Lawmakers urge drug trial disclosure to be mandatory
 Member ID:     Free Membership
  Special Offers
  Help  Nasdaq: MKTW
Enter symbol(s):

Find symbol
Live quotes

Keyword search

Subscribe to Retirement Weekly today!


Jim Cramer’s Every Investment and Trade
Get Cramer’s personal portfolio and email alerts before he makes his trades. Try it free.
IRS Tax Help - We Solve IRS Problems
Our expert team of ex-IRS agents, tax attorneys and accountants negotiate with the IRS to reduce your back taxes. Settle debt for pennies on the dollar. Get help now!


Election 2004
Latest economic report
Economic Preview
Capitol Report
Economic Calendar
Washington Events
SEC Filings
Bond Report
Irwin Kellner
More Features

ETF Trader NEW
A methodology to invest in exchange traded funds
Herb Greenberg's RealityCheck
A must-read for investors
looking for new ideas
Hulbert Interactive
Customize your search
of the HFD database
Retirement Weekly
Get the retirement you want
The Technical Indicator
Technical analysis for sophisticated traders 
Hulbert Financial Digest
The definitive guide to investment newsletters
HFD Honor Roll & Profiles
Detailed newsletter performance ratings
MarketWise University
Courses to help teach you
to trade & invest like a pro
CBS MarketWatch LIVE
Get real time streaming quotes & charts.
Caribbean Cruise
Join us for a luxury cruise & investment insights.

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.

<a href=""><IMG SRC="" WIDTH=336 HEIGHT=280 BORDER=0></a>
Oracle wins antitrust case, can pursue PeopleSoft
House overturns overtime rules
U.S. stocks end higher on tech strength; Dow lags
U.S. initial jobless claims plunge 44,000 on storms
Texas Instruments shares up; Nokia, National help
Free! Sign up here to receive our Weekly Roundup e-Newsletter!
Open a Harrisdirect account!
Get 50 Commission Free Trades
Company: Eli Lilly and Company
Get Breaking News sent directly to your inbox
 Create An Alert

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 official 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.

Latest Industry News   Get Alerted on News in this Industry
Consumer group sues Albertsons 11:57pm ET 09/09/04
Biotech up, pharma down as Neocrine shares retreat 5:11pm ET 09/09/04
Neurocrine shares fall despite drug-trial result 11:35am ET 09/09/04
Ten global stocks contrarian investors would love 12:01am ET 09/09/04
Drug makers under pressure to disclose more test data 5:24pm ET 09/08/04

SPONSORED LINKS Get listed here
Jim Cramer’s Every Investment and Trade
Get Cramer’s personal portfolio and email alerts before he makes his trades. Try it free.
IRS Tax Help - We Solve IRS Problems
Our expert team of ex-IRS agents, tax attorneys and accountants negotiate with the IRS to reduce your back taxes. Settle debt for pennies on the dollar. Get help now!
Mortgage Rates Just Got Lower
Lock in the lowest rates of the summer. Refinance your home, get a home equity loan, or consolidate your debt while rates are low. Get up to 4 free quotes from trusted lenders. Apply now!
Compare Credit Cards - 0% APR and More
Compare credit cards with 0% APR on purchases and/or balance transfers. Also, compare cards that give cash back, other rewards and more. Choose from multiple offers for good or bad credit.
TimingCube: Up 900% Since 2000 - 4 Trades a Year
Join thousands of Trend Timers who have taken control of their financial future. If you are a long-term investor, TimingCube can help you achieve your goals and dreams. Try it risk-free for 30 days.

Find out which investment newsletters really pay off!
Donít pay $100, $200 or more a year for investment advisory newsletters that donít consistently beat the market. Instead let the Hulbert Financial Digest tell you which advisors Ė based on past performances Ė are most likely to make money for you. Subscribe today and get 50% off the regular price and 3 free bonuses-worth $65.

Front Page | Discussions | Mobile | Alerts | RSS | Premium Products | Free Membership
Feedback | Letters to the Editor | Site Index | Company Info | Investor Relations | Jobs | Advertising Media Kit

License CBS MarketWatch news, plus custom financial tools and data, from MarketWatch Information Services.

MarketWatch is traded on the Nasdaq stock exchange under the symbol MKTW.

Partner Sites: | | | | World Business News Alliance

TRUSTe: Click to Verify

© 1997-2004 MarketWatch, Inc. All rights reserved. Terms of Service. See our Privacy Policy - updated 4/3/03.
MARKETWATCH, the MarketWatch logo, and BIGCHARTS are registered trademarks of MarketWatch, Inc.
CBS and the CBS "eye device" are registered trademarks of CBS Broadcasting, Inc.

Intraday data provided by Comstock, a division of Interactive Data Corp. and subject to terms of use.
Historical and current end-of-day data provided by FT Interactive Data.
Intraday data delayed 15 minutes for Nasdaq, and 20 minutes for other exchanges.
SEHK intraday data is provided by Comstock and is at least 60-minutes delayed.
All quotes are in local exchange time.