Paul Holmes 22 Oct 2002 // 11:00PM GMT
Situation Analysis: In 1982, Barney Clark made medical history by becoming the first recipient of the Jarvik-7, the world’s first “artificial heart.” Attached by a tangle of wires to a support system the size of a dishwasher, Clark lived under an intense media microscope before dying 112 days later. The Jarvik-7 was a bold scientific experiment – and a public relations debacle. Few understood that the Jarvik-7 was never meant to be a miracle cure for heart failure, and the public’s hopes were inadvertently set far too high. Clark’s televised suffering left the public confused and skeptical about the science of heart replacement technology.
Eventually, the Federal Drug Administration pulled the plug on human testing of artificial hearts. So when Abiomed, Inc. announced almost 20 years later that the FDA had approved human testing for its AbioCor™ Implantable Replacement Heart, the company knew it faced a challenge. It knew it would have to persevere through a complex combination of hopefulness and suspicion on the part of the media and the general public. In early 2001, Abiomed and Brodeur Worldwide’s Health Technology Practice teamed up to manage communications around the pending clinical trial of the AbioCor heart. This campaign wasn’t about generating headlines. Instead, Abiomed and Brodeur Worldwide were tasked with educating a wide and diverse audience about the device’s promise—without overpromising.
The research conducted into similar medical milestones – especially Jarvik-7 – and the “Patient First” mentality were critical elements in formulating a thoughtful, appropriate strategy for introducing the world to AbioCor. Ultimately, it was this strategy that freed the trials from overblown expectations and controversy, allowing AbioCor’s technology to shine through. And shine it did – not only did the story dominate the news for days on end, but AbioCor even went on to be named Time’s Invention of the Year.
Objectives and Audience Analysis:
The AbioCor Implantable Replacement Heart is the product of more than 20 years of research and development. Fully implantable and powered by a small battery pack, the device is designed not only to extend the lives of patients who would otherwise die of heart failure but also to offer a satisfactory quality of life. From the start, Abiomed and Brodeur Worldwide articulated three simple goals for the clinical trial: manage expectations; differentiate AbioCor from previous heart-replacement technologies; and above all else put the interests of the patient first.
Key to these three goals was Abiomed’s overarching philosophy that it and the FDA alone – and not the media – would determine how to define the “success” of the clinical trial. “Managing expectations” meant educating the media, the medical community and medical consumers that in an end-stage heart failure patient eligible for the clinical trial, “extending life expectancy” can mean adding just 30 days to their lives – but 30 days of higher-quality life. “Differentiating AbioCor from previous heart-replacement technologies” meant carefully explaining that the device is self-contained and allows greater mobility for its users. “Putting the interest of the patient first” meant ensuring the confidentiality of those participating in the clinical trial and the privacy of their families. Thought leaders, the media, the medical community and the FDA were among Abiomed’s audience. It should also be noted that Abiomed is a public company and is therefore obligated to keep its shareholders informed of “material information.” Abiomed and Brodeur had to be sure to balance the information needs of investors, the media and the public with the needs of the patients who would receive the AbioCor device.
Research and Planning:
The Brodeur team conducted exhaustive secondary research, analyzing media coverage of the Jarvik-7 implant of 1982 and of subsequent cardiac medicine breakthroughs. Each member of the team read the 383–page “Bill Schroeder Story,” a day-to-day chronicle of the second Jarvik recipients’ experience written from his family’s perspective. The team also performed an in-depth analysis of coverage surrounding the world’s first hand transplant in 1998 and of the recent debate over cloning. This research yielded insight into the expectations and attitudes of often-quoted medical thought leaders and of leading writers and editors at key medical and general publications.
Many of the thought leaders quoted by the media during the Jarvik-7 operation in 1982 – and many of the writers themselves – would again be commenting on and covering the AbioCor clinical trial. Brodeur’s research was coupled with Abiomed’s primary research (years of interviews with clinicians, ethicists and patients) to arm the combined PR team with enough information to meet its goals.
Together, Abiomed devised and Brodeur Worldwide managed a communications policy mandating a 30-day “quiet period” around any AbioCor implant during the clinical trial. Abiomed officials said they would not reveal the name of any of the patients participating in the clinical trial and would leave clinical updates to the medical facilities participating in the trials—unless the physicians or patients requested otherwise. To balance potential negative reaction by the media of the “quiet period” policy, Abiomed and Brodeur made extensive pre-trial efforts to disseminate as much information as possible about the device, the nature of the human trials, and the need for patient privacy.
On April 18, 2001, Brodeur and Abiomed hosted an invitation-only media seminar at the National Press Club in Washington, D.C. Billed as a “learning session,” the seminar sought to ensure that reports about AbioCor and the clinical trials would be accurate in their depiction of how the device works and how Abiomed alone would define success for the initial clinical trials. The event provided Abiomed officials with another opportunity to articulate the mechanics of and rationale for its 30-day quiet period. Prior to the event, Brodeur and Abiomed conducted a series of messaging and media training sessions. The Brodeur team created media kits and invited the media and VIPs, aggressively followed-up with every invitee and supported the creation of a real-time webcast of the seminar for media and non-media alike. The team also created contingency communications programs in the event of the patient’s death or other major medical setbacks during the first clinical trial. On July 4, 2001 – two days after the surgery and due to a news leak – officials at Jewish Hospital in Louisville,
Kentucky held a press conference announcing they had implanted the first AbioCor device into a patient there. Shortly thereafter, in response to inquiries, David Lederman, Abiomed’s CEO, reiterated the communications policy in a letter to shareholders:
“(We) carefully studied the successes and failures of prior human clinical studies of breakthrough devices. We consulted ethicists, physicians, and government officials. Most of all, we spoke with patients facing end-of-life as a result of heart failure. The result was a set of patient protection measures and ethical guidelines that I believe to be among the most thorough and effective ever implemented for a medical device trial…
“(We) prepared in advance to do all that was possible to ensure that communications and media relations were patient-centered, not publicity-centered. Working with all of our participating clinical trial sites and their surgical and medical teams before the trial began, we established ground rules intended to guarantee the patient’s complete anonymity and maximum privacy. We also thought it was important to insulate the clinical teams, as well as the many Abiomed technical personnel providing onsite support to those teams, from the distractions and turmoil attendant to close daily scrutiny. To this end, we have resisted demands for daily or real time release of patient information. Based on our constructive interaction with responsible local, national and international journalists, I believe that our intentions have by and large earned us the respect and cooperation of the media.”
Evaluation of Success:
The April National Press Club seminar was a spectacular success and laid the foundation for the balanced coverage of the clinical trial. Representatives from 22 major media outlets were onsite for the event, including ABC and Fox affiliates and CNN, Reuters, Conus TV, Belo Capital Reporting and CBS News. According to the NPC, the Abiomed seminar was one of the most widely viewed events ever held at the NPC with over 1,100 people registered for the real-time webcast and 4,662 total registrants viewing within a week of the event. A major AP story was picked up by print media outlets around the country and the event yielded 129 stories on local television newscasts, including a national story on Fox News Channel, and nine radio stories. As a result of the NPC event and aggressive media and opinion leader outreach, AbioCor was the subject of a front-page story in Newsweek and features in noted news outlets such as National Public Radio. Central to those stories was the company’s “quality of life” and “patient-centered” approach.
The first implantation of the AbioCor device yielded a mountain of media coverage. The story was front-page and top-of-the-broadcast news for days on end. The Brodeur PR team analyzed hundreds of the most visible news stories, determining that an overwhelming majority accurately reflected Abiomed’s key messages about life expectancy and quality of life for patients with the AbioCor device. Further, the name of the patient was kept out of the media for almost six weeks and then only revealed at his request. “Medicine’s latest effort to tackle one of the most difficult technological challenges ever attempted is remarkable for yet another reason – its absence of controversy,” the Washington Post wrote in a page 1 article analyzing Abiomed’s communications policy.
Finally, this excerpt from an October 15 Los Angeles Times article shows that the program’s goals were indeed met:
“These first three AbioCor implants have been accompanied with restraint and respect for the privacy of family and patient that were totally lacking in the 1980s Jarvik-7 experience… ‘They’ve been very careful not to turn it into a media circus—not to make exuberant claims about how well the patient is doing and to emphasize again and again how sick he was and how experimental the implantation of this device is,’ says sociologist of medicine Renee Fox, professor emeritus of the University of Pennsylvania, and author of a book, Spare Parts, which chronicled the Barney Clark experience.”