“People look to recommending bodies to make a recommendation,” said Paul Offit, a pediatrician at Children’s Hospital of Philadelphia. “Now we’re just floating out there.”
The panel shied away from making a decision in either direction about Johnson & Johnson’s shot.
Instead, members said they wanted more data before deciding whether to resume use of the vaccine. Every state has halted administration of that particular shot at the recommendation of the CDC and the Food and Drug Administration after a rare and severe type of blood clot was identified in six women among the 7.5 million people who received the shot.
The panel agreed to reconvene within 10 days. But no date has yet been set for a follow-up meeting, leaving pharmacies and medical centers around the country with little idea of when they’ll be able to reschedule vaccination appointments for the Johnson & Johnson shot that they were forced to hastily cancel this week.
While Johnson & Johnson isn’t being used as widely as the two other coronavirus vaccines with emergency authorization from the FDA, pausing its use still has an effect on hundreds of thousands of Americans who were scheduled to receive it.
It’s unclear exactly what the panel might accomplish by waiting another 10 days.
Members said they wanted more time to collect patient data. But the instances of the blood clots are so rare — just 1 case per every 1 million shots — that some outside experts are skeptical there will be very much more material to review.
“It’s not clear to me just how much more data they’ll get,” said Walter Orenstein, former director of the CDC National Immunization Program.
Members of the panel expressed deep concern about the severity of the blood clots, which killed one of the six women and left another in critical condition. Similar clotting cases have been linked to AstraZeneca’s vaccine in Europe, causing a number of countries to place limits on the vaccine’s use.
But the panel didn’t provide a clear explanation of the risks.
As we wrote yesterday, dying of the coronavirus is still far, far more likely than developing a serious complication from the Johnson & Johnson vaccine. Medical professionals and patients need a clear understanding of the risks involved with getting vaccinated versus not getting vaccinated.
By allowing the “pause” to continue — without providing much clarity as to why — the panel could be further exacerbating a growing skepticism among the public about the vaccine.
“I just wish there was some attempt to describe relative risk,” Offit said. “Your chance of dying in a car accident is 1 in 12,000. You could argue you have a greater chance of dying in the car on the way to get the vaccine.”
The panel didn’t have to do nothing.
Members could have gone down several paths.
They could have recommended that administration of the vaccine be resumed, with doctors explaining the known risks to patients. They could have recommended limiting the vaccine to only older patients, considering all six women were under 48. Or, they could have recommended ceasing the vaccine entirely.
Norman Baylor, former director of the FDA’s Office of Vaccines Research and Review, said he expected more debate over the various options.
“I guess from my perspective I thought those options would be discussed further,” Baylor said.
Kavita Patel, a doctor and health policy researcher:
Panel members stressed the availability of other vaccines.
Far more vaccines from Pfizer and Moderna – which received FDA approval months before Johnson & Johnson – are being used around the country.
The White House says 25 million doses of both vaccines have been distributed every week and 28 million more doses will be made available this week. And Pfizer has promised to boost production by 10 percent above what it previously promised.
“We are very fortunate, because we have multiple other alternatives in the U.S. to help stop this pandemic. We have very good, well-proven alternatives where we are not seeing safety signals,” said Helen Keipp Talbot, an associate professor of medicine at Vanderbilt University and committee member. “I think that puts us in a little bit of a different position, and we can be much more cautious and thoughtful and use the old model of, ‘First, do no harm.’”
Ahh, oof and ouch
AHH: The Biden administration is beginning to undo a Trump-era ban on abortion referrals.
The Department of Health and Human Services has proposed a new rule revoking restrictions put in place by the Trump administration that prohibited providers who received federal funding from the Title X family planning program from referring patients for abortions.
After the Trump-era rules went into place, about a quarter of the nearly 4,000 providers receiving Title X funding, including Planned Parenthood, left the program. The Biden administration estimated that the Trump rule had resulted in the Title X program serving about 1.5 million fewer women each year.
“But the Biden administration stopped short of immediately suspending the Trump regulation, which went into effect in 2019. While some abortion rights advocates had sought that additional step, administration officials believe that moving carefully and deliberately will increase the odds of the proposed changes being upheld in court,” the Associated Press’s Ricardo Alonso-Zaldivar reports.
Planned Parenthood has said it would start participating in the program as soon as next year if the Biden rule is finalized.
A case on the Trump-era rule is before the Supreme Court. The Biden administration has asked the court to dismiss the case, given the change in administration position, but Republican state attorneys general are pushing for it to go before the conservative-leaning court.
OOF: Despite dire warnings, drug companies did little to build up a stockpile of antivirals in case of a pandemic.
The year 2003 should have been a wakeup call for the threat of emerging infectious diseases: two influenza strains leapt from birds to humans in Hong Kong and the Netherlands, and a coronavirus known as SARS was spreading around the world. Scientists scrambled to prepare for a pandemic, Nature’s Elie Dolgin reports.
But as the threat subsided, so did drug company interest in creating therapeutics that could target a wide range of antivirals.
The pharmaceutical industry has historically focused on just a few viruses, like HIV and Hepatitis C. When the novel coronavirus emerged in 2019, there were few strong candidates to combat it, aside from remdesivir, a drug developed to treat hepatitis C and Ebola.
Now there is renewed interest in creating an arsenal of drugs to beat the next pandemic. The National Institutes of Health said that it will a program to develop therapeutics against coronavirus and other viruses with pandemic potential, while a coalition of more than 20 life-sciences companies and venture-capital firms plans to launch a side project aimed at developing antivirals that can combat a broad spectrum of viruses.
OUCH: Drug overdose deaths have surged during the pandemic.
More than 87,000 Americans died of drug overdoses in the 12-month period that ended in September, according to preliminary data from the CDC. The numbers represent a 29 percent rise in overdose deaths compared to the prior year.
“And unlike in the early years of the opioid epidemic, when deaths were largely among white Americans in rural and suburban areas, the current crisis is affecting Black Americans disproportionately,” she writes.
The economic stimulus package Congress passed last month includes $1.5 billion for the prevention and treatment of substance use disorders. The Biden administration also seems more open to harm-reduction strategies aimed at making drug use less deadly. It announced last week that federal funding can now be used for rapid fentanyl test strips, which can detect whether fentanyl has been mixed into drugs.
On the Hill
The ranking Republican on the House Ways and Means Committee will retire.
Rep. Kevin Brady (R-Tex.) announced that he will not seek reelection after he finished serving his current term in Congress. Brady was first elected to the House in 1996 and has become a powerful player within the Republican caucus, the Texas Tribune’s Abby Livingston reports.
Because of party-imposed term limits, Brady would not have been able to remain in his top role on the influential House Ways and Means Committee if he remained in office. The committee, which legislates tax law, plays a key role in shaping health policy.
An auspicious vaccine rollout
Bhutan administered vaccines to 93 percent of its adult population in two weeks.
“For months, Bhutan sat on hundreds of thousands of doses of AstraZeneca’s coronavirus vaccine, waiting for the stars to align,” The Post’s Antonia Noori Farzan reports. “Despite receiving a supply of vaccines in January, the small Himalayan kingdom didn’t begin immunizing its population until March 27, a date that was selected through astrological consultations with Buddhist monks.”
But once the date arrived, the country made up for lost time. Like many other countries leading the vaccine race, the country of fewer than 1 million people had an advantage because of its small size.
Officials are now prevailing on the few remaining holdouts to get their shots, noting that King Jigme Khesar Namgyel Wangchuck has indicated that he will not get vaccinated until everyone else in the country does.
“All of us must come forward, so that we make way for His Majesty to receive the vaccine as soon as possible,” said a statement from Health Minister Dasho Dechen Wangmo. “It is an opportunity to serve the aspiration of our King.”
Elsewhere in health care
A new study pits magic mushrooms against a common antidepressant.
The first head-to-head comparison of psilocybin, the active ingredient in magic mushrooms, and a commonly prescribed antidepressant found that the psychedelic reduces depression as well as escitalopram, an antidepressant known by the brand name Lexapro.
“[R]esearchers lauded the study authors for paving new ground with more rigorous research into psilocybin — a sizable feat for a stigmatized and in many places illegal drug,” Stat News’s Erin Browdin reports. “But they also criticized the decision to make a single, basic depression questionnaire the study’s primary outcome, given that the researchers also performed a number of other assessments of well-being that appeared to give psilocybin an edge.”
Scientists at the Center for Psychedelic Research at Imperial College London found no statistically significant difference in the depression scores of patients who received the psilocybin and those who received Lexapro. Secondary measures — for instance, of social or work functionality — appeared to give psilocybin the edge but did not include the detailed statistical analysis necessary to draw concrete conclusions.
The study is part of a renewed wave of research into the possible therapeutic benefits of psychedelics. In November 2020, Oregon became the first state to legalize psilocybin for therapeutic use. Several cities, including D.C., have decriminalized psilocybin.
Sugar rush
Surgeon General Vivek Murthy’s 4-year-old son crashed his interview on CBS News:
