Fred A. Baughman, Jr., M.D. and Craig Hovey
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 Only then, in 1960, was thalidomide banned around the world. There were up to 12,000 cases worldwide. But the US was spared. Reviewing the world's literature on thalidomide, Dr. Frances Kelsey of the FDA found reason for alarm and lead the FDA refusal to license thalidomide for marketing in the US. But we saw occasional cases in the US, largely in the offspring of Armed Forces families stationed abroad; and there were cases aplenty in Canada, many of which were seen in amputee clinics in the states. That was the late fifties and early sixties. The FDA no doubt protected the public good. |
Roberta Bivins
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 And then there were the failures of biomedicine, rendered more visible by its many successes: iatrogenic disease, nosocomial infection, antibiotic resistance, thalidomide.
Western consumers were disenchanted by science, and living in societies rapidly transforming around political movements—including feminism, environmentalism, anti-racism, and multiculturalism?dedicated to redressing social imbalances which had often been reinforced by the science of earlier eras. |
Mike Adams, the Health Ranger
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 Hey pregnant women, take thalidomide for your cancer! Don't worry about your unborn children. This chemical is perfectly safe! Result: 10,000 children born with physical deformities. Doctors continued to use infants and pregnant women in pharmaceutical experiments for the next fifty years. See Vaccines and Medical Experiments on Children, Minorities, Woman and Inmates (1845 - 2007).
1960's
Feed your children processed foods! White bread is good for them, don't you know? And monosodium glutamate is perfectly healthy for children, which is why food companies add it to baby food! |
Bill Sardi
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 Anything that interferes with new blood vessel formation, as does the drug thalidomide, results in birth defects. The cancer-resistant rodents in the Sloan Kettering trial had their "id" genes disabled during adulthood, when they were largely inactive. [Nature 401:670-7, 1999]
In another genetic experiment, researchers used telomerase, an enzyme that repairs the ends of genes, called telomeres, to produce cells that are immortal, or perpetually young. The idea was to see if youthful cells would resist cancer. |
Andreas Moritz
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 The patients developed symptoms similar to the ones caused by the drug thalidomide (which recently has been reintroduced for specific disorders). Mothers who had taken large amounts of B6 during their pregnancy also reported deformities in their children's bodies. It took a long time before the nerve damage was linked to vitamin poisoning. As it turned out, many patients, who had been diagnosed with multiple sclerosis, were poisoned by vitamin B6. There are many unsuspecting people taking vitamin B6 today without the faintest idea that they are slowly injuring their bodies from the inside out. |
D. Lindsey Berkson
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 Before thalidomide, medical experts believed that the placenta acted as a complete protection for the developing baby from harmful outside influences. The thalidomide tragedy shattered that theory.
Many other children who were exposed to thalidomide in the womb had perfectly fine limbs, but instead had problems with heart and organ malformations, brain damage, deafness, blindness, autism, and epilepsy. Some were spared any ill effects. It appeared to be the timing of thalidomide ingestion rather than the dose that influenced the babies' deformities. |
Fred A. Baughman, Jr., M.D. and Craig Hovey
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| FDA—PARTNER IN VICTIMIZATION OF THE PUBLIC
In the late fifties thalidomide became the sleeping pill of choice, primarily in the UK and continental Europe, but actually worldwide. Soon there followed an epidemic of thousands of newborns with phocomelia—seal-like congenital amputations, previously almost unheard of. After rounds of denials from the drug's various manufacturers, the persistence of Professor Widikund Lenz, a German geneticist, made clear the causal association of the drug. Only then, in 1960, was thalidomide banned around the world. There were up to 12,000 cases worldwide. |
Shannon Brownlee
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 Amendments strengthening the Food, Drug, and Cosmetics Act were passed in 1962 in the wake of thalidomide, the drug that caused devastating birth defects when it was given to pregnant women. A series of midair collisions prompted the passage of the Federal Aviation Act twenty years later. Today, heart-wrenching stories like that of Deamonte Driver are helping focus the nation's attention once again on the plight of the uninsured. One state, Massachusetts, has already passed legislation aimed at insuring all residents. Others are considering similar proposals. |
Melody Petersen
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 The companies could no longer distribute samples of an unapproved drug to doctors for experimental purposes as Merrell had done with thalidomide.
The law also required drug companies to tell regulators about the injuries and deaths that had been blamed on their products. It became illegal to keep these reports hidden in corporate file drawers. In addition, the law forced the companies to change their promotional tactics. No longer could they only describe the expected benefits of a drug in their advertisements, which were then directed only at physicians. |
| She had been reviewing the application that Merrell submitted to gain approval to sell thalidomide in the United States. Dr. Kelsey had become concerned, however, about the poor quality of the company's scientific data. She had also found a report in the British Medical Journal in December 1960 that said the sedative appeared to damage the nerves of some patients. Merrell executives had become furious with Dr. Kelsey for delaying the sale of their product as she asked them for more data to prove it was safe. |
Fred A. Baughman, Jr., M.D. and Craig Hovey
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| I doubt the FDA would have banned thalidomide. Just as they do today with addictive, dangerous, and deadly, but non-essential, drugs (sleeping pills, pain pills, psychiatric pills), they would have found a way to champion the marketplace cause of thalidomide.
In the mid-nineties they resisted calls to ban the pediatric use of tricyclic antidepressants despite reports of sudden deaths, such as in the cases of Shaina Dunkle and Cameron Pettus.
In 1998, the FDA was forced to remove three drugs from the market because of safety problems, more than in any similar period in its history. |
Melody Petersen
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| In promotional materials, Griinenthal said that thalidomide was "completely safe." With these promises, millions of people outside America had begun taking the drug to help them sleep. Foreign doctors were also giving the medicine to pregnant women to alleviate the nausea and vomiting of morning sickness. The German company proclaimed in its advertisements that the drug was "especially well-suited for calming down anxious, nervous and restless children . . . Excellent for babies. |
Jeffrey M. Smith
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 The thalidomide of Genetic Engineering"
1. One brand of the supplement L-tryptophan created a deadly US epidemic in the 1980s.
2. The company genetically engineered bacteria to produce the supplement more economically.
3. Their product contained many contaminants, five or six of which were suspected as the cause of the disease.
4. Discovering the epidemic required multiple coincidences, suggesting that adverse reactions to GM foods may be hard to identify. |
Melody Petersen
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| It is now estimated that thalidomide caused deformities in some eight thousand infants around the world. Thousands of other babies were so malformed that they died before they were born. Only about forty of those cases were in the United States, although there has never been an accurate count. Some of the worst cases in America were reported in patients in Cincinnati who had been treated by Dr. Nulsen. |
Fred A. Baughman, Jr., M.D. and Craig Hovey
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| Frances Kelsey of the FDA found reason for alarm and lead the FDA refusal to license thalidomide for marketing in the US. But we saw occasional cases in the US, largely in the offspring of Armed Forces families stationed abroad; and there were cases aplenty in Canada, many of which were seen in amputee clinics in the states. That was the late fifties and early sixties. The FDA no doubt protected the public good. The drug companies urging FDA approval and marketing did not win out.
What about today? I doubt the FDA would have banned thalidomide. |
| Reviewing the world's literature on thalidomide, Dr. Frances Kelsey of the FDA found reason for alarm and lead the FDA refusal to license thalidomide for marketing in the US. But we saw occasional cases in the US, largely in the offspring of Armed Forces families stationed abroad; and there were cases aplenty in Canada, many of which were seen in amputee clinics in the states. That was the late fifties and early sixties. The FDA no doubt protected the public good. The drug companies urging FDA approval and marketing did not win out.
What about today? |
Melody Petersen
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| Public outrage about the thalidomide tragedy stirred Congress to reconsider Senator Kefauver's proposal. On October 10, 1962, members of both the House and the Senate unanimously passed the Kefauver-Harris amendments. None of Kefauver's proposals aimed at reducing drug prices was left in the bill, but the new law greatly strengthened the FDA's control over the marketing and promotion of prescription drugs. It also required the companies once again to focus on good science. |
| Merrell had explained that the doctors would be part of "a trial" of thalidomide. Actually, the "trial" was later revealed to be more about promoting the sleeping pill than about gathering scientific information. For one thing, the company's marketing department was in charge of it. And according to internal documents later obtained by The Sunday Times of London, Merrell told its sales reps that the "objective" of signing up doctors to participate in the trial was "for the purpose of selling them on Kevadon," the company's brand name for the drug. |
Ray Strand, M.D.
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 An image that will forever be imprinted on my mind, this helpless infant was one of more than eight thousand that thalidomide impacted. It not only affected limbs, but almost every organ in their tiny bodies, including the heart, gastrointestinal tract, liver, and urinary tract. It was a tragedy of unequaled proportions, because it was the fault of innocent, unknowing mothers taking a drug for a minor problem during pregnancy. Had they known the risks involved, no European mother would have ever considered taking thalidomide. |
Dr. Timothy Scott
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 Many countries began demanding various animal studies that had not been required before thalidomide. The FDA further tightened its requirements. It was this very conservative approach that caused many to believe that if a drug was approved in America, it must be quite safe.
The problem with this very cautious and, hence, very slow process is that it also prevents newly discovered, life-saving drugs from getting to the market quickly. The person with a life-threatening disease might die long before the drug that could save his or her life is ever approved for use. |
D. Lindsey Berkson
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| Does the word thalidomide ring a bell? It was a prescription drug given to pregnant mothers with morning sickness in the early 1960s that produced offspring with flippers instead of arms and legs. Before thalidomide, medical experts believed that the placenta acted as a complete protection for the developing baby from harmful outside influences. The thalidomide tragedy shattered that theory. |
Dr. Timothy Scott
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| Even among those who have heard about thalidomide, many are not aware that, though it was prescribed in countries all around the world, it was never approved for use in the United States.18 The FDA's approval process, though inadequate by today's standards, was more stringent than that found in most countries. Those more demanding standards saved countless babies from the terrible physical effects continuing to plague thousands of adults in countries all across the world. |
Patrick Quillin, PhD,RD,CNS
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 However, lets compare the risk to benefit ratio of thalidomide and alternative cancer treatment:
-Thalidomide.
>Benefits: an entirely elective drug used to relieve the mild symptoms of nausea.
>Risks: taken during an extremely vulnerable phase of life, pregnancy. We know, for instance, that small amounts of alcohol will not harm most healthy adults, but the same amount of alcohol could create permanent birth defects when consumed by pregnant women.
The results of thalidomide use were catastrophic, with thousands of newborn infants suffering irremedial birth defects. |
| Meanwhile, the Food and Drug Administration cites examples in which premature permission to use newly discovered therapies ended in disaster--like the thalidomide situation. However, lets compare the risk to benefit ratio of thalidomide and alternative cancer treatment:
-Thalidomide.
>Benefits: an entirely elective drug used to relieve the mild symptoms of nausea.
>Risks: taken during an extremely vulnerable phase of life, pregnancy. |
Ray Strand, M.D.
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| Of the infants that were exposed to thalidomide between days 35 and 48 after their mothers' last menstrual period, 20-30 percent were born with severe limb and organ defects.6
I vividly remember seeing a baby on the front cover of a major magazine with no legs, and arms that were developed only down to the elbows. An image that will forever be imprinted on my mind, this helpless infant was one of more than eight thousand that thalidomide impacted. It not only affected limbs, but almost every organ in their tiny bodies, including the heart, gastrointestinal tract, liver, and urinary tract. |
| But Americans' faith in its protective regulator didn't take its giant leap forward until after a terrifying international event known as the thalidomide Tragedy.
Thalidomide: The Titanic of the Pharmaceutical Industry
The Titanic has become the metaphor for the disastrous consequences of our untainted belief in the safety and invincibility of technology. |
Dr. Timothy Scott
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| In the case of thalidomide, the special circumstance was pregnancy.)
More than half of those beginning an antidepressant (whether an older tricyclic antidepressant or a newer SSRI antidepressant) have one of the more common side effects.17 Examining the most popular antidepressant ever sold (Prozac) and what is currently the most popular antidepressant (Zoloft), we can get some idea about how often these mind drugs affect both the mind and the body. |
Fred A. Baughman, Jr., M.D. and Craig Hovey
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| Just as they do today with addictive, dangerous, and deadly, but non-essential, drugs (sleeping pills, pain pills, psychiatric pills), they would have found a way to champion the marketplace cause of thalidomide.
In the mid-nineties they resisted calls to ban the pediatric use of tricyclic antidepressants despite reports of sudden deaths, such as in the cases of Shaina Dunkle and Cameron Pettus.
In 1998, the FDA was forced to remove three drugs from the market because of safety problems, more than in any similar period in its history. |
Jacky Law
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 Indeed, the condition was christened phocomelia because its limb manifestations were so similar to the flippets of a seal. 'Thalidomide is an excellent example of how regulators should not allow themselves to be hustled to approve drugs for marketing reasons or because patent term is eroded by delay,' says former UK medicines regulator, Dr John Griffin. 'Regulators should be not influenced by these commercial considerations.'23
The side effects of the drug were so dramatic that the link between them and the new drug soon became apparent. And Kelsey's standing was revised accordingly. |
D. Lindsey Berkson
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| It appeared to be the timing of thalidomide ingestion rather than the dose that influenced the babies' deformities. While some of the mothers with limbless children had taken only two or three thalidomide pills during their entire pregnancy, ingestion occurred between the fifth and eighth weeks when the babies' arms and legs were developing.
An interesting note is that eleven out of 380 children born to thalidomide victims in the United Kingdom have limb defects, a figure which is five times higher than the usual rate for the general population. |
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