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CIBA-GEIGY VOLTAREN KIDNEY DAMAGE CLAIMS

Executive Summary

CIBA-GEIGY VOLTAREN KIDNEY DAMAGE CLAIMS were revised April 1 in promotional materials to include a renal failure statement from the product's labeling. Physician advertising approved by FDA prior to the NSAID's launch in August 1988 had read: "No cases of renal failure were observed in 4,000 patients in clinical trials." FDA asked the company to add a cautionary phrase relating to postmarketing experience with Voltaren (diclofenac) to balance the trial results. The cautionary phrase, now being added to the promotional claim, states: "Cases of significant renal failure in patients receiving Voltaren have been reported from postmarketing experience." The revised Voltaren claim was alluded to by PBS TV documentary host Judy Woodruff as a tagline to the March 28 news show "Frontline." Woodruff ended the program, "Prescriptions for Profit," by saying: "One final note about Voltaren. While its safety record remains good, the FDA has recently criticized Ciba-Geigy for understating in its promotional materials the risk for kidney damage from Voltaren." The Voltaren postscript came at the end of a show that focused on the postmarketing side effect experiences with Lilly's Oraflex (benoxaprofen) and Johnson & Johnson's McNeil product Zomax (zomepirac sodium). NSAID marketing was the point of departure for the documentary's examination of what it described as increasingly aggressive promotional tactics used by drug firms to sell their products. Geigy's Voltaren promotion was a frame piece for the show. The opening segment focused on the company's use of baseball great Mickey Mantle as a celebrity spokesperson for Voltaren and the dramatic effect that that campaign had on the effort to build a niche for the product in U.S. NSAID market. The TV documentary portrayed the Mantle promotional swing as a way to promote the benefits of the arthritis drug without having to discuss its potential adverse effects. An FDA drug ad official was quoted as saying the celebrity endorsement is a way around current agency promotional regs (see box below). The Zomax segment repeated the claims of a Lubbock, Texas ex-detailman for McNeil about the escalation of the drug's marketing campaign after the first reports of anaphylaxis associated with the drug. Commenting on FDA's lack of access to information company detailmen provide doctors, FDA Office of Drug Standards Evaluation Director Peter Rheinstein, MD, told "Frontline": "Absent a whistleblower in the company or a fly on the wall, it's not clear to me how we could have access to information about selling techniques used within a company. We simply don't have the authority to go in and get that under most circumstances." In the rehash of the Oraflex introduction and Lilly's use of press releases to convey the image of the drug as a disease-modifying product, PBS showed pictures of regulatory letters from FDA to Lilly. The letters were signed by Jerome Halperin. Frontline did not point out the irony that Halperin is now a senior exec (in the consumer health business) with Ciba-Geigy. The Pharmaceutical Manufacturers Association (PMA) said it plans to draft a letter to "Frontline's" executive producer within the next couple weeks to respond to the program. PMA is beginning to collect comments from the companies mentioned or pictured in the show to get individual corporate responses and statements, a spokesperson said. PMA President Gerald Mossinghoff appeared on the "Frontline" program in an interview which showed him saying he would not discuss specific companies or specific promotional practices. Mossinghoff cited the antitrust restrictions on an association's involvement in pricing as part of the restraints on his comments. He also noted the competitive nature of the drug business and PMA member companies. FDA DRUG AD DIV. DIRECTOR FEATHER ON PBS TV "FRONTLINE," MARCH 28 Transcript of 'talking-head' shot with FDA Rx Drug Ad Division Director Ken Feather from TV documentary on NSAID promotions aired in Washington on March 28. FDAer Feather was asked about the propriety of using a celebrity to promote an Rx drug. He responded: " We think it's a way of getting around our regulations to some extent, an attempt to get around our regulations anyway. "It's just a rather cut-throat world out there now for the pharmaceutical industry."
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