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Articles from 2006 In October


Cook, Roche Diagnostics Honored by MD&DI

Roche Diagnostics was selected for being the first company to make pharmacogenetic diagnostics a reality, and being a leader in the movement toward personalized medicine.

New York Times Finally "Gets It" about Device Development

How refreshing, then, to read Barnaby Feder's lengthy wrap-up of last week's TCT conference. You can visualize the light bulbs going off in his head as his week of observation leads him to understand how the relationship between doctors and device companies really works, and why it's necessary. He still slips in a knee-jerk assumption from time to time, but for the most part he provides great detail about various safety, conflict of interest, and technological issues, and puts them in their proper context. Amazing what relying on actual reporting instead of unfounded assumptions will do. The Times needs to get its writers into the field more often.

Wyeth Sues J&J over Drug Used in Cypher

Autopsies Underscore Risk of Clotting from Drug-Eluting Stents

One can't use this data to infer that drug-eluting stents are always unsafe: The sample size is small and the patients may be extreme cases, by virtue of their having died already. But if her findings can be used to determine how and why the clots form, the next generations of the technology could be markedly improved. Therefore, her work is potentially significant, and worth paying attention to.

FDA Guidance Reformats Annual Reports for PMA Products

"Annual reports that contain well developed and meaningful information will be an important tool for the agency and the industry to assure postmarket safety and protect the public," the agency states in the document. "When manufacturers prepare the type of analysis this guidance describes and provide this information to FDA in annual reports, industry and FDA will be better positioned to recognize and address possible safety signals." Let's hope so.

FDA Updates Alert on Counterfeit Glucose Test Strips

Using the counterfeit products could produce inaccurate readings of blood glucose levels, prompting a patient to take too much or too little insulin, both of which can have serious health consequences. FDA also announced a collaboration with the Federal Trade Commission and Mexican and Canadian authorities in an effort to stop advertisements and sales of products misrepresented as cures or treatments for diabetes. Most of the products in question are dietary supplements.  

Stents: What Now?

The risk question is so important that J&J and Boston Scientific are jointly funding a massive study that might answer it. Abbott is also at a crossroads. Yesterday it announced it has abandoned Zomaxx, the drug-eluting stent it developed, after trials showed that it was less effective than Taxus and thus would suffer in the marketplace, reports Bloomberg News. It will continue development work on the Xience, the drug-eluting stent technology it acquired from Boston Scientific as part of the Guidant deal.

Boston Scientific Says Taxus No More Risky Than Cypher

This has made some doctors leery of using them -- hence a proven significant difference would mean a lot for short-term profits. Fittingly, this morning both J&J and Boston Scientific announced that they will support studies of 48,000 patients with drug-eluting stents, to try to get to the bottom of the clotting issue, according to Bloomberg News.

Questions Arise about Overuse of Test

Read the piece and judge for yourself.

Carotid Artery Stents Too Risky?

A smaller German study published earlier this month found a lower but still statistically significant difference. Both research teams called for an end to carotid artery stenting. These findings contrast with U.S. studies showing that stenting is safer. Clearly, more research needs to be done. Maybe a very large NIH study in progress will shed some light on this. But, don't be surprised to see this news put a damper on stenting procedures for now, which is bad news for the device companies with carotid stents on the market or near introduction.