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Avandia Decision Underscores New Culture of Openness at Federal Drug Regulator

By October 1, 2010July 17th, 2019Dangerous Drugs

Recently I wrote about Dr. Frances Oldham Kelsey, whose leadership helped the FDA establish scientific standards that drug companies had to meet before they could market their drugs in the U.S. Another article about the FDA in the New York Times recently caught my attention, as a dangerous drug injury lawyer, for its discussion of how the FDA has changed in recent years to become more transparent. The FDA’s new openness with the public about how it decides which drugs to approve or not approve helps it to interact with the scientific community. It also holds the FDA accountable to protect the public from drug companies focused on profits rather than patient safety, even though the agency sometimes finds it difficult to do so.
Under the Bush administration, the FDA didn’t publicly discuss its deliberations about drug approvals, and staff members were expected to present a united front once decisions were made. The agency also didn’t conduct deep investigations into drugs’ safety and effectiveness. Under Obama, competing views and disagreements among FDA scientists have been aired publicly. The FDA presents a less united front and allows the public to how complicated the matter of drug safety can be. Dr. Joshua Sharfstein, principal deputy commissioner for the FDA, said, “I think that FDA’s credibility really depends on being able to explain its decisions well. We can’t expect people to think that FDA has decided, therefore it’s the right answer.” In my view as a dangerous prescription medication attorney, the right answer is always protection of patients’ safety and well-being rather than the interests of drug makers.
Even with the agency’s new openness, patients should not rely only on the FDA to protect them from drug companies that market dangerous medications. The agency seems unsure of how to handle the complexity of its decision-making sometimes, and this can result in dangerous drugs being allowed to stay on the market. Questions about FDA decision-making processes have been especially pointed in the case of Avandia, the diabetes drug that is associated with heart risks. Dr. Steven Nissen’s study showing Avandia’s dangerous effects, about which I have written several times, prompted doctors, patients, and legislators to wonder why the FDA had not been the one to do this study. Nissen’s study was not conducted according to the FDA’s procedures for scientific evaluation of medicines. However, the FDA had in fact done its own study with the same results that Nissen found. The agency just hadn’t made it publicly available — so no one knew about it until Nissen’s study.
Even though the FDA is charged with ensuring drugs’ safety and effectiveness, drug manufacturers also are legally required to warn the public about risks that their products might pose. That means that even if the FDA approves a medication for sale, the drug maker can be held responsible for any failure to warn patients. If a manufacturer knows or should have known that the medication could hurt people, and doesn’t make this information public, patients who are hurt by this medication can sue the drug maker to recover the costs of their medical treatment, along with compensation for pain and suffering, loss of quality of life and past and future wages.

The defective medication lawyers at Carey, Danis & Lowe help victims of dangerous, defective drugs. If you or someone you love have been seriously harmed by a medication, we can help you recover compensation from the company that caused your injury. Under the law, victims of this kind of negligence are not required to pay those costs imposed upon you through no fault of their own. Our attorneys can help you hold the drug manufacturer responsible and cover the often steep costs of medical care, lost wages and more, as well as compensation for lost quality of life. To learn more or set up a free, confidential evaluation of your case, please call Carey, Danis & Lowe for a free consultation, toll-free, at 1-877-678-3400 or contact us through our website.