Report: Data about safety, efficacy of top drugs is tough to access

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Information from regulators about the safety and effectiveness of more than a third of America's top-selling drugs is not readily accessible to doctors or the general public, according to a report released Friday by the nonpartisan Sunlight Foundation.

The Washington, D.C.-based foundation, which focuses on digitizing government data to make it more accessible, said information about older drugs, including Pfizer Inc.'s cholesterol fighter Lipitor, hormone-replacement therapy Premarin and antidepressant Effexor, was particularly sparse on the U.S. Food and Drug Administration Web site.

In all, basic information about nine out of the top 25 most-prescribed medications was not available from the FDA online, the report said. The FDA regulates the drug industry.

"Some information for drugs approved in 1997 or earlier is online, but only if someone ... made a formal Freedom of Information Act request," the Sunlight Foundation said in its report. "Approval information on many popular drugs ... (remains) behind closed doors."

The FDA did not immediately respond to a request for comment.

The Sunlight Foundation said the Obama administration's open-government directive that asks agencies to identify and publish at least three datasets not yet available online could be used to make information on important medications more accessible.

Agencies are expected to have a plan in place to comply with Obama's order within six months, the foundation said.

The foundation pointed out that FDA documents are posted in a nonsearchable format, making it difficult for researchers or the public to find information readily. What's more, large sections of these documents are redacted, mostly to protect proprietary information, but the foundation said there is no way to determine why such details are removed.

"Doctors base their decisions on how to treat patients by reading the available medical literature," the foundation's report said.

Doctors who spend time reading original research reports sometimes come away with different interpretations of the data than drug-company representatives pushing medications, the foundation said. It pointed to a report last year in the New England Journal of Medicine that looked at FDA studies and determined that "several commonly prescribed antidepressants don't work as well as the literature published in major medical journals suggest."

Other top medicines whose original research has not been available on the FDA's Web site, according to the report, are cardiovascular drug Plavix, ulcer treatment Prevacid, hypertension therapy Diovan, potassium booster Klor-Con, cholesterol reducer Tricor and allergy reliever Nasonex.


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