Stark change in rhetoric over the last month. I'm not excited for this at all.
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It is, of course, obvious that speed, or height of fall, is not in itself injurious ... but a high rate of change of velocity, such as occurs after a 10 story fall onto concrete, is another matter.
I just got this from a physician mail list...Gottlieb was the first FDA chief under President Trump:
Call w/ Scott Gottlieb (Former FDA Commissioner) 2-28-20
The most important takeaway: coronavirus is unlikely to simply disappear. Most likely scenario is it will
spread in the US and ultimately we’ll need therapeutics near-term and a vaccine long-term for this to go
the way of the annual flu. Significant uncontrolled transmission in the US could lead to draconian
measures (work from home, school cancellation, etc) that may meaningfully impact GDP.
His thoughts below:
1. This virus has infects 2-4 ppl for each infection (R0 = 4) and has low enough fatality rate that is
can spread easily, but still high enough to cause significant damage. As close to a “worst case
scenario virus” that we have seen in modern times.
2. Coronavirus is already here and spreading in the US. US’s surveillance has been very poor (we
are not testing for it). It is a “when” not an “if” re: seeing real outbreaks
3. Denominator on the case fatality rate is much higher in reality. Cited an imperial college
modeling paper that thinks its 10x higher. So rather than 2% CFR its probably .2% in reality
4. The best case scenario is that outbreaks emerge in the US but we are able to contain it to get
thru summer. By fall it may come back but hopefully we have a therapeutic or prophylactic at
that point. The monoclonal “passive immunity” MABs (e.g. VIR REGN) are more achievable near-
term than a vaccine.
5. Gov’t should be doing more to incentivize development of tx, prophylaxis, and diagnostics.
Should cost between $5-15B to bring a successful MAB to market for this..meanwhile $3 trillion
value was wiped from the markets this week. Device industry is not diving in because gov’t has
not made it clear they will be compensated.
6. Remdesivir challenges: it is IV, not oral. scale up will be tough because there are many “non-
trivial intermediates” in the chemistry process.
~~
• High level takeaway
o Suspect it will be much lower than the 4% in hubei
o 2-4 R0 is scary. Sweetspot of something virulent enough to cause severe illness + death
but cautious enough it can spread widely
o As close to this as anything we have seen in modern times
• CFR depends on denominator – how confident are you that we have that
o Not confident.
o We know lots of asymptomatic and midly asymptomatic
o Based on everything I read, laymen perception, I think its <1% CFR in a developed world
and in US.
o In China kids are not getting sick. My suspicion they are just not presenting but they are
infected
o Looks like 80% of people develop asymptomatic or mildly symptomatic
o 15% is more significant disease – 10% of that is pneumonia
o 1% become critical
• Real # of cases, 82K reported, you think real # is 4-10x higher? What is your intuition
o Imperial college did really good modeling – they say 10x higher.
o Think they missed a whole bunch of patients
o Relied on CT scan in early #s, those were really sick people.
• Hospital burden?
o I think it’s a when it comes here, not an if, I think we’ll be able to control outbreaks
o Increased # of cases, will see a decline in flu season, some excess capacity in hospitals
and will also see a fall in elective surgery
o I think we can get capacity constrained quickly tho if we see widespread spread
• Statements suggesting vaccine in pivotal in a couple months etc, is that in anyway feasible given
what you have seen for process of dev’ing a vaccine
o Some belief you can get into safety trials in months. Maybe vaccine in dev you can put
into 1L health care workers. For licensed vaccine and distribute widely, we are far away
from that
o A therapeutic and maybe a prophylactic MAB not a vaccine is more near term. Need
some technological innovation here. Believe sometime in March we will see cases
increase. If not, will be a hell of a break.
o I think propagation here is extremely likely. See outbreaks in march. Disuprtion to
normal life, then mitigate it. See decline in real summer months, then it can come back
in fall. Technology is key.
• How much confidence do you have in remdesivir
o Idk enough about it. Believed to have activity before.
o Certainly WHO went to China and got a glimpse and came back pretty confident
o Injectable drug, hard to manufacture. Intermediates that are not trivial so scaling will
take time
o Some kind of prophylaxis and tx impt. A MAB like REGN. HC workers
o Can provide enough backstop that could mitigate it
• So strategy is contain and delay until we get an opp coming out of prophylaxis and treatment
o That is my perception of harsh reality. That would be my strategy.
o Prevent as much introduction as possible, that buys you time. Have them take simple
steps to take a big impact
o At same time, build out screening capacity and have a real concerted effort to develop a
therapeutic
o How much will it cost us to make multiple shots on goal
o Whether it is 5-15B..its not going to be $1TN. This already took $3TN out of the market.
MAB prophylaxys would give real level of comfort.
o We are pricing in economic impact since ppl saying it will lead to significant disruption
and impact GDP
• How serious is Pharmaceutical supply chain issues
o FDA announced first shortage. Listed drugs made only in China and also sole sourced
drugs. I wonder if diagram overlaps.
o What is mad ein China and Hubei is a lot of starting materials that are shipped to India.
Some of that, China is the sole source. Sometimes manufactures don’t even know since
they get them from India, who gets it from China.
o So may not be maintaining cntro of starting solvents.
o Many manufactuers have significant supplies on hand. Branded drugs are far more likely
to have that level of supply
o Risk that may only have 2-3 mo inventory.
o Hurricanes struck Puerto rico and took out 10% of drug manufacturing. Thought w
ewould have shortage but we did not. We worked to get them back online quickly.
Channeled resources there
o Lst we put out, we were transparent we listed individual drugs
• Canceling schools
o Italy put whole section under lockdown wen at dozens but not hundreds
o Japan canceled school
o Itl ltake a couple dozen diagnoses to see NYC recommend that businesses shut mass
transit etc.
o 2-3 dozen cases in local community indicates transmission maybe even sustained
transmission
• Mentioned some of changes. CDC, pandemic. What do we need to do differently.
o We are early days here. May be will not be major outbreaks and a lot of alarm will
dissipate. I don’t think so but its possible
o On diagnostic side lot of lessons learned. Simultaneously work with labs to get a
diagnostic available.
o EUA does not contemplate labs, just approved kits. Need to get academic labs into game
o With Zika we dramatically expanded screening is we got Quest into it. They ran a
diagnostic lab very early. Need to bring on that capacity.
o That is a lesson learned
o EUA, law needs to be amended to modernize it
o On Tx side, early days but having capacity is important. We think about tx, moth balled
some excess capacity
o Think about MAB prophylaxis. What co has been paid by fed gov to take this on full tilt
to dev something and scale it up. REGN probably nearest to having the capacity and
have a huge platform. But no one told them to do it
o There were products that worked against MERS – why did we not get it approved? Idk
why we didn’t do that. A broad spectrum drug against coronavirus
• What effect does this have on tx and vaccine effect.
o Device industry has not step forward yet. Still outstanding questions if they will get
reimbursement
o Having a discussion around how evil pharma CEOs are. Suspect it will put a damper on
drug pricing deate and some vilification. Interesting to see if tone shifts a bit.
o And also may see big rallies get canceled. This could really change political narrative
• Solution that China is testing is NOT coming from china, it is from US. And its not local EU cos
that are innovating. Its us cos that have expertise
• Passive immunization
o Being done in China where put plasma from recovered ppl to sick ppl
o There was a publication suggesting it wasn’t too effective. Forget the details. Tried it on
some doctors.
• Do we have enough hospital beds to handle an outbreak?
o We have more capacity than maybe anywhere else in the world except a handful of
cases like Singapore.
o Capacity will get stretched
• Paint best vs worst case scenario
o Best is we have great surveillance in next few weeks and able to test thousands a week.
Dissipates in summer and does no resurge. Or it resurges and we have tx
o Bad case is its everywhere, confounded by flu, onc we start testing we realie its here
then next week we find 50 cases in NY in one day. At that point enough spread that very
hard to contain. If want to break chain of viral propagation, the steps will be FAR more
draconian
Good rundown. Honestly it makes me about less stressed about it.
Sent from my iPhone using Tapatalk
It is, of course, obvious that speed, or height of fall, is not in itself injurious ... but a high rate of change of velocity, such as occurs after a 10 story fall onto concrete, is another matter.
cases by country... updated daily:
https://www.worldometers.info/coronavirus/
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