Its Not Only The Smoking That Can Kill You

One usually thinks of a doctor as one who gives out prescription – sometimes much too easily.  I’m often known as the doctor who declines to push drugs.

I take these things seriously.  I’ve studied long and hard and know what drugs can do – both positively and negatively.  If the risks outweigh the benefits, I can be down-right stubborn.  However, I’ll always have an alternative that can help.

I’m reminded of one case where a woman wanted Chantix (varenicline) – a prescription medicine FDA approved to help people stop smoking — and I said “No.”  To my knowledge and experience, the drug has some problems. The last patient I saw who was already taking Chantix asked me for a renewal. I told her that the symptoms of which she was complaining would probably disappear completely if she got off the Chantix.  I never saw her a second time.

This should explain — at least in part — why I can take care of people so quickly.  They disappear when they know they can’t get drugs off me very easily.

What about Chantix?  The stuff hits the nicotine receptor to satisfy the craving without actually ingesting the deadly poison nicotine.

Heck nicotine gum or patches ARE nicotine, and people are supposed to cut back, not just find a new delivery system.  Plenty of people — decent people — smoke while they are wearing a patch, thus increasing  the amount of nicotine going into their system.

It takes work to combat a chemical addiction — perhaps one of the most powerful of all — as people routinely go back to the stuff after an awfully long time off it.

Then you have a nice antagonist, like Welbutrin (bupropion) that helps people stop.  Of course it is the same molecule that also serves as an antidepressant, so some people with bipolar illness have been either worsened and disequilibrated or sometimes even diagnosed correctly for the first time when being treated with this.

I have seen patients go off the deep end.   The only reason for this to happen that I can figure out is that the doctor didn’t check, or ask the right questions.  Most people are misdiagnosed as simple depression until the doctor’s treatment launches them in to a manic stage.  Then – Eureka! – they are revealed to be bipolar.  Unfortunately, the same doctors don’t recognize this manic state and give them benzodiazapenes for their new-found “nervousness.”  (SIGH!)

In our “cost-reduction-is-the-only-concern” medical system, this happen all too often.  I’ve also seen it in populations where patients are treated in groups where everyone went on bupropion – such as in prisons and the Army.

I actually lived through this one with several patients in a VA smoking cessation group.  I think the clinic learned from this error, and I expect things are at least a little better now, but at the time, I hit the ceiling.  Which was appropriate because the patients were bouncing off the walls! But newer than bupropion, there is Chantix (varenicline) which carries a black-box warning.  If you don’t know what that is, allow me to explain (be afwaid!  Be vewwy afwaid!).

A black box warning is the strongest form of warning issued by the FDA about a drug, just one step short of removing the drug from the market.  A real scary paragraph is printed on the box or bottle or package insert of a drug, telling just what awful things are known to happen to some unfortunate people who take this drug.  Just so you don’t overlook it, the paragraph is set inside a big-black-bold outline – a black box.

In the case of Chantix, the warning highlights the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking this drug.  The warning is also on the packaging for Zyban – which is the same thing as Wellbutrin but marketed to the smoking-cessation patients.

All this sounds pretty horrible and you wonder why the stuff is still on the market, but the black box warning — while imperfect — is the strongest punch our friends at the FDA can manage to pack. This stuff can cause suicidal thoughts and actions — something we are getting used to living with for antidepressants.  But seriously, these people are psychiatric patients already. Does anyone actually want to take this kind of a risk to stop smoking?

All kinds of notices about safe medication practices and such have been of interest, but in 2007 Chantix seems to have hit the jackpot when in just one period it had more side effects than any other drug. Period.

So where did this drug come from?  As far as I can tell, cytisine was once upon a time a natural substance occurring in plants, before our buddies at Pfizer did research which seems as if it were aimed at taking this natural partial agonist of the nicotinic receptor and tweaking the molecule enough that it could be patented.  Yeah, the straightest way to the money.

Here is the original article in the Archives of Internal Medicine.

Cytisine may actually be of some help in smoking cessation, but the meta-analysis (looking at the studies already done and figuring out what has been going on) is of limited use, mainly because they had not been done with a high enough level of technical expertise.

Okay, so the people doing natural substances may not have had access to the most clever people at writing up experiments, and surely did not have a ton of money, but this is not an indication for “tweaking” a molecule to make money off it, as far as I can figure. But they did, and now we have serious neuropsychological side effects. So I refused to give it to the person I mentioned at the beginning of this article because she had a history of suicide attempts.  She wanted to risk it but I did not.  It was her life and my medical license both at risk, and I take both of them very seriously.  Call me a worry-wart.

Some doctors give patients whatever they want and don’t consider the consequences.  I was right when I refused this woman Chantix and I refuse to compromise my standards.

But wait — there’s more.

Our friends at the FDA expedited the review of this drug because it did not look as if there were any safety issues and the stuff looked fairly effective.  Of course — if nothing else — we should know by now that you have to use something for a while before the problems show up.

“Expediting” drugs is usually a poor idea unless they are essential to save large populations from fatal diseases – like AIDS or malaria or something.  But for smoking cessation?  Let’s get real!

In our modern medical system (a crippled system, but that’s just my opinion as a doctor for about 30 years), giving somebody a drug to stop smoking is pretty unreasonable.  It’s even worse because most systems won’t provide a counselor to help, and every successful smoking cessation program I’m acquainted with involves behavioral counseling.

In these cases, we should require a mental health tracker for each patient. Before you say that sounds excessive, can you tell the difference between a mood and behavior change that is just part of life, and one that may be a medication side effect?  Don’t worry; most mental health professionals can’t either, and sometimes I will admit that even I have a devil of a time.

My unfavorite side effect is … death.  We talk about human life being precious, but if we believed that, we would look at the end of this article and see spelled out clearly that the desire for profit is a big hunk — if not all — of the reason this drug is still available.

I am not the only one wondering why this stuff is still out there. The answer is that people like pills.  They are easy and not demanding.

I have seen legions of people who “do” the patch without behavioral or emotional support and then tell me it does not work. Smoking cessation is not and does not have to be a monster.

Medicalization of problems can actually make them more difficult to solve, largely because doctors have forgotten most of what they have learned in medical school.

One of the first things they tell you in any class on therapeutics known to me is that you are supposed to present alternative forms of treatment so that the patient can make an intelligent, meaningful informed consent.  This is always deferred. To whom?  To nurses? To pharmacists? Good folks, assuredly, but can we actually expect them to know about non-pharmaceutical aids in quitting???

It seems that 80% of long term quitters are cold-turkey quitters. I find this not too tough to believe, because I tell patients that smoking can induce liver enzymes and make them need more meds and I have always been at least a little surprised by how many of them just plain quit, sometimes getting toxic on meds, so now I actually warn them.

I do not think “cold turkey” is the only way nor do I proselytize it. I remember when I was working the early trials of Prozac (fluoxetine) and the Selective Serotonin Reuptake Inhibitors (SSRI) drugs that people just suddenly stopped smoking.

It is now believed that pretty much anything dopaminergic can be some assistance, but I would suggest framing this in a non-pharmacological manner. If people want to go for dopamine, it is good to eat lots of avocados — a fine California product that I would be delighted to popularize.  I do not know if eating lots of avocados would help people stop smoking, but with all those nice oils and such, it seems a lot better than a pill with a risk of death.

How about some research I saw a while ago that suggested that smokers who had real trouble quitting (not everyone does) might be depressed. Treating that first might make it easier for the person who has trouble quitting to quit.

Now not all treatments are pharmacological.  The French taught me in medical school to present alternative treatments to whatever I was presenting and that is something I think everyone gets taught, even in America. Educational programs, buddy systems, support networks — things that have nothing to do with medication seem to work for a lot of folks. Like every challenge in life the answer is to know yourself, face your demons, and get the help you need, while you make your own path.