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Many people decry science-based government regulation of medical products, cures, or devices as an intrusion on the freedom of the people to make up their own minds on the effectiveness of such things. In this age of heightened skepticism of government and scientists, this question is once again relevant. Why should government and scientists be the ultimate arbiters of what you can sell to people or what products they can buy and use? Why not leave it up to the consumers themselves? With this question in mind, I visited the Museum of Quackery and Medical Frauds. This museum is located within the Science Museum of Minesota as an exhibit called “Weighing the Evidence”. The exhibit contains many bogus therapies and medical devices. In this essay, I will mention some. An interesting pseudoscience featured in the museum is Phrenology. Phrenologists stated that distinct areas of the brain were responsible for an individual’s cognitive functions, and then they claimed that by measuring the shape of a person’s skull they could gain insight into the extent to which these brain areas underlying the skull determined a person’s behavior and cognitive abilities. The central assumption of phrenology was that any area having a dominant effect in the personality would result in the skull over that area exhibiting a bump, which they would measure. Phrenology has been debunked by scientists. The phrenology areas of the brain do not correlate to brain function, and the bumps in a person’s skull do not correlate to brain shape. Regardless, phrenology was very popular from the mid-1800s and into the first third of the 20th century, and was used for things such as defending and treating criminals, evaluating a parent’s love for a child, and matching people for marriage. Whereas most phenologist relied on palpation, measuring tapes, or calipers to assess the “bumpiness” of the skull, others used more sophisticated equipment such as the psychograph. The museum has one such device invented and patented by businessman Henry C. Lavery which could measure a person’s skull and rate 32 different mental faculties from deficient to very superior. Needless to say, this is all bunk.  Trying a Psychograph Cap One picturesque character featured in the museum is Dr. John Harvey Kellogg. Kellogg was a bona fide surgeon and is most known as the inventor of the corn flake. Kellogg was also the staff physician of one of the most popular medical spas of the early 20th century, Battle creek Sanitarium. At this site he subjected his patients to all sorts of therapies that have not been validated by science such as electrotherapy, hydrotherapy, mechanotherapy, phototherapy, thermotherapy, and others. Kellogg was also a great believer in using vibrations because, according to him, they improved health and relieved constipation. To this end, he invented a vibratory chair that vibrated 60 times per second and of which a working model is featured in the museum. Again, there is no evidence that this therapy works. There are many other bogus products and therapies featured in the museum ranging from tonics, magnets, and vibratory belts, to radio waves and lights of different colors. You may chuckle at some of the crazy claims, therapies, and devices featured in the museum, but it can be argued that at most they made people waste their money, and if the people liked them, that’s their business. The problem is that some therapies actually killed patients, and at the beginning of the 20th century the US government had limited authority to protect consumers. For example, before the deleterious effects of the radioactive element radium became widely known, it began to be marketed as an all-natural enhancer of health that would restore vigor, improve sex life, and cure many diseases. Radium was included in a wide array of products ranging from chocolates and suppositories to toothpaste and dressings. This led to many people suffering from radiation poisoning and cancer. One famous case was the radium girls. These were women working at factories painting the dials of watches with radium-laced paint, which they were told was harmless. As part of their work, the women would often lick their paintbrushes to sharpen them, a practice that was encouraged by their supervisors. These women developed several illnesses including widespread damage to their mandibles; a condition that became known as radium jaw. The radium girls, as they were then called, sued their employers, and the resulting trial and associated publicity led to the passing of labor safety and work compensation laws as well as the creation of the Occupational Safety and Health Administration (OSHA). Another famous case involved radium-laced water of which one particular brand was Radithor. The American industrialist and amateur golf champion Eben Byers was prescribed Radithor for an arm injury in 1927. He became a big fan of the stuff and over three years consumed 1400 bottles. Byers began losing his teeth and developed cancer in his mouth. His upper jaw and most of his lower jaw had to be removed leaving him severely disfigured, but his bones continued deteriorating and holes formed in his skull. He died in 1932 and was buried in a lead-lined coffin. His remains were exhumed in 1965 and were found to be dangerously radioactive. It has been calculated that Byers consumed more than three times the lethal dose of radium. Due to his high social profile, Byers became the poster boy for the ill-effects of radium, and its use declined thereafter.  A Bottle of Radium-Laced Water The final case that led to strong regulation of health products and therapies were the 1937 deaths of more than 100 persons, many of them children, as a result of the ingestion of Elixir of Sulfanilamide which contained the poisonous solvent diethylene glycol. Next year congress passed the Federal Food, Drug and Cosmetic Act, and as a result of this a proof of safety would be required before the release of any new drug or cosmetics. Going back to the question posed at the beginning of this post, history indicates that the average person is no match against bogus drugs or therapies cloaked in pseudoscientific mumbo jumbo backed by clever marketing campaigns. We need scientists to evaluate these things, ask questions about their safety and effectiveness, and conduct tests. We also need government to enforce the conclusions of the evaluation by the scientists. Additionally, many compounds or therapies may be safe but not effective or untested, and people want them to be labelled as such to prevent them from wasting their money. This is the function of science-based government regulation. The photo of the bottle of Radithor by Sam LaRussa is used here under a Creative Commons Attribution-ShareAlike 2.0 Generic (CC BY-SA 2.0) license. The other photographs belong to the author and cannot be used without permission.
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I had an exchange on Twitter with people alleging that doctors are finding that the drug hydroxychloroquine is 100% effective against COVID-19 and posting videos of patients claiming they had been cured by this drug. I tried to explain that this evidence is not valid and provided a link to one of my previous posts that addressed these claims. Then I stated that we need to wait for the results of the clinical trials. The response I got was that if doctors and their patients have tried it and are convinced it works, then that’s all the evidence we need. Unfortunately, this is simply not true. Even before hydroxychloroquine came along, the majority of patients hospitalized with COVID-19 would survive. If all patients are treated with hydroxychloroquine, then how do we know which patients got better because of the drug and which got better because they were going to get better anyway, or because of other treatments? In an uncontrolled clinical environment in the middle of a pandemic, patients are not randomized into matched groups and their treatments controlled and blinded to exclude placebo effects and other biases. Patient testimonials and doctor’s opinions are valuable to design clinical trials, but they have many shortcomings and should never be used to establish whether a drug works or not. All doctors know (or should know) this. However, the main point of this post is not to address the claim that hydroxychloroquine is 100% effective against COVID-19, but rather the attitude of scientists towards such claims, especially when they are reported using the media instead of the regular scientific channels. Scientists know that products or therapies that are 100% effective are rare, and this is even more so in the case of major diseases like COVID-19. Some vaccines, hormones like insulin, or a few antibiotics have approached this level of effectiveness, but this is not very common for most other compounds or drugs. About 86% of the drugs tested in clinical trials are found not to be effective and are not approved. Claims of 100% efficacy for a drug or therapy will trigger a strong (and warranted) skeptical response from most scientists.  Quack I have been around a while, and I have read many investigations into multiple bogus claims regarding miracle cures or procedures promoted by quacks. One of the characteristics of these individuals is that they inflate the claims they make regarding the efficacy of their products or therapies beyond the bounds of credibility. If these fraudsters wanted to be believable, they would probably look up the percentage cure rate of the best science-sanctioned therapy and then inflate the claims for their products or therapies by a few percentage points to make them look significantly better but not impossibly so. However, the target audience of these individuals is not scientists but the general public, which has no experience with scientific research or clinical trials and their nuances.
As I have explained before, the best way to promote a bogus product or therapy is to make your audience assimilate your product as part of their identity. If you can achieve this, your audience will be impervious to evidence that the product does not work. This is because any attack on your product will be viewed by the members of your audience as a personal attack on themselves. From this vantage point, it is unfortunate that the president of the United States has promoted the use of hydroxychloroquine. In the current politically charged atmosphere, I am concerned that this identity-forming process seems to be coalescing around the notion that if you don’t accept that hydroxychloroquine works, then you are against the president and thus part of a left-wing conspiracy. It is then all too easy for unscrupulous individuals to exploit this situation by linking themselves to the “pro-president” audience and peddle hydroxychloroquine or other as yet unproven drugs or therapies for COVID-19. If their claims are questioned, all they have to do is argue they are being attacked by the same system that their audience believes is against them and the president. I was skeptical about hydroxychloroquine from the beginning, not because the president promoted it, but because the data for its effectiveness was weak. Thus when I hear these claims for 100% effectiveness of hydroxychloroquine (or any other drug or therapy for that matter), this immediately raises a red flag, and I close my mind to them. This may not seem the scientific thing to do, but remember that keeping your mind too open can be dangerous. As far as I’m concerned, like the late astronomer Carl Sagan said, “Extraordinary claims require extraordinary evidence.”, and the burden of proof is on those individuals who make these claims. It is up to them to produce high-quality evidence to support that what they claim is true, and, seriously, with a 100% success rate this should not prove too difficult, right? At this point you may argue that even if the effectiveness of hydroxychloroquine is less than 100%, but something like 80%, or 50% or 30%, that would still be significant and important. My answer to this is, yes, but this HAS to be established by well-designed clinical trials. At the moment, many clinical trials of hydroxychloroquine are ongoing, and several of these trials are sufficiently well-designed to yield unambiguous results. As I write this, among the best trials completed so far, one has indicated that hydroxychloroquine does not work as a prophylactic against COVID-19, and another has indicated that hydroxychloroquine does not reduce the risk of death among patients hospitalized with COVID-19. The FDA recently revoked its emergency use authorization of hydroxychloroquine, because based on the available evidence it’s unlikely to be effective in treating COVID-19 and any potential benefit from its use outweighs the potential risks. Many of these trials were designed to address the initial claims for hydroxychloroquine being very effective when administered alone or with certain antibiotics. A new claim has been made that hydroxychloroquine is only effective when it is administered with zinc, and new clinical trials are being performed to evaluate this possibility. As I stated above, I am skeptical about hydroxychloroquine, but I don’t want to be right, I want to save lives, and I hope the combination of hydroxychloroquine with zinc works. However, the public has to understand and accept the need to perform clinical trials and stop relying on testimonials and other anecdotal evidence. Image of a quack doctor selling remedies from his caravan; satirizing Gladstone's advocacy of the Home Rule Bill in Parliament is a Chromolithograph by T. Merry, 1889, and comes from the Welcome Collection. The image was modified and used here under an Attribution 4.0 International (CC BY 4.0) license, and no endorsement by the licensor is implied. |
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