I wish I knew what was going on with the company. I think you are right; there may be a “split” between power groups in the company. I know one thing: the attorneys are clear where they stand! I don’t know: maybe they do a risk-benefit analysis…we stand to earn X dollars, while a penalty would be Y dollars. I am clueless. I just know that I am sticking to the label. That’s my story, and I’m sticking to it. Fortunately, the products I have now don’t lend themselves to off-label use at all. One is a biologic, and you can’t even get it without a confirmed diagnosis for the indicated disease state.

Well, I’m still really tired. I’m going to go take another iron supplement and go to bed. I hate getting old.

So I have to ask a potentially loaded question, but it is again a genuine one. A skeptic reading the account would ask - so why did the company keep sending you to those docs? As you said, they were rx’ing a lot yet the situation was “begging for off-label promotion.”

The skeptic would say - for four years, the company - or field directors - got what they wanted. Then concern about liabiiity set in (was this post-Neurontin?). So they create the scenes of reps coming in to be “sure” that no one was going off label. Creates the appearance of propiety and concern … four years later.

But, as you suggest, it sounds like there may have been splits within the company between different levels of management - or concerns about splits - between groups that were more and less comfortable with tacit or active off-label promoting. Is that any closer to it?

When you say, “record” the conversation, I assume you mean your own notes, not electronic.

At the same time, I and others were whining pretty hard about why those doctors were in our quota. We kept pointing out that it was begging for off-label promotion. Finally, 4 years later, they got taken out. In the meantime, any rep who had recorded notes from conversations with those doctors was interviewed. It was non-adversarial–the company was actually trying to figure out what they had done to encourage off-label promotion. The questions they asked me were about what managers and upper management had told us and had us do. There were no repercussions for the reps involved. I don’t know what happened ultimately, because I left the company, but I was encouraged by that.

As for using my knowledge to expand the market, I don’t know that I do that. I understand how the drugs I sell work and I understand a little about the various parts of the brain, but I’m NOT a doctor. What I can do is engage docs on a scientific level–I think it is more a gestalt they get from me than anything else. My point to Former was that he was being patronizing in suggesting that I have nothing to offer a physician (because they are some sort of deities and I am a peon rep).

You ask very good questions, Justice, and I appreciate your insight. I would say there is a difference between a clinical that addresses an off-label, but related, topic for a drug (i.e., panic for a drug with GAD indication) and a completely off-the-wall off-label indication (bipolar for Neurontin, although I still have a couple of docs who swear by it, go figure.).

I see on another thread that you have a Ph.D. in neuropharmacology (I think I have the field right).

And you are using your training to expand the market for your company (I have no problem with that). But you have also suggested that the sales person and the science person are not always easy to balance. You were once “called on carpet,” you suggest, for pushing sales beyond FDA margins. And you have also, along with others, pushed back from the field against expectations that could tempt at least some to push sales beyond science.

Every field has its high-wire acts so such challenges are not unique or concerning in themselves. But I would be interested in your insights into how you see yourself managing them over the years, as well as other colleagues who you know. What does it take to do it well? What tend to be the reasons when things don’t go so well?

As elsewhere, learning about things I don’t know is, for me, the _best_ thing about Pharmalot.

Anyway, I think you make my point which I first stated above. Getting an article in a referreed journal (like JAMA) is a much lower bar than getting an FDA approved indication. The CLASS example shows that one can get an article in JAMA which is total baloney (or bologna, for the continentals).

You write: “The question of the quality of the research published in journals is a different one than whether pharma should be allowed to distribute them.”

If research published in journals is pretty easy to spin, I think that is absolutely material to whether reps should be allowed to distribute “peer-reviewed” studies related to unapproved uses. So, once again, the distinction you make has logical but not practical relevance.

So the actual question: Should reps be able to hand out potential baloney that appears to support unapproved indications and/or unreal benefits and/or lesser-than-actual risks?

Me and the Wax Creature would vote “No.” Dan Troy and his Ad Company votes “Yes.” I assume that you are with Troy and the Ad Company.

The question of the quality of the research published in journals is a different one than whether pharma should be allowed to distribute them.

Everyone points out that the authors of the articles have pharma connections. Of course they do!!! Who else is going to fund these studies? Don’t say the government–it is NOT the job of the government to do medical research. It may be appropriate to demand more transparency around the research, but let’s stop with the self-righteous outrage about who writes the articles and does the trials. Of course trials have a commercial purpose; drug companies have an interest in expanding the market for their product. This is a case of different constituencies having interests that merge (scientists are curious, doctors want advances in medicine, patients want better drugs, and drug companies want to make money), while also having some interests that conflict. That is an argument for oversight and regulation–in an environment that is conducive to innovation and risk-taking–not for the sanctimonious outrage expressed by the likes of the Congress creature Waxman.

Re: the guidelines that Jack2 first excerpted and I posted above, they are drafts that the FDA is circulating (hat tip to Gooz News, as Ed would say).

Let’s be specific: the famous JAMA CLASS study publication in which study Pharmacia was seeking FDA approved GI benefit for Celebrex. As published, CLASS appeared to show that. JAMA wrote editorial in praise of cox-2s and Celebrex in particular. And even Bob Temple noted that this probably had an enormous impact on rx’ing Celebrex.

Turns out, of course, it was baloney. CLASS, as it appeared in JAMA, left out the second six months of the data. Once those back in, the GI benefit disappeared.

That is why FDA (which had all the data) did not allow Pharmacia/Pfizer to claim GI benefit for Celebrex. And thus why you won’t find it on the label.

Now let’s say (hypothesis) that Celebrex turns out to have significantly increased CV risks at higher doses. In the new regime as proposed, docs would have been flooded by reps giving them the JAMA editorial and talking up the GI benefit till cows come home. This was, after all, “medical information,” canonized (so it appeared) in JAMA.

So docs would and did start rx’ing Celebrex in much greater numbers. For a benefit that turned out to be bogus. And, in the process, _could_ have ended up killing some number of people because of Pharmacia’s duplicity.

All enshrined in what seems to be the most reliable peer-reviewed journal there is, and even with an editorial.

Bob Temple ended up saying that the “hype” of the article probably “has more impact than our labeling does.”

Undoubtedly, it did.

Is that the future folks want?