Brief Summary
This video explores the tragic history of the drug thalidomide, which caused severe birth defects in thousands of babies in the 1960s. It discusses how the drug was initially marketed as a safe sedative, the role of Dr. Frances Kelsey in delaying its approval in the US, and the long-lasting impact on the victims and their families. The video also covers the drug's later rehabilitation and use in treating various diseases, highlighting the complex ethical considerations around its continued use.
- Thalidomide was a sedative drug marketed as safe, even for pregnant women, but caused severe birth defects in thousands of babies.
- Dr. Frances Kelsey's delay in approving the drug in the US prevented a larger tragedy from unfolding.
- The victims and their families faced immense challenges, with many being abandoned or struggling to access proper care.
- Thalidomide was later found to have beneficial effects in treating certain diseases, leading to its reintroduction, but with strict regulations.
- The story of thalidomide highlights the importance of rigorous drug testing and the complex ethical considerations around the use of potentially harmful drugs.
In the early 1960s, thalidomide, a new wonder drug, was slated to arrive on American shores. Marketed as a safe sedative that could also treat a range of other ailments, it was hailed as a miracle drug. The German company that developed thalidomide, Grünenthal, claimed that even pregnant women could take it safely. Samples of the drug were handed out widely, including to the company's own employees.
However, one doctor at the FDA, Dr. Frances Kelsey, became uneasy with the lack of rigorous scientific studies and the slipshod presentation of safety data provided by Grünenthal and the US distributor, William S. Merrill. Despite tremendous pressure to approve the drug, Dr. Kelsey's stubborn delay of the drug's approval for more than a year prevented a large-scale tragedy from unfolding in the United States.
The reach of thalidomide continued to be felt across the world, including in Trinidad and Tobago, where Jazelle Cole was born with limb deformities. Many families faced immense challenges in caring for their children, with some being abandoned or struggling to access proper care. Some families even resorted to "mercy killings" of their deformed infants.
The drug companies, including Grünenthal, initially argued that the children's deformities were caused by everything but thalidomide, delaying and complicating the legal process for the victims. It took decades for the companies to issue apologies and provide compensation, which many survivors felt was inadequate.
Despite the tragic history of thalidomide, the drug was later found to have beneficial effects in treating various diseases, including tuberculosis, Crohn's disease, multiple sclerosis, and certain types of cancer. In the 1990s, ophthalmologist Dr. Robert D'Amato discovered that thalidomide could starve blood flow to cancerous tumours, leading to its use in the treatment of multiple myeloma.
The reintroduction of thalidomide has come with strict regulations, including the requirement for female patients to undergo pregnancy tests before and during treatment. While the drug's scientific rehabilitation has been beneficial, the video highlights the complex ethical considerations around its continued use, given the lasting impact on the victims and their families.
The thalidomide tragedy led to significant regulatory reforms in the pharmaceutical industry, with the FDA guidelines that we live under today being created in the immediate wake of the scandal. However, the video notes that the scientific rehabilitation of thalidomide has come with a heavy cost, as new cases of thalidomide-related birth defects continue to be reported, particularly in Brazil.
The video concludes by expressing the hope that there will be no further discussions about thalidomide, other than a note in history, and that a solution will be found to "bury the light" and prevent any further tragedies.
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Transcript
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0:00 [Music] afternoon I have several announcements every doctor every hospital every nurse have been notified every woman in this country must be aware that it's most important that they check their medicine cabinet that they do not take this drug in the early 1960s no drug struck more fear into the hearts of pregnant women one of the most horrifying episodes in medical history then thalidomide it changed our relationship with the drugs we use one reason us drug laws are so strict solide and became an example of what many Saw as corporate greed at its worst British thomi children so far have not received any compensation from the rich company that
0:47 made the drug which crippled them so brutally but this dark chapter is only part of thom's enigmatic Story one that continues to reverberate today I had used up every other alternative when I took the [Music] lamide in 1960 a new wonder drug was slated to arrive on American Shores a sedative that was said to also treat a range of other ills a hypnotic as the doctors call it that was the answer to a prayer its generic name was FID divide the Hallmark defining quality of theide
1:35 was its safety so safe that in Germany there was no prescription needed the German company that developed theide KY grunenthal claimed that even pregnant women could take it the drug company had handed out samples of this drug all over the place starting with employees of its own company on Christmas day in 1956 a baby girl was born in Germany without ears and she was the daughter of an employe of the drug company grunenthal no immediate connection was made to thalidomide which soon sold nearly as well as aspirin in some European countries we received it in quantities like a th000 pills there was
2:22 tremendous pressure all over the world to get this wonderful new drug on the market they had2 million tablets ready to go the moment the FDA approved the drug which was almost a foregone conclusion until one doctor came along and began working at the FDA it just so happened that my first application was for the drug selenide I got this because I was new and they thought I should have an easy one to start on but Dr Kelsey was uneasy with what she saw as the lack of rigorous scientific studies and the slipshod presentation of safety data provided by grunenthal and William S Merill the US distributor of the drug the best thing
3:08 that could be said about thalidomide at the time was simply that you could not kill a rat no matter how much thalidomide the rat at with thalidomide being prescribed for Mourning sickness in other countries Kelsey became particularly concerned with what effect it might have on a developing fetus in June of 1961 an article appeared promoting its safety during late pregnancy it was allegedly written by a Dr Ray noon but in fact the article was written by the medical director of the drug company about 6 months later long ignored evidence became public in Germany linking thalidomide to a rash of birth defects although hundreds of thousands of pre-market samples had been provided to American doctors Dr Kelsey's stubborn
3:56 delay of the drugs approval for more than a year had prevented a SAR scale of tragedy from unfolding in the United States Dr Kelsey was absolutely a unique hero in American history but thom's reach continued to be felt across the rest of the world including in Trinidad in Tobago where Jazelle Cole was born when I came along I'm a firstborn and they were a young married couple I mean I was never unloved or not wanted or anything like that but I I would be foolish to think that it was easy for them my disability is uh the official term is felia coming from the Greek meaning shorter arms or flipper like I think
4:41 people always expect that I would have been angry and I'm certainly not angry and never have been long discussed but seldom implemented major regulatory reforms were finally forced on the pharmaceutical industry following the thalidomide Scandal for some time President Kennedy has tried to get to approve new controls but without much success now with the thalidomide scare most of the opposition is melted largely the same FDA guidelines that we live under today were created in immediate wake these regulations were too late for thides thousands of surviving victims across the world who soon became the story Philip AB brador is one example her mother rejected her 10-year-old
5:28 called Davies lead the relatively normal life for a boy without arms my another young mother her husband her sister and her doctor are charged with the mercy killing of her deformed infant I'm one of the lucky ones in that my parents were adamant that I was their daughter and their daughter first before anything else and it was treated as such many were put in homes because they just didn't know what to do some families battled with doctors to have amputation of fingers and toes and whatnot to accommodate these Prosthetics many families were broken irrevocably instead of quickly settling the drug companies dug in with
6:15 grunenthal originally arguing that the children's deformities were caused by everything from nuclear fallout to botched home abortions anything but the lamide it was a very long and difficult process most cases were eventually settled but litigation continues with some survivors saying the original settlements cannot cover the cost of their Specialized Care grunenthal didn't apologize to its victims until 2012 50 years after the tragedy unfolded they issued a statement saying that it has taken them the 50 years to come forward to say anything because they were shocked they don't have a right to be shocked the shock doesn't belong to them
7:02 despite all that the limides victims endured over the decades they could long take solace in one simple fact theide is now banned everywhere the now banned pomide the drug was banned in 1962 and I would have liked to have seen it never used again there's a tremendous amount of luck in science it's almost like an Easter egg hunt in 1992 while conducting Research into macular degeneration opthalmologist Robert deato began his own hunt this one to find a pill that might restrict blood vessel growth I started searching for drugs that cause some sort of damage to a fetus a birth defect and at the top of
7:48 this list was thalidomide although thalidomide had been banned around the world unbeknownst to many the drug was later made available for limited humanitarian use that thanks to a chance Discovery in 1964 a doctor in Jerusalem was taking care of a patient who had such severe leprosy that he was in pain and couldn't sleep he decided to treat the patient with lomite to see if it would help with the sleep and began to notice that there was also improvements generally in the leprosy after much trial and error Dr damato finally had a similar breakthrough when he demonstrated that the lamide could starve blood flow to cells a discovery that held the potential for treating cancerous
8:35 tumors the people that really understood the results were excited because we had a tool that we didn't have before but the knee drug reaction was This Is A Dangerous Drug no one would ever want to use it there was thousands of victims that still remain there had been a promise that flamide would never be developed again we had to make a decision what position we were going to take many would have thought and expected that we would have been screaming no no no no no but following a surge of reports about promising studies that's not what happened we are nervous we are of course frightened and dismayed but we realize that this is not a perfect world theide is back the Food
9:20 and Drug Administration says the lamide will be the most restricted drug ever distributed female patients taking the drug will even have to submit to PR [Music] tests since then phalidomide has gone on to combat a surprising variety of diseases from tuberculosis and Crohn's disease to Multiple Sclerosis and symptoms of HIV and AIDS and demato's hunch about the drugs effect on cancerous tumors paid off in a groundbreaking treatment for certain types of the disease lamine and its derivatives have become the primary treatment for multiple Myoma it it's a very fine line that I walk and many of us walk when we think about theum mide in today's world
10:07 clearly you can see what it has done to the thousands of us who are still on this Earth but if it provides some kind of assistance help relief of suffering then I cannot in good conscience be opposed brener who saw the Curative Powers firsthand after being prescribed it for a deadly skin disease says that the drug circuitous history tells us a great deal about The Accidental nature of drug Discovery it's kind of surprising I think to most people to learn that drugs are in fact developed and then become as they're called a drug in search of a disease when you have a drug that has a
10:52 powerful activity whether it's negative or not that powerful activity could be used for something something good if you could figure out what that was but for all its benefits the scientific Rehabilitation of thalidomide has come with a heavy cost we were told this could never happen again in Brazil where the drug is used extensively to treat leprosy researchers report that the lamide children continue to be born as many as 100 since 2005 by one recent estimate 50 years down the road I would like to think that there's no such thing as thin M that we have created something we have developed something that would allow us
11:39 to bury the L light literally destroy it get rid of it so that there are no further discussions other than a note in [Music] history [Music]
