- Jun 2007
What a racket. And it's barely regulated.Greene said that amniotic stem cells derive their healing power from an ability to develop into any kind of tissue, but he failed to mention that mainstream science does not support his claims. He also did not disclose that he lost his license to practice medicine in 2009, after surgeries he botched resulted in several deaths. Instead, he offered glowing statistics: amniotic stem cells could help the heart beat better, “on average by twenty per cent,” he said. “Over eighty-five per cent of patients benefit exceptionally from the treatment.”
“Patients come back to the center saying, ‘I can walk farther, I can breathe easier, I can sleep better,’ ” he proclaimed. “It’s remarkable, the outcomes we’ve been seeing for the last few years.” In the second row, a slender woman in a striped jacket, who had hobbled into the meeting on a wooden cane, pumped her fists in the air. “Stem cells!” she cheered.
For more than half a century, the regenerative possibilities of stem cells—which the body stores to repair damaged tissue and organs and restore blood supply—have tantalized the medical community. Bone-marrow transplants for cancer patients, which rely on blood stem cells, fulfill this potential. But alongside legitimate, scientifically proven treatments, an industry has sprung up in which specialized clinics offer miracle remedies from poorly understood stem-cell products.
These clinics are multiplying in the United States. According to a tally by Leigh Turner, an associate professor of bioethics at the University of Minnesota, there were twelve such clinics advertising to consumers in 2009; in 2017, there were more than seven hundred.
It's a long article, but worth it. I had no idea this was a thing. Sounds like a damn South Park episode.Nearly fifteen years ago, the F.D.A. established rules on the use of human tissue. If the tissue was “minimally manipulated” and used in the same way it originally functioned in the body, it didn’t need F.D.A. approval as a drug. However, if the cells were modified in a lab, or were given a new purpose—such as using placenta cells to treat a brain disease—they would be considered a drug, and would have to undergo F.D.A. review.
The problem is that the agency left it up to manufacturers to decide which group their products belonged to. Seeking F.D.A. approval entails running multiple human trials, which can cost hundreds of millions of dollars. There was no incentive for the stem-cell manufacturers to put their treatments through this process, so they took the position that their products didn’t count as drugs.
The F.D.A. rarely disagreed with their stance. From 2010 to 2017, the agency sent warning letters to only seven of the hundreds of companies that made or marketed stem-cell treatments, according to a tally of letters in the F.D.A. database. The agency said it could not confirm the exact number because it “does not maintain lists of actions by product.”
In the early twenty-tens, the agency decided it should issue stricter guidelines on the use of human tissue. But it wasn’t until November, 2017, that the guidelines were updated, clarifying that many tissue products, including amniotic stem cells, must be characterized as drugs. The F.D.A. gave the clinics another three years—until 2020—to comply. (In the meantime, the agency continues to send warning letters to more companies.)
Gottlieb, the former F.D.A. commissioner, said he is disappointed that, during this interim period, few firms have submitted their products to the F.D.A. for approval as drugs. “There are literally hundreds of clinics, and some of them are engaging in very risky actions,” he said. “They’re crossing the line.”
The Birth-Tissue Profiteers