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Thalidomide—The Good and The Bad

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I was listening to the BBC world news the other day and a story caught my attention. The story was about an epidemic of birth defects in Brazil, particularly in the slums of Rio de Janeiro.[1] Pregnant women had apparently been taking Thalidomide—a drug I thought had been taken off the market decades ago. Apparently it has not.

Thalidomide was a part of my childhood. I remember when I went to primary school and noticed a girl in my year with a different arm. Like all children, I was curious about it. Her arm was short with three fingers at the end of it. The fingers worked, and she could use her arm really well. She was also very fast at running. Nevertheless, this student was “different.” When I told my mother about her, she explained that a drug called Thalidomide had caused this. In fact, my mother explained that she herself had been offered the drug during her pregnancy with me, but fortunately had refused or I might have been born with a short arm too.

The Grünenthal Group developed Thalidomide in 1953 to relieve insomnia, and it was then found to help pregnant women deal with morning sickness. Women like the Duchess of Cambridge who experienced hyperemesis—severe morning sickness—were offered the wonder drug as a cure for pregnancy-induced nausea. Thalidomide was licensed for use in Britain in 1958. I was born in 1960.

images (6)In 1961, an Australian doctor, William McBride, wrote to the medical journal, the Lancet, noting an increase in the number of babies born with abnormal limbs at his hospital. In every case the mother had taken thalidomide during pregnancy. Not all the infants had malformations of limbs. Some were blind, others deaf, some had very severe heart malformations, spinal cord defects, cleft lips, genital abnormalities, kidney malformations or severe brain damage. Not all survived infancy. The most visible confirmation that thalidomide caused fetal “abnormalities,” however, were the shortened limbs of the “thalidomide babies.”

Thalidomide was withdrawn from use in Britain shortly after McBride’s letter in 1961.  Yet, over 2000 babies were born with affected limbs in Britain between 1958 and 1961 and more than 10,000 worldwide. So as I listened to the BBC report, I was astonished to hear that Thalidomide was still available. I thought the drug had been removed completely. Apparently not. In Brazil, despite the evidence of birth defects, Thalidomide was re-licensed in 1965 as a treatment for one of the most painful aspects of leprosy—skin lesions. By 2004, doctors started using Thalidomide to treat leprosy and AIDS in other developing countries. Most recently, the European Union has licensed Thalidomide for use in the elderly to treat myeloma. No country allegedly uses the drug for morning sickness in pregnant women because its fetal effects have been well documented.

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Unfortunately, pregnant women do still take Thalidomide, particularly in Brazil. One of the reasons is that Brazil has an enormous leprosy problem and reports 30,000 new cases each year. Doctors use Thalidomide to help leprosy patients sleep (the drug was originally developed for insomnia) and because it has anti-inflammatory properties that reduce the pain associated with the skin lesions. In Brazil, the majority of leprosy patients live in the slums around Rio de Janeiro. All live in poverty, many are illiterate or very poorly educated, and large numbers are women of childbearing age. Most of the leprosy sufferers do not have access to adequate healthcare, but when the lesions become too painful they either drag themselves to clinics or, more often, take pills originally prescribed to a friend or family member. According to the BBC report, the pills are not labelled “for men only,” and men are not routinely told to keep “pills out of the reach of women.” Additionally, women of childbearing age are not given contraceptives or told to avoid pregnancy while taking Thalidomide. As a result, over 100 infants have been born affected by Thalidomide in the past year.

Leprosy_PR_2010

Leprosy, also known as Hansen’s Disease, is caused by the bacteria, Mycobacterium leprae and Mycobacterium lepromatosis.

The BBC didn’t report any findings in other developing countries where the drug is also used. At first I thought the reason the BBC chose to focus on Brazil was because of the recent spate of protests against government policies. Then I thought maybe the interest in Rio de Janeiro was because the 2016 Summer Olympics are scheduled for Rio. But after searching around on the internet for more articles, reports, and discussions, I found nothing about “thalidomide babies” in other countries—just Brazil.

There are certainly other drugs on the market that have harmful side effects. Accutane, widely prescribed in the developed world for acne, for example, has very serious side effects if taken by a woman while pregnant. That has not stopped its use. When I was prescribed Accutane in the mid- 1990s my doctor explained the side effects of the drug and would only prescribe it for me on MINOLTA DIGITAL CAMERAcertain conditions. He asked me to sign a triplicate form promising to use two forms of contraceptives and if these failed, abort any resulting pregnancy. The paperwork was witnessed, and I received one copy along with a prescription for an oral contraceptive pill, a box of latex condoms, and spermicide. I left the office knowing that under no circumstances could I afford to get pregnant while taking Accutane and for several months following the treatment. I was informed and I gave my consent. I wonder if patients prescribed Thalidomide in developing countries receive such warnings and sign triplicate paperwork agreeing to the terms of use. My gut feeling is that they don’t, and I have not been able to find out the details of the informed consent process used in Brazil.

So does that mean that Thalidomide should not be prescribed to alleviate the painful lesions of leprosy? Campaigners, doctors, and leprosy sufferers argue that Thalidomide is absolutely vital to treat the worst symptoms of the disease. They agree that the benefits clearly outweigh the known risks. Yet this assumes that everyone who takes the drug is aware of the known risks and has received adequate education about its dangers.

Interestingly, in India, another nation with a huge leprosy problem, Thalidomide is never used. The World Health Organization does not recommend its use; instead the WHO recommends prednisolone (prednisone in the US) to reduce inflammation and pain, and the anti-leprosy drug clofazimine to heal the lesions and prevent further outbreaks. Thalidomide, according to the WHO, merely reduces inflammation and induces sleep (no small thing for those who cannot sleep because of pain), while clofazimine prevents actual outbreaks.[2]

So why does Brazil continue to use Thalidomide? Dr. Eduardo E. Castilla, a physician in Brazil, suggests that one of the main reasons Thalidomide is used in Brazil is because it is an addictive drug. Many leprosy patients become addicted to its tranquilizing effects and need more and more to achieve the same results. In addition, claims Dr. Castilla, although Thalidomide is indicated only for use in acute episodes of neuritis caused by the leprosy lesions, healthcare workers that serve the slums around Rio De Janeiro often ignore the guidelines and give Thalidomide to addicted and suffering patients for months, even years, instead of just a few days as the drug is intended. Castilla also argues that there is evidence in Brazil that second generation babies with similar deformities are being born to first generation Thalidomide “victims.” (I have not been able to find any more information on second generation “Thalidomide babies”). But I was struck by another point that Dr. Castilla made. Research to date (done mainly in the 1960s) has focused on the effects of Thalidomide on the fetus from maternal use of the drug. Castilla maintains that there has been no similar research into the potential effects of Thalidomide on the male sperm. If Thalidomide continues to be used widely in developing countries for the lesions of leprosy and AIDS, and, since 2008, as treatment for bone-marrow cancer and myeloma in developed countries, shouldn’t we start to ask more questions and demand more research?[3]

Thalidomide was sold under the brand name "Distaval"

Thalidomide was sold under the brand name “Distaval”

Thalidomide is alive and well sixty years after it was first introduced for morning sickness. Most of the babies born with Thalidomide-induced abnormalities have lived with them their entire lives. Some have their entire lives yet to live. Some Thalidomide babies died in infancy, some enjoy fulfilled and active lives. Others are yet to be born. In 2009, a group of scientists at the University of Aberdeen claimed to have solved the “50-year puzzle” after discovering how Thalidomide causes limb defects. They found that a component of the drug prevented the growth of new blood vessels in developing embryos and that this stunted limb growth.

I wonder about the girl I knew back in primary school.

I wonder how she dealt with the questions, the stares, and the limitations Thalidomide gave her.

I wonder if she is still a good runner?

I wonder if she would remember me?

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[1] The written report can be found at Angus Crawford, “Brazil’s new generation of Thalidomide babies,” 23 July 2013, http://www.bbc.co.uk/news/magazine-23418102

[2] Dr. VPanniker, Medical Officer, Communicable Diseases (Leprosy Group) WHO, “The Return of Thalidomide: New Uses and Renewed Concerns.”

[3]Dr. Eduardo E. Castilla ”Thalidomide, a Current Teratogen in South America,” http://www.thalidomide.org/web/children-born-i-brazil/#sthash.7SSido8n.dpuf

5 Comments Post a comment
  1. Hi! I’m a qualified pharmacist and your post has really left me completely surprised as I also thought that thalidomide had been taken off the market. I had some vague idea that it was still being used, but strictly off limits for nausea during pregnancy. It was a terrible tragedy to all the deformations and damages. I flip at how humanity sometimes just doesn’t learn from history.

    September 3, 2013
  2. Glenn Harrison #

    Hi i am a English thalidomide person and was very inerested in the comments about 2nd generation issues because i have a daughter who has similar problems to myself

    September 4, 2013
    • Sandra Trudgen Dawson #

      Glenn, Thanks so much for sharing. I don’t have any articles about second generation issues but this was a comment in article by the Brazillian doctor. Your situation does suggest that there needs to be more research into the drug.

      September 4, 2013
      • Glenn Harrison #

        i have been trying for years now,but when your up against massive drug companies and govements its very hard indeed, but we keep trying and looking so everything helps large or small

        September 4, 2013
  3. Enrique Plasencia #

    Hi Sandra:
    I’m a first generation thalidomide affected, mexican. I knew since the 1990s that this medicine was used in Brazil for treatment in leprosy and boys and girls born with short arms or legs. I knew that in Mexico one leprosy hospital tryed to use (was in 1968) but central gobernment authority denied the petition. I knew about the Brazilian case by this Swedish publication, that now is online. Enrique Plasencia http://ffdn.se/web/children-born-i-brazil/

    September 4, 2013

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