Behind Antismoking Policy, Influence of Drug Industry - Wall Street JournalFebruary 8, 2007, Page A1Government Guidelines Don't Push Cold Turkey; Advisers' Company TiesBy 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.FISCALLY FIT
• 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."
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.RELATED READING
Questions about the so-called real-world effectiveness of NRT began with this California study, published in 2002 in the Journal of the American Medical Association.This thorough review of the published literature on nicotine replacement therapy found substantial evidence for its efficacy.Presented at a world tobacco conference in the summer of 2006, this National Cancer Institute survey of 8,200 smokers trying to quit found surprising success rates for those not using medication.The U.S. Surgeon General's advice 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.
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.
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 firstname.lastname@example.org
WSJ RELATED READING:Impact of Over-the-Counter Sales on Effectiveness of Pharmaceutical Aids for Smoking CessationJAMA. 2002;288:1260-1264.Nicotine replacement therapy for smoking cessationThe Cochrane Database of Systematic Reviews 2006 Issue 4
http://220.127.116.11/reviews/en/ab000146.htmlWhat Does U.S. National Population Survey Data Reveal About Effectiveness of Nicotine Replacement Therapy on Smoking Cessation?NCI, US DHHS (WCTOH 2006 PPT)You can quit smokingUS Surgeon General (May 2003)
Everybody Loves a Quitter - Wall Street JournalFebruary 8, 2007FISCALLY FITBy TERRI CULLENTerri's Husband Stops Smoking 'Cold Turkey,' But Is That the Best Way to Kick the Habit?
Late last year, just after my husband Gerry turned 40, he promised me that at New Year's he'd quit smoking for good. So far, I'm happy to say, he's kept his promise.
Stopping now may add years to Gerry's life. The Centers for Disease Control and Prevention estimates that adult male smokers lose an average of 13.2 years of life and female smokers lose an average of 14.5 years of life because of smoking.TALK WITH TERRI
How do you convince a loved one to stop smoking? Former smokers, did you quit cold turkey or use medication and/or therapy? What tips do you have for preventing a relapse? Join me and your fellow readers in a discussion on the best ways to kick the habit.
While I'm thrilled Gerry's trying to live a healthier lifestyle, he's made it tougher on himself by quitting cold turkey. Gerry doesn't believe in medicating his way to quitting, because he doesn't believe in medicating his way to anything. (Seriously, it's easier to get our dog to swallow a pill.) He also balked at the cost of smoking-cessation treatments. Nicotine-replacement patches and gum costs $40 to $60 per kit, which can cover up to 12 weeks of treatment, while Pfizer's antismoking drug Chantix costs about $3.79 a day.
Quitting cold turkey has definitely saved us money, but five weeks of a smoke-free Gerry has been hard on everybody: He's been extremely irritable, snapping at my family and his coworkers. (Though apologies soon follow.) His hands are also shaky, causing him more frustration because he's constantly dropping tools at work. And he's gaining weight from eating everything in sight.
Despite the drawbacks, Gerry says he can already feel the difference in his body after almost 25 years of smoking. He's breathing a bit easier, and the rattling cough that greets me each morning is fading. What delights Gerry is how much better things smell and taste. "I feel like I'm tasting pizza for the first time," he said one night while we were dining out. (This may be one of the reasons he's eating so much more.) He's also saving money: Gerry was a relatively light smoker, going through a pack every three days. At $6.50 a pop, he'll still save $1,014 a year by breaking the habit.
It's impossible to put a price on the potential benefit to his health. Smoking is the most-preventable cause of serious illness and premature death, according to the U.S. Centers for Disease Control and Prevention. Roughly 45 million Americans smoke, and one in five deaths each year are smoking-related, the CDC says. In fact, Gerry's father's brush with throat cancer last year strengthened my husband's resolve to quit.
Like Gerry's dad, my parents smoked heavily in their younger years. I remember vividly when I was a child helping my mom take down curtains for cleaning -- white curtains stained yellow from the smoke that permeated our apartment. It turned me off smoking for life. For her part, my mom remembers all the times I urged her to quit and -- as the medications and doctors visits mount -- she now wishes she'd stopped sooner. When my mom finally decided to give up smoking at age 45 she stopped cold turkey, and she says it was one of the hardest things she's ever done.
How early in life you quit smoking has enormous consequences. A June 2004 study of nearly 35,000 male British doctors showed that the doctors who stopped smoking at age 60 gained at least three years of life expectancy. Those who stopped at age 50 gained six years and those who stopped around age 40 gained nine years. Smokers who quit before age 35 had nearly the same life expectancy as non-smokers, the study found.
I knew Gerry was potentially shortening his life by smoking, but I never urged him to stop -- I believed the only way he'd successfully quit would be to resolve to do it on his own. Besides, I begged my parents to quit for years to no avail, so what good would nagging Gerry do? The fact is, I didn't need to convince him -- for the last 10 years Gerry's been saying he knows he needs to stop. Each time he'd say it, I'd agree and point out that he's not getting any younger. When he finally told me that turning 40 and dealing with his father's cancer had convinced him it was time to quit, I was relieved, feeling he'd finally give it up for good. Still, I urged him to consider medication to deal with withdrawal. Typical of Gerry, he was determined to tough it out.
But is that a good idea? Corinne Husten, Epidemiology Branch Chief at the CDC's Office on Smoking and Health, says trying to quit on your own without the help of smoking-cessation aids is the least-effective way to quit. Just about any type of assistance to quit smoking can double your chances of success, she says.
Studies have shown that products such as nicotine-replacement patches and gum, and services such as individual or group counseling, are more effective at getting smokers to quit than going cold turkey. Some studies have shown that prescription drugs may be slightly more effective than over-the-counter medications, Dr. Husten says.
Still, while most studies show that smoking-cessation products and services are more effective than going cold turkey in the near term, there's debate in the health-care community over whether that's true over time. As this article [Ed. note: See front-page WSJ story above] explains, even in trials where medicine doubled success rates, about 90% of users relapsed. Critics also question the pharmaceutical industry's influence on studies the government uses to make recommendations about medication to help smokers quit.
Ideally, smokers should talk to their doctors first about which way to proceed in case there are issues with medical history that might dictate one treatment over another. Regardless, it's a good idea for smokers to try various smoke-cessation treatments and services to determine which works best for them, Dr. Husten says: "If one treatment's not working, try something else."
People who want to stop smoking can find support services, both in person and by telephone, by calling (800) QUITNOW. Callers will be referred to local treatment centers where they can get counseling and other assistance to help smokers quit. For those who can't afford treatment programs or medication, some states offer free services.
A month into his mission to stop smoking, Gerry's grown even more adamant that he doesn't need help. Still, it's clear the worst isn't over -- he's as tense as ever and his food binging is starting to worry me. If his withdrawal symptoms don't ease soon, I'll urge him to reconsider trying to go it alone. I also jotted down the Quitnow number and placed it in his wallet, in case there's a time when he feels an overwhelming urge to have a cigarette.
So what's Gerry doing with the money he's saving by quitting smoking? To show Gerald how much money we save by not smoking, Gerry drops a $20 bill into the college-savings section of Gerald's four-slotted piggy bank each week. (Eventually, we'll deposit the money into his 529 college savings account.) Gerry tried his best to never smoke where our son could see him -- in fact, he was so paranoid about it that I wonder if Gerald even knows of his father's habit. But at seven, he's old enough to have seen adults and older children smoking -- and, like any child, to be curious about it.
Even if Gerald doesn't know about his father, he's seen what smoking can do to the people he loves. We talked with Gerald about the dangers of smoking back when his grandfather was diagnosed with cancer -- the oncologist provided a photo of the tumor in my father-in-law's throat that helped drive that lesson home. Gerry hopes his frequently pointing out the cost of smoking, combined with our continuing to talk about the health risks, will be enough to discourage Gerald from picking up the habit.
How do you convince a loved one to stop smoking? Former smokers, did you quit cold turkey or use smoking-cessation treatments? What tips do you have for preventing a relapse? Write to me at email@example.com, and then join me and your fellow readers in an ongoing discussion on the best ways to kick the habit.WSJ Forum:Referenced BMJ study:Mortality in relation to smoking: 50 years' observations on male British doctors