Big Pharma has developed new forms of ‘research’ to serve its own interests.
The medical research world has been concerned about the problem of ghost writing for more than a decade. Over the past few years, the issue has been repeatedly raised in the mainstream media. Most of the commentary has focused on the ethics of academics signing their name on papers they did not write and on some of the most egregious actions by pharmaceutical companies.
But these efforts miss the ways in which Big Pharma has developed new forms of medical research to serve its own interests.
How Ghost Writing Feeds Big Pharma Profits
According to a study by Marc-André Gagnon and Joel Lexchin in PLoS Medicine, Big Pharma firms spend twice as much on promotion as on research and development. But it is worse than that: More and more medical R&D is organized as promotional campaigns to make physicians aware of products. The bulk of the industry’s external funding for research now goes to contract with research organizations to produce studies that feed large numbers of articles to medical journals.
Internal documents from Pfizer, made public in litigation, showed that 85 scientific articles on its antidepressant Zoloft were produced and co-ordinated by a public relations company. Pfizer itself thus produced a critical mass of the favourable articles placed among the 211 scientific papers on Zoloft in the same period. Internal documents tell similar stories for Merck’s Vioxx, GlaxoSmithKline’s Paxil, Astra-Zeneca’s Seroquel, and Wyeth’s hormone-replacement drugs.
To promote the now-notorious Vioxx, Merck organized a ghost-writing campaign that involved 96 scientific articles. Key ones did not mention the death of some patients during clinical trials. Through a class-action lawsuit against Vioxx in Australia, it was discovered that Elsevier had created a fake medical journal for Merck – the Australasian Journal of Joint and Bone Medicine – and perhaps 10 other fake journals for Merck and other Big Pharma companies.
In another example, GlaxoSmithKline organized a ghost-writing program to promote its antidepressant Paxil. According to internal documents made public in 2009, the program was called “Case Study Publication for Peer-Review,” or CASPPER, a playful reference to the “friendly ghost.” Such strategies are not exceptions; they are now the norm in the industry.
Most new drugs with blockbuster potential are introduced accompanied by 50, 60, or even 100 medical journal articles. Any firm that refused to play this game in the name of ethics would likely lose market share. Profits in the pharmaceutical industry depend on companies’ capacity to influence medical knowledge, and create market share and market niches for their products.
A Call for Evidence-Based Medicine
In 2008, research showed that pharmaceutical companies systematically failed to publish negative studies on their SSRIs – formally called selective serotonin reuptake inhibitors, the Prozac generation of antidepressants. Of 74 clinical trials, 38 produced positive results and 36 did not; 94 per cent of the positive studies were published, compared to only 23 per cent of those that were negative, and two-thirds of those were spun to make them look more positive.
Physicians reading the scientific literature got a biased view of the benefits of SSRIs. This helps to explain the huge number of antidepressant prescriptions, in spite of the fact that, according to a meta-analysis in the Journal of the American Medical Association in January 2010, the drugs did not bring more benefits than a placebo for 70 per cent of people taking SSRIs. Compared to a placebo, however, SSRI antidepressants can result in serious adverse drug reactions.
With this we see one of the problems with the ghost management of medical research and its publication. Pharmaceutical companies want upbeat reports on their drugs. They design, write, and publish studies that are likely to show their drugs in a positive light – and there are myriad ways to do so. Ghosts sometimes bend the truth, and sometimes even commit fraud, with grave results.
Why do academics sign their name on scientific articles they did not write, using research they did not perform? Because they are rewarded, both by their universities and by their colleagues, for how much they publish and for the prominence of the publications. Pharmaceutical companies and their agents are very good at placing articles in prestigious journals, and they then make them even more prominent by having their armies of sales reps circulate them and talk them up.
Researchers who sign their name on studies and analyses (perhaps scientifically correct) that are favourable to the industry can expect to see these articles increase their prestige and influence, and possibly even funding.
What happens, however, when a researcher produces studies and analyses (also scientifically correct) showing that some products are dangerous or inefficient, as some did about Vioxx before the scandal broke? Reading Merck’s internal emails, revealed during the class-action lawsuit, it was exposed that the company drew up a hit list of “rogue” researchers who needed to be “discredited” or “neutralized” – “seek them out and destroy them where they live,” one email read. Eight Stanford University researchers say they received threats from Merck after publishing unfavourable results.
In the ghost management of research and publication by drug companies, we have a new model of science. This is corporate science, done by many unseen workers, performed for marketing purposes and drawing its authority from traditional academic science. The high commercial stakes mean that all of the parties connected with this new corporate science can find reasons or be induced to participate, support, and steadily normalize it. It also biases the available science by pushing favourable results and downplaying negative ones – and sometimes through outright fraud.
As long as pharmaceutical companies hold the purse strings of medical research, medical knowledge will serve to market drugs, not to promote health. And as long as universities grovel for more partnerships with these companies, the door will remain wide open to proceed with the corruption of scientific research.
Photo courtesy of Reuters.