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FDA hearing to highlight secret clinical trial data


Next week the Food and Drug Administration's (FDA) transparency taskforce will be holding a hearing asking for people to comment on the issue at the core of the multi-media investigation we released today, "Heart of the Matter: How Congress and Special Interests Kept Clinical Trial Data Secret":

The topics to be covered are: (1) early communication about emerging safety issues concerning FDA-regulated products, (2) disclosure of information about product applications that are abandoned (which means that no work is being done or will be undertaken to have the application approved) or withdrawn by the applicant before approval, and (emph. added) (3) communication of agency decisions about pending product applications.

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Fewer than half of medical clinical trials published in the last year in leading medical journals are reported on the government site, according to a new study published by the Journal of the American Medical Association (JAMA).

According to the study, despite a 2005 requirement by medical journal editors that researchers register their studies online before acceptance in a major journal, just 147 out of 323 articles published in the past year were properly registered before the end of the trial. To meet the requirement, researchers are supposed to state what outcomes they will measure to figure out ...

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How well do popular drugs work?


Here at Real Time we are beginning to dig into examples of secret data--data the government collects, that could affect our health and safety, but we, the public, can't see.

The U.S. Food and Drug Administration (FDA) is a treasure house of data on the safety and efficacy of prescription drugs. Before a drug company can market a product in this country, it must first submit a plan to test the drug. Agency scientists review and analyze the results once they are submitted. Yet it's not always easy to get your hands on this information.

"One major ...

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Grassley feted by alternative med lobbyist


A self-proclaimed lobbyist for an alternative health organization--who left a prominent conservative group more than a decade ago under a cloud of financial mismanagement--is hosting a fundraiser next week for Sen. Chuck Grassley (R-IA). Grassley, who recently earned fame for his tweets on health care, has a reputation as a strong crusader for drug safety. But he has also has championed policies favoring the alternative health industry, which some consumer critics charge is not adequately regulated by the federal government.

Read more over at Party Time.

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