[HN Gopher] Project Covalence
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       Project Covalence
        
       Author : dmnd
       Score  : 69 points
       Date   : 2020-06-16 17:09 UTC (5 hours ago)
        
 (HTM) web link (blog.samaltman.com)
 (TXT) w3m dump (blog.samaltman.com)
        
       | hairytrog wrote:
       | It is now clear that Covid-19 is not as dangerous as was thought
       | and hyped by media and governments worldwide, and that the
       | prescribed shutdown cure has been and will be much worse than the
       | disease itself. Please see (https://swprs.org/a-swiss-doctor-on-
       | covid-19/) for a pretty clear summary or follow Aaron Ginn.
       | Covid-19 vaccine development is nearly useless at this point.
       | That said, we need countermeasures and resilience to such events
       | in the future.
       | 
       | The expectation is we may be well be in 50% to 100% infection
       | rate if serology yield is 1/5. Pretty scary. This means the
       | disease was extremely rapid, and we would've been absolutely
       | trashed if it had been significantly more lethal. We need to
       | invest massively on R&D against such potential threats. Covid-19
       | shows that state control wouldn't have done much to prevent
       | global devastation, and that state control can itself cause the
       | devastation. We need technological countermeasures such as one
       | week vaccine development and deployment or transition to more
       | separate economic spheres with permanent and complete travel bans
       | and highly controlled trade between countries or geographic
       | regions.
        
         | nostromo wrote:
         | Just today I was reading that vaccinations in many countries
         | were stopped to prevent Covid-19 transmission, and now children
         | are starting to die.
         | 
         | https://www.nytimes.com/2020/06/14/health/coronavirus-vaccin...
        
         | shoyer wrote:
         | This is actively dangerous misinformation.
         | 
         | In places where the pandemic is not under control, there have
         | been vast numbers of excess deaths:
         | https://www.nytimes.com/interactive/2020/04/21/world/coronav...
         | 
         | We are still far from the peak in most parts of the world.
         | 
         | New York City has a population about 8 million, with 24,000 [1]
         | excess deaths and an antibody positive rate of about 20% [2].
         | Do you really think it would be acceptable to let another
         | 50,000 people in New York die (0.6% of the population) to reach
         | herd immunity?
         | 
         | [1] https://www.bloomberg.com/news/articles/2020-05-11/new-
         | york-... [2] https://www.cnbc.com/2020/05/20/antibody-testing-
         | shows-coron...
        
           | hairytrog wrote:
           | Lots of downvotes on my comment. A somewhat hilarious denial
           | of what is plainly visible. Did you people even read the
           | linked summary? The economy was hijacked for a complete non-
           | threat, driven by increasingly discredited studies, "experts"
           | speaking in apocalyptic terms, and a media looking for
           | crisis.
        
         | [deleted]
        
       | simonebrunozzi wrote:
       | Hmm, sounds more like a PR statement rather than the usual
       | (insightful) posts that Sam writes. Anyway...
       | 
       | > Project Covalence's platform, powered by TrialSpark, is
       | uniquely optimized to support COVID-19 trials, which are ideally
       | run in community settings or at the patient's home to reduce the
       | burden placed on hospitals and health systems.
       | 
       | What's a "platform" in this case? I'd love to read simpler words.
       | Is it a... piece of software to coordinate things? A physical
       | machine? Else?
        
         | sudhirj wrote:
         | > supports trial execution, 21 CFR Part 11 compliant remote
         | data collection, telemedicine, biostatistics, sample kits for
         | at-home specimen collection, and protocol writing.
         | 
         | Does that not make sense to people in this field?
        
           | ryanseys wrote:
           | Depends what you mean. I'm a software engineer working on
           | clinical study software and it makes sense to me. Though, I'm
           | sure there are plenty of problem spaces that I don't work in
           | whose jargon wouldn't make sense to me.
           | 
           | Here's a brief breakdown of the various terms though:
           | 
           | > trial execution
           | 
           | The act of running the clinical study.
           | 
           | > 21 CFR Part 11 compliant remote data collection
           | 
           | 21 CFR Part 11 compliance is a set of standards that must be
           | adhered to when running clinical studies. To be compliant
           | means you meet these standards and people or businesses that
           | want to run studies can be sure that you're following the
           | rules.
           | 
           | > Telemedicine
           | 
           | Medical visits typically done over video chat / phone calls
           | or other digital means as opposed to going physically
           | somewhere to be tested or evaluated.
           | 
           | > Biostatistics
           | 
           | Data science + medical data
           | 
           | > Sample kits for at-home specimen collection
           | 
           | Like 23&Me but for collecting other stuff from people at
           | their homes. E.g. stool samples, COVID-19 swabs, etc. You
           | mail the participant a kit, they collect their sample, mail
           | it back to you, you process the sample, and that informs the
           | data in your study.
           | 
           | > Protocol writing
           | 
           | Writing and codifying the procedure of how the clinical study
           | will be run. Covers everything from enrollment, inclusion /
           | exclusion criteria for the study, study running, and study
           | closing and archiving.
        
           | memexy wrote:
           | Who and what field? If you mean programmers and regular HN
           | visitors then no, those words have no meaning for me. What
           | does each one mean and why is it important for running
           | medical trials? Other than protocol writing, which sounds
           | like a list of rules, I have no idea what the rest means or
           | why it would be important in a trial.
        
         | memexy wrote:
         | I looked at the site
         | 
         | > Participate in a clinical trial at no cost to you or your
         | health insurance.
         | 
         | Why would health insurance be involved when running medical
         | trials and why would it cost anything? The pitch doesn't make
         | sense to me. I always assumed medical trials were free for the
         | participants. No idea who their target demographic is which
         | makes me suspicious already.
        
           | akiselev wrote:
           | The FDA forbids charging for any medication or medical device
           | that isn't approved so medical trials are free by definition,
           | but the Affordable Care Act requires health insurers to cover
           | routine cost of care incurred during qualified trials. In a
           | Phase I trial under medical supervision, for example, might
           | not cost the patient's insurance anything but a Phase 3 trial
           | for chemotherapy might cost a ton just to deal with side
           | effects and drug administration.
           | 
           | As all things healthcare, it's complicated.
        
             | memexy wrote:
             | Ah, I see. Thanks for the explanation. I had a narrow view
             | of what "trial" meant. So it sounds like as soon as
             | approved treatments are involved then insurance gets
             | involved.
        
           | type0 wrote:
           | > Why would health insurance be involved when running medical
           | trials and why would it cost anything?
           | 
           | To cover for the possible adverse effects
        
             | memexy wrote:
             | Yes. That's not my question. Are you saying drug trials
             | don't cover such costs and that this is standard? Because
             | that's the pitch the company is making and it sounds odd
             | 
             | > We put the patient in the driver's seat before, during,
             | and after a trial. Because it's not just doctors who help
             | build a healthier future. It's patients. And it's time to
             | do right by them.
             | 
             | It sounds like they're saying, "patients are treated very
             | badly and we're here to fix that problem". How bad is it to
             | be in a drug trial currently? Are trial participants really
             | treated with neglect? I don't understand what actual
             | problem they're addressing.
        
               | curryst wrote:
               | If they did, there's always going to be a debate over
               | whether something was caused by the trial. You get a rash
               | and have to go see a dermatologist, was it a result of
               | the trial or unrelated? Or more seriously, you develop
               | cancer. Was it from the trial, or from an unrelated
               | issue? Other people might show symptoms, but it would
               | still take time you don't have for them to sort out
               | whether other participants have cancer, and whether
               | that's a result of the trial or if they just had a higher
               | than average number of people with risk factors.
        
               | memexy wrote:
               | So how is this company addressing all those issues?
        
             | gumby wrote:
             | Actually AEs, and especially SAEs, are more often than not
             | handled by the clinical investigators or trial sponsor, for
             | a variety of reasons.
             | 
             | Insurance policies often don't cover you while you're
             | enrolled in a trial ("you wouldn't have broken your leg if
             | you hadn't been in that cholesterol drug trial so we don't
             | cover that").
             | 
             | The agency really cares a lot, especially about SAEs, and
             | if someone is hit by a trolley while in a cholesterol drug
             | study they will want the company to promptly determine that
             | the drug didn't cause them to stumble, or lose vision, or
             | be confused about where they were. We used to joke at one
             | company, "but being hit by a meteor is not an SAE."
        
       | jxramos wrote:
       | I've actually been wondering as covid19 winds down and people's
       | lived experiences no longer perceive it as the doom and gloom
       | threat it once held sway with, if given that perception whether
       | the market rewards will continue to stand and attract massive
       | investments in pursuit of a vaccine where the rewards may not
       | outweigh the risks.
       | 
       | I would think that would be a pretty strong signal that covid is
       | not as large a risk if big industries don't think it worthwhile
       | to pursue any longer. Along those lines of thinking have any of
       | the big pharmaceutical companies given serious pursuit of a
       | vaccine or is it mainly smaller outfits?
        
         | Shank wrote:
         | > I've actually been wondering as covid19 winds down and
         | people's lived experiences no longer perceive it as the doom
         | and gloom threat it once held sway with, if given that
         | perception whether the market rewards will continue to stand
         | and attract massive investments in pursuit of a vaccine where
         | the rewards may not outweigh the risks.
         | 
         | This is an extremely long (56 word) and complex sentence. I
         | fear that your point may be lost because of its length. Do you
         | mind restating your thesis?
        
         | cinntaile wrote:
         | Most of the big pharma companies are developing a vaccine. [0]
         | The ones that aren't specifically mentioned by name are
         | probably funding some of the smaller biotech companies instead.
         | 
         | [0] https://en.wikipedia.org/wiki/COVID-19_vaccine
        
       | DiabloD3 wrote:
       | Good luck with that, Sam.
        
       | chintan wrote:
       | Great initiative! There needs to be more effort towards
       | streamlining these trials.
       | 
       | At TrialX [1], we also launched Covid Labs Initiative to _Hack
       | The Pandemic_ [2] by bringing together hackers in Clinical Trials
       | informatics space - Drop us a note hackcovid@trialx.com if
       | interested.
       | 
       | We are seeing an unprecedented activity on-the-ground at various
       | orgs[3,4,5] where we power the clinical trials recruitment. There
       | is a huge interest in patient/volunteer community. Any effort to
       | streamline and accelerate would be welcome.
       | 
       | 1. https://trialx.com
       | 
       | 2. https://trialx.com/covid-labs/
       | 
       | 3.
       | https://www.pennmedicine.org/coronavirus/covid-19-clinical-t...
       | 
       | 4. https://www.centerwatch.com/covid-19-treatment-information
       | 
       | 5.
       | https://clinicaltrials.med.nyu.edu/clinicaltrials/?keyword=C...
        
       | dzink wrote:
       | Why set up a separate brand to funnel COVID trial business to
       | TrialSpark? From their own site, TrialSpark is a VC-backed
       | company which primarily runs trials for major drug companies to
       | recruit more patients with painful chronic conditions (like
       | Astma, COPD, Diabetes, inflammatory, skin problems etc, but not
       | cancer)for drug studies. The highly profitable medical areas are
       | clearly attractive for Pfizer, but the sales pitch of TrialSpark
       | is to identify high cluster areas of a disease in small
       | communities, recruit community doctors and incentivize them to
       | attract patients to drug studies with 1.9x higher than usual
       | conversion rate.
       | 
       | So why the separate brand?
        
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       (page generated 2020-06-16 23:00 UTC)