As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH:
This summer Hy-Vee stores announced that any employee must undergo stem cell therapy prior to being considered a candidate for joint replacement.
That’s worth repeating:
The 102nd-largest retailer in America now mandates that employees undergo injection of stem cells obtained from their own fat or bone marrow into the joint, a therapy which has never been approved by the Food and Drug Administration (FDA), before they can be considered for a joint replacement. Simultaneously, the FDA is warning patients of the dangers of such therapies and actively sending letters of warning to practitioners of stem cell therapies. Regenexx, the very company contracting with Hy-Vee to do the therapies, has been sued by the FDA in the recent past and lost.
This is astonishing. But let’s back up.
What are stem cells?
Stem cells are cells that have not yet differentiated into the cells that make up tissues like blood, bone, brain, or skin. As such, they’re sometimes called the body’s “master cells,” since they have the potential to turn into, and therefore theoretically regenerate, damaged or missing tissue such as cartilage.
Do we use stem cells for anything in mainstream medicine?
Stem cells are frequently used in the treatment of cancer. Since chemotherapeutic drugs are so toxic to bone marrow, oncologists often take bone marrow from patients before treatment, remove any cancerous cells, culture the stem cells to increase their number, and transplant the cells back into the patient after chemotherapy. This so-called “stem cell transplant” or “bone marrow transplant” allows much higher doses of chemotherapy to be used. It is the only FDA-approved use of stem cell therapy.
If stem cells are not FDA approved for other treatments, how are doctors using them?
American medicine gives wide leeway to doctors in diagnosis and treatment. Around 20 percent of all drugs in the U.S. are prescribed “off-label,” for instance. This means that the drug is being used for something that its package insert does not indicate the drug has been FDA approved for. A good example is the use of gabapentin (Neurontin) for the neuropathic foot pain that bothers some people with diabetes. Gabapentin is approved by the FDA for only two indications: postherpetic neuralgia (pain that often lingers after a bout of shingles) and prevention of a specific type of seizure. But there is modest evidence that gabapentin is slightly better than placebo at treating diabetic foot pain, so it gets used pretty extensively for that purpose.
So even treatments that have not been definitively proven helpful can be prescribed or rendered by licensed physicians willing to accept the potential liability.
Is there potential for stem cell therapy, or is it all a scam?
We have seen unorthodox therapies be vindicated in the past. Electroconvulsive therapy, known popularly as “electroshock” therapy, is a very effective treatment for depression (and nowhere near as dramatic or barbaric as it appears in movies).
There is definitely potential for stem cells. We’re just not at a point yet where we can say with any certainty when or how they should be used. A recent review by Dr. Scott Rodeo concluded that “…there is little evidence in the scientific literature for many of the available cell formulations that are currently offered to patients.” A search for a meta-analysis of the use of stem cells for joint pain, for example, reveals that fewer than 600 patients have been included in trials that (marginally) met quality criteria. Compare that to the tens or hundreds of thousands of patients that have been included in the evaluation of more mainstream treatments. This is why almost no insurance provider covers their use.
You could say that stem cell therapy is at the peak of the old Gartner hype cycle:
Don’t look for stem cell therapy in this figure; it’s not there (the “cultured or artificial tissue” refers to growing organs in the lab). But if stem cell therapy were present, it would be at the very Peak of Inflated Expectations, and we’re years or decades from the Slope of Enlightenment. Between here and there is the Trough of Disillusionment, and that’s a bad place to be if you’re Hy-Vee in a couple years.
So what should employers do?
The Kansas Business Group on Health shares employers’ frustration with the cost and inefficacy of the healthcare system. But we believe that patients—your employees—are better served by attacking the problem at its source, with increased funding of research and improved market transparency, than by promoting the use of alternative treatments that have not yet been proved effective.
If your employees come to you asking for stem cell therapies, encourage them to look for a clinical trial. Their enrollment would increase the knowledge of all of medicine, and it would be free.
If somehow, against the advice of the KBGH, a company decides to be more permissive of stem cell therapies, we would encourage that the company insists that the doctor use informed consent documentation that complies with the standard set forth by the International Society for Stem Cell Research so that they know what they’re signing up (and paying) for.