A Really Tough Day for Stem Cell Advocates

A Really Tough Day for Stem Cell Advocates

The FDA’s Stem Cell “Workshop” just ended, and if you’re a person who wants continued access to stem cell therapies outside of clinical trials (or a transplanter of “unproven stem cell therapy”), it was a very depressing day. It was way worse than I had feared in my post yesterday.  http://rickjaffeesq.com/2016/09/07/fda-stem-cell-meetings-close-hand-stakeholders-sides-worried-one-side-really-worried/

Sure the two ethicists said that it was wrong and unethical to provide unproven stem cell therapy except in FDA sanctioned clinical trials. But the real punch came from two of the last speakers who discussed some horror stories of the severe harm caused by “unregulated” and “unproven” stem cell transplanters.

Stem Cell Horror Stories

Unregulated Stem Cell Therapy Causes Cancer

A Harvard fellow who co-wrote the recent oft-quoted case study of the stroke patient who traveled the world doing stem cells only to develop a stem cell treatment induced CNS tumor throughout most of his spinal column gave the gory details of the case, including a painstakingly detailed complete histology of the tumor. The only good news (if it can even be called such) is that, if I understood correctly, he concluded that the stem cells causing the tumor were not the patient’s but were the result of an allogenic transplant the patient received.

Unregulated Stem Cell Therapy Causes Blindness

The other presenter, an eye doctor, talked about three patients who received stem cells for macular degenerative disease. The procedures were performed in a South Florida stem clinic by a nurse practitioner, not under the supervision of a licensed physician. In each of the three cases, there was severe harm, requiring emergency surgery with catastrophic negative results to the eye sight of the patients. Of course these might be unusual and exceptional cases, but they will no doubt be used by the FDA to demonstrate the need for exactly the draft guidance documents which it is proposing to stop these medical horror stories from reoccurring.

FDA Implored to Stop the Maiming by Snake Oil Stem Cell Transplanters

Other members of the panel including leaders of disease advocacy/research entities all decried “unproven stem cell therapy” and implored the FDA to put these unethical stem cell purveyors of false hope out of business.

One panel member pointed out that the problem was just not in the U.S. and that there were these kinds of clinics in many parts of the world and because of the internet, it was easy to find out about them. One clinician lamented that when prospective patients call him and he has to tell them that he has no treatment options for them, the patients get mad and argue with him.

 They should all be delicensed!

The day’s moderator was Irv Weisman, who is one of the biggest names in academic stem cell research. In his summary, he suggested that U.S. physicians who perform unregulated stem cell transplants abroad to skirt U.S. regulations be delicensed.

To listen to these guys, it would appear that stem cells given outside of clinical trials have never helped anyone. In one sense that might be true. If all you care about is scientific data from well-designed FDA clinical trials, then they are right.  Anecdotal evidence is not science, and all seemed to agree that all the non FDA trial data which is published is not worthy of consideration because of design flaws.

There is a Consensus

The absolute, universal consensus of today’s workshop was that stem cells should only be available in the U.S. in FDA approved clinical trials, until such trials prove that there is a safe and effective non homologous use for them. And anyone who provides “unproven stem cell therapy” to patients outside of clinical trials is a greedy, unethical charlatan who should lose their medical license…That’s a tough message, but no doubt a welcome one for the FDA since the elimination of non-homologous autologous stem cell therapy outside of clinical trials is the purpose and end result of the four draft guidance documents.

One thing I am clear on: the positions taken today by the people the FDA considers the thought leaders in the field really, really need to be addressed by the stakeholders on the other side next week, head on.

I’m going to give this a good think over the next day or two and maybe make some suggestions to my presenter friends.

Stay tuned.

Rick Jaffe, Esq.


16 thoughts on “A Really Tough Day for Stem Cell Advocates

  1. Excellent question Mr. Jones. What we have here is big business academia in sync with big business FDA to keep the status quo. Thousands of patients have had stem cell therapy with quality of life improvements. This evidently will count for nothing as the FDA, an agency paid for through our taxes, does the bidding of those like Weissman. One only needs to follow the money to see why opposition to patients getting this medical treatment is so great. It’s a shame that the U.S. has allowed the FDA and academia to have so much power and the people who need and want treatment to have so little. It’s business as usual in DC, the FDA being no exception. Shame on them for even having a moderator like Irv Weissman, whose own ethics are under a cloud as Bill notes. Workshop indeed!

  2. I think it is about time for the OIG to step in and close down the unregulated stemcell clinics. It is only with FDA approved trials and treatments that stemcell therapy can move forward. Medicine is not like the “wild west”. Some of the promises and charges for these treatments are outrageous.

      1. One of the biggest impediments to stem cell trials are the unregulated stem cell treatments. Why should a company bother to go through the expense to do research which is meaninful when they can bilk patients for unregulated and unproven treatments? I am CEO for a small stem cell reasearch company, Antria. When we look for capital to fund our studies the question we are always asked is, “why bother going through the FDA, there are plenty of clinics already making a profit already”. Stem cells don’t cure everything, and they need to be regulated so that unscrupulous doctors as seen on 20/20 don’t scam patients with false promises and large fees.

        1. When discussing stem cell “fraud” like the cases reported on 60 minutes, we should be careful to make a distinction between licensed medical doctors, former medical doctors in foreign countries whose licenses were revoked, and people impersonating licensed medical doctors.

  3. So, it would appear that despite the presumably laudable business he runs pursuing research on stem cells with all the attendant difficulties in securing funding, Leonard has a conflict of interest in his desire to “close down unregulated stem cell cinics” in favor of allowing only highly restrictive FDA approved trials and treatments. Sadly, and inevitably, as pointed out by Barbara, most of these “moral and ethical” stances in reality ultimately all boil down to money.

      1. No conflicts here. Unfortunately money is what is motivating these unregulated stem cell clinics which are charging ridiculous fees for unproven techniques. They prey on the most vulnerable patients who have no protection. The “wild west” of stem cell therapy needs to be reined in. Please don’t pass the Laetrile.

    1. Unfortunately, money seems to be one of the main motivators of many of the unregulated stem cell clinics that are in operation. I recently spoke to a patient who paid $3K to have autologous SVF injected into his joint. His arthritic pain never improved. When he spoke to his orthopedist 3 months later he basically said “too bad”. Only with rigorous research will we find out what stem cell therapy can do. Hopefully the “wild west” of stem cell therapy is going to be “reined in”.

      1. there are always going to be examples of a therapy working or not working. happens all the time with
        approved drugs. In cancer over 550k people die each year, most of whom have received multiple rounds of FDA approved drugs. Are you concerned about all the money phama companies make on drugs that don’t work?

  4. Considering the costs involved in FDA approved IND trials it will be decades before we know the range of safety and efficacy for stem cell treatments if we rely only upon them. I believe that most US based sites using MSCs are treating patients under IRB approved trials, which must maintain certain safety standards, as dictated by the IRBs. These patients/studies are contributing to the overall knowledge base regarding stem cell treatments, presumably with informed consent as to the experimental nature of the treatment, which would be an immutable requirement of any IRB.

    To point to forseeable potential complications or individual treatment failures as evidence of “renegade” status of all non FDA clinical trial related treatment, is at best disingenuous.

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