As lid flipped open on thalidomide cover-up, more questions about drug safety in U.S.
“Money makes the world go ‘round,” goes the purposeful, old hyperbole. Throughout our history, humans have struggled to “keep the world going ‘round,” however, without hurting others in the process.
You’d be hard pressed to find another industry that does more “spinning” of this sort than pharmaceuticals. Weapons, perhaps, are a close second. It’s now apparent that the drug industry has not only a long history of glossing over adverse effects, but also of misinforming investigators and the public when a problem is found.
A case reported on May 13th by Business Insider magazine involves the infamous, birth-defect-causing drug thalidomide. Sixty years after the drug became over-the-counter in what was then West Germany, officials in the state of North-Rhine Westphalia issued a report finding a “deliberate misinformation campaign” on the part of the manufacturer.
In the mid-1950s to mid-1960s, thalidomide was used as an antiemetic for pregnant mothers. That use was disastrous, as it caused serious pediatric health problems, and often death. Approximately 10,000 babies were born with phocomelia, related to the malformation of the limbs and/or severe nerve damage. Only half of the children survived into adulthood.
Now, German officials say the pharmaceutical company, Grünenthal, worked to deceive those responsible for determining if the disaster was connected to thalidomide (branded then as Contergan and Distaval). Grünenthal declined comment to Business Insider, except to say, “We deeply regret the thalidomide tragedy and it will always be part of our corporate history.”
Thalidomide is still in use, but mainly as a cancer treatment and for a leprosy complication. It’s contraindicated for pregnant women or “women who may become pregnant,” as many television commercials say.
Nobody wants another thalidomide-like tragedy. The headlong rush to get drugs into as many people as possible still exists in the pharmaceutical industry, however. Though regulations were stiffened in the wake of Grünenthal’s grievous mistake, how many times has the FDA readjusted and relaxed requirements since then? The pushing and the politics (let’s not forget greed) create a very dangerous momentum for unproven treatments.
On my DEADLY PRESCRIPTION blog here, we’ve discussed the dozens of ways Big Pharma controls or attempts to control the outcomes of clinical trials. The FDA is a slow-moving giant, ever willing to cut corners and cut deals with the drugmakers. This is a deadly combination. We need pharmaceuticals to get out of the business of overseeing themselves, and we need a more efficient, more nimble FDA that’s not rubbing elbows with Big Pharma half the time.
While we’re at it, direct-to-consumer advertising ought to be banned again. It only heats up demand from the public and, in turn, doctors are pressured by patients to give them what they want. It’s an irresponsible and cynical way to do business. There’s plenty of money to be made by running responsible pharmaceutical corporations. Many of them have untreated afflictions themselves, namely psychopathy and avarice.
My upcoming novel, DEADLY PRESCRIPTION, is about a fictionalized criminal world where the “Godfathers” are Big Pharma CEOs and the product is legal.