Fw: Zyban (aka Wellbutrin) Probed in 24 Deaths ...

[Guest guest]

From: " Ilena Rose " <ilena@...>

Sent: Friday, April 06, 2001 10:36 PM

Subject: Zyban (aka Wellbutrin) Probed in 24 Deaths ...

> ~~~ I finally figured out why the corporate sponsors of ACSH and their

> spin-offs would fund " anti-smoking " campaigns ... to sell more drugs ...

~~~

>

>

> http://www.montrealgazette.com/news/pages/010302/5025695.html

>

> Debating Zyban's safety

>

> Role of anti-smoking drug being probed in 24 deaths

>

> JEFF HEINRICH, The Gazette

>

> In the database of the world's largest drug company, the

> premature death of Hammock at age 48 is listed as Adverse

> Event No. CD/00/4960.

>

> A Bombardier aircraft upholsterer who lived in Lachine, Hammock

> died suddenly the morning of Aug. 17, 1999, 10 days after

> starting treatment with Zyban, the anti-smoking pill.

>

> His widow and five children suspect the drug killed him.

>

> His family doctor reported a possible connection. But a Quebec

> coroner last March concluded Hammock had died of natural causes:

> fatal arrhythmia.

>

> What led to those abnormal heart rhythms, which were serious

> enough to cause cardiac arrest, severe enough to cause Hammock to

> collapse on the job and die?

>

> Was it the drug? Was it because Hammock, a pack-a-day Belvedere

> smoker since his teens, already ran a high risk of heart failure?

> Or was it a symptom of his withdrawing from a lifelong addiction

> to nicotine?

>

> On those kinds of questions hinges the worldwide debate over the

> safety of Zyban, a top-selling medication that was launched in

> 1997 and is used by one million Canadians and 14 million other

> people worldwide.

>

> The drug is being investigated as the possible cause of at least

> four other deaths in Canada, including that of 26-year-old

> Montrealer Landry in February, as well as of 18 deaths in

> Britain and one in Australia.

>

> GlaxoKline, the British-based pharmaceutical giant that

> makes Zyban, denies any proven link so far between its drug and

> the fatalities. So do investigators at Health Canada and other

> countries' health authorities.

>

> What makes many of the cases disturbing is how relatively healthy

> - for smokers - some of the patients like Hammock were before

> they started taking Zyban, and how sudden and unexpected their

> deaths were.

>

> Zyban's active ingredient, bupropion hydrochloride, a kind of

> anti-depressant, also is marketed to psychiatric patients (as

> well as some smokers) under the brand name Wellbutrin.

>

> A stimulant, it works by changing the balance of chemicals in the

> brain to reduce a person's craving for nicotine. A typical

> treatment lasts three months, with the patient quitting smoking

> after the first week.

>

> Studies suggest one in three patients on Zyban remains off the

> weed even a year later. Hammock didn't get that far.

>

> " Charlie quit smoking, but unfortunately he had to quit breathing

> to do it, " his widow, Peggy-Ann -Hammock, quipped bitterly

> in an interview this week, lamenting the sudden end of a marriage

> that lasted 31 years.

>

> " It was my worst nightmare. You say goodbye to your husband in

> the morning on his way to work, and he doesn't come home. "

>

> A trim 159 pounds, Hammock had an otherwise clean bill of health

> before he started taking Zyban, his medical chart shows: normal

> blood pressure, low cholesterol levels, no history of heart or

> lung problems.

>

> After a checkup on July 28, 1999, and a series of routine lab

> tests, his family doctor pronounced him fit enough " to live to

> 100, " -Hammock told The Gazette.

>

> Hammock had been encouraged to quit smoking with Zyban after

> hearing how well it had helped a co-worker at Bombardier break

> her habit. And he'd seen ads for the product on U.S. cable TV.

>

> Ten days after his physical, he got his prescription filled. But

> after a few days of popping the little purple Zyban pills, first

> once, then twice every 24 hours, something went wrong.

>

> " He started telling me how peculiar he felt, " said -Hammock,

> who works as the daycare supervisor at Meadowbrook elementary

> school in Lachine.

>

> " As a family, we noticed he was majorly agitated. I kept saying

> to him, 'Charlie, maybe you shouldn't be taking this Zyban.' But

> he thought the side-effects would wear off after a few days, so

> he stayed on it. "

>

> The night before he died, there was a major blowup at the family

> supper table. Hammock was testy, irritable, far more than he'd

> ever been in previous attempts to quit smoking. " I said, 'Calm

> down, you're going to have a stroke,' " -Hammock recounted.

>

> Like other anti-depressant drugs, Zyban carries a significant

> risk of seizures: one in 1,000 people will have fits or go into

> convulsions as result of taking it.

>

> According to Glaxo's lengthy monograph for Zyban, 2 per cent of

> patients will also experience some heart palpitations while on

> it. But the jury is out on whether those palpitations can be

> deadly.

>

> The monograph only warns doctors to be careful prescribing the

> drug to patients who've had a recent heart attack and other

> cardiac problems, saying studies have yet to prove its safety for

> those people.

>

> Early on the morning of his death, around 8:30 a.m., Hammock

> phoned his wife from work to say he'd had a bad dizzy spell. He

> also told his supervisor he had a headache, the coroner's report

> shows.

>

> Less than two hours later, he collapsed in Dorval. At 10:20 his

> supervisor found him unconscious, lying on the floor of the

> Canadair Global Express jet on which he'd been working.

>

> His heart was beating but he had no pulse and he wasn't

> breathing.

>

> An Urgences-Sante technician tried to revive him with a

> defibrillator, but it was too late. After an ambulance ride to

> Sacre Coeur Hospital, Hammock was pronounced dead.

>

> His family was left in shock, searching for answers. They called

> his doctor. They called Glaxo Canada's telephone helpline and

> talked to a company nurse. The closest they got to an explanation

> was two months ago, when another official called back.

>

> " The woman told me my husband's case was now registered in an

> international database of adverse events to Zyban, and that the

> company was accumulating evidence, " -Hammock recalled.

>

> " I told her that wasn't good enough. I told her, 'How many people

> are going to die before you pull this drug from the market? When

> will we as consumers know there's something wrong with this

> drug?' "

>

> The Glaxo official pointed out that as a smoker Hammock had been

> at risk of heart disease. " 'But he didn't have heart disease,

> and he didn't die of it, either,' " the widow remembers

> responding. " 'He went from perfectly healthy to dead in 10 days.

> Explain that.' "

>

> This week, Glaxo Canada's chief medical officer tried.

>

> " It's always a difficult call " whether the death of a patient

> like Hammock " was due to an underlying problem or due to the

> drug, " said Dr. Anne , an infectious-disease specialist

> who is the company's vice-president of research and development.

>

> " People who smoke are at greatly increased risk: they're about

> five times more likely than non-smokers to have a heart attack or

> heart problems, " she said from Glaxo Canada headquarters in

> Mississauga, Ont.

>

> " So these events occurring in a patient population which is

> taking the medication doesn't necessarily, of course, implicate

> the medication as the cause. "

>

> According to Health Canada data dating back to September 1999 -

> the most recent it and the company say are available - there have

> been 407 adverse events related to Zyban and 67 related to

> Wellbutrin.

>

> Of the Zyban events, 312 involved three deaths, seven non-fatal

> heart attacks, 64 convulsions or seizures, seven cases of

> hypoglycemia (low blood sugar), 163 allergic reactions, 52

> psychiatric reactions (including one suicide attempt), and 16

> reports of vision problems.

>

> Health Canada's Therapeutic Products Program, which monitors drug

> safety, " continues to work with the manufacturer to re-evaluate

> and update the safety profile of Zyban, " it said in a January

> 2000 report.

>

> Asked about the hundreds of adverse events, Glaxo's said

> she wasn't surprised.

>

> " The more people that take any product, even Aspirin, the more

> side-effects or adverse events are going to be reported, " she

> said.

>

> " When you have that number of people (more than one million

> Canadians on Zyban) taking anything, even taking a glass of

> water, some are going to report different adverse events. "

>

> What about possible effects on the heart? Shouldn't Zyban users

> be warned about palpitations - and stop taking the drug at the

> first sign of them?

>

> " Not necessarily, " said.

>

> " I mean, you have to remember the context in which this product

> is being used: during withdrawal from an addicting substance

> (nicotine). And one of the side-effects of withdrawal is often

> palpitations. "

>

> Coming off a nicotine addiction is never pleasant, she added. " It

> tends to cause a series of physical symptoms: anxiety,

> palpitations, insomnia are all very common withdrawal syndromes. "

>

> Aren't the unexpected deaths of younger Zyban patients like

> Hammock and especially the 26-year-old Landry last month rather

> unusual?

>

> Not really, said.

>

> " We have young people who die suddenly all the time. You hear

> reports of kids in the gym playing basketball or whatever

> dropping dead. Young people do die sudden death. "

>

> Will the survivors of Zyban patients like Hammock never get a

> definitive answer? Will they never know for sure whether Zyban

> did or did not kill their loved one?

>

> Perhaps not, said.

>

> Just as the families of cancer victims can't know if the drugs in

> chemotherapy did more harm than good, those with experience with

> Zyban may never get the answer they're looking for.

>

> " Cancer drugs are just as hard to decide, " noted. " Are

> adverse events a side-effect of the medication or a progression

> of the malignancy? We're always faced with these difficult

> situations. "

>

> -Hammock can't shed her suspicions, though. Zyban and

> Wellbutrin are a $70-million-a-year business for Glaxo in Canada.

>

> If the products are tarnished by safety concerns, the firm stock

> could take a hit.

>

> " They may be watching the value of their stock, " she said.

>

> " But it seems to me that when there are as many sudden deaths as

> this, Glaxo should be erring on the side of caution and pulling

> Zyban off the shelves. "

>

> For now, Adverse Event No. CD/00/4960 languishes in an

> international registry, part of a puzzle, perhaps, or simply a

> footnote in the controversial history of a popular drug.

>

> " I'll be sure to put that on his tombstone, " his widow said

> sardonically. " 'Here lies my husband, part of the evidence in an

> international database.' I'm sure Charlie would like that. "

>

>

> ~~~~~~~~~~~~~

>

> More on this Drug

>

> http://www.mentalhealth.com/drug/p30-b04.html#Head_4

>

>