December 10


Sen Grassley to Offer Mandatory Drug Data Registry Bill

Fri, 10 Dec 2004

AHRP applauds Senator Chuck Grassley for spearheading legislation that will require pharmaceutical companies to register ALL drug trials and report their results in a public database.

Given the record of deception and concealment of adverse data, anything other than a comprehensive, public database would defeat the purpose of transparency and accuracy. Company-run databases are inherently subject to manipulation by the very companies whose internal marketing documents have demonstrated a propensity to commit fraud in the interest of profit margins.

AHRP applauds ABC News for having the guts to air a factual, hard hitting investigative report on Prime Time Live.

See:Drug Maker Withheld Paxil Study Data
ABC News Uncovers Documents Unknown to Regulators and Many Doctors

We continue to question the rationale of The New York Times policy that puts reports about drug safety and medical ethics in the Business section rather than the national news section inasmuch as health care issues have significant public interest. The business section does not reach as many readers as does the A-national section of the paper.

Contact: Vera Hassner Sharav

December 10, 2004
A Top Republican to Offer Drug Data Bill

A top Senate Republican on health care issues, Charles E. Grassley of Iowa, plans to introduce legislation early next year that would require pharmaceutical companies to register drug trials and report their results in a public database, an aide said yesterday.

Several Democrats have introduced similar proposals in the Senate and the House. But the involvement of Mr. Grassley, who led recent hearings involving the drug industry and federal drug regulation, may be a significant advance because it signals some bipartisan support for such a bill.

“The plan would be to introduce the bill early in the next Congress,” said the aide, who spoke on the condition of anonymity.

The aide also said that Senator Grassley would introduce a separate bill around the same time that would create an independent office within the Food and Drug Administration to oversee drug safety.

Last month, Mr. Grassley, the chairman of the Senate Finance Committee, led a hearing into the F.D.A.’s oversight of Vioxx, the arthritis pain reliever that Merck withdrew from the market after a clinical trial showed that among people taking the drug for at least 18 months, the risks of heart attacks and strokes increased.

Earlier in the year, he was involved in questions of how information from pediatric tests of antidepressants had been disclosed.

While Senator Grassley’s aide said that work on the clinical trials bill was still going forward, it is likely to contain some features the Democrats proposed. Under that plan, makers of drugs and medical devices would be required to register any product trial involving human subjects in a government-run database before it could proceed. Companies would also be required to report test results in the same system.

Some academic researchers argue that registration of clinical trials at their inception will prevent companies from hiding unfavorable results or stopping such trials before completion. They also say that a complete inventory of test results involving a particular drug will provide valuable information about how well it works.

The push for greater disclosure of drug trials gained added support this year after reports that the makers of some antidepressants had emphasized tests showing that children and adolescents experienced positive results while playing down studies indicating that the drugs did not work or that they might, in a few instances, have the potential to be dangerous.

Under such pressure, a number of drug makers have started posting clinical trial results and related data on company Internet sites.

The industry’s trade group, the Pharmaceutical Research and Manufacturers of America, has also started a Web site where companies can post trial findings. But the group says it does not believe that a mandatory test-disclosure system is needed and its Web site does not require companies to register their trials when they begin.

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