Health groups' funding faulted
Not-for-profit advocates often have strong ties to the drug industry.
http://www.sacbee.com/content/news/projects/drugs/story/13132395p-13976434c.html

By Dorsey Griffith and Steve Wiegand -- Bee Staff Writers
Published 2:15 am PDT Sunday, June 26, 2005

"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."

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."