One of the greatest innovations benefiting public health was regulation. In the pre-FDA “patent medicine” days, there were countless products on the market that ranged from useless to directly harmful. This was a time when you could sell radioactive tonics, cocaine-laced elixirs, and products containing poisons, like turpentine. The sellers of these products made many unsupported claims and preyed disproportionately on the poor. While there were some real medicine in the mix, like aspirin, on the whole the industry did more harm than good.
The 1906 Pure Food and Drug Act transformed the industry. In the name of consumer protection, this law and later revisions required that ingredients be accurately listed on the label, that products could not make claims that were not evidence-based and reviewed, and that products had to demonstrate safety. Requiring that something as vital as medicine be safe, effective, and transparent seems obvious, and we mostly take these protections for granted.
And yet, over the last three decades we have been systematically unravelling these fundamental protections. We are arguably getting close to a “post regulation” era, with a functional return of patent medicines and snake oil. The most critical inflection point here was the Dietary Supplement Health and Education Act of 1994, which essentially deregulated the supplement industry and created the category of “structure function” claims that can be made without review.
In my opinion, there is no meaningful difference today between the supplement industry and the patent medicine industry of the 19th century. They make wide-ranging and often implausible claims without evidence to back them up, products are rife with substitution, contamination, and adulteration, and there is very little efficacy to be had. And on the whole I would say the industry does far more harm than good.
There is another layer to this trend toward deregulation, and that is decriminalization for serious drugs. I am not arguing that criminalization for drugs like cannabis is the optimal way to deal with them. I would prefer thoughtful evidence-based regulation, but now we are headed back toward the pre-FDA wild west.
Cannabis is just one example. David has written an excellent series of articles on cannabis as the new herbalism, so I won’t repeat that here. I also agree with his take, that the new popularity of medical cannabis “(1) vastly inflates the potential of medicinal uses of marijuana and (2) ascribes near-mystical powers to smoking or making extracts out of marijuana, rather than identifying and isolating constituents of the plant that might have medicinal value.”
Just as with herbalism, we are dealing with years of propaganda convincing much of the public that herbs (including cannabis) are somehow not drugs. This is mostly just the appeal to nature fallacy, but also often includes an appeal to ancient wisdom, and to consumer self-empowerment. These marketing methods, by the way, are identical to those of the patent medicine industry of the 19th century.
What this leads to is a culture of self-treatment and experimentation, without a sufficient appreciation for the risk/benefit analysis. This is combined with social media, which allows for the rapid spread of dubious claims, and the fomenting of anti-expertise conspiracy theories and a post-truth culture.
Another example is Kratom, which we have also covered. Kratom is quite simply a drug that causes opiate-like effects, including psychoactive effects, addiction, and withdrawal. It can cause liver damage and a host of other side effects and toxicities. This does not mean it isn’t a useful drug – all drugs have side effects. But like all drugs, we need to understand its constituents, control for dosing, and study the pharmacodynamics and kinetics to be able to determine its safe use. In effect it currently is a narcotic-like over-the-counter unregulated drug.
Now psilocybin (usually sourced from mushrooms) is emerging as another common product of self-treatment that is skirting regulations. Like cannabis, it is being decriminalized in many states, but without substituting criminalization with regulation. Use is spiking recently, including among children. Many people are using it to self-treat depression and anxiety.
Psilocybin and other hallucinogenics are an interesting category of psychoactive drugs, and may ultimately lead to effective new treatments for some conditions. Like cannabis, being criminalized hampered research. But now there is an overcorrection.
For all of these drugs, we need to chart a course from heavy-handed criminalization to evidence-based regulation. Quite simply, these and other compounds are powerful drugs, with all the risks that entails, including addiction. What would be optimal for public health is for there to be continued research into drugs like these, just like any new drug, to establish safe and effective use.
We have a long history that clearly indicates without such evidence-based regulation the net result will be more harm than good.
