VIAGRA: Should Be Covered, But Needs Tougher Warning

      Viagra is a "serious treatment," not a "recreational" or "lifestyle" drug, that HMOs should cover, a group of doctors, lawyers and activists recommended yesterday to the California Department of Corporations. "Erectile dysfunction is a serious medical condition with serious underlying causes. Viagra is a remarkable scientific breakthrough ... but it's lost in all the hype," said Dr. Mike Magee, senior medical advisor for Pfizer Inc., which makes Viagra. The AP/Contra Costa Times reports that the Department of Corporations, which oversees HMOs in the state, called the hearings to investigate whether Kaiser Permanente broke state law when it announced earlier this summer that it would not cover Viagra (Dearmond, 8/20). The Los Angeles Times reports that "[a] number of state legislators urged department Commissioner Dale Bonner earlier this month to take whatever action is necessary to prevent denial of care to HMO members based solely on their ability to pay" (Marquis, 8/21).

A Cause For Concern
      Julie Stewart, spokesperson for the department, said regulators were concerned because Kaiser "publicly admitted that it was not covering the drug because of its cost." Kaiser has since given other reasons for not covering Viagra. California law prohibits an HMO from denying medical treatment for financial reasons. "We feel there is going to be a dangerous precedent set if plans are allowed to do blanket denials. Plans can't hide behind a joke," said Stewart (AP/Contra Costa Times, 8/20). Magee also noted that the cost of Viagra is about one-third of that of other Food and Drug Administration-approved treatments for erectile dysfunction. He added, "Because Pfizer recognizes the complexity of reimbursement decisions over the need to manage medical costs, we have worked with plans that have developed reasonable limits on the number of pills reimbursed per month" (Pfizer release, 8/20). At a hearing on the same issue in San Francisco Tuesday, Kaiser's Dr. Sharon Levine testified, "There is no great threat to affordability, and therefore no greater threat to access, than the rapidly escalating costs of pharmaceuticals." She added, "Unless we develop a broad societal consensus about how to find a balance ... between the benefit derived and the cost incurred ... we risk undermining the very concept of an insured pharmacy benefit" (Los Angeles Times, 8/21).

It's An Outrage?
      Liz Helms of Citizens for the Right to Know said it was "outrageous and irresponsible" to not cover Viagra. Steven Cooper, an attorney representing plaintiffs who were denied Viagra coverage, said more restrictions are needed for preventing HMOs "from denying such claims based on an arbitrary definition of what is 'medically necessary.'" However, Dr. Cheryl Tanigawa, medical director for PacifiCare in Southern California, said, "We further believe that regulatory or legislative mandates for the coverage of new drugs will threaten pharmacy benefits for Californians." The HMO is currently making Viagra coverage decisions on a "case-by-case special approval process" (AP/Times, 8/21).

Health Hazard?
      Meanwhile, Public Citizen sent a letter yesterday to the Food and Drug Administration demanding that the agency "have an advisory committee review ... Viagra and add warnings about possible heart and circulatory problems to the drug's label, USA Today reports (Rubin, 8/21). The New York Times reports that the group's petition is in response to a joint American College of Cardiology and American Heart Association statement warning that Viagra is "potentially hazardous" to more people than previously reported (8/21). While patients taking nitrate drugs have always been warned not to use Viagra, the August 10 ACC/AHA statement said that "even heart patients who aren't on nitrates could experience problems" from also taking Viagra. USA Today reports that these patients include: "those with ischemia, or decreased blood flow to heart muscle"; "those with congestive heart failure, borderline low blood pressure and borderline low blood volume"; and "those on multiple drugs to lower their blood pressure." Dr. Adolph Hutter, co-chair of the task force that studied the issue, said the "problem is that exertion from sexual intercourse can cause heart patients who've taken Viagra to need nitrates for the first time." He said, "It doesn't mean that they can't use it, but the physician should evaluate those patients carefully" (8/21).

A Blue Picture
      In Public Citizen's review of the literature on Viagra, the consumer group said it "found several other possibly dangerous side effects that had not been made public," contending that these findings "are either not discussed or misrepresented in the FDA-approved labeling for Viagra." Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, said the FDA's review of Viagra "may be a cause for concern." Public Citizen alleges that Viagra's warning label doesn't mention periarteritis, or "severe inflammation of blood vessels" that was found in animal studies. The warnings also neglect to mention that vision problems more severe than the possible "blue" vision mentioned on the warning label could occur, claims Public Citizen. Wolfe said the way Viagra manipulates men's enzyme levels could "lead to rapid degeneration of the retina."

Response, Please
      FDA spokesperson Brad Stone said his agency had not fully analyzed Public Citizen's letter yet, but that "on the basis of the best data we have, we still believe that Viagra is a safe and effective drug when used as labeled" (New York Times, 8/21). Responding to Public Citizen's letter, Pfizer "notes that 3.5 million prescriptions have been written" for Viagra "and about 30 million tablets dispensed since FDA approval four months ago." In addition, "[d]ata collected since Viagra came on the market have not revealed any unexpected problems with the drug," Pfizer said (USA Today, 8/21).