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FDA Doctor to Be Honored for Fighting Against Manufacturers of Dangerous Drugs

By September 17, 2010July 23rd, 2019Drug Safety

Though my work as a dangerous drugs attorney focuses on helping people who were victimized by defective medications, I believe strongly that scientists and regulators have an important role in keeping us safe from dangerous drugs. In a recent New York Times article, I read about one such person, Dr. Frances Oldham Kelsey, who will be honored by the U.S. Food and Drug Administration for her lifetime of work on the behalf of patients and consumers. Kelsey, now age 96, was one of the first FDA scientists to insist that drug manufacturers demonstrate that their products are safe and effective, rather than allowing them to push through their applications for approval without rigorous review.
Fifty years ago, Kelsey reviewed the William S. Merrell Company’s application for approval to sell Kevadon (thalidomide), a drug that was being prescribed to many European women to alleviate morning sickness during pregnancy. Thalidomide is now famous for causing severe birth defects: “thalidomide babies” were born without limbs, or with flipper-like limbs. When it applied for approval to sell the drug in the U.S., Merrell already had a bad relationship with the FDA. Kelsey sensed that the company was holding back important information, so she insisted that the company provide test results that showed that thalidomide was safe. Merrell complained to her superiors, insisting that she was “depriving” people of the medication’s benefits, but her bosses backed her up. It soon became clear that she was right to be suspicious. She found reports that the drug caused nerve damage, which Merrell had withheld. The company backed away.
Kelsey might have recognized that something was amiss with thalidomide because of her earlier pharmacological work at the University of Chicago. There, she had helped a professor establish that a widely used medicine, elixir of sulfanilamide, contained a poisonous industrial solvent. The drug had been marketed without any restrictions even though it was linked to scores of deaths, and in the aftermath, Congress passed the 1938 Food, Drug, and Cosmetic Act to force drug companies to test the safety of their products.
But by 1960, Congress had not yet given the FDA the authority to force companies to show that their drugs were safe and effective. Drug manufacturers could simply file information with the FDA and begin selling their drugs 60 days later, as long as the FDA didn’t object. Drug manufacturers sent their new concoctions to doctors and simply asked them to try them out in patients, rather than performing the controlled tests that are now required. After the Washington Post ran a front-page article about Kelsey’s refusal to approve thalidomide for sale in the U.S., Congress finally gave the FDA power to require the drug industry to show their products’ safety and effectiveness. President John F. Kennedy awarded Kelsey the Distinguished Civilian Service Medal. Kelsey and her colleagues then created the rules that are still in effect today for how medical testing must be performed, with three separate phases for clinical trials in humans, and protections for human subjects and against conflicts of interests.
On Sept. 15, 2010, Kelsey received the first Kelsey Award from the FDA, an honor to be bestowed on an FDA staffer each year. For the last two decades, the FDA has leaned more toward drug manufacturers’ desire to get their drugs approved swiftly, even without detailed data about the drugs’ safety and effectiveness. But now that the Kelsey award has been established, as a dangerous medication lawyer, I hope that more FDA staffers will follow in her footsteps and focus on patient and consumer safety over drug companies’ interests. Kelsey’s experiences show clearly that drug companies do not assume that it’s their job to keep patients safe. Drug companies have been trying to fast-track the approval of their drugs for decades, regardless of the drugs’ safety and effectiveness, because there are profits to be made in doing so. The case of thalidomide demonstrates that the public should not trust drug manufacturers to look out for public interests, nor even the FDA in all cases, since FDA scientists before Kelsey had not necessarily insisted on proof of drugs’ safety either.
The law gives patients and consumers their own weapons to fight back against drug companies when necessary. Drug companies are legally required to warn consumers of risks that may come with taking their drugs. If they don’t, and patients suffer because they took a drug that they wouldn’t have if they’d known the risks, drug manufacturers can be held responsible for the harm that their drugs caused. Patients who suffer injuries can require the drug manufacturers to pay for medical expenses, lost wages, permanent injuries, and pain and suffering related to the injuries that these drugs caused.

The defective prescription drug lawyers at Carey, Danis & Lowe help victims of dangerous prescription and over-the-counter drugs fight back against the drug manufacturers that injured them. While some patients choose to join class-action lawsuits against drug manufacturers, we can also file our clients’ cases individually, so that we can provide them with personal attention and recover the greatest amount of compensation, whether through settlement or trial. Because we work with so many clients who have been hurt by dangerous drugs, we are sympathetic to and knowledgeable about the problems and concerns our clients share, and we are successful at upholding their rights.
If you or a loved one have been hurt by a dangerous prescription or over the counter medication, please let Carey, Danis & Lowe help. For a free consultation, call us toll-free at 1-877-678-3400 or contact us through our website.