FDA advisory panel chair pulls out of conference amid ethics flap

By Toni Clarke

WASHINGTON (Reuters) - The chairwoman of an advisory panel to the U.S. Food and Drug Administration said she will withdraw from a drug industry conference after the consumer rights group Public Citizen leveled conflict-of-interest allegations against her.

Dr. Lynn Drake, a lecturer at Harvard Medical School and current chairwoman of the panel that advises the FDA on drugs to treat skin and eye conditions, was scheduled to speak in February at a conference whose aim, according to its brochure, is to help companies "walk away with strategies to successfully present before a committee and avoid potential roadblocks."

In a letter sent on Thursday to FDA Commissioner Margaret Hamburg, Dr. Sidney Wolfe, founder of Public Citizen's Health Research Group, called on the agency to either require that Drake not attend the meeting or remove her from her position as chairwoman of the Dermatologic and Ophthalmic Drugs Advisory Committee.

FDA advisory committees exist to give the agency an independent assessment of a company's application to market a new drug. Different committees specialize in different disease areas. Committee members are provided with background documentation and clinical trial data and asked to help the agency determine whether the benefit of a proposed product outweighs its risks.

The FDA is not bound to follow the advice of its committees, but almost always does so. For drug companies, millions or billions of dollars can ride on an advisory committee's recommendation, which more often than not determines whether a drug will be approved.

Reached by telephone, Drake said she had not fully understood the nature of the meeting, which is being organized by CBI, a company that arranges conferences for the pharmaceutical industry and charges companies up to $2,199 to attend.

"It was my understanding that this was an educational program," she said, adding that she was neither offered nor asked for payment beyond her expenses. "I believe there is value in educating the industry."

What she did not expect was that her name and photograph would be used to promote the event for profit. She said she had not seen the brochure before being contacted by the FDA following the Public Citizen letter. When she did see it, she said, "I gasped!"

"Had I been privy to this document I would never have approved it," she said, adding that she will withdraw from the event.

CBI did not immediately respond to a request for comment left after hours.

Wolfe said Drake's agreement to participate in the conference showed poor judgment and "raises concerns that the advisory committee member is approaching the work of the committee from a pro-industry perspective."

Drake said she asked the FDA ahead of time if the agency had any objection to her attendance. The FDA confirmed that it was asked and did not object but said its response was based on limited information.

"It appears that Dr. Drake was not given a full understanding by the conference organizers of how she and her role at this conference would be characterized, and such a portrayal was inconsistent with what she had agreed to," the FDA said in a statement.

"Dr. Drake has provided strong leadership and guidance to the agency," it added. "We look forward to continuing to work with her."

Drake's presentation, titled "Pitfalls to Avoid as You Prepare for, and Present to, an Advisory Committee," was scheduled for February 7. She would, according to the conference brochure, tell her audience about "mistakes she has seen first-hand that she wishes the sponsoring companies had avoided."

Wolfe, who served on the FDA's Drug Safety and Risk Management Advisory Committee from 2008 to 2012, said he does not remember reading or hearing that the FDA has any explicit policy on advisory committee members' participation in such conferences.

"It is urgent that the FDA develop and articulate a written policy applicable to all advisory committee members to avoid repetition of this type of shameful episode, which could undermine public confidence in FDA advisory committees and in the agency itself," he said.

The FDA said it provides all advisory committee members annual ethics training, which outlines specific standards, including not using their public position for private gain.

Wolfe also drew attention to Drake's curriculum vitae, which is posted on the FDA's website and which he said contains 32 items that are redacted under an exemption designed to protect trade secrets and other confidential business information. He said he has made a Freedom of Information request for an unredacted copy of the CV, "because the full CV may further elucidate Drake's background and relationship with the pharmaceutical industry."

Drake said there is nothing in her resume that she would be afraid to show anyone. The FDA said it routinely redacts the CVs of advisory committee members to remove personal information and identifiers such as phone numbers, email or home address.

(Editing by Eric Walsh and Ken Wills)

Source: http://news.yahoo.com/fda-advisory-panel-chair-pulls-conference-amid-ethics-000747317--finance.html
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