Consider This: Hidden costs of hidden research
. . .our health
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News: Seroquel trial
Allegations that AstraZeneca failed to warn patients that its drug Seroquel contributed to weight gain and diabetes came to light yesterday when documents were opened as part of a lawsuit over the billion dollar anti-psychotic drug. Instructions to divert direct questions about side effects advised the sales force to "neutralize" concerns about this despite knowing it's own doctor pointed to "reasonable evidence" about impaired glucose regulation." Court documents also reveal off-label use, and the vetting of negative trials. The case...
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News: FDA on list of high risk agencies
A GAO report put the Food and Drug Administration (FDA) on the list of "high risk" areas vulnerable to fraud, waste, mismanagement. Prepared for the 111th Congress, the report notes there are "significant challenges that compromise its ability to protect Americans from unsafe and ineffective products." The GAO calls for the agency to: "improve the data it uses to manage the foreign drug inspection program, conduct more inspections of foreign establishments, systematically prioritize and traced promotional materials for review, and...
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News: Differences in anti-psychotic drugs
Research supported by NIMH confirms second generation antipsychotic medications are not homogeneous. These findings add to a growing body of literature comparing drugs for efficacy, side-effects and costs. The current study from German researchers appears on-line in The Lancet....
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News: Harvard psychiatrist courted pharma
Documents in a class action law suit show an active courtship between psychiatrist Dr. Joseph Biederman and Johnson and Johnson to fund a center at Massachusetts General Hospital to promote marketing goals. Discussions dating from 2002 address "deliverables" and positioning the company for child and adolescent pharmacology. Emails were posted on the Wall Street Journal. The documents are part of a class action law suit over pediatric use of Risperdal. Additional stories: Reuters, The Philadelphia Inquirer, Bloomberg News, The...
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News: New drugs more costly, more side effects, not better
The newer classification of drugs (Zyprexa, Risperdal, Geodone) commonly prescribed for schizophrenia, as well as bipolar disorders and behavioral management for children and teenagers have been found to be no more effective than the older drugs, according to an article published in the American Journal of Psychiatry. Studies of adults have led to similar findings which could challenge the record profits of drug companies that have recently obtained additional applications for treating children. Bloomberg.com reports that generics are already denting...
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News: Drugs in pipeline
PhRMA, the pharmaceutical marketing and research trade association, announced a list of drugs in varying stages of development for treating psychiatric disorders. Although the announcement specifies 301 drugs, the number of new agents is actually less. Many of the drugs, including Zyprexa, Concerta, Zoloft, Seroquel, are already available but the clinical studies and applications are pending for new uses. The 32-page report is available from PhRMA....
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Commentary: Race, genetics, metabolism: drug therapy and clinical trials
by L. DiAnne Bradford

Genes influence how drugs are metabolized. Yet most clinical drug trials are conducted on Caucasians, with little study of Asians and African Americans. Noted psychopharmacologist, Dr. DiAnne Bradford, writes about the impact of these genetic differences for drug therapies.
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News: Update: Drug companies
The Congressional Quarterly reports that new information is being sought to clarify whether GlaxoSmithKline had data about suicide risks for its anti-depressant Paxil as early as 1989. In May 2006 it alerted health professionals about the risk compared to placebos. Seroquel extension sought In an attempt to maintain high profits on its blockbuster drug Seroquel, AstraZeneca is asking to extend patent protection in the US and the European Union. It is also trying to Teva, a generic giant Teva from...
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News: Drug curbs alcohol cravings
A new study showed that the drug topiramate might have promising results for treating alcohol dependence. The results of a double-blind trial (N=371) appearing in the Journal of the American Medical Association reported that those taking the drug had fewer heavy drinking days, but also more side effects, than those taking a placebo. The 14-week double-blind trial was conducted at sites in 17 cities....
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News: Anti-psychotics cut addictive cravings
Results of a 14-week double-blind study reported in the American Journal of Addiction showed both olanzapine and resperidone cut cravings for marijuana and cocaine for people with schizophrenia....
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News: JAMA reviews studies of pediatric antidepressants
According to an article in JAMA, a review of 27 pediatric trials (including major depression, OCD and other anxiety disorders) showed selected benefits of antidepressants appear to outweigh risks of suicide attempts. Variations occurred depending on age, severity, and study characteristics. This follow recent news that prescriptions for antidepressants declined after revisions in FDA labeling and media coverage of suicide attempts....
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News: Medication choices for treating bipolar
A double-blind, placebo-controlled study (N=366) appearing in the on-line New England Journal of Medicine reports that, as an adjunct to mood stabilizers, anti-depressants added no more benefit than a placebo to people diagnosed with bipolar disorder. Work was conducted by a consortium of medical schools in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), sponsored by the National Institute of Mental Health....
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