Biology 30 – Reproduction Unit, STS connection for concept 3
By Ingrid Ypma
Thalidomide
In 1957, a German pharmaceutical company named Chemie Grünenthal, began to market a new sedative called Thalidomide that was also effective at relieving flu symptoms, nervous exhaustion and also morning sickness in pregnant women. Prior to its release, the drug was subjected to a number of laboratory tests, including animal field tests using mice and rats as subjects. Rodents were the only animals tested and the company reported that they found no significant side effects. The drug was not tested on pregnant animals for it was believed at this time that drugs could not pass the placental barrier. Because of its apparently few side effects the drug became widely prescribed to women across Europe and its use spread to other corners of the globe within a few years.
Before the drug could be released in the United States of America, the pharmaceutical company that produced the drug was required to submit an application for approval to the Food and Drug Administration. Dr. Francis Kelsey was assigned to review the drug and was concerned about the possibility of the drug producing some negative neural side effects. Because of her hesitation, the release of the drug was delayed in the United States for the period of one year. During this time, reports began to surface that many of the women who took Thalidomide during pregnancy were delivering babies with severe birth defects. The most common of these defects was a condition termed Pharcomelia, a condition in which the child develops short, flipper-like limbs. The evidence linking Thalidomide to birth defects was so convincing that the drug was taken off the market in 1961. Further tests conducted at this time with pregnant rabbits and monkeys showed that the drug produced side effects similar to thousands of cases of “Thalidomide babies”.
Since the Thalidomide tragedy, the medical community has enforced many more standards in drug research and has also emphasized stricter regulations on the licensing of drugs.
1.
Although
testing procedures in the 1950’s were not as strict as they are today,
Thalidomide was still required to go through testing to ensure that it was safe
for humans. What may be some reasons that these safety mechanisms did not work?
2.
Should all
pharmaceutical companies be required to test new drugs on a variety of animals
before the drug may be released?
3.
It is believed
that side effects were not observed in mice because they metabolized the drug
differently than the humans did. Is it useful to use the results of animal
testing as an indication of the benefit or harm that may result when humans
consume the drug?
4.
Because the new
standards and regulations of drug testing are so rigorous, it is very expensive
and time consuming to produce a new drug. Comment on the effectiveness of these
new policies. (Consider safety issues as well as the possibility that the
release of a beneficial drug may be slowed by these policies as well.)
In 1965, Thalidomide was found to be an effective treatment for a skin disorder in leprosy patients and continues to be used in the world today for such uses. Research is also being done to determine Thalidomide’s effectiveness in treating conditions found in both AIDS and Cancer patients.
5. Is it irresponsible or scientifically creative for science to find alternate uses for products or drugs that have failed miserably and have been found to be harmful to humans?
References
Freiman, F.L. and Schlager, N. Failed Technology : True Stories of Technological Disasters. New York : ITP, 1995.
Harris, Steven B. The Right Lesson to Learn from Thalidomide. http://w3.ag.uiuc.edu:8001/Liberty/Tales/Thalidomide.Html
Microsoft Encarta Encyclopedia. Thalidomide. Microsoft Corporation, 1993-2000.
Stephens, T. D., and Brynner, R. Dark Remedy: the Impact of Thalidomide and its Revival as a Vital Medicine. Cambridge : Perseus Publishing, 2001.
Thalidomide Victims Association of Canada
http://www.thalidomide.ca/wit.html