Health - Politics, Wellbeing, Medicine

Although matters related to health are discussed elsewhere in the Jackson Progressive, some articles belong squarely on a separate page. This page features articles related to health that are not treated in other areas.

Doctors Denounce Milk Ads Starring Marc Anthony, Britney Spears, and Other Celebs as Deceptive

July 25, 2000 - Washington, D.C.-A doctors' organization will file a petition tomorrow with the Federal Trade Commission (FTC) requesting an immediate investigation into health claims in "milk mustache" ads featuring Marc Anthony, Britney Spears, and other celebrities. Read the article.

St. John's Wort (hypericum)

The British Medical Journal reports the results of a study in Germany that an extract of St. John's Wort is as effective in the treatment of depression as the drug imipramine, and much safer. Dr. Michael Philipp, of Bezirkskrankenhaus Landshut, and colleagues write that the extract may be considered as an alternative first choice treatment in most cases of mild to moderate depression without psychotic symptoms. The article appeared in the December 11, 1999 issue. Read a summary or the full text of the article.

Drug Trials Results Skewed by Questionable Practices

11/17/99
In the pharmaceutical world, the ability of a drug to achieve its intended effect is tested by blind clinical trials. The volunteers are divided randomly into two groups, one of which is given the trial medicine and the other is given a substance, a placebo, which has no effect upon the person. If the trial medicine exhibits a significantly greater effect upon the medicine-taking groups as compared to the placebo-taking group, then it is regarded as effective. In other cases, a trial drug is compared in effectiveness with a known and accepted drug. The results of such trials are submitted to the Food and Drug Administration, which must approve the sale and use of the drug. It is obvious that the safety of the public depends upon the integrity of the trials.

Two articles in a recent issue of the Journal of the American Medical Association (Vol 282, No. 18, November 10, 1999) cast a cloud upon the procedures used by the pharmaceutical industry and the medical profession to test new drugs. Two researchers, Helle Krogh Johansen, MD, DMSc. and Peter C. Gotzsche, MD, DMSc, in the course of performing a meta-analysis on a number of trials of Fluconazole, a new antifungal agent manufactured by Pfizer, Inc., discovered a pattern of reporting which biased the trials to the extent that they seriously overstated the effectiveness of the drug.

Meta-analysis is a statistical method of combining the results of numerous trials to arrive at a greater level of precision than is possible with any of the individual trials. A valid meta-analysis requires a through knowledge of each individual trial, including its methodology.

Johansen and Gotzsche's research initially indicated that 18 relevant trials had been performed. After excluding several trials due to duplication and methodology, they mailed requests for further information to the remaining 15 authors, requesting details about the trials. Seven authors failed to respond. The remaining authors were less than cooperative, giving a number of excuses, such as busyness and unavailability of data.

Upon further study, it appeared that some trials were reported more than once, with different researchers' names upon the reports, thus duplicating the results of favorable trials.

The editorial in the same issue of JAMA stated:

This evidence shows that covert reporting of the same data in clinical trials artificially skews the balance of opinion in favor of the new drug. Why is this happening? Reviewing these case studies, it is hard not to suspect that this practice, which serves commercial interests so well, is deliberate, and, because it confuses and biases information important to the care of patients, it has to stop.

The authors also found serious flaws which would have been obvious to any trained researcher. In most of the trials, fluconazole was compared in its effects to the drugs amphotericin B and nystatin. Instead of a three results, however, the results for amphotericin B and nystatin were combined in many of the trials, and, given that at the time of the trials nystatin was known to be ineffective for the particular purpose for which fluconazole was being tested, the combination of amphotericin B and nystatin had the effect of combining amphotericin B with a placebo, thus lowering its efficacy. In addition, whereas fluconazole is well absorbed after oral intake, amphotericin B is poorly absorbed and is not recommended for oral use, and there is little documentation of its clinical effect when given orally. In most of the trials, nevertheless, amphotericin B was given orally.

These findings are appalling. The editors of the AMA Journal are rightfully concerned. The behavior of the companies and researchers involved approaches a criminal conspiracy to commit fraud upon the FDA, the medical profession, and, ultimately, the unsuspecting public, to which these drugs are being prescribed. We do not believe it to be alarmist in calling for an investigation by the FDA, if not the U. S. Department of Justice.

Fair Conduct and Fair Reporting of Clinical Trials (editorial), JAMA

Problems in the Design and Reporting of Trials of Antifungal Agents Encountered During Meta-analysis, JAMA