Dr. Eric Topol
Doctor calls out Biden admin. over Covid-19 drug
04:13 - Source: CNN
CNN  — 

The Omicron variant of the coronavirus is causing Covid-19 cases to spike, with an average of more than 747,000 new cases a day, according to the latest numbers from Johns Hopkins University. That’s almost three times the average daily cases from a year ago, when the country was going through its previous peak, and it’s putting an incredible strain on hospitals and emergency rooms.

The good news since the last peak is that the US Food and Drug Administration authorized new antiviral pills. Both Paxlovid and molnupiravir were given emergency use authorization in late December to treat mild to moderate Covid-19. They interfere (through different pathways) with the virus’ ability to replicate – and they can be taken at home, before someone becomes seriously ill.

Molnupiravir reduces the rate of hospitalizations in high-risk patients by about 30% and carries some possible side effects, but Paxlovid reduces the rate of hospitalizations by around 90% and is considered safer. In other words, Paxlovid is a bit of an antiviral superstar.

“I actually consider it the biggest advance in the pandemic since the vaccines, and the safety is part of it,” Dr. Eric Topol, executive vice president for research at Scripps Research in San Diego, told CNN Chief Medical Correspondent Dr. Sanjay Gupta. “It’s very rare to see something with this much efficacy of nearly 90% reduction of hospitalizations and deaths with no safety issue beyond placebo.”

The bad news? Supply is very limited for both but especially for Paxlovid. Patients and their doctors are struggling to find it.

Just 160,000 courses have been delivered across the country, and with more people now hospitalized with Covid-19 than at any other time during the pandemic, these pills are in short supply.

“There’s hardly any of these pill packs around,” Topol said.

Kim Kramer has heart failure, which puts her at higher risk of having a severe case of Covid-19. Throughout the pandemic, the 62-year-old from Newnan, Georgia, has been very careful to not get infected: limiting contact with the outside world, faithfully wearing a mask when out and about, and using plenty of hand sanitizer.

She’s vaccinated and boosted, but SARS-CoV-2, the virus that causes Covid-19, finally caught up with her: She tested positive on January 3.

Though her symptoms were mild – tender sinuses, scratchy throat, headache – she emailed her primary care physician, Dr. Erika Martinez-Uribe at Piedmont Newnan Hospital, to let her know.

“Because I have heart failure, I figured she should know,” Kramer said. “She emailed me back the next day and said ‘Kim, I think you would benefit from this new antiviral medication. … Would you be interested in trying it?’ ”

Kramer was given a prescription for molnupiravir, the antiviral made by Merck – not Paxlovid, the more effective drug made by Pfizer.

“Honestly, it was availability,” Martinez-Uribe said of the choice. “By luck, I was able to find one pharmacy in our entire 30-mile area here in Newnan that had the molnupiravir.”

And that’s not just the case in rural Georgia.

Plaxovid’s scarcity is a story heard across the country

Desi Kotis, an associate dean at the University of California, San Francisco School of Pharmacy and the chief pharmacy executive for UCSF Health, said UCSF was the only one out of the five University of California campuses (including Los Angeles and San Diego) to receive Paxlovid.

“UCSF only got 40 patients worth, and it was gone pretty quickly: in less than 10 days,” she said, adding that once the Paxlovid was gone, they moved on to molnupiravir.

“We are not getting the supply that’s needed,” Kotis said. “The numbers are not even near close to reasonable terms. … And there’s no rhyme or reason how the supply is being allocated.” She said UCSF isn’t due for another shipment until the last week in January.

The US Department of Health and Human Services is in charge of distribution and allocation. According to the Office of the Assistant Secretary for Preparedness and Response, antiviral pills like Paxlovid and molnupiravir are distributed based on population.

Shireesha Dhanireddy, professor of medicine at the University of Washington School of Medicine and Harborview Medical Center, said the hospital system is meeting the need of patients, but that’s only because it’s using National Institutes of Health guidance, which prioritizes treatment for those at highest risk: the immunocompromised and the elderly and unvaccinated. This last category, the unvaccinated, may not sit right with some people.

“We’re using these medications judiciously and really giving them to the people that would most benefit from these therapeutics,” Dhanireddy said. “If we opened it up to vaccinated individuals, we would not have enough therapy.” 

She said that many of the people who are seeking this therapy may not need it to recover from Covid-19, particularly if they’re vaccinated or boosted. After all, even if protection against infection has dropped off with Omicron, studies have found that vaccination remains very protective against severe disease.

Said Topol, “the availability is so limited, and more people who are unvaccinated are going to wind up in need. The supply is so darn limited, and that’s really what’s holding us back.”

Under fire for not making the Big Bet

The Biden administration has drawn criticism for not doing for oral therapies like Paxlovid what it did for vaccines: that is, placing a big bet on them before the results were in.

“And so the [significant] orders were only placed after the trials showed the benefit,” Topol said. “That basically was part of that vaccine-only strategy: that the idea was, the government thought that vaccines were going to do the job and didn’t put a bet on the pills. It was actually worth the bet at the time, especially when you look backward. I think the whole idea is, you pull out all the stops.”

White House Covid-19 Response Coordinator Jeff Zients said during a briefing on Wednesday that the administration and Pfizer agreed last spring to work together to cut red tape and source key supplies, which “dramatically” accelerated the clinical trial process by about seven months, as well as the manufacturing timeline. Zients said this allowed the first Paxlovid pills to be shipped in December, months ahead of schedule.

Zients also pointed out that the administration acted “early and aggressively” to secure more Paxlovid. Indeed, last week, President Biden announced that his Covid-19 response team doubled the US order of the antiviral, from 10 million to 20 million treatment courses to be delivered in the months ahead.

According to an analysis by CNN, those 20 million treatment courses could eventually prevent more than a million hospitalizations, based on Paxlovid’s high efficacy. But given the time it takes to scale up production, the majority of those doses won’t arrive for months.

In addition to patients losing out on life-saving treatments, Topol said, Paxlovid’s potential for reducing transmission – which would avert myriad disruptions such as medical professional shortages, school closings and flight cancellations – has also been lost.

“If we started to say, ‘Look, health care workers, we need you back to work, and we know that this is safe and that it suppresses the viral load by more than 10-fold quickly,’ it would be a way to keep our health care work force taking care of patients, where we need them,” Topol explained. “We’re seeing a virus takedown, and a virus-induced lockdown, especially in our health facilities. And here we have a potential remedy. But we don’t have it.”

What’s next?

Experts predict that the situation will get worse before it gets better as the number of people infected continues to go up.

Dr. Anthony Fauci, Biden’s chief medical adviser, said Tuesday that the Omicron variant, with its efficiency of transmissibility, will ultimately find just about everybody. Aside from record daily case counts, there are 145,982 people now hospitalized with Covid-19, according to HHS – more than at any other time during the pandemic.

More people getting infected, albeit with a milder variant, translates simply into more people being hospitalized, placing an even greater burden on an already-stretched health care system and all the workers who keep it running.

In light of those dire predictions, those 20 million doses can’t come soon enough.

In Minneapolis, 26-year-old Clay Byington tested positive for Covid-19 after gathering with friends and family over the holidays. Despite being vaccinated, he has two risk factors for a more severe outcome: He has a high BMI, and he’s Native American.

“I didn’t get close to having to gasp for air, but when the coughs came, it definitely sent the aches down the body, through the neck,” Byington said. He read many accounts of young and even vaccinated people getting very sick, very quickly. “And I know that me being overweight just kind of worried me.

“Once you’re sick and you’re feeling the symptoms and you’re kind of like, ‘Oh, my goodness, is this going to get worse?’ ”

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His doctor was able to prescribe Paxlovid. Byington said it helped ease his fear and anxiety, and he had an easy, uneventful recovery.

As for Kramer, she started her course of molnupiravir the evening it was prescribed, and within 24 hours, all her symptoms “kind of faded away” with no side effects.

Her doctor, Martinez-Uribe, is very glad about Kramer’s outcome. But she said she’s concerned about the future.

“We continue to see a huge spike in the hospital system, and it is overwhelming our system to an incredible degree. The Omicron variant is very infectious and rampant at the moment,” she wrote in a later email. “I believe I can speak for my colleagues in that we are beleaguered, and strained in dealing with staffing shortages and the pandemic overall. This makes the work harder.”

Like doctors and public health experts everywhere, she urges everyone who can to get vaccinated and boosted.

“I hope we can vaccinate the world to prevent more variants from arising,” she said. “This should really be our collective global goal. We are going to be chasing our tails otherwise.”