Heinous Histories collide: Down but not Out.
By, Diepiriye S. Kuku-Siemons
May 2006
Thalidomide was sold in the 1950s as a sleep aid and as relief for morning sickness associated with pregnancy. Originally manufactured by Grünenthal in northwest Germany, the drug was sold in over 50 countries worldwide. Usage of the drug spread like wildfire as pregnant women finally found concerted relief from the myriad of hormonal effects on the body during pregnancy. Until 1960, it was for many a wonder drug. For others it was a nightmare. Recent research is shedding new light on the drug.
Thousands of women gave birth to children with missing or stunted limbs. Discursive reports from around the globe suggested a link between the drug and infants born with stumps instead of limbs. In a total vacuum of empirical evidence proving thalidomide’s link to birth defects, in 1960 Grünenthal sought to expand its market to the United States. Though reports of birth defects associated with thalidomide emerged from around the globe, FDA approval of the drug was initially thought to be facile, if not for one persistent newly appointed FDA reviewer, Frances Oldham Kelsey. Her persistence earned her the highest civilian award in the United States, the President’s Award for Distinguished Federal Civilian Service.
Drug manufacturers, quick to regain public confidence in their products and ethics, looked towards extensive testing on animals before introducing innovations to human testing and later for FDA approval. As a result of the lack of extensive knowledge about thalidomide’s adverse effects on the human fetus, lack of adequate legislation and monitoring of testing, as well as flagrant negligence on the part of the profiteers at the time, many countries passed new laws that required extensive animal testing of pharmaceuticals.
Thalidomide and DMPA
In 1998, the FDA approved thalidomide for the treatment of erythema nodosum leprosum, which is associated with Leprosy or Hansen’s disease. Thalidomide has also proven an effective treatment as a first line therapy in combination with dexemathosone for multiple myeloma. Research is already underway to investigate premature indications of the efficacy of thalidomide (1) in treating HIV-related symptoms, prostate cancer, gliblastoma, lymphoma and Crohn’s disease. Since 2002, Australian researchers have found a doubling of T-cells in 224 cancer patients, promoting the body’s autoimmune response to attack cancer cells.
Despite the newly discovered efficacy of thalidomide, many clinicians are reticent to prescribe the drug to women, given its tainted past. Many medical providers refuse to administer thalidomide to any female of fertile age regardless of the suffering from the very cancers or inflammatory diseases where thalidomide is showing great promise. Sufferers of Behcet's Disease, for example, where symptoms may include debilitating internal ulcers, find relief from thalidomide. A myriad of treatments have failed to relieve these symptoms, rendering many wheelchair bound.
Hope.
There is hope. Some doctors have begun pairing thalidomide treatment with long-tern contraceptives for women of fertile age. Usage of Depo Medroxyprogesterone Acetate (DMPA), also known as Depo Provera, allows patients to benefit from thalidomide, since its 99.7% long-term efficacy alleviates concerns over the birth defects associated with thalidomide.
DMPA is the most pliable method of contraception to pair with thalidomide treatment. As a tri-monthly injectable contraceptive, DMPA eliminates the human error, inconsistency and non-compliancy associated with other methods such as oral contraceptives. Moreover, as opposed to permanent sterilization (e.g. tubal ligation), DMPA is reversible, making it a better option for women who wish to maintain the option to conceive at least four weeks after ending thalidomide treatment. (2) DMPA stimulates appetite, which is often a hurdle in cancer treatment and post-surgery recovery. (3) DMPA assures that both male and female sufferers of some of humanity’s most debilitating diseases can benefit from the most up-to-date advancements in medical research.
(1) http://en.wikipedia.org/wiki/Thalidomide
(2) http://www.fda.gov/cder/news/thalidomide.htm
(3) http://www.cancersymptoms.org/anorexia/medications.shtml
May 2006
Thalidomide was sold in the 1950s as a sleep aid and as relief for morning sickness associated with pregnancy. Originally manufactured by Grünenthal in northwest Germany, the drug was sold in over 50 countries worldwide. Usage of the drug spread like wildfire as pregnant women finally found concerted relief from the myriad of hormonal effects on the body during pregnancy. Until 1960, it was for many a wonder drug. For others it was a nightmare. Recent research is shedding new light on the drug.
Thousands of women gave birth to children with missing or stunted limbs. Discursive reports from around the globe suggested a link between the drug and infants born with stumps instead of limbs. In a total vacuum of empirical evidence proving thalidomide’s link to birth defects, in 1960 Grünenthal sought to expand its market to the United States. Though reports of birth defects associated with thalidomide emerged from around the globe, FDA approval of the drug was initially thought to be facile, if not for one persistent newly appointed FDA reviewer, Frances Oldham Kelsey. Her persistence earned her the highest civilian award in the United States, the President’s Award for Distinguished Federal Civilian Service.
Drug manufacturers, quick to regain public confidence in their products and ethics, looked towards extensive testing on animals before introducing innovations to human testing and later for FDA approval. As a result of the lack of extensive knowledge about thalidomide’s adverse effects on the human fetus, lack of adequate legislation and monitoring of testing, as well as flagrant negligence on the part of the profiteers at the time, many countries passed new laws that required extensive animal testing of pharmaceuticals.
Thalidomide and DMPA
In 1998, the FDA approved thalidomide for the treatment of erythema nodosum leprosum, which is associated with Leprosy or Hansen’s disease. Thalidomide has also proven an effective treatment as a first line therapy in combination with dexemathosone for multiple myeloma. Research is already underway to investigate premature indications of the efficacy of thalidomide (1) in treating HIV-related symptoms, prostate cancer, gliblastoma, lymphoma and Crohn’s disease. Since 2002, Australian researchers have found a doubling of T-cells in 224 cancer patients, promoting the body’s autoimmune response to attack cancer cells.
Despite the newly discovered efficacy of thalidomide, many clinicians are reticent to prescribe the drug to women, given its tainted past. Many medical providers refuse to administer thalidomide to any female of fertile age regardless of the suffering from the very cancers or inflammatory diseases where thalidomide is showing great promise. Sufferers of Behcet's Disease, for example, where symptoms may include debilitating internal ulcers, find relief from thalidomide. A myriad of treatments have failed to relieve these symptoms, rendering many wheelchair bound.
Hope.
There is hope. Some doctors have begun pairing thalidomide treatment with long-tern contraceptives for women of fertile age. Usage of Depo Medroxyprogesterone Acetate (DMPA), also known as Depo Provera, allows patients to benefit from thalidomide, since its 99.7% long-term efficacy alleviates concerns over the birth defects associated with thalidomide.
DMPA is the most pliable method of contraception to pair with thalidomide treatment. As a tri-monthly injectable contraceptive, DMPA eliminates the human error, inconsistency and non-compliancy associated with other methods such as oral contraceptives. Moreover, as opposed to permanent sterilization (e.g. tubal ligation), DMPA is reversible, making it a better option for women who wish to maintain the option to conceive at least four weeks after ending thalidomide treatment. (2) DMPA stimulates appetite, which is often a hurdle in cancer treatment and post-surgery recovery. (3) DMPA assures that both male and female sufferers of some of humanity’s most debilitating diseases can benefit from the most up-to-date advancements in medical research.
(1) http://en.wikipedia.org/wiki/Thalidomide
(2) http://www.fda.gov/cder/news/thalidomide.htm
(3) http://www.cancersymptoms.org/anorexia/medications.shtml
posted by Diepiriye at 2:33 AM
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