Unintended Pregnancy An American Epidemic - amazonia.fiocruz.br

Unintended Pregnancy An American Epidemic

Unintended Pregnancy An American Epidemic - opinion you

Abortion is legal throughout the United States and its territories, although restrictions and accessibility vary from state to state. Abortion is a controversial and divisive issue in the society, culture and politics of the U. In the late s and early s the Republican Party has generally sought to restrict abortion access or criminalize abortion, whereas the Democratic Party has generally defended access to abortion and has made contraception easier to obtain. Wade and Doe v. Bolton decriminalized abortion nationwide in , abortion was already legal in several states, but the decision in the former case imposed a uniform framework for state legislation on the subject. Unintended Pregnancy An American Epidemic.

InAmerica had a stroke of luck. That was when the application to begin mass-marketing the drug thalidomide in the United States landed on the desk of Frances Oldham Kelsey, a reviewer at the Food and Drug Administration.

Accessibility Navigation

Today we know that the drug can cause a range of severe congenital deformities and even infant death when taken by pregnant women for nausea. Between andthe sedative would result in thousands of infants in Canada, Great Britain and West Germany born with serious deformities, including the shortening or absence of limbs. The U. Why not? What stood between the drug and the health of the American public was none other than Kelsey and the FDA. As a medical reviewer, Kelsey had the power Americxn Unintended Pregnancy An American Epidemic a drug from going to market if she found the application to be lacking sufficient evidence for safety. After a thorough review, Kelsey rejected the application for thalidomide on the grounds that it lacked sufficient evidence of safety through rigorous clinical trials.

Today we Unintended Pregnancy An American Epidemic it for granted that the FDA wisely spurned an unsafe drug. Eugene Geiling at the University of Chicago to Unintnded about a research assistant position and to express her interested click obtaining a PhD. Geiling, a medical officer at the FDA known for his studies of the pituitary gland, wrote back offering Kelsey a research assistantship and a scholarship for doctoral study.

Unintended Pregnancy An American Epidemic

InKelsey joined Geiling at the University of Chicago. That consequential step in Kelsey's career may been due to a fortuitous error on the part of Geiling.

How the United States escaped a national tragedy in the 1960s

Kelsey was first introduced to the dangers of mass marketed unsafe pharmaceuticals inwhen the FDA enlisted Geiling to solve the mystery of Elixir of Sulfanilamide. Sulfanilamide effectively combated infections, but it came in a large and bitter pill that needed to be taken in large dosages. To make the drug more appealing, especially to children, manufacturers added it to a solvent with artificial raspberry flavor. The problem was that the solvent they chose was diethylene glycol—commonly known as antifreeze. Between September and October, the drug killed people.

Navigation menu

Geiling and his lab of graduate students, including Kelsey, set out to determine what exactly in the elixir was killing people: the solvent, the flavor or the sulfanilamide. Through a series of animal studies—which at the time were not required by federal law for Unintended Pregnancy An American Epidemic drug to go to market—Geiling and his lab were able to click that it was the diethylene glycol that was the cause of death.

The public outcry to this tragedy prompted Congress to pass the Federal Food, Drug, and Cosmetic Act ofwhich added a New Drug section requiring manufacturers to present evidence that Unintended Pregnancy An American Epidemic drug was safe before going to market. Kelsey graduated from medical school inand went on to work for the Journal of the American Medical Association before starting work as a medical reviewer at the FDA in Chemists reviewed the chemical makeup of the drug and how the manufacturer could guarantee its consistency, while pharmacologists reviewed animal trials showing that the drug was safe. Though this appears to be a rigorous and thorough process of checks and balances, Kelsey admitted https://amazonia.fiocruz.br/scdp/essay/pathetic-fallacy-examples/existentialism-and-nihilism-the-value-of-your.php some weaknesses in her memoir, including the fact that many of the medical reviewers were part-time, underpaid and sympathetic to the pharmaceutical industry.

The most troubling deficiency in the process was the 60 day window for approving or rejecting drugs: If the 60th day passed, the drug would automatically go to market.

Categories

She recalls that this happened at least once. For Kelsey and the other reviewers, thalidomide did not pass muster.

Unintended Pregnancy An American Epidemic

Not only were there pharmacological problems, but Kelsey found the clinical trials to be woefully insufficient in that the physician reports were too few and they were based largely on physician testimonials rather than sound scientific study. She rejected the application. Reports of Pregnnacy side effect peripheral neuritis—painful inflammation of the peripheral nerves—were published in the December issue of the British Medical Journal.

She asked for more information from Merrell, who responded with another application merely stating that thalidomide was at least safer than barbiturates. Kelsey then sent a letter directly to Merrell saying that she suspected they knew of the neurological toxicity that led to nerve inflammation but chose not to disclose it in their application. Merrell grew increasingly upset that Kelsey would not pass their drug, which had been used in over 40 other countries at this point. If neurological toxicity developed in adults who took Epidemmic, Kelsey wondered: What was happening to the fetus of Unintended Pregnancy An American Epidemic pregnant woman who took the drug? Her concern hit on what would be the most dangerous effect of thalidomide in other countries.]

One thought on “Unintended Pregnancy An American Epidemic

Add comment

Your e-mail won't be published. Mandatory fields *