Drug Makers Kept Many Clinical Trial Results A Secret: Studyhttp://pharmalot.com/drug-makers-kept-many-clinical-trial-results-a-secret-study/Thirty-five percent of all trial results for 15 drugs that were approved in 2012 by the Food and Drug Administration were not publicly disclosed. And nearly 30 percent of the trials conducted for those drugs failed to meet legal disclosure requirements.
“This confirms that pharmaceutical companies often fall below legal and ethical standards,” said Jennifer Miller, an assistant professor in the Division of Medical Ethics at the NYU School of Medicine and a co-author of the study, (
http://bmjopen.bmj.com/content/5/11/e009758.full?sid=ae78878f-12f0-41a0-8852-45a390a9c0a2) which was published in BMJ. The study examined 318 clinical trials involving almost 100,000 participants.
The findings come amid growing clamor from academics and consumer groups to press drug and device makers to release trial data. If research is not published or reported in accessible registries, physicians and patients are prevented from having a complete picture of the risks and benefits of medicines.
Was Swine Flu A False Pandemic? Pharmalot From the famous Pharmalot blog by Ed Silverman (formerly a reporter at the Newark Star Ledger):
http://anthraxvaccine.blogspot.com/2010/01/was-swine-flu-false-pandemic-pharmalot.html That’s the contention by more than a dozen members of the Parliamentary Assembly of the Council of Europe, which reportedly plans to conduct an inquiry into the influence that drugmakers may have had on the World Health Organization, scientists and governments. A resolution was introduced last month by Wolfgang Wodarg, a member of Germany’s Social Democratic Party who chairs the PACE health committee, and it reads:
“In order to promote their patented drugs and vaccines against flu, pharmaceutical companies have influenced scientists and official agencies, responsible for public health standards, to alarm governments worldwide. They have made them squander tight health care resources for inefficient vaccine strategies and needlessly exposed millions of healthy people to the risk of unknown side-effects of insufficiently tested vaccines. The birds flu campaign (2005-06) combined with the swine flu campaign seem to have caused a great deal of damage not only to some vaccinated patients and to public health budgets, but also to the credibility and accountability of important international health agencies. The definition of an alarming pandemic must not be under the influence of drugsellers.”
Wodarg contends that WHO standards forced governments to react by signing contracts and, consequently, taking almost all responsibility thereafter. “In this way, the producers of vaccines are sure of enormous gains without having any financial risks. So they just wait until WHO says ‘pandemic’ and activate the contracts,” Wodarg, who intends to hold an emergency debate this month, tells PharmaTimes. “The victims among millions of needlessly vaccinated people must be protected by their states, and independent scientific clarification should provide evidence and transparency for national and, if necessary, European courts.”
Posted by Meryl Nass, M.D. at 12:07 AM
