Date: Wed, 29 Mar 2000 11:03:52 -0700

To: Recipient List Suppressed:;

An article titled Rezulin's Swift Approval, Slow Removal Raise Issues (1) dated 3/23/00 by David Williams, (LA Times Staff Writer) describes the FDA’s hesitancy to withdraw Rezulin from the U.S. Market. Based on this and several other articles describing the FDA’s attitude regarding public safety, I believe we have a very serious problem with this agency, its leadership, and the decisions they are currently making. I encourage you and the Times’ investigative staff to discover what is causing this cavalier behavior. It needs to be stopped immediately.

The article goes on to state, "When Graham and at least four other FDA physicians concluded at an internal agency meeting on Jan. 6 that Rezulin should be promptly withdrawn, Woodcock and her deputy, Dr. Murray M. Lumpkin, again held firm in their support of Rezulin. " This steadfast denial of serious medical evidence raises several questions in my mind. Is it possible that these two are on the payroll, or have received previous funding/payments from Warner Lambert? Could we have a conflict of interest in this crucial agency?

Even Rep. Henry A. Waxman (D-Los Angeles), and a member of the Congress Commerce Committee which oversees the FDA said, "But this whole experience leaves a lot of questions about how FDA conducts [its] whole drug-approval process. " So who will answer these questions? Who will report these answers to the American public?

If true, these facts demonstrate a blantant disregard for scientic evidence, as well as post market surveillance. Similar problems exist in other current and past FDA applications as well as their management of the breast implant situation.

The General and Plastic Surgery Devices Panel of the FDA met on March 1-3 this year (2), to provide advice and recommendations to the agency for 3 premarket approval applications (PMA’s) for the ongoing sale and use of Saline Breast Implants. To date, all breast implants are still in the approval process by the FDA. None have ever been found safe and effective by the FDA for their intended use.

One of these applications was denied because the data were incomplete. The other two were recommended for conditional approval by this panel. The following are excerpts from the FDA’s summary report of this meeting. (2) "The cumulative rate of a first occurrence of any complication was 43% for augmentation patients and 73% for reconstruction patients at 3 years as assessed by Kaplan-Meier statistical analyses. The panel voted 9 to 1 to recommend approvable with conditions. The conditions included a requirement that Mentor Corporation work with FDA to complete and update the mechanical testing, that Mentor continue to collect long-term follow-up data, that Mentor perform further statistical analyses of the data, and that all efforts be made to fully inform patients of all potential risks associated with the use of breast implants." (This sounds like Dr. Woodcock’s attitude that all dangers can be handled by safety-labeling.)

"The four-year cumulative rate of a first occurrence of a complication was 60% for the augmentation patients and 84% for the reconstruction patients by Kaplan-Meier analyses. The panel voted unanimously to recommend approval with conditions for this PMA. Some of the conditions were that the sponsor continue long-term follow-up, to revise the risk characterization in reconstruction, and to include literature information"

Please help us understand this. The FDA panel is recommending, and the FDA is likely to approve, the surgical use of two state-of-the-art implant devices, which when tested to FDA guidelines for up to four years, average greater than a 50% complication rate in the best case scenario and over 78% for their intended application (breast reconstruction for mastectomy patients). I wouldn’t even buy tires for my own car if I new to expect these type of results! Do you sincerely believe that hundreds of thousands of young women are going under the knife for elective surgeries with this knowledge? I don’t either, because their plastic surgeons will not tell them the truth.

The FDA’s attitude is better labeling. In the case of medicines and breast implants, these labels are called package inserts. I would be willing to bet that fewer than 5% of all breast implant recipients (since the inception of implants) have ever seen the package insert that accompanies their device. So what good does it do to require better labeling by the manufacturers, until every plastic surgeon in all 50 states is required by law to provide this label prior to surgery, as part of a federally mandated ‘Informed Consent"? Currently, informed consent to surgery is state mandated.

Do implants cause connective tissue disease? Who cares! Hundreds of studies have been published on this topic with the same conclusion, more research is needed. Well its time that the FDA quit using hundreds of thousands of young and ill women as human guinea pigs on this issue. Is it safe to breast feed with implants? No one knows because there has never been a peer reviewed study published on this issue.

The bottom line is simple. Breast implants are not safe and have never been proven safe in over 37 years of human testing. Yet our FDA wants the testing to continue after being told by the manufacturers themselves that there is an up to an 84% failure rate after only 4 years. This has to stop!

Dan Buck

430 N. Broadway

Redondo Beach, CA 90277

310-798-1963

1. http://www.fda.gov/cdrh/gpsdp.html#030100