Et tu, Dr. Drew?

Earlier this week, pharmaceutical giant Glaxo-Smith-Klein (GSK) paid $3 billion to settle charges that it improperly marketed drugs. For those of you not familiar with how drug companies go about the uglier side of their business, it can work like this: consultants, marketers, representatives, and paid “experts” are paid to deliver specific messages about medications.  These messages are delivered to doctors, consumers, and anyone else whose behavior can be influenced to improve drug sales.  This is neither immoral nor illegal—normally. But drug companies have for years skirted the edges of legality, sometimes falling onto the wrong side of ethics and the law.

As part of the Government’s complaint against GSK, they allege that celebrity doctor Drew Pinsky was part of a scheme to “promote the use of Wellbutrin SR for unapproved uses.” Forbes’ Matthew Herper summarizes the allegations quite well. I’m not entirely surprised that a celebrity doctor should be accused of improper behavior, or that an expert may have been payed to engage in marketing. What caught my interest was a question from journalist Kevin O’Reilly posed during a twitter discussion with me and writer David Dobbs (that I get to converse with folks like this is one of the wonderful things about twitter). He asked a relatively simple question: “What should, or could Dr. Drew do to set things right.”

Setting aside legalities, and positing that the allegations are true, it is a breach of trust. We can divide that breach into two categories: breach against the public, and breach against the patient.  The duty to the individual patient should be obvious. A physician also has a duty to society. Physicians hold a position of power and respect and should not abuse this for their own benefit.

The clearest ethical breach here is that of informed consent. When a patient is prescribed a drug, they should be informed of the possible risks and benefits but also any other motivations the physician may have to prescribe the drug. This can be as “big” as accepting large fees to promote the drug or as small as getting a box of donuts from a drug rep.  There are limits, of course.  I may run into a drug rep with whom I am also friends.  Maybe we run into each other on the way to work and he buys my coffee–as a friend. Even though we might not report every little occurrence to our patients, we have to be honest with ourselves and recognize that even small gestures influence our prescribing behaviors.

If a donut or a cup of coffee can influence my behavior (and it can), what might a few hundred thousand bucks do to my judgement?

To “set things right” in this sort of situation, an ethical thing to do would be to publicly state that, while he might not have consciously intended to breach his ethical responsibilities, the very nature of his relationship to GSK was likely to affect his statements and advice, and that his patients and the public should take this information into account in evaluating his advice*.  If it were me and I wanted to rebuild trust with my patients and with the public, I would commit to make no further agreements that could create a conflict of interest, since my primary interest should be to my patients.

 

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*That being said, from what I’ve read, his claims about Wellbutrin seem to be well within accepted practice. While a drug company can only make claims that it has proved to the FDA, doctors may choose to use drugs in any way they see fit.

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7 Comments

  1. PAS

     /  July 6, 2012

    Looking through here, one of the prominent drug that I can chime in on: Advair. Specifically, the complaint states that GSK was: “Promoting Advair, a combination of asthma drugs, for first line use in mild asthma patients whose asthma could be controlled on one component alone – contrary to the FDA-approved label, specific FDA guidance and established Asthma treatment guidelines.”

    I work for a pharmacy processor that handles prior authorization principally for State Medicaid programs. I am not a clinician, but in an average year I touch about 45,000 cases almost exclusively within the public sector. Principally I’m doing initial documentation and review according to state guidelines prior to handing off to a clinician. One Medicaid program started requiring prior auth on Advair based on suspecting issues of the above for beneficiaries who hadn’t received a prescription for a single agent inhaled steroid within the last six months.

    Advair rapidly became one of the most requested drugs on this program. In a minority of cases, patients had received treatment with a single agent drug, which simply wasn’t documented due to samples or a previous insurance. In the overwhelming majority of cases these patients had not received prior treatment with a single agent drug. When asked what inhaled steroid patients were that steroid was frequently ‘Albuterol’ or ‘singular’ or ‘claritin’. Many, many prescribers seemed to be under the impression that Advair contained only one ingredient.

    Reviewing some of the treatment guidelines, documented in such resources as AHFS-DI and others, they overwhelmingly emphasize the use of a single agent inhaled steroid in asthma after its being inadequately managed by a drug like albuterol. They are even more emphatic that this dosage should be optimized to the lowest effective dose, particularly in children before other drugs are considered.

    I was unaware of this lawsuit until today. Looking back at the disparity between prescribing practices and what the treatment guidelines say, I’d always assumed there was something fishy going on with GSK.

    The majority of the requests we saw come in were not for patients with severe disease. Less than 1 in 10 had so much as a claim for albuterol within the last 60 days (as mentioned, the computer checked for albuterol and inhaled steroids). Page 73 of the doc above involves False Claims Act info that specifically cites examples of cases more or less identical to what I’m describing

    The Advair evidence makes up a good chunk of that document – it is systematic and revolting and shows utter and complete disregard for the treatment guidelines, the science, and the safety of the patients.

    As for Dr. Drew… I dunno. I listened to Loveline of that era, and recalled a few mentions of the drug, particularly when it came up around odd drug sexual side effects. I pulled the following from DRUGDEX which is a citation a modest sized open label study with a pretty high response rate from 1998:

    Ashton AK & Rosen RC: Bupropion as an antidote for serotonin reuptake inhibitor-induced sexual dysfunction. J Clin Psychiatry 1998; 59(3):112-115

    PMID: 9448656 double blind, noting significant differences in sexual dysfunction vs SSRI, 1997

    And a smattering of others. With regards to what I recall of Dr. Drew’s statements at the time, I don’t find them at all out of line with the data available at the time, or the observations of a physician practicing in a psychiatric field. Unfortunately, I can’t see the evidence presented in the above document, it speaks to only indirect payments. That’s something I’d like to see before outright condemnation.

    In general, what I’ve heard from Dr. Drew has always been well in line with the science, and he’s always appeared to hold himself to very high ethical standards. Given the fields he works in, and the company he keeps in the realm of celebrity physicians, that seems quite admirable.

  2. DLC

     /  July 7, 2012

    The only off-label use I can see for Wellbutrin is quitting cigarettes? I had previously thought that Chantix was just re-labelled Wellbutrin but Google is saying not so. Perhaps Dr Drew also suggested wellbutrin as an aide to addiction therapy ? Whichever it is, he should speak up for himself about it.

    • Wellbutrin is bupropion. Bupropion was also marketed as Zyban for smoking cessation. Compared to other antidepressants, it seems to have fewer sexual side effects. I’m certain it is used in addiction therapy either for depression, smoking, or both. But surreptitiously delivering marketing points not approved by the fda is crappy.

  3. For me, Dr. Drew jumped the shark on Loveline. It’s pretty bad when Adam Corolla’s off-color humor is the only reason to watch the show.

    To summarize, an antidepressant with fewer sexual side effects is good (I’m sure impotence is pretty damn depressing.), but claims not approved by the FDA are, well, not.

  4. david

     /  July 8, 2012

    I can’t imagine a single legitimate reason for Dr Drew, or anybody else whose primary position is as a “celebrity doctor” educating the public, to accept any money ever from a pharma company. In my mind the only way he can “set things right” is to disclose, apologize, and quit.

    disclosure: I work for a pharma, but not GSK. I have no conflict of interest with any competing products. I don’t believe the company I work for would do something like this. At least, I hope not.

  5. becca

     /  July 11, 2012

    Hrmm. How would one go about getting FDA approval for “fewer sexual side effects” as a claim?
    I don’t actually want to limit doctors (at least those who aren’t paid by companies!) to making claims that are FDA approved, if there is a basis in the literature for them (ideally, they would cite the studies, but given the attention span of the average consumer of this kind of media, that may not be practical).
    His quoted statement “we recommend wellbutrin (aka buproprion) to patients if other SSRIs have had undesireable sexual side effects” seems reasonable to me. It sounds like what I’d consider “best practices” based on the evidence in this particular case- is it in some way bad medicine?
    I don’t know. I really can’t be outraged here. He should totally disclose in the future, GSK should cut it out (though they claim they have) and perhaps Dr. Drew should get a minor ding (a fine of 50% of what he was payed by GSK to go to a patient advocacy org?), but it’s not high on my list of outrages for the day. Maybe I just don’t understand medical ethics.

    • It really depends a lot on whether he was shilling for a drug without disclosing it. GSK was accused of promoting it improperly, but even if DD didn’t, a full disclosure of possible COIs would have been a good idea.

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