Direct-to-consumer advertising of implantable defibrillators: a shocking development or just keeping pace with the times?

Turn on your television today and you might think that you have just opened your pharmacology textbook or Physicians’ Desk Reference instead. Names such as Boniva^®, Nexium^® and Cialis^® seem to be heard during television advertisements as frequently as Coca Cola^®, Geico^® and Lucky Charms^®. Different pharmacologic compounds used to treat conditions, such as osteoporosis, erectile dysfunction and seasonal rhinitis, must no longer just compete with each other in randomized clinical trials. They need to win the hearts and minds of potential patients in 30-second commercials on Sunday night at 9:00 p.m. in between Extreme Makeover: Home Edition and Desperate Housewives. The ‘patient’ has now become the ‘consumer’. Direct-to-consumer advertising has become commonplace for the pharmaceutical industry just as it has for the food services, the airline, the hotel and the insurance industries. Now it is the medical device industry’s turn. Many Americans have already seen commercials for artificial knees designed especially for women and, recently, the first implantable defibrillator advertisement was broadcast to the general public in the USA.

In January 2007, Medtronic, Inc. released its ‘What’s Inside’ campaign, a US$100 million initiative to raise physician and patient awareness of the indications for implantable defibrillators. Slightly under a third of the campaign’s budget will go towards the television and magazine advertisement, which was described as very focused advertising by a senior member of the public relations branch of Medtronic. The television advertisement begins, “If you’ve had a heart attack or heart failure, inside this little device you just might find 10,000 more kisses, snow, 200 more football wins. This is an implantable cardiac defibrillator, a device that is always there for you, close to your heart, with the power to restart it in case of sudden cardiac arrest”. Unlike many of the pharmaceutical advertisements that now compare features of one product over another (Cialis’ longer duration of action versus Viagra^® so “you can be ready when the moment is right” or the once-monthly dosing of Boniva compared with weekly dosing of Fosamax^®), Medtronic’s current advertising is designed to raise awareness of implantable defibrillators in general. The company name only appears at the very end of the advertisement and the defibrillator shown in the television commercial doesn’t even have the company name or logo engraved on the outside of the device as all currently available defibrillators do.

Raising public awareness of an underutilized and potentially life-saving technology is certainly a good thing, and Medtronic should definitely be complimented for its informative and pleasing advertising campaign. However, why now aggressively market a technology that has been around for over 25 years? Randomized clinical trials demonstrating significant mortality improvement in patients at high risk for sudden cardiac death have been completed for several years, and no new indications for implantable cardioverter defibrillator implantation have recently been released. The answer may be related to the recent downturn in sales experienced by the defibrillator industry over the past 2 years. This phenomenon has been at least partially attributed to the negative press caused by a series of device safety alerts that began with a Medtronic advisory in April 2004. This was followed by a series of defibrillator advisories from Guidant, Inc. (now Boston Scientific) in 2005. This series of advisories received a large amount of public attention after The New York Times printed a story about a 21-year-old college student from Minnesota who died suddenly after his device failed to resuscitate him due to its faulty circuitry. According to this May 24, 2005 article, “the Guidant Corporation did not tell doctors or patients for 3 years that a unit implanted in an estimated 24,000 people… contains a flaw that had caused a small number of those units to short-circuit and malfunction” [1]. Suddenly, a technology of which the public had very little awareness, except maybe that the US Vice-President Dick Cheney has a defibrillator, now had negative stigma associated with it and the companies that manufactured them. As a physician caring for many patients who either have life-threatening arrhythmias or have significant risk factors associated with sudden cardiac death, I spent many more hours counseling my patients on the benefits of this potentially life-saving technology after they had heard negative press stemming from the advisories. Patients were rightfully concerned about having an unreliable device permanently implanted into their bodies. Some referring physicians began to question this technology and sent fewer patients for implantation of these devices. It appeared that something needed to happen to reignite interest in this advanced technology and direct-to-consumer advertising may be the answer.

It is still too early to tell whether this advertising campaign has had a significant effect on the public perception of defibrillators or sales of Medtronic or its competitors’ devices. Yet, a Medtronic company spokesman noted that the response by patients has exceeded expectations with a large number of calls to the company and hits on its website. Many more people than expected have downloaded the ‘Risk Assessment Checklist’ that asks six questions and suggests a visit to the doctor for most of the possible answers. Will this checklist really inspire people to seek out physicians and will physicians be receptive to these patient concerns? More importantly, from either a business or public health standpoint, will this lead to a greater rate of defibrillator implantation and a decrease in the rates of sudden cardiac death?

A significant amount of research has already been published regarding direct-to-consumer advertising and the medical industry. If you type in ‘direct-to-consumer advertising’ in Medline, you will see over 300 citations. Almost every branch of medicine is represented, including oncology, psychiatry, orthopedics, genetics, geriatrics, urology and even pediatrics. You will also notice that pharmaceutical advertising is becoming a global phenomenon as articles are written from the USA, Finland, the UK, The Netherlands, Canada, Turkey, Australia and New Zealand. Yet, many countries still ban advertising pharmaceuticals and pharmaceutical devices to the public. Studies have shown that physicians view direct-to-consumer advertising of pharmaceuticals negatively. In a study that received surveys back from 784 physicians (from a total of 1781 mailed), only 5.1% of physicians believed that the advertisements provide enough information on other treatment options and 1.3% felt that the advertisements provide enough information on the cost of the medication. A total of 56% of physicians believed that advertising increased the time they spent with their patients. Overall, only 9.8% of physicians felt that direct-to-consumer advertising of pharmaceuticals was a positive trend in healthcare [2].

Although direct-to-consumer advertising may not be popular with physicians, studies have demonstrated its effectiveness on physicians’ prescribing practices. The influence of patients’ request for direct-to-consumer advertised antidepressants was examined using six standardized patient types by crossing two conditions (major depression or adjustment disorder with depressed mood) with three request types (brand-specific, general or none). A total of 152 family physicians and general internists participated and experienced 298 unannounced standardized patient visits. When major depression was portrayed, 76% of patients were prescribed an antidepressant if they made a general request, 53% if they made a brand-specific request but only 31% if the patient did not make a specific request for medication. The results were more impressive for standardized patients with adjustment disorder, a condition traditionally less likely to be prescribed medication. If the patients did not specifically request medication, they received it only 10% of the time, yet if the patient requested a brand-specific drug, they received an antidepressant 55% of the time [3].

Whether Medtronic’s advertising campaign will be successful in increasing the number of patients receiving implantable defibrillators remains to be seen. Will physicians embrace the ‘Risk Assessment Checklist’ and consider a defibrillator implant for a patient to whom they might not have offered one? Will at least some of these devices actually save lives? Since I believe that raising public awareness of common, life-threatening medical conditions and informing patients of potentially life-saving and underutilized technologies are good things, I suspect the answer to these questions is ‘yes’.