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This article cross-posted from Consortium News
Frances Kelsey, whose work for the Food and Drug Administration blocked U.S. approval of the dangerous drug, Thalidomide.
What about the thousands of patients exposed to unnecessarily dangerous levels of radiation during mammogram screening and colonoscopies by General Electric medical imaging devices?
As I prepare for my umpteenth (and hopefully last) scheduled scan over the past five years to check if that grapefruit-sized lymphoma tumor has left my pelvic area for good, I am relieved to remember that most of the scanning devices have had a Siemens, not a GE label.
As the Times reported, the F.D.A. spying focused on doctors who believed the agency gave shortshrift to concerns about excessive radiation coming from medical imaging devices. Lichtblau and Shane wrote:
"The extraordinary surveillance effort grew out of a bitter dispute lasting years between the scientists and their bosses at the F.D.A. over the scientists' claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation."A confidential government review in May by the Office of Special Counsel, which deals with the grievances of government workers, found that the scientists' medical claims were valid enough to warrant a full investigation into what it termed 'a substantial and specific danger to public safety.'"
During the first few decades of my life, there were no such scan scams to worry about. The influence of the pharmaceutical corporations, however, was already huge -- and dangerous. Often, it took courageous whistleblowers -- people of integrity unwilling to betray the public trust -- to prevent disaster.
Thalidomide
It has been more than 50 years since my first extended visit to Europe as a university student. Most readers will be too young to remember, but a "wonder-drug," Thalidomide, had just come on the market. This drug gave temporary rest and relief to millions, especially prospective mothers with morning sickness and problems sleeping. It was very popular in Germany.
Stationed in Germany more than a decade later, I witnessed the human results of the horrible side effects of Thalidomide, which had become available all over Europe, and beyond. Over 10,000 babies in 46 countries were born without limbs or otherwise disfigured and disabled. Those still alive would be in their late 40s/early 50s now.
How did the United States escape this plague? One whistleblower, a woman named Frances Kelsey of the U.S. Food and Drug Administration saw through the charade of the drug company swindlers and stood up to it.
Although Dr. Kelsey came under extreme pressure to fall in step and approve Thalidomide, she scorned the testing that had been done by the Thalidomide manufacturer and blocked introduction of the drug into America.
For her unusual courage and integrity, President John Kennedy gave her the President's Award for Distinguished Federal Civilian Serivce in 1962, after it became clear that she had single-handedly prevented a public health disaster from befalling us in the United States.
Dr. Kelsey will be 98 on July 24; her courage should be celebrated -- particularly in the light of the behavior of our present-day F.D.A. The F.D.A.'s current commissioner, Dr. Margaret Hamburg, should be put on the griddle -- and sooner rather than later.
As the 60s and 70s wore on, the horrible damage caused by the drug made itself known. And what also became clear was the reality that a decade of American babies born whole, with all their limbs, owed a debt of gratitude to Frances Kelsey, whistleblower par excellence!
A close friend of mine, Tom Clark, tells me that he is of that generation. Tom added that his mother suffered miserably from morning sickness in bearing him. He is gratefully aware that he might well be missing a limb or two today, had his mother been able to acquire Thalidomide in the United States.
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