The quacks are winning, at least in the short term. They appear to be more clever, nimble, versatile, and relentless than our regulatory system can (or apparently wants) to handle. If that is the collective will of our democratic society, then so be it. I disagree, and will continue to shout into the wind, but I will recognize the will of the majority. But – I don’t think that’s the case. The evidence suggests that most people operate as if the regulatory infrastructure protects them from outright quackery. It doesn’t.
An excellent, and rather sophisticated, example of this reality is the recent explosion in domestic stem cell clinics. We have been writing about stem cell tourism for years. Starting about a decade ago, dubious stem cell clinics were popping up largely in countries with poor regulation, like China, India, and Mexico. Their business model appeared to be to attract wealthy and desperate Westerners to their clinics with the promise of cutting-edge stem cell therapy for their incurable disease. Desperate patients would spend tens of thousands of dollars to get a witches’ brew of what was claimed to be stem cells injected into whatever body part was the problem.
The results were predictably horrible. At best patients wasted a lot of time and money on false hope. At worst, desperate families were bankrupted by the expense, devastated by the failed outcome, and often directly harmed by the treatment.
While we tried to sound the warning bell, the mainstream media was busy promoting such clinics with their gullible reporting. They were falling for the same con as the patients – assuming that because stem cells are cutting edge science, any stem cell clinic must be legitimate. At the time we could recommend to the public that if you have to travel to a country with poorly regulated medicine to get a treatment, you probably shouldn’t. That advice is no longer sufficient – because this same dubious stem cell clinic model has been imported to the US, with an even savvier con.
Patient-funded research
The Washington Post, to their credit, recently published an excellent overview of the situation. They report on the rapid growth of direct-to-consumer stem cell clinics in the US since 2009, increasing from just a few to over 700, and probably more. Mark Berman, a Beverly Hills plastic surgeon, is responsible for a lot of this increase. He co-founded Cell Surgical Network, which is essentially a franchise of dubious stem cell clinics. For $30,000 his company will train doctors to extract a patient’s fat, prepare it with his special centrifuge, and then inject it back into patients.
Here is the common model that these stem cell clinics have developed. First, Berman claims that his treatments are outside of the FDAs purview because you cannot consider the patient’s own fat a “drug”. This is a common tactic of the charlatan – to characterize legitimate attempts at regulatory quality control in medicine as overreach. Or, you can always go further and claim there is a conspiracy. As the WaPo reports about some of these stem cell doctors:
The two doctors say the FDA, in taking a tougher stand, is acting on behalf of the pharmaceutical industry, which doesn’t want competition for its medicines.
Berman and his cohorts are flatly wrong. The FDA does regulate what are called “biologics” – treatments that are not drugs but they are proteins, blood products, cells, and other material prepared from biological sources. So taking adipose tissue from a patient, treating it, and then injecting it as a stem cell treatment is legitimately considered a biologic and under FDA purview.
A core part of the stem cell clinic model, which we have seen before from charlatan innovators like Stanislaw Burzynski, is to claim that you are doing research. The treatments are therefore experimental, which nicely obviates you from having to provide evidence for safety and efficacy. They call it “patient-funded research” because the patients are still paying out-of-pocket thousands of dollars for the treatment. This, of course, raising its own problems.
There is a carefully designed system, evolved over decades, for protecting the public from unethical medical research. The rules are not arbitrary, have been extensively vetted and debated, and are there to protect people. This system includes getting an investigational new drug license (IND) for any new drug or biologic that you want to study in humans. Any human studies also have to be approved by an investigational review board (IRB), whose purpose is to make sure all ethical guidelines are strictly adhered to.
These guidelines include that subjects are given proper informed consent (they know what they are getting into), that the treatment is plausible and reasonable, meaning based on what is known upon enrollment it is more likely to help than to harm. Subjects should be given proper medical monitoring throughout the study, and appropriate care for any adverse effects. The rules also include that subjects do not pay for experimental treatments or associated care.
The idea is that you gather the data first, in as ethical a way as possible. You then have to publish your data, good or bad. Then, if you can adequately prove that your treatment is safe and effective it will get approved, and you can finally sell it to patients.
Berman and his fellow entrepreneurs completely bypass all of these ethical regulations. They just wave off the FDA, then claim to be doing experiments on people but without IRB approval, and they charge their “subjects” directly for the treatment. They think simply calling this “patient-funded research” bypasses these ethical rules.
They have also discovered they can exploit the regulatory apparatus for clinical trials for some free advertising. Some clinics register with clinicaltrials.gov to give their “research” a patina of legitimacy and also to possibly lure patients to their clinic. What we rarely if ever see from such “patient-funded research” scams is legitimate published scientific research, the kind capable of determining whether or not the claimed treatment is truly effective.
Meanwhile these stem cell clinics are making high-pressure sales pitches to their potential patients, with emotional claims based on video-taped testimonials. They pull the typical con we often see from snake oil salesmen, claiming that their many happy customers are all the evidence they need. Overbearing regulatory agencies should just get out of their way so they can get busy curing patients. They further claim patients have a right to “alternative treatments.” Many states, in fact, now have “health care freedom laws” exactly to that effect.
Of course the only thing that makes a treatment “alternative”, apparently, is that it is not backed by adequate scientific research. So they are claiming that patients have a right to experimental treatments without all the safeguards put in place for an ethically-managed human research – and they have the privilege of paying for it all themselves. How nice.
The whole thing is a massive scam, that seeks to undermine and bypass regulations put in place specifically to protect the public from exactly this kind of scam. It is amazing and disheartening how well the whole con is working. The quacks are winning indeed.
A failure of regulation
The core problem here is that we simply do not have the regulatory infrastructure we need to adequately protect the public from this type of exploitation. We have a patchwork system, which in itself is not necessarily bad, but it does allow for rather wide cracks through which scam treatments can slip.
At the federal level we have mainly the FDA, DEA, and the FTC. The FDA has been deliberately weakened in some ways, in order, for example, to give a free pass to the supplement industry. But even when they have the regulatory power, they lack the resources. They are playing a losing game of whack-a-mole.
In a perfect world they should be able to shut down every one of these dubious stem cell clinics, or at least make them comply with strict research guidelines. Berman and his ilk, however, are essentially laughing at the FDA. He is directly challenging their authority, and the FDA simply does not have the resources to call him out. Perhaps there is also a lack of political will at play as well.
At the state level the departments of health, who license physicians and other health care providers, are the main mechanism for regulations. The states are supposed to enforce a minimum standard of care among providers, but they rarely do. As I stated above, in many states there are laws which undermine their own departments of health by carving out exceptions to the standard of care. The departments are hobbled, so that the charlatans are free to prey upon the public unhindered.
But again, there appears to be a massive lack of political will to really enforce even a basic minimum standard of care – otherwise such stem cell clinics would not be allowed to operate. In the end it is the unfortunate reality that patients are left to fend for themselves. The public is not adequately protected from outright quackery. The charlatans have learned how to thrive within the system, out in the open, openly defiant, while they make millions off the desperate.
We can do better.