51 deaths ADHD drugs ...

P.net!53ab2750!not-for-mail
From: "VERACARE"

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,
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
212-595-8974



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 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 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/fdc...o?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/fdc...o?targetAN=140
60125006 ). 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 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 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.

FAIR USE NOTICE: This may contain copyrighted (C ) material the use of
which
has not always been specifically authorized by the copyright owner.
Such
material is made available for educational purposes, to advance
understanding of human rights, democracy, scientific, moral, ethical,
and
social justice issues, etc. It is believed that this constitutes a
'fair
use' of any such copyrighted material as provided for in Title 17
U.S.C.
section 107 of the US Copyright Law. This material is distributed
without
profit.

Ilena wrote in message ...
P.net!53ab2750!not-for-mail
From: "VERACARE"


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



51 out of around 100,000 per year of miss-prescribed and errors is quite
insignificant.

"vernon" wrote in message
g.com...

Ilena wrote in message
...
P.net!53ab2750!not-for-mail
From: "VERACARE"


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



51 out of around 100,000 per year of miss-prescribed and errors is quite
insignificant.

EVERY death is significant.

MOST significant that the FDA concealed information from the public, and
WHY!

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
212-595-8974



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 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 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/fdc...o?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/fdc...o?targetAN=140
60125006 ). 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

vernon wrote:
Ilena wrote in message ...
P.net!53ab2750!not-for-mail
From: "VERACARE"


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



51 out of around 100,000 per year of miss-prescribed and errors is quite
insignificant.

You are mistaken in your interpretation of the numbers. The NY Times
reported that this was a study of five years of records, 1999 through
2003. The number of deaths is also incorrect.

"Twenty-five people died suddenly and 54 others suffered serious
unexplained heart problems while taking stimulant drugs like Ritalin
from 1999 through 2003, according to reports sent to federal drug
regulators."

Now, let's take a minute and analyze this. Twenty-five people died over
the course of 5 years. That averages to 5 deaths per year. The NYTimes
then reports that "...[a]bout 29 million prescriptions were written in
2004 for Ritalin, Adderall and similar drugs to treat attention deficit
disorder and hyperactivity, most of them for children."

Assume that the average prescription rate is *only* 25,000,000 per year.
Since these medications are Schedule II, which means that only a one
months supply can be written at a time, approximately 2,083,333 people
per month are, on average, being prescribed these medications.

Assume that all 5 deaths happened in the same month, and you wind up
with a rate of 2.4000003840000614400098304015729e-6.

Compare that with the odds of being struck by lightening:

http://www.lightningsafety.noaa.gov/medical.htm

My younger son attends a special school for physically handicapped
students. In the past three years, two classmates have died for no
apparent reason, the last being in December 2005. One of the kids in my
neighborhood died from running the bases. His father is a DDS and was at
the school at the time. He is trained in using a defibrillator and could
not resuscitate his son.

I would classify this report and just this side of relatively meaningless.

JanD wrote:
"vernon" wrote in message
g.com...
Ilena wrote in message
...
P.net!53ab2750!not-for-mail
From: "VERACARE"


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


51 out of around 100,000 per year of miss-prescribed and errors is quite
insignificant.

EVERY death is significant.

MOST significant that the FDA concealed information from the public, and
WHY!

The study took a while and had to be verified are reasons that come to
mind. Sorry you do not have one, a mind that is.

Diversion deleted. Jan cannot deal with facts, but must trash the FDA,
FTC and anyone who dares to disagree with her.

vernon wrote:
Ilena wrote in message
...
P.net!53ab2750!not-for-mail
From: "VERACARE"


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



51 out of around 100,000 per year of miss-prescribed and errors is quite
insignificant.

"vernon" wrote in message
g.com...

Ilena wrote in message
...
P.net!53ab2750!not-for-mail
From: "VERACARE"


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



51 out of around 100,000 per year of miss-prescribed and errors is quite
insignificant.

EVERY death is significant.

MOST significant that the FDA concealed information from the public, and
WHY!


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
212-595-8974



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 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 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/fdc...o?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/fdc...o?targetAN=140
60125006 ). 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

JanD wrote:
vernon wrote:
Ilena wrote in message
...
P.net!53ab2750!not-for-mail
From: "VERACARE"


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


51 out of around 100,000 per year of miss-prescribed and errors is quite
insignificant.

Instead of cutting and pasting, please attempt to address my comments:

You are mistaken in your interpretation of the numbers. The NY Times
reported that this was a study of five years of records, 1999 through
2003. The number of deaths is also incorrect.

"Twenty-five people died suddenly and 54 others suffered serious
unexplained heart problems while taking stimulant drugs like Ritalin
from 1999 through 2003, according to reports sent to federal drug
regulators."

Now, let's take a minute and analyze this. Twenty-five people died over
the course of 5 years. That averages to 5 deaths per year. The NYTimes
then reports that "...[a]bout 29 million prescriptions were written in
2004 for Ritalin, Adderall and similar drugs to treat attention deficit
disorder and hyperactivity, most of them for children."

Assume that the average prescription rate is *only* 25,000,000 per year.
Since these medications are Schedule II, which means that only a one
months supply can be written at a time, approximately 2,083,333 people
per month are, on average, being prescribed these medications.

Assume that all 5 deaths happened in the same month, and you wind up
with a rate of 2.4000003840000614400098304015729e-6.

Compare that with the odds of being struck by lightening:

http://www.lightningsafety.noaa.gov/medical.htm

My younger son attends a special school for physically handicapped
students. In the past three years, two classmates have died for no
apparent reason, the last being in December 2005. One of the kids in my
neighborhood died from running the bases. His father is a DDS and was at
the school at the time. He is trained in using a defibrillator and could
not resuscitate his son.

I would classify this report and just this side of relatively meaningless.

"JanD" wrote in message
news:z8OGf.544654$084.52893@attbi_s22...

"vernon" wrote in message
g.com...

Ilena wrote in message
...
P.net!53ab2750!not-for-mail
From: "VERACARE"


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



51 out of around 100,000 per year of miss-prescribed and errors is quite
insignificant.

EVERY death is significant.

Really?


MOST significant that the FDA concealed information from the public, and
WHY!

Concealed?

sure.
How would they conceal public knowledge.


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

FDA is a farce, O.K.

Long posts are purely by those who have no clue AND or are simple minded
trolls.

"Mark Probert" wrote in message
...
vernon wrote:
Ilena wrote in message
...
P.net!53ab2750!not-for-mail
From: "VERACARE"


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



51 out of around 100,000 per year of miss-prescribed and errors is quite
insignificant.

You are mistaken in your interpretation of the numbers. The NY Times
reported that this was a study of five years of records, 1999 through
2003. The number of deaths is also incorrect.

"Twenty-five people died suddenly and 54 others suffered serious
unexplained heart problems while taking stimulant drugs like Ritalin from
1999 through 2003, according to reports sent to federal drug regulators."

Now, let's take a minute and analyze this. Twenty-five people died over
the course of 5 years. That averages to 5 deaths per year. The NYTimes
then reports that "...[a]bout 29 million prescriptions were written in
2004 for Ritalin, Adderall and similar drugs to treat attention deficit
disorder and hyperactivity, most of them for children."

Assume that the average prescription rate is *only* 25,000,000 per year.
Since these medications are Schedule II, which means that only a one
months supply can be written at a time, approximately 2,083,333 people per
month are, on average, being prescribed these medications.

Assume that all 5 deaths happened in the same month, and you wind up with
a rate of 2.4000003840000614400098304015729e-6.

Compare that with the odds of being struck by lightening:

http://www.lightningsafety.noaa.gov/medical.htm

My younger son attends a special school for physically handicapped
students. In the past three years, two classmates have died for no
apparent reason, the last being in December 2005. One of the kids in my
neighborhood died from running the bases. His father is a DDS and was at
the school at the time. He is trained in using a defibrillator and could
not resuscitate his son.

I would classify this report and just this side of relatively meaningless.


That's what I said.

Ever wonder about how many die of no apparent reason?

From the little I have seen, it is sickening. Not a conspiracy, but lack of
involvement and laws to determine.

"vernon" wrote in message
g.com...

"JanD" wrote in message
news:z8OGf.544654$084.52893@attbi_s22...

"vernon" wrote in message
g.com...

Ilena wrote in message
...
P.net!53ab2750!not-for-mail
From: "VERACARE"


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



51 out of around 100,000 per year of miss-prescribed and errors is quite
insignificant.

EVERY death is significant.

Really?

Absolutely!!


MOST significant that the FDA concealed information from the public, and
WHY!

Concealed?

sure.
How would they conceal public knowledge.

Now, YOU are being a troll.


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

FDA is a farce, O.K.

Long posts are purely by those who have no clue AND or are simple minded
trolls.

Very Untrue!