By Chad Hobbs
From the White House to newsrooms all around the country, there has been a lot of talk about quickly developing treatments to combat against the novel coronavirus strain at the heart of the COVID-19 pandemic sweeping across the globe. There is much to be commended on the speed in which a possible vaccine has been created. In a matter of months, one is in trials which is light speed compared to the amount of time it took to create other mainstream vaccines which are commonly used against a whole slew of other viruses.
Over the past several weeks, it has been hard to turn on a television without hearing phrases such as “off label use” or “cutting through archaic FDA red tape.” Losing a loved one is never easy, and under the current climate, the push to quickly find remedies to this new, deadly virus is totally understandable. For someone such as myself with a nursing degree, there is an uneasiness about this hasty approach the government is being pushed to take in rolling back regulations to expedite discovery of COVID-19 treatments.
Grumbling about the long, exhaustive process the FDA requires pharmaceutical companies to traverse in order to approve a new drug is nothing new. I, myself, would more than likely join the chorus of support for circumventing the FDA were it not for knowing the cautionary tale Thalidomide provides.
The off-label usage of medicines to treat ailments for something other than they were originally developed for is nothing new. In fact, many drugs have continued to exist because of this practice. How many people do you hear of using Viagra to treat high blood pressure, or chest pain, like Pfizer originally developed it for?
In the fall out from World War II, sleeplessness was a huge problem, particularly in Europe. The world appeared addicted to tranquilizers and sedatives during that time period. In the U.S., it is estimated that one out of every seven citizens regularly took them. Various barbiturates were the drugs of choice, but with this class of drugs comes a large list of side effects, including fatal overdoses.
In 1957, a German pharmaceutical firm which first synthesized thalidomide began marketing the drug as a replacement sedative to barbiturates. They claimed lab tests could not find a level high enough to cause test rats to die from overdose, and there were no side effects. As a result, the drug was sold over-the-counter. The “completely safe” medication quickly gained popularity, and within three years, it was sold in over 40 countries, rivaling aspirin in total sales.
After discovering the wonder drug also alleviated nausea, many doctors began off label prescribing thalidomide to pregnant women to relieve morning sickness. The pharmaceutical firm said there were no dangers to pregnant women, and it was so successful that it became the gold standard around the world for morning sickness.
In the United States, however, the drug met one of its few obstacles in FDA inspector Frances Kelsey. Despite huge pressure, and even death threats from both pharmaceutical companies and her supervisors at the FDA, Kelsey refused to allow the drug to be approved for use in the United States due to lack of known data, especially its effects on pregnant women.
Meanwhile, in countries around the world where the drug was being used, doctors began noticing a correlation between mothers who had taken the drug and severe birth defects in the children they delivered. Many were either stillborn or died soon after birth due to extreme defects. Those who survived were born with shortened limbs and flipper like appendages for hands and feet. Others were born missing limbs or fingers and toes. By 1962, the drug had been banned in most countries but not before the damage was done.
Though FDA trials were going on prior to this discovery, the actions of Kelsey prevented tens of thousands of mothers from enduring the tragedy so many other pregnant women around the world were forced to endure due to the lack of testing and trials performed before those countries decided to trust the word of a pharmaceutical company on blind faith.
Because of Kelsey’s relentlessness, and the light it shined on the pharmaceutical industry, many of the FDA’s current regulations were soon passed by congress. This is why it takes so long for drugs in the U.S. to be approved today.
Everyone is anxious for a vaccine and treatments for COVID-19, but let us not forget the cautionary tale thalidomide taught the world years ago.
Sometimes, the treatment can be worse than the disease. Many lives were lost, and many more were permanently disfigured and deformed. This was the price the world once paid for rushing to an off-label prescription without proper testing just to treat morning sickness, of all things.