Medical regulations aren’t all red tape
The government body in Australia that regulates drugs, the Therapeutic Goods Administration (TGA), exists to make sure the drugs offered in the pharmacy are safe and actually do their job. But not long ago regulatory testing was less demanding than it is now. Unfortunately, it took a widespread scandal to shape medical regulations all around the world into the robust systems they are today.
The scandal that started it all
Most, if not all, medical experts and regulators know the story behind the thalidomide scandal.
It’s 1957, a wonder drug from Germany promises to cure insomnia, stress and anxiety, and even help with a mother’s morning sickness. Tests from the manufacturer show no problems in rats nor humans. Excitement for the drug spreads while it’s released in 46 different countries around the world. As the drug’s popularity soars, its manufacturer turns their sights on distribution within the United States. When thalidomide is submitted to the FDA for approval, one scientist, Dr. Frances Kelsey, sticks to her scientific guns and requests more testing data. The disapproval from Dr. Kelsey meant thalidomide was never released to the US public. Only a smaller portion of the population received the drug for clinical testing.
Dr. Kelsey receiving an award from President Kennedy for being a bad ass. Source: Wikimedia
Dr. Kelsey’s diligence saved much of the United States from the wide spread disastrous effects of thalidomide. Starting immediately after thalidomide’s release, babies were born with severe deformities. Babies, whose mothers had taken the drug, were not developing limbs properly and were often born with shortened or even absent arms and legs. In July of 1961 an Australian doctor, Dr. William McBride linked thalidomide to these horrific birth defects. Finally, in November of 1961 the drug was pulled from the pharmacy shelf worldwide.
Estimates suggest thalidomide caused 10,000 miscarriages. 8,000 of the 20,000 affected children, known as thalidomide babies, died within their first year of life. Those that survived still live with the consequences of poor medical regulatory procedures today.
Response to thalidomide scandal
Before the thalidomide scandal, drug regulations varied widely across the world. In response to the scandal, the United States introduced an amendment which requires a new drug to be tested for both efficacy and safety before approval. Today this requirement seems like a given but before this scandal clinical tests were only concerned with the safety of a drug.
Will a reasonable dose of this drug kill anyone? No? Cool, drug approved.
Now manufacturers must prove their new drugs are both safe and successful at what they claim it can do. With each new approval application, manufacturers must provide a large amount of data including safety, efficacy, dosing information, side effects, how long the drug stays in the body, and any other drugs that should be avoided while taking this new drug. Applications for approval can take months if not years. And they’re not cheap. Not to mention the long process of creating the drug first.
Some people think such an arduous process to get a drug approved stifles scientific research and medical breakthroughs. But, in reality they keep the public safe from dangerous drugs and shady manufacturers. Now, one can argue these demanding testing procedures also help to increase the already large cost of modern medical care but that’s a story for another post.