October 15

Senator Says FDA Asked Canada NOT to Suspend Adderall, Drug used for ADHD – NYT

Senator Says FDA Asked Canada NOT to Suspend Adderall, Drug used for ADHD – NYT

Fri, 11 Feb 2005

The New York Times reports that not only has the FDA failed to act to protect children and adults from a drug that has been linked to about 20 sudden deaths, but the FDA attempted to stop Health Canada from withdrawing the drug, Adderall, an amphetamine, from the Canadian market.

Canadian officials were guided in their decision to withdraw the drug, by the evidence (fatalities):

“It’s very difficult to generate a benefit-to-risk balance when the risk is sudden and unexpected death.”

FDA officials, by contrast, repeatedly demonstrate greater concern for industry’s interests than safety considerations. The NYT quotes Dr. Robert Temple of the F.D.A. "There is little evidence that the drugs caused any of the deaths." Dr. Temple always seems to side against the cautionary principle of medicine–"First, do no harm."

FDA officials always seems to find arguments against linking evidence of deadly events to the drug in question: "There is a tendency to believe that sudden death doesn’t occur in children. That is wrong.” Dr. Temple added: “Psychiatrists say that these drugs are needed."

The reason "psychiatrists say these drugs are needed" is that psychiatry has failed to develop non-drug treatment alternative options. Psychiatrists have become 100% dependent on psychotropic drugs. This dependency has led to a disturbing symbiotic relationship between the psychotropic drug manufacturers and the prescribers of these drugs. Both psychiatry and the drug industry have a primary stake in promoting the extensive use of drugs – even when the scientific evidence shows the drugs pose unjustifiable risks of harm.

Senator Chuck Grassley, chairman of the Senate Finance Committee, in the letter Thursday to the F.D.A. wrote that reports given to his staff suggested that the agency was not acting with scientific integrity.

Indeed, that lack of scientific integrity was also demonstrated when the FDA stilthily changed its recently issued warning (October 15, 2004) on antidepressant drug labels – without any scientific justification.

Dr. Steve Romano, Pfizer vice-president announced during court proceedings in which the antidepressant Zoloft figures prominently, that the FDA had rescinded the statement acknowledging: “A causal role for antidepressants in inducing suicidality has been established in pediatric patients.”

That clear statement of causality reflects a deliberative, scientifically arrived at conclusion. FDA’s recsinding of the agreed upon language (issued on October 15) blurs the clarity and reduces the impact of the Black Box warning.

Once again, FDA officials demontrate an unconscionable disregard for safety issues in an effort to accommodate the drug industry sustain its profit margins – even if children’s health and lives are sacrificed.

Contact: Vera Hassner Sharav


February 11, 2005
Senator Says F.D.A. Asked Canada Not to Suspend Drug

WASHINGTON, Feb. 10 – A day after Canadian officials suspended the use of a hyperactivity drug amid reports of deaths associated with its use, Senator Charles E. Grassley of Iowa contended that United States health officials had asked the Canadian regulators not to do so.

Senator Grassley, a Republican, said on Thursday that the Food and Drug Administration had made the request of Canadian health officials because the F.D.A. could not handle another “drug safety crisis.” Mr. Grassley said he was basing his contentions on reports from whistle-blowers within the agency.

Dr. Robert Peterson, director general of the therapeutic products directorate at Health Canada, said through a spokeswoman that reports that F.D.A. had asked Health Canada to refrain from suspending the drug “are untrue.”

Brad Stone, a spokesman for the F.D.A., declined to respond directly to Mr. Grassley’s contention but said of Dr. Peterson’s rejection that, “We believe the Canadian response is the correct one.” Canadian health officials, citing 20 deaths among patients taking the British-made drug Adderall XR, said on Wednesday night that they were suspending sales of the hyperactivity drug indefinitely. The F.D.A. is allowing the drug to continue to be sold in the United States, saying there is little evidence that Adderall XR caused the deaths.

Mr. Grassley, who has been investigating the Food and Drug Administration for about a year, demanded in a letter written on Thursday that the agency answer questions about any discussions its officials may have had with the Canadians about the drug.

Dr. Robert Temple, director of the F.D.A.’s office of medical affairs, said the agency’s decision to permit the continued sale of Adderall was not influenced by the controversies swirling around the F.D.A.

“It’s still our job to get as close as we can to the right answer and not panic and do things for the wrong reasons,” Dr. Temple said.

Matthew Cabrey, a spokesman for the maker of Adderall, Shire Pharmaceuticals Group of Britain, said Adderall was safe and effective. “We are very surprised at the actions of Health Canada, and we disagree with their interpretations of the data around these extremely rare cases of sudden death,” Mr. Cabrey said.

The controversy – and the sudden appearance of Mr. Grassley, the chairman of the Senate Finance Committee, in it – promises to engulf the F.D.A. in more questions about its oversight of the pharmaceutical industry.

Critics have accused agency officials of being too cozy with drug makers and of being slower than their counterparts in other nations to acknowledge drug-safety problems.

The controversy is also bound to fuel a long-running battle over whether drugs like Adderall and Ritalin are overprescribed to children, and whether the drugs’ longterm risks have been adequately explored.

More than 700,000 Americans use Adderall and its extended release counterpart, Adderall XR. Shire sold $759 million of Adderall products in the United States last year and $10 million in Canada.

In the letter Thursday to the F.D.A., Mr. Grassley wrote that reports given to his staff suggested that the agency was not acting with scientific integrity.

“Unfortunately, such allegations raise additional concerns about the culture at the F.D.A.,” he wrote.

Dr. Peterson of Health Canada described discussions between the two regulatory bodies as “collegial.”

Differing health regulations govern the differing responses of the two agencies to the Adderall reports, Dr. Peterson said. Canadian law lets regulators suspend a drug’s sales while safety questions are investigated; United States law does not. Health Canada approved Shire’s application to sell Adderall XR in January 2004. In September, the company reported to Canadian authorities that 20 people, 12 of them children, had died suddenly in the United States while taking the drug.

Shire asked the Canadian regulators for permission to change the drug’s label to reflect the possible dangers, as had been done in the United States that month.

Some of the deaths, which had not been previously reported to Canadian authorities, occurred well before Health Canada approved Adderall XR for sale, Dr. Peterson said.

Canada and the United States both require pharmaceutical companies to report all adverse outcomes from drugs promptly.

“We were surprised to find these cases,” Dr. Peterson said in an interview on Thursday.

Dr. Peterson said that an early analysis of the data suggested that Adderall XR might be linked to two to three times as many sudden deaths as Ritalin and its cousin, Concerta, which are prescribed for similar disorders.

Further, Dr. Peterson said that Canadian authorities were uncertain about how to warn patients about the risks of sudden death.

“It’s very difficult to generate a benefit-to-risk balance when the risk is sudden and unexpected death,” Dr. Peterson said.

Mr. Cabrey of Shire Pharmaceuticals said that the company had forwarded reports of the deaths to Canadian authorities promptly.

Dr. Temple of the F.D.A. said that 7 children taking Ritalin and Concerta died during the same period that 12 children taking Adderall died, suggesting equivalent risks. Many had structural problems with their hearts and several were engaged in vigorous exercise, he said.

There is little evidence that the drugs caused any of the deaths, he said.”There is a tendency to believe that sudden death doesn’t occur in children. That is wrong,” Dr. Temple said. He added: “Psychiatrists say that these drugs are needed. To get rid of them for something that may well be a background rate of death is not responsible.”Doctors have known since the 1930’s that stimulant medications like these can calm hyperactive, or aggressive, children. But no one knows precisely how the drugs induce this effect, and there have always been concerns about the drugs’ long-term effect on development.

Prescriptions for these drugs to be used by children with attention-deficit disorder more than doubled in the 1990’s, experts say, heightening the concerns of some doctors.

The drugs are far more popular in the United States than in Europe. Last year, doctors in the United States wrote more than 23 million prescriptions for the four most popular drugs used to treat attention deficit disorder.

Gardiner Harris reported from Washington for this article, and Benedict Carey from New York.

Copyright 2005 The New York Times Company

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