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. 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.
The Hopkins researchers admitted they lacked familiarity with the rudiments of Good Clinical Practice, the universally accepted standards for the conduct of medical experiments on human subjects. These standards protect trial participants from abuse and help to ensure study data are a truthful reflection of what was observed during the experiments.
The researchers have acknowledged that possibly thousands of adverse events went unrecorded due to poor or non-existent record keeping.
Furthermore, HIVNET auditors noted it was common practice for the researchers to assess adverse events based on second-hand or third-hand accounts observed by other, less-qualified staff, rather than seeing the study participants themselves. Even more alarming, the researchers expressed ignorance of the safety-reporting regulations, which had been incorporated into their own study protocol.
In short, the HIVNET study violated some of the most elemental standards of clinical research, rendering the results — especially those pertaining to drug safety — invalid. Upon learning of the results, the company withdrew its application to the FDA to market the drug for preventing the transmission of HIV. Anthony S. Nevirapine figured prominently in this effort.
Under pressure from countries desperate for an AIDS victory, the WHO reaffirmed its support for the trial and its questionable findings. Also like Tuskegee, the researchers ignored ethical norms, in this case the Declaration of Helsinki, and permitted the interests of science to take precedence over the well-being of their human subjects. After all, there is much at stake. Likewise, there is the reputation of the HIV Prevention Trials Network, which provided the operational support or lack thereof to the trial.
There also is the reputation of the NIH leadership and its scientists, who should have monitored the study more closely. At the very least, they should not have awarded an international clinical research grant to physicians whose clinical research skills were unproven. Most important, there is the reputation of the NIH itself.
It is expected to exemplify the highest standards for scientific integrity and to produce results that are both credible and sustainable. Sadly, this all must now be called into question. It was not long after Fauci successfully persuaded President Bush to invest his prestige and that of the U. Yet, instead of acknowledging their errors, the NIH bureaucracy has tried to silence its critics through intimidation, false accusations, character assassination and job termination.
Congress is reviewing hundreds of documents and the sworn testimony of a number of NIH officials that substantiate the allegations made by the whistleblowers. However, this review serves only to perpetuate the cover-up. Most of the IOM panel members have conflicts of interest that call into question their objectivity.
By receiving research funding from the NIH, these individuals are unlikely to jeopardize their own standing with the institution. The terms of reference for the inquiry are so narrowly written, it will be impossible to draw any meaningful conclusions from the effort. Instead of addressing the failed NIH research process, reprisals against whistleblowers and the cover-up, the IOM team will address only the validity of the data from a scientific standpoint.
This is not what the public interest requires. The specter of Tuskegee has returned to government-sponsored clinical trials. This site uses cookies to improve performance. If your browser does not accept cookies, you cannot view this site. There are many reasons why a cookie could not be set correctly. Below are the most common reasons:. This site uses cookies to improve performance by remembering that you are logged in when you go from page to page.
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