Aug 06 2018

More Stem Cell Quackery

We’re doing it wrong. We are definitely making an effort to regulate the practice of medicine and sale of health-care products and services to protect the public from fraud and abuse, as we should. But we are doing it wrong, or at least not well enough.

Just one of the many examples is stem-cell quackery, which I have discussed before. Stem cells are an exciting area of research, and the basic technology is advancing significantly. Clinical applications, however, take time, and with a few exceptions we are simply not there yet. We are currently, therefore, in the sweet spot for abuse.

A recent article in the San Francisco Chronicle, called The Merchants of Hope, highlights the problem. The article should have been called The Merchants of False Hope, but otherwise it did a good job of exposing dubious stem cell clinics that have made their way to the US. A decade ago stem cell clinics were popping up in China, India, and other countries with lax regulation, leading to an industry of stem-cell tourism. But now you can find dubious stem cell clinics right here in the US.

Stem cells, for a quick review, are cells that can turn into other types of cells. There are pluripotent stem cells that can turn into several other kinds of cells, such as the cells in your bone marrow that can make different kinds of blood cells. There are also totipotent stem cells that can turn into any kind of cell. Researchers have gotten good at making totipotent stem cells, even out of mature skin cells. This technology holds the promise of treating a long list of conditions by replacing diseased or damaged cells with new ones.

Where the technology is having problems is in controlling what the stem cells do. We have to coax them into turning into the desired type of cell, in surviving in the correct location and functioning properly. Further, we need to keep them from growing out of control, essentially causing a tumor. This is proving challenging.

What current dubious stem cell clinics generally do is inject some type of stem cells into the problem tissue, as if it were a magic potion, and then hope for the best. That’s really it. They have not leap-frogged the technology by 20 years, they have not worked out all the technical problems, and they have not tested their treatments to prove that they actually work. Clinics (especially in China and similar locations) often do not even disclose what they are injecting, or carefully track outcomes. Unsurprisingly, “alternative medicine” practitioners are taking the lead in providing these dubious treatments. American researchers who have tried to track the outcomes retrospectively find a trail of devastation and trashed hopes. They conclude:

Collected evidence indicates substantial patient exploitation using the power of hope,” and risks using unproven SCIs (Stem Cell Interventions). 

The main problem (other than practitioners with questionable ethics) is that the regulatory infrastructure does not have adequate resources to implement the current strategy for protecting the public, and they are too slow to respond to changes in the health care market.

In the case of stem cells, the FDA has the power to regulate the cells themselves as a biological product, but the FDA lacks the resources and often the regulatory teeth to effectively shut down such fraudulent practices. They set their sites on the worst offenders, but 10 more pop up in their place.

States have the power to regulate the practice of medicine, but they generally lack the resources and political will to do an effective job. Some states have instituted laws requiring stem cells clinics to post notices that their treatments are unproven – an entirely ineffective measure that gives them the illusion they are addressing the problem.

There are also many loop holes to exploit, such as research. Unethical practitioners have learned that they can easily pretend to be doing clinical research, although they still charge their “subjects” for the treatment, and never publish any results.

Whenever I write about such topics there are those who comment that people should be free to offer and to use whatever service they want, and the free market will sort it out. This position is both ethically dubious and factually challenged. First, we can say from history that the free market does not “sort it out.” Dubious treatments persist, even when they are harmful and/or worthless. The problem is made clear by reading the many comments by the victims of such clinics.

If someone with all the trappings of legitimacy (white coat, letters after their name, state licensure) tells you they can fix your serious health problem with some fancy new medical technology, why would the average person doubt them? A non-expert would lack the knowledge necessary to judge the claims for themselves. They are also in a compromised position, because they may be desperate from their illness or that of their loved-one.

In short, offering dubious treatments obscured with technical jargon to desperate patients is predatory and arguably fraudulent behavior. We don’t let the market sort out fraud and abuse – we make fraud and abuse illegal. Market forces are excellent at working out issues of quality, service, convenience, and cost that are perceptible to the consumer. Medical services generally are not – it is often impossible to tell how a specific treatment affected an individual patient. We need statistical data to know what the risks and benefits are.

There is also a huge knowledge and experience gap between practitioner and patient (or at least a perceived one).

Finally, if you buy a bad product that breaks, you won’t buy that product again. If you opt for a medical treatment that is dubious, you may die or suffer horrible morbidity. You may have had to get a second mortgage on the house to pay the tens or hundreds of thousands of dollars for a treatment based entirely on desperation and false hope. Saying the market will “sort it out” is cruel.

Transparency is a first step, but it is not sufficient. The FDA needs the resources and the legal ability to much more quickly and effectively shut down clinics that are exploiting desperate patients with unproven therapies. States need to step up also and do their job of regulating the standard of care – otherwise there is effectively no standard.

I don’t think that is what the public wants, or thinks that they currently have. The public believes they have more protections than they actually have, which makes them more vulnerable. Desperate patients tell themselves that the treatments must be legit, or otherwise they would not be allowed. Inadequate regulations just serve as a false sense of security, playing into the hands of charlatans and quacks.

The rise of dubious stem cell clinics is yet another sign that we are doing it wrong, and need to make some serious changes to how we protect patients (i.e., all of us) from health care predators.

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