I’m becoming increasing convinced that patient suits against stem cell clinics are going to have strong impact, including based on the new steps taken by a particular law firm. For background, I’ve written extensively about these suits over the years and we’ve seen more recently that another academic group (Claire Horner, Evelyn Tenenbaum, Douglas Sipp, Zubin Master) has published a paper on the suits.
The law firm stepping up against clinics is GRYC or Grossman, Roth, Yaffa, and Cohen. They not only have and continue to represent patients in suits against unproven, for-profit clinic firms including most prominently against U.S. Stem Cell (USRM), but also they’ve become more outspoken about the problem of stem cell clinics and risks to patients.
GRYC attorney Andrew Yaffa has been quoted pretty extensively in the media and now speaks in a GRYC law firm website video (below and on the firm’s website) on “3 shocking facts about stem cell clinics.”
The video has three main accusations about the clinics:
- Clinics are basically advertising on clinicaltrials.gov.
- Clinics are using unproven fat stem cells, but often promising some kind of panacea
- They are not following good manufacturing processes and are using “industrial grade enzymes” from a janitorial supply company.
This video is a tough blast directly at the clinics, but the stakes are high for patients and the clinics need to be confronted. The video has only been up a few days, but already has more than 3,000 views.
I have a feeling we’re going to see more lawsuits against such firms across the country.
Fully agree with James. We have developed a Registry database that is of low cost to practitioners to collect” real world data”. I would urge regulatory agencies of this area mandate that anyone who offers these treatments collect data on an independent, database registry. This will allow for transparency of outcomes to the general public on the now numerous products that are now offered to patients.
Gerard Malanga, MD
Databiologics
Dear Admin and those who share Admin’s view on this topic:
I give you the benefit of the doubt that, if private stem cell clinics’ treatments were altering the illnesses and disorders of treated patients in a beneficial manner, you would not object to their practices – with “beneficial manner” meaning altering the natural history of patient’s illnesses and disorders to improve physical health and effect cures. Furthermore, recognizing the complexities of the human life, human biology, and medical treatment, you would also allow that not every patient will benefit from a treatment confirmed to benefit other patients.
Now, if you thought one or more of the varied treatments now being administered in private clinics could prove efficacious, you might be satisfied by the prospect that such efficacy would eventually be established in FDA-authorized clinical trials as well. I do not recall this sentiment being express by you in this forum, but perhaps you have done so here or elsewhere. However, this possible prospect has not figured significantly in the exchanges in this forum which I have read, though, a priori, one might have expected it to be so.
Instead, Admin, you have directed the discussion to fraud. Not only warning that treatments are “unproven,” but also that they are generally fraudulent. Meaning that they are administered with the knowledge that they will provide no medical benefit, will not act in a beneficial manner. But I ask you, “What would be the origin of such knowledge? How would clinics know that their treatments are ineffective?” And if Admin is sure that this is the case, “Then why does Admin promote FDA-authorized trials of the same treatments?”
I am quite confident to say that Admin and FDA-authorized stem cell clinical trial groups have little idea whether FDA-authorized clinical trials have shown any efficacy. The trial sizes are too small and the dose of stem cells administered is unknown. Until at least the stem cell dose problem is fixed, these authorized trials are going nowhere. On the other hand, stem cell clinics have sufficient treatment numbers, but they also lack stem cell-specific dose data. Although incorporating stem cell dose in their treatments would give them greater statistical power, if the private clinics documented treatments and outcomes systematically, they might quickly resolve the question of efficacy with their large treatment volumes. Some clinics and patients may have already resolved the issue for themselves. But they owe it to themselves and the rest of humanity to record in a manner that objectively and quantitatively describes their experience.
Admin, I think you know how hard it is with human subjects to establish scientifically that an effect of interest never occurs. However, what scientists can do very well is estimate if the effect of interest ever occurs, and if so, with what degrees of frequency and uncertainty. I wish you would spend more of this forum motivating the FDA and our community to organize scientific investigations of efficacy in the current sphere of active stem cell treatments in private clinics. I’m aware of some groups that are beginning to explore such collaborations. We need more, including government agencies like NIH, NSF, and FDA, as well as not-for-profit foundations. But most importantly, before any such efforts can be realized, we need the FDA to develop new regulatory paths that make such collaborations possible and legal.
James @ Asymmetrex
The FDA is running out of fingers to plug up the leaking dike…
R3 Stem Cell Now Offering Umbilical Cord Tissue Regenerative Therapy
https://markets.businessinsider.com/news/stocks/r3-stem-cell-now-offering-umbilical-cord-tissue-regenerative-therapy-1027396510
Yes, FDA is dealing with a flood and even the “new” FDA hasn’t done enough.
Those medical claims in that PR are in my opinion highly questionable.
Dear Admin and Commenters:
Lawyers posing as scientific experts and suing stem cell clinics is not the solution to the present challenges in the private delivery of stem cells medicine. As I watch this video, I hear gasoline being thrown on the fire that will exploit patients even more and, in some cases, rob and destroy critical honest clinical practices.
The FDA needs to do more than set up ill-informed barriers and bring injunctions against a few politically expedient examples of presumed “bad actor” clinics. Both the NIH and FDA need to get off of their political hinies and act with the scientific authority that the public entrust to and expects from them. The NIH can offer carrots to drive manifest research collaborations to get to the reality of what is occurring with thousands of patients now being treated in well-intended private stem cell clinics. Put some emphasis on the “good actors” for a change, who are attempting to innovate medical treatment, as is the historical imperative of investigative medicine.
The FDA should use its enforcement powers to guide private clinics to implement scientific designs like patient follow-up and treatment documentation, so that data from private clinics can be organized and interrogated for evidence of efficacy or the lack of efficacy. Support, promote, encourage, and guide the “good actors,” and the “bad actors” will be driven out by market forces as patients find their way to and choose honest clinics led by physicians and other health care practitioners who are motivated by a desire to improve the quality of life and health of their patients as well as financial interest.
James at Asymmetrex
actually “basically advertising” they are not. They are listing their trials like they are supposed to, as does every other medical company.
unproven? there have been countless treatments given by thousands of stem cell clinics with substantial success, including US Stem Cell.
“industrial” enzymes…really…are you kidding….you mean the industry standard used in ALL hospitals and labs?
John- my sister is a lawyer and a linguist, and we have interesting discussions about the words “evidence” and “proof”. In science those words are used sparingly, because scientists are trained to be skeptical, especially of their own bias. We’re not perfect, and the impulse to overstate our results is sometimes hard to suppress, but if you ask THREE scientists, you’ll usually get to the truth.
I’d like to know what researchers (such as yourself?) are accomplishing and how soon these accomplishments will translate into effective treatment – and offer legitimate physicians an effective treatment for suffering patients. What DO you learn/accomplish on a monthly or even annual basis? Who can we look to for reliable information on progress?
Constance- I’m happy to tell you what we are accomplishing with the blessing of the regulatory agencies that are responsible for oversight of drugs. Stem cells and their derivatives are drugs.
Researchers are doing multiple legitimate clinical trials using pluripotent stem cell-derived retinal pigment cells for macular degeneration. There are legitimate clinical trials for spinal cord injury and Type I diabetes using pluripotent stem cell-derived cells. There are legitimate trials in progress for ALS, stroke, and retinoblastoma using neural stem cells. There are 4 groups of researchers worldwide who are in the process of getting approval for neuron replacement therapy for Parkinson’s disease. One of those is mine. Many other groups are working toward cardiac disease treatments using pluripotent stem cells.
The point of getting approval from the FDA or another regulatory agency is to relieve the patients of worry about whether the researchers have done everything possible to make sure the cell therapies are safe and effective. I wouldn’t expect someone to accept my word that a treatment was safe and effective- I welcome oversight. The clinic down the street does NOT welcome oversight. If they did, they would work with the FDA…and they wouldn’t ask you to pay for the treatment.
I wish that scientific evidence would be sufficient, but I’m all for lawyers going after these clinics.