50 years later, tragedy still offers lessons for research professionals

Harald F. Stock, PhD, Chief Executive Officer of Grünenthal GmbH – the German pharmaceutical company that developed thalidomide in the late 1950s – 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 memorial statue depicting a child with phocomelia, the malformed limbs that are the most recognizable consequence of fetal exposure to thalidomide.

Thalidomide was only on the market for a short period of time, but its effects were widespread. Sales of the drug were halted in many countries after it was linked to severe congenital defects in children whose mothers who took it during pregnancy as a sleep aid or to prevent morning sickness. Even though the Food and Drug Administration (FDA) refused to grant approval, there was some exposure in the US from samples and investigational supplies.

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 was approved 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.

Survivors found Grünenthal’s apology hollow and insulting, pointing to a poor track record of dealing with survivors and the company’s failure to conduct adequate preclinical testing before marketing thalidomide to pregnant women. Grünenthal has never accepted responsibility for the tragedy and continues to insist that its drug development program met the standards of the time. Even if this assertion were true, it’s worth considering in a broader historical context. The Nazi Doctors’ Trial had taken place in Nuremberg just over a decade before, and 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 and the Declaration of Helsinki were published, leading to the development of the Common Rule and the system of human research protections that exists today.

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