What if the (very) young pharmaceutical rep is right?

I loved my old status.  Perhaps, reveled in it would be a better description.

I was a crotchety generic-medicine only doctor.**

Sadly, my status changed today.  Dabigatran (Pradaxa) was the culprit.

It was a little nerve-racking.

I wrote the order, looked at it, thought it out again, talking to myself, “John, are you sure you don’t want to do it the old way…{Pause to think}…No…I am embracing the new.”   And then, I closed the chart and handed it to the nurse.

“What’s that?  Pradaxa?” asked the nurse.

“Stop the Lovenox…you sure?”

My face must have told the story.

Eight days had passed since dabigatran’s approval. “That’s plenty of time to mourn warfarin’s demise,” I thought.   Enough studies, enough blogs; it was time that the rubber hit the road.

Later that day, to another EP colleague, I asked “Have you used Pradaxa yet?”

“No, I don’t want to…because they want me to.” 

He must have liked his independent-of-pharma status too.

For nearly a decade, most electrophysiologists have had the luxury of prescribing primarily generic medicines. When doctors were scolded for over-using expensive medicines, we EPs could sit back, fold our hands behind our heads and proudly say, “that’s not us, we use only generics.”

But now, for the first time in years, I am compelled to use a drug that a pharmaceutical rep wants me to use.  Right or wrong, that change in status tugs at me a bit.  I am going to have to learn about PAs (prior authorizations), Medicare-d and donut-holes. That’s sad.

But in the case of dabigatran (Pradaxa)–and we are going to have to call it Pradaxa, because dabigitran is so much more difficult on the vocal cords–the drug rep is likely right.

Pradaxa’s primary strengths (from the 18000 patient RE-LY trial) are:

  • Fewer strokes.  
  • Less intracranial bleeding.
  • No INRs.
  • No dietary issues.
  • No drug interactions.
  • Blood thinning occurs one hour after a dose–not 3-4 days.  This will result in shorter hospital stays, and AF is the most common cardiac cause of hospitizations.
  • In the RE–LY trial, 12,000 patients took Pradaxa, and they did well. 
  • Pradaxa has been approved in Europe (for treating blood clots in the veins–DVT, VTE) and no significant safety issues have been reported.

There’s very little not to like.

A new chapter in doctoring.

JMM

**Until Pradaxa’s recent approval, the only commonly prescribed non-generic CV-drug an electrophysiologist used was Pfizer’s class III anti-arrhythmic drug dofetilide.  AF ablaters find this drug especially useful.

Disclosure:  I turned down an invitation to become a Boehringer Ingelheim-trained “expert” speaker.  Primarily because being non-conflicted feels so good.

6 comments

  1. Facing change, evaluating the old and new and then embracing change in any aspect of life requires knowledge, wisdom & courage. When the change involves the well-being and perhaps the very life of another person, the demands on the decision-maker are only greater.

    Regardless of how your decision turns out, I prefer it to that of your colleague. Refusing to even evaluate a new direction because of a hostility to "them" would seem to go against the basic precept of the Hippocratic Oath. I'd would rather put myself in your hands…

  2. Hi Dr. John,

    Excellent points here!

    Welcome to the wonderful world of "rep-accessible" docs, as you would now be described by the drug industry-funded website 'Policy & Medicine'. (Their mission: “Supporting Innovation Through Collaboration” is a CorporateSpeak tagline that roughly translates as: “We Put Doctors On Our Payroll So They’ll Flog Our Drugs For Us”).

    According to 'Policy & Medicine', a recent U.S. study is “troubling” for both patients and physicians. (Oddly enough, as a heart attack survivor and consumer of a fistful of cardiac meds every morning, I am not remotely “troubled” by this study’s results. In fact, I’m considerably cheered up!)

    The study by AccessMonitorâ„¢ surveyed 500,000 American physicians, nurses and other drug prescribers. It also tracked both the planned and completed sales calls of 41,000 pharmaceutical representatives, which is about half of all drug reps in the U.S.

    The report found that the number of health care professionals now willing to see visiting drug reps is down by 20%.

    That's a significant drop, and a cause for alarm by Big Pharma and their lobbyists at 'Policy & Medicine'.

    This is also significant because research shows that detailing visits by a drug company's sales reps are measurably effective in changing a doctor’s prescribing habits to favor that company’s drug.

    As you first wrote in a previous post on Pradaxa, the jury may still be out on a number of serious questions that have yet to be answered about the drug (compliance, gastrointestinal issues, MI risks). At this point in early prescribing, we simply don't know yet if we have a miracle drug or another Vioxx here.

    And this introduction couldn't have come at a more crucial time for Boehringer, whose female "desire drug" flibanserin has just been trashed by the FDA last month, and who also stand to lose patent protection (and an estimated $1.5 billion in annual sales) on two of their older blockbuster drugs later this year, Flomax and Mirapex.

    Speaking of Mirapex, Boehringer has been ordered to pay punitive damages in a growing number of class action lawsuits after the company was found in U.S. courts to have “breached their duty of care to individuals taking Mirapex, since they knew or ought to have known of the serious behavioral-related complications associated with Mirapex, and failed to adequately warn patients and physicians about the dangers of Mirapex.”

    Given that, congratulations on turning them down to become one of their paid "thought leaders"!

    More on this at THE ETHICAL NAG: MARKETING ETHICS FOR THE EASILY SWAYED: 'Fewer Doctors Are Now Agreeing To See Drug Reps' – http://ethicalnag.org/2010/05/28/fewer-physicians-see-reps/

  3. ACM, CT,

    Thanks for your thoughtful comments.

    It is a balance. So many of the valuable drugs that a cardiologist uses were once brand-name. Carvedilol was Coreg, Lisonpril was Prinivil, Simvistatin was Zocor. They turned out to be great for selected patients. For instance, most of my ICD patients on the big-four drugs (these three plus a blood-thinner of some sort) live long enough to get another more pressing non-cardiac disease. This, I believe–in no small part–is related to the above cardiac regimen.

    But as you know, this rosy scenario of "good" drugs isn't always the case. Take seldane, propulsid and vioxx (as you have written mention) as examples.

    The cynic in me has been fostered over the years. I fight it, but then pharma punches back with "expert'-touted failures like Multaq. Arrgghh.

    Paradaxa is likely different. As Sir Charles (Barkley) says, "I may be wrong, but I doubt it." Time will tell.

    JMM

  4. I screwed up on that one. Cardioquin is of course on the market still. I was thinking of that "Cardiac Quinolone" anti-arrhythmic that came out briefly while you were in Residency.

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