To: Mkilloran who wrote (5758 ) 10/1/1998 12:43:00 AM From: Zebra 365 Read Replies (2) | Respond to of 9523
Die with a smile on your face, indeed. ABCNEWS.com abcnews.com . Hey guys, let's do a quick survey on Viagra, the super erection booster, which has now been on the market six months. So, how many of you out there who have regular trouble achieving an erection would be happy to risk death for one good shot at feeling bionic? You know, die with a huge smile on your face? Now, how many who have only a teeny bit of trouble (temporary performance or size anxiety) would risk dying with a smile on your face if you were assured Viagra would rid you of sexual failure? I'm asking these sensitive questions because, although some deaths have been possibly linked to Viagra, there's this idea making the rounds that some men are so macho even death means little if they can get their penis to feel like a stick of cement for a day. Risky Business? Let's not be shy about this and wither on the vine. If it makes you feel any better, let me assure you that I too have had temporary insecure feelings. But, let me quickly add, certainly not feelings to die for. On the chance that you're among those who joke about how wonderful it would be to die erect with a smile on your face, let's address the odds of this actually happening. After all, we joke about such delicate matters as death because we really don't think there's much of a chance it could happen to us. Let's take this one step at a time. At last count, the Food and Drug Administration had received reports of 69 possibly Viagra-related deaths in the United States. (Doctors have written upwards of 4.8 million prescriptions for the drug.) The agency and the drug's manufacturer, Pfizer, assure us that a cause and effect relationship is difficult to establish. That may be true, but what concerns me is that the FDA's system of monitoring drug side effects is woefully inept. The agency doesn't have a good mechanism for getting a quick handle on a drug's safety as use widens beyond initial limited testing. The FDA even admits that only a tiny fraction of side effects are detected and reported by doctors and drug companies. Labels Tell All—or Do They? Let's now turn to Viagra's labeling in the United States. Labels and package inserts provide crucial information for us, and especially for our doctors, about a drug's known risks. That helps us decide whether a drug like Viagra is worth it, no matter how handicapped we may feel sexually. For example, Viagra's labeling cautions against the concurrent use of nitrate drugs. It also notes that there's some degree of cardiac risk associated with sexual activity. Well, thank you, FDA and Pfizer for that detailed warning. Fortunately, on the basis of a scientific literature review, the American College of Cardiology and the American Heart Association have gone further , advising that Viagra is “potentially hazardous” to patients with insufficient blood flow to the heart, congestive heart failure and borderline low blood pressure. They also warn that people with high blood pressure who take more than one drug may be at risk, and that those taking medications like erythromycin or Cimetidine, or who have kidney or liver disease, should be wary of Viagra. In a petition to the FDA, the Washington-based Health Research Group reminds the agency, also on the basis of medical literature, that Viagra's labeling doesn't warn about animal studies showing the drug can cause severe blood-vessel inflammation. Even the FDA's own review flags this as a possible cause for concern. Trials and Error And why is it that Viagra's labeling doesn't inform us of medical conditions that excluded certain patients from the drug's pre-approval trials? Among those were people with liver problems, history of stroke, blood pressure of more than 170 over 100, and those who take aspirin or non-steroidal anti-inflammatory drugs (most for arthritis). And why doesn't Pfizer's prescribing information tell doctors there's no safety data on patients with bleeding disorders or active peptic ulcers? Makes a lot of sense, doesn't it? With certain medical reporters and doctors behaving like company flacks and presenting Viagra as a wonder drug for the masses, without much potential downside, little wonder that jokes abound about Viagra. From the start, we haven't gotten the information if we're to seriously consider taking this drug, or to respect it for better or worse. Die with a smile on your face, indeed. Nicholas Regush produces medical features for ABCNEWS. In the weeks ahead, he'll take an inside look at other trouble spots in medicine, herald some innovative achievements and analyze medical trends that will likely have great impacts on our lives. Have PFUN Zebra Disclosure: I am not short PFE at this time but have shorted it several times in the past 6 months.