Putting On The Brakes
Putting On The Brakes
Originally shared by M Sinclair Stevens
Women Work: Doctor, Pharmacologist, Director of Scientific Investigations at the FDA
Although I had heard quite a bit about the the thalidomide horrors, I never knew who was responsible for saving countless American mothers and their children its effects until yesterday when Dr. Frankie Kelsey died at 101.
"Frances Oldham Kelsey, a medical officer at the Food and Drug Administration in Washington, who raised concerns about thalidomide before its effects were conclusively known. For a critical 19-month period, she fastidiously blocked its approval while drug company officials maligned her as a bureaucratic nitpicker."
....
This is why we need strong government protections...because corporations care only about making money.
"In Washington, she joined a corps of reform-minded scientists who, although not yet empowered by the 1962 law that required affirmative FDA approval of any new drug, demanded strong evidence of effectiveness before giving their imprimatur."
"At the time, a drug could go on the market 60 days after the manufacturer filed an application with the FDA. If the medical officer determined that the submission was incomplete, the drug company could provide additional information, and the clock would start anew."
"Meanwhile, pharmaceutical drug companies commonly supplied doctors with new drugs and encouraged them to test the product on patients, an uncontrolled and dangerous practice that relied almost entirely on anecdotal evidence."
But thalidomide was not the only supposed wonder drug that she investigated.
"In Chicago, she helped Geiling investigate the 107 deaths that occurred nationwide in 1937 from the newly marketed liquid form of sulfanilamide, a synthetic antibacterial drug used to treat streptococcal infections. In tablet form, it had been heralded as a wonder-drug of the age, but it tasted unpleasant."
"Because the drug was not soluble in water or alcohol, the chief chemist of its manufacturer, S.E. Massengill Co. of Bristol, Tenn., dissolved the sulfanilamide with an industrial substance that was a chemical relative of antifreeze. He then added cherry flavoring and pink coloring to remedy the taste and appearance."
Massengill rushed the new elixir to market without adequately testing its safety. Many who took the medicine — including a high number of children — suffered an agonizing death."
http://www.washingtonpost.com/national/health-science/frances-oldham-kelsey-heroine-of-thalidomide-tragedy-dies-at-101/2015/08/07/ae57335e-c5da-11df-94e1-c5afa35a9e59_story.html?po
Originally shared by M Sinclair Stevens
Women Work: Doctor, Pharmacologist, Director of Scientific Investigations at the FDA
Although I had heard quite a bit about the the thalidomide horrors, I never knew who was responsible for saving countless American mothers and their children its effects until yesterday when Dr. Frankie Kelsey died at 101.
"Frances Oldham Kelsey, a medical officer at the Food and Drug Administration in Washington, who raised concerns about thalidomide before its effects were conclusively known. For a critical 19-month period, she fastidiously blocked its approval while drug company officials maligned her as a bureaucratic nitpicker."
....
This is why we need strong government protections...because corporations care only about making money.
"In Washington, she joined a corps of reform-minded scientists who, although not yet empowered by the 1962 law that required affirmative FDA approval of any new drug, demanded strong evidence of effectiveness before giving their imprimatur."
"At the time, a drug could go on the market 60 days after the manufacturer filed an application with the FDA. If the medical officer determined that the submission was incomplete, the drug company could provide additional information, and the clock would start anew."
"Meanwhile, pharmaceutical drug companies commonly supplied doctors with new drugs and encouraged them to test the product on patients, an uncontrolled and dangerous practice that relied almost entirely on anecdotal evidence."
But thalidomide was not the only supposed wonder drug that she investigated.
"In Chicago, she helped Geiling investigate the 107 deaths that occurred nationwide in 1937 from the newly marketed liquid form of sulfanilamide, a synthetic antibacterial drug used to treat streptococcal infections. In tablet form, it had been heralded as a wonder-drug of the age, but it tasted unpleasant."
"Because the drug was not soluble in water or alcohol, the chief chemist of its manufacturer, S.E. Massengill Co. of Bristol, Tenn., dissolved the sulfanilamide with an industrial substance that was a chemical relative of antifreeze. He then added cherry flavoring and pink coloring to remedy the taste and appearance."
Massengill rushed the new elixir to market without adequately testing its safety. Many who took the medicine — including a high number of children — suffered an agonizing death."
http://www.washingtonpost.com/national/health-science/frances-oldham-kelsey-heroine-of-thalidomide-tragedy-dies-at-101/2015/08/07/ae57335e-c5da-11df-94e1-c5afa35a9e59_story.html?po
amazing how today, still, pharma companies are trying to avoid scrutiny of their product over profit. So many "trusted" drugs are found to be inadequately tested and responsible for deaths. I have personal experience with that. I wonder if we have any Kelsey's left.
ReplyDeleteA few, but they are vastly outnumbered by the legions of folks paid to conduct clinical trials... and construe the results in ways aimed to appeal to the stock market...
ReplyDelete