Society and Culture
The Bendectin case, and the subsequent removal of the drug from the US market, has had a number of consequences. Firstly, there was an immediate increase in the rates of hospitalization for nausea and vomiting in pregnancy. Secondly, to-date a safe medication that alleviates morning sickness in pregnant women - not a trivial matter as the most severe form of nausea and vomiting of pregnancy, called hyperemesis gravidarum can be life-threatening or cause women to terminate their pregnancy - is not available in the US. The lack of availability of a safe and effective drug for the treatment of nauseas and vomiting of pregnancy has resulted in the use of other, less studied drugs in pregnancy. Thirdly, it has been claimed that subsequent to the Bendectin experience drug companies stayed away from developing medications for pregnant patients. As a result only two medications (oxytocin, cervidil) were approved between 1962 and 2010 for obstetrical indications by the FDA. Lastly, the perception that all medications are teratogenic increased among pregnant women and healthcare professionals. The unfounded fear of using medications during pregnancy has orphaned many women from receiving the appropriate treatment they require. Leaving medical conditions untreated during pregnancy can result in adverse pregnancy outcomes or significant morbidity for both the mother and baby. Ongoing education of physicians and the general public has resulted in improvements in the perception of medication use in pregnancy; however, further advances are required to overcome the devastating effects of the Bendectin saga.
From a legal perspective, the case through Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993) set a new standard for admitting expert testimony in federal courts in lieu of the Frye standard. 8
Read more about this topic: Pyridoxine/doxylamine
Famous quotes containing the words society and, society and/or culture:
“Children belong in families, which, ideally, serve as a sanctuary and a cushion from the world at large. Parents belong to society and are a part of that greater world. Sometimes parents are a channel to the larger society, sometimes they are a shield from it. Ideally they act as filters, guiding their children and teaching them to avoid the tempting trash.”
—Louise Hart (20th century)
“Anarchism is the only philosophy which brings man the consciousness of himself; which maintains that God, the State, and society are non-existent, that their promises are null and void, since they can be fulfilled only through man’s subordination.... The individual is the heart of society, conserving the essence of social life; society is the lungs which are distributing the element to keep the life essence—that, is, the individual—pure and strong.”
—Emma Goldman (1869–1940)
“If mass communications blend together harmoniously, and often unnoticeably, art, politics, religion, and philosophy with commercials, they bring these realms of culture to their common denominator—the commodity form. The music of the soul is also the music of salesmanship. Exchange value, not truth value, counts.”
—Herbert Marcuse (1898–1979)