http://www.nytimes.com/2010/09/14/health/14kelsey.html?_r=1&hpw"Dr. Frances Oldham Kelsey is 96 now, nearly deaf and barely mobile, as modest as her faded house in this Washington suburb. And though her story is nearly forgotten, she was once America’s most admired civil servant — celebrated for her dual role in saving thousands of newborns from the perils of the drug thalidomide and in serving as
midwife to modern pharmaceutical regulation. "
The late 1950's was a time of a new beginnings: a time when optimism and energy flourished. World War II was now a memory, and instead it became replaced with growing visions and a developing scientific epicenter. Innovations became prevalent and tomorrowland seemingly arrived. Housewives were serving TV dinners in less than 5 minutes of preparation and X-ray machines were being found at shoe stores everywhere. It would only be a matter of a few years before Boeings 707s would be able to transverse nations in a matter of hours, or faster vehicles would drive coast-to-coast on Eisenhower's new turnpike systems. Successful nations only became more and more so, following the advent of technology, which I can only say cast a heavy and increasing anxiety of international threat of annihilation. By the late 1950's nuclear war drills became commonplace in schools across North America, only to be supported by a booming fallout shelter business.
Recurring threats between the U.S., Southeast Asia, and the Suez Canal only reminded the world that World War II was not the last word. Central and eastern european nations, I could say, were developing the most rapidly. The USSR was the first to launch the Sputnik satellite, and when the launch of the first U.S. satellite exploded in 1957, the USSR was applauding the launch of their second satellite. Perhaps Germany experienced the shorter end of the stick during WWII, as the final years of the war had been a living nightmare. Most citizens had no idea if they would wake up alive the next morning, and had even began expecting to open their eyes to bombing or dangerous wastes. So it was no surprise, that when tranquilizers and sleeping pills were introduced in Germany in the early 1960's, citizens were supported to partake in its usage as a way to relieve post-war anxiety. I found that almost 1 million people in Great Britain were using barbiturates daily and almost 15% of central European prescriptions were a barbiurate or sedative of some sort. Not to mention, suicide by sleeping pills was the seemingly popular way to check out. The U.S. didn't stray far behind, while they produced over 4 billion sedatives in just 1955 alone. Pharmaceuticals flourished. Get this, the U.S. actually allowed usage of a prescription medicine that could speed up the process of suntanning: "You can turn the color of a life guard!" was at the head of their vision statement. I am sure most everyone is familiar with Huxley's Brave New World, where he described how the dependence upon alcohol in forgetting Communist threats and society's woes would soon be cross-tolerated with invention of a "wonder drug"--a pill which could help people unwind without, psychiatrically speaking, ellicit any abusive or dependent symptoms. "Will the pharmacologist be able to do better thant he brewers and distillers?"
It was no surprise then, that just a month after Huxley's statement, that Germany began distribution of a newly, and uninvestigated, "wonderdrug" Thalidomide within large parts of Europe. This was done under the leading German pharmaceutical company Gruenthal, which was mainly given its fame after mold production of industrial penicillin. Oh and by fame, I mean notorious for throwing drugs in the market without any sense of adequate testing...forget exhaustive testing at the least. Thalidomide was first administered to help decrease feelings of uncomfort in pregnant women. Soon enough, it was discovered that this drug had absolutely no effect as an antibiotic, but what it did show, was a high sedative affect in humans. Surprisngly, this drug showed no affects in animals. In fact, the toxicity test results were beyond remarkable. Even at the highest doses, it was nearly impossible to attain the LD50 (the dose at which 50% of the subjects die). (WHICH THIS BRINGS ME TO AN ENTIRELY DIFFERENT SUBJECT RELATING TO VEGANS AND USERS OF MEDICINE. EVERY SINGLE DRUG AVAILABLE IN THE U.S HAS BEEN TESTED AND KILLED MILLIONS OF ANIMALS). By the way, there were at least some rules, which detailed that drug could not be put on the European markets without "successful results" (even slightly below a
n LD50 denotes success) in both humans and animals. So of course Gruenthal manipulated their research, to forcibly induce results with compound treatments to show that, in company, Thalidomide can produce sedative effects.
Through fiscal means, Gruenthal managed to leak its force within scientific journals internationally recognized, supporting the usage of Thalidomide. Giving out free samples to companies and physician offices everywhere, advertisements with children reaching for a bottle of Thalidomide (Distaval) stated "This medicine could save your child's life" (as it was also used as a means to calm children down in anxious moments. It even came to the point that this drug was commonly known as the "babysitter" as it had the powerful ability to always produce consistent sedative effects. In fact, this drug became so commonly used that pregnant women did not even list it on injested medications on routine physicals. Eventually, this drug found its way across the entire world, (and for once I am happy to admit that the FDA disallowed entrance of this drug into the U.S) totalling over 12.4 million dollars of sales in 1961. Thaldomide began being mixed into other pharmaceutical treatments, to which even an addition to common advil and tylenol.
This is a PERFECT example how fiscal interests and greedy powers can inflict horrible results. The lack of extensive research, and the growing rush to get a "goldmine" drug into the market ended up, within JUST TWO YEARS OF ADMINISTRATION, producing birth defects in the thousands. Children were being born with fetal limb abnromalities and loss of external structures, such as the ears and nose. And JUST three months ago, Germany finally began dispensing compensation for thalidomide victims (OVER 40 YEARS LATER. please read!!:
http://www.goinglegal.com/article_863416_101.html). Thalidomide, even now, is still being released as an off-label drug as a "special needs" medication to patients with severe pain. In truth, Thalidomide may have some beneficial effects to those women whom are not pregnant or not planning to become pregnant. However, that is only a short-term vision. It is, an essence, a hippocratic dilemna. It can destroy you or it can save you. Though, there is nothing to be said until it undergoes years of extensive treatment, as such all pharmaceuticals should. YOUR PATIENTS ARE NOT YOUR RESEARCH. And to all of us becoming physicians, I think the take-home statement is this: be aware that short-term success does not mean long-term benefits. We may be doing more harm than good. I think the even bigger question may be why individuals choose to venture into pharmaceuticals for purposes so unnecessary. There are clearly more homeopathic and physical ways of doing so. Listen to your body, not the pills.
