Wednesday, January 04, 2006


Drug Safety

Are Our Drugs Safe?

Medicine is only as trustworthy as the science on which it is based. “Independent university investigators play a very important role in drug and device development. . . Their participation is a key factor in you having confidence that the medicine you put in your body is good for you.” (James Kahn, UCSF, quoted from University Inc., Jennifer Washburn, 2005)

In order for a new drug to get to market, it must undergo a rigorous set of experiments, starting with in vitro laboratory tests and culminating with a series of clinical trials on human subjects. Finally, if these experiments are able to demonstrate that the drug is both safe and effective, the research should be published in a peer-reviewed journal so that other scientists may scrutinize and repeat the work. But what constitutes “safe” or “effective,” and how do we know that rigor and objectivity have been applied to the fullest?

One key criterion of objectivity is that the investigator must remove as many potential biases as possible from his or her research. In other words, the investigator should not have any stake in the success or failure of the experiment. In terms of expanding our understanding of nature, results that refute a hypothesis are just as valuable as those that support the hypothesis. The same is true for experiments on new drugs, even if that drug could potentially cure cancer or AIDS. Negative results may tell us that an expensive new treatment is no more effective than a cheaper existing treatment, or that the side effects are potentially deadly.

One bias that has become increasingly common in the past decade is that of the researcher who has a financial stake in the product s/he is testing. Even when the researcher has integrity and intends to publish negative data about a product, the company sponsoring the research will often resist with all the weapons in its arsenal, including expensive law suits against the scientist(s), data dredging (manipulation of the data to support a more positive spin), dishonest press releases. Sheldon Krimsky, a professor at Tufts University, found that one-third of lead authors in Massachusetts research institutions had significant financial interests in their own research (e.g., investments in or grants funded by the drug company for whom they are doing research or potential patents). (Washburn, 2005, op. cit.) The Lancet claimed that they could no longer find people without a financial interest in a drug or therapy to write a review about it (Seattle-Post-Intelligencer, 2/13/97)

Is Commerce Corrupting AIDS Research

Financial Conflicts of Interest in Academic Medicine

It used to be that the majority of research on new drugs and treatments was publicly funded and conducted by university researchers. Now, approximately 70-80% of the funding for such research comes from the private sector, creating conflicts of interest and calling into question the objectivity of these studies and the safety and efficacy of the drugs and treatments marketed as a result.

Big Pharma has many tricks to promote their drugs and gain the public trust. For example, pharmaceutical companies often sponsor lunches for medical students as a way to market their new drugs. They ply professors and doctors with fancy dinners, gifts, trips and free prescriptions, all designed to influence their prescribing habits. Furthermore, the pharmaceutical companies are more likely to design the drug trial protocol themselves and then seek a university (for credibility) to do the research, maintaining control over the data and the right to publish (or bury) the data. They sometimes even hire “ghost writers,” a prominent professor who gets first-authorship rights (and sometimes an honorarium), but who otherwise has nothing to do with the research. This was the case with the recent stem cell scandal in South Korea.

Dawn of McScience

In 1999 Jesse Gelsinger, 18, died in a gene therapy clinical trial. As a result, the federal government shut down human studies at 20 institutions from 1999-2001. In order for a drug to be considered safe and effective, human studies must be conducted, but only if the new drug or treatment is unlikely to harm the human guinea pigs (as demonstrated in prior in vitro and animal studies), not just because the share holders or the lead researcher stand to gain from its sales. Unfortunately, trials involving humans, are susceptible to the same corruptions and biases as other research with the potential for financial profit. In one study of a bone marrow transplant treatment for leukemia patients, 80 out of 82 patients died during the trial, with an estimate that at least 20 of the deaths were attributable to the trial itself.

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