Viagra Gains Some Advocates As Treatment For Lung Disease Diane Adkins, who has a life-threatening lung disease, used to take a drug that cost more than $100,000 a year and that had to be pumped round the clock into a vein through a hole in her chest. Now she has replaced it with a pill that costs about $10,000 a year. But her insurance company will not pay for the cheaper drug, even though it paid for the more expensive one. As the company explained in a letter, ''Your benefit program covers this medication for men over the age of eighteen (18) only.'' The drug is Viagra. Wisecracks aside, the blue pill that treats erectile dysfunction, a common but less than fatal male malady, may have a new role in treating pulmonary hypertension, a rare but deadly disease that afflicts mainly women. Results of a clinical trial in India, published this week in The Journal of the American College of Cardiology, showed that Viagra increased the ability of patients to exercise by about 40 percent. The authors said that was greater than the effect seen with other drugs in different trials. Although the trial involved only 22 patients, it was the first randomized test to compare Viagra against a placebo for pulmonary hypertension, the journal said. Pfizer, the manufacturer of Viagra, said it expected results of its own much larger and more definitive trial around the middle of the year. Investigators expect to present results at the American Heart Association's annual meeting in November. But because doctors are allowed to prescribe a drug for any use, once it wins regulatory approval, some are already using Viagra for pulmonary hypertension. The drug is even being given to babies. ''I thought it was a joke,'' said Drew Walen of Nashville, recalling his reaction when a doctor told him to give the drug daily to his infant son, George, whose lungs did not develop properly because of a congenital problem. Pulmonary hypertension is different from hypertension, the common condition of high blood pressure. The pulmonary disease involves extremely high pressure in the artery that carries blood from the heart to the lungs to pick up oxygen. The disease, also called pulmonary arterial hypertension, can make even routine tasks an ordeal.
Cialis and Levitra They began: "Remember that guy who used to be called 'Wild Thing'? The guy who wanted to spend the entire honeymoon indoors? Remember the one who couldn't resist a little mischief? Yeah, that guy. He's back." At that point, the ends of the blue V from the Viagra brand logo rose behind the man's head like a pair of devil horns; that image has also appeared in the print ads, which have run in newspapers and magazines. The language made it clear that "Viagra is intended for sex," Mr. Stone said, and thus the campaign improperly omitted information about the drug's approved purpose and side effects. A spokesman for Pfizer in New York, Daniel J. Watts, said the company "will comply with the F.D.A. directive" and "end the ads in this form." He said he was "not sure whether anything will replace them right away." The campaign was the first work created by a new agency handling Viagra ads aimed at consumers, McCann Erickson Worldwide in New York, part of the McCann Worldgroup division of the Interpublic Group of Companies. A spokesman for McCann, Stewart Alter, referred questions to Pfizer. The campaign is part of efforts by Pfizer to maintain Viagra's lead in the market for erectile dysfunction treatments in the face of intense competition from two new prescription drugs, Cialis and Levitra.
F.D.A. Criticizes Viagra Ads F.D.A. Criticizes Viagra Ads, Prompting Pfizer to Halt Them New advertising for Viagra that depicts men who take it as devilish drew criticism from the Food and Drug Administration, leading its maker, Pfizer, to say yesterday that it would discontinue the campaign. The dispute is indicative of the give-and-take involved in the F.D.A.'s administering of rules covering the advertising of prescription drugs directly to consumers. The campaign, composed of television commercials and print ads that began appearing in August, mentioned the Viagra brand name but did not describe the condition it is meant to treat, erectile dysfunction. Such pitches, known as reminder ads, are not required to disclose side effects or include other disclaimers that appear in ads mentioning a specific treatment along with a brand name. Brad Stone, a spokesman for the F.D.A. in Rockville, Md., said that in a letter sent to Pfizer last Wednesday, the agency contended that language used in the campaign "crossed the threshold into making what could be considered a drug claim," which would have required the disclaimers. The F.D.A.'s division of drug marketing, advertising and communications objected to the language at the start of the commercials, Mr. Stone said.
