Re: FDA Urged Withholding Data on Antidepressants

[Guest guest]

I know there are real problems for some kids with antidepressants, but I hope

all of this doesn't cause problems for the ones who are helped by them.

My daughter is much less obsessed and calmer since starting a low dose of Zoloft

and the same is true for another child in her class.

I think these medications can have a benefit in treating OCD for some people,

including children.

Each case is individual.

FDA Urged Withholding Data on Antidepressants

[More SSRI info from today's Washington Post]

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

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

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.

" 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.

" 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.

© 2004 The Washington Post Company

[Guest guest]

At this point, it's only been determined that the drugs are

ineffective (no better than a sugar pill given to control groups) and

unsafe for children with depression in the studies done and that the

FDA had a hand in not disclosing that information for the target

group of depressed children.

> I know there are real problems for some kids with antidepressants,

but I hope all of this doesn't cause problems for the ones who are

helped by them.

> My daughter is much less obsessed and calmer since starting a low

dose of Zoloft and the same is true for another child in her class.

> I think these medications can have a benefit in treating OCD for

some people, including children.

> Each case is individual.

ave been removed]

[Guest guest]

We are not using them to treat depression. My daughter has OCD and also anxiety

related to the OCD. I can tell you that Zoloft is helping her with her

obsessions.

There is also a young man in her class who has become a different fellow thanks

to Zoloft. Before he was constantly anxious and worried. He also had obsessions.

It was so bad he couldn't get much of his work done.

He is not so much happier and less stressed. He is able to let go of the

obsessions enough to focus on other things.

I think you have to look at each case individually and not condemn something

with a broad stroke. That said, I do think that sometimes drugs get prescribed

too easily for children.

Re: FDA Urged Withholding Data on Antidepressants

At this point, it's only been determined that the drugs are

ineffective (no better than a sugar pill given to control groups) and

unsafe for children with depression in the studies done and that the

FDA had a hand in not disclosing that information for the target

group of depressed children.

> I know there are real problems for some kids with antidepressants,

but I hope all of this doesn't cause problems for the ones who are

helped by them.

> My daughter is much less obsessed and calmer since starting a low

dose of Zoloft and the same is true for another child in her class.

> I think these medications can have a benefit in treating OCD for

some people, including children.

> Each case is individual.

ave been removed]

[Guest guest]

As far as I know, Zoloft is still approved for treating pediatric OCD

in the U.S., so you don't need to feel badly about that. I'm glad it

is helping. After dealing with PANDAS in my own family, I can

commiserate with trying to find something that helps. I haven't seen

anything mentioned about OCD studies in the February report or the

reports coming out this week. I don't think you will see Zoloft

pulled as a treatment for OCD based on the depression studies, the

two diagnoses were separated in the studies.

> > I know there are real problems for some kids with

antidepressants,

> but I hope all of this doesn't cause problems for the ones who

are

> helped by them.

> > My daughter is much less obsessed and calmer since starting a

low

> dose of Zoloft and the same is true for another child in her

class.

> > I think these medications can have a benefit in treating OCD

for

> some people, including children.

> > Each case is individual.

> ave been removed]

>

>

>

[Guest guest]

Just a thought here. Ever heard of Ritalin-Free Kids. I think you

can do homeopathy at the same time as drugs.

> > I know there are real problems for some kids with

antidepressants,

> but I hope all of this doesn't cause problems for the ones who

are

> helped by them.

> > My daughter is much less obsessed and calmer since starting a

low

> dose of Zoloft and the same is true for another child in her

class.

> > I think these medications can have a benefit in treating OCD

for

> some people, including children.

> > Each case is individual.

> ave been removed]

>

>

>