The FDA’s ongoing risk for Americans
“All too often, patients and clinicians mistakenly view FDA approval as an indication that a product is fully safe and effective.” The new 2017 warning about the U.S. Food and Drug Administration (FDA) comes from Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, a division of the Johns Hopkins Bloomberg School of Health, the only institution of its kind in the world.
The 2017 warning is the latest in a string of critiques by medical journals, national news agencies and universities, including STAT News, Kaiser Health, the New York Times, The Milwaukee Sentinel Journal, ProPublica, ABC News, CBS News and Yale News, among others.
Widespread criticism of the federal agency began more than a decade and a half ago, in 2001, as experts began questioning the FDA’s approval process for prescription drugs that ended up causing serious side effects after the agency allowed them on the market.
How bad is the problem?
The FDA is supposed to protect the public. Critics say its failures are killing Americans. Vioxx is a prime example. The anti-inflammatory drug was approved by the FDA in 1999. A 2004 article about Vioxx in The New York Times quoted an FDA scientist who estimated that high doses of the COX-2 inhibitor were “associated with more than 27,000 heart attacks or deaths.”
Merck knew about its potentially lethal side effect, but left Vioxx on the market for five years before recalling it in 2004. Congress questioned the FDA about “why it allowed Vioxx to be sold for so long” as clinical evidence continued to mount against it. In 2012, ABC News covered the shocking FDA shortcoming that’s responsible: The FDA has no legal authority to force companies to recall their products.”
The FDA’s approval process itself is also suspect. In 2014, a Yale University study concluded that “more than one third of the drugs” the FDA authorized between 2005 and 2011 “were approved on the basis of a single trial,” and were not focused on “clinical endpoints like death.” It was the first systematic analysis of the standards used by the FDA to approve drugs
Where does that leave the American public?
A number of major drug companies have been sued successfully by victims of medications that stayed on the market despite their serious side effects. The list includes 35 prescription drugs.
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