I recently binged the Wondery podcast Bad Batch from reporter Laura Beil. Like her previous podcast Dr. Death, Beil leads us through another fascinating medical mystery. This time, a handful of patients in Texas, Florida, and Arizona develop life-threatening infections after receiving an injection of stem cells.
Beil’s accounts of these ordeals sprinkled throughout the series were harrowing. One patient experienced total body pain so excruciating they couldn’t be touched. Another was in so much pain after the injection she passed out and nearly got into a car accident. And three patients ended up being transported to the same big-city hospital, where a family member started putting the pieces together.
The crux of the story Beil unwraps for listeners is how stem cell therapy–an unethical medical treatment–is able to occur and who is responsible for these situations when it goes wrong. Is the supplier that harvested stem cells from umbilical cord blood responsible? Or perhaps the distributor selling the stem cell product is culpable? Are the healthcare clinics or the doctors and chiropractors injecting the cells accountable? What is the responsibility of regulatory agencies to control unapproved medical procedures?
While you might not be surprised to find that all parties bear some responsibility, Beil remarkably narrates the story through all of these lenses. To do so, she interviewed patients, doctors, scientists, and insiders–including an FDA regulator, a lawyer representing six patients, and unbelievably, both the CEO and the Director of Medical Education of the stem cell manufacturing company at the heart of the story.
Stem cells have been touted as a miracle cure for a host of various disorders ranging from spinal cord injury to Parkinson disease, so I suppose it’s not surprising that the number of clinics offering this type of therapy have exploded in recent years. However, the reality is that stem cells have only been approved by the FDA for a handful of rare blood disorders. This specific treatment, known as hematopoietic stem cell transplantation is life-saving for patients with these conditions. While stem cells may hold promise for the treatment of other diseases, and theoretically make sense, they have not yet been found safe and effective for other conditions in clinical trials.
So what is it about stem cells that is so appealing as a cure-all?
Stem cells have the incredible ability to form any cell in the body. Embryonic stem cells in the very first stages of life create entire organisms. Cells of the body are mostly specialized; muscle cells are distinct from skin cells, brain cells, heart cells, etc. In disease, when a certain type of cell is defective, it is theoretically possible that stem cells could be used to make new healthy specialized cells and cure the disease. The operative word in that sentence being, theoretically.
In the lab, scientists have coaxed stem cells to make various specialized cells under very specific conditions (meaning controlling the genes expressed and bathing the cells in the proper microenvironment of nutrients and growth factors). It’s important to remember that the human body is far more complex than a petri dish in a lab. For nearly all potential clinical uses of stem cells, we don’t know the conditions required for creating new specialized cells in the body.
Manipulating the specialization of cells is just one of the hurdles to the expanded clinical use of stem cells. Another issue is controlling transplantation and engraftment of the cells. Our body is designed to reject foreign material including organs and cells, though we have made progress in the field of transplantation that would likely be helpful. Directing the cells to the damaged area of the body and integrating into the organ so they could function are other technical hurdles that would need to be worked out before stem cell injection therapy could be clinically useful.
Taken together, there’s no rational explanation that an injection of the same stem cell product could cure diabetes in one patient and arthritis in another. Healthcare providers offering a stem cell cure are lying–whether to just their patients or also themselves may be up for debate. They are no less culpable for adverse reactions if they believe the treatment will work.
If they’re only indicated for rare blood disorders, why are stem cells being offered as therapy for other conditions?
The short answer is that stem cells shouldn’t be offered as therapy except for the few select indications for which they are approved. The longer answer involves a mix of greed, desperation, and false hope coupled with the inability of regulatory agencies to prevent it. Stem cell companies sell a product that is not regulated and can be dangerous, as evidenced by the patient outcomes in Bad Batch. Despite their inability to prevent these procedures, the FDA cautions the public about stem cell therapies, warning that they have led to serious infections, blindness, and death. These warnings do little for those who have already been adversely affected by a stem cell injection.
When a patient is suffering and exhausted other options, they are unfortunately easy prey for the promise of false hope. Often, stem cell companies and clinics offering these therapies have convincing ads and confusing consent forms suggesting the treatments are FDA-approved. They are not. Healthcare professionals promising hope to desperate patients in this way abuse the trust that patients have in them.
The vials of stem cells in Bad Batch were found to be contaminated with a pathogenic bacteria, which led to severe sepsis in some patients. Even with this information, responsible parties pointed fingers at others. The CEO of the manufacturing company blamed doctors for mishandling the product, the Director of Medical Education downplayed the seriousness because the FDA didn’t immediately issue a recall (it has since been recalled), even the FDA regulator seemed to shrug it off as a problem of logistics and understaffing. But each of them was to blame. Beil unveiled yet again another healthcare system failure that put patients at risk.
What does the future of stem cell therapy hold?
Stem cell research is fascinating and I’m certain that scientists will discover novel clinical uses for stem cells that will change lives, but it will require much more research and large, well-designed clinical trials. Notably, these trials should include a group of patients that receive a placebo injection in a blinded fashion so that neither doctors nor patients knows who got stem cells until after the results are recorded.
If you or a loved one is considering stem cell injection therapy, please think twice. If you’re reading this in 2020, just don’t do it. If you find this article sometime in the future, do your research. Ask your doctor if it is FDA-approved. Look up the clinical trials and ask questions. Be wary of anecdotes, that is, stories of individual patients improving after stem cell therapy. Some of those patients may have gotten better on their own or improved because of another treatment they had. Ask for data, not just potentially exaggerated stories. Be critical, and remember that at best, the injection might do nothing for you, but at worst, could cause a serious reaction or death.
Because the regulatory agencies can’t keep up with the proliferation of stem cell therapy clinics, the only solution to ending this ethically reprehensible practice is to better inform patients seeking treatment. Thank you Laura Beil, for shedding light on this topic. It’s now up to the rest of us to spread the word.
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I purposefully omitted direct discussion of the people and companies involved in Bad Batch because I think this issue is bigger than any individual, clinic, or corporation. However, if you would like to follow what has happened since Bad Batch aired, see this Washington Post article and follow @BadBatchWondery on Twitter. And of course, if you haven’t already, go download and listen to Bad Batch wherever you get your podcasts.