Terra Sigillata

As I sat to write a post this morning, I became more engaged in a story in the New York Times magazine by Dr Daniel Carlat entitled, “Dr. Drug Rep.” Joseph of Corpus Callosum recently commented here about being solicited to recommend fellow physicians in the local area and nationally who he perceived as “thought leaders” in his specialty.

Carlat was such a physician who was cultivated by Wyeth to discuss their antidepressant, Effexor XR, to fellow physicians at conferences and in doctors’ offices. His piece in the NYT magazine chronicles his development by Wyeth as a drug spokesperson and the increasingly unnerving ethical conundrums he faced in the process:

She handed me a folder containing the schedule of talks, an invitation to various dinners and receptions and two tickets to a Broadway musical. “Enjoy your stay, doctor.” I had no doubt that I would, though I felt a gnawing at the edge of my conscience. This seemed like a lot of money to lavish on me just so that I could provide some education to primary-care doctors in a small town north of Boston.

Like many of my physician colleagues who accept honoraria from drug companies to talk about the latest therapies, most go into the arrangement with the purest intentions of providing education for fellow docs. This is a very common practice and Carlat cites a study that estimated 25% of US docs receive drug money for lecturing to physicians or for helping to market drugs in other ways. Carlat:

If I gave talks to primary-care doctors about Effexor, I reasoned, I would be doing nothing unethical. It was a perfectly effective treatment option, with some data to suggest advantages over its competitors. The Wyeth rep was simply suggesting that I discuss some of the data with other doctors. Sure, Wyeth would benefit, but so would other doctors, who would become more educated about a good medication.

What Carlat found was that he was being cultivated as an expert drug representative:

“Dr. Carlat: Our main target, Dr. , is an internist. He spreads his usage among three antidepressants, Celexa, Zoloft and Paxil, at about 25-30 percent each. He is currently using about 6 percent Effexor XR. Our access is very challenging with lunches six months out.” This doctor’s schedule of lunches was filled with reps from other companies; it would be vital to make our sales visit count.

Carlat details how companies specializing in prescription data-mining sell data to drug companies for reps to know which doctors are heavy prescribers of the drug class but not that company’s drug. Most health care professionals know of such companies like IMS Health but Carlat reveals how the American Medical Association is also complicit in this practice by providing the missing link in matching prescription information to specific doctors:

Pharmacies typically will not release doctors’ names to the data-mining companies, but they will release their Drug Enforcement Agency numbers. The A.M.A. licenses its file of U.S. physicians, allowing the data-mining companies to match up D.E.A. numbers to specific physicians. The A.M.A. makes millions in information-leasing money.

(In 2006, the AMA began the Physician Data Restriction Program (PDRP) that permits member physicians to opt out of prescription tracking.).

However, Carlat became increasingly disturbed about the data and physician feedback that Effexor caused hypertension in a small but significant percentage of patients receiving the drug. With so many other antidepressants available that did not cause this side effect, he began to think more critically about the purported superior efficacy of Effexor relative to other antidepressants.

A year after starting my educational talks for drug companies (I had also given two talks for Forest Pharmaceuticals, pushing the antidepressant Lexapro), I quit. I had made about $30,000 in supplemental income from these talks, a significant addition to the $140,000 or so I made from my private practice.

Some people might think that doctors are making a killing out there and while $140,000 USD is a good living, it’s not that great considering how much training (and student loans) go into making a physician. So, as Calart says, there is definitely financial incentive for some docs to sign up with drug company education programs.

Carlat now fulfills his educational mission at Tufts School of Medicine and as publisher of a psychiatry newsletter, The Carlat Psychiatry Report. The newsletter is advertised prominently as being unbaised and, as such, he takes no drug company support for its publication or web hosting.

For more in-depth revelations on drug company marketing strategies, take some time to read the open-access PLoS Medicine publication, “Following the Script: How Drug Reps Make Friends and Influence Doctors.” Written by a former drug representative and a Georgetown physiology professor, the work was supported by a consumer education grant “as part of a 2004 settlement between Warner-Lambert, a division of Pfizer, and the Attorneys General of 50 States and the District of Columbia, to settle allegations that Warner-Lambert conducted an unlawful marketing campaign for the drug Neurontin (gabapentin) that violated state consumer protection laws.”

Comments

#1 PhysioProf
November 26, 2007

I’m neither a physician nor an ethicist, but it seemed pretty apparent to me that what he faced were not “ethical conundrums”, but clear conflicts of interest.
#2 idlemind
November 26, 2007

…it seemed pretty apparent to me that what he faced were not “ethical conundrums”, but clear conflicts of interest.

You say “poe-tay-toe,” I say “poe-tah-toe…”

It’s a slippery slope. It sounds like Carlat’s personal line was crossed when he perceived that actual harm to patients may result from the drug he was helping market. That would seem to be a bright line, indeed, except that absent bad results from from drug trials there is a good chanced he’d never know he’d crossed that line unless he prescribed an awful lot of the drug and it was harmful a sufficient percentage of the time for him to notice it. So not so bright a line, after all…
#3 PalMD
November 26, 2007

There are a number of ethical issues involved. First, though, it seems fairly clear based on a number of studies that physicians are influenced by drug advertising, lunches, etc., even when we think we are not.

First, we have a fiduciary duty to our patients to make the best possible decisions for them, independent of our own interests. A legitimate question is whether that duty extends to other doctor’s patients. If I influence another doctor into a potentially conflictual prescribing habit, what ethic have I violated?

Second, we are inevitably tainted/influenced by financial relationships. If I am pushing Effexor to other docs, I am (perhaps unconsciously) pushing it to myself as well.

Third, given there will always be financial incentives in medicine (for instance, I make more money if I see more patients), which of these incentives are more or less ethical than others? If I rush my patients a bit in order to pay the rent this month, is that better, worse, or neither than being influenced in my prescribing habits.

Fourth, there is another influence on prescribing habits other than Pharma: insurers. I receive incentives/withholds based on my adherence to certain formularies.

Tough issues.
#4 AnnR
November 26, 2007

It would be interesting if the decile ratings were made available as a part of all these physician rating schemes that have been in the news.

That way if I’m a patient who thinks a drug is always the answer I could pick a Doc with a high rating. If I’m somebody who is suspicious of such things I could pick a Doc with a lower rating.

Why shouldn’t we patients know that kind of thing as well?
#5 PalMD
November 26, 2007

I’m not sure that made sense (at least to me). Decile ratings of what? What do you mean by “…who thinks a drug is always the answer…”?
I do not think it means what you think it means.
#6 Abel Pharmboy
November 26, 2007

PalMD, I think AnnR was referring to Carlat’s original article (pg. 3 on the web) where a rep described a doc they were targeting:

As the reps became comfortable with me, they began to see me more as a sales colleague. I received faxes before talks preparing me for particular doctors. One note informed me that the physician we’d be visiting that day was a “decile 6 doctor and is not prescribing any Effexor XR, so please tailor accordingly. There is also one more doc in the practice that we are not familiar with.” The term ‘decile 6′ is drug-rep jargon for a doctor who prescribes a lot of medications. The higher the “decile” (in a range from 1 to 10), the higher the prescription volume, and the more potentially lucrative that doctor could be for the company.

What Ann appears to be asking is that patients be privy to prescribing information so that if they want a statin Rx, for example, instead of being told to exercise and lose weight, she’d like to know which doc would have the greatest probability of giving her the script.
#7 PalMD
November 26, 2007

Thank you. I should have read more carefully. If her comment was tongue-in-cheek, i appreciate it much more.

I am concerned that too many people read this and, rather than taking home the message that doctors and society must be ever vigilant about conflicts of interest, get the idea that there is a Big Pharma/AMA/FDA, etc Conspiracy.
#8 Abel Pharmboy
November 26, 2007

PalMD: Unfortunately, there are already people who believe there is a Big Pharma/AMA/FDA conspiracy who frequent my comments, Orac’s, and also ream us on patient discussion boards. The goal is to get the medicines to the people who need them in the safest manner possible with, as you say, increased vigilance about conflicts of interest.

In your comment earlier this afternoon, you mentioned studies that demonstrate the influence of drug company relationships on physician prescribing habits. The watershed paper, I think, was this 2000 JAMA paper by Dr Ashley Wazana at McGill. If you go to her abstract, there’s a great list of more recent papers that referenced her work which describe strategies and position statements made by professional medical societies to minimize conflicts of interest in physician-industry relationships.

By the way, there is some pretty polarizing stuff on Dr Carlat over at the comment thread on the WSJ Health Blog. Some think he should return the $30K he made; others think that he could’ve made much more.
#9 PalMD
November 26, 2007

Interesting. Perhaps I need to give some examples over at my place. Thanks much.
#10 donna
November 27, 2007

I recently got off Effexor XR after taking it for years. I’ve had primary hypertension for years too, and developed high eye pressure last year — and never knew until the FDA forced the company to reveal last year that hypertension and increased eye pressure could be a side effect.

I think all side effects should be disclosed, even if rare. It’s ridiculous that I’ve had these other medical problems from something that was supposed to be helping me, and didn’t even know about the potential for these other problems.

And who knows what drug might have caused the need for the Effexor in the first place…

I had to talk my shrink into prescribing the one drug with few side effects that has been a lifesaver for me, lamictal. It wasn’t labeled as a treatment for bipolar at the time, but I thought it could work for me, and it does, beautifully. I took a low dose Effexor as a mood brightener. It was hard to get off it, too. Now I am using inositol and DL-phenylalaline instead of prescription drugs for mood and getting lots of omega fatty acids, and feel great.

But try selling that to a shrink. ;^) Nope, no profit there. ;^)
#11 Abel Pharmboy
November 27, 2007

Donna, I understand your frustration. Part of the problem with learning drug side effects is that they aren’t really appreciated until several million people take the drug (as opposed to the 2,000-5,000 carefully controlled patients in clinical trials). That’s why some consumer advocacy groups recommend that you not take a drug within the first 3-5 years following its release unless no real alternative exists for you.

I’m very glad to hear that Lamictal is working well for you.

Regarding supplements that might augment the effects of bipolar or antidepressant medicines, I’ve also read that 3g/day of omega-3 fatty acids are being prescribed by some psychiatrists. Your anger with your doc may be misplaced; they get no profit from prescribing drugs. Most psychiatry colleagues of mine just want to do what’s best for their patients, regardless of whether it’s a prescription, diet, and/or therapy.
#12 Abel Pharmboy
November 27, 2007

PhysioProf: sorry for the delay in responding to your original comment as well as that of idlemind. I, too, am neither a physician or ethicist. I would contend that it is reasonable to accept an honorarium from a drug company to give a presentation on their drug, but only if I first reviewed the literature and was allowed to come to my own, unrestricted conclusions about its benefits and risks. Putting a new drug in context with existing therapies is actually a valuable service if, of course, you are not being escorted around by salespeople.

Most “thought leaders” I’m aware of usually give such talks in satellite symposia at large clinical conferences. I also knew of drug company-employed detail people who provide docs with literature on new drugs but Carlat’s experiences to provide a paid dog & pony show during sales visits was something I had not known was common (again, because I am not a physician.).
#13 PalMD
November 27, 2007

I would argue that any “quid pro quo” is very problematic, but like you said, an honorarium is not unreasonable, as a physician, like any professional, should be paid for their professional time. However, once you enter into that type of relationship…hmmm…ethics are difficult.
#14 albatross
December 3, 2007

PalMD:

Well, there clearly are some hard-to-see (for patients) financial and other incentives influencing doctor’s decisions. I’d like to have a better understanding of this myself.

The problem is, as a (hopefully) smart person with no medical training, I pretty much can only catch bad decisions by my doctor when they’re either obviously nuts or when I notice my health declining or my problems being ignored. (And even that’s hard, because some problems are better off ignored than treated.) Did my doctor put me on Lipitor instead of some other statin because she gets a reward for prescribing Lipitor? Did she order that chest X-ray because she gets some kind of payoff from the radiology clinic, because she thought it would be good cover in case of lawsuit, or because she really thought it was a good idea for my case? It’s pretty hard to judge that as a patient, and it’s not clear that anyone else is keeping track of it.