1) ECOG Thalidomide Dex vs Dex for myeloma. My first RCT. I had previously led small Thal trials at Mayo. But leading this pivotal RCT required luck. I had proposed a small Ph II, so they let me be PI. But @theNCI mandated a change to Ph III RCT design. ascopubs.org/doi/10.1200/JC…
2) Celgene Thal Dex vs Dex placebo RCT. Given success of ECOG trial, which led to thalidomide approval by FDA, I was asked by Celgene to lead their company trial: a confirmatory trial for regulatory approval. Company trials are easier to run. ascopubs.org/doi/10.1200/JC…
3) ECOG high dose vs low dose dexamethasone: A patient, the late Michael Katz proposed this trial. Glad we listened. Results led to a dramatic reduction in myeloma deaths & morbidity worldwide. Also gave Rd backbone used in most regimens. @TheLancetOncolthelancet.com/journals/lanon…
4) ECOG MPT vs MPR: Slow accrual. So by the time the results of this trial came, melphalan based regimens were out of favor. Shows how long delays in opening, and slow accrual that affect many RCTs in the US. @akeithstewart the trial PI did all the work. ashpublications.org/blood/article/…
5) Mayo Clinic Thalidomide Zoledronic Acid vs Zoledronic acid for smoldering myeloma. Managed to get @NIH R01 grant to fund an RCT. Not just lab correlatives, but actual trial costs! These grants are scarce now. Precursor to Lenalidomide smoldering RCT. nature.com/articles/leu20…
6) Takeda Ixazomib vs Placebo Maintenance RCT. Great lessons from interactions with FDA and the sponsor on trial design and endpoints for maintenance. Novel design with early read out of PFS, but continue trial for OS endpoint. @TheLancetthelancet.com/journals/lance…
7) ECOG Lenalidomide versus Observation for smoldering myeloma. I’ve written a long thread about the 15 year saga. This trial together with the RCT by @mvmateos changed paradigm for high risk smoldering myeloma. Great working with trial PI @SagarLonialMDascopubs.org/doi/10.1200/JC…
8) ECOG ENDURANCE VRd vs KRd for myeloma. 10 year effort. Was struggle to open. But accrued fast. Results show why RCTs are important. It’s also 2 RCTs in one! 2nd one: Len 2 years vs Len till progression is ongoing. Great working with trial PI @myelomaMDthelancet.com/journals/lanon…
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To my followers who wonder what MOC is, and why many doctors are tweeting about it. Thread.
1) Maintenance of Certification (MOC) is a redundant requirement thrust on US physicians by a private organization. We resent it.
2) MOC is causing frustration and burnout. Over the years, ABIM certification and MOC have become entrenched and institutions and insurers require it and will not accept any other alternative.
I am advocating on behalf of my colleagues in the US for change. To end MOC.
3) MOC requires us to pay fees imposed on us by a private organization and take multiple choice question tests irrelevant to our practice.
10 suggested action items for physician colleagues suffering under the burden of @ABIMcert MOC. #MedTwitter
1. If your institution allows it, stop participating in MOC. Personally, MOC has no value to me.
2. If your institution requires ABIM certification, advocate for @InfoNbpas as alternative option.
3. Do not participate in more than one ABIM MOC specialty, the one that’s required by your institution. Save your money. Don’t spend a penny more than you have to.
I see a lot of wrong analysis on accelerated approval and surrogate endpoints.
It’s always easy to criticize from the outside. The criticisms raised are well known to the FDA and investigators. They are considered. We go in eyes fully open. We try to do what’s best for patients
Without accelerated approval using surrogate endpoint of overall response rate in single arm trials, for 2-3 years lives would have been lost waiting for drugs like Velcade, Revlimid, pomalidomide, Daratumumab, carfilzomib and more.
1) @costplusdrugs — where you can get >2000 prescription meds at lower price than almost any other pharmacy in America. Has revolutionized the generic prescription drug market. @mcuban costplusdrugs.com
2) @PayorDieFilm — the story of lives lost due to the high price of insulin in America. Likely contributed to why all 3 big insulin manufacturers have now cut the price of insulin by >70-80%. @scottaruderman @NSmithholt12
Watch on @paramountplus @mtvdocs
3) Inflation Reduction Act provisions to cap Medicare Part D copays.
For 2024, the out of pocket max for Part D drugs that a patient pays in copays is capped to a max of ~$3250. A huge relief to many.
Two days ago I did 60 ABIM MOC questions in Heme and Onc (against my will).
Almost all were esoteric/ irrelevant questions. Rare things that doctors rarely see. #MedTwitter
What’s my opinion?
1/
I spend a lot of time in medical teaching and writing. I write for UpToDate for 20 years, and all of the major Hem Onc textbooks.
In my opinion, the MOC questions are useless for routine Hem Onc clinical practice. Useless to assess “walking/ essential knowledge”.
2/
What’s worse: Every 3 or 4 questions that I spent time and answered, I would get a note that it was a “test question”. No answer was given at the end, making it a complete waste of time and making me an unwilling partner to test questions for the ABIM. @DavidSteensma
3/