Just go read it. Daniel Carlat, M.D. is ON FIRE! Truly, this is priceless -- and horrifying, in a singular moment. Kenilworth, again, dead at the switch -- this really is "the gang that can't shoot straight".
Or. . . "This, ladies and gentlemen, is how marketing a second-rate drug is handled -- downtown-style!" (Is. It. Just. Payola? Then. More. Payola?):
. . . .Oddly, [Schering-Plough] just sent me a Saphris® Speaker Bureau invitation packet. I guess my 2007 New YorkTimes Magazine memoir describing the tangled ethics of promotional speaking has not yet become required reading at Schering-Plough.
Their invitation packet starts with this cover letter flattering me by saying, “As a recognized thought leader and well-respected healthcare professional among your peers, we are seeking your participation as a speaker in our Schering-Plough Saphris® Speaker’s Bureau. . . .”
Then there is this Speaker Bureau Agreement in which you have to promise to go to a Schering-Plough training meeting (it’s not so bad — you get $3,000 plus all expenses for a day and a half meeting), and in which you promise to use only company-sponsored information for your presentations. . . .But the meat of the packet is called Exhibit A. . . which tells you how much you’ll be paid:
▲ $1,600 for a 45 minute power point presentation or informal “peer discussion group.”
▲ $1,000 for a 45 minute web-based live presentation (you get $600 less because you don’t have to leave the comfort of your office)
▲ Total maximum (called “contract total aggregate”) amount that you may receive over the course of the year is $170,000. . . .
Indeed. Color me stultified, here. Actually, I'd long known of the practice. But now, at least, we all may openly-decide whether our professionals' judgment is independent -- or bought and paid for.
4 comments:
Well as we've been pulling apart the asenapine reviews that the FDA released as part of the background package for the Psychiatry Drugs Advisory Committee (PDAC),
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/ucm126199.htm
the FDA has made another blow against transparency. If you go to drugs@fda which lists all drug approvals and is the official public repository for publicly released reviews there is absolutely nothing there for asenapine.
(see http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist)
I've seen this before when there are significant changes in labeling over the years some versions of labels wind up publicly available and others don't.
So much for Commissioner Hamburg's commitment to transparency and addressing complaints that things are too hard to find on the FDA website even when available.
Salmon
$170,000!
I wonder what kind of contract they would have for me.
Salmon
Wow -- could it be too new to be there, yet on the Web? Is that even a possibility?
I am not defending -- just trying to understand.
Truly baffling.
Namaste
N.B.: Sorry it has taken me so long to get this post up -- but between you and Marilyn Mann -- I am always in good hands. . . .
I doubt it. The approval letter and the approved labeling are there. If they were going to post the reviews they would have done it at the same time.
If you read the transcripts this was a major theme at the FDA transparency meeting in June.
a) not posting reviews.
b) posting only parts
c) redacting things that should not be redacted
d) not posting labeling changes consistently.
e) posting reviews as pdf image files rather than pdf text files so you can't search on them or copy things, (e.g. iloperidone).
d) posting things on the FDA website but burying them so it's extremely difficult to find or refind a second time. (e.g.asenapine)
These were all comments by people who look for drug reviews on the FDA website constantly, e.g. Sid Wolfe from Public Citizen.
I believe the lack of posting is intentional. When I go back and try to rebuild the history of certain labeling changes. I find that later labeling versions that tend to obfuscate or tone down safety are consistently missing from the series.
Some labeling changes actually seem to be promotional in nature like the slow changes in class labeling for ADHD drugs to push pediatricians to diagnose bipolar disorder in children over the last few years and to prescribe other drugs (e.g. antipsychotics). Whereas before the labeling was incredibly obtuse as to the known but uncommon dose related stimulant induced psychosis. (Just stop the drug let it wear off and use at a lower dose.)
Methylphenidate (Ritalin/Concerta) are extremely well behaved drugs in terms of dose, exposure, and effect and a 0.3 mg/kg dose with give the very close to the same exposures and time course of effects in a 7 yo as in an adult.
In fact the dosing since the 1960's was to start low (0.3 mg/kg/day) and titrate up (to 1 - 1.2 mg/kg/day) because of this and around the same time as the push for pediatric bipolar began a number of KOLs began pushing for physicians to begin dosing Concerta, Adderall etc.. at extremely high doses (1.5 mg/kg/day) with no titration period and titrate up from there. This of course was resulting in doses higher than the average that had been used in practice and numerous independent clinicians over decades had found to be the doses (not too low and not too high).
FDA even helped out with this push to diagnosis kids with bipolar disorder several years ago when they held an AC meeting warning of the dangers of BP in children on stimulants who got 'psychotic' for which they inappropropriately included irritable in the definition. This was under Shirley Murphy, the ex-Glaxo VP of pediatric marketing strategy that Rep. Rosa DeLauro complained about, and was due to a change in the law on pediatric drug approvals to include an AC meeting to look at toxicities 1 year post an approval. For Concerta this was a supplement (I believed a higher dose strentgh) that they used to justify this.
Murphy was making a big stink about it in the press before the AC meeting and then she got shot down by their own reviewers at the AC meeting and had to an Emily Latella (SNL) saying 'never mind'. but we'll get back to you after we confirm. With her finally following up and quietly confirming the lack of it being a big deal a year later.
Other inappropriately redacted information you can tell from other things they leave in that it's so as to not show what slip shod work they let through which if it had been done properly very likely would have shed like on certain toxicities including death.
When you see something like this 1 or 2 times it's easy to attribute to mistakes, but when you follow these things like I do and you see it over and over and over and always in the drug companies favor you become suspicious. In fact for drugs I know inside stuff about I would try to predict what would not come out which should and I was right about 9 times out of 10.
Salmon
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