Adderall Deaths - Canada Suspends ADHD Drug, FDA Disagrees
Linked to 20 deaths, Shire Pharmaceuticals' Attention Deficit and Hyperactivity Disorder drug Adderall was suspended by Health Canada, resulting in a ten per cent drop in the UK company's shares, according to a Bloomberg report.
The US FDA instead, citing their evaluation of Adderall before approval of the drug, says it has no plans to change the status of the drug in the United States.
This uncovers a fault in the regulation of pharmaceutical drugs: the absence of ongoing monitoring of the "performance" and especially the safety of drugs. Once approved, it appears that the FDA relies on voluntary reporting by the drug companies to tell it about side effects - a bit like having the fox guard the hen house.
According to Senator Grassley of Iowa, the US agency has even asked its Canadian counterpart not to suspend the drug. Grassley is quoted in the article, published in the New York Times, as saying 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."
Why is there such a difference in the treatment of the drug's safety problems by Canadian and US authorities? One reason may be a difference in the laws of the two countries, where Canadian legislation allows suspension of a drug while security concerns are investigated, while US law apparently does not support such a course of action.
Another reason is that there seems to be a much closer relation of the pharmaceutical industry and the FDA than there is to corresponding agencies in other countries. After all, the FDA is looked upon as a "lead agency" in drug approvals and drug safety. Expanding sale of drugs to other countries is much easier after FDA approval has been obtained.
That would presume that the FDA is upholding the highest standards on drug safety, which however does not seem to be the case. Perhaps the agency should take a cue from National Institutes of Health chairman Dr. Elias Zerhouni, who, according to the LA Times, says that consulting payments from drug companies are "a systemic problem" and asks for an ethics summit, a forum for wider discussion on conflicts of interest in medical research.
Shire Shares Fall After Canada Pulls Adderall XR Drug
Feb. 10 (Bloomberg) -- Shares of Shire Pharmaceuticals Group Plc, the U.K.'s third-biggest drugmaker, fell the most in two years after Canada ordered the withdrawal of its best-selling product, Adderall XR, after it was linked to at least 20 deaths.
Adderall XR, used to treat attention deficit hyperactivity disorder, had third-quarter sales of $140 million, more than 40 percent of Shire's revenue for the period. Shire, whose shares fell 10 percent, maintains the drug is safe and "strongly disagrees with the conclusions drawn by Health Canada,'' the Basingstoke, England-based company said today in a statement on Regulatory News Service.
Health Canada told Shire yesterday to take Adderall XR off the Canadian market, where it had sales of $10 million last year, based on information the company supplied about the deaths of 14 children and six adults. The drug remains available in the U.S., its biggest market, where regulators advised parents to consult their doctors before changing their children's medication.
"We do expect this to have a negative influence on U.S. sales,'' said Javier Latorre, a fund manager at Deutscher Investment Trust in Frankfurt, which has about 56 billion euros under management. "What we do find astonishing is that two regulators have come to different conclusions on the basis of the same data.''
Shares of Shire fell 64.5 pence to 577.5 pence at the close of trading in London. The 10 percent drop was the steepest percentage decline for the shares since January 2003.
Drug Safety Concerns
The U.S. Food and Drug Administration has allowed the drug, sold as Adderall in the U.S., to remain on the market with a revised label warning against its use in patients with heart conditions.
"I think for kids who are stable on these medications and who don't have cardiac problems, there's no reason to make an immediate change,'' said David Fassler, 48, a professor at the University of Vermont College of Medicine in Burlington and a child and adolescent psychiatrist. "However I expect there will be parents who have questions and concerns.''
Some doctors may "alter their prescribing patterns until they have more information,'' he said.
Drug safety is getting increased attention since Merck & Co.'s Vioxx painkiller was withdrawn last September because of a link to heart attacks, prompting U.S. and European regulators to assess the risks of all painkillers in the same class.
'Climate Is changing'
"I do think the climate is changing,'' Fassler said. "I think we are becoming more aware that the FDA has had less resources to devote to post-marketing surveillance. Most of the emphasis in recent years has been on the approval of new medications. My sense is that there may be a re-evaluation of that balance under way.''
Adderall, has about 24 percent of the market share for attention deficit hyperactivity disorder treatments, which are most commonly prescribed for children. Adderall is an amphetamine, which stimulates the central nervous system and can increase the heart rate. The drug isn't sold in Europe.
"Health Canada's decision comes as a result of a thorough review of safety information provided by the manufacturer, which indicated there were 20 international reports of sudden death'' in patients taking either Adderall or Adderall XR, the agency said.
"Although we are complying with this request we strongly disagree with this decision,'' Shire spokeswoman Jessica Mann said in an interview. "We have confidence in the safety and efficacy of Adderall XR.''
None of the reported deaths occurred in Canada, Health Canada said. Adderall XR has been sold in Canada for a year.
'Real Question'
"The real question is whether this suspension could spill over into the U.S.,'' Nomura International Plc analyst Frances Cloud wrote in a note to clients. "In our view, the risk of this is low since the FDA has already seen this data and only requested a labeling revision.''
Nomura raised its rating on Shire shares to "buy'' from "neutral'' today. Of 21 analysts who cover Shire, 16 have a "buy'' rating, two have "hold'' ratings and three rate the shares a "sell.''
The FDA is consulting with Canadian authorities on their action and plans no immediate changes to the drug's labeling or approved use, the agency said in a statement on its web site.
"At this time, FDA cannot conclude that recommended doses of Adderall can cause sudden unexplained death, but is continuing to carefully evaluate these data,'' the agency said on its web site.
The FDA said in a public health advisory that it had evaluated the risk of sudden death with Adderall before approving the drug for use in adults last year. The agency said it decided not to take action at this time because, "it does not appear the number of deaths reported is greater than the number of sudden deaths that would be expected to occur in this population without treatment.''
The FDA drew that conclusion from the rate of sudden death based on 30 million prescriptions written between 1999 and 2003.
To contact the reporter on this story: Angela Zimm
To contact the editor responsible for this story. Mark Rohner
Last Updated: February 10, 2005 11:51 EST
- - - - -New York Times:
Senator Says F.D.A. Asked Canada Not to Suspend Drug
By GARDINER HARRIS and BENEDICT CAREY
Published: February 11, 2005WASHINGTON, 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.
- - - - -
LA Times:
NIH Chief Calls for Ethics Summit
Dr. Elias Zerhouni, who banned drug company payments to agency scientists, wants a wider discussion on conflicts in medical research.
BETHESDA, Md. — The director of the National Institutes of Health — describing consulting payments from drug companies as a "systemic problem" that threatened the integrity of his agency — has called for a summit of government and academic leaders to address conflicts of interest throughout American medical research.Update 19 February: Here is the FDA's statement on Adderall. A nagging question in my mind: "What are children doing taking amphetamines, anyway?
FDA ALERT [2/9/2005]Sudden Deaths in Children
Health Canada has suspended marketing of Adderall XR products from the Canadian market due to concern about reports of sudden unexplained death (SUD) in children taking Adderall and Adderall XR. SUD has been associated with amphetamine abuse and reported in children with underlying cardiac abnormalities taking recommended doses of amphetamines, including Adderall and Adderall XR. In addition, a very small number of cases of SUD have been reported in children without structural cardiac abnormalities taking Adderall. At this time, FDA cannot conclude that recommended doses of Adderall can cause SUD, but is continuing to carefully evaluate these data.
This information reflects FDA's preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.
See also:
Adderall's Rollercoaster Year
For the past year, Shire has been a continuous rollercoaster ride. The company took a major tumble in February 2005, when Canadian health authorities pulled Adderall off the market due to reports of 20 sudden heart-related deaths and strokes in children and adults using the extended-release pill. Fourteen of the deaths were children and two of the 12 strokes were in children. The adverse events were reportedly not associated with drug overdose or misuse of the drug.Pills Become Addictive Study Aid For Students (Adderall)
Saturday, 01 April 2006
Amphetamines work like Cocaine -- first and foremost, they are addictive. The psychostimulant drugs prescribed for millions of American children labeled ADHD, are amphetamines and are, therefore, addictive.
posted by Sepp Hasslberger on Monday February 14 2005
updated on Friday December 3 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2005/02/14/adderall_deaths_canada_suspends_adhd_drug_fda_disagrees.htm
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