By: Rand H. Fishbein, Ph.D. | CCNS
Editor’s Note: This article was originally published in 2005 by CCNS member, Rand H. Fishbein, Ph.D.
It has been more than 70 years since the U.S. Public Health Service began its study into the effects of syphilis on 399 human test subjects — all of them black, all of them poor and most of them illiterate. When the infamous Tuskegee experiments finally came to light in 1972, the public, at last, learned the horrible truth.
The men in the Tuskegee study were never told they had syphilis, nor were they told the real purpose behind their participation in the experiment. Worse, they were systematically denied treatments that would have eased their suffering. In the annals of U.S. medical history, the Tuskegee experiments have become synonymous with ethical misconduct at its worst. The federal government assured the public that malpractice of this sort would never happen again. Sadly, however, it has.
Beginning in 1997, a team of researchers from The Johns Hopkins University, generously sponsored by the National Institutes of Health, conducted a clinical trial of the drug nevirapine in Uganda. Known as HIVNET 012, the researchers sought to prove that the anti-retroviral drug was safe and effective in preventing the transmission of the deadly AIDS virus from pregnant mothers to their newborn babies. According to the NIH, approximately 800,000 children worldwide became infected with the human immunodeficiency virus — the organism that causes AIDS — through mother-to-child transmission in 2002.
In 1999, the researchers published their findings: One dose of the drug nevirapine, given to a mother shortly before delivery, and once to her newborn, significantly reduced the incidence of HIV transmission to the child. The World Health Organization affirmed its support of this simple and inexpensive regimen. The medical community quickly adopted nevirapine as the drug of choice for pregnant HIV-infected women in resource-poor countries.
Yet, as with the Tuskegee experiments, something went horribly wrong. In 2002, an audit of the HIVNET 012 trial raised questions about the validity of the study data. According to independent auditors, medical records of study participants could not support the published results, and numerous violations of the study protocol occurred without written explanation.