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Public Citizen sues FDA
to ban antidepressant
After demanding that the Food and Drug Administration ban Serzone (nefazodone) in 2003, Public Citizen is suing the agency for failure to act.
The drug has already been banned by authorities in Canada and Europe because of its tendency to cause liver damage. Australia and New Zealand are initiating its withdrawal.
The product is marketed in the U.S. with a "black box" warning, but it is blamed for 33 cases of liver failure, including nine deaths between April 1, 2002 and May 12, 2003.
The drug interferes with metabolism increasing the toxicity level of other medications a patient may be taking.
Public Citizen March 15, 2004
Antidepressants have a history of being linked to suicide attempts, most recently in children.
More antidepressant news
A new Prozac study involved 440 teenagers, aged 12 to 17, who were diagnosed with moderate to severe depression. They were divided into four groups receiving a daily dose of Prozac, Prozac plus talk therapy, talk therapy alone, or a placebo.
The results released after 12 weeks: The talk therapy plus Prozac group had the best outcome with 71% having a good response. The Prozac only group came in second at 61%. Talk therapy alone produced a good response in 43% compared to 35% of the placebo group.
Results for the remaining 24 weeks of the study are not available at this writing making it premature to hail Prozac as the solution to teenage depression as many professionals in the field are doing. It is noteworthy, for instance, that there were five suicide attempts among those assigned to the two Prozac groups compared to one in the other two groups. Suicidal thoughts in all four groups were said to be lower in all groups than in similar untreated cases, however.
Prozac is the only anti depressant approved for teenagers in the UK.
The study was funded by the National Institute of Mental Health at a cost to taxpayers of $17 million.
Paxil, GlaxoSmithKlein's antidepressant, is the subject of a lawsuit brought by New York State Attorney General Elliot Spitzer. The suit has charged the company with suppressing four studies indicating the that the drug is unsuitable for teenagers in part because it instigates suicidal thoughts.
Gardiner Harris New York Times, June 1 /04
Jenny Thompson Health Sciences Inst. 6/14/04
Drug Researcher Imprisoned for FDA Fraud
Ann Campbell, MD, received a 57-month prison sentence and was ordered to pay $1.5 million in fines and restitution for fabricating research data in a drug trial for Aventis Pharma, Inc. The Gasden, Alabama doctor admitted using the names of people who had not participated in a study conducted to assess safety and effectiveness.
Reuters March 24, 2004
It is a simpler matter to falsify research on animals because they can't testify to the contrary.
FDA promotes statin drugs by ignoring or even banning
dietary cholesterol control
According to Jonathan V Wright, MD, holder of the Linus Pauling award for achievement in natural medicine, red yeast rice is an ancient food crop that has never been known to cause problems for humans. Because an extract from the rice contains a natural form of lovastatin, the active ingredient in Mevacor, the Food and Drug Administration has seen fit to ban an extract made from this plant, thus denying people the right to use a natural plant as opposed to one of the troublesome statin drugs (CivAb drug page Winter 03/04; Winter 02/03) .
Unlike synthetic drugs, natural plants with beneficial medicinal properties, like red yeast rice, cannot be patented. Marketing is therefore competitive, which keeps the price at a reasonable level. With no opportunity for a big profit in the offing, drug companies view such plants as unwelcome competition. The first time they sued for red yeast rice to be banned, the judge dismissed their case, but they appealed and won. The government immediately banned the product before its marketers could contest the appeal decision.
"New research suggests that a plant-based 'portfolio' diet can be as potent as statin drug treatment in improving plasma liquid profiles in hypercholesterolemic adults," according to an article in Nutrition Close Up Vol 20 No 4, "Plant-Based Diet Stands Up to Statins."
"For primary prevention, it is usually most prudent to attempt to improve your cardiovascular risk through sensible programs of diet and exercise," Dr Sidney M Wolfe, MD, writes in Worst Pills, Best Pills, April 2004 as a prelude to discussing common misconceptions about the role of statin drugs and the effect of cholesterol in relation to other factors affecting cardiovascular health.
He advises questioning your doctor if s/he recommends a cholesterol-lowering drug, particularly if you are over 70 or if the drug is being prescribed for primary prevention.
Abbott Laboratories raises price of AIDS drug five times
Abbott Laboratories announcement that it was raising the price of its AIDS drug, Norvir was followed by a chorus of objections. The price would remain the same outside the United States, but would increase from $1,500 a year to $7,800 within U.S. borders.
Considering that U.S. taxpayers had footed the bill for developing the drug, it seemed unfair to many that Europeans should pay only 10% as much as Americans. Abbott countered that it had to increase the price in order to raise money for more research.
Iowa Senator Charles Grassley (R) has introduced legislation that would allow drugs to be imported from other countries. Importation is supported by Senator John Kerry (D) and New York Senator Charles Schumer (D). The FDA warns of difficulty in controlling counterfeit drugs if these bills are passed.
Gardner Harris, New York Times Apr 14, 04
Clariton price raised 13 times
"The price of Schering-Plough's top selling drug Clariton was raised 13 times in 5 years for a cumulative increase of more than 50%--over four times the rate of general inflation."
Marcia Angell The New York Review of Books "The Truth About Drug Companies" July 15 2004 (reported by Tom Paine)
Cholesterol lowering drugs
by Martha Treichler, RD,CDN
There are three serious reasons to be cautious about taking cholesterol-lowering drugs.
(1) There are possible serious side effects for every type of cholesterol-lowering drugs. Listen to the disclaimers on the TV ads, and read the fine print in the magazine ads.
(2) There are multiple complex causes of heart disease, but the pharmaceutical companies' ads imply that all you have to do to avoid heart disease is to take their pills. The emphasis should be on eating a healthy diet and exercising appropriately.
(3) And, finally, who knows what the right cholesterol level is for any individual? Until a few years ago , doctors told us that a level of 250 or below was good. Now, no level is too low. Any research that indicates very low cholesterol levels might be dangerous, especially in the elderly, is ignored.
Return to spring/summer 2004 CivAb
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