pharmaceuticals

Daniel Troy served as chief counsel for the U.S. Food and Drug Administration from 2001 to 2004. Starting September 2, 2008, he will head counsel for the pharmaceutical company GlaxoSmithKline. It shouldn't be a surprising hire. Before his stint with the FDA, Troy "fought the agency on behalf of the right to use medical-journal articles to suggest off-label uses for drugs and medical devices." He was also an active litigator who worked against consumer interests. "Representing the Washington Legal Foundation, an industry-supported business think tank, Mr. Troy argued for the protection of commercial speech ... . He was also part of the winning team representing Brown & Williamson in a suit against the FDA regarding tobacco advertising." His tenure with the FDA did not change his priorities. He was known to be a loyal friend of the very industries the regulatory agency is charged with monitoring. "Under Mr. Troy, the agency began filing amicus briefs opposing lawsuits against drug and medical-device makers, saying that having met the FDA's approval and labeling standards, manufacturers should be protected from state-based suits for damages." His hiring by GSK is just another example of the revolving door between government and industry. GSK's spin is that "His wealth of experience in the regulatory legislative area will be of enormous benefit to us, and ultimately to patients."

The Swiss drug company Roche has been suspended from the Association of the British Pharmaceutical Industry (ABPI) after adverse findings over its promotion of the weight-loss drug Xenical. The Prescription Medicines Code of Practice Authority, the body created by ABPI to handle complaints over its self-regulatory code of conduct, found that an agreement by Roche to invest £55,000 in a weight loss clinic that would prescribe the company's drug "brought discredit upon, and reduced confidence in, the pharmaceutical industry." The authority also found that by selling Xenical to the clinic owner, who posed as a pharmacist, Roche "had sold a prescription only medicine to a member of the public." The complaint was brought by Ryta Kuzel, the former head of UK regulatory affairs for Roche, who argues that she was fired because the company feared she would blow the whistle on the Xenical scandal.

"The Center for Medicine in the Public Interest, a recently created front group for pharmaceutical interests, has been churning out industry-funded propaganda that demonizes evidence-based medicine, universal health care, the government, and all critics of pharma while attempting to portray industry as a selfless provider of cures and education," write Norman Kelley and Adriane Fugh-Berman. CMPI's Peter J. Pitts has written opinion pieces for publications including the New York Times and Wall Street Journal, which fail to mention that Pitts is a senior vice president at Manning, Selvage and Lee (MS&L), a leading PR firm for the pharmaceutical industry.

As CMD recently reported, the Pharmaceutical Research and Manufacturers of America, or PhRMA, have instituted a voluntary, and therefore unenforceable, code to guide drug makers' relationships with doctors. Now, thanks to pressure from Congress, most notably by Senator Charles Grassley, the American Psychiatric Association (APA) needs to respond to concerns about the influence drug company money has on the association and its members. "In 2006, the latest year for which numbers are available, the drug industry accounted for about 30 percent of the association's $62.5 million in financing." There are serious questions about the association's leadership as well. "One of the doctors named by Mr. Grassley is the association’s president-elect, Dr. Alan F. Schatzberg of Stanford, whose $4.8 million stock holdings in a drug development company raised the senator’s concern." The New York Times analyzed Minnesota data from last year on drug company funding of doctors, finding that "on average, psychiatrists who received at least $5,000 from makers of newer-generation antipsychotic drugs appear to have written three times as many prescriptions to children for the drugs as psychiatrists who received less money or none."

Listen to this week's edition of the "Weekly Radio Spin," the Center for Media and Democracy's audio report on the stories behind the news. This week, we look at Dick Cheney's red pen, drug companies' new code and a match made in PR heaven. In "Six Degrees of Spin and Fakin'," we look at Montel Williams' pharma gig. The Weekly Radio Spin is freely available for personal and broadcast use. Podcasters can subscribe to the XML feed on www.prwatch.org/audio or via iTunes. If you air the Weekly Radio Spin on your radio station, please email us at editor@prwatch.org to let us know. Thanks!

The Pharmaceutical Research and Manufacturers of America (PhRMA) has announced a ban on giving branded items to doctors. The pens, notepads, mugs and other gifts are ubiquitous in medical offices. Some, like Senator Herb Kohl, think it is a step in the right direction. "We've been pushing to see reforms like this for some time now. Consumers will undoubtedly be the beneficiaries of these industry changes." But the voluntary code does nothing to stem the more egregious ways that drug companies influence doctors, including speaking fees and lavish "educational" events. Kohl has co-sponsored a bill to require drug and medical device companies to publicly disclose payments to doctors of $500 or more, but does not ban them. Industry watchdogs are not convinced. One complained that "It strikes me as an attempt to persuade people against doing anything that's serious." The industry’s new policy, the Code on Interactions with Health Care Professionals, "will ask the chief executives of large drug makers to certify in writing that 'they have policies and procedures in place to foster compliance with the code.'" But because it is voluntary, there will be no accountability or regulation. Former U.S. Representative Billy Tauzin now heads PhRMA. Tauzin said, "This updated code fortifies our companies' commitment to ensure their medicines are marketed in a manner that benefits patients and enhances the practice of medicine." CMD staffer Anne Landman recently wrote about the perils of letting industries self-regulate.

The U.S. Food and Drug Administration (FDA) approved Merck's human papillomavirus (HPV) vaccine Gardasil for the U.S. market in June 2006. As CMD previously reported at length, Merck launched an aggressive PR and advertising campaign to support Gardasil, even before the FDA approval, aware that GlaxoSmithKline had a competing vaccine in the wings. But GSK's Cervarix vaccine has hit snags in the U.S. In December, GSK was told that the FDA would not approve the application without further information. While recent guesses put a Cervarix entry into the U.S. market in 2009, The Financial Times is now reporting that "GSK said it had decided to await completion of a pivotal clinical trial to be filed with the US regulator during the first half of next year." This will push FDA approval well into 2010. Cervarix has been approved for sale in 67 countries and the BBC recently reported that the U.K. has chosen Cervarix over Gardasil for its HPV vaccination program.

Eli Lilly has been fined A$60,000 for issuing a media release promoting a version of its erectile dysfunction drug Cialis despite an Australian ban on direct-to-consumer advertising. In April Eli Lilly released Cialis Once-a-Day. To coincide with its launch, the company issued a media release headlined "New research reveals scheduled sex a turn-off," which promoting the results of a Lilly-commissioned opinion poll. The poll claimed that 74 per cent of Australian men said "spontaneity ... is an important part of sex." The Australian Consumers Association and Dr. Ken Harvey lodged complaints under the self-regulatory code of conduct operated by the drug industry's peak body, Medicines Australia. The Australian's health editor, Adam Creswell, reports that the minutes of the code of conduct committee state that Lilly's media release "included overly positive statements about the benefits of once-a-day treatment."

Listen to this week's edition of the "Weekly Radio Spin," the Center for Media and Democracy's audio report on the stories behind the news. This week, we look at the nuclear industry's largesse, Merck's marketing and cigarettes for kids. In "Six Degrees of Spin and Fakin'," how is secondhand smoke like an uncurbed dog? The Weekly Radio Spin is freely available for personal and broadcast use. Podcasters can subscribe to the XML feed on www.prwatch.org/audio or via iTunes. If you air the Weekly Radio Spin on your radio station, please email us at editor@prwatch.org to let us know. Thanks!

A recent investigation by BBC Television showed British American Tobacco (BAT) violating its own voluntary marketing and advertising codes in Malawi, Mauritius and Nigeria. Contrary to BAT's public pronouncements that it doesn't want children to smoke, the company was caught using marketing tactics in these countries that are known to appeal to young people, like advertising and selling single cigarettes, and sponsoring non-age-restricted, product branded musical entertainment.

As trading has become more global and corporations have become more multinational, countries started discovering that they have little recourse to rein in the harmful behavior of corporations. As public clamor to regulate multinationals has grown, companies have increasingly responded by adopting "voluntary codes of conduct." But what are the real purposes for these codes? Are they just window dressing, or worse?