|
|
CURRENT NEWS December 17, 1998 - Source: The Associated Press Senator Bob Dole for VIAGRA Mannequine Hoping to improve sales of its Viagra drug, Pfizer Inc. has hired former presidential contender Bob Dole for a television advertising campaign to raise awareness about impotence. The former Senate majority leader will participate in a series of public service activities, including speaking engagements and educational advertising that focus on impotence and men's health in general. Pfizer would not disclose how much it is paying Dole, who will not mention Viagra by name in the messages that will start early next year. The Dole ads mark Pfizer's first use of television advertising associated with Viagra. The company is weighing whether to use any ads that directly mention the product. Last May, Dole, 75, acknowledged he participated in the trials for Viagra, which he has called a ``a great drug.'' ``That's certainly got our attention,'' said Pfizer spokeswoman Marianne Caprino. ``I'm convinced this campaign can help men pay attention to health problems they might otherwise be afraid to discuss,'' Dole said in a statement. Viagra was the most successful introduction of a new prescription drug in history, but its sales have not kept up the early pace. The drug is expected to have sales of $800 million for the year, far below the $1 billion estimates analysts initially predicted. Since its introduction in April, more than 6 million Viagra prescriptions have been written. Pfizer had planned on launching direct to consumer ads on television for months. But that strategy was derailed last month when the federal government required to the company to add several new warnings to its label, provisions that also would have to be mentioned in any broadcast ads. Those new warnings include telling patients to be careful with the drug if they have a history of heart disease, blood pressure problems or certain eye disorders. Pfizer is not the first drug maker to launch a campaign about impotence. Vivus Inc., of Menlo Park Calif. and maker of Muse, hired actor Gavin MacLeod of ``Love Boat'' fame last year. Between 10 and 20 million men in the United States have impotence, but only about 10 percent of them receive treatment. Dole has appeared on talk shows and before Congress to promote early detection and treatment for prostate cancer and its common side effect, impotence. Dole was diagnosed with prostate cancer in 1991 and underwent surgery that doctors said rid him of the disease. December 12, 1998 - Source: Company press release Astra gains approval for MUSE across Europe MUSE, a new local therapy for the treatment of impotence (erectile dysfunction), was granted European Union mutual recognition approval on December 1. The product has so far been launched in five countries, including Sweden and the UK. A European study found MUSE to be effective in 64 percent of men with organic erectile dysfunction (impotence due to physical causes). A large US study also reported that MUSE is effective and well-tolerated. Swedish -based Astra has exclusive marketing and distribution rights to MUSE in Europe, Australia, New Zealand, South America and a number of other countries through an agreement with VIVUS Inc. from California. November 30, 1998 - Source: Company press release NO serious cardiovascular adverse events associated with the use of MUSE ``MUSE is a local treatment for a local problem. VIVUS' post-marketing surveillance program, which tracks reports of adverse events associated with commercial sales of MUSE® (alprostadil), confirms that there is no apparent increase in cardiovascular risk associated with the use of MUSE,'' said Dr. Al Spivack, VIVUS' Medical Safety Officer, a Clinical Professor of Medicine at Stanford University and a Fellow of the American College of Cardiology. MUSE Clinical Trial Data In prospective, double-blind, placebo-controlled Phase III clinical trials, 1,156 patients with severe, organic erectile dysfunction were randomized to home treatment with either MUSE or placebo for a three-month period. In the 564 men receiving MUSE, five serious cardiovascular adverse events occurred during the three-month double-blind period. Only one of these events in a patient with known pre-existing recurrent angina was ``possibly'' related to the use of MUSE. There were 2,875 occurrences of sexual intercourse. In the 592 men receiving placebo, 10 serious cardiovascular adverse events occurred during the three-month double-blind period. There were 500 occurrences of sexual intercourse. There were no deaths in either group. Three patients suffered myocardial infarction (heart attack); all three were in the placebo group, and these events were not related to sexual intercourse. November 25, 1998 - Sources: Various sources Death toll of Viagra rising: 242 FDA reported yesterday that 242 men have now died after having prescribed Viagra. Out of these, 130 are Americans. The death toll of non-Americans (55) sounds alarmingly high, given that Viagra has been in use, e.g., in Europe, only since mid-September. After more than two months' use in the USA, FDA reported only 16 deaths, as you have been able to read in our regular column Viagra Safety Online. FDA and Pfizer Inc. are advising doctors about new warnings and information in the product labeling for Viagra (sildenafil) in response to postmarketing reports of serious adverse events. The new information augments the original drug labeling which warned against the concomitant use of Viagra and nitrates. Revised in consultation with FDA, the new labeling is intended to help make sure that consumers and doctors are fully informed about the benefits and risks of using Viagra, know that consideration must be given to the cardiovascular status of patients prior to prescribing Viagra, and know how to safely use the drug. As with all approved drugs, there have been postmarketing reports of important side effects with Viagra. These have been reviewed carefully by FDA since Viagra's approval in April l998. Although a causal relationship cannot be established from these reports, they are being mentioned in the labeling. FDA typically requires manufacturers to update their labeling with such information. It is important to note that the postmarketing reports involving Viagra constitute only a small fraction of the more than six million prescriptions written for this drug. FDA continues to believe Viagra is safe and effective if used according to the updated labeling. The company is providing the updated information about the serious postmarketing events in a letter to health professionals. The labeling notes that it is not possible at present to determine whether the cardiovascular events are directly related to Viagra, to sexual activity, to the patient's underlying disease, or to a combination of these factors.
Information added to the labeling includes: November 11, 1998 - Sources: Reuters and CNN Add impotence to the list of smokers' ills Despite attempts by tobacco advertisers to make smoking appear sexy, scientists say its effect can be just the opposite - impotence. In a report broadcasted last Sunday on "60 Minutes", CBS News said a host of researchers and studies had found male smokers to suffer about twice as likely as nonsmokers some form of impotence. November 6, 1998 - Source: PR Newswire Innovation, focus and new drugs to sustain Pfizer's growth into the 21st century By the end of the year, Pfizer will have completed its evolution from a group of diverse businesses into a company focused exclusively on prescription and self-medication pharmaceuticals for humans and animals, William C. Steere, Jr., chairman and chief executive officer of Pfizer Inc, said today. "We've never been more clearly focused as a pharmaceutical company," Mr. Steere told about 300 financial analysts, reporters and guests at a meeting held at the company's headquarters, "and on our goal of becoming number one in our industry." He noted that the Pfizer core businesses have never been stronger, citing the "unrivaled strength of our current and ever-expanding product line." "Our product portfolio is young, strong and growing," he said. "Earlier in the decade, we launched six products in six years. We are now conducting clinical-development programs that could potentially lead to the launches of eight products in three years-- - with more to come." This year Pfizer introduced two new products: Trovan, a broad-spectrum antibiotic, and Viagra, a treatment for erectile dysfunction. Trovan, launched in February, is already among the top 10 most-prescribed brand-name antibiotics. Viagra, on the market for 6 months, has surpassed every record for a successful launch of a new drug. "Today we stand on the threshold of a golden age of science," he continued. "Thanks to genomic mapping and our increased understanding of the way enzymes and proteins function, we're beginning to comprehend the process of disease itself. Tremendous opportunities lie before us." Other Pfizer officials addressing the meeting said sales of Viagra had "plateaued" in the United States after the drug's April launch, but remained strong. They also disclosed that priapism - or persistent erection - had been seen in small number of Viagra patients and that a warning about that possible risk will be added to the pill's package insert. November 5, 1998 - Source: Reuters Singapore approves Viagra; sales in Russia uncertain The Singapore Ministry of Health said on Friday it had approved the sale of the anti-impotenc drug Viagra produced by U.S. drug maker Pfizer Inc. It said in a statement it "has decided to take a cautious approach towards its introduction into Singapore." The initial registration of the drug would be valid for six months after which a re-evaluation would be conducted, it said. Doctors in Singapore would be required to keep a separate dispensing record for the drug, it added. Meanwhile in Russia... Pfizer Inc. said Thursday sales of its hit impotency drug Viagra were uncertain in Russia due to its flagging economy. "Economic realities here are going to have a certain effect, but we hope that, as word spreads, sales will pick up," said Robert Marshall, head of New York-based Pfizer's Russian office. The drug was officially launched in Russia on Wednesday after a one-month delay which Pfizer attributed to the effects of the economic crisis. Many banks saw their activities suspended, leading to interruptions in imports of goods, including pharmaceuticals. About $1 million worth of Viagra has been imported into Russia, but Marshall said the economy was still too unstable to allow predictions on future sales. Some Russian medical professionals at a symposium on the drug's launch said Russian "muzhiki," or "real men," may have trouble confessing to a need for the little blue pill, even if they can afford it. Pfizer officials said they were hoping to boost sales of the drug by getting it included on a list of vital medications that the government would pay for when prescribed to patients. November 4, 1998 - Source: CNN More and more women are turning to Viagra The popular impotence drug for men, Viagra, has been on the market for seven months. But now, thousands of women with sexual problems are also taking the little blue diamond. According to Pfizer, the drug's manufacturer, Viagra has been prescribed for some 150 000 women. Viagra works for both men and women by increasing the blood flow to the genitals. Women need this blood flow, just as men do, to achieve sexual arousal. Dr. Irwin Goldstein, the principal investigator for Viagra clinical research program, said he and his colleagues at Boston University Medical Center have not yet done a Viagra study with women, but says they have prescribed the drug to some 50 female patients. He said it has worked for most of them. "It has shown evidence of enhanced lubrication, less pain, more arousal, less problems with orgasm", Goldstein said. The Food and Drug Administration has not yet approved Viagra for women, but doctors can prescribe it for both sexes. Goldstein said there's no reason to think the side effects, such as headaches and temporary visual problems, will be any different than in men. Viagra for men and women can be deadly if taken with heart medicine containing nitrates. It will be next year before Pfizer releases its results of studies with women and Viagra. Meanwhile, other pharmaceutical companies are investigating other treatments for women with sexual problems. October 29, 1998 - Source: American Journal of Hypertension Two blood pressure drugs linked to impotence Two drugs commonly prescribed to treat high blood pressure -- lisinopril and atenolol -- appear to cause sexual dysfunction in men. Although lisinopril seems to do this only temporarily, atenolol may have a more lasting effect, Italian researchers report in the October issue of the American Journal of Hypertension. Previous research findings have suggested that the class of high blood pressure drugs known as beta-blockers -- which includes atenolol -- can cause sexual dysfunction in men. Some findings have also suggested that a different class of drugs called angiotensin converting enzyme (ACE) inhibitors -- such as lisinopril -- are not usually associated with such sexual impairment. But these findings have not been as clear or consistent as researchers would like. To clarify, Dr. Roberto Fogari and colleagues at the University of Pavia, Italy, studied 90 men, ages 40 to 49, who were married and sexually active, had no previous problems with sexual dysfunction, and had recently been diagnosed with high blood pressure. The men took a placebo (inactive pill) for 4 weeks, then either lisinopril or atenolol for 16 weeks. After that, they took a placebo for another 4 weeks, and then switched over to the drug they had not taken earlier for 16 weeks. After they started taking the placebo for the first time, the men reported having sexual intercourse less frequently. This drop-off may have been "a consequence of psychologic factors related to the diagnosis of hypertension and the need for drug treatment," Fogari and colleagues speculate. The men reported a further decline in sexual activity the first 4 weeks they took either atenolol or lisinopril, "perhaps related again to psychologic factors or to blood pressure lowering itself," the researchers write. "During the first month of (drug) therapy, sexual activity... significantly declined with both (drugs)," the researchers write. But with ongoing treatment, sexual activity "tended toward recovery in the lisinopril... but not in the atenolol group." These findings suggest that the decline in sexual activity seen among those taking atenolol was due to the drug's "pharmacologic mechanisms," the researchers write. October 28, 1998 - Source: Reuters Pfizer Hires Britannia to Promote Viagra Pfizer, the maker of Viagra, has hired the former royal yacht Britannia for a promotional launch of the anti-impotence drug. The yacht, now a tourist attraction in Scotland, played host to four royal honeymoons during its 44-year career. All four ended in divorde. The Britannia, given a £2.5m refit before being opened to tourists at Leith Docks in Edinburgh earlier this month, also plays host to business functions. Viagra's maker, Pfizer Inc. has hired the yacht for a promotional launch for the drug in Britain. "We are more than happy to have the firm on board", said a spokesman for the yacht's new Scottish owners. Buckingham Palace declined to comment on the yacht's new use. October 28, 1998 - Source: The Dallas Morning News Report: Airline Pilots Warned About Use of Viagra Airline pilots are being warned that Viagra can impair the ability to distinguish between blue and green, colors frequently used in cockpit instrument displays and taxiway lights at airports, The Dallas Morning News reported yesterday. Officials with the Federal Aviation Administration say flight doctors are being urged to tell pilots not to fly within six hours after a dose of the impotence treatment drug. "Although only 3 percent of all patients report visual disturbances, this blue-green impairment could be dangerous", while flying at night or in bad weather, said Air Force Dr. Donato Borillo, who wrote about the subject in the Fall edition of the Federal Air Surgeon's Medical Bulletin. In addition to problem with colors, "full attention to the instrument scan and the task at hand may be compromised", Dr. Borillo wrote.
|
