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Executive Summary

An estimated "100 VNRs [video news releases] will be distributed this year promoting ethical drugs to consumers," Baruch College (New York) Assistant Professor of Marketing testified at the Senate Labor & Human Resources Committee's Dec. 11-12 drug marketing hearings. A former advertising and public relations executive, Secunda cited A.C. Nielsen figures indicating that "75% of the stations in this country now use [VNRs of all sorts] regularly on their news shows." Due to their proliferation, he suggested that they be required to identify their source of production and that VNRs concerning pharmaceuticals be precleared by FDA. Retired pharmaceutical industry executive David Jones described VNRs as one of the latest techniques used by pharmaceutical manufacturers to create public demand for Rx drug products. Jones agreed with Secunda that companies be "required to disclose prominently their sponsorship of all communications about prescription products." Committee Chairman Kennedy (D-Mass.) exploited Jones' experience at the Pharmaceutical Manufacturers Association, Marion, Ciba-Geigy and Abbott to provide the public with a rare opportunity to share an insider's view of the development of promotional/educational efforts to spur consumer demand. Jones noted that at Ciba-Geigy he was a "champion" of aggressive techniques of promoting. He cited several campaigns such as Ciba-Geigy's Transderm Scop promotions to the general public and Abbott's telling of the erythromycin/Legionnaire's Disease story as effective and useful educational campaigns which did not go beyond labeling and accepted use. Asked by Kennedy why such practices are so common in the industry, Jones explained that "the primary reason is that [the industry] simply stumbled across a technique that works brilliantly. It does work very well to create demand for both approved and unapproved uses." He urged Congress to "keep watching" the industry because "the new tools of creating demand are so powerful that their use will not be reformed easily." Describing the use of VNRs, Jones said they are disseminated to local television stations for use on medical news reports of news broadcasts. VNRs are "usually" prepared in two segments. "The first segment is maybe a 90-second, packaged medical news feature that can be aired as is. The announcer is never seen and has a generic, midwestern modulated voice so that it doesn't look like it was produced by somebody else." "The second track is frequently either raw footage that the local station can edit to put their own story together, or it contains everything ready for airing except the announcer's voice," Jones continued. "There are blank spaces and a written script for the local health reporter to read so that it looks like the local health reporter produced the story. The [recorded] experts always nod off-camera slightly, as if they're looking at someone. So the local station splices in their reporter, who [appears in the final product] nodding earnestly, as if they're conducting an interview with someone in Stockholm or Paris whom they've never met and will never meet." Jones appraised VNRs as "very good theatrical productions." Secunda noted that VNRs are attractive to local television stations which generally do not have adequate news budgets "to do all of their own original reporting and production. He added that they are attractive to advertisers, which are concerned "that television commercials are losing their ability to stimulate consumer sales." Because VNRs appear to be news broadcasts, viewers are "not as wary as they would be when watching commercials" and may be "more likely to pay close attention," Secunda pointed out. Pharmaceutical Manufacturers Association President Mossinghoff testified on the second day of the hearings that producers of VNRs cannot be responsible for how they are used by local television stations. How a VNR is used "is really up to the news organization," Mossinghoff said. "It's up to the station or the network how best to use it." That situation is similar to the description of press release materials prior to the Oraflex launch at the beginning of the last decade. At that point, FDA decided that it could hold companies responsible for their press materials if they appeared designed to mislead the news media. Jones also criticized the use of the financial media and medical journals by companies as a way around FDA approvals or peer reviews of studies and new indications. It is "very common," Jones said, for companies to write scientific papers for doctors under whose names the articles are published. "Doctors are very busy, particularly those who already have established some name. It's very common to have medical writers on staff within the company or to have a stable of freelance writers that you can hire, that can be brought in to draft an initial article for the investigator, work with the investigator to finish the article and then turn it over to the placement specialist within the company to prepare it for publication," he said. The firm can "decide on which publication is the most likely to consider it. If it's something like JAMA or the New England Journal of Medicine, that could take a while," he continued. Consequently, a firm "might make a marketing decision to get that message out there faster and target a more news-oriented magazine that will pick up the story more quickly. So it's a very sophisticated, well financed operation to assure that the doctors who are willing to help the company get their papers published." Jones divided physicians for hire into three categories: preachers, apostles and saints. "The preachers are eager to please and not hard to convince. Sales reps can always find a few when they are needed," he said. "The apostles are investigators who have published and want to publish more. They have to be recruited more carefully by company doctors because they have a reputation to protect, but they are often very willing to accept grants to do the work that a company wants and accept help to publish and speak," Jones continued. "The saints are the deans of their discipline and may let you come close if you contribute enough to their building fund." The choice as to which to select "depends on whether you want them on afternoon daytime talk shows or speaking to major medical meetings," he said. Asked by Kennedy how many doctors are working with drug companies, Jones suggested: "If you were to take a survey of the policy-making bodies of every major medical specialty in this country, you would find that every physician on those panels is a paid consultant to one or more drug companies. Their reach goes very, very far." Jones noted under questioning, however, that all doctors are likely "at least" to see the articles before publication. Many will provide a rough draft that the drug company ghostwriters will turn into finished copy. Using the example of an Abbott program to promote Tranxene (clorazepate) as a benzodiazepine without drowsiness side effects, Jones explained how the financial media can be used to go around medical journals. Abbott was tempted to promote the non-drowsiness claim based on the "colorful, computer-generated pictures" by a brain researcher studying fast and slow brain-waves. Jones noted that the researcher had used Tranxene in his studies and the pictures indicated that benzodiazepines "increase the fast and reduce the slow brain-wave activity." The company "wanted to get the message out as fast as possible to reach both the public and the medical profession," Jones told Kennedy. Abbott took the story to Forbes, he said. "They liked it. The article was headlines, 'Not a sedative, more an alert." The claim of a non-drowsiness action "would have been laughed out of the FDA," Jones said. He noted that Tranxene continues to carry the label reference to drowsiness. "The news media now is a major outlet, particularly when the message you're trying to distribute is a little questionable. If your message couldn't stand the scrutiny of the major medical meeting and the professionals who were in that audience, you just go straight to the news media, talking with local television health reporters. It's a major challenge for these people to know where the product comes from, who produced it, whether it's good, sound information based on good science or whether it's just hype." "It's a major industry. Almost every public relations agency, certainly that I'm familiar with, now has a whole department dedicated to medical public relations, to promoting drugs, devices" and health services."

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