Anti-smoking drug linked to suicide

Would you take a wonder drug that offered to free you from decades of
nicotine addiction? Even if other users reported sinister psychological
side effects? For Derek de Koff, the answer was easy – after 12 years as a
smoker, he was ready to try anything to kick the habit. Or so he thought...

I'd heard about Chantix, a relatively new drug from Pfizer that blocks
nicotine from attaching to your brain receptors. That way, you stop
receiving any pleasure from cigarettes at all. The drug, snuggling up to
those receptors the same way nicotine does, reduces withdrawal cravings
and unleashes a happy little wash of dopamine to boot. Wonderful things
they can do nowadays.

My doctor wished me luck as he wrote out the prescription, telling me it
was the single most important decision I'd ever make. I had the medication
that night, 35 minutes after dropping into a pharmacy. While waiting, I
gleefully chain-smoked Parliament Lights. One of Chantix's big perks is
that you can smoke for the first seven days you're on it (most people take
it for 12 weeks) – more than enough time, I thought, to say goodbye to an
old friend.

I swallowed my first pill the next day before work. It was a beautiful
autumn morning, an almost obnoxiously cinematic day to turn over a new
leaf. But by the time I was halfway to the office, I started to feel a
slight nausea coming on. Of course, that is a common side effect, as are
constipation, gas, vomiting and changes in dreaming. These five symptoms
were emblazoned in a large font on the patient-information sheet.

My stomach settled as I finished my first cup of coffee. I slipped into my
boss's office, proudly announcing that I'd just started taking Chantix.
"You've probably seen the commercial," I said. A CGI tortoise races
against a sprightly CGI hare, while a paternal voiceover reminds us that
quitting smoking "isn't for sprinters... it's all about getting there!"
Clinical trials demonstrate a whopping 44 per cent of patients were still
off cigarettes after 12 weeks, the ad says. The tortoise winks knowingly.

"You know, I saw something about Chantix," my boss said, sounding vaguely
concerned. He tracked down the story on a CBS website. It was a
sensational report on Carter Albrecht, a Dallas musician formerly with
Edie Brickell & New Bohemians. Albrecht had started taking Chantix with
his fiancée, with seemingly dramatic consequences. She claimed he had had
bizarre hallucinations that worsened when he drank. One evening he
attacked her, something he'd never done before. He then ran to his
neighbour's house and kicked at the door, screaming incomprehensibly. The
neighbour was so panicked he wound up shooting Albrecht through the door,
killing him.

I tried not to roll my eyes. It seemed obvious this was nothing more than
scaremongering – perhaps Big Tobacco had launched a spin campaign.
Millions of Americans were on Chantix. Why focus on the negatives?

The next night, I nodded off listening to Radiohead's In Rainbows, feeling
a little guilty that I'd paid zero dollars for it. I had a quick blip of a
dream: a dark, inky fluid was jolting violently from the corners of my
ceiling, zigzagging its way across the walls and wooden floor in jerky
sync to the music.

It was only a dream, though it seemed more immediate and visceral than my
usual fare, which I rarely remember after waking up. The following night,
things got even stranger. I fell asleep with Bravo blaring on my TV and
dreamed that a red-faced Tim Gunn was pushing me against the wall. "But I
always thought you were so nice," I said.

By night four, my dreams began to take on characteristics of a David
Cronenberg movie. Every time I drifted off, I'd dream that an invisible,
malevolent entity was emanating from my air conditioner, which seemed to
be rattling even more than usual. I'd nap for 20 minutes or so before
bolting awake with an involuntary gasp. I had the uneasy sense that I
wasn't alone.

I smoked a cigarette, then tried going back to sleep. But each time I
started napping, I'd dream that something increasingly ominous – carbon
monoxide? vampires? – was sucking the vital essence out of me. Soon the
clock on my desk ticked over to 3.20am.

The most unsettling thing about sleeping on Chantix is that I never felt
like I was truly asleep. Some part of me remained on guard. It was more
like lucid dreaming, what I thought it might feel like to be hypnotised.
And it didn't entirely go away come morning. As I showered, shaved and
scrambled into clothes, I tried to shake a weird, paranoid sense that I'd
just been psychically raped by a household appliance.


The early problems with Chantix

On 25 January, Pfizer was able to share some good news: Japan – where 40.2
per cent of all men still smoke – had green-lighted the manufacturing and
marketing of its smoking-cessation drug. But a few days later, the Chantix
news was less cheering. On 1 February, the US Food and Drug Administration
(FDA) warned that Chantix, which had fourth-quarter sales of $280m (£143m
– up from $68m a year ago), could cause serious psychiatric problems,
including suicidal thinking. Several weeks earlier, Pfizer had
independently changed the small-print booklet that accompanies all drugs
to say: "All patients... should be observed for neuropsychiatric symptoms
including changes in behaviour, agitation, depressed mood, suicidal
ideation and suicidal behaviour." (Previously the fine type had listed
suicidal ideation as a rare adverse reaction.)

Now, after investigating an escalating number of complaints from doctors,
patients and healthcare providers, the FDA was citing 34 suicides and 420
instances of suicidal behavior in the US. Couldn't those cases have had to
do with depression brought on by nicotine withdrawal, compensatory
dopamine notwithstanding? Perhaps, said the agency, but some occurred
among people who were still smoking while taking the pill.

Varenicline, Chantix's chemical name, was approved by the FDA in 2006. In
development for over a decade, it is the first smoking-cessation medicine
designed to work specifically on nicotine receptors, and at first glance
it would appear that it performed quite well in testing. "At week 12, we
looked at how many of the smokers didn't touch a cigarette for the last
four weeks of treatment," says Dr Anjan Chatterjee, a medical director at
Pfizer. "Forty-four percent." But the tortoise in the ad doesn't say how
patients fared later on. "About 23 per cent still hadn't taken a puff from
week nine to week 52," Chatterjee admits, "so the relapse rate was about
77 per cent." Still, that's not bad given that only 7 per cent of smokers
using the nicotine patch or gum are still off cigarettes after six months.

A total of 3,659 people were hand-picked for the Chantix tests before it
came on to the market, an almost equal number of men and women, with an
average age of 43. Nearly all were white, and the tests excluded anyone
with a history of depression, panic disorder, heart disease, kidney or
liver problems, alcohol or drug abuse, and diabetes. These exclusions
aren't mentioned in the original "Who Should Not Take Chantix" part of the
patient-information sheet, which merely states that the drug wasn't tested
on people under 18. (Pfizer does tell patients they should let their
doctors know if they have kidney problems or take insulin.)

Around five million prescriptions have been filled in the US thus far. So
why would so many groups have been excluded from the testing, particularly
for a drug with such potential mass appeal? "In order to satisfy the FDA's
criteria, we have to isolate all the different variables that could affect
the outcome," says Chatterjee. "We can't use very sick people or people
who would not tolerate the drug." An FDA spokesman acknowledges this:
"It's not unusual to exclude people with major medical or psychiatric
illnesses from some clinical trials," says Susan Cruzan.

"When they tested the drug, the sample they chose simply isn't
representative of the people they're targeting," says Dr Daniel Seidman,
the director of smoking cessation services at Columbia University Medical
Center. "By excluding drinkers, you're artificially inflating your
results, potentially. I run a clinic, and two out of three [smokers] I see
have a psychiatric or mood problem. None of these people would have been
part of the original trials."

Public Citizen, a consumer-advocacy group, recommends that people not use
Chantix – or most new drugs, for that matter – for seven years. "The first
seven years are when problems will occur," says Dr Sidney Wolfe, editor of
worstpills.org.

"I remember hearing that argument," Chatterjee said, a few weeks before
the FDA's new warning was issued. "And it's just so illogical. If no one
uses the drug for seven years, there's no one to report experiences at the
end of seven years – so you're exactly where you were at the beginning."

While I was on Chantix, I didn't scan websites for news about it. As my
dream life continued plunging into strange and increasingly grotesque
territory, I did think of Carter Albrecht a couple of times, but his story
still seemed like a freakish occurrence. As Chatterjee would explain:
"What we know of the story has come only from the press. But the level of
alcohol in [Albrecht's] body was over three times the legal drinking limit
in Texas. In the controlled clinical trial, these kinds of changes in
behaviour were extremely rare, occurring almost as often as with the
placebo. Based on the tests, we have no evidence of any kind of consistent
relationship between Chantix and aggressive behaviour." Nor was the rate
of depression any different between those taking Chantix and those on a
placebo.


Self-destructive fantasies begin to set in

It wasn't until after I'd stopped taking Chantix (and switched to the
patch) that I would read about other cases, ones in which violence was
directed inward rather than out. In December, Omer Jama, a TV news editor
in the UK, slashed his wrists and died a few weeks after going on Champix.
(In the UK, Chantix is known as Champix, but the FDA objected to the name
because it was "overly fanciful and overstates the efficacy of the
product".) Shortly thereafter, a 36-year-old welder hanged himself after
completing a 13-week Champix regimen.

The term suicidal ideation looks pretty dead on the page, and if you were
ever to experience such a symptom, it's unlikely you'd pick up on it right
away: "Here comes that damned suicidal ideation again. I had better call
my physician." For me, self-destructive fantasies slowly began cropping up
as cartoonish flights of fantasy – nagging, almost imperceptible chatter
that became a little more concrete and domineering with every passing day.

A week into my Chantix usage, I started to feel as if the city landscape
had imperceptibly shifted around me. Mundane details began to strike me as
having deep, hidden significance. The neon arch above McDonald's: the
lights blinked on and off in some sort of pattern, and I needed to crack
the code. One of my co-workers was messing with some papers: what is he
trying to imply with all that damned crinkling? Sitting in the subway: a
man hurries to get inside. His hand, holding a cup of coffee, gets stuck
in the closing door. I watch the hand wriggle. The lid bursts open and
steaming brown liquid hits the floor. Fingers twitch and splay. Coffee
splashes in criss-crossing slats through the subway car. It was a sign –
something bad was going to happen.

It felt as if the essential barrier between reality and my imagination had
eroded. Was it because I wasn't getting enough REM sleep, so my dream life
was rebelling, pouring into daylight, insisting to be attended to, one way
or another?

Meanwhile, smoking cigarettes had become an exercise in futility. At work,
I'd put on my coat, head out, and light up – but there was no pleasure to
be found, just a truly nasty taste.

One afternoon, I was typing away at advertising copy and as I did so, I
began to wonder how I had succeeded in fooling myself that my life had any
sort of value at all. Writing? Sure, it was what I'd wanted to do since I
was six – but at the end of the day, who cared? Maybe I should just go
downstairs and leap in front of a tour bus. Or launch my head through the
computer screen. All this seemed logical, but also weirdly funny, even at
the time: I could see how crazy these impulses were, I could recognize
them as suicidal clichés. But I couldn't make them go away.

A few minutes later, they did, and I thought, "Who was the depressed
seventh-grade goth girl who had just muscled into my brain?" I hadn't
thought of suicide in any serious way since I was a teenager, and that had
just been adolescent posturing. I had no interest in killing myself –
that's why I wanted to quit smoking in the first place.

Seidman, who has seen only a handful of patients on Chantix, says that:
"One guy said he was having waking nightmares – actually experiencing
nightmares while he was awake." Last week, Dr Mary O'Sullivan, the
director of the smoking cessation programme at St Luke's-Roosevelt
Hospital, part of Columbia University in New York (who, like Seidman, says
she has no ties with Pfizer), saw her first Chantix patient with "suicidal
ideation". This was "quite a shock", she says. "He had no background of
mental illness, no underlying tendency to depression." However, before
then she had "given it to well over 200 patients without a single side
effect". And she still believes that in terms of smoking cessation: "It's
been a miracle drug."

"I haven't seen suicide in patients, and I haven't seen psychotic breaks,
either," says Dr Elliot Wineburg (also no Pfizer affiliation) of the Mount
Sinai School of Medicine. "But as far as people successfully quitting
smoking, I also haven't seen great results."

My own, spectacularly unscientific, survey of people on the drug was
equally mixed. "It's getting easier by the day," says Nicholas Bullock, a
27-year-old art director. "And the nausea has stopped as well." Others
said Chantix worked but left them feeling temporarily lobotomised. Chris
Masters, a 26-year-old investment-firm manager, began experiencing
"daytime hallucinations. In the car, I'd feel my cell phone vibrate and
roll the window down." On the way to a wedding in the country, "I decided
I would plough into a herd of sheep if the street I was looking for didn't
come up soon." And then there's Elizabeth McCullough, a 48-year-old
musician. "Chantix made me desperately suicidal, just crazy," she says. "I
joked to my friends that Chantix was the ultimate quit-smoking drug,
because when you kill yourself, there's no chance of relapse."


Fantasies progress into blackouts and hallucinations

Since the FDA's announcement, those hare-and-tortoise commercials seem to
have disappeared from the airwaves. Is the voice-over being retooled?
"Yes, we're currently updating our branded campaign in order to reflect
the changes to the label," says Francisco Debauer, a Pfizer spokesperson.
"In the meantime, we'll be airing our unbranded ad in TV and print" – the
My Time to Quit campaign, which never mentions Chantix, but directs people
to a website that eventually leads to them to another, which does.

The drug would appear to be at a crossroads – perhaps the worst, rarest
adverse reactions have been reported, perhaps more cases are still to
come. Pfizer says no lawsuits have been filed, but there are certainly
injury lawyers hungrily putting up Chantix web-pages. Smokers who want to
quit are left with a more difficult decision – and the strong advice, if
they do take the drug, to be on the lookout for mood changes.

After a few weeks on Chantix, I had managed to stop smoking altogether –
but it didn't feel like a triumphant turn of events. I'd become rather
reclusive, avoiding calls from friends, and basically just shuttling back
and forth between my office and my apartment. I began to dread six
o'clock; it meant I had to walk through the streets again. The subway was
now out of the question; it made me too nervous. I stopped going to the
gym, too.

I wondered whether Chantix was zapping my brain's pleasure-delivery system
to such a degree that not only did I find no reward in cigarettes, but I
also found no reward in socialising, exercising, writing, or any of my
usual self-stimulating tricks. I'd pace the floor, sit on the bed, channel
surf, pace some more, try to read, but the room had a stale, sinking
feeling. Maybe I should go and grab a drink – then at least I might be
able to get some rest.

There was no warning against drinking while on Chantix, and even if there
had been, I can't say with any honesty that I'd have adhered to it. (I
wasn't taking any other medication, though.) But while I've had my fair
share of dark and drunken nights over the years, what I experienced on
Chantix was something else altogether. One evening, I steeled myself to go
on a date, but after a few drinks with the guy, I abruptly burst into
tears mid-sentence. The crying jag lasted about 30 minutes, with the
thought "I can't do this any more" looping through my head. This was
happening a lot lately, as though someone had spliced other people's
thoughts into the tape whirl of my brain.

Another night, at an East Village bar, an older man in a trenchcoat caught
my attention. I chatted him up for a while, until I realised I was
actually trying to go home with the shadow cast by a potted plant. With
alcohol in my system, I was somehow able to take this hallucination in
stride: "The man who got away...?" But that same evening ended with my
taunting a skinhead who was improbably on the corner of Avenue A and 14th
Street. "You must be lost," I snapped. "Are you looking for 1993?" He
ended up chasing me into a deli and saying he was going to murder me. (The
guy at the register called the cops and the skinhead fled, so I'm fairly
confident that he, at least, was real.)

I've blacked out a handful of times before, but now it wasn't unusual to
have five or six hours completely wiped out of my memory. I'd wake up with
my clothes on, music blasting, and strange half-eaten sandwiches lying on
the floor that I had no recollection of buying. One morning, I found an
unopened container of dental floss in my coat, as well as a batch of
business cards from people whom I couldn't remember at all. Later that day
I received a text message: "I had a great time meeting you ... I could
have talked to you for another two hours. :)" I have no idea who that
person was.

Why didn't I just stop taking the drug? I did consider it. But there's
something particularly dispiriting about quitting a medicine that's
supposed to be helping you quit smoking. I kept thinking that my body was
still getting used to being on Chantix and off cigarettes, that I should
wait until everything readjusted itself.

A few nights later, a friend invited me to a party and I reluctantly
agreed. I was still avoiding my closest friends for fear that they'd
notice changes in my behaviour. But maybe I'd feel better if I stopped
keeping to myself, for just a night. At the party, I tried to impersonate
myself as best I could, but I found myself staring and nodding blankly,
actually having difficulty understanding what people were trying to say,
and getting oddly touchy at offhand comments.

I was offered a piece of cake on a plate, and a fork. For the life of me,
I couldn't figure out the puzzle. How the hell were these pieces supposed
to fit together? Fork. Plate. Cake. What sort of maniac would present me
with something like this at a party? I abandoned the cake for a vodka
tonic, which I drank in silent rage.

I left without saying goodbye. In the cab, I watched the city slash past
the windows and was tempted to just throw open the door. Running up the
stairs to my apartment, I barely had the door open before the crying
started again. I sat on the edge of the bed, doubled over, and I felt
severely ill, as though some freakish primal despair had finally been
loosened from my stomach. The sensation was more like vomiting than any
sadness I've ever experienced, and the shrieking sobs were punctuated by
sudden jags of rage. Like a spoiled teenager, I'd suddenly uproot drawers
from the bureau, push all the belongings off shelves with a sudden swat of
the arm, smash a glass against the wall, and then the crying would take
over yet again. Meanwhile, the room seemed to be pulsing and reverberating
around me, and my eye would keep zeroing in on objects – the television,
the AC, a pair of shoes – and feel as though they were somehow buzzing
with life and gleefully watching me endure the biggest meltdown I'd ever
had. I had somehow ruined myself, and suicide seemed like a good way to
avoid the embarrassment of this fact being exposed.

The next morning, I called in sick to work and started cleaning up the
considerable mess I'd made. I had to throw out a bunch of broken CDs,
smashed glasses, torn clothes, ripped photographs, and the remaining boxes
of Chantix from my medicine cabinet. It was a good call, I think. The
second most important decision I'd ever make in my life.


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Query: Independent.co.uk The Web
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ricky23 said:

Well Yes! the information is right, chantix does lead to those kind of effects and so the FDA has asked the manufacturer Pfizer to add it up under the chantix side effects displayed on the chantix bottle. But then guys we all know that like all other drugs chantix is a allopathic medicine which is bound to give side effects. The only solution is that you take is drug under proper doctor prescription. What is good is that it is effective and has helped many people quit however if it does not suit your body the doctor can suggest you alternative cures. If you are interested in undertaking a chantix course then first learn everything about this medicine from _http://www.chantixhome.com

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vinny said:

Shane, did you ever actually read the article directly on the independent.co.uk site?

because if it was ever there it has been utterly cleansed. there is not even a cached search result on google for it (when doing a domain-specific search on either the headline or a text extract - this nearly ALWAYS finds something)

so, either it was never on that site, or more interestingly, a very thorough clean-up job has been done.

(edit: lots of other blogs & news aggregators also cite this broken link)

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ricky23 said:

What is good is that it is effective and has helped many people quit

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