Thalidomide was never legal in the USA.
Thalidomide in America
Posted on November 2, 2011 | By Steve W. Berman
On September 18, 1962, a baby boy was born in the small town of Brownfield, Texas. Immediately after he was born, doctors noted that the boy had serious and disfiguring birth defects. He was missing his right leg, including his foot. He had no fingers on his right hand and his right arm ended above the elbow.
The baby, named Philip Yeatts, has lived his life without the use of his right leg or hand. He persevered and grew into a strong-willed and determined man. In fact, he became a professional racecar driver, using a specially modified car to win a championship in the U.S. Legends Series in 2008.
Its tempting to end Philips’ story there, and honor his courage and determination to overcome his disability. But there is much more to this story. We believe that Philip was not simply victim of poor luck. We think that his birth defects were a preventable tragedy, side effects from a dangerous drug called thalidomide.
Those of us who were alive in the early 1960s remember the tragedy caused by thalidomide. The drug was widely available in Europe, given to pregnant women to ease morning sickness. We now know that the drug caused debilitating birth defects, resulting in thousands of infant deaths and shocking deformations throughout Europe and elsewhere around the world. The pictures Americans saw of thalidomide babies shocked the nation’s collective consciousness, infants with what appeared to be flippers where arms should be, among other severe malformations.
Yet, at the same time the tragedy seemed so far away.
The FDA never approved the drug here, so it was never widely used in the U.S., or so we were told. Later, Billy Joel’s song “We Didn’t Start the Fire,” would juxtapose the European tragedy, “children of thalidomide,” with a much more American tragedy, “Starkweather homicide.”
The belief that America avoided the thalidomide tragedy has persisted for nearly 50 years now, but we believe we have discovered evidence that casts doubt on the story. Newly uncovered and translated documents, combined with new medical advances that help us to better understand how thalidomide works, suggests that there may be many victims in the United States that were never identified.
Even worse, our research has uncovered evidence that the thalidomide tragedy was foreseeable and preventable, but due to the greed of a number of drug companies, safety risks were overlooked and covered up.
The origins of thalidomide take us back to post-war Europe, specifically to the early 1950s in Germany. In 1953-54, German pharmaceutical company Chemie Grunenthal synthesized thalidomide for the first time, and subsequently received a German patent to begin producing and distributing the drug. Grunenthal originally considered the drug a panacea, or at least marketed it as such, claiming it could cure everything from the common cold to premature ejaculation.
New documents suggest that on Christmas Day 1956, an earless baby was born to the wife of a Grunenthal employee who had taken thalidomide during pregnancy. Yet, instead of slowing down development and running more tests, the company continued to push ahead. A mere 10 months later, in October 1956, the drug was released for commercial, over-the-counter sale in Germany.
In 1956, the company entered into an agreement with U.S. pharmaceutical company Smith Kline and French (SKF) to begin domestic testing of thalidomide on animals and humans, including pregnant women.
By August 1958, a pregnant woman participating in the SKF trial delivered a malformed baby. Unlike Grunenthal, who decided to move ahead with the drug, SKF declined to market it in the U.S. However, from what we have seen, the company never let the public know about its test results. The failure to disclose test results is no trivial matter; it is possible that if SKF had sounded an alarm bell early, the distribution of thalidomide in the United State and elsewhere might have been slowed, and less people would have been exposed to the drug.
Having failed to convince SKF to distribute the drug,
Grunenthal signed a U.S. distribution agreement for thalidomide with the William S. Merrell Company. Merrell began human trials simultaneous with animal trials in February 1959, and expanded the trials to include pregnant women in May 1959, all while conceding that it had no access to any human clinical safety data.
We believe that sometime during 1959, Grunenthal destroyed its testing data.
In September 1960, Merrell submitted a New Drug Application (NDA) with the FDA for commercial sale of thalidomide, which Merrell named Kevadon. The proposed label in the application specified that the drug was intended for use by pregnant women.
One month later, Merrell began its “Kevadon Hospital Program,” a series of large-scale “clinical trials” that we believe were nothing more than a marketing effort to pave the way for expected sales of the drug in the United States. Merrell kept disorganized and occasionally nonexistent records of who, where and when Kevadon was distributed and even informed doctors that they did not need to keep records of the “studies” either. Again, the drug was recommended for use treating morning sickness in pregnant women.
As part of this trial, we believe that more than 2.5 million doses of the drug were given to more than 20,000 patients. While those trials ran, the FDA’s Dr. Frances Kelsey repeatedly denied Merrell’s application to sell thalidomide, deeming its testing to be incomplete. She encouraged testing on pregnant animals.
Continued...
Fast forward:
United States
On July 16, 1998, the FDA approved the use of thalidomide for the treatment of lesions associated with Erythema Nodosum Leprosum (ENL). Because of thalidomide’s potential for causing birth defects, the distribution of the drug was permitted only under tightly controlled conditions. The FDA required that Celgene Corporation, which planned to market thalidomide under the brand name ''Thalomid'', establish a System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) oversight program. The conditions required under the program include; limiting prescription and dispensing rights only to authorized prescribers and pharmacies, keeping a registry of all patients prescribed thalidomide, providing extensive patient education about the risks associated with the drug and providing periodic pregnancy tests for women who are prescribed it.
On May 26, 2006, the U.S. Food and Drug Administration granted accelerated approval for thalidomide (Thalomid, Celgene Corporation) in combination with dexamethasone for the treatment of newly diagnosed multiple myeloma (MM) patients. The FDA approval came seven years after the first reports of efficacy in the medical literature and Celgene took advantage of "off-label" marketing opportunities to promote the drug in advance of its FDA approval for the myeloma indication. Thalomid, as the drug is commercially known, sold over $300 million per year, while only approved for leprosy.
http://www.news-medical.net/health/History-of-Thalidomide.aspx
