FDA dithers dangerously on regulating sketchy ‘stem cell’ care and kid vaping

fdaStemCells-300x200Yet more derelictions of duty by the federal Food and Drug Administration are happening now, in its handling of largely hokum treatments and health-threatening devices.  The latest examples: drug safety regulators step back from their oversight of those who peddle sketchy “stem-cell” treatments for a bevy of ills. And twiddle their thumbs as who knows how many more young people get addicted to nicotine because experts just aren’t ready to regulate e-cigarettes and vaping.

Here’s what the Associated Press reported about the agency and how it has allowed a boom in unsupported therapies using so-called stem cells (real versions, shown above):

“Hundreds of clinics pushing unproven stem cell procedures caught a big break from the U.S. government in 2017: They would have three years to show that their questionable treatments were safe and effective before regulators started cracking down. But when the Food and Drug Administration’s grace period expired in late May — extended six months due to the pandemic — the consequences became clear: Hundreds more clinics were selling the unapproved treatments for arthritis, Alzheimer’s, Covid-19 and many other conditions. ‘It backfired,’ said Leigh Turner, a bioethicist at UC Irvine. ‘The scale of the problem is vastly larger for FDA today than it was at the start.’ The continuing spread of for-profit clinics promoting stem cells and other so-called ‘regenerative’ therapies — including concentrated blood products — illustrates how quickly experimental medicine can outpace government oversight. No clinic has yet won FDA approval for any stem cell offering and regulators now confront an enormous, uncooperative industry that contends it shouldn’t be subject to regulation.”

Fat profits have pushed the boom in this area, the news service reported:

“Turner and other experts have tracked the growth of the clinics for nearly a decade. Clinics charge between $2,000 and $25,000 for adult stem cell injections and other infusions that they advertise for an assortment of conditions, including diabetes, autism, cancer, multiple sclerosis, and vision problems. Some clinics use stem cells derived from fat, harvested via liposuction, and then reinjected into patients, aiming to repair joints or fight disease. Others use bone marrow or blood taken from umbilical cords after birth. There is no government tally of how many clinics operate in the United States. But Turner counted more than 1,200 of them in 2019, up from the 570 clinics he and a co-author identified in 2016. He’s working on an update but says the number has consistently grown.”

The outfits put the public at real health risk, the AP reported:

“The FDA has repeatedly warned Americans to steer clear of unapproved and unproven stem cell therapies, which have occasionally caused blindnessbacterial infections, and tumors. During the FDA’s three-plus years of “enforcement discretion,” the agency sent formal warning letters to more than a dozen businesses performing the riskiest procedures. Regulators also prevailed in a Florida court case to shut down a major clinic offering unproven treatments. Another case against a similar prominent company is pending in California. [But many] stem cell doctors continue to argue that their in-office procedures are outside the FDA’s purview. But the FDA has concluded that processing stem cells and giving them to patients with serious diseases amounts to creating a new drug, which the agency regulates.”

Researchers with the Pew Charitable Trusts have scoured peer-reviewed journals, government and news media reports, other literature, social media, and FDA databases to try to catalog cases in which patients have claimed injuries due to purported stem-cell treatment, finding hundreds of instances from 2004 until September 2020.

The Pew experts, however, quickly found a big problem in the harm reporting — the FDA was not a central part of the system, as it is supposed to be with, say, problem prescription drugs or medical devices. This led these experts to write:

“[I]t’s clear from the cases that are reported that these procedures can cause serious and sometimes life-threatening harm, and that more should be done to protect patients. These findings also highlight the need for strong FDA oversight and help to underscore why the agency needs to fully implement its regulatory framework and significantly expand the scope of its enforcement activities against all businesses offering unapproved and unproven” so-called stem-cell treatment.

The FDA, around 2017, recognized that care involving “regenerative” or “stem cell” therapies was taking off, especially as rigorous researchers with bona fide credentials were investing serious resources, including billions of dollars from funders like the state of California, in hopes of finding important ways to treat many different types of conditions in innovative ways.

While the serious part of medical science has been slow to find or to claim advances in the field, that has not stopped swift and unsupported claims from being made about “stem cells” and “regenerative” treatment. The FDA said it legally needed to take the time for thoughtful regulation over a burgeoning and potentially important area, explaining the years of delay now in agency oversight — a postponement extended by the coronavirus pandemic.

With agency punting on a crackdown, kids keep vaping

The agency also has hemmed and hawed on oversight of e-cigarettes and vaping, recently postponing a court-ordered reckoning for major makers of popular, non-combustion nicotine delivery devices, notably the market-leading product pushed by the San Francisco-based company Juul.

After seeing how its lax regulation of e-cigarettes led to an explosion of the devices’ use by the young, and, as well as by older users who may be trying to unhook themselves from tobacco cigarettes, the FDA cracked down on vaping and its related products. The agency has ordered that the devices may be sold to adults only and it has banned sweet and fruity flavors that studies show lure young people to vape.

These measures — and the pandemic — have led to declines in e-cigarette use by young folks, federal researchers have found, with the New York Times reporting:

“This year, 11.3% of high school students reported that they currently vape — down from 19.6% in 2020 and strikingly lower than the 27.5% reported in 2019, according to a report of the survey issued Thursday by the Centers for Disease Control and Prevention. Even with the drop, the survey found that more than 2 million high school and middle school students were currently using e-cigarettes. And because the declines came during the pandemic, some public health experts questioned whether the data really signaled a change in youth vaping trends over the long term.”

The CDC research also may raise further questions about FDA oversight in this area, as the agency has zeroed in on Juul and other companies that once dominated the vaping market with replaceable “pod” systems for flavored, nicotine-rich vapes. The agency has said much less about targeting the now measurable “surge in sales of disposables and in popularity among disposable brands, notably Puff Bars,” the newspaper reported.

The FDA, by Sept. 9, was supposed to have made big decisions about the fate and future of e-cigarettes and vaping. Instead, agency officials punted, acting against millions of applications submitted to it — including several million put in by one vendor alone — and telling makers and sellers their products no longer could be sold. The agency, however, said it needed more time to consider what to do about Juul and other market leaders. It has not clarified how it will enforce its ban against the makers and sellers whose applications it rejected. Anti-tobacco and health advocacy groups are up in arms over the FDA punting on a major health concern.

In my practice, I see not only the harms that patients suffer while seeking medical services but also their struggles to access and afford safe, effective, and excellent medical care. This has become an ordeal due to the soaring complexity, uncertainty, and costs of treatments and prescription medications, too many of which turn out to be dangerous drugs.

The U.S. health care system has become so big, difficult, and daunting that ordinary folks need all the help they can get in wrangling with it, including knowing they have a top-notch, well-functioning federal agency protecting their prescription drugs, medical devices, and what they eat and drink every day.

We have much work to do to rein in the excesses of Big Tobacco with e-cigarettes, vaping, and smoking, as well as the unsupported claims by those offering “regenerative” or “stem cell” treatment. No, the federal government should not impede innovation. But it also can’t roll over for private enterprises eager to profit off the public’s lack of information and careful consideration of what may pose risks to our individual and collective health. Enough, already, of the FDA playing Mr. Nice Guy. It’s time to step up and protect taxpayers from harms.

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