Sunday, May 17, 2009

A Marketing Expose, and Reflections on Anecdotal Evidence

This post began as what I assumed would be an expose of more sleazy behavior on the part of the big drug firms, and somehow morphed into a commentary on anecdotal evidence in today's culture.

Several of my esteemed fellow bloggers picked up on an article in the Wall Street Journal (subscription required to access), revealing Bristol-Myers Squibb's problems with a "celebrity" spokesperson, one Andy Behrman. Briefly the story goes like this. Behrman had described his problems with bipolar disorder in his 2002 book, Electroboy:A Memoir of Mania. Bristol-Myers got him on their new antipsychotic, Abilify, and in 2004-2005 paid him $400,000 to give speeches telling the world how Abilify had revolutionized his therapy, especially by eliminating the terrible side effects he had suffered from previous drugs for bipolar. In fact, he made his first video extolling life on Abilify after only 4 days of treatment, far too early for most of the side effects to show up. He ended up having sufficiently severe side effects to discontinue the drug in less than a year. (Accounts differ on how much of that information he shared with his company handlers.) Company PR people kept telling him the script he was expected to follow in these talks: Abilify had no side effects, it gave him his life back, and he was not being paid any money by Bristol-Myers to say this.

Apparently believing that he had a career doing this sort of thing, Behrman and his lawyer approached Bristol-Myers with a long-term contract deal, which fell through. The company says he demanded $7.5M; Behrman and his lawyer insist it was not that much, but don't say what they did ask. Behrman then tried to shake down the company for other support, such as agreeing to back a new book venture (could there have been a hint here that the new book would say nice things about Abilify only if he was paid?). By this time apparently even Bristol-Myers had had enough of this dude, so no support was forthcoming. Behrman then waited until the 3 years were up on the nondisclosure agreement that he had signed with the company when he first started speaking for them, and began to go public with his new claims. He is now, he says, writing a book to warn about the dangers of overly aggressive drug company marketing, which he claims misled him.

Bottom line: If you want to accuse Bristol-Myers of sleaze for hiring on such a guy to extol their drug on such flimsy grounds, you also have to measure Mr. Behrman's own behavior on the sleaze-o-meter, and it seems by his own admission that he was quite happy to lie about the drug's side-effect profile so long as B-M was paying him generously to do so. The marriage between Andy Behrman and B-M was one made in heaven, it would seem. So I cannot use as reliable a source as Mr. Behrman as any sort of barometer as to the extent of skullduggery in drug company marketing.

What I can do, however, is note that (as we have exhaustively covered in previous postings) the companies that make so-called "second-generation" antipsychotics like Abilify have invested muchos bucks in slanting the scientific database, making it seem that their drugs are more effective and safer than they really are, both for conditions for which they seem truly to be indicated (psychosis) as well as for conditions where the indications are far more tenuous (bipolar). It is only in the last year or so that careful reviews and meta-analyses have begun to make it clear that these drugs are simply not what they were cracked up to be. But what's of import here is that Bristol-Myers was not content merely to cloud the scientific evidence. They obviously felt the need to pile on anecdotal testimony and were willing apparently to pay top dollar for it. (Behrman at one point collected $10,000 per day in speaking for the company, while "key opinion leaders" on physician speakers' bureaus might see only a third or half of that amount.)

What are we to make of this in an era in which, we are told, the randomized controlled trial is king, and evidence-based medicine is the emperor, and anecdotal evidence is so far down the food chain that it can no longer even be detected?

This in turn makes me wonder about the way the popular media now covers "medical breakthroughs." I believe there is a consistent pattern. Docs on the faculty at Stanvard Medical School do a major study providing evidence that statin drugs make warts go away. So this study gets trumpeted on the evening TV news and in the daily paper (assuming there are any more daily papers). They summarize the trial data and interview the study's author, and maybe one outside physician to show that it's all kosher. But there is an obligatory further piece to the story. There has to be an interview with John Jones of Oshkosh, WI, who was a subject in the study, who reports that yes indeed he took the statins and yes indeed his warts went away.

I have given some interviews to reporters in the last couple of years in which I discussed randomized trial data with them, and then they asked me if I could provide them with a "real" patient they could interview. In my case the answer was nearly always "no." You could hear their eyes glaze over on the phone line, and they lost no time in finding an excuse to hang up on me.

The PR folks at Stanvard Med School know this, so that when the news release goes out about the statin-warts trial, you can be sure that they tell the media that not only is the study author available for an interview, but Mr. Jones is standing by in Oshkosh.

My question: If med schools are supposed to be about educating the public about real medical science, is it really appropriate for Stanvard's flacks to push Mr. Jones onto the media, thereby reinforcing and giving more legs to the idea that only if you have personal testimony is something really real in medical science? Or should Stanvard grow a spine and tell the media, if they ask for an interview, "sorry, we keep our patient and subject records confidential; and besides we don't think that personal stories prove anything one way or the other in medical science"? If they followed this last tack, is it possible that we might see a slow re-education of the general public about the weaknesses of anecdotal evidence? I know-- dream on.

Wang SS. A celebrity patient's backing turns sour for drug company. Wall Street Journal, May 14, 2009:A1.


Video News Releases said...

The AMA Code of Ethics, Opinion 5.045, provides guidance on filming patients in health care settings. The following sections of the opinion may be relevant to the discussion here.

(4) Physicians retain their responsibility to maintain professional standards whenever medical or surgical encounters are filmed for public broadcast. They should be mindful that the educational content of the finished product may become marginalized, potentially distorting the portrayal of the patient-physician encounter and of the medical procedures. Physicians should accurately convey the risks, benefits, and alternatives of treatments to an audience of prospective patients, and should refuse to participate in programs that foster misperceptions or are otherwise misleading.
(5) Independent peer groups, such as medical specialty societies, also may help prevent misleading information from reaching the public by making themselves available to producers to assess the accuracy of program content. They may help dispel misperception by providing educational resources and, if necessary, taking corrective or disciplinary action.
(6) As advocates for their patients, physicians should not allow the care they provide or their advice to patients regarding participation in filming to be influenced by financial gain or promotional benefit to themselves, their patients, or their health care institutions.
(7) If a physician is compensated beyond services to the patient, the amount and conditions of compensation must be disclosed to the patient.

To view an example, click on Video News Releases. Then scroll down and click on "Depression symptom rating scale.” Alternatively, go to the UT Southwestern Web site and enter the search term “Video News Releases.” Then scroll down and click on “Depression symptom rating scale.”

Consider whether or not there were any violations of the AMA Code of Ethics in this public broadcast. What additional information might one need in order to make this determination?

Anonymous said...

According the AMA Code of Ethics, Opinion 5.045, “Physicians should accurately convey the risks, benefits, and alternatives of treatments to an audience of prospective patients. . .”

For an alternative viewpoint on depression symptom rating scales, read “The ‘McDonaldization’ of Psychiatry: Psychiatric Knowledge is Not the Equivalent of ‘Fast Food." The article may be found by clicking on Anonymous.

Anonymous said...

"As advocates for their patients, physicians should not allow...their advice to patients regarding participation in filming to be influenced by financial gain or promotional benefit to...their patients..." --AMA Code of Ethics

In the video news release, note that the patient's product was prominently displayed.

What is this news release about?

Press Release said...

Ten months earlier, a press release featuring the same patient was published. Click on "Press Release" to view the report.

Did the physicians accurately convey alternative treatments to the audience of prospective patients?

Anonymous said...

Excellent post and perspective/insight on Andy, and how pharma critics such as myself have to insist on objectivity when evaluating news such as this.