Monday, March 30, 2009

Devastating Indictment of Industry-Funded CME Published

Occasionally, a piece of investigative journalism sets into motion processes that strike corrupt business practices at their core. Such an article was published yesterday in the Milwaukee Journal Sentinel, written by John Fauber and Suzanne Rust.

The article is entitled “Drug firms' cash skews doctor classes: Company-funded UW courses often favor medicine, leave out side effects.” It is such a devastating indictment of the corruption inherent in drug company funding of CME that it will become required reading for all those involved in health care policy.

The University of Wisconsin has a huge program of industry funded CME. Why? This is fueled largely by George Mejicano , UW’s associate dean for continuing education. Mejicano, who was profiled by Medical Meetings magazine in 2008,
was the driving force behind winning $12.3 million from Pfizer for a CME program on smoking cessation, $3.5 million of which went to UW. Pfizer, of course, markets Chantix, the new smoking cessation drug which is effective but laden with side effects, such as nausea and insomnia, and, potentially, suicidal ideation. These side effects should not necessarily dissuade doctors from prescribing a drug which may ultimately save many lives, but they should be made aware of these risks.

Unfortunately, Fauber and Rust found that the smoking cessation course produced by UW does not even mention Chantix’s side effects. The reporters asked Dr. Mejicano to comment on this and on the fact that the course did not disclose that clinical trials of Chantix excluded patients with common comorbid conditions, such as mental illness and heart disease. Here’s how he responded: “UW's Mejicano said he did not think the side effects or the people excluded from the clinical trials should have been included in the course. He said such courses are rarely comprehensive and are designed to meet selected learning objectives.”

Indeed—and this is precisely the problem with industry funding of CME. The drug companies, via the proxy of various third parties, set the agenda for medical education. That agenda does not include saying bad things about the funder's product. I commend Mejicano’s honesty for essentially admitting this, thought it was apparently an unwitting confession.

The article goes on to profile other UW CME courses, in each case showing how the content is biased in favor of the supporter’s drug. This rogues' gallery includes a course pushing Boehringer Ingelheim's Mirapex for restless leg syndrome and one hawking Bayer’s Yaz and Pfizer’s Xanax XR for premenstrual dysphoric disorder.

I wonder if the American Medical Association, that great defender of industry sponsorship of CME, will respond to this article. Perhaps they can reference it in their new and embarrassing “fact sheets” on CME, which I reviewed here.

Thursday, March 26, 2009

Tufts Blows It

I like Tufts. I'm a voluntary faculty member there, and recently the university promoted me to associate clinical professor of psychiatry (from "assistant") even though I'm a loose cannon in the world of psychiatry.

But Tufts officials just made a silly mistake when they rescinded an invitation to Paul Thacker, one of Senator Charles Grassley's aides, to speak at a conference on conflicts of interest in medicine and research. See full coverage of this issue in today's Boston Globe.

According to Christine Fennelly, a Tufts spokesperson, the decision to disinvite Thacker was made because Senator Grassley has sent a letter requesting financial disclosures to Dr. Helen Boucher, an infectious disease specialist at Tufts. The Globe article quotes Fennelly thusly:

"Indeed . . . the administration felt it prudent to not engage someone from the Senator's office while we respond to the Senator's inquiry."

I don't know who made this decision, but it is a poor one for many reasons. It sets a tone of antagonism rather than cooperation, of opacity rather than transparency. It also deprives the Tufts community of Thacker's opinions. I've had several conversations with him and have found him to be a fascinating person, extremely knowledgable about the effects of conflicts of interest in medicine and in many other fields, and someone with a strong moral compass. Before working for Grassley, he was an eminent and award-winning investigative journalist--you can read about some of his accomplishments in this Wikipedia entry. Some of you may recall this influential article in entitled "A Climate-Controlled White House," in which it was revealed that the Bush administration pressured top federal scientists to toe the party line on global warming (please--let's just call it "climate change," shall we?) That was Paul Thacker's work.

Thus, in this decision, Tufts is doing everything a top academic center should never do. It is limiting academic freedom, it is ignoring a contrarian point of view, it is rejecting a distinguished thinker, and it is alienating a vocal portion of its own academic community.

Hopefully, the officials will change their minds. I'm pretty sure Thacker won't be offended if he is re-invited, even under conditions of public relations duress.

Tuesday, March 24, 2009

The AMA, Ethics, and "404 Not Found"

As I announced last week, the APA (American Psychiatric Association) has voted to phase out pharmaceutical industry funding of CME symposia at its annual meeting. The APA now has bragging rights as the first national medical organization to make this needed reform.

So what's shaking over at the AMA (American Medical Association)? Acting on a tip from Kate Peterson at The Prescription Project's blog, PostScript, I did a little investigating. As some faithful readers may recall, last fall, the AMA's Council on Ethical and Judicial Affairs (CEJA) released a report in which they recommended that doctors and medical institutions "must not accept industry funding to support professional education activities." But when the report was brought before the AMA House of Delegates in November, the representatives of for-profit MECCs (medical education and communication companies) were allowed to speak directly to the committee charged with evaluating the proposal. These MECCs, whose very existence depends on industry funding, were persuasive, and the AMA tabled the proposal (see here for details), asking CEJA to go back to the drawing board.

Since then, some unfortunate things have occurred. First, the excellent CEJA report on industry involvement in medical education has been removed from the AMA website. If you follow the original link, you get an unceremonious "404 Not Found" and "The requested document was not found on this server."

I asked CEJA officials why the document was censored, and received a prompt response from Bette-Jane Crigger, Director of Ethics Policy, that read, in part:

Because the report was referred back and CEJA is continuing its deliberations, the document is not posted to CEJA's Web pages. This is standard practice. The document was available last spring as proposed policy in the Delegates Handbook for the 2008 Annual Meeting of the House of Delegates, not as a CEJA posting per se. So, neither censorship nor anything irregular.

Fair enough. I also asked if I could receive a copy of the report to post on my blog for posterity. The answer was not encouraging:

I rather doubt the Council would favor allowing you to post the prior version of its report, but I will raise the question at our next conference call.

Meanwhile, it appears that the eventual conclusion of the revised ethics report is in little doubt. The AMA has posted a series of "fact sheets" from their National Task Force on CME Provider/Industry Collaboration. There are three in all, plus a "Get the Facts Toolkit." For chuckles and giggles, I suggest you read these documents. They appear to have been written by a pharma-funded public relations firm. Here are some choice excerpts:

The pharmaceutical, biotechnology and medical device industries play a significant role in informing healthcare professionals about the availability, value, and proper use of medications, vaccines, and medical devices.

(Yes, and we call this "advertising").

These industries have adopted voluntary guidelines on interactions with healthcare professionals.

(That's right, with a gun to their heads called the "Physician Payments Sunshine Act").

The company then provides funding in the form of an educational grant to an educational provider, for example a medical school, organization or agency that manages the grant funds and is responsible for ensuring independence from commercial influence. In all cases, the company has no input into the faculty selection or content of the educational activity.

(Except that, if the company is displeased with the faculty or the content, they will choose a different MECC to fund--not that this incentive could possibly lead to any influence over content, of course).

The CME activities that are supported by industry must be unbiased, open to a variety of viewpoints, and must not serve as marketing or promotional vehicles for industry.

(Which is why all industry-funded CME focuses singularly on conditions for which the company markets a product--no "promotion" there).

Ethics are important for the AMA and for all of us. But when ethics comes face to face with $1.2 billion in annual industry funding for CME, we pretty much know how lopsided the battle will be.

Friday, March 20, 2009

The King of Cringe Strikes Again

As I've written on this blog before, Dr. Joseph Biederman is an outstanding scientist but is also the prototypical MGH/Harvard narcissist. I speak from experience, having attended the MGH psychiatry residency from 1992-1995. We all joked about our arrogance and hubris and narcissism. It was almost a badge of honor. When you are at the top-ranked psychiatry department in the nation (as MGH has been every single year from 1995 to 2008, according to U.S. News and World Report) you are entitled to an extra heaping of, umm, positive self-regard, shall we say.

So Biederman's seemingly outrageous comments, as reported in today's New York Times, have to be taken into context.

Here are the comments:

In a contentious Feb. 26 deposition between Dr. Biederman and lawyers for the states, he was asked what rank he held at Harvard. “Full professor,” he answered.
“What’s after that?” asked a lawyer, Fletch Trammell.
“God,” Dr. Biederman responded.
“Did you say God?” Mr. Trammell asked.
“Yeah,” Dr. Biederman said.

If you've tasted MGH culture, you'd find this comment very funny. Biederman was not really saying that he was just below God; instead, he was cracking a joke about academic hierarchy at Harvard, presumably to break the tension at the deposition.

The more damning documents are those implying that Biederman promised Johnson & Johnson officials positive data about their products. I haven't reviewed the published studies in question, but knowing the quality of Biederman's research, I suspect that it is well-done and above board. He may have already seen some preliminary data showing advantages of Risperdal over Zyprexa in pediatric bipolar disorder, or showing that Concerta was unlikely to retard growth. I'd be extremely surprised if he manipulated these studies in some fraudulant way to create the results he promised. That's not the way Biederman rolls.

Call him the King of Cringe. Disagree with his opinions about the prevalence of pediatric bipolar disorder. Call him greedy, even. But scientifically, I continue to respect him and I believe that he ultimately has the best interests of his patients at heart.

Thursday, March 19, 2009

APA Votes to Phase out Industry-Funded CME

The American Psychiatric Association has officially decided to phase out all industry-funded symposia that take place at their annual meetings. The vote occurred at the meeting of the organization's Board of Trustees last weekend.

The Board was presented with several recommendations of the "Ad Hoc Work Group on Financial Relationships between the APA and the Pharmaceutical Industry," a group which was formed by President Nada Stotland one year ago. I am one of several members of that group.

The official phrasing of the decision was: "The Board of Trustees voted to direct the Medical Director/CEO to phase out industry supported symposia (ISS)."

The timing of the phase-out is unclear.

In related business, the Board voted to "direct the Medical Director/CEO to explore the elimination of meals provided by pharmaceutical companies in conjunction with educational activities (as of 2010)." Basically, this means that even if some symposia are allowed in 2010 and in subsequent years, they may not be allowed to serve meals.

The APA is now the first national medical society to separate industry influence from continuing medical education. Let us hope that other organizations take the hint.

AstraZeneca Behaving Badly. Very, Very Badly.

Many bad things have been reported lately about Astra Zeneca’s efforts to bury negative data about Seroquel. This revolting story of data manipulation, deceit, and academics selling their opinions to the highest bidder is being covered widely. See these excellent stories in the Washington Post, the Minneapolis St. Paul Star Tribune, The St. Paul Pioneer Press, as well as incisive blogging at Clin Psych and BNET.

These days, we hear so much about drug companies behaving badly that “accusation fatigue” sets in. We’re tempted to throw up our hands and say, “All the drug companies do this, what else is new?”

Resist the temptation. Yes, Eli Lilly's behavior was wretched, and it recently pled guilty to off-label marketing of Zyprexa for treating agitation in dementia.

But AstraZeneca has truly grabbed the brass ring of subterfuge. The Seroquel documents are revealing a company-wide pattern of blatant deceit and manipulation that is astonishing, and should make any psychiatrist think twice before believing anything Astra Zeneca has to say about Seroquel, either in the past, the present, or the future.

I'll contribute to the discussion by adding yet another data point to the mix. Here is an AstraZeneca-supported CME article
which appeared as a supplement to Current Psychiatry. The title is “Issues associated with the use of atypical antipsychotic medications,” and it is dated December 2008. The identified authors are Henry A. Nasrallah, Donald W. Black, Joseph F. Goldberg,
David J. Muzina, Stephen F. Pariser, but presumably the text was written by ghost-writers at Dowden media.

Ultimately, you can most accurately think of the author as being AstraZeneca itself.
The article begins by trying to distract attention from the metabolic side effects of Seroquel by blaming the patients rather than the drug:

While the incidence of both obesity and diabetes is soaring among the general population, these conditions are more prevalent in patients with schizophrenia, even those who have no history of antipsychotic drug use.7 Prevalence rates for both diabetes and obesity are approximately 1.5 to 2 times higher in people with schizophrenia and other affective disorders than in the general population.4… Thus, it is difficult to predict which patients will be affected and the precise role drug treatment might play in this process.

The argument here is that these patients get fat because there are schizophrenic, not because they use Seroquel or similar obesity-promoting drugs.

Of course, AZ is forced to reference the well-known official statement co-published by the American Diabetic Association and the American Psychiatric Association which implicated Seroquel and other atypicals as causing weight gain and diabetes:

The ADA/APA statement ranked clozapine and olanzapine as being associated with the greatest risk of weight gain, diabetes, and dyslipidemia.4 Risperidone and quetiapine were put into an intermediate risk category for weight gain, while aripiprazole and ziprasidone were, at the time, too new to categorize. More recent data have shown ziprasidone and aripiprazole to be relatively weight-neutral.8

But check out how they go on to back-track, creating an alternative reality in which people are supposedly questioning this data:

However, the consensus statement must be interpreted with caution. Criticism has been leveled at the report from many corners, including the Division of Neuropharmacological Drug Products of the FDA, which argued that insufficient data were available to appropriately “rank” obesity/diabetes risks for the atypical antipsychotic agents.18

The criticism they are referring to was a one page letter from the FDA,
but it had nothing to do with weight gain. The letter cautioned that actual data connecting the atypicals to diabetes was minimal, and that more studies needed to be done to better characterize the relative ranking of each drug in terms of the potential to cause diabetes. But the FDA officials were clear that some drugs cause more weight gain than others: “The ADA correctly points out that SGAs have different weight gain liabilities.” Obesity, of course, is one of the main risk factors for diabetes—so you do the math.

Finally, the authors return to their main theme—insulting schizophrenics:

Other authors pointed out that efficacy considerations of these drugs are a critical and overlooked component of the discussion and that the data used to compare the agents did not adequately control for key lifestyle factors such as overreliance on “junk food.”19,20

That’s right—the problem isn’t Seroquel; the problem is that crazy people are junk food junkies!

Here is my modest proposal. Because of these documents, Astra Zeneca’s credibility is officially out the window. They should not be allowed to be involved in any medical education event. They should be banned from hiring promotional speakers and from supporting CME. AstraZeneca has lied to the medical community once too often.

Wednesday, March 11, 2009

FDA Posts Said to be Filled--It's Hamburg and Sharfstein

According to the Wall Street Journal, president Barack Obama has decided on Dr. Margaret "Peggy" Hamburg as the next commissioner of the Food and Drug Administration, and Dr. Joshua Sharfstein as the next deputy FDA commissioner. No formal announcements have been made yet, but I assume that the WSJ has some pretty credible sources.

You can learn more about Dr. Hamburg from this interesting biography published by the National Library of Medicine. You can find out more about her extremely impressive credentials on the website of Henry Schein, a medical and dental equipment company where she serves on the Board of Directors. Hamburg is a public health maven, and has made a name for herself in designing a great tuberculosis control program in New York City and more recently in combating the threat of bioterrorism at the Nuclear Threat Initiative.

Joshua Sharfstein is currently head of the Baltimore Health Department, and is the son of Steve Sharfstein, a former progressive president of the American Psychiatric Association. You can read some background in a past WSJ blog posting here, where you can find links to a variety of interesting initiatives, such as his scrutiny of over-the-counter cold medicines for children. Like his father, Josh Sharfstein has a sharp eye out for drug industry improprieties--when he was a resident, he alerted the New England Journal of Medicine that Pfizer was inviting docs to a “rack ‘em up and toss ‘em down” event including billiards and lots of alcohol. He wrote that “attending such an event is unethical, according to the guidelines of the American Medical Association’s council on ethical and judicial affairs.”

From the Carlat perspective (honesty in medical education, putting patients ahead of profits), both of these appointments are excellent. I look forward to the next few years at the FDA!

Tuesday, March 10, 2009

Janssen, Dr. Weiden, and the Future of Promotional CME

Industry funding of accredited CME is on its way into the dustbin of medical history, but what's next? Recently, my mailbox has been flooded by letters from a consortium including Janssen Pharmaceuticals, PV Update Publishing, and Peter Weiden, a professor of psychiatry at University of Illinois at Chicago.

The letters bear the return address of PV Update Publishing, and include teaser copy such as "A message from Peter J. Weiden, MD. See inside for details." A letter inside (read the web version here) bears Dr. Weiden's photo and quotes him saying things like "Partial medication adherence can make managing patients with schizophrenia problematic." It looks like your typical phony industry-sponsored CME, but when you check the fine print, you read:

"This promotional educational activity is brought to you by Janssen®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and is not certified for continuing medical education. The speaker is presenting on behalf of Janssen® and must present information in compliance with FDA requirements applicable to Janssen®."

In other words, this is not CME, but promotion. Dr. Weiden is hired directly by Janssen to expound on the benefits of Risperdal Consta.

Is this the kind of promotional education that will replace industry sponsored CME? Probably. It's something I feel a little bit better about. It's honest. It's clearly advertising. It doesn't put Dr. Weiden in the awkward position of trying to defend the integrity of a supposedly academic article that is really advertising, as he had to in this exchange with me here (J Clin Psychiatry, June 2008, page 1020-1021, subscription required for access).

This is analogous to the "product theaters" that I predict will gradually replace industry-supported symposia at medical meetings.

Let the drug companies advertise their wares transparently, just like any other type of company. And keep CME pure.

Friday, March 6, 2009

Give a Drug Talk, Go to Jail?

Just as hired guns were getting used to the fact that their fees will soon be posted on the web for the world to see, federal prosecutors have made their lives a little more stressful. According to this recent article in the New York Times, they are planning to nab some of these consultants on kickback charges.

It’s illegal to prescribe treatments in return for payments from drug companies. Of course, no physician is going to admit that they do this. But anybody who has ever been involved in the unsavory business of speakers' bureaus knows that it happens all the time.

It can be rather subtle—call it “soft kickbacks.” When I was hawking Effexor for Wyeth in 2002, there was no explicit agreement that I would get more speaking gigs if I prescribed more of their drug. Not even a wink or a smile. But I knew that the company was keeping track of my prescribing history, and that it couldn’t hurt my relationship with them if I enriched by patient population with Effexor scripts. Add to this the fact that Effexor was not significantly different from several other antidepressants, and you have the right mix of ingredients for a kickback-esque situation.

I don’t recall consciously thinking, “I’m going to prescribe Effexor rather than Zoloft for Mr. Jones so that I can make my handlers happy.” It was more like breathing an atmosphere hypersaturated with Effexor money, Effexor thoughts, and Effexor rewards. Any doctor who chooses to put him or herself in such a situation ends up treading a line, and as the amount of money increases, the incentive to think actual kickback thoughts increases as well.

Thus, for example, when orthopedic surgeons are pulling in several million per year for consultation, immorality is highly likely to happen.

According to Lewis Morris, chief counsel to the inspector general of the Department of Health and Human Services
, big ticket surgeons are going to be the target of most of these investigations. But doctors prescribing the same drugs that they help to market can’t be far behind.

Imagine this scenario: Dr. X gives Seroquel talks for AstraZeneca. Dr. X also writes plenty of Seroquel prescriptions. Patient Y becomes obese after a year on Dr. X’s Seroquel. On the web, Pt. Y finds out that Dr. X made $50,000 from AstraZeneca over the past year. Pt. Y is not happy, and there are plenty of attorneys around looking for business. Dr. X could get into serious legal trouble.

This scenario, which may have sounded far-fetched only a few months ago, should now strike fear into the hired gun’s heart, and will hopefully lead to a gradual end of this dodgy marketing practice.

Thursday, March 5, 2009

Psychiatry's Leadership is Getting Real

I believe it is important to give credit where credit is due. The current issue of the American Journal of Psychiatry features a commentary entitled "Conflict of Interest--An Issue for Every Psychiatrist." The article is authored by all 23 editors and editorial board members of the journal, with additional contributions from three others. This is a who's who of psychiatry, including Jerry Rosenbaum, the psychiatry chairman at Mass General, Robert Freedman, the Editor-in-Chief of the journal, Nancy Andreason, winner of the National Medal of Science, and many others.

Furious Seasons criticizes the piece for being too vague and offering no specific solutions, but I see it differently. The authors do a good job of laying out the major issues related to conflicts of interest in psychiatry, and in fact they do have some specific recommendations:

"More acceptable alternatives—-industry support of education through unrestricted gifts to APA, universities, or other public institutions and journal advertising that resembles sponsorships on public television rather than network prime time commercials—-will likely result in less financial support than we currently receive for our professional activities, because this financial support would no longer be assumed by the companies as part of their marketing strategy. The subsidy that each of us has been receiving is part of what has fueled the excesses that are currently under investigation. Accordingly, in the future it may cost more to attend meetings, to earn CME credits, and to receive journals."

It seems to me they are recommending that industry money be disconnected from specific educational programs, and instead should be donated to medical societies and universities into pools of money that can be used to fund any education, even programs that don't serve the specific promotional aims of the funders. If instituted, this would represent a huge change in business as usual.

Perhaps they are vague in not naming names--but when they reference "congressional hearings and articles in the New York Times or Boston Globe" it's pretty obvious who they are talking about. Look, this is a guild, folks, and you don't smear members of your own guild (unless you are as reckless as I am!). I think it is remarkable that these 26 authors were able to agree on a document that is pretty critical of industry's coziness with psychiatry--especially since many of them are direct beneficiaries of industry's largesse.

On another note, while the Furious Seasons post quoted me accurately in the opening paragraph, it was pulled from a different context--namely a December 1 posting in which I was responding to recent revelations on serious conflicts of interest regarding Dr. Biederman and Dr. Goodwin. The comment was meant to point out that if psychiatry were a patient, it would need ICU treatment to pull it out of its ethical crisis. The fact that the leaders in the field could have written this AJP commentary shows that the patient is looking much healthier.

Monday, March 2, 2009

The Seroquel Deception Documents

As I covered in my last post, AstraZeneca is in the midst of a Disney World sized headache in Orlando, where a federal judge is sifting through various allegations regarding the safety risks of the antipsychotic Seroquel. That headache has now become a blinding migraine, because the judge ordered many of the disclosure documents unsealed, and as predicted, we all now have a front-row seat at data manipulation at its finest.

There's too much to comment on so I'm happy to report that the extremely clever anonymous blogger at Clinical Psychology and Psychiatry has already done much of the heavy lifting for us. You must immediately go to this post to see how the pharmaceutical industry actually works.

Apparently, back in 2000, the marketing and scientific honchos at AZ knew about the results of an internal meta-analysis showing that Seroquel is less effective than both Risperdal and that ancient antipsychotic Haldol.
Rather than alerting physicians to this critical piece of data, they had one of their hired guns issue the following statement in a press release: "Almost 50 years later, however, many patients are still taking these medications [such as Haldol], even though more effective treatments like Seroquel exist."

Yes, this is one of those nausea moments, for physicians, for the unsuspecting public, and especially for AZ investors, who are watching their stock's inexorable tumble down, down, down.