User:Briceluessenhop/Diethylstilbestrol

Medical Ethics in regard to the approval and use of Diethylstilbestrol have been violated in a number of ways. The Vice President of the American Drug Manufacturers Association, Carson Frailey, was employed by drug companies creating DES in order to help get it approved by the Food and Drug Administration (FDA). Nancy Langston, the author of The Retreat from Precaution: Regulating Diethylstilbestrol (DES), Endocrine Disruptors, and Environmental Health, states that “Frailey persuaded fifty-four doctors from around the country to write to the FDA, describing  their  clinical  experiences  with a  total  of  more  than  five  thousand patients. Only four of these fifty-four doctors felt that DES should not be approved, and the result was that, against the concerns of many of the FDA medical staff, the FDA’s drug chief Theodore Klumpp recommended that the FDA approve DES.”

“the  FDA  leadership  decided  to  deal  with  scientific uncertainty  with  a  compromise,  allowing  the  drug  to  be  available  only  with  a prescription” without knowing if DES was harmful and/or had long term health risks correlated with its use. The decisions made by the FDA leaders to approve DES without further study and convince doctors to dissimulate opinions on the use of DES is ethically wrong.

“warnings [for DES were] made available  only  on  a  separate  circular that patients would not see. Doctors could get this warning circular only by writing to  the  drug  companies  and  requesting  it. Letters  between  companies  and  FDA regulators  reveal  that  both  groups  feared  that  if  a  woman  ever  saw  how  many potential risks DES might present, she might refuse to take the drug—or else she might sue the company and the prescribing doctors if she did get cancer or liver damage after taking the drug.” Women were not informed about the possible effects of DES because doctors and FDA regulators were afraid DES would fail and never be approved costing the drug companies millions of dollars. The act of distributing potentially dangerous medicine to patients regardless of the affect and harm it may do solely for monetary gain is unethical. Another example of this began in 1939, [when]a physician named Dr. Karl John Karnaky of Houston began experimenting with the use of DES in pregnant women, and he soon became an enthusiastic promoter of DES for all pregnancies. As he later recalled, ' The drug companies came to Houston, ... fed me and dined me ... and I started using it.' " This example displays how the drug companies distributing DES would persuade doctors to use and distribute DES.