Jeannine Mallard enrolled in a South Florida stem cell clinic’s study thinking it might help with her progressive eye disease, but now she claims the experimental treatment left her blind.
She found the study posted on a government-run database, ClinicalTrials.gov.
Mallard faces surgery to remove her eye altogether, according to Grossman Roth Yaffa Cohen, the Coral Gables, Fla., law firm representing her in a lawsuit against U.S. Stem Cell Clinic—one of several clinics the Food and Drug Administration is working to stop from marketing stem cell products without agency approval.
“This is nothing short of a profit driven scam where these snake oil salesmen take advantage of the hope that stem cells offer and the most vulnerable people that are desperate for help,” Mallard’s attorney Andrew B. Yaffa told Bloomberg Law in an email.
In fact, three of Yaffa’s four stem cell malpractice clients found these allegedly unscrupulous stem cell clinics on ClinicalTrials.gov. The National Institutes of Health database was created to help prospective research volunteers find potential studies. But there’s growing concern these stem cell clinics are using the database as a way of advertising unproven therapies, Yaffa said.
“It’s a horrible angle that they exploit,” Yaffa told Bloomberg Law. “They advertise it as a stamp of safety, or approval, if you will.”
FDA Scrutiny Growing
FDA Commissioner Scott Gottlieb has promised to crack down on unscrupulous stem cell clinics “that abuse the trust of patients and endanger their health.” Since it rolled out its regenerative medicine framework a year ago, the agency has issued a number of warning letters to companies including U.S. Stem Cell, Cell Surgical Networks, and StemGenex Biologic Laboratories LLC in San Diego.
Despite this crackdown, a growing number of businesses are using ClinicalTrials.gov to sell their products, University of Minnesota bioethicist Leigh Turner told Bloomberg Law.
“It’s an interesting thing that’s taking place where there’s an apparent increase in the regulatory activity,” but the market continues to expand, Turner said. The latest published data show 432 businesses operating a total of 716 stem cell clinics in the U.S., and Turner said those numbers continue to grow.
Businesses appear to be making calculated decisions that the odds they’ll be investigated and disciplined are low, Turner said. “And so far they’ve been right.”
StemGenex describes its research as “at the forefront of collecting data to support the safety and efficacy of stem cell therapy through five clinical studies registered with the National Institutes of Health.” While that language stops short of saying the NIH has endorsed the study, both Yaffa and Turner said it’s misleading.
“They really play it up as a marker of credibility when it’s not,” Turner said.
Health-care providers often send their patients to ClinicalTrials.gov as the go-to source for credible information, he said. “There needs to be better screening in place. It shouldn’t be as easy to get junk studies listed on there as it is.”
Urging More Enforcement
The International Society for Stem Cell Research wants the FDA to step up enforcement against “unproven stem cell clinics that submit false and misleading promotional information to the database” for clinical trials.
“We believe that the ClinicalTrials.gov database should be a safe place for patients and physicians searching for accurate information regarding clinical trials,” ISSCR president Douglas A. Melton wrote in a Nov. 20 letter to the FDA. Melton is a pancreatic stem cell researcher and co-director of Harvard University’s stem cell institute.
The ISSCR letter responds to draft guidance the FDA issued in September detailing how it would go after those who violate ClinicalTrials.gov regulations. That draft guidance focuses on drug and device companies that failed to register their studies as required.
The ability of stem cells to develop into many different cell types offers enormous promise to treat afflictions like spinal cord injuries and diseases such as diabetes, but the FDA has approved only a few. The clinics under fire offer treatments for conditions ranging from eye disease to hip and knee ailments, but their studies don’t have FDA approval.
FDA Enforcement Options
The FDA has options if it decides to ramp up enforcement on ClinicalTrials.gov, two FDA regulatory attorneys told Bloomberg Law.
“The fact that studies are being done, if true, would not in itself be false or misleading,” said Kinsey S. Reagan of Kleinfeld Kaplan & Becker LLP.
“But if FDA finds additional statements or links to statements in the Clinicaltrials.gov submission by a stem cell company that promote the safety or efficacy of the investigational treatment in a false or misleading way, FDA presumably would be motivated to take action,” he said in a Nov. 21 email.
Carol Pratt, a Portland, Ore., attorney with Lee & Hayes, said the FDA also could go after companies conducting a study without agency approval. These stem cell companies assert that they are only doing what’s called “minimal manipulation” to the stem cells and therefore aren’t covered by FDA regulations. The agency has disagreed in its warning letters.
The FDA also could exercise enforcement through its certification requirements for ClinicalTrials.gov submissions, Pratt and Reagan said.
Clinic Owner Responds
The FDA sought a permanent injunction against Cell Surgical Networks in May to stop it from marketing to patients stem cell products that don’t have FDA approval. Cell Surgical Networks operates about 100 clinics across the country.
Mark Berman, co-founder of Cell Surgical Networks, told Bloomberg Law he agrees with the other clinics’ claims that the stem cell treatments are surgical procedures that shouldn’t be subject to FDA regulations. He said company co-founder Elliot B. Lander registered their work on ClinicalTrials.gov “because we started our program (and it still remains) as a way to investigate the safety” of his company’s treatments.
“We neither own nor manufacture anything. It’s a complete violation of your rights as a patient for the government to control how you use your own body parts unless we were to actually alter your cells (e.g. genetically modify or add particular chemicals, etc. to them),” Berman said in an email.
StemGenex and U.S. Stem Cell Clinic didn’t respond to Bloomberg Law requests for comment.
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(Updated to include comments from co-founder of Cell Surgical Network in last four paragraphs.)
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