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The Devastation Caused By Thalidomide, and Why It’s Still Around

The Devastation Caused By Thalidomide, and Why It’s Still Around

When it was introduced to the market for the treatment of nausea in pregnancy in the late 1950s, thalidomide was hailed as a miracle. Within just a few short years, it had turned into a nightmare, a drug that caused thousands of birth defects worldwide and caused untold pain and suffering for parents and children. By the early 1960s, the backlash was so intense that the drug had been forced off the market, and it ushered in a new age of drug reforms and compensation settlements that changed the face of drug development forever.

This week, we were reminded that the legacy of thalidomide is still active today, as many of the drug’s victims are in their 50s and 60s and alive today. In Australia and New Zealand, an $81 million settlement to compensate some of these victims was just negotiated, illustrating that the full extent of the harm done by the drug hasn’t been addressed yet. Many people with thalidomide-related birth defects need assistance and care to perform basic tasks, thanks to the fact that the drug left them with missing, foreshortened, or impaired limbs. Lifetime care can become expensive, and without support, people may be forced into institutions even if they’d prefer to live in the community. Such settlements enable them to live independently, although they can never fully compensate them for their experiences.

The study brings thalidomide to mind for many who haven’t thought about the notorious drug in a while, but it’s a reminder that the story of this medication, developed in Germany, is a complicated one. It was withdrawn from the market by 1961 after the very obvious connection between thalidomide and birth defects was made, but this triggered a significant reform to the drug development process: the mandate of careful testing to determine whether drugs could cause additional health problems for pregnant women. Sometimes, it can take years to realize the connection, as was the case with DES, a medication that can lead to greater risk of cancer in the daughters of women who take it in pregnancy.

Thalidomide also marked the widespread use of civil suits to demand funds from drug makers to pay damages so people could get assistance with medications, aides and other things they needed to survive as a result of their thalidomide-related injuries. This in turn made drug companies more wary, but it also set a clear precedent for others to follow: if a drug had harmed you, you could go to the manufacturer or distributor to ask for retribution, in addition to reporting it and participating in surveillance studies to analyze the full extent of the problem.

But there’s another side to the thalidomide story which many people are not aware of, and it’s an important part of the drug’s legacy too. While it may have been withdrawn from the market in 1961, it was back in use almost immediately, and continues to be in use today. How can such a toxic and potentially dangerous medication still be made available for sale? The story is a complicated one and it illustrates how a poison can become a tonic in the right hands and the right conditions.

After being deemed unsafe in pregnancy, thalidomide was widely avoided initially, but even once a drug has been withdrawn, it still has potential, and for drugmakers, this is critically important, because they are desperate to get their research and development investment back. Thus, in the 1960s, it began to be used, very hesitantly, to treat leprosy. Physicians discovered that it could be very effective for some patients in some situations, and it continues to be used for this purpose today. It’s also used in the management of multiple myeloma.

Thalidomide has become an option in these cases because if there’s nothing available, even a toxic treatment is worth a chance. Patients taking thalidomide are carefully counseled, ordered to use two forms of birth control, and strongly advised about the risks of pregnancy while on the drug. Even with these precautions, misuse does occur, and some pregnancies develop; thus, a new generation of people born with thalidomide-related impairments is developing. They have fewer opportunities for seeking compensation, as their parents knowingly took the drug and often signed documentation releasing their legal rights to limit liability for physicians, drugmakers and others involved in the process of getting the drug to the patient.

As the practice of medicine grows ever more advanced, some toxic medications are still kept in the arsenal of options for when all else fails, and thalidomide is one such example.

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Photo: Duckwailk.

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91 comments

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12:57AM PST on Dec 11, 2013

Every few years we get a big backlash against some medicine that is found to cause bad side effects that were not noticeable until large masses of people took the drug on the market. Think Vioxx and other Cox 2 Inhibitors.

But I think that rather than ban a drug altogether, patients should be allowed to make informed decisions about the costs and benefits of each medicine. If I were given a choice between a shorter life with good health and little pain and a longer life with poor health, severe pain, and poor quality of life, I'd certainly choose the former!

Thalidomide obviously has other issues, since its problems carry to unborn children, but in general, let the patients decide the cost and benefit, acknowledging the risks, rather than the drug companies afraid of liability.

11:24PM PST on Dec 9, 2013

The problem seems less that thalidomide is still around-- leprosy is nasty-- but rather, that patients seem to want to risk the odds on a pregnancy under those conditions.

9:06PM PST on Dec 9, 2013

ty

8:51PM PST on Dec 9, 2013

thank you for the article. feel bad for the children who grew up the birth defects, their parents are now either too old to take care of them or dead, so now it will be the job of the state to take care of the children. very sad for everyone

8:30PM PST on Dec 9, 2013

Well said, Leslea H. Most of the articles appearing on Care2 about medicine seem to be written by people who never took a science coarse once they got past the 10th grade.





8:14PM PST on Dec 9, 2013

one of the most horrific drugs made

6:22PM PST on Dec 9, 2013

Most substances with medicinal properties can be dangerous depending on the dose and way they are taken.
The problem comes when things are hailed as miracles and are put on the market and prescribed without really knowing the full effects.
Unfortunately, medicine is a business where keeping the patients regularly healthy is not so much the goal as healing them once they fall sick. I guess that's partly why, for example, Paracetamol is still given away as candy in many places, despite it can cause serious dangers to the pancreas. How many doctors warn their patients it might be worth having a sporadic mild headache than taking paracetamol at the first sign of discomfort?
It is tru phramaceutic companies undergo studies before releasing their products, but some of the studies (like long term effects) can not be tested as necessary because that makes the investement a potential waste and that's no business.
It also goes to porve that, although they surely warn of dangers sometimes, experimenting with animals is not really that effective. But then again, using animals is cheaper and ethically more viable than human experimentation. Very sad.

4:30PM PST on Dec 9, 2013

Leslea H. You are absolutely correct. However, in the article's defense, it DOES say that with care and caveats it is used successfully today.

And please, before jumping on me (or Leslea) neither of us are diminishing the dangers of the drug (or any drug used inappropriately, for that matter) It can be very dangerous, life-threateningly so.

3:42PM PST on Dec 9, 2013

Thalidomide was what made testing potential human drugs on animals compulsory. What was never mentioned, though, that Thalidomide had been tested on our fellow animals, and the end result would have been the same as it does not cause birth defects in rats.

Essentially, testing on animals is not to protect humans, but to ensure that when Corporate Drug Companies are sued due to side effects, they pay out less!

Capitalism the new God.

2:55PM PST on Dec 9, 2013

Most prescribed drugs are all very new. Meaning within the past one or two decades. Very close to every single prescription ever released will have serious side effects and force it off the market with a class action lawsuit. There are only a handful of useful prescription drugs.

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