Who benefits from corporate-sponsored clinical trials?

by Daniel R. Hoffman, Ph.D.

In the wake of GlaxoSmithKline's $3 billion fine, The Atlantic this week published a commentary that questions the integrity of a system where for-profit pharmaceutical companies design, sponsor and promulgate studies that form the basis of medical therapeutics.

The issue is not a new one and the fact of entrusting the public well being to profit-seeking corporations extends beyond pharmaceuticals and health care. The issue here is whether the market, characterized by its Reagan-Friedman acolytes as omniscient, rational, and fair-minded, can resist its own nature and protect the public interest.

Once upon a time government and nonprofit research organizations sponsored the vast majority of clinical trials. During those decades hospitals and medical schools designed and ran trials. That was before the private market-as-god ideology took hold and demanded cutbacks to government research funding. Now pharmaceutical companies fund the overwhelming proportion of clinical trials.

In their unceasing effort to reduce fixed overhead, pharmas outsource the management of trials to contract research organizations (CROs). The CROs themselves are an enormous, for-profit sector where each competitor bases its appeal to prospective clients on its past record of successfully delivering studies that eventually gained regulatory approval. 

This obvious, rooting interest of CROs became well known, so an additional layer was added to oversee trials and provide some assurance that they are conforming to ethical standards and scientific rigor. Institutional Review Boards (IRBs) are the agencies that emerged to fill this role. As it turns out, the IRBs are funded by the same sponsoring pharmas and CROs they ostensibly regulate. The net effect was essentially to just add another conflict-of-interest layer.

After trials are completed, their sponsors publish the results in purportedly objective, peer reviewed, medical journals. The thrall of putatively objective medical journals to trial sponsors, however, is due to their reliance on pharma advertising to remain solvent. Likewise, the journal editors and reviewers depend on pharma company grants to support their research labs, postdocs and other personnel.

As a result, the publication of clinical trial results runs contrary to the scientific spirit of open inquiry. Trial sponsors own the data generated by their studies and, not surprisingly, that means the results for only about half of all completed trials are ever made public. The overwhelming number of those studies that are disclosed show favorable results for the test drugs. 

The compromised position of journals came under scrutiny in recent years, so they also added a layer to create the appearance of integrity. One such layer is the Committee on Publication Ethics (COPE), a body composed of luminaries in academic medicine. The problem is that, once again, the research and consulting conducted by physicians in academic medicine are dependent on pharma funding. For example, COPE's Web site discloses that its chairperson provides "writing, editing, training and consultancy services for [12 named] pharmaceutical companies."

The everyday results from this chain of control by the medical-industrial complex occur because physicians base treatment guidelines on the evidence gleaned from published studies. Most physicians rely on a small number of "thought leaders" within their respective specialties to interpret the "medical literature" for them. Here again, independence from corporate largesse is rare. In any case, the sponsoring pharmas deny independent physicians in academia and elsewhere access to the raw data from those studies. As a result, even the small number of physicians who try to develop therapeutic guidelines for prescribing and treating by independently assessing the studies must rely on articles with incomplete data.

The system is not always and necessarily pernicious; a segment of people at pharmaceutical companies and in medical research actually try to run clinical studies with a high level of scientific integrity. The question is how to encourage their work while preventing the Avandias and Vioxxes. 

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