Could a prescription medication for people who want to quit smoking actually cause them to commit suicide? Well, in at least 150 cases (between 2006 and 2010) the shocking answer is, yes.
(Image Credit: Aprilzosia on Flickr)
How could something like this slip through the bureaucratic cracks?
From MSNBC -- Smoking Pill Suicides Overlooked In Missing Reports ...
Hundreds of reports of suicides, psychotic reactions and other serious problems tied to the popular stop-smoking drug Chantix were left out of a crucial government safety review because Pfizer, Inc., the drug’s manufacturer, submitted years of data through “improper channels.”
From Zimbio -- Health Risks Underestimated for Popular Smoking Cessation Drug Chantix ...
The Institute for Safe Medication Practices has recommended that the FDA conduct an investigation after discovering Chantix’s manufacturer, Pfizer, failed to submit 589 reports about serious and fatal adverse events linked to the drug between 2006 and 2010. Exactly 150 of these reports were for completed suicides.
So the million dollar question is -- How did this happen? I don't think it would be a stretch to suggest the answer has something to do with money, big money and big profits.
From Hooked: Ethics, Medicine, and Pharma - Chantix and Suicide ...
So, given that there's a history of drug companies manipulating the FDA reporting system to conceal serious adverse reactions of profitable drugs, is it completely possible to trust Pfizer's innocence in this matter? And for that matter, is it realistic to imagine that with all the technical staff, legal talent, etc. that a company as big as Pfizer has at its fingertips, that no one knew what were the proper channels for reporting serious adverse effects? I'm just asking.
Here is a video that's taking a closer look at Chantix, it's from WPAHS News -- Does Smoking Cessation Drug Chantix Cause Violent Behavior?
But this story is more than the controversy surrounding Chantix. It's also about real people, real people that are trying (and often failing) to quit smoking. Let's not forget about them.
I thought with all the craziness surrounding this latest report on Chantix that I would try to find someone who has actually used it, and see what they had to say. So I shot out a message to some of my Facebook friends, and low and behold, I found a friend that has used Chantix in the past. Here is her personal experience with this smoking cessation drug ...
Wendy first used Chantix in November of 2008, and during the one month that she was taking the pills she experienced little to no side effects. In fact, she was very happy with how well Chantix was working for her. She told me that after taking the pills for just a week, she began to stop craving cigarettes (mainly due to the fact that they began to leave a horrible taste in her mouth). Overall she was able to stay smoke-free for about nine months, and says she felt great and was able to breathe much easier during that time. But as with any addiction, her cravings did return, especially when she found herself out with other smokers. And eventually, Wendy gave into the temptation and began to smoke again. Not too long after she began to smoke on a regular basis again, she decided to give Chantix another try. But on her second try with Chantix, she found the pills were giving her a very bad upset stomach, so she stopped taking them after just a few days. Today, Wendy is a smoker, but one who is still very determined to find a way to quit.
I'm sure many people can relate to Wendy's story. Quitting smoking is not an easy thing to do, maybe it's even one of the hardest. In the end, I think we need a place for drugs like Chantix on the market, but safety has got to come before profits.
And just in time to include in this post, I was able to get some comments from Thomas Glynn, PhD, Director, Cancer Science and Trends, and Director, International Cancer Control for the American Cancer Society.
- There are now more than 7 million people who have used Chantix -- and with such a large number of users of any medication, there would be expected to be adverse effects, either tied to the drug itself or randomly. And, with Chantix, there has been very little study which can distinguish what, if any, adverse effects can be tied directly to its use, is random, or is tied to the effects of quitting smoking (since smokers who are in the process of quitting experience many adverse reactions, including many which cannot be distinguished from use of a medication - e.g. depression, suicidal ideation);
- The ISMP is a watchdog group, although a reputable one, and has no official status in the regulation of drugs. They do not allege in their report that Pfizer (the manufacturer of Chantix) deliberately hid any information from the FDA and, when responding to the report from ISMP, FDA asked Pfizer to re-adjust their reports, they did so immediately;
- The FDA itself has said that this report from ISMP does not change their view of Chantix, i.e. it merits close monitoring by physicians of patients to whom they prescribe it, but that there is clear benefit to its use and they do not see reason from current data to warrant further action other than the appropriate Black Box Warning, which they have already issued and continued reminders to physicians to monitors patients closely to whom they have prescribed Chantix.
- It is important to remember, from a public health standpoint, that tobacco use kills more than 440,000 Americans every year, and sickens more than 8 million. While any adverse reaction to a drug, and especially one that could involve suicide, must be taken very seriously and investigated thoroughly, it is important that this investigation be done objectively (and swiftly), so as not to endanger patients who use it, but also to avoid the danger of removing a drug from the market which can save many lives through help in quitting tobacco use.
I agree, we cannot forget that smoking is the real killer here, and anything we can do to help someone quit is also helping to save a life.
What do you think? Do the benefits of Chantix outweigh the risk of severe side effects? Is this really about misfiled paperwork or is it about money and profits? Let us know your thoughts in comments.
Contributing Editor Catherine Morgan
Also at Catherine-Morgan.com
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