[CO-CURE] Speed kills - Ritalin deaths

[Guest guest]

In a message dated 2/9/2006 9:30:49 PM Eastern Standard Time, writes:

[This may be of interest, given that a recent study appeared

on Co-Cure that asked " Does methylphenidate reduce the symptoms

of chronic fatigue syndrome? " Methylphenidate is the generic name

for Ritalin. See

http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0601E & L=CO-CURE & P=R2048

for more information on this study.]

From: " VERACARE " <veracare@...>

Date: Thu Feb 09, 2006 06:03:11 AM US/Eastern

" VERACARE " <veracare@...>

Subject: 51 deaths ADHD drugs_Sen. Grassley " Mows Down FDA Handling of ADHD

Drug Safety_Crawford joins lobbying group

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

FYI

Children have been dying as the FDA looked the other way: 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,

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, , 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

212-595-8974

veracare@...

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 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. 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 C 2006 ABC News Internet Ventures

<http://www.thepinksheetdaily.com/NR/FDC/images/pdly/print_masthead.gif>

THE PINK SHEET

February 07, 2006

Number 004

Grassley Mows Down FDA Handling Of ADHD Drug Safety

14060207004

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 von Eschenbach,

Grassley 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

& '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=140

50929002> ).

" 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=14060

125006> ).

One topic the committee will likely address will be how to

distinguish Sparlon from other ADHD drugs with regard to potential safety

issues.

-Kathleen

Contents copyrighted C 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 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 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.

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 ie 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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understanding of human rights, democracy, scientific, moral, ethical, and

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mjh

" The Basil Book "

http://foxhillfarm.us/FireBasil/

[Guest guest]

Thema: [ ] [CO-CURE] Speed kills - Ritalin deaths 

Datum: 10.02.06 04:07:29 (MEZ) Mitteleuropäische Zeit

Von: foxhillers@...

Beantworten:

An: ADD_ADHD , orthomolecular ,

Million thanks Marilyn, you are back!

Hugs,

Katharina

Sincere regards,

Katharina