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
4/ Simply classifying people as financially conflicted vs not is useless without taking into account whether a real conflict exists or is meaningful.
You may end up with "non conflicted" people with $0 against their name who are non experts— knowledge from books, not experience
5/ After all none of your institutions will let you open a trial without funding. The vast majority of trials, especially in oncology, even many NIH funded ones require support from Pharma.
You also cannot lead a trial and refuse to attend investigator meetings or be an author
6/ On the other hand we also cannot say everyone gets money, everyone is conflicted, and therefore nothing really matters.
Because there are certain conflicts that do matter. Either based on the type of conflict. Or the $ amount.
We need a balance.
7/ So as hard as it is, look at the details: What kind of conflict. How much.
For reviews, guidelines, editorials you need people without 𝘴𝘪𝘨𝘯𝘪𝘧𝘪𝘤𝘢𝘯𝘵 COI. If you want 𝘻𝘦𝘳𝘰 $ COI as a purity test, you end up with non experts who have never led therapeutic trials.
8/ Don't try to exclude real experts by holding them to impossible standards that you yourself will not meet if you were in their situation running the type of trials they do. Doing so can be a conflict of interest in and of itself.
9/ I had posted this table a while back. The left box is are the most important conflicts. The middle box is just unavoidable for people leading clinical trials and is ok for most activities. The right box is a disclosure like your employment but not a financial COI.
10/ Open payments has errors. It misses some stuff. It includes erroneous stuff. Don't use it as yes/no and write papers that xyz% are conflicted. It gets you a paper. But it's not the truth. It reveals you have probably never led a therapeutic trial, especially in oncology.
11/ I have been worried about conflicts of interest for years. But I'm in a ultra unique position to dictate my terms. Its not possible for most investigators. They are leading trials to help patients. Not for the coffee and breakfast served at investigator meetings.
12/ So I cringe when I see good investigators labeled as conflicted because open payments shows they received some $. Those kind of papers are lazy research. Details matter. Just coz they are hard to get doesn't mean you go for whatever metric you can get easily: McNamara fallacy
13/ I also do not like the move to make people list every irrelevant thing in the name of full disclosure. That just defeats the purpose of disclosure. If everyone is conflicted, then no one is conflicted. Is that the goal? Make it look like everyone has conflicts?
14/ These exhaustive disclosures are like the fine print. Disclaimers. No one reads. Designed to make it look like everyone have something to disclose. Which means patients and physicians are going to think, well it looks like everyone has a conflict so it doesn't matter.
15/ We need to make people disclose as a conflict of interest what's materially relevant, if there is something of that nature to disclose.
16/ In fact if it's left box items, then even disclosure may not be enough for certain activities like reviews, guidelines, editorials etc. If its middle box items then with disclosure most activities would be fine because it is unavoidable for people leading therapeutic trials.
17/ Your can have the right box item in some tiny fine print listed if it makes you happy. But those are not conflicts of interest. It's just disclosures. Just like someone discloses their employment.
And yes. I don't have the time to fight the $168 reported against my name for 2017 for some breakfast I didn't eat.
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.
People are counting waves differently. Some say we are in our 5th wave.
We are a big country so as a wave spreads it looks like 2 waves, but it's one wave sequentially in 2 places.
Initial 2 peaks is first wave Apr-Sep 20.
2nd wave Nov 20-May 21.
3rd wave is the current one.
Easier to appreciate when you look at deaths because with cases, numbers over time have been affected by test availability.
So looking at deaths, the first two peaks are one wave, affecting separate parts of the country as COVID spread initially. We are now in end of 3rd wave.
When you look at individual states easier to appreciate 3 waves. New York and Texas below.
Here are my Top 5 #ASH21@ASH_hematology myeloma abstracts. #ASH21VR
Links to the full abstract. As in the past, I left out studies where similar results were already presented or published before. Top 5 based on new data, clinical impact & methodology
I was just thinking of flying to see family. #OmicronVariant threatens plans because we have no idea what countries and airlines will do at the last minute.
The last thing you want is to be stuck for days in a quarantine hotel.
Like what happened to passengers on these two flights.
People are rightly confused how is it that we have another wave when 60% or more are vaccinated, & 40-50% of the population has probably had COVID.
Where is immunity?
Thread.
1/ How strong and durable immunity is following infection or vaccination depends on many factors.
2/ The strength and durability of the immune response depends on the nature of the antigen, how it is presented to the immune system, number of exposures, etc.
3/ With Covid we also got a bad deal: A new serious virus that we were not immune to, that spreads easily, & mutates.
4/ The immune response is more durable with repeated exposure: generation of a true secondary immune response. microbiologynotes.com/differences-be…
With natural infection sometimes one infection is long enough to trigger a durable secondary response. Sometimes its not, & you are susceptible.
Just like anti vaccine folks found Gibraltar, another place they keep pointing to is Vermont, the most highly vaccinated state.
Best for people know the facts.
1) No state has done as well as Vermont in this pandemic: fewest lives lost. They know what they are doing.
2) Vermont is the best vaccinated state and vaccinations have kept deaths low. Since June 1 by which data everyone had an opportunity to be vaccinated, deaths have continued to stay low in Vermont. But have increased in many less well vaccinated states.
3) Even Vermont is not as well vaccinated as it should be. So 72% while #1 in the US is lower than many countries. There are vulnerable people and unvaccinated people, so with delta cases will occur.