health

"Documents and emails released this week ... suggest Pfizer's marketers influenced" research on the drug Neurontin "by declining to release or altering the conclusions of studies that found no beneficial effect from Neurontin for various off-label conditions," reports Keith Winstein. The Food and Drug Administration approved Neurontin for epilepsy and shingles. In 2004, Pfizer's Warner-Lambert unit admitted to promoting "off-label" uses. Companies can't promote drugs for unapproved uses, though doctors can prescribe off-label. Pfizer paid $430 million for the offense and claimed it ensured "there was no improper marketing after it purchased Warner-Lambert in 2000." But the new documents, which were submitted in a lawsuit against Pfizer, detail more recent attempts to boost off-label sales. After one study showed Neurontin didn't lessen diabetic nerve pain, a marketer suggested "delaying the publication for as long as possible." One researcher emailed that she was told "not to publish anything that damages Neurontin's marketing success." Pfizer also failed to publish results that Neurontin didn't ease post-operative nerve pain. Lastly, after the drug was shown to have no effect on bipolar disorder, a Pfizer consultant writing up the study excluded 16 patients and changed how other patients were characterized, thus "turning a failure into a success."

1974 ad for "True" brand low-tar cigarettes The U.S. Supreme Court opened its 2008-2009 session today by hearing a case about whether cigarette makers have defrauded smokers with implied claims about the relative safety of "light" and "low tar" cigarettes. At issue is the question of preemption, a legal doctrine that holds that federal laws can take precedence over some state laws. The tobacco companies are arguing that they should not be held responsible for labeling and advertising that was approved by the Federal Trade Commission (FTC). The FTC, which has long required that cigarette packs be labeled as to how much "tar" and nicotine they deliver, argues that the agency itself was fooled because tobacco companies hid internal research data that showed smokers did not benefit from switching to light or low tar cigarettes. In August 2006, U.S. District Court Judge Gladys Kessler, in the landmark U.S. Department of Justice case against the industry, ruled that cigarette makers purposely misled smokers into believing that light cigarettes were more safe than regular cigarettes, and now more than 30 class action lawsuits on the issue of the tobacco industry's "light" and "low tar" cigarette fraud are currently pending across the U.S. The Supreme Court's ruling in this case could either affirm or invalidate all of them.

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.

On October 1, 2008, the city of San Francisco put a law into effect that prohibits the sale of cigarettes in pharmacies. Walgreens drug store chain and Altria/Philip Morris have filed lawsuits against the city over the measure. In a September 30, 2008 statement about the new law, San Francisco Mayor Gavin Newsom related the city's simple rationale: "Pharmacies should be places where people go to get better, not where people go to get cancer."

Familiar corner drug store chains like Rite Aid and Walgreens have long cultivated an image of being all about health. Their web sites feature photos of friendly-looking pharmacists in white coats ready to help us with our health care needs. The Rite Aid company Web site tells us they are "committed to the healthcare needs of our customers." CVS says its vision is to "strive to improve the quality of human life" by making "high-quality health and pharmacy services safe" and easy to access. Walgreens says it stands ready to help people by supplying "health and wellness products" and health information. If all this makes you feel that these drugstore chains have your best interests at heart, it's certainly by design. But don't be taken in too easily.

The U.S. Environmental Protection Agency (EPA) is poised to end "a six-year-old battle between career EPA scientists" who want to regulate a chemical linked to thyroid problems in pregnant women and children, and the White House and Pentagon, where officials oppose setting a drinking-water safety standard for the chemical, perchlorate. Guess who's likely to win? The EPA's "preliminary regulatory determination," obtained by the Washington Post, claims that setting a perchlorate drinking-water standard wouldn't result in a "meaningful opportunity for health risk reduction for persons served by public water systems." The document was heavily edited by the White House Office of Management and Budget (OMB). Among the OMB's comments was "that there was 'no need'" to include "detailed data" that showed that "infants would be exposed to perchlorate levels above" levels deemed safe by the National Academy of Sciences. Perchlorate is present in rocket fuel; many contaminated water sources are near military bases. In an attempt to avoid costly clean-ups, defense companies formed the Perchlorate Study Group, which has questioned whether perchlorate in drinking water poses a health problem.

The Burson-Marsteller PR firm did pro bono communications and media relations support for America's Health Care at Risk: Finding a Cure, which is billed as "a bi-partisan conference bringing together major stakeholders in the health care debate for a high-level dialogue aimed at generating real and lasting solutions." While organizers of the conference were thrilled to have the free help, they may have been wise to check on B-M's health credentials. B-M has had a close relationship with cigarette maker Philip Morris and the tobacco industry as a whole over the years, having organized the smokers' rights group the National Smokers Alliance for PM in the early 1990s. In addition, B-M has performed crisis management work for corporate clients on a variety of issues, including Salmonella (Schwan's and Jewel Supermarkets), worldwide product recall and relaunch (Perrier), and Mad cow disease/BSE (McDonald's and the National Cattlemen's Beef Association). B-M is glad for the opportunity to burnish its image. Chris Foster, Chair of Burson-Marsteller's U.S. Health Care Practice said, "We are proud to be part of this bi-partisan effort to develop real solutions for one of the major challenges facing the U.S. today."

Kevin Anderson, blog editor for the UK Guardian, was bemused by an advertisement posted in the Washington DC subway. "This ad of a man's beer belly stuffed with bills railing away against trial lawyers probably makes little sense to the average American. ... Figuring out who is behind ads like this is even more interesting. The ad highlights an innocuous sounding website www.ConsumerFreedom.com (because who would be against consumer freedom?). What is this group? SourceWatch gives the history and current campaigns of the Center for Consumer Freedom. They originally started to fight against smoking restrictions in restaurants backed with money from tobacco giant Philip Morris. They have since expanded into other areas including anti-anti-obesity. Hard-hitting news funny man Stephen Colbert gets to the bottom of the story in this interview of Rick Berman, the PR man behind the Center for Consumer Freedom."

Public interest groups, including the Center for Science in the Public Interest, are blasting the Food and Drug Administration for relying on industry-funded studies in evaluating the safety of bisphenol A, a chemical widely used in food packaging materials. The FDA's BPA draft assessment says the chemical is safe, ignoring numerous independent and government-funded studies which show risk of harm including brain and prostate damage to developing infants, fetuses, and children, as well as increased risk of diabetes and heart disease. Instead, the FDA relied on two studies funded by an arm of the American Chemistry Council, a trade organization representing chemical manufacturers. Employees of SABIC Innovative Plastics and Dow Chemical, which manufacture BPA, coauthored the two studies. The studies' lead author, Rochelle Tyl of Research Triangle Institute in North Carolina, previously worked for the chemical industry and received research funding from the plastics industry.

Germany's Federal Medical Society is proposing to classify nicotine addiction as an illness, saying doctors should evaluate and treat heavily addicted smokers the same way they do patients suffering from physical illness. They hope that labeling smokers as being sick will pressure more of them to seek professional help to overcome their addiction. The label may be more than just a strategy, though. In June 1998, the Director of the U.S. National Institute on Drug Abuse, Alan I. Leshner, Ph.D., testified before a Congressional panel that addiction, including nicotine addiction, is now considered to be a chronic, recurring brain disease. German health insurance companies fear the Medical Society's proposal will lead to a spike in smoking-related claims, and are unenthusiastic about paying for medical treatment for something they consider to be a "self-inflicted addiction." About 140,000 German citizens die annually from smoking-related illnesses.