A Look at Stem Cell Treatments in Mexico with Ties to California

First part of KBPS' stem cell treatment series

A San Diego television station this week aired a solid series exploring the world of unproven stem cell treatments, including therapies in Mexico and involving a California company.

The work was produced on KBPS by David Wagner and ran as a two-part series(see image above). UC Davis researcher Paul Knoepfler, who earlier this year documented the existent of 570 unregulated stem cell clinics nationally, described Wagner's work as "an important new piece...on for-profit investigational stem cell treatments."

Companies mentioned by Wagner included Stemedica Cell Technologies, Inc., Global Stem Cell Health, Inc., both in the San Diego area, and Hospital Angeles in Tijuana, just south of San Diego in Mexico.

Stemedica is the firm connected to nationally reported treatments of the late hockey great Gordie Howe and former professional quarterbacks John Brodie and Bart Starr. (See here and here.)

'Unnerved' Researchers and Proliferation of Stem Cell Clinics: The Perspective from Los Angeles Times

The Los Angeles Times this past weekend picked up on the growing concern about the spread of dubious stem cell clinics triggered in many ways by a first-ever study by a UC Davis stem cell researcher. 

Pulitzer Prize-winning columnist Michael Hiltzik wrote,

"The proliferation of clinics nationwide offering stem cell therapies unnerves many researchers, who fear that unrealistic public expectations could undermine their own credibility. Patients with hard-to-treat conditions such as multiple sclerosis and Parkinson’s are easy marks who can be led to forgo established therapies in favor of unproven ones."

The headline on Hiltzik's piece said,

"These new stem cell treatments are expensive — and unproven"

Hiltzik interviewed a California lawyer who is working in the field. Hiltzik wrote,

"'Stem cell scientists include the best and the brightest doing great work, and I admire them,' says Janice Mulligan, a San Diego attorney currently assembling evidence for a potential class-action lawsuit against unnamed stem cell clinics. "At the other end of the scale, there’s snake oil.'"

Hiltzik also spoke to Paul Knoepfler, the UC Davis researcher who co-authored the study about stem cell clinics with Leigh Turner of the University of Minnesota. Hiltzik wrote,

"In an article just published in Stem Cells Translational Medicine, Knoepfler described his visit to one informational seminar sponsored by a clinic pitching a $5,999 stem cell treatment to about 30 attendees. Each was given a pack of forms to fill out, including a credit application. The spiel, he reported, featured personal anecdotes and 'questionable medical claims' — including the assertion that '90% of patients had a 50% or better improvement.'"

'False Hopes, Sizable Profits' -- The Nation's Largely Unregulated Stem Cell Clinics

Locations of stem cell clinics identified in Knoepfler/Turner study
Graphic by Cell Stem Cell 

The biggest stem cell story in the country this week reported that at least 570 dubious stem cell clinics exist throughout the nation that could pose a danger to both the pocketbooks and health of patients.

California led the nation with 113 clinics, with Beverly Hills having the most (18) of any city. The clinics promise to cure or ease afflictions ranging from autism to Alzheimers through the use of scientifically untested treatments.

The study is the first effort to get a handle on the size of an industry that has been little regulated by the Food and Drug Administration (FDA) but appears to promise almost miraculous results.

Results of the study were reported yesterday in the Washington Post, the Los Angeles Times, Fox News, The Sacramento Bee and many other outlets.  A search at midday today on Google turned up 7,230 citations, including articles in France, Mexico and Italy.

One of the authors of the study from the journal Cell Stem Cell is Paul Knoepfler, a stem cell scientist at UC Davis.  He has long campaigned for more action dealing with some of these clinics. In September 2015, he wrote on his blog about what he called "predatory clinics."

"These clinics prey on vulnerable patients and their families. The clinics use hope as a marketing tool. A weapon.

"As the number of such clinics has mushroomed in the US and elsewhere the risk to both patients and to the larger stem cell community proportionately rises too. We are in a situation today where the dangers from such clinics have never been higher."

Co-author of the study, Leigh Turner of the University of Minnesota, said in an article in The Bee by Adam Ashton,

"The problem is that so much of the information that’s provided by the industry, so many of the marketing claims being made, they’re not particularly accurate. They’re not trustworthy, and they don’t have any meaningful science behind them."

In a story by Karen Kaplan in the Los Angeles Times, Turner said,

"There is an obvious need for the FDA, FTC (Federal Trade Commission), state medical boards and other regulatory bodies to play a more effective role in regulating the marketplace for stem cell interventions.' Without it, these clinics are able "to peddle false hope for sizable profits.'"

Randy Mills, president of California's $3 billion stem cell agency, said in The Bee that the Knoepfler/Turner study "highlighted a 'broken system' at the FDA that lets some clinics proceed with almost no oversight while requiring others to undergo studies that could tie up their services for decades. He said there are likely far more clinics offering stem cell therapies than Knoepfler and Turner identified, with many of them operating discreetly.

"'There’s so much stuff going on today, but it’s going on because that’s the system the FDA set up and that’s the system the FDA incentivizes,' he said."

Knoepfler noted a bit of irony yesterday concerning the study in a posting on his blog, The Niche. He wrote, 

"I’m glancing over at the (Scientific American) article (on the study) just now and BOOM I see an ad for a stem cell clinic appear at the top and it is even one of the ones in the database we created for our article. The ad is focused on selling stem cells to treat autism in children, an area that raises a lot of questions.

"How can it be a good thing to have an ad for a stem cell clinic right next to the article about the challenge of stem cell clinics in America? The way the web works these days, perhaps it isn’t so surprising that articles having anything to do with stem cells will often be accompanied by ads for stem cell clinics. This one just really stuck out to me today because of the context."

Google and other media outlets routinely place advertisements for these stem cell clinics on many Web sites and blogs, including this one. Some of the newspapers carrying stories about the Knoepfler study also carry ads for such clinics. 

California's Battle for Easing Regulation of Stem Cells Attracts Global Notice

Highlights
CIRM CEO Mills mentioned
FDA regulation/Regrow co-mingled
A tale of dubious stem cell treatments

California's $3 billion, 11-year-old effort to produce a stem cell therapy -- largely ignored by the mainstream media -- broke into global cyberspace today in a reasonably significant way.

The agency was featured in a piece on Buzzfeed, an online news operation that has chalked up more than 173 million unique visitors worldwide in the last 30 days.

The article by Dan Vergano focused on the efforts by the California Institute for Regenerative Medicine or CIRM, as the agency is formally known, and others to persuade the FDA to ease up on regulations so that stem cell therapies can be more quickly developed.

Vergano wrote,

"Despite a decade of scientific hype, progress has been slow in proving that these new treatments actually work. Some scientists are particularly frustrated with the slow pace of FDA review. In a Fox News op-ed published last month, for example, C. Randal Mills, the head of the prestigious California Institute for Regenerative Medicine (CIRM), called for the federal government to loosen its safety rules, promising “medical breakthroughs” for arthritis, back pain, and diabetes."

Mills has focused his efforts since last year on FDA regulation. But his campaign is being co-mingled in the media with the Regrow Act, an industry effort that the agency has not taken a position on.

Paul Knoepfler, a UC Davis stem cell researcher, also recently brought FDA regulation and Regrow together in a piece in the San Francisco Chronicle recently. Vergano interviewed Knoepfler for the Buzzfeed article,

"'We have been telling people to cut down the stem cell hype, and then we turn around and have this talk about miracles and beautiful medicine....Wishful thinking here could have a whole slew of dangerous consequences.' Most worrisome, (Knoepfler) said, is that desperately ill patients looking cures might end up with tumors instead."

Jim Gass, NYTimes photo by Carlos Moreno

One such case was chronicled this week by New York Times reporter Gina Kolata. Her hair-raising story told the tale of patient Jim Gass, a 66-year-old lawyer from San Diego. The article began,

"The surgeon gasped when he opened up his patient and saw what was in his spine. It was a huge mass, filling the entire part of the man’s lower spinal column.

"'The entire thing was filled with bloody tissue, and as I started to take pieces, it started to bleed,' said Dr. John Chi, the director of Neurosurgical Spine Cancer at Brigham and Women’s Hospital in Boston. 'It was stuck to everything around it.'"

"He added, 'I had never seen anything like it.'"

Prodigious Pricing and Stem Cell Treatments: Implications for the California Stem Cell Agency

The most widely read item in the last 10 years on the California Stem Cell Report is one that deals with the cost of a possible stem cell treatment.

Newscom image

The piece contains a $512,000 figure and has chalked up 10,714 page views as of this evening. It deals only with a potential treatment in a fully legal and medically acceptable situation. The item is also nearly two years old. The $512,000 number is likely to have been modified by the researchers involved.

Now comes an item by UC Davis stem cell researcher Paul Knoepfler, who has put together a survey of prices of stem cell “treatments” that are being offered around the world. The costs are for procedures available largely outside established medicine with its accompanying government certification and testing.

Knoepfler reported today on his blog that American clinics – non-FDA approved – run about $10,000 per procedure, with more than one treatment usually described as necessary. Outside of the United States, the procedures run up to $100,000.

Knoepfler wrote,

“Whether inside or outside the US, insurance does not cover the costs of these potentially dangerous, unproven treatments.”

He noted that high profits are associated with the procedures. He said,  

“Part of the way that clinics cut corners to boost their profits is by not following FDA regulations, putting patients in danger. Clinics typically do not do pre-clinical studies to get evidence of safety and efficacy before starting to sell their offerings to patients. Clinics also do not include sufficient follow up in the cost of the treatments. They do not publish their data to get peer review and feedback. They often do not have GMP compliant facilities or devices.”

Knoepfler concluded,

“Of course other costs to patients going to dubious clinics, sometimes not considered, include the price of false hope, potential injury due to dangerous stem cell ‘treatments,’ possibly being excluded from a real clinical trial in the future and injury from deferring other arguably more real treatments.”

The high readership on the 2013 cost item on the California Stem Cell Report is likely due to readers who are considering some sort of stem cell procedure.  Knoepfler will also likely see a similar trend.

The strong interest in stem cell costs is something for the California stem cell agency to consider as it invests in clinical trials. Obviously the expense is of considerable concern to those not ensconced within the stem cell community, where the focus is on a euphemism called "reimbursement," shorthand for making a handsome profit.  Stem cell insiders sometimes shrug off the possibility of a severe, negative kickback on prices. 

But it has already happened in other areas of medicine. A physician protest involving the cost of a particular cancer treatment received national attention in 2013. The article about it in the New York Times received 500 reader comments.  

Obviously no stem cell therapies will reach the marketplace if they do not offer the potential for profit. Nonetheless, if one of the California agency's trials is successful but also carries a prodigious pricetag, California taxpayers who have financed the agency are likely to look askance at the agency’s work.

California's Trounson Wants to 'Shame' the 'Malefactors' of Stem Cell Medicine

Alan Trounson at Cornell
Cornell photo

The former president of the California stem cell agency, Alan Trounson, has kept busy since leaving his post last month. Just this week he authored an opinion piece in The Scientist. Earlier this month he was at Cornell decrying the lack of federal funding for research.

In his article in The Scientist, Trounson called for the outing of stem cell clinics that sell untested and expensive treatments to desperate people.  “Malefactors” is what he called them.

He wrote,

 “It is time that a ‘shame file’ of unregistered and unscientific treatment centers is constructed and widely communicated to warn patients of the dangers of these unregulated and inadequately managed therapies being offered internationally.”

Trounson suggested that the Institute of Medicine could host such a file and help protect uninformed patients. But he also said Alliance for Regenerative Medicine, an industry group that is also engaged in lobbying, could do better in helping to expose dubious stem cell clinics.

He said,

“While this organization and its members do not approve of unregistered clinical trials, they ought to be more active in ensuring the scientific integrity of all studies going forward.”

Trounson said that the $70 million Alpha clinic effort that he championed at the California stem cell agency is also aimed at tackling the problem. Grant applications in that program are due to be reviewed this fall. 

Trounson warned that fringe stem cell clinics damage the entire field.

“The activities of these medical tourism centers are a major barrier to the delivery of genuine cell therapeutic clinical trials by bringing the whole field of cell-based therapies into disrepute.”

At Cornell on June 6, Trounson, who is a senior scientific advisor at CIRM until the end of this month, was the keynote speaker for a symposium on stem cells that also featured broadcast journalist Charlie Rose.

The university put out an item on the appearance. Trounson was quoted as saying,

"The [federal] government looks handicapped in this area. You've got a budget situation where you cannot seem to put more money into research — in fact, less money is going into research. We have to convince the people elected to government that this is an incredible revolution and that we need to keep funding the science."

That could be a pitch for the California stem cell agency as well. It is scheduled to run out of money for new grants in less than three years and is currently looking at ways to develop new funding sources.

California Stem Cell Agency Blogs on Questionable Stem Cell Clinics

The California stem cell agency has taken notice of a piece in the New York Times that reports on questionable practices of enterprises that say they are stem cell clinics. 

In a blog item written yesterday by Don Gibbons, senior science and education officer at the agency, the agency said that the practices described in the article generated a cautionary advisory to patients last month by the stem cell agency and 12 other organizations. 

Gibbons noted that much of the Sept. 9 Times article by Laura Beil focused on one clinic,  the Regenerative Medicine Institute in Tijuana, which is just on the California-Mexico border. Gibbons’ item reported that one U.S. expert says that some of the clinic’s key procedures would not pass muster in this country.

Gibbons continued,

“Most important, the clinic has not produced any publishable data. We all have great hope for the promise of stem cell science, but I think it is fair to say that anyone who legitimately cares about that promise wants to find out what is the right type of cell to put in each patient. When is the right time for the transplant, and what is the best method of delivering the cells. We will never learn those things without collecting data in a well-designed clinical trial and sharing that data.”

The Times article quoted UC Davis researcher Paul Knoepfler as saying,

“There is absolutely no legitimate reason for such clinics to be not publishing their data.”

Gibbons also said that the International Society for Stem Cell Research, which backed away under threats of lawsuits a few years ago from some criticism of dubious stem cell clinics, plans to release this week a new statement on these sorts of treatments.

We should note that Times article, which is syndicated to many newspapers in this country, did not pick up the widely reported instances of deaths and injuries from these treatments. It did report that problems exist in this country as well as abroad. The article said, 

“In the United States, too, it is easy to conduct business outside government oversight, said Dr. George Q. Daley, who studies stem cells for blood diseases at Harvard Medical School. Close down one shady operation, he went on, and more seem to randomly pop up.

“Even questionable publicity does not necessarily hurt business. Regnocyte, a company in Florida, posted an unflattering CNN report about it on its Web site under the heading ‘special coverage.’”

Flim-Flam Stem Cell Artists Targeted by CIRM

The California stem cell agency has joined with other prestigious stem cell organizations to help put a stop to the flim-flam artists that prey on desperate people by promising miracle cures from stem cell treatments.

The agency announced the action today on its blog, declaring that it has posted a new patient advisory document that provides a “ robust and detailed set of issues patients should consider when making treatment decisions.”

Don Gibbons, CIRM's senior science and education communications officer and author of the blog item, said the document addresses one of his special concerns: Internet “ads that come up on web searches and seem to be offering everything to everyone.”

Some of those ads can be found on many stem cell-related web sites, including this one, that carry ads that are placed there automatically by Google.