FDA launches lawsuits against stem cell clinics after patients rendered blind
pharmafile | May 10, 2018 | News story | Medical Communications, Sales and Marketing | FDA, Stem cells, US, macular degeneration, pharma
At the request of the FDA, The US Department of Justice has launched legal action seeking to shut down stem cell clinics in California and Florida for allegedly peddling scientifically-unproven treatments which have left some patients blind.
The stem cell therapy practiced by the clinics in question involved the use of liposuction to procure stem cells from the patient’s own fat, before injecting those cells into the patient’s eyes as a treatment for macular degeneration.
The California lawsuit specifically targets California Stem Cell Treatment Center across its two locations in Beverley Hills and Rancho Mirage, as well as its owners, cosmetic surgeon Mark Berman and surgeon and urologist Elliott Lander. According to the details of the suit, both proprietors have around 100 affiliated clinics across the US which have, in total, treated over 6,000 patients, with each treatment costing thousands of dollars and none of which have been approved by the FDA.
The Center has found itself in the sights of the US regulator before. In August last year, the FDA revealed it had seized around 500 smallpox vaccine doses which the establishment intended to combine with body fat-derived stem cells in the treatment of patients.
In Florida, the legal action focuses on US Stem Cell Clinic and its officers Kristin Comella and Theodore Gradel, where four patients treated for macular degeneration suffered severe adverse effects, including being rendered blind. Again, this clinic has been in the FDA’s sights, with the regulator warning in August last year of 14 separate “significant objectionable conditions”, including failure to take adequate measures to ensure its treatments were free from contamination.
California Stem Cell Treatment Center said it would be willing to fight back against the action, with Lander arguing that there is “a lot bigger issues at stake than our business. When we do these surgical procedures, we are giving patients access to healing cells in their own body. If it had to be approved as a drug product, it would take hundreds of millions dollars and years to achieve that.”
“They would have to go out of the way to claim your own personal cells that are taken out of your own body are drugs,” added Berman.
Similarly, US Stem Cell Clinic CSO Comella commented: “My entire career has been dedicated to studying and developing treatments utilising the body’s own natural ability to heal. I remain steadfast that no government agency should deprive individuals of their right to harness the cells that exist in their body.”
FDA Commissioner Scott Gottlieb has been clear on the regulator’s aim of cracking down on unlicensed treatments over the past year. In relation to these particular cases and the proliferation of similar clinics, he was quoted as saying: “It’s important that we send a stronger deterrent message. If people are putting patients at risk and creating patient harm, we’re going to take action […] From my standpoint, this is a field where there’s a lot of medical promise, but we also see bad actors putting people at risk, harming patients and peddling false hope.”
Matt Fellows
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