A Skeptic's Thoughts on Epidemiology, Autopsies, and Drugs

I’ve been a public policy nerd for most of my professional life, and was identified as a skeptic by a teacher when I was in the 7th grade, so I’ve been watching recent developments and developing a loosely connected assessment, illustrated with a handful of anecdotes.

100 Questions

A few years ago on a flight from Atlanta to Detroit, I took my middle seat next to a young woman and we exchanged the usual pleasantries, including what we did for a living.

“I’m an epidemiologist with the Centers for Disease Control,” she said, to which I replied, “I have about a hundred questions, if you don’t mind.” She didn’t. We spent two hours discussing her work, with me gleaning information that would be useful in my work with pharmaceutical clients. As we landed, I thanked her for her time and attention.

“Thank you,” she said. “I love talking about my work. I’m headed to a big family weekend, and no one in my family wants to hear about what I do. If I even start, they decide to go to the movies.”

Now I wonder if she’s been wiped out in the purge. If so, it’s a tragic loss of expertise and enthusiasm, with few prospects in the private sector.

Which brings me to my next point – there’s a distinct difference between government and the private sector.

Sheriff Joe Was Right, Once

Many years ago I worked for the Maricopa County (Phoenix) Executive. I directed communications and did a bit of troubleshooting in customer service issues. At the time, we had a Board of Supervisors on a mission to move various county services to the private sector, with the belief that it would bring competition and efficiency that a large county government couldn’t deliver.

As part of the movement, the Board decided to outsource the Office of the Medical Examiner to the private sector. The County ME had a small staff, a few vehicles, and a capable lab for performing autopsies. The Supervisors, in their privatization fever, decided that a private entity could save money, so they issued a Request for Proposals.

As the deadline arrived, exactly one bidder submitted a detailed proposal. They wanted hundreds of thousands of dollars so they could hire and train staff, and purchase and equip several vans. Oddly enough, there were no companies in the private sector that were already in the business of retrieving bodies, conducting field investigations, and performing autopsies. Who knew?

(At this point I’ll note that this was one time that I agreed with Sheriff Joe Arpaio, who opposed the idea. His deputies worked well with the medical examiner’s office, and he didn’t want to start from scratch with a bunch of rookies.)

Back to Medicine and Public Health

In various consulting assignments I have worked with pharmaceutical research teams on 24 different new drug applications, including therapies for migraines, COPD, cystic fibrosis, glaucoma, depression, psoriasis, psoriatic arthritis, and ankylosing spondylitis. I won’t overstate my role or expertise, but I’ve been to multiple FDA advisory committee meetings and have seen the work of dedicated FDA staffers and division directors as they oversee the process for assessing and approving new prescription drugs.

With this background, I think you can see why I’m deeply concerned that the FDA is now under the “leadership” of an individual who is wrapped up in baseless theories and exhibits a flawed understanding of medicine, physiology, epidemiology, and basic principles of public health policy. It’s likely that highly qualified people at every level in the FDA will leave the agency rather than work under such questionable guidance. It’s also likely that good drugs will become mired in the review process and bad drugs will be approved without sufficient evidence or analysis.

In Other Words…

I have been a critic and fan of government regulation for decades. I’m critical because I see occasional bias or unnecessary obstacles. I’m a fan because I know that most regulation exists for the purpose of protecting citizens from physical or financial harm.

Good regulation involves collaboration among knowledgeable people, compromise, reasonable interpretation, and effective implementation. Bad regulation exists when ill-informed people grab the wheel, demonstrate their ignorance or bias, and drive everyone into the ditch.

I welcome your observations in the comment section.