Drugs like thalidomide have caused birth defects and even death, so how do they make it market and into our medicine cabinets?
Are the drugs we take safe? There’s an assumption that if a medication can be purchased over the counter or is prescribed by a doctor, then it can do no harm. While the FDA goes to great lengths to ensure the medications available in the US are safe, that’s not always the case. New medications usually make their way to market after years of testing, but that doesn't mean we know all the possible long-term effects. It’s just not possible to predict all the effects of a drug in 30, 40 or 50 years when the drug has only existed for less then a decade. And in some cases, people have paid with their health or even their lives.
Every year, drugs are removed from the US market, and medications that are approved here are banned in European countries or other regions due to health concerns. One of the biggest pharmaceutical tragedies of the past decade was thalidomide, a sedative drug that expectant mothers took in the ‘50s and ‘60s to curb nausea and morning sickness. What wasn’t known was that the drug would also cause birth defects, resulting in approximately 10,000 mothers delivering infants with shortened limbs, heart problems, damaged hearing or eyesight, and in some cases, brain damage.
Most of the cases were in Germany, where the drug was manufactured, and in Great Britain. Thalidomide was never approved for sale in the US, but millions of tablets were distributed to physicians during a clinical testing program, making it impossible to know how many pregnant women were been given the drug.
Just last week, five decades after the harmful drug was pulled from the market, the German pharmaceutical firm that sold it apologized. The head of a survivors' group dismissed Gruenenthal’s apology, not surprisingly calling it “too little, too late.” Instead, they want to see reparations made to those affected.
The drug was pulled from sale in late 1961 after doctors linked it to birth defects, but the company has kept mum until now. "We have been silent and we are very sorry for that," the company said, blaming the delay in speaking out on their “silent shock” over the whole incident.
Much has changed since thalidomide hit the market and controls are more stringent, but prescription medications have become a much bigger business since then, too, with addiction to legal drugs skyrocketing. Pharmaceutical companies are rushing to discover the next wonder drug that will make them billions, giving them the power to influence culture and our health in ways that we all need to be aware of.
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