August 7th, 2009
Placing blame for the XTent failure
The Wall Street Journal has printed a piece blaming the Obama Administration’s efforts at health reform for the failure of XTent Inc., a venture-backed maker of drug-coated stents that decided to dissolve this week.
Stents have been used for years to keep arteries open after a heart operation.
XTent did seem on the edge of success when it went under. It won approval in March to market its stent in Europe. It won approval for critical clinical trials here in June.
Officially the company blamed the economy. It claimed its stents were “customizable” in that they could be made to fit the size of a lesion, and their drug load could thus fit the needs of the patient.
So what really happened?
Policy may have been partly to blame, but not American policy. European surgeons don’t start using something right away, just because a supplier has won marketing rights. Authorities have to be sold not just on the idea that a product works, but that it’s cost-effective.
The Journal screed by venture capitalist Rob Kuhling does, without stating it, point out something unique about the American system. U.S. doctors start trying therapies as soon as they are allowed to, never mind the cost. This acts as a subsidy to American drug and device companies. They can sell one doctor, one clinic, one hospital at a time, as soon as they have the right to. They don’t have to sell countries first.
Another unique aspect of the American system is that we may never know whether a treatment is cost-effective or not. We don’t collect the data. We don’t do the analysis. This data-collection and analysis is a part of the Obama plan — it’s called comparative effectiveness — but doctors are not required to base treatments on the results.
There’s another possible reason for the XTent failure, moreover. You’re soaking in it.
The Duke Clinical Institute recently conducted a study on how news impacts medical practice. The example they looked at was the use of drug-coated stents, like those sold by XTent.
In September 2006 the European Society of Cardiology heard several studies indicating that drug-coated stents may actually carry higher risks of a later heart attack than non-coated stents. Treatment patterns in the U.S. changed rapidly, the study showed.
In other words, once word of the studies filtered out over the Internet doctors acted, even before they knew whether the conclusions were the right ones for their patients.
The lesson that the president of the American Heart Association took from this, apparently, was that you should not believe everything you read on the Internet. But, again, there is another way of looking at it.
Doctors are hungry for data. In the absence of solid data they will grab what is at hand. If comparative effectiveness research is available, it will find an eager audience.
That, too, may put investors in XTent’s successors at greater risk of losing their investments. But the blame should not be laid at the feet of policy or the Internet.
It should be laid at the feet of science, of research, of data. Doctors are hungry for it. They have a right to be.
Dana Blankenhorn has been a business journalist since 1978, and has covered technology since 1982. He launched the Interactive Age Daily, the first daily coverage of the Internet to launch with a magazine, in September 1994. See his full profile and disclosure of his industry affiliations.
Subscribe to ZDNet Healthcare via Email alerts or RSS.
| 08/07/09
