Monday, August 28, 2006

Medtronic: Could Direct-to-Consumer Advertising Backfire?

For the past week, there have been reports about Medtronic's direct-to-consumer (DTC) advertising campaign to promote automatic implantable defibrillators, devices costing about $20,000-$30,000 that detect and treat rapid, abnormal heart rhythms that can be potentially fatal in people with abnormal heart function.
The company announced plans to spend $75 million to $100 million to improve sales of implantable defibrillators, which have been hurt by doctors concerned about recalls and by worries about proposed sharp cuts in Medicare reimbursement for the devices.

The campaign will include Medtronic's first large-scale advertising aimed directly at patients. Such ads are common for prescription drugs but have been a rarity in the medical device business.
But could such a DTC campaign backfire? Physicians have typically been the individuals to recommend such expensive, life-saving technology to their patients based on recent studies demonstrating a survival benefit to many patients with significantly compromised heart muscle function. Will doctors become frustrated by every patient with normal heart function or no heart diease at all (and hence are not appropriate candidates) calling their clinic to see if they might be candidates for expensive ICD's or who demand immediate appointments because they might fear "sudden unexpected death?" Are doctors' offices prepared for the emotionally-charged ads of people whose lives have been saved by these devices that then ask: "Are you protected?" (or something like this?). Will doctors feel coerced to act, especially when the implication of not acting might be perceived by their patients as not doing enough to protect them, at all costs? Doctors are not oblivious to these marketing tactics, especially in lieu of the "ask your doctor" pharmaceutical campaigns that have preceeded the medical device industry's proposed campaign.

The indications for appropriate referral for ICD's are complicated. Not all patients need them. But some do. The real question is separating the wheat from the chaff - and no advertising campaign can do this. Such a campaign might raise unnecessary fears in our patient population and subsequently cross an important line that shouldn't be crossed: recommending health care for financial incentive rather than by actual need. Oh sure, it might pay off on the short run (some doctors might enjoy the increased volume of patient visits) and their actions with this ad campaign couched in the "feel good" guise of "saving lives." But it might also alientate the very physicians in whom Medtronic relies to recommend their devices, tacitly implying they are incapable of appropriately recommending such therapy to their patients.

But Medtronic is savvy. No doubt this upcoming campaign has been thoroughly vetted by consumer focus groups. But were doctors part of those focus groups? I doubt it.



CardioNP said...

Geez! Arrgh! Now I can expect receiving a plethora of phone calls about ICDs. Hope they include some sort of comment that pts should contact an electrophysiologist if they think they need an ICD :).
Thanks for the heads up.

Has HRS seriously considered recommending T wave alternans as part of the w/u prior to ICD to help sort out the higher risk pts?

DrWes said...


As I see it, the campaign will be "direct to the patient." Many patients have never heard of an electrophysiologist, so yes, expect the phone calls.

Regarding HRS, this announcement via Biowire on 22 Aug 2006:

"Cambridge Heart, Inc. (OTCBB:CAMH) today announced that an Executive Summary of the 2006 Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death has been jointly released by the American College of Cardiology (ACC), The American Heart Association (AHA) and the European Society of Cardiology (ESC). In this new guideline, collaborated on with the Heart Rhythm Society (HRS) and the European Heart Rhythm Association, T-Wave Alternans received a Class IIa guideline under the section, Electrocardiographic Techniques and Measurements.

The consensus guideline states, 'It is reasonable to use T-Wave Alternans for improving the diagnosis and risk stratification of patients with ventricular arrhythmias or who are at risk for developing life-threatening ventricular arrhythmias. (Level of Evidence: A).'"

But remember, t wave alternans is really good for sorting out LOW risk patients (i.e. a negative test has strong negative predictive power) but positive or indeterminant tests are treated the same (and simple PVC's can cause an indetermitant test), so it doesn't prevent these indeterminant patients from getting ICDs.

Medicare is looking for any way they can limit their expense... look for this testing to become required for previously asymptomatic patients with low EFs, especially when the number of device implants increases following Medtronic's ad campaign!

CardioNP said...

Thanks for the HRS info! Will mention this to my collaborating docs.

And start polishing a spiel regarding the risks/benefits of ICDs in layperson terms (perhaps with the emphasis on the negative?)