Once covid vaccines launch, we might trick ourselves into believing they cause everything from colorectal cancer to diabetes to heart disease & lupus. Well-meaning data miners could do real harm. We need to vaccinate ourselves against that. Here’s how. 1/
Consider that many people have avoided going to the doctor for regular checkups during covid. They haven’t gotten preventative care. They haven’t been diagnosed with emergent conditions. They might now have heart disease or cancer and not yet know it. 2/
Here’s a paper showing that cancer diagnoses have gone down during covid. They say “The delay in diagnosis will likely lead to presentation at more advanced stages and poorer clinical outcomes.“ jamanetwork.com/journals/jaman… 3/
Consider that COVID vaccines will first go to vulnerable people, older people (& healthcare/front-line workers). They will go in for those long-delayed checkups in the month or two after they are vaccinated & get diagnosed w/ many conditions. Better late than never... but... 4/
...b/c FDA will approve vaccines based on a few months of follow-up data, many will debate their “long-term safety” over months/years. I think it’s highly unlikely current front-runner vaccines will have long-term safety issues, but people understandably will want data. 5/
Researchers will mine healthcare data for correlation of covid vaccination w/ emergence of all kinds of medical problems in the months after. They’ll compare rate of cancer, heart disease, lupus, etc in vaccinated people vs historical records & see an increase in everything. 6/
They will compared to current unvaccinated people and see that the vaccinated people have more of everything (except covid)... because they are actually going in to see their doctors for checkups and those diseases are being diagnosed. 7/
There MAY BE a somewhat fairer comparison... wait until after the pandemic when everyone is going back in for checkups and then compare the rate of diseases among the vaccinated and unvaccinated, but be careful to match on age, weight, prior health status. 8/
Even then it’s likely that less healthy people will be more likely to be vaccinated, so it might be hard (though given how politicized vaccines are, not impossible in America) to find similarly vulnerable people who have elected to go unvaccinated. 9/
There is arguably a better way to really establish long-term safety of vaccines but it may not be entirely satisfying. Compare people vaccinated with different vaccines but at same time to one another, not to past or to unvaccinated. 10/
We are likely to see the launch in a tight period of time (within a few months of one another) of several vaccines. Potentially 2 adenoviral vaccines (AZ, JNJ). Potentially 2 mRNA (Moderna, Pfizer), & one adjuvanted-protein (Novavax). 11/
These are very different types of drugs. It’s extremely unlikely they would cause same long-term adverse effects if they had any. Even the two mRNAs could plausibly be different enough that we shouldn’t assume that a long-term safety problem of one would apply to other. 12/
Therefore, if we somehow functionally randomize who gets the various vaccines & compare diagnosis rates for all diseases, we will hopefully see same patterns of diseases associated w/ all vaccines; even if higher than in past b/c of covid neglect, means they are all safe... 13/
...except in the eyes of the hardened anti-vaxxers who will say that they all are dangerous. But doing this kind of real-world experiment won’t be easy. The vaccines won’t come out exactly at the same time. If we get 50M vaccine courses of Pfizer’s mRNA first... 14/
...it might disproportionately go to most vulnerable people. Then next vaccines might go to less vulnerable (healthier) people. And so on. Also, vaccines might not be similarly effective. We already know that neutralizing antibody titers are lowest for adenoviral vaccines... 15/
...and highest for adjuvanted-protein vaccines, which looks to emerge just after adenoviral & mRNA vaccines. & also they aren’t similarly tolerated. mRNA vaccines are especially painful... that might cause people to have a stronger negative association & that might... 16/
...cause some patients to worry about long-term consequences & over-report symptoms that result in over-diagnosis of conditions that, while absolutely real for many patients, involve subjectivity on part of physician (eg fibromyalgia, migraine, chronic fatigue). 17/
Ultimately, best way to deal w/ worry that such analyses might kick up is to consider in advance how flawed they would be & not fall for them. Hopefully researchers won’t write up papers w/ such flawed conclusions. Certainly they should fail peer-review (remember that?). 18/
Remember the flawed analysis of infection rates back when researchers didn’t consider the false positive rate of covid tests? I do. Here’s one of my tweet threads about it. Consequences are going to be greater when it comes to analyzing vaccine safety data. 19/
I’m sure we’ll see advanced guidance on proper real-world analysis in credible journals. & when vaccine safety news comes out, we all (especially media) should first look to data-driven people w/ integrity: @DrWoodcockFDA, Moncef Slaoui, @EricTopol, Dr Fauci @NIAIDNews et al. /20

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More from @PeterKolchinsky

25 Oct
What would you change US stock market hours to if you could & why? (long on thoughtfulness please, funny is an option, keep puns short)
Here’s another thought. How about introducing newly public companies to market by starting with short trading hours, 3 days a week & then opening up to standard hours after 1-2 years?
What would be ideal public exchange hours from the standpoint of emerging biotech companies (consider their needs) and the funds that provide most of their backing?
Read 5 tweets
16 Oct
Delays in FDA approval of a vaccine probably won’t change when most of us get a vaccine. PFE says it might be able to seek approval by end of Nov, so Dec approval possible. But will only have 100M doses ready by YE (50M courses). So unless you have... nytimes.com/2020/10/16/hea…
So unless you have reason to think you would be among the 50M first up to get vaccinated, what will determine when you get vaccinated is the pace of production. & for most of us, our ticket likely won’t be called until 2Q21. So approval delays of 1-2 months won’t change that.
You might even prefer that the vaccines be vetted more carefully. Of course, the people who would be impacted by delays are those slated to get the first doses. Front-line workers, vulnerable. They too might prefer to know the vaccines are safe and effective.
Read 6 tweets
29 Sep
It seems @icer_review’s heart is showing a little in today’s report on essential compassion & fairness of proper insurance w/ low OOP costs for medicines. But they still have a lingering attachment to math that’s been rightly criticized as racist... icer-review.org/wp-content/upl… 1/
...by patient advocate @SuePeschin in this short, incisive piece. morningconsult.com/opinions/cost-… I wonder if it’s a bit uncomfortable for policymakers ICER claims to have influenced w/ its math. After all, #badmathkills 2/
.@icer_review says if medicines for kids w/ sickle cell disease don’t make the cut according to their math (which @SuePeschin has pointed out is deeply flawed), insurance should make those meds unaffordable to them (w/ high OOP costs) as leverage over drug companies. Harsh.
Read 9 tweets
30 Aug
No viruses in this one but it’s still fun. In the spirit of the enemy of my enemy, there was once a time when MALARIA was a dangerous friend worth having in the fight against a deadlier pathogen: SYPHILIS. Like Godzilla vs Mothra, doctors would infect patients dying... Image
...from syphilis w/ malaria to cause them to spike a raging fever. Syphilis is a really nasty bacteria that for millennia was considered incurable, though patients could recover if their had a high enough fever... esp on Saturdays. Image
Malaria was hardly a walk in the park & one might not consider trading malaria for syphilis to be medically ethical, except that there was a drug, quinine, for malaria. So idea was to cure syphilis w/ malaria & cure malaria w/ quinine. Fun fact: quinine glows in black light: Image
Read 8 tweets
28 Aug
With each new drug, patients w/ lung cancer live longer. If first one hadn’t been rewarded, all rest wouldn’t have followed. Only insurance makes all affordable. Eventually they go generic; society saves money & humanity forever enjoys longer life span. Biotech Social Contract! Image
Flagging here for a few thought leaders in or soon to be Washington as they consider how healthcare should work. @Tcardenas @ngoroff @StefFeldman @JoeBiden
Here’s the whole paper, from folks at FDA, who are fortunate to see the totality of the constant effort to push back against the threat of disease that weighs upon us all. ascopubs.org/doi/full/10.12…
Read 4 tweets
26 Aug
For RA Capital’s next Business of Biotech course, I could use some advice. Do students learn as effectively listening to an audiobook as when they read the actual book? If you’ve taught and grappled with this, please add your comments.
I’m thrilled that thegreatamericandrugdeal.com is available as an Audiobook, though I’m wondering whether old school is better for teaching.
Internet is filled with advice. Here’s a thoughtful piece. But lately I’ve been getting all my peer-reviewed scientific analysis from twitter so figured I would come back for more. psychologytoday.com/us/blog/friend…
Read 4 tweets

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