In one of the cases involving drug giant Pfizer, arrest warrants in Nigeria were reported to have issued against three top executives of the company. It was in this country that 11 children died and many suffered serious injuries during the clinical trial of the anti-meningitis drug "Trovan" (trovafloxacin). The allegation is that Pfizer’s investigators failed to adequately inform subjects’ families of the dangers of joining the trial.

The US House of Representatives has initiated an investigation into alleged anomalies in the conduct of third world clinical trials on cholesterol conducted by Schering-Plough Company and Merck & Co., two other big multinational companies. This is part of an investigation into how clinical trials are managed in both the United States and internationally.

Indeed, the increased scrutiny of how so-called research based drug corporations test the effects of their new products comes at very critical time for the hard-pressed high profit giants. Clinical trials are, in effect, experiments conducted on human beings to determine safety and effectiveness of specific chemicals for the treatment of disease. They must therefore be subjected to intense regulatory oversight to protect individual subjects and their families. Also, they are rather expensive undertakings considering the numbers of human beings needed in such trials to ensure epidemiological validity.

For either of these reasons, clinical trials of new medicines have increasingly been shifted to impoverished third world countries. In many of these countries regulatory mechanisms are either weak or non-existent with reduced emphasis on international ethical standards. As well, poverty and ignorance drives people in such countries to accept higher risks with lower financial compensation than individuals in more developed countries.

Most observers of the international pharmaceutical sector are hoping that publicizing the current situation will put pressure on the big companies to lead the way towards more responsible behavior in the development and marketing of medicines. It is expected that this will mean greater attention to concerns for human needs rather than desires for higher profits.

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There was a related article in last week’s issue of the "New England Journal of Medicine." The paper reviewed data from studies on 12 different anti-depressants (drugs for treating mental disorders) involving more than 12,000 human subjects. The data, obtained from US Food and Drug Administration reviews, allowed comparison of published studies with those whose results were not publicly disseminated.

The study, referred to by researcher experts as "meta-analysis", showed that published results were significantly more likely to report positive (safe and effective) results than unpublished data reported only to the FDA which included negative (unsafe or ineffective) outcomes. Such a selective publication of clinical trials and the outcomes within these trials could effectively hamper evidence-based assessments of anti-depressants by medical practitioners.

The article concludes with the following statement: "We cannot determine whether the bias observed resulted from a failure to submit manuscripts on the part of authors and sponsors, from decisions by journal editors and reviewers not to publish, or both. Selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients."

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In the light of the survey reports showing a significant number of Filipinos who experience hunger, a special series on under-nutrition published in The Lancet should be of great relevance to policy makers, public health practitioners, and health service providers of the Philippines. The series is written by an independent team of public health scientists from both developed and developing countries.

It is of particular interest that the Philippines is included among the only 20 countries where 80 percent of the world’s undernourished children live. With the National Nutrition Council recently placed under the Department of Health, the health sector now has the opportunity and the challenge to re-focus attention on nutrition as one of the major determinants of health especially among the Filipino poor.

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Organized medicine led by the Philippine Medical Association and the specialty societies are showing that they are just another interest group in the debates on reforming the pharmaceutical industry. Their loud objections to stricter generic prescribing, including threats to join "hospital holidays" (translated as a boycott of patients), do not speak well of sincere professionalism and concern for patient’s welfare when their vested interests are threatened.

Health reform advocates may well ask, "Who pays for those expensive full page advertisements in the newspapers?"