So broadly, how did those cases turn out?

What struck me in thinking about the recent decisions against the social media companies of such eye-popping magnitude that there really was a similarity with two other very important cases over the last number of decades in which we had two other obvious causes of harm to the public health.

In the first case, tobacco, going back to the 1990s, and of course, evidence from the surgeon general's office going back to the 1960s that there was a problem.

And also against Merck, which had been selling over two billion dollars a year of its blockbuster anti-inflammatory drug Vioxx or Rofecoxib as the generic name.

And again, there were many of us who were saying, and in, in fact, are a fair amount of research documenting that there was an elevated risk of cardiovascular disease, whether myocardial infarction or stroke, in people taking Vioxx compared to people taking other anti-inflammatory drugs after controlling for all possible confounders.

And in both instances, smoking causing lung cancer and a number of other diseases from cardiovascular disease to other cancers, and Vioxx raising the incidence of heart attack and stroke.

In both instances, there was evidence that was there, many of us were completely convinced by it, and yet neither Congress nor the executive branch, particularly in the case of the FDA, did very much to mitigate that risk.

So what are some examples, and is there any way to protect against that kind of outcome?

So this does seem like a, a cost savings for people who don't have prescription drug insurance.

insurance.Right. And again, I think you, you raise an important point in that this will only be relevant to people who don't have health insurance, which sadly will be a much bigger number this, you know, next year this time than it is now.

But if you've got health insurance of any kind, Medicare, Medicaid, VA, um, Blue Cross Blue Shield, UnitedHealth, whatever, uh, you will not get a better deal from Trump Rx because you can't use your health insurance, uh, on Trump Rx, at least as currently, um, defined.

So, uh, you've got to be somebody who does not have health insurance b- um, that covers drug benefits.

Now, w- what about those folks wh- who are gonna rise in numbers? Well, again, it's very hard to know because you go to TrumpRx.gov and as of the moment what it mostly has is an enormous picture of President Trump and then another picture of an American family walking through the sand toward an American flag, but we don't yet know.

And again, it's fair, this is just early days, um, but if you contrast that, let's say, with Mark Cuban's Cost Plus Drugs business, which was a real boon, where, y- he just said, "Let's make drugs available for the lowest price and then charge a dispensing fee and shipping," and he's got real numbers on that website-

I, how do you read this moment?

moment?Well, (clears throat) couple of important points.

But generally speaking, and my assumption is, that when- once drugs are approved, they've been tested rigorously enough that if they're approved, they're probably okay.

I think probably okay is a good term to think of because, um, I think what Americans deserve is not probably okay.

I think we deserve to know that even though every patient is different and you can never tell 100% of the time how something's gonna work, we do rely a little bit more on probably okay than we ought to.

So for example, the drug that was in the headlines a number of years ago for Alzheimer's called Aduhelm, and it's part of this larger problem that going back to the AIDS epidemic in the 1980s, the FDA was trying to get drugs out there approved as quick as possible for obvious reasons.

People were dying every single day and there's nothing good to treat them.

So they created this thing called the accelerated approval pathway, which made a lot of sense at the time, and it said even if a company has a drug that may or may not work, if it looks like it maybe makes a lab test look better, let's approve it, get it out there, and then make the company do a study afterwards to see if it really works.

And that way, you won't have AIDS patients, um, or cancer patients feeling like there was a-... a drug that could have helped me, but the FDA took so long to study it that, you know, I died, or my friend, or my mother or father died before the drug was made available.

So, I don't, as a patient, know w- where should my worry be placed? I've heard a, a, interviewed a doctor here that said, you know, they don't take a drug that hasn't been around and approved for a long time just to avoid the kinds of things you're talking about.

Hmm.

... as many listeners will know, there was a medication heavily promoted in Europe and Japan and in many countries around the world, but not here, for pregnant women, in particular, that was a sedative and an anti-nauseant.

And they applied for marketing permission in the US and there was a new, uh, doc at the FDA named Frances Kelsey, and she said, "I don't see evidence that this is safe." And the pushback was, "Don't be a pointy-headed government bureaucrat, slowing everything down.

Just approve the damn drug and let Americans have access to it, uh, so that they don't have their freedom impaired." And she said, "No, I want evidence that it was, uh, that it's, it's safe." Turns out, as this debate was going on and the industry was saying, "Y- you're just taking too long to approve our drug," it turned out that no, it wasn't safe.

It caused fetal damage, uh, in utero, such that kids were born instead of with normal limbs, with little flipper-like appendages in their arms and legs and a lot of other internal derangements.

And suddenly, it was realized, well, there wasn't safety data.

It was widely used around the world, but not in the US thanks to Dr. Kelsey's keeping it off the market here, saving thousands of potential, um, families from the tragedy of having their kids have a bad birth defect.

Mm-hmm.