Health Highlights: March 16, 2021

Opioid Maker Purdue Pharma Files Bankruptcy Plan

Purdue Pharma has filed a bankruptcy restructuring plan that seeks to end thousands of lawsuits over the role that its painkiller Oxycontin played in the U.S. opioid epidemic.

It requires members of the Sackler family to relinquish control of the company and remakes it into a new corporation with revenue targeted exclusively at reducing the nation's opioid crisis, The New York Times reported.

There's also a pledge from the Sacklers to give $4.275 billion from their personal fortune -- $1.3 billion more than their original offer -- to states, municipalities, tribes and other plaintiffs for costs associated with the opioid epidemic.

Payments could start to different groups of lawsuit plaintiffs if the plan is approved by a majority of the company's creditors and Judge Robert Drain of federal bankruptcy court in White Plains, N.Y., the Times reported.

The largest of those groups includes state and local governments that have faced devastating costs due to the opioid epidemic. Others include: individual plaintiffs such as families whose relatives overdosed or guardians of infants born with neonatal abstinence syndrome; hospitals and insurers; and tribes.

However, it's not clear if the plan will be accepted because dozens of states and the District of Columbia have said the bankruptcy process would prevent them from direct legal action against individual members of the Sackler family whose contributions are insufficient, the Times reported.

Sweden Latest Country to Suspend Use of AstraZeneca COVID-19 Vaccine

Sweden is the latest of more than a dozen nations -- many in Europe -- that have temporarily suspended use of the Oxford-AstraZeneca COVID-19 vaccine after a small number of people developed blood clots after receiving the vaccine.

However, the company insists there is no link between the vaccine and blood clot risk, and a number of experts say suspending use of the vaccine is a disaster for Europe's already-delayed introduction of vaccines, CBS News reported.

A review of 17 million people in the U.K. and Europe who've received the vaccine found that fewer than 40 developed blood clots, which is "even lower than you'd expect to find in the general population," according to AstraZeneca.

The incidence of clotting is similar to that seen with all vaccines, including the Moderna and Pfizer vaccines currently being used in the U.S., according to CBS News.

Moderna Starts Testing COVID-19 Vaccine in Younger Children

Moderna has launched a study of its COVID-19 vaccine in children younger than 12, including babies as young as six months.

The company expects to enroll 6,750 healthy children in the United States and Canada, but Moderna spokeswoman Colleen Hussey didn't reveal how many had already been signed up or received their first shots, The New York Times reported.

In another study, Moderna is testing its vaccine in 3,000 older children, ages 12-17, and may have results by summer. But even if the results are favorable, the vaccine wouldn't be immediately available because it would have to be approved for use in children.

"There's a huge demand to find out about vaccinating kids and what it does," Dr. David Wohl, medical director of the vaccine clinic at the University of North Carolina, told the Times. He's not involved in the studies.

California Sues Country's Largest Nursing Home Chain

California is suing the largest nursing home chain in the United States for allegedly submitting false information to Medicare's nursing home ratings system.

The lawsuit against Brookdale Senior Living -- which operates multiple nursing homes in California -- was filed on Monday, The New York Times reported.

It's one of the first lawsuits to accuse a nursing home company of submitting false information to the ratings program that was introduced over a decade ago for the nation's more than 15,000 nursing homes.

The system issues stars -- 1 is the worst, 5 is the best -- to nursing homes, which they use to attract potential residents, the Times reported.

California prosecutors said that until April 2018, Brookdale won "undeserved higher star ratings" by exaggerating the number of hours that registered nurses worked.

The prosecutors said Brookdale had continued to game the statistics even after the U.S. Centers for Medicare and Medicaid Services (CMS) improved how it collected staffing data, to crack down on nursing homes' inflating their figures, the Times reported. Starting in 2018, the CMS began using payroll records to calculate nursing homes' ratings, rather than relying on nursing homes to report the amount of time nurses spent with patients. In the California lawsuit, prosecutors accused Brookdale of "falsifying its payroll-based journals."

"The chain's manipulation has allowed Brookdale to attract prospective patients and their families to its facilities by misleading them about its quality of care," the lawsuit said.

Prosecutors also accused Brookdale of illegally evicting or transferring residents so that the chain could "fill its beds with residents who will bring in more money." In one instance highlighted in the suit, prosecutors said Brookdale discharged a 78-year-old resident who suffered from heart and kidney disease without even removing his catheter, the Times reported.

The lawsuit seeks civil penalties and an injunction to prevent future unlawful conduct. Under California law, civil penalties are up to $2,500 per violation. In this case, where the violations are committed against seniors or people with disabilities, the law provides for an additional penalty of up to $2,500 per violation, the Times reported.

A Brookdale spokeswoman didn't immediately respond to a request for comment, the Times said.

Organ Transplant Recipients May Not Be Protected by One Dose of COVID Vaccine: Study

Only 17% of organ transplant recipients developed antibodies against the new coronavirus a few weeks after receiving their first dose of the Pfizer or Moderna COVID-19 vaccines, researchers report.

Previous studies have shown that the first shot of the vaccines is enough to trigger antibody production in nearly all people with a healthy immune system, the Associated Press reported.

But transplant recipients take powerful immune-suppressing drugs to prevent organ rejection, which also increases their risk of COVID-19.

Transplant recipients weren't included in clinical trials of COVID-19 vaccines, so Johns Hopkins researchers checked antibody levels a few weeks after a first vaccine shot was given to 436 people who'd received new organs in recent years, the AP reported.

Transplant recipients may have stronger antibody production after a second vaccine dose, and that's something that will be investigated, said study co-author Dr. Dorry Segev, a transplant surgeon.

The U.S. Centers for Disease Control and Prevention says fully vaccinated people can scale back some, but not all, masking and distancing precautions, but Segev said these findings show that may not apply to transplant recipients.

"From what we know, transplant patients cannot assume that they are safe after being vaccinated," and may need post-vaccination blood tests to be sure, Segev told the AP.

Of most concern, people whose transplant medications include a particular type of anti-metabolite were far less likely to respond to the shot than those who don't require that kind of drug, the team reported Monday in the Journal of the American Medical Association.

The new report is disappointing if unsurprising, because people with weak immune systems don't respond as well to other vaccines, Dr. David Mulligan, Yale University's chief of transplant surgery and immunology, told the AP.

Mulligan urged patients to check in with their transplant center for advice. Those waiting for a lifesaving organ transplant might be able to get vaccinated first. He added that some people who've already had a transplant might be good candidates to temporarily cut back on certain immune-suppressing drugs. And the immune-compromised should be sure to get both vaccine doses for maximum protection.

The American Society of Transplantation and some other transplant groups have already warned that transplant recipients may have a weak immune response to COVID-19 vaccines.

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