So the public can't rely on the FDA to release everything that is important to know, and objective data that the agency uses to make its decisions have become quite valuable for understanding not just the FDA's decision process but also whether it has been making good calls or bad ones. (For example, when I was trying to investigate how the agency was handling a massive case of fraud that undermined the data behind a number of approvals, the agency refused to release the names of the drugs that were affected.) On occasion, the agency is not just slow to release information about problems it is finding with drugs, but it has even been willing to reassure the public about products that later turn out to be dangerous. Reporters like me have encountered similar roadblocks when covering the FDA. In fact, the FDA redacted some of the same documents differently and even redacted one of my own letters to them on a different matter. Other documents have whole pages, paragraphs or sentences redacted with no explanation for what has been withheld or redacted and why. “They delivered hundreds of pages simply marked, for example, ‘57 pages removed,’ or ‘43 pages removed.’. But what they provided is quantity, not quality. they have been responsive to the Finance Committee's Ketek investigation because they made available millions of pages of documents to the Committee. A decade ago Senator Charles Grassley of Iowa, when looking into a case where the FDA made a bad call in approving a dangerous drug, said the FDA put up “every excuse under the sun” to prevent the release of requested documents: The FDA has long had a reputation for opacity even congresspeople, who have the power of subpoena, have been frustrated by the agency's refusal to provide basic information that could help reveal the true story behind a bad decision. When things go wrong, though, it's often damnably hard to figure out precisely what happened. No matter how good the agency is, some of the time it's going to get a decision wrong, and Americans will be put at risk and even die. The FDA has the unenviable position of making life-and-death decisions every day. That's the precise opposite of transparency, and in the FDA's case, it might be putting people's lives at risk. The FDA's refusal is a graphic demonstration of how the agency feels obliged to protect corporate secrets, even at the expense of consumer safety. The reason: doing so might hurt a pharmaceutical company. The agency refuses to release these data, yet without them, the public is unable make an informed decision about whether or not to take a drug. Even data hinting at research misconduct in key drug trials. Data that can give us insight into what elements of a clinical study researchers haven't made public. Data about adverse events patients had when taking the drug. The underlying cause of the bloodbath, ironically, is the FDA's opacity regarding certain important data about the performance of drugs. Yet soon after the FDA announced the new interface, the stocks of four companies-Sarepta Therapeutics, Ionis Pharmaceuticals, Biogen and Acadia Pharmaceuticals-plunged. It's not something that the public should be very excited about FAERS certainly isn't a precise enough tool to tell market speculators whether to dump a stock, any more than a sledgehammer is a precise enough tool to amputate a limb. Not only was FAERS already public, albeit in a slightly less user-friendly form, the database is also messy, context-free and subject to all sorts of biases and errors, making it nigh impossible to interpret properly. The FDA's attempt at transparency was far from revolutionary it was the release of a Web interface to a drug side-effects database known as the FDA Adverse Event Reporting System (FAERS). Jittery traders, sifting through scraps of context-free information provided by the agency, dumped their drug stocks, triggering a brief but brutal plunge. In an attempt to achieve the “greatest level of transparency,” the FDA caused the stock prices of four biotech companies to hemorrhage. But in late September it looked like the agency had overshared. The Food and Drug Administration is seldom accused of being too transparent.
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