FTC Sets the Clinical Study Standards for Advertising Health-related Claims – Part One

FTC and umbilical cord-derived stem cells

The recent FTC actions against a physician who practiced miraculous regenerative medicine suggest a tightening of the allowed actions and activities of the field with respect to making claims and advertising, which clinics use to differentiate themselves from the group down the street. However, the recent FTC court action shows the perils going forward of not paying attention to what a court issued in the Order the FTC obtained in October 2018. I will cover in this post some of the implications based on statements made in the Order for physicians who want to practice regenerative medicine and advertise it.

Related Posts: FTC Actions Against Stem Cell Clinics Making Deceptive Claims about Amniotic Fluid Products – Part OnePart TwoPart Three, Part Four, Part Five

In what I suspect was a coordinated effort with the FTC’s court victory in late October, the FDA Commissioner in December 2018 issued a press release in which he indicated that the FDA was tired of waiting for companies, health care providers and clinics to contact them about their non-compliant regenerative medical products and services. The press release reaffirmed the FDA’s commitment to using a risk-based approach to deal with what clearly has become a free-for-all in the regenerative medical community. The FTC decision should encourage companies and other interested parties to contact the FDA, but beyond the fact that the FTC has taken a dim view of the use of amniotic stem cell-containing products, what about the other products and materials that are being used in the regenerative medical community, like umbilical cord-derived stem cells?

The FTC established in the Order that to claim a therapeutic benefit for a regenerative medical preparation or service a clinic or health care professional needs proof, and they laid out the framework for what constitutes proof in order for someone to make “health-related claims”. The primary requirement is that for whatever treatment you want to advertise, you need to have clinical evidence obtained from Level 1 human clinical trials performed by experts in the field of the pathology being treated. For example, the FTC won’t accept evidence based on animal studies to support advertised claims of therapeutic benefit. This puts pressure on manufacturers of magical goop de jour, which are usually the sources for “evidence” about the utility of the magical goop. Consequently, the therapies that consist of cells in one form or another, like umbilical cord-derived stem cells, need to have serious clinical support before a clinic can advertise that the preparation is of benefit, much less that the magical goop is superior to or equivalent to conventional therapy.

The FTC even included bone marrow and peripheral blood in the definition of “Stem Cell Therapy” that was included in the Order signed by the judge on October 25, 2018, while also naming other therapies that contain stem cells, like amniotic fluid, adipose tissue and umbilical cord blood. Other definitions indicate that the list provided isn’t exhaustive, meaning that any regenerative medical therapy consisting of stem cells probably will be covered by the Order, including recently introduced products like umbilical cord-derived stem cells. Keep in mind that the FTC Order covers all stem cell-containing preparations, so a physician won’t be able to make claims of superiority for a BMC or PRP treatment over conventional therapy, unless there is Level 1, double-blinded and placebo-controlled studies performed by experts that support such a claim.

I suspect the FDA was quite keen to have an FTC Order define statutory requirements for anyone to advertise the benefits of any stem cell-containing therapy over conventional therapy. It should surprise no one that the requirements outlined in the FTC Order exactly track with the requirements the FDA has long enforced for gaining approval of any biological product or drug. That the FTC Order included bone marrow and peripheral blood preparations in its scope of coverage, means that all therapeutic preparations in use by the regenerative medical community require Level 1 data if someone wants to advertise a particular preparation as having therapeutic benefit.

Furthermore, this outcome is in line with FDA declarations about the need for Level 1 studies when physicians want to do prospective clinical studies with BMC, since the Agency claims that the only homologous use of bone marrow is for treating hematopoietic deficiency as a result of a patient having undergone an ablation of their bone marrow. This indication for use applies to donor-derived bone marrow transplants, which makes sense, given the allogeneic status of the bone marrow implant. However, it doesn’t make sense for a physician who wants to study and report on the results of treating an orthopedic pathology with a patient’s own BMC, since there are no safety concerns with an autologous treatment. But physicians are getting push back from Institutional Review Boards (IRBs) who are asking if the proposed prospective study involving autologous BMC is accepted by the FDA as a homologous use of BMC. This is a good example of the IRBs doing the dirty work of the FDA, since the FDA studiously avoids stating what is or isn’t homologous use for BMC. And guess who the IRBs report to? They are regulated by the FDA, of course.

If you have problems envisioning how a Level 1 clinical study using BMC can be performed, you are not alone. The most important limitation is that bone marrow aspiration is an invasive procedure and I don’t think there are too many IRBs that would allow a patient to be a control, since a control subject would need to undergo a bone marrow aspiration, but have the BMA thrown away.

As it happens, we have one example of an FDA-monitored Level 2 prospective, placebo-controlled clinical trial involving BMC. I refer to the publication by Shapiro, et al. (2016). I recall reading the abstract with great interest when it first became available, but that interest turned to head scratching, since the main conclusion was that in the authors’ FDA-monitored clinical study protocol, in which patients with bilateral knee OA had both of their knees randomly treated in a blinded (to the patient) fashion with either saline or BMC, there was no statistically significant difference in pain mitigation between the BMC- and saline-injected knees at six months.

While the Shapiro, et al. paper pre-dates the FTC Order by a couple of years, and isn’t a Level 1 study, the need to have each patient be their own control so as not to “waste” a control subject’s bone marrow shows the difficulty of doing a BMC therapeutic study in the classic mode of placebo-controlled studies. Regardless of this difficulty, the regenerative medical community best heed the FTC Order about stem cell-containing preparations and advertising health-related claims. This means that all of the emerging and much-hyped, but unsupported products with magical components like umbilical cord-derived stem cells shouldn’t be advertised, let alone used, since in the eyes of the FTC there is no evidence of clinical benefit. Furthermore, if there is no evidence of clinical benefit for a particular preparation, a physician using this type of material might be accused of fraud, since a patient will be paying for a therapy that has no therapeutic benefit. This leads me to offer a one-word warning: lawyers.

I will continue my review of the FDA-sanctified Level 2 Shapiro, et al. clinical study of autologous bone marrow for treating bilateral knee OA in the next post, in case you are wondering what kind of hoops their group jumped through to do a higher level clinical study involving BMC.

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