January 19, 2005 http://www.kimbannon.com/home/petition.php
- Dr. Randall R. ‘Rush’ Wayne, M.A., Molecular Biology, Harvard University, PhD, Biochemistry, University of California

"The medical profession and scientific establishment have terrorized too many people with these worthless [Hiv] tests.”

Aired on Fox News Channel, February 3, 2005.
- Jonathan M. Fishbein, MD Former Director, Office for Clinical Research Policy at the Division of AIDS (DAIDS) at the National Institute of Allergy and Infectious Disease (NIAID), the US National Institutes of Health (NIH)

"Until recently, I was the Director of the Office of Policy in Clinical Research Operations at the National Institute of Allergy and Infectious Disease Division of AIDS. In that capacity, I was responsible for ensuring the integrity of government-funded AIDS drug trials by insisting upon good clinical practice and the rigorous oversight of all AIDS-related field work.

“It was an impossible task. At every turn I found my efforts frustrated by a management system guided more by politics than by sound science. Nepotism and bureaucratic intrigue permeate DAIDS. Scientists are pressured to produce results at the expense of regulations whose purpose is to protect the safety, rights and welfare of study subjects, not to mention the preservation of scientific integrity.

“For seven months, I learned of numerous instances of scientific and professional misconduct at DAIDS. I brought some of these to the attention of my supervisor as I am required to do by law. My vigilance was rewarded with a notice of termination and slander against my good name and reputation. Frustrated, I decided to step forward as a whistleblower in the hope that public exposure would bring about the needed change. That has yet to happen. Instead, NIH has worked fervently to suppress my allegations and delegitimize my credibility. They will not succeed...

“Among the most serious charges I have leveled against NIH is that the agency knowingly and cunningly covered up evidence of shoddy conduct in a trial examining the safety and efficacy of [Aids drug] nevirapine ...

“Far from being a wonder drug, nevirapine can be very dangerous. It has been subjected to numerous changes in its labeling by the FDA, owing to reports of liver toxicity and a potential for fatal rashes when administered in multiple doses. But with the administration of just one dose, viral resistance can result in half the patients to whom the drug is prescribed...

“This was not the conclusion reached by NIH-backed researchers from The Johns Hopkins School of Medicine when they undertook a landmark study of nevirapine in Uganda in the late 1990s. The study, known as HIVNET 012, purported to show that the drug was safe and effective in preventing HIV transmission to newborns.

“What was not immediately apparent was that some of the most basic procedures of Good Clinical Practice were absent from their work.

“The original HIVNET results were...hailed by many in the AIDS community as an unqualified victory in the fight against AIDS. As most of the international AIDS research community, as well as the World Health Organization, embraced these findings, the NIH and the investigators are unwilling to admit to any flaws.

“However, when third party auditors from nevirapine's manufacturer, Boehringer Ingleheim, looked into how the Uganda trial was run, they found critical compliance issues that compromised the integrity of the study...A second audit sponsored by DAIDS essentially confirmed what the manufacturer discovered. With the validity of the data very much in question, Boehringer Ingelheim withdrew its license application to the U.S. FDA.

“The NIAID swung into action. Deputy Director LaMontagne assured the public ‘there is no question about the validity of the data,’ citing only that ‘the problems are in the rather arcane requirements in record keeping.’ This was quite an understatement and a willful deception of the public. From there, DAIDS maintained the deceit by concocting an expensive and elaborate ‘remonitoring’ of HIVNET 012 in which the conclusions were never in doubt.

“And as if that weren’t enough, DAIDS used threats and intimidation to silence those employees who knew the truth and might potentially speak out...

“It now appears that this endorsement of nevirapine may have been premature. No policy, no matter how well intentioned, should be based on poor science. Yet that is what HIVNET 012 was.

“Of even greater importance is what the experience with HIVNET 012 has taught us about one government agency. NIH is broken and needs to be overhauled. Those responsible for suppressing the truth about poor scientific conduct and deceiving the public should themselves be reprimanded and removed from positions of authority. Acts of retaliation by senior managers against employees simply doing their job should be fully and fairly investigated.”

— Phillip Johnson, Senior Professor of Law, University of California at Berkeley

“If you were to go back and audit the evidence without a prejudice in favor of the reigning theory, the conclusion would be that [HIV is] harmless. A correlation does not prove causation. People who are very sick have lots of infections and foreign proteins in their blood. They may test positive for lots of things, but that doesn’t mean that those things are causing their condition.”

- AIDS, a Second Opinion