Medtech Industry Responds to Forbes Article

“Dangerous Devices,” the cover story of the November 27 issue of Forbes magazine, has attracted widespread criticism from members of the medical device community. In the article, the authors focus on recent high-profile device recalls and safety concerns. They also call into question the medtech industry's “overly lax regulatory process, trials that are far less demanding than those for drugs, and a lack of follow-up after treatment.”

“The Forbes article offers a good news–bad news wake-up call to the medical device industry,” says Aimee Corso, founder and principal of the MedAlign Group (Redondo Beach, CA), a healthcare marketing and communications consultancy . “The good news is that the medical device industry has finally made it to the cover of a national business publication. The bad news is that the article doesn't help the cause. In fact, the most visible mainstream print debut for the medical device industry fails to point out any redeeming value for medical products.”

Written by Forbes staff writer Matthew Herper and senior editor Robert Langreth, the wide-ranging article gets under way with a dismissive assessment of the premarket approval (PMA) process used by FDA to evaluate the safety and efficacy of Class III medical devices and combination products being readied for commercialization.

The authors quickly make it clear that they have little faith in the way that the PMA process was applied to the approval of drug-eluting stents. “It turns out that the teensy tubular scaffolds have never been shown to prevent heart attacks or save lives; their human trials were smaller, of shorter duration, and more narrowly focused than trials for many new drugs; and half of all applications involve ‘off-label' uses, deploying stents in ways that weren't studied at all in clinical testing,” they write.

But the authors don't stop there. Noting that “79 devices have been yanked off the market in the past five years because of potentially fatal side effects,” the article recites a litany of safety issues that have arisen with “gadgets” ranging from implantable cardioverter-defibrillators to carotid stents. In addition to naming stent manufacturers Johnson & Johnson (J&J; New Brunswick, NJ) and Boston Scientific (Natick, MA), the authors also question the performance of FDA approved or cleared products made by Abbott Laboratories (Abbott Park, IL), Medtronic Inc. (Minneapolis), Concentric Medical (Mountain View, CA), and CHF Solutions (Brooklyn Park, MN).

“The real issue here is the need for a systematic, standardized method for evaluating new technologies over time,” says Randel E. Richner, founder and president of reimbursement consulting firm Neocure Group LLC (Newton, MA). “From a social, clinical, and economic perspective, we are distraught over attaining the correct threshold for monitoring, oversight, and public safety activities. Because if we regulate medicine or medical device development too greatly, we will destroy the impetus for incremental discovery and breakthrough.

“We are continually trying to figure out where and how the line should be drawn, so that government regulators can step in as necessary, but without dampening the innovation that is keeping us alive into our 80s and 90s,” she adds.

In addition to legitimate concern over the proper shape of regulatory methods, says Richner, the medical device industry also suffers from public perceptions about the risks associated with medical technologies. “The public embraces new medical inventions, but we are all deathly afraid of the risk that they represent for each of us as individuals and as providers of new technologies,” she says.

“On top of this, because of the media's fascination with ‘Oprah events,' the public is less and less willing to accept the consequences of imperfect science—or to accept any risk in medicine,” says Richner. “Risk acceptance thresholds are always higher in life-threatening and serious diseases for which there are few or no medical options. But when it comes to risk, the scientific and emotional controversies are never-ending.”

With such a depth of risk-averse sentiment, public opinion can be easily swayed. “By focusing on inflammatory rhetoric and calling out only instances of bad outcomes or situations, the public media has found it can manipulate public opinion with only half the story,” says Mark S. Perlotto, executive vice president and chief marketing officer of Adair-Greene Healthcare Communications (Atlanta). “The Forbes article has the potential to turn the sentiment toward the companies mentioned and the industry as a whole to the negative perception.”

The long-term effects of such articles can linger for years. “Negative public opinion toward the industry as a whole, and individual companies like J&J, has the potential to adversely affect positive brand equity that has been built up over many years,” adds Perlotto. “For that reason, companies like Boston Scientific—and especially J&J—have to consider very seriously how to respond to this article and the implied accusations made in it.”

Although the Forbes authors have experience in healthcare-related topics, both are relative newcomers to the field of medical devices. Herper's previously published articles for Forbes have focused primarily on the pharmaceutical industry, with a few recent stories on the related area of drug-eluting cardiac stents. Prior to joining Forbes, Langreth was an associate editor at Popular Science for three years, and covered the drug industry as a staff reporter at The Wall Street Journal for five years.

“The Forbes reporters certainly had one angle they followed to justify their hypothesis,” says Corso, “but they were able to do so because there is not a body of data out there to contradict them—or at least no information that is accessible without the use of a Medline or other clinical news sources.”

“Medical device companies have to do a better job of continuously communicating the positive contributions they make to the advancement of health and medicine to counteract these negative attacks by the media,” says Perlotto.

“Unfortunately, combating an assault in the public domain by the public media is never an inexpensive proposition,” he says. “I would expect that articles such as this one will give great rationale to increase the budgets for public relations and consumer communications.”

“We as an industry must continue to commit dollars and time to quantifying and qualifying the health economics behind devices as well as demonstrating the immeasurable value of life-saving therapies,” agrees Corso. “We must take our cues from other industries and realize that functions like corporate communications and public relations will be as important as R&D and business development in ensuring and protecting the health of our companies in the new era of consumer-directed care.”

“If the general public wants to know why new medications and new device technologies grow ever more expensive,” says Perlotto, “the ‘defensive spending' that articles like this force companies to engage in is a good place to start.”

The complete text of the article by Matthew Herper and Robert Langreth, “ Dangerous Devices,” Forbes (November 27, 2006), is available via the Forbes Web site at www.forbes.com/home/forbes/2006/1127/094.html.

© 2006 Canon Communications LLC

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