Commercially Funded Research

The pharmaceutical industry is widely considered one of the most ethically challenging industries. Ethical questions start at the stage of which treatments to research (is too much emphasis given to “diseases of the rich”?), continue with how research is conducted (is there true informed consent?), how outcomes are reported or suppressed (does the scientific community have all the facts needed to evaluate a treatment?), what monopoly rights are given to companies and for how long, how the companies market them to doctors (are there distorting inducements?) and to patients (is direct marketing of medicines ethical?), and how they are priced. Recent years have soon more awareness of these issues, and greater efforts to provide regulation or self-regulation, or at the very least transparency.

One of the nagging issues is academic research conducted or funded by pharmaceutical companies. Finding a new drug is basically science, and so not surprisingly the drug companies hire leading academic researchers and conduct research of academic nature and quality.

The companies have many incentives to want to publish their results in academic journals. Academic researchers who are not employees are much more willing to cooperate in research if it will advance their academic careers, which means publication. Even in-house researchers are interested in keeping their academic credentials up to date. Favorable results have much more credibility when they are published in a reputable journal.

On the other hand, the companies have many obvious incentives to skew the research. The difference between an accepted drug and a rejected one can easily be billions of dollars per year. There is also an incentive to skew reporting. A company has an incentive to publish successful results, but reporting unsuccessful trials involves bother and expense that does not contribute to the bottom line, even though its scientific value may be as great as a positive result.

At first, it was assumed that the normal peer review process was sufficient to deal with these problems. Since every article is reviewed by qualified academics, and since every researcher in a journal has to provide other scientists the opportunity to replicate or refute the results, it seemed unnecessary to ask after the hidden or manifest motivations of the author.

Unfortunately, this approach became discredited as it became known that researchers were obtaining huge sums from pharmaceutical companies to support research, without informing their peers. The furtive nature of industry support, together with some obvious abuses such as ghost-written articles, cast doubts on the ability of peer review to root out abuses. Add to this the fact that most of the reviewers also receive industry funding, and you have a system that doesn’t merit public trust.

The next stage was to reply on transparency. Studies from industry would be considered by journals on an equal basis as those from research institutions, but authors would have to disclose any substantial industry backing. Then the reviewers and the readers would have the tools to evaluate any possible bias in the study.

The effectiveness of transparency rules is now also questionable. A June New York Times article explained: “To protect research integrity, the National Institutes of Health require researchers to report to universities earnings of $10,000 or more per year.” The article also reported that three leading psychiatry researchers from Harvard University each failed to report over a million dollars in income from pharmaceutical companies. The professors all announced that the money they receive doesn’t affect their scientific objectivity in any way; one responded, “My interests are solely in the advancement of medical treatment through rigorous and objective study.” But the public obviously wonders why, if there is nothing to hide, so much is being hidden.

In 2005, the prestigious Journal of the American Medical association raised the bar even further. For the first time, research sponsored by commercial companies would actually be held to a higher standard than that sponsored by not-for-profit organizations; a non-industry participant has to vouch for the results. Other journals have so far failed to follow suit, the British Medical Journal criticized the JAMA policy as itself violating academic integrity by creating a double standard.

It would obviously be useful to have some kind of objective measure of the relative quality of industry-funded studies vs. non-profit ones, and this is just what was carried out in a recently published study funded by the US National Institutes of Health. The study compared the reporting quality in the different sectors, in the area of weight-loss studies. The meta-study found that on average the reporting quality in industry-sponsored studies was considerably higher.

Of course data quality is only one aspect of a good study, and in any case this is a sample of one, so it is premature to draw far-reaching conclusions. Still, the result does not surprise me. I am not so na├»ve as to think that commercially-sponsored research is not skewed by extra-scientific considerations, rather I am cynical enough to acknowledge that non-profit research has its own incentive system with its own distortions. Just as you don’t always maximize the profits of your firm by doing the most pressing science, you don’t always maximize your opportunity for promotion or obtaining grant money in this way.

In fact, cynicism is not the right word. Both in industry and in research institutions, there is a lot of very good science and almost all practitioners have a genuine interest in scientific advancement. In both there is a good but far from perfect correlation between funding and good practice, and the conflicting biases complement each other in many ways. No one likes to report negative results, and everyone likes to be seen as an innovator of some new direction.

The most important thing is that the research community has the ability to evaluate any potential distortions. For that reason, I believe that the strict rules on transparency regarding industry funding are justified and in fact vital, and obviously need to be more carefully enforced. But discriminatory rules within the peer review process are wrong and are based on an artificial distinction between the incentive systems in the academic and commercial research worlds.