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Wyeth Vs. Levine: Joe Six Pack Trumps The FDA

The New York Times has called today’s US Supreme Court ruling in the Wyeth vs. Levine suit the “most important business case in years.” I have been following this case for many months, astonished that a medical malpractice suit had gotten all the way to the Supreme Court. But even more shocking is the fact that the court actually ruled that lay juries may evaluate the accuracy of FDA-approved drug labels written for healthcare professionals.

In other words, after a team of FDA regulators decide on the very best language to describe potential risks of a drug -  Joe Six Pack can overrule their expertise and hold the drug company liable for any deficit (as he interprets it) in label language, awarding millions to anyone who experiences harm, no matter how well disclosed that risk is.

I reached out to Wyeth’s attorney, Bert Rein, for comment. Here are the highlights from the interview (a podcast is available here)…

Dr. Val: The New York Times is calling Wyeth vs. Levine the most important business case in years. Can you summarize what just happened?

Rein: The court determined that Wyeth’s liability for Ms. Levine’s injury was not preempted by the FDA-approved drug label warnings. They were not convinced that the FDA had declined to strengthen the warning language on the label prior to Ms. Levine’s injury, though Wyeth had in fact requested a label change. In addition, the court held that the FDA’s regulatory regime was insufficient to preempt Ms. Levine from suing Wyeth, because the FDA doesn’t have a regulational requirement for all label updates to undergo federal approval. The court therefore ruled that the suit was well founded and that the state of Vermont should decide whether or not Wyeth’s conduct was appropriate.

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Posted in: Pharmaceuticals, Politics and Regulation

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How To Get Physicians To Use The Same Science-Based Playbook

Pretty much everyone agrees that we need to improve the quality of healthcare delivered to patients in the US. We’ve all heard the frightening statistics from the Institute of Medicine about medical error rates – that as many as 98,000 patients die each year as a result of them – and we also know that the US spends about 33% more than most industrialized country on healthcare, without substantial improvements in outcomes.

However, a large number of quality improvement initiatives rely on additional rules, regulations, and penalties to inspire change (for example, decreasing Medicare payments to hospitals with higher readmission rates, and decreasing provider compensation based on quality indicators). Not only am I skeptical about this stick vs. carrot strategy, but I think it will further demoralize providers, pit key stakeholders against one another, and cause people to spend their energy figuring out how to game the system than do the right thing for patients.

There is a carrot approach that could theoretically result in a $757 billion savings/year that has not been fully explored – and I suggest that we take a look at it before we “release the hounds” on hospitals and providers in an attempt to improve healthcare quality.

I attended the Senate Finance Committee’s hearing on budget options for health care reform on February 25th. One of the potential areas of substantial cost savings identified by the Congressional Budget Office (CBO) is non evidence-based variations in practice patterns. In fact, at the recent Medicare Policy Summit, CBO staff identified this problem as one of the top three causes of rising healthcare costs. Just take a look at this map of variations of healthcare spending to get a feel for the local practice cultures that influence treatment choices and prices for those treatments. There seems to be no organizing principle at all.

Senator Baucus (Chairman of the Senate Finance Committee) appeared genuinely distressed about this situation and was unclear about the best way to incentivize (or penalize) doctors to make their care decisions more uniformly evidence-based. In my opinion, a “top down” approach will likely be received with mistrust and disgruntlement on the part of physicians. What the Senator needs to know is that there is a bottom up approach already in place that could provide a real win-win here.
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Posted in: General, Politics and Regulation, Public Health, Science and Medicine

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Comparative Clinical Effectiveness Research: Good News In Shades Of Gray

When I first heard about the new emphasis on comparative clinical effectiveness research (CCER) in Obama’s economic stimulus bill I thought, “Thank goodness! Maybe now science will truly regain its rightful place and we’ll end the CAM, ‘me-too’ drug, and excessive-use-of-technology madness that is wasting so much money in healthcare.” In fact, I was so excited about the new administration’s apparent interest in objective analysis of medical treatment options, that I intended to write a jubilant blog post about it. However, as with most things that seem black and white at first glance, further analysis reduces them to shades of gray.

What Is Comparative Clinical Effectiveness Research?

The new economic stimulus bill, also known as The American Recovery and Reinvestment Act (ARRA) includes 1.1 billion dollars for clinical comparative effectiveness research. Interestingly, CCER is not defined in the bill though AHRQ describes it this way in their glossary:

“A type of health care research that compares the results of one approach for managing a disease to the results of other approaches. Comparative effectiveness usually compares two or more types of treatment, such as different drugs, for the same disease. Comparative effectiveness also can compare types of surgery or other kinds of medical procedures and tests. The results often are summarized in a systematic review.”

Any mention of “comparative cost effectiveness” or value-based language is notably absent.

How Does It Work?

The government’s new CCER initiative will be administered through a Federal Coordinating Council for clinical comparative effectiveness research. The FCC consists of a group of 15 federal employees, half of whom “must be physicians or other experts with clinical expertise.” [Meaning, none have to be physicians.] Some have suggested that the FCC is the first step toward an organization modeled after Britain’s National Institute of Health and Clinical Excellence (NICE). NICE is regularly tasked with helping the NHS to decide which medical treatments should be available to their beneficiaries, and which should not be covered (based on their efficacy and cost).

The budget for the CCER will be divvied up as follows:

400 million – left to the discretion of the Secretary of HHS with 1.5 million to go to the Institute of Medicine for a report regarding where to focus CCER attention initially
400 million – to the office of the director, NIH
300 million – to AHRQ

Here is a quote from the ARRA bill, discussing the mechanics of CCER:

“The funding appropriated in this paragraph shall be used to accelerate the development and dissemination of research assessing the comparative clinical effectiveness of health care treatments and strategies, including through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions and (2) encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data: Provided further, That the Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1,500,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by not later than June 30, 2009 that includes recommendations on the national priorities for comparative clinical effectiveness research to be conducted or supported with the funds provided in this paragraph…”

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Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation, Public Health

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Research, Minus Science, Equals Gossip

“A person is smart. People are stupid.”

- Agent K (Tommy Lee Jones), Men In Black

Regular readers of my blog know how passionate I am about protecting the public from misleading health information. I have witnessed first-hand many well-meaning attempts to “empower consumers” with Web 2.0 tools. Unfortunately, they were designed without a clear understanding of the scientific method, basic statistics, or in some cases, common sense.

Let me first say that I desperately want my patients to be knowledgeable about their disease or condition. The quality of their self-care depends on that, and I regularly point each of them to trusted sources of health information so that they can be fully informed about all aspects of their health. Informed decisions are founded upon good information. But when the foundation is corrupt – consumer empowerment collapses like a house of cards.

There is growing support in the consumer-driven healthcare movement for a phenomenon known as “the wisdom of crowds.” The idea is that the collective input of a large number of consumers can be a driving force for change – and is a powerful avenue for the advancement of science. It was further suggested (in a recent lecture on Health 2.0), that websites that enable patients to “conduct their own clinical trials” are the bold new frontier of research. This assertion betrays a lack of understanding of basic scientific principles. In healthcare we often say, “the plural of anecdote is not data” and I would translate that to “research minus science equals gossip.” Let me give you some examples of Health 2.0 gone wild:

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Posted in: General, Public Health, Science and Medicine, Science and the Media

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Where Does Sanjay Gupta Register On The Quackometer?

Four weeks ago I wrote a blog post about Sanjay Gupta’s nomination by the Obama administration as our potential new Surgeon General. Many of you voiced concerns about Sanjay’s nomination, specifically because of his poor handling of the Raelians’ Clonaid fiasco, his inability to counter Michael Moore’s health statistics as presented in Sicko and his relationship to the pharmaceutical industry.

As I wondered about what Sanjay Gupta might be like as Surgeon General – and specifically how he might assist in “restoring science to its rightful place” – I decided to educate myself about his thought processes by purchasing his recent book “Chasing Life.” The question I sought to answer was, “is Sanjay Gupta a crank?”

The short answer is: I’m not sure.  Although I wouldn’t go so far as to say that he is a crank, I think he’s more likely to be a shruggie. For those of you who haven’t read my post on shruggies, here’s the definition:

Shruggie (noun): a person who doesn’t care about the science versus pseudoscience debate. When presented with descriptions of exaggerated or fraudulent health claims or practices, their response is to shrug. Shruggies are fairly inert, they will not argue the merits (or lack thereof) of complementary and alternative medicine (CAM) or pseudoscience in general. They simply aren’t all that interested in the discussion, and are somewhat puzzled by those who are.

The longer answer involves an exploration of Gupta’s disturbing insistence on flirting with cranks, if it gets him publicity. The back cover of Chasing Life caries an endorsement from Deepak Chopra – and the inside page a favorable review from Andrew Weil. Normally, I would assume that the author of any book endorsed by those two would contain an intolerable blend of science and pseudoscience and refuse to read it. But for the sake of the readers of Science Based Medicine, I stifled my gag reflex and purchased the book. I hope that my sacrifice will benefit you all.
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Posted in: Book & movie reviews, Public Health, Science and the Media

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The Many Faces Of Snake Oil

It is my unhappy duty to reveal yet another depressing example of dishonest gain in medicine. This time, however, patients were not the only victims. Many healthcare professionals, including physicians, were prey to what has been called “an intellectual property ponzi scheme.”

In a press release dated January 28, 2009, the HealthCentral Network announced the acquisition of a company called Wellsphere from its young CEO, Ron Gutman. Many of my fellow medical bloggers are familiar with Wellsphere as they’ve received countless email form letters from its CMIO, Dr. Geoffrey Rutledge. The form letters are flattering, and suggest that the company would like to feature the blogger’s writing on their platform.

But what happens next is disturbing – to become a member of Wellsphere, bloggers provide access to their blog’s RSS feed. Hidden in the fine print is the blogger’s consent for Wellsphere to publish the entire feed (in other words, all of the blogger’s written work) and that once it’s published on their site, they own the intellectual property rights to it.

Astonishingly Wellsphere convinced some 1700 bloggers to join their network, and have now sold their site (which is comprised almost entirely of blog post content) to HealthCentral Network for an undisclosed amount, likely in the millions.

How much did the health bloggers get for their writing? As far as I know, zero dollars.

In the reference section below you will see copies of emails sent by Dr. Rutledge and excerpts from the website’s Terms of Use document.

Is this the biggest scam ever pulled on health bloggers? You decide. The Wall Street Journal health blog reports:

As for the thousands of bloggers HealthCentral picks up with the merger, there is already grumbling in the blogosphere that Wellsphere built its business on health bloggers who don’t benefit from the deal. “But most are happy and we hope with all our resources and quality-content background we will really strengthen these engagements,” Schroeder told us.

Interesting statement from Schroeder – “most are happy.” He clearly hasn’t read the comments section of my blog. If there ever were a time for the medical/science/health blogosphere to rise up “Motrin moms-style,” it would be now. You may Tweet in protest by entering your comment with “#wellsphere” on Twitter. Or kick it old-school here in our comment section.

If you have any additional information, feel free to post it in the comments section below.

References:

Here is the introductory form email sent out by Dr. Rutledge:
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Posted in: General, Health Fraud, Science and the Media

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How Is Alternative Medicine Like Earmark Spending?

I recently watched a special news report about John McCain leading the charge towards making legislative earmarks illegal. The Economist defines earmarks this way:

Earmarks, for the uninitiated, are spending projects that are directly requested by individual members of Congress and are not subject to competitive bidding.

Most Americans are rightly upset about the practice of slipping pet projects into larger, well-vetted, and consensus-built legislative initiatives. They know instinctively that it’s morally wrong to sneak in personal favors and appropriate tax payer dollars to special interest groups without allowing others to weigh in. I certainly hope that McCain and his peers will succeed in discontinuing this corrupt practice.

Coincidentally, just after I watched this news report about earmarks, I went online to catch up on my blog reading. The first post I encountered made reference to an opinion piece written by Deepak Chopra, Andrew Weil, Dean Ornish, and Rustum Roy in the Wall Street Journal. Chopra et al. were asking Americans to redouble their efforts to adopt healthy lifestyles (including wholesome diets and regular physical activity) as a means to promote good health and avoid disease. At the end of the article they slipped in a plea for President-elect Obama to consider integrating alternative medicine practices (which included everything from healthy diet to meditation and acupuncture) into a government-sponsored approach to health.
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Posted in: Nutrition, Politics and Regulation, Science and Medicine, Science and the Media

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Who Should Ascend To The Office Of Surgeon General?

President-elect Obama’s nomination of CNN medical correspondent, Sanjay Gupta, for the Office of Surgeon General of the United States has ignited a firestorm of debate across the Internet. Some argue that he is not qualified for the position, others say that his charisma would be a boon to public health communications, though the lay majority appear to have mixed feelings.

It is highly irregular for a Surgeon General nominee to be announced before the Secretary of Health and Human Services is confirmed. This faux pas in itself may speak to an irresistible opportunity for self-promotion, or that the Senate confirmation hearing is not the independent review event that we assume it is.

At age 39, Gupta has long aspired to become the Surgeon General, as sources close to him report that he has been saying (since age 33) that “it’s the next logical step in his career development.”

But before we draw conclusions about who’s right for the job, we need to understand what the job entails.

I asked Dr. Richard Carmona, 17th Surgeon General of the United States, to explain the roles and responsibilities of the office. A summary of our conversation follows:
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Posted in: Politics and Regulation, Public Health, Science and the Media

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Farewell To The Medscape Journal: Profits, Losses And A Canary In A Coal Mine

On January 31, 2009 The Medscape Journal will be discontinued.* One can only assume that the journal’s parent company, WebMD, could no longer justify the cost associated with a free, open-access, peer-reviewed medical journal that receives no income from advertisers or sponsors. The Medscape Journal’s budget has been supported by revenue generated from Medscape (the website), and their robust Continuing Medical Education (CME) business.

In these challenging economic times, American companies are taking a cold, hard look at their P and L spreadsheets and nixing the least profitable parts of their businesses. The inevitable “non-profit” casualties present an ethical dilemma. What will become of the noble pursuits that are based upon “doing the right thing” rather than making a profit?

There is no such thing as completely unbiased publishing (humans all have personal agendas – whether conscious or unconscious), though The Medscape Journal came about as close to it as any medical journal ever has. The journal is free to authors and readers, and provides 24-hour online access to both professional and lay viewers from around the globe. There are no advertisements or outside sponsors, peer reviewers work without compensation or specific recognition, and editors are paid a minimal salary (full disclosure: I know this because I was an editor for The Medscape Journal several years ago). CME credit is offered for articles determined to be of special relevance, but no articles are commissioned specifically for the purpose of CME.

The Medscape Journal is a wonderful experiment in high ethics. It espouses, in my opinion, the gold standard principles of medical publishing. Tragically, market forces (or perhaps the lack of perceived value by its own parent company) killed it. So what does this mean for medical publishing? If there is no economic model for “pure science” then are medical journals doomed to go the way of health media – promoting sensational or biased science for profit?
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Posted in: Announcements, Medical Academia, Science and the Media

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The Christmas “Miracle”

I noted that “humor” is a designated category at Science Based Medicine, and that I hadn’t made full use of it yet. I hope that the holiday season has put you in the mood for a whimsical look at Christmas – from my “skeptical family” to yours. Enjoy!

***

My sister Vicki lives in Grand Rapids, Michigan with her husband, three children and an alarmingly large and slobbery Saint Bernard named Gilbert. Several Christmases ago she decided to teach her then 5-year-old son, Harrison, about Christmas tree decorating. She took him to a Christmas tree farm and helped him select a tree. They hauled it back to the house and my sister managed, with no help whatsoever from Gilbert, to set it up in a nice corner of the living room. The tip of the tree reached the ceiling and its full figured branches spread from icy window to window.

Vicki and Harrison spent hours and hours winding lights, tinsel, ornaments, paper angels and popcorn strings around the tree. Little Harrison couldn’t wait to see the final product, with glittering lights and a magical star to top off their fine work. They decorated into the early evening, and the living room grew dark as the sun set over the snow covered neighborhood. At last it was time to plug in the tree lights.

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Posted in: Humor

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