To: rhering who wrote (7822 ) 10/29/2003 3:40:17 PM From: Proud_Infidel Read Replies (3) | Respond to of 25522 It would appear yet another analyst stepped in it......I am not so sure the firm saw this FDA report before issuing their outlook. It sounds as though they were making this call on stock action alone, but I may be wrong..... Brian 2:40PM Johnson & Johnson upgraded to Outperform at RBC on valuation 49.45 -1.09: -- Update -- RBC Capital upgrades to Outperform from Sector Perform based on valuation, as the stock is trading at a 5-year low on an absolute forward P/E basis and trades at 0.95x the S&P 500 (avg 1.14x); firm thinks today's sell-off offers an especially good entry-point for long-term investors, as it appears to be based on old news about the safety of the co's Cypher stent. Target is $60. ***************** Today's Headline: FDA: Serious J&J Heart Device Problems Wednesday October 29, 2:49 pm ET By Debra Sherman CHICAGO (Reuters) - The U.S. Food and Drug Administration (News - Websites) on Wednesday said Johnson & Johnson's (NYSE:JNJ - News) newest heart device may cause blood clots and other side effects, and it linked the device to more than 60 deaths. The news sent J&J's shares down to their lowest point in more than a year before recovering somewhat. It was the second such warning sent to doctors since the launch of the device in April 2003. Regulators said the company's drug-coated stent, a tiny wire mesh device used to prop open surgically cleared arteries and deliver medicine to keep them open, resulted in more than 290 cases of blood clots among patients 30 days after receiving the device. It said the Cypher stent was linked to deaths in more than 60 clotting cases. In other cases, the stent was associated with injury requiring medical or surgical intervention, it added. The FDA has also received more than 50 reports, some involving deaths, that J&J considers to be possible hypersensitivity reactions, the letter said. The symptoms include pain, rash, respiratory alterations, hives, itching, fever and blood pressure changes. "We've implanted over 100 of these stents and I haven't seen any of those problems," said Lloyd Kline, a cardiologist with Rush University Medical Center in Chicago. "We need more information. Was it used in the way it was used in the trials? Are these the very sickest patients? There are a lot of questions that need to be answered." The long-awaited devices have been expected to revolutionize the treatment of clogged coronary arteries, by sharply reducing the need for repeat procedures. Analysts have expected the drug-coated stents to double the size of the current market to $5 billion by 2005. In July, the FDA sent the first letter to doctors, which said it was reviewing reports of problems with the stent and was working with J&J to reduce the incidence of potentially deadly blood clots. J.P. Morgan analyst Michael Weinstein said his concern was that events of this type may have been under-reported. The actual incidence of blood clots, he noted, is still quite low at roughly 0.06 percent. In its letter, the FDA added it does not have enough information to determine whether the incidence of clotting and hypersensitivity reaction with the Cypher stent differs from those experienced with stents that are not coated with drugs. The cause of these events has not yet been determined, the FDA said, adding that it was working with the company to gather more information. "They're posting this update because it's brand-new technology that's only been out on the market for about six months, so the FDA feels it's important to encourage physicians to report any (clotting) when using the Cypher stent," said Terri Mueller, a J&J spokeswoman. "Despite this call for physicians to report (clotting), our rate is still well below that of a bare-metal stent." The FDA letter also noted that hundreds of thousands of patients have been successfully treated with the Cypher stent, the first of its kind on the U.S. market. Mark Ricciari, an interventional cardiologist at Northwestern Memorial Hospital, said that unless the incidence of blood clotting is more than 1 percent there should be no cause for alarm, and it probably will not change the way the device is being used. "This is getting a lot of scrutiny because it has been marketed so aggressively and has been adopted so readily, more than any other product I've ever seen," said Ricciari, who participated in some of the clinical trials testing the stent. Shares in Johnson & Johnson fell $1.14, or 2.3 percent, to $49.40 in afternoon trading on the New York Stock Exchange (News - Websites) . Earlier the stock dropped as low as $48.10. Shares in Boston Scientific Corp. (NYSE:BSX - News), which currently has its version of a drug-coated stent under regulatory review, were up $1.77, or 2.7 percent, at $67.32, also on the NYSE. (Additional reporting by Jed Seltzer and Ransdell Pierson in New York)