DC Medical Malpractice & Patient Safety Blog

As if there aren’t enough things to think about when a medical device is implanted into your body, here’s a new, 21st-century concern: hacking!

As reported on AboutLawsuits.com, Medtronic, the manufacturer of the Paradigm insulin pump, is investigating the cybersecurity of the drug delivery device used by diabetics in lieu of daily injections. The concern is that the pumps could be hacked, and reprogrammed to overdose patients with insulin.

McAfee, a name known among computer users for its security software, identified the flaw, and indicated that the problem might not be limited to this particular piece of equipment. As medical devices increasingly rely on wireless technology for delivering meds such as antibiotics, chemotherapy and anesthesia, their software could be vulnerable to outsiders less concerned with medicine than life-threatening havoc.

So far, Medtronic has reported no hacking problems among its 200,000-some insulin pump patients.

But FDA warnings are nothing new to Medtronic; we recently wrote about problems with another of its infusion pumps, and a couple of years ago a Paradigm model was recalled.

But, really, hacking?

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 question will never be answered with any certainty. But it's worth thinking about, because many of us will eventually be required to make our own hard choices about what kind of treatment to get for a scary disease.

The known facts about Jobs are these. He had an unusual form of slow-growing cancer of the cells in the pancreas that make insulin. His kind of cancer is called an "insulinoma" or an islet cell cancer. When the cancer was first found in 2003, he put off surgery to cut it out for nine months, while he tried dietary treatments advocated by his friend and diet doctor Dean Ornish.

Ornish is a controversial physician with one foot in the camp of scientific medicine but the other dipping deep into the stream of unproven, "alternative" therapies. He advocates a vegan diet that most people find very difficult to adhere to.

Did the delay in surgery doom Jobs to an early death? The best answer seems to be, "Hard to say, but it didn't help him any in the long run." A blog called Science-Based Medicine, written by oncologist David Gorski, has some interesting thoughts. I enjoyed his piece, and especially his back-and-forth with a commenter on his site who identified himself as a medical oncologist. Here is Gorski's bottom line about the allure of "magical thinking:"

Just eat this root, do these colon cleanses, let this healer manipulate your energy fields, and everything will be fine. No nasty invasive surgery that will permanently alter your body and how it functions. No poisonous chemotherapy. Unfortunately, reality doesn’t work this way, no matter how powerful the reality distortion field. Ultimately, reality intrudes, as it did for Jobs. When it did, when a followup scan apparently revealed that his insulinoma had grown, Jobs realized he had made a horrible mistake and tried to correct his course by undergoing surgery right away. It’s not clear whether his time in his self-created medical reality distortion field ultimately led to his demise or whether his fate was sealed when he was first diagnosed. Again, there’s just too much uncertainty ever to know for sure, and even if Jobs did decrease his odds of survival significantly it’s impossible to say whether the delay meant the difference between life and death in his specific case. What is clear is that no reality distortion field can long hold cancer at bay. Reality always eventually wins over magical thinking, no matter how much it might appear that magical thinking is winning at any given time.

My own take is this:

Cancer is scary, and even brilliant patients like Steve Jobs can become desperate, and tempted into trying an unorthodox treatment – remember laetrile? And although many cancer treatments have terrible side effects, at least they are based on science, not wishful thinking. Before you or a loved one decides to depart from what established medicine recognizes as the best practice for your diagnosis, learn about the science, not the magic, involved in those choices.

To help separate reality from fantasy, consult Quackwatch.com, a nonprofit resource that addresses health-related frauds, myths, fads and questionable therapies.

Stephen Colbert knows a thing or two about hypocrisy in the USA and how to get a laugh out of it. In this segment on his show, he interviews Susan Saladoff, director of the HBO documentary, Hot Coffee, about the myth of frivolous lawsuits.

Why mention this on a patient safety blog? Because the medical industry continues to do its best to dismantle the only way that Americans can demand accountability when they've been injured by unsafe and unethical medical treatment. They call it tort reform, but it's really tort deform, as Susan Saladoff tells Colbert.

PS: The segment starts at 15:15 on the timer.

When you get up close and personal with your cellphone, what are you exposing yourself to, literally? Dangerous radiation? Maybe. Nasty germs? Most certainly.

Two studies examining different potential hazards of cellphones have been in the news lately. One concerns the ongoing debate about the radiation risks of extended close contact with your phone, and the other concerns its hospitality to surface germs.

The first study involved members of the advocacy group Environmental Health Trust and was published in the journal Electromagnetic Biology and Medicine. It says that exposure measures per FCC guidelines underestimate how much radiation most people receive from their cellphones, according to a story in the Los Angeles Times.

The study authors say that current assessment methods use a large, liquid-filled plastic model of the adult human head, but that more than 9 in 10 people have smaller heads and therefore higher proportional exposure than what is assessed. Most important, children receive twice as much microwave radiation to the head as adults, the study estimates, and 10 times the amount to bone marrow.

Not to mention the possible exposure to other body parts when, say, a phone is stowed in your pocket.

The scariest possible side effect of cellphone use is brain cancer, although whether microwave radiation from cellphones can damage DNA and cause cancer is a subject of debate. See the National Cancer Institute fact sheet.

The Electromagnetic Biology and Medicine paper requests that the cellphone industry use a different method to certify phones for use, one that considers different sizes of users, and those who are pregnant.

A Danish cellphone study found no relationship between cellular telephone use and the incidence of cancer, but the British Medical Journal found problems with some aspects of that study.

Bottom line, there are passionate researchers on both sides of this issue and we really have no definitive science to argue conclusively that cellphones do or do not pose a radiation risk. As in most things, moderation is in order. Use cellphones only as necessary, and store them, ideally, away from your body.

In contrast, it's unequivocal that your phone goes with germs like peanut butter goes with jelly.

As reported on WebMd, 9 in 10 cellphones in a United Kingdom study served as host to bacteria including E. coli. And the reason is simple: People don’t wash their hands after using the toilet.

In this study, the E. coli came from fecal bacteria, which can survive on hands and surfaces for hours.

The researchers studied cellphones in 12 cities across the U.K. and asked users about their hand hygiene. Here’s what they learned:

• 9 in 10 phones were carriers of bacteria


• 8 in 10 hands were carriers of bacteria


• 16 in 100 hands and 16 in 100 phones bore E. coli bacteria.

If dirty hands are touching cellphones, they’re also touching other surfaces. Said one of the researchers: “They're spreading fecal bugs on everything they touch really."

"We didn't ask people whether they'd used their phones in the toilet. That might be something that would be interesting to study," she said.

Well, interesting is an interesting word, but it definitely would be illuminating, probably in ways most people don’t want to know.

Wash your hands. Often. It’s really just that simple.

In the past, evaluating the impact of hospital accreditation was challenging because there was no nationally standardized data. So the Joint Commission and the Centers for Medicare and Medicaid Services (CMS) compared hospitals it accredited with those it didn’t using other evidence-based measures of quality. Those included data that are mandatory to report publicly for common diseases such as heart failure and pneumonia.

From 2004 to 2008, according to a study in the Journal of Hospital Medicine, 8 in 10 accredited U.S. acute care and critical access hospitals outperformed nonaccredited hospitals by these measures.

The study concluded, “Hospitals accredited by The Joint Commission tended to have better baseline performance in 2004 than nonaccredited hospitals. Accredited hospitals had larger gains over time, and were significantly more likely to have high performance in 2008 on 13 out of 16 standardized clinical performance measures and all summary scores.”

The differences, the report says, became significantly more pronounced over five years of observation. But it also says that it’s unclear whether accreditation is solely responsible for improved performance or simply reflects general hospital characteristics associated with performance.

So the study’s authors note that nonaccredited hospitals shouldn’t necessarily be considered substandard because even hospitals lacking accreditation had a “reasonably strong” adherence to quality-of-care standards.

It’s a good idea, however, for hospital patients and prospective patients to find out if their treatment facility is accredited by the commission, simply because such status appears either to promote improved performance, or to indicate that a hospital’s standard procedures are associated with improved performance.

Other things to keep in mind about the Joint Commission’s accredited hospitals:

• They tend to be large, for-profit operations, located in urban areas.


• They are less likely to be government-owned, located in the Midwest or to be defined as critical access.


• The proportion considered high performers – 90% adherence to 13 of the 16 measures – was notably higher in accredited hospitals than those that were never accredited.

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.

A review of money paid over three years from orthopedic device manufacturers to orthopedic surgeons is an eye-opening manual of influence-peddling at best and conflict of interest at worst.

A study published in Archives of Internal Medicine concluded that once surgeons were required to disclose these payments, they declined in both total number and amount. Also notable was the increase in the proportion of consultants with academic affiliations.

The study was prompted by the U.S. Department of Justice (DOJ), which in 2005 investigated payments to orthopedic surgeons by the five largest manufacturers of artificial hips and knees.

“There is ongoing discussion of physician relationships with the pharmaceutical industry and medical device manufacturers,” the study authors wrote. “Our objective was to use data made available by [the DOJ] lawsuit to describe the extent of orthopedic surgeons’ financial relationships with implant manufacturers.”

The study defined the number of surgeons receiving payments and the amounts paid, comparing that data in the years before, right after and a couple of years after the DOJ settlement with the manufacturers in 2007.

In 2007, the manufacturers paid 939 orthopedic surgeons more than $198 million. In 2008, they paid 526 surgeons more than $228 million, but this figure includes $109 million in royalty buyouts from one company.

When limiting analysis to only the three companies that reported data for all four years, the authors found that the average payment by device makers per surgeon was $212,740 in 2007, $193,943 in 2008, $246,867 in 2009 and $233,108 in 2010.

But the proportion of surgeons receiving payments who had academic affiliations increased from fewer than 4 in 10 in 2007 to more than 4 in 10 in 2008. A similar pattern was seen in 2009 and 2010 for the three companies that continued disclosing payments by choice.

Of course, without mandatory disclosure, who knows how much was paid to whom. The authors concluded, “There is a need for clearer specific requirements for disclosure to allow for meaningful long-term analyses to be performed.”

In an accompanying commentary titled "Industry Payments to Physicians," Dr. Robert Steinbrook of the Yale School of Medicine analyzed the study findings. “Unfortunately, the public data provide no information about how the payments relate to research and device development, the choice of hip or knee implant or other aspects of patient care,” he said.
“The disclosure of industry payments should not divert attention from the real issues with regard to conflict of interest. These are the minimization or elimination of financial ties between physicians and industry in areas other than research support, bona fide consulting related to basic and clinical research, and legitimate payments related to intellectual property.”

“In the United States, the rules regarding the disclosure of industry payments are about to change,” Steinbrook notes. “With mandatory disclosure of payments and amounts imminent, there should be many new opportunities to better control conflicts of interest in medicine.”

Here, here.

Last week the U.S. Preventive Services Task Force (USPSTF), about which we wrote recently, weighed in with another advisory to cut back on what has long been standard gynecological practice.

As Reuters reported, although Pap smear tests are still the best practice for the prevention of cervical cancer, the USPSTF says that many women needn’t have one every year. The task force recommends the test be given every three years for most women.

Pap tests examine cells from the cervix for cancer or precancerous changes. The same cells can be used for HPV testing.

In proposing changes to its 2003 recommendations, the task force said evidence is still lacking to weigh risks and benefits of tests screening for human papilloma virus (HPV). That stance is opposite of most cancer patient advocates, who support such tests.

But the American Cancer Society agreed with the Feds on the new recommendations.

Routine annual Pap tests appear to present the same problems as the routine prostate-specific antigen (PSA) tests the task force addressed a couple of weeks ago, suggesting it be used only for high-risk men. "If you test every year you find a lot of benign infections that would go away on their own. … You end up overscreening, overmanaging and overtreating women who are not actually at risk of getting cervical cancer," Philip Castle of the American Society for Clinical Pathology told Reuters.

"Everybody agrees on almost everything: Let's get rid of regular annual Pap testing, let's get rid of teenage screenings, let's screen women who aren't getting screened," said Debbie Saslow, the American Cancer Society's director of breast and gynecologic cancer.

Side effects of overtesting could include vaginal bleeding, pain, infections, risks of pre-term delivery and psychological issues about facing a possible cancer diagnosis.

Although the task force doubted the effectiveness of the HPV test in preventing cancer, other groups said the combination of regular Pap plus HPV testing was indicated for women older than 30 if done every three to five years.

The HPV virus is common, can cause genital warts and can lead to cervical cancer. As the Reuters story noted, usually, the immune system eradicates HPV, especially in younger women. The task force found HPV screening causing more false positive cancer results than the Pap alone.

Specifically, last week the task force recommended a Pap smear test every three years for women between the ages of 21 and 65 who have had sex and have not had their cervix removed. The panel found "little to no benefit" in screening women older than 65 who had been previously tested and not enough evidence of benefit for women younger than 21.

The conservative Cato Institute is out with a new study arguing that putting limits on malpractice verdicts could be doubly bad for patients. It could result in both inadequate compensation for victims of malpractice, and could reduce the incentives of malpractice insurance carriers to hit malpracticing doctors with financial penalties to encourage better and safer care.

Here's a quote from the executive summary of the study done by Shirley Svorny, professor of economics at California State University, Northridge:

First, caps on awards may result in some patients not receiving adequate compensation for injuries they suffer as a result of physician negligence. Second, because caps limit physician liability, they can also mute incentives for physicians to reduce the risk of negligent injuries. ...

This paper reviews an existing body of work that shows that medical malpractice awards do track actual damages. Furthermore, this paper provides evidence that medical malpractice insurance carriers use various tools to reduce the risk of patient injury, including experience rating of physicians’ malpractice premiums. High-risk physicians face higher malpractice insurance premiums than their less-risky peers.
In addition, carriers offer other incentives for physicians to reduce the risk of negligent care. ...

If the medical malpractice liability insurance industry does indeed protect consumers, then policies that reduce liability or shield physicians from oversight by carriers may harm consumers. In particular, caps on damages would reduce physicians’ and carriers’ incentives to keep track of and reduce practice risk.

The malpractice liability system is the sole means by which consumers can bring some measure of accountability to health care providers who cause harm to patients. So the new Cato study provides important support for the idea that tinkering with the system, which the medical industry claims would produce more affordable health care, could be exactly the wrong approach for patient safety.

Paralleling the growth of the hospice industry, the number of hospital-based palliative care programs has more than doubled since 2000. According to a new survey by the Center to Advance Palliative Care, nearly two-thirds of hospitals surveyed had palliative care teams.

Palliative care focuses on easing the symptoms, stress and pain of serious illness, whether chronic or terminal. In the latter case, it often precedes hospice care, whose goal also is to alleviate suffering, but only for people who are terminally ill.

The report concludes that, thanks to the growing cost of treating an aging population and because it’s simply more humane, palliative care should receive more financial support. The researchers say that previous studies conclusively demonstrated that many seriously ill patients suffer treatable pain and distress, and are financially devastated because of the high costs of medical care. Palliative care, they argue, offers a logical and patient-centered approach to improving medical care by focusing on quality of life and by matching to patient and family needs.

As reported by Kaiser Health News, unlike hospice services, palliative care programs are more common at nonprofit hospitals. That accounts for some stark geographic differences in the survey results – nonprofit hospitals are less common in the South.

As described on WebMD, a Center to Advance Palliative Care poll showed that 9 in 10 people have no idea what palliative care is. But once it's explained to them, 9 in 10 say they would want it for themselves or for their loved ones.

But that requires a prescription – only a doctor, not the patient or relative – can request palliative care. And sometimes you must remind your doctors that you need to be treated as a whole patient, not a body part. If a doctor is focused on treating your tumor, he or she might not ask about your trouble sleeping, your skin rash, how exhausted your spouse is. But that’s exactly the job of a palliative care professional.

Now, for the study’s state-specific report card.

Regions where larger hospitals more were most likely to have palliative care teams:

• District of Columbia -100%


• Vermont - 100%


• Maryland - 90%


• Nebraska - 93%


• Minnesota - 89%


• Oregon - 88%


• Rhode Island - 88%


• Washington - 83%

The District, which only has big hospitals, is the only jurisdiction where every hospital patient has access to palliative care.

States where hospitals were least likely to have palliative care teams:

• Kansas - 47%


• New Mexico - 44%


• Georgia - 43%


• Louisiana - 43%


• Texas - 42%


• Arkansas - 38%


• Oklahoma - 30%


• Alaska - 29%


• Alabama - 28%


• Delaware - 20%


• Mississippi - 20%

If you or someone you love is planning a hospital visit with the potential for ongoing treatment, find out if the facility where you will be treated has a palliative care program. If not, consider the options within your health plan network, and if none offers a palliative care program, ask your insurance company why not.

And make sure your primary care doctor and your surgeon understand your interest in receiving such care.

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

It’s a widely, if grumpily, accepted fact that primary care physicians spend less time with patients than either would like. There are only so many minutes in the day, and there’s always more paperwork than time to address it.

No medical practitioner is more overburdened than a primary care physician, because in many health plans, he or she is the so-called “gatekeeper” to specialized care. Patients must see one in order to warrant a referral to someone else – a dermatologist, a cardiologist, a psychiatrist, a surgeon.

So no wonder that the American Medical Association recently asked the Centers for Medicare & Medicaid Services (CMS) to reimburse network physicians in fee-for-services health plans for phone calls, counseling and other efforts they expend to coordinate care for chronically ill patients.

No question that the labyrinthian nature of the U.S. health-care system demands much of people obliged to navigate it on behalf of others, and these professionals deserve to be compensated, according to independent health-care journalist Merrill Goozner.

But with shrinking coverage, strained budgets and the inexorable increase in the cost of health care, how will these merit pay raises be funded? How about, Goozner suggests, by the medical establishment reassessing and realigning its priorities? How about by embracing a rational sense of proportion?

There’s an ocean of difference in what providers are paid. Specialists often receive two or three times the fees paid to a primary care doc. Goozner says it’s difficult to justify that the “relative value” of back surgery or angioplasty is so much more than other kinds of treatment involved in gate-keeping. These two specialties, he says, are exemplary of “the most expensive and overused procedures in medicine, incentivized by the extraordinarily high fees earned by the surgeons who do them.”

Whether or not you agree with the politically driven Congressional mandate that any new spending must be offset by federal budget cuts – known as the “pay-for” rule – maybe Medicare should adopt the same policy. If Congressional Republicans find it acceptable to charge emergency flood relief with a pay-for, if President Obama is OK with sending the bill for his jobs package to the nation’s millionaires, maybe medicine should cover the coordination of care pay-for with a reduction in the inflated fees for specialist care.

“Congress needs to come up with nearly $300 billion over the next decade simply to hold physician salaries where they are,” Goozner writes. “The permanent fix would set a cap for total physician pay; and allow it to rise over time for inflation. But why not require that CMS adjust payments to the various specialties to meet that cap? Otherwise, in a few years we’ll be right back where we are today: a permanent fix that wasn’t permanent at all, with new services inflating the total tab beyond the cap.”

The problems with the cancer drug Avastin are never ending. The FDA has issued a another warning about the drug’s dangers, this time involving ovarian failure, jaw necrosis (bone decay), blot clots and excessive bleeding.

We’ve written about Avastin as well, most recently last week in regard to its use as an injectable drug for macular dengeration, and about the risks it poses for breast cancer patients.

To explore just one of the reasons for the new warning, consider a study that found that 34% of women treated with Avastin during chemotherapy suffered ovarian failure, and most have not recovered their full fertility; only 2% given chemotherapy alone experienced ovarian failure.

Avastin was approved by the FDA in 2004 to treat nonsmall cell lung cancer and colorectal cancer in combination with chemotherapy. It received approval in 2008 to treat breast cancer, but that was revoked in 2010, and reconfirmed in June of this year.

When used for its original purpose, Avastin’s side effects can include high blood pressure, heart attacks, heart failure and the development of holes in the nose, stomach and intestines. All drugs carry the risk of side effects. Sometimes, they’re worth it. Increasingly, expanded use indicates that that’s not the case with Avastin.

Last week, Steve Grossman, an advocate for greater FDA funding, voiced an argument on his blog, FDA Matters, that not only should the government’s food and drug watchdog consider the safety and effectiveness of drugs, therapies and medical devices in its approval process, but also their cost.

In the past, Grossman has supported a split in medical treatment responsibility -- the feds conduct risk-benefit analysis, and insurers, physicians and pharmacists make decisions about cost-benefit. It’s hard enough to determine safety and efficacy without loading cost factor into the equation.

But, he writes, “Two events [recently] have left me wondering whether there are certain limited circumstances when FDA should be able to take product cost into consideration.”

The September publication in the British medical journal Lancet of a report called “Delivering Affordable Cancer Care in High-Income Countries” concluded that as cancer care becomes increasingly expensive, affordability, accessibility and value must factor into treatment.

Grossman knows that Medicare, Medicaid and private insurers will look to the report for insight into cost containment and support for tough decisions they make in the near future about who gets what treatment.

Thanks to problematic realities such as drug shortages in the U.S. – which disproportinately affect cancer drugs – Grossman says the FDA should have a voice in this conversation. “Patients suffer, research is delayed and more expensive drugs are often substituted (or patients do without),” he writes.

Apart from shortages and manufacturing problems, economics are helping to steer this issue into the danger zone. If it’s not sufficiently profitable for manufacturers to make older cancer drugs (because patent protection has expired), the FDA can’t address the shortage situation without considering cost. It might have to find ways to favor less effective or riskier products, Grossman suggests, only because they can be made available at a market-driven price.

The second event that prompted Grossman to reconsider the separation of medical treatment responsibility relates to the FDA’s unintentional role in exacerbating the crisis in affordable cancer care. Numerous new cancer products have joined the market in the last few years, more are coming, and they’re expensive -- about $100,000 per cycle. Some patients need multiple cycles or multiple expensive drugs.

So when asked what would the FDA do if a drug was only 90% as good as the safest and most effective therapy on the market (a metric that defines "standard of care") but would be available for only 10% of the cost, Grossman gave the stock answer: The FDA approves only therapies that are as good as or better than the existing standard of care. The cost aspect is not part of the decision.

Eureka! In light of the Lancet study, wouldn’t patients benefit if the feds had some room to consider standards of care, risk-benefit and comparative cost?

“It scares me to write this,” Grossman admitted. “the whole notion of FDA putting cost on the table seems like an abandonment of principles, as well as fraught with potential misuse.”

The FDA is not permitted to approve a drug, biologic or device that is not quite as effective or safe as predecessors solely because it will make care more affordable and accessible. “I am not yet an advocate for this,” Grossman states, “but I think it is one of the possibilities that we need to be discussing.”

It’s a pretty radical idea. But how often does significant, positive change occur on a grand scale without a radical element pushing the envelope?

... 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.

Fact: About 1 in 20 patients contracts an infection related to his or her hospital care.

Fact: An average of 1 in 7 Medicare beneficiaries is harmed in the course of his or her care, costing the government an estimated $4.4 billion every year.

Fact: Nearly 1 in 5 Medicare patients discharged from the hospital is readmitted within 30 days. That’s approximately 2.6 million seniors at a cost of over $26 billion annually.

In April, Health and Human Services Secretary Kathleen Sebelius introduced a new program in which a coalition of health-care interests – hospitals, professional medical provider organizations, patient advocates, insurers, pharmaceutical companies – define and establish standards to turns these facts into old news.

Called the national Partnership for Patients (NPP), the program aims to address problems such as medication errors and lack of infection control that, Sebelius said, can happen “when hospitals do one thing, health plans do another and Medicare goes in a third direction.”

To see the generic pledge NPP members make, link here.

Sebelius said the administration’s Affordable Care Act would earmark as much as $1 billion in funding and considerable human resources to reach two primary goals for the next three years:

• Keep patients from getting injured or sicker. Reduce preventable hospital injuries by 40 percent, which will prevent 1.8 million injuries and save 60,000 lives; and


• Help patients heal without complication. Cut preventable hospital readmissions by 20 percent, which will save more than 1.6 million patients from complications prompting a return to the hospital.

The effort is doomed to fail if it’s not embraced industry-wide with something more than lip service. It’s easy for a single establishment or organization to express support, and considerably more difficult for it to enumerate exactly how it intends to effect positive change.

Clearly, with so much energy and funding being directed to the NPP, the government must demand accountability. Sebelius’ promise that hospital Medicare and Medicaid payments would reward those delivering the best care nods toward that obligation, but patients and anybody who cares about hospital safety have a right to expect to be told the whole story as it unfolds. What have members promised to do? How is their progress being tracked and measured? What are the consequences of failure?

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.

We’ve all heard tabloid tales of hospital personnel taking unauthorized peeks into celebrity patient files and selling the dishiest contents for personal gain. But there’s also reason for the rest of us to to guard our medical records like we do our bank accounts.

According to a survey by PricewaterhouseCoopers, nearly 4 in 10 doctors and hospital staffers have caught one patient trying to use somebody else’s identity to obtain health-care services.

As reported on MedPage Today, patients seeking medical care under another name was the second most common privacy or security issue reported by providers. Medical identify theft is the fastest-growing form of identity theft; 1.42 million Americans were victims in 2010 at a cost of $28 billion.

Security breaches occur most often by the careless treatment of patient files in doctors’ offices, hospitals, insurance companies or life science organizations. These problems can be as simple as leaving a document visible to others, posting comments on Facebook or conducting improper elevator conversation. Other common transmitters of swiped ID are stolen laptops and smartphones. Patient data is used to submit fraudulent claims and to seek medical care in somebody else’s name.

This isn’t about the high-techery of computer hacking, but the low-techery of clueless, careless or corrupt medical personnel. As summarized by MedPage, the survey concluded that “Digitized health information is becoming increasingly popular, but the majority of health organizations are ill-prepared to protect patient data as the health-care industry moves toward electronic systems.”

More than half of the survey respondents said they had experienced at least one issue with information privacy and security over the past two years. One in 4 insurers reported improperly transferring files that contained protected health information.

That’s unacceptable, and as a patient, you must ensure the security of your information. Inform your health-care and insurance providers that privacy and security are as important an aspect of your health care as a prompt and proper diagnosis. That you have zero tolerance for compromised files.

James Koenig, director of the Health Information Privacy and Security Practice at PricewaterhouseCoopers, noted that the federal Health Information Technology for Economic and Clinical Health (HITECH) Act requires medical privacy breaches to be disclosed, but only for paper-based health information, not electronic records. That’s an unacceptably huge gap in privacy coverage.

The headline is no joke. It's what experts think is the explanation behind vision-ruining infections in the eye that happen occasionally with injections into the eye of a drug used to halt the progress of macular degeneration.

As the thinking goes, if the doctor is talking during the time he or she is drawing the drug from the vial into the syringe, tiny droplets of the doctor's saliva can then be transmitted into the patient's eye.

Another cause of eye infections in patients who get these injections is less than sterile conditions in the pharmacies that take a single vial of the drug and divide it up into the tiny doses for individual eye patients.

Whatever the cause, the infections known as endophthalmitis happen in about 1 in 1,000 injections of both of the commonly used drugs for the wet form of macular degeneration: Avastin (also used in cancer treatment) and the far more expensive Lucentis.

Read this New York Times piece for more on the subject, and about how a raft of publicized cases of infections with Avastin seems to be driving much of the eye injection business to Lucentis despite its higher price -- $2,000 a dose compared to only $50 a dose for Avastin.

The per-capita U.S. expenditure for health care is twice that of the average industrialized nation, and it’s growing at an undsustainable rate. One reason for that grim reality, says a survey of doctors in the Archives of Internal Medicine, is that a considerable amount of health care is unnecessary. Patients, they say, get too much care.

You can’t read a big-city newspaper without encountering stories about people without adequate medical insurance going without medical care. But folks being overtreated? Not so much.

Nearly half of the of the 440-some respondents believe their own patients receive too much care, and just more than half believe the amount of care is just right. Nearly 3 in 10 said they were practicing more aggressive medicine than they would like.

They gave three primary reasons for their indulgent care:

• concern over malpractice lawsuits (that is, if you overtreat, accusations that your care was wanting lose their punch);


• clinical performance measures (that is, you have to “prove” your worth); and


• inadequate time to spend with patients (that is, if you don’t have time for people, give them tests and treatments to fill the void of communication).

The study concluded that “physicians are open to practicing more conservatively,” and that “physicians believe they are paid to do more and exposed to legal punishment if they do less. Reimbursement systems should encourage longer primarly care physician visits and telephone, email and nursing follow-up, rather than diagnostic intensity.”

In an accompanying commentary to the study, Dr. Calvin Chou sees “a kind of trained helplessness” in the physicians’ responses. They practice aggressively because they have no recourse.

Chou suggests that doctors address the problem through communication and by avoiding burnout.

His reflection mirrors our feelings. As far as avoiding burnout, well, we’re not career counselors, but we do understand the value of communicating with patients. Larding unnecessary tests and treatments into patient care is like giving kids expensive toys and too much sugar when you don’t have time sit down and go over their homework. It’s a replacement for time, and it’s not without side effects.

We also believe the concern about malpractice lawsuits causing defensive medicine is off target. When patients sue for not having been tested enough, it's because a simple test was available that could have headed off the catastrophe which then occurred.

There's no "defensive medicine" in ordering the right test, and it's perverse to suggest that a doctor might only order a valuable test on a patient because of the threat of being sued if he doesn't.

We've written about this topic before on this blog here and here.

Kathleen Sharp tells a good, if scary, story. In “Blood Feud: The Man Who Blew the Whistle on One of the Deadliest Prescription Drugs Ever,” she describes how two Big Pharma companies conspired to develop and market an anti-anemia drug despite evidence of devastating side effects.

In a recent op-ed in the New York Times, she argues that scarily rampant fraud in health care is partly the fault of the feds.

The Obama administration announced plans to cut $320 billion over 10 years from the projected growth of Medicare and Medicaid by raising premiums and deductibles, lowering payments to providers and requiring recipients of home health care to make co-payments.

But, Sharp asks, what if instead of charging consumers more and eliminating services, the focus was on diminishing the estimated $100 billion that’s lost every year from these programs in the form of fraud? And the additional 150 billion fraudulent dollars collected in the rest of the health-care industry?

Here’s how taxpayers are defrauded:

• hospital chains buy drugs at steep discounts, then bill Medicare the retail cost;


• doctors bill for procedures never performed and drugs they receive free from pharmaceutical companies;


• pharmaceutical companies promote drugs for uses not approved by the FDA;


• laboratories pay kickbacks and/or offer discounts to doctors and hospitals that refer patients.

Individual cases of fraud would have more muscle, Sharp says, if the Justice Department moved front and center, rather than allowing individual state attorneys general to prosecute them. Although chronically understaffed, the department had more than 1,300 whistle-blower cases under investigation in the beginning of 2011; can anyone but the most dogged reporter track their progress? Two years ago, an additional $198 million was appropriated to fight health-care fraud, and where did that go?

“The only way to tell if taxpayers are getting their money’s worth of farud-fughting,” Sharp writes, “is for the Department of Justice to routinely publish, among other statistics on corporate fraud, a breakdown of the number of cases it opens and the number originating from whistle-blowers.”

So how would a more actuarial accounting of federal investigations boost successful prosecutions and fight fraud? The $2.5 million recovered in health-care fraud cases in 2010 is peanuts, Sharp says, because even if cases are settled, Big Pharma writes it off as a cost of doing business: If it costs $1 million to sell $10 million in drugs, that’s a good return.

At the end of last week, the Centers for Disease Control and Prevention reported that 15 people had died and 84 were ill from eating listeria-contaminated cantaloupes.

It’s the deadliest food-borne outbreak in 13 years.

Listeria is a bacteria that causes listeriosis, a kind of food poisoning. Every year, according to WebMd, approximately 2,500 people become seriously ill with listeriosis. Most people recover on their own, but the outbreak is particulary dangerous for pregnant women, newborns, the elderly and people with compromised immune systems. Once diagnosed, they are given antibiotics.

Listeria can infect a variety of foods, and it’s more insidious than some other food-borne microbes because it thrives under refrigeration and can incubate for weeks before a person exhibits symptoms. The latter makes it difficult to identify the origin, and therefore stop the supply line of germs.

Here’s a primer on listeriosis.

Symptoms include one or more of:

• fever


• muscle aches


• nausea


• diarrhea


• headache


• stiff neck

Prevention involves practicing safe food handling:

• While shopping, bag raw meat, poulty and fish separately from other food items.


• Store food as soon as possible after shopping.


• Wash your hands before and after handling food.


• Wash fresh produce by rinsing well under running water.


• Use two cutting boards, one for fresh produce and one for raw meat, poultry and seafood.


• Wash knives and cutting boards in the dishwasher to disinfect them.


• Cook, refrigerate or freeze meat, poultry, eggs, fish and prepared foods within two hours of preparation.


• Refrigerators should be 40 degrees or colder. But because listeria grows in the cold, clean refrigerator spills promptly.


• Reheat leftovers to at least 165 degrees; don’t eat undercooked hamburger and beware the risk of eating raw fish.


• If in doubt, throw it out.

If you’re pregnant, do not eat:

• hot dogs, lunch or deli meats unless steaming hot;


• soft cheese unless the label says they’re made from pasteurized milk;


• refrigerated pate or meat spreads;


• raw milk;


• store-prepared salads, such as ham, chicken, egg, tuna or seafood.

Like cops, soldiers and other professionals regularly confronted with the specter of death, doctors sometimes relieve the stress of their reality through humor.

How can a doctor, whose job is supposed to include the compassion of nonjudgment, laugh about your dread disease?

While such behavior can be deplorable in the wrong setting, at the wrong time, it can also be beneficial, suggests a report by the Hastings Center, a nonprofit research institution dedicated to bioethics and the public interest. Writer Katie Watson is a professor in the Medical Humanities and Bioethics Program at Northwestern University’s medical school, and she also teaches improvisation and writing at the comedically renowned Second City Training Center in Chicago.

Watson says there’s a lot of literature about humor in medicine -- clinician-patient relations, and the health benefits of laughter -- but relatively little about what occurs between health-care providers who might treat serious, frightening or painful subject matter in a light or satirical way.

“The claim that being a physician is so difficult that ‘anything goes’ backstage misuses the concept of coping as cover for cruelty, or as an excuse for not addressing maladaptive responses to pain,” Watson writes. But “blanket dismissals of gallows humor as unprofessional misunderstand or undervalue the psychological, social, cognitive and linguistic ways that joking and laughing work. Physicians deserve a more nuanced analysis of intent and impact in discussions of when gallows humor should be discouraged or condemned in the medical workplace.”

Watson examines why we joke and looks at various uses of humor that serve as a bonding and coping mechanism among insiders. She notes how standards have changed in the “backstage” humor of doctors and medical students – “cadaver antics,” in which medical students clowned around with body parts, were once a rite of passage, but today they’re rarely tolerated. Students are taught to treat cadavers with respect, as former people.

Like other fine-line definitions, whether gallows humor is appropriate turns on the ethical question: “When is joking a form of abuse – of a patient, of trust, or of power? A joke about a patient’s condition told in front of the patient or the patient’s family is unethical because it has the potential to harm them.” But sometimes the butt of a doctor’s joke isn’t a person, it’s a condition. Like death.

That’s not harmful, Watson suggests. And it might help the people who must deal with it, who must, she writes, “integrate this terrible event and get through the shift.”

And that might help the next patient get better care.

All-metal hip implants are proving to be a brewing epidemic of injury to patients: the failure rate is much higher than metal-plus plastic or ceramic hip implants, and now, doctors are finding that the metallic debris from wear and tear incites an immune reaction from the body that causes tissue damage.

When tiny fragments of metal wear off of the hip, the body responds by having scavenger cells gobble up the metal. These cells can chew the metal into smaller fragments, but those fragments include electrically charged ions, which can trigger damage to surrounding tissue and early implant failure.

Read more in this article by the New York Times' Barry Meier, who owns this failed hip implant story.