‘Shkreli Awards’ Shame Healthcare Profiteers

Lown Institute berates greedy pricing, ethical lapses, wallet biopsies, and avoidable shortages.

Greedy corporations, uncaring hospitals, individual miscreants, and a task force led by Jared Kushner were dinged Tuesday in the Lown Institute‘s annual Shkreli awards, a list of the top 10 worst offenders for 2020.

Named after Martin Shkreli, the entrepreneur who unapologetically raised the price of an anti-parasitic drug by a factor of 56 in 2015 (now serving a federal prison term for unrelated crimes), the list of shame calls out what Vikas Saini, the institute’s CEO, called “pandemic profiteers.” (Lown bills itself as “a nonpartisan think tank advocating bold ideas for a just and caring system for health.”)

Topping the list was the federal government itself and Jared Kushner, President’s Trump’s son-in-law, who led a personal protective equipment (PPE) procurement task force. The effort, called Project Airbridge, was to “airlift PPE from overseas and bring it to the U.S. quickly,” which it did.

“But rather than distribute the PPE to the states, FEMA gave these supplies to six private medical supply companies to sell to the highest bidder, creating a bidding war among the states,” Saini said. Though these supplies were supposed to go to designated pandemic hotspots, “no officials from the 10 hardest hit counties” said they received PPE from Project Airbridge. In fact, federal agencies outbid states or seized supplies that states had purchased, “making it much harder and more expensive” for states to get supplies, he said.

Number two on the institute’s list: vaccine maker Moderna, which received nearly $1 billion in federal funds to develop its mRNA COVID-19 preventive. It set a price of between $32 and $37 per dose, more than the U.S. agreed to pay for other COVID vaccines. “Although the U.S. has placed an order for $1.5 billion worth of doses at a discount, a price of $15 per dose, given the upfront investment by the U.S. government, we are essentially paying for the vaccine twice,” said Lown Institute Senior Vice President Shannon Brownlee.

Webcast panelist Don Berwick, MD, former acting administrator for the Centers for Medicare & Medicaid Services, noted that a lot of work went into producing the vaccine at an impressive pace, “and if there’s not an immune breakout, we’re going to be very grateful that this happened.” But, he added, “I mean, how much money is enough? Maybe there needs to be some real sense of discipline and public spirit here that goes way beyond what any of these companies are doing.”

In third place: four California hospital systems that refused to take COVID-19 patients or delayed transfers from hospitals that were out of beds. Wall Street Journal investigation found that these refusals or delays were based on the patients’ ability to pay; many were on Medicaid or were uninsured.

“In the midst of such a pandemic, to continue that sort of behavior is mind boggling,” said Saini. “This is more than the proverbial wallet biopsy.”

The remaining seven offenders:

4. Poor nursing homes decisions, especially one by Soldiers’ Home for Veterans in western Massachusetts, that worsened an already terrible situation. At Soldiers’ Home, management decided to combine the COVID-19 unit with a dementia unit because they were low on staff, said Brownlee. That allowed the virus to spread rapidly, killing 76 residents and staff as of November. Roughly one-third of all COVID-19 deaths in the U.S. have been in long-term care facilities.

5. Pharmaceutical giants AstraZeneca, GlaxoSmithKline, Pfizer, and Johnson & Johnson, which refused to share intellectual property on COVID-19, instead deciding to “compete for their profits instead,” Saini said. The envisioned technology access pool would have made participants’ discoveries openly available “to more easily develop and distribute coronavirus treatments, vaccines, and diagnostics.”

Saini added that he was was most struck by such an attitude of “historical blindness or tone deafness” at a time when the pandemic is roiling every single country.

Berwick asked rhetorically, “What would it be like if we were a world in which a company like Pfizer or Moderna, or the next company that develops a really great breakthrough, says on behalf of the well-being of the human race, we will make this intellectual property available to anyone who wants it?”

6. Elizabeth Nabel, MD, CEO of Brigham and Women’s Hospital in Boston, because she defended high drug prices as a necessity for innovation in an op-ed, without disclosing that she sat on Moderna’s board. In that capacity, she received $487,500 in stock options and other payments in 2019. The value of those options quadrupled on the news of Moderna’s successful vaccine. She sold $8.5 million worth of stock last year, after its value nearly quadrupled. She resigned from Moderna’s board in July and, it was announced Tuesday, is leaving her CEO position to join a biotech company founded by her husband.

7. Hospitals that punished clinicians for “scaring the public,” suspending or firing them, because they “insisted on wearing N95 masks and other protective equipment in the hospital,” said Saini. Hospitals also fired or threatened to fire clinicians for speaking out on COVID-19 safety issues, such as the lack of PPE and long test turnaround times.

Webcast panelist Mona Hanna-Attisha, MD, the Flint, Michigan, pediatrician who exposed the city’s water contamination, said that healthcare workers “have really been abandoned in this administration” and that the federal Occupational Safety and Health Administration “has pretty much fallen asleep at the wheel.” She added that workers in many industries such as meatpacking and poultry processing “have suffered tremendously from not having the protections or regulations in place to protect [them].”

8. Connecticut internist Steven Murphy, MD, who ran COVID-19 testing sites for several towns, but conducted allegedly unnecessary add-ons such as screening for 20 other respiratory pathogens. He also charged insurers $480 to provide results over the phone, leading to total bills of up to $2,000 per person.

“As far as I know, having an MD is not a license to steal, and this guy seemed to think that it was,” said Brownlee.

9. Those “pandemic profiteers” who hawked fake and potentially harmful COVID-19 cures. Among them: televangelist Jim Bakker sold “Silver Solution,” containing colloidal silver, and the “MyPillow Guy,” Mike Lindell, for his boostering for oleandrin.

Colloidal silver has no known health benefits and can cause seizures and organ damage. Oleandrin is a biological extract from the oleander plant and known for its toxicity and ingesting it can be deadly,” said Saini.

Others named by the Lown Institute include Jennings Ryan Staley, MD — now under indictment — who ran the “Skinny Beach Med Spa” in San Diego which sold so-called COVID treatment packs containing hydroxychloroquine, antibiotics, Xanax, and Viagra, all for $4,000.

Berwick commented that such schemes indicate a crisis of confidence in science, adding that without facts and science to guide care, “patients get hurt, costs rise without any benefit, and confusion reigns, and COVID has made that worse right now.”

Brownlee mentioned the “huge play” that hydroxychloroquine received and the FDA’s recent record as examples of why confidence in science has eroded.

10. Two private equity-owned companies that provide physician staffing for hospitalsTeam Health and Envision, that cut doctors’ pay during the first COVID-19 wave while simultaneously spending millions on political ads to protect surprise billing practices. And the same companies also received millions in COVID relief funds under the CARES Act.

Berwick said surprise billing by itself should receive a deputy Shkreli award, “as out-of-pocket costs to patients have risen dramatically and even worse during the COVID pandemic… and Congress has failed to act. It’s time to fix this one.”

Large Numbers Of Health Care And Frontline Workers Are Refusing Covid-19 Vaccine

Large Numbers Of Health Care And Frontline Workers Are Refusing Covid-19  Vaccine

TOPLINE

Despite the Covid-19 death count in the United States rapidly accelerating, a startlingly high percentage of health care professionals and frontline workers throughout the country—who have been prioritized as early receipts of the coronavirus vaccine—are reportedly hesitant or outright refusing to take it, despite clear scientific evidence that the vaccines are safe and effective.

KEY FACTS

Earlier this week, Ohio Gov. Mike DeWine said he was “troubled” by the relatively low numbers of nursing home workers who have elected to take the vaccine, with DeWine stating that approximately 60% of nursing home staff declined the shot. 

Dr. Joseph Varon, chief of critical care at Houston’s United Memorial Medical Center, told NPR in December more than half of the nurses in his unit informed him they would not get the vaccine.

Roughly 55 percent of surveyed New York Fire Department firefighters said they would not get the coronavirus vaccine, the Firefighters Association president said last month.

The Los Angeles Times reported Thursday that hospital and public officials in Riverside, Calif., have been forced to figure out how best to allocate unused doses after an estimated 50% of frontline workers in the county refused the vaccine.

Fewer than half of the hospital workers at St. Elizabeth Community Hospital in Tehama County, Calif., were willing to be vaccinated, and around 20% to 40% of L.A. County’s frontline workers have reportedly declined an opportunity to take the vaccine. 

Dr. Nikhila Juvvadi, the chief clinical officer at Chicago’s Loretto Hospital, said that a survey was administered in December, and 40% of the hospital staff said they would not get vaccinated.

KEY BACKGROUND:

recent survey by the Kaiser Family Foundation found that 29% of healthcare workers were hesitant to receive the vaccine, citing concerns related to potential side effects and a lack of faith in the government to ensure the vaccines were safe. Frontline workers in the United States are disproportionately Black and Hispanic. The pandemic has taken an “outsized toll” on this segment of the population, which has reportedly accounted for roughly 65% of fatalities in cases in which there are race and ethnicity data. A study published by the journal The Lancet over the summer found “healthcare workers of color were more than twice as likely as their white counterparts” to test positive for the coronavirus. According to a Pew Research Center poll published in December, vaccine skepticism is highest among Black Americans, as less than 43% said they would definitely/probably get a Covid-19 vaccine. Dr. Juvvadi told NPR that “there’s no transparency between pharmaceutical companies or research companies — or the government sometimes — on how many people from” Black and Latino communities were involved in the research of the vaccine. Dr. Varon said that “the fact that [President] Trump is in charge of accelerating the process bothers” those individuals who refuse to be immunized, adding “they all think it’s meant to harm specific sectors of the population.” In an op-ed published in the New York Times earlier this week, emergency physicians Benjamin Thomas and Monique Smith wrote that “vaccine reluctance is a direct consequence of the medical system’s mistreatment of Black people” and past atrocities, such as the unethical surgeries performed by J. Marion Sims and the Tuskegee Syphilis Study, best exemplifies “the culture of medical exploitation, abuse and neglect of Black Americans.” 

CRUCIAL QUOTE: 

“I’ve heard Tuskegee more times than I can count in the past month — and, you know, it’s a valid, valid concern,” said Dr. Juvvadi.

WHAT TO WATCH FOR:

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in a Friday interview that it’s “quite possible” the Covid-19 vaccine could be required for international travel and to attend school at some point in the future.

BIG NUMBER:

40 million. In early December, government officials said they planned to have 40 million doses available by the end of 2020, which would be enough to fully vaccinate 20 million Americans. However, according to the Centers for Disease Control and Prevention, less than 3 million Americans have received the first dose of the vaccine, with 14 million doses have been distributed.

The Health 202: When will 2021 feel normal again? Here’s what eight experts predict.

We won't be back to normal from coronavirus pandemic until Fall 2021 -  Business Insider

Around half a million Americans are now getting a coronavirus vaccine shot every day. But that pace must accelerate considerably if the United States has any hope of quashing the virus in 2021.

Public health experts differ on how quickly that might happen  and when things might start to feel “normal” again around the country.

To inaugurate our first Health 202 of the new year, we asked eight experts for their predictions.

After all, we all want to know when we can go to concerts and ballgames again. Or even just go to the office. (Let’s start small.)

We asked two questions. The first has to do with when the United States will reach “herd immunity” — the point at which enough people are immune to a virus, either by recovering from it or getting vaccinated against it. Herd immunity generally kicks in when about 70 percent of people are immune, although experts differ on the precise threshold.

To reach herd immunity with the coronavirus, approximately 230 million Americans would need the vaccine. As of yesterday, just 4 million had gotten the first of two shots. Daily immunizations have increased considerably over the past few days, with about 500,000 people getting the shot each day, but experts say that number needs to at least double and ideally quadruple.

We also asked these experts when they personally expect their lives to return to normal.

Here are their responses, edited lightly for clarity and brevity.

When will enough Americans be vaccinated for the U.S. to reach herd immunity, based on how things look right now?

Carlos del Rio, professor of medicine and global health at Emory University

“At the current pace it will take a really long time. … I think if we can get our act together and start vaccinating 1 million people a day like President-elect Biden is promising, then we can get to 260 million people getting at least one dose … more or less or by late August or early September. If we really scale up and get to 3 million per day, then we can get to 260 million people in [less than] 100 days or three months. Can we do it? Yes! But it will require coordination, leadership and funding. So, as you see, my answer is: It depends.”

Eric Topol, director and founder of Scripps Research Translational Institute:

I think by July, if we get 2 to 3 million people vaccinated per day, and even sooner, if we have a rapid neutralization antibody assay to be able to defer those who have had a prior infection and mounted a durable immune response. Yes, that is optimistic, but it can be done.”

Jay Bhattacharya, professor of medicine at Stanford University:

“There is a lot of disagreement in the scientific literature about the herd immunity threshold, which is certain to vary from place to place. I don’t think anyone responsible would confidently say what it is, and would never put forward a single number for the U.S. as a whole. Rather, the key question is how rapidly we inoculate people who have a high risk of mortality conditional on infection — most older folks and some late middle-aged folks with severe chronic conditions. Prioritizing them for vaccination will yield the greatest benefit in reducing covid-19-related mortality, regardless of when herd immunity is hit.”

Jesse Goodman, professor of medicine and infectious diseases at Georgetown University:

“I am not sure that in the near future we will reach a level of population immunity where the virus will be virtually shut down, as we are accustomed to with measles. Through immunity due to vaccination, combined, unfortunately, with infections in the unvaccinated, we should reach a state where the risk of exposure is reduced due to a mostly immune population. While cases will still occur, our health system will no longer be stressed and large outbreaks should be less common.

“I am hopeful we can get to such a situation in the last quarter of this year, provided vaccine production, access and acceptance go well and no mutant viruses arise that gain the ability to escape current vaccines.”

Kimberly Powers, associate professor of epidemiology at the University of North Carolina at Chapel Hill:

“That question is difficult to answer, as there is considerable uncertainty around the level of immunity we would need in the population to achieve herd immunity, along with the speed with which we can expect widespread vaccine uptake to occur.”

Leana Wen, public health professor at George Washington University and former Baltimore health commissioner:

“Right now, vaccine distribution is progressing at an unacceptably slow speed, and at this current rate, it will take years to reach herd immunity — if ever. If we are able to pick up speed by many times in January, there is still a chance we could substantially slow down the infection and perhaps approach herd immunity in 2021.”

Marc Lipsitch, professor of epidemiology at Harvard University:

“I think you mean ‘will enough Americans be vaccinated to reach the herd immunity threshold?’ My answer is possibly not because we don’t know if the vaccines protect enough against transmission for the threshold to be achievable, and because the new variant may increase that threshold substantially.”

Michael Osterholm, chairman of the Center for Infectious Disease Research and Policy at the University of Minnesota:

“There are three factors that will independently determine when enough Americans will either be protected from covid-19 via vaccination or development of antibody following actual infection.

First, when will there be sufficient vaccine produced and distributed so everyone can receive their two doses? This includes vaccinating those who may have immune protection from actual infection but are vaccinated anyway to increase durable protection. Second, will enough people agree to be vaccinated? And finally, what is the durability of vaccine-induced protection over time? 

“Each of these factors will play a role in achieving local, regional or national herd immunity protection. I feel confident we can achieve the first factor of sufficient vaccine by the late summer or early fall. But ultimately, the second two factors, how many will be vaccinated and how durable is immune protection will determine the answer to this question. I hope, when considering all three factors, it will be late summer or early fall, but we all realize hope is not a strategy.”

When do you expect your own daily life to feel similar to pre-pandemic times?

Carlos del Rio:

I am hoping to be ‘close to normal’ by December 2021 more or less. However, as a physician seeing patients, I will probably continue to wearing a face mask and goggles for much longer.”

Eric Topol:

“In 2022.”

Jay Bhattacharya: 

“Given the changes that the previous year has had on my professional and personal life, I do not expect my daily life to ever feel similar to pre-pandemic times. More broadly though and given the disappointingly slow roll out of the vaccine to the vulnerable in many states, I anticipate that American society will start to feel more like normal by April 2021.”

Jesse Goodman:

“Hopefully late this yearlife should begin to feel similar to pre-pandemic times. However, it is likely that both great vigilance and some social distancing will still be needed, particularly if the population is not nearly all vaccinated. In addition, we may well require periodic immunization against the current and, possibly, other emerging coronavirus variants.”

Kimberly Powers: 

“I expect daily life to feel more normal by sometime this summer, but I think it will be 2022 before some mitigation measures can be fully relaxed.  And I expect that our society will feel ongoing consequences of this pandemic — physical, mental, emotional, and economic — for years to come.”

Leana Wen: 

“I don’t know. I was much more optimistic a few weeks ago. But given the lag in vaccine rollout thus far and how under-resourced our public health systems are, I am concerned things for much of 2021 will feel more like 2020 than 2019.”

Marc Lipsitch:

I think that sometime in the second half of the year there will be enough vaccination in the U.S. and some other countries that we will begin to treat covid-19 more like seasonal flu, which is deadly to large numbers of people but does not overwhelm health care and does not cause us to curtail normal social contact. This is because with enough vaccine in those at high risk of death and hospitalization, transmission may continue (at a reduced level thanks to some immunity in the population from prior infection and vaccine) but the outcomes will be less severe.”

Michael Osterholm:

“I’m not sure it ever will. We will not go back to a pre-covid-19 normal. We will instead exist in world with a new normal. And even that will in part be determined by the availability of adequate vaccine supply to cover everyone in high, middle and low income countries. I look forward to the day when my office hours are as they were pre-covid-19.”

Fauci says he didn’t expect such a high US death toll from COVID-19

https://thehill.com/homenews/sunday-talk-shows/532405-fauci-says-he-didnt-expect-such-a-high-us-death-toll-from-covid-19

Fauci says he didn't expect such a high US death toll from COVID-19

Anthony Fauci, the nation’s top infectious diseases expert, said Sunday he did not expect the death toll from the coronavirus to be so high in the U.S.

“There is no running away from the numbers,” Fauci told guest host Martha Raddatz on ABC’s “This Week.”

“It’s something that we absolutely have got to grasp and get our arms around and turn that, turn that inflection down by very intensive adherence to the public health measures uniformly throughout the country with no exceptions,” he added.

Statistics held by John Hopkins University show that 350,215 deaths have been recorded in the United States so far, a number that has been quickly growing over the last two months.

“I did not” expect the death toll to reach the recent milestone of 350,000 in the U.S., Fauci said.

“But, you know, that’s what happens when you’re in a situation where you have surges related to so many factors inconsistent adhering to the public health measures, the winter months coming in right now with the cold allowing people or essentially forcing people to do most of their things indoors as opposed to outdoors.”

Raddatz asked Fauci how effective he thought proposals by President-elect Joe Biden would be, such as a 100-day mask mandate and a target of 100 million vaccinations.

“The goal of vaccinating 100 million people in the first 100 days is a realistic goal. We can do 1 million people per day,” Fauci said. “You know we’ve done massive vaccination programs, Martha, in our history. There’s no reason why we can’t do it right now.”

US hits 350,000 COVID-19 deaths amid fear of surge after holiday gatherings

https://thehill.com/homenews/532396-us-hits-350000-covid-19-deaths-amid-fear-of-surge-after-holiday-gatherings

As U.S. inches closer to 350,000 Covid-19 deaths, one model proj -  WRCBtv.com | Chattanooga News, Weather & Sports

More than 350,000 people have died of the coronavirus in the U.S., with another surge of cases and deaths expected in the coming weeks as a result of smaller holiday gatherings.

The country reached the grim milestone early Sunday morning, according to data compiled by Johns Hopkins University. More than 20 million people have been infected since the pandemic began nearly one year ago, according to the tally.

Public health experts attributed a nationwide spike in cases, hospitalizations and deaths in early December to a large number of Americans traveling over the Thanksgiving holiday, and pleaded with citizens to stay home for Christmas and New Year’s celebrations. 

Multiple states have reported a record number of cases, including North Carolina and Arizona, according to the Associated Press. New York hit 1 millions cases total as of Saturday, becoming the fourth state to do so along with Texas, Florida and California.

Last month, federal officials approved two vaccines by Pfizer and Moderna for emergency use. The first round of doses have been administered to doctors, nurses and other front line healthcare workers as well as nursing home residents.

The elderly and other patients deemed “high risk” are the next group of Americans slated to receive vaccines with public health officials estimating younger and healthy citizens can expect to be eligible for vaccination toward the middle to end of spring. 

The Centers of Disease Control and Prevention last week reported more than 2 million people in America have been vaccinated, far short of the 20 million figure the federal government initially said it hoped to top by this time. That number has since grown to 4.2 million as of Sunday. 

“We would have liked to have seen it run smoothly and have 20 million doses into people today by the end of the 2020, which was the projection,” said Dr. Anthony Fauci, the nation’s leading infectious disease doctor. “Obviously, it didn’t happen, and that’s disappointing.”

Fauci said a targeted approach in assisting local governments in vaccine rollout programs is the best way for the federal government to make up for lost time. 

“There really has to be a lot more effort in the sense of resources for the locals, namely, the states, the cities, the counties, the places where the vaccine is actually going into the arms of individuals,” Fauci said. 

Atul Gawande on Coronavirus Vaccines and Prospects for Ending the Pandemic

https://www.newyorker.com/news/the-new-yorker-interview/atul-gawande-on-coronavirus-vaccines-and-prospects-for-ending-the-pandemic

Atul Gawande on Coronavirus Vaccines and Prospects for Ending the Pandemic  | The New Yorker

Atul Gawande is outlandishly accomplished. The son of Indian immigrants, he grew up in Athens, Ohio, and was educated at Athens High School, Stanford, Oxford, and Harvard, where he studied issues of public health. Before working as a surgeon at Brigham and Women’s Hospital, in Boston, he advised such politicians as Jim Cooper and Bill Clinton. He teaches at Harvard and is the chairman of Ariadne Labs, which works on innovation in health-care delivery and solutions, and he recently spent two years as the C.E.O. of a health-care venture called Haven, which is co-owned by Amazon, JPMorgan Chase, and Berkshire Hathaway.

Gawande is also a writer, and he has been publishing in The New Yorker for more than two decades. In 2009, heading into the debate over the Affordable Care Act, President Obama told colleagues that he had been deeply affected by Gawande’s article in the magazine called “The Cost Conundrum,” a study conducted in McAllen, Texas. Obama made the piece required reading for his staff. Gawande’s most recent book, a Times No. 1 best-seller, is “Being Mortal: Medicine and What Matters in the End.”

Since the beginning of the coronavirus pandemic, Gawande has been sharp in his criticism of the Trump Administration and, like Anthony Fauci and other prominent figures in public health, insistent on clear, basic measures to reduce levels of disease. After the election in November, President-elect Biden formed a covid-19 advisory board and included Gawande among its members. Earlier this week, I spoke with Gawande for The New Yorker Radio Hour. In the interview, which has been edited for length and clarity, Gawande says that President Trump’s relative silence on the issue after the election might be a blessing (considering the alternative). He suggests that the development of vaccines promises great things down the line, a return to relative normalcy some months from now. But, before that happens, he says, we may not only see terrible rates of illness and death—we will also experience an almost inevitably contentious rollout of the vaccine. Questions of who gets the vaccine and when will test a deeply divided society. As Gawande put it, “The bus drivers never came before the bankers before.”

We currently have one of the highest death and transmission rates of covid-19 in the world. What went wrong?

There’s so many things that went wrong, but you can boil it down to the difficulty of pulling together. One of the most critical things you have in the toolbox in public health is communications. It’s your ability to have clear priorities and communication about those priorities to your own public and to all of the players who get stuff done. We didn’t get testing started early. We weren’t calling the laboratories together to get testing built and created right from the get-go. And then fast-forward to where we are today. We still are in a world where we have not had clear communications from the top of the government around whether we should be wearing masks and having an actual national strategy to fight the virus. I would boil down what went wrong to not committing to communicating clearly and with one voice about the seriousness of what we’re up against and what the measures are to solve it.

When this began, I read “The Great Influenza,” John M. Barry’s book about 1918 and the horrendous flu that killed millions worldwide, and many hundreds of thousands in the United States. I thought to myself, Well, it’s not possible that we would repeat these mistakes, because, after all, we learn from history, even if the President of the United States does not. How is it possible that we made these same mistakes on such a mass scale? Do you lay it all at the feet of the President?

There’s a big part of this that I lay at the feet of the President. Imagine Pearl Harbor happened, and then we spent seven or eight months deciding whether or not we were going to fight back. And then, seven or eight months into it, a new President is going to come in who says, O.K., we are going to fight now. But you now have substantial parts of the country already arrayed against the idea that fighting it is worthwhile. In the meantime, some states have fought the attack and other states have not, and they’ve had to compete with each other for supplies. That’s the mess we have.

In May, I got to write about this in The New Yorker: the hospitals learned how to bring people to work and have them succeed. It was a formula that included masks, included some basic hygiene, some basic distancing, and testing. That’s been the formula, and is the formula still, for making it possible for people to resume a normal life. But we did not have a commitment from the very top to make this happen on a national basis. And we are continuing to litigate that issue to this very day.

You are now on President-elect Biden’s advisory board on covid-19, and I wonder what kind of coöperation you’re getting from the Trump Administration’s own advisory board.

Well, remember: up until just a few days ago, there was no contact allowed at all between any Administration officials and the Biden-Harris transition team. So only in the last few days have there started to be the contacts that would allow for basic information to be passed. I think it’s too early to say how well those channels of communication are turning out.

I’m sorry to interrupt, Atul, but, just to be clear here: we’re in a public-health emergency. Are you saying that the President’s theories, ill-founded and fantastical theories about the election, held up any communication whatsoever between President Trump’s advisory board and President-elect Biden’s board?

Absolutely. And I want to put a pin in what that means, in concrete fact. Here, we had a vaccine trial that came out three weeks ago showing a successful, effective vaccine, followed, just a few days later, by another vaccine trial. We did not have access to the information they were getting about the status of those trials. We did not have access to information about supplies. So, at the beginning of the year, with Operation Warp Speed, the target was three hundred million vaccines produced by the end of the year. Instead, what we’re seeing is reportedly thirty million or so by the end of [December]. We’re seeing in the press some backtracking from that as well. What were the bottlenecks that meant that this couldn’t be done? Is it a shortage of raw ingredients? Are they having stockpile problems? Is it a problem with the actual production processes?

Here’s another one when I’m talking to colleagues around the country who are going to be involved in distributing the vaccine: We hear about everything from shortages of gloves, uncertainty about supplies of needles and syringes for three hundred and thirty million people to get two rounds of doses. There’s no information yet on how many vaccines will be allocated to a given state or a given big pharmacy company like CVS or Walgreens—places that are an important part of the distribution chain. So there’s a lot of basic information that hasn’t been known. That discovery process is just starting.

The Biden Administration-to-be’s covid-19 task force has got a seven-point plan to stop the pandemic. What are the crucial elements of that plan?

It’s the same story that we’ve known since April: It’s mandating masks—that’s one of the most important tools we have for driving transmission down. It’s testing and being able to make sure that there’s widespread availability of testing. It’s supplies for the places that are going to need proper gloves, masks, et cetera. It’s continuing, based on the level of spread in a given community, to tune how much capacity restriction you have on indoor environments, whether it’s bars and restaurants or weddings or other gatherings that are seen to be currently driving transmission. Those are all critical elements. I’m firmly in agreement with where the President-elect is going on heeding the advice from public-health people that schools can be opened. But, in order for kids to be back in schools, especially elementary and middle schools, there’s still a lot of work to do to insure they have the supplies that they need to maintain distancing, to have the right ventilation.

Thanksgiving was a week ago. Anthony Fauci says that what he fears is a spike on top of a spike, a leap on top of a leap. Do you share that fear?

I do. A lot of people heeded the C.D.C. advice to not travel during Thanksgiving and to limit the size of family get-togethers. And I think that will help a great deal. But clearly large numbers of people did not heed that advice. And that’s the reason for the fear of the spike on top of a spike. We saw that, during the Thanksgiving weekend, we had the highest level of hospitalizations at any time in this pandemic, including the darkest days of spring. That’s going to have consequences in the days to come. I’m concerned that we’ll go into the Christmas holiday week with even higher spikes that will make that holiday all that much more challenging. Spike upon spike upon spike is the fear in this six-week-long period.

One of the signal disasters, as you said earlier, in the Trump Administration was communications, both what the President said about the pandemic and how he said it, the language he couched it in and the attitude he took toward it. Since the election, Trump doesn’t even talk about it on a daily basis.

No, he’s, he’s been awol. He had said in his statements: You know, it’s covidcovidcovid; all they want to talk about is covid. But watch, he said, the news will go away the day after the election. Instead, he’s the one who went away the day after the election. He has hardly spoken on what we’re up against, how bad things are, and what is going to be required. It’s interesting, however. In some ways, that is preferable to his coming in and constantly undermining the public-health messaging. So you have seen the C.D.C. and F.D.A. be able to step up. I can only surmise that what he’s clearly been focussed on is figuring out how to hold on to power. The irony is it’s left the field clear.

President-elect Biden is saying very clearly that this should be thought of as a war. We have to be on a war footing and understand how grave this is. Now you’re getting a unified message that’s coming across, and it’s coming from the President-elect on down and from the career scientists. In the face of the rising levels of disease in the country, you now have some Republican governors who had [opposed] a mask mandate now implementing the mask mandate. And they’re not getting contradicted by the President in that process. So, ironically, look, if I have to have President Trump on the airwaves contradicting everybody, or being awol, I’d rather have him be awol.

Thankfully, we can look forward to a vaccine, but that presents enormous logistical challenges. What are the challenges, and how do you view that rolling out?

Well, this is an undertaking on another scale from anything we’ve been doing in the last year. We have deployed north of a hundred and twenty million coronavirus tests in the course of eight months. This is going to be three hundred and thirty million vaccinations, done twice, and hoping to accomplish it in the course of six months or less. This is with vaccines that are new and that haven’t been produced at this volume before. Their clinical data is just undergoing review for approval by the F.D.A. The task is muddied by the fact that we don’t have a clear understanding of what the supply situation is that we have inherited from the Trump Administration. We also don’t know even what the prioritization is.

I’m concerned that what will happen when the new Administration starts is that they will inherit a lot of public confusion, because each state is now coming to its own conclusion about how they’re going to prioritize things. There’s going to be such demand. People are going to clamor for this vaccine. And, if they think that the system is rigged, we will have even more trouble.

After health-care workers and nursing homes, who gets the vaccine next? It’s almost like some terrible philosophical, moral, ethical conundrum that philosophers are faced with all the time. What are your discussions like when it comes to those next levels?

There are eighty-seven million essential workers who are at heightened risk of exposure. They are, say, meatpackers who are exposed to co-workers, or grocery-store workers or bus drivers who are exposed. You’ll be able to go to your local pharmacy and get a vaccine, but what they need to know is, how do they identify who’s the bus driver and who’s not?

Will the government be able to guarantee us that wealthy people, connected people, won’t be able to jump the line?

I think this is one of the critical tests—and an opportunity. The chance to prove that the system is not rigged should not be underestimated. It’s hard. Think about it. The bus drivers never came before the bankers before. You’re going to have Zoom workers who want to go back to normal, and I cannot blame the number of people who will say, You know, thank God I can finally not be in fear. Let me get the vaccine. What do you mean, I have to wait five months? I can imagine a million ways [of jumping the line], people paying someone twenty-five hundred bucks to get your work I.D. tag. This is all about rallying people together. It can’t just be about the rules. It has to be about how we all understand this and work together to say, These are the folks most at risk. They make our subways work. They make our buses work. They get our food supply to us. They make it possible for me to go grocery shopping, and I’ll just have to wait three or four months for my turn.

What you’re talking about is community and common interest and fairness. Many people are very good about that on the level of rhetoric, but, when it comes to their health and their children’s health or their parents’ health, that’s where rubber meets the road.

The mass debate and antagonism we’ve had over the last few months is nothing compared to the splits we will see over “I want my family to be vaccinated.” You know, one person in the family might get vaccinated. Another person might not because they have an illness profile or they have a job that fits in that way. You’ll have children who some families will want to have vaccinated and others will not want to have vaccinated. Pediatric clinical trials have only just gotten under way, and we won’t see those results for a while.

I have a child with severe autism, and so I pay very close attention to the anti-vaxxer movement. And the statistics, the numbers of people who say they will not be vaccinated, is enormous. Doesn’t that have serious implications not only for them but for our over-all effort?

It does. It seems, if we can get around seventy per cent or so of people vaccinated, that would stop the transmission just through vaccination alone. Now if, once people start getting vaccinated, they start throwing their masks away and you can’t get them to do anything else like distancing, then you’re really relying on vaccination as the sole prong of the strategy come three, four months from now. I think there are lots of things that are pushing in the direction of keeping the numbers of people who resist vaccination smaller than those surveys indicate.

What are the numbers?

The numbers suggest that it’s up to as much as forty per cent, even up to fifty per cent, who have said that they are not ready to take the vaccine [even] if the F.D.A. approves it. Part of the reason it’s good that health-care workers would go first is just demonstrating that we ourselves are willing to get vaccinated. Health-care workers are everywhere, which means we’re all going to know people who got vaccinated, and we’re going to see that they did all right.

The reality is that there are memes around anti-vaccination, like: the vaccine will change your D.N.A., or people are injecting a location transmitter into you, a conspiracy to be tagging everybody in the country. We’ll have to be able to combat crazy conspiracy theories. I’ll just summarize by saying this will be contentious, but I’m quite hopeful that we will get to large enough levels of vaccination so that we will be able to get this under control and return to a significant degree of normalcy.

Has there ever been any kind of distribution effort like this in American history?

I draw on things like the polio campaigns, which, you know, took polio from being an annual summer pandemic, in the early fifties, that left kids paralyzed, to essentially being gone a few years after the vaccines came out. Then you had H1N1, where we were in position to vaccinate seventy-million-plus people. So I think there is some precedent. We have not tried to say, Let’s eradicate this disease in one year. Smallpox took a couple of decades. I think we can get [the coronavirus] under control without necessarily eradicating it.

What would it take to eradicate it—or are we never going to eradicate it?

You don’t have to vaccinate every single human being in order to eradicate it. You need to get enough people vaccinated so that the disease stops spreading and dies out. I’m hopeful that we can get it under control here, but, to get eradication, to go back to global travel like before, you would have to get the whole world vaccinated. And that will take years. If we are well vaccinated here, we will feel comfortable over time lifting our restrictions on travel in the United States. And we will become freer to travel to many places around the world. And we will begin to realize what a lot of public-health people like me have been saying, which is that this can’t just be about distribution of vaccine in the United States. This is also going to need to be about enabling global vaccination.

At what point do you think you will be comfortable eating in crowded restaurants, flying on planes, living the life that you lived a year ago?

I think it will be after I get vaccinated [and we have enough data to know the vaccines are stopping transmission]. I’m actually a trial participant. One of the things that’s running through my brain is when I’m going to feel comfortable—when I find out whether I got a placebo or I got the vaccine.

What trial are you in?

I’m in the Moderna trial. After the booster shot, I got a fever, and I had the whole reaction that you would have expected. So I’m going to guess that I got the vaccine. But I won’t feel comfortable that I got it until I actually get that confirmation. But this isn’t about me. I want to see the evidence that the vaccine is lasting. What is the story three months from now? Are the antibodies showing indications that it lasts? I suspect that we’ll really feel comfortable, that we’re able to largely return to normal, maybe in about six months’ time. But, you know, we’re going to go through this gray-zone period where a lot of people have been vaccinated, and I will feel among them. I’m so desperate to go to a concert! Live music is the thing I’ve missed the absolute most.

Dr. Fauci has been a paragon. At the same time, he said, it could be a year and a half for a vaccine to be deployable. Why was the timeline so much faster in the end?

It was insane, some of the timelines that the scientists hit. For example, from the moment that the genome for the virus got sequenced to the moment when the N.I.H.-Moderna team actually was producing the vaccine, it was days. I think it was like a week or something like that. That’s just beyond belief.

What was the science, the discoveries, that made that possible?

Well, it was years of work to build the platform that could deliver the genetic information. Those first few days of success were built on years of work that folks like Dr. Fauci get credit for, because he’s been contributing to the creation of that kind of platform for some years now, as have many biotech companies and many university labs and the government.

Atul, we’re sitting here and watching the year 2020 end—and not a moment too soon. What do you expect will be our situation in December, 2021?

Well, for one thing, I think we’ll be having normal holiday experiences. We’ll be able to get together with our families and spend time. It’s harder for me to predict from my vantage point with as much confidence, but I think that if that’s happening, we will be on better economic terms as well. Right now, airlines, hotels, and any face-to-face service industry—bars, restaurants, child care, health care—I think all of those things are coming back.

This terrible year taught me something about hope

The first month of the pandemic was also supposed to be the month I got pregnant, but my clinic closed and plans changed. Doctors and nurses needed personal protective equipment to tend to patients with covid-19, not women with recurrent miscarriages.

When the clinic reopened several months later, it turned out my husband and I had only been delaying yet another loss: In late August, he obeyed the medical center’s strict coronavirus protocols by waiting anxiously in the car while I trudged inside, masked and hand-sanitized, to receive a miscarriage diagnosis alone. I searched the ultrasound screen for the rhythmic beat of a heart, and then accepted that whatever had once been there was now gone.

But that was 2020 for you, consistent only in its utter crappiness. For every inspiring video of neighbors applauding a shift change at the hospital, another video of a bone-tired nurse begging viewers to believe covid was real, it wasn’t a hoax, wear a mask.

For every protest organized by activists who understood racism is also a long-term crisis, an appearance by the Proud Boys; for every GoFundMe successfully raising money for a beloved teacher’s hospital bills, a bitter acknowledgment that online panhandling is our country’s version of a safety net.

Millions of citizens stood in line for hours to vote for the next president and then endured weeks of legal petitions arguing that their votes should be negated. The basis for these legal actions were conspiracy theories too wild to be believed, except that millions of other citizens believed them.

And that was 2020 for you, too: accepting the increasingly obvious reality that the country was in peril, built on iffy foundations that now buckled under pressure. My loved ones who worked as waiters or bartenders or physical therapists were choosing between health and paychecks, and even from the lucky safety of my work-from-home job, each day began to feel like watching America itself arrive at a hospital in bad shape, praying that doctors or clergy could find something they were able to save.

Is there a heartbeat?

You want the answer to be yes, but even so, it was hard to imagine how we would come back from this.

What kind of delusional person would even try to get pregnant in this world? In my case it would never be a happy accident; it would always be a herculean effort. And so it seemed I should have some answers.

How do you explain to a future child: Sorry, we can’t fix climate change; we can’t even get people to agree that we should wear masks in grocery stores? How do you explain the frustration of seeing brokenness, and then the wearying choice of trying to fix it instead of abandoning it? How do you say, Love it anyway. You’re inheriting an absolute mess, but love it anyway?

I found myself asking a lot of things like this in 2020, but really they were all variations of the same question: What does it mean to have hope?

But in the middle of this, scientists worked quietly in labs all over the world. They applied the scientific method with extraordinary discipline and speed. A vaccine was developed. Tens of thousands of volunteers rolled up their sleeves and said, Try it out on me.

It was approved, and a nurse from Long Island was the first American televised receiving it. Her name was Sandra Lindsay, an immigrant from Jamaica who had come to the United States 30 years ago and who had spent the last year overseeing critical care teams in back-to-back shifts. She said she had agreed to go first to show communities of color, long abused, brushed-off or condescended to by the medical system, that the vaccine was safe.

Here was hope. And more than that, here was hope from a woman who had more reason than most to be embittered: an exhausted health-care worker who knew too well America’s hideous racial past and present, who nonetheless also knew there was only one way out of the tunnel. Here she was, rolling up her own sleeve, and there were the lines of hospital employees ready to go after her, and there were the truck drivers ferrying shipments of syringes.

I can’t have been the only person to watch the video of those early inoculations, feeling elated and tired, and to then burst into tears. I can’t have been the only person to realize that even as 2020 revealed brokenness, it also contained such astounding undercurrents of good.

The scientific method works whether you accept it or not. Doctors try to save you whether you respected public-health guidelines or not. Voter turnout was astronomical because individual citizens realized they were all, every one of them, necessary pieces in a puzzle, even if they couldn’t see what the final picture was supposed to look like.

The way to believe in America is to believe those things are passed down, too.

Sometime in October, a couple of months after my last miscarriage — when the country was riding up on eight months of lonely and stoic birthdays, graduations, deaths and weddings — I went into the bathroom and saw a faint second line on a First Response pregnancy test. It was far from my first rodeo, so I knew better than to get excited. I mentioned it to my husband with studied nonchalance, I told him that I’d test again in a few days but that we should assume the worst would happen.

Two weeks after that, I had a doctor’s appointment, and then another a week later, each time assuming the worst, but each time scheduling another appointment anyway, until eventually I was further along than I’d ever gotten before — by one day, then three days, then thirty.

I am not a superstitious person. I don’t believe that good things always come to those who deserve them. I believe that stories regularly have sad endings and that it’s often nobody’s fault when they do, and that we should tell more stories with sad endings so that people who experience them know that they’re not alone.

But 2020 has taught me that I am, for better or worse, someone who wants to hope for things. To believe in the people who developed vaccines. In the people who administered them. In Sandra Lindsay. In the people who delivered groceries, who sewed masks, who have long cursed America’s imperfect systems and long fought to change them, who still donate $10 to a sick teacher’s GoFundMe.

At my most recent appointment, the doctor’s office was backed up in a holiday logjam. I sat in the exam room for nearly three hours while my husband again waited anxiously in the car. I texted him sporadic updates and tried to put hope in a process that so far had not seemed to warrant my hope.

It all felt precarious. The current reality always feels precarious.

And yet there we all are together, searching for signs of life, hoping that whatever we emerge to can be better than what we had before, and that whatever we build will become our new legacy. The sonographer finally arrived and turned on the machine.

There was a heartbeat. There was a heartbeat.

Wisconsin health-care worker ‘intentionally’ spoiled more than 500 coronavirus vaccine doses, hospital says

A hospital employee outside Milwaukee deliberately spoiled more than 500 doses of coronavirus vaccine by removing 57 vials from a pharmacy refrigerator, hospital officials announced Wednesday, as local police said they were investigating the incident with the help of federal authorities.

Initiating an internal review on Monday, hospital officials said they were initially “led to believe” the incident was caused by “inadvertent human error.” The vials were removed Friday and most were discarded Saturday, with only a few still safe to administer, according to an earlier statement from the health system. Each vial has enough for 10 vaccinations but can sit at room temperature for only 12 hours.

Two days later, the employee acknowledged having “intentionally removed the vaccine from refrigeration,” the hospital, Aurora Medical Center in Grafton, Wis., said in a statement late Wednesday.

The employee, who has not been identified, was fired, the hospital said. Its statement did not address the worker’s motives but said “appropriate authorities” were promptly notified.

Wednesday night, police in Grafton, a village of about 12,000 that lies 20 miles north of Milwaukee, said they were investigating along with the FBI and the Food and Drug Administration. In a statement, the local police department said it had learned of the incident from security services at Aurora Health Care’s corporate office in Milwaukee. The system serves eastern Wisconsin and northern Illinois, and includes 15 hospitals and more than 150 clinics.

Leonard Peace, an FBI spokesman in Milwaukee, would not comment on the Bureau’s involvement but said of the episode, “We’re aware of it.” The FDA did not immediately respond to a request for comment.

The tampering will delay inoculation for hundreds of people, Aurora Health officials said, in a state where 3,170 new cases were reported and 40 people died Wednesday of covid-19, the disease caused by the coronavirus, according to The Washington Post’s coronavirus tracker.

“We are more than disappointed that this individual’s actions will result in a delay of more than 500 people receiving the vaccine,” the health system said in a statement.

The Wisconsin incident comes as states continue to grapple with a bumpy rollout of the first doses of the Moderna and Pfizer-BioNTech vaccines, which were approved less than a month ago and prioritized for health-care workers and residents and staff of long-term care facilities. So far, distribution has lagged well behind federal projections, raising doubts about whether the outgoing administration will meet its already revised goal of 20 million vaccines distributed by the end of the year.

As of Wednesday, the Centers for Disease Control and Prevention said 12.4 million doses of the vaccine had been distributed across the United States, but only 2.6 million of those had been administered. (This means that just 1 in 125 Americans has received the first dose of the vaccine.) Trump administration officials have said these numbers lag behind the actual pace of vaccination, which they also vowed would accelerate starting next week.

The Moderna and Pfier-BioNTech vaccines, the first two regimens to gain regulatory approval for emergency use, are two-shot protocols with intricate logistical requirements. Moderna’s vaccine doesn’t require subarctic temperatures, as does the Pfizer product, but it does need to be kept cold. It can be stored at freezer temperatures for six months, the company says, and kept at regular refrigerated conditions for 30 days. It can be maintained at room temperature for only 12 hours, though, and can’t be refrozen once thawed.

Complex storage requirements are among the reasons state officials are imploring providers to administer vaccine quickly once it is received.

In its original statement, Aurora Health said it had successfully vaccinated about 17,000 people over the previous 12 days. Its initial review, it said, had found that the 57 vials were simply not returned to the refrigerator after “temporarily being removed to access other items.”

The hospital apologized, saying, “We are clearly disappointed and regret this happened.”

It is not clear what motive the employee may have had to spoil the vaccine doses. The hospital said it would release more details about its investigation Thursday.

California reports first case of new coronavirus variant

https://www.axios.com/california-covid-coronavirus-variant-1081cbb4-5d2c-42f2-8785-b35e567296c9.html

California reported its first case of a new variant of the coronavirus that may be more transmissible, AP reports.

The big picture: California is the second state to document a confirmed case of the variant — which originated in the United Kingdom — after Colorado reported the first case in the United States on Tuesday.

  • California Gov. Gavin Newsom announced the infection during an online conversation with Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, according to AP.
  • The governor said the case was located in Southern California, but he did not provide any other details about the person who was infected.
  • “I don’t think Californians should think that this is odd. It’s to be expected,” Fauci said Wednesday, per AP.

Of note: There is thus far no evidence that the new variant is more deadly — only that it appears more transmissible. There is also no evidence that COVID-19 vaccines will be less effective against the new variant.

  • A non-peer reviewed study by the Centre for Mathematical Modelling of Infectious Diseases at the London School of Hygiene and Tropical Medicine found that the variant is 56% more transmissible than other strains.
  • The British government previously warned that a new variant could be up to 70% more transmissible.

Go deeper: What you need to know about the coronavirus mutation

Pfizer: “No data” to show single dose of vaccine offers protection after 21 days

https://www.axios.com/pfizer-single-dose-data-716702dd-324f-42b9-b88d-07df43ca198a.html

Pfizer said in a statement that there are “no data” to demonstrate that a single dose of its coronavirus vaccine will provide protection from infection after 21 days.

Why it matters: The U.K. announced on Wednesday that it would shift its vaccination strategy “to give as many people in at-risk groups their first dose, rather than providing the required two doses in as short a time as possible.” Some provinces in Canada are doing the same.

  • Pfizer confirmed in response that although some protection appears to begin as early as 12 days after the first dose, two doses of the vaccine — separated by three weeks — is the only regimen that proved to be 95% effective in Phase 3 trials.
  • “Everyone will still receive their second dose and this will be within 12 weeks of their first,” the U.K. government added in a statement. “The second dose completes the course and is important for longer term protection.”

The big picture: Pfizer’s warning comes as many countries, including the U.S., debate how to rapidly deploy the vaccines in the most effective way possible. The U.S. is on pace to fall far below its target of vaccinating 20 million people by the end of 2020, with only 3 million single-doses administered as of Wednesday night.