Catherine Richert: July 13, 2005
The Senate health committee is investigating potential financial conflicts among members of an FDA advisory committee panel that recently recommended the agency allow silicone breast implants back on the market. The probe may be a sign of what is to come for other advisory panels as the committee’s spokesperson says chairman Michael Enzi (R-WY) considers potential conflicts of interest a serious matter and is not ruling out further investigations.
The breast implant advisory panel recommended in April on a five-to-four vote that Mentor Corp’s silicone implant be approved. Consumer advocates point to the panel as an example of what they believe is biased advice that FDA often gets from the outside experts who are supposed to be an objective source of information to help the agency make tough decisions on the products the agency regulates.
At issue are the number of plastic surgeons who sat on the panel and recommended the Mentor product for approval. Waivers are typically granted to those who could financially gain from the approval of a product or have money invested in the company making the product.
For instance, Michael Miller, a voting member of the panel and plastic surgeon, is reported to be a consultant for Inamed. Inamed makes a breast implant that the same advisory panel in April recommended not be allowed on the market.
The health committee’s probe comes as Senate and House lawmakers separately are pushing legislation that would effectively prevent FDA from appointing advisory panel members that have financial ties to the products in question. In recent weeks, advisory panel members, consumer and patient advocates, and even some at FDA have questioned the safety of silicone implants.
Enzi will not hold a hearing or introduce legislation on conflicts-of-interest before the August recess, but spokesman Craig Orfield does not rule out future action by the committee.
Barbara Brenner of Breast Cancer Action was contacted June 29 by a health committee investigator, asking her what she knew about conflict-of-interest issues on FDA panels in general.
“These are really critical questions, especially when the public and lawmakers start asking them,” Brenner said.
Other officials involved in the breast implant issue contacted by FDA Week say that they were also asked about depositions that two former Mentor employees gave in 2003. The employees said the company hid information from FDA about defective implants that were prone to rupture.
The health committee investigation was prompted by a letter, sent to Congress soon after the advisory’s committee’s Mentor decision, calling for lawmakers to look into the matter. The letter was signed by Command Trust Network, The National Research Center for Women and Families, In the Know, National Organization for Women, National Women’s Health Network, and Our Bodies, Ourselves.
The groups urged the committee to address seven questions, including why the advisory committee recommended Mentor’s product for approval even though in the groups’ view the manufacturer presented questionable and incomplete data, how the agency chose advisory committee members, and why other sources of rupture data were not provided in the advisory committee hearing.
Enzi and health committee ranking Democrat Edward Kennedy (MA) are not the only lawmakers looking into financial conflicts among FDA advisory panels.
Last month, Rep. Maurice Hinchey (D-NY) attached an amendment to the fiscal year 2006 FDA spending bill that would prohibit advisory panels with members who have received waivers from receiving federal funds. Sen. Richard Durbin (D-IL) says he will try to attach a similar provision to the Senate’s version of the spending bill, a Durbin spokesperson says.
FDA also is conducting its own conflict-of-interest probe.
In March, four senators asked the HHS Inspector General’s office to look into conflicts-of-interest on advisory panels, citing a 2003 breast implant committee as well as the COX-2 safety committee that met in early 2005 as two panels that had members with strong financial ties to the products in question.
In response to a request by Senate Democrats Barbara Boxer (CA), Dianne Feinstein (CA), Mary Landrieu (LA) and Debbie Stabenow (MI), HHS asked FDA’s chief counsel Gerald Masoudi to evaluate the need for a formal IG investigation.
FDA would not comment on the status of Masoudi’s work.
Silicone implants have been off the market since the early nineties when FDA began questioning their safety, but they are sometimes used in reconstructive surgery.
July 12 was FDA’s deadline to make a decision on Mentor’s implant approval. At press time, the agency had not made its decision. — Catharine Richert
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