Cetus's costly stumble on IL-2

Article Abstract:

A recent review process for approval of a potential therapeutic agent by the Food and Drug Administration (FDA) broke new ground on several fronts. The substance, interleukin-2, has been developed by Cetus, a biotechnology company, to treat renal cell carcinoma. As such, IL-2 was the first of a group of biological response modifiers to be reviewed by the FDA under a regulatory approach that included recommendations from the newly established Center for Biologics Evaluation and Research. Cetus's name for IL-2 is Proleukin, and the company has a strong financial interest in marketing its product. The meeting between Cetus representatives and the FDA took place in public; Cetus failed to convince the governmental body that IL-2 would do what it was supposed to. In the aftermath, the company's stock prices plummeted and the president resigned. The significance of this case is that it may be a symbol for the fate of biotechnology companies in general. Since such companies sell ''financial promise,'' the impression that the FDA will not approve their products could lead to withdrawal of financial backing. On the other hand, the FDA went on to approve some biological modifiers: Cetus may be an isolated, very special, case. A brief history of the Cetus-FDA relationship is provided; new data were arriving right up to the last minute before the advisory committee convened. When IL-2 works, it works very well; but it does not work for most patients. The agent is highly toxic with many undesirable side effects and a mortality of as much as four percent. Fears have been expressed about deaths that might ensue if the drug were administered at less well-equipped medical centers than the National Cancer Institute, where it has been extensively tested. A broader issue facing the FDA is whether, in cases where no hope can be extended to patients, a toxic drug should be approved as the best available approach. The FDA declares itself ready to meet again at Cetus's discretion; when a new application will be presented, however, is not known. (Consumer Summary produced by Reliance Medical Information, Inc.)

Health aspects, Evaluation, Laws, regulations and rules, Complications and side effects, Licensing agreements, United States. Food and Drug Administration, Drug testing, Interleukin-2, Cetus Corp., Proleukin (Medication)

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NIH goes "extra mile" on Gallo

Article Abstract:

Robert C. Gallo of the National Cancer Institute is regarded as a controversial scientist as well as a capable one. While some believe him to be the true discoverer of the AIDS (acquired immunodeficiency syndrome) virus, at least as many feel that the virus was stolen by him from Luc Montagnier, a French scientist. Although top officials at the National Institutes of Health (NIH) have concluded that Gallo did nothing wrong, new pressures are being brought on the NIH to involve outside observers, to eliminate concerns that the internal investigation may not have been entirely objective. The National Academy of Sciences has prepared a list of scientists qualified for conducting this outside investigation; the peer committee will be selected from this slate by James O. Mason, the assistant secretary for health. Gallo himself applauds the move, saying that when he is vindicated by an independent panel, the controversy may finally be put to rest. (Consumer Summary produced by Reliance Medical Information, Inc.)

Investigations, History, HIV (Viruses), HIV, Ethical aspects, Medical research, United States. National Institutes of Health, AIDS (Disease), Gallo, Robert C.

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