|Blog Archive: June 2003|
Note: Starting in 2003, blog updates will occur sporadically. I'm just too busy now to maintain a schedule of daily updates. Thanks for understanding.
Monday, June 23, 2003
Looks like Big Pharma has some competition in the business of lying, cheating, and corrupting science:
Studies of Dietary Supplements Come Under Growing Scrutiny
When a California judge handed down a $12.5 million false-advertising judgment against the maker of an ephedra-based weight-loss pill late last month, he also issued what amounted to a bill of reproach against the science of dietary supplements
The company, Cytodyne Technologies, maker of Xenadrine RFA-1, the supplement implicated in the death of a Baltimore Orioles pitcher, had not just exaggerated the findings of clinical trials it commissioned, Superior Court Judge Ronald L. Styn said in ruling on a class-action suit, but had also cajoled some researchers into fudging results in published scientific articles.
The evidence, Judge Styn said, had left him no alternative but to conclude that the researchers had set out to create a study that “justified the money being spent” by Cytodyne and would ensure that they received further work from the company.
The Cytodyne case is part of a swelling tide of litigation that is raising serious questions about the way makers of ephedra and other dietary supplements use – and often misuse – the promise of scientific proof to market their products.
Tuesday, June 17, 2003
Now Serzone is under the gun:
Health officials probe anti-depressant Serzone
EDMONTON, ALTA. – Health Canada is looking into problems with popular anti-depressant Serzone, which has been linked to more than 100 cases of serious liver damage.
Thursday, June 12, 2003
Looks like the U.S. Food and Drug Administration (FDA) will take a look at Paxil (called “Seroxat” in Britain) as a result of the report issued across the Atlantic:
Britain Warns of Paxil's Risk to Children
By Shankar Vedantam
The British government warned doctors yesterday against prescribing the antidepressant Paxil to children, spurring the U.S. Food and Drug Administration to confirm that it is conducting its own investigation into the safety of the drug for younger patients.
The British warning said the medicine appeared to increase the risk of suicide or suicidal thinking among children with depression.
The U.S. agency is examining the same studies that Paxil's manufacturer submitted to British authorities.
“There is data that has come to light that may be noteworthy,” said an FDA official yesterday, speaking on the condition of anonymity. “We will take whatever action is deemed appropriate to protect the public health.”
The FDA official gave no timetable for a decision, but said, “when you have a serious question like this, you want to do the analysis as quickly as possible.”
Is this the beginning of the end of the antidepressant era? I hope so, but I still think that safety issues are a bit of a red herring. Lack of effectiveness is (or should be) the main reason why we need to be skeptical of antidepressants. If the drug doesn't actually do what it's supposed to do, then why worry about safety?
Wednesday, June 11, 2003
Wow, Britain is really starting to crack down on antidepressants:
Britain Says Use of Paxil by Children Is Dangerous
The New York Times
British drug regulators warned yesterday that GlaxoSmithKline's popular antidepressant Paxil causes depressed children to become more suicidal and should not be prescribed for them.
That conclusion came from the combined results of nine studies on Paxil, known as Seroxat in Britain, that the company recently submitted to British regulators.
“It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks,” the statement from the British government's Medicines and Healthcare Products Regulatory Agency said. “The implications of the new pediatric data on the safety of paroxetine (Paxil) in the adult population remains under close review.”
Alan Metz, vice president for clinical development at Glaxo, said the company was not warning American doctors against using the drug for depressed children. He noted that Paxil was not approved in the United States for treating children but that many doctors prescribed the drug for children anyway.
($.lq$}It's difficult for me sitting here to tell doctors what they should do with their patients,($.lq$} Dr. Metz said.
Frankly, I don't really know what to make of all this. I haven't looked at the data. The whole point is moot, actually, when you stop to consider the fact that antidepressants don't really work, anyway. So if they're glorified placebos, and they might have some dangerous side-effects, then why use them at all?
Monday, June 9, 2003
More evidence that the mental-health industry has a long way to go:
Trauma counselling may do harm
By Helen Tobler and Julie Smith
Stress debriefing straight after a traumatic event does not help people and can do more harm than good, an expert has warned.
Sunday, June 1, 2003
Excellent article in Britain's Independent:
Drug firms profit from 'murky' link with journals, study shows
Companies are misleading doctors, patients and governments to push their medicines, says a special edition of the 'BMJ'
The “murky” relationships between the world's leading pharmaceutical companies, supposedly independent medical journals and family doctors are exposed in the British Medical Journal today. [...]
Experts for the BMJ analysed the way in which five antidepressant drugs were submitted to the Swedish authorities for marketing approval. As well as submitting “favourable” trials sponsored by the drugs companies themselves, the journal found that some studies were being submitted twice, or even three times, but in different publications so that the pile of evidence looked weightier. “Selective” submissions meant trials that did not strongly support the drugs were left out.
Skepticism from Down Under (the article appears on the website of the Australian Broadcasting Corporation):
ANALYSIS: Gaps revealed in antidepressant research
Some people might develop a form of tolerance to antidepressants over the long term, according to a controversial hypothesis by an Italian psychiatrist – but is there enough good science to prove him right or wrong?
In a recent issue of the Journal of Clinical Psychiatry, Dr Giovanni Fava of the University of Bologna in Italy, calls for more research to be done on the effects of the long-term use of antidepressants following his comprehensive literature review of their negative effects.
“Patients are encouraged more and more to take antidepressant drugs for longer periods of time,” said Fava, who is also attached to the State University of New York at Buffalo. “However, there is very little research on what actually happens with long-term treatment.”
In his review, Fava found a range of long-term effects, including loss of effectiveness and withdrawal symptoms. He also found evidence that the longer the period of treatment, the more likely the patient is to relapse into depression when they stop taking the drugs.
In my view, Fava is mostly barking up the wrong tree. The problems he cites are almost beside the point. The main problem with antidepressants is that they don't work any better than placebos.
© 2004 Alex Chernavsky email@example.com