AUSTIN, Texas — Nobody has to tell Ken Albrecht how tough it is to quit cigarettes.
“I’m old enough that everybody I knew when I was growing up smoked,” the Dallas resident said. “If there’s a way to help get people off cigarettes, that’s fine...” But his voice trailed off as he recounted a dinner four years ago at a restaurant in Dallas, the 34th birthday celebration for his son, Carter.
Back then, Carter Albrecht had plenty to celebrate. His indie pop band, Sorta, was drawing crowds. On keyboards, he was landing high-profile gigs with Paul Simon and other national acts. He had a recording session lined up with Charlie Sexton.
Over dinner that night, Carter had talked about a new pill called Chantix. Carter was convinced that it would help him kick his smoking habit. His parents now think the pill led to his death, and they’re part of a class action suit accusing manufacturer Pfizer of concealing that the product could cause erratic behavior. Pfizer denies the allegations, but the plaintiffs may have gotten a boost from a recent study linking bizarre psychological episodes to the main ingredient in Chantix.
The pill’s active ingredient, varenicline tartrate, was said to work by interfering with the brain’s response to nicotine, interrupting the pleasure sensation and manipulating dopamine levels.
In promotional materials, Pfizer had said 44 percent of smokers in its drug tests had quit within 12 weeks of taking Chantix. Potential side effects, according to an ad transcript, included “nausea, headache, insomnia and abnormal dreams.”
In 2007, its first full year on the market, sales of Chantix peaked at $883 million.
Ken Albrecht and his wife, Judy, heard their son out.
“Both Judy and I had a reaction at the time that taking a pill to stop smoking didn’t make sense,” Ken Albrecht said. “I said, ‘What does it do?’ And Carter said, ‘It changes the chemistry of your brain.’ And Judy said, ‘What?’ And Carter said, ‘No, just the thing where you want nicotine.’”
On Sept. 3, 2007, after a night of drinking in Dallas bars, Carter Albrecht beat up his girlfriend, stormed off and tried to kick in the door of nearby house. From inside, a neighbor shot him dead.
“I really believe it was the drug,” his girlfriend, Ryann Rathbone, told the Dallas Morning News the next day. “He would have never been abusive toward me, never, ever.”
The case, cast as a crazy-Texans-and-their-guns story, made national headlines. Ken Albrecht’s phone rang and rang.
“We were just inundated with calls from people saying, ‘This happened to my brother or my sister,’” Albrecht said. “That was all I needed to listen to, having my heart totally broken, other people who thought it was just them.”
Over the next few years, the Food and Drug Administration received hundreds of reports of erratic behavior among users of Chantix. More than 1,000 lawsuits, including the Albrecht family’s, were consolidated into a class action in federal court in Alabama. Plaintiffs claim the company failed to disclose the side effects; Pfizer denies the accusations. A trial remains distant.
For the big drug companies, the smoking-cessation market remains lucrative. According to a report released last week by the Centers for Disease Control and Prevention, based on 27,000 interviews, 68.8 percent of American adult smokers want to quit, 52 percent have tried to within the past year and only 6 percent succeeded.
But evidence continues to mount against Chantix. Last week, researchers at several major universities reported the findings of their study on nicotine-replacement products in the journal PLoS One. Out of 3,249 cases of psychological episodes reported to the FDA, 90 percent were linked to the ingredient in Chantix, 7 percent to bupropion, sold under the name Wellbutrin, and 3 percent to nicotine-replacement products.
The researchers urged the FDA, which has already started requiring Pfizer to warn patients of psychological side effects, to classify Chantix as a last resort for patients who have failed to quit using other treatments.
“What we know now is that when we compare the safety profile of the three smoking-cessation categories, the Chantix profile looks the worst,” the lead researcher, Thomas Moore of Institute for Safe Medication Practices in Alexandria, Va., told The Daily.
“Pfizer stands behind the benefit-risk profile of Chantix,” the company said in a statement.
New scientific research may lead only to more scientific research, said Linda Mullenix, a law professor at the University of Texas. Corporate defense lawyers, she said, take their guidance from the case of Dow Corning, which collapsed into bankruptcy in the face of lawsuits concerning its silicone breast implants.
“The corporate defendants are not going to sit by,” she said. “There will either be counter studies, or they’ll bring expert testimony to question the studies.”
Told about all the new research in a telephone interview, Ken Albrecht choked up at the memory of his son’s last birthday dinner.
“Both of us looked at each other,” Albrecht recalled. “And he ended up taking the pill. And the rest is history.”
“I’m old enough that everybody I knew when I was growing up smoked,” the Dallas resident said. “If there’s a way to help get people off cigarettes, that’s fine...” But his voice trailed off as he recounted a dinner four years ago at a restaurant in Dallas, the 34th birthday celebration for his son, Carter.
Back then, Carter Albrecht had plenty to celebrate. His indie pop band, Sorta, was drawing crowds. On keyboards, he was landing high-profile gigs with Paul Simon and other national acts. He had a recording session lined up with Charlie Sexton.
Over dinner that night, Carter had talked about a new pill called Chantix. Carter was convinced that it would help him kick his smoking habit. His parents now think the pill led to his death, and they’re part of a class action suit accusing manufacturer Pfizer of concealing that the product could cause erratic behavior. Pfizer denies the allegations, but the plaintiffs may have gotten a boost from a recent study linking bizarre psychological episodes to the main ingredient in Chantix.
The pill’s active ingredient, varenicline tartrate, was said to work by interfering with the brain’s response to nicotine, interrupting the pleasure sensation and manipulating dopamine levels.
In promotional materials, Pfizer had said 44 percent of smokers in its drug tests had quit within 12 weeks of taking Chantix. Potential side effects, according to an ad transcript, included “nausea, headache, insomnia and abnormal dreams.”
In 2007, its first full year on the market, sales of Chantix peaked at $883 million.
Ken Albrecht and his wife, Judy, heard their son out.
“Both Judy and I had a reaction at the time that taking a pill to stop smoking didn’t make sense,” Ken Albrecht said. “I said, ‘What does it do?’ And Carter said, ‘It changes the chemistry of your brain.’ And Judy said, ‘What?’ And Carter said, ‘No, just the thing where you want nicotine.’”
On Sept. 3, 2007, after a night of drinking in Dallas bars, Carter Albrecht beat up his girlfriend, stormed off and tried to kick in the door of nearby house. From inside, a neighbor shot him dead.
“I really believe it was the drug,” his girlfriend, Ryann Rathbone, told the Dallas Morning News the next day. “He would have never been abusive toward me, never, ever.”
The case, cast as a crazy-Texans-and-their-guns story, made national headlines. Ken Albrecht’s phone rang and rang.
“We were just inundated with calls from people saying, ‘This happened to my brother or my sister,’” Albrecht said. “That was all I needed to listen to, having my heart totally broken, other people who thought it was just them.”
Over the next few years, the Food and Drug Administration received hundreds of reports of erratic behavior among users of Chantix. More than 1,000 lawsuits, including the Albrecht family’s, were consolidated into a class action in federal court in Alabama. Plaintiffs claim the company failed to disclose the side effects; Pfizer denies the accusations. A trial remains distant.
For the big drug companies, the smoking-cessation market remains lucrative. According to a report released last week by the Centers for Disease Control and Prevention, based on 27,000 interviews, 68.8 percent of American adult smokers want to quit, 52 percent have tried to within the past year and only 6 percent succeeded.
But evidence continues to mount against Chantix. Last week, researchers at several major universities reported the findings of their study on nicotine-replacement products in the journal PLoS One. Out of 3,249 cases of psychological episodes reported to the FDA, 90 percent were linked to the ingredient in Chantix, 7 percent to bupropion, sold under the name Wellbutrin, and 3 percent to nicotine-replacement products.
The researchers urged the FDA, which has already started requiring Pfizer to warn patients of psychological side effects, to classify Chantix as a last resort for patients who have failed to quit using other treatments.
“What we know now is that when we compare the safety profile of the three smoking-cessation categories, the Chantix profile looks the worst,” the lead researcher, Thomas Moore of Institute for Safe Medication Practices in Alexandria, Va., told The Daily.
“Pfizer stands behind the benefit-risk profile of Chantix,” the company said in a statement.
New scientific research may lead only to more scientific research, said Linda Mullenix, a law professor at the University of Texas. Corporate defense lawyers, she said, take their guidance from the case of Dow Corning, which collapsed into bankruptcy in the face of lawsuits concerning its silicone breast implants.
“The corporate defendants are not going to sit by,” she said. “There will either be counter studies, or they’ll bring expert testimony to question the studies.”
Told about all the new research in a telephone interview, Ken Albrecht choked up at the memory of his son’s last birthday dinner.
“Both of us looked at each other,” Albrecht recalled. “And he ended up taking the pill. And the rest is history.”
