It was just another bit player in the German drug company Chemie Grunenthal stable of star drugs. Only a small-time med, for the rare disease of leprosy.
Then it got a big break; a chance to come out of the shadows and into the limelight of bigtime moneymakers. Someone noticed that the drug had a hidden talent, a side effect that caused drowsiness. Bingo! Could the drug be sold into a broader market as a sedative?
Animal tests were conducted to determine the drug's safety. "We could not find a dose high enough to kill a rat," claimed its developers. Next were human trials.
Clinical exams of 20,000 patients across West Germany, including 3,700 women of childbearing age, 200 of whom were pregnant. Again, no red flags.
The drug was advertised as "completely safe" and "non-addictive." Hailed as a "wonder drug," it was sold as a remedy for morning sickness, nausea, and as a sedative.
Along with the touted treatments for physical ailments, the manufacturer also claimed it would treat the emotional problems of "anxiety, depression, and tension." It was the debut of the first mass-marketed psychotropic drug, a pharmaceutical to manage emotions.
As befitting its new status, the generic leprosy drug thalomid was given the brand stage name, thalidomide.
In 1957, West Germany began selling thalidomide as an Over-The-Counter medicine. It soon rivaled the revenue of Chemie Grunenthal's best-seller, aspirin.
Four years after thalidomide's introduction, its fame turned to heart-wrenching infamy. Massive pressure from the public and press swept thalidomide from the shelves. What happened?
Ob's began to notice an alarming increase in stillbirths and birth defects. Something was going radical wrong. Babies were being birthed with heart and abdominal abnormalities; twisted limbs, missing ears, fingers; shortened or missing limbs or no limbs at all.
But by this time (1961) it was too late. An estimated 7,000 thalidomide babies were born in West Germany and up to an estimated 100,000 thalidomide newborns in the 46 nations where the drug was sold OTC.
The US was mostly, but not entirely, spared this tragedy. The FDA banned its sale. But the William S. Merrell Company, together with Chemie Grunenthal ducked the ban under the ruse of large-scale clinical trials involving 20,000 participants.
So where did Chemie Grunenthal go wrong? Few in their 20,000-patient study were tracked long enough to reveal that, though thalidomide did not harm the mother it either killed or deformed her baby. And that's the flaw in today's follow-up examinations; they average only six to eight weeks.
The danger that women in their child-bearing years face today in ingesting a drug, especially the psychotropics, of infant mortality and malformation is as real as it was in the thalidomidic years.
Every year 150,000 babies in the US are born with structural, functional, or metabolic defects. About 70 percent of these abnormalities have an undetermined cause. Could there be other thalidomide-like drugs whose long-term effects have yet to be detected?
Thalidomide and its chemical cousins (analogs) lenalidomide, pomalidomide and apremilast are marketed in 70 nations, mainly for cancer treatment. However, the chemical treatment for cancer is another spectacular failure of the pharmaceuticals.
Despite spending $100 billion/year for cancer drugs, the disease is rampant in the US. One in 2 men and 1 in 3 women will contract the Big C, and the number of new cases of cancer is predicted to double in 30 years.
The justification for marketing thalidomide and its analogs as cancer drugs is shaky. It only guarantees that birth defects will continue. Here's why:
(1) Even one pill of the analogs is enough to interfere in the development of the fetus.
(2) Doctors may prescribe the analogs for off-label use and fail to inform their patients about these dangerous drugs.
(3) The analogs are sold in 70 nations. Poor monitoring---and in some countries, no monitoring---will invariably cause more stillbirths and congenital defects.
But lest I give Big Pharma a bad rap, I should mention that Chemie Grunenthal did apologize in 2012 for the biggest pharmacological disaster of all time. It took 50 years.
Sincerely,
Bob Scroggins, New Milford, PA