The Thalidomide Tragedy ~ Will History Repeat Itself?

Jan 30th, 2009
Many of us remember the horrific incident of the drug, thalidomide. Some are still living with the dreadful effects firsthand or through their loved ones. What is the status of thalidomide today?

Many of us remember the horrific incident of the drug, thalidomide. Some are still living with the dreadful effects firsthand or through their loved ones. For those who are unfamiliar, let me quickly provide a history recap.

The drug thalidomide was sold from 1957-1961 in about 50 countries under approximately 40 different names. It was given to pregnant women for morning sickness, stress, and to help them sleep. Between 1956 and 1962, roughly 10,000 children were born with severe malformations. Yes, the date is correct. The first baby was born in 1956 to the wife of a Chemie Grunenthal (the drug manufacturer) employee who had given his wife samples. The baby was born with no ears. Thousands would be born with no arms and/or legs and an assortment of other deformities before tracing the cause back to Chemie Grunenthal and thalidomide. Of course, they spent several years attempting to deny any connection. After all, the drug was tested on mice with no bad effects. Have you ever seen a baby with no arms or legs? The sight can be quite disturbing so I will not include photos in this article. However, so that you understand the severity of the malformations, I suggest you search “thalidomide babies” in any image search engine. Expect to see pictures of newborns as well as survivors now in their fifties.

Meanwhile, the FDA in the United States had not approved thalidomide claiming it needed further study. Some still found its way into the system and 17 babies were born in the U.S. with thalidomide caused birth defects.

By now, you might be wondering why I am dredging up old appalling events. Can’t we just let it be? It was fifty years ago and what's done is done. The answer is, “NO!” Firstly, those thalidomide babies are now in their fifties and dealing with the everyday challenges of their disabilities as well as growing old. Secondly, we are about to embark on a new generation of thalidomide babies. In fact, in some countries it has already begun.

Thalidomide was not sold or prescribed for decades, but it did not go away. Research in alternate uses quietly continued and discovery of other potential applications continues. On July 16, 1998, FDA approved the use of thalidomide (made by Celgene, under the label Thalomid) for the treatment of a painful condition associated with Leprosy. Other newly discovered uses include treatment of painful lesions in the mouth and esophagus in AIDS patients allowing them to eat and minimize the potential of malnutrition and treatment of some rare forms of cancer such as Multiple Myeloma.

The FDA claims it has implemented very strict regulations for marketing and prescribing thalidomide to avoid exposure to pregnant women. This all looks great on paper but is enveloped with one major loophole – trust in human nature. The FDA cannot guarantee that the female patient will abstain from sexual intercourse or use two highly effective birth control methods at the same time. They cannot guarantee that the male patient will abstain or use a condom since thalidomide is present in male semen. Just take a moment to consider how many HIV positive and drug-addicted babies are born every day. If abstinence or precaution was not exercised in these high-risk situations with grave consequences, then what makes the FDA think that it will be when a patient is being treated with thalidomide? What regulations will the FDA impose regarding the annual estimated 32,000 (U.S.) rape related pregnancies? Will they insist that rapists be sure that their victims are not on thalidomide or use precautions if they are? That notion is about as crazy as perfectly abiding human nature. As thalidomide use increases, so will the percentage of rape victims on thalidomide increase. With new uses being found, thalidomide use IS on the rise. Thalomid sales reached nearly half a billion dollars in 2007 and almost the same for the first nine months of 2008. Meanwhile, another thalidomide derivative, Revlimid, sold by Celgene has seen amazing growth. With sales of 2.8 million in 2005 to just under one billion for the first nine month reporting period of 2008, it may soon be easier to ask how many people are NOT being treated with some form of thalidomide.

As if all of this is not enough to be concerned about, the FDA also states “You should not buy Thalomid (thalidomide) over the Internet because you will bypass important safeguards designed to protect your health (and the health of others).” Ironically, as I did my first Internet search for current information of thalidomide a sponsored ad came up (as I suspect will also happen on this article’s page) for a company in Canada selling generic thalidomide. They cannot ship thalidomide to the U.S. but my point is how easy it is attained on the Internet in other countries.

More in-depth research would be necessary to acquire specific information on the level of control and monitoring in other countries. However, as I began exploring information I found many references to Brazil where thalidomide has been in use for many years to treat the high number of leprosy cases. There are claims that although controls are in place the drug is still making it to other people outside of the control and monitoring limits. An estimated 800 infants with thalidomide birth defects have occurred as recent as 1995-2005.

I do not believe the FDA and its strict regulations will be 100% successful in the prevention of more “Thalidomide Babies”. In my opinion, even one more is too many. In this age of medical advancement and technology, why should anyone have to live a life with no arms and legs or other severe deformities caused by a drug known to have these horrific effects? I find it hard to imagine the lack of the discovery of alternate drugs to replace thalidomide. Instead, we keep searching for more uses to keep it in the marketplace.

Where do we draw the line? Do we wait for history to repeat itself – again, again, and again?

Thalidomide information on the FDA site

http://www.fda.gov/Cder/news/thalinfo/default.htm

Help Avoid More Thalidomide Baby Births

http://www.bukisa.com/articles/28716_help-avoid-more-thalidomide-baby-births

prism
Married with a wonderfully intense, energetic, persistant 13yo son. We homeschool and stay very busy with a wide variety of interests - reading, science, gardening, cooking, dance, Lego's, Robotics, The Internet, 4H, Camp Fire USA are just a few that…
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