Top News arrow Conflict of Interest arrow Public Policy arrow Nicotine Fix--Evidence of Collusion: Pharma-Govt Smoking Guidelines
Nicotine Fix--Evidence of Collusion: Pharma-Govt Smoking Guidelines Print E-mail
Saturday, 10 February 2007
"The federal government's campaign could discourage potential quitters who don't want to spend money on quitting aids or don't like the idea of treating their nicotine addiction with more nicotine."

A front page investigative report by Kevin Hellker of The Wall Street
Journal documents collusion between pharmaceutical companies that produce
smoking cessation paraphernalia, and paid academics whose position on
government health policy advisory committees ensures that government
policies support industry's business aspirations--regardless of the
scientific evidence.

"Dr. Michael Fiore holds a chair at Wisconsin that is funded by
GlaxoSmithKline. He directs a tobacco research center that received nearly
$1 million in funding from makers of quit-smoking medicine in 2004 and
$400,000 in 2005. Between 1999 and 2004, Dr. Fiore personally pocketed
$10,000 to $40,000 a year from the quitting-aid industry for honorariums and
consulting work. He says he stopped such work in 2005. In the U.S.
government's 2005 civil case against the tobacco industry, it chose Dr.
Fiore as an expert witness."

Dr. Fiore chaired the 2000 guidelines is in charge of revising federal
guidelines on how to get smokers to quit. The WSJ reports: "He also runs an
academic research center funded in part by drug companies that make
quit-smoking aids, and he personally has received tens of thousands of
dollars in speaking and consulting fees from those companies.  Conflict of
interest? No, says Dr. Fiore, who has consistently declared that doctors
ought to use stop-smoking medicine. He says his opinion -- reflected in
current federal guidelines -- is based on scientific evidence from hundreds
of studies."

Guidelines promulgated by the Public Health Service of the Department of
Health and Human Services have the force of mandatory practice
guidelines--physicians who fail to adhere to those guidelines--even when
they are wrong--are at risk of liability suits. Yet, those guidelines are
shown  to be governed by corporate marketing agendas--NOT science. 

The WSJ reports that  "Those opposed to urging medication on most quitters
note that cold turkey is the method used by the vast majority of former
smokers. They fear the federal government's campaign could discourage
potential quitters who don't want to spend money on quitting aids or don't
like the idea of treating their nicotine addiction with more nicotine."
Furthermore, studies comparing smokers who quit "cold-Turkey" and those who
used pharmaceutical assisted smoking cessation products show that after nine
months a greater number of smokers who quit cold-Turkey remained tobacco
free than those who used any of the pharmaceutical enhancements.

At least nine of the 18 member committee that recommended the 2000
guidelines had financial ties to makers of stop smoking paraphenalia.  Dr.
Fiore who again heads the revision committee says "only 7" of the 26 member
committee has such ties.  (As anyone who has watched such committees knows,
26 members do not forumulate the recommendations--a kitchen cabinet made up
of 2-3 present policy recommendations that the others rubber stamp).

Hellker nails the undisclosed personal conflicts of interest:
"Those who advocate medication sometimes fail to disclose that they have
financial ties to companies. In an article on Voice of America's Web site
last year, Jack Henningfield, identified only as a smoking-cessation expert,
urged smokers to "go to the consumer-friendly Web site that I like, which is
www.quit.com." Dr. Henningfield is a principal of Pinney Associates, a
consulting firm whose largest client is GlaxoSmithKline, operator of the
quit.com site. Other articles citing Dr. Henningfield's views on smoking
have identified him as a professor at Johns Hopkins School of Medicine
without mentioning the GlaxoSmithKline connection. Dr. Henningfield, who
holds a doctorate in psychology, is an adjunct professor at Johns Hopkins.
He says only 10% of his income comes from Hopkins."

"Dr. Henningfield says he always tells journalists about his financial ties
to industry. But in an interview with The Wall Street Journal last summer,
Dr. Henningfield promoted the use of stop-smoking medicine without
volunteering any information about those ties. He says he thought
GlaxoSmithKline's public-relations firm had already provided the information."

Similarly, Dr. Fiore is shown to be less than forthright:
"In at least two medical-journal articles that Dr. Fiore wrote or co-wrote
promoting the use of stop-smoking medicine, no mention was made of his
financial ties to the makers of those treatments. Dr. Fiore says the editors
of those journals may have ignored his disclosure or he may have failed to
provide it. If the latter, "I am sorry about that," he says, adding that
those are two of more than 150 medical-journal articles he has published."

This case example demonstrates that Big Pharma and Big Tobacco have a
symbiotic relationship that keeps the cash flowing.

While Big Tobacco's profiteering from selling an addictive product is no
longer a matter of controversy, Big Pharma is curently profiteering from
addictive prescribed drugs--in particular those affecting the central
nervous system, such as: antidepressants, sleeping pills and
antipsychotics--all of which carry label warnings against stopping
cold-Turkey.

Contact: Vera Hassner Sharav
212-595-8974
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http://online.wsj.com/article/SB117088041013301313.html
WALL STREET JOURNAL
NICOTINE FIX
Behind Antismoking Policy, Influence of Drug Industry  Government Guidelines
Don't Push Cold Turkey; Advisers' Company Ties
By KEVIN HELLIKER
February 7, 2007 11:21 p.m.; Page A1

Michael Fiore is in charge of revising federal guidelines on how to get
smokers to quit. He also runs an academic research center funded in part by
drug companies that make quit-smoking aids, and he personally has received
tens of thousands of dollars in speaking and consulting fees from those
companies.
Conflict of interest? No, says Dr. Fiore, who has consistently declared that
doctors ought to use stop-smoking medicine. He says his opinion -- reflected
in current federal guidelines -- is based on scientific evidence from
hundreds of studies.

. Terri Cullen's husband Gerry stopped smoking cold turkey, rejecting
nicotine-replacement treatments to ease withdrawal. But it hasn't been easy:
Gerry's been irritable, shaky, and he's gained weight. Is there a better way
to quit?

Now debate is growing about that evidence, and about who should be entrusted
to interpret it. Some public-health officials say industry-funded doctors
are ignoring other studies that suggest cold turkey is just as effective or
even superior to nicotine patches and other pharmaceuticals over the long
run, not to mention cheaper.

At stake is one of the most important issues in the nation's public-health
policy. Cigarettes kill an estimated 440,000 Americans a year. Helping
America's 45 million smokers kick the addiction could save untold numbers of
people.

The Public Health Service, part of the Department of Health and Human
Services, issued guidelines in 2000 calling for smokers to use nicotine
patches, gums and other pharmaceutical aids to quit, with a few exceptions
such as pregnant women. Dr. Fiore, a University of Wisconsin professor of
medicine, headed the 18-member panel that created those guidelines. He and
at least eight others on it had ties to the makers of stop-smoking products.

Those opposed to urging medication on most quitters note that cold turkey is
the method used by the vast majority of former smokers. They fear the
federal government's campaign could discourage potential quitters who don't
want to spend money on quitting aids or don't like the idea of treating
their nicotine addiction with more nicotine.
"To imply that medications are the only way is inappropriate," says Lois
Biener, a senior research fellow at the University of Massachusetts at
Boston who has surveyed former smokers in her state. "Most people don't want
them. Most of the people who do quit successfully do so without them."

Guidelines Revision
The panel is now working on a revision of the guidelines, scheduled for
completion early next year. Dr. Fiore, an internist, is again chairman. He
says this time only seven of 26 members have industry ties. Karen Migdail, a
spokeswoman for the revision effort, says it involves so many voices that
"it's hard for one perspective to have an influence on the process." She
says Dr. Fiore is "one of the leading experts" in smoking cessation and
well-suited to the job.

Presented at a world tobacco conference in the summer of 2006, this National
Cancer Institute survey
<http://online.wsj.com/public/resources/documents/nrt-hartman-02082007.pdf>
5 of 8,200 smokers trying to quit found surprising success rates for those not using medication.
The U.S. Surgeon General's advice
<http://online.wsj.com/public/resources/documents/nrt-5day-02082007.pdf> 6
on how to quit smoking includes a recommendation to buy stop-smoking aids
such as nicotine patchs or a nicotine inhaler.

Dr. Fiore says his panel will give a fair hearing to all points of view on
smoking cessation. He says the process is sufficiently collaborative to
prevent bias, his or anyone else's, from creeping into the final product. He
notes that many of the studies questioning the effectiveness of stop-smoking
medication arose after the publication of the 2000 guidelines. The panel
will scrutinize them closely before reaching any conclusions, he says.

David Blumenthal, director of the Institute for Health Policy at
Massachusetts General Hospital, questions the government's choice of Dr.
Fiore. "The chairman of the committee should be unquestionably impartial,"
says Dr. Blumenthal, who has published extensively on conflicts of interest.

Pharmaceutical companies make several products to help smokers quit. Some
give a nicotine fix without a cigarette, such as GlaxoSmithKline PLC's
Nicorette gum and nicotine-laced Commit lozenges. Nicotine, the addictive
agent in cigarettes, is considered benign relative to the carcinogens in
cigarettes. Bupropion, an antidepressant, and Pfizer Inc.'s Chantix -- both
pills available only by prescription -- aim to reduce cravings without using
nicotine.

Many clinical trials have randomly assigned smokers to take one of these
products or a placebo. Such randomized trials are considered the gold
standard in many medical fields, and they have consistently shown that
nicotine-replacement therapy or other medicine confers a benefit.

But these trials have limitations. They tend to compare quitters who wanted
medication and got it with those who wanted medication and didn't get it --
which is a different group from quitters ready to try going cold turkey.
Also, clinical trials tend to attract highly motivated quitters who may not
represent the population as a whole. Even the placebo group in these trials
often boasts double the success rate of the population of quitters
generally.

Studies of quitters outside clinical trials have shown no consistent
advantage for medicine over cold turkey, the pharmaceutical industry's
primary competitor. An unpublished National Cancer Institute survey of 8,200
people who tried quitting found that at three months, users of the nicotine
patch and users of bupropion remained abstinent at higher rates than did
users of no medication. But at nine months, the no-medication group held an
advantage over every category of stop-smoking medicine. The study was
presented at a world tobacco conference last summer.

Real-World Situations
Similar so-called population studies -- which review results of people who
already quit or tried to, rather than prospectively randomizing subjects
into groups -- have also suggested that cold-turkey quitting can compete
with medication in real-world situations. These studies, in California,
Massachusetts and Australia, have their own limitations. One is that they
depend on people to remember what they did rather than monitoring them in a
controlled experiment.

Questions about the so-called real-world effectiveness of NRT began with
this California study
<http://jama.ama-assn.org/cgi/content/abstract/288/10/1260> 3, published in
2002 in the Journal of the American Medical Association. This thorough
review <http://209.211.250.105/reviews/en/ab000146.html> 4 of the published
literature on nicotine replacement therapy found substantial evidence for
its efficacy.

The surgeon general's five-day program for smokers preparing to quit
recommends nicotine patches or other medication.

Kenneth Strahs, GlaxoSmithKline's vice president of smoking-control research
and development, notes that his company's products won approval from
regulators at the Food and Drug Administration who demand randomized
clinical trials. "The FDA does not conclude either safety or efficacy based
on retrospective population studies," says Dr. Strahs. Smoking-control
products account for a small fraction of the company's revenue.

The researcher who raised the first serious questions about
nicotine-replacement therapy says it may fall into a rarely discussed gap
between efficacy in clinical trials and effectiveness in the real world.
Greater use of medication is not "associated with any increase in successful
quitting in the population," says John Pierce, a University of California,
San Diego, professor of medicine who was lead author of a 2002 Journal of
the American Medical Association article finding no superior benefit from
over-the-counter nicotine substitutes in California.

"If we're going to be intellectually honest, we have to be willing to
examine the issue of whether current users [of medication] are obtaining
long-term rates of abstinence that are higher than anyone else," says
Kenneth Warner, a tobacco researcher and dean of the University of Michigan
School of Public Health. "That's going to be very hard for people to do in
the smoking-cessation community," because belief in the value of medication
runs so deep, he adds.

All sides in the debate agree that intervention by doctors and other
health-care providers to confront smokers can be effective in encouraging
quitting. Dr. Fiore says the primary goal of the guidelines is to spur such
intervention, and he says they have been successful in sharply raising the
proportion of doctors who discuss smoking with their patients. Also
undisputed is that behavioral support, whether from professional therapists
or quit-line counselors, can be valuable.

As the federal government weighs the data in making new recommendations,
many of its advisers are receiving money from companies with a stake in the
outcome. Dr. Fiore holds a chair at Wisconsin that is funded by
GlaxoSmithKline. He directs a tobacco research center that received nearly
$1 million in funding from makers of quit-smoking medicine in 2004 and
$400,000 in 2005. Between 1999 and 2004, Dr. Fiore personally pocketed
$10,000 to $40,000 a year from the quitting-aid industry for honorariums and
consulting work. He says he stopped such work in 2005.

In the U.S. government's 2005 civil case against the tobacco industry, it
chose Dr. Fiore as an expert witness. He was asked to estimate the damages
owed to federal taxpayers as a result of smoking and to devise a plan for
spending those damages. Dr. Fiore came up with an estimate of $130 billion,
and a plan to spend about $5.2 billion a year of that mostly on counseling
and medication -- a measure that could have doubled the size of the
stop-smoking medicine market. (Later, the government reduced its request for
damages to $10 billion.)

The American Cancer Society has allowed its logo to be placed on
stop-smoking products in exchange for money. A Cancer Society spokesman
defends that decision, crediting the pharmaceutical industry for bringing
invaluable marketing muscle to the society's Great American Smokeout every
November.

Those who advocate medication sometimes fail to disclose that they have
financial ties to companies. In an article on Voice of America's Web site
last year, Jack Henningfield, identified only as a smoking-cessation expert,
urged smokers to "go to the consumer-friendly Web site that I like, which is
www.quit.com."

Dr. Henningfield is a principal of Pinney Associates, a consulting firm
whose largest client is GlaxoSmithKline, operator of the quit.com site.
Other articles citing Dr. Henningfield's views on smoking have identified
him as a professor at Johns Hopkins School of Medicine without mentioning
the GlaxoSmithKline connection. Dr. Henningfield, who holds a doctorate in
psychology, is an adjunct professor at Johns Hopkins. He says only 10% of
his income comes from Hopkins.

Dr. Henningfield says he always tells journalists about his financial ties
to industry. But in an interview with The Wall Street Journal last summer,
Dr. Henningfield promoted the use of stop-smoking medicine without
volunteering any information about those ties. He says he thought
GlaxoSmithKline's public-relations firm had already provided the
information.

In at least two medical-journal articles that Dr. Fiore wrote or co-wrote
promoting the use of stop-smoking medicine, no mention was made of his
financial ties to the makers of those treatments. Dr. Fiore says the editors
of those journals may have ignored his disclosure or he may have failed to
provide it. If the latter, "I am sorry about that," he says, adding that
those are two of more than 150 medical-journal articles he has published.

Dr. Fiore and other members of the Society for Research on Nicotine and
Tobacco refuse to accept any funds from the tobacco industry, even
unrestricted research grants. Smoking-control activists say there's a big
difference between tobacco companies, which they say engaged in scientific
deceit for a half-century, and drug makers that are trying to help smokers
quit. Reflecting the view of many in the antitobacco camp, Harry Lando, a
University of Minnesota nicotine researcher, says, "I view the
pharmaceutical industry as our ally."

After the federal panel with industry-funded scientists came out with its
guidelines in 2000, a campaign against cold turkey took root. The Web site
of the highest-ranking physician in America -- the surgeon general -- calls
it a "myth" that cold turkey is the best way to quit. In November 2006,
during the week of the Great American Smokeout, doctors around the country
participated in a campaign called "Don't Go Cold Turkey." The creator of the
campaign was GlaxoSmithKline.

Advocate Rejected
The how-to-quit Web site of the federal Centers for Disease Control and
Prevention rejected a request from John Polito, an ex-smoker in Mount
Pleasant, S.C., to include a link to his Web site, WhyQuit.com, which
advocates cold-turkey quitting. In a 2002 letter explaining the rejection,
the agency told Mr. Polito that drug therapy has been shown to double quit
rates.

In an interview, CDC epidemiologist Corinne Husten said the real reason for
the rejection is that the CDC doesn't recommend private Web sites. However,
the CDC site long included a link to GlaxoSmithKline's quit.com site. Asked
about that, Dr. Husten said, "Some things have gotten on the [CDC] Web site
that shouldn't be there." (After the interview, the CDC removed the quit.com
link.)

Pressure may be growing for doctors to follow the federal guidelines. An
article in the December issue of the journal Tobacco Control argued that
failure to follow the guidelines could be deemed medical malpractice.

Some health officials don't go along with the federal government's tilt
against cold turkey. The state of California's help-line for smokers
presents cold turkey as an equally viable option to medication. "The
effectiveness of pharmaceutical aids has been proven short-term; long-term,
it's still in debate," says Hao Tang, a research scientist with the state
department of health services. California has succeeded in reducing its
smoking rate to 14%, six percentage points below the national average.

After three decades of smoking, Linda Holstein quit nearly three years ago
using a nicotine patch as well as nicotine gum, which on occasion she still
pops into her mouth. Elated at being free from cigarettes, Ms. Holstein, a
Minneapolis attorney, says, "The gum helped very much."

Others say ingesting medicinal nicotine prolonged withdrawal, leading them
ultimately back to cigarettes. During the 20 years that Tanya Blakey, a
Georgia teacher, smoked two packs a day, she tried to quit countless times
using nicotine-replacement therapy. "Every time I stopped using the NRT,

I was smoking again within two or three days," says Ms. Blakey. This week
she is celebrating two years without a cigarette, this time having used no
medication.

Write to Kevin Helliker at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

Hyperlinks in this Article:
(1) http://online.wsj.com/article/SB117078602972699801.html
(2) http://online.wsj.com/article/SB117078602972699801.html
(3) http://jama.ama-assn.org/cgi/content/abstract/288/10/1260
(4) http://209.211.250.105/reviews/en/ab000146.html
(5)
http://online.wsj.com/public/resources/documents/nrt-hartman-02082007.pdf
(6) http://online.wsj.com/public/resources/documents/nrt-5day-02082007.pdf
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