Which is it—51 or 186 deaths linked to ADHD drugs?

Reuters reports that sudden death, high blood pressure, heart attacks and strokes have been reported in people prescribed psychostimulants (i.e., amphetamines) for a controversial behavior disorder–ADHD–a disorder about which there is no consensus.

Why has the FDA concealed from the public 51 deaths from ADHD drugs until now?

"Through 2003, 24 deaths were reported from 1999 through 2003 among U.S. patients who took Adderall for ADHD, the FDA staff report said. The agency excluded cases that appeared linked to intoxication from multiple drugs or other causes.

Another 16 deaths were reported through 2003 in U.S. patients who took Ritalin or other ADHD drugs known as methylphenidates, the report said. Eleven deaths were reported among other drugs besides Adderall in the amphetamine class, it said."

"Conclusions about the relative safety of these two stimulant therapies cannot be made on the basis of this analysis," the FDA staff said.

Evidence of the FDA’s failure for well over a decade to protect children’s lives from unsafe, widely misprescribed drugs used to control behavior–as opposed to treat illness–can be analyzed by counting the preventable  human casualties.

The FDA is convening a long overdue Advisory Committee meeting  to address the death toll from ADHD drugs–the very same class of drugs that the Drug Enforcement Agency is at "war" with when consumed without a doctor’s prescription.

How many parents have been informed that the drugs they feed their child to get him (ADHD drugs are mostly prescribed for boys) to sit still and pay attention–are in the same family as the drugs former First Lady, Nancy Reagan campaigned against urging kids to "just say NO."

Parents should be taught to tell doctors who are quick to prescribe psychotropic drugs for children to "Just say NO."

AHRP board member, Allen Jones, will be testifying  about undisclosed conflicts of interest that undermine the integrity of FDA’s advisory committees.

The advisory panel members’ undisclosed conflicts of interest demonstrate the FDA’s complicity in putting financial interests above safety. And it demonstrate’s FDA officials’ disregard for federal conflicts of interest requirements.  It is, perhaps, not just a coincidence that while still under investigation, former FDA Commissioner, Lester Crawford, has joined a lobbying group that promotes food and drug industry interests.
 
Elen Liversidge will be testifying on behalf of the thousands of famileis whose children are casualties of psychotropic drugs–stimulants, antidepressants, and antipsychotics–all of which are dangerous and toxic.  It might be more effective if these drugs don’t just carry a black box, but a scull and bones.

 
Contact: Vera Hassner Sharav
veracare@ahrp.org
 

http://abcnews.go.com/US/print?id=1595545

FDA reports 51 deaths of attention drug patientsReuters

WASHINGTON – Deaths of 51 U.S. patients who took widely prescribed drugs to treat attention deficit disorder prompted regulators to start watching for heart attacks, high blood pressure and other problems in 2004, a report released on Wednesday said.

The U.S. Food and Drug Administration staff did not say the drugs were responsible for the fatalities, but they urged close monitoring for "the rare occurrence of pediatric sudden death during stimulant therapy."

"These reports themselves do not establish a causal relationship between these medications and cardiovascular adverse events," wrote Dr. Gerald Dal Pan, director of the FDA’s Office of Drug Safety, in a separate notice on the agency Web site.

The information was released one day ahead of an FDA advisory panel meeting on how best to study potential risks from the drugs, which include Shire Pharmaceuticals Group Plc’s Adderall and Novartis AG’s Ritalin.

FDA staff scientists and experts will provide updated information at the meeting about serious health problems that have been reported, the agency said.

Use of drugs to treat attention deficit hyperactivity disorder, or ADHD, was controversial before the cardiac issue emerged, with many doctors and parents arguing the medicines are overprescribed.

The FDA said it decided to seek input from an advisory panel after reports of sudden death, high blood pressure, heart attacks and strokes among some of the millions of adults and children who have taken the medicines.

Through 2003, 24 deaths were reported from 1999 through 2003 among U.S. patients who took Adderall for ADHD, the FDA staff report said. The agency excluded cases that appeared linked to intoxication from multiple drugs or other causes.

Another 16 deaths were reported through 2003 in U.S. patients who took Ritalin or other ADHD drugs known as methylphenidates, the report said. Eleven deaths were reported among other drugs besides Adderall in the amphetamine class, it said.

"Conclusions about the relative safety of these two stimulant therapies cannot be made on the basis of this analysis," the FDA staff said.

Thirty additional deaths of methylphenidate patients were recorded but they were either non-U.S. cases or occurred outside the review period, the report said.

Shire spokesman Matthew Cabrey said data have not shown any correlation between Adderall and the sudden deaths reported among children. He said the company supports the FDA’s review of the matter.

Health Canada temporarily suspended Adderall sales last year after 20 reports of sudden death in people who took it. The agency allowed Adderall back on the market after concluding it could not prove the drug was more risky than other therapies.

Novartis said its own review found no increased risk of cardiovascular problems in patients who took methylphenidates compared with the general population.

The FDA also has been studying if ADHD drugs may be related to psychiatric problems.

Republican Sen. Charles Grassley charged the FDA had taken a "disjointed" approach to the drugs over the past year. In a letter to the agency, the Iowa Republican suggested a "comprehensive" review of all ADHD medicines.

Shares of British firm Shire fell 3.2 percent to 890.2 pence in London trading. Novartis shares gained 5 cents to close at $54.70 on the New York Stock Exchange.

Copyright 2006 Reuters News Service. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Copyright © 2006 ABC News Internet Ventures

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THE PINK SHEET   
February 07, 2006
Number 004
Grassley Mows Down FDA Handling Of ADHD Drug Safety

Senate Finance Committee Chairman Chuck Grassley (R-Iowa) is urging FDA to conduct a comprehensive review of side effects associated with attention deficit/hyperactivity disorder drugs.
In a Feb. 7 letter to Acting FDA Commissioner Andrew von Eschenbach, Gr! assley acknowledges that the agency is taking steps to discuss safety concerns related to ADHD drugs, but says that the planned advisory committee meetings are inadequate.

On Feb. 9, FDA’s Drug Safety Risk Management Advisory Committee will discuss cardiovascular events associated with ADHD drugs. On March 22, the Pediatric Advisory Committee will discuss neuropsychiatric adverse events in the pediatric ADHD population.
 [Editor’s note: To 1sign up for a webcast <http://www.fdaadvisorycommittee.com/>  or order a video/DVD of these meetings, visit FDAAdvisoryCommittee.com.]

Grassley said he remains "concerned that lost between the two meetings is a comprehensive review of all adverse events for this entire class of medication for all populations served."
He called FDA’s actions thus far "ad hoc and disjointed."

Additionally, Grassley added, "While both psychiatric and cardiovascular risk signals have cropped up across this class of drugs this past year, it appears that FDA is just now beginning to ‘discuss approaches’ for studying these risks."

In June 2005, the committee concluded that reports of suicidality with Johnson & Johnson’s Concerta and other methylphenidate products did not constitute a new signal for concern.
In September, FDA issued a public health advisory on suicidal thinking in children and adolescents taking Lilly’s Strattera for ADHD. The agency said it would not add a warning to other ADHD products pending an analysis of post-marketing adverse events from those products (2"The Pink Sheet" DAILY, Sept. 29, 2005 <http://www.thepinksheetdaily.com/fdcreports/story/viewStory.do?targetAN=14050929002> ).

"I question why it has taken nearly an entire year for FDA to begin to address these concerns, given the serious nature of the adverse events associated with these drugs," Grassley said.
FDA’s Psychopharmacologic Drugs Advisory Committee will convene March 23 to review a pending ADHD drug, Cephalon’s Sparlon (modafinil), which has the same active ingredient as Cephalon’s sleep disorder therapy Provigil (3"The Pink Sheet" DAILY, Jan. 25, 2006 <http://www.thepinksheetdaily.com/fdcreports/story/viewStory.do?targetAN=14060125006> ). One topic the committee will likely address will be how to distinguish Sparlon from other ADHD drugs with regard to potential safety issues.
-Kathleen Michael
   
Contents copyrighted © F-D-C Reports, Inc. 2006; protected by U.S. Copyright Law.
   
Former FDA Chief Joins Lobby Shop
By Marc Kaufman
Washington Post Staff Writer
Wednesday, February 8, 2006; A06

Former Food and Drug Administration commissioner Lester M. Crawford, whose
sudden resignation last fall after less than three months in office remains
a mystery, has joined a lobbying firm that specializes in food and drug
issues.

Crawford is listed as "senior counsel" to the firm Policy Directions Inc.
Among the companies and organizations listed as clients are Altria Group
Inc. (formerly Philip Morris Companies), Merck & Co. Inc., the
Pharmaceutical Research and Manufacturers of America (PhRMA,) the Grocery
Manufacturers of America and the American Feed Industry Association. A
spokesman for the firm said neither Crawford nor anyone else wished to
discuss his appointment.

When he resigned in September, Crawford said simply that it was time for
someone else to lead the agency. Sens. Mike Enzi (R-Wyo.) and Edward M.
Kennedy (D-Mass.) have asked the Department of Health and Human Services
inspector general to look into whether Crawford resigned because of an
undisclosed financial conflict of interest.

Laura Bradbard, spokeswoman for the office, said yesterday that the
investigation is ongoing and that her office has subpoenaed information from
three financial firms used by the former commissioner.

Crawford is barred from lobbying former colleagues at the FDA for a year,
but he can give clients strategic advice about food and drug issues and can
lobby members of Congress.

Policy Directions was founded by Frankie L. Trull, a prominent defender of
animal testing for medical research and critic of animal rights groups. On
its Web site, the company says Crawford joined last month but gives no
indication what his role will be.

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