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Biotech / Medical : IPIC -- Ignore unavailable to you. Want to Upgrade?

To: WeirdPro Randy who wrote (861)	11/7/1997 4:56:00 PM
From: Pancho Villa	Read Replies (2) \| Respond to of 1359

WP Randy RE: >> ......we still need to wait for the Harvard study, but the tunnel ain't so dark anymore.<< I guess divergence of opinions is what makes the market interesting. I am of a contrary opinion but respect your views. regards, Pancho

To: WeirdPro Randy who wrote (861)	11/8/1997 7:37:00 PM
From: Pancho Villa	Read Replies (2) \| Respond to of 1359

Randy, IMO your views on the Framingham study are overly optimistic. Had you read this when you made your previous assessment? here is a copy from an article in the WSJ. The Wall Street Journal -- November 7, 1997 Technology & Health: Heart-Valve Study Finds Leaks More Common ---- By Laura Johannes and Robert Langreth Staff Reporters of The Wall Street Journal As much as 6% of the general population has the type of heart-valve leaks that prompted the sudden recall of two popular diet drugs in September, according to a new study to be presented at an American Heart Association meeting next week. That is larger than the 1% to 2% initially estimated by the Food and Drug Administration when it pulled the drugs, but significantly smaller than the 32% rate the agency found in seemingly healthy people who had taken the medicines. The data, from the long-term Framingham Heart Study, one of the most respected surveys in the field, provides the best information to date on the so-called "background" rate of heart-valve abnormalities. Its results, somewhat complex to interpret, will be presented at an AHA gathering in Orlando, Fla., and are likely to be used both by plaintiffs' attorneys attempting to prove the dangers of the drugs and by the drug companies attempting to minimize the safety risks. The researchers performed echocardiograms -- ultrasound imaging tests of the heart -- on 3,529 patients in the early 1990s. They found a large incidence of tiny problems -- about 10.5% of the population had some type of leaks in aortic valves and about 87% in the mitral valves. The mitral valve is a triangular piece of tissue that regulates blood flow between the two chambers within the left side of the heart. The aortic valve regulates blood flow between the left side of the heart and the arteries that bring blood to the rest of the body. Serious problems with the heart valves can lead to a shortened life. But only about 3.5% of the women and 6% of the men met the criteria the FDA used to classify aortic valves as "abnormal," said Emelia J. Benjamin, an author of the study. For mitral leaks, 1.1% of the women met the criteria and 1.5% of the men. In its survey, which primarily included women, the FDA found aortic leaks in 28% of diet-drug users, mitral leaks in 8% and either one or both leaks in 32%. Unlike the FDA, the Framingham researchers didn't count how many people had both, making an exact comparison to the 32% figure impossible. "There is still room for concern" about appetite-suppressant drugs, says Dr. Benjamin, a professor at Boston University School of Medicine who began the study as a matter of general interest before the heart-valve problems surfaced in diet-drug users. "But a lot of women are panicking, and this shows we need to let the dust settle first." Robert O'Neill, director of the FDA's office of epidemiology, said the Framingham study seems to support its request to recall the drugs -- showing a much lower incidence of valve problems in the general population than the agency found in diet-pill users. The FDA has said in the past that its own survey of 48 obese people who had never taken the appetite suppressants showed no abnormalities -- suggesting that the 32% rate in its survey was alarmingly high. American Home Products Corp., which sold both Redux and Pondimin, the two recalled drugs, declined comment, as did Interneuron Pharmaceuticals Inc., which developed Redux. The two drugs were taken by six million people in the U.S. Critics of the FDA decision immediately seized on the data as a victory, especially in light of a survey published last week by The Wall Street Journal, which found valve abnormalities in only 8% of 750 users of the drugs who were tested at 21 medical centers -- only a few percentage points higher than the Framingham findings in the normal population. "There was a media frenzy, and they pulled the drugs," says Morton Maxwell, an obesity specialist at the University of California, Los Angeles. But the Framingham study also casts doubt on the drug defenders' theory that any high incidence of valve abnormalities may have been related to users' underlying obesity, rather than being a side effect. Dr. Benjamin said her findings showed no general relationship between obesity and valve leakage, or regurgitation, and that "if anything, the more obese you were, the less regurgitation you had." Gerard Aurigemma, a cardiologist at the University of Massachusetts in Worcester, says the Framingham study is valuable because it looked at "a more appropriate" age range than did the Coronary Artery Risk Development in Young Adults study, a large survey cited by the FDA. The so-called Cardia study, which looked at people 23 to 35 years old, found a 1%-2% abnormality rate. In contrast, the people in the FDA sample of 291 patients that resulted in the drug recall had a median age of about 48. The average age in the Framingham study was about 55. Heart-valve problems tend to increase with age. - Copyright c 1997 Dow Jones & Company, Inc. All Rights Reserved.