I'll simply note that even though less than five per cent of these social media campaigns to date have actually caused a pharma major to grant the affected cancer patient pre-approval "compassionate use" access, the trend is accelerating -- and all the numbers are certain to balloon. And with that ballooning, will come some very emotional (and quite justifiable) pressure -- on the companies -- to grant every dying patient access.
The balance, it seems, for the drug or biologic candidate maker, is that all adverse events related to a given candidate must be reported to FDA, as the agency prepares its approvability analysis. Even so, granting stage IV cancer patients access -- as an unfortunate matter of biological statistics -- means that many of them will die shortly, in any event. And that in turn means that Merck or BMS must then make an evaluation of whether the candidate was any factor in the patient's demise. And that -- like all science -- takes time.
So -- when someone nearing the end of their battle with for example, pancreatic cancer, uses change.org to garner 150,000 signatures for access. . . Merck must think carefully about whether pembrolizumab ought to be sent to their oncologist, for free use.
Of course BMS must do the same for its nivolumab anti PD-1 candidate.
Or is the relatively slight delay inherent in post-mortem analyses of compassionate access pre-approval patients' end of life data, best serving the higher social good? Afterall, in some cases, these biologics will extend to the patient a meaningful amount of quality time -- maybe even a year or more. The data is too new to say, with any degree of certainty.
It is a difficult balance, to be sure -- but it would be a mistake, in my view, to think that Merck and BMS are insensitive to the plights of the cancer patients. This is far less about the last penny of future profit (in my view, looking at pharma's motivations, from experience) than it is about trying to get a safe candidate to market -- for all patients -- as quickly as is humanly possible.
Be excellent to one another -- and we will, in any event, have more and better data -- at ASCO in Chicago in June. See you then.
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Note 1: the graphic at above right was derived in part from the NYT story first linked above. My appreciation goes out to Carl Kleiner, for that.
7 comments:
Off topic but would like to hear your thoughts:
http://abcnews.go.com/Politics/wireStory/high-court-voids-contribution-limits-23157781
Best commentary I read on this difficult conundrum, by far! Kudos Condor.
Relevant to Merck:
http://www.fiercebiotech.com/story/stallergenes-beats-merck-market-fda-oks-its-allergy-pill/2014-04-02
I'll first address todays USSCt decision -- the others likely tomorrow:
As much as it pains me to say so, I think today's decision is right, as a matter of constitutional construction.
People have first amendment political speech and spending rights.
I don't think corporations' rights should be equal to the peoples' rights -- so I continue to think Citizens United was wrongly decided -- and bad policy, to boot.
But to the extent that today's decision means that an individual person may decide to spend the base cap for as many candidates as he or she likes (without limits), I think that is what the founders envisioned.
It pains me to say so, because it means that Sheldon Adelman and the Koch brothers are free to essentially buy smaller federal election cycles. . .
But I think that is what the framers envisioned, at least as to the white landed gentry of their day.
Conspicous disclosures -- far and wide -- of the amounts spent should acheive the ends Congress was after -- and be less restrictive than outright bans on political speech.
And still -- I hate the idea that one needs to be a millionaire to run for any office now.
That's my $0.02. . . Ugh. I
ll get over it.
Namaste
Thanks for the sentiment anon. no. 2, and as to the allegy pills -- those have always been just nice to have dividends, from teh old S-P consumer health businesses. . . and as I've said, that whole set of assets is likely to be spun-off, or split off -- and a little lss likely to be sold for cash. It just means those businesses are worth a little less today than yesterday.
Said another way, it does not shock me that yet another legacy S-P product got beat. Not at all.
Sorry -- but that's the Hassan legacy.
Namaste -- baby lobster tails and rosemary new potatoes -- with a fizzie side pairing (rasberry mint?) up next!
Woot -- and Namaste
PS: Please excuse my typos on the Supremes' decision. . . just kind of rushing through here. . . post workout.
Condor - a correction (I believe) on the allergy pills. These are not consumer health material - Rx only with a boxed warning (for the Stallergenes product) to boot.
Thank you!
Didn't know that... As prescription only product, it might merit a new post in the morning!
Thanks! I'm clearly off a bit here... Sheesh -- but nothing some more chocolate cake won't cure! Hah!
And do stop back!
Namaste
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