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.

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.

Britain Warns of Paxil's Risk to Children

By Shankar Vedantam
Washington Post Staff Writer
Wednesday, June 11, 2003; Page A14

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.”

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.

Trauma counselling may do harm

By Helen Tobler and Julie Smith

02jun03

Stress debriefing straight after a traumatic event does not help people and can do more harm than good, an expert has warned.

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.

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.