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 problem is that FDA reviews are electronically available only for drugs approved since 1997,” wrote Dr. Erick H. Turner, a FDA drug reviewer turned transparency evangelist, in recent submitted testimony to the FDA’s transparency task force. “A researcher interested in a drug approved in, say, 1995, must file a “paper FOIA” request and wait perhaps several years to have it fulfilled.”
These “old” data can provide crucial insights. Dr. Turner, who is now on faculty in the Department of Psychiatry at Oregon Health & Science University, and colleagues published a much noted study last year in the New England Journal of Medicine, where they showed that several commonly prescribed anti-depressants don’t work as well as the literature published in major medical journals suggests.
They found that in peer-reviewed literature, antidepressant drugs beat placebos in nearly 100% of clinical trials. However, when FDA documents for particular drugs were analyzed–several of which were approved before 1997 and had to be collected via the Freedom of Information Act–only half of the trials were positive. “This discrepancy was due to a combination of nonpublication and,” wrote Turner, “for lack of a better word, “spin”.”
Turner also noted even for drugs approved more recently, “coverage is spotty.” There are, for example, a certain set of drugs first approved for treatment of schizophrenia and later for bipolar mania. While the schizophrenia reviews are available online, none of the mania reviews are posted. Also, when a drug is widely prescribed for off-label use, but the FDA has rejected this usage do to safety or efficacy concerns, that analysis is “currently kept secret from healthcare providers and their patients.”
Turner also noted that even when FDA review documents are posted online, they are “posted in a user-unfriendly fashion.” While they make their way through the agency review process, agency scientists can easily navigate electronic documents via hyperlinks. But, when a FOIA request is submitted, then agency staff print out the documents, physically redact certain information, and then create a new PDF, which is then not easily searchable.