Maker of Chantix sponsors UW course on smoking cessation
By John Fauber of the Journal Sentinel
* Side Effects: Are Doctors' Loyalties Divided?
A Pfizer promotional campaign for the controversial drug Chantix - which includes financing a course for doctors through the University of Wisconsin-Madison - has helped the drug dominate the prescription smoking-treatment market while burying mention of its serious side effects.
Chantix now accounts for 90% of smoking cessation prescriptions, even though the Food and Drug Administration has been investigating the drug for a rash of serious side effects, such as suicidal behavior and blackouts.
None of the side effects are mentioned in the UW continuing education online course, which is paid for by Pfizer. The course directly mentions only Chantix as a first-line treatment, even though the drug is one of seven first-line treatments, according to national guidelines.
Further, organizations such as the Department of Veterans Affairs, say Chantix should not be considered as a first-line treatment.
Last May, the VA's pharmacy benefits management services raised concerns about the drug's side effects. That followed the Federal Aviation Administration's ban on the drug for pilots and air traffic controllers.
And unlike most drugs that are advertised to consumers and that list side effects, Pfizer's "My Time to Quit" ads do not mention any of those problems. One recent ad doesn't even mention Chantix by name.
"I suspect that it is a way to avoid having to address head-on that this product has some potentially very serious side effects," said Dominick Frosch, an assistant professor of medicine in the UCLA Department of Medicine.
Earlier ads run by Pfizer have mentioned the drug's side effects.
Frosch noted that there are several alternative treatments for quitting smoking, including five nicotine-based products - like the patch or gum.
Would smokers rather use one of those products "or a drug that might make me suicidal?" he asked. "I think it's a no-brainer."
Pfizer defends product
Sally Beatty, a spokeswoman for Pfizer, said Chantix is a highly effective treatment, resulting in 22% of smokers abstaining one year after treatment, compared with 9% of those who got a placebo. She noted that smoking is responsible for 438,000 deaths a year in the U.S.
Beatty said the goal of the "My Time to Quit" campaign is to help people quit smoking.
She said the idea is to provide information about nicotine addiction and reinforce the value of talking to a doctor about setting up a plan to quit smoking.
Pfizer's grant to UW is unrestricted and it has no role in the course content, she said.
She said Pfizer communicates all relevant information about the safe use of the drug to doctors and patients in numerous ways, including on the drug's package label.
"When considering the use of Chantix (varenicline) for their patients, health care providers should discuss the risks of smoking, the health benefits of quitting and the product's efficacy and safety profile," Beatty said. "Pfizer believes the benefits of Chantix outweigh its risks."
UW officials said doctors do not take the class expecting that it is the equivalent of "Smoking Cessation 101." They use such courses to fill in gaps, not to learn a subject comprehensively for the first time, according to a statement from the communications office of the UW School of Medicine and Public Health.
And there are links that can be clicked on that will take doctors to the national guidelines that address all the first-line treatments and issues such as side effects.
"Learners understand how the course is designed," the statement says.
Linking to the guidelines is not required to obtain credit for the course.
Public targeted directly
The UW course and the Pfizer's "My Time to Quit" ads are examples of two emerging trends in medicine: Dramatic growth in spending by drug companies to advertise directly to consumers, as well as drug company funding of doctor education courses that promote drugs made by those companies.
The typical American consumer now sees about 16 hours of prescription drug television ads each year.
In 2005, $4.2 billion was spent on such ads, compared with $1.1 billion in 1997.
At the same time, drug company funding of continuing medical education courses for doctors increased from $302 million in 1998 to $1.2 billion in 2006.
Pfizer pays for UW course
UW's smoking cessation course is being paid for as part of a $3.5 million grant from Pfizer. So far, about 140 learners, including about 100 doctors, have taken the course.
At UW, drug companies spend about $13 million a year to fund its doctor education courses, and the university receives about 27%, or nearly $3 million of that money. The rest goes to other entities such as the private firms that put together the course materials.
Steven Teplinsky, a 45-year-old Milwaukee native now living in Baltimore, said he took Chantix two years ago. Teplinsky, who has schizophrenia, said he stopped smoking for about five weeks and then got uncomfortable and anxious. He said he thought he might have to go into the hospital.
But after going off the drug and starting to smoke again, he stabilized, he said.
He said he would never go on the drug again. "My mental health is so important."
On the other hand, Crystal Goodwill, 30, and her husband, Anthony, 30, went on the drug about a year ago and had no significant problems, she said.
Goodwill, who works as a financial assistant at the Medical College of Wisconsin, was prescribed the drug by Ileen Gilbert, who directs the smoking cessation program at Froedtert Hospital.
She said she had night terrors on one occasion, but she and her husband have continued to abstain from smoking, even after going off the drug. They took it for three months.
"I had a great experience with it," said Goodwill, who tried other methods to quit but was unsuccessful.
It should not be a surprise that Pfizer has been able to maintain a strong market share for Chantix despite all its problems, said Michael Oldani, a former Pfizer drug representative who now works as an assistant professor of medical anthropology sociology at UW-Whitewater.
From doctor education courses and television ads that don't discuss the drug's side effects, to an army of drug reps and medical experts who are able to spin information about the drug, it's classic drug marketing, said Oldani, who writes about pharmaceuticals and culture.
"You need experts to be selling the drug, reps doing damage control and medical consumers requesting it by name," he said. "They have mastered the way to maintain market share."
Both the consumer ads and the doctor education courses often start within two years of when the FDA approves a new drug.
Effects often unforeseen
That's also when problems with unforeseen side effects often occur.
Clinical trials of a drug often exclude large numbers of people with various conditions. The clinical trials of Chantix excluded people with mental disorders along with many other conditions.
Just last month, a new FDA analysis of Chantix published in JAMA showed there were 153 cases of suicidal thoughts or suicidal behavior among users of the drug between May 2006, when it was approved, and November 2007.
And those cases likely represent only a fraction of the actual number, the FDA says.
No link was found between suicide and several nicotine skin patch products.
The JAMA report noted that in the first quarter of 2008, Chantix accounted for more serious injuries (1,001) than the top 10 best-selling drugs combined (837).
Nevertheless, in 2008, its sales were $525 million, which amounted to about 90% of both dispensed prescriptions and total dollars, according to data supplied by IMS Health.