DRUG BUST Alan Cassels
WE TRUST strongly in our medical system because, metaphorically speaking, we largely don’t mix church and state. For the most part, the medical care we receive from our hospitals and doctors is supported by public funds and delivered on the basis of human goodness, charity and justice. Examples that show how strenuous we are in ensuring that commerce doesn’t taint our medical care include:
- We don’t let doctors sell drugs; pharmacists do that.
- We don’t let drug companies run medical schools; universities do that.
- We don’t let drug manufacturers write prescribing guidelines for physicians; independent experts do that.
- And we don’t let people selling drugs or medical devices write medical journal articles; academic physicians do that.
Or, at least, that’s what I thought.
April was a particularly hard month for rude awakenings. Cracks in the crumbling edifice between commerce and medicine were revealed and new research unveiled gross, sometimes shocking, levels of conflicts of interest in our medical system. We are finding evidence of academic doctors selling themselves to the highest bidders, medical journals allowing themselves to be prostituted by drug companies and medical schools allowing doctors in residence to be bribed with drug company trinkets. I would argue that of all the factors threatening to undermine our trust in medicine, financial conflicts of interest top the list.
Don’t believe me? Then believe the data: In April, four separate research studies published in four diverse areas showed the widespread and rampant nature of conflicts of interest in medicine. One derives from the world of cancer research. One is from psychiatry. One is from medical education and the last is from the world of medical journals. As you absorb these examples, try to decide for yourself if we are doing enough as a society to eliminate the conflicts of interest infecting medicine.
What do I mean by conflict of interest? Wikipedia generally defines it as “any situation in which an individual or corporation (either private or governmental) is in a position to exploit a professional or official capacity in some way for their personal or corporate benefit.”
One study from the cancer world examined the frequency and impact of conflicts of interest as they related to high-impact, published, clinical cancer research. It basically asked the question: “Are researchers who publish in cancer journals conflicted?” (For instance, do they own shares or have stock in or otherwise benefit financially from their association with a drug manufacturer or do they work for the drug company whose drug they are studying?) The reviewers looked at cancer research published in eight major journals in 2006 to see if conflicts of interest were reported and, if so, who funded the research? They also wanted to discern if there is a real association between the research funders and what the research concludes (i.e. do the industry-sponsored researchers have more positive things to say about their sponsor’s drug than the researchers not on industry’s payroll?)
Their results? Out of 1,534 original oncology studies, almost a third (29 percent) of the researchers had a conflict of interest, including industry funding, yet only 17 percent declared they had received such funding. Studies paid for by industry funding were twice as likely to focus on treatments (as opposed to other aspects of cancer care) and randomized trials that assessed survival were more likely to report positive survival outcomes when there was an obvious conflict of interest. In other words, the drug is shown to “work” better if there is company money involved.
The authors concluded there are indeed conflicts of interest in the clinical cancer research published in high-impact journals; often, those conflicts are not disclosed and the conflicts result in a more positive spin being put on the results of the trial.
The next example comes from the world of mental illness. A report by Boston researchers found that 90 percent of the authors of three American Psychiatric Association (APA) clinical practice guidelines in psychiatry had financial ties to companies that manufacture drugs mentioned in those guidelines. Worse yet, the authors had financial connections, including owning equity in the companies that made the recommended medications, being a consultant or corporate board member, or receiving honoraria. None of these conflicts were disclosed in the guideline.
Translation: The academics who wrote the major guidelines for American physicians on treating serious mental illness – schizophrenia, bipolar disorder and major depression – were basically all funded by the drug companies. If you thought only well meaning psychiatrists, interested in the welfare of patients, provided the guidelines, you’d be wrong. The picture looks even darker when you narrow in on the conflicts of interest of the authors of the guidelines for only bipolar disorder and schizophrenia: Here, 100 percent of the authors had such conflicts. Most people would consider these findings very worrisome, including Tufts University professor Sheldon Krimsky, one of the co-authors of this report. Tufts published a 2006 study examining conflicts of interest of the creators of psychiatry’s “Bible,” the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders).
In a telephone interview with Krimsky from his office in Boston, he told me we should be worried about conflicts of interest because they can lead to a “distortion of the scientific record” and that industry-funded activities may lead to an “interpretation of the science in a direction that may not be defensible.”
While he’d like to see these guidelines do a much better job of disclosing conflicts of interests among the authors, such disclosure is only an intermediate step towards erecting a solid firewall between drug companies and guidelines for physicians. “The innovators must be separate from the evaluators,” he notes. That’s right, a separation of church and state.
No doubt guideline committees, such as those sponsored by the APA, need to come clean about their financial conflicts, but they must go further to avoid them in the first place. At the very least, groups like the APA should admit they’ve got a huge potential PR liability on their hands, and if they don’t prevent drug companies from putting their own people on guideline committees, the APA shouldn’t be surprised when our doctors scorn or ignore their guidance.
What about smaller things than prescribing guidelines? What about trinkets – do they influence what our physicians think about drug companies? A recent study conducted in two medical schools in the US found that exposure to even small pharmaceutical items affected a doctor’s treatment preferences.
You might find this hard to believe. Most physicians I know scorn the idea that they could be “bought” with trinkets. (We’re talking drug company pens, free drug samples and other logo-laden paraphernalia.) Most physicians are adamant that these small, promotional items are unlikely to influence prescribing behaviour. Yet, in this study, the researchers measured whether exposure to these items result in doctors looking more favourably on drug companies and whether or not the medical schools with more restrictive policies towards pharmaceutical marketing produce doctors with different attitudes.
Researchers conducted a randomized, controlled experiment with more than 300 senior level medical students at two US medical schools. One of the schools (University of Miami) allowed the students to be exposed to small, branded promotional items for the cholesterol-lowering drug Lipitor (atorvastatin). The control group was comprised of students at the University of Pennsylvania School of Medicine where restrictive policies are in place to limit pharmaceutical marketing.
What did they find? The Miami students exposed to the Lipitor swag were obviously more enamoured with the drug compared to the control group in Pennsylvania. On a “skepticism” scale, the Miami students held more favourable attitudes toward pharmaceutical marketing compared with the other group of students where the opposite effect was observed. Basically, those students not marinating in drug company promotion were less swayed by promotional items related to the drug.
The authors concluded “subtle exposure to small, pharmaceutical, promotional items influences implicit attitudes toward marketed products among medical students.”
A study published in April by Sergio Sismondo at Queens University in Kingston looked at the relationship between drug companies and medical journals and asked, “Are medical researchers and medical journals too close to the pharmaceutical industry for comfort – or patient safety?”
We’ve all heard of the phenomenon of “ghostwriting” where big, important names in medical academia are asked to put their names to papers written by others (often drug company hacks). But Sismondo pushes the concept a bit further referring to the “ghost management” of pharmaceutical research and publication where cradle-to-grave medical publishing is “managed” every step of the way by pharma funders. He notes there has always been a problem with plagiarism and the misallocation of credit (like the prof who puts his own name on the hard work of his graduate students), but those scenarios are only the tip of the iceberg.
A more serious problem in medical publishing is the pharmaceutical industry using “willing participants” in the form of researchers seeking fame, glory and money associated with huge, multimillion-dollar studies. These people, known in the marketing world as KOLs (Key Opinion Leaders), are luminaries who put their names to the body of academic published research and serve as speakers and de facto promoters of the company’s products. They put their names to studies that are published according to the objectives of the funders (usually the drug companies). The published studies are then reprinted and distributed to the offices of physicians and anyone else who influences drug formularies.
As Sismondo says, “Those articles may look like independent confirmation of the reps’ pitches [and] plagiarizing KOLs lend their good names to the pitches.”
If you were to ask me if conflicts of interest are a problem in medicine, I’d say, “Ask the data and then decide for yourself.”
Alan Cassels is a drug policy researcher at the University of Victoria and the co-author of the bestselling Selling Sickness. He does not work for the pharmaceutical industry.