For example, H1N1 flu vaccine back to about 1910, allow a few years to convince the world it’s legit (though vaccination was known then, so that should help), and spare tens of millions around the world ravages of Spanish Flu in 1918.
Or consider the madness of King George III, rumored to have been due to porphyria, for which there is now an RNAi-based treatment. That diagnosis is now considered in error, but if were true and he had been treated, how would world history have changed? ncbi.nlm.nih.gov/pmc/articles/P…
If this worked in reverse and you tried to commercialize aspirin or Tylenol today instead of many decades ago, they probably wouldn’t be approved due to their side effects (GI bleeds, liver failure, respectively).
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To all drug developers... you may be aware of @CMSgov proposed guidance on coverage of approved abeta mAbs for Alzheimer's. I think most critical yet vague words are: "The study results are not anticipated to unjustifiably duplicate existing knowledge." cms.gov/medicare-cover…
Those words are buried way deep in document. They are only hope I could see in this document that CMS won't be taking over FDA's job as arbiter of which drugs work or don't work (indeed, FDA essentially did punt that question to CMS in case of Aduhelm, but not usually).
Even with these words, it appears even if a drug were FDA approved based on proper RCT studies that establish clear benefit-risk w/ great outcomes, @CMSGov gets to demand another RCT... as long as not same as what registrational studies studied. @CMSGov
HNY… but first I’ll venture predictions for COVID in 2022+: we retire “pandemic” & welcome new endemic pain-in-the-butt virus. It’s too early to know how much of a pain (worse than flu?) but 2022 could be telling (omicron bad omen). We’ll have benefit of new drugs… but…
…we’re already discovering that monoclonal antibodies can’t be relied upon for long. Omicron has evolved around many of the existing antibodies. There are antibodies that neutralized both SARS1 & SARS2… but seem to not work well for Omicron.
That’s like having a cousin that has less in common with you than you have with a chimp. That’s remarkable. With Omicron, SARS2 showed us a capability most didn’t really think it would exhibit on such a short timescale (I didn’t). And yet, if one theory of how it arose is true…
It would seem that the final healthcare deal has been baked & it would seem that it’s going have some absurd unintended consequences. Get ready for seniors getting more injections. Here’s why…
The compromise on price controls is that they will only be imposed after a period of market exclusivity. How long is that period? Forget patents. Small molecule drugs will be price controlled after 9y on market & biologics after 12y, (for Medicare only).
That means that given a choice between funding development of a biologic or small molecule drug, it’s going to be more attractive to fund the biologic. But biologics are typically injected/infused, therefore cost more to administer, have lower adherence than small molecule pill.
This is grassroots, not PhRMA. We offer solutions! We support real negotiation: play products off one another to get better prices. Help patients by lowering what insurance can demand OOP for medicines they need. And save by ensuring all drugs go generic w/o undue delay. 2/
But you must not redefine the word “negotiation” to mean that government can just dictate the price of a new drug & force a company to accept it under threat of a ruinous tax. That’s not negotiation, even if you like calling it that. That’s a repudiation of basic economics. 3/
What if it worked like this for all appropriately prescribed treatments?
And you don’t have to accept the injustices of medical debt collection. Defend yourselves by knowing your options. Read more here. Again, thank you for great coverage by @NPLB_orgnopatientleftbehind.org/publications/w…
Focusing on EpiPen, academics suggest patents on device improvements are problem. They acknowledge patents may be essential to incentivizing valuable improvements yet lament poor patient access. Yet never mention “INSURANCE” (except one footnote). How did peer review miss it?
Must we reinvent innovation incentives to fix what are clearly failings of insurance design in America? How about proper insurance w/ low out of pocket costs. To then save $ for society AS A WHOLE, enforce genericization w/o undue delay. This is for you: nopatientleftbehind.org/about/our-vide…
But whenever patients can’t afford a drug, first thought should be whether insurance is doing what it’s supposed to. If not, propose fixing it. If you think society as a whole is overpaying for something, present evidence for why & then let’s talk about solving market failures.