Healthy Skepticism Library item: 1648
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Publication type: news
Griffith D.
Health Group's Funding Faulted
The Sacramento Bee 2005 Jun 26
http://www.sacbee.com/content/news/projects/drugs/story/13132395p-13976434c.html
Keywords:
Zeno Lunesta insomnia Sepracor Ambien NSF medicalized
Notes:
Ralph Faggotter’s Comments : Presented here, in relation to insomnia, is good case study in how the pharmaceutical industry influences advocacy groups, the media and the public, to expand the proportion of the population who may be classified as needing their products, to down play adverse effects,to ignore non-drug therapies and to medicalize normality.
Full text:
x – close Recent Stories By Dorsey Griffith and Steve Wiegand
Health groups’ funding faulted
Not-for-profit advocates often have strong ties to the drug industry.
By Dorsey Griffith and Steve Wiegand — Bee Staff Writers
Published 2:15 am PDT Sunday, June 26, 2005
For the makers of the newest sleeping pill to hit the U.S. market, the last week of March couldn’t have brought better news.
“Insomnia is a condition that is under-recognized, under-diagnosed, and as a result, under-treated,” warned the National Sleep Foundation, as it proclaimed March 29 “Insomnia Awareness Day” and March 27 to April 2 “National Sleep Awareness Week.”
UCDavis Health
A poll released by the nonprofit group disclosed that 50 percent of adult Americans have problems getting to sleep at least once a week, and 10 percent – about 22 million people – rarely get a good night’s sleep. Those findings were reported by virtually all of the country’s major newspapers and television networks, including The Sacramento Bee.
Lost in the somber warnings and survey results, however, was that the poll, the proclamations and the press kits that spread the information were paid for by sleeping pill manufacturers.
Or that 10 of 23 members of the National Sleep Foundation’s board have, or have had, financial ties to sleeping pill manufacturers, the very same industry that represents the main source of revenue for the foundation.
Or that the New York public relations firm that contacted medical reporters about the poll also made sure to mention the mid-April release of Lunesta, the first sleeping pill approved for extended use by the federal Food and Drug Administration.
If all this seems a little incestuous, it’s also an example of the relationships many not-for-profit health advocacy groups have with the definitely-for-profit health industry.
The groups run the gamut of causes and targeted consumers, from the National Women’s Health Resource Center to the Coalition for Children’s Health to the Alliance for Aging Research.
Leaders of organizations that advocate on behalf of people with specific diseases, disorders or conditions concede their groups couldn’t survive without corporate sponsors, and contend it’s natural that chief among them are companies that sell products to treat the ailment.
“The largest single source of National Sleep Foundation funding is pharmaceutical and medical device companies,” said Richard Gelula, chief executive officer of the Washington, D.C.-based NSF. “Just like the largest area of support for the Daytona 500 comes from Ford, GM, oil and tire companies.”
But there’s a difference. At car races, company logos and brand names brazenly adorn everything from car hoods to driver helmets. Drug company-advocacy group alliances often remain unknown to consumers.
“The public may be getting hoodwinked because they may think these nonprofits are independent,” said Daniel Borochoff, president of the American Institute of Philanthropy, a watchdog group that provides donors with information about nonprofits. “But how can they do it independently if they are paid by the drug companies?”
Borochoff and other critics say that even the best-intentioned advocacy groups can ignite public fears about conditions that may not be medical problems, divert attention from more serious health issues and put pressure on doctors to prescribe medications that may not be necessary.
Sleep Foundation transformed
While some of these advocacy organizations begin as true grass-roots associations that later come to rely on financing from the pharmaceutical industry, others – sometimes referred to as “Astroturf” groups – sprout directly from drug company seed money. And some are hybrids.
The National Sleep Foundation was born when the American Academy of Sleep Medicine, a professional group of sleep doctors and researchers, gave former academy officials $100,000 to begin a sleep education and public awareness group.
The group’s metamorphosis soon began. The NSF was officially launched in 1991 with the release of a sleep-problems survey paid for by the Searle drug company. The following year, Searle’s blockbuster sleeping pill, Ambien, was approved for sale, and the company provided the NSF grants for “insomnia awareness” workshops in 20 cities.
In succeeding years, the foundation has staged at least one national event a year, often built around a survey about a sleep-related problem, and usually sponsored by a pharmaceutical firm. It also has won widespread praise from sleep medicine researchers and doctors for its work publicizing the problems of sleep apnea and the effects of sleep deprivation on driving.
But its original connection with the American Academy of Sleep Medicine is no more. The academy’s Web site makes no mention of the NSF, and while it links to other sleep organizations’ sites, it does not link to the NSF. Academy officials declined to comment on the NSF.
Drug company support key
Advocacy groups aren’t required to publicly list individual sources of income, although many include general financial statements with the annual reports posted on their Web sites.
The National Sleep Foundation’s 2003 annual report, for example, vaguely lists “contributions” as a revenue source. In another section of the Web site, the group says it “is supported by a number of sources, including individual donors, memberships, sales of educational materials, advertising, investment income and grants. Our grant sources include foundations, corporations and federal agencies.”
However, an analysis of the group’s 2003 revenue sources, provided to The Bee by the NSF, shows more than half of the $2.6 million collected that year came from drug companies, including $481,000 from Sanofi-Aventis, which now markets Ambien; $205,000 from Elan, which developed the sleep drug Sonata; and $267,000 from Pfizer, maker of the over-the-counter aid Unisom. Of the $1.4 million the NSF received in direct grants and sponsorships, including support for the annual gala, almost two-thirds came from drug companies.
The NSF’s Web site also states that grants from corporations are accepted only on a no-strings basis, and that the foundation “alone determines the ideas and content published or promoted in the program created by the grant support.”
The publicity campaign preceding the release of this year’s poll and Insomnia Awareness Day, coordinated by a public relations firm called the Zeno Group, appears to have violated that guideline.
Included in the NSF information sent to reporters was a pitch for coverage of the release of the Lunesta sleeping pill.
The NSF’s Gelula said it was a “mistake” for the PR group to have mixed the messages. Under terms of an agreement among the NSF, the Zeno Group and Lunesta maker Sepracor, the foundation was to provide information and direction, the PR group was to handle the publicity and the drug company was to handle the financing.
“They crossed the line in terms of what they were supposed to do,” Gelula said. “There was supposed to be a firewall. The fire got through the firewall.”
Gelula declined to disclose how much money Sepracor gave the NSF in 2004 and 2005. “I’ll be damned if I do, and damned if I don’t,” he said. But he did say the group would not enter into similar agreements again.
“The people behind this organization have too much at stake, too much integrity.”
Drug firms fund directors
The people behind the NSF include a 23-member board of directors, who are listed on the foundation’s Web site, www.sleepfoundation.org. What isn’t listed are the financial ties of at least 10 of the members of the board of directors to the drug industry, through research grants, consultancies or honoraria. For example, board chairman James K. Walsh, a psychologist, has received money from 25 drug companies.
Other board members have similar links. Dr. Phyllis Zee was a paid consultant to five sleeping-pill makers. Meir H. Kryger was an investigator in trials of Modanifil for narcolepsy and excessive daytime sleepiness.
Gelula said all foundation board members have to fill out conflict-of-interest statements, disclosing their financial dealings with the sleep industry. When asked for a copy of that statement, however, Gelula said he couldn’t locate one.
In contrast, the American Academy of Sleep Medicine, whose membership consists of sleep doctors and researchers, posts a detailed conflict-of-interest policy on its Web site.
Even the appearance of a connection between drug company money and advocacy group leaders is a matter of some concern in the medical profession. Critics point to the revelation in February that 10 members of a 32-member advisory panel to the Food and Drug Administration had financial ties to the companies that make the painkillers Vioxx and Bextra. All 10 had voted to keep the drugs on the market, despite research findings that the drugs could cause cardiac problems.
Whether a bias is “real or perceived, it’s detrimental to medicine and to physicians,” said Dr. David Campen, a rheumatologist and medical director for drug information, use and technology for Kaiser Permanente Northern California. “We need to be far more transparent.”
Problems ‘medicalized’
Critics of the advocacy organizations worry that in the groups’ zeal to publicize their cause, they tend to overstate the problems they are trying to conquer.
“Clearly there are some good examples where advocacy groups have made some important contributions to the quality of care,” said Dr. Richard Deyo, who teaches at the University of Washington. “For example, in the area of breast cancer, the groups have actually helped change surgical procedures.”
But Deyo, co-author of “Hope or Hype: The Obsession with Medical Advances and the High Cost of False Promises,” said some advocacy groups “medicalize” everyday conditions.
“ ‘Social anxiety syndrome,’ we used to call that ‘shyness,’ “ he said. “I think that often the groups are well-meaning in publicizing a problem, but they go overboard, and the result is people worry about things they really shouldn’t worry about.”
The problem, some say, is that groups avidly promoting less serious conditions distract people from focusing on more serious health issues.
“Toenail fungus is trouble, but it doesn’t deserve the same level of attention as obesity,” said Art Caplan, chair of the Department of Medical Ethics and director of the Center for Bioethics at the University of Pennsylvania.
Experts fault sleep polls
There is no debate that, in some cases, insomnia is a grinding, debilitating affliction. For 32-year-old Michelle Silva, it’s been a lifelong problem. Although reading, watching TV or drinking warm milk help her fall asleep at bedtime, she often jerks awake a couple of hours later and can’t fall back to sleep.
“I think I am a typical professional who has work on her mind, who is thinking about projects in the middle of the night, what my plans for the weekend are and worrying about various issues in my life,” said Silva, a public information officer at the UC Davis Medical Center.
Over the years, Silva has quit drinking coffee, practiced yoga and still exercises regularly to secure a steady eight hours of nightly sleep, but nothing has worked consistently. Over-the-counter sleep aids would help for about a week, then not at all.
Today, she takes Ambien, a drug she says works well and doesn’t make her groggy in the morning. Still, she acknowledges there is no magic pill for insomnia.
“I know it’s just a Band-Aid,” she said. “It doesn’t deal with the underlying fact of why you’re not sleeping.”
That’s precisely what concerns many sleep experts, who say polls and publicity that deal superficially with sleep problems can raise unnecessary concern in people, sending them to their doctors with exaggerated fears.
“The problem with regular doctors is they are not trained in sleep medicine,” said Sat Bir S. Khalsa, an instructor at the Harvard Medical School’s Sleep Disorders Program. “They just want to get the people out of their office because they have only two minutes to see them, (so they) pull out the PDR (Physician’s Desk Reference) and give them the latest pill and send them on their way.”
Just this month, the National Institutes of Health concluded that non-drug therapies – such as turning off the bedroom television – are as effective as drugs for treatment of short-term insomnia.
The hazard, Khalsa said, is treating a problem that may not exist with a medication that may not be particularly effective.
A Duke University clinical trial for Lunesta, funded by Sepracor, for example, found that after six months of use, people who took the drug got to sleep just 15 minutes faster than those who took a placebo. They slept 30 minutes longer and got up 1.6 times during the night, instead of twice.
Extent of insomnia debated
There also is considerable debate in medical circles over how widespread serious insomnia problems are, whether they are getting more prevalent and how best to treat them.
In contrast with the NSF’s survey, showing that 50 percent of Americans said they had trouble getting to sleep, the National Institutes of Health estimated recently just 30 percent complain of sleep deprivation.
Experts also contend that the amount of uninterrupted sleep a person needs varies from individual to individual, and that there is no scientific evidence that eight hours a night is necessary, or even optimal.
“People have been waking up at night for one reason or another for thousands of years,” said Dr. Daniel Kripke, a sleep researcher and professor of psychiatry at UC San Diego, who is a leading critic of sleeping pill use. “It doesn’t mean we all have insomnia.”
Referring specifically to NSF directors and staff, Kripke said, “they’re not all bad, but it’s clear that a lot of what they’re doing is intended to sell sleeping pills to people who probably would be made worse by them.”
The NSF’s Gelula said the group’s job is to present information about sleep disorders, not sell sleeping pills.
“We are in a commercial area, and I am aware that someone may benefit, that education may benefit a certain party,” he said. “I don’t know what we are supposed to do about our mission, which is to educate the public.”
News media fail to probe
The NSF’s mission was greatly aided this spring by the news media, which provided extensive coverage of the poll and the drive to establish what an NSF press release called an “epidemic” of insomnia in America.
In addition to U.S. newspapers and television networks, the poll was reported all over the world. (The French news agency Agence France-Presse titled their version of the story “Too Sleepy For Sex in the States.”)
Lost in the percentages and anecdotes was the fact that the survey didn’t actually measure how many people have sleep problems, but how many people say they have sleep problems.
“A poll is of limited value in determining the scope of a medical problem,” said Jerome M. Siegel, a UCLA psychiatry professor and expert on sleep disorders. “A poll is not a clinical study.”
Almost no media outlets questioned the efficacy of sleeping pills as a treatment, and few reported who paid for the poll. A Bee survey of 84 stories on the poll in major papers and networks found that only 17 mentioned the foundation’s pharmaceutical sponsors.
Only one of the media outlets studied, the “CBS Evening News,” truly emphasized the drug company link.
“Does it hurt the credibility of the poll that the foundation is heavily funded by the pharmaceutical industry?” a CBS reporter asked NSF board member Meir Kryger.
“I guess it might in some people’s minds,” Kryger replied. “(But) the foundation has done a lot of things that have nothing to do with the pharmaceutical industry.”
The “free media” blitz was accompanied by the launch of what is expected to be a yearlong $60 million advertising campaign by Sepracor to push sales of Lunesta. The initial commercial featured a butterfly flitting languidly across the screen, accompanied by advice to “leave the rest to Lunesta.”
Officials for Sepracor did not return phone calls from The Bee. But Wall Street analysts reported the firm had more than 40,000 orders from pharmacists through the first part of May, one of the fastest starts in history for a prescription drug. In conference calls with securities analysts, Sepracor officials have estimated the drug will reach sales of $500 million a year.
The FDA is considering applications for three new sleeping pills in addition to Lunesta. The rush comes as patents for Ambien, which dominates more than 75 percent of the U.S. sleeping pill market, are set to expire next year. If the patents expire, the new brand-name sleep aids are likely to be joined by a flood of cheaper generic pills that could attract more customers.
And if there is a consumer stampede for sleeping pills, some medical people worry, it could be fueled by information provided by drug company-financed advocacy groups and disseminated by gullible media.
“You put the word ‘foundation’ in (a group’s name), or ‘patient’ or ‘consumer,’ and everybody assumes it’s unbiased information,” said Dr. Sharon Levine, associate executive director of The Permanente Medical Group in Northern California.
“Many of these organizations get their primary funding from some commercial interest and the commercial interest buys a consumer face. It really highlights the desperate need that consumers and physicians have for independent, credible information. We certainly aren’t getting it from marketing.”
About the writer: * The Bee’s Dorsey Griffith can be reached at (916) 321-1089 or dgriffith@sacbee.com. MONDAY: Drug ads may be hazardous to your health.The Sacramento Bee – Get the whole story every day – SUBSCRIBE NOW!