Infamous Birth Defect Drug Thalidomide's Unlikely Comeback

TEASE:

DATE: August 1, 1962

ARCHIVAL (PRESIDENTIAL NEWS CONFERENCE, 8-1-62):
PRESIDENT JOHN F. KENNEDY: Afternoon. I have several announcements… Every doctor, every hospital, every nurse has been notified. Every woman in this country must be aware, that it’s most important that they check their medicine cabinet and that they do not take this drug.

NARRATION: In the early 1960s, no drug struck more fear into the hearts of pregnant women…

ARCHIVAL (CBS NEWS, 12-26-75):
WALTER CRONKITE: One of the most horrifying episodes in medical history.

NARRATION: …than Thalidomide. It changed our relationship with the drugs we use.

ARCHIVAL (ABC NEWS, 3-23-81):
ANCHOR: One reason US drug laws are so strict: Thalidomide.

NARRATION: And became an example of what many saw as corporate greed at its worst.

ARCHIVAL (NBC NEWS, 12-25-72):
REPORTER: British Thalidomide children so far have not received any compensation from the rich company that made the drug which crippled them so brutally.

NARRATION: But this dark chapter is only part of Thalidomide’s enigmatic story. One that continues to reverberate today.

ROCK BRYNNER: I had used up every other alternative when I took Thalidomide.

ACT I:

NARRATION: 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.

ARCHIVAL (CBC GLOBAL NEWS REPORT):
MORLEY SAFER: A hypnotic as the doctors called it, that was an answer to a prayer. Its generic name was thalidomide.

ROCK BRYNNER (AUTHOR, “DARK REMEDY”): The hallmark, defining quality of Thalidomide was its safety. So safe, that in Germany there was no prescription needed.

NARRATION: The German company that developed Thalidomide, Chemi Grünenthal, claimed that even pregnant women could take it.

ROCK BRYNNER: 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 employee of the drug company Grünenthal.

NARRATION: No immediate connection was made to Thalidomide – which soon sold nearly as well as aspirin in some European Countries.

ARCHIVAL (CBC BROKEN PROMISES):
DR. CLAUDE MURPHY (CANADIAN OBSTETRICIAN): We received it in quantities like 1000 pills. There was tremendous pressure all over the world to get this wonderful new drug on the market.

ROCK BRYNNER: They had 2 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.

ARCHIVAL (FDA INTERVIEW, 2-23-95):
DR. FRANCES KELSEY: It just so happens that my first application was for the drug Thalidomide, I got this because I was new, and they thought I should have an easy one to start on.

NARRATION: 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 Grünenthal and William S. Merrell, the U.S. distributor of the drug.

ROCK BRYNNER: The best thing 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 ate.

NARRATION: With Thalidomide being prescribed for morning 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.

ARCHIVAL (CBC BROKEN PROMISES):
ANCHOR: It was allegedly written by a Dr. Ray Nulsen. But, in fact, the article was written by the medical director of the drug company.

NARRATION: About six months later, long-ignored evidence become 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 delay of the drug’s approval for more than a year had prevented a similar scale of tragedy from unfolding in the United States.

ROCK BRYNNER: Dr. Kelsey was absolutely a unique hero in American history.

NARRATION: But Thalidomide’s reach continued to be felt across the rest of the world including in Trinidad and Tobago, where Giselle Cole was born.

GISELLE COLE (ADVOCATE FOR THALIDOMIDE VICTIMS’ RIGHTS): When I came along – I’m a first born – they were a young, married couple. I mean I was never unloved, or not wanted, or anything like that, but I would be foolish to think that it was easy for them. My disability is – the official term is “phocomelia,” coming from the Greek meaning “shorter arms,” or “flipper- like.” I think people always expect that I would’ve been angry. And I’m certainly not angry and never have been.

ACT II:

NARRATION: Long discussed but seldom implemented, major regulatory reforms were finally forced on the pharmaceutical industry following the Thalidomide scandal.

ARCHIVAL (CBC BROKEN PROMISES):
ANCHOR: For some time President Kennedy has tried to get congress to approve new controls but without much success – now with the thalidomide scare most of the opposition has melted.

ROCK BRYNNER: Largely, the same FDA guidelines that we live under today were created in the immediate wake.

NARRATION: These regulations were too late for Thalidomide’s thousands of surviving victims across the world — who soon became the story.

ARCHIVAL (CBS NEWS, 12-26-75):
REPORTER: Phillipa Bradbourne is one example. Her mother rejected her.

ARCHIVAL (CBS NEWS, 12-14-72):
REPORTER: 10-year-old Carl Davies leads a relatively normal life for a boy without arms.

ARCHIVAL (CBC BROKEN PROMISES):
ANCHOR: Another young mother, her husband, his sister and her doctor are charged with the mercy killing of her deformed infant.

GISELLE COLE: I’m one of the lucky ones, and my parents were adamant that I was their daughter, and their daughter first before anything else. And I 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 what not to accommodate these prosthetics. Many families were broken irrevocably.

NARRATION: Instead of quickly settling, the drug companies dug in, with Grünenthal originally arguing that the children’s deformities were caused by everything from nuclear fallout to botched home abortions – anything but Thalidomide.

GISELLE COLE: It was a very long and difficult process.

NARRATION: Most cases were eventually settled, but litigation continues with some survivors saying the original settlements cannot cover the cost of their specialized care. Grünenthal didn’t apologize to its victims until 2012 – 50 years after the tragedy unfolded.

GISELLE COLE: 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.

NARRATION: Despite all that Thalidomide’s victims endured over the decades, they could long take solace in one simple fact.

ARCHIVAL (NBC NEWS, 12-25-72):
JOHN CHANCELLOR: Thalidomide is now banned everywhere.

ARCHIVAL (CBS NEWS, 7-30-73):
ANCHOR: The now banned Thalidomide…

ARCHIVAL (CNN, 7-18-98):
REPORTER: The drug was banned in 1962.

GISELLE COLE: And I would have liked to have seen it never used again.

ACT III:

DR. ROBERT D’AMATO (BOSTON CHILDREN’S HOSPITAL): There’s a tremendous amount of luck in science. It’s almost like an Easter egg hunt.

NARRATION: In 1992, while conducting research into macular degeneration, ophthalmologist Robert D’Amato began his own hunt — this one to find a pill that might restrict blood vessel growth.

DR. ROBERT D’AMATO: I started searching for drugs that caused some sort of damage to a fetus, a birth defect and at the top of this list was Thalidomide.

NARRATION: Although Thalidomide had been banned around the world, unbeknownst to many, the drug was later made available for limited humanitarian use thanks to a chance discovery.

DR. ROBERT D’AMATO: 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 Thalidomide to see if it would help with the sleep, and began to notice that there was also improvements, generally, in the leprosy.

NARRATION: After much trial and error, Dr. D’Amato finally had a similar breakthrough when he demonstrated that Thalidomide could starve blood flow to cells — a discovery that held the potential for treating cancerous tumors.

DR. ROBERT D’AMATO: The people that really understood the results were excited, because we had a tool that we didn’t have before. But the knee-jerk reaction was this is a dangerous drug, no one will ever want to use it. There was thousands of victims that still remain. There had been a promise that Thalidomide would never be developed again.

GISELLE COLE: We had to make a decision what position we were going to take. And many would’ve thought and expected that we would’ve been screaming, “No, no, no, no, no!”

NARRATION: But following a surge of reports about promising studies, that’s not what happened.

ARCHIVAL (CBC GLOBAL NEWS, 3-10-97):
GISELLE COLE: We are nervous. We are of course frightened and dismayed. But we realize that this is not a perfect world.

ARCHIVAL (NBC NEWS, 9-23-97):
ROBERT HAGER: Thalidomide is back.

ARCHIVAL (CNN, 7-18-98):
ANCHOR: The Food and Drug Administration says Thalidomide will be the most restricted drug ever distributed.

ARCHIVAL (CBS NEWS, 7-16-98):
ELIZABETH KALEDIN: Female patients taking the drug will even have to submit to pregnancy tests.

NARRATION: Since then, Thalidomide 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 D’Amato’s hunch about the drug’s effect on cancerous tumors paid off in a groundbreaking treatment for certain types of the disease.

DR. ROBERT D’AMATO: Thalidomide and its derivatives have become the primary treatment for multiple myeloma.

GISELLE COLE: It’s a very fine line that I walk, and many of us walk, when we think about Thalidomide in today’s world. 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 to Thalidomide.

NARRATION: Brynner, who saw Thalidomide’s curative powers firsthand, after being prescribed it for a deadly skin disease, says that the drug’s circuitous history tells us a great deal about the accidental nature of drug discovery.

ROCK BRYNNER: 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.”

DR. ROBERT D’AMATO: When you have a drug that has a 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.

NARRATION: But, for all its benefits, the scientific rehabilitation of Thalidomide has come with a heavy cost.

ARCHIVAL (BBC NEWS, 7-23-13):
REPORTER: We were told this could never happen again.

NARRATION: In Brazil, where the drug is used extensively to treat leprosy, researchers report that Thalidomide children continue to be born — as many as 100 since 2005 by one recent estimate.

GISELLE COLE: Fifty years down the road, I would like to think that there’s no such thing as Thalidomide, that we have created something and we have developed something that would allow us to bury Thalidomide – literally. Destroy it. Get rid of it so that there are no further discussions, other than a note in history.

(END)