pharmaceuticals

Medical research conflicts of interest are in the news lately, thanks to recent congressional hearings by Senator Charles Grassley. But are journalists part of the problem? A new study in the Journal of the American Medical Association (JAMA) found that reporters for print and online media outlets failed 42 percent of the time to mention drug company funding of research cited in their stories. When asked, however, 88 percent of newspaper editors insisted that their publications "always or often" included funding information in their stories -- even though only 3 percent actually had a policy requiring such disclosure. "If you're wondering about professional standards," comments Merrill Goozner, "the Association of Health Care Journalists lists reporting the financing of research and conflicts of interest of researchers as its number one guideline for health care reporters. This latest survey shows that the word has yet to filter down to the majority of reporters out there." The JAMA study also found that 67 percent of news stories mentioned the brand names of drugs rather than their generic names, further reinforcing pharmaceutical industry marketing campaigns. Once again, editors of the offending publications claimed that their reporting practices were better than they actually were, with 77 percent of editors insisting that they always or often reported only the generic names of medications.

The National Institute for Clinical Excellence (NICE), a UK government agency charged with deciding whether drugs should be subsidized by the British government, has been criticized by some patient groups for refusing to approve new and expensive drugs. Groups including the National Kidney Federation, the Arthritis and Musculoskeletal Alliance, the National Rheumatoid Arthritis Society, Beating Bowel Cancer, the Royal National Institute for the Blind and the Alzheimer's Society have all objected against NICE decisions. "All of these charities received sums of up to six figures from drug companies in 2007," reports Jeremy Laurance, the health editor with The Independent. "A positive decision by NICE on a drug not only guarantees sales to the NHS but can influence global markets worth billions of pounds. Yet none of the charities named has criticised the high prices charged by the pharmaceutical companies for their products in their recent campaigns," he wrote.

The pharmaceutical company Eli Lilly has announced that it will begin reporting its payments to doctors in late 2009, using an online database. But the disclosure is limited to payments of more than $500 made for giving talks or advice to the company; payments for other services or gifts will not be included. Payments made before 2009 will also not be disclosed. Eli Lilly president and CEO John Lechleiter explained the move by stating, "We've learned that letting people see for themselves what we're doing is the best way to build trust." In mid-2007, as the U.S. Senate Finance Committee was investigating drug company grants to patient groups, Eli Lilly began disclosing its grants to U.S. nonprofit groups and educational institutions. Its new registry of payments to doctors comes as Congress considers the Physician Payments Sunshine Act. The bill would require disclosure of any drug company payment to doctors of more than $25, whether the payment was for food, travel, entertainment, gifts, consulting fees or any other purpose.

To develop its new website that tries to help the public understand direct-to-consumer drug ads, the U.S. Food and Drug Administration (FDA) "turned to a nonprofit front group erected by Shaw Science Partners, a public relations firm that specializes in launching new drugs," according to the Center for Science in the Public Interest (CSPI). EthicAd, the nonprofit behind the FDA site, is funded by Shaw Science and its own board members. Shaw Group founder Michael Shaw admitted that "if not all, almost all" of EthicAd's funders "do work for industry." EthicAd also "shares the same physical address as Shaw Science Partners." CSPI gives a negative review of the FDA site, calling it "jargon-filled" and lacking advice on how to evaluate messages about drug side effects, among other consumer topics. CSPI is calling on the FDA "to scuttle the web site, to terminate its relationship with the drug companies' PR firm, and to seek out advice from leading physicians, pharmacists, or consumer groups."

With the start of the school year, debate has heated up again about Gardasil, Merck's vaccine against human papillomavirus. Since writing my series of four articles on The Politics and PR of Cervical Cancer last year, I have continued to track the developments and have noticed some interesting trends. While Gardasil has not been the financial jackpot that Merck was hoping it would be, there is still a steady push for vaccination and even still for mandates. Even though it has not played out as positively as Merck planned, it is too early to turn our attention away from their efforts to sell their so-called "vaccine against cancer." Merck's obvious corporate steamrolling has generated a public backlash and has also faced general concerns about possible health risks from vaccinations, along with conservative opposition to the idea of government health mandates. These reactions slowed the company's money train but didn't bring it to a full stop.

According to a recent Gallup poll, the public has "a dimmer view of the pharmaceutical industry than they do of the advertising / public relations sector, if you can imagine such a thing," writes Mark Dolliver. "When a top-selling pain reliever like Vioxx is pulled off the market for increasing patients' risk of heart attack or stroke, consumers take note." Loreen Babcock, who heads Omnicom Group's "relationship-marketing agency" Unit 7, says drug companies should use social media to improve their public image. She notes Johnson & Johnson's use of YouTube, and Novartis' contest for the best consumer-generated flu vaccine video, also on YouTube. "This effort leverages the fact that consumers trust other consumers more than company spokespersons," explains Babcock. In PR parlance, that's called the third party technique. Another trend is "an increasing emphasis on conveying [drug] information to the people who want it, as opposed to the public en masse." Marketer Lynn Day predicts that drug companies are "going to be providing much more targeted and educational approaches" than traditional direct-to-consumer advertising.

From Pfizer's new Lipitor adPfizer's getting ready to resume advertising for its cholesterol drug Lipitor. In February, the drugmaker pulled its Lipitor ads, over charges they were misleading. The old ads featured artificial heart inventor Robert Jarvik, who appeared to be giving medical advice though he isn't a practicing physician. The new ads feature "John E.," a baby boomer and heart-attack survivor who "didn't take a cholesterol-fighting drug before his heart attack ... despite a history of high cholesterol." A Pfizer marketing executive said, "When we did testing with consumers ... John really resonated with them." But will the ad boost sales? According to a new study, the impact of direct-to-consumer (DTC) drug advertising on sales is "highly variable" and, for two of the three drugs studied, the ads "had no apparent impact." The study, which was published in the British Medical Journal, compared drug sales in French-speaking versus English-speaking Canadian provinces. Like most countries, Canada bans DTC ads, but Canadian viewers still see them via U.S. television. Advertising executives maintain that DTC ads do boost sales. "Had anyone ever heard of erectile dysfunction or overactive bladder before the drugs were advertised?" asked one.

Screen capture of a TV ad for Vytorin, taken from YouTubeThree million people worldwide are taking the new, heavily advertised anti-cholesterol drugs Zetia and Vytorin, despite a lack of clinical evidence that they reduce cardiovascular disease or heart attacks, or help patients live longer. Vytorin and Zetia brought in $5.2 billion last year for Merck and Schering-Plough, placing them among the best-selling drugs in the world. The Food and Drug Administration approves many drugs based on whether they perform a specific action, like lowering cholesterol, without requiring long-term trials on whether they extend life or lower disease risks. Other FDA-approved drugs have been found to be ineffective or even dangerous. A possible link between Vytorin and cancer cannot be proved or ruled out after three studies, reports AP. In 1999, the FDA approved the diabetes drug Avandia, because it lowered blood sugar; it was later found to increase heart attacks. But pharmaceutical companies oppose changing the current system. Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, says the FDA's approach enables patients "to access life-saving and life-enhancing remedies more quickly."

An analysis of Merck internal documents concluded that the pharmaceutical company carried out a clinical study of Vioxx in 1999, "primarily to support a marketing campaign before the drug's launch." Merck stated that the study was done "to test side effects of the painkiller Vioxx," which was pulled from the market in 2004, after being linked to an increased risk of heart attacks. The 1999 study compared Vioxx to the widely-used painkiller Naproxen, in order "to accelerate uptake and advocacy for Vioxx," according to the Merck documents, which were disclosed during litigation. Another document -- a nomination of the 1999 study for a marketing award -- said the study was "designed and executed in the spirit of Merck marketing principles." Carrying out clinical studies for marketing purposes "would raise ethical and scientific questions, from whether study participants were unknowingly -- and needlessly -- put in harm's way, to whether a company's research is reliable." Earlier analyses of Merck documents found evidence the company ghostwrote academic articles and minimized patient deaths in Vioxx trials. The authors of the Merck document analyses were paid consultants in Vioxx lawsuits against Merck.

Internal documents from the global drug company Eli Lilly reveal that it trained its sales force to avoid discussing the diabetes risk from Zyprexa, a drug used to treat schizophrenia and bipolar disorder. After research revealed that some patients gained weight and had high blood sugar levels that presented an increased risk of diabetes, an internal company sales document stated that "we believe it is essential to weaken this link to neutralize the diabetes/hyperglycemia issue. ... Neutralizing any concern from our customers will be essential to the future growth of Zyprexa in the marketplace," reports Bloomberg. The document came to light during court proceedings in Alaska. In 2002, the drug's sales force was advised, "We will NOT proactively address the diabetes concern. ... The competition wins if we are distracted into talking about diabetes."