Re: FDA denies trying to block Vioxx results

[Guest guest]

I'm not surprised, a. Previously, they tried and were successful in

keeping Dr. Graham's concerns about Arava (leflunomide) quiet, too. It's

awful.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

[ ] FDA denies trying to block Vioxx results

>

> FDA denies trying to block Vioxx results

>

> Last Updated: 2004-10-08 12:14:36 -0400 (Reuters Health)

>

> WASHINGTON (Reuters) - The U.S. Food and Drug Administration denied

charges

> it tried to suppress a safety official's findings that painkiller

Vioxx,

> which was pulled from the market last week, raised heart attack risks.

>

> Dr. Graham's study on the Merck & Co Inc. arthritis drug was

sent

> through the " standard review process " before being made public in

August,

> the FDA said in a statement released late Thursday.

>

> Graham told Senate Finance Committee Chairman Grassley on

Thursday

> that FDA officials pressured him to keep quiet or water down his

conclusions

> about Vioxx, according to Grassley.

>

> Conversations between Graham and his supervisor were part of the " open

> discussion and frank exchange about scientific and medical issues "

that are

> part of the process for reviewing staff research presentations, the

FDA

> said.

>

> " After that discussion, it was Dr. Graham's decision to revise the

> abstract, " or a summary of his findings, the FDA said.

>

> Graham, associate director for science in the FDA's Office of Drug

Safety,

> concluded that patients taking Vioxx were more likely to suffer heart

> attacks than others who took rival medicine Celebrex, made by Pfizer

Inc.

>

> Graham's findings were presented at a medical conference in France on

Aug.

> 25.

>

> Grassley, an Iowa Republican, is investigating how the FDA handles

safety

> concerns about medicines.

[Guest guest]

I'm not surprised, a. Previously, they tried and were successful in

keeping Dr. Graham's concerns about Arava (leflunomide) quiet, too. It's

awful.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

[ ] FDA denies trying to block Vioxx results

>

> FDA denies trying to block Vioxx results

>

> Last Updated: 2004-10-08 12:14:36 -0400 (Reuters Health)

>

> WASHINGTON (Reuters) - The U.S. Food and Drug Administration denied

charges

> it tried to suppress a safety official's findings that painkiller

Vioxx,

> which was pulled from the market last week, raised heart attack risks.

>

> Dr. Graham's study on the Merck & Co Inc. arthritis drug was

sent

> through the " standard review process " before being made public in

August,

> the FDA said in a statement released late Thursday.

>

> Graham told Senate Finance Committee Chairman Grassley on

Thursday

> that FDA officials pressured him to keep quiet or water down his

conclusions

> about Vioxx, according to Grassley.

>

> Conversations between Graham and his supervisor were part of the " open

> discussion and frank exchange about scientific and medical issues "

that are

> part of the process for reviewing staff research presentations, the

FDA

> said.

>

> " After that discussion, it was Dr. Graham's decision to revise the

> abstract, " or a summary of his findings, the FDA said.

>

> Graham, associate director for science in the FDA's Office of Drug

Safety,

> concluded that patients taking Vioxx were more likely to suffer heart

> attacks than others who took rival medicine Celebrex, made by Pfizer

Inc.

>

> Graham's findings were presented at a medical conference in France on

Aug.

> 25.

>

> Grassley, an Iowa Republican, is investigating how the FDA handles

safety

> concerns about medicines.

[Guest guest]

FDA Urged Withholding Data on Antidepressants....unbelievable!

http://www.washingtonpost.com/wp-dyn/articles/A9802-2004Sep9.html

FDA Urged Withholding Data on Antidepressants

Makers Were Dissuaded From Labeling Drugs as Ineffective in Children

By Shankar Vedantam

Washington Post Staff Writer

Friday, September 10, 2004; Page A02

The Food and Drug Administration has repeatedly urged antidepressant

manufacturers not to disclose to physicians and the public that some

clinical trials of the medications in children found the drugs were

no better than sugar pills, according to documents and testimony

released at a congressional hearing yesterday.

Regulators suppressed the negative information on the grounds that

it might scare families and physicians away from the drugs,

according to testimony by drug company executives. For at least

three medications, they said, the FDA blocked the companies' plans

to reveal the negative studies in drug labels, and in one case the

agency reversed a manufacturer's decision to amend its drug label to

say that the drug was associated in studies with increased hostility

and suicidal thinking among children.

Rep. Greg Walden (R-Ore.) said the FDA should be encouraging drug

manufacturers to disclose more information. (Ron Winn -- AP)

_____Biotech Headlines_____

• Victims Push for DNA Bill On Hill (The Washington Post, Sep 10,

2004)

• Journals Insist Drug Manufacturers Register All Trials (The

Washington Post, Sep 9, 2004)

• Getting Out Of Biotech's Second Tier (The Washington Post, Sep 8,

2004)

• More Biotech News

_____Free E-mail Newsletters_____

• Lean Plate Club

See a Sample | Sign Up Now

" Why would FDA require a company to remove stronger labeling? "

demanded an incredulous Rep. Greg Walden (R-Ore.) yesterday, at a

hearing of the House Energy and Commerce subcommittee on oversight

and investigations. " FDA should want to encourage a company to do

that kind of thing. "

Janet Woodcock, FDA's deputy commissioner for operations, responded

that regulators believe the jury is still out on the drugs. The

negative trials, she said, did not mean the medications were

ineffective.

Several representatives noted that the study results were obtained

at tremendous cost to the American public because Congress granted

companies profitable patent extensions as an incentive to conduct

the trials.

Rep. Henry A. Waxman (D-Calif.), a member of the subcommittee, said

it was absurd to give companies profitable patent extensions on

their drugs to encourage the trials and then limit dissemination of

the results. He said his staff had estimated that a patent extension

given to Pfizer Inc. was worth $1 billion dollars. Wyeth

Pharmaceuticals, he said, made $500 million.

The hearing was prompted by widespread complaints that crucial

information about the safety and effectiveness of antidepressant

medications had not been communicated to physicians and the public.

More than two-thirds of all studies of antidepressant use among

depressed children have failed to show the drugs are effective.

Prozac is the only medicine to be specifically approved to treat

children's depression, but a number of other drugs are widely

prescribed.

Most physicians have not had access to the negative data and are

prescribing the drugs to millions of American children largely

because the drugs have proved effective among adults. Two internal

FDA analyses recently concluded that the class of medications is

associated with an increased risk of suicidal behavior among

children.

At the hearing, Pfizer Vice President Cathryn M. Clary testified

that FDA had told the company that existing language in the label

for Zoloft, which suggested " that efficacy has not been established "

for depressed children, was sufficient. Pfizer had planned to add

that two studies of Zoloft found the medication was no better than

sugar pills.

We do not feel it would be useful to describe these negative trials

in labeling, " FDA officials wrote in a letter to the company, " since

these may be misinterpreted as evidence that Zoloft does not work. "

FDA's Woodcock said agency officials had told Wyeth to scale back a

label change that warned that the drug Effexor had been linked to

suicidal thoughts, hostility and self-harm.

Rep. Greg Walden (R-Ore.) said the FDA should be encouraging drug

manufacturers to disclose more information. (Ron Winn -- AP)

_____Biotech Headlines_____

• Victims Push for DNA Bill On Hill (The Washington Post, Sep 10,

2004)

• Journals Insist Drug Manufacturers Register All Trials (The

Washington Post, Sep 9, 2004)

• Getting Out Of Biotech's Second Tier (The Washington Post, Sep 8,

2004)

• More Biotech News

_____Free E-mail Newsletters_____

• Lean Plate Club

See a Sample | Sign Up Now

" It was not very understandable, " Woodcock said in an interview when

asked why the FDA had found the Wyeth label objectionable.

Wyeth and other companies were instead asked to insert a general

caution that physicians should carefully monitor the risk of suicide

among all patients with depression. Agency officials said at the

time that the caution was a reiteration of good clinical practice.

ph S. Camardo, senior vice president at Wyeth Pharmaceuticals,

said company scientists had disagreed with the FDA on how to

interpret the data in its labeling.

" We thought our proposal was reasonable, so it was a bit of a

surprise, " he said of the FDA ruling that substituted a less pointed

warning.

In the agency's most recent internal review of the antidepressant

studies, FDA scientist Tarek Hammad concluded in August that

children taking Effexor had 8.84 times the risk of suicidal behavior

or thinking compared with children taking sugar pills.

British authorities warned physicians last year not to prescribe a

range of antidepressants to children. The FDA has called for a more

cautious interpretation of the data, which an agency advisory

committee is expected to discuss at a meeting next week.

Yesterday's hearings, which included testimony from officials from

seven pharmaceutical companies, grappled with ways to make negative

study results about drugs more accessible to the public. Recent

proposals by manufacturers, medical journal editors and members of

Congress have called for various schemes for publicly registering

all drug trials and, in some cases, disclosing the results.

- In , " " <Matsumura_Clan@m...> wrote:

> I'm not surprised, a. Previously, they tried and were successful in

> keeping Dr. Graham's concerns about Arava (leflunomide) quiet, too. It's

> awful.

>

>

>

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

>

>

> [ ] FDA denies trying to block Vioxx results

>

>

> >

> > FDA denies trying to block Vioxx results

> >

> > Last Updated: 2004-10-08 12:14:36 -0400 (Reuters Health)

> >

> > WASHINGTON (Reuters) - The U.S. Food and Drug Administration denied

> charges

> > it tried to suppress a safety official's findings that painkiller

> Vioxx,

> > which was pulled from the market last week, raised heart attack risks.

> >

> > Dr. Graham's study on the Merck & Co Inc. arthritis drug was

> sent

> > through the " standard review process " before being made public in

> August,

> > the FDA said in a statement released late Thursday.

> >

> > Graham told Senate Finance Committee Chairman Grassley on

> Thursday

> > that FDA officials pressured him to keep quiet or water down his

> conclusions

> > about Vioxx, according to Grassley.

> >

> > Conversations between Graham and his supervisor were part of the " open

> > discussion and frank exchange about scientific and medical issues "

> that are

> > part of the process for reviewing staff research presentations, the

> FDA

> > said.

> >

> > " After that discussion, it was Dr. Graham's decision to revise the

> > abstract, " or a summary of his findings, the FDA said.

> >

> > Graham, associate director for science in the FDA's Office of Drug

> Safety,

> > concluded that patients taking Vioxx were more likely to suffer heart

> > attacks than others who took rival medicine Celebrex, made by Pfizer

> Inc.

> >

> > Graham's findings were presented at a medical conference in France on

> Aug.

> > 25.

> >

> > Grassley, an Iowa Republican, is investigating how the FDA handles

> safety

> > concerns about medicines.

[Guest guest]

FDA Urged Withholding Data on Antidepressants....unbelievable!

http://www.washingtonpost.com/wp-dyn/articles/A9802-2004Sep9.html

FDA Urged Withholding Data on Antidepressants

Makers Were Dissuaded From Labeling Drugs as Ineffective in Children

By Shankar Vedantam

Washington Post Staff Writer

Friday, September 10, 2004; Page A02

The Food and Drug Administration has repeatedly urged antidepressant

manufacturers not to disclose to physicians and the public that some

clinical trials of the medications in children found the drugs were

no better than sugar pills, according to documents and testimony

released at a congressional hearing yesterday.

Regulators suppressed the negative information on the grounds that

it might scare families and physicians away from the drugs,

according to testimony by drug company executives. For at least

three medications, they said, the FDA blocked the companies' plans

to reveal the negative studies in drug labels, and in one case the

agency reversed a manufacturer's decision to amend its drug label to

say that the drug was associated in studies with increased hostility

and suicidal thinking among children.

Rep. Greg Walden (R-Ore.) said the FDA should be encouraging drug

manufacturers to disclose more information. (Ron Winn -- AP)

_____Biotech Headlines_____

• Victims Push for DNA Bill On Hill (The Washington Post, Sep 10,

2004)

• Journals Insist Drug Manufacturers Register All Trials (The

Washington Post, Sep 9, 2004)

• Getting Out Of Biotech's Second Tier (The Washington Post, Sep 8,

2004)

• More Biotech News

_____Free E-mail Newsletters_____

• Lean Plate Club

See a Sample | Sign Up Now

" Why would FDA require a company to remove stronger labeling? "

demanded an incredulous Rep. Greg Walden (R-Ore.) yesterday, at a

hearing of the House Energy and Commerce subcommittee on oversight

and investigations. " FDA should want to encourage a company to do

that kind of thing. "

Janet Woodcock, FDA's deputy commissioner for operations, responded

that regulators believe the jury is still out on the drugs. The

negative trials, she said, did not mean the medications were

ineffective.

Several representatives noted that the study results were obtained

at tremendous cost to the American public because Congress granted

companies profitable patent extensions as an incentive to conduct

the trials.

Rep. Henry A. Waxman (D-Calif.), a member of the subcommittee, said

it was absurd to give companies profitable patent extensions on

their drugs to encourage the trials and then limit dissemination of

the results. He said his staff had estimated that a patent extension

given to Pfizer Inc. was worth $1 billion dollars. Wyeth

Pharmaceuticals, he said, made $500 million.

The hearing was prompted by widespread complaints that crucial

information about the safety and effectiveness of antidepressant

medications had not been communicated to physicians and the public.

More than two-thirds of all studies of antidepressant use among

depressed children have failed to show the drugs are effective.

Prozac is the only medicine to be specifically approved to treat

children's depression, but a number of other drugs are widely

prescribed.

Most physicians have not had access to the negative data and are

prescribing the drugs to millions of American children largely

because the drugs have proved effective among adults. Two internal

FDA analyses recently concluded that the class of medications is

associated with an increased risk of suicidal behavior among

children.

At the hearing, Pfizer Vice President Cathryn M. Clary testified

that FDA had told the company that existing language in the label

for Zoloft, which suggested " that efficacy has not been established "

for depressed children, was sufficient. Pfizer had planned to add

that two studies of Zoloft found the medication was no better than

sugar pills.

We do not feel it would be useful to describe these negative trials

in labeling, " FDA officials wrote in a letter to the company, " since

these may be misinterpreted as evidence that Zoloft does not work. "

FDA's Woodcock said agency officials had told Wyeth to scale back a

label change that warned that the drug Effexor had been linked to

suicidal thoughts, hostility and self-harm.

Rep. Greg Walden (R-Ore.) said the FDA should be encouraging drug

manufacturers to disclose more information. (Ron Winn -- AP)

_____Biotech Headlines_____

• Victims Push for DNA Bill On Hill (The Washington Post, Sep 10,

2004)

• Journals Insist Drug Manufacturers Register All Trials (The

Washington Post, Sep 9, 2004)

• Getting Out Of Biotech's Second Tier (The Washington Post, Sep 8,

2004)

• More Biotech News

_____Free E-mail Newsletters_____

• Lean Plate Club

See a Sample | Sign Up Now

" It was not very understandable, " Woodcock said in an interview when

asked why the FDA had found the Wyeth label objectionable.

Wyeth and other companies were instead asked to insert a general

caution that physicians should carefully monitor the risk of suicide

among all patients with depression. Agency officials said at the

time that the caution was a reiteration of good clinical practice.

ph S. Camardo, senior vice president at Wyeth Pharmaceuticals,

said company scientists had disagreed with the FDA on how to

interpret the data in its labeling.

" We thought our proposal was reasonable, so it was a bit of a

surprise, " he said of the FDA ruling that substituted a less pointed

warning.

In the agency's most recent internal review of the antidepressant

studies, FDA scientist Tarek Hammad concluded in August that

children taking Effexor had 8.84 times the risk of suicidal behavior

or thinking compared with children taking sugar pills.

British authorities warned physicians last year not to prescribe a

range of antidepressants to children. The FDA has called for a more

cautious interpretation of the data, which an agency advisory

committee is expected to discuss at a meeting next week.

Yesterday's hearings, which included testimony from officials from

seven pharmaceutical companies, grappled with ways to make negative

study results about drugs more accessible to the public. Recent

proposals by manufacturers, medical journal editors and members of

Congress have called for various schemes for publicly registering

all drug trials and, in some cases, disclosing the results.

- In , " " <Matsumura_Clan@m...> wrote:

> I'm not surprised, a. Previously, they tried and were successful in

> keeping Dr. Graham's concerns about Arava (leflunomide) quiet, too. It's

> awful.

>

>

>

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

>

>

> [ ] FDA denies trying to block Vioxx results

>

>

> >

> > FDA denies trying to block Vioxx results

> >

> > Last Updated: 2004-10-08 12:14:36 -0400 (Reuters Health)

> >

> > WASHINGTON (Reuters) - The U.S. Food and Drug Administration denied

> charges

> > it tried to suppress a safety official's findings that painkiller

> Vioxx,

> > which was pulled from the market last week, raised heart attack risks.

> >

> > Dr. Graham's study on the Merck & Co Inc. arthritis drug was

> sent

> > through the " standard review process " before being made public in

> August,

> > the FDA said in a statement released late Thursday.

> >

> > Graham told Senate Finance Committee Chairman Grassley on

> Thursday

> > that FDA officials pressured him to keep quiet or water down his

> conclusions

> > about Vioxx, according to Grassley.

> >

> > Conversations between Graham and his supervisor were part of the " open

> > discussion and frank exchange about scientific and medical issues "

> that are

> > part of the process for reviewing staff research presentations, the

> FDA

> > said.

> >

> > " After that discussion, it was Dr. Graham's decision to revise the

> > abstract, " or a summary of his findings, the FDA said.

> >

> > Graham, associate director for science in the FDA's Office of Drug

> Safety,

> > concluded that patients taking Vioxx were more likely to suffer heart

> > attacks than others who took rival medicine Celebrex, made by Pfizer

> Inc.

> >

> > Graham's findings were presented at a medical conference in France on

> Aug.

> > 25.

> >

> > Grassley, an Iowa Republican, is investigating how the FDA handles

> safety

> > concerns about medicines.