Barton to FDA-If you folks can't fix it, we'll fix it for you.

[Guest guest]

> SSRI-Research

> Thu, 9 Sep 2004 19:33:24 -0700 (PDT)

> drugawareness] Barton to

> FDA- " If you folks can't fix it, we'll fix it for

> you. "

>

> Here is yet another great report from CBS Market

> Watch on the Congressional

> hearings today.

>

> It is a national disgrace and horror that one out of

> six children in the US

> are taking these drugs!!!!!! Even after leading the

> way for the past 15 years

> in this battle to get the truth out about these

> antidepressants, I am shocked

> at these figures! This is sickening to see what we

> are doing to our hope for

> the future - our children.

>

> Dr. Tracy

> ______________

>

> Ann Blake Tracy, Ph.D.,

> Executive Director, International Coalition For Drug

> Awareness

> Author: Prozac: Panacea or Pandora? - Our Serotonin

> Nightmare & audio tape on

> safe withdrawal: " Help! I Can't Get Off My

> Antidepressant! "

> Order Number: 800-280-0730

> Website: www.drugawareness.org

>

>

>

> While advocates of the new policy say it should

> apply to all new drugs, the

> committee focused on pediatric trials of

> anti-depressant drugs due to an

> ominous trend in suicidal behavior in children and

> teens taking the drugs.

>

> Committee members noted that the problem will only

> get worse, with one out of

> every six children in the United States reportedly

> taking a prescription

> anti-depressant.

>

> Yet against that backdrop, the lawmakers pointed

> out, only three out of the

> 15 pediatric studies of anti-depressants done so

> far, showed that the drug

> actually worked in children. And it was only those

> three pediatric trials that

> were published in medical journals as " stand-alone "

> studies, the committee

> members said.

>

> " People want to know, 'Where are the other 12

> studies, why aren't they

> published?' " said Committee Chair Joseph Barton

> (R-Texas). He noted that the

> evidence of increased suicidal behavior in young

> people on anti-depressants was

> gleaned from " mostly undisclosed studies. "

>

>

>

http://cbs.marketwatch.com/news/story.asp?guid=%7BFA43AA76-2DC8-4FE8-A788-AE2A6F\

820CAD%7D & siteid=google & dist=google

>

> Lawmakers: Drug trial disclosure should be mandatory

>

> Drug makers may have to disclose pediatric trial

> data to get exclusivity

>

> By Laura Gilcrest, CBS MarketWatch

> Last Update: 5:03 PM ET Sept. 9, 2004

> E-mail it | Print | Alert | Reprint | RSS

>

> WASHINGTON (CBS.MW) -- Drug companies may be

> required to make results of all

> of their clinical trials - both favorable and

> unfavorable - available to the

> public, and such disclosure could even become a

> condition of firms' gaining

> market exclusivity.

>

> The heated debate over whether drug companies should

> have to disclose results

> of studies showing that a drug doesn't work came to

> Capitol Hill Thursday at

> a hearing before the House Energy and Commerce

> Committee.

>

> While advocates of the new policy say it should

> apply to all new drugs, the

> committee focused on pediatric trials of

> anti-depressant drugs due to an

> ominous trend in suicidal behavior in children and

> teens taking the drugs.

>

> Committee members noted that the problem will only

> get worse, with one out of

> every six children in the United States reportedly

> taking a prescription

> anti-depressant.

>

> Yet against that backdrop, the lawmakers pointed

> out, only three out of the

> 15 pediatric studies of anti-depressants done so

> far, showed that the drug

> actually worked in children. And it was only those

> three pediatric trials that

> were published in medical journals as " stand-alone "

> studies, the committee

> members said.

>

> " People want to know, 'Where are the other 12

> studies, why aren't they

> published?' " said Committee Chair Joseph Barton

> (R-Texas). He noted that the

> evidence of increased suicidal behavior in young

> people on anti-depressants was

> gleaned from " mostly undisclosed studies. "

>

> Also troubling is the fact that only Eli Lilly &

> Company's (LLY: news, chart,

> profile) anti-depressant Prozac is currently

> approved for use in children,

> but physicians more frequently prescribe other

> anti-depressants for their

> pediatric patients, Barton said. " Do these (other

> anti-depressants) work in kids at

> all? " he asked. Committee Vice Chairman

>

> Dave Weldon (R-Fla.) agreed. Given the increased

> risk of suicidal behavior

> linked to the drugs, " If a sugar pill works just as

> well as an anti-depressant,

> should doctors prescribe the drugs off-label in

> kids? "

>

> Barton and other committee members argued that

> so-called " no-effect " study

> results should be part of labeling for

> anti-depressant drugs. Some lawmakers

> went further, arguing that the problem is serious

> enough to rework the law

> granting drug makers six months of market

> exclusivity for conducting pediatric

> studies

>

> Edward Markey (D-Mass.) -- who with Henry Waxman

> (D-Calif.) is sponsoring a

> bill that would make clinical trial registration

> mandatory - said that the

> exclusivity law should require " broad disclosure " of

> clinical trials as well as

> pediatric trial results in drug labeling.

>

> However, industry representatives who spoke at the

> hearing argued that drug

> companies have been forthcoming in sharing trial

> data with FDA and the medical

> community, and that the process should remain

> voluntary. Caroline Loew, an off

> icial with the Pharmaceutical Research and

> Manufacturers of America, said that

> the clinical trial database that the trade group

> launched this week would

> contain " the results of all 'hypotheses-testing'

> clinical trials, regardless of

> outcome... " Loew said that the database would be

> most useful if administered by

> with PhRMA partner or an independent third party

> free of " government

> involvement at this time. " .

>

> Strongly advocating mandatory clinical trial

> disclosure, Richard Gorman of

> the American Academy of Pediatrics, told the

> committee that Congress has the

> task of " balancing the rights of the drug company

> with the needs of patients, "

> Gorman said, noting that his group thinks more

> transparency in clinical trial

> data " should benefit children. "

>

> At Thursday's hearing, Barton also blasted FDA for

> what he called

> " stonewalling and incompetence " in response to the

> committee's request for agency data on

> the evidence of rising suicidal tendencies in

> children on anti-depressants.

> The Texas lawmaker referred to an internal e-mail

> sent by an agency staffer

> charged with responding to the committee's request,

> instructing FDA employees to

> withhold from the committee draft notes and memos on

> pediatric studies of

> anti-depressants.

>

> The FDA's lack of cooperation " makes me wonder if

> this is sheer ineptitude or

> something worse, " Barton said. He told FDA official

> Janet Woodcock, who spoke

> at the hearing, to advise FDA Acting Commissioner

> Lester Crawford: " If you

> folks can't fix it, we'll fix it for you. "

>

> At the hearing, Woodcock told the panel that, " FDA

> welcomes a continued

> dialogue regarding the kind of information from

> clinical trials that would be

> useful to providers, patients and families so they

> can make meaningful treatment

> decisions. " She added that the agency would also

> consider what further action

> might be necessary to assure the safe use of

> anti-depressant drugs in children.

>