DC Medical Malpractice & Patient Safety Blog

It's another science-versus-commerce face-off.

Last Friday, the Institute of Medicine released a report commissioned by the FDA that proposes a vastly different and more rigorous approval process for medical devices. In the wake of several recent, well-publicized recalls of devices causing grievous injury, such as hip implants, the report has generated attention well beyond the medical-regulatory nerd community.

As the IOM, an arm of the National Academy of Sciences, explained, "Devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the 510(k) process.... Some policymakers and patients have expressed concern about the ability of the 510(k) process to ensure that medical devices on the market are safe and effective. Other policymakers and patients, as well as the medical-device industry, have asserted that the process has become too burdensome and time-consuming and that it is delaying important new medical devices from entering the market."

So the FDA asked the IOM to answer two questions:

• Does the current 510(k) process protect patients optimally and promote innovation in support of public health?


• If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally?

The answers? No, and (we're paraphrasing here) you need a makeover.

"The IOM finds that the current 510(k) process is flawed right from its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process ... the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle."

Before the report was released, the medical device industry issued a pre-emptive strike. As reported in the New York Times, the industry called the report biased, and claimed that a greater regulatory burden would retard innovation, cost jobs and harm patients. "An official of a group that represents surgeons who implant hips and other artificial joints," the paper reported, "has also voiced support for a recent filing by a pro-business organization that challenged the scientific report’s credibility and argued that the F.D.A. was statutorily required to ignore it."

If it's not surprising that device manufacturers would object to greater scrutiny and bureacracy, it's highly unusual for any business interest to orchestrate a campaign against a thoroughly vetted recommendation before its report has been published. The IOM, The Times said, "was unaware of a previous instance in which one of its reports, sight unseen, was the target of a similar effort to invalidate it."

Ralph F. Hall, a professor of law at the University of Minnesota who also represents the medical device industry, denied that the pre-publication diss was intended to undermine its message, but only to question the IOM's methods of review. “I could have waited until the report came out,” Hall told The Times. “That seems intellectually less than satisfactory with me.”

So, someone whose professional obligation is to thoughtfully and thoroughly examine circumstances and then carefully apply the law to them is OK with assumptions about something unseen and indictments of a 12-person panel of doctors, lawyers, and academics who did perform the necessary due diligence?

The FDA commissioned the report, but it isn't required to take its advice. In fact, as noted by MedPage Today, Jeffrey Shuren, M.D., and director of the FDA's Center for Devices and Radiological Health, said the agency isn't keen to dump the fast-track approval process for moderate-risk devices. "FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs," Shuren said.

Still, the agency will invite the public to comment on the report, and hold a public meeting in the next few weeks.

Patient and consumer advocates applaud the IOM report. Diana Zuckerman, president of the National Research Center for Women and Families, told MedPage Today that there are four major problems with the 510(k) process:

• it doesn't require device-makers to submit clinical trials;


• it doesn't mandate inspections of manufacturing facilities;


• it doesn't require post-marketing studies;


• it doesn't give the FDA any authority to rescind approval if the device is found to be unsafe or ineffective.

Most devices, from low-tech tongue depressors to something more complicated, such as pacemakers -- are fast-tracked with 510(k) approval. That requires companies seeking approval for a low-to-moderate risk device to prove that it's substantially similar to another device on the market. Completely new and high-risk devices, such as an implanted heart defibrillator, must provide clinical data demonstrating safety and effectiveness.

As noted in The Times' story, so-called metal-on-metal artificial hips (the subject of much scrutiny and many lawsuits), seemed to work well when tested on mechanical simulators. But they failed when implanted in patients.

No one questions the fact that governmental oversight agencies can be inefficient and slow. But when the use of a product or device presents life-or-death issues, can you be careful enough?

To make your feelings known about the IOM report and to find information about recalled products and devices, contact the FDA's Center for Devices and Radiological Health:

(800) 638-2041; dsmica@fda.hhs.gov

Food and Drug Administration

10903 New Hampshire Avenue

WO66-5429

Silver Spring, MD 20993

Kimberly White had a hysterectomy with a variety of attendant issues she thought were private matters between her and her health-care providers.

She says Tufts Medical Center is responsible for proving her wrong.

As reported in The Boston Globe, she sued the hospital and a primary care doctor for allegedly faxing sensitive medical history documents to a machine used by several of her co-workers.

Two of them, she said, read the records, causing her embarrassment sufficient enough to affect her daily life and her livelihood. As The Globe reported, "White said it exacerbated other medical issues and stalled her career. She has been out on disability for nearly all of the time since, she said."

White said she had asked her doctor to fax a required form for her work disability claim to her employer. Instead, she said, four pages of her medical records were sent. “I feel like I might have walked in (the office) naked,” White said.

White's personal records, she emphasizes, were delivered to people who know her. “I can’t go back there,” she told The Globe. “I am so embarrassed. ... I couldn’t live with knowing what these people knew about me.”

The hospital has denied wrongdoing, and a spokeswoman said it takes patient privacy very seriously.

It's impossible to be a conscientious consumer of medical services if you don't know how much a procedure, an office visit or a lab test will cost. If you live in Florida, however, and are in need of urgent care, the mystery about costs is about to lift.

As reported on the St. Petersburg Times' Tampa Bay.com, a new health care transparency law requires urgent care clinics to post prices on their 50 most frequently provided services. The price of failure to do so? $1,000 per day until they comply.

As patients pay an ever greater share of their health costs, budgeting--or even self-rationing, in some cases--becomes a reality. But doctors opposed to posting prices say that health care pricing is too complex for such simple translation. Myriad insurance company billing codes and several ways to pay (cash, private insurance, government programs) will lead to information, they say, that's more misleading than informative.

The new law says posted prices apply only to patients who use credit cards or pay cash for services, not those with insurance. And it applies to urgent-care clinics, but not facilities such as hospital emergency rooms. Individual primary care physicians aren't required to post prices, but if they do so voluntarily, they are excused from paying license fees and fulfill continuing medical education requirements for a certain period.

Consumer and business groups including Florida Public Interest Research Group and Associated Industries of Florida support the legislation.

Doctors ... not so much. They're unclear about the requirements and which types of practices must comply. Apart from urgent care centers, what about clinics that accept walk-in patients? They're not wild about the cash/credit-only provision, because most patients at many clinics have some insurance coverage, and posted prices might drive away people who really need care. The continuing education enticement isn't particularly alluring, they say, because many physicians must meet course requirements to remain board certified.

But in an industry long overdue for transparency, this is a step in the right direction.

There's no shortage of stories about the dire effects of a missed diagnosis. But what about the repercussions of a false diagnosis?

Two doctors writing on MedPage Today say that the medical industrial complex should be equally concerned about the number of patients diagnosed with a specific disease who do not, in fact, suffer from it. "How prevalent are false diagnoses of disease?" they ask. "And which ones?"

Clifton Meador, M.D., and George Lundberg, M.D., previously have raised the flag of inquiry into how anyone can accurately assess a diagnostic process in light of increasing numbers of people described as "well and worried well" who seek medical treatment. A troubling aspect of "this influx of well people," they say, is an increasing number of test results that show false positives--the indication of a problem when there isn't one--and its corollary, false diagnosis of nonexistent disease.

If you don't have an accurate picture of the incidence, demographics and nature of a disease or disorder, you can't organize the most effective response to it. Or the most cost-effective--you'd have to live on Jupiter to be unaware of the escalating cost of medical care.

As the MedPage authors point out, medical literature "is filled with studies on the accuracy of specific disease diagnoses but the focus has been exclusively on missed diagnoses." A common metric of analysis here is data from autopsies to determine how many patients died while suffering from a specific disease that was overlooked while they were alive.

Why, they want to know, don't we seem to care about the flip side of that review? That is, how many people were falsely diagnosed with a specific disease while alive that wasn't in evidence upon their death?

They found only one paper that examines the prevalence of false diagnoses of a specific disease within a defined population. It concluded that four times as much disability came from the false label "heart disease" as from actual heart disease.

This isn't about the occasional hypochondriac who seeks medical attention because other forms of attention are lacking in that person's life. False positives and overdiagnosis have consequences. For a person who has been diagnosed with a nonexistent disease:

• The patient starts on the conveyor belt of further testing and treatment, which can bring their own side effects and complications.


• The disease cannot progress because it does not exist.


• The patient is often satisfied to have a name, any name, for his or her problem, even if the disease does not exist.


• The doctor is satisfied to have named the condition, believing the diagnosis to be correct.


• The false positive test result leading to the diagnosis may become negative when repeated in the future, reassuring the patient and the doctor that the "disease" is in remission or is a mild form. But unless the patient sees another doctor who doubts the false diagnosis and repeats the testing, the false diagnosis will persist.

"Our 50 years in medicine tells us that this error is common," say Meador and Lundberg,"and that it is very difficult to remove a false diagnosis of any disease.

If the question about why scientists and their enablers ignore errors of false diagnosis remains unanswered, at least you, the patient, can help disrupt the cycle of false diagnosis/overtreatment/financial waste by:

• considering the possibility that you might not be unwell, only worried about being unwell;


• keeping complete records of symptoms of illness--what they are, when they occur, patterns about when and under what circumstances they appear and subside;


• asking your doctor what else can cause your discomfort besides the problem she has diagnosed;


• seeking a second opinion; and


• consulting a psychological therapist to examine if physical symptoms can be the result of emotional disturbance.

Technology is a wonderful thing. Most of us rely on it to do our jobs, remain informed, communicate and plan and participate in recreational activities.

But like a wonder drug that can render a dread disease a manageable irritant, technology has side effects and some of them are dark, indeed. Writing on his health news blog, Gary Schwitzer recounts the ominous tale of a pharmaceutical company's sly efforts to pretend to be a Facebook friend but whose motives were clearly mercenary.

Marilyn Mann is a well-informed medical consumer; she has to be, she's a breast cancer survivor whose daughter has heterozygous familial hypercholesterolemia (FH), a genetic disease that elevates LDL cholesterol to dangerous levels. She is an administrator of a Facebook group--Familial Hypercholesterolemia (FH) Discussion Group--that enables networking for people with FH and their family members.

Schwitzer reports that recently, Mann got a message from a public relations woman who had joined the Facebook page: "A few months ago, I had emailed you about some research I was doing about a new treatment for FH. I am now working with a pharmaceutical company, and the company currently has a drug in development to help treat people with severe FH that may not be responding to current therapies."

The PR woman continued: "I am trying to do exactly what you are doing--to educate patients and physicians about this disease and to raise awareness so that undiagnosed patients can get the help they need. ... I thought it might be good for us to connect so that I can explain to you a little about what the company is doing and to see how we can work together to reach a larger audience. Through my work in FH, I am regularly in touch with many of the world's leading researchers and the people who work at the company to discuss ways we might be able to collaborate...."

On its face, the approach was friendly and compassionate. Mann spoke with the PR woman, who disclosed that she was working for Genzyme, the company developing the drug to treat FH. The woman wanted Mann to recruit journalists to generate stories about people with FH.

Mann politely declined, saying, "Genzyme's purpose is to sell their products. My purpose is to help patients. Those two goals are not the same."

Not only was the PR person actively trying to manipulate the news--there's a difference between raising awareness about a disorder most people never heard of and working to ensure your employer has skin in the game--but her behavior could be seen as a form of electronic stalking. "I think it was creepy for this PR woman to join the Facebook page,"Mann told Schwitzer, "lurking there and observing on behalf of her drug company client. The idea of having a drug company planting human interest stories in the press is yucky ...a big corporation pulling string behind the scenes. I'm not interested in being used in that way."

As the informed person she is, Mann knew about the Genzyme drug, believed it had limitations based on trials and so informed the PR person.

The PR rep had clearly identified herself, her employer and the nature of her interest in the Facebook community. So why was her attempt to exploit it so unseemly?

As Schwitzer noted, it wasn't just the attempt to join a discussion group because of its potential usefulness for a certain company, it was the attempt to influence news coverage that that was so offensive. Whether you're voting for your local school board, signing a legal contract or making a determination about treatment for a medical condition, you need objective, complete information. Such decisions aren't made by listening to feel-good human interest stories.

Genzyme intended its FH drug not as first-line therapy, but as an additional treatment for people whose cholesterol is not controlled with a statin. Typically, those patients have the most severe forms of FH. It is their stories Genzyme wants the media to tell, not those of people who can control their cholesterol with a statin--they don't need another drug.

Schwitzer says tactics like those of Genzyme might fall under the category of "disease mongering," an effort to "sell" sickness by profit-driven interests beyond the boundaries of what science and medicine accept. The subject is well covered in PloS Medicine by writers Ray Moynihan and David Henry. The point, they say, is to sell products, not to inform, educate or otherwise help medical consumers understand and maintain their health.

If you're a member of a medical-topic social media group, be aware that sometimes a fox gains entry to the henhouse with very little commotion. If you're asked to tell your story, or to find other people who will, make sure it's for the greater good, and not just somebody's bottom line.

Aching back, stiff fingers, cranky knees... We like to self-prescribe common painkillers such as ibuprofen (Advil), naproxen (Aleve) and celecoxib (Celebrex) for all manner of discomfort. But a new study from the University of Florida casts renewed doubt on the long-term use of these drugs known as NSAIDS--nonsteroidal anti-inflammatory drugs.

It found that people with hypertension and coronary artery disease who address chronic pain with regular NSAID use may have increased risk of death from heart attack, stroke and related events.

Physicians already discourage the use of NSAIDs by heart attack patients and the elderly because earlier studies showed a relationship between the drugs and higher risk of stroke and heart attack.

People who also take aspirin--another type of NSAID--for cardiovascular prevention might be especially at risk because these other NSAIDS appear to compromise aspirin's anti-clotting effect, might increase the risk of bleeding and raise blood pressure.

The study's authors advise patients not to stop prescribed use of these drugs before discussing it with their doctors. Further studies probably will focus on whether all NSAIDS share these dangerous properties, or only some.

Hospitals are subject to clear standards and procedures for infection control, but germs don't care whether they live in an operating room or a medical office exam room.

The Centers for Disease Control and Prevention (CDC) do. It recently issued "Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care" for all manner of ambulatory care centers, including doctors' offices and outpatient testing and lab facilities.

Among the most basic practices such facilities should follow are:

• Develop and maintain infection prevention and occupational health programs.


• Assure sufficient and appropriate supplies necessary for adherence to standard precautions (hand hygiene products, personal protective equipment, injection equipment).


• Assure at least one individual with training in infection prevention is employed by or regularly available to the facility.


• Develop written infection prevention policies and procedures appropriate for the services provided by the facility and based upon evidence-based guidelines, regulations, or standards.

Patients generally are not aware, nor should they be, if their health-care providers have undergone the necessary training to adhere to these guidelines. But they're common sense, and if anything seems amiss when you visit your doctor--say, the nurse doesn't wash her hands before offering a thermometer--ask what measures are being taken to protect you from someone else's germs.

Okay, it might be a touch sarcastic. But this poster is backed by good science. How did it come about?

Read the back story on this cardiology website.

Never underestimate the doggedness of an insurance company in guarding its own treasury from malpractice claimants. Even when the patient wins, you can often count on a multi-year battle in the appeals courts to collect what you are owed.

For our firm's client Sharon Burke, an eleven-year odyssey has finally ended in her favor, after a second trip to the District of Columbia Court of Appeals.

Ms. Burke's malpractice case concerned a misreading of her MRI scan that caused a fateful delay in finding a problem in the arteries feeding blood to her brain. The delay led to a disabling stroke for her. Read more details here.

On the first go-round, the Court of Appeals denied the radiologists' motion for a new trial. You can read about that decision on our firm's website about verdicts, here.

But that decision came three years after we won the verdict at trial. So on Ms. Burke's behalf, we wanted the interest that had accrued on the verdict during that 3-year span.

That started round 2 of the appellate war. We calculated the interest owed based on the fluctuating interest rate provided by the District of Columbia statute. The rate varies with the rate of interest published by the Internal Revenue Service for underpayment of taxes, which in turn is pegged to the interest rate on U.S. Treasury bonds. That's a fair system, because it gives the winning party a rough approximation of the market interest rate on the money owed while the defendant holds onto the money during the appeal.

Between our verdict in March 2004 until the final judgment in March 2007, the rate had climbed from 3 percent to 6 percent. So we asked for interest for each quarter based on the interest rate then in effect. That came to a little under $500,000.

The insurance company really liked the 3 percent rate that was in effect when the verdict first came down. That saved it a little under $200,000 from what we calculated it owed. So it asked the trial judge to order the lower interest rate. To our surprise, the trial judge granted the insurer's request. The judge had "discretion" to change the interest rate downward, but we appealed her decision, since we said there was no reason to penalize Ms. Burke with a sub-market interest rate on the money the radiologists' insurer owed to her.

This week, four years later, the District of Columbia Court of Appeals agreed with our argument. It said the trial judge had abused her discretion in lowering the interest. The court noted the important public policy behind "post-judgment" interest. The idea is to "make the plaintiff whole" -- that is, when you win a lawsuit and the defendant owes you money, if the defendant wants to hold onto the money while it appeals, in fairness, you should get something close to what the market would have paid by way of interest.

You can read the decision on our website.

Now Sharon Burke will finally get paid everything she is owed. It won't restore her brain health, but it will help the dignity and quality of her life.

It was supposed to be a routine hernia operation. But then the surgeon ordered the anesthesiologist to give the patient a blood-thinning drug. The anesthesiologist, who wasn't familiar with the drug, injected the drug directly into the patient's i.v. line, as soon as the surgeon ordered it. That was a double mistake, and it started a cascade of consequences for the patient, who later became our law firm's client.

The legal issue in the medical malpractice lawsuit we filed was: Who was responsible for the misuse of the drug? Just the anesthesiologist, who should have known better than to inject the drug intravenously, and so soon? Or the surgeon too?

That issue was finally resolved this week in our client's favor. Here is what happened.

The too-quick use of the drug Lovenox, which was intended to prevent blood clots in the legs after the surgery, caused bleeding in the spinal cord, with permanent nerve damage for our client. The use of the drug was against the "black box warning" on the drug's official labeling, which said doctors should wait after a spinal anesthetic at least several hours, and also against the official policy of the Washington, DC hospital where the surgery happened.

The anesthesiologist settled out of court on the eve of trial and turned over to the injured patient the anesthesiologist's cross-claim for "contribution" against the surgeon.

The trial court then ruled, after a hard-fought trial, that the surgeon was jointly responsible with the anesthesiologist for the injury.

After a long battle, the District of Columbia Court of Appeals affirmed the trial court's ruling in all respects. You can read the decision on our firm's website here.

U.S. News & World Report recently issued its ranking of Best Hospitals in the United States as well as a host of interpretive articles to help people refine their understanding of what constitutes "best" and how to locate the "best" hospital in your area.

The article "When a Hospital is Bad for You" explains that a facility offering excellent treatment for someone seeking treatment for, say, a broken leg can be less than the best place for someone who needs her aortic valve replaced.

Because the U.S. is a developed nation with regulatory oversight, few hospitals offer truly abysmal care. Such incompetence is rewarded with the withdrawal of credentials and a shuttered physical plant.

But there are important differences, and when it comes to your health, you can't be too careful about separating the merely good from the superior. As the magazine says, "Rates of postsurgical complications such as bleeding, infection, and sudden kidney failure vary surprisingly little, according to a recent study of nearly 200 hospitals across the country. What does differ are deaths from such complications," said John Birkmeyer, M.D., and the study's co-author.

Here, according U.S. News, are five signs that should prompt you to continue shopping for a hospital that meets your medical needs:

• 1. Low volume. This falls under the "practice makes perfect" category. A hospital should be able to provide figures for the most recent year, along with death and complication rates, and you should ask for them. If it doesn't have much experience with the procedure you need, go elsewhere. According to the Leapfrog Group, a business-sponsored organization that evaluates hospital performance, these are acceptable numbers, per year, for some common procedures:
  bypass surgery-- 450;
  coronary angioplasty and stenting--400;
  weight-loss surgery--125;
  aortic valve replacement--120;
  repair of abdominal aortic aneurism--50;
  removal of cancerous portions of esophagus and pancreas, respectively--13 and 11.

  If these numbers are low, ask your doctor about options.



• 2. Low surgeon volume. A hospital can register high-volume numbers for procedures, but individual surgeons might be low-volume practitioners. Some operations, such as aortic valve replacement, require lots of practice to maintain sharp skills. Your surgeon should be willing to supply the latest yearly total as well as rates of death and complications for your procedure. If not, or if he or she seems indignant at the request, seek alternatives.


• 3. No intensivist. Hospitals that employ specialists to care for patients in intensive care, versus the traditional practice of surgeons or other physicians taking charge of their intensive care patients show a decrease of deaths of 25% or more. Specializing in critical care, intensivists work primarily inside the ICU; surgeons, in contrast, spend most of their time in the OR. Hospitals with more than 250 beds should be able to summon an intensivist to the ICU within five minutes of being paged.


• 4. Not enough nurses. A study in the Journal of the American Medical Association found that a patient's risk of dying was much higher where nurses on surgery floors had more than seven patients during an average shift; the ideal number is four or fewer. Also, a nursing corps that holds four-year RN degrees versus two-year RN degrees notched a lower rate of surgery-related deaths. Patients should contact a hospital's director of nursing to find out its nurse-to-patient ratio.


• 5. Too many readmissions. This is a relative figure, so you must compare several hospitals to determine which has the lowest rate. The higher the rate of readmission, the greater the likelihood that a hospital struggles to coordinate care after discharge.

For more tips and practical websites for research, check out our firm's patient safety newsletter, which devoted an issue to finding the right hospital.

If you believe the stereotype, surgery isn't a warm and fuzzy medical specialty (that would be family doctors), it's a cold, clinical engineering-like pursuit. And a surgeon is more likely to be known as "the knife" than "the smile."

The head of one major transplant center, however, would like to rearrange the stereotypical furniture. Says Andrew Klein, M.D., "Operating rooms are social environments where everyone must work together for the patient's benefit. When a surgeon, who is in the position of power, is rude and belittles the rest of the staff, it affects everything."

Klein and Pier Forni, Ph.D., authors of an article about civility and medicine in the Archives of Surgery, said an operating room is a crucible of stress that can manifest in bad personal behavior that isn't good for anybody. They acknowledge that scientific studies are reinforcing perceptions that outcomes improve when the surgical team cooperates.

As reported in MedPage Today, Klein and Forni found that rancor and the rudeness it engenders may be tied to heart disease and depression. They point to one study that deemed that "high-risk" uncivil behavior in the surgical suite increased the risk of postoperative death and complications.

The incivility extends beyond the OR and so do its side effects. In one study, 96% of nurses for the Department of Veterans Affairs' reported witnessing disruptive physician behavior. A survey by the Institute for Safe Medication Practices showed that 75% of nurses sought a co-worker's help to understand a confusing physician's order because they didn't want to interact with the doctor themselves. Seven percent of the nurses blamed doctor intimidation for medication errors.

In their article, Klein and Forni lobby for surgeons and OR teams "to lead a civility initiative in healthcare." That includes reviewing hiring criteria for surgical employees to look beyond the traditional standards of "accomplishments, knowledge, training, and productivity" in the hope of identifying ways in which prospective candidates can be assessed for how they function in a social environment.

We're thankful that there appears to be a growing awareness of the value of the "what you learned in kindergarten" approach to a collegial work environment. See: Testing for Life-Saving Communications Skills in Young Doctors

"The temptation to ignore warning signs that a surgeon will not play well in the sandbox with peers and co-workers is seductive when large clinical practices and (National Institutes of Health) funding are at stake," Klein said.

Like other workplaces, the writers suggest, hospitals should develop a code of conduct for medical and administrative staff. They also champion the idea of cultivating relationships at work, because a culture of caring fosters loyalty.

If your doctor, your nurses, your patient advocate cooperate and have empathy for each other's professional roles and responsibitlities, your care will improve. Ask if the hospital where you are scheduled to be treated has a code of conduct. As a patient, you should not tolerate rude behavior among the people caring for you. If you don't think someone on your care team is being treated properly, speak up. It's the right thing to do for her, and the best thing for you.

Article first published as Does Being Polite Save Lives in the OR? One Surgeon Says Yes on Technorati.

Bo, the presidential family pooch, might be a real sweetie, but he can still make some people sneeze.

According to the New York Times, the notion that certain dog breeds--such as Portuguese Water Dogs, of which Bo is a member--are less likely to stimulate an allergic response seems to be misguided.

A study in American Journal of Rhinology and Allergy found no difference in the quantity of allergens in homes with supposedly low-allergy pets—poodles, Wheaten terriers, schnauzers, Bo--and those not identified as being hypo-allergenic.

It’s possible that some breeds do produce less dander (tiny bits of fur and skin), but it’s more likely a trait of an individual dog. Researchers acknowledged that how much time you spend in a room with a dog could be critical to your allergic response, and that information was not tested.

Here boy! Roll over! Sit! Fetch me a tissue!

Hold your cellphone against your head too long and you can get a brain tumor. Text too often and you can forget how to spell. Converse on your Bluetooth while waiting in line and annoy everyone around you.

One of those statements is undeniably true, one could be true, and one—about brain tumors—is probably false, according to a new study in Environmental Health Perspectives.

Because data is sparse about cellphone use by youngsters and about use periods longer than 15 years, be prepared for ongoing speculation about how cellphones affect your brain. And be mindful, the study says, that "Research cannot in principle prove the complete absence of an effect, but only place limits on its possible magnitude.”

Still, the conclusion is fairly compelling: “Although there remains some uncertainty, the trend in the accumulating evidence is increasingly against the hypothesis that mobile phone use can cause brain tumours in adults.”

Of course, we can’t promise that somebody won’t whack you in the head if you text and chat during the movie.

A couple of implantable devices recently received new scrutiny with negative results.

Medtronic issued a “medical device correction” about possible diminished battery life of its infusion pump, the SynchroMed II. The device is surgically implanted to deliver painkilling medication.

According to About Lawsuits.com, of 140,000 implants worldwide, 55 were reported to have reduced battery performance. Designed to last 84 months, some batteries failed as early as 48 months. Medtronic issued a caution about the problem in July 2009, and an update earlier this month. And in February, certain models of the SynchroMed infusion pump were recalled thanks to a defective design that could result in an overdose during refill.

Pump failure can result in the return of pain, can cause patients to experience drug withdrawal and, for patients with multiple sclerosis who receive the drug baclofen, can be life-threatening.

The SynchroMed II is not being recalled, nor is it recommended that it be removed. Patients who have the device and whose symptoms reappear, or who hear a device alarm should contact their doctors immediately. For additional information, call Medtronic Patient Services, (800) 510-6735.

For women with pelvic organ prolapse, in which urinary and/or sexual organs droop or slip out of place, surgery is sometimes indicated. The FDA warns that if surgical mesh, rather than stitches, is implanted to strengthen the vagina, the risk of complications including tissue erosion, pain, infection, bleeding and urinary problems is greater. (Sometimes the mesh is implanted through the abdomen, which is not subject to the advisory.)

According to MedPage Today, “the number of adverse events linked to the device has been increasing in recent years.” Between 2008 and 2010, five times as many such events were reported than between 2005 and 2007.

"The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh," William Maisel, M.D., M.P.H., deputy director of FDA's center for devices and radiological health, said in a statement. "Mesh is a permanent implant--complete removal may not be possible and may not result in complete resolution of complications."

Although the mesh often corrects the anatomical issue, after reviewing reports for a 14-year period of use, the FDA concluded that the greater risk was not accompanied by greater clinical benefit than nonmesh surgery. Its advisory was issued in advance of a committee meeting in September to examine the safety and effectiveness of surgical mesh for the treatment.

As quoted by the McClatchy-Tribune News Service, Diana Zuckerman, president of the National Research Center for Women & Families, said an advisory wasn’t strong enough. “The troublesome issue is how is that going to affect what actually happens to patients as long as this product is still on the market and widely available.”

If your doctor has advised surgery to correct pelvic organ prolapse, be sure to discuss the implications of both mesh and stitches.

The road from conception to useful application for a new drug therapy, when properly navigated, is fully mapped, carefully followed, scientfically rigorous and honestly appraised. Not so with a big study of the lucrative drug Neurontin, according to Yale researchers.

In the case of Neurontin, a drug to treat epilepsy, critical parts of that journey took a few unauthorized detours, according to a report in the Archives of Internal Medicine.

Researchers at the Yale School of Medicine reviewed documents relating to the epilepsy drug gabapentin, a drug patented as Neurontin by Pfizer in 1994, that they concluded were misrepresented by the pharmaceutical company as a clinical trial.

Instead, they said, it was a “seeding trial,” which they described as “An important and expensive form of marketing, … a study of an approved drug or device in which the primary objective may not be to answer an important scientific question but rather to introduce a new product and induce clinicians to use it.”

In other words, seeding trials juice the market by enticing practitioners to sample and prescribe a drug that’s already FDA-approved.

Joseph Ross, M.D., said that Study of Neurotonin: Tritrate to Effect, Profile of Safety (STEPS) “was a seeding trial posing as a legitimate scientific study. The trial itself, not trial results, was part of a marketing strategy used to promote gabapentin and increase prescribing among investigators without informing trial patients or investigators."

As noted in the Los Angeles Times, the STEPS study also was intended to fend off efforts by a competitor to introduce a rival drug.

The breach wasn’t against the law, but it wasn’t ethical because the purpose was primarily to promote, not to discover, and because trial participants and physicians might be unaware of the studies’ true purpose.

The Yale team said STEPS’ stated purpose was to examine doses of gabapentin within a patient population of 2,759. Two articles about its results were published in scientific journals, but, the team noted, outside sources had questioned the study’s design as uncontrolled (that is, it didn’t include a separate, or "control," group of participants who didn’t receive the drug). In addition, it was not a blind study. Scientific rigor demands that study participants remain unaware—blind—about whether they are receiving a drug or a placebo (fake drug).

There's more. The Yale team said, "Data quality during the study was often compromised," and some documents appeared to suggest that marketing personnel helped to collect data and witnessed the trial, not just the results.

Article first published as Neurontin Research Was So Flawed It Deserved to Be Called Marketing, Not Science on Technorati.

Only someone who suffers from asthma can understand the panic that comes with a sudden attack that feels as though you’re suffocating. Many such victims reach for an inhaler to dispense the drug albuterol, which provides lung relief.

Now, a new study published in the New England Journal of Medicine confirms not only the drug’s benefit, but a whole lot more -- about how caring can enhance treatment.

It found that asthma patients given a placebo (inert drug, aka fake treatment) or no treatment felt better despite measurable differences in lung function improvement as compared with those receiving drug treatment.

One of the study’s authors, Ted J. Kaptchuk, associate professor of medicine at Harvard Medical School, described for WebMD the elegance of the research: "Disease is what doctors search for--the underlying physical thing they can detect with labs and imaging and can express in hard numbers," he said. "Illness is what a patient experiences. ...There is a difference between what doctors find and what patients experience."

What the asthma study demonstrates is that making patients better requires treating illness as well as treating disease. Thirty-nine asthma patients stopped taking the drugs prescribed for their condition. Then they randomly underwent four different regimens during which lung function was tested regularly. They were:

• treatment with an albuterol inhaler;


• treatment with an inhaler with no active drug (a placebo);


• treatment with bogus acupuncture (the device appeared to puncture the skin like acupuncture needles, but didn’t); and


• no treatment.

As expected, the albuterol treatment registered improved lung function by 20%. And not unexpected was that the placebo treatments improved lung function somewhat--7%. It was interesting that patients who got no treatment also improved by 7%.

But truly surprising was how patients reported their condition. Asked how much better they felt, they said 50% better with the albuterol; 46% better after fake acupuncture and 45% better after using the inert inhaler. The latter two positive reports could be attributed to the “placebo effect,” which is often seen among study subjects who don’t know that they’re not receiving the real McCoy. But even after knowingly receiving no treatment, they said they felt 21% better.

As lead study author Michael E. Wechsler, M.D. told WebMD, "with this study we saw that part of taking care of the discomfort … is being there. …There is definitely some mind-body interaction in asthma that relates to the shortness of breath that patients feel."

People who study the placebo effect draw a distinction between objective medical outcomes (in this study, lung function) and the subjective medical outcomes of patient-based feelings (in this study, less shortness of breath).

They hope to raise consciousness that, sometimes, medical research dismisses subjective results to overwhelmingly favor objective results. But the artful practice of medicine addresses the reason for the suffering as well as the suffering itself.

That said, it would be foolish to ignore the whole picture painted by the asthma study. Treatment with a proven drug clearly resulted in superior lung function. And without the availability of that treatment, people will experience preventable asthma attacks. The goal is for patients to receive medical treatment and medical care.

Cancer of the trachea--or windpipe--is extremely rare, representing only 1% of all cancers. One patient, who had been diagnosed in 2008, had undergone chemotherapy, radiation and surgery, but his tumors were threatening to block his windpipe when technology came to the rescue last month.

The first-ever synthetic windpipe was transplanted on June 9, and last week the patient left the hospital. Created in a lab without using donor tissue, the new trachea was made only of synthetic material and the patient's own stem cells. The process took fewer than two weeks, versus waiting months for an organ donor, CNN reported.

In addition to bringing this patient back from the brink, the landmark procedure means he won't require immune-suppressing drugs, which have significant side effects and can render subjects vulnerable to infection.

As if the doctor-patient relationship isn't one-sided enough, the subservience patients often feel can be made even worse when you must wait way beyond the appointed time for your consultation.

For some patients, time is money, and for all patients whose doctors assume the doctor's time is more important than yours, extended waiting is disrespect. One study last year pegged the average wait time at doctors' offices in the United States at 24 minutes.

Everyone understands that medicine is fraught with emergency, and sometimes a physician simply must accommodate an unexpected patient. But some doctors are never on time; for them, running late is business as usual.

Others are told by superiors and insurance companies to book consultations at 15- or 20-minute intervals; if one patient has more than one problem, or a complication arises that requires 30 minutes' time, every patient after her will be seen late. So, does the doctor cut off the appointment in order to maintain the schedule, or does she meet the medical need at the risk of making everyone else late?

As doctors are increasingly besieged with paperwork demands and lower fees from Medicaid and Medicare, is it fair for patients to expect prompt service? Apart from making a scene, is there recourse when your 10 a.m. appointment begins just before lunch?

Some patients, according to several recent reports including one on CNN, are turning rude behavior into financial penalty. They're invoicing tardy physicians for time spent cooling their heels in the waiting or exam room. And physicians are paying.

Not too long ago, doctors would have scoffed at the idea of reimbursing patients for time spent waiting. But some told CNN they give patients money or a gift, sometimes even without being asked.

"I love this!" Dave deBronkart, co-chair of the Society for Participatory Medicine, told the network. "It's magnificent that some physicians are valuing patients' time. It's a commitment to designing a practice that truly serves patients."

Others ... not so much. One woman left her doctor's office at 8:40 when the gynecologist hadn't shown up for her 8:00 a.m. appointment. Encountering the doctor in the parking lot, the patient asked about the delay. "The doctor told me she had a little one and she was never in the office until ten to nine," she remembers. "I asked her why she scheduled appointments at 8 a.m., and she said to give the patients time to do paperwork. I was so mad I was shaking. I never went back to her."

DeBronkart blogged at E-Patient Dave when he waited 45 minutes for an X-ray. He told CNN that the head of the radiology practice later called and acknowledged the need to change how they scheduled patients.

Some physicians have seen the patient-waiting light, and are doing their best to ensure it isn't red. MedPage Today reported about one who offers Starbucks gift cards and text messages patients if he's running behind. Another, who practices boutique medicine, books only about 10 patients per day for at least 30 minutes each and charges a $125 annual fee per family for the convenience. If he is late, he pays $25.

The MedPage story makes clear that it's easier for some practices, such as surgery, to run more efficiently than a primary care office. Offices at greater risk of being late can address the problem and possibly mollify patients by:

• offering wireless Internet;


• ensuring good cell phone service, and providing space where waiting patients can talk privately;


• texting, emailing and/or calling patients if they're running late.

One patient who tries to turn waiting time into work time is concerned that if billing tardy doctors becomes fashionable they will start charging everyone more. They should focus on prevention, he says.

As a patient, you can minimize your likelihood of a shortened fuse from a longer wait by:

• scheduling your appointment at the beginning of the day or right after lunch;


• locating doctors with demonstrable on-time practices via an organization such as Ideal Medical Practice, which identifies superior practices; and


• putting a value on your time and invoicing your doctor for an unreasonably long wait.

Want to go to medical school? How well do you listen? How well do you work in a team? Those issues are now being tested by the nation's newest medical school in screening applicants.

This is not just a matter of touchy-feely. Preventable deaths and malpractice have been proven to happen all too often when arrogance trumps smooth teamwork and easy communication among members of medical teams.

But testing communication skills is not so easy. So in the new testing regime created by the leaders of Virginia Tech Carilion medical school, medical school applicants are given a series of quick, speed-dating type interviews where they have to show how they respond to real world scenarios that require good communication and teamwork skills.

Gardiner Harris has a fascinating account in the New York Times about the new program. A key quote from the article brings home its importance:

A pleasant bedside manner and an attentive ear have always been desirable traits in doctors, of course, but two trends have led school administrators to make the hunt for these qualities a priority. The first is a growing catalog of studies that pin the blame for an appalling share of preventable deaths on poor communication among doctors, patients and nurses that often results because some doctors, while technically competent, are socially inept.

The second and related trend is that medicine is evolving from an individual to a team sport. Solo medical practices are disappearing. In their place, large health systems — encouraged by new government policies — are creating teams to provide care coordinated across disciplines. The strength of such teams often has more to do with communication than the technical competence of any one member.

You fill a prescription with a brand-name medication. The pills are light-blue ovals that come in a plastic bottle. When the generic version becomes available, your insurance company insists that you purchase only that, and your doctor agrees.

This time, the pills are round, white and come in a carboard blister pack. If the medicine works the same, who cares?

Two physicians writing in the New England Journal of Medicine, argue that we all should.

They say letting generics look like the brand name original makes for safer and even more effective medicine.

The doctors argue against a practice called "trade dress." The term refers to federal laws that protect the unique appearance of brand-name drugs by prohibiting generic pharmaceutical manufacturers from making similar-looking pills or designing similar packaging.

The researchers accept that trade dress has played a meaningful role in keeping drugs safe. It can prevent different medications from being mistaken for each other, thwart counterfeiting and prevent shady pharmacists from making unauthorized substitutions of generic for brand-name drugs and skimming the extra profit for themselves.

But drugs that are supposed to perform one way but look different every time you refill the prescription, suggest researchers Jeremy Greene and Aaron Kesselheim, can lead to medication errors, can be unnecessarily more expensive and can diminish the generic drugs' effectiveness, thanks to the placebo effect not kicking in for the generic drug.

A placebo, or "fake" drug, is a sugar pill or other inert substance used in medical trials to test different treatments among trial subjects who are unaware if they are being given medicine or something that just looks like it. Often, however, patients receiving the placebo respond positively, sometimes strongly so.

As reported on MedPage Today, The NEJM researchers note that "A resurgence of research on the placebo effect suggests that drug appearance can have a distinct functionality." They say a medication's packaging and the perceived dollar value of products can influence a product's effectiveness as well.

So because one medicine that always looks different can be confusing, because generics make up about 70% of all U.S. prescriptions but less than 20% of prescription-drug costs and because a patient's mind is a powerful player in his or her ability to heal an ailing body, the researchers support amending regulations to permit generic drugs to resemble their brand-name counterparts.

Such changes would codify a consistent, organized system of pill appearance that would:

• simplify the complexity of certain medical regimens;


• encourage the use of generic drugs when appropriate; and


• increase a patient's ability to take the medication as directed.

Here's a case that opens a window on how tabloid newspapers get intimate details of celebrity's medical lives: They pay hospital employees to rifle through private medical records.

The University of California, Los Angeles (UCLA) Health System has agreed to pay the federal government $865,000 to resolve allegations that its employees violated patient privacy, according to investigative journalists at ProPublica.

Between 2005 and 2008, UCLA employees repeatedly snooped in patient medical records, including those of celebrity patients Farah Fawcett, Britney Spears, Michael Jackson and former California first lady Maria Shriver. ProPublica had reported earlier how Fawcett (now deceased) had set up a sting operation to catch leaks to the National Enquirer about her cancer. In 2010, a former UCLA employee pleaded guilty to four counts of illegally reading private and confidential medical records.

The agreement with the U.S. Department of Health and Human Services requires UCLA to train health system employees who have access to patient records, to sanction those who break the rules of the Health Insurance Portabilityand Accountability Act (HIPAA) and to assign an independent monitor to assess its compliance for three years.

Most medical malpractice lawsuits are not settled or decided by trial. They are abandoned by the patients and family members who brought them. A study in the medical journal Health Affairs reviewed the outcome of 3,695 malpractice claims filed in Massachusetts between 2006 and 2010, The Boston Globe reports.

Nearly 60% of the lawsuits filed against hospitals, doctors and other medical providers were abandoned. Twenty-six percent were settled, and a mere 15% went to trial. The journal concluded that "claims are not dropped because a large percentage of them are frivolous, but for other reasons."

According to the malpractice attorneys interviewed by researchers, plaintiffs most often drop lawsuits because, after learning more about the medical procedure that went wrong, they conclude their case is weaker than they imagined.

The study recommends that that hospitals and insurance companies adopt policies to encourage lawyers on both sides to exchange information more quickly and discuss cases more openly. "Such reforms would greatly reduce both the frequency and the duration of cases that are dropped," read the journal report, "and thus the cost of malpractice litigation."

Another thing that might help, from this lawyer's experience, is for hospitals to talk more candidly with patients and their families when the patient winds up worse off for the hospital experience. Many patients come to legal advocates like me to investigate a potential malpractice suit because they are first bewildered at what happened, then suspicious when the doctors and nurses won't talk to them. We have to do extensive investigations to get to the bottom of events, and sometimes -- although not nearly as often as seemed to happen with the lawsuits in this study -- we discover that the care was acceptable but it was just a tragic outcome.

Generally, a gut-check is an informal, instinctive assessment. But researchers at the University of San Diego Health System took matters literally in studying the impact of gender in major gastrointestinal surgery. They found that women are more likely than men to survive the procedure.

Published in the Journal of Surgical Research, “The Battle of the Sexes: Women Win Out in Gastrointestinal Surgery” examines the major differences that affect treatment success, and aims to create new therapies that improve survivability of surgical patients.

“[M]edical outcomes could be optimized by tailoring therapies based upon each individual’s unique genetic make-up as well as other characteristics. Gender is among the most important traits,” said Carrie Y. Peterson, M.D., lead author of the study. Among the procedures that fell under her scientific knife: stomach, intestinal, liver and pancreatic surgeries.

“The results suggest that female hormones might enhance the immune system -- a process previously shown in animal models and also observed in trauma patients,” said Peterson. “Thus, there is a hope that negating the effects of testosterone or giving estrogen to male patients could be considered part of a treatment plan.”

Other factors that might contribute to higher survivability rates:

• females have more elective operations;


• females have surgery more often in teaching hospitals; and


• when symptoms occur, females seek medical attention sooner than men.

MarylandReporter.com reports that the state will request an exemption from a new requirement by Medicare that hospitals demonstrate their quality of care. Taking effect Oct. 1, the requirement financially rewards hospitals that meet the new standard and penalizes those that don’t.

Robert Murray, executive director of the Health Services Cost Review Commission, said the state will document for the feds that “Maryland already has those programs in our system.” The commission has tracked the quality of hospital care for three years.

“The health reform act says you can be exempt from this regulation if you show you already meet or exceed [the national requirement]," Murray said.

Maryland is the only state in the country with a waiver from the Medicare payment methodology, which was negotiated in 1977 when Medicare agreed to pay hospitals in Maryland on the basis of commission-set rates. Other states since have been granted waivers but only Maryland has maintained its waiver.

At its annual meeting last month, the American Medical Association's House of Delegates adopted several new policies, including one that recognizes that bisphenol A (BPA) interferes with human hormones, one that decries the practice of competitive eating and one calling for more research on full-body scanners used in airports.

The AMA says BPA is an endocrine-disrupting agent and wants products with the potential to increase human exposure to the chemical to be clearly identified. Studies have shown that BPA may be linked to male sexual dysfunction, cardiovascular disease, diabetes and liver abnormalities.

BPA is used to soften plastics in baby bottles, cups and plastic packaging. In 2008, the FDA said there was evidence to connect commonly used levels of BPA to some health issues, but its conclusions were questioned by an advisory panel.

Competitive eating, in which contestants speedily ingest the most food possible within a certain time limit, is a practice the AMA finds deleterious to gastrointestinal health (and thinking people everywhere find disgusting and offensive in a world where millions starve every day.) The AMA's Young Physicians section noted that speed eaters are in danger of vomiting, reflux, choking, stomach rupture, diabetes and tooth enamel erosion.

Calling for more research, the AMA determined that there aren't enough data on potential health risks of the new full-body scanners used at some airports. Radiation experts and medical physicists agree that the full-body backscatter scanners that create an anatomically accurate image produce minuscule levels of radiation that pose no real health risks. But questions remain: What effects will the low-dose X-rays have on skin and what would happen if a machine's "on" mechanism jammed and delivered a dose of radiation that is exponentially higher than intended?

A drug prescribed for smoking cessation is linked to an increased risk of heart problems, according to a study published July 4 in CMAJ (Canadian Medical Association Journal). Varenicline, known by the brand name Chantix, was associated with a 72% increased risk of a serious cardiovascular "event."

That sounds huge, but the scientific number-crunching shakes out a bit differently. Although attention must be paid, many critical minds are not ready to dump the drug. Fifty-two (1.06%) of the participants who took Chantix had serious cardiovascular events compared with 27 (0.82%) of those who took a placebo.

One bottom line for smokers who may want to rationalize continuing to puff: It's always better to stop smoking. No excuses.

When varenicline was launched in 2006, the FDA noted that it could raise the risk of cardiac problems, and the federal agency recently updated the label for Chantix to reflect that risk among smokers with heart disease. And we wrote about the drug a couple of years ago. But the new study's authors said, "These increased risks ... are seen in smokers with or without heart disease."

The irony, of course, is that one major risk of smoking is heart disease.

The Chantix-using subjects of this trial were able to abstain from smoking at a significantly higher rate, an achievement that should potentially confer a cardiovascular benefit. Many members of the medical community believe the drug should remained a valuable treatment option, given the devastating effects of smoking. Apart from heart issues, nicotine and the other ingredients of cigarette smoke, of course, compromise lung function and can lead to lung cancer, and also increase the risk of stroke and diabetes.

The results were based on a review of 14 studies of approximately 8,200 smokers or users of smokeless tobacco. Most had no history of heart disease. They were followed for as long as a year, a comparatively short term that gives many researchers pause. It's possible, for example, that the risk diminishes over time.

Dr. Taylor Hays from the Mayo Clinic opined, "Although these results suggest a measure of caution should be taken in prescribing varenicline for tobacco dependence treatment ... [T]he risk for cardiovascular events is low and is far outweighed by the benefits of diminishing the truly 'heartbreaking' effects of cigarette smoking."

If you're taking Chantix, don't stop without consulting your doctor. If you're unable to stop smoking via other methods, discuss the cost-benefit question of treatment with Chantix.

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.

Ever since the U.S. Preventive Services Task Force suggested relaxing the rigid schedule for mammography testing in 2009, patients seeking a unified, authoritative voice on the topic have been rewarded with confusion. Probably because the medical community, too, is unresolved about who needs what kind of breast screening and when.

A study published this week in the Annals of Internal Medicine, is the latest participant in the discussion. It articulates as well as any previous research the notion that mammograms are situationally useful, and promotes the idea that such testing should be customized to each patient.

For women with a normal genetic profile, the timing and frequency of a mammogram, the researchers say, depend on the patient's:

• breast density;


• age;


• family history; and


• personal preference.

Age, history and, to a lesser degree, density, are not new factors in the tricky equation of when to have a mammogram, but personal preference? Since when does science ever acknowledge, much less respect, that what's preferable might also be good medicine?

Although the study researchers made clear that, apart from genetic mutation, breast density is the single-most important consideration in determining the suitability of relatively frequent screening, mammograms often result in false positives -- the suspicion that you have cancer when you really don't. That feeds a cycle of anxiety, unnecessary exposure to radiation, expensive follow-up procedures including surgery and physical discomfort. The artful conclusion here is that such a tangle of concern can undermine the utility of the procedure.

Because dense breasts (more muscle tissue, less fat) are the strongest risk factor for cancer, women with that anatomical profile should have mammograms more frequently. But after an initial screening at age 40 to establish a baseline reading and determine breast density, women lacking other risk factors--such as the two genetic mutations known to increase cancer risk--who aren't comfortable with such frequency, might be acceptably excused from it.

The American Cancer Society and the Task Force would disagree. The former recommends
that women screen initially at 40, and repeat the procedure every year or two thereafter. The latter recommended that women begin screening sometime between 40 and 49, depending on risk factors, and every two years after 50.

As usual, the best guidance for women seeking clarity is to establish and maintain an open line of communication with their physicians that results in a mutual decision about their treatment.

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.