August 9, 2018 Richard Jaffe

Last week, a highly regarded reporter from a major east coast national newspaper reached out to me to talk about stem cells. She had read some of my posts and thought they were interesting, but I could tell that she didnít agree with basically anything I said in support of patientsí rights to access their own body parts.

She asked me why I thought the FDA hadnít filed a preliminary injunction against US Stem Cells and the California Stem Cell treatment center. I hadnít really thought about the why. But my immediate reaction was that the FDA has bigger fish to fry. She understood immediately and almost simultaneously we both said ďthe opioid crises.Ē Maybe itís thatís simple and suggests that some perspective is needed as stem cell thought leaders and the press lament the proliferation of the for-profit stem cell clinics and attempt to shame and cajole the FDA to shut down all the these lowlife stem cell profiteers (their words and sentiment).

So how much harm are the private stem clinics doing?

A recent study tweeted by the Big Dog entitled ďConcise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem-Cell Based InterventionsĒ was published in Stem Cell Translational Medicine. Here is a pdf of the study.

Bauer_et_al-2018-STEM_CELLS_Translational_Medicine (1)

The authors did a google search of all reported AEís and stem cells. They separated the AEís into two categories: AEís reported in the medical literature and those reported in the mass media. There were a total of 35 serious AEís, including 11 deaths. Two of the deaths were from direct injection into the brain, another was from a stem cell injection into the right carotid artery. Well, Iíve finally found people with less common sense than the folks who thought that having a nurse practitioner inject stem cells into both eyeballs of patients was a good idea.

None of these three above described deaths occurred in the US, and only one of the total 11 reported deaths occurred in a U.S. clinic. I canít tell from the article how strong of a causal connection there was, but most of the listed deaths appear to this layman to be strongly presumptively caused by the stem cell intervention. (AEís are just associations and do not necessarily demonstrate causation because of co-morbidities in the treated.) But letís make the reasonable assumption that all the reported deaths and other serious AEís were caused by the stem cell interventions.

Thirty five reported serious AEís in the world based on medical literature and mass media

We donít know the denominator, i.e., how many stem cell interventions there have been, but I have to believe itís a big number, at least tens of thousands of stem cell interventions throughout the world. But who is to say that all serious stem cell AEís are reported. So letís double the number and double it again. Thatís 140 serious AEís with 44 deaths and 4 in the US. (Mindful that this is just an extrapolation based on nothing, and the real numbers are 35, with 11 deaths, one of which was in the United States.)

Under the real reported numbers or the hypothesized extrapolation, itís not a big number.

What about the benefit of stem cell treatments?

Iíve interacted with many physicians using different forms of stem cells and Iíve spoken to many, many patients. Although it will fall on deaf ears, and itís not science, many of these doctors and patients actually believe that stem cell treatments have a demonstrable clinical benefit in individual patients.

Of course not in every disease

I havenít personally seen any interesting and hopeful results in ALS. MS patients tell me that stem cells have helped them, but they all seem to need periodic retreatment, and Iíve never heard of a MS patient being cured by stem cells.

Iíve heard about some semi-miraculous results in autism, and know of one case where stem cell treatments appears to have normalized a moderately autistic child.

The biggest benefits Iíve heard about are in the orthopedic field, joints and ligaments. Iím not a scientists, but Iím betting that the orthopedic applications of stem cells will prove out, perhaps even without extensive clinical trials. It seems to work that well. Iím guessing that sooner rather than later most regular orthopedists are going to have to use it, damn the FDA or lose market share.

But letsí forget about the benefit or possible benefit of stem cells and look at the other side of the ledger.

How many people die of drug overdose each year?

Seems like the best number available is 60,000 drug overdose deaths, with 42,249 deaths due to opioids (in 2016). Hereís the article from where these numbers come.

These numbers are insane! As the article points out, opioid deaths now eclipses the number of women who die each year of breast cancer.

By way of reference, auto accidents cause around 37,000 fatalities a year, but basically everyone in the country can be a victim in an auto accident, but obviously only people taking opioids can die of an opioid overdose. So the denominator in auto accidents is very substantially larger, meaning that the chances of an opioid user dying of opioids is a lot higher than the changes of dying in a car accident, even though the total number of deaths are not that far apart.

Here are some war comparative data points: over 58,000 US soldiers died in the Vietnam War, over 54,000, in the Korean War, 4500 in the Iraq war.

When comparing the Stem Cell AE articleís charts with the drug watch article on opioids, Iím going to guess that the medium age of death of the 42,249 U.S. opioid overdose deaths is probably at least three decades younger than the 11 reported world wide stem cell deaths, and that my friends is a tragedy.

And when an FDA approved drug (or class of approved drugs, namely synthetic opioids like fentanyl) kills 42,249 young people in one year, that my friends is a national crises requiring the strongest possible response from the agency which (perhaps mistakenly) approved these drugs for use in humans.

The fact that there are 500, 700 or even 1000 or more clinics using stem cells on patients not in accordance with FDA guidance document interpretations of FDA regulations, and that there have been 35 reported world-wide serious AEís, (including one death in the U.S.) is not a national crises and does not require the strongest possible response from the FDA.

Rather, it is a regulatory issue which needs to be addressed, balancing the risks and benefits, and also considering that weíre talking here about using a personís own body parts as the basis of the therapy. As Iíve said repeatedly, that makes it different, or at least it should. Admittedly, the regulators and Congress do not seem to agree, yet.

But on the other hand, that might help explain why the FDA is not ďballs to the wallsĒ going after all or even a significant percentage of these operations despite the pleas of the stem cell establishment and the press. If so, as painful as it is for me to say, Iím grateful that the FDA realizes that it has bigger fish to fry.

Rick Jaffe, Esq.

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One thought on ďSome perspective on private stem cell clinics and the FDAís responseĒ

Barbara says:
August 9, 2018
This is what patients have been saying for years. The number of deaths from FDA approved drugs other than opioids is also staggering. Patients should be allowed to use their own stem cells for treatment without the interference of academic resistance and regulatory barriers. Trying to convince the media to do more than write opinion pieces however, may be futile.