Medtronic Marketers Try to Sell Implantable Cardiac Defibrillators Direct to Patients

The latest subject of direct to consumer (DTC) advertising is medical devices. The Minneapolis Star-Tribune reports,

Medical technology giant Medtronic Inc. will launch a $100 million marketing campaign today to raise awareness about the dangers of sudden cardiac arrest -- and the role of heart defibrillators in saving lives.

Fridley-based Medtronic said the 'What's Inside' sudden cardiac arrest ad campaign is part of a bigger awareness push that is the largest in size and scope in company history.

'This is about saving lives,' said Dr. David Steinhaus, vice president and medical director of Medtronic's Cardiac Rhythm Disease Management division. 'Sudden cardiac arrest kills more people than breast cancer, lung cancer and HIV/AIDS combined.'

Sudden cardiac arrest can be prevented with a device called an implantable cardioverter defibrillator (ICD) -- a stopwatch-sized device implanted in the chest that shocks an errantly beating heart back into rhythm. But a series of safety recalls by manufacturers in 2005 -- including market leader Medtronic -- dampened demand for the device in the past year

Part of the problem is that patients who need the devices aren't necessarily getting them -- Medtronic estimates roughly 850,000 Americans are in this category.
Sometimes prospective patients don't have symptoms, which can make it difficult for doctors to persuade them to undergo an ICD implant procedure, Medtronic's Steinhaus said.

In addition, sometimes patients are not referred to the appropriate specialists (called electrophysiologists) who implant the devices -- which is why Medtronic is also targeting the general cardiology community with physician education programs, he said.

Sorry, but to me, this one smells bad from the get go.

The kicker here is the populations of patients for whom ICDs might be indicated. The notion that there are patients who ought to have ICDs implanted, but are walking around, without any symptoms, in blissful ignorance of this fact does not make a lot of sense to me.

Right now, there are two groups of patients for whom ICDs might have benefits that outweigh their harms. The first are patients who have already had a "near sudden death" experience, i.e., patients who have dropped their blood pressure, or fainted (had syncope) due to a particularly dangerous kind of rapid heart beat (ventricular tachycardia). To have had such diagnoses, such patients, have had to already come to medical attention. They do not need advertising campaigns to tell them they ought to have an ICD. [For a discussion of this group, see Josephson ME et al. The role of the implantable cardioverter-defibrillator for prevention of sudden cardiac death. Ann Intern Med 2000; 133: 901-910.]

The second group are patients at very high risk of such deranged heart rhythms. The MADIT II Trial suggested that patients who have had a heart attack (myocardial infarction) and have poor heart function (left ventricular ejection fraction less than 30%) have increased survival after placement of an ICD. [Moss AJ et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002; 346: 877-883.] The SCD-HeFT trial suggested that patients with congestive heart failure who are moderately symptomatic (New York Heart Association classes II and III) and have a ventricular ejection fraction of less than 35% may also so benefit. [Gardy GH et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005; 352: 225-237.] Again, most people who have had myocardial infarction resulting in poor heart function are not walking around blissfully unaware of these major problems, nor are people with at least moderately symptomatic heart failure.

Furthermore, there are many legitimate reasons that people who fit into the categories listed above should not have ICDs. In particular, many people with such serious heart disease also have other severe medical problems. The benefits versus harms of ICDs is unknown in such patients, who would have been excluded from the trials above. (For example, MADIT II excluded anyone with another severe disease that increased the risk of death during the trial time-frame.) Patients with other severe medical problems could die or become seriously ill from these other problems before having any opportunity for an ICD to prevent a dangerous rhythm disturbance.

So I question the whole notion that the DTC advertising would flush out tens of thousands of patients who were totally unaware that they could benefit from ICD placement.

So why do this advertising campaign? Is it just a result of how marketers have come to dominate nearly every health care organization, including device manufacturers? Many of those of the marketing persuasion seem to be totally focused on selling more product. That may be good for the marketers' careers, but it may not be good for those having these particular products implanted in their chests.

In health care, our goal should be first only to do things to patients whose benefits are likely to outweigh their harms, not just to move expensive products off the shelves.

Hat tips to the Over My Med Body blog and the Schwitzer Health News Blog.

Please also see the comments on SurgeonsBlog, on having one's mind blown by one of the print advertisements from this campaign in the New York Times.