GRIFFIN study results show trend to significant PFS benefit with quad induction. For high risk I'm already convinced of Dara-VRd. For standard risk, would like to see OS benefit, but I have to think more. Congrats Dr. Jacob Laubach & colleagues. #ASH21
More on GRIFFIN in this tweet by @AuclairDan which summarizes the data well. Although this trial is a randomized phase II (not a Phase III), it's meeting Phase III endpoints. #ASH21
Only in a broken system can you increase prices like this. Every time your competitor increases price you do on the same day. Because you can. Because there is no completion. Because there is no law that prevents hikes like this on the exact same product.
The price hikes succeed because there is a vulnerable population that needs the drug to stay alive and so has to spend whatever it takes. It is government that needs to step in and protect them. @t1international#Insulin4all
Recs for using free light chains (FLC) in practice. #ASH21
1) We get a lot of consults for abnormal FLC ratios /levels. If FLCs are the only abnormality, you don't need to do much unless involved/uninvolved ratio is >8.
2/ If there is clinical concern for light chain process like amyloid or if there is intact immunoglobulin M spike, u can do more. But uncomplicated FLC ratio <8 is almost never going to be high risk SMM. #ASH21
Light chain MGUS with FLC ratio <8 is managed like low risk MGUS.
3/ When we first established the normal FLC range it was a new test and the consequences of abnormal value was not known. A very strict cut off was used. We know now that the normal ratio is affected by age and creatinine. @sykristinsson#ASH21ash.confex.com/ash/2021/webpr…
Reminder: You cannot compare seriousness of Omicron with delta or wild strain by comparing crude rates of hospitalization or deaths
Omicron faces a different, more immune population: half the world is vaccinated and/or had Covid. Millions of vulnerable have died due to COVID.
1/
Vaccination rates are very high in age >65 population. So the most susceptible now are younger & more fit. So Omicron even if intrinsically more serious will appear milder.
Even age adjusted comparisons won't account for pre-existing immunity from prior Covid or vaccination.
2/
Even if omicron causes less serious disease, the high transmissibility is itself a concern because:
a) more rapid spread will cause more people to be affected in a short period of time: A smaller % of a larger number getting very ill will take up hospital & ICU beds
3/
Should Covid vaccines have been 3 doses from the start? Perhaps. But remember it was a miracle we got highly effective vaccines developed, tested, approved & administered within a year of the pandemic.
Science is not magic. We did better than anyone hoped for. I'm thankful.
Science is continuous learning. Science means we are guided by the best research data we have in the moment. Not what we may have in the future.
If we learn something new, or if the virus changes, we adapt.
We now know a booster is better. So we recommend one. Simple as that
So yes, next year we may recommend another booster or a modified variant specific vaccine. We don't know. It depends on what the research shows. Depends on what the risks look like at the time.
This was enormously difficult & is not sustainable. Coz if you lead trials some small amount gets invariably reported.
$0 is possible only for people who don't lead therapeutic trials. #MedTwitter
2/ I had to go through all kinds of contortions to get to $0, including taking my name off many papers even though I was an investigator. Ride separately from other investigators to meetings. Avoid drinking even bottled water in long meetings to get zero dollars reported.
3/So we have a problem. If you want experts with zero $ conflicts you will end up with people who don't lead clinical trials.
The $ amounts reported do not mean that investigators are enriching themselves: it can be meetings, being authors on papers. Actual cost to do the trial
FDA advisory panel votes in favor of EUA for molnupiravir for treatment of COVID. @Merck
Molnupiravir is a pill taken twice a day for 5 days starting within 5 days from onset of symptoms. @Merck
The main issue with this drug is that in the interim analysis there was a 50% reduction in risk of hospitalization and death. In full analysis the benefit narrowed to 30%.
Is a 30% decrease in risk of severe Covid good enough? Yes in my opinion.