Drug-Eluting Stents’ Recent Woes Only a Hiccup

(From July 2007 MedMarkets.)

In July, it was reported by Johnson & Johnson that the company’s second quarter U.S. sales of Cypher, its landmark drug-eluting stent, were off 41% from 2006, while non-U.S. sales had fallen by a less precipitous 30%.  Three facts were eminently behind this decline: the late-stage thrombosis problem linked to drug-eluting stents, the irrepressible drive for lower costs that have on their own given new life to bare metal stent sales (aside from the thrombosis issue, that is) and the increased sales of competing drug-eluting stents (in Europe) by Medtronic and Abbott Labs.

It was a safe prediction that demand for drug-eluting stents would take a hit from the thrombosis risk issue, since it was negative press about a technology that had heretofore been viewed with Pollyanna-esque potential.  It was also a safe bet that it would only be a matter of time before cost conscious healthcare providers and payers would again suggest that the less expensive bare metal stents may well be indicated for many patients.  And, lastly, duopolies in markets, as was the case of J&J and Boston Scientific with Cyper and Taxus, just don’t last.  Drug-eluting stent sales were destined to take a hit.

Here are the facts:  The problem with overprescribing drug-eluting stents is indeed a real problem.  The increased risk of thrombosis has been demonstrated sufficiently.  The pending introduction of drug eluting stents by competitors is a certainty. The picture is certainly less rosy for drug eluting stents than was evident two years ago.  Real demand has increased for bare stents. Real demand has not actually increased for coronary artery bypass, but its steady decline has become at least momentarily less steep.  All bad news for drug eluting stents.

But here are the other facts:  Coronary artery disease is a major health issue.  Coronary artery bypass is a highly invasive procedure in light of alternatives.  Percutaneous angioplasy alone is associated with high rates of restenosis.  Percutaneous angioplasty with bare metal stenting is associated with unacceptably high rates of restenosis.  Percutaneous angioplasty with concommitant use of drug-eluting stents is associated with dramatically reduced rates of restenosis.  Needless to say (but we will), all this is good news for drug eluting stents.

Therefore, let us make a not-so startling prediction:  while J&J (and Boston Scientific, for that matter) will definitely see lesser sales in drug eluting stents in the next few years, it won’t be due to a shrinking market, just more slicing of the pie as Medtronic, Abbott, et al get their DES products on the market.  The reasons why drug-eluting stents were introduced are why continued development of drug-eluting stents will remove late stage thrombosis as a factor inhibiting market growth.  And as for cost, it will simply simply temper market growth of DES.

New technologies, especially in the medical field, have a dramatic ability to be associated with pendulum-like effects.  Market introduction of new technologies can put tremendous momentum into the swing in the market toward these technologies’ adoption, frequently beyond the limits justified by the clinical evidence, which in turn can rapidly cause the momentum to force the pendulum back toward older technologies or techniques often with amnesia-like disregard of the older technologies’ limitations that drove new tech development in the first place. 

The Lessen of New Technology Introduction 

Good scientists are always able to clearly communicate, in defensible terms, the precise conclusions (and their limitations) that can be drawn from research.  The market, however, is a hyper-reactive beast that is variously subject to bouts of euphoria and melancholy not typically justified by the facts.  So the potential for drug-eluting stents to result in dramatic reductions in restenosis should no more have been impetus for their unrestrained prescription than their potential to cause late stage thrombosis should lead patients, doctors or investors to conclude that the restenosis with bare metal stents or the invasiveness with coronary artery bypass really weren’t so bad after all.

By turn, let’s look at DES analogously to laparoscopic cholecystectomy, a new technology that was also initially forecasted with delirious potential but then faced a backlash ensuing from unforeseen complications.  Like DES, laparoscopic cholecystectomy had such a favorable profile due to its clinical benefits that its potential was quickly stretched by all who had incentives (which were MANY) to include procedures and/or penetration rates that were quickly seen for what they were:  utterly unrealistic.  This writer is familiar with a particular surgeon who, during the burgeoning rise of laparoscopy, which was forecasted almost to be the “only” way to perform abdominal surgery, was heard to loudly pronounce that the forecasted ultimate 75% plus rates of penetration by bowel resections by laparoscopy were utter nonsense (he used a different word). 

As is often the case when faced with contrasting viewpoints (even ends of the spectrum), the truth is usually in the middle.  Like laparoscopic cholecystectomy centering on safe, clinically benefitted caseload, drug-eluting stents — especially with continued development — will similarly center on a safe, clinically-benefitted caseload.

The recommendation for manufacturers is to be ahead of the pendulum, anticipating when it is about to swing the other way and marshalling the clinical evidence to defend the legitimate market potential for new medical technologies — and not one more iota of potential.  As much as Wall Street will reward favorable forecasts that are exceeded, it is even more ready to punish those forecasts that are missed.

(Afterword:  A recent “report” by an unnamed source predicted that, as a result of the late stage thrombosis problem of drug-eluting stents, the next few years would see an absolute increase in the number of coronary artery bypass procedures.  Nonsense.)

 

Tags: medtech, stents, drug-eluting

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