FDA announces action against two stem cell clinics: Is that a ‘crackdown’?    

Kevin Lomangino is the managing editor of HealthNewsReview.org. He tweets as @KLomangino.

Numerous news outlets covered the FDA’s announcements yesterday (see here and here) of enforcement action against two stem cell clinics that were alleged to offer unapproved and unsafe treatments.

Many reports framed the announcement as a ‘crackdown’ on unscrupulous businesses:

New York Times: F.D.A. Cracks Down on ‘Unscrupulous’ Stem Cell Clinics

Washington Post: FDA cracks down on stem-cell clinics, including one using smallpox vaccine in cancer patients

NPR: FDA Cracks Down On Stem-Cell Clinics Selling Unapproved Treatments

LA Times: FDA cracks down on clinics selling unproven stem cell ‘therapies’

By all accounts, the two clinics being targeted by the FDA are engaged in dangerously dubious activity. Most observers say the announcement of action against those clinics – and additional unspecified enforcement action to come — is a welcome assertion of regulatory authority.

But does it rise to the level of a ‘crackdown’?

The FDA has kept mainly to the sidelines for years as these unscrupulous clinics have become more aggressive about hawking their wares. (We and many others have kept tabs on this progression and rang alarm bells over it.) The FDA’s announced action targets two clinics that are arguably the “worst of the worst” — one of which gained notoriety in the New England Journal of Medicine after one of its patients went blind.

Considering the context, the FDA’s announcement sounds more like a tentative first step to exert some minimal control over this mess.

Journalists who declare this a “crackdown” risk handing the FDA an easy PR victory that could diminish pressure for further action.

‘It is relatively easy to make bold pronouncements’

Leigh Turner, PhD, a University of Minnesota bioethicist who’s done much to call attention to the Wild West environment surrounding stem cells, suggests that “crack down” indicates some kind of substantial and sustained effort to quell inappropriate behavior. He says it remains to be seen whether that’s actually what the FDA has in mind.

“I’m encouraged by today’s news but it is premature to claim that the FDA has cracked down on such businesses or will definitely do so over the next several months. It is relatively easy to make bold pronouncements. We’ll see whether the FDA is prepared to engage in the difficult work needed to better regulate this marketplace.”

The agency announced that it will be stepping up enforcement actions against clinics that “abuse the trust of patients” and “endanger their health.” That’s a definition which Turner says leaves a lot of room for interpretation.

“I don’t know what to expect from the FDA in terms of whether the agency will limit regulatory action to ‘a few bad actors’ or take a more systemic approach to the direct-to-consumer marketplace for unproven and unlicensed stem cell interventions,” he said. “I’m worried we’ll see the FDA act against only a handful of businesses while pretending they have somehow provided adequate regulatory oversight.”

Timothy Caulfield, a University of Alberta law professor who’s also been working hard to rein in stem cell hype, said he was “grateful that the FDA has so clearly articulated that there is a problem and that unproven stem cell therapies are in the market.”

However, Caulfield sees what he describes as “problems with the [FDA] messaging.”

More than ‘a few bad actors’

“The FDA was signaling that there should be a bright line that divides the stuff they have jurisdiction over from the stuff they don’t.  Where that line is drawn will matter… a lot.  I hope the FDA isn’t going to retreat to a narrow interpretation of what it covers as this will leave a lot of space for the marketing of bunk.  What is needed is a broad regulatory response, particularly since the science is still evolving.”

Like Turner, Caulfield took issue with the FDA’s claim that there are only “a few bad actors” in this area. In fact, he said, “There are probably hundreds.  This is a big, widespread problem.”

Many of the news reports describing a crackdown did, eventually, acknowledge uncertainty regarding the FDA’s intentions.  Both STAT and CNN quoted Turner and described his misgivings regarding the road ahead.

But such nuance will be lost on many readers who see only a headline message suggesting substantive action.

Clinics offering unproven therapies have spread to storefronts across the country and are part of a burgeoning, lucrative marketplace.

It will take a lot more than a bold announcement to fill the regulatory void that these businesses thrive in.

“The practical effect of all this could be that the FDA makes an announcement, people think there’s no story anymore and they assume that everything’s taken care of when there’s really been no systemic response to the larger problem,” Turner says. “It’s a lot bigger challenge than the rhetoric we’re hearing would suggest.”

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