Stonewall the Profits

Warning Urged on Stimulants Like Ritalin

GAITHERSBURG, Md., Feb. 9 — Stimulants like Ritalin could have dangerous effects on the heart, and federal regulators should require manufacturers to provide written guides to patients and place prominent warnings on drug labels describing these risks, a federal advisory panel voted on Thursday.

The committee's action was unexpected. The Food and Drug Administration had convened the panel to help it determine how to research possible heart risks of the drugs. The agency had not asked the committee to address the drugs' labels, and agency officials seemed taken aback by the votes, saying they would not act on the committee's recommendations anytime soon...

The committee voted unanimously to recommend patient guides, and it voted 8 to 7 to suggest that stimulant labels carry the most serious of the agency's drug-risk warnings — a "black box."

"I must say that I have grave concerns about the use of these drugs and grave concerns about the harm they may cause," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and a panel member.

The votes came after F.D.A. medical officers described reports of 25 sudden deaths among people taking stimulants — the deaths were mostly children — and a preliminary analysis of millions of health records that suggested stimulants might increase the risks of strokes and serious arrhythmias in children and adults. The reports of sudden deaths never exceeded one in a million for any stimulant drug, although the F.D.A. usually receives reports of only a fraction of drug problems.

The preliminary analysis suggested that the stimulants might increase heart risks more than twofold. Such an increase may not be significant in children, whose heart risks are low, but could cause concern in adults, panel members said.

One of the drugs, Ritalin, has been marketed since 1955, and dozens of studies have shown it to be safe and effective. But no studies have been of sufficient duration or included enough participants to evaluate stimulants' long-term effects on the heart.

...Dr. Thomas R. Fleming, a professor of biostatistics at the University of Washington and a panel member, said stimulants might be far more dangerous to the heart than Vioxx or Bextra, drugs that were withdrawn over the past two years because of their ill effects on the heart...

Methylphenidate ( Ritalin ) is chemically related to amphetamine and has similar if less potent effects on the body and mind.

Adderall is amphetamine, and to suggest it has any different long term effects than amphetamine abuse is sheer marketing.

Drugs like these make hundreds of millions of dollars for drug companies every year. For this reason there is no incentive for drug companies, or physicians or psychologists or basic researchers who are financed by drug companies to examine their effects carefully. I imagine the FDA was taken aback alright.

But that's what happens when cardiologists get to examine data that psychologists feel is irrelevant, and why science works best when data is freely available for examination by all.