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May 4, 2018

Don't be rash when approving medications

by Ryan Handel, Opinions Editor
Parkinson's Disease is a devastating neurological disorder affecting about 1 million Americans. The degenerative disease is marked by tremors, difficulty moving, and slurred speech, and can eventually lead to dementia and depression. So when the drug Nuplazid was developed, which could effectively treat the psychosis associated with Parkinson's, it was natural that everyone wanted the medication available as quickly as possible. Due to this public pressure as well as pressure from the company that developed Nuplazid, Acadia Pharmaceuticals, the drug was quickly pushed onto the market without going through the full FDA (Food and Drug Administration) approval process.
The fast approval of the drug Nuplazid has sparked major controversy. Courtesy of AWKO Law
The fast approval of the drug Nuplazid has sparked major controversy.

Despite high hopes that Nuplazid would be a miracle drug for Parkinson's, its brief time on the market was a deadly disaster. After its approval on April 29, 2016, 244 Nuplazid-related deaths were reported within the first 10 months. Now, two years later, the death toll has risen to over 700. In addition, the drug has been linked to fatigue, nausea, insomnia, falls and life-threatening incidents. Finally, in recent weeks, the FDA has begun to review the safety of the medication and will consider taking it off the market.

The Nuplazid catastrophe was largely due to the eagerness of the FDA to listen to a money-focused industry and the unknowledgeable public, rather than taking the time to perform the necessary scientific tests to ensure that the medication was safe for human use. This tragedy is a prime reason for a major reform that must occur in healthcare policy. All drugs must be required to go through a rigorous approval process before becoming available for consumption, even if the drug has the potential to be life-saving. The risk of an event like what happened with Nuplazid is far too great.

Unfortunately, Nuplazid was far from the first drug that approved too quickly, leading to dire consequences. Perhaps the most famous medication that falls under this category is Thalidomide, a morning sickness drug developed in Western Germany in the late 1950s. Similarly to Nuplazid, Thalidomide was touted as a "miracle drug," only this time for morning sickness rather than Parkinson's, and because of this was rapidly approved in 46 different countries. However, it did not take long for the terrible nature of Thalidomide to become apparent.

The first reports to pour in were those of nerve damage suffered by Thalidomide users; often this nerve damage was severe or permanent. But the most notable, and horrifying
Many children of mothers who took Thalidomide suffered from severe defects. Courtesy of Helix Magazine
Many children of mothers who took Thalidomide suffered from severe defects.

The majority of drugs must go through an extensive reviewal process by an independent committee. They first test the drug in a laboratory setting and then in animal trials, before finally testing it on humans. However, certain drugs with the potential to be life-saving can go through a process called Accelerated Approval, allowing them to be put on the market without being fully tested. Nuplazid was put through Accelerated Approval, a mistake that led to the deaths of hundreds of Americans.

Of course, many patients in poor health have no chance to live other than by trying an untested drug. In these isolated cases, an exception should be made to allow the drug to be taken. However, allowing so-called "miracle drugs" to be put completely on the market through Accelerated Approval poses too great of a health risk. Accelerated Approval also allows too much room for corruption, including outside corporate influences, to push a drug onto the market when it does not belong. Because of this, the FDA should put an end to the Accelerated Approval loophole.

In addition to the Nuplazid and Thalidomide fiascos, hastened drug approval worldwide has led to tragedy in many other cases. In the 1980s, the antihistamine Seldane was taken off the market after it was found to cause irregular heart rhythms. As recently as 2016, the muscular dystrophy drug Eteplirsen was approved before doctors had even confirmed that it worked, despite confirmed risks.

These past mistakes by both the U.S. and by other countries prove that the drug approval process must become more stringent. As previously stated, exceptions can be made in isolated cases, but Accelerated Approval should be eliminated. The FDA cannot continue to succumb to corporate and public pressure. The health of Americans is far too important.



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