Thalidomide was originally created in Germany to be a non-addictive sedative with a lower risk of dependency for sleep. The drug became popular because it was a morning sickness reprieve that was over the counter and affordable. This drug had an unforeseen effect on fetuses. It caused an influx of miscarriages and congenial mutations. One of the mutations is “the hands and feet are bound to the child’s trunk, absent or underdeveloped” ( Fact Check-FDA did not approve thalidomide for pregnant women in 1950s or 1960s). Other mutations include ocular, auricular, and internal organ mutations. Children unborn and born suffered the effects of Thalidomide. “An estimated 80,000 fetuses had mutations, and 20,000 more who survived were born without limbs” (1). These connections were not found until a significant amount of children were born. Thalidomide was not safe for pregnant women, but we did not find that out until Thalidomide submitted an application to the FDA for the drug to be approved in America.
FDA not approved!
This was Frances Kelsey’s second NDA case, meaning she didn’t yet have a backlog of reviews to get through. She dismissed physicians’ testimonies in favor of actual scientific evidence. She asked for more information from the developer, but they responded with another application. Knowing that thalidomide causes neurological toxicity in adults, she was wary of what effect it would have on human fetuses. Kelsey kept digging and stalled the FDA’s approval (McNeill). There have been no mutations caused by Thalidomide in the US because of Kelsey’s thoroughness. “Kelsey received the President’s Award for Distinguished Federal Civilian Service for her work in protecting the public from the drug.” (1) This very public case increased the basic testing done on pharmaceuticals so much so that “the 1962 drug amendments bill passed that year to change drug regulation” (1). Through Kelsey’s discretion, the US has more regulation and testing required for FDA approval saving countless lives. Thalidomide is not a very safe drug to use and many have suffered because of it, however it’s creation led to the FDA bolstering their requirements for our future.
Other Uses!
In general, Thalidomide helps prevent skin symptoms, nerve damage caused by leprosy, and blocks certain natural substances that cause swelling. Some more uses for Thalidomide is that it treats certain complications of HIV, HIV-associated diarrhea, HIV-associated wasting syndrome, a type of skin cancer. It also treats multiple myeloma by strengthening the immune system to fight cancer cells (Thalidomide: Medlineplus Drug Information). Thalidomide has also been used to treat some types of cancer and tumors, severe weight loss in patients with weakened immune systems, chronic graft versus host disease, and Crohn’s disease (4). A side effect in using Thalidomide to treat cancer is damage to nerves in the fingers and toes. There may also be blood clots, drowsiness, rashes, or dizziness. Some “Doctors found that it helps regulate the body’s immune system and helps control inflammation” (Thalidomide: Research advances in cancer and other conditions). The risks associated with Thalidomide are very high, therefore they must match the risks of illness to be treated.
Creating a safer Thalidomide!
Thalidomide has some benefits for other illnesses, which led to the investigation and creation of drugs that were safer. Two chemically similar drugs are Revlimid and Pomalidomide (Pomalyst). “Pomalidomide is the generic name for the trade name chemotherapy drug Pomalyst ” (Cancer, Cleveland Clinic). There are normally no side effects with this Pomalidomide and if there are side effects, they are reversible and stop when the treatment stops (5). It should never be taken during pregnancy, just like thalidomide. What causes this drug to work against cancerous cells is unknown. It may act by inhibiting the growth of new blood vessels in tumors, enhancing the immune system, or decreasing cytokine and growth factor production (5). Pomalidomide lowers the risks and side effects of Thalidomide. Revlimid is an oral cancer drug that is used for the treatment of multiple myeloma, myelodysplastic syndrome, and mantle cell lymphoma (Revlimid Drug Information: The MMRF). It works against cancer cells partly by supporting the immune system. Revlimid side effects are reversible and has a clearer treatment process, but it has fewer uses. Pomalidomide is effective for many things, however it is not known how it helps decrease cancerous cells. There are pros and cons to both medications, but they are safer than Thalidomide. Thalidomide had an extremely negative effect on the world, but Thalidomide’s errors led to safer regulations and more scientific advancements.
Bibliography
- “Fact Check-FDA Did Not Approve Thalidomide for Pregnant Women in 1950s or 1960s.” Reuters, Thomson Reuters, 27 Aug. 2021, https://www.reuters.com/article/factcheck-thalidomide-fda/fact-check-fda-did-not-approve-thalidomide-for-pregnant-women-in-1950s-or-1960s-idUSL1N2PY2F7. \
- “Thalidomide: Research Advances in Cancer and … – Mayo Clinic.” Thalidomide: Research Advances in Cancer and Other Conditions, 3 July 2021, https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/thalidomide/art-20046534.
- McNeill, Leila. “The Woman Who Stood between America and a Generation of ‘Thalidomide Babies’.” Smithsonian.com, Smithsonian Institution, 8 May 2017, https://www.smithsonianmag.com/science-nature/woman-who-stood-between-america-and-epidemic-birth-defects-180963165/.
- “Thalidomide: Medlineplus Drug Information.” MedlinePlus, U.S. National Library of Medicine, 15 Aug. 2009, https://medlineplus.gov/druginfo/meds/a699032.html.
- Cancer, Cleveland Clinic. “Pomalidomide.” Pomalidomide | Chemotherapy Drug Information | Chemocare.com, https://chemocare.com/chemotherapy/drug-info/pomalidomide.aspx.
- “Revlimid Drug Information: The MMRF.” Themmrf.org, 10 June 2020, https://themmrf.org/multiple-myeloma/treatment-options/standard-treatments/revlimid/#:~:text=Revlimid%2C%20also%20known%20as%20lenalidomide,Revlimid%20is%20manufactured%20by%20Celgene.
