Health Highlights: June 3, 2021

NFL Scraps Race-Based Evaluations of Dementia Claims by Former Players

A controversial race-based method of evaluating dementia claims by former NFL players will be scrapped, the league says.

The dementia claims of Black former players in the roughly $1 billion concussion settlement between the league and 20,000 former players were being measured differently from white players, The New York Times reported. The new policy could lead to reassessment of hundreds of previously denied cases.

Payments to former players can be worth hundreds of thousands of dollars.

Several months ago, a federal judge overseeing the settlement ordered the league and lawyers representing former players covered by the agreement to review the use of separate standards for evaluating dementia in white and Black players.

In August, two retired Black players launched legal action against the seven-year-old settlement, accusing the NFL of "explicitly and deliberately" discriminating against Black players by using separate race-based measures to determine their eligibility for dementia-related payouts, the Times reported.

The suits were dismissed, but they triggered close scrutiny of how the NFL made decisions about the payments.


FDA Warns Against Use of an Implantable Heart Device

Medtronic's Heartware Ventricular Assist Device (HVAD) system should no longer be implanted into end-stage heart failure patients due to an increased risk of neurological problems and death, the U.S. Food and Drug Administration says.

The agency also said there have been complaints that the internal pump may delay or fail to restart.

Medtronic has halted the distribution and sale of the HVAD system and issued a notification letter telling doctors to stop new implants of the device.

The company has received over 100 complaints involving delay or failure to restart the HVAD pump, including reports of 14 patient deaths and 13 cases where removal of the device was necessary.

The FDA said doctors should follow the instructions provided in the notification letter, including: stopping new implants; using an alternative, such as the Abbott Heartmate 3 Left Ventricular Assist System; and advising patients who have the Medtronic system to continue normal use of device components and to contact the company for replacement items, such as controllers, batteries, AC/DC adapters and carrying case.

Medtronic's notification letter also says doctors should inform patients that elective device removal is not recommended, and decisions about removing the HVAD pump should be made on a case-by-case basis, with careful consideration of the patient's clinical condition and surgical risks, the FDA said.

About 2,000 patients in the U.S. and 4,000 worldwide have the HVAD system, according to Medtronic. The system was approved for use in the U.S. in November 2012. Medtronic recalled a subset of the HVAD pumps in December 2020.

Salmonella Outbreak Linked to Raw Frozen Breaded Chicken Products: CDC

A salmonella outbreak that appears to be linked to frozen breaded chicken products has sickened 17 people in six states, the U.S. Centers for Disease Control and Prevention said Wednesday.

Eight people have been hospitalized, but no deaths have been reported

The CDC said raw frozen breaded stuffed chicken products may look cooked because they might be breaded or browned, and urged consumers to handle and cook these products safely before eating them.

Carefully read the labels on these products, follow cooking instructions exactly as they are written, always use an oven and use a food thermometer to check that the products are cooked to an internal temperature of 165 degrees Fahrenheit, the CDC advised.

Never use a microwave or air fryer to cook these products. Wash your hands and any surfaces used to prepare the products.

Most people infected with salmonella develop diarrhea, fever, and stomach cramps anywhere from 6 hours to 6 days after being exposed to the bacteria.The illness usually lasts 4 to 7 days, and most people recover without treatment, the CDC said.

In some people, the illness may be so severe that the patient is hospitalized.Children younger than 5, adults 65 and older, and people with weakened immune systems are more likely to have severe illness, the CDC noted.


New Drug For Vaginal Yeast Infections Approved by FDA

A new and expensive anti-fungal drug to treat vaginal yeast infections was approved by the U.S. Food and Drug Administration this week, but critics say it's not needed.

Brexafemme (ibrexafungerp)is a one-day oral treatment and the first of a new class of triterpenoid anti-fungal drugs. The drug kills candida, the yeast that causes a vaginal infection, according to drug maker SCYNEXIS, The New York Times reported.

The current standard oral drug, Diflucan (fluconazole), inhibits the growth of yeast, but does not kill it.

"This approval for a new anti-fungal drug provides an additional treatment option for patients with vulvovaginal candidiasis, or vaginal or vulvar yeast infections, and represents another step forward in the FDA's overall efforts to ensure safe and effective antifungal drugs are available to patients," Dr. Sumathi Nambiar, director of the F.D.A.'s division of anti-infectives, said in a statement.

But price is an issue.

The estimated list price for a four-tablet Brexafemme treatment will range from $350 to $450, said Dr. David Angulo, chief medical officer at SCYNEXIS. The average retail price of fluconazole on GoodRx is $29.81, the Times reported.

It's not clear that the new drug is even needed, added Dr. Denise Jamieson, chair of gynecology and obstetrics at Emory University School of Medicine in Atlanta.

"I don't see a tremendous amount of resistance," she told the Times. "I can't really comment on whether this is going to be a large addition or not. It's always helpful to have another option, and then you have to consider things like cost and tolerability."

The FDA's approval of the new drug was panned by Dr. Michael Carome, director of Public Citizen's Health Research Group.

"This drug is not necessary and few women should need it," Carome told the Times. "Fluconazole is available at very low cost and in general is very effective. The cost of this is just outrageous."

One clinical trial used to support the FDA approval showed 50 percent efficacy at 10 days after treatment, and 60 percent 25 days after treatment, the Times reported, and another trial showed 64 percent efficacy at day 10 and 73 percent at day 25.


Guns and Trucks Among Prizes in West Virginia COVID-19 Vaccine Lottery

Guns, trucks, cash and scholarships will be offered as prizes in weekly lotteries to encourage West Virginia residents to get COVID-19 shots, state officials announced.

They said that beginning June 20, the state will hand out $1 million and other prizes weekly until Aug. 4, when two grand prizes of nearly $1.6 million and $580,000 will be announced, CBS News reported.

Along with cash prizes, there will be two new custom-outfitted trucks, 25 weekend visits to local state parks, five lifetime hunting and fishing licenses, five custom hunting rifles and five custom hunting shotguns, and two full four-year scholarships to any institution in West Virginia for vaccinated 12- to 25-year-olds.

"The prizes to me are secondary to the fact that we're trying to save your life," West Virginia Governor Jim Justice said Tuesday at a news conference, CBS News reported.

"All of our hospitalizations, all our our ICU units, all of our deaths, for the most part, are all people that have not been vaccinated. I don't know how it gets any simpler than that," he said.

"These vaccinations are amazingly safe and they'll protect you -- I don't know how in the world people are sitting on the sidelines still saying, 'No, I'm not going to do one, I'm not going to do it'" Justice added. "Then they go off and they travel, and then there is absolutely what I would say is a lot of 'sad singing and slow walking,' and that's what goes on at a funeral."

Acknowledging that some might question the practice of essentially bribing people to get immunized against a deadly virus, Justice said he will do whatever works.

"If you step back and think, now why in the world would you have to give away something to get somebody vaccinated. Unfortunately it's the way of the world in a lot of situations," Justice said. "The faster we get them across the finish line, the more lives we save."

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