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51 deaths ADHD drugs ...
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| Ilena Rose 2006-02-25, 9:41 pm |
| P.net!53ab2750!not-for-mail
From: "VERACARE" <veracare@ahrp.org>
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
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 C 2006 ABC News Internet Ventures
<http://www.thepinksheetdaily.com/NR...nt_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/fd...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/fd...do?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.
| |
| vernon 2006-02-25, 9:41 pm |
|
<Ilena> wrote in message news:ndkmu1p38hpgqnf01e7l2vcm86kqu1l54l@4ax.com...
> P.net!53ab2750!not-for-mail
> From: "VERACARE" <veracare@ahrp.org>
>
>
> 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" <here@here.com> wrote in message
news:43eb74a0$0$3228$9a6e19ea@unlimited.newshosting.com...
>
> <Ilena> wrote in message
> news:ndkmu1p38hpgqnf01e7l2vcm86kqu1l54l@4ax.com...
>
>
> 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
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 C 2006 ABC News Internet Ventures
<http://www.thepinksheetdaily.com/NR...nt_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/fd...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/fd...do?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
| |
| Mark Probert 2006-02-25, 9:41 pm |
| vernon wrote:
> <Ilena> wrote in message news:ndkmu1p38hpgqnf01e7l2vcm86kqu1l54l@4ax.com...
>
>
> 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.
| |
| Mark Probert 2006-02-25, 9:41 pm |
| JanD wrote:
> "vernon" <here@here.com> wrote in message
> news:43eb74a0$0$3228$9a6e19ea@unlimited.newshosting.com...
>
> 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:
"vernon" <here@here.com> wrote in message
news:43eb74a0$0$3228$9a6e19ea@unlimited.newshosting.com...[vbcol=seagreen]
>
> <Ilena> wrote in message
> news:ndkmu1p38hpgqnf01e7l2vcm86kqu1l54l@4ax.com...
>
>
> 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
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 C 2006 ABC News Internet Ventures
<http://www.thepinksheetdaily.com/NR...nt_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/fd...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/fd...do?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
| |
| Mark Probert 2006-02-25, 9:41 pm |
| JanD wrote:[vbcol=seagreen]
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.
| |
| vernon 2006-02-25, 9:41 pm |
|
"JanD" <JanD@insightbb.com> wrote in message
news:z8OGf.544654$084.52893@attbi_s22...
>
> "vernon" <here@here.com> wrote in message
> news:43eb74a0$0$3228$9a6e19ea@unlimited.newshosting.com...
>
> EVERY death is significant.
Really?
>
> MOST significant that the FDA concealed information from the public, and
> WHY!
Concealed?
sure.
How would they conceal public knowledge.
>
> AHRP board member, Allen Jones, will be testifying about undisclosed
> conflicts of interest that undermine the integrity of FDA's advisory
> committees.
FDA is a farce, O.K.
Long posts are purely by those who have no clue AND or are simple minded
trolls.
| |
| vernon 2006-02-25, 9:41 pm |
|
"Mark Probert" <markprobert@lumbercartel.com> wrote in message
news:tkQGf.51$u74.29@fe08.lga...
> vernon wrote:
>
> 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.
| |
| Twittering One 2006-02-25, 9:41 pm |
| "Committee consultant Steven Nissen (Cleveland Clinic) said that the
black box warning should include a statement that sympathomimetic
drugs, such as the ADHD drugs methylphenidate and amphetamine, have
been know to increase blood pressure, which may lead to heart attack,
stroke and sudden death. The warning should also address the
uncertainty of the data, Nissen said.
Nissen proposed the requirement of a black box and a medication guide
for the committee to vote on, in addition to a discussion of the formal
questions posed by FDA to the committee. The agency's questions
addressed future studies to evaluate the risk of cardiovascular events
with ADHD drugs.
However, Nissen said that the potential risk with the drugs is such
that the committee "can't just discuss future strategies."
Dr. Steve Nissen is The Best of The Best
when it comes to cardiovascular issues.
I formerly wrote for the National Lipid education Council.
and had ocassion to work with Dr. Nissen,
in my modest writerly capacity.
Anything Dr. Nissen says,
we should Hear.
As I have on usenet for years, under my other
AOL name, Virginiaz,
Adderall causes me cardio problems, eg
an irregular heart rhythm, and some serious
mood problems.
Dexedrine does NOT cause me those problems.
High BP can be controlled with adjuvant meds,
eg, for high blood pressure.
An irregular heart rhythm is more serious,
and requires more careful attention
and monitoring.
I have tried ALL the AD[Hi!]D meds,
except Cylert, now offer the market.
Ritalin, for me, was safe.
But Concerta presented, for me, some surges in BP
and anxiety, when the release in medicine surged
into my blood stream, as Concerta is designed
to precisely that. Concertal also cause me
some GI distress, because, I believe,
the capsule releases some of the medicine
as it passes through the lower GI system.
Also because the surge in medicine caused
a responsive anxiety-like IBS response, minor,
but for me, aggravating enough to feel uncomfortable.
All in all, I don't think Ritalin was harmful on
CV system, like Adderall.
Ritalin can irritate my skin, but the rashes
are not nearly as bad, as say, other medications
cause, a mere chemical irritant or drying effect.
But what works almost transparently for me
is Dexedrine.
My BP is higher off Dex, than on it, not
uncommon for people who respond positively
to an AD[Hi!]D medication.
My only real problem is rebound fatigue,
so I manage that with exercise, and other
personal judgements.
But Dexedrine, I feel normal.
I have no CV adverse effects.
I have no skin rashes, in fact, my skin inflammation
is better controlled.
I have no GI distress.
I have no over-speediness, an effect I can
sometimes experience on Concerta.
Dexedrine is perfect for me.
I NEED MY AD[Hi!]D MEDS
NOW NOW NOW!
As for Black Box labeling, I have not followed the data
recently, but labeling with cautionary info
is not terrible, if it allows patients to continue
using a medication that helps, with no
serious adverse effects.
Adults can make their own assessments of how
thy feel on a medication, but children often
cannot.
A teenager is old enough to make his/her own
decision. Younger kids may not be involved
in the decision.
Dexedrine makes my life and my chemically
over ~ sensitive body
A Better Place
To Be ~ !
"It let's Us be Us,
As Ms.
Clairol used to say ~ !
With much less aggravation,
Pain, & scratching,
But a tad more unencumbered
Imagination
For our pagination ~ !"
~ Twittering LSTOO & Folly IAG
| |
| Twittering One 2006-02-25, 9:41 pm |
| Without checking the data,
I suggest that Accutane might be just as dangerous.
| |
|
|
"vernon" <here@here.com> wrote in message
news:43ebedbe$0$2875$9a6e19ea@unlimited.newshosting.com...
>
> "JanD" <JanD@insightbb.com> wrote in message
> news:z8OGf.544654$084.52893@attbi_s22...
>
> Really?
Absolutely!!
>
>
> Concealed?
>
> sure.
> How would they conceal public knowledge.
Now, YOU are being a troll.
>
>
> FDA is a farce, O.K.
>
> Long posts are purely by those who have no clue AND or are simple minded
> trolls.
Very Untrue!
| |
|
|
"Mark Probert wrote:
> JanD wrote:
>
> 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.
So you say.
I take YOUR word for nothing.
>
> "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:
No, I don't think so.
This is a diversion, trying to justify the deaths.
>
> 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.
| |
|
|
"Twittering One" <twitteringone@aol.com> wrote in message
news:1139541505.278846.145360@g47g2000cwa.googlegroups.com...
> Without checking the data,
> I suggest that Accutane might be just as dangerous.
We aren't talking about *Accutane*
| |
| Brad_Chad 2006-02-25, 9:41 pm |
| If conventional doctors had any moral integrity, they would have at
least given all their ADHD patients a choice of either medication, or
help with finding their Hidden Food Sensitivities. Instead, they go
straight for the drugs. They don't tell their patients anything about
the Hidden Food Sensitivity controversy. What greedy wimps. They sold
their soul to the pharmaceutical companies.
Brad_Chad
| |
| vernon 2006-02-25, 9:41 pm |
|
"JanD" <JanD@insightbb.com> wrote in message
news:riWGf.788828$xm3.28346@attbi_s21...
>
>
> This is a diversion, trying to justify the deaths.
You really do have a problem with reality.
Justify???
| |
| vernon 2006-02-25, 9:41 pm |
|
"JanD" <JanD@insightbb.com> wrote in message
news:bnWGf.788863$xm3.769561@attbi_s21...
>
> "Twittering One" <twitteringone@aol.com> wrote in message
> news:1139541505.278846.145360@g47g2000cwa.googlegroups.com...
>
> We aren't talking about *Accutane*
YOU are not talking about anything relevant.
| |
| vernon 2006-02-25, 9:42 pm |
|
"Brad_Chad" <Brad_Chad62@yahoo.com> wrote in message
news:1139555727.985879.188590@g14g2000cwa.googlegroups.com...
> If conventional doctors had any moral integrity, they would have at
> least given all their ADHD patients a choice of either medication, or
> help with finding their Hidden Food Sensitivities. Instead, they go
> straight for the drugs. They don't tell their patients anything about
> the Hidden Food Sensitivity controversy. What greedy wimps. They sold
> their soul to the pharmaceutical companies.
>
> Brad_Chad
Pharms had nothing to do with it.
It's crass laziness along with putting up with idiotic mommies.
| |
| Bob Kaplow 2006-02-25, 9:42 pm |
| In article <tkQGf.51$u74.29@fe08.lga>, Mark Probert <markprobert@lumbercartel.com> writes:
> "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."
How many people died over the same period of Tylenol (or the many generic
equivalents) overdose? How many more suffered life threatening
complications, or are now on a wait list for an organ transplant from
Tylenol. And why aren't these same people SCREAMING to pull Tylenol off the
market.
--
Bob Kaplow NAR # 18L >>> To reply, there's no internet on Mars (yet)! <<<
Kaplow Klips & Baffle: http://nira-rocketry.org/Document/MayJun00.pdf
www.encompasserve.org/~kaplow_r/ www.nira-rocketry.org www.nar.org
You [should] not examine legislation in the light of the
benefits it will convey if properly administered, but in the
light of the wrongs it would do and the harm it would cause if
improperly administered -- Lyndon Johnson, former President of
the U.S.
| |
| Mark Probert 2006-02-25, 9:42 pm |
| JanD wrote:
> "vernon" <here@here.com> wrote in message
> news:43eb74a0$0$3228$9a6e19ea@unlimited.newshosting.com...
>
> EVERY death is significant.
Like the girl who was killed by her parents denial of the existence of
AIDS?
| |
| Mark Probert 2006-02-25, 9:42 pm |
| JanD wrote:
> "Mark Probert wrote:
>
> So you say.
>
> I take YOUR word for nothing.
Who said to take my word, although you would be wise to do so. I posted,
right below your asinine remark, a quote from a NYTimes article to
support my statement. IOW, I posted facts.
>
> No, I don't think so.
Yes, you do not think. However, in a risk assessment, comparison is a
valuable tool to see just what degree of risk is involved.
> This is a diversion, trying to justify the deaths.
Wrong. You raise a red herring. I am NOT trying to justify the deaths
simply because no one has said that there is a direct connection between
taking the medications and the deaths. What is reported is something
that someone believes is of statistical significance. My analysis
attempts to put that claim into a statistical perspective so that
intelligent people can make their own risk assessment.
[vbcol=seagreen]
Continuing...
For this statistical point to have significant clinical meaning, a study
must show that taking these medications actually increases the risk of
death. The point I made is that there are many "healthy" children who
die for no apparent reason, and to draw any conclusion from this current
report, other than more study and research is needed, is absurd.
Of course, Jan, I do not expect you to understand this as your agenda of
hating children, wanting them to have wasted lives, wanting to see sick
and dead children due to lack of vaccination, etc. will stand in your
way of reason.
| |
| Mark Probert 2006-02-25, 9:42 pm |
| vernon wrote:
> "JanD" <JanD@insightbb.com> wrote in message
> news:riWGf.788828$xm3.28346@attbi_s21...
>
> You really do have a problem with reality.
>
> Justify???
Jan's problem is that she is semi-illiterate and virtually totally
innumerate. She completely lacks any logical reasoning skills, and her
communication capability has not developed beyond cut'n'paste or one
sentence responses. She ran a day care center for 38 years, had Hulda
Clark's nefarious offspring in her midsts, and has the morality of a
Mengele.
| |
| Mark Probert 2006-02-25, 9:42 pm |
| vernon wrote:
> "Mark Probert" <markprobert@lumbercartel.com> wrote in message
> news:tkQGf.51$u74.29@fe08.lga...
>
> That's what I said.
Yeah, but not as well as I did... 
The numbers really do not add up very well.
> Ever wonder about how many die of no apparent reason?
Like I pointed out in the paragraph above, yes, on three occasions in
the past 2 years. One boy rode the bus with my younger son and they hung
out together outside of school. He did not wake up one morning.
One boy was the captain of my son's school's wheelchair basketball team.
No arms and two underdeveloped legs. He used one to operate the joystick
on his power chair, and the other, the longer of the two, for dribbling,
stealing and shooting. His mother thought he was sleeping on the school
bus when he came home from school.
The third is a neighborhood kid who had just finished running the bases
and died.
> From the little I have seen, it is sickening. Not a conspiracy, but lack of
> involvement and laws to determine.
It is very shocking for parents to sudden lose a child who is in
apparent good medical health. Sadly, even on autopsy, the actual cause
of death cannot often be determined. I know in the two cases where I
know the families well, they still do not know what happened. Both boys,
having physical disabilities, had been carefully examined and monitored
over the years.
| |
| Mark Probert 2006-02-25, 9:42 pm |
| JanD wrote:
> "Twittering One" <twitteringone@aol.com> wrote in message
> news:1139541505.278846.145360@g47g2000cwa.googlegroups.com...
>
> We aren't talking about *Accutane*
You may not be talking about it, but the discussion has expanded to
discuss the death of children.
| |
| Mark Probert 2006-02-25, 9:42 pm |
| Bob Kaplow wrote:
> In article <tkQGf.51$u74.29@fe08.lga>, Mark Probert <markprobert@lumbercartel.com> writes:
>
> How many people died over the same period of Tylenol (or the many generic
> equivalents) overdose? How many more suffered life threatening
> complications, or are now on a wait list for an organ transplant from
> Tylenol. And why aren't these same people SCREAMING to pull Tylenol off the
> market.
Damn, Bob, stop making sense.
APAP has one of the narrowest windows between "therapeutic" and "toxic"
of all medications. Several years ago, while I was in ICU after having
aspirated during a test, there was a girl in who was on life support
after ODing on APAP.
Assuming that the AD/HD medications pose a risk, the risk is barely
significant, and we will not know how significant, if at all, until it
is determined that the rate of death is adversely affected by the
medication, when compared to unmedicated people.
| |
| Mark Probert 2006-02-25, 9:42 pm |
| Brad_Chad wrote:
> If conventional doctors had any moral integrity, they would have at
> least given all their ADHD patients a choice of either medication, or
> help with finding their Hidden Food Sensitivities. Instead, they go
> straight for the drugs. They don't tell their patients anything about
> the Hidden Food Sensitivity controversy. What greedy wimps. They sold
> their soul to the pharmaceutical companies.
What a maroon.
| |
| Vashti 2006-02-25, 9:42 pm |
| It wasn't a dark and stormy night when Bob Kaplow wrote:
> How many people died over the same period of Tylenol (or the many
> generic equivalents) overdose? How many more suffered life threatening
> complications, or are now on a wait list for an organ transplant from
> Tylenol. And why aren't these same people SCREAMING to pull Tylenol
> off the market.
Um, cause these people have had a really bad headache at some point but
not ADHD?
Vashti
| |
|
| How the heck does anyone with ADHA read such a long Cut & Paste
POSTING? IT would take 30mg of AdderallRX for me to want to read such
a long Posting. Unfortunately, I an not on Adderall.
Nothing like not sleeping from 3 to 6 AM, then sleeping until 10 AM.
The being tired and sleepy all day. Falling asleep after a light
supper.
I live on coffee but it does not stop the sleepyness during the day.
I am an adult over 60, good physical condition, 14% body fat, exercise
4 times a week, eat healthy yet I am darn tired all the time.
OBTW, 25 or 50 out of 100,000 is NOT ALARMING! Wonder what the
DWI/death rate per 100,000 motor vehicle accidents?????
JanD wrote:
> "vernon" <here@here.com> wrote in message
> news:43eb74a0$0$3228$9a6e19ea@unlimited.newshosting.com...
>
> 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
> 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 C 2006 ABC News Internet Ventures
>
> <http://www.thepinksheetdaily.com/NR...nt_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/fd...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/fd...do?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" <here@here.com> wrote in message
news:43ec97ec$0$26542$9a6e19ea@unlimited.newshosting.com...
>
> "JanD" <JanD@insightbb.com> wrote in message
> news:riWGf.788828$xm3.28346@attbi_s21...
>
> You really do have a problem with reality.
>
> Justify???
You have a problem?
J U S T I F Y. Look it up.
| |
|
|
"vernon" <here@here.com> wrote in message
news:43ec9854$0$26542$9a6e19ea@unlimited.newshosting.com...
>
> "JanD" <JanD@insightbb.com> wrote in message
> news:bnWGf.788863$xm3.769561@attbi_s21...
>
> YOU are not talking about anything relevant.
Incorrect, that was "Twittering One".
Try to follow.
| |
|
|
"vernon" <here@here.com> wrote in message
news:43ec98b4$0$26542$9a6e19ea@unlimited.newshosting.com...
>
> "Brad_Chad" <Brad_Chad62@yahoo.com> wrote in message
> news:1139555727.985879.188590@g14g2000cwa.googlegroups.com...
>
>
> Pharms had nothing to do with it.
> It's crass laziness along with putting up with idiotic mommies.
Incorrect.
It is the DOCTORS.
YOU left out idiotic DADDIES!
Says a lot about YOU!
| |
|
|
"Bob Kaplow" <kaplow_r@encompasserve.org.mars> wrote
<snip diversion>
> , Mark Prober writes:
<snip diversion>
>
>
>
>
> --
> Bob Kaplow
| |
|
|
"Mark Probert blathered:
<snip diversion>
> Bob Kaplow wrote:
<snip diversion>
>Mark Probert <markprobert@lumbercartel.com> writes:
>
| |
|
|
"Mark Probert" <markprobert@lumbercartel.com> wrote in message
news:th1Hf.3$wY6.0@fe10.lga...
> JanD wrote:
>
> Like the girl who was killed by her parents denial of the existence of
> AIDS?
EVERY death is significant
| |
|
|
"Mark Probert wrote:
> JanD wrote:
>
> Who said to take my word, although you would be wise to do so. I posted,
> right below your asinine remark, a quote from a NYTimes article to support
> my statement. IOW, I posted facts.
Do show PROOF of these facts, straight from NYTIMES![vbcol=seagreen]
>
NO need. Let't stick with the SUBJECT!
The subject is NOT YOUR analying, NOR being struck by lightening.
Nor YOUR anecdotes to fit the occasion, HYPOCRITE.
Nor insulting me.
The subject IS:
P.net!53ab2750!not-for-mail
From: "VERACARE" <veracare@ahrp.org>
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
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 C 2006 ABC News Internet Ventures
<http://www.thepinksheetdaily.com/NR...nt_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/fd...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/fd...do?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.
| |
|
| 02-06-06
"Mark Probert" <markprobert@lumbercartel.com> wrote in message
news:0sqFf.690$qW1.351@fe08.lga...
Anecdotes are bullshit and prove nothing.
Poor Mark.
"Mark Probert" <markprobert@lumbercartel.com> wrote in message
news:1C1Hf.8$wY6.2@fe10.lga...
> vernon wrote:
>
> Yeah, but not as well as I did...
>
> The numbers really do not add up very well.
>
>
> Like I pointed out in the paragraph above, yes, on three occasions in the
> past 2 years. One boy rode the bus with my younger son and they hung out
> together outside of school. He did not wake up one morning.
>
> One boy was the captain of my son's school's wheelchair basketball team.
> No arms and two underdeveloped legs. He used one to operate the joystick
> on his power chair, and the other, the longer of the two, for dribbling,
> stealing and shooting. His mother thought he was sleeping on the school
> bus when he came home from school.
>
> The third is a neighborhood kid who had just finished running the bases
> and died.
>
>
> It is very shocking for parents to sudden lose a child who is in apparent
> good medical health. Sadly, even on autopsy, the actual cause of death
> cannot often be determined. I know in the two cases where I know the
> families well, they still do not know what happened. Both boys, having
> physical disabilities, had been carefully examined and monitored over the
> years.
>
>
>
| |
|
|
"Mark Probert" <markprobert@lumbercartel.com> wrote in message
news:NC1Hf.9$wY6.2@fe10.lga...
> JanD wrote:
>
> You may not be talking about it, but the discussion has expanded to
> discuss the death of children.
E X A C T L Y! YOU diverted it to that. Rather that stick with the subject!
YOUR *gang* followed.
Now back to the *subject*
P.net!53ab2750!not-for-mail
From: "VERACARE" <veracare@ahrp.org>
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
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 C 2006 ABC News Internet Ventures
<http://www.thepinksheetdaily.com/NR...nt_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/fd...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/fd...do?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.
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| |
| Mark Probert 2006-02-25, 9:42 pm |
| JanD wrote:
> "Mark Probert" <markprobert@lumbercartel.com> wrote in message
> news:th1Hf.3$wY6.0@fe10.lga...
>
> EVERY death is significant
I'll take that as a YES, and expect you to either call me a liar or
claim that what you said is what you said, or play some other silly
semantic game.
| |
| Mark Probert 2006-02-25, 9:42 pm |
| lynn wrote:
> How the heck does anyone with ADHA read such a long Cut & Paste
> POSTING? IT would take 30mg of AdderallRX for me to want to read such
> a long Posting. Unfortunately, I an not on Adderall.
Jan has intimated over the years that she does not believe that AD/HD
exists. Since it does not exist in her "mind", you should be able to
read it if you just try harder.
> Nothing like not sleeping from 3 to 6 AM, then sleeping until 10 AM.
> The being tired and sleepy all day. Falling asleep after a light
> supper.
>
> I live on coffee but it does not stop the sleepyness during the day.
The stimulant effect of coffee is often lost on AD/HDers because the
caffeine allows your mind to settle and, then you fall asleep.
> I am an adult over 60, good physical condition, 14% body fat, exercise
> 4 times a week, eat healthy yet I am darn tired all the time.
Gotta pic? ;)
> OBTW, 25 or 50 out of 100,000 is NOT ALARMING! Wonder what the
> DWI/death rate per 100,000 motor vehicle accidents?????
You missed the point of my post. The NUMBER of deaths was over a period
of 5 years, thus an average of no more than 10 a year. With 25 MILLION
prescriptions being written annually, any causative factor has got to be
incredibly minute, ASSUMING THAT ONE EXISTS. There is no basis for
making that assumption at this time.
> JanD wrote:
>
| |
| Mark Probert 2006-02-25, 9:42 pm |
| JanD wrote:
> "vernon" <here@here.com> wrote in message
> news:43ec97ec$0$26542$9a6e19ea@unlimited.newshosting.com...
>
> You have a problem?
>
> J U S T I F Y. Look it up.
You were referring to my post when you made the claim I was attempting
to justify the deaths. No one with a positive reading comprehension
level could read that into what I wrote. Since you are nearly illiterate
and totally innumerate, you did, thus proving me correct.
| |
| Mark Probert 2006-02-25, 9:42 pm |
| JanD wrote:
> "Mark Probert wrote:
>
> Do show PROOF of these facts, straight from NYTIMES!
Do go and read the article. I am sure that if you have difficulty with
the BIG WORDS, you can find a neighbor who graduated 8th grade to help you.
You can also do a GoogleNews search and find a few hundred other
articles addressing the same points.
>
> NO need. Let't stick with the SUBJECT!
Yes, the subject is the deaths that are purportedly related to taking
certain types of medication. Try to read the subject line for
comprehension.
> The subject is NOT YOUR analying, NOR being struck by lightening.
Jan, I do not do analying. However, my analysis of the facts as
presented by the NYTimes and other newspapers IS on topic. You just do
not like the fact that you cannot refute what I said. If that upsets
you, too bad.
> Nor YOUR anecdotes to fit the occasion, HYPOCRITE.
Nothing of the sort. I posted things from my family's experience. Here
are links regarding the December death:
http://pqasb.pqarchiver.com/newsday...s+goal%2C+A+Mas
sapequa+son+proved+his+basketball+talent
http://tinyurl.com/clubd
Sorry, but the full link has expired.
> Nor insulting me.
I was not insulting you, but describing your shortcomings. Since these
are facts, they cannot be insulting.
> The subject IS:
>
No, that is NOT the issue, so I snipped it.
Now, do try to address the points I made. Cutting and pasting is the
sign of an illiterate.
| |
| Mark Probert 2006-02-25, 9:42 pm |
| JanD wrote:
> "vernon" <here@here.com> wrote in message
> news:43ec9854$0$26542$9a6e19ea@unlimited.newshosting.com...
>
> Incorrect, that was "Twittering One".
>
> Try to follow.
| | |