Regulatory Open Forum

 View Only
Expand all | Collapse all

Off Topic - How is everyone doing?

  • 1.  Off Topic - How is everyone doing?

    Posted 16-Mar-2020 09:04
    Hi All.

    I was wondering how everyone was coping in current circumstances, how worried are people? 

    We are not in lock down in the UK but panic buying is in full swing! Luckily I can work remotely but I do fear around what will happen to a number of industries. Virgin Atlantic are reportedly asking employees to take eight weeks un-paid leave! How as people going to cope! 

    James

    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------


  • 2.  RE: Off Topic - How is everyone doing?

    Posted 17-Mar-2020 06:43
    Doing fine.  I think the media is doing a great job of making a huge thing out of this which is causing over-reaction.  WHO has reported around 300.000 people die globally each year from Influenza flu.  There has been what 5.000+ deaths so far with COVID-19?  I am definitely not under-minding the situation at all, but I know a couple elderly people in 2018 and 2017 who died just from the regular flu because there was an "outbreak" in their assisted care facility.  I just think instead of closing places down, the media should be reinforcing good sanitary hygiene like when you sneeze, cough, washing hands, etc.  There is no need to stop concerts, stop sporting events, or close restaurants.  Just use good hygiene !  And for heaven's sake don't cough on people ! lol

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------



  • 3.  RE: Off Topic - How is everyone doing?

    Posted 17-Mar-2020 07:20

    My thoughts are the same Richard.

    The media, especially social does a great job of taking things to the extreme! I am not trying to down play anything but the wider impact to the economy is going to have a real significant and long lasting impact on a lot of peoples live's. If the government in the UK made it mandatory to close, companies could claim on the insurance and the impact would be reduced. With current guidance being 'we advise', insurance companies will not pay out and I hope they address. 



    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------



  • 4.  RE: Off Topic - How is everyone doing?

    Posted 18-Mar-2020 06:55
    Agree with RIchard and others on the media hype and the hysteria of hoarding and buying that has taken place.  I, for one, enjoy a much easier commute.  I have enough supplies (I wonder if some people ever cleaned their domiciles or thought about food for more than 2 days) to last until the supply chain catches up.  Gasoline is less than $2/gallon, Can't complain at this point, although the cancellation of sports, concerts, theatre, etc. will take a toll.  Amazing to me is that people are taking "extra" precautions which they should have been taking anyway, witness the decline in regular influenza occurrences.  Use common sense, folks, and we will be OK.

    ------------------------------
    James Bonds J.D.
    Director Regulatory Affairs
    Atlanta GA
    United States
    ------------------------------



  • 5.  RE: Off Topic - How is everyone doing?

    Posted 17-Mar-2020 13:16
    I guess I get to the the person to disagree. I am glad that we are taking action to flatten the curve and not experience what Italy is experiencing, where they needed to choose who got ventilators.

    I have TP (no panic buying here, just the usual Costco amount bought prior to the issue), and am sheltering in place, and have been working from home since late last week.

    ------------------------------
    Corey Jaseph RAC
    Director of Regulatory Affairs
    South Jordan UT
    United States
    ------------------------------



  • 6.  RE: Off Topic - How is everyone doing?

    Posted 17-Mar-2020 13:39
    Edited by Hiral Dutia 17-Mar-2020 14:17
    I agree Corey. I am glad so many people are working to flatten the curve. I'm on day 5 of "social distancing" and it is hard! But it's important for people who can stay home to do so. Great explanation of social distancing here by the Washington Post and why it works in flattening the curve for infectious diseases:

    https://www.washingtonpost.com/graphics/2020/world/corona-simulator/

    Keep in mind that the US is still massively undertesting, and many of the milder suspected cases are not reported as a result. Until testing is fully deployed, we don't really know how many cases we truly have. Good news is that in the last few days, Roche, Thermo, and Hologic have all received emergency use approvals for test kits. I am hopeful that we see a massive ramp up in testing in the coming days.

    ------------------------------
    Hiral Dutia
    Sr. Regulatory Affairs Specialist
    Third Pole Therapeutics
    Waltham, MA
    USA
    ------------------------------



  • 7.  RE: Off Topic - How is everyone doing?

    Posted 18-Mar-2020 03:05
    Edited by Julie Omohundro 23-Mar-2020 20:36

    I guess I'm somewhat in between.  My comments apply only to the US and, where noted, specfically to North Carolina.

    I think the media is over-hyping this, but I think so are the politicians, and they play off of each other.  I think things would be handled quite differently if it weren't a major election year.

    I do not think any country's healthcare policy should be based on what happens in another country.  That is like basing your risk management plan for a device with one intended use on the risk profile of the same physical device with a different intended use.  Apples and oranges.  There is a reason FDA is cautious about accepting foreign data.

    As of this evening, two weeks after our first case was reported, we have a total of 63 cases in NC, in 16 of 100 counties. With a total population of 10 million, that's 0.002% of the population. And it is just reported cases, not hospitalizations that could tax our healthcare system, which is sizable. 

    This is not a curve that needs flattening.  It may need flattening in a week or two or three, but not now.  At this point, there is barely a curve to flatten, and, in many of our rural counties, there may never be one.  And yet the governor has ordered the closure of every public school, restaurant, and bar in the entire state.

    I would definitely shut down all events involving crowds, while I think the hand-washing thing is overrated. Our winter flu season is driven almost entirely by millions of Americans packing themselves into flying petri dishes over the holidays, not by people dining in restaurants and/or neglecting to wash their hands.  Viruses spread quickly when they are airborne and inhaled. Even so, a virus isn't likely to spread very quickly in gatherings limited to a few people, including 2-4 people gathered at a table in a restaurant. The virus will spread, yes, but not very quickly.  IMO, at this point in time, a far more rational decision would have been to limit closings to the counties that have at least one reported case.

    In the meantime, my HVAC guy came by today and gave me an update on what he'd seen and heard, traveling around several counties. He said that people are buying toilet paper and hand sanitizer. They are also buying guns. He said that this was not because they are afraid of the virus or people who have it, but to protect their food, when it is not just toilet paper and hand sanitizer that are gone from the sheives.


    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 8.  RE: Off Topic - How is everyone doing?

    Posted 17-Mar-2020 13:39
    Same. Once we had our first case of community transmission, everything changed. We're all working from home if we can. Every day brings a new round of recommendations and closures. There was a dental conference attended by 15,000 two weeks ago, so now all of the dentists in my province are self isolating to prevent further transmission. The government is begging people to stay home. 

    I fear for our poor health care workers when I see the numbers coming out of Europe. Once the genie gets out of the bottle, you can't get it back in.

    ------------------------------
    Karen Long RAC
    Vancouver BC
    Canada
    ------------------------------



  • 9.  RE: Off Topic - How is everyone doing?

    Posted 18-Mar-2020 03:06
    Not at all off topic and a very human concern - thank you for asking.

    Different places are adopting different strategies - and it's not at all clear what is going to work.  Down Under our Federal government is insisting that schools should not be closed as the disruption to the work force (including health care workers) from having to stay home to care for kids is a greater cost than the low grade illness suffered by the young, and the potential build up of herd immunity.  Seems like  very big roll of the dice to me.  Also our State governments are all making different noises.

    The thing that constantly seems to fail to be recognised is the inexorable exponential arithmetic of this and the sheer speed of growth of the epidemic.  It appears patients are more often than not asymptomatic for around 5-7 days after infection, but they are capable of passing on the infection in that early phase.  Depending on which stats you read this thing doubles around every 4-5 days.  which means that the number of people tested today reflects those infected around a week ago and the actual number of cases today is something at least 2-3 times higher, before accounting for under-testing.  4-5 days doubling translates to an order of magnitude around every 2-3 weeks.  Doesn't take long to go from thousands to millions at that rate.

    Which is why it's so important to isolate/avoid contact and take advantage of the internet when you can!  My biggest challenge is to remain focussed on the task in hand and keeping away from news sites and facebook while working at home :)

    Take care everybody.



    ------------------------------
    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@brandwoodckc.com
    ------------------------------



  • 10.  RE: Off Topic - How is everyone doing?

    Posted 18-Mar-2020 08:36
    Edited by Paul Brooks 18-Mar-2020 08:39

    James thanks for asking this question and starting this thread.

    I think that our RAPS community is more than just another professional community. We are a network of friends and colleagues who come together to generously support each other professionally, but there's also a strong social aspect to our community.

    I am sure many of us are apprehensive and concerned with what's happening in our world that is beyond our immediate control, but equally as we adjust to this new world of social distancing and teleworking I hope we can all stay engaged and take time to look out for each other.

    The RAPS office has closed, but all of our staff are teleworking as we focus on ensuring we continue to support the RAPS mission and our members. Many of you are aware we have postponed our EU conference in Brussels and we are re-configuring many face-to-face activities, including chapters to more virtual delivery.

    I think its more important than ever for everyone to stay engaged and stay connected as we overcome this situation and work to maintain our vital sector and prepare to return to more normal times.

    Thank you for participating in our community and let's focus on supporting each other as we get through this together.   



    ------------------------------
    Paul Brooks
    Executive Director
    Washington DC
    United States
    ------------------------------



  • 11.  RE: Off Topic - How is everyone doing?

    This message was posted by a user wishing to remain anonymous
    Posted 18-Mar-2020 09:15
    This message was posted by a user wishing to remain anonymous

    Hi all,
    a word of caution. I live in Northern Italy and I can assure you this does not look like the regular flu. ICU wards are overwhelmed and the situation is pretty grim. I read in this thread the same comments I heard from my colleagues just a couple of weeks ago. Learn from our mistakes: don't panic, but don't underestimate either.
    The curve HAS to be flattened. Stay safe friends!  




  • 12.  RE: Off Topic - How is everyone doing?

    Posted 18-Mar-2020 15:39
    Edited by Julie Omohundro 18-Mar-2020 15:46

    Thinking in terms of "the" anything seems to be missing the point.  There is no "the," there is only what happens when many factors collide.  The virus itself is just one factor.  Age is another.

    Italy has the oldest population in Europe, with about 23% of residents 65 or older. The median age in the country is 47.3, compared with 38.3 in the United States, and 40 in the UK. Many of Italy's deaths have been among people in their 80s, and 90s.  I'm from Florida, the state with the largest percentage of its population over age 65 (19%), so I appreciate these statistics.  I think a lot of Americans would find "older than Florida" to be a bit of a staggering concept, one that would put Italy's hospitalization and mortality rates in a somewhat different perspective.

    From an interview with Aubree Gordon, an associate professor of epidemiology at the University of Michigan:
    The overall mortality rate is always going to depend on the demographics of a population.  The reported mortality rates have not been adjusted for the underlying demographics of a population. Given Italy's demographics, you would expect their mortality rate to be higher on average, all else being held equal, compared with a country with a younger population.

    Key here is "all else being held equal."  Young populations are often found among developing countries, where a lack of infrastructure, including medical resources, would be likely to offset the "advantage" of a younger population.

    Culture also plays a role.  It's my impression that multiple generations mingle much more in Italy than in the US.  If my impression is correct, that unfortunately could mean greater exposure of the elderly to a virus circulating in the population. 

    I'm not sure what you mean when you say that the ICU wards being overwhelmed does not look like "the" flu.  Influenza is the reason the US stockpiles ventilators, because it has the potential to overwhelm ICU wards too.  What a novel influenza virus might look like in any given population is as unknown as it is with a novel coronavirus. 

    The story of the Spanish flu, the first epidemic involving the H1N1 virus is a fascinating case study of the many different factors that can drive, effect, and interact with a virus, including a world war.  Because of this epidemic, for many decades H1N1 was considered to be an especially deadly virus. Then, in 2007, an analysis of the available data concluded that most of the victims probably died of a bacterial infection, rather than H1N1.  And that the "Spanish" flu epidemic probably originated at Ft. Riley, Kansas.

    Speaking of ventilators, another statistic (if correct, sigh) of interest is that Italy seems to have about 1 ventilator for every 5,000 people, where the US seems to have 1 for every 3,500.



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 13.  RE: Off Topic - How is everyone doing?

    Posted 19-Mar-2020 13:54
    Edited by Julie Omohundro 23-Mar-2020 22:18
    So I realize forgot to talk about me.  I do not worry, a decision made young about how I wanted to live my life, based on observation of adults around me.. I agree that "Worry never robs tomorrow of its sorrow, it only saps today of its joy." (Leo Buscaglia)  Instead, I am as keenly interested in the coronavirus and the pandemic as I am in many other things in this fascinating universe we have the great luck to live in for a time. 

    A little over a year ago, I moved from south Durham (part of the Research Triangle) NC to Mebane, roughly 30 minutes down I-40 from where I used to live.  Instead of a townhouse complex, I now live at the end of gravel road off a country highway, surrounded by trees.

    I live on the border of Orange and Alamance counties.  As of last night, NC had a total of 97 cases.  The statewide count has gone from 33 to 64 to 97 in the past three days. Durham county has reported a third of the cases; no reports in either Orange or Alamance County, and still no deaths.  The Durham count makes me wonder if the reports have any real value for tracking the spread of the virus.  I'm thinking maybe Durham ("the City of Medicine") is just where they were tested/diagnosed.

    A cousin called to ask if I were "hunkered down."  I said it was hard to tell. :)

    So far, I haven't adjusted my lifestyle much, but I haven't needed to.  In reality, in case no one has noticed, I live mostly on the internet.  So far, transmission rates of the virus itself via the internet have been very low, while transmission rates of hysteria have been astronomically high.  Fortunately, I seem to have been born with a natural immunity to the latter.  The former, maybe I'll find out.

    I think everything will probably stay just out ahead of me.  For example, yesterday I had an appointment in the thriving metropolis of Burlington (pop.50,000+), in Alamance county.  Normally, as long as I was in the Big City, I would have taken the opportunity to have lunch at one of the restaurants that is a little higher end than the truck stop diner close to me. :)  But yesterday was the first day that the governor's order to close restaurants was in effect.

    I decided I would do takeout, and discovered that restaurants aren't just closed, but locked down, i.e, you can't even go inside to order take out. I don't think this was part of the governor's order, so probably a business decision. It made for an odd contrast, shopping areas with locked down restaurants scattered among the open stores and shoppers coming freely in and out.

    The skeletal restaurant staff were eager to chat (they tend to be people people).  Both manager and ...takeout server?...came out to my car.  The server had a grandmother with an autoimmune condition, so the family was delivering everything to her door.  Literally, setting it down and walking away, and then she opened her door and took it inside.  The other was a manager.  She wasn't worried about the virus, but about their laid-off staff and how they would survive without their paychecks. 

    The server said that there were three coronavirus patients currently at UNC Medical Center.  I didn't press for details, but presumably she knows someone who works there, so the information is probably, if not rock solid, reasonably close.  Pretty much everyone in this area knows people who work at UNC and Duke.

    I learned from the guy in the meat department at Harris Teeter than the governor cannot legally force grocery stores to close, and that, so far, HT corporate is saying that they will not close, no matter what.  A manager told me that the toilet paper companies are not planning to increase production, which makes business sense.  They know perfectly well that they already make as much as is needed, and ramping up in response to hoarders would just leave them with a lot of unsold product a month or two down the road.  The store I was in normally has sales of $500,000 a week; this week it was looking at closer to $1 million, but everyone understood that this would balance out with lower sales somewhere down the road.  The manager said that they had no supply shortages in terms of what people actually need, just limits on distribution channels that could not keep up with the hoarding. There has been talk of a shortage of truck drivers in the US for some years now, so that may be the main limiting factor.

    I went into Durham this morning.  In most shopping areas, it seemed that 2-3 chain stores had closed, but otherwise, maybe a little less business than usual for a week day morning, maybe not.  Regardless, I'm thinking of tomorrow as The Last Friday, and this weekend as The Last Weekend for the Triangle, in terms of most non-essential stores being open and shoppers out as usual.  I think Mebane and Burlington are good for at least another week.  


    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 14.  RE: Off Topic - How is everyone doing?

    Posted 18-Mar-2020 09:32
    A lot of opinions expressed here that reflect the lack of knowledge we have about this virus. Is it same as or better than influenza? The experience in Seattle is different than what was originally described from China. Infectious disease specialists in Seattle say they cannot distinguish, based on signs and symptoms, between influenza and COVID-19. The mortality rate is probably 10 times that of influenza. 

    I am doing fine, but will isolate myself in my NYC apartment and not go out unnecessarily until the infection rate stops doubling in 24 hours as it did between Monday and Tuesday here in the City.

    ------------------------------
    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
    ------------------------------



  • 15.  RE: Off Topic - How is everyone doing?

    Posted 18-Mar-2020 09:43
    Hi James and thanks for asking.

    Agree that there is too much media hype.  Our politicians and scientists need to make clear that the reason we are "flattening the curve" is basically to buy time without overwhelming our medical facilities for in patient activities; and for vaccine development and production and therapeutic treatment of patients. I saw this explanation on a broadcast from the UK. The use of the term "sheltering in place" is a visual reminder to many of us here in the US of our children in schools when gunmen are running loose in the facilities.  Not good.  Quarantine is effectively what we are doing although I prefer some other terminology.  Any suggestions.

    Personally during the months of January through the end of March I am in my Florida office which is a routine I've been following for 15 years. Located just south of West Palm Beach the media does not create the panic that we've seen in the New York New Jersey area and in Northern California. However positive cases and deaths in Florida follow the rest of the country.  We moved up our return to New Jersey about 10 days earlier, mostly because we believe that things will get worse before they get better.  And besides our kids most of which are in NJ and a few in the Walnut Creek area of northern CA are driving us crazy; first to stay in the south and now to return.

    We wish all good health.


    ------------------------------
    Robert Schiff PhD, RAC, CQA, FRAPS
    CEO
    Schiff & Company, Inc.
    583 Mountain Avenue
    North Caldwell, NJ 07006
    rschiff13@aol.com
    973-568-3361
    ------------------------------



  • 16.  RE: Off Topic - How is everyone doing?

    Posted 18-Mar-2020 13:02
    Hello James and All,

    This is an incredibly important topic. I tend to trust the experts rather than the media. Although, there is a lot of great information being shared out there on Twitter by experts and discussions on LinkedIn and some in certain Clinical Research Facebook groups. I'm not sure if anyone caught CNN's "Unseen Enemy" that was shown again this past weekend, but it eerily predicted something similar, including the social media hysteria reactions and hoarding of toilet paper we are seeing.  Luckily we all work in an industry of incredibly smart, talented scientists and clinicians that are banding together to collaborate and share equipment, staff and information. 

    I'm in Colorado where it seemed to have started in the high country with travelers to the ski resorts. My younger colleagues snowboard every weekend, so we started to work from home last week. Not only have resorts now been ordered to shut down by our Governor, anyone who was at resorts is being asked to stay away from others, sick or not. Our company is based in Manhattan and sent us Lysol wipes, Purell  and Kleenex in January to prepare everyone and our entire company is now remote. I appreciate working for a company that is taking this threat seriously.

    It is not the young, healthy people I worry about, it's my family, friends and colleagues that are older or have underlying health conditions. I know we all have similar stories. For me, this includes my 12 year old nephew who is constantly in and out of Children's Hospital Colorado after many rounds of chemotherapy and failed stem cell transplant from his sister. It includes my elderly aunt who lives alone in Northern Colorado and is on Oxygen and my dad's wife in Tennessee who has COPD. Even I was hospitalized with Pneumonia a few years back and my asthma didn't help it. 

    I really, really hope that we are overreacting. However, I'd rather overreact than under react. I really hope we won't be Italy, very shortly.

    Thank you to those who are on the front lines as healthcare workers. delivery drivers, grocery store workers, school cafeteria workers, janitors and of course to those in developing diagnostic tools, treatments, vaccines and hopefully cures for this unfortunate pandemic.

    Be well all,
    Lindsey

    ------------------------------
    Lindsey Summers, MBA
    Director, Pharmaceutical Consulting Division Green Key Resources, LLC
    Communications Manager - RAPS Colorado Chapter
    Communications Director - AMWA Rocky Mountain Chapter
    Denver, CO
    Direct: 720.543.8692
    Mobile: 303.437.0391
    lsummers@greenkeyllc.com
    www.linkedin.com/in/lindseysummers

    http://www.greenkeyllc.com/ph/

    Regulatory Affairs / Medical Writing & Publications / Medical Communications & Information / Clinical Operations / Clinical Quality / Drug Safety / Data Management / SAS Programming / Biostatistics / Drug Development Project Management / Clinical Development / Medical Affairs & Monitoring / Epidemiology / Health Outcomes

    Please note that in the state of California, Green Key conducts business under the name GK Pacific, LLC.
    ------------------------------



  • 17.  RE: Off Topic - How is everyone doing?

    Posted 19-Mar-2020 03:01
    Hi All
    In the Czech Republic we have been in total quarantine for the second week, it is not possible to go out without a mask, only shopping, pharmacy, work and home. This lock down will take for  another 3 weeks. We have declared an state of emergency.
    For instance ŠKODA AUTO (Wolkswagen Group) stopped car production for 3 weeks yesterday and sent people home. Uncertainty is as high as everywhere else.
    The media inform us very well and in my opinion the government has taken very strict measures, people support all measures.
    Stay healthy and safe.

    ------------------------------
    Evangelos Tavandzis
    Lead Auditor, Consultant
    Praha
    Czech Republic
    ------------------------------



  • 18.  RE: Off Topic - How is everyone doing?

    Posted 19-Mar-2020 06:16
    Hi All.

    It is great to hear from everyone. The impact will be different for us all and it is great to hear that we are at least, healthy!.... for now! On a personal note, I am fine and my family is also healthy. I cannot say that we have not been affected by this as we have. My twins birthday party for this weekend has had to be cancelled and we were also due to fly out on holiday next Friday, this has also been cancelled! 

    In the UK, our Prime Minister announced yesterday that schools will close from tomorrow. Children who have parents that are key workers will still go to school though. I expect London to be put on lock down by the end of the week as the requests for people not to socialise is not being followed.

    I think our government is doing quite a good job at the moment, I am sure many would disagree but this situation is unprecedented, is there a right or wrong way of doing things! The wrong thing would be doing nothing at all but we are all addressing this. Should we be taking quicker and stronger action? Who knows. One thing I know for sure is that we will all get through this!


    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------



  • 19.  RE: Off Topic - How is everyone doing?

    Posted 19-Mar-2020 11:20
    Hi all!
    Here in Massachusetts, we are in a "hot spot" and given how fast the numbers are going up, the govt. is making the correct moves to shut everything down and try and isolate people as much as possible. We want to try and make sure the hospitals are not overwhelmed. There is scientific merit to the idea of letting everyone "get it" and build up herd immunity as fast as possible, but the toll that would take on the health care system is catastrophic. The majority of people will be fine, but it is also societies duty to protect the minority, and part of that is slowing the spread of the disease so that everyone has access to the medical support they need. That said, it is also the responsibility of society to support those who will be without pay to slow the spread of disease, something here in the US we are shamefully bad at. 

    Has the media gone crazy, of course, that is the media's MO over the last decade. To me, that is a separate question. It is also responsible for the seeds of panic it has sewed, the toilet paper hysteria, the hording, and general stupidity surrounding the response. 

    It will be very interesting to see how the next few weeks play out.

    ------------------------------
    Sara Montminy
    Manager, Medical Writing
    Mansfield MA
    United States
    ------------------------------



  • 20.  RE: Off Topic - How is everyone doing?

    Posted 19-Mar-2020 12:53
    Edited by Julie Omohundro 20-Mar-2020 11:25
    I'm rapidly coming to the conclusion that it will only overwhelm the healthcare system if the healthcare system just sits there and lets itself be overwhelmed.  Efforts to slow the virus should just be one side of the story.  Efforts to expand capacity should be the other and, if existing manufacturers "ramping up" isn't going to cut it, then those efforts should be much wider.  It appears that the vaguely alluded to "capacity" comes down to two things 1) ventilators and 2) healthcare staff.  A  little googling tells me it is not that hard to make a ventilator, e.g.:

    https://www.ncbi.nlm.nih.gov/pubmed/8143481
    https://interestingengineering.com/diy-ventilators-might-ease-supply-shortage-amid-coronavirus-pandemic https://www.goodnewsnetwork.org/doctors-plane-save-womans-life-constructing-makeshift-ventilator-plane-parts/

    It seems to me by now every innovation-smitten engineering school in the country should be cranking these out. Whether they are or not, I can't say, but if so, they've been doing it very quietly.

    Also, the amount of skill required specifically to use a ventilator does not require hours of classwork, or a lot of time, so that one trained healthcare worker should be able to handle quite a lot of patients who need ventilation.  It seems to me that every healthcare provider in the country should be training pretty much their entire staff right now.  Whether they are or not, I can't say, but if so, they've been doing it very quietly.

    So most recently I've been wondering whether this pandemic might not prove to be Death by Protocol.

    As for the media, that's been its MO way longer than the last decade.  Just on the internet for the past decade, which has removed filters and oversight.  Individuals on LinkedIn (and presumably FB and twitter) are doing as much, possibly much more...damage as the "mainstream" media, e.g., a Johns Hopkins MD who imagined himself to be "in public health" and therefore fully qualified to advise everyone to lay in three months of food and medical supplies.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 21.  RE: Off Topic - How is everyone doing?

    Posted 19-Mar-2020 13:25
    Julie I agree with your assessment. It's truly amazing that our country has not geared up to make ventilators and it's taken so long to get diagnostic products in place which still aren't totally available. It also seems that Covid-19 vaccines and therapeutics are now in development; many of which are being developed outside the United States. The implication here is that we in the US should have been working with our colleagues worldwide and not apparently disregarding or waiting until the last minute until there were major concerns.

    Information was available in December and early January about the emerging epidemic. Either our government simply paid no attention to it or there was a gross failure to connect the dots. The situation has an analogous similarity to the events leading up to 9/11.

    Julie you and I sometimes take contrarian views of situations. Now we are all in the same boat.


    ------------------------------
    Robert Schiff PhD, RAC, CQA, FRAPS
    CEO
    Schiff & Company, Inc.
    583 Mountain Avenue
    North Caldwell, NJ 07006
    rschiff13@aol.com
    973-568-3361
    ------------------------------



  • 22.  RE: Off Topic - How is everyone doing?

    Posted 19-Mar-2020 15:06
    I think my perspective is that, if two MDs can cobble together a working ventilator with only the materials on hand mid-flight, we don't need "our country" to address the shortage of ventilators. And I'm pretty sure the same MDs are up to the task of training other MDs and healthcare professionals in the use of a ventilator, without any need for government involvement.  Except that none of that is "per protocol."

    To be clear, I'm not anti-government, and I'm specifically pro-FDA (sometimes I think maybe more than FDA is), but in a crisis situation, I'm not pro people sitting around waiting for the government or anybody else to tell them to do what they already know they can do, clearly needs doing, and the people who normally do that are telling them that they alone can't do it fast enough.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 23.  RE: Off Topic - How is everyone doing?

    Posted 19-Mar-2020 15:38
    UK call for companies to assist in the supply of ventilators:

    The government is looking for businesses who can support in the supply of ventilators and ventilator components across the UK as part of our response to COVID-19.

    As well as manufacturers, we are looking for businesses with the following skills:

    • design/specification
    • rapid prototyping
    • contract/product assembly
    • certification/regulation/testing
    • logistics
    • medical training

    https://www.gov.uk/government/news/production-and-supply-of-ventilators-and-ventilator-components

    Anyone have any idea how long this type of effort is likely to take, from the moment the government says, okay, make us some ventilators to when the first ventilators are ready for distribution?  I gather they are looking for existing manufacturers, but also for companies that can go from design to manufacturing.  And of course through the regulatory hoops, per protocol.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 24.  RE: Off Topic - How is everyone doing?

    Posted 23-Mar-2020 21:40
    Edited by Julie Omohundro 23-Mar-2020 21:40

    This effort sounds promising, but maybe I'm biased, since the coalition will be led by an NC company.  As of Friday, they expected to start production today and make their first deliveries by Wednesday, ramping up to 10 million masks a week in 4-5 weeks.

    http://www.ncto.org/news-events/press-releases/

    "Dr. Peter Navarro, assistant to the President and director of the White House Office of  Trade and Manufacturing Policy, worked with the coalition and helped expedite the production of these masks. The first face masks have been approved by the U.S. Department of Health and Human Services."

    Anybody know if this approval is somehow different than FDA approval?  Anyone know which emergency use guidance these companies are likely to be following?  I can't keep up...



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 25.  RE: Off Topic - How is everyone doing?

    Posted 20-Mar-2020 08:08
    Great conversation. I made the difficult decision to leave MN and go into self-isolation in the UK where I also live. Glad to see both governments stepping up and making some decisions for the public, as they should do. I am still surprised/concerned/amazed at the people who are not listening to the warnings and taking precautions. Hopefully the 'hype' will result in fewer of us being infected, at which point I think the media will be satisfied with the berating they are getting. 

    Regarding the media, they are in a 'damned if you do, damned if you don't' position. If they don't report on it, they will be accused of not doing their job and hiding information from the public. If they do report, they are accused of inciting fear and panic. I think we have forgotten how the information environment has changed; it is not intended to be watched/read/followed 24/7. It also isn't meant in the short news bits to provide the full picture. We all are still (if not more) responsible for seeking out additional information from a variety of sources (yes, also technically the media, but in a different capacity). So really it is US who are creating the hype by our impulsive actions/reactions to what we very quickly hear on the news and from others.

    Just my 2-bits. Now back to work (oh wait, I am working... :)) and another cup of good coffee in the comfort of my home!

    Stay safe - and remember, hand sanitizer, elbow, 3 feet.


    ------------------------------
    Lena Cordie-Bancroft
    Victoria MN
    United States
    ------------------------------



  • 26.  RE: Off Topic - How is everyone doing?

    Posted 22-Mar-2020 23:51
    Edited by Julie Omohundro 23-Mar-2020 14:03
    Lena, I also lean toward the responsibility for actions falling to those who take them.  In this case, the media have taken actions and the public has taken actions.  I think each is responsible for their own.

    Not going to get off onto a media rant, but I will clarify that I think overhyping is measured as much or more by the quality of the reporting as the quantity.  The alternative to "don't report" isn't "report 24/7," nor is it reporting misleading or erroneous content, just to fill a void.

    As for not listening to precautions, spring break is in full swing here, and apparently the beaches have been far from deserted, sigh.  The government may be stepping up and making decisions for the public, but for the airlines and other businesses, maybe not so much.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 27.  RE: Off Topic - How is everyone doing?

    Posted 23-Mar-2020 12:36

    Wow. It is so distressing to read these cavalier posts about the disease, its ability to spread exponentially, and its rate of killing patients at more than 20 times the flu.

    It is also distressing that my post to obey the recommendations was reported to RAPS as inappropriate. Posts that are suggesting that we decide for ourselves whether to dismiss or even disobey the WHO, state, and CDC recommendations remain.

    People of every age are dying, not just the elderly. Hospitals in the US, especially rural hospitals already on the verge of bankruptcy for serving uninsured people without reimbursement from the ACA (as they had been reimbursed better 4 years ago), are already choosing who gets a ventilator and who dies. Because of limited testing availability in the US, we have no idea about the extent of the infection.

    "This week, it's going to get bad" says the US Surgeon General.

    Please respect the "herd" and obey all the requirements and recommendations. We might not reduce the exposure, but we can "flatten the curve" so that many don't need extensive health care at once.

    https://www.msn.com/en-us/news/world/italy-pandemics-new-epicenter-has-lessons-for-the-world/ar-BB11vMrO?li=BBnb7Kz



    ------------------------------
    Andrea Chamblee Esq., RAC, FRAPS

    This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

    Silver Spring MD
    United States
    ------------------------------



  • 28.  RE: Off Topic - How is everyone doing?

    Posted 23-Mar-2020 14:01
    Edited by Julie Omohundro 26-Mar-2020 14:13
    Andrea, I'm sorry to hear that your post was reported as inappropriate.  I tried searching for it, but the server keeps timing out.  But perhaps it wasn't just reported, but also "moderated," and therefore is no longer there to be found.

    Based on my recollection, I think it was probably one in which you mentioned the name of someone holding political office.  I personally don't care if people do this (or anything else much, except outright name-calling and hate talk), but mentioning a politician or partisan group has a high probability of getting your post reported in any forum that that is not dedicated to partisan politics.  Probably more so in a forum that is dedicated to professional subject matter.

    This seems to be even more likely (and perhaps rightly so) if the mention seems to be gratuitous, i.e., adding nothing to the content of the post.  That was my reaction, which is why I remember it, while my memory of the content is by now rather hazy.  This is often the end result of a gratuitous mention--it not only adds nothing to the content, but can distract from it to the point that the content gets overlooked or forgotten.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 29.  RE: Off Topic - How is everyone doing?

    Posted 23-Mar-2020 16:31
    Hi Andrea.

    First, let me state emphatically that if a post is presenting a viewpoint on a system like this, in my opinion, unless it is completely out of line or somehow or other unacceptable from the perspective of unprofessional, reporting said post as "inappropriate" seems not only a bit childish but also is likely to stifle the entire purpose of this forum - namely to provide a place for a reasoned exchange of ideas on topics.  I may or may not agree with all of the positions taken and I often choose not to engage in a discussion when I am not certain that my opinions would be welcomed by the "masses" or might not even be understood by the people involved in the discussion.

    That said, I will say I find it unusual (and honestly have trouble understanding) how we can "flatten the curve" when people who shows symptoms have a 2 week incubation period for the virus during which, again, as I understand it, these same asymptomatic people can still spread the virus during the incubation.  That doesn't mean I don't respect the opinions of the very highly educated members of the medical community - I spent years as a volunteer EMT in my local fire department.  I just don't know how well anything short of a full shelter-in-place for 2-3 weeks is going to work to eliminate the spread of the virus.  I suspect that the government officials and these same medical personnel are in the same position and this is obviously not a situation where the US will likely be able to get to simply because you have the circumstances of medical, police, fire and military personnel needing to be at their respective posts throughout this because of the issues with "human nature" being as they are.  I commend everyone who is taking this seriously.  This is not something to be minimized at all.  And please don't take my comments as in any way not accepting your position that people need to be less cavalier about this disease or simply ignoring the advice of the medical field.  I just simply am saying that as a person, I find it hard to accept that sort of full quarantine we are going to be able to flatten the curve to the extent that some people would suggest.  Could limiting exposure by taking steps that make sense help the medical industry?  Absolutely.  And again, I commend people on here for thinking through what is realistic.  I don't subscribe to reporting posts that I don't like or that I don't agree with.  This is where the problem lies - people who believe they "know better than the politicians or _____" (fill in the blank with whomever you want to argue about!) and they are going to deal with this like nothing is happening worse than the common cold.

    ------------------------------
    Victor Mencarelli
    Global Director Regulatory Affairs
    MelvilleNY
    United States
    ------------------------------



  • 30.  RE: Off Topic - How is everyone doing?

    Posted 23-Mar-2020 17:50
    Edited by Andrea Chamblee 23-Mar-2020 17:51
    I hope to help with your statement that "I find it unusual (and honestly have trouble understanding) how we can "flatten the curve" when people who shows symptoms have a 2 week incubation period for the virus during which, again, as I understand it, these same asymptomatic people can still spread the virus during the incubation."
    They can't spread the virus during the incubation period as long as they are self-quarantining, especially 2 weeks before showing symptoms.
    Or at least they can only spread it to the people they are living with, and not the hundreds of people who touch the same doors at work, the same grocery carts in stores, the same tables and surface areas in restaurants, and the same people they pass by and expose.
    That's why the self-quarantining is so important, any why these posts dismissing the need to do this are so dangerous.
    We'll probably all get the virus eventually; that's true. It's more important that we don't all get it at the same time. This graphic depiction may help. It shows how the local hospitals are going to been to withhold treatment in some regions unless we "flatten the curve."
    https://covidactnow.org/

    ------------------------------
    Andrea Chamblee Esq., RAC, FRAPS

    This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

    Silver Spring MD
    United States
    ------------------------------


  • 31.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 09:52
    I suspect you two are using the term "quarantine" differently which is causing the confusion here.

    As I read it, Andrea is using the term for everybody staying away from each other for two weeks (or at least as much as humanly possible) and Victor may be using it more like "those who have been exposed or have symptoms go into quarantine."

    Thus, you end up with different "curves" at the end, and a different impact from non-symptomatic people.

    g-

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------



  • 32.  RE: Off Topic - How is everyone doing?

    Posted 25-Mar-2020 12:32
    Been meaning to add...

    I also think there may be some confusion between not taking the media hype seriously versus not taking the epidemic seriously.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 33.  RE: Off Topic - How is everyone doing?

    Posted 23-Mar-2020 18:33
    I have not read anything like every post on this forum, but I don't think of it as a forum in which to discuss public health policy except as it relates to the regulation of medical products. For example, FDA's recent guidance on ventilators, or how manufacturers might go about "ramping up" with due consideration for both regulatory restrictions and patient safety seem perfectly on target to me, but this type of discussion, no.

    This is not to say that I think these topics "should not" be discussed here, but that I don't agree that "the entire purpose of this forum...is to provide a place for a reasoned exchange of ideas on topics."  If that's its purpose, then to me it has become just another plain vanilla online forum without focus or scope or any professional purpose, and may as well not even be under the RAPS banner.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 34.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 14:03
    "obey all the requirements and recommendations"

    Which requirements and recommendations are you referring to?


    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 35.  RE: Off Topic - How is everyone doing?

    Posted 25-Mar-2020 12:42
    I do not think it is physically possible to obey all the requirements and recommendations, nor even to keep track.

    "The cacophony that comes from having CDC recommendations different than World Health Organization (WHO) recommendations different than NIH and FDA recommendations is overwhelming. Then your state governor declares a state of emergency and says you're supposed to follow WHO guidelines, but OSHA says you have to follow CDC guidelines. You just want to pull your hair out."

    Amy Compton Phillips, Chief Clinical Officer
    Providence St. Joseph Health, which treated the first confirmed US COVID-19 case



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 36.  RE: Off Topic - How is everyone doing?

    Posted 23-Mar-2020 13:09
    For those suggesting the media "hype" is inherently unreliable, I hope you'll consider spreading that trope is playing into the hands of dictators. It is a common practice to make citizens "reject the evidence of your eyes and ears." "It was their final, most essential command."- George Orwell

    The media is always unreliable is exactly what Putin and other dictators wants Americans to think.

    NYTimes  The Atlantic

    Please be careful out there.



    ------------------------------
    Andrea Chamblee Esq., RAC, FRAPS

    This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

    Silver Spring MD
    United States
    ------------------------------



  • 37.  RE: Off Topic - How is everyone doing?

    Posted 23-Mar-2020 13:27
    I agree with this. I find the disdain of the media coverage concerning, and it has been that way since this first arose.

    ------------------------------
    Corey Jaseph RAC
    Director of Regulatory Affairs
    South Jordan UT
    United States
    ------------------------------



  • 38.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 09:48
    It's sad, but to some extent the media has done this to themselves. By splitting into their separate political "pools" for some years now [presumably because they need someone to pay for their content and the hyper-partisans are most likely to pay] they have convinced many that every article has an "agenda." Thus, when they report scientific facts, it is assumed by many that they have some sort of partisan spin - even if they don't. I admit to this being one reason I tend to do my own research on nearly everything.

    I have now sworn off my social media too, because way too many people want to post content that basically says "see CV19 proves my political position is right." Sigh.

    I hope our nice professional forum stays focused on solving issues related to this crisis and doesn't turn into that.

    g-

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------



  • 39.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 11:03
    Every article has an agenda, often multiple agendas.  Sometimes it's just one agenda and is as simple as someone thought it would increase readership.  (If it bleeds, it not only leads, but if it doesn't bleed, it might not even get written.)  The simplistic nature of the prime agenda sets up a scenario in which the media is easily used by anyone who can spin a good story.  The world is not short on people and organizations eager to use the media. Thus the multiple agendas.  This is exacerbated by a lack of deep knowledge of the subject matter, which makes the media not only easy to use, but easy to deceive.  Especially when the subject matter is complex, like a pandemic or medical device safety.

    But I think the focus on agendas is something of a mis-direct, as the relationship between agenda and the value of the information included in the article is tenuous at best, and that doesn't even get into the media's ability to present information that potentially has value in a way that the value is realized.  I don't think the media knows what a scientific fact is. much less how to present one in a way that is not misleading or flat out wrong.

    Moreover, the process that the media typically follows, even when it is trying to "investigate," strikes me as pretty much destined to produce garbage.  Would you conclude that a medical device is safe and effective because someone told you so and someone else said so too?  Me neither.

    I have been tending to my LI connections for the last year or so, and I'm happy to say I haven't seen any articles in my feed so far of the kind you describe. But I have no doubt there are legions of them out there.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 40.  RE: Off Topic - How is everyone doing?

    Posted 23-Mar-2020 19:04
    Edited by Julie Omohundro 24-Mar-2020 19:42
    Ok, I'm an Orwell fan, so I can't let this one pass:

    "I watched him with some interest, for it was the first time that I had seen a person whose profession was telling lies--unless one counts journalists."  George Orwell, Homage to Catalonia

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 41.  RE: Off Topic - How is everyone doing?

    Posted 23-Mar-2020 14:22
    Does anybody know how to interpret this statement as it applies to CDC case counts posted on Monday mornings?

    This page will be updated regularly at noon Mondays through Fridays. Numbers close out at 4 p.m. the day before reporting.

    It could mean that counts posted on Monday are as of 4PM on Friday, or as of 4PM on Sunday.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 42.  RE: Off Topic - How is everyone doing?

    Posted 23-Mar-2020 19:35

    Great question. I mainly work remote anyways, so no big change there. However, our town, Knoxville, TN, is slowly heading into lockdown. Non-essential biz were notified just today. 

    I think the govt and media reaction has been extreme and unwarranted. People's reaction has been mixed with some behaving like zombie apocalypse is imminent and others twerking in Florida for Spring Break, but many others have adjusted their habits. I and my family are only going out when it is essential and adding some hygienic measures. My biggest concern is how does gov't and biz get back to operational state. Since it isn't clear, I assume gov't (gov't bodies, schools, DMV, Building & Safety, etc) will stay shut much longer than necessary and people will start showing their disagreement by opening up their biz and trying to recover their lifestyle long before gov't gives a green light.

    It is really stunning that this happened given the relatively small number of high severity cases in the US.  Outside of Washington, California, and New York, there have been approximately 202 deaths as of tonight (Johns Hopkins CV site) due to coronavirus. By comparison, 90 people die in car accidents per day in US (we still drive our cars confidently), 18,000 people will die from the flu in the US this year (nobody wants to get the flu, but does anyone think the end of the world is near when flu season starts?),  3,000 will die from foodborne disease in US this year (Has anyone integrated food inspection steps into their daily habits), 647,000 Americans will die from heart disease this year (Americans are overweight and it is getting worse). 

    Why such a strong reaction to Cvirus? I don't know. It is surreal.



    ------------------------------
    Adam Atherton
    Farragut TN
    United States
    ------------------------------



  • 43.  RE: Off Topic - How is everyone doing?

    Posted 23-Mar-2020 20:17
    Edited by Julie Omohundro 25-Mar-2020 14:33
    Many reasons for the strong reaction, including political, economic, and/or psychological reasons.  The only two reasons really pertinent to health that I have been able to identify:

    1) "Exponential."  I have focused entirely on the data being posted by the NC Department of Health.  That is a short history, with daily increases ranging from 19% to 94% increases over the number of cases reported the previous day, with something between 30% and 40% looking to be the median so far.  As of last Tuesday, we had 33 cases. Today the number stands at 297, nearly a 10-fold increase. 

     I have crunched the numbers based on a 30% increase daily and it seems that, at his rate, we would have 10 million cases (the entire population of North Carolina in about 6 weeks.
    ___________________________________

    Can anyone check my numbers?
    03/17 - 33 cases
    03/18 - 64 (+94%)
    03/19 - 97 (+52%)
    03/20 - 137 (+41%)
    03/21 - 184 (+35%)
    03/22 - 255 (+39%)
    03/23 - 297 (+16%)
    03/24 - 398 (+34%)
    03/25 - 504 (+27%) NEW

    ___________________________________


    2) "Ventilators."  My best information (and I don't think anyone's information is very good) is that the overwhelming majority of deaths are due to "a primary inflammatory response" of the lungs (oh...and/or organ failure, not sure if that is separate or related), and, further, that patients who experience this symptom will...probably/almost certainly/certainly die without a ventilator.  I have had a harder time finding ventilator numbers to crunch, much less useful information about what the numbers actually represent, but I think some facilities may already have all of theirs in use, and, without resupply, all of them are likely to be out of ventilators within the next...week or two, maybe three.

    What you need to know next (but I don't think anyone is telling us, perhaps because they don't know) is what percent of those who contract the virus will need ventilators.  However, it seems pretty clear that when you combine "exponential" with "ventilators," the prognosis isn't good.

    On the other hand, it's a virus, and like all living organisms, unpredictable.  No one knows how this is going to play out.  That said, if I were inclined to do more than "hope" ("...is not a strategy") that I and loved ones would survive this pandemic, I'd probably be googling "DIY ventilators" for instructions (there are plenty out there) and then heading over to Lowe's or Home Depot for parts.

    You could also follow this effort (there I go, braggin' about NC again):
    http://www.ncmbc.us/announcements/diy-hack-a-vent-innovation-challenge/

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 44.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 00:38

    Hi Julie, I always appreciate your insight.

    Let's look at this with a risk management perspective; probability, severity, and mitigations.


    Probability would be range depending on how the population is divided. Very low would be those with healthy immune systems and limited social interactions; while those with compromised immune systems and more socially connected would be a relatively higher, not high, probability. Both probabilities are increasing at this time, however we also know the number of cases is underreported because people who are asymptomatic or have mild symptoms aren't necessarily going to be tested.

    Severity would also be range to account for the different symptoms, including asymptomatic, mild, and severe, including death. Severity and probability are distinct parts of the puzzle.

    Mitigations would be tiered and clocked in, as necessary. Ideally, you want to implement the most effective mitigations, but they are often costly and may not be warranted (locking down countries, shutting down businesses/large gatherings/schools) - this is third tier. First tier would encourage people to be vigilant in their normal behavior - wash hands, stay home when sick, be mindful of vulnerable population and alter behavior around them, limit travel to riskier areas, vaccination, don't be stupid. This may be enough, i.e. manageable. Second tier would be implemented when first tier is not effective by itself and targets optional gathering of people such as conferences, games, asking employers to make arrangements for remote work or schools make arrangement for online classroom, where feasible. We should still be in 1st tier, but some places (Illinois, Ohio, Kentucky, Italy, California) and businesses (Disney, many malls, airlines) are in 3rd tier. Schools and churches are generally in 2nd tier. People behaving like zombie apocalypse is inevitable and stocking up on toilet paper and bottled water are behaving like 3rd tier. BTW, Ventilators are a mitigation for high severity, very low probability cases and should be available throughout tiers.

    The tricky part about risk management is avoiding placing too much emphasis on the worst case scenario. For CVirus, the worst severity is death and there is a non-zero probability it could occur, but that is not the case across the entire population, indeed it is remote, at best. It may feel like it is more prevalent because we are hammered by CVirus bad news constantly, but what news reports or social media shares should not drive probability or severity.

    We did not give tier 1 mitigations enough time to work (part of the reason was people did not take it seriously. Getting the word out so people get it is part of tier 1), now we are generally at tier 2 and moving slowly to tier 3. While China is manipulating the numbers and is not an example to follow, South Korea took a more rational approach (combo of tier 1 and tier 2) and is dealing effectively with CVirus. Why we chose to do differently is what I don't understand.

    THIS. IS. INSANE.

    Thoughts?



    ------------------------------
    Adam Atherton
    Farragut TN
    United States
    ------------------------------



  • 45.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 18:27

    I like the risk management approach, but I don't think available data (such as it is...or is not, sigh) support your assumption that death is a remote probability or that cases needing ventilators are very low probability.  At least, not if you are defining probabilities the way I've usually seen them defined when risks associated with a medical device are assessed.  The head of our state health department reports 29 coronavirus patients are currently hospitalized in NC.

    This CDC report summarizes cases February 12 through March 16, with a focus on severe outcomes.  If I'm reading the data correctly, hospitalization was required in roughly 20-30% of cases, ICU in 5-10%, and death rates were 2-3%.  My understanding is that, if a coronavirus patient needs to be admitted to the ICU, there is a high probability that they will need a ventilator.  So without ventilators, it seems that death rates and ICU rates will start to converge.



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 46.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 21:13

    Hi Julie,

    Interesting report. Thank you for sharing.

    The data in the report comes from cases reported to CDC by states and jurisdictions as of 16 Mar. 

    * 12% of cases required hospitalization (508/4226). Half were 65yo or older.
    * 2.9% of cases were in ICU (121/4226). Half were 65yo or older.
    * 1% resulted in death (44/4226). Half were 65yo or older.

    In general, severity of CV symptoms increases with age.

    As far as risk management mindset, it looks like some clarification is needed. As you know, when it comes to probabilities it is all about the denominator. If looking at CV cases from a general population perspective, the probability of dying from CV is remote. Ventilators will be needed in these extreme cases. CV is serious, but its prevalence is nothing like the flu or the cold. Be safe.



    ------------------------------
    Adam Atherton
    Farragut TN
    United States
    ------------------------------



  • 47.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 22:01
    Looking at CV from a general population perspective, if these figures are predictive, and if, per my NC number-crunching, the entire population were to contract CV in the next 4-8 weeks, the probability of dying within the general population would be 1 in 100; For those ages 20-64, more like 1 in 350. That's with enough ventilators available to treat all of them.

    Again, I'm talking about how I usually see the frequency of occurrence described when assessing the risks associated with use of a medical device.  In that situation, the probability of events that are likely to happen in 1 out 100-350 patients would typically be described as moderate.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 48.  RE: Off Topic - How is everyone doing?

    Posted 25-Mar-2020 08:51
    Hi Julie,

    14971 processes that go off the rails with "If...If...If..." usually end up with very conservative, read unreasonable, estimates of risk (I know of one medical device mfr that has no low risks in the risk assessment for a simple and obviously low risk product because of this). In those cases I push back strongly on the few because the strong opinion is usually based on anecdotal or gross assumptions or personal experience (which makes it seem real), but is not supported by available data. I am NOT saying you are unreasonable (indeed I read and learn from your posts), just that there are a number of assumptions involved when saying the entire population will be plagued by a virus.

    I agree that high severity, lower probability events in a med device risk management process are usually assigned moderate risk. Moderate risk usually requires subsequent mitigation.

    Hang in there. Be prudent, not paranoid. I appreciate the back and forth. Persevere.

    ------------------------------
    Adam Atherton
    Farragut TN
    United States
    ------------------------------



  • 49.  RE: Off Topic - How is everyone doing?

    Posted 25-Mar-2020 10:31
    Don't disagree about processes sometimes going off the rails, and agree with the reasons that this can happen.

    Whether you assume that the entire population will be infected or that only the 4,226 will be infected, the probabilities remain the same.  That is to say, your numerator for deaths can be 44 and your denominator can be 4,226, or your numerator can be 44 x (44/10,000,000 = 200,000) and your denominator can be 10 million.  The probability will remain the same, 1%.  I'm not accustomed to 1% being described as remote or very low within the context of medical devices, but these labels are not set in stone, and I think different industries may apply the same labels to different probabilities.

    I come back to your original question, which is why the big fuss over CV?  That's my answer--it's because people are not thinking that a 1% death rate is remote or very low.  This in spite of flu epidemics with similar or higher death rate, because they think they know that "the flu" does not infect the entire population.  In contrast, they do not think they know what percent of the population will ultimately be infected by COVID-19.  What they also think they know is that, unless the rate at which the virus is spreading starts slowing down (a lot) and very quickly, we will soon have (may already have) more patients who need ventilators to survive than we have ventilators.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 50.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 03:13
    Edited by Arthur Brandwood 24-Mar-2020 03:15
    Hi Julie

    Every country has their own curve and doubling time.  You can see the global data in the WHO situation reports daily at https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports.

    The epidemic curve in today's report is interesting, and scary.  You can see the earlier China epidemic which has now been controlled, and the current pandemic curve which is showing no signs of abatement.



    If you take the ex-China numbers (which were available in the earlier sitrpeps) you can plot them out logarithmically. This gives a global (Ex China doubling rate of around every 5 days and a ten fold growth every 2 weeks or so.   Implications are that if unchecked this has a potential to infect a sizeable chunk of global population by mid May.  So the social distancing efforts really matter.  Let's sincerely hope it is brought under control or at least slowed well before then.  Stay home folks!

    Back to more regulatory angle.  Great to see FDA and MHRA being flexible on emergency manufacture of ventilators.

    Arthur 


    ------------------------------
    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@brandwoodckc.com
    ------------------------------


  • 51.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 05:07
    Hi All. 

    Just to update on things here in the UK.

    Last night, our Prime Minister announced that the UK is now in lockdown and the police will have the powers to fine, or I am guessing in the extreme.. arrest!

    The lockdown is for an initial three weeks and we are only allowed for very limited purposes:
    • Shopping for basics
    • One form of exercise a day
    • Medical need
    • Travelling too and from work that is "Absolutely Necessary", healthcare workers etc.

    The first day is always going to be a mixture as people adjust, collect things from work but I fully expect people to take notice of the restriction. 

    The government has also advised that around 1.5 million people are labelled as 'Vulnerable' and most at risk from having complications from the Coronavirus. These people are being told to self isolate for 3 months. Personally, I fear that I will be sent a letter which will make things even more scary and real! 

    Stay safe everyone. 



    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------



  • 52.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 18:31
    Do you know if the 3 months isolation for the vulnerable is for their protection only, or for the public at large?  My initial thought was for their protection only, but if they are likely to need ventilators, then they could be the ones that the authorities most want to flatten. :)

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 53.  RE: Off Topic - How is everyone doing?

    Posted 25-Mar-2020 03:42
    It is kind of two-fold Julie. The idea is to obviously protect them and to help flatten the curve. If a high number of people contracted the virus and required hospitalisation, the NHS could not cope and they would die.

    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------



  • 54.  RE: Off Topic - How is everyone doing?

    Posted 25-Mar-2020 09:33
    Yes, I appreciate that.  I was just wondering if the 3 months is advice or order.  As an order, seems excessive at this point in time.  Actually, as advice, too, IMO, but if it is "just" advice, then it doesn't matter, as it leaves "the vulnerable" free to adapt as conditions evolve.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 55.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 08:37
    Arthur, I agree that every country (and in the US and other countries, every state/province/territory) has its own curve. That's why I've ignored all data related to the media COVID-19 darlings, China and Italy, as well as US data, and focused on North Carolina.

    I think how much social distancing efforts will really matter remains to be seen, as does whether they prove to be beneficial or destructive.

    I think the regulators have considered their choices, the potential consequences of those choices, and have elected to be "flexible."

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 56.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 09:54
    Edited by Paul Brooks 24-Mar-2020 10:07
    The trajectory of infections reported in the US is not good (see chart below - reported one wonders how many more not reported). Presumably the death rate will track this and also not be good. I think we all share responsibility to do everything possible to attempt to flattened this chart, at the rate its going I think the US healthcare system will be totally overwhelmed. Some States are earlier than others in their graphs, but I think the pattern is repeating.   

    We are seeing similar challenges across the globe and we know we are all in this together. 




    This is a time to join forces, to support each other, we are at war with a deadly virus (granted not deadly to all) and we must protect our fellow citizens.  

    In my opinion maintaining social distancing is essential to staying safe and staying healthy, for your sake and the benefit of our community. 


    ------------------------------
    Paul Brooks
    Executive Director
    Washington DC
    United States
    ------------------------------



  • 57.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 10:26
    Paul I am in complete agreement with you.  Infection rates vary by all sorts of variables including population density, age of the population,  travel frequency, etc. We also need to keep in mind that testing is varying geographically within the United States.  Infection rate curves are in themselves highly variable.

    ------------------------------
    Robert Schiff PhD, RAC, CQA, FRAPS
    CEO
    Schiff & Company, Inc.
    583 Mountain Avenue
    North Caldwell, NJ 07006
    rschiff13@aol.com
    973-568-3361
    ------------------------------



  • 58.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 10:44
    I find the mortality (the key outcome) graphics presented by the NYTimes to be particularly informative as it compares locations by a constant value - when the 25th death occurred in that location on a logarithmic scale. It makes the trends clear.

    https://www.nytimes.com/interactive/2020/03/21/upshot/coronavirus-deaths-by-country.html?action=click&module=Top%20Stories&pgtype=Homepage

    ------------------------------
    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
    ------------------------------



  • 59.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 10:30
    Edited by Adam Atherton 25-Mar-2020 12:59
    Hi Paul,

    I agree with most of what you said. As far as the death rate tracking the increase in confirmed cases in the US, it has not (I have been tracking this regularly). A few weeks ago (an eternity in CVirus time), the CV death rate in US was steady at 1.75% *** of confirmed cases***. With the backlog of testing happening now, the death rate is 1.27% and dropping (591/46,485). I assume the death rate will continue declining slowly as the backlog is addressed before holding steady at a higher death rate than now.

    ------------------------------
    Adam Atherton
    Farragut TN
    United States
    ------------------------------



  • 60.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 11:37
    Edited by Julie Omohundro 24-Mar-2020 11:39
    North Carolina is now at 398 cases (+34%) still with 0 deaths.  However, as I said, there is a short history here. 

    I'm also keeping in mind that a good bit of time is likely to have elapsed between testing/reporting and death.  I'm thinking generally in terms of two weeks, but it seems this illness may last much longer than the flu, so maybe more like three weeks.  If the rate is, say 2%, then NC might not see its first death for another week or two, even though that case has already been diagnosed and reported and the patient might not even be in serious condition yet.

    It does seem like we might be settling in on a rate of around 30%.  When I get a chance, I will recrunch my numbers using this rate instead of 50%.  There is no sign of truly exponential growth, which isn't just fast, but gets faster over time.  If the rate is changing in NC, right now it seems to be going the other way, without benefit of social distancing.  Like I said, viruses are unpredictable.

    I will use the date the governor ordered the restaurants closed as the start date for anything resembling meaningful social distancing.  The CDC currently puts the gestation period between 2 and 14 days, so, if  social distancing is having any meaningful impact, I don't think it can realistically be expected to show up in the rates for a week, and the early efforts and their impact were so lukewarm, it could easily be two weeks. 

    On the other hand, if social distancing is not having any meaningful impact, those who are deeply wedded to it as a solution are unlikely to give up on it for at least four weeks, by which time the question may be largely moot.  Similarly, if rates decrease, many will insist this correlation proves cause and effect, even if the rates were decreasing well before social distancing could have possibly kicked in.  Thus rainmakers and purveyors of magic elixirs can always make a good living by taking credit for natural forces, as long as they can tell a good story. Especially if they can sell it to the media.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 61.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 11:56
    Edited by Julie Omohundro 24-Mar-2020 12:01
    I can project scenarios that are both reasonable and dark, in which social distancing turns out to be more destructive than beneficial, but I don't see the point in potentially upsetting a lot of people when I think there is nothing to be done about it now.  Anyone who wants to figure out those scenarios can do so easily enough.

    I personally don't feel comfortable encouraging other people to socially distance themselves, especially when I have no way of knowing what its impact will be.  Government officials feel the need to make policy, whether they think they have any way of knowing or not.  I'm generally happy to follow that policy, although this pandemic has got me wondering whether the US is the only country that as a Prohibition-like experience rooted deep in its collective memory.  Watching our government officials, so far it seems to me that the lessons of Prohibition are still well rooted in theirs.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 62.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 12:37
    Prohibition is a fair comparison both when addressing gov't and people's responses. I suspect something very similar will occur now. Gov't has zero clue when to revert to normal operations. However, people, both personally and business owners, do and they will begin making changes to gain their lifestyle and livelihood back when they think it is safe and necessary. This will be MUCH sooner than gov't says. Same with Prohibition. Gov't locked down, people persevered and made a way. Gov't finally figured out Prohibiltion wasn't working and repealed the 18th amendment, but it took a while.

    By the way, Julie, based on your NC numbers provided earlier your cases are growing at daily rate of 36.5%.

    ------------------------------
    Adam Atherton
    Farragut TN
    United States
    ------------------------------



  • 63.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 14:02
    Yes, I have been wondering how people will decide when it is safe to go back in the water.  Or if they will finally just tire of being safe and decide it's time to test them.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 64.  RE: Off Topic - How is everyone doing?

    Posted 25-Mar-2020 09:39
    Julie,

    Totally agree that each curve is unique. However, I think there is a challenge in focusing just on "North Carolina" or "Minnesota" or whatever in a country as mobile as ours. It has struck me this week how many cases locally (and in TX which I follow because my elderly parents live there) start with "person went to an event in NYC" or some version thereof. So if a couple people go to NYC and come back to NC and then proceed to expose 5 people each, all the sudden you shift your curve.

    This may already be less likely now than 2 weeks ago (good luck finding a flight to anywhere right now) but certainly is a really messy factor in all of this. Travel between countries is challenging enough (see how this spread originally) but in the end countries can and have shut borders. Between states in the US - I'd guess almost impossible.

    g-

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------



  • 65.  RE: Off Topic - How is everyone doing?

    Posted 25-Mar-2020 11:03
    Edited by Julie Omohundro 26-Mar-2020 14:18
    No doubt, but that is not a challenge for me, since I'm not charged with making public policy.  I am charged with making my own decisions, but, as I stated previously, I'm so "socially distanced" anyway, there can be a lot of play in the numbers, and it's not going to translate to me being much more socially distanced than I already am.

    As for airline travel, that is something else that probably varies by tidepool, as different airlines serve different cities and also travel niches, and different cities have different economies that are supported by different types of travel.  I'm guessing there are normally a whole lot of flights out of MSP to medtech-related destinations.

    "I fly Southwest," which seems to have plenty of seats out of RDU open this week and beyond, but warns that the flights might be cancelled. (Ya think?)  It is also driving me crazy with email after email advertising great rates, which I cannot take advantage of, because pretty much every event I might want to go to has been cancelled and every place I might want to visit is in the process of closing down.  If all I can do is buy groceries, may as well stay home.  In any case, the sales suggest to me it has plenty of seats, but can't sell them, because very few people want to get on a plane right now.

    With regard to local cases starting elsewhere, the spring breakers seem to have gotten home somehow.  And unfortunately, since their schools and dorms will remain closed, a good number of them probably actually did go home.  So where our flu epidemics are driven by winter holiday day travel, this one is likely to get a measurable boost from spring break travel. :(

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 66.  RE: Off Topic - How is everyone doing?

    Posted 25-Mar-2020 12:14
    My worst case scenario for spring breakers is that the impact of their travel has just started to show up in some of the case counts (especially Florida) and could become increasingly evident naitonally over the next 2-3 weeks, just when policymakers will be closely watching the data for some indication as to whether social distancing is working, or whether more stringent measures are needed.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 67.  RE: Off Topic - How is everyone doing?

    Posted 28-Mar-2020 14:51
    And now it seems that the NC DHHS has pretty much thrown in the towel on testing as a useful means of tracking the virus, and will instead use the same type of surveillance approach it uses for influenza:

    1. Tracking only lab-confirmed cases is not a reliable or accurate way to understand the pandemic.
    2. We will use influenza surveillance tools, which are designed to track widespread respiratory illness.

    http://www.wakegov.com/humanservices/publichealth/providers/Documents/COVID-19%20Provider%20Guidance%2003%2023%2020%20Final.pdf
      
    Another interesting trend, including but not limited to NC, is that various experts are cautioning that "we are only seeing the tip of the iceberg" in case counts.  It isn't clear to me how they can know this without having seen the iceberg, in which case they have not seen only the tip.

    I just reached out to a friend who works with cardio patients at a local hospital.  She said she was called off today because of too few patients, has yet to see a COVID-19 patient (although it supposedly can affect the heart) and that the ICU census shows open beds.  I give up...

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 68.  RE: Off Topic - How is everyone doing?

    Posted 24-Mar-2020 13:06
    Edited by Andrea Chamblee 24-Mar-2020 14:14
    This has been an informative conversation! Yes, when I used the word quarantine I used it incorrectly. What I meant was social distancing. By the way, as much as I like for it to be true that these measures are unnecessary, the news today indicates our country will be the newest epicenter of the disease, with many deaths. Stay inside, everybody! Our grandparents lived through the depression and fought the Nazis, so we can get through this.
    https://www.washingtonpost.com/world/2020/03/24/coronavirus-latest-news/

    ------------------------------
    Andrea Chamblee Esq., RAC, FRAPS

    This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

    Silver Spring MD
    United States

    ----------------------------------------


  • 69.  RE: Off Topic - How is everyone doing?

    Posted 25-Mar-2020 03:47
    Hi All.

    If we ever needed a highlight of how serious this is getting, the NHS s opening a new hospital in a conference centre!! The Nightingale Hospital will open in the ExCel Centre in London UK which will be able to hold 4000 patients! 


    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------



  • 70.  RE: Off Topic - How is everyone doing?

    Posted 25-Mar-2020 15:20
    Hi James.

    Here in NY these event centers have been in process of converting for the past day or so with expectation to be able to handle non-COVID 19 patients by end of the week.  The idea is to clear as many non-COVID 19 patients out of the hospitals as is humanly possible in order to expand access in the hospitals for COVID 19 patients or vice versa.  I know that they are planning to house between 1000-2000 patients at the Jacob Javitts Center in Manhattan and additional patients at the Westchester Civic Center (not sure on numbers for that location though).  Essentially this is something that most of us saw as a real possibility if you were watching what was happening here in NY City and NY state.  The other thing I have found really impressive (although I am sure some of this has to do with keeping the business open and running!) has been the idea of so many different companies (many of whom you might never expect to get into the space) who are making medical equipment (there is another thread on the Exchange here specifically about a couple of them) or alcohol-based hand sanitizers and rubs.  My fear, as someone with micro experience in my past, is that the sanitizers will leave people more complacent or will be used in lieu of handwashing.  The problem with the in lieu of is that the evidence shows that if the hands are not clean before use of the sanitizer then the sanitizer is less effective...I know that this has been considered a "next best" issue but I also have seen situations where people chose not to use the sink to wash their hands and instead simply used the sanitizer and thought they were completely safe...

    ------------------------------
    Victor Mencarelli
    Global Director Regulatory Affairs
    MelvilleNY
    United States
    ------------------------------



  • 71.  RE: Off Topic - How is everyone doing?

    Posted 25-Mar-2020 18:25
    I can't speak to use of hand sanitizers by healthcare professionals, but I have seen sanitizer used in lieu of handwashing so offen, I had concluded that this was their main appeal for many consumers...much quicker and easier than handwashing.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 72.  RE: Off Topic - How is everyone doing?

    Posted 26-Mar-2020 10:20
    Hi Victor.

    They were saying on the news this morning that NYC was about to be hit really hard with this. I don't think there is any optimism over here that this will be sorted by Easter!

    How prepared do you think you are over there?

    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------



  • 73.  RE: Off Topic - How is everyone doing?

    Posted 27-Mar-2020 08:48
    Edited by Emily Stamm 27-Mar-2020 08:47
    I think the people of the US are just about entirely across the spectrum.  As you probably can see from the discussion just on this thread, some people think there is nothing at all to worry about; some are extremely conservative having actually self-quarantined without symptoms for 3 weeks already; and most are somewhere in between.  I think Julie's comment about the spring break students is going to cause a lot of extraneous unaccountable data that is likely to cause the medical profession to be confounded when data from infections skyrockets all around the country in the next few weeks thanks to their unwillingness to modify their all-important spring break plans of dancing on the beach in Miami last week.  

    As for the medical personnel, I can't tell you how impressed I have been with the overall response here in New York State.  Retired personnel, people with backgrounds in any medical field, people who just want to be "useful" during this time have been coming out of the woodwork.  I know several "front line" medical personnel (MDs, DOs, RNs, EMTs) who are currently running on 12-14 hour shifts already and they have already said that they are expecting at some point during all of this there will be a period where they might be 18 hours on shift and 6 hours off especially if medical personnel begin to become ill in any large or even moderate numbers.

    My own company (I work in personal care, cosmetics, OTCs) has transitioned any of our production capacity we can bring online to manufacturing hand sanitizers and I know several other companies are trying to figure out how best to transition to ventilators and masks/shields or gowns.  I have seen several of my friends posting photos of themselves after a 13 hour shift with tight fitting PPE and it is not pretty - although I am impressed with how the FDA has been responding to issues and questions both by answering emails/calls and more importantly providing assistance to companies by way of guidance documents including providing what amounts to an ultra-simplified hand sanitizer formula in one of the temporary guidance documents and allowing this formula to be shipped immediately provided you use the exact formulation, USP grade ingredients and the product is labeled according to the guidance (which really is the base labeling required for any hand sanitizing product by the monograph as it exists today).

    I think the biggest issue currently is actually the situation for the economy both in terms of companies not being open (or opened with significantly decreased staffing) and companies who are trying to continue "business as usual" as best possible by working from home.  We have our children trying to learn by the internet, mom and dad are trying to work to continue being paid, and the internet speeds are slowing significantly when you have hundreds or thousands of people all competing for the same bandwidth in a community.

    ------------------------------
    Victor Mencarelli
    Global Director Regulatory Affairs
    MelvilleNY
    United States
    ------------------------------



  • 74.  RE: Off Topic - How is everyone doing?

    Posted 27-Mar-2020 11:18
    Just to be clear, I don't think I or anybody else knows...much of anything, including how this pandemic will play out.  I think those who think that "there is nothing to worry about...somewhere inbetween" are not thinking, they are believing.

    I have to add a shout-out for the respiratory therapists (RTs), who are as "front line" as anybody in this particular crisis.  I"m not an expert in this area, but I think an RT on LI summed it up nicely:  I am constantly reading about the lack of ventilators and the panic it is causing in different states. What I am not reading about is the associated lack of Respiratory Therapists to run these ventilators. Many of these patients require advanced modes of ventilation that only an experienced and well-educated RRT can initiate and manage.  They are seeing the same behavior you describe for other personnel, former RTs (retired or previously transitioned to some other specialty) are coming out of the woodwork.

    I have less enthusiasm for people with no expertise and skills just trying to be "useful," as they can, and sadly often do, wreak more harm than good.  But that's a topic for another time and place.  One area in which some of the folks in this forum might actually be useful is helping to assure that companies making emergency medical supplies on the "exempt" list when stay-at-home orders are issued.

    This is not likely to be a problem in areas with a measurable medical device industry.  However, If your company is in an area that has a few medical device manufacturers (or maybe just yours), but not enough companies in this sector to support a trade association that would realize that this is a special case (and therefore will lobby those who are issuing these orders), you might consider giving your CEO a heads up on this.  In a crisis, it is not easy to identify "essential" functions across the full spectrum of functions that maintain our society under normal circumstances, especially when often the "non-essential" are lobbying long and loud.


    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 75.  RE: Off Topic - How is everyone doing?

    Posted 25-Mar-2020 19:11

    Because this seems to be thread where Cvirus is discussed from different perspectives I am posting link to Fauci's NEJM article on COVID-19 posted today. Please note the following, "the overall clinical consequences of Covid-19 may ultimately be more akin to those of a severe seasonal influenza (which has a case fatality rate of approximately 0.1%) or a pandemic influenza (similar to those in 1957 and 1968) rather than a disease similar to SARS or MERS, which have had case fatality rates of 9 to 10% and 36%, respectively."

    Take appropriate measures to protect yourself and others, especially the vulnerable. There is no need to panic. We will get through this soon.

    https://www.nejm.org/doi/full/10.1056/NEJMe2002387



    ------------------------------
    Adam Atherton
    Farragut TN
    United States
    ------------------------------



  • 76.  RE: Off Topic - How is everyone doing?

    Posted 26-Mar-2020 12:11

    Not to get back into defining terms, but "soon" is also in the eye of the beholder.  I'm not sure what everyone else is expecting/preparing/hoping for, but if we can cease social distancing in two weeks, for me that will be very soon.  In three weeks, soon.  After that, I'm going to start to get impatient and then descend into crankiness.  But the numbers I have to work with suggest I am unlikely to get too cranky.  (Well, not about social distancing, anyway.)

    I finally found a decent calculator, so I have a bit more confidence in these figures.  Starting with the 504 cases reported in North Carolina as of Tuesday, I ran the numbers out to 10 million cases (100% NC state population = 100% NC herd immunity) assuming four different rates of daily increase (20, 30, 40, 50):

    o If reported cases increase at 20% per day, the entire NC population will have been infected in about 6 weeks.
    o If reported cases increase at 30% per day, the entire NC population will have been infected in just over 4 weeks.
    o If reported cases increase at 40% per day, the entire NC population will have been infected in just under 5 1/2 weeks.
    o If the rates increase at a rate of 50%, the entire NC population will have been infected in about 3 1/2 weeks. 

    Either way, using these figures, social distancing seems unlikely to be useful here in another 3-5 weeks, even if the virus continues to spread for a while longer, given that the objective of social distancing is not to slow the rate of increase just for the sake of slowing it, but to reduce stress on our healthcare system (especially ICUs and ventilators, it would seem).

    No matter how stressed the healthcare system might get if cases increase at a brisk rate of 50% daily, in 3.5 weeks, at this rate there will be nobody left to infect, so the rate of increase will stop.  Add a week or so for the most recently diagnosed cases to progress to the point of needing hospitalization and however overwhelmed our healthcare system might be at that point, it can't get more overwhelmed, because there will be no new cases to overwhelm it.

    On the other hand, if the rate of increase slows to a steady 20% (about the best I think we could expect from social distancing, as opposed to outright quarantine), this should give considerable relief to our healthcare system.  At the same time, assuming the virus continues to spread until everyone in the state has been infected, it will stretch the epidemic out to 6 weeks. If social distancing continues for another 6 weeks, then I'll be getting pretty cranky.  But, under this slow-spread scenario, that seems unlikely.

    Activity on the supply side should start to increase the capacity of our healthcare system noticeably before then. I'm expecting only moderate relief, and only from companies that already produced masks, ventilators, etc.  There is probably a limit on how much they can ramp up without capital investment and hiring, which would mostly take too long. But they can almost certainly make a meaningful dent with increased shifts and economies of scale.

    This is the math and basically how it seems to me that it almost has to play out this way in every state, although the rates of increase will vary and the size of the state's population will determine how long it would take to max out..and that's assuming it runs through the entire population, which such epidemics never do, at least not all in one season.  "Herd" immunity specifically does not mean every member of the herd, but the herd in general.

    Other important population factors will affect rate of increase, which of course will not obligingly settle out at a perfect X% per day for the duration.  In New York, it should spread rapidly in NYC, but it should take a good bit longer to saturate rural upstate areas.  NC has several densely populated hubs and a lot of rural and small town areas.  Predictably, the virus is catching fire in Charlotte as I type.  The Research Triangle holds a large population, but it is less dense, so a little slower there.  As of yesterday, we now have two cases in reported in Alamance County.

    I was initially puzzled when people would talk about the speed with which the virus was spreading in one breath and then predict "we" would be dealing with the epidemic through summer in the next.  But that's another definition.  "We" as a country, probably.  "We" as individuals, or individual cities, or even states, probably not.  The timeframes will be different in different states, some concurrent, sequential, some overlapping, from the first case in Washington State to the last case in...if there were a betting pool, my money would be on Karinen, South Dakota.  Never heard of it? Well, there you go. 

    If you want to crunch some numbers for your pwm city or state, but aren't a number-crunching whiz, this online tool is easy to use:

    https://www.rapidtables.com/calc/math/exponential-growth-calculator.html

    Initial value (x0): Enter current case count
    Growth/decay rate (r):  Enter your choice of rate of increase
    Time (t): Enter your choice of number days or weeks
    Value at time t (x(t)):  This tells you how many people will have been infected after that many days/weeks, at that rate of increase.

    There is probably another tool out there in which you could enter total population and it would calculate time, but I found it easy enough to use trial and error, and this is just an approximation, anyway.

    Please keep in mind that this is more like a conceptual model that will produce some useful numbers in terms of getting some kind of sense of what is going on and how things are likely to play out, but the exact numbers are unlikely to be realized in the "real" world.

    .

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 77.  RE: Off Topic - How is everyone doing?

    Posted 26-Mar-2020 12:30
    Last post for me on this thread.

    The epidemiologist who created the CV model many are depending on realized he had a major error and has corrected it down. You can read more about at link and elsewhere. As far as the speed of spreading, the model author has admitted based on empirical evidence that CV spreads much faster than anticipated. The significance of this is that many, many more people probably have CV and are asymptomatic or at least feel they can manage their minor symptoms. Second link is to Dr Fauci's NEJM article published yesterday where he has revised his expectations way down too. See you later.

    https://www.dailywire.com/news/epidemiologist-behind-highly-cited-coronavirus-model-admits-he-was-wrong-drastically-revises-model?utm_source=facebook&utm_medium=social&utm_campaign=benshapiro

    https://www.nejm.org/doi/full/10.1056/NEJMe2002387

    ------------------------------
    Adam Atherton
    Farragut TN
    United States
    ------------------------------



  • 78.  RE: Off Topic - How is everyone doing?

    Posted 26-Mar-2020 13:43
    Edited by Julie Omohundro 26-Mar-2020 14:07
    Indeed, the problem with basing a model on empirical evidence is that it is only as good as the evidence.  But if you are in a position that you feel you must try to predict something like death rates or total cases, I don't know of any other way to do it.  It would seem that neither does Dr. Fauci.

    I have left predictions to the public health officials and have limited myself to running the math, which isn't dependent on empirical evidence.  As a result, my modeling doesn't predict anything (although certainly if someone wants to use it for that purpose, they can give it a shot), but instead describes the basic interplay between rate, population size, healthcare system capacity, and the need for/value of social distancing.  At best, I think it does provide some idea of how long social distancing is likely to be of value, but "some idea" as in more like 1-2 months than 3-6 months. And even that is limited to NC. It also helps to identify some of the main factors that can potentially influence these variables, and, in turn, these relationships. 

    Its strongest merit is based in the fundamental truth (and I do not use that language lightly) that, if and when we reach a point that there is no one else in the population to infect, the epidemic ends. At least, in that population.  It has already ended in the population of people who have been infected and either recovered or died.

    I don't see any expectations (or predictions) in Dr. Fauci's article.  While he may have some expectations on a personal level, as a scientist, he should not only discount them, but try to avoid letting them bias his science.  And, while he may have to make predictions based on empirical evidence and assumptions for the purpose of guiding public policy, as a scientist, he should know only too well that he has no way of knowing the extent to which the assumptions are valid or the empirical evidence is adequate.

    Adam, I wish you luck in achieving your goal of this being your last post.  I keep telling myself the same thing, but so far, no luck...obviously...to the point that I have probably given up on kidding myself.

    PS I don't know if you are aware that one of NC's counties on your side of the Smokies has actually closed.  Not closed restaurants, schools, etc, although probably there is that too, but actually closed its borders.  It is isolated and sparsely populated enough that, who knows, it might be able to ride this whole thing out.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 79.  RE: Off Topic - How is everyone doing?

    Posted 26-Mar-2020 14:51
    Edited by Julie Omohundro 27-Mar-2020 14:14

    OK, I AM READY TO SAY IT OUTLOUD NOW.  It looks like the rate of increase in NC is declining.

    Rate of increase in case count, March 18-27:
    94-52-41-35-39-16-34-27-26-20%

    This cannot be the result of social distancing, which has not been meaningfully in effect here anything like long enough to have had any measurable impact on case counts.

    If social distancing has an impact, it seems unlikely to start showing up in the case counts for at least another week.  Unfortunately, its impact may be countered/obscured by the impact of spring break, which, if it had one, should start showing up in the data at about the same time. I think it is more likely to have had an impact in NC than a lot of other states, both because we have beaches and also because there has always been this weird connection between Florida and NC.  I expect we will have more than our share of spring breakers who mingled on our own beaches and those who mingled on Florida's beaches, and then returned to their homes in NC.

    Today's case count in NC is 636.  For the first time, 2 deaths have been reported.  For those who are interested in death rates, those cases were probably diagnosed and added to the case counts a week or so ago, when the counts were lower.  Last Friday, the count was at 137, which actually represents all cases diagnosed the previous day.  If both cases were diagnosed last Thursday, then they would represent a death rate of 1.5%.  This seems consistent with a lot of death rates I have seen posted around, for the US and individual states and cities and counties, all of which seem to fall in the 1-2% range.






    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 80.  RE: Off Topic - How is everyone doing?

    Posted 27-Mar-2020 15:13
    Today's case count is 763, an increase of 20% over yesterday's count, so the rate is still declining.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 81.  RE: Off Topic - How is everyone doing?

    Posted 02-Apr-2020 12:11
    In North Carolina, the increase in case counts is approaching zero, based on tests reported to our DHHS:

    Some of the recent data may be attributable to social distancing, but that didn't begin to kick in here at all until our governor ordered the restaurants to close on 03/18.  From there things progressed, but rather slowly, until our statewide stay-at-home order went into effect at 5PM on 03/30.

    I'm liking our DHHS these days, as they seem to want to see the same data I do. This morning they have added a lot of new statistics, including data on ventilator availability (691 in use out of 2,818 statewide, 81% of hospitals reporting) and PPE (188,730 N95s received from the National Stockpile thus far, out of 500,000 requested).

    Alamance County reports 13 cases; Orange County 37, no deaths.  I'm still going out once a day, preferably mid-morning, a short run to a nearby grocery store, or maybe a swing through a drive-thru, for a little variety in my diet. 

    Most people seem to be following the 6-foot rule, and a few are wearing masks. My local grocery store has put up plexiglass shields at the registers, where 6 feet is a bit of a challenge, to help protect cashiers and customers from each other.  Walmart has put down small blue squares on the floor in its customer service area, separated by 6 feet, each labeled, "Stay 6 feet apart."  Yesterday I was out a little after 5:00, when I-40 and local roads and parking lots would normally be packed.  They were far from deserted, but traffic was more like what I would normally expect to see on a mid-morning run.


    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------