The FDA is going after stem cell clinics that peddle unproven treatments

FDA is going after stem cell

Inside Mark Berman’s clinic in Rancho Mirage, California, is a sign he’s obliged by law to post. It reads “Not FDA Approved.”

Patients who come here to the California Stem Cell Treatment Center can get treatments for ailments ranging from sports injuries to muscular dystrophy. For upward of $5,000, Berman, a plastic surgeon by training, will remove a small portion of their fat, process it, and inject it back into them.

This is called “fat-derived stem cell therapy”; the premise is that the stem cells in your fat can jump-start the healing process. “The stem cells could be good for repairing everything from Alzheimer’s to paralysis to neurodegenerative conditions,” says Berman. “These cells are miraculous for helping heal. We don’t have a choice. We have to use them.”

The problem is there’s not much evidence to back up the claims Berman is making. And it’s not just him — there are more than 100 clinicians in the Cell Surgical Network, a group he co-founded in 2010 to promote the same kind of adult stem cell regenerative medicine he practices. According to a 2017 report by three Food and Drug Administration scientists in the New England Journal of Medicine looking at the benefits and risks of this kind of stem cell therapy, “This lack of evidence is worrisome.”

FDA is going after stem cell

Fat-derived stem cells “may have a positive effect,” says Brad Olwin, a professor of molecular cellular and developmental biology at the University of Colorado Boulder with more than 30 years of experience working with stem cells. “They may be beneficial; it’s clearly a possibility. The problem is the research hasn’t been done.”

So little evidence exists, in fact, that the Department of Justice, on behalf of the FDA, is suing Berman’s clinic as well as a clinic in Florida for experimenting on patients with misleading products. The complaint was filed in May 2018 and the investigation is ongoing, according to the DOJ.

Given the popularity and abundance of these clinics nationwide, the FDA is also taking steps to modernize regulation in the field. But despite these efforts to streamline a path to legitimacy for stem cell clinics, unregulated medical procedures persist, at times leading to patient harm.

“Innovation”: the latest GOP smokescreen on climate change policy

GOP smokescreen on climate change policy

The politics of climate change are shifting against the GOP. New polling shows that majorities of Republicans accept that climate change is a problem and support steps to address it. It is mainly the stubborn core of far-right conservatives, mostly older white men, that still rejects reality altogether.

It’s a crucial juncture for the party. There are two ways it could go.

The first is a good-faith search for conservative-friendly climate solutions. A handful of Republicans are taking this route, supporting a bill called the Energy Innovation and Carbon Dividend Act, introduced in the House in November and (in a slightly different form) the Senate earlier this month. It would implement a $15 carbon tax, rising at $10 a year, with all the revenue returned as per-capita dividends, aiming to reduce US carbon emissions 40 percent within 10 years and 90 percent by 2050. It’s a credible, ambitious climate effort. It’s got two Republican co-sponsors in the House and one in the Senate.

(It is distinct from the similar though somewhat less ambitious proposal from the Climate Leadership Council, which is backed by several retired Republicans and the Americans for Carbon Dividends PAC.)

The problem is that most GOP funders and elected officials remain devoted to the cause of protecting fossil fuels, and protecting fossil fuels is, by definition, incommensurate with serious action on climate change.

In his latest piece, Jenkins attempts simultaneously to cling to a bunch of the denialist myths he’s peddled for years and to chide climate activists for their lack of “maturity” in not supporting nuclear power or a carbon tax — solutions to a problem he does not believe warrants attention. (Large swaths of the left support the former and there is near-universal support on the left for the latter, but never mind that.) The sole intellectual organizing principle seems to be that the left, or at least the left of Jenkins’s stale imagination, must be bad and wrong.

GOP smokescreen on climate change policy

But in other cases, there is some rhyme and reason to the bullshitting. One recent rhetorical gambit from Republicans is a retreat from “climate change is a hoax” to “we don’t know how much humans contribute,” which, as I wrote recently, is just another way of denying the science. (There is much uncertain in climate science, but human contribution is not part of it. We are definitely causing global warming.)

And when science denial becomes sufficiently untenable, the final line of defense, now as ever, is economic: Anything government does to counter climate change will just mess up the economy and cost taxpayers money. Sen. Marco Rubio (R-FL) told CNN he believes the climate is changing, but “I’m also not going to destroy our economy.”

However, with clean energy technologies so visibly booming, coal so visibly dying, and climate change in the headlines, a purely negative message is not enough. GOP “moderates,” the ones who still want to appear on Meet the Press, need some kind of positive message.

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