August 10, 2003
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Some things that I hadn't thought of in connection with the drug industry that came out recently in the New York Times...
http://www.nytimes.com/2003/08/07/health/07DEPR.html?th
-GlaxoSmithKline, for instance, has acknowledged that just one of its nine studies of Paxil in children and adolescents has been published — a study that made only passing mention of suicide and concluded that the drug was effective against depression. According to the F.D.A., the combined results of all nine trials show that the drug is not effective against depression in patients under 18. Of the S.S.R.I.'s, only Prozac is approved by the F.D.A. to treat depression in children and teenagers, although doctors also widely prescribe the others.
-Dr. Graham Emslie, a professor of psychiatry at the University of Texas Southwestern Medical Center who was a researcher in four of GlaxoSmithKline's studies of Paxil, said he suspected that the other studies went unpublished at least in part because the results were unfavorable.
-"Some of these studies were finished a couple of years ago," Dr. Emslie said. "But negative trials tend not to get published."
-Dr. Perera, the GlaxoSmithKline official, said that publishing studies "takes time." He declined to say if the company would seek to publish the eight Paxil studies that have not appeared in journals.
-According to Dr. Emslie, other companies have withheld negative studies of S.S.R.I. 's. "I know of at least a half-dozen other studies of antidepressant treatments in children and adolescents that have been completed but as yet have not been published," he said. "More than enough time has passed for these to be published at least in abstract form." He refused to identify the companies or the drugs involved because he, like other researchers involved in similar research, has signed contracts promising secrecy.
-With negative results not disclosed, researchers and physicians often believe that drugs are more effective and safer than they actually are, according to Dr. Marcia Angell, a former editor of The New England Journal of Medicine. "It changes the way medicine is practiced," Dr. Angell said.
-"There is simply no scientific evidence whatsoever, no placebo-controlled double- blind study, that has established a cause-and-effect relationship between antidepressant pharmacotherapy of any class and suicidal acts or ideation," said Dr. Charles B. Nemeroff, a professor of psychiatry at Emory University who worked as a consultant and spoke on behalf of Lilly.
-In an interview, Dr. Nemeroff said he believed that his statement was accurate then and remains so, since he has not seen any published study to contradict it.
Not seen any published study which contradicts the drugs efficacy &safety? I wonder why? Could it be that the results of those unpublished studies were so full of detrimental information to the profitability of the drug companies that it benefited them not to publish those; only publishing those which produced favorable results? And my doctor wonders why I stopped all my anti-depressants?!
Often, public monies pay for the drug research. How about if the data of all studies performed under public research grant funding be released upon completion of the studies?
Drug price-gouging: http://www.nytimes.com/2003/08/07/business/07DRUG.html&OQ=th
-But the growing disparity between American and foreign drug prices has led to a surge of sentiment against the industry in Congress — even among Republicans, who have been the recipients of most of the drug makers' campaign contributions. The industry has become the largest contributor to federal political campaigns, donating about $21 million to parties and candidates during the 2002 election, according to the Center for Responsive Politics.
Fed govt pays lots to pharmaceutical research, so why do drug companies say they need to recoop costs in exhorbitant drug prices with long-term patents they refuse to give up?
A possible Medicare drug benefit solution would be if pharmaceutical companies charge Medicare 30% above what they'd sell the drug to the wholesalers for. Obviously, if the drugs can be sold by Canada at a profit, buying them from the wholesalers, which still garners the pharmaceutical companies enough profit to pay for their research, etc, where's the problem with selling the drugs here at a reasonable price?
As I said, much research is funded by public monies: http://www.nytimes.com/2003/08/07/opinion/07THU3.html?th
-Several years ago Dr. Varmus's group issued an open letter, signed by some 30,000 colleagues, calling on the publishers of scientific journals to make their archived rsearch articles freely available online. Most journals declined, so they would not undercut the profitable business of selling expensive subscriptions to libraries. But there is a basic inequity when much of the research has been financed by public money.
It's about time!
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