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Frances Oldham Kelsey, PhD, MD An American HeroMarianne Skolek Salem-News.com
Time to slow down and honor those who made a difference, before the big pharmaceutical companies had control.
(MYRTLE BEACH, S.C.) - For those not familiar with the name Frances Oldham Kelsey, she became nationally famous in 1962 when she prevented the sedative drug Thalidomide from entering the United States.
Thalidomide was found to have caused birth defects in 10,000 European children in the late 1950s and early 1960s. For preventing an American Thalidomide tragedy, Kelsey was awarded the government's highest civilian award, the President's Distinguished Federal Civilian Service Award.
Kelsey's civil service career began in August, 1960, when she became a medical officer for the Food and Drug Administration (FDA). After one month on the job, Kelsey was asked to review what was expected to be a simple and routine marketing application for Thalidomide. Thalidomide, a sleep inducer, had been developed in West Germany in the 1950s, and was widely marketed in Europe; belief in its safety was so widespread that the drug was available without prescription.
Dr. Kelsey soon became suspicious of the safety of Thalidomide. Kelsey promptly asked Richardson-Merrill, distributor of Thalidomide, for additional animal study data and reports of all clinical trials of Thalidomide to supplement the company's application for American approval.
She later notified the company that she suspected Thalidomide might have some effect on unborn children, although she did not yet suspect it as a cause of deformity. Throughout her review, Kelsey remained concerned that the company had failed to provide adequate data to demonstrate the safety of Thalidomide.
On July 15, 1962, the Washington Post ran an article about Kelsey that began, "This is the story of how the skepticism and stubbornness of a government physician prevented what could have been an appalling American tragedy...."
A wave of publicity and acclaim swept the world. Only a month later, Congress voted to award a gold medal to Kelsey, "in recognition of the distinguished service to mankind ... by withholding, despite the great pressures brought to bear upon her, approval of the horror-drug Thalidomide which has caused thousands of babies to be deformed."
In October, 1962, with Kelsey present at the ceremony, President Kennedy signed a landmark drug law, the Kefauver-Harris Amendments . The law required drug manufacturers to register with the Food and Drug Administration proof that new drugs were both effective and safe,and provided for more rapid recall of new drugs deemed hazardous.
Today Dr. Kelsey is in her 90's and retired from the FDA. I would love to have the opportunity to sit down with Dr. Kelsey and ask her how she would feel about a drug called OxyContin -- nicknamed "Hillbilly Heroin" throughout the country.
It was promoted by its manufacturer to physicians and patients as less likely to be addictive or abused. This deceptive marketing has resulted in an epidemic of deaths and addictions in every state in the country, as well as Canada. The loss of young lives is in itself a crime. This is how our conversation would begin -- Yes Dr. Kelsey there was a Federal prosecution of the pharmaceutical company and yes they pled guilty to charges against them. But we are still left with the devastation of families in deaths and addictions because a company making billions of dollars a year manufacturing and marketing OxyContin has no conscience.
I would ask Dr. Kelsey how she feels about pain societies funded by Purdue Pharma defending physicians charged with the deaths of patients for running "pill mills" and prescribing OxyContin recklessly resulting in destruction of life. These same pain societies reaping the rewards of heavy funding by Purdue Pharma and huge salaries does not want any interference by the Federal Drug Administration, the Department of Justice or the Drug Enforcement Agency.
These pain societies do not want "skepticism and stubbornness of a government physician" which could prevent another American tragedy.
If I were ever given the opportunity to tell Dr. Kelsey, she is an American hero and this country is indebted to her, I would ask her to fast forward to the present and how OxyContin was allowed to become this country's new Thalidomide. And then I would pray for the next Dr. Kelsey to become our new American hero and stop this madness -- we owe it to our children and their children.
Marianne Skolek is an Activist for Victims of OxyContin and Purdue Pharma - "a criminally convicted pharmaceutical company" Marianne is an Activist for Victims of OxyContin throughout the United States and Canada. In July 2007, she testified against Purdue Pharma in Federal Court in Virginia at the sentencing of their three CEO's, Michael Friedman, Howard Udell and Paul Goldenheim, who pled guilty to charges of marketing OxyContin as less likely to be addictive or abused to physicians and patients.
She also testified against Purdue Pharma at a Judiciary Hearing of the U.S. Senate in July 2007. Marianne works with government agencies and private attorneys in having a voice for her daughter Jill, who died in 2002 after being prescribed OxyContin, as well as the voice for scores of victims of OxyContin. She has been involved in her work for the past 7-1/2 years and is currently working on a book that exposes Purdue Pharma for their continued criminal marketing of OxyContin.
Marianne is a nurse having graduated in 1991 as president of her graduating class. She also has a Paralegal certification. Marianne served on a Community Service Board for the Courier News, a Gannet newspaper in NJ writing articles predominantly regarding AIDS patients and their emotional issues. She was awarded a Community Service Award in 1993 by the Hunterdon County, NJ HIV/AIDS Task Force in recognition of and appreciation for the donated time, energy and love in facilitating a Support Group for persons with HIV/AIDS.
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