The winter of 2006 was a period that cardiac stent manufacturers would rather forget. Negative studies out of Europe reported on the dangers of late stent thrombosis (LST) in patients with drug eluting stents (DES), causing widespread panic among some interventional cardiologists and the investor community. But more importantly and often overlooked as a consequence, the grim news created tremendous anxiety among millions of DES patients, many of whom were recovering from recent heart attacks.
In response, the FDA convened an expert panel to take a closer look at DES and their risks. Up until that period, the DES market was experiencing a growth spurt capturing close to 90% of the market, and overtaking bare metal stents as the product of choice for interventional cardiologists.
However, the bad press from Europe prompted many cardiologists to switch back to bare metal stents, while at the same time Wall Street advised investors to shy away from DES manufacturers, at least until the late stent thrombosis crisis was put to rest.
Yet in the midst of all the turmoil, a few high-profile cardiologists in the US recommended a more measured approach, questioning the accuracy of the European data which was based on nothing more than a meta analysis, and not a full-blown study. Some cardiologists argued that the decision to avoid DES might be shortsighted.
Back in 2006 there were two major stent producers—Cordis, a division of Johnson & Johnson that makes the Cypher stent, and Boston Scientific's Taxus stent product line. Citing internal studies, both companies insisted at the time, that DES were safe and effective and that LST was rare. In addition, uncertainty over how long DES patients should take the antiplatelet drug clopidogrel (Plavix), was a mitigating factor.
Nevertheless, Wall Street panicked, and as a result stent manufacturers took a hit.
Now, three years after the DES scare, Cordis and Boston Scientific turned out to be right. Several new studies have refuted much of the negative data that surfaced in 2006. In fact, data from some recent studies show that when it comes to LST and other problems, DES had about the same risk factors than older bare metal stents.
While industry analysts don't expect stent penetration to return to pre-2006 numbers, the forecast for 2009 looks pretty good. In fact, two new players Abbott and Medtronic have entered the market, threatening Cordis and Boston Scientifics' dominance. In addition, there is healthy R&D activity into DES technology as companies look to develop the next generation of stents.
“In the last 12 months, and especially in the last three months, we have actually seen penetration rates start to pick up,” says Tao Levy, a VP at Deutsche Bank in New York. Levy noted that the new safety data that has surfaced is in direct contrast to the 2006 studies and as a result the community has gotten a lot more comfortable with those safety issues and the use of newer stents is giving some comfort to clinicians as well.
The DTC experiment
Prior to 2006, advertising for DES and bare metal stents was limited to the professional sector. But in 2008, in reaction to the sales slump that re-sulted from the negative publicity, Cordis gambled on a risky DTC campaign. The commercials featured heart stent patients who conveyed personal stories about how they were given a second chance, thanks to the Cypher stent. The campaign was met with harsh criticism from the cardiology community. Critics claimed that stents were complex devices and the choice of what stent should be used was a complicated decision, even for doctors. “These devices are little more complex than some of the other medical devices—there are a lot of nuances with them, DTC marketing can be misleading,” says Levy, who added that for something that's more complex like DES, it's probably best to leave it with the professional marketing channel.
Christopher Allman, executive director/corporate communications for Cordis, said that the Life Wide Open campaign is more than just the TV and print ads.
“The web portion of that campaign is still under way,” he says. When asked if Cordis would pursue DTC in 2009, Allman says the company wouldn't discuss its 2009 plans.
“I don't know how helpful the DTC campaign by J&J Cypher was. It was during a period of controversy, a lot of misleading information, a lot of patients were assuming right off the bat that DES might be dangerous,” says Deutsche Bank's Levy.
For the other major stent companies, it doesn't look like DTC is in the forecast.
Jonathon Hamilton, senior director, public affairs for Abbott, which markets the Xience line of stents, says that DTC is not in the company's focus. Joe McGrath, a spokesperson for Medtronic said that none of the company's current marketing plans for its Endeavor stents include DTC advertising. The provider side isn't too keen on DTC either.
“I would rather that the companies provide physicians with more information about how they could inform their patients,” says Cam Patterson, MD, director, Carolina Cardiovascular Biology Center, associate chair, research; Ernst and Hazel Craige distinguished professor of Cardiovascular Medicine, UNC Chapel Hill.
For its part, Boston Scientific expects to remain aggressive in developing new technologies.
“Our R&D budget in 2009 will be in excess of 10% of revenues at an estimated $1 billion. Our platinum-chromium based Element Stent family is expected to be introduced in Europe by the end of this year putting us well in front in the delivery of new DES for 2009 and beyond,” says Boston Scientific's spokesperson Steve Goodyear.
“We will focus our marketing and communications efforts on physicians and the hospital professionals who help them do their jobs,” continues Goodyear, who added that Boston Scientific will communicate and reach out to other audiences including the investor community and the mainstream consumer. “We expect to have dialogue with those audiences as well. But any substantial [DTC] marketing will be a longer-term consideration.” Boston Scientific also distributes the Promus Everolimus-Eluting Stent, manufactured by Abbott.
While there is no doubt that the stent industry is still feeling the sting from the 2006 studies, experts are optimistic about the future of DES sales compared to bare metal. Levy says 88% levels are unlikely, and 60% is probably too low. “The happy medium will be around 70% and we will see some slight growth going forward, and we don't expect any more new players.” Levy predicts that prices will remain relatively stable, although he noted that some of the newer entries are coming out at a slightly more expensive price than the older stents. “That's why I don't think that you are going to see much pricing pressure,” he says.
According to Boston Scientifics' data, DES penetration compared to bare metal has risen from roughly 61% in 2006, to an estimated 75% at the end of November 2008.
Patterson views increased competition as a good thing. “It's better to have a nice mix of options.” Patterson says that each of the stent platforms has differences not only in the drug that they elude, but in the profiles of the stents themselves and having more flexibility is enormously important. “Now we have the ability to think a little more cleverly and broadly about treatment approaches for an individual patient.”
Patterson notes that as more players enter the market, there's more attention paid broadly to the impact of the technology rather than focusing on one single stent platform. “That reduces some of the paranoia factor that fed into the late stent thrombosis issue of three years ago.” Patterson asserts that the emerging trends in research are going to smooth out the hills and valleys of stent deployment and “give us an umbrella of safety.”