Breaking News

Watchdog sues genetic testing company, a medical device offers a chance to avoid amputation, & FDA calls for therapies to treat meth and cocaine addiction

October 5, 2023
Reporter, Morning Rounds Writer
Good morning. Today's news covers a lawsuit alleging a genetic-testing company oversold some tests, a look at a device that might help prevent certain limb amputations, and what's happening to those white Covid vaccine cards.

legal

Genetic testing company sued over claims about its fibromyalgia test

A consumer watchdog filed a lawsuit against EpicGenetics yesterday, alleging the diagnostic company made false and misleading claims in marketing its blood tests for fibromyalgia and other diseases. The Center for Science in the Public Interest focused its suit on two blood tests for fibromyalgia and other diseases — the FM/a Test and the 100Sure Test — which the company describes with nearly identical language. The nonprofit says the two tests are not nearly as accurate as their maker claims they are, and don't distinguish between fibromyalgia and other diseases with similar symptoms such as rheumatoid arthritis and lupus.

The suit cites a STAT investigation of EpicGenetics from October 2021 showing that EpicGenetics was using an aborted clinical trial at Massachusetts General Hospital to sell an unproven diagnostic, which can cost $1,080 without insurance. This isn't the first time that watchdogs sounded the alarm about the company's work. STAT's Eric Boodman has more.


addiction

FDA wants drug manufacturers to come up with treatments for meth and cocaine addiction

Overshadowed by the opioid epidemic, there is another overdose crisis from another drug class: stimulants. A growing share of drug deaths are now attributed to a combination of opioids and stimulants, or stimulants alone. There's no medication now approved to treat addition to methamphetamine or cocaine, but the FDA wants to fill that gap. The agency issued draft guidance yesterday to encourage drug manufacturers to come up with new treatments for addition to meth, cocaine, or prescription stimulants.

Certain medications, the agency said, could be eligible for expedited approval pathways given the urgency of the crisis and the lack of other treatments. Few such drugs are under development and only a handful of trials have been carried out to help people cut down on or abstain from stimulants. STAT's Lev Facher has more, including FDA's openness to trial endpoints other than complete abstinence from drug use, as measured by a urine drug test.


infectious disease

FDA experts to weigh dropping an extinct component from flu shots. No brainer, right? Maybe not

Late last week the WHO recommended removing a component from some flu vaccines because the viruses it protected against appear to have gone extinct. Today, the FDA's expert vaccines panel, the Vaccines and Related Biological Products Advisory Committee, will vote on whether it makes sense to remove the influenza B/Yamagata component from quadrivalent (four-in-one) shots sold in the U.S.

On some levels, this is a no-brainer, STAT's Helen Branswell tells us. This lineage of flu B viruses was last spotted in late March 2020, when the Covid-19 pandemic was taking off globally. Flu labs around the world have been searching for it in the intervening years, but it appears not to have survived in the era when mask wearing, social distancing, and substantially reduced global travel severely constricted transmission of non-Covid respiratory viruses.

But there may be regulatory challenges to getting this done. Many of the trivalent (three-in-one) flu licenses held by manufacturers who sell to the U.S. may have lapsed in the years since quadrivalents came on the market.

If the suggestion is adopted, U.S. flu shots would likely revert at some point to protecting against two types of influenza A — H1N1 and H3N2 — plus the remaining flu B lineage, B/Victoria viruses.



Closer Look

Hoping 'the amputation never happens': a new device turns veins into arteries

Vein-becoming-artery-with-LimFlow-crossing-stent-1Courtesy LimFlow

Cynthia Elford was in danger of losing her right leg after vasculitis, a genetic disease that blocks blood flow to the legs, had already taken her left one. Because traditional surgical methods had failed to save her left leg, an interventional cardiologist offered her a new treatment from a company called LimFlow. "I didn't want my leg off because I don't know that I would have been able, emotionally, to get through it," Elford told STAT's Lizzy Lawrence. 

The device, which the FDA approved last month, uses an old surgical technique: a stent connects the blocked artery to an open vein, allowing blood to flow through and heal injuries. LimFlow lets doctors perform the surgery via a catheter inserted at the bottom of the foot. Experts caution the device will help only some people with peripheral artery disease, and it remains to be seen if patients will retain legs long-term. Read more.


pandemic

End of an era: No more CDC vaccination cards

GettyImages-1234768446Robyn Beck/AFP via Getty Images

Depending on your point of view, those ubiquitous Covid vaccine cards are on their way to becoming collector's items or headed to the recycling bin. Government-distributed Covid vaccines are no more, so the CDC has ceased printing them, the Associated Press reported yesterday. New York State had already discontinued its "NYS Wallet App" on July 28 "because demand for instant access to vaccine records has subsided." Many other states offer digital records of the jabs, but CDC had also issued more than 980 million cards between late 2020, when the first vaccines rolled out, through May 10.

If you still want to document your vaccinations, you'll have to ask, just as you might for other immunizations. Some clinics, pharmacies, or health departments that administered the shots can provide those records. Every state and some cities have an immunization registry, though rules vary on how to get copies recording yours.


awards 

MacArthur genius grants honor research in reproductive health, air quality, and gene expression

The MacArthur Foundation introduced its newest Genius Grant Fellows yesterday, part of its mission encouraging people with exceptional talents to pursue their own creative, intellectual, and professional pursuits. This year's class is full of writers, scientists, artists, social scientists, humanists, teachers, and entrepreneurs. The fellowship, along with a stipend of $800,000 paid over five years, can be used to exercise their own creative instincts, advance their expertise, or pivot their careers. Fellows in the life sciences include:

  • Diana Greene Foster, a demographer and reproductive health researcher at University of California, San Francisco investigating how reproductive health care policies and access impact individuals' physical, mental, and socioeconomic well-being, as she wrote in this First Opinion.
  • Linsey Marr, an environmental engineer at Virginia Tech examining indoor and outdoor air quality and the airborne transmission of infectious bioaerosols, known for her work on influenza and Covid-19.
  • Jason Buenrosto, a cellular and molecular biologist at Harvard University developing methods and technologies that advance our understanding of the mechanisms regulating gene expression, focusing on single-cell methods he and his colleagues created.

More around STAT
Check out more exclusive coverage with a STAT+ subscription
Read premium in-depth biotech, pharma, policy, and life science coverage and analysis with all of our STAT+ articles.

What we're reading

  • How a big pharma company stalled a potentially lifesaving vaccine in pursuit of bigger profits, ProPublica
  • Exclusive: Failed biotech gives a rare peek inside the tough breaks — and tough choices — that led to its demise, STAT
  • Perspective: I try to be a body-positive doctor. It's getting harder in the age of Ozempic, NPR
  • Esketamine tops quetiapine for treatment-resistant depression in head-to-head trial, STAT
  • Just how germy are airplanes? We put one to the test, Seattle Times
  • FDA cites Fresenius Kabi for contamination problems that CDC linked to deadly sepsis cases, STAT

Thanks for reading! More tomorrow,


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