We all know about the biases inherent in drug industry sponsored phase III clinical trials. Ben Goldacre, for example, cites evidence in his book Bad Pharma that claims industry-funded trials are “twenty times more likely to give results favouring the test drug” (see here).
But even basic scientists who study the effects of drugs on lab rats and cells in petri dishes may be biased because of funding from the pharmaceutical industry.
In other words, industry bias is present from the very beginnings of a drug’s life cycle starting even before phase I trials and continuing through the publication of trial results, which are often written by industry-paid ghostwriters!
Here’s the press release:
This “new perspective” was published today in the open access journal PLOS Biology: How Basic Scientists Help the Pharmaceutical Industry Market Drugs. The author, Adriane Fugh-Berman MD, charges that basic science, not just clinical trials, is “plagued by financial conflicts of interest.” Fugh-Berman identifies evidence showing that industry-funded studies on animals and cell cultures can be as biased as industry-funded clinical trials, and can distort data on medical treatments.
Citing a 2007 survey that found that four of ten basic scientists had a relationship with industry, and a Cochrane Collaboration systematic review that showed that investigators receiving industry funding are more likely than non-industry-funded investigators to publish results that favor a sponsor’s drug, Fugh-Berman calls on basic scientists to commence a conversation about how conflicts of interest affect basic science.
Generally, “positive” studies (those with results favoring treatment) are more likely to be submitted to peer-reviewed journals and therefore be published than are “negative” studies that find no benefit of a tested treatment. Animal studies may determine the potential benefits or risks of a drug therapy, so suppression of negative animal data may result in humans being exposed to a drug that should not have graduated from animal to human trials. Investigators may agree not to publish negative data because they fear jeopardizing current or future funding. The article stresses the ethical need for publication of negative results, since the lack thereof may make a drug appear more beneficial than it is. While basic scientists may believe that scientific journals will not publish negative studies, this is no longer true; PLOS ONE and other highly regarded journals have pledged to publish high-quality research with negative results.
Fugh-Berman concludes that though biomedical researchers depend on industry for funding, accepting a sponsor’s gifts “creates an opportunity for results to be suppressed or spun to advantage a targeted drug or disadvantage competing therapies.” Regardless of who is sponsoring research, scientists should be ethically bound to accurately report both positive and negative studies. In addition to selective reporting, Fugh-Berman highlights the practice of ghost-writing & ghost-management, and their potential for spreading marketing messages.
Dr. Fugh-Berman was a guest on my Pharma Marketing Talk show where she talked about ghostwriting. Listen to this audio snippet from that show:
|Pharma Ghostwriters May Also Write Some Consumer Health Magazine Articles|
In this 2-minute audio snippet, Adriane Fugh-Berman, MD, Associate Professor at Georgetown University Medical Center and Director of PharmedOut, talks about the practice of medical journal ghostwriting and suggests that ghostwriters may also write articles for publication in consumer health magazines.
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You can hear the full interview of Dr. Fugh-Berman here: