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.

The New York Times and AP bungled their fact checks of Trump’s speech — badly

Trump

Fact-checkers wandered into false equivalency territory Tuesday night after President Trump’s Oval Office address on immigration and Democrats’ response to it.

The Associated Press was clobbered on Twitter after it anointed the Democratic claim that Trump was at fault for the shutdown “false,” saying that the Democrats are at fault too. As the AP put it on Twitter: it takes “two to tango.”

The New York Times, meanwhile, attempted to fact-check a “should” claim made by Democrat Chuck Schumer — the kind of statement that doesn’t really lend itself to a fact check at all.

Fact-checking has evolved during Trump’s time in office — mainstream news outlets are far more likely to call a lie a lie than they used to. Even on Tuesday night, big outlets relied on policy expertise to clearly dispute Trump’s false claims.

But the night also revealed that outlets still feel the urge to find fault on both sides or assign neutral blame for political problems. The political press has long wanted to cover politics like a sport, to cover the plays of each party as if they are morally and ethically the same. On a night when the president looked the public in the eye and lied about why the government has been shut down for weeks, the press needs to not fall into the false equivalency trap.

The Associated Press tried to fact-check who is to blame
Following Trump’s speech, House Speaker Nancy Pelosi and Senate Minority Leader Chuck Schumer delivered a rebuttal in which they placed blame for the shutdown squarely at Trump’s feet.

Trump

“The fact is, on the very first day of this Congress, House Democrats passed Senate Republican legislation to reopen government and fund smart, effective border security solutions,” Pelosi said. “But the president is rejecting these bipartisan bills, which would reopen government over his obsession with forcing American taxpayers to waste billions of dollars on an expensive and ineffective wall — a wall he always promised Mexico would pay for.”

Blaming Trump is entirely reasonable. The shutdown began last month, when Republicans still controlled both the House and Senate, and after the Senate unanimously passed a funding bill that would’ve kept the government open but didn’t fund Trump’s wall.

But in response to criticism from his far-right supporters, Trump at the last minute decided not to support the Senate bill. During an Oval Office event with Pelosi and Schumer, Trump even said he was “proud to shut down the government” and vowed he wouldn’t blame Democrats for it.

R. Kelly reportedly faces a new criminal investigation after Lifetime’s docuseries

criminal investigation

After 25 years’ worth of accusations of sexual misconduct against R. Kelly, the R&B legend may be about to face legal consequences again.

Following the airing of Lifetime’s Surviving R. Kelly, a six-part docuseries about the singer and the persistent allegations that he has abused young women and girls, the district attorney in Fulton County, Georgia, has reportedly opened a new investigation into Kelly’s alleged abuse.

(Kelly has denied the idea that he is holding anyone against their will, and some of the women in question have told the police that they live with Kelly voluntarily. Their families argue that they have been brainwashed.)

An attorney for the family of Jocelyn Savage, one of the women who is allegedly being held by Kelly, told CNN that he was contacted by the Fulton County district attorney shortly after Surviving R. Kelly aired. The office of the district attorney has not commented on the matter, and no warrant has been issued against Kelly.

However, a warrant has been issued for the arrest of Kelly’s manager James Mason, who police say has threatened Kelly’s accusers. The police have been unable to find Mason.

And in Illinois, Cook County State’s Attorney Kim Foxx has asked any of Kelly’s potential victims to come forward. “There’s nothing that can be done to investigate these allegations without cooperation between victims and witnesses,” Foxx said. “We cannot do this without you.”

criminal investigation

Lifetime’s Surviving R. Kelly appears to have effectively focused attention back on Kelly and the question of his alleged misconduct. The series was highly watched, with each of the six episodes averaging 2.1 million viewers, and after it aired, two Dallas radio stations announced that they would no longer support Kelly’s music. “If the courts won’t take care of [Kelly] in terms of punishing him, then we’ll stop playing his music as punishment,” said radio host DeDe McGuire.

Many of Kelly’s fans continue to support him, however, and Spotify has reported that after Surviving R. Kelly aired there was a 16 percent spike in streams of Kelly’s music.

Kelly has not officially commented on the series, but his lawyer described it as “lies” and threatened to sue before it aired. According to TMZ, Kelly is planning to “expose” his accusers with a website and Facebook page called “Surviving Lies,” but the website has yet to go up, and Facebook removed the Surviving Lies page for violating its community standards.

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