The off-label use of prescription drugs is often misunderstood by conflating it with the non-evidence-based use of drugs. I actually don’t have an issue necessarily with using drugs off-label. A distinct issue is whether or not drug companies can promote off label uses, and how they can advertise their drugs at all. A recent court decision may loosen restrictions on the pharmaceutical industry (and by extension the supplement industry and the marketing of any health product).

In a case that could have broad ramifications for the pharmaceutical industry, a federal appeals court on Monday threw out the conviction of a sales representative who sold a drug for uses not approved by the Food and Drug Administration. The judges said that the ban on so-called off-label marketing violated the representative’s freedom of speech.

The ongoing battle between regulation and free speech rages on. First for some background, in the US the FDA regulates the marketing of drugs, which are defined as a substance that is used to treat or modify any disease. Supplements are now defined as substances use to enhance or improve some structure or function in the body, but cannot be claimed to treat any specific disease. So these categories are based, for regulatory purposes, on the kinds of claims that are made for them.

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Both here and at Science-Based Medicine I and my co-bloggers often tackle health products that are marketed with unsupported claims. The pattern is now well established – the product is sold as a “supplement” so that it doesn’t have to deal with the pesky FDA, the claims are vague “support and enhance” nonsense, the products are generally good for whatever ails-ya, testimonials or worthless in-house studies are offered in place of peer-reviewed research, and the whole thing is cloaked in sciencey but meaningless technobabble. Some products are also sold through multi-level marketing (MLM), which itself is a highly dubious (if technically legal) practice.

It is very common, especially for products sold through MLM, for someone who sells the product to appear in the comments or to send in an e-mail defending the product. The tone is very different from the critical comments we get from “true believers” – the believers tend to be more angry and personal, while the sales reps speak in talking points as if they are reading from a brochure. The formula there is well-established as well. The same talking points pop up again and again, it’s all boilerplate.

Recently Harriet Hall wrote an excellent article at Science-Based Medicine about a product called ASEA, which is essentially salt water. Selling “magic water” is a great scam, and there are endless variations of it. There is a certain psychological appeal to water which makes it easy to believe it has healing properties. It’s also cheap, safe, and easy to distribute. Water, in a way, is the perfect snake oil – just add some pseudoscience. I won’t duplicate Harriet’s article, which covers the topic of ASEA well, but I will give a quick summary. ASEA is nothing but salt water. The company claims it has been treated with a proprietary process to create:

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It is my contention that scientific skepticism is an intellectual discipline and a cognitive skill set more than anything else. It is also a philosophy, a value system, and an approach to knowledge – but these are hollow without the knowledge and skills to apply that philosophy.

This is especially true in our complex world, with sophisticated pseudoscience alongside mature and highly technical real science, ideologies of every stripe pushing their agenda, governments with power to protect, and markets and corporations with a profit motive to deceive. The internet is also drowning us in information, much of it dodgy.

It is therefore not enough to have a generally skeptical outlook, or even to call oneself a skeptic. Skepticism is a journey of self-knowledge, exploration, and mastering the various skills that comprise so-called metacognition – the ability to think about thinking. <shameless plug> For a thorough discussion of metacogntion, you can check out my Teaching Company course: Your Deceptive Mind: A Scientific Guide to Critical Thinking Skills. I also understand it makes a wonderful gift.</shameless plug>

As an example of the need for metacognitive skills in navigating this complex world there is confirmation bias. This is definitely on my top 5 list of core skeptical concepts, and is a major contributor to faulty thinking. Confirmation bias is the tendency to perceive and accept information that seems to confirm our existing beliefs, while ignoring, forgetting, or explaining away information that contradicts our existing beliefs. It is a systematic bias that works relentlessly and often subtly to push us in the direction of a desired or preexisting conclusion or bias. Worse – it gives us a false sense of confidence in that conclusion. We think we are following the evidence, when in fact we are leading the evidence.

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“I’m Good Enough, I’m Smart Enough, and Doggone It, People Like Me!”
– Daily Affirmations With Stuart Smalley.

Self-help books are full of advice for thinking positively, and using affirmations to tell ourselves that the reality we wish to be true is in fact true. This is interesting because psychologists have discovered that people in general have a large positive cognitive bias – a wishful thinking bias. All other things being equal, we will tend to assume that what we wish to be true is actually true. Sometimes we can maintain this belief despite significant contradictory evidence.

It may be that this bias exists because it relieves cognitive dissonance. Essentially, it makes us feel better, and that may be sufficient. However, there is also a theory that such wishful or positive thinking is, to an extent, self-fulfilling. People who think they will be successful will take advantage of opportunities and work harder to make that success a reality. Expectations can even affect other people, the so-called Pygmalian effect. If teachers believe that a student will perform better, that expectation may improve the student’s performance.

Richard Wiseman points out, however, that visualizing the goal (“I am a success in my business”) does not work (so much for positive affirmations). What is helpful is visualizing the process by which a goal can be achieved.

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