ֱ

Rare Vaccine Death; Vape Loophole Exploited; No Paxlovid for the Imprisoned

— This past week in healthcare investigations

MedpageToday
INVESTIGATIVE ROUNDUP over an image of two people looking at computer screens.

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

Rare Vaccine Death

After Monica Melkonian died from a rare side effect of the Johnson & Johnson vaccine in April 2021, her husband finally shared .

Melkonian died from the blood clotting disorder dubbed vaccine-induced immune thrombotic thrombocytopenia (VITT), or thrombosis with thrombocytopenia (TTS), which killed 9 people in the U.S. after J&J had distributed 14 million doses -- amounting to a fatality rate of 0.00006%.

Though KHN reported that her husband Stan Thomas remains firmly pro-vaccine, he doesn't want his wife's death to be in vain.

"They're not taking time to explain the acceptable risk," Thomas said of health officials. "They're not taking time to communicate what shots are good for what age groups."

Had his wife known that women ages 30 to 49 were at a slightly higher risk for the side effect, she might have thought twice. She was 52 years old.

Still, Thomas said, "When it's 8 million doses and two people are going to die from it, who thinks it's going to be you?" The side effect causes the immune system to attack platelets needed for clotting. Melkonian suffered extensive brain bleeding, and ultimately couldn't be saved.

Melkonian and Thomas both had jobs related to the pandemic, and had discussed which vaccine to get frequently before Melkonian settled on the then one-and-done Johnson & Johnson shot. Thomas still went to get vaccinated after her death, despite his grief.

Only one person in J&J clinical trials experienced the same side effect, and survived. Though J&J's vaccine is still on the market, Melkonian's case contributed to the CDC's decision to recommend only the Moderna and Pfizer vaccines.

Vaping's Dirty New Secret

Vaping companies are exploiting a loophole in the FDA's regulatory crackdown against vaping products by using "synthetic" nicotine in disposable vaping products, reported.

Last year, the FDA banned flavored nicotine products, all but eliminating the use of candy flavors that appeal to kids and teens, like vanilla, sour apple, and cotton candy. Juul gave up every flavor except mint and tobacco, casting its product as a tool to help adults stop smoking.

But dozens of new products poured into the space left by Juul, advertising themselves as "tobacco-free" because of their use of synthetic nicotine not derived from plants. This allows them to evade FDA oversight. They now make up 20% of vape shop sales, according to ECigIntelligence, and grew by 290% between 2020 and 2021.

Meredith Berkman, a founder of the organization Parents Against Vaping E-Cigs, told the Times, "These companies like Puff Bar and others are deliberately driving their trucks of poison through this huge loophole." Cartridge and pod-based products have nearly disappeared, only to be replaced by disposable products that resemble Juul, the FDA's main focus, less.

Lawmakers, the Times reported, are attempting to change the regulatory language in an omnibus budget bill to close the loophole, but it's like playing a game of whack-a-mole as more companies pop up. The barriers to entering the vape market are relatively low, Samantha Shusterman from the Massachusetts attorney general's office said. "They're not following any of the laws," she said.

Paxlovid for All, Except Imprisoned

Prisons have barely requested antivirals to treat COVID-19 in their inmates, . Since Pfizer's Paxlovid was authorized in December, the federal Bureau of Prisons has only gotten 160 doses of the drug from a system responsible for the health of 150,000 people.

An HHS spokesperson told STAT that the Bureau of Prisons (BOP) has to request the doses for them to be distributed, and it hasn't done so for additional doses. They told STAT, in part, "At no time since December 2020 has [BOP's central pharmacy] been without COVID therapeutics inventory." Prison health experts also told STAT that antivirals were hard to give out on a large scale because of drug interactions and potential complications in people with liver impairment.

But early treatment with antiviral pills, rather than injections or infusions, are one of the most convenient ways prisons could treat COVID. But even as four federal prisons saw huge spikes in COVID rates at the end of January, no new doses were requested. People in prisons are three times more likely to die of COVID-19 than the rest of the population, after adjusting for age, according to a

And Pfizer's clinical trials found that its product reduced the risk of hospitalization and death from COVID-19 by 89% in high-risk patients.

Lauren Brinkley-Rubinstein, co-founder of the COVID Prison Project at the University of North Carolina-Chapel Hill, told STAT, "Wide access to this would have prevented death and prevented suffering among a marginalized population that really would have benefited."

STAT also found that even while the government distributed 600,000 doses of GlaxoSmithKline's monoclonal antibody sotrovimab to combat Omicron, the Bureau of Prisons only got 300 doses.

  • author['full_name']

    Sophie Putka is an enterprise and investigative writer for ֱ. Her work has appeared in the Wall Street Journal, Discover, Business Insider, Inverse, Cannabis Wire, and more. She joined ֱ in August of 2021.