FDA Urged Withholding Data on Antidepressants - Washington Post - Sept 10/2004

[Guest guest]

In my opinion this is pure theatre. It will be " not

me " all around, confusion will dominate, maybe a few

will become scapegoats, and eventually they will blame

" the system " and the need to revise it and then they

will revise it to more benefit the drug companies. Ya

gotta love the justice in that system.

 

 

> Thu, 9 Sep 2004 22:35:17 -0400

> [sSRI-Research] FDA Urged Withholding Data

> on Antidepressants - Washington Post - Sept 10/2004

>

> washingtonpost.com

>

> 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, and

> in one case the agency reversed a manufacturer's

> decision to disclose that its 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

> proven 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.

>

> Joseph 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

>