Among other things, Americans are notorious for short attention spans, so it is no surprise that we're not hearing about swamp draining or deep states though it seems like deep fakes are here to stay. Maybe this is due to, or despite of, the incredible loss of public confidence in government institutions, particularly of the medical variety. For the CDC, which started the pandemic in damage control having strayed from science into politics, this may have been a fatal blow, leaving them as a very expensive white [coat] elephant.
The FDA's story is more complicated.
As part of "Warp Speed," the FDA was key in getting life-saving vaccines to market, and while this was at the direction of the administration, it did not become a political hot potato. Sadly, this seems to have come at the expense of therapeutics, but that is not the FDA's fault. In any event, the FDA has always gotten its fair share of criticism whenever something goes sideways.
Some of this criticism is unjustified. Really. It is. Unlike Europe where manufacturers must demonstrate product safety and effectiveness, the U.S. is concerned, almost exclusively, with effectiveness. Everything has side-effects, right? As long as treatments for side-effects are profitable, this isn't likely to change.
The FDA is also seen as an administration within the executive branch, which some say makes them part of the swamp, while others, see that as an opportunity for legislation by regulation. Kind of a swamper thing to do. The real problem isn't with the FDA but with all those who think they can make the FDA do their bidding. This was recently revealed in the Federal Register. You read the Federal Register, don't you? Well, you should.
In the early '90s Congress passed the Mammography Quality Standards Act which became officially effective in '94 with implementation by the FDA in '95. This was a good thing. Slow, but good. Fast forward thirty years, three full decades, and the FDA is updating regulatory requirements to include breast tissue density reporting to both patients and their referring physician. Before you say "'bout damn time," ponder this: do you really want a federal agency who cannot hold a steady course? If so, you've got the CDC.
The fascinating thing about the publication in the Federal Register isn't the meat of the changes which are so inherently reasonable you must wonder why this was not universally practiced already, but what can be gleaned from comments, and the FDA's responses. There are 156, with the publication aggregating similar comments and grouping them accordingly. It can be a fun read, but much of it is mundane, and some clearly coming from sources with a vested interest in influencing the outcome.
If you're a deep state denier, the FDA responses will give you hope, on account of the logic in their responses, but also their fidelity to the U.S. constitution. Several commenters seemed to expect that the FDA could, and should, do whatever they wanted and the FDA consistently pointed to the MQSA and the limits inherent in the enabling congressional act. For example, some seemed to think this act, which covers mammography, could be extended to include ultrasound and MRI imaging modalities. Why? Just because. After all, this was under an administration whose leader stood before cameras and declared he was going to do something he knew would not withstand constitutional challenge. Why? Just because. The FDA was having none of it.
Some comments were far worse, but you have to understand the larger context: women's health has long been neglected and it is long overdue for at least minimal communication of this health issue. And minimal it is. Two reports are required, one for the patient and another for the referring physician. Here's where it almost becomes "blame the victim" as the required text in the patient report targets an eight grade reading level. Some comments claimed that was too high, suggesting a fifth grade reading level, and none suggesting anything higher. If it doesn't frighten you that folks (elites?) that have the ear of a critical federal agency thinks the public, women in particular, are illiterates, then it should. It gets worse. One objected to the lowest density classification as "fatty" as this might offend some patients, but the FDA only requires the fully detailed classification in the physician report. The patient report condenses the four classifications down to two: dense, or not dense. Even a woman can understand that, right?
This publication is an interesting read, but stepping back what is really frightening is that it has taken 30 years to get to this point. Our country's neglect of women's healthcare is a shameful societal failing. Even with something as serious as breast cancer, and even with broad public awareness, we have not done right by the 51%. Shame on us. On all of us.
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