intro to Treatments

 While the Trump administration was very aggressive at vaccine development and approval, the administration was more than willing to let the FDA stand in the way of any potential treatments.  The FDA actually banned some potentially effective treatments, which never made sense to me. In my mind, a treatment is far more valuable than a vaccine, and I suspect a lot of people feel the same way.  I don't have a survey to prove what people think, but I have numbers to make my case and I suspect a lot of people intuitively feel the same way.

To start, let's say that I have two groups to 100 people who each has an equal change of some Bad Thing happening to them, but it hasn't happened yet.  The Bad Thing could be catching a virus or getting cancer or anything else.  Now let's say that I have a Prevention that will reduce the risk of the Bad Thing.  That could be a vaccine or a Non-Pharmaceutical Intervention or diet and exercise or anything else, and I give the Prevention to only 1 of the groups so I can compare and determine the effectiveness (like in a trial).  Assume also that the Prevention causes few if any side effects.

For the first example, let's say that my two groups have a 50% chance of the Bad Thing happening to them, and let's say that the Prevention will lower that by 50%. So the control group will see the Bad Thing happen to 50 people and the test group will see it happen to 25 people (50% of 50%).  In this series I have repeatedly made the point that a 20% reduction is worth doing assuming that it comes with other benefits so 50% is definitely passing my criteria.  However, from the standpoint of the people in the study, the Prevention was only 25% effective.  Seventy-five percent had no change in their status at all.  All fifty people who weren't going to get sick didn't get sick and twenty five people who were going to get sick still got sick.  The only people it helped were the twenty-five people who were going to get sick who didn't because of the Prevention.  

Of course, people don't know which group they belong to.  The people who didn't get sick might ALL believe that they were in the fifty percent that wouldn't have gotten sick anyway, or they might all believe that they were in the group that would have gotten sick but the Prevention worked.  The twenty five people who did get sick would assume that the prevention didn't work.   But nobody could say for sure that they were helped by the Prevention.  A lot of people would have an anecdote about a friend or family member who did or didn't get the Bad Thing and assume that they were this group or that.  It's just statistics.

Now let's play with the percentages a little more.  Let's keep the risk of getting the Bad Thing at 50%, but bump the risk reduction up to 90%.  Now 45 people who would have gotten the Bad Thing won't get it and only 5 will.  From the standpoint of the group, 45 had a change in their chances.  Fifty didn't get the Bad Thing but they wouldn't have anyway and five got it even with the prevention.  Again, no one can tell whether they would have gotten it without the Prevention.

By this logic, even if the Prevention was 100% effective, it's still kind of hard to get excited about when you look at it that way.

But what if the Bad Thing was much rarer?  Let's say only 10% are susceptible.  Or 5%. Or 1%.  Clearly in those circumstances,  it's going to be hard to sell people on a Prevention when your odds of getting the Bad Thing go from, say 10% to 5% and most likely you won't get it at all.  

I speculated that this is why doctors don't bother much recommending exercise.  Because the Bad Thing (example, hypertension or diabetes) is a vague future problem and the benefits are -- numerically -- rather low.  A 20% or 25% reduction in a problem you don't even have yet?  Kind of hard to get excited about.

Now let's look at a treatment or a cure (I consider the two terms to be synonymous in this case though that's not necessarily the case).  In this case, the Bad Thing has already happened and it's causing some amount of suffering.  So now the question is, will a Treatment make the Bad Thing go away?  So back to my study scenario.  Let's say I have two groups of 100 people, each group has the Bad Thing and in each group, the Bad Thing will go away on it's own, say 50% of the time.  If I give one group the Treatment and it's 50% effective, then the situation in much the same.  You'd think the Treatment was only 25% effective because only 25 people had a change in their status.  Fifty recovered who would have recovered anyway and twenty-five didn't recover who wouldn't have recovered anyway.  So it should be the same, but my contention is that, that's not how people think.  They'll assume that 75% of people who got the Treatment recovered.  Period, full stop.  And if the Treatment is 90% effective, then 95% of the people who got it recovered.

Let's compare the higher percentages.  Again, the numbers are the same. If 90% of people with the Bad Thing recover on their own, then unless the Treatment introduces some additional harm, it's going to be considered at least 90% effective and more like 95% effective, if it's effective at all.

I don't think this is quite a placebo effect, but perhaps it's similar.  I think it's mostly down to human experience.  If you have a headache, you take a pain-killer like aspirin, ibuprofen or acetaminophen for it.  Of those three, ibuprofen is actually the most recommended, but it's not 100% effective (but it is very effective), and a lot of headaches go away on their own, especially if they are due to something you ate or drank the night before.  But so many headaches go away after taking ibuprofen, that you just assume that ibuprofen made them go away.  However, if you ever ran out of ibuprofen and kept forgetting to get more, you might be surprised how many headaches go away on their own within a few hours.  If if you're taking ibuprofen for a headache every day you consider that the ibuprofen isn't really working after all.

But that's not how it goes.

So it is my contention that all this crap with the rona and people yelling at each other over masks and protesting because schools will or won't open or they have to go back to the office could have been largely avoided if, in addition to vaccines, the FDA made a point of approving more Treatments, and further I'd guess that if only one were available, a Treatment would be better than a Prevention, if it could be given at home and not while lying in a hospital bed.  Given my example above, I'm not necessarily saying that people would be healthier with a Treatment vs a Prevention, but they'd be more willing to live with the Bad Things. 

And my contention is borne out by experience.  There are many pills that exist to treat conditions that could be avoided by a healthier lifestyle, like high blood pressure or type 2 diabetes.  Those pills are often expensive and have unpleasant side effects.  And every day people would rather take the pills.  And the most frightening conditions are not the ones that you're sure to get but the ones for which no effective treatment exists (like cancer, which even if you survive it often involves the loss of an organ).  I would estimate that given the choice between donating money to develop an effective vaccine for cancer or donating money to develop an effective treatment, almost everyone would donate for the treatment.

Of course, the government can't legislate medical breakthroughs.  But I didn't see the same money being thrown at the Treatment problem as I did at the Prevention.  Even when the FDA could be bothered to approve a Treatment, almost in the same breath as announcing it's availability, the Prevention angle was still promoted ("Even with this new Treatment approved, we remind people that Vaccines are still the most effective way out of the pandemic").  That fact, leads me to think that the FDA and CDC implicitly agreed with my assessment.  Given an effective treatment, most people would select it over a vaccine and stop fearing the Bad Thing.  And for whatever reason they can't have that.

Note that the presence and ubiquity of vaccines didn't stop the fear of the rona.  Masks and other restrictions were the rule of  the day and vaccinated people went along with it.  By my example, I think people intuitively knew that the effect of the vaccine was limited.  I suspect that things would have been different with a Treatment and people wouldn't have allowed masks and other limits to stand.  But we'll never know.

And of course, the effects are coupled.  For every Bad Thing, there's another Bad Thing down the road.  You can get the Bad Thing, but then you have to worry that you'll go to the hospital or die, each of which is a Bad Thing.  So while suffering from the Bad Thing you have to worry about the Treatment for the current Bad Thing as well as Prevention for the next one.  Both are necessary.  However, the Federal Government and FDA only really put a priority on Preventing the Coronavirus.  It's various half-hearted attempts to facilitate Treatments either didn't work (Remdesivir) or were impractical (monoclonal antibodies) or were seemingly handicapped from the start (like the bizarre restrictions on Paxlovid, but more on that later).  

And preventing people from taking Hydroxychloroquine (HCQ) and Ivermectin makes no sense at all.  The FDA doesn't bad chicken soup for people with a cold.  Those drugs (and soup) don't hurt, so why not?  Unless the FDA and CDC's goal is not the health of the American people but the health of Pfizer and Merck's balance sheets.

I mentioned in my piece about the US Dietary Guidelines that one of the criticisms is that the Dietary Guidelines are published by the Department of Agriculture, which had an incentive to increase the sales of food, and therefore can't really be trusted to publish a diet that would result in fewer calories being consumed.  The same argument can be made with the FDA. The former chairman of the FDA sits on the Board of Pfizer.  And, for some reason, the FDA seems to act as a rubber stamp for Pfizer.  In fact, the FDA pushed Pfizer to submit an application for its vaccine to be given to children between 6 months of age and 5 years of age.   Not to Moderna or Johnson&Johnson.  Pfizer.  That's not acting as an "approval" agency but rather acting as a marketing agency.

Now, Pfizer is a big drug company and they know what they are doing and the fact that most of their drugs get quick approval is likely due to the fact that they do their work properly.   They probably don't submit anything that they don't think will get approved.  And in the case of the toddler vaccination, Pfizer didn't go along with it and pulled the application because they didn't think it was effective.  But it was a stark reminder about who the FDA is really working for.  Let's face it, the FDA talks to Big Pharma multiple times per day.  But even if there are medical doctors on the various FDA panels, they probably haven't treated a sick patient in decades.  So even without trying to be corrupt, they can't help but be influenced by the lawyers and lobbyists from Big Pharma.

Remdesivir is expensive and therefore profitable, there are a lot of people paid to spin the study results to the FDA.   HCQ and Ivermectin are cheap.  No one is lobbying the FDA for their approval. Meanwhile, sick American's suffered because of the FDA listened to the wrong people.