MD&DI has named Cook Group (Bloomington, IN) and Roche Diagnostics (Indianapolis) as its 2006 Medical Manufacturers of the Year. Feature articles on the winners appear in the November issue. Cook was selected for its innovative approaches to product development that always keep patient needs in mind, and for coming up with cutting-edge technologies that could reshape healthcare. 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.
The mainstream media tends to make a number of harmful assumptions when covering the device industry. These include: the corporate world’s motives are inherently suspect, device development is no different from drug development, and any relationship between a doctor and a device company must constitute an insidious conflict of interest. In my experience, the New York Times has been the worst offender. 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.
Bloomberg News reports that Wyeth yesterday filed suit against Johnson & Johnson, accusing it of breaching a contract allowing it to use Wyeth’s sirolimus drug with J&J’s Cypher drug-eluting stent. J&J denies the allegations, the details of which are blacked out in the public version of the document. The lawsuit if pursued would take a few years to play out, but could potentially be devastating for J&J’s drug-eluting stent platform.
Today’s Boston Globe has a feature about Dr. Renu Virmani, a pathologist who studies diseased tissue. In recent years she has analyzed drug-eluting stents taken from patients who have died, and her findings are not favorable. In one recent study, she found that 14 of 23 patients had had a blood clot that blocked all or part of the artery. 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.
After a device receives PMA approval, its manufacturer must file a report annually with FDA updating it on manufacturing, design, and labeling changes, among other things. For years, it appeared, very little was ever done with this information. But in this era of heightened postmarket surveillance, CDRH would like to see annual reports reformatted to better highlight potential safety issues. Today, it released a draft guidance outlining how it would like to see annual reports formatted. The public has 90 days to submit comments. “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.
Ten days after announcing that counterfeit blood glucose strips for use with LifeScan, Inc.’s One Touch brand blood glucose monitors are in circulation, FDA has uncovered two more counterfeit lot numbers and posted suggestions for how to identify the phony products. 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.
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This week’s TCT conference underscores a lack of consensus about the future of stenting technology, reports the New York Times. It appears, says Barnaby Feder after sitting through a ton of presentations, that while drug-eluting stents present an increased risk of clotting, bare-metal stents are not necessarily a safer option, as they present an increased risk of restenosis. But alternatives to stenting, such as drug therapy and bypass surgery, present their own sets of risks. 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 released a study showing its Taxus drug-eluting stent is no more likely to cause blood clots after one year than Johnson & Johnson’s Cypher, reports the Boston Globe. J&J has been saying clotting is less likely to occur in Cypher than Taxus. European studies have shown that as many as 2.9% of drug-eluting stents cause clotting within three years. 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.
Today’s New York Times has an article on the controversy over the NC-stat, a nerve-testing system made by Neurometrix (Waltham, MA). Some doctors say it is by far the best way to diagnose carpal tunnel syndrome and other conditions involving nerve damage. Others say that the company has been too aggressive in marketing it to doctors who aren’t qualified to use it, or who use it much more often than needed. The 15-minute procedure can net the doctor a profit as much as $250. Is this an example of innovation or waste? Read the piece and judge for yourself.
Two European studies report that patients who have carotid artery stents to prevent stroke are much more at risk of stroke than those who have surgery to remove plaque, reports the Los Angeles Times. French researchers reported in today’s New England Journal of Medicine that stented patients were 2.5 times more likely to suffer a stroke than surgery patients. 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.
