Opinion: Virus drug tests need more rigor

The Food and Drug Administration approved the first oral contraceptive in 1960. Open-source data indicates that development of “the pill” began in the early 1950s and clinical tests were initiated in 1954.

By my math, that’s more than 60 years ago. Since that time, millions of women have availed themselves of this form of contraception.

One could reasonably assume that with this much raw data available, it would be possible to arrive at a conclusion as to the safety and efficacy of “the pill.”

So, it comes as a surprise to me that, 60 years after the fact, a pharmaceutical company is just now applying for permission to sell a birth control pill over the counter. The main reason given for requiring a prescription was to allow healthcare professionals to screen for symptoms of blood clots.

An Associated Press article by Matthew Perrone tells us that for a drug to be approved for over-the- counter sales, “In each case, companies must show that consumers can understand the drug’s labeling, evaluate its risks and use it safely and effectively without professional supervision.”

As a data point, I just peeled the label off my bottle of Aleve and discovered more than 35 bullet-point warnings that could harm me.

According to Perrone’s article, HRA Pharma, the pharmaceutical company applying for approval, spent seven years conducting the studies required by the FDA. This was after HRA purchased the company in 2014, so you see that reams of data were available prior to the seven-year tests.

A rough timeline for the oral contraception pill looks something like four years in development, six years in clinical trials and then FDA approval. The rough timeline for the COVID-19 drug would read something like six months development, six months trials of some sort, leading to FDA approval.

Additionally, the federal government attempted to mandate that large numbers of the citizenry, under penalty of some legal action, get a COVID shot, a COVID booster and a third shot.

“The pill” getting approved for OTC sales is not the same as the COVID shot. My point, here, is that both drugs required FDA approval after rigorous testing. One took approximately 10 years for approval, and even after 50 years of everyday use required further testing to ensure safety. The other took less than two years for approval and then was required for some citizens to continue their employment.

At the same time medical professionals at all levels continued to assert that no shortcuts had been used in the approval process for the COVID drug. How rigorous was the testing?

Public disclosure: I have received the COVID shots.

Rube Render is a former Clovis city commissioner and former chair of the Curry County Republican Party. Contact him:

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