Without leading a trial it's hard for you to realize how hard it is to do one and you may end up throwing stones at investigators trying to do their best. #ASH21
See this thread on how many people control the design of a trial. Most of this thread applies also to investigator initiated non randomized trials also. #ASH21
When you have this brilliant idea on how a trial should have been designed, in many cases the PI is also brilliant enough to know the same but they often had to make the hard choice of putting their foot down and not have a trial at all or compromise. #ASH21
No PI is wealthy enough to find their own trial. No one not even the NCI is willing to give funding for a trial and not get to have their two cents into the design.
No institution is willing to give you open a trial without funds. #ASH21
Funders always call the shots. If Pharma is running the trial they value your input but ultimately yours is not the only input that matters. They have many considerations.
For investigator initiated trials, you still need funding. Those who fund have review committees. #ASH21
Criticizing a trial is fine. In practice we have to do it to make sure we make the right decisions for our patients.
But when publicly criticizing from the vantage point of an expert, always worth considering: Have I ever led an investigator initiated clinical trial/RCT? #ASH21
Reporters may well do the same in COVID times. Not all experts are experts in clinical trials & don't recognize the trade-offs one has to make, even between speed vs perfection. "Have you ever led a clinical trial" is a good screening question. At least have some balance #ASH21
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In the global race to vaccinate against COVID, the US is lagging behind most developed countries. ig.ft.com/coronavirus-va…
In fact, countries which have lower vaccination rates than us are mainly those with inadequate access to vaccines.
Overall we are at #93 of about ~225 countries in %fully vaccinated. Excluding small countries with less than 200,000 population, we are at still >#60 in the race.
This is not due to limited vaccinate availability but vaccine hesitancy.
Vaccine hesitancy is not due to a uniform cause. There are many reasons. But mostly it is due to misinformation about Covid and Covid vaccines spread on media and social media.
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/