The Vital Stick the FDA Must Have : Silicone controversy underscores need for subpoena power
Dow Corning, the besieged manufacturer of silicone breast implants, appointed Keith R. McKennon last week as its new chairman and chief executive, signaling the company’s recognition that it has a major “crisis of public perception” on its hands.
McKennon insists that his chief concern is not “damage control” but rather Dow’s “overriding responsibility to the women using silicone” implants. But McKennon’s soothing words ring hollow when one recalls that Dow stonewalled for weeks the Food and Drug Administration’s request to publicly release internal documents indicating that the company may have ignored warnings of some Dow scientists about implant safety. And they sound sadly familiar as well to the estimated 2 million women who used A.H. Robins Co.’s Dalkon Shield, an intrauterine birth control device during the 1970s and early 1980s.
THE MISSING TOOL: The pressures on the makers of drugs and medical devices to both make a profit and a safe product too often conflict. That’s why pending federal legislation designed to beef up the FDA’s ability to protect the public’s health and safety by giving the agency the power to subpoena company records is long overdue.
The FDA stands virtually alone among federal agencies in its lack of subpoena power. The Department of Agriculture, the Environmental Protection Agency, the Department of Transportation and the Federal Trade Commission all have subpoena power. Without it, the FDA’s only recourse has been to cajole drug companies into producing data. The agency does no testing of its own. It must depend on the companies to rigorously test their products and devices before seeking FDA approval. It must depend on them as well to tell the FDA about all possible risks associated with those products--in addition to their therapeutic benefits.
But too often, the agency and the public it serves have been disappointed. The FDA has not known of some of the risks of products it has approved for sale because the drug companies refused to tell and refused as well to heed the warnings of their own research scientists or of physicians prescribing those products.
THE OBVIOUS NEED: That’s what happened when scientists at A.H. Robins discovered that the Dalkon Shield’s unique string caused pelvic infection that could lead to sterility and possibly even death in many of the women who wore it. But Robins repeatedly quashed negative internal reports and effectively rebuffed the FDA’s efforts in the early 1970s to probe the intrauterine device’s safety.
And that may have been what happened in recent months with silicone implants. The FDA called for a voluntary moratorium on their sale and use last month after disclosure of confidential internal documents indicating that Dow may have ignored warnings of possible health risks. The FDA implant advisory panel is reviewing this new evidence and later this week will recommend to agency Commissioner David A. Kessler whether to make the moratorium permanent. Kessler is expected to make a final decision regarding silicone implants in coming weeks.
Arming the FDA with subpoena power will not guarantee that the nay-sayers within a drug company and the medical community will be heard, but it will increase the chance that they will.
Critics fear that subpoena power will allow the FDA to conduct “fishing expeditions” into company records. But companies concerned about unwarranted government investigations can seek protection in court. Reps. Henry A. Waxman (D-Los Angeles) and John D. Dingell (D-Michigan) have introduced legislation this term to give the FDA this power. The implant controversy should give that bill enough momentum to pass.
