Healthy Skepticism Library item: 811

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Publication type: news

Harris G, Carey B.
Senator charges FDA interceded for drug: Grassley says agency asked Canada not to ban Adderall XR
The New York Times 2005 Feb 11

Full text:

Officials at the Food and Drug Administration asked Canadian regulators to refrain from suspending the use of the hyperactivity drug Adderall XR, because the FDA could not handle another “drug safety crisis,” according to Sen. Charles Grassley, R-Iowa, who said Thursday that he based his claims on reports from whistle-blowers in the FDA.

Dr. Robert Peterson, director general of the therapeutic products directorate at Health Canada, said through a spokeswoman that the reports “are untrue.”

Brad Stone, a spokesman for the FDA, said, “We believe the Canadian response is the correct one.”

Canadian health officials, citing 20 deaths among patients taking Adderall XR, announced Wednesday night that they were suspending sales of the hyperactivity drug indefinitely. The FDA is allowing the drug’s sales to continue in the United States, saying there is little evidence that Adderall XR caused the deaths.

Grassley, who has been investigating the FDA for about a year, demanded in a letter written Thursday that the FDA answer questions about any discussions with the Canadians over the drug.

Dr. Robert Temple, director of the FDA office of medical affairs, said its Adderall decision was not influenced by the controversies swirling around the agency. “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,” Temple said.

Matthew Cabrey, a spokesman for Adderall’s maker, Shire Pharmaceuticals, said that 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.”

The controversy — and the sudden appearance of Grassley, the chairman of the Senate Finance Committee, in it — promises to engulf the agency in more questions about its oversight of the pharmaceutical industry. Critics have accused agency officials of being too cozy with drugmakers and being slower than international counterparts 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’ long-term 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 XR in the United States last year and $10 million in Canada.

In a letter dated Thursday to the FDA, Grassley wrote that reports given to his staff suggested the agency was not acting with scientific integrity. “Unfortunately, such allegations raise additional concerns about the culture at the FDA,” he wrote.

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, Peterson said. Canadian law allows regulators to suspend a drug’s sales while safety questions are investigated; U.S. 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 regulators 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 never before been reported to Canadian authorities, occurred well before Health Canada approved Adderall XR for sale, Peterson said.

Canadian law, like that in the United States, requires drug companies to report all adverse outcomes from drugs promptly.

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

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

Cabrey of Shire said the company forwarded reports of the deaths to Canadian authorities promptly.

Temple, the FDA medical affairs director, said seven 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.