Some patient-advocate witnesses at hearings paid by drugmakers

[JohnMack]

Source: Boston Globe

Drug firms' funding of advocates often escapes government scrutiny
Many patient groups depend on it, raising tricky ethical questions

By Diedtra Henderson, Globe Staff | March 18, 2007

WASHINGTON -- Elzora K. Brown could stand before a microphone and calmly describe the swath of devastation that cancer has cut through five generations of her family. Her great-grandmother, grandmother, mother, three sisters, and three nieces had breast cancer . And, at age 31 , Brown was diagnosed with the same kind of cancer.

"My own story is replicated in the lives of high-risk families across the globe," Brown told an audience of Food and Drug Administration advisers considering a controversial application to allow wider sales of silicon gel breast implants, " families who every single day quietly and patiently confront the ravages of breast cancer with far more courage and fortitude than I could ever muster and with far fewer resources than I have at my own disposal."

Brown's message about the need to reduce disproportionately high mortality rates among African-American women, like herself, resonated whether she was testifying before the FDA, addressing the nation's mayors, or speaking with members of Congress, where she was a staff assistant to former US House Majority Leader Jim Wright.

What few in Brown's audiences knew is that the patient advocate personally profited from her cancer-survival message, accepting funding from major pharmaceutical companies that produce cancer treatments, according to tax records.

Brown, 57 , wears a wig to conceal graying hair slowly growing back after she successfully fended off a second cancer; last June she underwent her final chemotherapy treatment for ovarian cancer. Through speaking engagements for the Breast Cancer Resource Committee, a patient-advocacy group Brown founded in 1989 , she highlighted the benefits of early cancer screening, offered a support group for African-American women, and called attention to the need for diversity among participants in clinical trials for new treatments. The efforts earned her dozens of awards, including one from the Washington, D.C., mayor for community service, and a presidential appointment to the National Cancer Advisory Board .

Patient advocates like Brown regularly testify at FDA public hearings, packing an emotional punch as advisers vote on controversial drug and device approvals.

Congress has homed in on examples of excessive compensation to managers of some nonprofits that underwrite what Senator Charles E. Grassley , Republican of Iowa , has derided as "champagne lifestyles." And others have targeted conflicts of interest that taint medical research and creep into FDA advisory panels. But little attention has been paid to smaller nonprofits, especially patient groups that are largely funded by the drug industry.

Public Citizen's Peter Lurie , who testifies frequently before FDA panels, noticed a shift as public hearings "were becoming contaminated by people who didn't represent the public in any way. They represented particular moneyed interests." Lurie, deputy director of the consumer advocacy organization's health research group, said, "It's a fair question: Who represents patients and how they come to call themselves" patient representatives?

In 221 advisory committee meetings scrutinized, 32 of 44 speakers representing patients said they had received funding from a company that would be affected by the FDA's decision, according to a recent journal article that Lurie co authored about conflicts of interest on FDA advisory panels.

While the FDA scours its advisers' backgrounds for such information, the agency does not require disclosures when patients testify.

Nor do drug makers highlight such ties.

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