Time for a Change: Why the FDA Should Require Greater Disclosure of Differences of Opinion on the Safety and Efficacy of Approved Drugs

 In Notes

The United States is no stranger to pharmaceutical medicine scandals and tragedies. In the past fifty years, a number of “good drugs” have “gone bad,” resulting in severe effects for the patients who took them and leading to huge class action and products liability lawsuits. In 1971, a study confirmed the damaging effects of diethylstilbestrol, or DES, a synthetic estrogen drug given to pregnant women from 1941- 1971 to help prevent miscarriages. Many daughters of the women who took DES have been diagnosed with a rare vaginal cancer and show an increased risk of developing breast cancer, along with other fertility problems. Many sons of the women who took DES have been diagnosed with testicular cancer and other reproductive system disorders. Additionally, negative effects of DES have appeared in the grandchildren of the women who originally took the drug.

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