Over the years I’ve often written about how unlicensed stem cell clinics and their physicians are putting patients at risk. In most if not all cases they are doing this simply for their own personal monetary gain. I do think that some of them truly believe they are helping patients, but still that doesn’t excuse risky behaviors that are throwing vulnerable patients into harm’s way.
The other reality here is that some of the stem cell clinic doctors are also putting their own practices and careers in serious jeopardy as well by potentially breaking ethical codes and even in some cases possibly the law. They aren’t doing this as some kind of ‘medical Robin Hoods’, but rather again for cash.
What are they doing that’s so risky?
Here’s a top 10 list.
- 10. Selling stem cell interventions to patients for diseases that are outside the doctor’s area of expertise. Would you let a dermatologist do heart surgery on you? Would you as a plastic surgeon consider yourself qualified to treat patients with arthritis, MS, ALS, autism, etc. specifically for those disorders? Doctors treating patients outside their field of specialty are setting themselves up for big trouble. If literally anything goes wrong, can’t you just hear the trial lawyer saying, “Members of the jury, Dr. XYZ was practicing outside of his/her area of expertise when this problem occurred…”
- 9. Conducting stem cell procedures without proper training. A weekend golf course-located stem cell “course” doesn’t quality a doctor to transplant stem cells into patients. Lack of training could easily be the basis for a malpractice suit or state medical board action.
- 8. Not properly conducting informed consent with patients. As a doctor, you must tell patients about risks and alternatives.
- 7. Not disclosing to patients that the doctor has a financial conflict of interest. At these clinics the doctors performing the experimental for-profit procedures are making money by convincing patients to buy the unapproved, experimental stem cell interventions aka “treatment”. They must tell the patients that in advance.
- 6. Enabling many other doctors to do risky medicine. If you “train” other doctors to do stem cell procedures or you provide them a source of unapproved medical devices, etc. that enable them to put patients at risk, then you as a physician share in the responsibility and consequences that may come from that including litigation.
- 5. Introducing stem cell drugs into interstate commerce. Doctors at stem cell clinics cannot legally be involved in transport of unapproved stem cell products from one state to another in the US, but sometimes they are. Importantly, keep in mind that introducing a stem cell drug “into interstate commerce” also more generally means pretty much any use of a stem cell drug product because of the much wider FDA definition that does not have to involve transport of the final product from one state to another. Simply anything used to make the drug need only come from another state.
- 4. Exporting stem cell products out of and into the US. It is illegal for clinics to export or import unapproved human products/drugs across US national borders without permission in advance from the FDA and other agencies. Yet this happens all the time.
- 3. Using investigational stem cell drugs that have not been approved the FDA. This may be a violation of federal law. Sure the FDA can be slow to act, but they will eventually come ‘a-knockin’ on your door if you are marketing and using an unapproved biological drug.
- 2. Illegal service referrals. Some physicians doing stem cell interventions at dubious clinics may well have now set up illegal referral networks with other physicians. This is a very dangerous situation to be in as a stem cell clinic doctor as this is explicitly a criminal act.
- 1. Treating children with risky, experimental stem cell interventions to make yourself money and sometimes using those children for PR. We see it happening more often. Parents whose children have autism, CP, or other issues are increasingly contacting me to ask about stem cell treatments and some tell me that their children have already gotten treated at clinics in the US. Yes, a stem cell clinic doc putting any patient at risk is not a good thing, but doing this with children to make money and for PR is more questionable and should something go wrong is far riskier to the doctor.