60 Minutes highlights concerns about clinics marketing unverified stem cell treatments

Last night, 60 minutes aired a report describing the dangers of what has become known as stem cell tourism – people traveling to other countries to receive unverified “treatments”. You can watch the episode here. In the story, they spoke with Gary Susser, whose son Adam has cerebral palsy. Susser and his wife took Adam to a doctor in Mexico, who injected Adam with stem cells but provided no evidence that the injections would be effective. They were not. In the story Susser said:

"I see how people are preyed upon by hucksters and charlatans. And people who have a special child don't need any more expense, don't need any more heartache, and don't need any more false promises. They need the truth and they need hope."

Susser and his wife worked with 60 minutes to investigate a clinic in Ecuador that advertises therapies for 70 incurable diseases including cerebral palsy.

This trend of overseas clinics offering “modern day miracles,” as the Ecuadorian clinic’s website promises, is one that has concerned both CIRM and the International Society for Stem Cell Research (ISSCR). In 2010, when the ISSCR held its annual meeting in San Francisco, CIRM and ISSCR co-hosted a symposium about these clinics and the concerns they raise. A video of that session is available on the CIRM website.

At that same meeting, then-head of the ISSCR Irv Weissman used his opening address to both tout a new ISSCR website designed to help people identify clinics offering true therapies (A Closer Look at Stem Cell Treatments), and also discussed what he saw as the dangers of stem cell tourism. In countries without strong oversight bodies such as the Food and Drug Administration in the U.S., clinics can make claims about potential therapies without backing those claims up with any proof that the procedure will work or even be safe. An investigational treatment offered for sale, which is what these clinics described on 60 minutes are offering, is not the same as a clinical trial, which would show whether the new treatments are safe and effective.

In the 60 minutes piece, the clinic under investigation had proposed injecting cells that, when scrutinized by Dr. Joanne Kurtzberg of Duke University, turned out to be disintegrating. She said:

"There are huge dangers if you injected that into someone's blood or spinal fluid because all these little fragments and debris would get trapped somewhere in the blood stream and could cause a stroke, or in the brain could cause an inflammatory reaction."

Weissman spoke with Stanford’s Krista Conger, who wrote a story on the topic for the magazine Stanford Medicine. In it Weissman said:

“This is a new field. We are learning what kinds of stem cells can regenerate which kinds of failing organs. But we always remember that our first goal is to do no harm. That’s why we begin our tests in animals before moving into early phase clinical trials in humans, and at every stage we verify the solidity and reproducibility of the science and that the investigators have no potential commercial or personal conflicts of interest that could influence the outcome of the trials. Any attempt to commercialize unproven treatments in the absence of independent or regulatory oversight endangers not only the lives of those who receive the treatments, but also the entire field of regenerative medicine.”

Conger also quoted CIRM grantee Jeanne Loring, director of the Center for Regenerative Medicine at the Scripps Research Institute in La Jolla, Calif.:

“When we report something good about stem cells, it gets picked up in the media, or in a blog that patients read. It gives them more ammunition to say that the FDA is stupid for denying access to treatments that seem like they should work.”

At CIRM, we know how frustrating the timeline of developing new therapies can be. We also have friends and family members with diseases desperately in need of new therapies. That sense of urgency is constantly reiterated by our board members, ten of whom serve on the board as patient advocates. (Our board member Jeff Sheehy has blogged about the role of advocates in accelerating the pace of new therapies.)

That’s why we’re working with industry, pushing teams to collaborate, and engaging the FDA to try to speed that timeline and get new therapies to the patients who need them. Today we have 43 projects in various stages of working their way to the clinic, with several we hope to see enter clinical trials in the next few years. You can read more about our projects in development and the steps along the path to a new therapy on our website.

If people are considering clinics outside the U.S., please do read the ISSCR web page. They have a good list of qualifications to look for in identifying clinics that are being truthful about what they offer rather than simply peddling hope. Included in what they suggest people look for is oversight of investigational treatments to be sure the physicians are qualified, the investigational treatment is prepared appropriately, and that the risks and potential benefits are accurately and clearly explained. People should also look for published records showing results from clinical trials. CIRM also has a page about stem cell tourism and what we are doing to try to speed the timeline to new therapies.

A.A.