US FDA lies about THR. And lies. And lies. And lies.

posted by Carl V Phillips

As I mentioned to some of you, I am going to write about the leaked EU document that shows their plans to ban e-cigarettes, but I will come back to that (perhaps it will be disavowed as a horrible bit of anti-public-health anti-democracy by then, and I will not have to — we can dream, can’t we).  But today, at the request of one of our members who needs to respond to an employer’s claims about the US Food and Drug Administration’s position on e-cigarettes, I thought I would start a series about the FDA claims.  FDA is probably the single biggest anti-THR liar of the last couple of years, so this is probably overdue.

I am going to partially outsource the content of this post to Brad Rodu, who posted on FDA lying about THR a few months ago (it is a quick read, so pop on over to it).  The post is about a page on the FDA website that claims, in boldface, no less:

To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products.

So the FDA, continuing the tradition of the US government for more than a decade, is telling people, “if you are considering using any tobacco product at all, then you might as well smoke.”

FDA’s only possible partial defense for the claims on this page (and I stress “possible”, “partial”, and “this page”) is that the primary purpose of the page is not to communicate to consumers or to provide scientific information, but to inform merchants and busybodies who might want to report on them that any comparative risk claim is “fraudulent”:

Claiming less harm or reduced risk of disease from using tobacco products misleads consumers to think that these products are safe to use.  FDA considers these kinds of claims to be health fraud.

The reason I start the discussion of FDA with this material is that it provides some useful insight about the organization that might not be generally understood.  FDA is a basically a law enforcement agency that does a little science, but many people mistake it for a scientific agency.  As with any branch of government that makes rules and focuses on enforcement, the mindset is not that of a scientist — seeking truth — but of a cop or legislator.  They declare how things are rather than seeking to learn about the world.

Consider the second quote, above.  Obviously not every claim of reduced risk would mislead consumers into thinking the products were safe.  For example, someone could say about a smokeless tobacco or e-cigarette product, “this product poses a health hazard to the user, however, that hazard is less than that from smoking.”  Frankly such a claim is such an understatement of the science that it could be used as an anti-THR lie, but it obviously would not be overstating the risk difference, and even more obviously would not lead to the conclusion the product is safe to use.  But the FDA “considers” even that fraud.

Considers.

Most people who think that FDA is a scientific agency would assume that “considers” implies a scientific conclusion based on scientific study.  The natural assumption would be that FDA has done that study and, taking the normal meaning of the word “fraud”, someone would assume that scientific study leads to the conclusion that it is false to say that smoke-free tobacco products are lower risk than cigarettes.  But once you recognize that FDA are cops and not scientists, it becomes clear:  FDA declares that any such claim is fraud — whether the claim is true or not.  They can define “fraud” to be anything they want, and in this case they have defined it to include true statements.

To further understand FDA, it is useful to explore why it is easy to mistake them for a scientific organization.  Much of what they do is to run and oversee a lot of studies, and those are a kind of science.  But despite the huge volume of work, there is not much scientific thinking going on.  The studies consist of carrying out the same couple of recipes, over and over again.  They are scientists in the sense that McDonalds employees are chefs.  More directly, it is like cops doing investigations, which generally follow the same routine — not unskilled and not thoughtless, for sure, but also not Sherlock Holmes.

Police follow fairly systematized procedures that mostly get the job done and mostly avoid the various obvious things that can go wrong if people are allowed to exercise more discretion.  The same observation applies to things like FDA’s pharmaceutical approval process.  But once we move beyond flipping burgers and interviewing the usual suspects, to trying to answer complicated questions based on complicated bodies of information, FDA is out of their expertise and — the evidence shows — out of their depth.

Just as it would not be wise to assign an average city police detective — however good he might be at his job — to, say, figure out who might be planning to attack an airliner somewhere in the world, it is not a good idea to trust FDA to do science that does not follow one of their recipes.  Unfortunately, the US government does not have an equivalent of the NSA for health science, so we are stuck with the FDA and their recipes.

Evidence for why this is such a problem can be found in the first quote, above.  Any scientist knows that there is no such thing as “scientifically proven”.  Proof naturally exists in math and logic and it is defined and created in law, but is absent in empirical science (it is often used as shorthand for “there is very very strong evidence supporting the claim” but that is not technically accurate).  Since FDA as a legal agency, it is used to dealing with “proof” in the legal sense.  What this means is when FDA declares that “if you follow our recipe for drug trials and particular results come out the other end, then particular things are proven“.  Again, it is them declaring something to be true, rather than discovering it; it is “proving” in a legalistic sense because the law declares that what matters is following the recipe, not true scientific inquiry.

Do not mistake any of this as excusing their lies.  They write in the language of science.  They portray themselves as having scientific expertise.  They explicitly offer scientific advice.  So they are subject to scientific standards and scientific criticism.  They could have chosen to just be honest cops, but they have chosen to be liars.

Even their legal declarations read as if they are making scientific claims.  In the second quote, they make the obviously false statement that consumers would over-interpret any possible comparative risk claim.  But it is they who are engaging in marketing tricks to mislead consumers.  If they said “we currently declare this to be fraud, regardless of what the science shows”, that would be honest.  If they said “no tobacco products have been subject to one of the two or three scientific recipes that we do, and we refuse to accept the scientific evidence”, that would be honest.

But when they suggest that the science supports their absurd claim that all tobacco and nicotine products pose exactly the same risk as smoking, they are lying.  It is not quite true to say that all of their statements about THR are lies, but remarkably close to all of their substantive claims are.  I will start addressing some of them.  I will quit when I run out of energy to do so — I suspect long before I run out of their lies.