Who Should You Believe?

John (Gold)
Joined: 18 Dec 2008, 23:57

23 Jan 2007, 00:27 #21

Concerns raised over doctors'
ties to drug companies
Problem of pharmaceutical firms paying physicians 'swept under the rug in Canada,' one researcher says

Carly Weeks

CanWest News Service, Monday, January 22, 2007

CREDIT: Bruno Schlumberger, CanWest News Service

Pfizer Canada, the maker of Nicorette, pays physicians to promote the gum as a product that can help smokers quit by reducing nicotine cravings.


OTTAWA -- To celebrate the launch of its new flavoured nicotine gum, Pfizer Canada hired "brand ambassadors" dressed in ski suits to give out free samples in Calgary and Toronto and published promotional material that touted the benefits of the new product.

The company's press release declares: "using Nicorette ice mint coated gum can help smokers quit by reducing nicotine cravings and withdrawal symptoms and significantly improve their chances to quit smoking."

The promotional quote isn't attributed to a Pfizer staff member, but to a Toronto-based general practitioner, who the company says was paid for participating in the promotion.

Canadians expect doctors to provide sound, neutral advice about treatment for health issues. But information is emerging that indicates some are paid to publicize and promote smoking cessation medication, possibly influencing the way smokers approach their battle to quit.

"There's enormous connections between what the drug companies do and what and how doctors practice and what they say and what they write," said Dr. Jerome P. Kassirer, professor at the Tufts University School of Medicine and editor-in-chief emeritus of the New England Journal of Medicine.

Pfizer regularly pays physicians in Canada in exchange for testimonials and research into its smoking-cessation aids without publicly disclosing those ties.

In the last year, there have been growing calls within the medical community for a change in rules to limit relationships with drug companies that could impact a doctor's impartiality.

"These companies, who are very shrewd, are not doing all this out of benevolence. They're doing it because they know that by using these methods, they're increasing the sales of their product -- which is what they want to do," said Dr. David Korn, senior vice-president for biomedical and health sciences research at the Washington-based Association of American Medical Colleges.

Korn is part of an expert task force examining new rules and conflict-of-interest restrictions in the hopes of ending questionable relationships between drug companies and the physicians they fund.

Although the issue doesn't receive the same level of attention in Canada, the problem is alive and well here, according to medical experts.
"I think it's been swept under the rug in Canada," said Kassirer, who recently wrote a book on the subject called On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health. "I think it's a problem in Canada."

The trouble with smoking cessation medication doesn't lie with product safety -- most experts agree they can help some people quit smoking. But there are growing concerns doctors funded by the drug industry may overly promote the benefits to encourage more people to buy the medication.

Doctors are featured repeatedly in Pfizer's promotional material and often speak to the media about the benefits of nicotine replacement therapy products, such as those produced by the company. Johnson & Johnson recently purchased Pfizer Consumer Healthcare, a branch of the parent company that is responsible for nicotine replacement therapy products and other non-prescription medication.

The company uses doctors to speak about its products because hearing from a credible member of the medical community reminds people about the grave problems associated with smoking, said Johnson & Johnson spokeswoman Krista Scaldwell.

"It's the seriousness of tobacco dependence," she said. "It is an addiction, rather than a habit ... Using doctors can make that differentiation."

But others see it as doctors bending the rules of their public contract to be honest, clear and unbiased in order to do the bidding for drug companies.

"I believe that when someone has a financial conflict of interest, that they are influenced, even subconsciously, to think in terms of the gift that they're getting from the company," Kassirer said.

There is evidence to suggest physicians funded by drug companies have a favourable bias toward nicotine replacement therapy products and other smoking cessation aids. A recent Canadian study found researchers who receive money from pharmaceutical companies are more likely to conclude nicotine replacement therapy has a better chance of helping people quit than those without drug company funding.

"It's possible that because of the way science has been conducted that some of the benefits have been overestimated somewhat," said Paul McDonald, a health studies professor at the University of Waterloo, who conducted the study.

The results, which will be made public at a conference in Texas next month, illustrate the need for better disclosure and code of conduct rules so Canadians are aware of any possible influences drug companies may have over research and public statements by doctors, McDonald said.

"I think it's going to be essential for things like smoking cessation treatment ... that the funders and program providers have very explicit policies that enable them to ensure there's no conflict of interest between whatever donations they might receive from any source, whether it be a pharmaceutical source or a government or non-profit organization," he said.

One doctor who has an ongoing relationship with Pfizer agrees Canada's medical community should adopt improved codes of ethics, but said receiving money from a drug company shouldn't suggest a lack of professionalism.

"You've got to make sure as a researcher you don't get co-opted as the spokesperson for that [medication]," said Dr. Peter Selby, clinical director of addiction programs at Toronto's Centre for Addiction and Mental Health. Selby was featured in a press release on a new smoking cessation pill developed by Pfizer titled: "Magic pill to get you to quit smoking!" It was distributed in June 2005 by the Ontario government-funded Media Network for a Smoke-Free Ontario to highlight Selby's research.

"It's as easy as open, pop, swig and swallow. Well, at least it will be," reads the press release.

Selby, who is a vocal supporter of smoking cessation products, said his relationship with Pfizer doesn't influence his research. Rather, he stands behind the products because they provide options for people who want to quit, including those who may not otherwise have access to counsellors or other quitting methods.

"We've got to figure out how do we reach half-a-million smokers who want to quit," he said.

Selby said the system isn't perfect, but that advertising medication that's readily available to the general public is better than not providing options to help people quit.

"There needs to be an ethical way of doing that, there needs to be criteria as to who gets medication and who doesn't," he said.
McDonald said he's not surprised by his study's findings, since similar ones done in other countries have indicated the same, but he's disturbed by the level of research conducted with the help of private-sector funding and the fact Canadians are none the wiser.

"What concerns me is an overwhelming majority of the studies that are being conducted are being conducted in whole or in part with private-sector funding or pharmaceutical funding," he said. "It's just that we need to take that into account in trying to determine how much confidence to have."
Copyright © The Vancouver Sun 2007
Online source: http://www.canada.com/vancouversun/news ... 166896871d
Reply

John (Gold)
Joined: 18 Dec 2008, 23:57

09 Feb 2007, 21:09 #22

NICOTINE FIX

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 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.

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.

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 [url=mailto:kevin.helliker@wsj.com]kevin.helliker@wsj.com[/url]
Source link: Behind Antismoking Policy, Influence of Drug Industry
Copyright © 2007 Dow Jones & Company, Inc. All Rights Reserved
Reply

Just Hannes
Joined: 18 Dec 2008, 23:57

09 Feb 2007, 21:27 #23

This one is very familiar in the story above:

"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"

Here we call this the social chewer Image or closet chewer.

The relapse of a "social smoker" 

Frits (63 days free)
Last edited by Just Hannes on 17 May 2013, 04:22, edited 1 time in total.
Reply

John (Gold)
Joined: 18 Dec 2008, 23:57

10 Feb 2007, 00:18 #24

I was wondering if anyone here would notice that, Frits.
It's my hope that the Agency for Healthcare Research and Quality (AHRQ), which is responsible for formulating U.S. cessation policy via expert panels, will awaken to the realization that allowing stakeholders to author policy is totally unacceptable. The article notes that in 2004 the current chairman and his programs received about $1 million from cessation pharmaceutical interests. How much in cessation pharmacology funding and research would he and his programs receive next year if he were to openly declare this year that there is little or no evidence that pharmacology is effective for smoking cessation in real-world use, as suggested by the current survey data evidence-base? Going from a million to zero based upon a single assertion reflects a massive massive conflict of interest.
Reply

Joel
Joined: 18 Dec 2008, 23:57

03 Sep 2007, 06:12 #25

NICOTINE FIX

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 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.

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.

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 [url=mailto:kevin.helliker@wsj.com]kevin.helliker@wsj.com[/url]
Source link: Behind Antismoking Policy, Influence of Drug Industry
Copyright © 2007 Dow Jones & Company, Inc. All Rights Reserved
Reply

Joel
Joined: 18 Dec 2008, 23:57

05 Apr 2008, 00:01 #26

Reply

Joel
Joined: 18 Dec 2008, 23:57

08 May 2008, 03:17 #27

Not sure how much news coverage it will receive but the U.S. Public Health Service has released an updated clinical practice guideline which, to none of our surprise, pushes the use of pharmacological interventions to "help" people quit smoking. I thought it would be a good idea to pop up this string and attach the following articles to give a little background of the public health community's views on the topic of smoking cessation:
Pharmacological Aids to Smoking Cessation
Pharmacological Aids Part II
40 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"
Hooked on the Cure
Is Cold Turkey the Only Way to Quit?
Wall Street Journal article explores pharmaceutical industry "Nicotine Fix"
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Addiction - the Surgeon General says ... 4.42mb 13.2mb 1.77mb 5.49mb 12:00 10/09/06
How did the people you know quit smoking? 1.90mb 18.8mb 0.77mb 2.34mb 05:10 09/27/06
My first encounter with NRT 3.99mb 16.1mb 2.13mb 6.66mb 14:37 11/16/06
WhyQuit's candid views about Chantix (and Champix) 17.8mb 53.3mb 7.11mb 22.0mb 48:16 10/19/07

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John (Gold)
Joined: 18 Dec 2008, 23:57

01 Jul 2008, 14:41 #28

BusinessWeek, In Depth June 26, 2008, 5:00PM EST text size: TT
Doctors Under the Influence? Controversy over a Pfizer antismoking drug is fueling debate about whether patients should be told of corporate ties
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/
main4213269.shtml.
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.
"MEDICATION IS JUST A TOOL"
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.)
FRAMING A TREATMENT
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 products.
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 2009.
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 medication."
With John Cady.

[url=mailto:arlene_weintraub@businessweek.com]Weintraub[/url] is a senior writer for BusinessWeek's science and technology department.
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Copyright 2000-2008 by The McGraw-Hill Companies Inc. All rights reserved.
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FreedomNicotine
Joined: 06 Dec 2008, 16:58

03 Jan 2010, 16:01 #29

Being that we are in to the New Year's, an advertising blitz has been going on in the media, in the form of radio, television and print ads. It may seem confusing to people first considering quitting and finding their way here to Freedom, for so much of what the ads say is in direct contradiction to what we teach here at Freedom. This thread discusses these contradictions. Other resources here at the site that explore the differences between quitting cold turkey and using various quitting aids are:
40 Years of Progress?
Hooked on the Cure
Wall Street Journal article explores pharmaceutical industry "Nicotine Fix"
Related Videos:
Video Title
Dial-Up
HS/BB
Audio
MP3
Length
Added
Addiction - the Surgeon General says ... 4.42mb 13.2mb 1.77mb 5.49mb 12:00 10/09/06
How did the people you know quit smoking? 1.90mb 18.8mb 0.77mb 2.34mb 05:10 09/27/06
My first encounter with NRT 3.99mb 16.1mb 2.13mb 6.66mb 14:37 11/16/06
WhyQuit's candid views about Chantix (and Champix) 17.8mb
Reply

Joel Spitzer
Joined: 13 Nov 2008, 14:04

11 Sep 2012, 11:24 #30

Last edited by Joel Spitzer on 11 Sep 2012, 13:03, edited 1 time in total.
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