Thursday, July 24, 2008

An Anonymous CafePharma post that deserves to be seen. . . .


UPDATED: 07.25.08 @ 8:30 AM EDT -- That fine gent -- at PharmaGossip -- has linked this, and made a poignant reference to the fantastic Joseph Heller novel "Catch 22". Do go see his!

I have also set the comments, and some observations on them, as a new post, here.

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Schering has prepared a "Dear Doctor" letter related to the cancer issue in its SEAS study. Here is one purported salesperson's incredulity -- given that Schering will only provide the letter to doctors who ask for it -- I thought I'd link the letter, and quote the salesperson's reaction:

Today, 01:14 PM Anonymous

Re: Is this what you were trying to show with SEAS?

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Quote:
Originally Posted by Anonymous

One word summary..CANCER

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I just had a Physician ask me for the letter explaining the Cancer concern coming out of SEAS. He saw it on the internet. Beautiful. It actually states that we will not be automatically sending letters to all Docs, instead we will hand them a letter if they ask about it. God I have to get out of this company quick. Again SP is doing the bare minimum to inform our customers. Personally, I am going to make copies and hand one to every doctor and nurse in my territory. This shell game bullshit is another SP manipulation of our credibility and I told my DM on the phone that this is what I plan to do. Nothing but silence on the other end. I don't think she had a clue about this. . . .

Jaw-slacking. Simply jaw-slacking.

5 comments:

Anonymous said...

In the US any written material provided by a companay relating to an approved drug including advertising is 'labeling'.

This is what the Food Drug and Cosmetics Act has to say about labeling:

FD&CA
SEC. 502. [21 USC 352] Misbranded Drugs and Devices
A drug or device shall be deemed to be misbranded

(a) False or misleading label. If its labeling is false or misleading in any particular.

(j) Health-endangering when used as prescribed. If it is dangerous to health when used in the dosage or manner or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.

Now if Vytorin is paid for by Medicaid or Medicare the following is something else to consider.

18 USC § 371. Conspiracy to commit offense or to defraud United States
If two or more persons conspire either to commit any offense against the United States, or to defraud the United States, or any agency thereof in any manner or for any purpose, and one or more of such persons do any act to effect the object of the conspiracy, each shall be fined under this title or imprisoned not more than five years, or both.

If, however, the offense, the commission of which is the object of the conspiracy, is a misdemeanor only, the punishment for such conspiracy shall not exceed the maximum punishment provided for such misdemeanor


Salmon

Anonymous said...

Quick correction. Not only advertising but printed materials are considered labeling for determination of misbranding.

See FD&CA SEC. 201

(m) The term "labeling" means all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.



(n) If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.


So if they only give out a letter about Cancer if requested, is this failure to reveal material facts? What about all the other clauses and the fact that it's illegal to introduce into interstate commerce a drug that's misbranded?

Discuss among yourselves.

Salmon

Condor said...

Salmon -- you've just gone where I was headed next -- swimming up the very same river, it seems -- I'll likely highlight yours, in a new post, later today, and with it, predict that in perhaps only a few days' time, the FDA will "give Schering a call" about less than complete transparency -- i.e., reticence on material saftey information. . . .

Perhaps I'll caption it:

"How to help an ordinary train-wreck. . . catch fire, and explode, to boot!"

Or, maybe I'll leave all of that right here -- it seems to flow so well.

But make no mistake -- this looks to fit the Hassan-led Schering pattern, to a tee -- torture a dubious position until it is bearely recognizable as compliance with the applicable law -- and thus gets one into EVEN MORE trouble, as opposed to getting one out of it.

Great post -- thanks for the research materials!

Anonymous said...

I just had a Physician ask me for the letter explaining the Cancer concern coming out of SEAS. He saw it on the internet. Beautiful. It actually states that we will not be automatically sending letters to all Docs, instead we will hand them a letter if they ask about it. God I have to get out of this company quick. Again SP is doing the bare minimum to inform our customers. Personally, I am going to make copies and hand one to every doctor and nurse in my territory. This shell game bullshit is another SP manipulation of our credibility and I told my DM on the phone that this is what I plan to do. Nothing but silence on the other end. I don't think she had a clue about this. . . .

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As a 30 year veteran, good for you. When the Zetia 49 Day plan rolled out and we were ordered to spend between $100 to $200 per day/ on Zetia target physicians regardless. Spend it, turn in the receipt, don't get turned away and if you do just leave Starbucks, unordered lunches, get them out to dinner, get the staff to save Zetia prescriptions.
I talked to a college friend of mine, who is now doing work for the Feds, and she basically explained to me that if this practise of "buying off" is a new policy and was just implemented to be reactive in light of negative medical studies, such that, sales and thus profits are declining, then I as a rep. could inadvertently be involved with bribery "by just following orders".

That was it.

When I am told I will spend this kind of money, no excuses, spend it on the Zetia targets that are dropping, get the receipts and we'll get the reps paid back and then in the eyes of Doctors we are now viewed as SO desparate with what little credibility we have left is FOR SALE.

I'm out and thank God. This is someday going to turn up on 60 minutes or better yet a 2 Hour Dateline Special.

I have never seen such arrogrance in lusting for power.

[Reprinted from CafePharma.]

Anonymous said...

[Also from CafePharma:]

merck is already doing this you snuka. honestly, its equivalent to the acc response to enhance letter: worthless. your dm was silent because she put the phone on mute to bang her head against the wall.

check your email - you can print it off that.

i can't wait until the layoffs. at that time a post from you will probably be like "got my severence and on the golf course. got like 50 interviews lined up with medical devices for four times as much as i made at sgp. go suck it!"