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Divided Loyalties?
Nonprofit Health Advocacy Groups Like to Portray Themselves as Patients' Allies. Can They Serve Corporate Benefactors at the Same Time?

By Tinker Ready
Special to The Washington Post
Tuesday, February 7, 2006

Diabetes patients anxious to weigh the pros and cons of an experimental diabetes drug called muraglitazar might expect some help from the American Diabetes Association (ADA). But they won't find much on the ADA Web site.

For example, there is no information about research linking the drug to possible increased risk of fatal heart problems. Also, the Web site has yet to report that the Food and Drug Administration (FDA) approved the drug only on the condition that its maker, Bristol-Meyers Squibb -- which last year donated more than $1 million to the ADA -- produce additional safety data first. The diabetes group acknowledges financial support from the drug maker in its annual report and on a Web page called "Corporate Health Ambassador Case Study," but not the precise amount of the donation.

Similarly, if patients have questions on drugs for bone loss, they might think the National Osteoporosis Foundation (NOF) would help sort things out. But the NOF Web site doesn't get into the scientific debate over the long-term effects of Fosamax, the most popular osteoporosis drug on the market. Merck, the maker of Fosamax, is a longtime NOF donor, and it's named in NOF's annual report. But the organization does not disclose how much it gets from Merck and other supporters.

In general, groups like the NOF and the ADA don't raise alarms about drug safety -- even for drugs made by non-donors. The groups portray themselves as advocates rather than watchdogs, committed to improving awareness of the diseases and raising funds to develop cures and preventive measures. But some consumer groups say these nonprofit organizations sometimes put their corporate sponsors' interests ahead of their patients'.

Amy Tenderich, a blogger who created the Diabetesmine.com Web site, said she shares with many diabetes patients a hunger for information on new treatments. "You want to know what's coming. Is it safe? Is it going to save my life?" she said.

Even though she thinks the ADA is an important resource for diabetics, she is cautious about getting drug news from the organization.

"Those of us in the diabetes community also disseminating information take everything the ADA says with a grain of salt," she said. "It is clear that the organization . . . is very careful not to step on the toes of its supporters and the advertisers in its magazines."

The ADA says it didn't go into detail on muraglitazar's safety because it doesn't have access to the clinical data; the NOF says it restricted its Fosamax information to what was available from the FDA. Both groups say their policies are not influenced by their corporate partners. At the same time, they court sponsors with a promise of increased access.

For example, a statement on the ADA Web site reads, "At ADA, we strive for new and ongoing relationships that not only provide goodwill but also make good business sense for the companies that work with us." Reads another statement, "Companies find American Diabetes Association (ADA) sponsorships and cause-marketing programs to be effective in amplifying their message and increasing their reach to consumers."

Marc Boutin, vice president of the National Health Council, an advocacy group that includes nonprofits and drug companies, says the patient-oriented groups haven't sold out; they just see their priorities differently from watchdog groups. They know their constituents -- people with chronic diseases -- care not just about drug safety but also about access to potentially effective drugs, even those that carry serious risks.

"We know all prescription drugs are not going to work as they are intended and that there is going to be a risk for some people," Boutin said. "The challenge is: How do we balance that risk with the need for drugs right now? . . . I don't think the industry [donations have] any impact on this."

Each year, the makers of drugs and medical devices donate millions of dollars to disease-related nonprofits. The groups are not required to disclose details of their corporate funding, and most release only limited information, typically in annual reports and at sponsored events. In such cases, they generally report contributions within dollar ranges -- acknowledging donors, for example, that give between $50,000 and $100,000.

At the ADA -- which reported raising and spending more than $200 million last year -- the most generous donors give $1 million or more. That group includes Eli Lilly, AstraZeneca and Novo Nordisk -- all companies working on new drugs for diabetes. The NOF reported revenues of about $6.3 million in its 2004 annual report.

Some groups' Web sites feature the names of their corporate donors, but often these names appear only in an annual report. Exact donation amounts are rarely listed, though some groups are willing to provide numbers on request.

People who look to these groups for independent information may never learn about their financial ties to drug makers. That needs to change, say some consumer advocates, now that nonprofits are playing a larger role in drug safety debates. When disease advocacy groups weigh in on a drug up for review by the FDA's Drug Safety and Risk Management Advisory Committee, they say, the public may be unaware of potential conflicts of interest.

During his recent two-year term on the committee, Wake Forest University health sciences researcher Curt Furberg frequently heard testimony from disease advocacy groups. Unlike other speakers, he said, spokesmen for the groups do not identify their potential conflicts of interest at these meetings. But Furberg said they often sound like they represent drug companies.

Typically, he said, the groups will present a patient to testify that a drug with emerging safety problems changed his life for the better.

"I don't doubt that," Furberg said. "But it is interesting that there was no widow at the hearing who says, 'My husband took these drugs and he had a heart attack and died and it changed my life.' It's not balanced. . . . My sense it that one point of view is missing -- the bad news."

Boutin and others argue that the disease advocacy groups are not in industry's pocket: Drug company money accounts for a relatively small part of most groups' budgets, he said. Plus, he added, most groups have guidelines to deal with any conflicts of interest these relationships might create.

Thomas Moore, a drug safety analyst at George Washington University Medical Center, isn't convinced that the guidelines are working.

"The whole system is unbalanced because there aren't any skeptical advocates out there," he said.

Who's Your Daddy?

Industry funding of medical research has been on the rise since Congress passed a 1980 law encouraging additional collaboration between industry and academic scientists. Concerns about this trend have prompted a move toward greater transparency. Rather than restrict such alliances -- which supporters say encourage innovation -- journals, universities and government panels now routinely require scientists to disclose potential conflicts of interest, including funding from drug companies.

So when a researcher writes a journal article, he often notes his industry supporters. But when Robert Lindsay, director of the clinical research center at Helen Hayes Hospital in New York, spoke as NOF president from 1992 to 1999, no such disclosure was required. (The NOF lists corporate donors -- including osteoporosis drug makers Aventis and Eli Lilly--in its annual report, but not specific amounts.)

As recently as 10 years ago, osteoporosis was an under-recognized and under-treated disease, says Cindy Pearson, director of the National Women's Health Network. Now the opposite is true, says Pearson, whose Washington-based advocacy group doesn't accept industry funding: More younger women are being tested and treated -- sometimes unnecessarily, she says -- for a pre-condition called osteopenia.

"I'm not ready to say that NOF is a front group," she said, "but this is a real issue. The continued over-promotion of the disease seems more about marketing than women's health needs."

The NOF supports an aggressive approach to bone density screening and treatment. Some medical experts advocate more conservative, targeted testing. But NOF treatment guidelines have not been revised.

Women who are diagnosed with low bone density often are prescribed the bone loss drug Fosamax, made by long-time NOF supporter Merck. Fosamax sales rose from $1.3 billion in 2000 to $3.2 billion in 2004.

Lindsay, now a member of the group's board of trustees, said bone density testing needs to be more targeted and NOF guidelines updated -- much more is known about bone strength today than when the guidelines were written in 1999. But he disagreed that industry funding impacts NOF policies.

"I was president of the organization for seven years and I never thought industry tried to pressure us to do anything that was inappropriate," he said. Judith Cranford, NOF's executive director, agreed.

Still, when preliminary evidence emerged last March that long-term use of some osteoporosis drugs -- including Fosamax -- may weaken bones, this news was never posted on the NOF Web site. In deciding what to post, "what we do is follow the FDA recommendations and information," said Cranford. The FDA has so far said nothing about the safety question.

When her doctor prescribed Fosamax for her osteopenia several years ago, Sammy Stevens, a 63-year-old high school Spanish teacher, went to the NOF Web site for information.

After taking hormone replacement therapy for many years, she wanted to make sure Fosamax was not another drug with potential safety problems.

"When I looked for information [on the site] about Fosamax, I always reached a dead end," said Stevens, who lives in Broken Arrow, Okla.

Stevens, who communicates with osteoporosis patients all over the world via Internet bulletin boards, never considered the group's funding sources. "I sort of thought they were funded by the government," she said.

Common Interests

The ADA also offered little detail when worrisome information recently surfaced about a pending diabetes drug.

In October, researchers from the Cleveland Clinic reported in the Journal of the American Medical Association that muraglitazar -- the first in a promising new class of drugs that could reduce both blood fat and blood sugar -- was linked to a rise in heart attacks and strokes. The ADA took note in a short piece it posted temporarily on its Web site, but the story did not come up in a recent search on the site for "muraglitazar."

Like the NOF, the American Diabetes Association generally does not get involved in drug safety debates.

"No one in our arena does, because we don't have the data to know whether something is safe or not," said Richard Kahn, the ADA's scientific officer. In the case of muraglitazar, a drug not yet on the market, he said, the organization had to defer to the FDA because the agency has access to all of the company's clinical data.

"An article appears that says the drug has an unfavorable profile, but [the drug] is not approved." He said. "For consumers of the world, it's moot. And we can't weigh in on that debate because we don't have the data," Kahn said.

The ADA does present information on experimental drugs, but usually in the context of an abstract or press release from the group's annual scientific meeting.

When an approved diabetes drug comes under scrutiny, the ADA will sometimes offer guidance to physicians, Kahn said. "But our organizations are not in a position to make factual statements about whether a universe of people should not take a drug or should take a drug."

Some diabetes activists feel that's an appropriate response. Jeff Hitchcock, creator of the "Children with Diabetes" Web site, says the FDA -- not the ADA -- should monitor drug safety. As a disease advocate, he sees industry as a welcome partner.

"It is industry that has advanced diabetes care over the years, not advocacy or research organizations," he said. At the same time, he agreed more candor about industry ties might answer critics' worry about conflicts of interest.

"Perhaps fuller disclosure might mitigate that," Hitchcock said.

For their part, health advocacy groups see this as unnecessary. The way they see it, the interests of patients sometimes overlap with those of drug makers. "They are living with these diseases and they are living with these prescription drugs," said Boutin of the National Health Council. "They're in a pretty good place to decide where this balance ought to be. I don't think it has anything to do with the companies." ยท

Tinker Ready is a freelance writer in the Boston area. Research for this story was supported in part by the Fund for Investigative Journalism. Comments:health@washpost.com.

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