June 22, 2006

Graphic hepatitis C ads raise ethical qualms

By John Sullivan
Inquirer Staff Writer

As the head of liver transplantation at Thomas Jefferson University Hospital, Victor J. Navarro has seen many ailing patients with hepatitis C. But they don't look like the man in a half-page, color newspaper ad with a battered and bruised face, his eyes glassy.

"If Hep C was attacking your face instead of your liver, you'd do something about it," the ad reads. "Ready to fight back?"

While Navarro and other experts applaud the ads for raising interest in the viral disease, they think the campaign by drugmaker Hoffmann-La Roche Inc. could cause unnecessary alarm, in part because the vast majority of hepatitis C patients will not die of it.

"It's a marketing tool to make people fearful of hep C," Navarro said.

Roche's drugs, which are improvements over past medications, also work on only half of all patients, and cause considerable side effects. The campaign could leave those who cannot benefit believing they will wind up like the man in the ad.

The ad also is part of a larger marketing effort by Roche to quietly sponsor hep C seminars for the public and support patient groups and many liver physicians. Ethicists say the financing raises questions about whether the advice at such seminars can be objective.

Roche spokesman Mike Nelson said the company was simply trying to get out the word about the disease so more people can be helped. Nelson says nearly 600,000 hepatitis C patients have been diagnosed but haven't been treated, and may not know about the company's current market-leading options: Pegasys (interferon and an antiviral substance) and Copegus (an antiviral).

Nelson also said the ad was meant to be strong "to break through the clutter."

Roche said nearly 56 million people had seen the ad as of April, and more would see the ad in the coming weeks, part of a national blitz Roche launched last year in 250 newspapers, including The Inquirer and Philadelphia Daily News, and seven major magazines, such as Time. The ads also are plastered on 4,000 billboards and in 40,000 posters.

Roche officials would not disclose the cost of the campaign, which will run through July, but such large newspaper ads cost as much as $50,000 a day.

Leonard B. Seeff, who oversees hepatitis research at the National Institutes of Health, originally thought the ad came from an advocacy group.

"I think the ad is awful. Patients with hepatitis C do not look like that," said Seeff, who has been working on a study partly funded by Roche. "On the other hand, if you're trying to get the message across, one way is to make it look bad."

Seeff, who said his opinion did not reflect that of the NIH, said that he also was concerned because only a few people will die from hepatitis C.

"They mostly die from all kinds of things other than chronic liver disease," he said. "They should not think it's a death sentence."

Some doctors and advocates see a strong profit motive behind the campaign. "Ultimately it sells more of their drug," said Sidney M. Wolfe, director of Public Citizen's Health Research Group.

Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said it was not good policy for the United States to rely on companies to sponsor public-health campaigns. Such efforts tend to go to diseases for which companies have developed drugs, while other needy areas are ignored, he said.

Hepatitis C is a viral liver ailment that is the most common chronic blood-borne disease in the country.

The National Institutes of Health estimates that about four million people have hepatitis C in the United States. That number is expected to double in the coming decade as more people learn they are infected.

Many people got the disease from having received tainted blood or organs before adequate tests were developed in 1992. Most new cases are caused by intravenous drug use. A few contract the disease through high-risk sexual behavior, according to the Centers for Disease Control and Prevention.

Most people don't know they've been infected because the disease often doesn't cause symptoms for decades. The only way to confirm a diagnosis is to take a sample of the liver and examine it for scarring.

Only a fraction of those infected - from 1 percent to 5 percent - die of the disease. Yet it remains the No. 1 cause of liver transplants.

About 70 percent to 80 percent of those with the liver disease suffer from a stubborn genetic variant called genotype 1 that resists treatment.

The cocktail of antiviral drugs works in only 30 percent to 40 percent of those cases, and even less often in African Americans, according to the World Health Organization.

For the remaining 20 percent to 30 percent who have genotype 2 or 3, treatment works about 80 percent of the time. Averaging the two groups means that treatment only works in half the cases. Roche claims higher success rates.

While most insurance covers the therapy, uninsured patients must weigh that success rate against the cost, which can run up to $64,000 per year for some genotypes. The drugs are given several times a week, from 24 weeks to 48 weeks.

Still, hepatitis drug sales and advertising have been brisk. Over the last five years, drug company spending to advertise interferon, including Roche's drugs, has jumped from $14 million to $75 million. For Roche's Pegasys, ad spending rose from $30,000 in 2004 to more than $965,000 last year, according to Yardley, Pa.-based Verispan, which tracks pharmaceutical marketing.

The push has paid off. The company sold $1.4 billion worth of hepatitis C drugs, making it a top seller for the firm, according to its 2005 annual report.

Some hepatitis C activists, including those supported by the company, say the ads may seek to take advantage of a small window of opportunity. Roche now controls more than 60 percent of the hepatitis-therapy market, but that could change as other companies win approval for new antiviral treatments due out in coming years.

"We have been advising most people that they should probably wait for the next class of drugs," said Michael Ninburg, president of the National hepatitis C Advocacy Council, who heads the hepatitis Education Project in Seattle, which gets funding from Roche.

Also recommending that are HepTREC, a hepatitis education and support group started by Amy Jessop and a doctor and nurse at Temple University. Roche gave the group more than $250,000 in its first two years.

"I wish that there was public funding that we could turn to," said Jessop, who taught public health at Temple. "But the reality is there is no funding."

Earlier this year, about 15 people sat in a dimly lit auditorium at Graduate Hospital in Center City to hear a lecture on hepatitis C. Jessop told the group that Roche was a sponsor. She never promoted Roche products.

In the crowd sat Marc B. Saxe, a 46-year-old drug counselor from Philadelphia, who was diagnosed with hep C in 1998.

Saxe says he was "freaked out" by the diagnosis and went untreated until last year, about the time the Roche ad first appeared. It has worked, he said.

"I thought it was disgusting," he said of the ad. "But if it gets people to think about it, great."

"I just want to get fixed."

Hepatitis C At a Glance

About 3.9 million Americans are chronically infected with hepatitis C.

Prevalence rates are up to 8 percent to 10 percent of African Americans.

Dialysis patients, hemophiliacs, drug addicts and people transfused with blood before 1990 are particularly affected by the disease.

Injectable drug use remains the main route of transmission.

Sexual transmission is thought to be relatively infrequent.

Of every 100 people infected with hepatitis C:

About 55 to 85 people may develop long-term infection.

70 people might develop chronic liver disease.

5 to 20 people may develop cirrhosis over a period of 20 to 30 years.

1 to 5 people might die from the consequences of liver cancer or cirrhosis.

SOURCES: World Health Organization and the Centers for Disease Control and Prevention

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