Dissident AIDS Database

Politico-socio-economicoFundingScientific biasHIV drug studies
AIDS drug researchers say firm pressured them
 Saltus Richard
  "It's just what traditionalists warned about as private investors took on an ever-growing role in US medical research : the company that pays for a drug study has the power to pressure scientists to make results look better than they are. That's exactly what scientists from Harvard University and the University of California at San Francisco say happened to them when they tried to publish results from a massive AIDS drug trial... The researchers say the biotech company that funded their study tried to put a positive spin on the results, then, when that failed, attempted to block publication altogether. The study in its unaltered form appears in today's Journal of the American Medical Association, but the fight is far from over. The company that funded the study, Immune Response Corp., has filed a multimillion dollar binding arbitration claim against the University of California and the lead scientist, alleging damage to its business... Dr. James O. Kahn, the study leader, said in an interview... ''finally they tried intimidation'' by filing the arbitration action seeking monetary damages... But, as the clashes between researchers and their private backers over publication rights become more frequent, scientific organizations are reacting with alarm. Cases like this ''are a major, major concern to us,'' said Irving Lerch, who heads a committee on Scientific Freedom and Responsibility for the American Association for the Advancement of Science. ''There are too many that have hit the public spotlight to make me think these are very rare events, and I think we have a problem we have to deal with,'' said Dr. David Korn, an official of the American Association of Medical Colleges. The study involved 2,500 patients infected with HIV, the virus that causes AIDS, and was the largest AIDS drug trial of the 1990s. Immune Response... wanted to test its ''therapeutic vaccine'' called Remune... Begun in 1996, the research study was halted in 1999 when a monitoring committee determined that patients who got the Remune injections were faring no better than those who got standard antiviral drugs without Remune. When it came time to write up the data for publication, Kahn, Lagakos, and others on the team concurred that the analyses showed no benefit from the drug. But scientists from Immune Response performed their own analysis of blood tests on a sample of 250 patients in whom, the company argued, some benefit could be seen - not in longer survival, but in having lower levels of virus in their blood. Dr. Ronald Moss, the company's medical director, argued that those data should be part of the report manuscript... ''The sponsor wanted a specific small piece of data included that they think shows their product works,'' Kahn said in an interview. ''We declined. We didn't think it was a valid analysis.'' In response, the company demanded the right to approve the researchers' manuscript before publication. They refused again.
  Globe, 11/1/20002000
Hormone Studies: What Went Wrong?
 KOLATA GINA
  Email from Dave Rasnick : This article below is important because it addresses the two main types of studies that are currently used by the pharmaceutical/health care industry to evaluate the clinical benefits (if any) of drugs: observational studies versus full-blown phase III clinical trials. As the article shows, clinical trials are considered to be the "gold standard". Virtually all anti-HIV drugs were approved based only on phase II clinical trials (AZT is the exception), which were relatively small studies relying on changes in surrogate markers such as viral load, CD4 counts etc. The phase II clinical trials for anti-HIV drugs did not determine whether the drugs prolonged life or at least improved the quality of the lives of HIV positive people. All of the claims for the life-saving benefits of the anti-HIV drugs are based on observational studies where different groups of people from different periods of the AIDS epidemic are compared. The different periods are arbitrarily chosen to correspond to the changes in the standard of care for those periods. For example, the reference period is often chosen to be prior to 1987 when AZT was approved by the FDA. Another period of "mono-therapy" would be from 1987 to sometime in the early 1990s, at which point the combination-nucleoside-analog-period takes over. The last period generally begins with 1996, when the HIV-protease inhibitor cocktails were approved by the FDA. Since AIDS peaked in the USA 1992-3 (with AIDS deaths peaking a few years later), AIDS Inc. has conveniently attributed the natural decline in mortality to the introduction of the protease inhibitor cocktails. But, there has not been even a single clinical trial that has shown that the drugs are the likely cause of the decline in the mortality... Since observational studies are easy to manipulate in order to get the answer you want, it's a good bet that the drugs companies will argue strongly for the superiority of observational studies over clinical trials. ["For nearly nine months, doctors and researchers have been struggling with an intractable problem: how could two large high-quality studies come to diametrically different conclusions about menopause, hormone therapy and heart disease? The question arose in July, when scientists saw data from a large federal study called the Women's Health Initiative, which was ended early when it became clear that a widely used hormone-replacement drug, Prempro, had risks, including heart attacks, that exceeded its benefits. That finding directly contradicted previous studies showing that the hormones reduced heart disease risk in particular, the Nurses' Health Study, a large research effort that has been going on for years. The question is why. To answer it, researchers are reviewing the data, scrutinizing the design of each study and examining other research that may help reconcile the disparate findings. But so far, as they noted at a recent symposium at the Harvard School of Public Health, they have had no luck... The Nurses' Health Study was what scientists call observational. Tens of thousands of nurses reported on their hormone use and their health. Researchers found that hormone users had 30 percent fewer heart attacks. By contrast, the Women's Health Initiative was the sort of study that is considered a gold standard thousands of women were randomly assigned to take the most widely used hormone preparation, Prempro, made by Wyeth, or a placebo, and their health was monitored. Women who took hormones had 40 percent more heart attacks."]
  New York Times April 22, 20032003