Reuters recently reported on the raid of a stem-cell clinic in Hungary. This is welcome news, if the allegations are correct, but really is only scratching the surface of this problem – clinics offering dubious stem cell therapies to desperate patients. And in fact this is only one manifestation of a far greater problem – the quack clinic. They represent a serious problem for patients, doctors, and health care regulation.
Stem Cell Clinics
There is a very disturbing trend in the last few years – the proliferation of clinics offering stem cell therapy for a variety of serious, often incurable, diseases such as spinal cord injury, ALS, Parkinson’s disease, and other neurological disorders. These clinics claim to improve and even cure these diseases by injecting stem cells into the spinal cord or other parts of the body. Treatments typically cost 20-25,000 dollars, plus travel expenses, for a single treatment.
The problem is that these clinics do not have any published evidence that their treatments are valid. There is good reason to think that they are not – stem cell technology is simply not at the point yet where we can use them to cure such diseases. There are many technical hurdles to be overcome first – knowing how to control the stem cells, to get them to survive and become the types of cells necessary to have the desired therapeutic effect, and also figuring out how to keep them from growing into tumors. Basic issues of safety have not yet been sorted out.
So in essence what these clinics are claiming is that they are years, perhaps decades, ahead of the rest of the world. And yet they have no science to show for it. They should be able to produce dozens of studies demonstrating their technology, but they can’t.
Further, they should ethically be giving such treatments as part of clinical research, to establish their safety and efficacy, but they haven’t. What little information we have comes from outside observation. For example, Bruce Dobkin published a review of cases at one Chinese stem cell clinic. He concludes:
The phenotype and the fate of the transplanted cells, described as olfactory ensheathing cells, are unknown. Perioperative morbidity and lack of functional benefit were identified as the most serious clinical shortcomings. The procedures observed did not attempt to meet international standards for either a safety or efficacy trial. In the absence of a valid clinical trials protocol, physicians should not recommend this procedure to patients.
In other words – we don’t even know what the clinic doctors are injecting into patients and what happens to the cells, if any are even present. There are risks to the procedure without any evidence of benefit. And the clinic is not following standard ethical procedures for experimental treatments.
Although China seems to be a hot spot for such clinics, the recent raid occurred in Hungary. The reason for the raid was that the clinic in question did not have the permits necessary to use human tissue – the stem cells allegedly used by the clinic are reported to come from aborted fetuses. What is not clear is, if it were not for this issue, would the clinic still be free to offer a dubious treatment for serious diseases.
Robin Lovell-Badge of the National Institute of Medical Research in London is quoted as saying:
“I hope it scares others from offering untested treatments and will be a cautionary tale to members of the public.”
I share her sentiments but this statement strikes me as hopelessly naive. Such clinics have been in operation continuously over the last century, and they are increasing in number – not decreasing.
The Quack Clinic
Regardless of the treatment, the formula for operating a so-called quack clinic is now well-established. Typically such clinics are created by an individual, who may or may not be a physician. Often they are based upon one dubious treatment – this can be ozone therapy, an unconventional use of approved drugs, or an imagined new agent. Typically the therapy is based upon a fanciful and unproven philosophy of disease, such as the notion that all cancers are caused by fungal infections, or that all disease is caused by a liver fluke.
Clinics sometimes focus on one disease or condition to start, but over time the claims tend to expand to include more and more conditions (a good way to expand the customer base).
Here are the features of such clinics that should make any patient very cautious:
– The clinic often has an impressive name, such as “The Institute Of,” but lacks any formal affiliation with an established institution, like a university or hospital, and was founded and may even continue to be operated by one person. Essentially, a lone practitioner can easily surround themselves with the trapping of prestige and legitimacy by attaching fancy names to their operations.
– The clinic claims to treat or cure one or more diseases that is currently believed to be incurable. Their claims sound to good to be true.
– There is only one clinic in the world that can perform their special procedure or that uses their proprietary treatment. Sometimes, like with the stem-cell clinics, the treatment offered is a new and experimental treatment. The clinic takes advantage of the hype surrounding a new technology, but is premature in their claims.
– The clinic claims to cure a variety of diseases all with different causes and pathophysiology with a single treatment – the one cure for all diseases approach.
– The clinic is located in a country with little or no regulation.
– The clinic claims that it is the victim of repression. Typically they will say that either Big Pharma, the medical establishment, the insurance industry – or some other convenient villain is trying to suppress their revolutionary treatment.
– Testimonials are used to promote the treatments offered by the clinic, but they have not published appropriate research in legitimate peer-reviewed journals. Often this failing is defended with the excuse that they are “too busy curing patients to publish research.”
– When challenged by professional organizations, the clinic defends itself by appealing to politicians, using the testimonies of previous patients who believe they have been helped by the clinic and the accusation of a conspiracy of those trying to protect their monopoly. It is not difficult to find a sufficiently naive and scientifically illiterate politician to take up their cause and shield the clinic from efforts at regulation.
Of course, not every dubious clinic has every feature I outline above, but they tend to have most of them. Any of these features should be treated as a red flag and provoke extreme caution. Unfortunately, patients and families of patients with serious or terminal diseases are often desperate. They want to believe the extraordinary claims, and are encouraged to believe that they have nothing to lose. However, I have seen first hand that they do. Such clinics have bankrupted families who could not deny their loved-one the chance of a cure. They have also robbed the terminally ill of whatever time they had left to spend with their families.
Occasionally I have had patients admit with anger that they wasted tens of thousands of dollars and wasted the last six months of their life on a false hope. But most of the time such a realization is too painful – there is too much insult being added to injury. Patients and families often convince themselves that the dubious treatment was worthwhile, despite all the evidence to the contrary. One patient of mine, after having stem cells injected into their behind to treat Parkinson’s disease, was convinced that their disease would have been worse without the treatment – despite the fact that their disease was end-stage and about as bad as it gets. Another patient’s father convinced himself that taking his son with muscular dystrophy to Mexico, at a cost of about $50,000, was worthwhile because now his son seems to be drooling a bit less (his neurological exam was unchanged).
There is also the recently reported case of the mother who was convinced that her blind child could see after getting stem cell therapy in China, despite the fact that objective opthalmological exams showed the child to still be blind.
These stories are extremely sad. These are also the same people who will give glowing testimonials that will help ensnare the next victim, and who will come to the aid of the clinic when the regulatory agencies finally catch up with them.
Regardless of where along the spectrum the operators of dubious clinics are from well-meaning and self-deluded to deliberate and callous frauds, the harm they do to the most desperately ill is incalculable. It is frustrating that regulatory bodies are generally ineffective in dealing with such clinics, unless they run afoul of a specific law like a ban on using fetal tissue.
In the US, it is actually getting more difficult. So-called “health care freedom” laws are being passed in more and more states – these laws erode the standard of care and create a safe zone where dubious clinics can thrive without fear of regulation.
Lovel-Badge, quoted in the article about this recent stem-cell clinic raid, says:
“Many of us have been deeply concerned about some of the clinics that are offering untested, and often illogical ‘stem cell’ treatments,” he says. “They take advantage of desperate individuals or their family members, charging them large sums of money for procedures that are unlikely to work, may in fact be dangerous, and may use cells of dubious origin.”
You can remove the words “stem cell” from her first sentence. There are clinics offering many types of treatments that are equally harmful and exploitative. I am glad to see some mainstream media attention to this problem, but they vastly underestimate the nature and scope of the problem.
Without the ability and political will to enforce a reasonable science-based standard of care, the public will continue to be victimized by quack clinics.