Senator Says F.D.A. Asked Canada Not to Suspend ADHD Drug Spotlight on Adderall

"Senator Says F.D.A. Asked Canada Not to Suspend ADHD Drug Spotlight on Adderall"

" The controversy . . . promises to engulf the F.D.A. in more questions about its oversight of the pharmaceutical industry. "

[By Gardiner Harris And Benedict Carey, NY times.] http://www.nytimes.com/2005/02/11/politics/11drug.html?pagewanted=print&posi tion=

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.

Damned if they do, damned if they don't. There must be just as many articles out there complaining about FDA foot dragging as there are about reluctance to pull. Wasn't there legislation passed to force out a couple of drugs faster than planned by the FDA? Don'tcha love pressure groups?

One big fault I have with the article concerns this little statement [emphasis added]:

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.

Now I'm not sure if the heart thing was for Adderall or the other drugs, but it sounds like this might not be totally unexplained. Undiagnosed maybe, but not unexplained. Given a risk of heart problems as a known side effect of stimulants and a likelihood that congenital defects can go undiagnosed in an otherwise healthy and active child, shouldn't there be an imaging or ultrasound screening as part of the treatment protocol? And Heaven help us, now that I've said it, little Johnnie Edwards can restart his career based on that.

I often wondered if getting a CAT scan as part of a 50,000 mile physical (when insurance companies grudgingly pay for PSA tests and scoping) would be worth it. Heck, why wait until age 50? Scan at 40, at 30. Every once in a while a semi-trailer comes to city hall and will do a head to toe for $600 or focus on one of three areas for $200. That doesn't sound like that bad of an investment for a one-shot peace-of-mind screening. If it was commonplace, the cost would drop even lower. But a doc can't order it and keep his/her stats with the insurance company looking good. Might be nice to factor in a scan or two when funding your HSA.

But I believe the argument against such blanket screening is that there would be too many false positives and the cost wouldn't be justified due too the low probability of finding something. That's fine at a macro level in the government calculus of acceptable death rates. But it really sux at the personal level when you happen to be one of the "lucky" ones where something is found.

ADHD is a non-existent entity. Normal young male behavior has been pathologized, leading to a generation of normal young men being drugged in order to comply with a more feminized view of how they should behave. The drive to medicate these normal rambunctious boys has been spearheaded by several groups.

First of all, there is a pharmaceutical industry which has seen a whole new population of customers.

Secondly, there are child psychiatrists/psychologists who have to justify their existence by detecting and treating "disease"; when your only tool is a hammer, everything sooner or later begins to look like a nail.

Thirdly, there is the local school system largely consisting of young professional females educated in feminist college environments in which they are taught that they do not have to "tolerate" certain "undesirable" aspects of male behavior, and who therefore are alert to "nip in the bud" any boy who doesn't behave like a girl [as opposed to the days when school systems used to recognize that boys and girls are different and therefore would make allowances for normal boy behavior]; the parents are coerced by the school into drugging their sons.

And finally we find certain parents, who find that it is easier to drug their sons into submissive behavior rather than do the hard work of actually PARENTING. After all, when there is no Mom at home to actually mother the children, it's easier to just medicate them, isn't it?

Great observations; I agree with all your points.

shouldn't there be an imaging or ultrasound screening as part of the treatment protocol?

There's an excellent book by Mary Ann Block, an osteopath, on this exact thing in relation to ADHD. So many are so quick to drug without first doing a full physical workup to see if it's appropriate or necessary.

I tend to be an underconsumer of health care because my opinion is, if they start looking there's always something they can tweak that is just fine if you leave it alone and modify some lifestyle factor instead. I look for more holistic solutions than just test and drug, altho sometimes that is necessary too.

And speaking for the girls, if they act like boys with a high activity level they are targeted also. Additionally, common female social development leads to what many now diagnose as bipolar or depression. You know the scenario: the "today he loves me, tomorrow he's paying attention to that ditzy overdeveloped cheerleader and my life is ruined, I'm so ugly and unattractive and no one will ever date me" type girl whose whole life revolves around social success.

No child is allowed to grow up normal anymore when it's estimated that almost 20% of school-aged kids are on psychiatric drugs of one type or another for what are really common childhood behaviors.

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