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Monday, January 30, 2023

Fauci Q&A: On Masking, Vaccines, and What Keeps Him Up at Night

 When he was a young boy growing up in Brooklyn, Anthony Fauci loved playing sports. As captain of his high school basketball team, he wanted to be an athlete, but at 5-foot-7, he says it wasn't in the cards. So, he decided to become a doctor instead. 

Fauci, who turned 82 in December, stepped down as the head of the National Institute of Allergy and Infectious Diseases that same month, leaving behind a high-profile career in government spanning more than half a century, during which he counseled seven presidents, including Joe Biden. Fauci worked at the National Institutes of Health for 54 years and served as director of the National Institute of Allergy and Infectious Diseases for 38 years. In an interview last week, he spoke to WebMD about his career and his plans for the future. 

This interview has been edited and condensed.

It's only been a few weeks since your official "retirement," but what's next for you?

What's next for me is certainly not classical retirement. I have probably a few more years of being as active, vigorous, passionate about my field of public health, public service in the arena of infectious diseases and immunology. [I've] had the privilege of advising seven presidents of the United States in areas that are fundamentally centered around our response and preparation for emerging infections going back to the early years of HIV, pandemic flubird fluEbolaZika, and now, most recently the last 3 years, with COVID. What I want to do in the next few years, by writing, by lecturing, and by serving in a senior advisory role, is to hopefully inspire young people to go into the field of medicine and science, and perhaps even to consider going into the area of public service. 

Almost certainly, I'll begin working on a memoir. So that's what I'd like to do over the next few years.

Are you looking forward to going back and seeing patients and being out of the public eye?

I will almost certainly associate myself with a medical center, either one locally here in the Washington, DC, area or some of the other medical centers that have expressed an interest in my joining the faculty. I am not going to dissociate myself from clinical medicine, since clinical medicine is such an important part of my identity and has been thus literally for well over 50 years. So, I'm not exactly sure of the venue in which I will do that, but I certainly will have some connection with clinical medicine.

What are you looking forward to most about going back to doctoring?

Well, I've always had a great deal of attraction to the concept of medicine, the application of medicine. I have taken care of thousands of patients in my long career. I spent a considerable amount of time in the early years of HIV, even before we knew it was HIV, taking care of desperately ill patients. I've been involved in a number of clinical research projects, and I was always fascinated by that because there's much gratification and good feeling you get when you take care of, personally, an individual patient, when you do research that advances the field, and those advances that you may have been a part of benefit larger numbers of patients that are being taken care of by other physicians throughout the country and perhaps even throughout the world. 

So those are all of the aspects of clinical medicine that I want to encourage younger people that these are the opportunities that they can be a part of, which can be very gratifying and certainly productive in the sense of saving lives.

Looking back over your career, what were some of the highs and lows, or turning points?

I first became involved in the personal care and research on persons with HIV, literally in the fall of 1981. [That was] weeks to months after the first cases were recognized. My colleagues and I spent the next few years taking care of desperately ill patients, and we did not have effective therapies because the first couple of years, we did not even know what the ideologic agent was. Even after it was recognized after 1983 and 1984, it took several years before effective therapies were developed, so there was a period of time where we were in a very difficult situation. We were essentially putting Band-Aids on hemorrhages, metaphorically, because no matter what we did, our patients continued to decline. That was a low and dark period of our lives, inspired only by the bravery and the resilience of our patients. A very high period was in [the late 1990s] and into the next century [with the development] of drugs that were highly effective in prolonged and effective suppression of viral loads to the point where people who were living with HIV, if they had access to therapy, could essentially lead a normal lifespan.

We put together the President's Emergency Plan for AIDS Relief program known as PEPFAR, which now, celebrating its 20th anniversary, has resulted in saving 20-25 million lives. So, I would say that is … the highest point in my experience as a physician and a scientist, to have been an important part in the development of that program.

Do you feel like there's any unfinished business? Anything you would change? 

Certainly, there's unfinished business. One of the goals I would have liked to have achieved, but that is going to have to wait another few years, is the development of a safe and effective vaccine for HIV. A lot of very elegant science has been done in that regard, but we're not there yet, it's a very challenging scientific problem. 

The other unfinished business is some of the other diseases that cause a considerable amount of morbidity and mortality globally, diseases like malaria and tuberculosis. We've made extraordinary progress over the 38 years that I've been director of the institute We have a vaccine, though it isn't a perfect vaccine [for malaria]; we have monoclonal antibodies that are now highly effective in preventing malaria; we have newer drugs, better drugs for tuberculosis, but we don't have an effective vaccine for tuberculosis. So, malaria vaccines, tuberculosis vaccines, those are all unfinished business. I believe we will get there.

These new COVID-19 variants keep getting more and more contagious. Do you see the potential for a serious new variant that could plunge us back into some level of public restrictions?

Anything is possible. One cannot predict, exactly, what the likelihood of getting yet again another variant that's so different that it eludes the protection that we have from the vaccines and from prior infection. Again, I can't give a number on that. I don't think it's highly likely that will happen. 

Ever since Omicron came well over a year ago, we have had sublineages of Omicron that progressively seem to elude the immune response that's been developed. But the one thing that's good and has been sustained is that protection against severity of disease seems to hold out pretty well. I don't think that we should be talking about restrictions in the sense of draconian methods of shutting things down; I mean, that was only done for a very brief period of time when our hospitals were being overrun. I don't anticipate that that is going to be something in the future, but you've got to be prepared for it. There are some things that have been highly successful, and that is the vaccines that were developed in less than 1 year. And now, our challenge is to get more people to get their updated boosters. 

There's already been criticism of the FDA's discussion of an annual COVID-19 vaccine. One criticism is that the COVID vaccines' effectiveness appears to wane after several months, so it would not offer protection for much of the year. Is that a legitimate criticism?

There's no perfect solution to keeping the country optimally protected. I believe that it gets down to, "It's not perfect, but don't let the perfect be the enemy of the good." We want to get into some regular cadence to get people updated with a booster that is hopefully managed reasonably well to what the circulating variant is. There are certainly going to be people – perhaps the elderly, some of the immune-compromised, and perhaps children – who will need a shot more than once per year, but the FDA's leaning towards getting a shot that is [timed] with the flu shot, would at least bring some degree of order and stability to the process of people getting into the regular routine of keeping themselves updated and protected to the best extent possible. 

Do you think we need to move on from mRNA vaccines to something that hopefully has longer-lasting protection?

Yes, we certainly want next-generation vaccines – both vaccines that have a greater degree of breadth, namely covering multiple variants, as well as a greater degree of duration. So, the real question is, "Is it the mRNA vaccine platform that is inducing a response that is not durable, or is the response against coronaviruses not a durable response?" That's still uncertain. Yes, we need to do better with a better platform, or an improvement on the platform; that could mean adding adjuvants, that could mean a [nasal] vaccine in addition to a systemic vaccine. 

Do you always wear a mask when you go out into the world? How do you evaluate the relative risk of situations when you go out in public?

I've been vaccinated, doubly boosted, I've gotten infected, and I've gotten the bivalent boost. So, I evaluate things depending upon what the level of viral activity is in the particular location where I'm at. If I'm going to go on a plane, for example, I have no idea where these people are coming from, I generally wear a mask on a plane. I don't really go to congregate settings often. Many of the events I do go to are situations where a requirement for [attending] is to get a test that's negative that day. 

When you're in a situation like that, even if it's a crowded congregant setting, I don't have any problem not wearing a mask. But when I'm unsure of what the status is and I might be in an area where there is a considerable degree of viral activity, I would wear a mask. I think you just have to use [your] judgment, depending on the circumstances that you find yourself in.

Doctors and health care professionals have been through hell during COVID. Do you think this might bring a permanent change to how doctors perceive their jobs?

Health care providers have been under a considerable amount of stress because this is a totally unprecedented situation that we find ourselves in. This is the likes of which we have not seen in well over 100 years. I hope this is not something that is going to be permanent, I don't think it is, I think that we are ultimately going to get to a point where the level of virus is low enough that it's not going to disrupt either society or the health care system or the economy. 

We're not totally there yet. We're still having about 500 deaths per day, which is much, much better than the 3,000 to 4,000 deaths that we were seeing over a year ago, but it is still not low enough to be able to feel comfortable. 

As a scientist, even a semi-retired one, what scares you? What wakes you up at night with worry? 

The same thing I have been concerned about for, you know, 40 years: the appearance of a highly transmissible respiratory virus that has a degree of morbidity and mortality that could really be very disruptive of us in this country and globally. Unfortunately, we're in the middle of that situation now, finishing our third year and going into year 4. So what worries me is yet another pandemic. Now that could be a year from now, 5 years from now, 50 years from now. Remember, the last time a pandemic of this magnitude occurred was well over 100 years ago. My concern is that we stay prepared. [We may] not necessarily prevent the emergence of a new infection, but hopefully we can prevent it from becoming a pandemic.

Source

Anthony Fauci, MD, interview, Jan. 27, 2023. 

https://www.medscape.com/viewarticle/987658

Surgeon General Says 13-Year-Olds Shouldn't Be on Social Media

 The U.S. Surgeon General says 13 years old is too young to begin using social media.

Most social media platforms including TikTok, Snapchat, Instagram, and Facebook allow users to create accounts if they say they are at least 13 years old.

"I, personally, based on the data I’ve seen, believe that 13 is too early. … It’s a time where it’s really important for us to be thoughtful about what’s going into how they think about their own self-worth and their relationships and the skewed and often distorted environment of social media often does a disservice to many of those children," U.S. Surgeon General Vivek Murthy, MD, told CNN.

Research has shown that teens are susceptible to cyberbullying and serious mental health impacts from social media usage and online activity during an era when the influence of the internet has become everywhere for young people.

According to the Pew Research Center, 95% of teens age 13 and up have a smartphone, and 97% of teens say they use the internet daily. Among 13- and 14-year-olds, 61% say they use TikTok and 51% say they use Snapchat. Older teens ages 15 to 17 use those social media platforms at higher rates, with 71% saying they use TikTok and 65% using Snapchat.

"If parents can band together and say you know, as a group, we’re not going to allow our kids to use social media until 16 or 17 or 18 or whatever age they choose, that’s a much more effective strategy in making sure your kids don’t get exposed to harm early," Murthy told CNN.

https://www.medscape.com/viewarticle/987665

$5.4 b COVID aid may have gone to businesses using questionable Social Security numbers: report

 The U.S. government may have awarded roughly $5.4 billion in COVID-19 aid to small businesses with potentially ineligible Social Security numbers, said a Washington Post report on Monday citing a new estimate from the Pandemic Response Accountability Committee, or PRAC. The estimate comes as the Republican-run House Oversight Committee plans to hold a hearing on Wednesday titled "Federal Pandemic Spending: A Prescription for Waste, Fraud and Abuse."

https://www.morningstar.com/news/marketwatch/20230130297/54-billion-in-covid-aid-may-have-gone-to-businesses-using-questionable-social-security-numbers-report

4D Molecular Could Be 'Attractive Acquisition Target': BMO

 

  • BMO Capital Markets initiated coverage on 4D Molecular Therapeutics Inc 
    FDMT
     with an Outperform rating and a price target of $50.
  • The analyst writes that 4DMT's platform has generated competitive gene therapies and been clinically validated through its five ongoing clinical programs.
  • BMO notes that 4D Molecular Therapeutics' Wet Age-Related Macular Degeneration (wet AMD) program addresses key limitations of approved/investigational therapies and can potentially confer a $5 billion
  • The company's cystic Fibrosis asset 4D-710 can be the first therapy delivering clinical effects in patients without treatment options, potentially unlocking around $3 billion opportunity.
  • In cystic fibrosis, a 3-5%+ improvement in FEV1 can drive FDMT stock over 50% higher and render the stock an attractive acquisition target. 
  • Potential announcements around partnerships would trigger further upside.

BioMarin Valuation Fair, But Expectations From Hemophilia Therapy Too High: BMO

 

  • BMO Capital Markets initiated coverage on BioMarin Pharmaceutical Inc 
    BMRN
     with a Market Perform rating and a price target of $107.
  • The analyst writes that Biomarin's first FDA-approved product, Voxzogo, for achondroplasia can drive around $1.5 billion in peak sales. Voxzogo commercial uptake will be significant, providing long-term growth to BioMarin.
  • BMO also says that while the management's market research indicates ~35-40% commercial uptake for hemophilia treatment (Valrox), adoption will be (s)lower due to uncertainty around the drug effect, limited effect durability, and required (bi)weekly monitoring for around one year.
  • The analyst models peak Valrox sales of ~$900 million and await updates around FDA approval (PDUFA on 3/31/2023).
  • According to BMO valuation multiples suggest, BioMarin is fairly valued. 

Drugmakers prevail in dispute over U.S. discount drug program

 

Drug manufacturers can limit healthcare providers' use of outside pharmacies for dispensing drugs under a federal drug discount program, a federal appeals court ruled Monday.

The ruling from a three-judge panel of the 3rd U.S. Circuit Court of Appeals based in Philadelphia is a victory for Sanofi SA, Novo Nordisk AS and AstraZeneca PLc. The companies had sued the U.S. Department of Health and Human Services (HHS) after it ordered them to stop restricting sales of discounted drugs to so-called contract pharmacies.

Spokespersons for Sanofi and AstraZeneca said the companies were pleased with the decision. HHS and Novo Nordisk did not immediately respond to requests for comment.

The case centers on the federal 340B program, in which drugmakers provide discounts to eligible healthcare providers that serve low-income populations. Drugmakers are required to participate in the 340B program in order to receive funds from government health insurance programs like Medicare and Medicaid.

Many providers eligible for the program do not have in-house pharmacies, and so contract with outside pharmacies. In 2010, HHS issued new guidance stating that 340B providers could use an unlimited number of contract pharmacies, replacing previous guidance that they could use only one such pharmacy.

In 2020, drugmakers began limiting 340B drug sales to contract pharmacies. They said such pharmacies had become overused, leading to illegal diversion of drugs and, in some cases, to the drugmakers providing double discounts on the same drug.

Sanofi, Novo Nordisk and AstraZeneca all continued to allow 340B providers without in-house pharmacies to use a single contract pharmacy. Sanofi and Novo Nordisk also allowed the use of multiple pharmacies in some cases.

HHS ordered them to stop, saying the new policies were not allowed under the 340B program. But 3rd Circuit Judge Stephanos Bibas said Monday that the federal law behind the program did not say anything about contract pharmacies.

"Legal duties do not spring from silence," he wrote.

The ruling reverses an order from a federal judge in New Jersey against Sanofi and Novo Nordisk, while upholding an order from a Delaware judge in favor of AstraZeneca.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Drugmakers-prevail-in-dispute-over-U-S-discount-drug-program-42849200/

Long Covid has an ‘underappreciated’ role in labor shortage: study

 Long Covid is keeping people out of work and may reduce on-the-job productivity for others, contributing to a labor shortage and weighing on the U.S. economy at large, according to a new study.

Long Covid — also known as long-haul Covid, post-Covid or post-acute Covid syndrome — is a chronic illness that results from a Covid-19 infection. Its potential symptoms number in the hundreds and, for some, can be debilitating and persist for years.

Up to 30% of Americans develop long Covid after a Covid infection, affecting as many as 23 million Americans, the U.S. Department of Health and Human Services said in November.

Symptoms can keep people out of work for substantial periods of time.

About 18% of people with long Covid hadn’t returned to work for more than a year after contracting Covid, according to a recent study by the New York State Insurance Fund, the state’s largest workers’ compensation insurer. Of this share, more than 3 in 4 were under 60 years old.

Another 40% returned to work within 60 days of infection but were still receiving medical treatment — presenting challenges such as reduced hours, lower productivity and other workplace accommodations, NYSIF said.

“If broadly reflective, these findings begin to fill information gaps about the labor market, including an underappreciated reason for the many unfilled jobs and the declining labor participation rate since the emergence of the pandemic,” according to the report.

There are about 1.7 open jobs per unemployed worker. The labor force participation rate was 62.3% in December, which has shown “little net change” since early 2022 and remains a percentage point below its pre-pandemic level, according to the Bureau of Labor Statistics most recent jobs report.

The NYSIF report examines 89,107 workers’ compensation claims filed from January 2020 to March 2022. The insurer approved 3,139 claims related to Covid-19, of which 977 involved long Covid as defined by certain criteria.

Researchers haven’t coalesced around a uniform definition of long Covid. NYSIF said a worker must have either been out of work or received medical treatment for at least 60 days to be counted as a long-Covid sufferer. And, because these are workers’ compensation claims, the data only count people who had a Covid exposure at work.

Other studies suggest long Covid has kept hundreds of thousands, and as many as 4 million Americans, out of work.

Long Covid has pulled people out of the labor force at roughly the same rate as annual retirements by baby boomers, according to Gopi Shah Goda, a senior fellow at the Stanford Institute for Economic Policy Research. In other words, it equates to an additional year of population aging.

Long Covid’s workplace effect comes as the demand for labor hovers near historic highs.

Job openings and the rate of voluntary departures by workers hit records following a broad economic reopening in early 2021, as Covid vaccines became widely available. Wages grew at the fastest pace in decades and the layoff rate hit record lows, as businesses competed for workers and then tried to retain them.

Long Covid research suggests the illness played an under-the-radar role in these broad pandemic-era labor trends, which likely funneled into inflationary pressure in the U.S. economy.

illions of people left the labor force in the early days of the pandemic, due to factors like illness, caregiving and fear of infection. But workers haven’t returned as quickly as imagined, particularly those outside their prime working years, Jerome Powell, U.S. Federal Reserve chair, said in November.

About 3.5 million workers are still missing, Powell said. He attributed at least “some” of that gap to long Covid.

People who can’t return to work because of long-haul symptoms may suffer many negative financial impacts like reduced income and the loss of employer-provided health insurance, NYSIF found. Claimants were also less likely to return the longer they were out of work, its data show.

Plus, long Covid medical costs for the average person are about $9,000 a year, without accounting for any insurance-related coverage.

https://www.cnbc.com/2023/01/30/long-covid-has-underappreciated-role-in-labor-gap-study.html