Rheumination

Reps. Even I Feel Sorry.

If you read this blog regularly, and I'm sure you do, you'll know that while I'm not anti-pharma, I do have ambivalent feelings towards these companies.  If it wasn't for their drugs, rheumatology would be a sad place to work today, but the near constant stream of reports of unethical/sleazy marketing by these firms leaves me feeling constantly uneasy.  The face of pharma, of course, is the drug rep.  These people are almost universally pleasant, the type of people you could get along with outside of work.  Of course, that's the plan.  I keep things pretty business-like.  No first names.  No golf.  I like to keep it that way, even though they must think that I'm quite the cold fish given that most MD-Rep interactions I see are definitely more cozy.  I just like to remember that the job of these guys is to get me to buy.  No more, no less.

These days though, I must admit that I feel a bit sorry for some of these people.  Along with many in these tough economic times, reps are starting to sweat.  It seems a week doesn't go by without new pharma job cuts.  I haven't seen anyone lose their jobs yet, but with the massive cuts around the world, it's likely a matter of time.

With Pfizer buying Wyeth, the Enbrel rep is looking a little uncomfortable.  Given that Pfizer is buying Wyeth for it's biologics though, I think maybe the Pfizer reps for Celebrex and Lyrica should be more worried.  I can foresee a day where we have one rep for the three meds.  

The Roche people aren't sweating the Roche-Genentech deal up here because both Rituxan and tocilizumab (Actemra) are marketed by Roche in Canada.  Weirdly, they have separate reps for the two drugs as I mentioned in a previous post.  This, of course, could change in the new belt-tightening environment.

The Schering Plough people didn't look too worried.  They seemed happy enough with their Remicade sales, probably because of  the GI indications, and seemed upbeat about the sooner than expected arrival of golimumab.  This of course was all before todays purchase of Schering-Plough by Merck.

Overall though, I think the importance of biologics in the bottom-line of these big companies may well save the jobs of many of the reps that rheumatologists see.  That's good because they  really are nice people.  Really, really nice.

Merckier and Merckier

So now, if this article is to be believed, we've gone from honest mistake, to biased reporting, to sleaze in fairly short order. Can it get worse? Wouldn't bet against it.

That was my last comment in my post concerning the disclosure of unseemly practices by Merck in the ghost-writing article in JAMA this spring.  I was not expecting more dirt to surface so soon, however, but so it has, and amazingly, the same company is involved and even the same trial, ADVANTAGE.  The initial study, published in the now embarrassed but obviously vengeful Annals of Internal Medicine, was purported to compare GI tolerability of Vioxx, in comparison with naproxen.  There were several hundred study sites with hundreds of physicians involved and thousands of patients.

  As in the JAMA study, reams of insider  information relating to the ADVANTAGE trial has arisen  from recent Vioxx law suits.  The mountain of documents have been gleaned and  distilled with rather depressing results by Hill et al., published in the Aug 19 edition of the Annals.  The authors have produced a convincing argument  that the trial from its inception was not a scientific endeavour, but rather a seeding study with purely marketing objectives. It should be noted as well that the physicians who published this Merck bashing story were also paid by the plaintiffs in the Merck trials.  Still, their evidence is rather compelling. They show that the study data itself was handled by the marketing department of Merck, as was the analysis and dissemination of results.As we know from the previous JAMA study, they then found a willing investigator to sign on as first author.  Even that author, Jeffrey Lisse, admitted as much;  

Merck designed the trial, paid for the trial, ran the trial. Merck came to me after the study was completed and said, "We want your help to work on the paper." The initial paper was written at Merck, and then it was sent to me for editing.

  The objective, according to the Annals paper,  was to get clinicians familiar with Vioxx so that they would be ready to prescribe when it came on-line shortly thereafter.  While some could argue that this may have been only a secondary objective, little doubt remains after reading the internal memo of  Merck marketing employee Rebecca Higbee;

        "It may be a seeding study, but let's not call it that in our internal documents" 

Good grief.  Now don't think that I'm completely naive.  I know there is almost always an element of marketing in anything a pharmaceutical company does but I admit that a study done for marketing purposes, by a marketing department,  on an unapproved medication would be more that I could have believed.  Probably more than the six hundred physicians that signed up could have believed, and certainly more than the thousands of patients who entered the  trial could have even imagined.

    Merck has, however, written an open letter rebuttal to the findings of the study in the Annals.  You be the judge.