Friday, February 16, 2018

I Will Reserve Judgment -- But This Seems "A Bridge Too Far": Rofecoxib, Which Cost Merck Over $4.85 Billion, In Settlements...


I've felt ambivalence, all day, about even mentioning this development, here (as I genuinely do not want to hurt the mentioned company's chances). But I do feel it needs to be said, at least to keep a complete record, on rofecoxib. [So I'll say it at night -- late -- where Poe's immortal words still profoundly echo, off carmel-colored marble hallways. . . smile.]

It seems that in the last few days, a smallish privately-held Cambridge drug firm raised $5 million. It raised the money, with an express plan to bring the drug that Merck called Vioxx® (rofecoxib). . . back to market.

This time, though -- to be fair to the people at Tremeau -- the drug will be prescribed (if and when it clears FDA) for an exceedingly small number of patients -- people with otherwise untreatable pain from hemophilic arthropathy. [The buzz is also a bit about non-opioid pain relief.] Here is a bit of the presser -- do go read it all:

. . . .About TRM-201

TRM-201 (rofecoxib) is a highly potent cyclooxygenase-2 (COX-2) selective non-steroidal anti-inflammatory drug (NSAID) with a well-established efficacy profile and is the first and only product granted orphan designation status for the treatment for hemophilic arthropathy. Rofecoxib is a non-narcotic analgesic, has no effect on bleeding time relative to placebo, and is the only COX-2 selective NSAID ever approved in the U.S. to demonstrate a reduced risk of gastrointestinal bleeding versus a traditional NSAID in a controlled trial. . . .


Yes, Merck did license this out. And yes, if it gives a small base of rare disease patients some relief -- even at some increased cardiac event risk -- I suppose that is a discussion best had between each patient, and his/her treating doctor. . . not the regulator, per se. Vioxx always did provide good pain relief, but in ordinary cases, with other alternatives, Merck itself decided to pull it from the market voluntarily, fourteen years ago. Now you know.

And I do fully-understand the counter-argument. Be excellent to one another. . . as I am out -- completely out, as Mr. Trump has refused to release the photo from January of 2017, of his signing a law that made it easier for the mentally ill to get weapons (repealing an Obama measure) -- weapons including those like the ones used yesterday in Parkland, Florida. What a coward -- 45 won't even own his public, and entirely notorious prior (and recent) supplications to the NRA, and its lobbyists. Ugh.

G'night.

नमस्ते

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