60 Minutes Smears Doctor Selling Stem Cells
60 Minutes, Dateline, and other television "investigation" news shows like to debunk alternative clinics and therapies. The format is almost always the same. Usually the news teams "interviews" a strange and sinister-appearing individual about a debatable medical treatment in a disreputable location. The medical doctor looks sketchy and sounds terribly ill informed. The therapy is ill advised and the interview makes the doctor out to be ignorant and unlikely to be creditable. There are short laboratory examinations revealing that the treatment is useless. Medical examiners are consulted: the therapy under question is dismissed as unproven, potentially dangerous, and without medical merit.
The 60 Minutes program in early January would prove to be just the same. A doctor operating a clinic in Ecuador primarily for Americans and international patients offered stem cell transplants to treat chronic medical conditions. The show focused on treatment that the clinic offered for cerebral palsy. Particularly irksome was that the clinic promoted this treatment on its website with the option of purchasing stem cells and having the material shipped for self-administration. As one would expect, the pricing for undergoing stem cell treatment in Ecuador was very expensive; what was surprising was the equally high cost of purchasing stem cells for delivery.
60 Minutes purchased stem cells directly through the website much like buying an item on Amazon.com. After the transaction was completed with a credit card purchase of $5000, a shipment of stem cells was delivered to the show producer in the US. The stem cells were transported under dry ice with no apparent disruption in delivery. An expert in stem cell research associated with the University of Virginia School of Medicine examined the stem cells, and microscopy demonstrated that the cells were dead – they would not only not be viable as a stem cell implant but would likely lead to an adverse reaction.
When 60 Minutes interviewed the primary doctor running the clinic and online operation, the Q & A was what one would expect from someone unknowledgeable and trying to hide something. On tape the answer to what stem cell treatment was supposed to do for an individual with cerebral palsy was pitifully inadequate and frankly ignorant. The doctor offered nothing intelligent to understand stem cell therapy and quit the interview after 10 minutes. Adding insult to injury, the doctor had been disciplined by a state medical board in the US and had lost his license.
I am not sure what is worse: that the doctor looked liked a numskull or that stem cell therapies currently offered by some clinics around the world are rip-offs and fraudulent.
As much as 60 Minutes's degradation of the operator of this stem cell clinic was horrific, the message that stem cell treatment is worthless and quackery is deliberate "obfuscation, derision and uglification" ( from Alice in Wonderland). Admittedly, there are a great many clinics offering a very wide range of stem cell treatments. Stem cells are not produced by well-recognized biologic laboratories. Instead, their manufacture is done by individual operators. Without oversight and inspection, it is not clear what exactly is involved in stem cell manufacturing. Most clinics claim to have a reputable method conducted in sterile laboratories with quality-control methods in place. However, it is unclear exactly what each clinic offers: there is no direct outside inspection to review how the stem cells are produced, kept, and administered. The clinics do offer elaborate scientific discussion about general characteristics of the stem cells and some talk about the methodologies used. Still, it is very difficult to know precisely what one is getting when one signs up for a course of stem cell therapy. The 60 Minutes show claimed that stem cells have no proven benefit. Yes, it is true that there are no large-scale clinical studies of a specific proprietary stem cell product. Yet there have been many case reports and demonstrations of stem cell treatment offering individuals benefits in a variety of conditions.
The big question remains, how does one determine if a stem cell therapy clinic offers a valuable service with good results? Are the stem cells manufactured with appropriate methodology, stored appropriately, and administered effectively and are there good quality control measures in use? Is the cost expense based on a track record of consistent results?
Until stem cell manufacturing and clinic operations come under well-supervised review, it is a "Wild West" out there. Reputable parties should create an independent quality control board. Until then, use stem cells only after a careful study of the clinic.
Why Not Add Allergy Treatment to Your Practice?
When we think of treating allergies – and this is the time of year when we begin to do just that – we think of prescribing Allegra or sending the patient to the allergist. For many young healthy adults, seasonal allergy is their first major disease requiring treatment. Undoubtedly, the majority will opt for over-the-counter antihistamines and allergy prescriptions. When these options fail, produce poor results, or cause severe adverse effects, many will opt to see the allergist. After a round of skin testing, many allergists recommend "allergy shots" to desensitize allergies with prescription medication. Although allergy shots are helpful to many patients, there remains a considerable failure rate and a significant risk of adverse reactions. What are the alternatives?
Diego Saporta, MD, is an allergist and member of the American Academy of Otolaryngic Allergy (AAOA). He has presented his preferred approach, sublingual immunotherapy, as an alternative to allergy shots at the AAOA. In fact, the AAOA offered such a course, "Sublingual Therapy in Allergy," from the 1960s to the 1980s. Dr. Saporta writes about sublingual immunotherapy in this issue of the Townsend Letter. Like allergy shots, sublingual immunotherapy employs increasing doses of antigen to desensitize the immune system from producing inflammatory chemicals that induce allergy reactions. As the doses of antigen are increased, the immune system shifts from a Th2 response, which is more allergenic, to a Th1 response, which is less reactive. The theory for injection and sublingual immunotherapy is the same. The difference is the treatment method. Saporta reports that sublingual treatment is as effective as injection therapy with fewer adverse events. Sublingual treatment can be used for asthma with less risk of asthmatic attack compared with injection immunotherapy. It is also less risky for the very young patient. Additionally, there is the convenience of administering the treatment at home rather than going to the office for an injection.
W. A. Shrader Jr., MD, prefers to use an allergy desensitizing technique that is wholly different from either injection or sublingual immunotherapy. Shrader's approach is a true "alternative" because it has not been approved by the FDA or AMA allergy specialty organizations. Shrader uses low dose allergen immunotherapy (LDA), which is not based on antigen desensitization. He states that standard injection immunotherapy needs to use progressively higher doses of antigen to induce IgG blocking antibodies that inhibit histamine allergy reactivity. The very high doses of antigen administered in immunotherapy lead to a greater likelihood of adverse reactions, especially in asthmatic individuals. Shrader's LDA immunotherapy is extremely low dose – generally no more than 1 millionth the dose of standard immunotherapy. The very low dose allergen is combined with the enzyme beta-glucuronidase. This enables a "potentiation" of the immunizing activity of the antigen. Rather than stimulating the production of IgG blocking antibodies, the LDA immunotherapy induces the production of T-regulator white blood cells (formerly called T-suppressor cells). The increased T-regulator cells decrease the allergenic response to a variety of antigens, enabling effective and safe desensitization.
LDA is based on an earlier treatment method used up until 2002 called enzyme potentiated desensitization (EPD). EPD was developed in the 1960s and was a successful alternative approach to allergy desensitization. In 2002 the materials employed to administer EPD were no longer available in the US. Shrader worked with a compounding pharmacy to create formulations similar to what was used in EPD treatment. LDA treatment is now available for treating not only inhalant allergies but also food allergies and chemical sensitivities. LDA treatment is administered by injection but is given less frequently than antigen immunotherapy. In addition to seasonal allergies, LDA treatment has been successfully employed for dermatologic conditions, headaches, inflammatory bowel disease, and other disorders.
Sublingual immunotherapy and LDA immunotherapy are two allergy desensitization therapies available now for office treatment. Shrader and Saporta encourage readers to learn how to administer allergy desensitization.
Jonathan Collin, MD