Cypher

FDA panel to mull DTC changes

Fri, 16 May 2008 06:59:55 -0400

Brace yourselves: An FDA advisory committee meets today to hash over the possibility of putting a side-effects hotline number in every DTC television commercial. The meeting comes at a time when drug ads are under increased scrutiny; just last week, Congress heard testimony about the ads, including expert assessment that commercials are engineered to play down warnings and emphasize benefits. One researcher said she'd found that 80 percent of TV viewers could recall drug benefits mentioned in commercials, but only 20 percent remembered side effects.

Print ads, you'll recall, already include FDA contact info so patients can report side effects. Some lawmakers and consumer groups say adding that info to TV ads as well would help regulators catch drug safety problems sooner.

- see the item at Pharmalot
- check out the Associated Press story

ALSO: A stent skeptic assails DTC advertising for Johnson & Johnson's Cypher product in the New England Journal of Medicine, saying the TV commercials cross an ethical line; J&J says the ad is balanced and points viewers to sources of more detailed information. Report

FDA panel: Approve Medtronic stent

Thu, 11 Oct 2007 06:59:55 -0400

Medtronic's new drug-coated stent may soon turn the Boston Scientific-Johnson & Johnson rivalry into a three-way battle for market share. The Minneapolis-based company got an FDA panel's recommendation yesterday, clearing the way for a final agency approval to market its Endeavor stent, perhaps by year's end.

At the advisory committee meeting, Medtronic presented data that showed its Endeavor stent to be less prone to clots than Taxus (Boston Scientific) or Cypher (J&J). It's this clotting problem that has depressed sales of the coated stents by almost a third this year. But the Medtronic data was based on a fairly short-term study, so long-term differences remain to be seen.

Meanwhile, Abbott Laboratories is waiting in the wings with its Xience stent, with hopes of an FDA approval during the first half of next year. Boston Scientific is Abbott's marketing partner for the product.

- check out Medtronic's release
- read the New York Times article

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Read more on: Medtronic | Stents

Data backs use of J&J's Cypher stent

Fri, 14 Sep 2007 06:59:57 -0400

On the scales of stent safety, the evidence is piling up in favor of the previously discredited drug-coated models--Johnson & Johnson's Cypher in particular. On top of positive research announced at last week's European cardiology congress comes a new meta-analytical study, published in today's Lancet, that concludes patients with drug-eluting stents don't have a greater risk of death than patients whose stents are bare.

Unfortunately for Boston Scientific, the study also suggested that patients implanted with the company's Taxus stent had a slightly increased risk of heart attack when compared with patients with Cypher stents. Taxus patients also were a bit more likely to develop blood clots and to require follow-up procedures, the study shows.

- here's J&J's release
- read the article from The New York Times

Related Articles:
Little common ground in stent controversy. Report
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Insurers may cut stent payouts. Report

Little common ground in stent controversy

Tue, 04 Sep 2007 06:59:57 -0400

Bad news first: Heart attack victims are more likely to die if they're fitted with a drug-coated stent than if they're given a bare one, according to an analysis of 2,300 patients in 14 countries, known as the Grace Registry.

But opposite-and-somewhat-equal good news, also presented at the European Society of Cardiology congress: Swedish researchers following drug-coated stent patients found no increased risk of death. And Boston Scientific, which makes the Taxus drug-eluting stent, also announced results of its own study--no increased risk of blood clots in patients four to five years on. (We'll take this latter study with a grain of salt, however.)

For its part, Johnson & Johnson, which markets the Cypher drug stent, deemed the Grace Registry findings "inconsistent" with other studies (those with results it likes better, of course).

- here's the report on the heart-attack study
- see the report on the Swedish study here
- check out release from Boston Scientific

Related Articles:
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Tough times for stent market

Fri, 17 Aug 2007 06:59:54 -0400

The market for drug-delivering heart stents has been spiraling toward earth since safety questions emerged last year. Experts say sales of the tiny devices will shrink by one-third in the U.S. this year--a drop of about $1 billion. The troubles have prompted big cuts at stent-makers Johnson & Johnson--which is shrinking by about 5,000 jobs, in part because of a 41 percent drop in Cypher stent sales--and Boston Scientific, which has seen a 32 percent decline in sales of its Taxus stent.

In mid-2006, research showed that the drug-coated stents caused a small increase in the risk of life-threatening blood clots, and by December the FDA was warning against off-label uses of the devices. The latter may have been the biggest blow, because about 60 percent of the implants were installed off-label.

The worst may be yet to come: one analyst predicts that the stent market will hit bottom in two or three quarters. However, the industry is working on a new generation of stents, hoping to jump-start the market.

- check out the article