Neuroscience
From The New York Times (06 September 2004; free registration required):
- Alzheimer's Disease: Negative Bapineuzumab Findings In Phase Iii Trial
Critical reading for those interested in Alzheimer's clinical trials: first results from the BAP Phase III program. The link includes additional links to a New York Times article and a company press release. From FierceBiotech: UPDATED: Pfizer, J&J...
- More M.s. Drug Woes: Avonex And 683699
Biogen and F.D.A. Issue Drug Warning By ANDREW POLLACK The New York Times Published: March 17, 2005 Biogen Idec's multiple sclerosis drug Avonex might cause severe liver damage in rare cases, the company and the Food and Drug Administration said...
- Reminyl (galantamine Hydrobromide) (continued)
Safety Concerns Reported on J.& J. Alzheimer's Drug By ANDREW POLLACK New York Times Published: January 22, 2005 Regulators are reviewing the safety of the Alzheimer's disease drug Reminyl after data from two clinical trials indicated...
- Issues In Clinical Trials: Gdnf And Parkinson Disease
Today's New York Times includes a front-page article about the culture of clinical-trials research: what happens to participant subjects when an experimental drug is pulled from testing and, among other issues, how teasing apart placebo-based from...
- Business World: Emd 281014 And Insomnia
From the New York Times website: Lilly to Buy Insomnia Compound By THE ASSOCIATED PRESS Published: October 28, 2004 Filed at 11:21 a.m. ET INDIANAPOLIS (AP) -- Eli Lilly and Co. will pay a German pharmaceutical company $29 million for the...
Neuroscience
Pharmaceutical Clinical Trials: Merck
From The New York Times (06 September 2004; free registration required):
Merck Says It Will Post the Results of All Drug Trials
By GARDINER HARRIS
Merck & Company says it will post the results of its clinical trials on drugs on a Web site run by the National Institutes of Health. The move comes ahead of a House subcommittee hearing this week where, it is expected, drug companies will be excoriated for refusing to publish unfavorable clinical trial results.
Merck said Friday that it had already posted on the Web site, ClinicalTrials.gov, the outlines of 46 studies, or every trial for which the company is currently recruiting patients as well as some others. By the end of the month, the company will post 50 more trials that are already under way but where patients are no longer being recruited. And as the studies are published, Merck will post links to their results, the company said.
"Merck has long been committed to publishing the results of all of our trials in a timely manner," said Dr. Peter Honig, a senior vice president, "and now we're strengthening that commitment." One reason for the new postings, Dr. Honig said, is the industry's growing image problem.
"Let's face it, the perceptions of the pharmaceutical industry as a whole are not healthy at the moment," he said.
In recent months, some doctors' groups, researchers, medical journal editors and legislators have criticized drug makers for selective disclosures of clinical trials. Many companies have long declined to make public the results of trials that put their drugs in an unflattering light. At the same time, they actively promote the results of positive trials.
Studies show that this has led to a persistent bias among published clinical trials in drug companies' favor. That bias, some experts say, can distort the practice of medicine and lead doctors to prescribe drugs inappropriately. The New York State attorney general recently sued GlaxoSmithKline for failing to disclose negative study results, saying the company's actions amounted to consumer fraud. Glaxo denied the accusations but agreed to post data on its Web site.
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- Alzheimer's Disease: Negative Bapineuzumab Findings In Phase Iii Trial
Critical reading for those interested in Alzheimer's clinical trials: first results from the BAP Phase III program. The link includes additional links to a New York Times article and a company press release. From FierceBiotech: UPDATED: Pfizer, J&J...
- More M.s. Drug Woes: Avonex And 683699
Biogen and F.D.A. Issue Drug Warning By ANDREW POLLACK The New York Times Published: March 17, 2005 Biogen Idec's multiple sclerosis drug Avonex might cause severe liver damage in rare cases, the company and the Food and Drug Administration said...
- Reminyl (galantamine Hydrobromide) (continued)
Safety Concerns Reported on J.& J. Alzheimer's Drug By ANDREW POLLACK New York Times Published: January 22, 2005 Regulators are reviewing the safety of the Alzheimer's disease drug Reminyl after data from two clinical trials indicated...
- Issues In Clinical Trials: Gdnf And Parkinson Disease
Today's New York Times includes a front-page article about the culture of clinical-trials research: what happens to participant subjects when an experimental drug is pulled from testing and, among other issues, how teasing apart placebo-based from...
- Business World: Emd 281014 And Insomnia
From the New York Times website: Lilly to Buy Insomnia Compound By THE ASSOCIATED PRESS Published: October 28, 2004 Filed at 11:21 a.m. ET INDIANAPOLIS (AP) -- Eli Lilly and Co. will pay a German pharmaceutical company $29 million for the...