DC Medical Malpractice & Patient Safety Blog

For a couple of years now, Southern California drivers have become used to seeing
billboards for a medical procedure that promises to turn overweight people into the thin creatures they want to be. By calling 1-800-GET-THIN, you could sign up for a gastric Lap-Band surgery at an outpatient facility and change your life. So they claimed.

Several people who took up the offer did change their life—they died.

Last week the FDA finally noticed. The agency issued a warning letter to eight of the surgical centers promoted on the oversized advertisements. The feds told GET-THIN to stop posting misleading advertisements. It’s a violation of federal law for advertising to minimize significant risks and complications of a procedure. It’s also illegal to fail to make clear that for Lap-Band to be truly effective, it must be accompanied by a significant change in the patient's eating habits and lifestyle.

Los Angeles Times columnist Michael Hiltzik said it was about time. “For nearly two years, my colleagues and I have been reporting on the 1-800-GET-THIN ad campaign,” he wrote. “In my very first column on the topic, in February 2010, I identified the people behind it as brothers Julian and Michael Omidi, and reported that Julian's medical license had been revoked by the Medical Board of California and Michael's medical license had been placed on probation. (Michael's probation has since expired.)”

The L.A. Times has reported the deaths of local patients after their surgeries were performed at advertised clinics, and on the lawsuits and coroners' reports that detailed them. “So far," Hiltzik wrote, “the known toll is four, with a coroner's ruling still pending on the death of a fifth patient, who expired after being rushed to a hospital in September from the surgery center where she had just undergone the procedure.

"We've reported on the shocking sanitary and safety conditions at one of the surgery centers affiliated with the ad campaign, and noted questions about whether the surgery centers' insurance billing has been proper.

"And we've reported that effective oversight of a potentially life-threatening procedure has been hampered by California's patchwork system of medical regulation, in which the medical board and the state Department of Public Health essentially pass the buck to each other over who should keep an eye on non-hospital surgery clinics like these.”

The Lap-Band is a cinch placed around the upper part of the stomach creating a smaller organ that minimizes the amount of food you can ingest. Although the procedure is approved by the FDA, and often is preferable to the more invasive and complicated weight-loss surgery that diverts food from being absorbed in the small intestines, it is not without risks that can be exacerbated if it’s performed in facilities whose personnel are less than vigilant or qualified.

Complications include the band moving out of position and eroding through the stomach wall. Nausea, vomiting, difficulty swallowing, gastroesophageal reflux disease (GERD) and pain can result. One study said as many as 1 in 3 10 Lap-Band patients experience band erosion and almost half will have the band removed.

Still, in some circumstances and for some people, it’s a suitable treatment for obesity.

But not the way GET-THIN promotes it. The billboards have included disclaimers that Lap-Band surgery has certain "risks, side effects, and contraindications," and that you should check with your own doctor before undergoing the procedure. That caution was too feeble for the FDA, especially because the disclaimers appear in such tiny type that they're "illegible."

The California insurance commissioner is investigating the Lap-Band industry for alleged fraudulent billings and misrepresented charges. Patient deaths and injuries have prompted a series of wrongful-death and personal injury lawsuits against GET-THIN, its affiliated surgery centers and doctors who performed the procedures. And a class-action lawsuit accuses GET-THIN of false advertising for failing to adequately disclose risks of the surgery and disciplinary problems of some of its doctors.

Hiltzik reported that the director of the L. A. County Department of Public Health complained about GET-THIN to the FDA, and the Omidis filed an administrative complaint against him, asserting that he was biased against them because he was a shareholder in Johnson & Johnson, which markets a competing weight-loss device they don't use. The director recused himself from matters involving weight-loss devices.

When the county coroner blamed the death of a Lap-Band patient at least partially on the "suboptimal" care she had received at a clinic affiliated with GET-THIN, the clinic accused the coroner's expert of a conflict of interest because she had once worked at UCLA, which they claimed was Lap-Band competitor.

As Hiltzik notes, the Omidis are less concerned about quality of care than they are in suing anybody who challenges their shaky performance. “[T] hey've sued me and my colleagues at The Times for reporting about them. So far, three of these lawsuits against us have been thrown out of court by state and federal judges. The plaintiffs have appealed the dismissals and filed more suits against us and commenters on our website.

"The public record is brimming with material — including complaints of wrongful death, negligence and irregularities in billing practices — that could fall well within the jurisdiction of several state regulatory agencies. It may be that the FDA has fired the first shot in what could be a barrage.”

Although this is a local issue, the fact that the Feds have finally taken notice is a cautionary lesson for anyone in search of an invasive weight-loss treatment. Often, these patients are desperate, depressed and vulnerable to claims that aren’t true, or only under certain conditions.

Always research the procedure to be informed about whom it suits, and what are the risks. Always investigate the background of the surgeon with your state medical board. Always investigate the facility at which it is to be performed with your state health department and insurance provider.

Another chapter in the book of “Big Pharma Behaving Badly” is being written, courtesy of a story by Bloomberg News. The news service obtained Bayer company emails reportedly showing executives discussing ways to illegally promote a long-controversial drug.

The suspect drug, Yaz, is a member of the family of birth control pills knows as Yasmin, which several studies suggest carry elevated risks for blood clots, and, possibly, pulmonary embolism, deep vein thrombosis and other life-threatening injuries. As noted on AboutLawsuits.com, an FDA advisory committee is supposed to review the data about the risks of Yaz and Yasmin next month.

The Bloomberg report charges that Bayer may have sought to market the birth-control pills for unapproved—or “off-label”—uses, misleading women about the health risks the drug posed. Specifically, Bayer is alleged to have discussed promoting the contraceptive Yaz to treat several types of premenstrual syndrome (PMS). The FDA has approved Yaz only for the most severe form of PMS.

Doctors are not prohibited from prescribing drugs for off-label uses, but manufacturers are not allowed to promote their drugs for any use other than what the FDA has approved. Earlier this month, we wrote about a large legal settlement paid by GlaxoSmithKline over its off-label marketing of a diabetes drug.

In the Bayer emails, a consultant allegedly suggested how the company’s sales representatives could converse with doctors in a way that invites them to conclude that Yaz is suitable for off-label use: asking doctors, for example, what percentage of their patients had common PMS symptoms, then asking what effect they thought Yaz might have on those situations.

An even bolder, in-your-face repudiation of federal law reflected in another email supposedly came from an executive promising that a doctor under contract to a Bayer unit would promote off-label use of Yasmin on the “Today” show.

According to AboutLawsuits.com, the FDA has warned Bayer at least three times in recent years about problems with Yasmin or Yaz advertisements. Bayer has been busted for its misleading ads overstating the efficacy and benefits, and minimizing the risks of Yaz and Yasmin.

“In 2009, Bayer was forced to run a $20 million corrective advertising campaign to address problems with Yaz advertisements that stressed the potential benefits in treating acne and symptoms of PMS, while minimizing the potential risk of blood clots and other side effects of Yaz,” the website reports.

As additional punishment for its loathsome marketing behavior, Bayer must get any U.S. advertisements for Yaz approved in advance by the FDA.

The legal process of suing someone or some organization involves “discovery,” in which both sides look for evidence from each other supporting their arguments. The Bayer emails were unearthed during the discovery process in numerous lawsuits involving Yaz and Yasmin filed against Bayer by women who took the medicine and suffered blood clots, strokes and gallbladder problems.

If a product is so great, why does its manufacturer have to bypass law and common decency to spread the word?

There’s ignorance, and then there’s dangerous, irresponsible, willful ignorance.

In a series of posts, the website HealthNewsReview exposed the bone-headed actions of Delta Airlines in showing an onboard video sponsored by an anti-science organization minimizing the importance of flu shots. The video “urges viewers to become informed about influenza and how to stay well during the flu season without resorting to the influenza vaccine.”

As you might imagine, the response has been vigorous, including an online petition to “tell Delta Airlines to stop putting their passengers’ health at risk.” The medical establishment weighed in formally in a letter to Delta CEO Richard Anderson from Dr. Robert W. Block, president of the American Academy of Pediatrics (AAP). He wrote:

“The American Academy of Pediatrics (AAP) objects to the paid advertisement/public service message from the National Vaccine Information Center (NVIC) being shown throughout the month of November on Delta’s in-flight programming….
While hand washing and covering sneezes are parts of a larger strategy to prevent the spread of influenza, influenza vaccine continues to be the best way to protect against the disease. It is especially important in enclosed settings where disease droplets can easily spread to passengers sitting in close quarters, especially infants and children and those with special health care needs.

The AAP and many other child health organizations have worked hard to protect children and their families from unfounded and unscientific misinformation regarding vaccine safety. The influenza vaccine is safe and effective.

By providing advertising space to an organization like the NVIC, which opposes the nation’s recommended childhood immunization schedule and promotes the unscientific practice of delaying or skipping vaccines altogether, you are putting the lives of children at risk, leaving them unprotected from vaccine-preventable diseases. Diseases like influenza can have serious consequences. From September 2010 to August 2011, 115 children died from influenza disease, most of whom were unvaccinated.”

Another physician, Val Jones, blogged about this dereliction of corporate responsibility as well, noting that the airline had ignored the righteous outcry and committed to running the video ads through November.

“Every year the influenza virus kills as many as 49,000 Americans and 500,000 individuals world-wide,” she writes. "… I don't understand why Delta, having been duly informed of their mistake, would continue to run ads from a group that misinforms Americans about vaccine-preventable illness. I wanted to believe that they would do the right thing….”

“Which means that I will NOT be flying Delta in the foreseeable future and I hope you won't either. When US physician organizations are flat out ignored by corporate executives, it leaves us with only one choice—to speak with our feet. Sadly, the bottom line may matter more to them than the health and safety of their passengers.”

If you wish to sign the online petition, link here. You may also Tweet your feelings to #DontFlyDelta hashtag.

Some things you just can’t make up.

A website is promoting breast cancer research through sales of its product. So far, so normal. But consider that the site, The Firearm Blog, “is dedicated to all things firearm related. If you are into AR-15 and AK carbines, skeet shotguns, self defense pistols or hunting rifles then there will be something here for you.”

And here’s the “good works” pitch: “DPMS have teamed up with Gun Broker to auction off a pink version of their Lite 16" rifle. 100% of the proceeds with go towards Susan G. Komen for the Cure, an organization which supports breast cancer research.”

Does anyone see anything amiss about an effort to eradicate a disease that kills by promoting a product that kills?

The offer prompted some lively commentary from the site’s readers; well, “lively” is one way to put it:

• "Perfect gun for a shoot-out at the Pepto-Bismal Corral."


• "Girls usually stop dressing all-pink before they’re 12, so what makes these manufacturers think that adult women would refuse to be seen in the woods without a pink gun and matching pink-shaded camo clothing?"


• "If there’s any one organization that hopes they never cure Breast Cancer, it’s the Susan G. Komen for the Cure foundation. These people make money off of every single pink item in the world. Who knew you could make money off of a color and a cause? … I think we should outlaw toy guns so that when children pick up a gun, they know it’s real. Even idiots deserve to live to voting age, apparently."

Which brings us to the topic of when a cause becomes a joke. Has the breast cancer lobby undermined its honor by pinkifying the world so much that people stop paying attention?

Some people think so, and they are calling it “breast cancer pinkwashing.” As noted recently on MedPage Today, several media outlets suggested that the pink ribbon campaign has gone too far; that “pink ribbon fatigue” has set in, and when an arms dealer gets attention by painting a rifle pink, you have to wonder if they’re right.

“Pinkwashing” refers to commercial interests promoting breast cancer awareness while also profiting from pink-themed products. As noted in the Boston Globe last year, “The application of pink—in the name of raising money and steering women toward the radiologist’s office—does seem to get broader and cheerier each year. Now, we have NFL balls decorated with pink ribbons and world landmarks bathed in pink light, from the White House to the Ancient Mayan pyramids of Chichen Itza.”

As Karuna Jaggar, executive director of Breast Cancer Action, told MedPage, “At one time, pink was the means. Now, it’s almost become the end in itself. In its most simplistic forms, pink has become a distraction. You put a pink ribbon on it, people stop asking questions.”

Research is based on asking questions. Cures and treatments for dread diseases are based on research.

According to the National Cancer Institute, more than 230,000 women will be diagnosed with and nearly 40,000 will die of breast cancer in 2011. Barbara Brenner, former executive director of Breast Cancer Action, once questioned all the money being raised during breast cancer awareness promotions. “If shopping could cure breast cancer,” she said, “it would be cured by now.”

Last year, KFC initiated a campaign to donate 50 cents to the Komen Foundation (the largest breast cancer foundation in the world) from every pinkwashed bucket of chicken sold. Now, fried chicken isn’t as lethal as a rifle, but given that obesity is a risk factor for the disease, does it strike you as an appropriate cross-promotion?

If you want to support businesses that do good works without selling out your health-promotion principles, Breast Cancer Action suggests you ask yourself these questions before spending your charitable dollars:

1. How much money from your purchase actually goes toward breast cancer? Is that amount clearly stated on the package?
2. What is the maximum amount a company will donate?
3. How are the funds being raised?
4. To what breast cancer organization does the money go, and what types of programs does it support?
5. What is the company doing to assure that its products are not actually contributing to the breast cancer epidemic?

There’s nothing wrong with wearing a pink ribbon or paying extra for a breast cancer postage stamp. But if colorizing the world prevents it from seeing clearly, it’s time to engage common sense in common cause.

Article first published as Breast Cancer Awareness: Too Much of a Good Thing? on Technorati.

Here’s another chapter in our ongoing (never-ending?) story of media complicity in spreading fake health “news.”

As noted on HealthNewsReview, a website that examines, exposes and debunks junk health news, last month MSNBC.com committed an act of disease-mongering in a story headlined “Plastic surgeon wants to fix your ‘runner’s face.'"

Like every human we've met, runners have faces, but there’s no such thing as a disorder whose symptoms are purely aesthetic and ascribed solely to people who run. Tellingly, the term was coined by … a cosmetic surgeon who is marketing a “treatment” for what isn’t a medical problem.

But when you’re selling something, especially something you made up, you have to use florid language that draws attention and stimulates response. But do the news media have to spread the colorful message in mindless repetition completely devoid of critical thinking?

Instead of calling out “runner’s face” for the bogus condition it is, MSNBC promoted the cosmetic surgeon’s treatment for the condition he invented. As HealthNewsReview commented, “This is what is called ‘advertising’ – not ‘journalism.’”

The story offered no information on the potential harm of the surgeon’s treatment, nor any sense of what it costs. The story offered no scientific data to underpin the story because there isn’t any. But it did pretend to be authoritative:

“Runner's face generally occurs in both men and women ages 40+ who exercise to improve their body, and in doing so end up with a skeletal and bony face,” pronounced MSNBC.com. “When exercising, an athlete burns off fat beneath the layers of his/her skin. The marked loss of fatty tissue results in a loss of volume which leads to a prominent appearance of the bones, accelerated development of skin laxity and deepening of wrinkles. Though you may look like a 20-year-old from the neck down--your face will easily give away your age.”

The “treatment” for the non-disorder effects a purely cosmetic result -- inject a combination of Botox-Restylane to smooth wrinkles and plump up the face.

If this is a health-care intervention, if this is a news story, then Kim Kardashian is a marriage counselor. With an advanced degree.

Article first published as The New "Disease" of Runner's Face on Technorati.

Perhaps you’ve heard the buzz about “bioidentical” hormones; that they’re safer and more effective than FDA-approved hormones.

Uh, no, says Harvard Women’s Health Watch. The buzz is not about health, it’s about hype.

Bioidentical hormones generally are described as compounds with the same chemical and molecular structure as those produced by the body. And, generally, they’re available by prescription: Estrace, Vivelle and Estring, for example, are drugs often prescribed as female hormone replacement therapy.

The “bioidentical” claims Harvard calls into question include:

• As replacement therapy, they’re not drugs but molecular copies of natural hormones. As the Harvard report says, “This is not true. Drugs are substances (other than food) that are intended to affect the structure or any function of the body. If custom-compounded hormones have effects in the body, they’re drugs.”


• Bioidenticals are safer than synthetic hormones. Harvard says, “Unknown. [They] haven’t been tested in large, long-term trials.”


• Estriol (a weak estrogen used in compounded hormones) offers women protection from breast cancer. Harvard says, “There is no evidence that this is true.”


• Saliva and blood tests are reliable indicators of hormone levels. Harvard says, “ This is not true. Such tests can only tell a women’s hormone level at one moment in time and thus are not useful for setting hormone doses.”



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

Posted In: Advertising , Product Safety

The chemical triclosan has been a popular ingredient in many household cleaning products despite the fact that its supposed antibacterial properties have not been proved. Making a questionable claim is one thing; promoting an ingredient that also might have harmful side effects is quite another.

Triclosan is found in so many products ranging from soap to toothpaste to cutting boards that a survey by the Centers for Disease Control and Prevention found traces of the chemical in the urine of 3 in 4 people older than five.

That’s a pretty heavy concentration for a chemical that might pose hormonal problems, make bacteria more resistant to antibiotics and pose an environmental hazard. That’s why both the FDA and the Environmental Protection Agency are studying its effects. In April 2010, the FDA announced that “in light of animal studies raising questions about triclosan’s safety, the agency is engaged in an ongoing scientific review to incorporate the most up-to-date data and information into the regulations that govern consumer products containing triclosan. … For some consumer products, there is clear evidence that triclosan provides a benefit. For other consumer products, FDA has not received evidence that the triclosan provides an extra benefit to health. At this time, the agency does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water.”

Manufacturers, as expected, disagree, and are lobbying hard to protect the $750 million they earn every year in sales of antimicrobial and antibacterial hand soaps. Some consumer groups and congressional representatives want an outright ban of triclosan in antiseptic products such as hand soap.

Recently, the FDA announced it was extending its scrutiny of triclosan. As reported by the New York Times, concern centers around studies showing that triclosan might alter hormone regulation in laboratory animals and/or promote resistance to antibiotics.

You have to wonder why, if soap manufacturers were truly sold on the safety of triclosan, a major player like Colgate-Palmolive would reformulate its Antibacterial Dish Liquid and Softsoap products, claiming that “changing consumer preferences” were responsible.

Dr. Douglas Throckmorton, the FDA’s deputy director for regulatory programs who was interviewed by The Times, said the ongoing review focused on hand soaps but could extend to other consumer products if the agency determined that triclosan raised health concerns. That apparently does not include Colgate Total, a toothpaste whose triclosan content helps fight gingivitis.

But soap? Because the FDA believes that traditional soap is just as effective as an antimicrobial variety, and because the possibility of hormonal disruption and the fostering of antibiotic-resistant bacteria are of much greater concern than whether your cleansing agent is trendy, you might think twice before washing up with triclosan.

Anyone who watches TV has been bewildered/amused/confused/annoyed by pharmaceutical ads that begin by explaining how your life can be perfect if you take this drug, and end with a rushed recitation of all the things that can go wrong if in fact you do take the drug.

Drug companies, of course, are obliged by the FDA to include potential side effects when they’re trying to sell you their products. But as proved by a recent study in PLoS ONE (a journal for peer-reviewed scientific and medical research), Big Pharma pretty much thumbs its nose at the FDA when it advertises in medical journals, where it's trying to sell its wares to doctors.

Among the nine publications reviewed by researchers were such mainstream journals as Annals of Internal Medicine, New England Journal of Medicine and Journal of the American Medical Association. About half of the ads reviewed violated at least one FDA rule, and about one-third were “possibly” out of compliance because of missing information. More than half of the drug ads failed to quantify serious risks. Fewer than 1 in 5 adhered to all FDA guidelines.

As explained by MedPage Today, the pharmaceutical industry spends $58 billion on marketing; the FDA’s division of marketing and advertising has $9 million. So what are the chances a miscreant marketer will get caught?

To help bridge the budget gap, the FDA recently implemented the “Bad Ad” program, asking physicians to report nonadherent or misleading ads. But that’s like asking the playground monitor to report bad behavior – what’s bad to one monitor is just kids being kids to another. As the researchers noted, the guidelines are difficult to enforce, don't emphasize transparency and ignore basic information relevant to prescribing.

The most common breaches or possible breaches of rules were:

• misused references to the scientific literature;


• misleading use of graphics;


• failure to cite references;


• overrepresentation of the experience with the drug.

By medical specialty, at least one FDA rule was broken by ads for:

• 6 in 10 hematology/oncology products;


• 5 in 10 cardiovascular and diabetes products;


• more than 4 in 10 psychiatric products.

As the researchers wrote, “Advertisements do a poor job of conveying basic information necessary for safe prescribing, with the majority failing to quantify serious risks.”

Despite their concerns, they said that “most advertisements we reviewed satisfied the majority of FDA guidelines.” It makes you wonder, though, about the squishy nature of the guidelines – the researchers also noted that an ad that makes no specific claim about efficacy and does not quantify drug safety is still in compliance.

The study recommends that the FDA update and simplify ad regulations, and require ads to explain risks clearly, offer information on absolute benefits and verifiable references and identify the appropriate population for the drug’s use.

All of that seems like a no-brainer. And another reason why, when your doctor prescribes a drug, you should ask what are the potential side effects and risks, and why he or she has chosen it over others. Read the patient information that’s included in the drug packaging.

Last November, the FDA ruled that tobacco manufacturers must include on their packaging graphic depictions of the horrors smoking can wreak. The new packaging was to take effect in autumn 2012.

Five tobacco companies now have taken the FDA to federal court, challenging the regulations. Among other things, they claim that the depictions:

• would unfairly dissuade adults from using a legal product;


• would cost millions;


• violate the First Amendment;


• “do not further any compelling governmental purpose”; and


• “would have few if any benefits.”

In case you're feeling the slightest twinge of sympathy for the tobacco makers, here's what Dr. Howard K. Koh, writing in the New England Journal of Medicine, says.

“A decade of experience in more than 30 other countries has demonstrated that such graphic warnings lead to an array of public health benefits. The warnings are more likely to be noticed than text-only labels, are viewed as more effective in communicating health risks to smokers and are associated with increased motivation on the part of smokers to quit smoking.”

Dr. Koh is assistant secretary for health in the U.S. Department of Health and Human Services. So he's defending his own decision. But knowing what we know about how tobacco poisons work throughout the human body, is this even a close question?

To see a slide show of the text and images for the new packaging, click here.

And if you want to harken back to the olden days before we had any warnings on cigarette packs, and when the manufacturers liked to use doctors to promote their smoky poisons, check out this tour through nostalgia.

Testimonials from satisfied customers sell products. Every marketer knows that. But testimonials from patients are the wrong way to decide if a drug deserves an endorsement worth billions in sales from the Food and Drug Administration.

Why? Because, as a Virginia cancer doctor explains in a new article, the testimonials from happy cancer patients mask the fact that many other patients were not helped, or worse, were killed by the drug.

The drug now being pushed to the FDA by the testimonial technique is called Avastin. It's been proven to help patients with some kinds of cancers: colon, brain, lung and kidney cancers which have spread beyond their first site of discovery. It doesn't cure the cancer, but it can strangle a tumor's blood supply and thus shrink a cancer.

Avastin was tried with advanced breast cancer, but rigorous studies found that it didn't help quality of life for patients with breast cancer, and it didn't extend their lives, even measured by months. Plus it comes with serious side effects, the most prominent being the potential to cause a hole to suddenly develop in the stomach or intestines, which can be fatal.

So the FDA said the manufacturer couldn't market it for breast cancer.

Now Genentech, the maker of Avastin, is taking another run at the FDA, using testimonials from patients and treating doctors to try to get the agency to change its mind.

Dr. Frederick C. Tucker Jr., an oncologist in Fredericksburg, Virginia, wrote an "op-ed" piece in the New York Times commenting on this stratagem by the drug company:

[A]necdote is not science. Such testimonials may represent the human voices behind the statistics, but the sad fact is that there are too many patients who have been treated with Avastin but are not here to tell their stories.

Avastin will not disappear because of the F.D.A. decision. It remains available for treating other cancers, and research to find its appropriate role in breast cancer treatment continues. In the meantime, the F.D.A., which is expected to make its decision in September, needs to resist Genentech’s attempt to have it ignore scientific evidence.

Serious progress in the treatment of cancer will not be the result of polemics, lobbying or marketing. Genentech’s money and efforts would be better spent on research for more meaningful treatments for breast cancer.

The Avastin website has photos of real patients who Genentech says have been helped by the drug. These photos tug at viewers powerfully. But they don't substitute for hard statistical analysis.

Several Supreme Court justices strongly suggested recently during oral arguments that Vermont’s attempt to restrict the use of drug prescription records for marketing purposes violates corporate free-speech rights. Vermont’s law is aimed at so-called data miners, companies that buy prescription records from pharmacies — minus patient identifying information — and sell them to drug makers.

The drug companies use the information to target doctors to try to persuade them to order the companies' products. Vermont Assistant Attorney General Bridget C. Asay told the court that the state’s interest is to “allow doctors to decide whether this information that they’re compelled to provide to pharmacies may be used in marketing that is directed at them.”

But skeptical justices hurled a barrage of questions in return, asking whether the state’s goal was simply to make it harder for drug manufacturers to convince doctors that their drugs should be prescribed instead of cheaper generic drugs.

“The state is interested in promoting the sale of generic drugs and correspondingly to reduce the sale of brand-name drugs,” Justice Ruth Bader Ginsburg said. “And if that’s the purpose, why doesn’t that run up against what this court has said — that you can’t lower the decibel level of one speaker so that another speaker, in this case the generics, can be heard better?”

Asay insisted that drug manufacturers are still free to pitch any message they want, but that doctors don’t want their histories of prescriptions to be used to target them. The Vermont law lets individual doctors "opt out" of having their prescription histories sent to the drug manufacturers.

There’s no doubt that pharmaceutical companies have an easier time if they have such information, she said, but “they have no First Amendment right to demand it, just as they have no right to demand access to the doctor’s tax returns, his patient files, or to their competitors’ business records.”

The federal government and 35 states are siding with Vermont in the fight, which has split lower federal courts.

The case is Sorrell v. IMS.

Source: The New York Times

A subway station might seem an unusual place to try to educate the public about protecting the rights of injured patients -- but maybe not so much when that station is the nearest to the Capitol building in Washington, D.C., and is traveled by thousands of staffers who work on Capitol Hill.

"Tell Congress to put patients first," the ads say. "There are 98,000 reasons why you should. 98000reasons.org."

The number refers to an oft-quoted report from the National Academies issued ten years ago that estimated that 98,000 patients died unnecessarily each year from medical errors.

Since then, as this blog has reported, the estimates of preventable deaths have climbed, despite a spate of efforts to make medical care safer.

The new ads are sponsored by the American Association for Justice, the lawyers' group that includes attorneys like me who represent patients in malpractice lawsuits. The ads are discussed in an article by Elizabeth Olson in the New York Times.

Several thought-provoking letters appear in the New York Times responding to the recent piece about the cancer treatment industry's advertisements. One letter was from Dr. James Rickert, of Bloomington, Ind., president of the Society for Patient Centered Orthopedics:

To the Editor:

As a cancer survivor who has faced recurrent bouts of disease, I agree that the intense marketing campaigns used by cancer centers only heighten the stress and anxiety of the difficult treatment decisions that all cancer patients face. It becomes nearly impossible, at a time when one feels that any poor decision could be fatal, to wade through all the non-science-based claims for success.

As a physician who treats many patients with terminal metastatic disease, I have seen that this marketing often leads to heart-wrenching guilt and second-guessing by patient and family alike when treatments fail. Rather than being allowed to accept that their disease was incurable despite the best medical care, patients often feel that they are somehow to blame for choosing the wrong institution in which to receive treatment.

This is a distressing example by our nation’s finest medical centers of the shameful practice of placing financial concerns before the needs of the patients that they claim to serve.

If our academic medical centers cannot offer better patient-centered, evidence-based care than this, where in the world shall the medical community look for leadership?

Dr. Rickert makes an even better case than I could about the dangers of relying on advertising to make important decisions.