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Feb 9 07 5:09 PM
Behind Antismoking Policy,
Influence of Drug Industry
Wall Street Journal
Government Guidelines Don't Push Cold Turkey; Advisers' Company Ties
February 8, 2007, Page A1
By KEVIN HELLIKER
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.
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
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.
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
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.
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
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
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
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.
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
Write to Kevin Helliker at email@example.com
Source link: Behind Antismoking Policy, Influence of Drug Industry
Copyright © 2007 Dow Jones & Company, Inc. All Rights Reserved
Feb 9 07 5:27 PM
Feb 9 07 8:18 PM
I was wondering if anyone here would notice that, Frits.
Sep 3 07 2:12 AM
Apr 4 08 8:01 PM
May 7 08 11:17 PM
Pharmacological Aids to
40 Years of
Methods: Who Should You Believe?
So How Did
Most Successful Ex-Smokers Actually Quit?
Most expert say
"Don't quit cold turkey"
Hooked on the
Cold Turkey the Only Way to Quit?
Journal article explores pharmaceutical industry "Nicotine Fix"
Jul 1 08 10:41 AM
by Arlene Weintraub
Editor's note: For a CBS Evening News report on medical conflicts that was made in collaboration with BusinessWeek,
go to: www.cbsnews.com/stories/2008/06/26/eveningnews/
In April, four experts on smoking cessation published a paper espousing an unconventional plan for helping hard-core nicotine addicts quit.
They proposed treating smokers as if they have a chronic disease akin to diabetes. Such patients should take prescription drugs for years to curb tobacco
cravings, the researchers advised.
The article, published in the prestigious Annals of Internal Medicine, might have slipped quietly into the vast body of antismoking
literature were it not for its two closing paragraphs. There, authors Dr. Michael B. Steinberg and Dr. Jonathan Foulds disclosed that they are paid by
manufacturers of smoking-cessation products for speaking and consulting. Among those companies is Pfizer (PFE), whose controversial drug Chantix the researchers
mentioned favorably, along with other treatments. Use of Chantix has led to reports of suicidal thoughts and other psychiatric symptoms.
To some, the Annals paper smelled suspiciously like disease-mongering to boost pharmaceutical sales. "There's an advantage
to the drug companies selling their products to smokers for a lifetime rather than for six weeks," says Adriane J. Fugh-Berman, a Georgetown University
scholar who co-wrote a scathing online attack on the paper for The Hastings Center, a health-ethics research group in Garrison, N.Y. "Medicine can be a
useful adjunct to quitting [cigarettes], but the goal should be quitting," she says.
The Annals paper appeared around the same time that Pfizer, at the urging of the U.S. Food & Drug Administration, was
strengthening warnings on Chantix's label. This timing has fueled concern that company-paid experts are trying to protect a drug with U.S. sales of more
than $680 million in 2007.
The researchers deny that. They say they follow only their independent judgment when recommending Chantix, a pill, and other drugs. They
emphasize that they don't necessarily urge lifetime use of any medicine. But they don't routinely reveal their Pfizer pay to hundreds of patients
they've steered to Chantix. That has thrust Steinberg and Foulds into the middle of a raging debate about proselytizing by medical researchers and how
corporate relationships should be disclosed to patients. "When [Chantix] goes wrong, it can go terribly wrong," says Dr. Daniel Seidman, director
of the smoking cessation clinic at Columbia University. "These guys may think [industry money] doesn't affect their opinions about the drug, but it
does. When someone pays you, there's a bias." (Seidman receives no pay from manufacturers.)
Pfizer hasn't taken a formal position on whether doctors should disclose funding sources to patients. Cathryn M. Clary, vice-president
for external medical affairs, says she fears too much transparency will create confusion. "The more information that's out there, the more difficult
it will be for patients to process," she says. Pfizer instructs the researchers it pays to disclose their compensation when speaking at professional
conferences. It also recently began disclosing grants for medical education on its Web site.
The smoky-smelling clinic at the University of Medicine & Dentistry of New Jersey (UMDNJ) run by Steinberg, an internist, and Foulds, a
PhD psychologist, is one of eight such centers in that state originally funded by the tobacco litigation settlements of the late 1990s. More than 500 smokers
come through the clinic each year. It boasts a 30% success rate helping patients to quit for six months or more. "The goal is to get more people not
smoking," Steinberg says. "The medication is just a tool to increase their chances of being successful." Adamant that his work for Pfizer and
other drug companies poses no problem, he adds: "We look at the data, and we look at our own clinical experience." Both doctors stress that
it's not standard practice to tell patients about potential conflicts.
Before Chantix's launch in August 2006, Steinberg and Foulds say they didn't work closely with the drug industry. They say they
collected modest fees for occasional consulting for companies such as Novartis (NVS) and GlaxoSmithKline (GSK), makers of over-the-counter nicotine patches,
gum, and lozenges.
Foulds is something of a celebrity in antismoking circles. Before moving to UMDNJ in 2000, he worked with the World Health Organization and
launched an extensive telephone hotline for smokers seeking to quit. He has written several journal articles on drug treatment for smokers and blogs for
Healthline, a consumer Web site. In 2006, Pfizer recruited Foulds to serve on its paid national advisory board for Chantix. The company also selected Foulds
and Steinberg to be "key opinion leaders," sending them to talk to doctors about Chantix over fancy dinners and paying them each $900 per
presentation. Foulds and Steinberg say that between them they have made a total of about a dozen appearances.
Pfizer's aggressive promotion of Chantix helped turn the drug into a sensation. The company has directed patients to a Chantix Web site
via a ubiquitous TV ad campaign called "My Time to Quit." By the end of 2007, its first full year of sales, Chantix had nearly doubled the size of
the U.S. market for smoking-cessation products, to $1.3 billion. Meanwhile, Pfizer gave grants to physicians who wanted to study the drug in settings beyond
those examined during the approval process. Such studies could expand the medicine's potential market. Steinberg received a $30,000 grant from Pfizer in
April 2007 to study the effect of Chantix on patients forced to forgo cigarettes while hospitalized for other illnesses. He says this was his first research
grant from a drug company. (The Robert Wood Johnson Foundation separately provided $300,000 for the hospital study.)
As Chantix's popularity grew, Steinberg and Foulds encountered an obstacle that helped inspire their article advocating long-term drug
use. They found many insurance companies wouldn't reimburse for Chantix, which costs about $100 a month, or for other less expensive antismoking
Steinberg and Foulds reasoned that if they compared nicotine use with diabetes, rather than with alcoholism or other addictions, they might
help change insurers' thinking. Diabetes causes many of the long-term problems that nicotine addiction does. "We wanted to compare it to a disease
that's well-covered," says Foulds, "and alcoholism isn't well-covered."
Over the past decade, financial ties between doctors and companies have proliferated, prompting concern that treatment is distorted by
industry money. The solution that has been widely embraced is disclosure of funding sources. But the rules are inconsistent and mostly voluntary. Moreover,
disclosures typically are made in medical journals, conferences, and other venues that patients tend not to see.
On the Web site for UMDNJ's smoking clinic, it's not easy for a layman to find disclosures. There is no clearly labeled list of
companies that pay Foulds and Steinberg that is directly accessible from the home page. There are links to journal articles, some of which reveal industry
ties. But getting the information takes effort. The online version of the Annals article requires a viewer to have a paid subscription for full
access. Their twice-a-year newsletter, The Nicotine Challenger, doesn't disclose their work for Pfizer, even in articles that speak highly of Chantix. In
last winter's issue, Steinberg wrote an article called "Chantix: Miracle Pill or Dangerous Problem?" At the time, the FDA was fielding reports
of severe depression in some patients who had tried the drug. Steinberg suggested that nicotine withdrawal itself can cause depression and that it made sense
to "continue to use this effective medication in our general population of smokers." Foulds includes a broadly worded disclosure on his blog, but
doesn't name companies for which he consults. Telling patients more about industry ties "would just puzzle them," Foulds says.
The UMDNJ tobacco experts are not alone in their call for long-term drug treatment of smokers, nor are they the only such advocates with
industry ties that aren't fully transparent. A new version of the U.S. Public Health Service guidelines for treating tobacco dependence, released on May
7, urges physicians to consider prescribing drugs, including Chantix. Prepared by a panel of 24 experts, it is capped off by a five-page list of those
panelists' potential conflicts. The disclosures are less than entirely forthcoming, however. The report reveals that the panel's chairman received
research funds from four drug companies, but it doesn't name them. Some panelists are listed as having minimal or no conflicts even though they have
acknowledged more extensive industry ties elsewhere. "Conflicts are in the eye of the beholder," says Jean Slutsky, director of the federal Center
for Outcomes & Evidence, which prepared the report. "All of us come to the table with conflicts."
UMDNJ patient Cynthia Bruning says she wishes she had known that the men who run the smoking clinic had ties to Pfizer. After two years of
attempting to quit with nicotine gum and patches, she tried Chantix twice, for a month at a time, with Steinberg's counsel. She had severe stomach pain,
vivid dreams, and insomnia. She dropped the drug and resumed smoking. Chantix affects the same brain pathways as nicotine, damping the euphoria people feel
when they take a drag. That curbs cravings but might also disturb normal brain activity.
Bruning, desperate to quit, just started Chantix for a third time. Learning that her doctors are paid by Pfizer hasn't changed her mind.
But in general she believes patients should be in the loop: "I don't agree with that policy [of nondisclosure]."
Steinberg sees no need to be more forthcoming. His passion for helping people quit is fueled by treating numerous cases of high blood
pressure and other problems precipitated by smoking. He emphasizes, "We've had a lot of people being very successful with Chantix."
Foulds is more reflective about the issue. His posts about Chantix on Healthline have generated a flurry of anonymous complaints, one of
which described a relative's suicide after taking the drug. Foulds continues to speak to groups of doctors on behalf of Pfizer, but lately he has been
pressing the company to share more information about potential side effects. "I'd like the company to take another look at the data," he says.
Dr. Douglas G. Vanderburg, a senior medical director at the company, says Pfizer is reexamining nine trials of the drug and plans to publish the results in
In January and then again in May 2008, Pfizer added warnings to Chantix's label saying patients should be watched for unusual psychiatric
symptoms such as suicidal thoughts. The company says in an e-mail that it sought to give doctors "more direct guidance" on using the drug.
On May 21, the Institute for Safe Medication Practices, a nonprofit group in Horsham, Pa., released a paper based on 3,063 reports of
"adverse events" submitted to the FDA by people taking Chantix. Among the findings: 227 had suicidal thoughts or behaviors, and 525 said they had
acted with hostility or aggression. Pfizer has sent a Chantix team on the road to speak to financial analysts and journalists. Still, some Wall Street
analysts fear that the FDA will require Pfizer to add a "black box"-one of the strictest warnings that can appear on a label-to draw more attention
to side effects.
Steinberg says he might revert to prescribing more patches and gum if Chantix acquires a black box. But for now he adds: "If someone is
doing well for six months, and they say, 'I think if I stop [taking Chantix] I might relapse to smoking,' I would feel comfortable continuing that
With John Cady.
Weintraub is a senior writer for BusinessWeek's science and technology
Copyright 2000-2008 by The McGraw-Hill Companies Inc. All rights reserved.
Jan 3 10 12:01 PM
Pharmacological Aids to Smoking Cessation
Pharmacological Aids Part II
Years of Progress?
Quitting Methods: Who Should You Believe?
So How Did Most Successful Ex-Smokers Actually Quit?
Most expert say "Don't quit cold turkey"
Is Cold Turkey the Only Way to Quit?
Journal article explores pharmaceutical industry "Nicotine Fix"
Sep 11 12 7:24 AM
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