Harald F. Stock, PhD, Chief Executive Officer of Grünenthal GmbH – the German pharmaceutical company that developed thalidomide – recently offered a public apology to those who were harmed by the drug. The occasion for Dr. Stock’s address was the unveiling of a statue honoring the victims. The statue, located in the western German city of Stolberg, depicts a child with the malformed limbs that are the most recognizable consequence of fetal exposure to thalidomide. The clinical term for these deformities is phocomelia.
Thalidomide was only on the market for a short period of time (1957-1962) but its effects were widespread. Sales of the drug were halted in many countries after it was linked to severe congenital defects in the children of women who used it during pregnancy as a sleep aid or to prevent morning sickness. Although the Food and Drug Administration (FDA) refused to approve the drug at the time, there was some exposure in the US due to clinical trials.
Thalidomide never completely left the world market and finally received FDA approval in 1998 for the treatment of erythema nodosum leprosum (ENL), a complication of leprosy. It gained an approved indication for multiple myeloma in 2006 and continues to be studied for other indications. Patients taking thalidomide, now known as Thalomid, and its derivative lenalidomide, marketed as Revlimid, are required to participate in restricted distribution programs aimed at minimizing the risk of fetal exposure. Both drugs are marketed in the US by the Celgene Corporation.
Critics of the company point to a poor track record of caring for survivors. Grünenthal has strenuously avoided taking responsibility for the tragedy and continues to assert that its drug development program met the standards of the time – a time not long after the conclusion of World War II put an end to the horrific human experimentation program of Nazi Germany, when the Public Health Service syphilis experiments and other abuses of human research participants were beginning to come to light in the US. It would be another 18 years before the Belmont Report was published, leading to the development of the Common Rule and the system of human research protections that exists today.
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