Friday, May 17, 2013

If Frances Kelsey Could Protect America From the Pharmaceutical Industry in 1962, Congress Can Today Posted: 05/17/2013 6:59 am

In recent weeks, Congress has been looking into last year's outbreak of meningitis, which killed 53 people and injured more than 700 Americans in 20 states. The cause was a taintedsteroid distributed by the New England Compounding Center (NECC), which is part of an obscure $2 billion-a-year niche of the pharmaceutical industry called "compounding pharmacies." Recent reports document that this rogue industry is out of control, operating dangerously in the shadows and putting the lives of millions of Americans at risk. Democrats have been trying to give the Food and Drug Administration (FDA) the authority to regulate this shadowy niche of the drug industry, but the companies and their Republican allies have pushed back, arguing that states can do a better job and that stronger federal regulations aren't needed. 

Sometimes it takes a scandal to get the public's attention, but it also helps to have a courageous figure who takes on big business to protect public health and safety. This David vs. Goliath conflict not only makes good drama. It can also make good public policy. And that's exactly what happened a half century ago when Frances Kelsey almost singlehandedly took on the pharmaceutical industry.
Frances who?
You've probably never of her, but she may have saved your life. In the early 1960s, Kelsey -- a doctor and research scientist with the FDA -- saved thousands of babies from severebirth defects by stopping a big pharmaceutical company from marketing the drug thalidomide. Equally important, Kelsey's courageous stance inspired Congress to revise the rules for approving new drugs protecting hundreds of millions of Americans, then and now, from unsafe medicines. 

Kelsey's battle with the makers of thalidomide is not only an inspiring tale of how one individual's expertise and courage protected the public interest against the corporate push for profits, but also a warning to drug companies and their lobby groups fighting new drug safety rules that would put public health and safety over drug company profits.

After World War II, many Americans and Europeans got hooked on sleeping pills and tranquilizers. One out of seven Americans took them regularly. Thalidomide was first introduced in Germany in 1957 by Chemie Grunenthal, a drug company. It was considered safe enough to be sold as a sleeping pill without a prescription. Then doctors began giving it to their pregnant patients suffering from morning sickness. By 1960, the company was marketing thalidomide in 46 countries, but not the United States. Its sales were almost on a par with aspirin.

In 1960, Richardson-Merrell Pharmaceuticals applied for FDA approval to market thalidomide in the United States under the brand name Kevadon. At the time,pharmaceutical companies were required to show that their drugs were safe, but could sell drugs 60 days after they submitted requests to the FDA, so long as the agency didn't object, which it rarely did, because it mostly relied on the manufacturers for information. At the time, the FDA did not require scientific clinical trials. Drug laws back then allowed companies to send new drugs to doctors for "research purposes," so Richardson-Merrell distributed thalidomide tablets to more than a thousand doctors who gave them to about 20,000 patients. Approximately 3760 of them were women of childbearing age, including at least 207 who were pregnant. The doctors were not required to track their patients to find out if the drug was working or having any harmful side effects.

Assuming that the Kevadon application was a slam-dunk, the FDA assigned it to Kelsey, who had just arrived at the agency a month earlier. Born on Vancouver Island, British Columbia in 1914, she had earned both her bachelor and master of science degrees in pharmacology from McGill University, and her Ph.D. in pharmacology as well as a medical degree from the University of Chicago. She taught pharmacology at the University of Chicago and the University of South Dakota and worked as a general practitioner from 1957 to 1960, when she moved to Washington to work for the FDA. She was one of only seven full-time physicians reviewing drug applications.

Kelsey's power to approve -- or deny -- the company's application was the result of the 1938 Food, Drug and Cosmetic Act that -- for the first time -- required pharmaceutical companies to prove that their products are safe before they can be sold. The pharmaceutical industry vigorously opposed the 1938 law, claiming it would be economic disaster for the drugmakers and pharmacies.

Despite powerful opposition, the law passed after a scandal that outraged the public. In late 1937, hundreds of children were poisoned and died after being given the antibiotic, Sulfanilamide, which was dissolved in a toxic solvent to make it easier for children to take.
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