If there’s anything that drives legitimate stem cell scientists up a wall, it’s their being lumped in with clinics offering unwary customers supposedly effective disease treatments through stem cell injections.

So you can understand why a documentary series titled “The Healthcare Revolution,” which is partially funded by a network of clinics that are hawking unproven therapies and are under fire from the Food and Drug Administration, has created an uproar among academic researchers.

As many as a dozen legitimate scientists have demanded the removal of interviews with them featured in the documentaries. Several say they were misled into lending their credibility to a project that promotes treatments that are scientifically unproven and could be dangerous. They were led to believe that they would be participating in a project about legitimate scientific progress in the field, complete with sober cautions that much of this work is still in its infancy.

It was pitched like it would be a ‘Nova,’ but it came out like an infomercial. Stem cell scientist Evan Snyder


“You have placed my interview among those of people who are charlatans and thieves,” stem cell biologist Jeanne Loring of the Scripps Research Institute in La Jolla wrote last week to Sara Sheehan, a producer of the series, in a letter republished by the California Stem Cell Report. Sheehan has apparently complied with her request to be removed from the documentary. Loring was the first scientist to sound the alarm about the series for the academic community.

The producers say they will honor similar requests from other researchers and from California’s stem cell research program, the California Institute for Regenerative Medicine (CIRM), whose president, Maria Millan, had been included in the documentary. The necessary changes will delay the distribution of what originally was to be a 12-episode series, which was to begin online Monday. At the moment, only two promotional clips and the opening episode can be viewed online.

The researchers say they were provided in advance only with videos of the installments in which their interviews appeared. Only after they consulted the website promoting the film did they discover that its thrust would exploit their credibility to lend legitimacy to treatments lacking any scientific validity.

“It’s a package that’s very misleading and not balanced,” says Evan Snyder of Sanford Burnham Prebys Medical Discovery Institute. “It was pitched like it would be a ‘Nova,’” he said, referring to the scientific series produced for the Public Broadcasting System, “but it came out like an infomercial.”


Lawrence S.B. Goldstein of UC San Diego says he was led to believe the producers were making a “balanced, sober documentary.” The trailer for the series posted on its website, however, was infused with hype—“It sounded like miracle cures from stem cells are here today—‘Give us your money and we’ll fix you up,’ giving false hope to people suffering from terrible diseases.”

CIRM says it asked that Millan’s interview be removed because the series “risked giving a distorted view for anyone who saw it and … inadvertently legitimized opportunistic bad actors.”

Here’s some context. Stem cells, which can develop into specialized tissues, theoretically bear great promise for treating such diseases as diabetes, Alzheimer’s, Parkinson’s and multiple sclerosis. But the research is arduous and in most cases inconclusive. The FDA has approved stem-cell-based treatment only for blood-forming stem cells in very limited circumstances.

Nevertheless, hundreds of commercial clinics have sprung up around the nation hawking treatments for those conditions and others, despite the absence of scientific validation. Typically, the treatments involve removing a patient’s fat by liposuction, extracting stem cells from the fat and injecting the cells back into the patient. These treatments often cost more than $10,000 and generally aren’t covered by insurance.


The FDA has launched an attack on the clinics purveying untested treatments. “Don’t believe the hype,” the agency warns on its website. “Some unscrupulous providers offer stem cell products that are both unapproved and unproven.” The agency won a significant legal victory on June 3, when a federal judge found that the FDA had properly deemed the purported stem cell treatments offered by Florida-based U.S. Stem Cell Clinic illegal and issued an injunction against the continuation of the treatments. A similar FDA lawsuit against Rancho Mirage-based Cell Surgical Network is pending in federal court in Riverside.

Kristin Comella, an executive of U.S. Stem Cell and a defendant in the FDA’s lawsuit, is among the “experts” in the stem cell field listed on the documentary’s website. (Also featured, Anand Srivastava and Deven Patel of Giostar, a stem cell clinic firm whose dubious history — including a roster of academic advisors that included several names without permission — we outlined in January.)

That brings us back to “The Healthcare Revolution.” Several of the academic experts who have asked to be deleted from the series say they gave their interviews during a scientific conference in Miami in January.

“It looked fairly harmless to me,” says Bruce Levine of the University of Pennsylvania, whose interview was removed from the documentary at his request. He and others say the interviews were straightforward and not adversarial. They also say the complete segments they’ve seen don’t appear to have been edited to give a misleading impression. Subsequently, the interviewees were sent a release form by Working Pictures, Sheehan’s production company.


It was only last week that the true nature of the project emerged. That’s when Cell Surgical Network sent customers and former customers an email announcing the documentary’s upcoming premiere. The email landed in the in-box of Doris Tyler, a Florida resident who is suing Cell Surgical Network and affiliates for allegedly leaving her blind via a stem cell treatment for an eye condition.

Tyler alerted her attorney, Andrew Yaffa, who passed the alarm on to Loring at Scripps. Loring scanned the documentary’s website and noticed that she and numerous academic colleagues were featured along with purveyors of unproven treatments. On June 13, she says, “I sent messages to everyone I knew” on the roster of participants.

Subsequently, Sheehan disclosed that Cell Surgical Network had partially funded the series, deepening the alarm and prompting most, if not all, the academic participants to withdraw. “That was the kiss of death for me,” Loring told me. “I do not want to be associated with those guys at all.”

Mark Berman, a founder of Cell Surgical Network and a defendant in the FDA case, declined to reveal the size of CSN’s financial contribution but says he exercised no control over the documentary content.


In an open letter to the academic scientists, Berman called their withdrawals a “knee-jerk reaction” and asked them to reconsider. Working Pictures says none has done so, however.

What disturbs many legitimate researchers is that the hawking of unproven or dangerous therapies could discourage patients from seeking standard medical treatment, to their disadvantage.

“I’m concerned by the association with unsavory characters who are selling unproven stem cell therapies directly to patients,” Levine says .

He found the inclusion in the documentary of patient testimonials about their treatments to be especially disturbing: “Patient testimonials without scientific evidence not only mean nothing, they have the potential to deceive patients who need medical therapies.”


Others take issue with the documentary’s apparent position that the FDA is an obstacle to innovative treatment. The producers, Loring says, “didn’t say, ‘Would you mind being in a film that portrays the FDA as the bad guy and the stem cell clinics as the heroes.’ We assumed the context would be appropriate.”

The producers say they’ve been blindsided by the controversy. “We had no idea that Cell Surgical Network was radioactive in this space,” Bobby Sheehan, a principal of Working Pictures and Sara Sheehan’s husband, told me.

That doesn’t speak well for the research the filmmakers performed for their project, since Cell Surgical Network would seem to be an established bête noire in the academic stem cell community. The documentary appears to treat the assertions of promoters of scientifically unproven “treatments” and of responsible scientists as equally valid, and takes the approach that presenting them as such is just a matter of allowing everyone to have a say. As such, it tips the scale toward giving the promoters’ claims undeserved legitimacy.

“Do we think that from a freedom of speech point of view Cell Surgical Network has the right to have an opinion?” Bobby Sheehan says. “We think that they do.” He suggested that the outcome of the FDA lawsuit against Cell Surgical should determine the legitimacy of its science and took issue with Loring’s distinction between “legitimate” and illegitimate research: “Until Cell Surgical loses their case against the FDA, or wins the case, [Loring’s] definition of legitimate stem cell science is a point of view.”


That’s unpardonably naive, if true. There are many uncertainties in stem cell research, but anyone who has done a dime’s worth of research into the field would know that scientific evidence for the efficacy of the treatments purveyed by the stem cell clinics operating outside the FDA’s oversight is nonexistent.

“There should always be open scientific discourse,” Snyder says. “But certain principles are accepted science that are not appropriate for discourse because they’re misleading to the public. If you give the idea that vaccines cause autism [a scientifically debunked claim] and you give it credibility as an alternative point of view, then you’re going to have the measles outbreak that we have now.”

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