Boston Scientific, J&J, Wall Street Gird for Bad News (Update3) http://www.bloomberg.com/apps/news?pid=20601109&sid=a_lygbtSgIhQ&refer=home By Michelle Fay Cortez March 23 (Bloomberg) -- Boston Scientific Corp. and Johnson & Johnson may get more bad news about their stent heart devices when results of a large patient study come out next week. Doctors and analysts say they expect the study, to be released at a science meeting March 27, to show that stents used to prop open clogged arteries are no better than drug therapy in preventing deaths and heart attacks for patients with cardiovascular disease. Sales of certain stents have been declining since last year when the devices were linked to an increase in blood clots. The latest study may raise new questions about the benefits of using the tiny mesh tubes that are implanted into the arteries of a million Americans annually. Boston Scientific's shares have fallen 10 percent and J&J shares are down 5.5 percent in the past month on rising investor concerns about the devices. ``Wall Street certainly has the expectation that there will be no difference shown'' between stents and drug therapy, said Thomas Gunderson, an analyst at Piper Jaffray & Co. in Minneapolis. ``Wall Street is worried about the media coverage that may fuel patients' fear that there is really no good reason to have a stent implanted,'' he said. Shares of Natick, Massachusetts-based Boston Scientific fell 47 cents to $15.12 at 1:37 p.m. in New York Stock Exchange composite trading, and New Brunswick, New Jersey-based Johnson & Johnson fell 50 cents to $60.36. Boston Scientific has dropped 12 percent this year, and J&J has fallen 8.6 percent. `Sizzling Hot' Study The latest study, involving 2,287 patients, was carried out to determine whether stents placed in arteries prevent deaths and heart attacks better than aggressive therapy using a combination of drugs to lower cholesterol, reduce blood pressure and prevent clots in patients with heart disease. No previous work has found such a benefit. Heart researchers at Buffalo General Hospital in New York state conducted the study, dubbed Courage. It will be released at the annual meeting of the American College of Cardiology in New Orleans. The study is ``sizzling hot,'' said Steven Nissen, president of the cardiology college and the chairman of cardiology at the Cleveland Clinic. ``It really asks the question, never before asked in the modern era, whether aggressive drug therapy without an angioplasty is as good or not as good as aggressive medical therapy.'' Angioplasty is a procedure in which a small balloon-tipped catheter is threaded into a clogged artery that carries oxygen- rich blood to the heart. Stents are left behind to keep the artery from re-closing. Reducing Chest Pain Doctors know angioplasty and stenting can reduce chest pains caused by blocked arteries. The new study was designed to see whether the procedures prevent deaths and heart attacks, too. Worldwide sales of stents last year came to $5.4 billion. Johnson & Johnson generated $2.62 billion of its total 2006 sales of $53.3 billion, from the product. Boston Scientific garnered $2.36 billion, or 30 percent, of its revenue last year from stents. Officials at both companies say a negative result shouldn't inhibit the use of stents. That's because previous smaller trials already suggested stents and drug use, often called medical therapy, yield similar clinical results for patients with heart disease. The stents used in the study were primarily the older, bare- metal models that aren't coated with medication. The companies and some analysts said use of the older models may have hurt the performance of the stents in the study. Nothing New No trial of artery clearing procedures, with or without a stent, ``has ever shown that it improves the already good survival from medical therapy,'' said Donald Baim, chief medical officer for Boston Scientific, in a March 20 telephone interview. The results of the study aren't applicable to patients with a heart attack or sudden chest pain caused by blocked blood flow to the heart. In those people, studies show restoring flow as quickly as possible with angioplasty and a stent saves lives. Stent sales are falling since European researchers last September tied coated stents to the formation of potentially deadly blood clots months or years after they were inserted. The best defense against clots is blood-thinning drugs that are recommended to patients for a full year after a stent is implanted. Boston Scientific today said it will spend up to $40 million on education and financial aid to encourage patients to follow doctors' orders and take the drugs for the entire year. Drug-Coated Stents A declining percentage of Johnson & Johnson and Boston Scientific sales are going to the more expensive, so-called drug- eluting versions of the stents considered by doctors to be better than bare-metal versions in keeping arteries open. In May 2006, about 88 percent of stents used at U.S. hospitals were drug-coated, according to Goodroe Healthcare Solutions, a consultant on hospital purchasing. Now some hospitals say they are using them about 60 percent to 65 percent of the time. Shortages are arising for bare-metal versions, doctors say. ``Drug-eluting stents are having a tough time,'' Piper Jaffray's Gunderson said. Patients often demand angioplasty, to clear out the clogged artery, with a stent used to keep it propped open, said Samin Sharma, director of interventional cardiology at Mount Sinai Medical Center in New York, in a March 21 telephone interview. When Sharma tells patients that more than half of a critical artery is blocked, they want aggressive treatment to open the artery, he said. ``You tell a patient they have a 70 percent or 80 percent blockage, and they freak out,'' said Sharma, who does 1,500 procedures a year, one of the highest rates in the U.S. ``People are telling them, `You are a walking time bomb.' They want things done now. That's American culture.'' Sharma expects the study will show patients getting stents will have less chest pain, fewer hospitalizations and better ability to exercise. He doesn't think they will live longer.
BSX is toast. So is anyone else who is heavily dependent on stent income. Read today's news. Study Raises Questions About Benefit Of Stent Heart Devices 2 minutes ago - Dow Jones News By Jon Kamp Of DOW JONES NEWSWIRES NEW ORLEANS (Dow Jones)--A closely watched trial released Monday may raise questions about whether a large portion of the more than 1 million U.S. patients who get stents each year really need the devices. The trial, called "Courage," showed no benefit in reducing death and heart attack among patients who had drug therapy plus coronary intervention, which usually involves stents, vs. patients with drug therapy alone. The study included 2,287 patients who were followed for up to seven years. The study looked at bare-metal stents because it was mainly compiled before coated stents hit the market, but analysts expect doctors to extrapolate the results to the much bigger coated-stent market. Boston Scientific Corp. (BSX) and Johnson & Johnson (JNJ) are the big coated-stent makers. The devices act as scaffolding in arteries, and use medication to combat renarrowing. Courage has been the talk of the American College of Cardiology's annual conference in New Orleans, where backers and foes have already lined up to highlight its importance and potential to alter clinical practice, or its supposed irrelevance. The data was released a day earlier than planned after a doctor who knew the results discussed it at an event Sunday night. The study is "really important," said Steven Nissen, outgoing president of ACC and chairman of cardiovascular medicine at the Cleveland Clinic, in an interview. "What we really learned here is that it's OK to defer angioplasty and give a trial of adequate therapy (with drugs), and you're not going to compromise your health if you do it," Nissen said. The Courage trial was sponsored by the U.S. Department of Veterans Affairs in collaboration with the Canadian Institutes of Health Research, and was supported by a host of pharmaceutical companies. The patients were enrolled at 50 U.S. and Canadian centers. The trial showed that, at the median follow-up point of 4.6 years, the estimated primary event rate among patients in the coronary intervention group was 19%, compared with 18.5% among patients only treated with drugs. There was a substantial reduction in angina among patients in both groups, and a statistically significant reduction among patients in the intervention group, although the gap between the two groups shrank over five years. Will Doctors Shift Gears? William Boden, chief of cardiology at Buffalo General and Millard Fillmore Hospitals, and lead investigator on the Courage study, believes the study will lead to a change in clinical practice over time. That would be an unfavorable development for the device makers. Nissen estimates that about half of all stent recipients fall into the category covered by the Courage trial - Boden estimated a much higher 85% rate. Boston Scientific is the biggest maker of coated stents in the U.S. and has the most on the line if Courage has a real impact on procedures. The company relies on stents for a higher portion of revenue than does chief rival Johnson & Johnson (JNJ). J&J's Cordis unit is the other seller of coated stents in the U.S. Shares of Boston Scientific were already falling Monday, hitting 4 1/2 year lows, following news this weekend that a coated stent made by Abbott Laboratories Inc. (ABT) looked good in a head-to-head pivotal study match-up with Boston Scientific's Taxus device. Boston Scientific gets to sell the Abbott device under an agreement between the companies but has to share the profits. Courage has opponents, including Boston Scientific's chief medical officer, Donald Baim. He was on the offensive early Monday when he said, at a company analyst meeting, that Courage was "programmed to fail." He added in a later statement that it was "entirely expected" that Courage would "fail to prove its unlikely thesis." Prior studies have shown, and doctors already know, that stents don't reduce the likelihood for death and heart attacks in stable patients, Baim said. The devices are instead intended to reduce angina, or painful chronic chest pain, and increase quality of life. Some other doctors have taken a similar stance regarding the study. Martin Leon, a professor of medicine at Columbia University School of Medicine who has been associated with multiple company stent programs, also thinks Courage was looking in the wrong direction. "I would go in and say the study design itself was flawed," Leon said in an interview. Early Comments Leon, an advisoe to Boston Scientific, commented on the study at a company-hosted event on Sunday night, confirming that it "failed." ACC decided to lift an embargo on Courage following a news report of the comments from Leon, who reviewed the Courage study for its planned publication in the New England Journal of Medicine. Boden, the Courage investigator, was not pleased. Speaking in an interview, he said members of the interventional community "obviously are threatened by the results of the study." Both Boden and Nissen, the ACC president, pushed aside the idea that the Courage results were irrelevant because the study's primary goal was to measure death and heart attacks, and it's already known stents aren't helpful for stable patients in avoiding those outcomes. "You think patients are told that?" Boden said. "We didn't know the answer to that question." Boden has ties to multiple pharmaceutical companies, including consulting fees and research grants. "The end point of heart attack and death is always relevant," Nissen said.