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Friday, April 7, 2017

Thalidomide: One of Many Big Medical Error Tragedies by Kate Raines

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Thalidomide: One of Many Big Medical Error Tragedies

doctor holding sign saying "medical error"Story Highlights
  • Thalidomide was first introduced as a mild sedative that was advertised as so safe it could be used freely by children and pregnant women, for whom it was also prescribed to alleviate the nausea and vomiting associated with morning sickness.
  • Within a few years after introduction of thalidomide, it became clear that the drug will killing many babies and causing severe deformities among many of the children who survived.
  • The pharmaceutical company that developed the drug initially denied responsibility for the harm it caused, but the insufficiency of its pre-marketing studies prompted much stricter laws pertaining to drug safety.
Thalidomide, which was aggressively marketed as a totally safe and effective treatment for morning sickness in early pregnancy, ultimately took its place as the drug that caused “the largest manmade medical disaster in history.”1 Patented in 1954, thalidomide was initially approved as the first non-addicting, non-barbiturate sedative2 and was used as a treatment for respiratory infections.3 Once it became clear that it also relieved nausea and vomiting in pregnant women, the drug quickly grew in popularity.

Not only was thalidomide widely prescribed in the 1950s, it was also considered so completely safe for use by pregnant women that it was sold over the counter and free samples were commonly distributed by doctors. Unfortunately, no pre-licensure clinical trials had been carried out to evaluate the drug’s safety profile in pregnancy and thousands of babies were subsequently born with devastating deformities, including missing arms and legs, with nearly half dying within their first year of life.

Timeline of the Tragedy

The Swiss pharmaceutical company Ciba first synthesized thalidomide as an anticonvulsant drug in 1953, but when it failed early laboratory studies for that use, its development was taken over by the German company Chemie Grünenthal, which introduced the drug as a mild sedative in 1956.
Unrecognized at the time, the first “thalidomide baby” was born to a Chemie Grünenthal employee that same year.4 Combined with aspirin, the drug was marketed as a cure-all for everything from the common cold to cancer.5 By 1958, the drug was available and enthusiastically promoted in 46 countries around the world, distributed on a scale similar to that of aspirin itself.
Thanks to the diligence of one woman newly appointed to the Food and Drug Administration (FDA), the U.S. was not among those countries. One of Frances Oldham Kelsey’s first assignments for the FDA was to review the marketing data for thalidomide.6 Reports of peripheral neuropathy (inflammation of nerves) and lack of persuasive safety data led her to request further information from the drug maker, thus delaying its approval, despite reportedly intense pressure both from the pharmaceutical company anxious to market the drug in the U.S. and from her supervisors at the FDA.7 She never received sufficient data to convince her to approve the drug.
Nevertheless, lack of regulatory approval for sale of thalidomide did not prevent its distribution: The Richardson-Merrell Company, which hoped to market thalidomide as an over-the-counter drug for disorders including “alcoholism, anorexia, asthma, cancer, poor schoolwork, premature ejaculation, and tuberculosis,”8 had distributed upwards of 2.5 million thalidomide tablets to more than 1,200 physicians, who then treated approximately 20,000 patients in so-called “clinical trials” that were shockingly unscientific.
What passed as a clinical trial of thalidomide consisted of handing out samples and seeing if anyone had any complaints. There were no requirements to keep track of those the pills were given to and no guidelines for any kind of follow-up.
At least 207 of the study patients were pregnant during the study period and 17 are known to have given birth to infants with typical thalidomide-induced deformities9 It is estimated that about 40 thalidomide-affected babies were born in the U.S,10 but that was a relatively small number compared to other parts of the world, where upwards of 10,000 infants were affected.

Doctors Recognize the Thalidomide Connection

By 1961, two doctors working independently of each other made the connection between thalidomide use and the rash of children born with a particular set of deformities characterized by “phocomelia,” shortened, flipper-like or missing limbs or ears, and often including severely abnormal internal organs. Widukind Lenz, MD in Germany and William McBride, MD in Australia each became convinced of the role of the drug and each sounded the alarm, alerting medical authorities to their suspicions.
In a lecture given just a few years before his death in 1995, Dr. Lunz said:
I had suspected thalidomide to be the cause of an outbreak of limb and ear malformation in Western Germany for the first time on November 11, 1961, and by November 16, I felt sufficiently certain from continuing investigations to warn Chemie Grünenthal by a phone call. It took ten more days of intensive discussions with representatives of the producer firm, of health authorities, and of experts before the drug was withdrawn.11
The drug was recalled in 1961.

Tragedy Leads to Changes in Drug Approval Process

As a result of the scope of the thalidomide tragedy, significant changes were made to the approval process for drugs in the U.S. Because the drug had passed legal scrutiny without thorough vetting of its safety profile in women who were pregnant or breastfeeding, one of the changes introduced was the requirement for specific safety studies before a drug can be used in pregnancy.

Thalidomide Still in Use

Despite the horrors associated with its previous use, thalidomide is in limited and carefully controlled distribution today, where it may be used to treat leprosy and multiple myeloma. It is also under study for other disorders such as HIV and Crohn’s disease. In some parts of South America and Africa, children are still being born with thalidomide-induced deformities.3

A Long Legal Battle

Even after thalidomide was recalled, the pharmaceutical company continued to deny its role in causing birth defects. Following scandal-filled years in which thalidomide developers were accused of deliberately burying pertinent data and a trial was prematurely settled, Grünenthal finally accepted limited responsibility in 1968. Victims did not receive any kind of compensation until 1973, though the company continued to take the attitude that “the lack of a verdict in the 1970 trial amounts to an exoneration.”4
In 2012, 50 years after the drug was recalled, the Grünenthal Group, original developers and distributors of the drug, finally issued a formal apology to victims of thalidomide. In the apology, Grünenthal CEO Harald Stock said:
We ask for forgiveness that for nearly 50 years we didn’t find a way of reaching out to you from human being to human being… We ask that you regard our long silence as a sign of the shock that your fate caused in us.
Thalidomide survivors and their families called the apology an “insult to the victims of the drug.”15


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