Light: A new Masada medical thriller coming this summer

Regulation

Regulation

By

Leonard Zwelling

https://www.wsj.com/opinion/the-jungle-is-a-cautionary-tale-for-doge-government-is-too-big-but-has-many-workers-we-cant-do-without-118f7726

I once had a seventh-grade social studies teacher named Miss Guido. As she was passing out the exam papers with which we would struggle for the next 45 minutes, she would always say, “it’s not that I think you will cheat, it’s that I know damned well you will. So don’t.”

In a sentence, that is why federal regulations are necessary.

I need to start by admitting that I have the heart of a cop. This was told to me by a good friend. He’s still my friend. I took no offense and he’s correct. This is why my being chosen to be the Vice President of Research Administration was so spot on. That job was egosyntonic with my personality for the basic task was to assure compliance with all federal regulations which apply to research at MD Anderson. I was the research cop. My responsibilities included oversight of human subjects research better known as clinical trials, animal care and use, biosafety, research misconduct, and a new one back then, conflict of interest. Most of these activities are regulated at the federal level and some also have a state regulatory component. Why was this all needed?

The reason is illustrated well in the attached article from The Wall Street Journal on March 15 by Peggy Noonan.

Ms. Noonan was retelling the story of the regulation of the meatpacking industry in the early part of the 20th century by Theodore Roosevelt after the publication of Upton Sinclair’s book The Jungle ripped the lid off of this industry rife with food contamination, worker abuse and terrible working conditions. This led to the Meat Inspection Act and the Pure Food and Drug Act. The second act increased the power of the Bureau of Chemistry which became the Food and Drug Administration. This is a prime case of why federal regulation for some human activities is necessary. As Noonan writes, “the arc of the moral universe is long but bends toward mischief.” It is not that humans are inherently bad. But some humans will take advantage of other humans by trying to cheat and this can endanger humans and other sentient beings.

My job as VP was to establish the regulatory infrastructure for research oversight at Anderson and to make sure it operated efficiently. Patients on clinical trials had to be informed of the benefits and risks of the trial. Animals had to be housed, fed, and handled per protocol as well. Dangerous substances in the laboratory had to be used and stored in accordance with federal rules. And should someone be alleged to have committed research misconduct, I had to make sure the process by which the allegation was investigated was above board and fair.

Just like me in my old job, federal workers are trying to do the right thing in regulatory matters, obey the law, and advance the progress in the area that they regulate be it food safety, air traffic control, or NIH grant applications. Most of these people do a good job. At the present time they are working in fear of Elon Musk and his DOGE bros taking away their jobs and undermining the oversight of regulatory compliance. This is all bad for us Americans. Imagine what the meatpacking industry would be like today without federal regulation (and in some places it’s still pretty bad). The food supply, water supply, air purity, and drug efficacy and safety all depend on federal regulation. And in all of these areas there are those who will try to cheat and by-pass the regulations. Always.

So, when your Republican or libertarian friends eschew regulation and say that the market will take care of things, roll out the case of the meatpacking industry in the early 1900s. Regulation is vital to our safety. Neither President Trump nor Elon Musk quite gets the jeopardy he may have placed us in with the actions of DOGE. Mr. Trump may have to start worrying about the hamburgers he eats.

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