January 24 Good Science News #2 Heroes
The history of science and medicine is well populated with heroic figures. For example, in 1854, Dr. John Snow, stopped a cholera outbreak in London and ushered in the age of both modern epidemiology and modern germ theory. One hundred years later, Dr. Jonas Salk developed the polio vaccine, saving countless thousands of lives. True heroes, both. History tends to favor heavy hitters such as Snow and Salk, but my favorite heroes are those individuals that do heroic acts by simply doing their jobs. Sometimes the political pressures to look the other war are great, sometimes the odds are not in their favor, but strict adherence to the letter of the law can go a long way. Consider the example of Dr. Francis Kelsey. Dr. Kelsey, a PhD./M.D., was hired in 1960 to review drugs for the U.S. FDA. One of her first assignments was thalidomide, a drug to be used to treat morning sickness in pregnant women. The drug had already been approved in Canada (Kelsey’s home country) and more than 20 European and African nations. But Kelsey held up approval, requesting more information regarding the unusual finding that thalidomide could damage developing peripheral nerves. She was also concerned about the effect that the drug could have on a pregnant woman’s developing fetus. At the time that Kelsey was investigating thalidomide, mass poisonings by pharmaceutical drugs were very rare, but not unheard of. In 1937, for example, the first commercially available antibiotic, sulfanilamide, was mixed with diethylene glycol to create a syrup. When the elixir reached the consumers, the result was a string of fatalities, for the solvent, ethylene glycol, is highly toxic. Before the concoction could be pulled from the market over 100 people had died from ingesting it. As a pharmacologist, Kelsey was undoubtedly well aware of the sulfanilamide tragedy. She was also aware, through her work that she completed during her PhD., that some studies were indicating that pharmaceuticals could pass across the placenta from mother to child. Could thalidomide do that? The results were unclear. Kelsey took a stand and was unwilling to approve the drug without more evidence. Thalidomide’s producers were putting the pressure on Kelsey to release the drug, they requested approval six separate times, but she held her ground. And the birth defects began to appear. Thalidomide, as it turns out, crosses the placenta and enters into the bloodstream of the developing fetus. No one saw the damage coming, because no one was seriously consider the damage that a pharmaceutical could do to a developing fetus. Except for Francis Kelsey. If thalidomide is present during fetal limb bud development, that development is arrested, and children are born without extended limbs, a condition known as phocomelia. During the late 1950’s, over 2,000 babies were born in the United Kingdom with the condition. By steadfastly refusing to approve the drug, Francis Kelsey prevented the drug from reaching the American market, and by doing so, she single-handedly, changed the course of American medical history. By simply doing her job, despite considerable political and economic pressure, Francis Kelsey became much more than a valued Federal employee. She became a hero.