VIAGRA SIDE EFFECTS: Good for Vivus? June 1st 1998, WSJ Interactive Viagra's Success Highlights Risks Of Sex to Those With Weak Hearts By NANCY ANN JEFFREY and ROCHELLE SHARPE Staff Reporters of THE WALL STREET JOURNAL As a million men have rushed to take the impotence pill Viagra in its just nine weeks on the market, the biggest drug craze since Prozac is spotlighting a new medical risk: Thousands of patients with severe heart disease are now able to resume intercourse, an intense physical exertion for such a vulnerable population. Since Pfizer Inc. began marketing Viagra in early April, the sex pill has breathed passion into the lives of countless couples long anguished by an inability to have sex. But its overnight popularity raises concern that the men who need it most are those least able to withstand the rigors of sex -- millions of men for whom impotence is merely a side effect of heart disease and other serious health problems. retrieve@1.cgi?id=SB896465566826354000.djm&template=doclink.tmplretrieve@1.cgi?id=SB896465566826354000.djm&template=doclink.tmplEU Drug Committee Recommends Viagra Be Made Available in Europe retrieve@1.cgi?id=SB896225855162583000.djm&template=doclink.tmplretrieve@1.cgi?id=SB896225855162583000.djm&template=doclink.tmplPfizer Probes Deaths Amid Gripes Over Lack of Viagra Guidance (May 27) retrieve@1.cgi?id=SB895858362196989500.djm&template=doclink.tmplretrieve@1.cgi?id=SB895858362196989500.djm&template=doclink.tmplPfizer Reports Six Deaths After Taking Impotence Drug (May 26) Of seven known deaths of men taking Viagra, five died of a stroke or heart attack during sex or shortly thereafter. All are believed to have had a history of heart disease or other cardiovascular problems. A sixth man died because of a bad combination with a nitrate drug commonly prescribed to heart patients. The cause of death in the seventh case is unresolved. This intersection of sex and death may pose a dilemma for doctors: Should they prescribe Viagra even to patients with the weakest hearts if these men demand it? "This is an ethical issue," says Richard Conti, chief of cardiology at the University of Florida College of Medicine in Gainesville, Fla., and past president of the American College of Cardiology. "Should we really be advising our patients who are at high risk to use Viagra just because they want to have sexual relations?" The university's Health Science Center in Jacksonville is investigating the death last month of a man in his 50s who went into cardiac arrest while having sex shortly after he took Viagra. He had a history of serious heart disease. The issue is at the forefront as almost 10,000 urologists from the U.S. and overseas gather in San Diego this week for the annual meeting of the American Urological Association. Attendance was up almost 50% from a year ago as urologists attended a standing-room-only session on impotence Sunday morning, taking breaks to trade the latest Viagra jokes and discuss the tradeoffs between sex and risk. The Pfizer sales booth at the San Diego Convention Center was brimming with dozens of doctors from China to Turkey to Argentina and other markets around the world where Viagra isn't yet sold but black-market pills can fetch $30 to $100 a pop. They lined up to get Viagra brochures, Viagra notepads in the shape of the pill itself, and lapel pins picturing Viagra tablets. A wall of Viagra video screens beckoned ("Natural response. Simple. Reliable. Effective."), and doctors begged for free samples. (None are available.) For American patients, the Viagra phenomenon is shaping up as an extraordinary real-life science experiment: What happens when a million men who had stopped having sex resume all of a sudden? The early results offer a reminder that sex brings problems as well as pleasure.
Sex and Cardiac Risk Sex increases the risk of a heart attack, but the risks remain low for both healthy and unhealthy men. Chances per million of a nonfatal heart attack in a 50-year-old male in any given hour: Healthy Male Male With Heart Disease Without sexual activity 1 10 With sexual activity 2.5 29  By comparison, the chances of a heart attack or stroke resulting from cardiac catheterization, a commonly administered heart test, are 1 in 1,000. Source: James Muller, director, Gill Heart Institute, University of Kentucky Medical Center, Lexington, Ky.
"VIAGRA-MONY," blared the banner headline in the New York Post after a Long Island woman sued her 10-year live-in mate for $2 million plus damages, charging that Viagra helped the 70-year-old man have sex for the first time in four years and that he left her, with pills in hand, two days later to move in with another woman. In this frenzy, few men clamoring for Viagra are eager to embrace such downers as any resulting heart risks. "I'm not worried. After sex, I feel better than before," says Murray, 59 years old, who lives in the Fort Lauderdale, Fla., area and has diabetes as well as occasional bouts of high blood pressure. He had been impotent for the past few years but, since starting on Viagra six weeks ago, he and his wife have resumed sexual relations at least once a week. Murray, who asked that his full name be withheld, joined a health club but never goes. He played an hour of tennis recently and thought he would collapse with exhaustion. But when he ponders the transformation from a virtually nonexistent sex life to nights on Viagra, a heart attack is the last thing on his mind. "I don't care about living forever," he says. "And I couldn't think of a better way to go." The advent of Viagra, doctors say, has sent thousands to the doctor's office for the first time in years, affording physicians the rare opportunity to catch long-undiagnosed problems of heart disease, diabetes, prostate cancer and other conditions that also cause impotency. Some 30 million American men are impotent, and serious cardiovascular problems are believed to be involved in more than 60% of the cases. It isn't known why these diseases render men unable to have sex, except that the impotence neutralizes a source of physical exertion that heart patients might be better off without. Science intervenes in the form of Viagra, returning prowess to men less able to bear it and restoring a source of physical activity that had long been absent. "This is the most activity some of these patients have had in years," says Stephen Auerbach, a urologist in Newport Beach, Calif. He says he won't prescribe Viagra to anyone who hasn't had an EKG in the past year. Viagra's label carries warnings aimed at cardiovascular patients. One cautions against combining Viagra with nitrate medications, the contraindication that has resulted in at least one death. On the drug's package insert, distributed to pharmacists and physicians, Pfizer also warns: "There is a degree of cardiac risk associated with sexual activity; therefore, physicians may wish to consider the cardiovascular status of their patients prior to initiating any treatment for erectile dysfunction." The question is whether doctors or patients will decide where to draw the line. "It's not that the pill is bad, it's that some doctors are prescribing it without a careful examination" to patients who shouldn't be on the drug, says Arnold Melman, president of the society for the study of impotence and an impotence specialist at Albert Einstein College of Medicine in New York. But a doctor who refuses also knows his patient could well get the drug from someone else, as ever more physicians jump on the Viagra craze. The urge to get hold of Viagra has added a new dimension of disinformation: sometimes patients lie. "I've literally yanked the prescription out of their hands because they lied to me," says urologist William Steers of the University of Virginia Medical School, who is presenting new research on Viagra's potency at the conference. He worries that his patients might fib about whether they take nitroglycerin tablets, which would put them at risk of death in taking both prescriptions. He calls their cardiologists while they sit in his office to double-check. The risk of a heart attack or stroke during sex arises in much the same way as it does during a run in the park. Typically, when a man has sex, his heartbeat races from 80 beats to 150 beats per minute, his blood pressure shoots up 66% to a systolic reading of 200, and his adrenaline increases threefold. The extra adrenaline can cause a blood clot, which can lead to a stroke or heart attack; the increased blood pressure can cause a blood vessel in the brain to burst, resulting in a stroke, says James Muller, director of the Gill Heart Institute of the University of Kentucky Medical Center in Lexington, Ky. To be sure, in heart patients the increased risk posed by sex is less than the risk of playing tennis, jogging or carrying firewood, Dr. Muller says. For a 50-year-old man with heart disease, the chances of having a nonfatal heart attack in an hour in which he has intercourse are close to 30 in one million, compared with a risk of 10 in a million for that same man in an hour when he isn't having sex. Add to that the possibilities of sudden cardiac death or stroke, and the chances that sex will induce a serious or deadly cardiovascular event rise to 90 in a million, still relatively low. But if a man is sedentary, that picture changes for the worse. Sedentary people who exert themselves increase their risk of heart attack 100-fold, so the chances of a nonfatal heart attack for a sedentary 50-year-old man with heart disease in the hour he has sex rise to three in 1,000. That is three times the risk involved in a cardiac catheterization, a common type of heart test, every time that man has sex. "People ought to think twice about that type of risk," Dr. Muller says.
Viagra side effects; good for Vivus? June 1st, 1998 Boom and Bust
By Alan Abelson What explosive times we live in! The fallout from those nuclear tests by both India and Pakistan is apt to prove extraordinary. Not the least of the consequences of those countries' demonstrated capability of blowing up each other -- and, in passing, a few billion other folks -- is certain to be an exponential rise in the number of people thronging the sidewalks with sandwich boards exhorting us to "Repent -- The End is Near." And we find that a truly annoying prospect. For one thing, the streets are crowded enough without an onslaught of wandering billboards. For another, if the end is near, we don't want to hear about it. Besides, instead of bugging us, why aren't they doing their shtick in New Delhi and Islamabad? This rather alarming view of what nukes in the hands of the Indians and Pakistanis portends has been very much encouraged by the profusion of dire prophecy leveled at us in the media. It was just about impossible last week to press the remote without a talking head filling the screen, enthusiastically expounding on the brilliant promise of planetary mayhem. Stay tuned. Speaking of Viagra, as we were tangentially a few paragraphs ago, on April 27, when the frenzy over Pfizer's impotence drug was at fever pitch and Pfizer shares were changing hands north of 118, we sounded a skeptical note, courtesy of a hedge-fund operator who loved the company and vouched for the product but thought the price of the stock was gaga. Since then, the shares have worked their way lower and closed Friday at 105. An inevitable exhaustion of speculative passion and disclosure of the death of six users of the pill (all of whom, let it be noted, were borne into the void wearing expressions of profound contentment) were among the chief depressants. A less frequently cited but nonetheless potent negative was the banning of the drug by Ho Chi Minh City in Vietnam. The city fathers alluded to public-health concerns in explaining their action, but the truth is, they're inveterately anti-fun (the last time they were seen smiling in public was when Saigon fell), and they may also have been slightly influenced by their reputed control of the local black market, on which Viagra fetches a 50% premium. Although down from their euphoric high of 121 3/4 , Pfizer's shares may still have a way to travel on the downside. That at least is the view of another savvy portfolio type we know who specializes in that amorphous area known as health care. We should say he also is a fan of the company and Viagra and bought long-time calls on the stock before it went ballistic (in July '97, to be precise). He hasn't sold, but he has thoroughly hedged his position. Our friend's caution is conditioned by nothing more complicated than a slowing in the impossibly torrid rate at which prescriptions were written for Viagra when it first hit the market. The total has declined from an astonishing 300,000 a week to 200,000, and the next set of figures revealing new prescriptions for the drug, he predicts, will evince a further drop of around 15%. His take on the trend is a decrease in "recreational" use (possibly reflecting a reconciliation of appetites with abilities). The decline, in any case, has left analysts confused (so, what's new?) and until they emerge into some more coherent state, he's convinced, the stock will remain under pressure. More specifically, he's looking for it to bottom out in the low 90s -- at which point he plans to unwind his hedge. With the market acting a little ragged, we decided it might be a propitious time to check in with David Tice, one of our favorite bears (and one of the few still standing). David puts out a service for professional portfolio managers dubbed Behind the Numbers, which accentuates the negative. Our timing turned out to be not as propitious as we thought -- we buzzed him on Thursday when the market was rallying -- and to our question as to how he was doing, he answered wryly that he would have been happier had we asked him a day or two earlier. The last time we quoted David in these columns was February 16, and the stock he panned was Micron Technology. It was 35 then and closed under 24 on Friday. So we decided, what the hey, let's try for another. Obliging as ever, David offered up as a short sale a Big Board company named Guidant Corp.
TA |