The reason Biogen's Alzheimer's drug is priced at $56,000 per year and not $112,000 is because they are being kind.
Nothing in the law or process that prevents them from setting whatever price they want. The system is not broken. There is no system.
Hope people at recent @icer_review meeting remember the comment I made at the myeloma meeting: Pharma is wary about lawmakers going after them for price increases. So the name of the game is going to be front loading. Get all you can get early.
Incidental COVID positive test after full vaccination without COVID symptoms is not COVID.
Better still I have been calling for Reinfection COVID and Post vaccination COVID to have their own names, because the natural history and prognosis will be different.
COVID is the name of a disease: SARS CoV-2 infection in people without prior immunity to SARS CoV-2 infection. It carried a certain hospitalization / mortality rate.
SARS CoV-2 infection in people who previously had COVID or were fully vaccinated are different diseases.
You have to define the natural history of each separately because both for the individual patient and for public policy the implications are different.
It doesn't mean Post Vaccination COVID cant be serious: it means the prognosis from such diagnosis will be different from COVID
The FDA basically has the stance that as long as efficacy and safety are shown, the magnitude of the clinical benefit, no matter how tiny, doesn't matter. The cost however huge doesn't matter. It's not in their purview.
In all other developed countries, regulatory approval is only the first of two steps.
I believe with existing law, CMS and insurance companies can play hardball and exercise the second step: Value. It would be better still if we had an automatic second step to assess value.
We are going to spend money we don't have. We are going to spend money that can go for other life saving treatments. No country has infinite resources.
Note that they didn't use neutralizing antibody test. But the results reported should still have a high degree of correlation.
Second, there is more to immunity than antibody titers. However, we do have data that neutralizing antibody levels do correlate with clinical efficacy.
What does this mean: After 1 dose, COVAXIN may not be as effective as COVISHIELD. Thankfully, 2nd dose of COVAXIN is given 4-6 weeks after first. Make sure to get the 2nd dose. After 2 doses, you have an excellent chance of the body being able to fight & destroy the COVID virus.
Based on what we know so far about the COVID delta variant, and what's happening in the UK, 40% of population fully vaccinated is NOT sufficient protection.
Which means he has 227 papers that have been cited 227 times or more. There are few people in the history of medicine who have a higher H index. It speaks to how much he has contributed to medicine.
You don't get much credit for editorials in academic promotions. But I have found them quite useful to advance a new concept, make an argument for change, or for advocacy. #MedTwitter
Here are 5 editorials that I hope highlight how you can make it work.
See thread.
1/ Redefining Myeloma
We wrote this to make the case that the disease definition for multiple myeloma was outdated, and made suggestions on how it should be revised. Few years later the definition was changed. @NatRevClinOncol@DianaNrco nature.com/articles/nrcli…
2/ Strategic Clinical Trials
In this editorial, we called for disclosure of the true purpose of a clinical trial which is often different than the primary objectives, & also for strategic investigator initiated randomized trials. @TheLancet@jocalynclarkthelancet.com/journals/lance…