The global drug firm Roche has decided to withdraw from the Pharmaceutical Research and Manufacturers Association (PhRMA), the peak lobbying group for the U.S. drug industry. Following its purchase of the biotechnology company Genentech, Roche decided that it prefers to belong to the Biotechnology Industry Organization. In The Star-Ledger, Susan Toddalso reported that "without Roche, PhRMA also loses critical revenue for carrying out its lobbying activities." Roche, she wrote, also "plans to pull out of another pharma-related affiliation, its sponsorship of a special pharmaceutical management program at Rutgers Business School." In Britain, Roche UK decided "not to renew its membership of the Association of the British Pharmaceutical Industry, after it was suspended for six months for 'bringing the industry into disrepute'," reported the Financial Times.

Pharmaceutical companies can't market unapproved or "off-label" uses for their prescription drugs, under U.S. Food and Drug Administration (FDA) rules. But the same companies' medical science liaisons (MSLs), "who are considered medical rather than sales staff, have greater freedom than salespeople as they visit doctors offices to discuss the science behind a medicine, including unapproved uses," reports the Wall Street Journal. Moreover, the number of industry MSLs is increasing. Dr. Jane Chin, a former MSL for Aventis and Takeda Pharmaceuticals, quit after being "pressured to do more for the sales team. ... Some pharma companies have the impression if you just hire somebody [with a professional degree] and you call them an MSL, it doesn't matter what they say." She now heads the MSL Institute, which provides ethical training. Novartis, "which has one of the largest MSL staffs in the industry," says it buffers its MSLs from marketing pressures by not giving MSLs "incentives for sales in their territories." The FDA allows "drug companies to respond to unsolicited requests for information from doctors, including off-label data, if they provide truthful, nonpromotional material."

As members of the U.S. Congress consider options on how to fund Obama administration plans to extend health care coverage to those currently uninsured, the drug and advertising are digging in to defend tax breaks on direct-to-consumer advertising. Representative Charles Rangel (D-N.Y.), the chairman of the House Ways and Means Committee, said that "one thing that's not off the table is that you can pick up $37 billion knocking out the deduction for [drug] advertising." The possibility that the tax deduction on drug promotion could be removed has angered the Association of National Advertisers (ANA). "What, anytime somebody doesn't like a particular product category, they're going to take away their tax deduction?" asked Dan Jaffe, ANA's Executive Vice-President. In a media statement, the ANA objected to any change that would make "advertising more expensive" as, it claimed, "advertising is critical to the economic recovery of our nation." The Pharmaceutical Research and Manufacturers of America did not respond to Advertising Age's request for a comment.

"Prescription drug ads have drawn fire for portraying healthy-looking, active and smiling patients while explaining benefits and then rushing through or providing distractions when required risk information is presented," reports Reuters. For example, an ad for a Schering-Plough allergy drug featured "a bee that flew around during a description of side effects but simply hovered while benefits were explained." These and other marketing tricks may "misleadingly minimize the risks" of drugs and medical devices, acknowledges the U.S. Food and Drug Administration (FDA). The FDA issued new marketing guidelines that say it will consider "the messages conveyed by the promotional piece as a whole" when evaluating whether ads "present risk information adequately." Representatives from two industry groups, the Pharmaceutical Research and Manufacturers of America and the Advanced Medical Technology Association, pointed to their voluntary ad guidelines as proof that their marketing is "responsible."

The Wall Street Journal has published a revealing story about one of the seamier sides of the drug industry's marketing campaigns: paying patients to offer testimonials about their drugs. As health industry observer Merrill Goozner explains, the story came to light because a "celebrity patient" had a "falling out with his corporate sponsor, Bristol-Myers Squibb. Andy Behrman is bipolar, and he earned $10,000 a day or $400,000 in total singing the praises of Abilify (aripiprizole, an atypical antipsychotic drug) to Bristol-Myers' drug salesmen and physician-consultants. Behrman's presentations worked off talking points provided by a public relations firm." He was supposed to tell people that the drug had no side effects and not to tell them that he was being paid by the company. "Behrman now claims he suffered serious side effects while on the drug," Goozner notes. He makes these and other charges in a new tell-all book. In response, the company says that he attempted to shake them down for a $7.5 million contract before turning against his former handlers.

Public relations and planning documents from AstraZeneca discuss promoting "off-label" or unapproved uses for the company's drug Seroquel. The U.S. Food and Drug Administration has approved Seroquel for schizophrenia, psychotic and bipolar disorders among adults. While doctors may prescribe drugs off-label, companies can't promote off-label uses for drugs. The AstraZeneca documents, which were uncovered during lawsuit proceedings, mention "plans to 'broaden Seroquel use on and off-label,' including among adolescents and patients with Parkinson's and Alzheimer's disease, at medical meetings, in sales calls and with patient-advocacy groups." A 2001 company PR plan lists as a goal to "encourage and support" Seroquel "use outside schizophrenia into a broad range of other patient populations," suggesting "aggressive market penetration" among elderly and adolescent patients. AstraZeneca faces nearly 10,000 lawsuits claiming it hid evidence of Seroquel's side effects. The pharmaceutical company calls those allegations "unproven," and says it didn't engage in "inappropriate promotion of Seroquel." In January, fellow drugmaker Eli Lilly paid a $1.42 billion fine for off-label promotion of Zyprexa, a competitor to Seroquel.

Pfizer has produced a great example of stealth advertising with its commercial promoting a Web site called MyTimeToQuit.com. The ad has the look and feel of a public service announcement, and mentions neither Pfizer, nor the popular smoking cessation drug it promotes -- Chantix (varenicline). The ad represents a growing trend in drug advertising called "help-seeking ads," which don't mention a drug by name, but instead address the condition the drug is meant to treat, and then drive viewers to a toll-free 800 number or a Web site that offers an option to learn more about a prescription drug meant to treat the condition. It is a sneaky, but legal way to advertise drugs that have particularly bad side effects, since avoiding mentioning the drug by name lets the company off the hook for listing its bad side effects in the ad, too, according to the U.S. Food and Drug Administration (FDA) rules. Chantix has some serious side effects, according to an alert the agency issued on Chantix, including "serious neuropsychiatric symptoms," like changes in behavior, depressed mood, suicidal ideation and completed suicide.

The pharmaceutical company Merck "paid an undisclosed sum to Elsevier to produce several volumes of a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles -- most of which presented data favorable to Merck products." The Australasian Journal of Bone and Joint Medicine carried "ads for Fosamax, a Merck drug for osteoporosis, and Vioxx" and "appeared to act solely as marketing tools with no disclosure of company sponsorship." Merck's marketing ploy was unearthed as part of the Australian Vioxx lawsuits. The publisher, Elsevier, admits "that the journals in question didn't have appropriate disclosures." A member of the journal's "Honorary Editorial Board," Australian rheumatologist Peter Brooks, has worked with Merck, Pfizer and Amgen, and put his name on "a few advertorials" for drug companies. "I'm sure many a primary care physician was given literature from Merck that said, 'As published in the Australasian Journal of Bone and Joint Medicine, Fosamax outperforms all other medications,'" a Bioethics.net blog states. "If physicians would not lend their names or pens to these efforts, and publishers would not offer their presses, these publications could not exist."

In Australia, the pharmaceutical company Merck is on trial. Australians who took the pain medication Vioxx allege that Merck and its Australian subsidiary, Merck Sharp & Dohme, "knew Vioxx increased the risk of heart attacks long before it voluntarily withdrew the drug from the market in 2004." Merck has paid $4.85 billion to U.S. Vioxx patients, but never admitted liability. As the Australian trial proceeds, Merck's public relations people from the Kreab & Gavin Anderson firm "follow journalists out of court, ask them what they are writing, hand out daily press releases and send 'background' emails they say should not be attributed to the company but which detail what they think are the 'salient points' from the evidence presented in court." The firm also phones reporters who write critical articles, to accuse "them of 'cherry-picking' the evidence and bombards newspapers with letters to the editor ... five were sent to The Australian in just seven days." Merck's Australian PR team, along with U.S. Merck spokeswoman Casey Stavropoulos, attends each day of the trial. The PR team sit near journalists covering the case, at one point even "looking over the shoulders of journalists at their notepads."