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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: Edderd who wrote (7675)	5/4/1998 9:42:00 AM
From: E'Lane	Read Replies (1) \| Respond to of 23519

Business Week Cover Story...not as "blue blinded" as other media. 2 Excepts... Business Week: May 11, 1998 Cover Story: COMMENTARY COMMENTARY: IS THIS PRESCRIPTION NECESSARY? The list of things that money can't buy has just shrunk by one. Now, millions of men who suffer from impotence have a $10 pill. It's a great day for medicine, not to mention male self-esteem. But for health insurers, Viagra raises difficult questions. Should they reimburse patients for Viagra pills? If so, are five pills a month enough? Or 30? Do 95-year-olds qualify? What if a patient is only a little impaired? Should it matter if his impairment has psychological roots--and what he mainly needs is psychotherapy? Sex is not what makes Viagra complicated. There are similar questions about mood drugs like Zoloft and Prozac, diet drugs, memory drugs, and growth hormones. For each, the issue is whether insurers--and by extension, society at large--must pay for drugs even if some patients taking them are not severely impaired but simply want to improve their lives. As modern medicine spits out more and more miracle drugs, these questions will grow in urgency. THINK TANK. Let's start with a basic principle: In general, insurers should pay for treatments, not for enhancements. This distinction was made by Tufts University philosopher Norman Daniels, a medical ethics expert. The terminology became a touchstone for a recently completed study by The Hastings Center in Garrison, N.Y., called On the Prospect of Technologies Aimed at the Enhancement of Human Capacities and Traits. With $140,000 from the National Endowment for the Humanities, the ethics center spent two years thrashing out the issue with 20 leading thinkers from law, philosophy, sociology, and medicine. It's easiest to understand the treatment vs. enhancement distinction with an example. Let's say two boys are candidates for growth hormone therapy because their full-grown height without treatment would be 5 feet 3 inches. The one whose shortness is caused by a brain tumor would qualify for reimbursement. The one who had short parents would not--for him, the therapy would be deemed an enhancement. That intellectual framework could help quell the chaos over Viagra. Cigna Healthcare says that until it sets a permanent policy, it will reimburse for just six pills a month--and only for ''a preexisting, documented condition of organic impotence, which is currently being treated by other medical means.'' Kaiser Permanente probably won't limit the number of pills, but is leaning toward reimbursing only 50% of the cost. And so on. Limits on reimbursement may seem arbitrary and unfair. But making tough calls is better than providing blanket coverage for unlimited usage at an enormous cost to policyholders--or going in the opposite direction and denying coverage for ''lifestyle'' drugs entirely. That would penalize people who truly suffer from dysfunction. And it would divide society by ensuring that only rich people could correct their sexual dysfunctions, treat their depression, combat their obesity, improve their memory, and raise tall children. The treatment vs. enhancement distinction isn't perfect. It opens up the perplexing question of how to define normality: How bad does your sexual function--or your memory, or obesity--have to be before you're considered impaired? And there's the honesty question: Insurers could try to duck out of paying for treatments by construing them as enhancements, while many patients would persuade their doctors to write prescriptions for drugs they don't absolutely need. Scott-Levin, a Newtown (Pa.) health-care consultancy, says over 90% of patients' requests for depression treatments like Zoloft and Prozac are honored by their physicians. While it's not the cleanest of distinctions, treatment vs. enhancement is a starting point for a much needed debate on who pays for what. The excitement over Viagra may be just the thing to get that debate rolling. By Peter Coy

To: Edderd who wrote (7675)	5/4/1998 9:51:00 AM
From: E'Lane	Read Replies (3) \| Respond to of 23519

Now where have we heard Viagra compared to Phen-fen before?? I still think that the lawyers are going to have a field day with this drug. If you just scan this article (sorry, it is long) be sure to read the last paragraph. Good summation... Business Week: May 11, 1998 Cover Story DANGER: READ THE LABEL Doctors are prescribing drugs for unapproved uses--and patients are at risk The thousands of men who are demanding Viagra from their doctors because they think it will enhance an already well-functioning libido might do well to think back on fen-phen. That's the combination of two obesity drugs, fenfluramine and phentermine, that diet clinics were prescribing to almost anyone who asked over the past few years, even though they had never been approved as a combination treatment. Nor were they O.K.'d as a diet aid for the slightly overweight. Then, last summer, researchers at the Mayo Clinic reported that some women taking the combination suffered serious damage to their heart valves--at least six required open-heart surgery--and fenfluramine was pulled off the market. Like fen-phen, Viagra is also being widely prescribed for uses other than the male impotence it was approved for. No one knows, however, what might happen if millions of sexually healthy men start taking the drug over a long period. It's even more worrisome if women start taking it--the drug has never been rigorously tested for them. The rush for Viagra highlights a troubling medical practice: Once the Food & Drug Administration approves a drug, doctors can prescribe it any way they see fit. It's called off-label prescribing, because the prescriptions are being written for diseases that aren't indicated on the label. The FDA has virtually no control over off-label prescriptions. In fact, 27 states have laws requiring that insurers pay for such prescriptions when given for life-threatening diseases. It's true that off-label prescriptions are often beneficial. Because few clinical trials are conducted using children, many drugs are not approved for kids, but pediatricians still prescribe them on the assumption that they've been proven safe. Then there are the discoveries, often during large clinical trials, that an already approved drug is effective against another disease. The FDA usually expedites approval for such additional uses, but doctors need not wait. Medical experts worry, however, that far too many off-label prescriptions are written without the science to back them up. Perhaps the most glaring example is the huge amount of antibiotics--up to one-fifth of all prescriptions, according to one study--that are uselessly handed out to cold sufferers. Colds are caused by viruses, and antibiotics simply do not work against viruses. By taking them, patients only contribute to the increase in antibiotic-resistant bacteria, a major health crisis. Still, doctors report that patients regularly demand antibiotics for colds--and they acquiesce. Off-label prescribing is likely to increase, because of a federal law passed in December that lets drugmakers promote unapproved uses directly to doctors if they can back up their claims with a published study. ''We think being able to selectively pick out an article and send it to 300,000 doctors is a bad idea,'' says Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, a watchdog organization in Washington. ''For that matter, it's a bad idea to engage in massive use of any drug off-label in the absence of clear data.'' HALCION DAZE. Wolfe can back up his point with plenty of examples beyond fen-phen (table). Take Halcion, a sleeping pill that has been banned in Britain but not in the U.S. The drug has been shown to increase aggressive behavior and psychosis if taken for more than 7 to 10 days. But an FDA study in 1996 found that 85% of Halcion prescriptions were for longer periods. The FDA does have some control over how an approved drug is promoted, and doctors are required to report any adverse effects to the agency. ''We have a provision that allows us to put in the label a warning about off-label use if that is causing a major health risk,'' says Dr. Murray M. Lumpkin, deputy director for the FDA's Center for Drug Evaluation & Research. But, he adds, ''it doesn't happen that frequently.'' In the case of Viagra, the FDA issued plenty of material on the drug's risks, which include headaches, blackouts, and vision problems. But it has no way of knowing how many doctors are passing on those warnings. Patients, though, might think back to fen-phen before reaching for a drug to spice up their sex lives. They may discover down the road that it was just not worth the risk. By Catherine Arnst in New York

To: Edderd who wrote (7675)	5/5/1998 10:15:00 AM
From: DaiS	Read Replies (3) \| Respond to of 23519

Ed, It appears you are a physician - how well does muse really work? I looked at some abstracts that I could get hold of, but not those you mention for the forthcoming AUA meeting. My impression is that very roughly, caverject: 50% hard erection with 80% sufficient for intercourse muse: 10% hard erection with 50% sufficient for intercourse but you say muse is 70% effective if used properly - does this mean that the silly joke about putting bait in the fishes mouth is not so silly after all? Is it possible that those studies reporting scientific results with a negative slant for muse are carried out by physicians who don't know how to (or don't want to!) teach the muse technique properly? However it does seem to me from what evidence is available that injecting is much more efficient - which is not so surprising. It seems that the dose inserted in the penis with muse is 10x higher than that injected to be effective. Have you really heard that there is an M2 on the way with improved uptake of drug from urethra? Is the urethral burning pain reported caused by the high dose of alprostadil used? Why not recommend to users prone to pain that they take a painkiller or drink of alcohol before use? What about a bit of local anaesthetic squirted in the urethra. In general, do you know whether Vivus are attempting to research these problems. Even though injection is efficient I read that it is not so popular (though the IMS sales figures for caverject are not that far behind muse). I heard that many men don't like injecting themselves, and their wives/partners don't like to do it for them. Also, is it true that the rapid erection achieved with injection is actually a turn off for wives - they feel they haven't caused it themselves? One defender of muse suggested that it was more a 'facilitator' giving that extra boost towards an erection sufficient for intercourse. Has there been switching from caverject to muse, then back again? Should we buy a few shares in Pharmacia or a few more in Vivus? Dai