Omicron Could Be as Deadly as Delta, Boosters’ Short Protection &‘Dangerous’ Oral COVID Pill from Merck: A Talk With William Haseltine

William Haseltine

[Music]

Marianne O’Hare : Welcome to Conversations on Health Care with Mark Masselli and
Margaret Flinter, a show where we speak to the top thought leaders
in health innovation, health policy, care delivery, and the great minds
who are shaping the healthcar e of the future.

This week Mark and Margaret, welcome virus scientist entrepreneur
and president of Access Health International, Dr. William Haseltine,
who's been writing extensively on the COVID pandemic for Forbes,
and a series of online books that are u pdated when new science
emerges. H is warning that the rapidly changing landscape of SARS -
co V - 2 the COVID 19 pandemic is shape shifting with Omicron
presenting a real threat much more contagious, and a bigger threat
than we yet understand.

Lori Robertson al so checks in , Managing Editor of F act C heck.org. She
looks at misstatements spoken about health policy in the public
domain separating the f ake from the facts . We end with a bright idea
that's improving health and wellbeing a n d everyday life. If you have
co mments, please email us at [email protected] o r find us on
Facebook, Twitter, or wherever you listen to podcast. You can also
hear us by asking Alexa to play the program. Now stay tuned for our interview with Dr. Wi lliam Haseltine h ere on C onversations on H ealth
C are.

Mark Masselli: P ills to treat COVID - 19 , t hey sound like an important part of the
solution to dealing with the pandemic. But a warning from our guest is attracting a lot of attention and controversy. You 'll hear him explain
in his own words why he's concerned about a new drug which could , and I emphasize could , have led to the Omicron variant.

Margaret Flinter: Dr. William Haseltine is at the forefront of medical research and application , he's taught at H arvard Medical School . H e designed the
strategy to develop the first treatment for HIV / AIDS. He's well known
for his groundbreaking work on cancer, he led the team that pioneered the development of new drugs based on the human genome information and now se rves as P resident of Access Health
International , t hat's a nonprofit t hink t ank and advisory group
dedicated to improving access to high quality, affordable care . Dr.
Haseltine we can't think of a better person to have with us today for
the show. Thank you so much.

Dr. William Haseltine: Y ou're welcome , and t hank you for that.

Mark Masselli: Yeah, and really w elcome back to Conversations on Health Care . Y ou
know the FDA has yet to authorize use of Merck’s Molnupiravir, an
antiviral medication for COVID pati ents. You have some pointed
thoughts about that. I'm wondering if you could share that with our

William Haseltine

listeners .

Dr. William Haseltine: W ell, the first thing is, we do need drugs both to prevent and to treat
COVID. Now that we know that there are variants of bla st through
almost all vaccines including people who have been infected and then
vaccinated, it's looking a little bit more like HIV, which is very hard to
vaccinate against, at least permanently. Now there is of course, the
hope that the vaccines will prot ect you at least for some time from
serious disease or death. That's really good news. Even if you get the
virus, maybe it won't be as bad for you , a nd it's a very good reason to
get vaccinated. But we have to add new tools to our armamentarium.

Just as we realized, once we knew that it would be hard to vaccinate
against HIV, we developed a whole series of drugs. Now, this virus is a
little bit different in the sense that when you get HIV, you have many
years to treat before somebody has manifest . Here, onc e you feel the
first symptoms, you may have three days to treat. That's the window
for the Pfizer jar. Now you've asked me about another drug called
Molnupiravir that Merck has pushed as a treatment. I have very grave
concerns that have been shared for man y years about this drug. This
is not a new drug. It's been around since the 80s. A lot of people have
looked at it and dropped it because it has some unfortunate
potentials.

How does this drug work? It actually causes the virus to mutate itself
to death. W hat it does, it's a mutagen (inaudible 00:04:10) it creates
mutations. It doesn't sound just on the surface of it. You want to
speed up th ese viruses ability to make mutations. It sounds like a
really bad idea. W hen you look at what happens in tissue cultu re with
other coronaviruses, including the MERS it just look the viruses that
come out of treatment of Molnupiravir are highly mutated.
Sometimes they have over 100 mutations in them . It makes --- and so
we know that if you treat somebody with Molnupiravir for a few days
they shed virus , those viruses are going to be mutant . I am very
worried that that drug not only is not particularly effective about 30%
effective at this point, if you take it early, but has potential to
significantly accelerate the rate o f variation of this virus, and
therefore the pandemic, that's not 100% c ertain .

France is taking these cautions, its lack of good efficacy, the fact that
it may cause mutations that are very difficult for especially pregnant
women and others, and the possi bility t hat it could make the
pandemic worse to not allow the drug to be used. So far as I know the
only country that’s not approved it for us even canceled their order.
This, as I say, t his drug was considered to be too dangerous to use for
biopreparednes s is not a good idea, in my opinion. I hope that the US
FDA reaches the same conclusions.

Margaret Flinter: Yeah. Dr. Haseltine, c larify for me, we've been following this because

William Haseltine

as you probably know this is one medication that's being made
available throu ghout the country on a preliminary basis anyway for
use. W e've all certainly been excited to think that there have been
opportunities to identify people at risk who are positive early on, treat
to reduce the burden of symptoms and hopefully prevent progres sion
to hospitalization, or even death. T his is an incredibly important issue.
My understanding, and I think you may have just said this, but I want
to make sure I heard it correctly, that we have not yet gotten
emergency use authorization for this drug in the United States. Am I
correct on that?

Dr. William Haseltine: You're correct. The FDA is --- a nd the committee was divided , that’s
unusual, I think, 13 to 10 decision. S ome of the scientists that were on
that voice exactly the same concerns I have just given you, they have
concerns as well. I think it's --- you can turn it down on efficacy, you
can turn it down on danger to mutagenesis, but I am very concerned
about exacerbating an already bad situation. W e now know we're not
the end of virus variation , Omicron has put the end to those hoax , and
w e don't want any more mutations than we have to put up with

Mark Masselli: T his is more about the drug itself less about where the clinical trial
was held, which is South Africa, they had a couple of other locati ons I
was doing it. It's the drug, not the location or was there anything
about the patient population t hat --- or any data that you looked at
that might have also stirred your concern , b ecause it sounds like you
have a historic concern on this drug , b ut a nything that you saw in
their documentation that gave rise to additional concern?

Dr. William Haseltine: Well, first of all, is tested around the world like you have to do if you
want to move quickly. South Africa was one of the places .

Mark Masselli: Yeah .

Dr. William Haseltine: It’s not even sure Omicron had originated in South Africa, it was first
found there. But by the time it’s found there, we found in lot of other
places that we didn’t find it. But let me say there is one additional
concern a nd that is that in their initial trial, going way back to October
2020, where they tried to use the drug to treat people who are
already ill , not within the little window from symptom, that three to
five day window, they failed the trial, but they did a dose escal ation .
T hey use a low dose, that doesn't really work so well. T he viruses that
come out are going to keep coming , a nd they're going to be mutated.
They use a low dose, a higher dose and finally this dose .

Now for a drug, you've got to use those escalation . But others who
looked at this drug for biopreparedness decided it was too dangerous
to use. Others who created research programs a re private companies
dropped the drug because they feared it was too dangerous to use.
Why it has been put forward as a drug to treat perhaps 10s o r more

William Haseltine

millions of people is beyond my understanding.

Margaret Flinter: You know, Dr. Haseltine I think the public and even those of us who
would consider ourselves reasonably well - informed, not experts like
yourself, but reasonably well - informed, I think are getting a little
whiplash about what is just really the --- maybe the normal evaluation
as knowledge becomes available , r ight. Th is week, I think we heard
about Janssen right that Janssen probably ought to be moved out of
the lis t of vaccines for COVID. We haven't seen anything official yet ,
b ut certainly there are some good evidence about both complications
and efficacy.

P olitico, I think, raised in its reporting this week that the Biden
A dministration is really frustrated about doctors and scientists going
on Twitter and cable to criticize their moves and thinking that that is
confusing to the public . But it seems to me this goes exactly to what
our experts have been saying is that we need to get all the opinions
out there so tha t people can hear the information , a lthough we worry
at the same time about misinformation, this is really hard for the
public. (Crosstalk)

Dr. William Haseltine: This is a very difficult situation f or everybody , a nd I sympathize with
the people in the Bid en A dministration. They're very good people.
They have the best intentions. But , you know what I'm really sad
about is we ha d a president who called t his a hoax. We have a
president who takes this really seriously (inaudible 00:10:34) a good
portion of his time, and has an excellent people around it , a nd we still
can't seem to make the progress, not because of the leadership but
b ecause of our people. We are divided. We have all sorts of reasons.
The moment you politicize a health issue, you've done somethi ng that
can be deadly dangerous to the population.

It’s not even necessarily completely political. It is a very complicated
situation. I think that Ed Young in T he Atlantic, today or yesterday
wrote a very, very good article. We're not prepared for this as a
people as a country and until --- he's --- actually something I've been
saying now for some time . U ntil we realize that we are our brother's
keeper, that what I do to protect myself and my family is to protect
me and it's to protect you , a nd you've got to do the same thing. We're
in deep trouble , a nd we're nowhere near there. R ight now, we're
facing, even as I speak today, a virus over the next few days that
Omicron is likely to double , a nd double after that . I f you keep
doubling 2, 4, 8, 16 ,32 i t takes you a week to 10 days to get
everybody , a nd by the way, that's what's happened in Africa a nd it's
what's happening in the UK right now , a nd it's what's happening right
now .

I just got a note from a friend on Twitter who said, I woke up and
everybody I kno w that (inaudible 00:11:59) was COVID . That sounds

William Haseltine

funny, but it's not so funny because it's happened to me, too. All of a
sudden, people I know are calling me up and say, W ill, I just had a
positive COVID test , a nd these are vaccinated , sometimes triple
v accinated people. T his is a situation which is rapidly evolving.

Let me take one message that has been given which I have a question
about why it came out of the White House, which is, oh this is a more
mild infection. I was suspicious of that. I looked at this virus, I couldn’t
--- the sequence and its behavior , I couldn't see anything that
suggested that it was more mild. T he recent papers that have just
come out of the UK say we can't see any difference either. When we
look at our patient population, alt hough it's very tiny right now, it
looks just the same or worse than D elta , s o I wouldn't be reassured.

I think that it's really difficult that I understand the difficulties of
trying to give a coherent public message in a rapidly evolving
situation. But j ust remember when the same group well me aning to
get people vaccinated says the vaccine will absolutely protect you.
Well, it doesn't. S ome of us said, le t's be careful about that statement.
Okay , a re we to be put in the doghouse because we raised an
impor tant issue , b ecause it doesn't conform to public health
message ? It's true , m aybe it does confuse the public. But this is a
confusing situation f or all us.

Mark Masselli: You raise an interesting point that I do want to get into a little later
about the so rt of the battle that's going on in the private science
community with the governmental science and what's happening
there. But I do want to sort of pick up on your point, there's been
spontaneous combustion because we've all had the same experience
that e verybody we know is all of a sudden calling us up and saying,
h ey, we've gotten this, which sort of goes to the question about
O m icron and its effectiveness with the vaccines . W hen are we going
to know whether or not the third shot , booster third shot what ever is
working, and whether M oderna or Pfizer is the best to take for that ? I
think people are really sort of lost and then just how Omicron evades
vaccine neutralization would be helpful . But talk a little bit about your
sense of when we'll have some def initive word on what might be the
best pathway for people in terms of vaccine protection.

Dr. William Haseltine: Well, let me say with respect to the third shot, we know the answer. It
doesn't protect you for very long, maybe only three months, the third
s hot . I f you've been infe cted, and had two doses of the Moderna or
the Pfizer vaccine, it doesn't protect you longer than three months
either. Maybe four months and , Mark , Mo derna maybe a shed shade
better, t hat's sort of I’d say three and a half instead of three months.
But when you look at the data that I've just seen, you don't --- you get
very little protection.

When Pfizer says something like, well, this three shots is significantly

William Haseltine

protective, it means it's tenfold less If you look at the data , protect ive ,
th a n it was against Delta. It also , or I guess, it also says a fter three
months you’ll have virtually no protection, a few people may, but
most people don't. T he answer is what to do? The answer is, which is
test yourself very frequently s o you know i f you're infected . G et
yourself a pulse oximeter s o you know whether or not you have to go
to the hospital. I f your oxygen level drops you know you're in trouble.
Hopefully it doesn't. Avoid crowds. Don't go to your Christmas parties.
Don't travel. Stay ho me. That's hard to say after all we've been
through. But I would strongly advise against bars, restaurants,
theaters, and parties.

Going to give you an example of a friends . I was --- I went to my last
party about three days ago. I said, everybody this is --- I'm not going
to anymore until Omicron is gone. I wish I hope you will listen to me.
One of my friends just wrote me, said, Wi ll, I wish I had listened. I
went out a nd somebody I was with had Omicron . N ow I'm isolated ,
and I h o pe I don't get it. That's what I would recommend. It's hard to
say, I know it's hard for people to do that. It's hard for businesses. This
is a time when you fill up your money back for the end of the year a nd
get some cash that it ti es you over for January and February, which is
a terrible month for retail. But it's pretty dangerous right now , really
dangerous.

Margaret Flinter: Well, it is sobering to put it mildly. I guess the question is, and after
living through this year, right, and this was the year when we had the
vaccine s o we were very optimistic. We gave 800,000 vaccines across
the state of Connecticut . We got very optimistic that this was going to
stop it. It feels like we're going to be back to what was very
inflammatory in our society, which was lockdowns and mandatory
quarantines and maybe school closings .

What is your sense? Are you having an opportunity to weigh in with
the policy people about whether these measures which really come
back to local people, right , governors and mayors and
superintendents of the Board o f Education to impose . What's your
sense of what's going to happen with those decisions? Are they
necessary? Are they the right thing to do right now, you know, if you
can't go to a bar, you probably shouldn't be going to your second
grade class either.

Dr . William Haseltine: Well, let me just say we have a model work hours, this is a UK, which
is not exactly like us, but close enough. They decided they would try
to tough it out , a nd boy do they have problems , a nd every day it gets
worse. In the past, our e xperience in most parts of our country --- the
UK experience has not been a happy one. It doesn't look like to me
we're going to do the things we need b ecause we don't have the
consensus that we need in our population. I'm writing a new book

William Haseltine

now on multimo dal COVID control. T he first thing I'm saying that we
need is a consensus society. If you don't have that, it doesn't matter
how good you are at everything else. We're the best in the world at
communications and drug development, vaccine development , a nd
t his hasn't done us any good. We have more people dead from this
than anybody else in the world, more Americans, and we're only 5%
countries that are 5 , 10 times bigger than us. Maybe India rivals us.
Okay, we're right there in the same boat with India. It is not a happy
circumstance.

W e think our health systems are better than India's , but the results
aren't better. But what can we say? We can only hope that we wise
up at --- I'm always projecting for it. How many years decades or
centuries is it go ing to t ake for us to get to a consensus society? How
many more disasters? Well, the coming i nfections lure like Omicron
bring us closer together or push us further apart.

Mark Masselli: I want to pick up on that threa d about the consensus society. I'm
wondering w ithin the scientific community and I alluded to it earlier.
These are your friends at CDC , at the White House , at NIH that you
know , a nd yet we seem to have some difference of opinion going on,
or their recommendations are not being listened to. What do yo u
think is at the heart of simply the CDC not coming out and saying the
third dose , the booster whatever , should be mandated . Where's the
disconnect t hat's h appening?

Dr. William Haseltine: I think it's a political disconnect , b ecause one of the things thi s is
teaching us which i t’ s teaching us again, is that leaders cannot lead
where they know we have to go. They can only lead where people will
follow. FDR a s a great example, I read a lot about FDR before World
War II, by the late 30s, he knew we were goin g to be in that war. But
the American people resisted just dug it in their heels. You watch how
he struggled and maneuvers and tried , he was a great leader of
people, a nd he did everything he can . B ut until Pearl Harbor, he
couldn't do very much , that chan ge things .

Omicron I don't think it’s going to be our Pearl Harbor for this. There
may be one which allows leaders to lead , a leadership wants them but
if you look behind you, and nobody's there , you're in trouble. I think
that's the lesson between the two presidents. One of them calls it a
hoax one who takes it really seriously , a nd the results were about this.

Margaret Flinter: Well, that is a good note. That is a good note, Dr. Haseltine f or us to
wrap up on . W e know you have a time deadline . W e've been speaking
with Dr. William Haseltine of virologist , the author of two books about
COVID. As you just heard somebody with a strong and clear message
about COVID variants, antiviral drugs and what we might expect going
into the new year. You can learn more ab out him at
www.williamhaseltine.com . Dr. Haseltine thank you so much for

William Haseltine

joining us again on C onversations on Health Care .

Dr. William Haseltine: Thank you very much. I appreciate it.

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Mark Masselli: A t Conversations on Health Care we want our audience to be truly in
the know when it comes to the facts about health care reform and
policy. Lori Robertson is an award winning journalist and Managing
Editor of FactCheck.org, a nonpartisan, nonprofit consume r advocate
for voters that aim to reduce the level of deception in US politics. Lori,
what have you got for us this week?

Lori Robertson: W ith the release of its pediatric COVID - 19 vaccine, Pfizer switched the
buffer used in its formulation to increase the stability of the product.
This allowed the vaccine to remain at refrigerator temperatures for
longer. The Food and Drug Administration okayed the change and the
changes also be en made to some doses for teens and adults. S ocial
media post however have misl eadingly suggested that the ingredient
swap is dangerous or was added to prevent heart attacks in children.
There's no evidence to support that.

The ingredient in question is Tris or R rimethylamine, which is used as
a buffer in the children's vaccine and w ill soon be available in some
a dult and t een formulations as well. A buffer keeps doses at the
correct pH , neither too acidic or too basic. The original iteration of the
Pfizer B io NT ech vaccine used phosphate buffered saline or PBS . Pfizer
and the FDA have said the switch was made to improve the stability of
its mRNA vaccine, which previously had to be kept ultra cold for long
term storage and lasted a month in a refrigerator on es thought . T he
newer version can last in the fridge for up to 10 weeks. Other e xperts
back that up.

Tris has safely been used in other vaccines and other products . L ess
stringent cold chain requirements are especially helpful for the
pediatric vaccine, which is being administered more in doctor ’ s
offices. As for social media post cla ims about Tris being dangerous or
a drug for heart attacks , in large quantities Tris can be used as a drug,
but here as in other vaccines and medicines the compound is present
in only a very small amount as an inactive ingredient to keep the
vaccine stable .

Dr. Kawsar Talaat an infectious disease physician and vaccine scientist
at the Johns Hopkins Bloomberg School of P ublic Health told us the
infinitesimal amount of Tris in vaccines has absolutely nothing to do
with the much larger volumes and higher conce ntrations of Tris being
given to people who are having heart attacks. The Pfizer BioNT ech
COVID - 19 vaccine is not known to increase the risk of a heart attack in
any population. Instead, the cardiac concern that has been identified

William Haseltine

for the two mRNA vaccine s is an increased risk of M yocarditis or
inflamma tion of the heart muscle and P ericarditis an inflammation of
the lining surrounding the heart particularly in young men . B ut these
adverse events are rare and as a buffer Tris would not be expected to
modify the risk in either direction. T hat's my fat check for this week.
I'm L ori Robertson, Managing Editor of F act C heck.org .

[Music]

Margaret Flinter: FactCheck.org is committed to factual accuracy from the country's
major political players and is a project of the Annenberg Public Policy
Center at the University of Pennsylvania. If you have a fact that you'd
like checked e - mail us at www.chcradio.com , we'll have
FactCheck.org's Lori Robertson check it out for you here on
Conversations on Health Care.

[Music]

Mark Masselli: Each week C onversations highlights a bright idea about how to make
wellness a part of our communities and everyday lives. F itness
trackers have become all the rage, especially among upwardly mobile
fitne ss conscious people seeking to monitor their own health and
fitness goals. But another trend has emerged in the age of wearable
devices. After a few months, about a third of users simply stop using
them, leaving a lot of costly devices sitting on the shelf and not in use.
The reality captured the imagination of Tufts University School of
Medicine , Professor, Dr. Lisa Gualtieri.

Dr. Lisa Gualtieri: I had read about the abandonment rates a nd I thought what if you
could take all of these abandoned trackers and give them to the
people who could benefit most from them .

Mark Masselli: She thought what if we could get disinterested owners to donate the ir
used fitness trackers and wearable devices to be repurposed and
donated to underserved populations .

Dr. Lisa Gua ltieri: A lot of the work that we've been doing has been with older adults,
racial and ethnic minorities. For a lot of people, they're quite
interested in owning one of these devices to help them increase their
fitness. F or a lot of people, the cost is pro hibitive , s o I think that that's
a barrier for a lot of people.

Mark Masselli: I n 2015, she launched her nonprofit enterprise R ecycle H ealth, an
online social media campaign to raise awareness for her program
which seeks donated wearable devices no longer in use , to provide
these expensive devices for free to those in need. She partnered with
organizations working with low income adults in wellness programs
and those with mental health issues, seniors in fall prevention
programs, minorities and veterans as well. Her goal is to start
collecting vital data on the deployment of these devices and the

William Haseltine

impact they may be having on behavior change in vulnerable
populations.

Dr. Lisa Gualtieri: What we do is talk to people about how active , how sedentary they
are, t o helping them to see it as an educational process where they
might start off with 2000 , 3000 steps as their goal to make that higher
when they're ready to .

Mark Masselli: S he's hoping to scale that number up significantly in the future, and to
expand thei r data collection on health outcomes for vulnerable
populations who gain acce ss to these wearables. Recycle H ealth, a
simple repurposing of personalized wearables providing these tools
for free to vulnerable populations, empowering them to engage in
activi ties that can improve their own health , provide useful data on
using these devices to improve population health. Now, that's a bright
idea.

[Music]

Mark Masselli: You've been listening to Conversations on Health Care. I'm Mark
Masselli.

Margaret Flinter: A nd I'm Margaret Flinter.

Mark Masselli: Peace and Health .

Marianne O’Hare: Conversations on Health Care is recorded at WESU at Wesleyan
University, streaming live at www.chcradio.com , iTunes, or wherever
you listen to podcasts. If you have comments, please e - mail us at
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