Mark McClellan, M.D., Ph.D.
Commissioner, Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. McClellan:
As you know, on October 14 and 15 the General and Plastic Surgery Advisory Panel met to consider the approval of Inamed’s silicone gel-filled breast implants. During the financial conflict of interest statement read by FDA’s Dr. Krause at the beginning of the meeting, the relationship between FDA advisory committee member Dr. Michael Miller, his institution (M.D. Anderson) and Inamed Aesthetics was cryptically alluded to. It was merely stated that the FDA “took into consideration certain matters regarding Dr. Miller.” According to the transcripts of the panel meeting, the FDA determined that Dr. Miller could fully participate in the proceedings because he had “reported his institution’s past and current involvement with firms at hand.”
I am writing to ask that the Food and Drug Administration (FDA) immediately investigate and fully disclose to the public the details and nature of the relationship between Dr. Miller, M.D. Anderson and Inamed, since there has been an apparent violation of FDA’s own Guidance requiring such disclosure at the beginning of advisory committee meetings.
- Was the FDA was made aware, prior to the meeting, of the details of the relationship between Dr. Miller, M.D. Anderson and Inamed Aesthetics? Was the agency aware that Dr. Miller was the lead “Project Director” in the development of a CD-ROM (copyright 2002) entitled, “Breast Reconstruction: What you Need to Know”? According to the M.D. Anderson website, the project was conceptualized by Dr. Miller and received funding from Inamed. The CD-ROM confirms that it was made with “major funding” from Inamed and includes a video of Dr. Miller making statements that breast implants are indeed “safe.” It thus appears that Dr. Miller had a clear, unequivocal relationship with the Inamed-funded project as an individual and not simply through his affiliation with M.D. Anderson, as was stated in the disclosure made during the panel meeting. In the video, Dr. Miller states that there was “great confusion” about breast implant safety in the 1990’s but that previous and ongoing studies showing that implants “do not cause disorders such as cancer or autoimmune disease” make him “confident that breast implants are safe”. Contrary to Dr. Miller’s remarks in the Inamed-sponsored CD-ROM, ongoing NIH research has linked women with certain genetic types with susceptibility to the autoimmune disease polymyositis if they have breast implants. Moreover, the issue of whether they are safe or not in other respects was the main topic of the advisory committee meeting, a subject on which it appears that Dr. Miller already made up his mind.
- If the FDA was made fully aware of the relationship between Dr. Miller, M. D. Anderson and Inamed through this project, why did the agency fail to disclose these kinds of details, including the amount of money involved, as had been done in a previous meeting of the same committee? If it was made aware, why did it allow Dr. Miller to participate, even becoming a ring leader for approval, in the meeting resulting in a vote favoring the approval of Inamed silicone gel-filled breast implants last month?
- If Dr. Miller did not disclose all of this information to the FDA, including the amount of money given by Inamed to M.D. Anderson, the fact that he was the project director and the fact that he had already made up his mind about his “confidence” in the the safety of implants as expressed in the Inamed-funded CD-ROM, what actions will the FDA take regarding the consideration of approval of silicone breast implants by this panel, heavily influenced by Dr. Miller, and what will be done about Dr. Miller’s future participation on this panel?
I strongly urge the FDA to address these concerns and make full public disclosure of the details of the relationship between M.D. Anderson, Dr. Miller and Inamed Aesthetics prior to making a final decision on approval of silicone gel-filled breast implants. The failure to do this would make a mockery out of the issue of conflict of interest and would trivialize its impact on decision making. Whether or not direct cash was paid to Miller, he is employed by an institution that received “major funding” to produce a CD-ROM under the directorship of Dr. Miller and featuring him concerning the safety of breast implants. It is highly likely that other advisory committee members may have had a different view of Dr. Miller’s enthusiasm concerning breast implant safety had they been aware of this conflict of interest. This should surely affect the FDA’s consideration of the advisory committee’s vote that was so significantly influenced by Dr. Miller’s support for approval.
Sidney M. Wolfe, M.D.
Public Citizen’s Health Research Group
 The FDA Guidance on Conflicts of Interest for advisory committee members states that disclosure into the record at the beginning of the meeting must be sufficient to “adequately enable a reasonable person to understand the nature of the conflict and the degree to which it could be expected to influence the recommendations the SGE [special government employee, in this case advisory committee member] will make.” Contracts and grants to the employer of the SGE must be disclosed. Guidance can be found at: (http://www.fda.gov/oc/guidance/advisorycommittee.html)
 Love LA, Weiner SR, Vasey F, Crofford LJ, Oddis CV, Starr MR, Bridges AJ, Targoff, IN, Gurley RC, Miller FW. Clinical and Immunogenetic features of women who develop myositis after silicone implants. Athritis Rheum 1992;35:S46. (Abstract of still ongoing research)
 In a meeting of this same advisory committee in July 2002, the following was read into the record concerning an advisory committee member: “..involves a contract to his employer and his consulting services with a competing technology firm. His employer receives funding between $100,000.00 and $300,000.00 per year on the contract that is unrelated to today’s agenda.” This large institutional contract was, in sharp contrast to the Inamed-M.D. Anderson grant, “unrelated” to the agenda of the advisory committee meeting and yet the financial details were disclosed.