Adding anti-depressant drug to smoking cessation therapy fails to help prisoners stop smoking

Who is surprised? What struck me about this story was that the drug in question, Nortryptiline, 'is not FDA-approved for smoking cessation but often is used for that purpose'. That it does not work for smoking cessation is not terribly surprising, as no interventions seem to have a long term success rate of more than about 5 per cent.

We know that the prison population is given drugs for smoking cessation that are not approved for this purpose. Are the prisoners informed that the drugs they are on are not licensed for this purpose?

Cautionary notes on Nortriptyline are as follows:

Do not use nortriptyline if you have recently had a heart attack, or if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant such as nortriptyline, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. 

This is shocking – a non-approved drug being used for behaviour modification purposes in a captive population.

In fact the leader of the research reported in this article, which concluded that the drug did not help smoking cessation in the long term, seems to think that the prison population is not captive enough: 'One thinks that you have a captive audience" in prison studies, she said. "However, half of the prisoners were either transferred to another prison within the study or released into the community.' Fluidity in the prison makes follow-up harder – surely this is hazardous for a drug which might induce suicidal tendencies.

Bear in mind that Glaxosmithklein received record fines recently for (among other things) improper marketing of drugs – selling them for non-approved uses. Why is it legal to do this in New York prisons? Looks like, as far as smoking cessation goes, anything goes – especially when a population already has limited choices.

Welsh Government awaits guidance from MHRA about whether to continue recommending Champix

The Welsh Government has acknowledged unease about funding Champix following reports of cardiac incidents in people taking it. It is awaiting advice from the MHRA. The study claiming that Champix was responsible for an increased risk of heart trouble found only a small elevated risk. I hope that the Scottish Government will follow suit – not specifically because of the heart attack risk, but for other reasons:

• because there is increasing anecdotal evidence of bad side effects including suicidal ideation and actual suicide. Court action is pending.
• because what's sauce for the goose is sauce for the gander. There is no safe level of secondary smoke, because of the potential effects of inhaling it. There is no safe level of Champix either, because it can lead to terrifying symptoms and behaviour changes that have proved fatal to people taking Champix and their loved ones.
• because there is no reason to fund smoking cessation, certainly not on the scale that it is currently being funded  Wanting to smoke is a state of mind, not an illness.

It is telling that heart problems can make authorities act when the other symptoms have not seemed to worry them. “We are talking about a fairly unhealthy section of the population anyway . . . one in two will die because of smoking," famously said Ailsa Rutter of Smoke Free North East – a shocking equation of long-term morbidity in middle or even old age with the traumatic consequences that smokers have experienced often within weeks of starting a course of Champix – by no means universally experienced in either case. 

Reports of the success of Champix as a quitting aid are quite possibly exaggerated. 

Champix and the heart

A number of media stories concern reports that Champix may be responsible for an elevated risk of heart attacks. The Mail, the Express, the Independent, Medical News Today and others including the Scotsman all carry the story. The increased risk is said to be 72 per cent, which while being around three times greater than the alleged risk of secondary smoke exposure causing lung cancer or heart disease is still not conclusive.

Alone among these stories, the Scotsman makes no mention of the injuries associated with Champix. Not everyone is affected by them, but many disturbing after-effects have been reported, some of which have led to suicide – enough to make many users and their friends call for the drug to be banned.  There are also reports that adverse incidents were reported through 'improper channels' (and here) in order to cover them up.

Study author Singh said: "I think our new research shifts the risk–benefit profile of varenicline. People should be concerned. They don't need Chantix to quit and this is another reason to consider avoiding Chantix altogether." Champix's history has been enough to get the drug withdrawn in France. It didn't need an inconclusive study on heart troubles to conclude that Champix could well be more trouble than it's worth.

Interestingly Medical News Today also states this:

Varenicline has been shown to modestly increase the chances of a successful quit attempt, compared to unassisted smoking cessation attempts. But overall, the majority of smokers who quit do so without any pharmaceutical assistance at all.

Surely this is a cue for a stop to ridiculous claims like this? and thousands of pounds of public money poured into smoking cessation aids, when most quitters don't need them.

Champix covering up

Another light blogging day. What Chris said.

Scottish Champix widow sues Pfizer

Champix was approved for use by the Scottish Medicines Consortium in January 2007. By 2008 BBC Scotland was reporting alleged bizarre, threatening and suicidal behaviour on the part of people who took the drug, and lawsuits were beginning in the US.

Brian McLinden died just over a year ago and it's been reported that his wife Patricia will also sue Pfizer.

It's odd that stories of sudden and traumatic death, and distressing behaviour, are considered to be a price worth paying for a lower smoking rate.

It didn't take public pressure to get rid of smoking in bars. It took a government-funded pressure group. But years of documented agony (and a non-too-impressive success rate) requires hundreds of people to take legal action before this drug is properly investigated and taken off the prescription lists. People stopped smoking before this drug came on the market and they will continue to give up after it's been dumped.

Nicotine receptors in the brain: Of Champix and vaccines

As the scale of the radiation disaster in Japan becomes clear we learn that a nicotine vaccine is on the way. Just what the doctor ordered.

Comparisons with Champix should raise alarm bells (see link from Dick Puddlecote's post). Champix works by attaching itself to and blocking nicotine receptors in the brain. As a side effect, it can also block serotonin receptors in the brain, as described here by lawyers involved in Champix litigation. Champix has been banned for use by pilots for many years now. The risk of adverse consequences is very well known.

Much as I distrust antis, I can't go along with the idea that they have produced a drug that would block smokers from experiencing any pleasure at all. Even although some people find it hard to believe it, parts of the brain do respond to nicotine specifically, and it is these receptors that the manufacturers of Champix have attempted to block.

Smokers are, however, expected to accept a fair risk that they will react badly to Champix. And that doesn't just mean a sore head. If you're unlucky, the Champix blocks your seratonin receptors too:

Varenicline, the active ingredient of Chantix, has only one significant side effect: it also has an affinity for the 5-HT3 serotonin receptor. If the varenicline binds to this serotonin receptor, the serotonin response, like the nicotine response, is inhibited. Serotonin regulates several stress hormones, so an inhibition of serotonin reception can lead to side effects like nausea, headaches, anxiety disorders, and changes in libido and appetite, similar to side effects seen for SSRI antidepressants.

There is no shortage of warnings and stories on the internet on this drug.

ASH Scotland, perhaps uniquely, tells us 'there is emerging evidence that varenicline is safe and effective for people with mental health problems'. Not by my definition of the word 'safe', there isn't.