Have you ever wondered why certain drugs get approved and others don't? In this video, we use the movie Kids in the Hall Brain Candy to find out.


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With an annual budget of 3.16 billion dollars and more than 14,000 employees, America’s Food and Drug Administration—or FDA—oversees the safety of all food and drugs produced and sold in the United States, as well as cosmetics, tobacco, and other related products.

Before a new drug can be prescribed and sold, it’s tested in phases.

The first phase, which can take years, involves testing on animals.

If no adverse effects are detected, it can then be administered to a small group of human volunteers, followed by larger numbers of humans after careful scrutiny.

Throughout those tests, a pharmaceutical company must show that its new drug is not only harmless, but also has advantages over other medications on the market—whether it’s more effective or cheaper to produce.

After years of successful internal tests, a company can then submit its findings to the FDA to apply for approval, which isn’t cheap. In 2020, the fee for an application requiring clinical data was a whopping 2,942,965 US dollars—and that’s on top of the years of testing a company has already done.

Obviously, this process is incredibly expensive, and pharmaceutical companies spend billions every year on research and development.

And since it’s so expensive to produce a new drug, pharma companies are financially motivated to chase patents that will make them money rather than fight less-common diseases whose cures wouldn’t be as lucrative.

That sounds cynical, but the FDA has mechanisms in place for these scenarios.

The Orphan Drug Act was created to give pharmaceutical companies an incentive to invest in cures for rare diseases.

There are also times when someone has a life-threatening disease that requires immediate treatment, and they don’t have time to wait for a ten-year approval process.

In these instances, the FDA may allow “compassionate use” exceptions to give those patients access to a treatment that hasn’t passed all of the trials.

And when a worldwide pandemic heightens the need for fast approvals, as the deadly and highly contagious COVID-19 virus did in late 2019, the FDA may also fast-track vaccine approvals for the sake of saving lives.

But it’s precisely that kind of situation that makes a regulatory body like the FDA seem lumbering and outdated. After all, when a virus can spread rapidly around the globe, growing at an exponential rate, what good is a drug-oversight process that can take a decade?

To understand why drug oversight is so crucial, through the FDA in the US and through similar regulatory bodies in other countries, let’s look at the history of wacky and deadly medicines that prompted the need for proper regulation.

The term “snake oil,” which refers to quack remedies that don’t work, has its roots in Asian-American history.

When thousands of Chinese workers arrived in the US in the 1800s to build the Transcontinental Railroad, some brought with them a medicine that was literally snake oil.

Made from the omega-3-rich oil of Chinese water snakes, this original snake oil was actually effective, because omega-3 fatty acids can reduce the pain caused by joint inflammation.

But when Americans tried making their own versions with oil from rattlesnakes—there was no medicinal effect. Of course, that didn’t stop “snake oil salesmen” from pushing them on the gullible public.

Soon a whole industry of bogus “patent medicines” had sprung up, propagated by hucksters and charlatans who promised that their phony tonics cured everything from headaches to “feminine trouble.”

With people getting ripped off—or worse, dying—from these quack remedies, the need for regulation was obvious.

In the US, President Roosevelt created the Federal Food and Drug Act in 1906 as a response to the spread of phoney “patent medicines.” This led to the creation of what we now know as the FDA.

But following World War II, when the developed world was hooked on sleeping pills and sedatives, a new German drug, Thalidomide became massively popular around the globe as a treatment for sleeplessness.

The drug wasn’t deadly, but it did cause severe birth defects when pregnant women used it. And in a tragic turn of events, an Australian obstetrician named Dr. William McBride found that the dangerous drug also cured morning sickness, leading to Thalidomide being prescribed to pregnant women in 46 countries.

As a result, more than 100,000 babies around the world were born with deformities that included the shortening or absence of limbs.

To prevent similar tragedies, the US government passed the Kefauver Harris Drug Amendments Act in 1962, giving more power to the FDA and extending the approval process.