When the FDA approves a drug, it is not only approving the drug. Its actions provide prolonged monopoly protection to a drug in a country where the seller can set whatever price they want, the buyer cannot negotiate price, and competitors will face more severe barriers to entry
If like other Western countries we had a 2-step process for prescription drugs: regulatory approval followed by value based pricing determination, I would have less problem with an FDA that is more lenient.
If like other countries barriers to market entry to competition are not so hard, then I would have less problem with an FDA that is more lenient.
If we didn't have "CME" meetings and "Ad Boards" that will proliferate once a new drug is approved with expert physicians telling colleagues how wonderful the new drug, and rampant off-label use was curtailed, then maybe the FDA can be more lenient.
Look at the Top 10 drugs that Medicare spends the most money on. It tells you how the game is played.

• • •

Missing some Tweet in this thread? You can try to force a refresh
 

Keep Current with Vincent Rajkumar

Vincent Rajkumar Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!

PDF

Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @VincentRK

11 Jun
The delta variant is the triple threat I have talked about. I am not saying this lightly. I take no pleasure in alarming people. It's just the facts after 2 months of being closely involved with the India COVID crisis. This is not last years COVID. Get vaccinated.
The message is not alarm. The message is that there is an easy solution that works. #GetVaccinated
Read 5 tweets
9 Jun
Vaccine hesitancy in alive and well in the US. And it is going to cost lives. The level of vaccination we have in the US is simply not sufficient against the delta variant.

Friends: tell unvaccinated friends to get vaccinated.

Leaders: lead. Talk to your constituents. Beg them
30 million people who got one dose of vaccine need second dose. One dose is not enough.

Another 60-100 million people need to be fully vaccinated.

Get vaccinated even if you had COVID before.

Im trying not to be alarmist even though I'm extremely worried.
The delta variant is a triple threat. It is here.

1) More transmissible: In India, If often if one family member had it, everyone got it.

2) Vaccine evasive: In UK study a single dose of Pfizer or AZ had only 33% protection against symptomatic COVID.

3) Likely more virulent
Read 8 tweets
8 Jun
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
Read 4 tweets
7 Jun
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.

@SarahKarlin @RESachs @DusetzinaS
Please for heaven's sake pass a law enabling Medicare to directly negotiate prescription drug prices. 90% of the public wants it.
Read 5 tweets
7 Jun
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.

We need to reform the system.
nytimes.com/2021/06/07/hea…
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.
Read 4 tweets
7 Jun
Important study on relative efficacy of COVISHIELD versus COVAXIN in India. @singhak_endo

Quite a difference in seropositivity after one dose. Difference narrows after 2 doses.

Get whichever vaccine you are offered first. Make sure you get both doses. medrxiv.org/content/10.110…
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.
Read 5 tweets

Did Thread Reader help you today?

Support us! We are indie developers!


This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Too expensive? Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal Become our Patreon

Thank you for your support!

Follow Us on Twitter!

:(