in 10 of those are preventable. No matter when they were given during a hospital stay, failure to follow up tests once a patient has gone home contributes to the risk of an adverse event. The risk is greater if they’re given on the day of discharge because results aren’t always available the same day a test is given, and if they are, there’s a smaller window for review.

There’s a cynical result here, too. “It appears that at least some late admission tests represent an opportunity to optimize test ordering,” the researchers wrote. “Tests ordered as a result of poor discharge planning may well be unnecessary….”

Their solution to the oversight and possible bill-padding practice is to implement discharge protocols that trigger computer alerts when discharge-day tests are ordered electronically to advise clinicians either that it is unlikely that results will be posted before discharge or that the tests have a high risk of being missed.

Our solution is for hospital patients and their advocates to make sure they know:

• when their doctors plan to discharge them;


• what tests are planned and when;


• when all tests conducted in the hospital can be reviewed; and


• when they have been reviewed.

Breast cancer is insidious. It’s not necessary to manipulate the truth to convince people that the disease should be eradicated.

Why, then, did its most prominent adversaries feel the need to mislead and deceive in order to promote breast cancer awareness and screening?

According to a story published in the British Medical Journal, (BMJ) Susan G. Komen for the Cure, the world’s largest breast cancer charity, misstated survival differences between women who receive mammograms and those who don’t. In advertising for Breast Cancer Awareness Month in 2011, Komen claimed that almost every breast cancer patient survives five years if her disease is caught early through mammography screening, but that only slightly more than 1 in 5 survive that long if it wasn’t.

But as we have written repeatedly, and as the BMJ researchers said, for most women, promoting routine mammograms ignores "a growing and increasingly accepted body of evidence [showing] that although screening may reduce a woman's chance of dying from breast cancer by a small amount, it also causes major harms."

"This benefit of mammography looks so big that it is hard to imagine why anyone would forgo screening. She'd have to be crazy," wrote Drs. Steven Woloshin and Lisa M. Schwartz of the Dartmouth Institute for Health Policy and Clinical Practice. "But it's the advertisement that is crazy."

Woloshin and Schwartz regularly write about exaggerations, distortions and selective reporting, and their broadside against Komen’s tactics was just the latest example of fake statistics used to persuade people to undergo what might well be unnecessary tests.

This year in the U.S. there are 175 officially designated “national health observances,” including rabies day, sleep awareness week and numerous observances for heart disease. Disease awareness is big, and no organization has done more to promote breast cancer awareness than Susan G. Komen for the Cure. It’s the outfit that created the pink ribbon signifier. Last year, we wrote about one of its more curious (some would call it hypocritical) promotions—a pink rifle.

Komen’s efforts “to save lives, empower people, ensure quality care for all and energize science to find the cures,” the writers say, are laudable. But it’s best known for promoting mammography screening. How can such a powerful voice continue to spread misinformation when an increasingly accepted body of evidence shows that although screening may reduce a woman’s chance of dying from breast cancer by a small amount, it also causes major harms?

Woloshin and Schwartz note that the timing of breast cancer diagnosis has little influence on long-term survival; evidence shows that mammography reduces a 50-year-old woman's risk of dying of breast cancer in 10 years from just over half of 1 percent to just under half of 1 percent.

"Five-year survival is all about what happens from the time of diagnosis," Woloshin and Schwartz write. "It is the proportion of women who are alive five years after diagnosis. Because screening finds cancers earlier, comparing survival between screened and unscreened women is hopelessly biased."

This isn’t new; what’s newsworthy is that the organization to whom many people turn for enlightenment and advice about breast cancer is selling, if not snake oil, something just as oily. Komen, the authors say, should be enlightening people not only about the potential benefits of mammography, but the possible risks.

As many as 20 to 50 in 100 women screened annually for a decade will experience at least one "false alarm" that leads to a biopsy. For every life saved by mammography, the procedure overdiagnoses 2 to 10 women. Many of them will undergo unnecessary interventions and treatment.

"Women need much more than marketing slogans about screening," Woloshin and Schwartz wrote. "They need -- and deserve -- the facts. The Komen advertisement campaign failed to provide the facts.

"Worse, it undermined decision making by misusing statistics to generate false hope about the benefit of mammography screening. That kind of behavior is not very charitable."

It’s about as charitable as a life-promoting organization making money by selling death-inducing rifles.

Lyme disease, a bacterial illness transmitted by the bite of a deer tick, is a major health concern in the Northeast and Mid-Atlantic regions. Health agencies are keen to prevent it, but some people believe that a government program to do so might be worse than the illness. The story is another example of how seemingly good ideas in medicine don't always pan out.

As reported last month in the Baltimore Sun, hundreds of Baltimore-area families who volunteered for a government study to spray their suburban yards with pesticide might be at risk. The chemical in the spray, bifenthrin, is classified by the Environmental Protection Agency (EPA) as a possible carcinogen.

Critics of the program note that the EPA is studying bifenthrin for possible harm to reproductive and immune systems. They say that prospective volunteers weren't well enough informed about the potential long-term health risks from being exposed to the pesticide.

Lyme disease can cause fever, headaches, fatigue and, if untreated, can affect the joints, nerves and heart. It’s nasty business. But, say critics of the three-state study underwritten by the Centers for Disease Control and Prevention (CDC), so is exposure to a dangerous pesticide.

Half of the families who signed up for the study have the edges of their yards sprayed with the pesticide commonly applied around homes to fight ticks, fleas and mosquitoes. The others’ yards are sprayed with water. The residents don’t know if they’re recipients of chemicals or mere H2O.

Dr. Clifford S. Mitchell of the state Department of Health and Mental Hygiene explained the study. "The question is, does it actually prevent a common, sometimes severe disease — and second, what's the lowest dose you can do?"

Jay Feldman of Beyond Pesticides, a nonprofit that works toward eradicating toxic pesticides, says that federal and state health officials have not adequately informed volunteers about all the potential health risks. "It's improper to be conducting a human experiment like this."

The Sun reports that an EPA analysis of bifenthrin cites nearly 1,300 incidents involving the pesticide from 2002 to 2009. Most were of "low severity," but even low amounts of the chemical can cause skin and respiratory irritation and dizziness.

The agency classifies it as a possible carcinogen based on rat exposure studies. It also has listed bifenthrin among a group of pesticides to be tested for their potential to act as "endocrine disruptors," which may affect humans or wildlife, even at low doses.

According to the CDC, 30,000 cases of Lyme disease were reported in 2010, most in the regions of study. Health officials believe that doctors often miss or don't report cases, so the actual number could be significantly higher.

Study volunteers were recruited via fliers mailed to residents in ZIP codes with a high incidence of Lyme disease. They sought people who were willing to have a "single, no-cost, commonly used pesticide application" to their yard and answer "short surveys" about ticks and their yards.

Health officials advised study participants not to walk in the sprayed area for 24 hours and to keep pets away. The chemical is highly toxic to aquatic life, so no yards within 100 feet of water are being tested. They say the study and the volunteer information was approved by state and federal review boards whose function is to safeguard people participating in research.

So, does bifenthrin work?

Preliminary results for all three states from the first year of the study indicate that the yards treated with pesticide had 62 percent fewer ticks overall than the yards sprayed only with water.

But residents of the treated households found just as many ticks on their bodies as the residents of untreated properties. And—here’s the money stat—essentially the same number of Lyme disease cases were reported in both groups.

Health officials say that if a second year’s analysis yields no difference in tick bites or infection between the two groups, they'll advise the public that spraying yards with pesticide doesn't help prevent Lyme disease.

But critics say such an outcome — discouraging more pesticide use — would not justify the risks the human subjects assumed. Said one, “We have no idea if we've caused more harm than good.”

According to the National Institutes of Health, (NIH) symptoms of Lyme disease begin days or weeks after infection.

They are similar to the flu and may include:

• body-wide itching;


• chills;


• fever;


• headache;


• light-headedness or fainting;


• muscle pain;


• stiff neck;


• a "bull's-eye" rash, a flat or slightly raised red spot at the site of the tick bite. Often there is a clear area in the center. It can be quite large and expanding in size.

To prevent Lyme disease, the NIH recommends taking precautions to avoid direct contact with ticks. Be extra careful during warmer months. Also:

• Avoid wooded or bushy areas, or areas with high grasses and leaf litter.


• Walk in the center of trails.


• Check yourself and your pets frequently during and after your walk or hike.


• When walking or hiking in wooded or grassy areas, spray all exposed skin and your clothing with insect repellant.


• Treat clothing, such as boots, pants, and socks, with a product containing permethrin, which remains protective for several washings.

Among the main reasons a pregnant woman undergoes prenatal testing is to determine if the baby has genetic abnormalities. These invasive procedures—amniocentesis and chorionic villus sampling (CVS)--involve testing the placental tissue, and they carry a slight (for most people) risk of inducing a miscarriage.

But as widely reported last week, including in a story by the New York Times, for the first time, researchers have mapped the entire genetic profile of a fetus using only a blood sample from the mother and a saliva sample from the father. This could mean that in the not-too-distant future, most prospective parents can know the DNA blueprint of a child long before it is born, and without the risks of an invasive, risky test.

It would enable countless genetic disorders to be detected and possibly treated in the womb.

The new technique, however, also has the potential to present serious ethical questions, possibly increasing abortions for reasons other than medical, such as personal parental preferences for certain traits.

The paper was published in the journal Science Translational Medicine.

The researchers deduced the DNA sequence of the fetus with about 98 percent accuracy, but the technology is not practical, affordable or accurate enough for widespread use currently. The researchers estimated that it would cost as much as $50,000 to map one fetal DNA today.

But as The Times noted, “The cost of DNA sequencing is falling at a blistering pace, and accuracy is improving as well. The researchers estimated that the procedure could be widely available in three to five years. Others said it would take somewhat longer. “

Parents concerned about passing on a genetic disease sometimes use in vitro fertilization and test the embryo before implanting into the womb. The new technique doesn’t require complete fetal cells, making DNA testing easier and less risky.

The genome was determined 18.5 weeks into the pregnancy; researchers said it might be possible to get accurate results in the first trimester, which is as early or even earlier than some invasive procedures.

It’s possible now to determine a fetus’ gender, paternity and whether it has Down syndrome via analysis of the mother’s blood. But determining the whole genome is more difficult. That enables detection of disorders including cystic fibrosis, Tay-Sachs disease and Marfan syndrome, which are caused by mutations in a single gene.

According to The Times, more than 3,000 such diseases occur collectively in about 1 in 100 births. They can be inherited or occur spontaneously in the fetus.

As described in The Times story by Marcy Darnovsky of the Center for Genetics and Society, a public interest group, the ethical concerns are about “who deserves to be born.”

Parents might opt for abortion if the fetus has a genetic disease, but also if it lacked a favored trait. “Moreover,” the paper said, “a full fetal genome sequence would turn up numerous mutations for which information is lacking as to whether they cause disease, posing a dilemma for expectant parents and their doctors.”

False positives are also a concern.

To learn more about healthy pregnancy and potential problems, read our article on prenatal care.

Health care experts have been saying for 30 years -- ever since a Canadian comprehensive study -- that the annual physical exam is useless and even counter-productive, turning up false alarms that subject patients to unnecessary and even dangerous further testing. Now an article by a physician journalist in the New York Times sums up the evidence and concludes that the annual physical needs to go.

Elisabeth Rosenthal's piece also has a good list of the top 10 tests, starting with the annual physical, that are wasteful and more harmful than good. Here's the list.

In October, we reported that the U.S. Preventive Services Task Force was recommending that routine screening for prostate cancer be suspended for most men. Last week, after six months of reviewing nearly 3,000 public comments, the task force confirmed its initial finding.

The discussion of prostate screening for cancer, as well as that of routine mammography, have helped raised consciousness that overtesting and overtreatment compromise the quality of health care.

The task force’s study was published in the Annals of Internal Medicine.

The PSA test, in which blood is tested for the presence of elevated levels of an enzyme that helps liquefy semen, exposes men to far more harm than it helps. Although elevated levels can indicate the presence of a cancer, research studies have shown that, at best, one life is saved for every 1,000 people screened over a 10-year period. But more than 100 of those 1,000 men will produce suspicious results when there is either no cancer or a cancer that is growing so slowly (or not at all) as to produce no threat. Forty of those 1,000 patients will become impotent or suffer urinary incontinence.

For most men, a positive test means having a biopsy, which carries its own risks such as pain, fever, bleeding, infection and hospitalization. If cancer is detected, 9 in 10 men will be treated surgically or by radiation even when the tumors are not life-threatening. The possible side effects are impotence, urinary incontinence, blood clots and other harms that the panel concluded are overwhelmingly persuasive in removing the PSA test from routine care.

Men concerned about prostate health and age-related problems such as reduced or intermittent urinary flow, should discuss them with their doctor for diagnosis and treatment other than PSA testing. The scientific evidence is overwhelming that it causes more harm than good -- for most men, and that means it's still worth a discussion to find out if you're in the group that may need closer watching.

The list of medical procedures no one welcomes is long and varied, but pretty much everyone would opt never to have a colonoscopy if it weren’t necessary.

It’s not so much the procedure that’s a problem, it’s the preparation—a diet restricted to clear liquids for 24 hours, and the ingestion of a nasty bowel-clearing drink no one will ever confuse with refreshment.

We recently wrote about the mixed messages that surround colon cancer scans, but they’re advisable for many people. Thanks to recent research, things could be looking up for the colonoscopy crowd.

As reported on MedPage Today, virtual colonoscopy, in which the lower intestine and colon are scanned externally by CT technology instead of viewed with an invasive probe, correctly identified 9 in 10 patients with larger adenomas—masses, or polyps, that aren’t cancerous but carry that potential. Standard optical colonscopy generally detects 9½ out of 10 such polyps.

Smaller masses, however, might not be be detected as successfully with virtual colonoscopy.

The study results were published in the Annals of Internal Medicine.

The less invasive procedure eliminates the need for the laxative that precedes traditional colonoscopy, but patients still ingest a solution; it contrasts stool on the image as different from other bowel contents. The interpretive software digitally erases the stool from anything a radiologist needs to see.

Although virtual technology does not appear to depict polyps smaller than 10 mm as reliably as larger masses, the vast majority of polyps that lead to cancer and affect survival outcomes are larger than 10 mm. For people who can’t—or won’t—tolerate the laxative bowel preparation, the CT scan might be the only way they get screened.

The study involved multiple facilities and 605 adults 50 to 85 years old who were at average to moderate risk for colon cancer. All were screened by both methods. Only four of the 26 lesions detected were smaller than 10 mm. All of the confirmed cancers were larger than 10 mm.

More than 6 in 10 study subjects said they’d opt for the virtual procedure over standard colonoscopy in the future. About 5 in 100 received additional diagnostic tests because something other than suspicious polyps were detected.

In addition to the loathsome preparation, traditional colonoscopy has inherent risks, primarily perforation of the bowel. Some people also might react to the sedative.

If you’re scheduled for a colonoscopy, discuss the pros and cons of each type of screening, including sigmoidoscopy, which is invasive, but requires less preparation than colonoscopy and usually no sedation. But it views only the lower part of the colon instead of the whole thing. So a lot of specialists liken it to undergoing mammography of just one breast.

Despite the news on virtual colonoscopy, for most people, conventional colonoscopy remains what doctors call the "gold standard."

A couple of weeks ago, a study published in Health Affairs reinvigorated the conversation about the usefulness of screenings for lung cancer. We have been among the voices questioning the widespread use of certain screenings because, in many cases, they are inappropriate, unnecessarily expensive and possibly harmful.

Now, another voice of reasoned consideration and moderation has reinforced the growing belief that for too long many diagnostic tests have been conducted not because they signify the best in medical care, but almost by habit bolstered by studies that seem significant but, on closer inspection, don't measure up.

Writing on HealthNewsReview.org, Harold DeMonaco, director of the Innovation Support Center at the Massachusetts General Hospital, said that the study authors provided some interesting numbers to back up their conclusion that insurers should screen high-risk individuals (long-term smokers who are at least 50) with low-dose spiral CT scans. That technology creates multiple images of the entire chest via X-rays, whereas a standard chest X-ray is a single snapshot of the entire chest.

“Of the 18 million or so smokers who fall into their eligibility criteria,” DeMonaco wrote, “they showed a potential for … 130,000 additional survivors of lung cancer due to early detection. It’s hard to argue that saving this many lives is not important. But the study does not look into the negative aspects of the double-edged sword that is lung cancer screening. While we are constantly berated for being anti-screening, it is important for people to understand what the risks and benefits are for any medical procedure including screenings.”

He referred to a large study funded by the National Cancer Institute (NCI) to determine whether screening with low-dose CT, as compared with chest radiography, would reduce mortality from lung cancer among high-risk smokers. We reported on that as well.

The NCI study, DeMonaco said, was sufficiently similar to the one reported by Health Affairs for its data to be relevant now. About 1 in 4 people who got spiral CT scans tested positive. If extrapolated per the current study, the numbers add up to 4.32 million positive findings. But more than 9 in 10 of those proved to be false positives. (See our post about the perils of false positives and false diagnoses.)

In revisiting this unwelcome scenario in this application, DeMonaco explained “that 4,086,720 people screened would have a false positive result. All would likely suffer from some degree of angst. Of those with false positive findings, 0.06 percent had a major complication possibly related to subsequent invasive procedures in the NCI sponsored study.”

So 108,000 people would experience a serious adverse event resulting from a procedure they had because the original scan showed falsely positive. Said DeMonaco: “Those events need to be considered when thinking about the 130,000 potential lives saved through screening. Few medical procedures are without risk and each should be viewed as a double-edged sword. Benefits as well as risks need to be considered. Reporting on just the benefits provides readers with only half the story.”

If your doctor prescribes a screening test, ask:

• What are the possible benefits?


• What are the possible harms?


• How often do harms occur?


• Are there alternative tests?

Maybe the national conversation about the rationing of health care finally is moving to a more thoughtful plane. Maybe, instead of incendiary language, half-truths and mistruths, Americans, with the help of the medical establishment, are beginning the think rationally about rationing.

As widely reported last week, a panel of physician groups representing the American Board of Internal Medicine Foundation officially recommends that doctors cut back on the routine use of 45 common medical tests and procedures, deeming them often unnecessary and thus more prone to cause harm than good.

As regular readers know, we’ve walked this path many times.

Rationing is neither a new idea nor, necessarily, a bad one. It all depends on context. Doctors and patients who communicate well ration care all the time. One example is “watchful waiting” in the case of a 70-year-old man with prostate cancer, for whom the practice of holding off on treatment in favor of monitoring the status of the disease makes sense unless and until the cancer grows to the point where it would be dangerous to let it continue. Often, these patients live a long life and die of something else, and treating the cancer would cause side effects much worse than living with the disease.

A patient with a sinus infection who wants her doctor to prescribe an antibiotic might be denied because sinus infections often are caused by viruses, which, unlike bacteria, don’t respond to antibiotics, and because even a bacterial sinus infection usually resolves on its own. So the “rationing” of prescription medicine is wholly appropriate in this case.

As medical costs spiral out of control, as insurance premiums match that ascent, rationing makes sense when such care won’t improve someone’s condition, or only incrementally, and with the potential for negative side effects.

As the New York Times explained, the panel, composed of nine medical specialty boards, recommended that doctors perform 45 common tests and procedures less often. It also said patients should question such services if they are offered. Eight other specialty boards, the paper said, are preparing additional procedures their members should perform far less often.

“The recommendations represent an unusually frank acknowledgment by physicians that many profitable tests and procedures are performed unnecessarily and may harm patients,” said The Times. “By some estimates, unnecessary treatment constitutes one-third of medical spending in the United States.”

Removing the discussion of overused and overpriced tests and treatments from the realm of politics and/or commercial interests (insurance and pharmaceutical companies) and staging it instead on a platform of science confers a welcome sense of authority. Of course, The Times adds, it also reflects the fact that insurers and other entities that pay these costs want to shift more of them to providers, including hospitals and physicians. So, sometimes, it’s in their best interest to rethink a treatment.

To promote critical thinking about what’s necessary and what’s habit, the nine medical boards have created Choosing Wisely in partnership with Consumer Reports. The educational initiative speaks to both medical professionals and patients.

According to the panel, among the overused tests that should be called into question are such procedures as EKGs performed during an annual physical examination when the patient has no symptoms of heart problems, and MRIs or X-rays whenever someone complains of back pain. For the complete list of the initial 45 tests and treatments, link here.

Of course, this isn’t the first time elements of the medical community have suggested reining in the desire to test, test, test. In November 2009, new mammography guidelines issued by the U.S. Preventive Services Task Force advised women to be screened less frequently for breast cancer, and the ongoing debate about the wisdom of regular and invasive prostate cancer tests (see our post here) have caused concern about government interference in personal health-care decisions and the rationing of treatment.

As The Times noted, “Some of the tests being discouraged — like CT scans for someone who fainted but has no other neurological problems — are largely motivated by concerns over malpractice lawsuits…. Clear, evidence-based guidelines like [these] will go far both to reassure physicians and to shield them from litigation.”

We’ve broached the topic of “defensive” medicine as well, concluding that malpractice lawsuits in the wake of a medical error are much less likely if the practitioner takes responsibility, apologizes and assists in rectifying a bad situation.

The solution to too many patients receiving too many tests and costly treatments isn’t about government control, restricting care from people who need it or protecting practitioners against lawsuits. It’s about the thoughtful use of medical resources and putting individual patients’ conditions into context to make informed instead of reflexive decisions. Call it rationing if you want; we call it wisdom.

Here’s another arrow in the quiver of patients well-armed against deficiencies in (well-meaning but often wrong) preventive medical care.

A survey published in the Annals of Internal Medicine concluded that primary care doctors can be as confused as the rest of us when they ponder information about screening tests.

“Most primary care physicians mistakenly interpreted improved survival and increased detection with screening as evidence that screening saves lives,” the authors wrote. “Few correctly recognized that only reduced mortality in a randomized trial constitutes evidence of the benefit of screening.”

An accompanying editorial in the same publication claimed that what physicians don’t know can harm their patients, and that screening for things such as breast and prostate cancer are widely overused.

Not that we love saying, “We told you so,” but we told you so.

As reported on MedPage Today, in a hypothetical scenario, about 3 in 4 physicians incorrectly said that increased five-year survival and early detection of cancer proves that a screening test saves lives. About 8 in 10 correctly said that a reduction in mortality in a randomized trial proves the efficacy of a screening test.

According to the study authors, "Misunderstanding of statistics ... matters, because it may influence how physicians discuss screening with their patients or how they teach trainees."

The researchers explained how measuring survival rates can be subject to bias. In a group of individuals who will die at 70, the five-year survival rate for those diagnosed with cancer because of symptoms they had at 67 will be 0 percent. But the five-year survival rate for those diagnosed through screening at 60 will be 100 percent.

"Yet, despite this dramatic improvement in survival ... nothing has changed about how many people die or when," they said.

This is such a common error in medicine that it has a name: Lead time bias. Take two imaginary people, who are both destined by fate to die on the same day from the same type of cancer. One learns of his disease three years earlier than the other, thanks to a screening test. But the test only added three years of worry to his life. It did not extend his life span a single day. That is why medical researchers always look to see if a screening test results in lower mortality (death) rates from the disease being screened for. Increase in survival means nothing without that, since it can all be lead time bias.

Screening for cancer that ultimately does not progress (as is often the case with, say, prostate cancer) also can boost survival rates but not affect mortality.

But in a randomized trial, which is the basis for solid science, mortality rates aren’t affected by these biases. So that’s the only measure that can prove that a screening test saves lives.

If even doctors, who are trained in the science if not always the art of medicine, have trouble weighting the evidence when deciding whether or not to order a cancer screening, what’s a patient to do?

Ask questions:

• Why are you recommending this test?


• What are its risks?


• What other ways are there to find out more about my problem?


• What do you think will or could happen if I don’t have this test?

First published on Technorati.

Merck can’t say it wasn’t warned.

In what the FDA Law Blog calls the first of its kind, the FDA last month sent the pharmaceutical manufacturer notification that it violated its promise to conduct postmarket research (PMR) on its diabetes drugs Januvia and Janumet.

The letter represents new authority Congress granted the FDA to compel the pharmaceutical industry to conduct followup studies to assure a drug’s long-term safety after problems have been reported. Violations of this obligation can result in charges of misbranding, and in fines of $250,000 and potentially more if they continue.

This is crucial to patient safety, because what many patients don't realize, but is openly acknowledged in the drug and device industry, is that the first few years a new product is on the market is a crucial test of how safe the new drug or device really is. And keeping track of bad events is really important, but scarcely done well in the United States, at least up to now.

The Merck drugs were approved in 2006 and 2007 respectively. The FDA’s Adverse Event Reporting System (AERS), an information database and postmarketing safety surveillance program for all approved drug and therapeutic biologic products, received reports of pancreatitis associated with the use of the drugs.

In 2009, the FDA recommended that doctors monitor patients for signs of pancreatitis (inflammation of the pancreas) after initiating treatment with Januvia or Janumet, or after increasing their dosage. The feds had found that 58 of 88 cases of pancreatitis in the drugs’ users required hospitalization, four in intensive care. And last year a study in the journal Gastroenterology found that Januvia might increase the risk of pancreatic cancer as well.

In light of the adverse events reported, Merck agreed to conduct PMRs via a three-month pancreatic safety study with rats. The final report was due last June.

But Merck’s study results were rejected because the FDA had not approved its design. The agency implied that the studies hadn’t reached sufficient levels of exposure to properly evaluate the safety concern.

The Warning Letter orders Merck to submit a plan for the study within 30 days of its issue. The trial must begin within six months of the agency’s approval of the plan.

The FDA was hardly demure in its Merck smack down: “You have not provided an adequate explanation for the cause of the delay of either of the milestones in the timetable for completion of the postmarketing requirement, nor did you propose to revise the agreed-upon timeline,” read a passage in the Warning Letter. “[Y]ou are more than 20 months late in achieving the June 15, 2010 final protocol submission milestone and more than 8 months late in achieving the final protocol submission milestone in the timetable, and you have not demonstrated good cause for these delays.”

The agency concluded that Merck’s drugs were misbranded, and threatened it with financial penalties and the wrath of “other federal agencies” that might consider Merck’s recalcitrance “when considering the award of contracts.”

When Big Pharma acts only in its own interests, ignoring that of the patients who consume its drugs, it appears the feds are more willing to treat it as the dangerous scofflaw it is. As the Law Blog reported, only days after the Warning Letter was issued last month, the FDA issued a Notice to Industry that read, “Once FDA notifies a drug sponsor of the need for a postmarketing study or clinical trial, the company is required to provide a timetable for completion, including study milestones, and periodic status reports on progress toward completion of the PMRs. If a company fails to comply with the timetable, FDA is authorized to take enforcement action against the company, unless the company can demonstrate good cause for the failures.”

Impressive expression of force. But given Congress’ generally weak-kneed submission to the medical industrial complex’s financial power, is there bite behind this bark? Merck hopes not. We hope so.

A recent series of articles published in the New England Journal of Medicine (NEJM) presented a less than clear picture of colon cancer screening. Gary Schwitzer, writing on HealthNewsReview.org took on the muddled message offered by the science journal, and the popular media’s woeful effort to offer context and meaningful advice to consumers. We’ve tackled the topic before as well.

Here's the latest advice from our Better Health Care newsletter on how to sort out your colon cancer screening options.

As Schwitzer notes, one NEJM study championed the benefits of colonoscopy screening, one trumpeted the potential benefits of a blood stool testing procedure called Fecal Immunochemical Testing (FIT) and an editorial pondered both.

Readers interested in seeing how medical journalism grapples with material that requires some depth might enjoy HealthNewsReview’s explanation of who went right, who went wrong and who is wandering around in the middle. But if you’re looking for the best, most concise information to enable you to take care of yourself, Schwitzer, a widely respected health news analyst, points to the Reuters coverage. We agree.

Its take-away message, gleaned from the NEJM editorial and explained with additional interviews, was that the best colon-health practice appeared to be colonoscopy screening for everyone who’s 60. The results would tell you if you're high risk or low risk. High risk people get regular colon follow-ups; everybody else stops worrying.

Here’s how a competent report helps readers objectively judge the information: Reuters was the only news organization that quoted the FIT researchers about their study as much as it allowed the colonoscopy researchers to tout their work. According to the FIT researchers, “the numbers of subjects who needed to be screened to find one colorectal cancer were 191 in the colonoscopy group and 281 in the FIT group, and the numbers who needed to be screened to find any advanced (cancer) were 10 and 36.”

This simple numerical analysis reflects a larger discussion we had in a recent edition of our patient safety newsletter about a concept called “numbers needed to treat”.

As Reuters notes, such objective qualities are important because the FIT test is much less expensive than a colonoscopy. “This simple, noninvasive and cheap test is equally good at detecting colorectal cancer and identifying the high-risk individual that should undergo a colonoscopy.”

Reuters also explained that the complication rate—bleeding, low blood pressure and slow heartbeat—was nearly five times higher in the colonoscopy group.

And just as important is the percentage of patients who follow the advice to get one or the other screening techniques. In both screening tests, the follow-through rate is low -- understandably, because the tests are bothersome and unpleasant at a minimum. But the FIT test was more popular than colonoscopy -- one in three patients went ahead and got the FIT test while only one in four got a colonoscopy.

Schwitzer’s report included further analysis from Harold DeMonaco, director of the Innovation Support Center at Massachusetts General Hospital. Of particular note for people considering colonoscopy or other colon diagnostic measures, he said:

• Early detection and removal of adenomatous polyps (benign tissue with the potential to become malignant) appears to reduce the risk of colon cancer. A considerable minority of adults will have adenomatous polyps on colonoscopy, including as many as 1 in 4 males.


• Colon cancer grows slowly. Good followup for people who have had an adenomatous polyp removed appears to reduce the risk of dying from colon cancer over several decades of observation.


• FIT appears to be as useful as a screening tool for colon cancer, but it’s not as good in detecting existing adenomatous polyps.


• FIT is easier, much less expensive and does not have the rare but important potential complications associated with colonoscopy.


• The right combination of colonoscopy and FIT remains unclear, as does the role of CT colonoscopy.

If a conclusive approach to colon polyps screening remains elusive, at least some things are clearer, and patients can make more informed choices.


Posted by Patrick A. Malone | Permalink | Email This Post

Posted In: Cancer , Testing

Here's more evidence for the charge that the health-care industry overscreens, overdiagnoses, overtreats and often overcharges.

A recent study by the University of Michigan published in the Archives of Internal Medicine found that expensive tests like MRIs are used more often than more effective screenings that cost less.

The study concerned peripheral neuropathy, a disorder in which the nerves relaying information to and from the brain don’t work properly. Symptoms include tingling, burning and numbness in the arms and/or legs. Diabetes is the most common cause of peripheral neuropathy.

Nearly 1 in 4 patients receiving neuropathy diagnoses undergo high-cost, low-yield MRIs while very few receive low-cost, high-yield glucose tolerance tests. Patients diagnosed with peripheral neuropathy typically are given many tests. As one of the researchers said, “We spend a lot of money to work up a diagnosis of neuropathy. The question is whether that money is well spent.”

The answer: no.

The researchers looked at 15 different peripheral neuropathy diagnostic tests, analyzing their frequency six months before and after the initial diagnosis. They concluded: “Currently no standard approach to the evaluation of peripheral neuropathy exists. We need more research to determine an optimal approach. We do a lot of tests that cost a lot of money, and there’s no agreement on what we’re doing.”

A more practical light on the subject was shone recently by Dr. Joe Kosterich writing on the KevinMD blog. Much of what he expressed echoed a couple of recent posts of ours. One was about practitioners being overly in love with technology, another about cost considerations in prescribing care.

“As the world speeds up we tend to assume that newer must be better,” Kosterich wrote. “In some instances it is but when it comes to health, less so than one might expect. The other tendency is to overlook simple solutions and go to complicated, and often expensive ones.

“In medical practice there is one step even before considering what to do with a given problem and that is whether there is a need to ‘do’ anything. The great untold story of health and medicine is that much of what ails us will actually resolve by itself and much will resolve by actions of the individual rather than what the doctor does.”

He revisited the truism that all medical interventions have potential side effects, that caregivers and patients must consider the benefit-harm balance in deciding on a course of care.

“Someone who has pneumonia caused by a bacteria will need an antibiotic and notwithstanding that they may experience side effects, the benefits outweigh the harm,” he explained. “The same side effects are not as acceptable if an antibiotic is taken to treat a viral sore throat where there will be no benefit at all.” This scenario, as we’ve noted, has a greater social harm of making microbes more resistant to pharmaceutical intervention.

“The notion of a simple blood test has appeal but no blood test is simple,” Kosterich wrote. “A false result can lead to more tests and unnecessary treatments as well as needless anxiety. An unnecessary scan adds to cumulative radiation exposure."

He reminded us about the overuse of screening tests, such as PSA for prostate health and mammograms for breast health. The list of “too much, too often” seems endless.

Relentless government and academic pressure, Kosterich said, has promoted the idea that treating numbers is more important than treating people. The financial incentives that
sometimes reward doctors who achieve certain “targets” can lead to conflicts of interest.
The knee-jerk clinical response to perform tests “just in case” ignores the fact that sometimes they yield inaccurate results.

“[H]arm can come from any medical intervention. This does not mean they should not be done but in every case there is a trade off of risk versus benefit. Protocols can never allow for this individual variability,” Kosterich stated.

Gary Schwitzer of HealthNewsReview recently alluded to a story in the Salt Lake Tribune that perfectly captured the test-now, analyze-later response of the medical community to new technology. He lauds the story, which describes how a bunch of independent radiologists promoted a scanning device that takes 360-degree CT images, never mind that it isn’t new technology, isn’t new to Salt Lake and it isn’t clear that the brand is superior to other systems. The reporter does a good job, Schwitzer said, of calling out the project’s hype and for championing informed decision-making on the part of patients.

Last on our list of inquiring minds that want to know why we can’t seem to strike the right balance for testing and treating illness comes in the form of a book review published in the Patient Safety America Newsletter. “Over-Diagnosed: Making People Sick in the Pursuit of Health” was written primarily by a practicing physician H. Gilbert Welch who surveyed the conditions under which Americans are subjected to questionable screening and overtreatment of "diseases" that will never have an adverse effect on their health. He explained the creep of illnesses "discovered" by lowering numerical diagnostic thresholds—it’s not that more people contract a disease, he said, it’s that we now identify a disease by more relaxed standards. “His point,” the review says, “is not that screening is worthless, but that the medical care industry has sold us some of this screening and we potentially ‘sick’ patients must be wary of how we understand and respond to the findings.”

Before medical school Welch majored in economics, and his book helps laypeople understand the notion of “loss leader.” In the medical realm, that translates as offering the public some sort of screening at below the actual cost in order to gin up the customer base for someone’s diagnostic and treatment facility.

This is a big topic that will require a social movement to fully address. But individual patients can flex some muscle to ensure they’re not the subjects of overtesting, overdiagnosing and overtreating. Patients, Kosterich suggested, should be mindful that:

• Most symptoms are not due to disease. A cough might be a symptom of lung cancer but hardly anyone who coughs has lung cancer. Likewise with a headache and brain tumors.


• Most conditions are not acute emergencies; they can be given time to resolve themselves. You do not always have to run to the doctor at the first sign of any symptom. Listen to your body.


• Tests and treatments play important roles but are not free from potential harm. Ask whatever questions you need to be able to weigh the benefits against the risks.

• Get back to treating people and not numbers so as to please governments and academics.


• Clean up the process of setting treatment and performance guidelines.

It’s difficult to make these calls when you feel the medical “experts” are better trained, better informed and smarter than you are. Sometimes they are. Sometimes they’re not.

In 2009 the U.S. Preventive Services Task Force recommended against routine mammograms for women in their 40s. That caused a political firestorm then, with ill-informed politicians claiming that bureaucrats were trying to hold back a lifesaving test to save money. The truth was, and is, that mammograms cause more harm than good unless the women being tested are already at significant risk.

Now, Canadian health-care watchdogs have echoed the U.S. opinion, and for the same reasons.

As reported in CMAJ, the Canadian Medical Association journal, the Canadian Task Force on Preventive Health Care says routine mammograms for women 40-49 are not necessary if they are at average risk of contracting the disease. Women with a personal/family history of breast cancer, or who have the BRCA1/BRCA2 gene mutations are at higher risk, and should be screened more often.

The report concludes that although mammography screening can reduce death from breast cancer among women aged 40–74 years, “the absolute benefit is small — especially for younger women — and is partially offset by harms caused by unnecessary intervention.”

Those harms include false positives, which prompt additional screening or tests that usually include more radiation exposure, uncomfortable biopsies and high anxiety. The disease is relatively rare in younger women, and their higher breast density compromises the ability of mammograms to be fully useful. So the Canadian report says that for women at average risk, an interval of two or three years is sufficient for mammography screening.

Like the earlier U.S. task force, the Canadians emphasize that providers and patients consider the benefits-harm trade-off when deciding about having a mammogram.

We have repeatedly covered this topic, as well the often-conflicting opinions always generated when a former standard of care gets called into question.

In addition to questioning the wisdom of screening younger women via mammography and magnetic resonance imaging, this task force also said that there is no evidence that “clinical breast examination or breast self-examination reduces the risk of mortality or other clinically relevant adverse outcomes.”

Here’s what the Canadian task force recommends for mammography screening for women at average risk, by age:

• 40–49 years, no routine screening;


• 50–74 years, routine screening every two to three years.

We’re big believers in “evidence-based” medicine. Most recently, we questioned the fuzzy-science circumstances surrounding the death of Steve Jobs. But a recent article in The Atlantic by Megan McArdle reminds us that, sometimes, the art of medicine should play as large a role as that of science and that, ultimately, striking that balance requires the patient and the doctor to communicate well.

McArdle has lived with a thyroid condition for many years that requires periodic blood tests to determine how well that gland is functioning. For a long time, a normal thyroid was deemed to register between 0.5 and 5 for Thyroid Stimulating Hormone (TSH). But several years ago, the American Association of Clinical Endocrinologists Association of Clinical Endocrinologists lowered that threshold to between 0.3 and 3.

McArdle’s TSH levels were at the edge of the new, narrower range, and she had many of the symptoms associated with “underactive” thyroid—hair loss, fatigue, hoarseness, constantly feeling cold. (Overactive thyroid symptoms include insomnia, nervousness, heart palpitations, increased risk of bone fracture and a host of unpleasant and health-threatening problems.)

Her problem was that the numbers, the science, didn’t indicate how bad she was starting to feel.

The treatment for an underactive thyroid (hypothroidism) is a drug—thyroid hormone. And, like all drugs, it’s not without risk, so practitioners prescribe the lowest dosage possible to avoid them. As McArdle eloquently puts it, “There are real risks to taking too much thyroid hormone—it can cause heart palpitations and increase your risk of fractures. Unfortunately, too little thyroid hormone can leave you fat, bald, constipated, and depressed.”

Conservative TSH guidelines err on the side of hypothyroidism, McArdle writes, because “being hyperthyroid can kill you, while being hypothyroid just, well, makes you fat, bald, constipated, and depressed.” As long as TSH levels are under 5, many doctors believe, you are being treated appropriately, no matter how you feel.

Many primary care doctors have yet to adopt the more stringent levels recommended by the endocrinologists association, McArdle says, and even those whose patients’ blood tests show the new normal of 3 sometimes suggest these overweight, sluggish, cold people should just overcome their vanity or go to the gym more often.

“I can understand why doctors want to stick to the number: it is objective, while ‘I'm tired and kinda blue’ is not,” McArdle writes. “And presumably, you will get idiot patients who want to be thinner than is natural for them, and will lie about their symptoms in order to be prescribed dangerous levels of thyroid hormone.

"But this is not much comfort to the thyroid patient struggling to get enough energy to make it through the day.”

Which brings us back to the limitations of “evidence-based” medicine and the need for respectful, constant communication between patients and their doctors. “Evidence-based medicine works best on things that are very easy to measure, like blood levels.” McArdle says. “It is very easy to tell whether a statin reduces blood cholesterol levels. It took a lot longer to tell whether it actually reduced heart attacks.

“The more we rely on a central board to make decisions for huge numbers of people, the more tempted we are going to be to rely on metrics which can be collected, aggregated and mined for data. Where does that leave the thyroid patient with ‘normal’ blood levels . . . and a collection of vague, frustrating—but nonetheless very real--symptoms?”

McArdle found an endocrinologist willing to treat her more aggressively than mere numbers indicated to many of his colleagues. Three weeks after beginning her hormone regiment, she wasn't so cold any more and her voice lost its scratchiness.

“I don't want to come out against evidence-based medicine; we should always be trying to figure out what works and what doesn't,” she writes. “But I do question what constitutes evidence. Will evidence-based medicine push us even more towards looking at numbers rather than listening to patients?”

Once upon a time an adult physical exam routinely included urinalysis, blood tests, echocardiogram and many other screening tests, such as a bone-density scan. But a new study in the Archives of Internal Medicine adds to the growing body of evidence that many such tests are inappropriate, unnecessary and costly beyond their value.

The study, as described by Kaiser Health News, examined the cost of common primary care practices that had been declared overused by a group of physicians known as the Good Stewardship Working Group. It includes internists, family physicians and pediatricians who are part of the National Physicians Alliance, which advocates universal, affordable health care.
Among that group’s conclusions:

• blood and other diagnostic tests were often ordered even for patients who had no related symptoms or risk factors;


• imaging studies such as CT scans or MRIs for low back pain and Pap tests to screen for cervical cancer in teenagers were unnecessary;


• writing prescriptions for antibiotics for children with sore throats who didn't have a strep infection was unwise;


• recommending cough medicines for children with upper respiratory infections and ordering head imaging tests kids who had fallen but didn't exhibit symptoms such as dizziness or loss of consciousness were unnecessary.

The activity most frequently performed without need was a complete blood cell count at a routine physical exam. In more than half of the surveyed routine physicals, doctors inappropriately ordered such tests that cost $32.7 million.

But the single costliest bad practice was prescribing brand-name statins before trying patients on a generic drug first – that accounts for $5.8 billion of the $6.8 billion total.

Study authors said their cost figures were conservative, given that they didn't factor the cost of follow-up tests or procedures prompted by an abnormal blood test reading result or imaging scan, even though in the absence of symptoms or risk factors the follow-up may be unnecessary and even cause harm.

Doctors order unnecessary and overpriced tests and drugs when there's no reason because it’s ingrained in their training, said one member of the Alliance, because some patients expect them and because doctors practice defensive medicine – you don’t get into legal trouble, goes that thinking, if you cover far more bases than you’ll ever need.

Those reasons are misguided on medical, legal and financial grounds.

The new study concludes that doctors alone can't rewrite these misdirections. Patients must inform themselves about when a test is indicated in order to be better medical consumers. And both doctors and patients must communicate. How often have you asked your doctor what the prescription he just prescribed will cost, and he says “I don’t know”?

If your doctor prescribes a test, make sure you know why, what side effects might result and how much it costs. If medication is prescribed, ask if there's a generic version and, if so, if it will suffice, and how much it costs.

Ignorance in standard medical care is not bliss. It's expensive.

Everybody likes a free lunch. And everybody who pays for health care in America likes a free health screening, so when the Giant Eagle grocery chain started offering free in-store allergy tests, lots of people accepted the offer.

As discussed on HealthNewsReview.org by Kevin Lomangino, editor-in-chief of Clinical Nutrition Insight, allergies are like prostate cancer and breast cancer. They are a public health problem that you simply can't test your way out of, at least based on current knowledge.

It’s important to detect and treat food and other allergies – they can be life-threatening. But as Lomangino says, “indiscriminate testing for allergies may be even worse than not enough testing.”

Dr. Richard Wasserman, an allergist in Dallas, told Lomangino that allergy test panels are being heavily marketed to doctors as a means to boost practice revenue. Never mind that such tests have been shown to generate a false-positive as much as half the time when used to detect food allergies. Wasserman said that many patients probably are being tested in situations in which a careful clinical history would rule out suspected food allergy.

As an allergist, Wasserman acknowledges that he might be biased against primary care docs conducting allergy testing. But his concerns about the overuse of food allergy tests are supported by guidelines from the National Institutes of health (NIH) about food allergies. Lab tests are frequently (and incorrectly) used as the sole basis for a food allergy diagnosis.

Which brings us back to the “Attention Shoppers! Free Allergy Testing On Aisle 2!” approach to health care.

Because so many tests indicate a positive result when there is no allergy, their subjects will avoid foods unnecessarily. These diagnoses require a more careful evaluation.

Wasserman offered a hypothetical Giant Eagle customer with nasal symptoms who received a false-positive test for allergy to ragweed. That person might start taking Allegra in the mistaken belief that it would reduce symptoms. But an expert clinical evaluation might have turned up a more serious ailment whose discovery was delayed because of the false test result. Or that person might experience a side effect of Allegra worse than the symptoms of the nonallergy.

"A positive test does not equal a diagnosis, which is the premise of the testing programs," Wasserman said. "These tests are fundamentally useless without a formal evaluation of the patient."

The NIH guidelines indicate a growing awareness of false, easy-fix allergy diagnoses, but Lomangino says we’re still a long way from implementing an evidence-based standard for allergy testing. One study showed that in 103 out of 111 children who were avoiding foods based on allergy test results had no reaction to the food when they ate it during a carefully conducted food challenge.

Such false diagnoses are disruptive. Special diets can be difficult to follow and restrictive diets can be more expensive. People can suffer unnecessary anxiety about accidentally eating the “wrong” thing.

So if you’re having symptoms of what you suspect is an allergy -- to food, to dust, to plants … whatever -- don’t seek confirmation at the same establishment where you're buying razor blades and Cheez-Whiz. And if your primary care provider gives you an allergy test that’s positive, before embarking on treatment, ask for a second opinion from a board-certified allergist.

Repeat after me: There's no free lunch. Ever.

Article first published as The No-Free-Lunch Lesson in "Free" Allergy Testing on Technorati.

A new research study gives hope that some patients who seem to be in a coma, or persistent vegetative state, may actually be aware of their surroundings and can communicate on a rudimentary level.

The even better news is that misdiagnosis of these patients, which studies suggest may be common, can be corrected by use of a simple, cheap and widely available brain wave test called the EEG, electroencephalogram.

The study was reported in the online edition of the prestigious British medical journal The Lancet.

Many patients who seem to be completely unaware of their surroundings after a brain injury do not show any response to this new kind of testing. But of the 16 patients tested in the new study, three patients did show a response, indicating that they had been misdiagnosed and should be reclassified as "minimally conscious."

The researchers gave the seemingly vegetative patients two simple tasks: imagine moving a right finger, and then imagine moving a right toe. The patients who passed the test were able to generate specific, repeatable brain wave responses in the same area of the brain, the pre-motor cortex, as normal healthy control patients could do with the same testing.

Other researchers have found that putting patients like this into MRI machines for functional MRI (f-MRI) testing also can show results that indicate the apparently unresponsive patient actually has a response deep within the brain. The brains of some of these patients light up in specific places on the f-MRI test when they are asked to imagine some specific athletic activity like playing tennis.

The problem with f-MRI testing is it's expensive and requires the patient to be transported to a radiology center.

Here is the conclusion of the authors of the EEG study:

Despite rigorous clinical assessment, many patients in the vegetative state are misdiagnosed. The EEG method that we developed is cheap, portable, widely available, and objective. It could allow the widespread use of this bedside technique for the rediagnosis of patients who behaviourally seem to be entirely vegetative, but who might have residual cognitive function and conscious awareness.

Brain scientists are excited that if these results hold up, we may have a way to communicate with some of the 25,000 Americans who lie in beds seemingly unaware but actually with something going on inside.

Article first published as New Hope for Communicating with Patients in a "Vegetative State" on Technorati.

A new study might add to the perception that U.S. medical care is uncontrollably expensive thanks in part to unnecessary tests. “Screening by Chest Radiograph and Lung Cancer Mortality" concludes that people who have an annual chest X-ray do not have a significantly lower mortality rate than people who don’t.

The study, whose lung data are part of a larger investigation into cancers of the prostate, colon/rectum and ovaries, examined people who were given either annual chest X-rays (chest radiography) or standard medical care without screening. In the 13 years’ of the study, 1,696 lung cancers were detected in chest radiograph group and 1,620 lung cancers in the control group. The radiograph group reported 1,213 lung cancer deaths, and 1,230 in the control group.

The results weren’t really a surprise; researchers said the study confirmed expectations rather than setting new ones.

Some healthy patients believe that safeguarding their good fortune means having any screening that can yield information. Often their physicians accommodate them out of an abundance of caution, a desire to please the customer or a fear (usually irrational) of being sued if they are perceived to have practiced poor medicine.

But as with recent guidelines announced by the U.S. Preventive Services Task Force (USPSTF) about Pap tests, mammograms and prostate-specific antigen tests, sometimes a test, especially for generally healthy people, serves little purpose other than addressing professional insecurity and reducing one’s bank account. And in the task force cases, it can cause harmful side effects.

A smoker or someone with a family history of lung cancer might not qualify as someone who can ignore advice to get screened. But now, the best practice for people at risk for lung disorders might not be a chest X-ray. The recent National Lung Screening Trial concluded that early detection of lung cancer from a spiral CT scan reduced the risk of mortality.

A spiral CT uses X-rays to generate multiple images of the entire chest; a standard chest X-ray generates a single image of the entire chest in which parts of the anatomy overlie one another.

The National Cancer Institute study involved current and former smokers, and compared a CT scan group with a chest X-ray group, not people with no known lung problems or those who hadn’t been screened at all. Still, the best way to diagnose lung cancer doesn’t seem to be with a chest X-ray, and unless you’re having a respiratory issue, you don’t need one as part of your annual physical exam.

It's natural to want an X-ray or MRI or some other kind of scan when you've had an injury that's so painful it hurts to use the involved body part. But many orthopedic surgeons are starting to speak out against the overuse of MRI scans in particular. They say it leads to over-diagnosis of injury and too much surgery on patients who don't need it.

To prove the point, orthopedist James Andrews did MRI scans on the shoulders of thirty-one professional baseball pitchers. Nine out of ten resulted in readings of abnormal shoulder cartilage, according to an article by the New York Times' Gina Kolata, who frequently writes about sports injuries and their treatment. Dr. Andrews' lesson: “If you want an excuse to operate on a pitcher’s throwing shoulder, just get an M.R.I."

The article also has a fascinating cautionary tale about a patient named Steve Ganobcik, who twisted his knee skiing, but was able to keep skiing for two more days on his vacation. He then underwent an MRI scan when the pain didn't go away. The orthopedic surgeon told him he had a torn ACL ligament in the knee and needed surgery. After two second opinion consultations, he discovered he had no torn ligament at all but a subtle fracture in one of his shin bones that needed no surgery.

The surgeon who steered him straight had his suspicions raised by Mr. Ganobcik's story. He could never have continued skiing with a torn A.C.L. The diagnosis “made no sense,” said Dr. Freddie Fu, chief of sports medicine at the University of Pittsburgh Medical Center.

This proves once again that the patient's story, as listened to by a careful and conservative doctor, can be the best guide to treatment.

The relentless campaign to convince every American woman of her imminent risk of fatal breast cancer doesn't measure up to any calm review of the numbers on who dies from what in the United States. And the value of regular mammograms for women is coming under increasingly skeptical scrutiny.

The latest skeptical report on breast cancer screening with mammograms comes this week in the "Well" column in the New York Times. According to the Times, of the 39 million women who undergo mammograms this year, somewhere between 4,000 and 18,000 of those will be helped by getting earlier diagnosis of a cancer that otherwise might have gotten out of control.

Last year at this time in this blog, we reviewed the numbers comparing breast cancer risk to those of other big killers. We showed that the usual statistic that most Americans have heard, that one in eight women will get or die from breast cancer, is wildly wrong. The numbers still are accurate today.

The point is not to pooh-pooh breast cancer. It's a terrible disease, and nobody should die from it. But nobody should be unduly scared of it either, when the odds are that many other ailments will kill you first.

Should you get a regular mammogram? It's a personal decision depending on your own family history and your own risk tolerance. Just don't let anyone tell you that you're being suicidal if you decide to skip it.

Earlier this month, the U.S. Preventive Services Task Force (USPSTF) recommended against the routine use of the prostate-specific antigen (PSA) test for most men. A couple of years ago, the same federal agency concluded that routine mammography for most women in their 40s and 50s was counterproductive.

Both declarations incited passionate arguments on both sides of the issues.

So who are these fearless people whose job is to articulate health protocols with the potential to roil the waters of any medical specialty?

As readers will see from the list at the end of this piece, the members are distinguished doctors and other caregivers from around the country. Nary a faceless bureaucrat among them, contrary to what you hear from critics on the right.

Established in 1984, the USPSTF, according to its website, “was convened to rigorously evaluate clinical research in order to assess the merits of preventive measures, including screening tests, counseling, immunizations and preventive medications.”

Anyone can look at the wide range of topics the agency addresses by linking to the site, and see whether a given recommendation is active, inactive or in progress.

As described in the Los Angeles Times, “If the world of primary-care physicians had a supreme wizarding council that only weighed in on screening tests and pills promising to head off disease, it would be called the U.S. Preventive Services Task Force.”

Wizardry is certainly one way to cultivate order within the chaos that is health care in America, a thick, perpetually simmering stew of commerce, politics, perpetual motion and consumerism. Wizards can ferret out the influence of a Big Pharma "task force" of physicians paid to hawk their product. They can disarm grass-roots movements that have declared otherwise worthy medical treatments suspect because of coincidence instead of science.

USPSTF wizards are obliged to filter out the noise and focus on the scientific evidence about screening tests, preventive medications, counseling and anything else that holds promise to treat symptoms or disease.

As the L.A. Times notes, the USPSTF has opined about “medications that promise to prevent heart attack or stroke, cancer screening tests that claim early detection means better chances of survival, HIV/AIDS screening in which privacy concerns are paramount.”

Sixteen people compose the USPSTF, representing physicians, nurses, health psychologists, epidemiologists and statisticians with expertise in primary care and preventive medicine. Their backgrounds include clinical practice, organizations and academic institutions outside of the federal government. They are nominated by institutions or individuals for four-year terms that can be extended by one or two years. They have no financial or professional conflicts-of-interest that could color their assessment of a preventive measure's value, and anyone under consideration for the task force gig may be asked to provide detailed professional and financial information to ensure objective judgment. The U.S. Public Health Service ultimately grants membership.

As The Times says, the work is not glamorous, “but it is remarkably influential. Once a measure has been accepted for study (a decision made by the Health & Human Services Department's Agency for Healthcare Research & Quality), task force members review the findings of an entire body of published studies on that measure. Then, they issue grades that not only recommend for or against the measure's widespread use, but bluntly grade the quality of research that has been done.”

Most USPSPF decisions are aimed toward primary care physicians who need advice on which screening tests or preventive medications are worth ordering and prescribing to their healthy patients. But its sphere of influence has grown. If a health plan or an insurer is uncertain about whether to cover a screening or diagnostic test, or wants to shift the cost of a preventive medication to a patient, the recommendation of the task force is often the deciding factor. Professional societies see this small, but influential agency as a standard-of-care bearer.

Everybody, even a Godlike doctor, needs a mentor.

Here are the current members of the US Preventive Services Task Force. The list is courtesy of Healthnewsreview.org.

Virginia A. Moyer, M.D., M.P.H. (Chair) Professor, Pediatrics Baylor College of Medicine, Houston, TX Chief, Academic Medicine Service, Texas Children's Hospital

Michael L. LeFevre, M.D., M.S.P.H. (Co-Vice Chair)
Professor, Department of Family and Community Medicine
University of Missouri School of Medicine, Columbia, MO

Albert L. Siu, M.D., M.S.P.H. (Co-Vice Chair)
Professor, Geriatrics and Palliative Medicine
Mount Sinai School of Medicine, New York, NY

Kirsten Bibbins-Domingo, Ph.D., M.D.
Associate Professor, Medicine, Epidemiology, and Biostatistics
University of California, San Francisco, CA
Co-director, UCSF Center for Vulnerable Populations
San Francisco General Hospital

Adelita Gonzales Cantu, Ph.D., R.N.
Assistant Professor, Family and Community Health Systems
University of Texas Health Science Center, San Antonio, TX

Susan J. Curry, Ph.D.
Dean, College of Public Health
Distinguished Professor, Health Management and Policy
University of Iowa, Iowa City, IA

Glenn Flores, M.D.
Professor, Pediatrics and Public Health
University of Texas Southwestern, Dallas, TX
Director, Division of General Pediatrics
UT Southwestern Medical Center and Children's Medical Center of Dallas

David C. Grossman, M.D., M.P.H.
Medical Director, Preventive Care and Senior Investigator, Center for Health Studies, Group Health Cooperative
Professor of Health Services and Adjunct Professor of Pediatrics
University of Washington, Seattle, WA

George J. Isham, M.D., M.S.
Medical Director and Chief Health Officer
HealthPartners, Minneapolis, MN

Rosanne M. Leipzig, M.D., Ph.D
Professor, Geriatrics and Adult Development, Medicine, Health Policy
Mount Sinai School of Medicine, New York, NY

Joy Melnikow, M.D., M.P.H.
Professor, Department of Family and Community Medicine
Director, Center for Healthcare Policy and Research
University of California Davis, Sacramento, CA

Bernadette Melnyk, Ph.D., R.N., C.P.N.P./P.M.H.N.P.
Associate Vice President for Health Promotion, Chief Wellness Officer, and Dean
College of Nursing
Ohio State University, Columbus, OH

Wanda K. Nicholson, M.D., M.P.H., M.B.A.
Associate Professor, Obstetrics and Gynecology
Director, Diabetes and Obesity Core Center for Women's Health Research
University of North Carolina School of Medicine, Chapel Hill, NC

Carolina Reyes, M.D., M.P.H.
Medical Director, Maternal and Fetal Medicine
Virginia Hospital Center, Arlington, VA

J. Sanford (Sandy) Schwartz, M.D., M.B.A.
Leon Hess Professor of Medicine, Health Management, and Economics
University of Pennsylvania School of Medicine and Wharton School, Philadelphia, PA

Timothy J. Wilt, M.D., M.P.H.
Professor, Department of Medicine, Minneapolis VA Medical Center
University of Minnesota, Minneapolis, MN

... goes to Skip Lockwood, head of a prostate cancer advocacy group called Zero. When the US Preventive Services Task Force recommended against routine screening of men with the PSA blood test, Lockwood said the PSTF's advice "condemns tens of thousands of men to die this year and every year going forward..."

Prostate cancer kills about 30,000 American men a year, so if Lockwood is right, that means the PSA test would have prevented MOST of those deaths. If it was that obviously beneficial, why would so many doctors and health care leaders have such doubts? Last year, in a less publicized statement based on the same research studies, the American Cancer Society also pulled the plug on its advice for screening with the PSA test.

The fact is that fears of just this kind of over-the-top reaction caused the PSTF to delay its advice for two and a half years after definitive studies came out from Europe and the US showing that PSA testing just doesn't do the job of putting any measurable dent in the death rate from prostate cancer. The PSTF was cowed by the blowback to its last big recommendation: that the numbers don't justify routine mammograms for women in their 40s.

PSA testing has generated a billion dollar industry of urologists doing surgery on men, with high rates of impotence and incontinence in their wake. At the risk of making a bold statement in the opposite direction of Mr. Lockwood's, it's almost malpractice now to put men into routine prostate cancer screening when the odds are much greater for harm than help.

Even the inventor of PSA testing came out last year against its routine use in low-risk men. The test is best reserved for high-risk men who need monitoring after they've already had prostate cancer and need to know if it's coming back.

But don't try to confuse the advocates with scientific facts. They'd rather play on emotions.

Article first published as The Award for Most Fear-Mongering Health Care Statement of the Year ... on Technorati.

No healthy man should get the PSA blood test to screen for prostate cancer, says the influential US Preventive Services Task Force in a new, strongly worded recommendation. As readers of this blog know, this recommendation has been a long time coming.

Prostate removal surgery, even in the most skilled hands, has a high rate of causing incontinence and impotence in the patient. So a test that detects early prostate cancer is valuable only if it prevents early death. The problem is the PSA test can't tell the difference between cancers that are so slow-growing they will never kill a man and those that can be deadly. Hence it directs millions of men to biopsies and extensive operations of uncertain value.

We reported in 2009 that two huge studies were published that year that found zero benefit for PSA testing in one American study and only a tiny benefit, but much more harm, in the European study. Seven lives were saved for every 10,000 men tested, but in the same 10,000, forty-eight were harmed by unnecessary surgery.

Last year, also as we reported, the inventor of the PSA test decried its widespread use and said it should be limited to monitoring men who already have had their prostates removed and need a marker of possible return of the disease.

The news that health insurers will be required to cover contraception and related counseling, courtesy of the Affordable Care Act (ACA) passed last year, received a lot of media attention and political blowback.

Because some people find that provision of preventive care for women objectionable, it overshadowed other elements of the new guidelines, which pertain to insurance policies whose plan years begin on or after Aug. 1, 2012. Such policies are referred to as “nongrandfathered” because they represent only new plans; a health plan in effect now cannot be “grandfathered” into this coverage, although some might include it anyway.

As defined by the U.S. Department of Health and Human Services, the mission of the ACA is to promote prevention of health problems in the hope of reducing the need to treat them. It also aims to make care affordable and accessible for everybody by requiring health plans to cover preventive services and eliminating cost sharing.

Although “preventive services” covers a lot of territory that can include marginally appropriate, cost-inflating measures, those required by HHS demonstrate strong scientific evidence of their health benefits, per research conducted by the Institute of Medicine (IOM). Not only must plans cover them, they may not charge a copayment, coinsurance or deductible if the services are delivered by a network provider.

In addition to the birth control measures, from which plans are exempt for certain religious employers, the following preventive services for women are mandatory and must be provided by insurers without cost sharing to policyholders for policies beginning on or after Aug. 1, 2012:

• well-woman visits;


• screening for gestational high blood sugar;


• human papilloma virus (HPV) DNA testing for women 30 and older;


• sexually transmitted disease counseling;


• human immunodeficiency virus (HIV) screening and counseling;


• breastfeeding support, supplies and counseling; and


• family violence screening and counseling.

Another episode in the if-you-build-it-they-will-come (and pay) story of medical technology has been written recently by hospital emergency rooms. In 1996, about 3 in 100 ER patients were given a CT scan; by 2007, the figure had grown nearly fivefold, to 1 in 7 ER patients, according to a new study in the Annals of Emergency Medicine.

Does this greater diagnostic investment result in fewer people being admitted to the hospital — which is a good thing — or are CTs being overused, and padding the health-care bill without much payoff?

The hospitalization rate following a CT scan was 26% in 1996, and 12% percent in 2007. During that period, the overall hospitalization rate of ER patients rose from about 11% to about 13%.

The cost-benefit issue was examined recently by Kaiser Health News, not only in the context of cost, but because CT scans — which render a three-dimensional image by coordinating a series of X-rays taken from multiple angles — can subject patients to excess radiation.

The researchers, from the University of Michigan Health System, said the radiation risk could be higher for children, patients receiving multiple scans and those who develop complications from the intravenous dyes the imaging often requires.

The American College of Emergency Physicians claimed that fewer patients being admitted to the hospital can be attributed partly to the diagnostic tool.

Hard to argue with a technology that appears to help cut hospital admissions by half, but the study also finds that this positive effect of CT scanning “appeared to diminish after 2003” when the rate “flattened and stabilized” as CT use continued to rise.

Dr. Keith Kocher, the study’s lead author, said, “There are risks to overuse of CT scans … so if they’re done for marginal reasons you have to question why. For example, patients who complained of flank pain (pain in the side) had an almost 1 in 2 chance of getting a CT scan by the end of the study period. Usually most physicians are doing that to look for a kidney stone, but it’s not clear if it’s necessary to use a CT scan for that purpose.”

“Also, during the study period, [emergency department] visits increased by about 30 percent,” Kocher said, “while CT use increased 330 percent, meaning the rate of CT use grew 11 times faster than the rate of ED visits.”

Several factors contribute to the increased use of CT scans:

• the greater availability of the equipment;


• doctors’ fear of being sued for malpractice;


• a perception that patients want the test; and


• financial pressure to make use of the machine.

A handful of symptoms accounted for a disproportionate use of CT scans in the ER — impairments of nerve, spinal cord or brain function; flank pain; convulsions; vertigo; headache; abdominal pain; and general weakness. Approximately 1 in 4 CT scans performed in the U.S. is done in an emergency department, the study found.

If CT scans are overused, figuring out how to reduce their use is tricky, noted Dr. Robert Wears, an emergency medicine doctor who wrote an editorial accompanying the study. Such decisions, he said, are made on a case-by-case basis.

“What is acceptable and appropriate use or nonuse of CT imaging is not an entirely objective question that can be neatly resolved by empirical data and formal analysis,” he wrote, “but rather a tangled, socially constructed issue involving competing views of risk, benefit and obligation, and the elusive question of how much certainty we must have.”

The last thing an injured or ill person wants to do is engage in a protracted discussion about the suitability of care — he just wants to stop hurting. Still, when a CT scan is prescribed, Kocher advises patients to ask if it’s truly necessary. Or ask this: If the CT comes out one way, how will the care be different from how it would be if it comes out another way? Here's where the doctor may hem and haw. The doctor will probably still want to do the scan, and maybe she’s right. But the greater the awareness of the issue, the sooner a reasonable and appropriate standard of care can be determined.

Article first published as Why is Use of CT Scans Soaring in Emergency Rooms? on Technorati.

The Centers for Disease Control and Prevention (CDC) reports that the rate of death from colorectal cancer has fallen substantially in recent years. It also noted that the decline could be even greater if more older adults were screened for colon polyps with colonoscopy.

National death rates from colorectal cancer dropped by 3% annually between 2003 and 2007. The national rate fell from 19.0 per 100,000 population to 16.7 per 100,000 during that period. The screening rate for people 50 to 75 years old was 65% in 2010, an increase from the rate of 52% in 2002.

The CDC says that one-third of the target population still is being missed.

The No. 1 reason why? Doctors fail to recommend screening to their patients.

Sometimes the failure to recommend colonoscopy is just a one-time oversight. Other times, it can amount to medical malpractice, especially when the patient is in a high-risk group such as someone who has had blood in their stool with no clear reason for it. On the Patrick Malone law firm website, we have an extensive discussion of colon cancer and medical malpractice, plus an important patient safety tip on why full colonoscopy is superior to sigmoidoscopy in screening for cancer.

Nearly 10 years ago, the National Quality Forum (NQF) published a report, Serious Reportable Events (SREs) in Healthcare. It identified 27 really horrible mistakes occurring in hospitals deemed largely preventable and of concern to both the public and health-care providers. Thanks to their extreme nature, these "adverse events" have come to be known colloquially as "never events." They include such medical misadventures as surgery on the wrong body part, festering bedsores acquired after admission, patient falls and life-threatening medication errors.

Establishing consensus of what constitutes preventable errors among everyone vested in the satisfactory delivery of health care--consumers, providers, researchers, etc.--facilitates clear accounting and resolution of them.

The report was revised in 2006, and once again the program is updating the list of SREs.

The take-home message this time is that SREs are an equal-opportunity aspect of practicing medicine that go beyond the confines of a hospital. The mission is expanding to collect data also from:

• ambulatory and office-based surgery centers;


• long-term care settings (including skilled nursing facilities); and


• physicians' offices.

The uniform approach to measurement helps to drive national improvement in patient safety through shared learning and prevention. More than half of the states use the NQF-endorsed list of SREs in their public reporting programs.

This update adds these "never events":

• death or serious injury of a newborn associated with labor or delivery in a low-risk pregnancy;


• patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen;


• patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology or radiology test results; and


• death or serious injury of a patient or staff associated with the introduction of a metallic object into the MRI area.

The NQF report is widely embraced as what health-care monitor Bob Wachter calls "a dominant force in the patient safety field." It has, he notes, a real and measurable impact: Medicare, for example, has stopped paying hospitals the extra costs associated with SREs. "While the money being withheld is relatively small...," Wachter says, "the policy has captured the attention of administrators and providers everywhere."

Still, Wachter sees room for improvement, noting that:

• many events on the list lack standard definitions, leaving them subject to interpretation;


• unintended consequences can occur, such as preventing a fall by tethering a patient to the bed who otherwise would benefit from walking;


• the "no pay for errors" policy might prompt private insurers to suspend all payments after a facility reports an SRE;


• the list doesn't capture some mistakes, such as diagnostic errors and errors of overuse; and


• some serious adverse events are not known to be fully preventable.

Greater accountability can only encourage sustained efforts to protect patients from sloppy, incompetent and witless medical behavior. Efforts to refine the process are good for both the providers and those of us who receive medical care.

Nobody wants to get lung cancer. Nobody who has it looks forward to the radical treatment such a diagnosis usually demands. But a recent research study lifted a bit of the dark cloud hovering over these patients. It found a significant decrease--20%--in deaths among lung cancer patients screened annually for three years with a certain type of CT scan compared with conventional chest X-rays.

This being lung cancer, and this being an evolving technology, caveats are in order: More than 90% of positive screening tests using both techniques were false positives, and the study did not assess the costs of false positive tests.

The high rate of false-positive results carries the potential for overdiagnosis and overtreatment. "Before public policy recommendations are crafted, the cost-effectiveness of low-dose CT screening must be rigorously analyzed," Christine Berg, M.D., of the National Cancer Institute, and co-authors wrote in their discussion of the results in the New England Journal of Medicine. "The reduction in lung-cancer mortality must be weighed against the harms from positive screening results and overdiagnosis, as well as the costs."

Approximately 157,000 Americans die from lung cancer every year; the study suggests that as many as 27,000 of them might be saved by CT screening. And although the key finding was that the technology resulted in fewer deaths, the study is notable as well for demonstrating no significantly harmful side effects. The landmark nature of the science was described by some authorities, including Dr. Otis Brawley, chief medical officer of the American Cancer society, as second in significance only to the surgeon general's 1964 report linking smoking to lung cancer.

Critical scrutiny now shifts from "does it help?" to "who does it help and how much does it cost?" Medicare pays about $300 for a CT scan, but positive results in lung cancer patients prompt additional testing, and where that ends is anybody's guess.

One observer casting a wary eye over not over the science but how it is represented to laypeople is Gary Schwitzer, blogging at MedPage Today. His beef isn't solely with the unknown costs of the increased use of CT scans, but in how the media chooses to present the findings with, in his estimation, little regard for the full story. Exemplary of such shoddy coverage, he says, is a national TV broadcast network for failing to offer any discussion of false positives and cost but sparing nothing in the hyperbole department. The network, he said, called CT scans "simple," a term with which he takes issue. Also, he said, "it cited a cost of a 'mere $99'--not to be matched in many locations across the U.S. and failing to take into account the follow-up costs of the considerable number of false positives."

Schwitzer claimed that the network "promoted screening advice that simply hasn't been established and didn't cite the source of that advice." He said it "offered to help viewers find hospitals who could scan them--journalism or advertising?"

Raising the flag of skepticism higher in hopes that the technology's end user--you, the patient--salutes, Schwitzer quotes Harry Demonaco, director of the Innovation Support Center at the Massachusetts General Hospital. The study, Demonaco says,"is really a tour de force that was masterfully crafted and operationalized. The authors presented the results in a well-balanced fashion. Unfortunately, the [broadcast news] report did not.

"There are 94 million smokers at risk for lung cancer in the United States today. According to the [study's] authors, only about 7 million of them would meet the eligibility criteria to have been included in the study. This is important because the results may not be generalizable to the remaining 87 million smokers."

Schwitzer concludes, "We know that journalists struggle with screening stories. A simple reminder may help them do a better job: All screening tests do harm; some may also do good. If you don't reflect that in your story, you're probably doing harm as well."

And might we just add: Harm comes in many forms--physical, financial and emotional. As a medical consumer, we hope you try to stay abreast of developments in medicine and technology that affect you and the ones you love. Remember, like everything else, if you read or hear news about something that seems to good to be true, you might not have the full story.

Making physicians aware of the cost of regular lab tests cuts the daily bill for those tests by as much as 27%, according to a new study.

The study, published in the May issue of Archives of Surgery, first monitored the baseline daily per-patient cost for two common lab tests - complete blood count and total chemistry panel – among surgical patients at Rhode Island Hospital in Providence. Once the baseline was established, researchers made weekly scripted announcements to the physicians-in-training who order most of the tests and to their attending physicians about the cost of those tests, but doctors were never told when or when not to order a particular test.

When the program began, the daily cost per non-intensive care patient was $147.73. Over the 11 weeks of the study, that dipped as low as $108.11 in the eighth week. There were a couple of weeks where the cost of tests went up from the previous week, but those corresponded with a new influx of intern physicians who were hearing the announcement for the first time.

Over 11 weeks, the official total saved was $54,967. (In practice, of course, the true amount saved would be less, as the official savings is based on the sticker price of the tests, not the amounts actually paid by Medicare or negotiated with third-party insurers.)

Study co-author Elizabeth Stuebing says the results show what can happen merely by giving physicians information they don’t usually get. “We never see the dollar amount of anything," she says. "The first week I stood up and said that in the previous week we’d charged $30,000 of routine blood work and I could hear gasps from the audience.”

Source: The Wall Street Journal

You can read an abstract of the study here.

When you see a specialist, you expect to hear from an expert who will diagnose your condition and then recommend the appropriate treatment. But that may not be the case, especially if you’re dealing with gastroenterologists and your symptoms appear to resemble those of Barrett’s Esophagus, a condition in which the lining of the esophagus is damaged by stomach acid.

When gastroenterologists were asked in a survey to cite the criteria for diagnosing and managing Barrett’s, most gave answers that differed from published guidelines, suggesting overdiagnosis and an excessive burden on patients.

Barrett's can be a precursor to cancer of the esophagus. It happens with repeated episodes of reflux when stomach acid is expelled upward into the esophagus. Typically the lower part of the esophagus closer to the stomach becomes chronically inflamed. Heartburn is the usual symptom from these repeated episodes of reflux, or even difficulty swallowing.

Under a microscope, Barrett's is diagnosed when a biopsy from the esophagus shows that the normal cells have been transformed into "dysplastic" or precancerous cells. The cells look more like those seen in the colon than those that should be lining the upper part of the gastrointestinal system.

In the survey of 261 gastroenterologists presented last week at Digestive Disease Week in Chicago, 23% failed to name the only criterion for Barrett’s endorsed by the official American College of Gastroenterology (ACG) practice guideline, while more than half listed other criteria.

Furthermore, about a third said they perform follow-up exams in patients with non-dysplastic Barrett’s more frequently than the 3-year interval recommended by the ACG.

The ACG guideline defines Barrett's as a change in the lower lining of the esophagus of any length to a columnar-type mucosa, with biopsy confirmation as intestinal metaplasia. Although 77% of respondents correctly indicated that such a finding would be adequate for a diagnosis of Barrett’s, respondents could name multiple criteria and a substantial number endorsed one or more criteria not included in the ACG guideline including (1) irregular-appearing squamocolumnar junction with biopsy finding of intestinal metaplasia (47%); normal-appearing squamocolumnar junction with biopsy finding of intestinal metaplasia (22%); visible columnar-type mucosa above the gastroesophageal junction (17%) and irregular-appearing squamocolumnar junction without biopsy ( 3%).

The guideline also indicates that, for nondysplastic Barrett's esophagus, follow-up endoscopy should be performed every three years. This interval was seconded by 55% of respondents in the survey. Some 34% respondents indicated that they perform endoscopies in such cases every one or two years, while another 9% said their preferred follow-up interval varied, depending on the length of the dysplastic segment.

The survey also found that, compared with salaried physicians, those with "productivity-based incomes" were significantly more likely to perform endoscopies at 1- or 2-year intervals in nondysplastic patients.

Source: MedPage Today

Reference: “Poor compliance with guidelines in the diagnosis and management of Barrett's esophagus" DDW 2011; Abstract Sa1064.

As an increasing number of patients being tested for prostate cancer contract potentially lethal drug-resistant infections, some physicians are rethinking their approach to prostate cancer screening.

Several studies released in the past year reveal that infectious complications from biopsies have more than doubled in less than a decade, and a growing percentage of patients who undergo needle biopsy tests are becoming critically ill and dying from bacterial infections, including sepsis.

A tissue biopsy of the prostate to detect cancer typically entails sending an ultrasound-guided needle about a dozen times through the rectum to collect specimens from the walnut-sized gland that sits under the bladder. The test carries an infection risk because the needle can take bacteria from the bowel into the prostate, bladder and bloodstream.

If the bacteria is resistant to antibiotics given at the time of the biopsy, the routine, 15-minute procedure can turn into a dangerous situation.

More than 1 million transrectal prostate biopsies are done in the U.S. each year to diagnose cancers in men whose screening blood tests suggest they may have the disease, but no studies have examined the risk of sepsis globally. Instead doctors are trying to gauge the scope of the problem from studies beginning to emerge from North America, Europe and Asia.

For example, a research team at the Odette Cancer Center in Toronto uncovered the emerging infection risk last year after examining more than 75,000 electronic records of biopsy patients treated in Ontario between 1996 and 2005.

The team discovered that the chance of being hospitalized within a month of the procedure had increased fourfold in less than a decade, reaching 4.1%in 2005 from 1% in 1996; of these, 72% were diagnosed with infections.

Source: Bloomberg News

Children at emergency departments in the U.S. had five times as many CT scans in 2008 as they did in 1995, according to a recent study, increasing not only risks associated with radiation exposure but also risk of “incidentalomas," the term physicians use for incidental findings that could be (but probably aren't) cancer.

In addition, the study, published in the journal Radiology, found that 6% of pediatric visits to the ER involved a CT scan, while an earlier study by the same research group, led by Dr. David Larson at Cincinnati Children's Hospital Medical Center, found an even greater rise in scanning during adult ER visits, with 25 percent of patients age 65 and older and 12 to 16 percent of younger adults getting a CT scan in 2007. CTs of the abdomen and pelvis were the most likely to turn up an incidental finding.

An earlier study published in the Archives of Internal Medicine found that nearly 40 percent of CT and MRI scans performed for research purposes at the Mayo Clinic from January through March 2004 turned up at least one incidental finding. In the 35 patients in whom doctors took further action (i.e. additional testing, specialist consultation, or surgery), only six were judged by researchers to have clearly benefited from an investigation, while in the rest there was no clear benefit or clear harm, such as complications from surgery for a benign tumor.

In response to growing concern about the rising numbers of incidentaloma, the American College of Radiology recently published detailed guidance for clinicians about how to approach such findings, and warns physicians that “subjecting a patient with an incidentaloma to unnecessary testing and treatment can result in a potentially injurious and expensive cascade of tests and procedures." The college advises physicians to carefully consider an individual patient's risk for cancer in deciding whether or not to recommend further evaluation.

It also advised patients who are told about an incidental finding to seek a second opinion to verify that the radiologist's interpretation of their scan is correct, to adopt a "healthy skepticism" about testing, and only to consent to scans absolutely necessary to establish a diagnosis or plan of action, rather than to those ordered “just to be sure.”

Source: U.S. News & World Report

A new Texas law that mandates insurance coverage for coronary artery calcium scanning and carotid artery ultrasound was “premature” and will have major ramifications for public health, a noted Texas cardiologist says.

In a commentary published in the Archives of Internal Medicine, Dr. Amit Khera, a cardiologist at the University of Texas Southwestern Medical Center in Dallas, says that although some of these tests may be right for some patients, mandating their use via legislation goes far beyond what the evidence to date supports.

"I'm not against this technology – I use it myself," Khera says. "But when you go from an individual doctor and a patient making a decision about a test to a statement like 'we should apply this to an entire population, and the evidence is so strong that we need a law,' I think then you need a much higher level of evidence and a more detailed look at all the ramifications."

Neither screening test has been proven in adequately powered trials to lead to diagnoses or preventive measures that translate into reduced adverse cardiovascular events. There is also no real consensus as to which patients might benefit from screening, what level of baseline risk would warrant further screening or what steps should be taken as a result of any given finding.

In terms of calcium screenings alone, Khera calculates that approximately 285,000 individuals in Texas who would be eligible for insurance coverage of screening based on criteria set out in the bill would be found to have calcium scores over 400, and many of these people would already have another indication for taking statin therapy. And, he notes, a one-time screen could be expected to result in 190 new cancers and find 190,000 incidental findings of "minimal consequence" that would inevitably be followed with further, possibly unnecessary tests.

In an editorial note accompanying Dr. Khera’s commentary, Archives editor Dr Rita Redberg commented that “at a time when states are facing crises in health insurance spending and cutting lifesaving treatments, and when Texas leads the nation in the percentage of residents without health insurance, it is remarkable that Texas has chosen this path."

A new bill modeled on the Texas legislation is also set for consideration in Florida.

Source: TheHeart.org

You can read an extract of Dr. Khera's original commentary in the Archives of Internal Medicine here.

One of the main arguments made by proponents of malpractice reform is that physicians would order fewer medical tests if patients could receive only a limited amount of money in a potential lawsuit. But that assumption may not be true, according to a recent study published in the journal Health Affairs. In that study, researchers from the University of Iowa found that not only does reducing malpractice costs not make physicians less concerned about being sued, it also doesn't necessarily result in them ordering fewer tests.

The study evaluated physicians’ perceptions about malpractice claims in states where more objective indicators of malpractice risk, such as malpractice premiums, varied considerably. It found high levels of malpractice concern among both generalists and specialists in states where objective measures of malpractice risk were low. The study also found relatively modest differences in physicians’ concerns across states with and without common tort reforms. These results suggest that many policies aimed at controlling malpractice costs may have a limited effect on physicians’ malpractice concerns.

Proponents of malpractice reform, including lawmakers, assume that physicians order unnecessary tests because they fear being sued, and this so-called "defensive medicine" is one of the main factors driving up health care spending.

However, opponents of malpractice reform argue that although some physicians request unneeded tests to avoid potential lawsuits, in many cases, physicians order tests because they're trying to do a thorough job with patients, while others order tests to exploit the “fee-for-service” system, which allows physicians to bill more when they perform more services or provide more care.

Source: Des Moines Register editorial

You can read the abstract of the University of Iowa study here.

The idea that doctors order unnecessary tests to avoid being sued has enough surface plausibility that people nod "of course" as if it's undeniable truth. The "fraud" of "defensive medicine" is two-fold: It doesn't really happen, at least not that anyone has ever proven, and even if it did happen, it would mean that doctors were committing fraud -- insurance fraud by ordering tests to protect their own rear ends and not to benefit the patient.

This is back in the news because the new Republican leadership of the House of Representatives wants to hold hearings about how cutting back on patients' rights to sue for redress when they've suffered preventable injuries from medical malpractice will allegedly improve the budget deficit.

Joanne Doroshow of the Center for Justice and Democracy has a new column in the Huffington Post that takes on this issue.

An excerpt:

While anonymous doctor surveys provide the principal foundation for the argument that widespread "defensive medicine" exists, credible organizations who have looked into the issue have had a very hard time identifying pervasive "defensive medicine," especially when managed care companies are paying the bill. For example, the Congressional Budget Office found tiny health care savings - "0.3 percent from slightly less utilization of health care services" - if severe tort reform were passed nationally. According to the CBO, if there is any problem at all, it's with Medicare, specifically its emphasis on "fee-for-service" spending, whereas private managed care "limit[s] the use of services that have marginal or no benefit to patients (some of which might otherwise be provided as 'defensive medicine')."

But there is another issue. In these anonymous surveys, doctors never actually identify specific tests or procedures they have conducted for the primary purpose of avoiding a lawsuit, let alone a service they would no longer perform if severe "tort reform" were enacted.

Read more here.

The headline is not exactly shocking, so the real news may be why the issue of how long work days can cause doctors to make errors is so rarely studied.

For nurses and residents (doctors in training), plenty of studies have found that when work days stretch beyond twelve hours, more mistakes are made, and patients become vulnerable to malpractice and even smaller errors.

But a new study of radiologists is one of the first to examine the effect of long work days on the performance of attending level physicians. The researchers gave a set of bone X-rays to radiologists at the beginning of their work day, and again at the end. Then they measured their accuracy at finding fractures. By the end of the day, the radiologists were making around one in twenty more errors -- both missing fractures and seeing ones that weren't there -- than at the start of the day. It's a small but significant difference.

The study in the radiology journal concluded:

"After a day of clinical reading, radiologists have reduced ability to focus, increased symptoms of fatigue and oculomotor strain, and reduced ability to detect fractures."

Dr. Bob Wachter, a UCSF patient safety guru, has a thoughtful piece on this in his own blog, which he titled: Tugging on Superman's Cape. Read it here.

Dr. Wachter riffed off a story he heard about legendary heart surgeon Michael Debakey performing sixteen open heart surgeries in a single day, even in his eighties. While the Baylor staffer who told Wachter this story was awestruck at Debakey's stamina, Wachter wondered what it would be like to be patient No. 16.

For the rest of us, there's a lesson when facing elective surgery. Surgeons love to stack up patients back to back and operate from the early morning to late in the day. If we have any choice, we should opt for a place early in the queue. Why tempt the gods of fatigue?

Article first published as Fatigue Wears at Doctors' Work Performance Too on Technorati.

The news about a major government study that found 20 percent fewer deaths in a group of heavy smokers who got annual CT scan screening for lung cancer has a few more statistics that are sobering for the rest of us who pay the price as a society for this screening.

The study enrolled 50,000 smokers and gave half of them CT scans and half regular chest X-rays, every year for three years.

All enrollees had to have had at least a thirty pack year history of smoking (that's the same as one pack a day times thirty years, or two packs a day times fifteen years).

After three rounds of screening -- a total of 75,000 CT scans in 25,000 patients -- they found a total of 18,000 suspicious findings that needed follow-up -- biopsies with long needles or some other kind of surgery. That was about a one-in-four incidence of suspicious findings per screen.

In those 25,000 people, eighty-eight lives were saved from lung cancer death. (The lung cancer deaths totaled 354 people in the CT group versus 442 in the control group of another 25,000 patients who got chest X-ray only for comparison.) That's where the 20 percent number came from for the headlines.

So, bottom line: take 25,000 people, give them 75,000 CT scans, do further testing and surgery and more followup on 18,000, and save 88 lives.

Now, those are 88 very hideous deaths prevented. Lung cancer is one of the worst. But the delicate problem is that it's also self-induced by smoking most of the time.

So who should pay for all this testing? That's the kind of thing we need to have a national conversation over -- not hysterical shouting about so-called "death panels" -- but what can we really afford?

You can read the data from the government agency here.

And to see how the news media handle the story, contrast the AP story "CT scans modestly cut lung cancer deaths," with the Washington Post ("significantly cut..."). Which is more accurate? It depends on how you focus your microscope. My vote is with the AP's writer.

It was nearly a year ago that the U.S. Preventive Services Task Force caused a huge uproar with the mildest imaginable recommendation about mammograms, and now two physician researchers say it might be time to point out that certain emperors are wearing no clothes.

In their Sounding Board article in the New England Journal of Medicine, Drs. Kerianne Quanstrum and Rodney Hayward note that some of the harshest cries against the Preventive Services Task Force came from those doctors with the highest vested self-interest in maintaining the importance of mammograms: radiologists with the Society for Breast Imaging. Yet nobody seemed to notice the obvious conflict of interest.

As the authors note:

When a given service is successfully extended to more people with more intensity, the profession providing that service tends to grow in importance and profitability. In the United States, where medical specialists often enjoy an exalted status in the minds of the public, if experts shout loudly that every woman 40 years of age or older must be screened annually for breast cancer, then breast cancer must be important, screening must be a basic human right, and doctors who provide this service must have great value and authority.

But what if those experts are basing their recommendations on more than the interest of patients alone? In any other industry, we accept the idea as natural that those providing a service or product hold their own and their shareholders' interests as a primary objective. Why have we failed to acknowledge that the same phenomenon occurs in health care? Although it is true that individual medical providers care deeply about their patients, the guild of health care professionals — including their specialty societies — has a primary responsibility to promote its members' interests. Now, self-interest is not in itself a bad thing; indeed, it is a force for productivity and efficiency in a well-functioning market. But it is a fool's dream to expect the guild of any service industry to harness its self-interest and to act according to beneficence alone — to compete on true value when the opportunity to inflate perceived value is readily available.

The objective facts, as Quanstrum and Hayward point out, are that the well known economics law of diminishing marginal returns applies in health care as much as anywhere. In mammograms, as the rareness of the tested condition increases, the hidden costs of the test goes up and the value goes down.

So for women between ages 60 and 69, you can save one life by subjecting only 400 women to mammogram screening (in the process of 5,000 screening visits and 400 false alarms in the same group over 13 years of follow-up). That's enough of a benefit to encourage everybody in the age group to get annual screening.

But in women between ages 40 and 49, the data show that to save a single life, you need to subject 1,900 women to screening and endure 20,000 screening exams with 2,000 false alarm tests during eleven years of follow-up. That puts the risk-benefit equation in more of a gray area where you cannot say definitely that no one should have it, or that no one should not have the screening.

And that was exactly the point of the Preventive Services' recommendation: To put the issue into the hands of individual doctors and patients and let them decide if family history or individual anxiety are enough to make the patient want to have the test. That's not a cop-out, it's a prudent bow to individual self-determination.

Here's another quote from Drs. Quanstrum and Hayward:

We must acknowledge that just as in any other profession or industry, self-interest is unavoidably at work in health care. Rather than even acknowledging practice guidelines offered by vested experts, we ought to borrow from the wisdom of sound governance and implement a system of checks and balances when it comes to the interpretation and application of medical evidence. At the same time, we need to recognize that these two tasks are distinct. Although the interpretation of medical evidence is (or ought to be) a scientific exercise, the application of that evidence, as in guideline formation, is ultimately a social exercise.

Decisions regarding practice guidelines can, and certainly should, be informed by evidence. But they will always require value judgments regarding how much evidence is sufficient to dictate care, for example, or whether and to what degree costs should be considered. By separating the processes of evidence review and guideline formation, fair disagreements about the quality or substance of the evidence can occur separately from, and before, disagreements about the implications for clinical care.

If you're a man over age 60, remember this number: 2. That's likely to be the new cutoff number that shows if your PSA test needs followup.

The PSA blood test for screening men with high risk of prostate cancer has come under a lot of criticism for subjecting thousands of men to biopsies and surgeries that cause impotence and incontinence without any proven benefit of longer life expectancy.

But a new research study says that a simple cutoff number on the PSA test predicts quite accurately which men are likely to get aggressive prostate cancers that need to be cut out. The number is 2.0. It's not a perfect predictor, but it does put a man in a much higher risk category if he has that result after age 60.

As reported in the New York Times:

About one in four men will have a P.S.A. score of 2.0 or higher at the age of 60, and most of them will not develop prostate cancer, said the study’s lead author, Andrew Vickers, associate attending research methodologist at Memorial Sloan-Kettering. But the score does put them in a higher-risk group of men who have more to gain from regular screening, he concluded.

The higher the score at age 60, the greater the long-term risk of dying from prostate cancer, Dr. Vickers and his colleagues found. Men with a score of 2.0 or higher at age 60 were 26 times more likely to eventually die of the disease than 60-year-old men with scores below 1.0.

Still, the absolute risks for men with elevated scores were lower than might be expected. A 60-year-old man with a P.S.A. score just over 2.0 had an individual risk of dying from prostate cancer during the next 25 years of about 6 percent, the researchers found. A 60-year-old man with a P.S.A. score of 5 had about a 17 percent risk.

“Most of those men are going to be absolutely fine,” said Dr. Vickers. “But they can be told they are at high risk and they need screening.”

Men with a P.S.A. score of 1.0 or lower at age 60 had a very low individual risk of death from prostate cancer over the next 25 years, the study found: just 0.2 percent.

Now, what if you're in the middle group -- with a PSA between 1.0 and 2.0? That puts you in a low risk group -- but not so low that you never need to worry. The decision to get the PSA test should depend on your family history and your own fears and concerns.

Some cancer screening tests have been so well proven to save lives, like the colonoscopy, that if you don't get one, you need more than your colon examined (to borrow from an old Cancer Society slogan about mammograms). But it's now clear that mammograms don't fit into guilt-trip status anymore. Using radiation to find lumps in the breast that are too small to feel with your hands has only a slight benefit.

Here are the numbers from the latest analysis in the New England Journal of Medicine. For every 2,500 women in the prime screening age group -- 50 to 69 -- you would need to give all 2,500 a mammogram at least every couple of years for ten years to save a single life. And in the process, 1,000 of the same women would turn up with a suspicious result, 500 of those would need a surgical biopsy, and five to fifteen of those would get cancers removed, and maybe entire breasts, that if left alone would never threaten the patient.

The medical journal analysis was written by Dartmouth medical school Dr. Gilbert Welch, who has long been a skeptic of the mammogram as a sacred cow of must-do medicine.

That means that the decision to have a screening mammogram is very much up to the individual. Some may want to take the risk of becoming an unnecessary patient to avoid the deadly but small risk of a preventable death from breast cancer. Others will prefer the option that seems to work better: Good vigilance and attention to small lumps, and then if a cancer develops, make sure you're in the hands of a multi-disciplinary team of cancer doctors who specialize in the latest treatments.

Here's an article by Gina Kolata about the latest study from Norway, in the New York Times.

And here's what the National Breast Cancer Coalition has to say about the myths and truths of breast cancer.

Recent news reports suggest that getting only part of your colon scoped for precancerous lesions might be a good enough way to prevent colon cancer. But the real story is that whatever test you get, there is a wide variation in the quality of the colon examinations that doctors do, and out of hurry or poor training, some doctors miss a lot of lesions that should be taken out.

So if you want to have a safe, effective -- and potentially life-saving -- exam, you need to do some simple doctor screening to make sure the doctor is right for you.

The good news is it's not that hard. Research has found that two simple questions will bring out what you need to know to assure that all the trouble you're going through to get your colon examined will be worthwhile.

Before I lay out the questions, some quick anatomy to make this easy to understand:

The food we eat passes through the stomach and then through nearly thirty feet of small intestine before hitting the large intestine, or colon. The place where the small intestine joins the colon is called the ileocecal valve. It connects the ileum, the final part of the small intestine, to the cecum, the first part of the colon. The cecum is also where your appendix dangles off the end of the colon. In most people, the cecum and the appendix are in the right lower section of your abdomen. Intestinal contents travel from there vertically, in the ascending colon, up your right side toward the liver. The colon then turns 90 degrees to cross your belly from the right to the left. This section is called the transverse colon. Then the colon turns south in the descending colon, which runs down the left side of your abdomen. Finally it moves sideways one more time, in the sigmoid colon, which then reaches the rectum and the anus.

A colonoscopy uses a flexible telescope inserted through your anus to travel the entire length of the colon, to where it ends at the cecum. Most of the visual inspection by the doctor is done while the scope is being pulled back from the cecum to the exit at the anus.

A sigmoidoscopy, by contrast, only inspects the first foot or so of your colon. In some people, that's enough to find most precancerous growths. But in many, it's not. African-Americans, for example, have a higher rate of colon cancer in the further reaches of the colon beyond where the sigmoidoscope looks.

So the smart choice is to go with the full colonoscopy, even though the bowel preparation you have to undergo is more burdensome. That's the recommendation of the American Gastroenterological Association, the doctors' group that specializes in the intestines.

Now for the two questions to get the best chance of a good colon exam:

First, ask the doctor:

What is your detection rate of precancerous polyps?

(These are technically called adenomas). The rate should be at least 20 percent -- or 25 percent in men patients and 15 percent in women patients. A lower rate means the doctor is very likely missing precancerous lesions that are waiting to turn into cancer -- when the whole purpose of the colonoscopy is to find them and snip them off before they go bad.

The second question for the doctor:

What is the amount of time you typically take to inspect the entire length of the colon?

This answer should be at least six minutes. It takes that long to adequately inspect all the nooks and crannies.

Both these questions get at the same issue. You want to minimize the chance that a hurried examination will give you a clean bill of health by mistake.

How often does that happen? Frightfully often. In research published this year, the rate of colon cancers in people who had had a colonoscopy within the previous five years was ten times higher when the doctors who did the colonoscopy had a detection rate of ten percent or less, compared to doctors who had a detection rate of twenty percent or more.

Dr. Douglas Rex of Indiana University has written guidelines for his fellow gastrointestinal doctors about how to do an adequate colon exam. Dr. Rex is an advocate for careful comparison shopping by patients. In an article he wrote for fellow practitioners, he estimated that the doctors with the lowest detection rates are missing 75 to 90 percent of precancerous growths in the colon.

That's a huge number. But patients can do their part to make sure their colon cancers aren't missed by asking these simple questions before they undergo a colonoscopy.

A new survey in a medical journal says the overwhelming majority of doctors believe that defensive medicine is costing the nation billions of dollars a year and they need protection from malpractice lawsuits. But does it really add up?

There is no question that U.S. patients undergo many more tests and procedures than any other country, and that we don't show anything good for it in our health statistics compared to other countries with much more inexpensive care.

Doctors typically say their peers order unnecessary tests because the patient will sue them if they don't.

This has always struck me as a strange admission.

To get paid, doctors have to attest to the necessity of any test they order, so when they order these so-called defensive tests purely to protect themselves, they commit insurance fraud.

Of course, if there's any chance the test may help the patient by revealing a treatable problem, then the test was necessary and doesn't fall into the category of insurance fraud or defensive medicine. Yet many doctors seem to think it's only the extra threat of being sued for not ordering the test that pushes them over the line to ordering it.

The Wall Street Journal's Katherine Hobson wrote up the new survey on her health blog, which appeared in Archives of Internal Medicine, and drew some interesting comments from readers. One patient told his own story:

* Gerald wrote:

I have read comments here with interest. I have had a doctor tell me he was ordering a test on me more out of a fear of being sued, and that it “was probably not necessary.” I was shocked. I said, “Doc, you are telling me that if I have a brain tumor, and die, that is not a serious enough risk for me to have an MRI, UNLESS YOU COULD BE SUED FOR IT!” I had some severe headaches.

The doctor turned red with embarrassment, and perhaps shame. He apologized and said he did not realize what he was saying. He could only be sued if turned out to have a serious medical problem that could have been prevented by the test. He was admitting that my life was not enough motivation for the test, but if he could be sued for the lost of my life; then it was good motivation for the test.

The survey was not scientifically rigorous. As reported by the WSJ:

Researchers say that 91% of the 1,231 doctors who responded to their survey “reported believing that physicians order more tests and procedures than needed to protect themselves from malpractice suits.”

The "belief" by a survey respondent that some doctors order tests only to protect themselves is a far cry from admitting that one personally does this.

Another commenter, who identified himself on the WSJ blog as Rod Tucker Esq., wrote:

Every survey such as this one should require that the doctors give their names and specific examples of the tests they had done which they did not feel were necessary. Then their patients could ask why they were forced to undergo these often harmful and usually painful tests and why they were forced to pay for unnecessary acts by the doctor. The insurance company could also refuse to pay because the test was by definition unnecessary.

No person in business (doctors get paid for their work and are by definition in business) has the right to demand that they get to mess up and not be responsible to the innocent person they hurt. So instead of trying to give doctors a free pass how about we treat them like everyone else and ask the cost of a test and decide for ourselves if it is necessary, just like we do when we buy anything else.

Food allergies are frequently overdiagnosed because the two tests commonly used have less than a 50% accuracy rate, according to a new authoritative study. As a result, whereas three in ten adult Americans think they have one or another food allergy, the actual number is more on the order of one in twenty (5%) adults, and a little higher for children (8%).

The new study was sponsored by the National Institute of Allergy and Infectious Diseases, a branch of the NIH, and was reported in the Journal of the American Medical Association.

The skin prick test and the antibody test are the two main tests done for food allergies, but the only real way to know if someone has a true food allergy is to challenge their body by slipping them a small amount of the food and seeing if a rash or even bigger reaction results. That's a scary prospect for many patients, so the food challenge test is seldom done.

Another issue is that many people have a food intolerance -- like lactose intolerance due to a missing enzyme that breaks down sugar in milk -- but that is not the same as a food allergy, which happens when the person's immune system goes haywire in response to an allergen.

Read more in Gina Kolata's article in the New York Times and Katherine Hobson's WSJ blog article.

This study reinforces advice I give in my book, "The Life You Save." I don't think anyone should make major changes in their life based on one or two test results without making really sure that they have the condition. That can mean confirmatory testing, a second opinion, or just plain education so that you understand that no test result is 100%.

It's a wonderful, Star-Trek kind of fantasy: have a machine scan your body and turn up any abnormalities in minutes, with no pain, no inconvenience and little fuss. Some patients actually do it: with whole-body CT scans, or more targeted CT scans aimed at the colon (often called virtual colonoscopy -- President Obama had one) or the heart.

The problem is there's no good evidence yet that these scans are worth the expense or the huge dose of X-ray radiation that a patient receives: typically the equivalent of 400 chest X-rays with a single CT scan.

General Electric, a manufacturer of CT scan machines, is trying to get the Food and Drug Administration to give its official approval to the use of CT scans as a substitute for traditional colonoscopy. The application is still pending. At a hearing this week, FDA scientists are expected to complain about the pressure they felt from agency superiors to approve the application despite their concerns about the radiation risks. Read more on this in an article by Gardiner Harris in the New York Times.

Whole body screening with CT scans is something that few sober doctors recommend, unless they own one of the machines. The FDA has a good discussion here explaining why an apparent "abnormality" found with a whole-body scan can mean nothing, while the scan can also miss true disease.

The bottom line is that the images produced by these machines are good, but not good enough to start cutting out the abnormalities they seem to show. With colon, heart and other body parts, no surgeon will operate based solely on a CT scan. They want a closer look with a scope that shows the actual organ -- as a colonoscope does.

The other important fact to know about whole-body screening is that if you feel good and have no disease symptoms, the odds are very high that nothing is wrong with you. No screening device yet beats the human brain at picking up signals of abnormality (with a few exceptions like the silent disease of high blood pressure).

When a 44-year-old male friend dropped dead the other day from a massive heart attack -- no prior symptoms, no warning of any kind -- I wondered if modern medicine could have done anything to prevent the tragedy. The answer I learned is that low-tech still beats high-tech hands down in preventing America's No. 1 killer.

Low-tech means getting regular exercise, eating right and paying attention to cholesterol, blood pressure and the other risk factors for heart disease, and it also means moving fast to get to a medical facility with any symptoms whatsoever that might be signaling heart attack. Those are the proven ways to lengthen your life span and avoid early death.

But my friend didn't have any symptoms or risk factors. What could he have done? That's where high tech comes in, but the answers are not encouraging. The available treatments are expensive and not very effective for people without symptoms.

He could have had the gold-standard test for narrowed arteries in the heart: an angiogram. That's an X-ray movie of the arteries that involves putting a tube into the groin, threading it up to the surface of the heart, and squirting dye through the tube to outline the inside of the blood vessels as high-speed multiple X-rays are taken. I've watched these movies for some of my medical malpractice lawsuits, and they are eerily fascinating: the dye looks like smoke as it pushes out of the tube and mingles with the blood in the arteries, which suddenly light up as if a switch has been turned on, with the heart quivering all the while behind the arteries.

The problem is that most of the time, angiograms on people without chest pain symptoms show nothing. Even when there are some symptoms, the angiogram is just as likely to turn up clean as a whistle, or with only minor narrowing, as it is to show serious disease.

A new study in the New England Journal of Medicine of 400,000 patients found that the odds of finding operation-worthy heart disease in patients getting a first-time angiogram without any known heart disease was only four in ten -- which means that the $2,500 procedure was wasted on six of every ten patients.

Now, you might think that the angiogram can still be worthwhile if it shows some blockages that can be cleaned out. But that's true ONLY IF those blockages are causing symptoms. The usual technique to unblock arteries -- with a balloon and a wire scaffolding (stent) to hold open the artery -- has been shown to work to relieve symptoms of chest pain, but it does NOT extend life in symptom-free patients. In those patients, it's thought that the heart has already learned how to deal with the blockage by shifting blood from another supply.

Here is a very good article from Harvard Medical School on who should get the balloon treatment -- called angioplasty -- and who shouldn't.

The bottom line: Angioplasty can save your life during a heart attack if it can be done fast enough to open the artery before permanent damage is caused to the heart muscle. But for symptom-free patients, angioplasty is worthless and exposes patients to the risk of dying from a complication of having wires and tubes poked into your heart. And for patients with non-debilitating chest pain, angioplasty doesn't work any better than taking drugs and making lifestyle changes.

People who get chest pain and learn they have heart disease should think of the pain as a gift from on high: It's given them a chance for a new lease on life. But for people like my friend whose first symptom is a fatal heart attack, there's not much that medicine can do. We're all fated to die at some time, and we haven't learned how to defeat fate. We can and should pay close heed to getting plenty of exercise, eating right and doing other things to lower our risk. But the risk will always be there.

The man who discovered the PSA test for prostate cancer now says the test is so overused it has become a public health disaster with an annual price tag of $3 billion in wasted testing.

Dr. Richard Ablin writes an op-ed piece in the New York Times calling for the test to be abandoned for routine cancer screening for men over age 50. At most the test is useful in men with a family history of prostate cancer and also useful to detect cancer coming back in men who have already has their prostates removed for cancer.

Dr. Ablin notes that the appropriate use of the test is a tiny portion of the amount of testing now occurring, driven by those who profit from use of the test. He concludes:

I never dreamed that my discovery four decades ago would lead to such a profit-driven public health disaster. The medical community must confront reality and stop the inappropriate use of P.S.A. screening. Doing so would save billions of dollars and rescue millions of men from unnecessary, debilitating treatments.

As this blog noted in an entry a year ago, large studies have been published showing that the PSA test saves very few, if any lives, when used for routine screening, and it causes many men to undergo unnecessary, painful and potentially harmful biopsies and surgery.

The political brouhaha that followed the new guidelines on mammograms has now died down, maybe enough so that patients can start to absorb the quiet truth about breast cancer and the role of mammogram screening.

The National Breast Cancer Coalition has worked since 1991 to get Congress to fund research and appropriate treatment for this disease. The Coalition believes in sticking to the facts and analyzing closely the research studies that have been published about what mammograms can and cannot do for women who aren't aware of a lump in their breasts.

Here is an excerpt from their discussion of the US Preventive Services Task Force recommendations:

Has breast cancer screening had a significant impact on mortality from breast cancer?

No, over 40,000 women continue to die of breast cancer each year, despite the emphasis on breast cancer screening in our country. To change this, we must address the facts about breast cancer and not simply accept what we want to believe. The fact is that all breast cancers are not equal and that we don’t currently have tools for “early detection” that are good enough for the life-threatening breast cancers.

But doesn’t early detection save lives?

Not necessarily. Some breast cancers are slow-growing and have a good prognosis, whenever they are found, whether small or large. Other breast cancers are aggressive and fast growing, and we don’t have the tools to catch them early enough or treatments that will work.

Why doesn’t mammography work as well for women in their 40s?

Younger women have more dense breast tissue, making mammography less accurate. Also, mammography is better at detecting slower growing tumors more common in older women, than the fast-growing, aggressive tumors more often found in younger women. And the balance of benefit vs. harm changes as women get older since the likelihood of breast cancer increases with age. The disease is relatively rare in younger women.

But shouldn’t a woman in her 40s have a mammogram if she feels a lump?

Certainly. The Task Force recommendations are meant to be guidelines for broad public health policy for healthy women with no symptoms, and an average risk for breast cancer. These guidelines are not meant for any woman with an increased risk or for any woman who feels a lump or change in her breast. Women who have any concerns need to visit their doctors and may need diagnostic mammograms. Mammograms taken to assess a problem are not the kind of mammograms we are talking about with these guidelines.

What’s the harm in trying to detect breast cancer early, even if our methods don’t work that well?

The harms from screening too early or too often include increased false positives, leading to increased imaging and radiation exposure, biopsies and scarring that can affect the accuracy of future mammograms, and anxiety. There is also the harm of overdiagnosis of breast cancer. This would involve treatment of cancers that would never be life threatening, and treatment of cancers that may regress, or go away on their own. The treatments for breast cancer are not aspirin, they are toxic and can be life threatening; the scenario of overdiagnosis should not be taken lightly.

The cancer coalition supports the Task Force's recommendation that women who are not in a high risk category (from a family history or presence of the BRCA gene) start thinking about mammograms around age 50, not age 40.

Here is another useful summary from the National Breast Cancer Coalition: 31 Myths and Truths about breast cancer. You can read it here.

We have discussed the statistics behind breast cancer screening in several entries on this blog. Read them here and here and here. My belief is that women need to understand the numbers and then make a personal choice. Politicians don't need to enshrine mammograms as some sort of constitutional right, as happened in the US Senate not long ago. We need more compelling evidence before this screening device goes onto the "do not touch" pedestal.

The new breast cancer screening guidelines demonstrate yet again why savvy patients need to understand the numbers behind risk/benefit studies before making the very personal decision about whether and how often to get a cancer screening test.

The recommendations of the U.S. Preventive Services Task Force that women hold off on routine mammograms until age 50, and then get one every couple of years instead of every year, are based on sophisticated statistical modeling that aimed to get the most benefit at the least harm. The benefit is saving lives. The harm is overdiagnosing, overtreating, and needlessly frightening women who receive "false alarms" with mammograms.

The key fact that women -- and all patients -- need to understand is that your risk of a "false alarm" depends on your risk for the disease. The lower your natural risk of disease, the higher the risk of a false alarm, and vice versa. The reason the task force said that women between ages 40 and 49 don't need screening is that with the low risk of disease in that age group, the chance of needless false alarm is much higher, and the benefit of discovering the occasional cancer is much lower.

For example, one statistical model, called the Stanford model, which the task force looked at, concluded that if women between ages 40 and 69 got mammograms every year, there would be on average 2,250 false alarms -- "false positive" results -- in every 1,000 women -- an average of two per woman tested over ten years. On the other hand, there would be a total of 164 years of life gained among these 1,000 women. When the mammograms were reduced to every other year, and only given between ages 50 and 69, the years of life gained were 99 and the false alarm rate went down to 780 per 1,000. That is the tradeoff.

Those extra 65 years (164 versus 99) of life gained among the 1,000 women also come at an economic cost: if 1,000 women have to get 10 mammograms each over 10 years, that cost is around $10 million (assuming $1,000 per mammogram).

We don't like to think about "rationing" medical care, but sensible decisions on both a personal and societal level have to take into account how much we're spending for how much gain, and what else the same amount of money could be spent on.

In my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst," I have an extensive chapter on the risks and benefits of breast cancer screening at different ages. Here is an excerpt:

What about saving lives with screening tests intended to catch early cancers? Here is how that statistic of a 25 percent reduction in deaths translates in the real world. If you thought that means that of every 100 women screened, 25 of them would be saved by mammograms, you would be making a natural assumption that many others have made, but you would be very far off the mark. The actual numbers come from a series of studies in Sweden involving some 280,000 women. Of those over age forty who did not undergo mammograms, 4 in 1,000 died of breast cancer over the ten years of the study. Of those over age forty who did have mammograms, 3 in 1,000 died of breast cancer over the same ten years. The reduction from 4 to 3 per 1,000 is where the 25 percent number comes from. Put another way, for every 1,000 women who participate in mammogram screening for ten years, 1 of them will be saved from dying of breast cancer.7 The odds of saving 1 life are a little improved if screening begins only at age fifty instead of forty. Of every 270 women who start screening mammograms at age fifty and undergo one every other year for the next twenty years, 1 life will be saved—or about 4 in 1,000, which is a lot more than the 1 in 1,000 lives saved for starting mammograms at age forty.

The new statistics from the Preventive Services Task Force concluded that the benefit from mammograms in women aged 40-49 was even lower than the Swedish estimates -- more on the order of one life saved for every 1,900 women screened, instead of one in 1,000.

Here's the bottom line, as I put it in my book:

Are those kinds of odds worth it to undergo the trouble of regular screening? That is a personal decision. My only point is that to make that decision rationally and realistically, you need to look at the numbers with eyes wide open.

I took a deposition a few days ago that underlined for me why we need to have public report cards on primary care doctors so that patients can separate the mediocre practitioners from the really good ones. I wrote an article explaining the idea. Read my entire piece on Huffington Post, which I called "One Good Reason to Get Mad About Health Care."

Swine flu testing is the latest example of an important issue for informed patients. Patients need to understand that some medical tests are valuable if there is a "positive" finding, but not much good at all if they are "negative." The problem is that the test is "insensitive," which means a negative result can miss the disease that's really there -- a "broken alarm."

For swine flu, in every 100 patients who actually have flu, the various brands of "rapid flu" tests will have a "positive" result (meaning the patient has the flu bug) for as few as ten of the 100 patients, or as many as 69 of the 100 patients. Even with the higher accuracy, that means that a lot of patients are being missed by these "rapid flu" tests. These statistics come from a New York Times article quoting newly published studies and experts in the field including the Centers for Disease Control and Prevention.

A CDC official told the Times:

“We’re saying you need to understand the limitations of these tests,” Dr. Timothy M. Uyeki, an author of the C.D.C. guidance, said in an interview. “The clinician should not base a decision to treat or not treat on the basis of a negative result.”

Another classic example of an "insensitive" test is the "hemoccult" test for hidden blood in the stool. If it's positive, you need further workup. If it's negative, it doesn't give you a clean bill of health for colon cancer. That's why the standard screening test for colon cancer is a colonoscopy, which looks at the entire length of the colon with a video camera.

My book "The Life You Save" has a chapter about understanding medical testing and why you cannot necessarily rely on a negative test result.

The point is: A negative result doesn't mean you have a clean bill of health. Sometimes you have to pay attention to other signs and symptoms.

Imagine if every 50-year-old woman thinking about whether to have a mammogram received the following "balance sheet" showing the "credits" and "debits" as understood by the latest research:

For every 1,000 women who have a yearly mammogram over the next ten years: Credits

1 woman will avoid dying from breast cancer

Debits
2-10 women will be overdiagnosed and treated needlessly

10-15 women will be told they have breast cancer earlier than they would otherwise have been told, but this will not affect their prognosis

100-500 women will have at least one "false alarm" (about half of these women will undergo a biopsy)

These numbers appear in an editorial in the British Medical Journal in July 2009, written by Dartmouth researcher H. Gilbert Welch, M.D., in response to news that the British National Health Service had scrapped a proposed pamphlet that would have described the benefits of mammograms, but failed to talk about their downside.

The key comparison in the above balance sheet is the ratio of one woman's life saved for every two to ten lives harmed by overdiagnosis. The one-to-two ratio comes from a study three years ago by Zackrisson and colleagues. The one-to-ten ratio is from a more recent study by Gotzsche. The tipping point for women in deciding whether to undergo annual mammogram screening is probably somewhere on this sliding scale. The test might not feel worthwhile if ten women are hurt for every one helped, but might seem worth it if only two were hurt for every one helped.

As the author writes:

Mammography is one of medicine’s "close calls"—a delicate balance between benefits and harms—where different people in the same situation might reasonably make different choices. Mammography undoubtedly helps some women but hurts others. No right answer exists, instead it is a personal choice.
To inform that choice, women need a simple tabular display of benefit and harms—a balance sheet of credits and debits.

Unfortunately, medicine hasn't yet pinned down the precise numbers on the balance sheet. For now, women need to be informed that there are varying estimates, and they need to make their own decisions.

Readers should note that this discussion applies only to cancer screening in low-risk women who have no noticeable lumps; women who can feel a lump in their breast are in a different risk category and need to see a doctor promptly.

Everyone has seen the ads: for cancer of the breast, prostate, colon and now thyroid cancer -- urging Americans to get a test to see if they have cancer and can get early life-saving treatment.

The new thyroid campaign says: "Don't forget to check your neck." However, it's a rare disease that kills about 1,600 Americans a year, but that many millions now may worry about because of this well-meaning campaign.

The trouble with cancer screening, as previously discussed in this blog about mammograms and prostate cancer PSA screening, is that in completely healthy people who have no symptoms and no special risk factors, screening can turn up far more false alarms and bring about dangerous and unneeded treatment, than the good that is done when a few cancers are caught.

A new article by Natasha Singer in the New York Times makes this point about the new thyroid media campaign, plus a proposal by Florida Congresswoman Debbie Wasserman Schultz to spend $45 million in federal money on a campaign to teach women under age 40 about how to examine their breasts. Critics of that proposal, including cancer surgeon Susan Love, say there is no benefit in early testing of women in their 20s and 30s for breast cancer. Dr. Love wrote the congresswoman: "Once you have made women more 'aware' of their potential risk, you will have nothing to tell them to do!"

The U.S. Preventive Services Task Force, a group of independent experts, recommends routine screening for only a few kinds of cancers, and breast mammograms for women under age 50 are the weakest of their recommendations. According to the article:

for otherwise healthy people with no symptoms,[Dr. Ned Calonge, chairman of the Task Force] said, only a few routine tests have proven to significantly reduce cancer deaths among certain age groups. The task force recommends pap smears for cervical cancer beginning no later than age 21; regular mammograms to screen for breast cancer in women starting at age 40; and tests for colon cancer starting at age 50. And the task force notes that the evidence supporting the breast cancer screening is not as strong as for cervical and colon cancers.

Most other types of screening, meanwhile, have not been proved to reduce the death toll from cancer, said Dr. Kramer at the National Institutes of Health.

“You need a high bar of evidence to start advertising screening to healthy people, most of whom will not benefit,” Dr. Kramer said.

One important caveat: Nobody should ignore symptoms. Once something bothers you or changes or seems unusual, you are no longer in the category of routine screening. Your risk is much higher and you should be checked promptly.

I discuss the reality behind cancer screening numbers in Chapter 8 of my new book on health care, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst." The title of Chapter 8 is: “Should I Be Tested?” Why Understanding the Numbers Is Crucial.

A good book entirely focused on this topic is by Dr. H. Gilbert Welch of Dartmouth, called "Should I Be Tested for Cancer?: Maybe Not and Here's Why."

Evidence continues to pile up for why patients need to read their own medical records. A new study finds it is distressingly common for primary care practices, especially big ones, to fail to inform patients about abnormal test results.

The study was published in the Archives of Internal Medicine and was reported by Nicholas Bakalar in the New York Times. The study was also featured in Tara Parker-Pope's "Well" blog at the Times, which features a number of horror story comments by readers.

Overall, the study found seven times out of 100, abnormal test results were not conveyed to patients. In two large primary care practices, one in four abnormal test results were never mentioned to the patient.

Bottom line: Patients who don't hear back the results of their testing can never assume that no news is good news. People need to ask for a copy of their test results from either the doctor's office or the lab where the test was done.

Getting and reading your own medical records is Step One in the nine-step system I recommend for getting the best medical care, in my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst."

The received wisdom of cancer treatment in the United States is that early detection and early treatment save lives. But this is not always true with some types of cancer. Sometimes the early detection of a cancer just means the patient lives longer with the knowledge of having cancer, but their life span is the same as it would have been with later detection.

A new study of women with ovarian cancer has found that women who undergo blood tests every few months to check for early signs of recurrence of the disease do not live any longer than women who wait until they feel symptoms from the cancer's return. The test is called CA125.

As reported by Andrew Pollack in the New York Times, the new study was presented at the annual meeting of the American Society of Clinical Oncology.

The reason that the CA125 test doesn't help is that some cancers are resistant to chemotherapy, so whenever treatment is started, it doesn't matter, and others are very sensitive to chemotherapy, so that they can be knocked back whether treatment is started early or a few months later. This is according to the lead author of the study, Dr. Gordon Rustin of the Mount Vernon Hospital in Middlesex, England.

Peace of mind is an important related issue. A lot of patients experience anxiety when they are waiting for the results of the periodic tests. For some, the knowledge makes them feel in control; for others, the anxiety is too much and they would prefer not to know. So getting the test becomes a very individual decision.

If you are pregnant and experiencing fatigue, dry skin, sleep loss, or weight loss, it may be worthwhile to find out whether you are a candidate for a thyroid test – these symptoms, while common in pregnant women, may be caused by underactivity (hypothyroidism) or overactivity (hyperthyroidism) of the thyroid gland.

If untreated during pregnancy, both conditions have been shown to result in higher risks for miscarriage, premature birth, preeclampsia, and even impaired intelligence in the child (in the case of hypothyroidism). But does such risk necessarily warrant a universal recommendation for thyroid tests in pregnant women? Ingfei Chen explores an ongoing debate on this issue in a New York Times article.

The thyroid gland produces hormones that regulate many important aspects of our bodies, including metabolism, body weight and heart rate. When there is too much of this thyroid-stimulating hormone (TSH), the pregnant woman suffers from hyperthyroidism and experience poor sleep, weight loss, and nervousness after giving birth. On the other hand, when the thyroid gland is underactive, the resulting hypothyroidism causes fatigue, weight gain and dry skin. Both conditions are manifested in very subtle symptoms but are risk factors for dangerous pregnancy complications.

While both an overactive and an underactive thyroid spell trouble for pregnant women, hypothyroidism is the more common and worrisome condition. Hypothyroidism, affecting 10 to 20% of women of childbearing age, is often undiagnosed but hampers fetal brain development. A study done 10 years ago reports that 19% of children born to women with untreated hypothyroidism had an IQ of 85 or lower, whereas the same measure was only 5% for those born to mothers with a healthy thyroid.

Although risks of an imbalanced level of TSH are known, the medical field is currently split on whether there is sufficient existing evidence for the benefits of treating the condition, and subsequently, of recommending universal screening. Studies are underway to track pregnant women with healthy and underactive thyroids, and their children will be tested for IQ. Until scientists arrive at conclusive results, the general clinical policy is to recommend a thyroid test to high-risk women (for example, a woman with family history of thyroid problems). However, more doctors have begun recommending the test to normal-risk expecting mothers, and many think that evidence for universal screening will soon be available, according to Dr. Stagnaro-Green, an endocrinologist at Touro University College of Medicine in New Jersey.

Widely hailed for saving lives through early detection of breast cancer, mammography may in fact “do more harm than good,” writes Roni Rabin of the New York Times. Rabin reports that British health care advocates and experts complained in a letter to The Times of London that candidates for mammography receive informational fliers that exaggerate the exam’s benefits and neglect to advise patients of potential harms.

Mammography detects cancers indiscriminatingly, picking up aggressive tumors as well as those so slow-growing that they present no health risks for women who have them. As a result, for every woman saved from deadly breast cancer by routine mammography, at least one other woman would have her life unnecessarily disrupted by overtreatment of a slow-growing cancer that’s not life-threatening.

Mammograms also often result in "false positive" reports which scare women who think the test has shown they have a deadly cancer when further testing shows they have no disease. This is particularly a problem when mammograms are used in low-risk groups like women under age 50.

Further, early detection of the deadly form of breast cancer may not necessarily be life-saving, says Dr. Ned Calonge, chairman of the United States Preventive Services Task Force, which writes consensus reports on all sorts of screening tests, because the cancers are too aggressive to treat even when found early.

In addition to unnecessary emotional distress and extraneous treatment and related costs, other potential harms of mammography include exposure to radiation during the exam.

On the other hand, many doctors, including the director of cancer screening for the American Cancer Society, still believe mammography should be recommended to women of normal risks for breast cancer (e.g. over 50 years of age, family history of the cancer), preferring overdiagnosis to delayed diagnosis.

Before a more definite conclusion is reached within the scientific community, patients should educate themselves about the benefits and harms of mammography, because the ultimate decision of whether to be screened is in their own hands.

The PSA screening test for prostate cancer causes far more men to undergo unnecessary and harmful treatment than it saves lives, according to two large new studies. As reported by Gina Kolata in the New York Times, one study that followed 77,000 American men for a decade found zero benefit in lowered death rates, while the other study, which followed 182,000 Europeans for nine years, found that only seven lives were saved for every 10,000 men screened with the blood test.

And for every one of those saved lives, forty-eight men were told they had cancer and underwent unnecessary treatment. That treatment can cause impotence or incontinence if it involves surgery, or problems with bowel elimination if it involves radiation.

The problem is not so much the test but the disease. Prostate cancer is usually very slow to grow, and in the cases where it is aggressive, it may already be too late to save the patient when it is discovered.

Both studies were published in the New England Journal of Medicine.

The same issue, on a less dramatic scale, applies to mammography screening for breast cancer. According to Dr. Michael Barry, who wrote an editorial in the NEJM accompanying the research studies, about ten women receive a diagnosis of breast cancer and undergo needless treatment for every one woman whose life is saved after having a mammogram. Breast cancer is much more dangerous than prostate cancer, so screening can still be warranted.

What doctors need, and still do not have, is a way to sort out cancers that would be deadly without treatment from those that would not.

The bottom line for patients is to ask careful questions of your doctor and understand the numbers before you decide whether cancer screening is right for you. Patrick Malone's new book, The Life You Save, has a chapter that helps patients sort through the statistics of cancer screening.

It's always intimidating to undergo an MRI scan or CT scan. The machines are loud and enormous and seem to swallow your body. For all the trouble and expense, patients deserve the very latest scanning equipment and should have their images read by only the most highly qualified doctors. Alas, there is a quiet scandal in the $100 billion/year medical imaging industry. Patients cannot count on the best unless they insist on it.

As quoted by Gina Kolata in the New York Times, radiology leaders say, in the words of one: "The system is just totally, totally broken." That from Dr. Vijay Rao, chair of radiology at Thomas Jefferson University Hospital in Philadelphia. One big problem is that insurers pay standard rates for scans, even if a scan on a 10-year-old machine produces a blurry image and results in patients undergoing unnecessary surgery or missing a diagnosis. There is also no financial incentive for scanning facilities to have the images interpreted by sub-specialists with more expertise in the body part being studied. But there is a big financial incentive for doctors to own their own scanning equipment, and that results in many unnecessary referrals for scans when the doctor's judgment about the patient's needs is clouded by financial conflicts of interest.

Wise patients should ask pointed questions before submitting to any imaging scan. Here is a list, adapted from Patrick Malone's new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, available at Amazon.

1. Is the scanning machine the latest generational available? If not, is there another facility nearby that has the latest generation? (In MRI scans for example, the stronger magnets on newer machines make for crisper images.)

2. Does the doctor who wants me to have this scan own the scanning equipment or the scanning facility? (If so, get an opinion from another doctor with no financial interest about whether you need the scan at this facility.)

3. Who will interpret the images? Is that doctor a sub-specialist in what's being studied? (Examples of radiology sub-specialties include musculo-skeletal, neuroradiology (brain and spine), abdominal and chest.) If not, can we get a second reading from a sub-specialist?

4. Is the scanning facility accredited by the American College of Radiology? (This ensures that basic standards are met, such as the technologist who runs the scanning machine being certified and the machine being regularly inspected for proper functioning.)

Involved patients will also want to sit down with the doctor and look at the images together. You will notice how much more detail comes out when the scan has been done on an up-to-date machine by well-trained personnel. In the New York Times article, you can see in a knee scan how the ligament is blurry on the left-side image but comes out clearly in the image on the right -- a slanting striated structure that connects the middle of the top of the tibia to the back of the femur.

One of the less common forms of cancer, oral cancer was diagnosed in about 35,300 Americans last year and caused the death of 7,600 people. Although oral cancer is one of the easiest to detect and diagnose, the five-year survival rate is only 59%, and more than 60% of cases are diagnosed in the late, incurable stages – which may be a result of people not regularly visiting their dentists or not asking to have visual exams, reports Laurie Tarkan of the New York Times.

The most effective way to screen for oral cancer is to carefully look for it. The dentist or dental hygienist should examine the cheeks, the gums, the floor of the mouth, the area behind the teeth, the palate and the tonsil area (pulling the tongue forward), and should feel the lymph nodes of the neck. Such visual exams are found to reduce mortality by 34% in a study done in India. Emerging on the market are alternative tests and devices that may be more sensitive than the traditional visual exams. However, no decisive study has been done to prove that the more expensive tests are necessarily better.

Dentists encourage patients to get a thorough visual exam every year, and they recommend it not only to the high-risk groups (smokers and heavy drinkers) but to every adult, because oral cancer has recently been linked to oral HPV, which is transmitted through oral sex.

Colonoscopy is widely known as a powerful screening/early detection test for colorectal cancer, capable of preventing, or so it was thought, up to 90% of cancers. However, recent studies show that colonoscopy misses many cancers, according to the New York Times in an article by Gina Kolata.

A newly published Canadian study documents the low success rate of colonoscopy in picking up cancer in the right side of the colon, an area where 40 percent of cancers occur. In the left side of the colon, the area directly above the rectum, where cancers should be easier to detect, colonoscopy missed a third of occurrences.

Does that mean patients should dismiss colonoscopy as an ineffective test? Quite the contrary. Although colonoscopy is now found to prevent only 60% of colon cancer deaths, it’s still “a good test,” said Dr. Ransohoff, gastroenterologist at the University of North Carolina. In the Times article, Kolata points out that colonoscopy works relatively well, in contrast with other screening tests: Mammograms prevent 25 percent of breast cancer deaths and the Prostate-Specific Antigen (PSA) test has not been proven to prevent prostate cancer deaths.

In addition, patients can help maximize colonoscopy’s effectiveness by doing their homework. Dr. Douglas Rex, Indiana University’s director of endoscopy and professor of medicine, said that polyps in the colons may be obscured if patients did not thoroughly cleanse the bowels. Taking half of the laxative the night before the test and the other half in the morning – a procedure not always done – can help clear out patients’ systems and improve the visibility of the inner wall of the colon.

Researchers also urge patients to seek out the best colonoscopists who are skilled in performing the test consistently. Patients should ask how many colonoscopies the doctor does each year (a good volume would be three to four colonoscopies a day), what percent of those turn up polyps (it should be around 25% in men and 15% in women; much lower suggests that the doctor is missing some), and how long the scope is in the colon (colonoscopists should take at least eight minutes to withdraw the endoscope; too short a time suggests a hurried look).

A torn meniscus that shows up on the MRI scan may not be the reason why your knee is hurting. For Cheryl Westein, who demanded an MRI and saw a torn cartilage on the scan, the culprit behind her painful knee was actually arthritis. Gina Kolata in a New York Times article reports recent scientific findings that further support what many physicians already believe: radiological imaging is a presurgical tool and “does not help with a diagnosis.”

Dr. Felson and Dr. Modic, in their separate studies, found that abnormalities in scans are common and are not conclusive evidence of a diagnosis. For example, 60 percent of healthy people who do not complain of back pain will turn out to have degenerative changes in their spines. Many abnormalities go away on their own in a few months, requiring no medical intervention.

Relying on scans for diagnoses can lead referring physicians to recommend “unnecessary or sometimes even harmful treatments, including surgery.” If the root cause of the knee pain is arthritis and not the torn meniscus, the pain will return even after a surgery repairing the meniscus, as the arthritic bones continue to wear down the cartilage.

It is important for patients to know that getting radiological imaging is often not the best way to find out what is causing their discomfort. More importantly, since scans reveal abnormalities that may not be “catastrophic findings”, doctors could be misled to recommend harmful regimens that result in extra expenses.

Patients who go in for MRIs are often told nothing is wrong, when in fact the scan is of poor quality and so misses the problem, as Gina Kolata's story demonstrates.

Doctors all agree that it is a good idea to get MRIs and other scans done at centers accredited by the American College of Radiology. But, they caution, there is a wide range of quality among those centers. Quality depends on the quality of the imaging coils put around the body part being scanned, the skill of the technicians and the expertise of the doctor reading the image:

At Massachusetts General Hospital, for example, Dr. Gazelle said, “musculoskeletal M.R.I.’s are read by someone who does musculoskeletal imaging every day” — and not “by someone who reads chest M.R.I.’s one day and musculoskeletal M.R.I.’s the next.”

Dr. Forman says it pays to check the credentials of a center’s radiologists.

“If you say, ‘Who will be reading my scan?’ and they say, ‘One of our radiologists,’ you don’t go to a place like that,” he said. (I checked the Web site of the first center I went to. The radiologist who read my scan was a generalist with no special training.)

It also pays to ask the radiology center whether it has the latest generation of scanners. The stronger the magnet in the MRI machine (the "M" in MRI stands for Magnetic), the higher quality the image it produces.

Misreadings of MRI scans can cause tragic, preventable injuries to patients, as our firm's experience has shown.

The other piece of advice we can extract from the article is not to place absolute faith in a first-time scan that turns out negative. If the scan is negative and you feel that something is still wrong--like there is still severe pain--it is worthwhile to get a second opinion.

An online service called inSPOT allows patients who test positive for STDs to use a website to notify sexual partners, anonymously if they so choose, of the possibility that the partners were infected. A report done by the San Francisco Department of Public Health finds that since 2004, 30,000 people have used the service to send 50,000 notifications of all sorts of diseases contracted through sexual activity.

This project has enormous potential health benefits because embarrassment and a desire to remain anonymous are factors that can prevent people from notifying past sexual partners of their risk of contracting the disease. Of course, as Dr. Richard Rothenberg of Georgia State University notes in the article, it is difficult to track the effects of the project because of confidentiality issues. Nevertheless, the project is valuable:

However, it may be difficult, if not impossible, to study the impact on health because the service is confidential, Rothenberg said. "I think we, and the authors, must be content with the idea that this appears to be an acceptable method to fulfill the moral imperative of notification, and it has a chance to be a better approach than what we currently do," he said.

A new LabCorp blood test called OvaSure is aimed at early detection of ovarian cancer, but OB-GYNs doubt its efficacy and safety, as false positives might lead to unnecessary surgery and extreme anxiety. Ovarian cancer often goes undetected until later stages, by which point it can be too late to treat it effectively. A test that makes early detection more feasible would therefore be a wonderful thing.

From the article:

The need for such a test is immense. When ovarian cancer is detected at its earliest stage, when it is still confined to the ovaries, more than 90 percent of women will live at least five years, according to the American Cancer Society. But only about 20 percent of cases are detected that early. If the cancer is detected in its latest stages, after it has spread, only about 30 percent of women survive five years.

But far from greeting the new test with elation, many experts are saying it might do more harm than good, leading women to unnecessary surgeries. The Society of Gynecologic Oncologists almost immediately issued a statement saying it did not believe the test had been validated enough for routine use.

“You’ve got industry trying to capitalize on fear,” said Dr. Andrew Berchuck, director of gynecologic oncology at Duke University and the immediate past president of the society. “We’d all love to see a screening test for ovarian cancer,” he added, “but OvaSure is very premature.”

The test is good news if it is indeed valid, but raising false hopes and causing unnecessary procedures and stress is an adverse consequence of all this hype.

The NY Times Well blog has a podcast of Dr. John Hickner, professor of family medicine at the University of Chicago, discussing why patients should always call their doctors to follow up after having a medical test done.

We have previously discussed the issue of medical test results getting lost in transmission: the patient will expect the doctor to call if there is bad news, and will feel reassured if he or she hears nothing, while the doctor's office will wait for the curious patient to contact them, or will simply forget, and the patient "falls through the cracks." As a result, the patient may not hear about important test results.

The best way for patients to deal with this is to remember to call their doctors after testing and keep in mind that no news is not necessarily good news.

Another thing that patients can do is always ask the testing facility for a copy of the test results. Some laboratories and radiology offices resist this, but every patient has a right to their own records.

Serious injuries can happen to patients from delayed treatment due to these failures of communication, so it's important for patients to be pro-active about their test results.

A new study from the journal Quality and Safety in Health Care, and discussed in the NY Times Well blog, reveals common testing mistakes by primary-care doctors. Of course, the same kinds of errors can happen in hospitals and other health care settings.

Out of close to the 1,000 mistakes experienced by 590 patients, the following testing mistakes were the most common:

-13% involved ordering the wrong test or failing to order a test

-18% involved performing the right test, but doing it improperly

-25% involved delays in getting tests back from the laboratory, failure to get the tests back at all, or errors on the results report

-7% involved failing to follow up with patients after receiving results from the laboratory

-75% of the mistakes caused the patient to suffer (through delays in proper treatment, greater expense, physical pain or worsened overall health).

What can a patient do about this? A possible solution would be to carefully ask and write down what specific test your doctor has ordered for you. Ask when the results of the test are expected from the lab. Then make sure you call to follow up after the doctor's office should have received the results. Read the results report, if you can get hold of it, to see the name of the test and make sure that the results are for the same test that was ordered and performed. All of these things might help reduce your risk. Calling the doctor to follow up is probably the most important item on the list, as Dr. Lamberts says in his quotation in the linked NY Times blog post.

Tara Parker-Pope recently had an article on how fewer and fewer patients trust their doctors.

About one in four patients feel that their physicians sometimes expose them to unnecessary risk, according to data from a Johns Hopkins study published this year in the journal Medicine. And two recent studies show that whether patients trust a doctor strongly influences whether they take their medication.

The distrust and animosity between doctors and patients has shown up in a variety of places. In bookstores, there is now a genre of “what your doctor won’t tell you” books promising previously withheld information on everything from weight loss to heart disease.

What are the reasons for this new distrust? Several factors appear to be involved:

(1) Patients often don't understand what is going on with their health care because doctors and nurses are too rushed to explain things to them. Dr. Sandeep Jauhar, cardiologist and author of Intern: A Doctor's Initiation, is quoted in the article with a story of a patient who was transferred from one hospital to another with no explanation for why. He blamed a "broken system" for such failures to communicate.

(2) There has been greater coverage in the news of medical error, the power of the drug industry and the flaws in health care administration.

(3) The Internet makes information much more available, so patients can be informed skeptics. Drug companies also market directly to patients, so they come into the doctor's office with their own desires and opinions on what medications they should take. The upside to this is that patients have the information to challenge a doctor's errors. The downside is that many end up taking a drug commercial, for instance, at face value and will not listen to a doctor's reservations about the efficacy of a drug.

Again, from the article:

“Doctors used to be the only source for information on medical problems and what to do, but now our knowledge is demystified,” said Dr. Robert Lamberts, an internal medicine physician and medical blogger in Augusta, Ga. “When patients come in with preconceived ideas about what we should do, they do get perturbed at us for not listening. I do my best to explain why I do what I do, but some people are not satisfied until we do what they want.”

The whole article is worth reading. In addition, the article's page also has an embedded video clip of interviews with people discussing their attitudes to their doctors.

In our previous post, we discussed Dr. Peter Bach's comments on Medicare funding for unnecessary (in his opinion) testing. In response to Bach's article on the subject, the NY Times published readers' letters, most of which were highly critical of Bach's proposals about Medicare and testing.

The first letter, from Dr. Brant S. Miller, is especially interesting because Miller argues that Bach's proposals are nothing new:

We already tried capitation with H.M.O.’s in the 1990s, and that turned out to be a disaster. The media reported countless abuses by H.M.O.’s that killed or maimed patients as the insurers paid doctors more for denying care and less for providing care. Fee for service turned into plea for service. So, here we go again.

Since the 1990s, patients have been told that your doctor is greedy and doing unnecessary tests. And by the way, you shouldn’t have to pay much out of pocket, and there shouldn’t be any forms to fill out. Meanwhile, Tim Russert dropped dead when a one-minute CT scan could have shown progression of disease in his left anterior descending coronary artery.

Another interesting letter is from professor of neurology Michael Hutchinson. Hutchinson criticizes Bach for making "sweeping statements" and corrects his portrayal of the facts regarding testing and equipment use:

In fact, an extensive study done by doctors at Massachusetts General Hospital on physician ownership of imaging equipment was published last year. The study failed to define a major increase in imaging by doctors who own their equipment compared with doctors who do not.

Perhaps this has to do with strict government regulation, but imaging costs have actually been declining in the last two years. The total cost of M.R.I. scanning is now a fraction of 1 percent of health care.

Hutchinson also points out that imaging leads to fewer hospital and emergency room visits and also fewer procedures done, which helps reduce health care costs overall.

Those two letters were intriguing, but all of the letters responding to Bach are worth perusing.

Peter Bach, former adviser to the Medicare and Medicaid administrator, wrote a NY Times op-ed arguing that the Medicare system pays doctors for how many tests they run with a given piece of equipment but not for how much time they spend with patients. Readers responded with letters on the subject.

From the op-ed:

Medicare pays doctors for specific services. If a patient has a checkup that includes an X-ray, a urine analysis and a physical, Medicare pays the doctor three separate fees.

Each fee is meant to reimburse the doctor for the time and skill he or she devotes to the patient. But it is also supposed to pay for overhead, and this is where the problem begins. To Medicare, a doctor’s overhead (or “practice expense”) includes such items as rent, staff salaries and the cost of high-tech medical equipment. When the agency pays a fee to a doctor who has performed a CT scan, it is meant to cover some of the cost of buying or leasing the scanner itself. Services using more expensive equipment generate higher fees.

Any first-year business school student can see the profit opportunity here. The cost of a CT scanner is fixed, but a doctor earns fees each time it is used. This means that a scanner becomes highly profitable as soon as it’s paid for.

In contrast, the doctor-patient visit, which involves no expensive equipment, offers no significant profit opportunity. So the best way for a doctor to make money in his practice is not to spend time with patients but to use equipment as much as possible. That means moving the maximum number of patients through the practice, and spending the minimum amount of time with each one.

Bach offers suggestions for how the system should be reformed. He also includes evidence showing the increase of testing.

The informed patient on Medicare should ask questions about exactly what tests are being performed and why, and should not be concerned with taking up too much of the doctor's time.

The NY Times has a long and informative article on the pressures physicians face to give patients with heart problems unnecessary CT angiogram scans, which are very expensive and not demonstrably more effective than cheaper tests.

Aside from the expense, the scans come with radiation exposure equal to as much as 1,000 chest X-rays.

Further, each scan creates an additional lifetime risk of cancer that is somewhere between 1 in 200 and 1 in 5,000, said Dr. David J. Brenner, director of the Center for Radiological Research at Columbia University. Younger patients and women are at higher risk.

Many patients do find it emotionally reassuring to get the results of these tests, since the CT scan allows the patient and doctor to actually see if the heart has any problems. However, perhaps part of the love of these tests stems from what Johns Hopkins professor of medicine Bruce Leff calls (in a letter to the NY Times editor) "gizmo idolatry":

As a geriatrician and health services researcher, I believe that the demand for cardiac CT scans is a textbook example of gizmo idolatry, or the implicit conviction that a more technological approach is intrinsically better than one that is less technological.

The other letters are worth reading as well.

Despite concerns about the efficacy of these tests, many doctors and patients swear by them and they will probably remain popular. As the article notes, Medicare decided to fund these CT scans despite lack of clear evidence of their usefulness, and private insurers will most likely follow suit.