Anti-smoking Drug Suits Filed Against Pfizer
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Chantix worked fine for me. The only remarkable side-effect was really vivid dreams. I know a couple of people who felt depressed while on it, and all of them quit taking it. (I have converted one of them to vaping.)
In my somewhat uninformed opinion, these lawsuits are a part of the problem with the American pharmaceutical industry. Not _the_ problem, not the biggest problem, but definitely a contributing factor to high prices, over-regulation, and limited choice.
In my somewhat uninformed opinion, these lawsuits are a part of the problem with the American pharmaceutical industry. Not _the_ problem, not the biggest problem, but definitely a contributing factor to high prices, over-regulation, and limited choice.
Not to change the subject... but I (and many others) have experienced
"vivid dreams" after switching to E-smoking. I think these "vivid dreams"
might be a tobacco withdrawal symptom.
For me… vivid is an understatement…“Wild” vivid dreams!
You are not alone in that. Wellbutrin made me angry to the point of violence, literally. And I'm a very kind and peaceful person despite my spunk and feistiness. I had irritability and unprovoked rage and it killed my libido......not good for a healthy girl in her 20's in a new relationship. I was so bad that my (now) husband insisted I NEVER take it again. It took an act of Congress to convince him that Wellbutrin XL is very different. In the past he also tried regular old Wellbutrin for smoking cessation but like me he experienced unprovoked anger and moodiness. The XL is very different though and I've had almost no side effects.
You are not alone in that. Wellbutrin made me angry to the point of violence, literally. And I'm a very kind and peaceful person despite my spunk and feistiness. I had irritability and unprovoked rage and it killed my libido......not good for a healthy girl in her 20's in a new relationship. I was so bad that my (now) husband insisted I NEVER take it again. It took an act of Congress to convince him that Wellbutrin XL is very different. In the past he also tried regular old Wellbutrin for smoking cessation but like me he experienced unprovoked anger and moodiness. The XL is very different though and I've had almost no side effects.
You mean that everyone who files a lawsuit against a drug maker for damages caused by one of their drugs is an opportunist?
You seem believe that not holding drug manufacturers accountable, while causing a lot of harm, is a good thing because it will lower the cost of the drugs they sell? If you want to live in a society without regulation or accountability, I would suggest a move to Somalia - a truly unregulated & lawless country, where you can engage in your fantasy of unregulated free choice without restraint.
I am not into politics. However, I do know these people have the right to sue for damages. The FDA really does not have the populace in mind. I believe it is all about the money.
An easy analogy of liability. Consumer buys a car and finds out he/she has no brakes. Consumer crashes and dies. WTH! Would the family sit back acting passive? Heck no! Get a lawyer! File for damages if one can prove that company knew about those brakes and did not disclose to consumers with recall. It takes allot of folks to complain to get things right!
An easy analogy of liability. Consumer buys a car and finds out he/she has no brakes. Consumer crashes and dies. WTH! Would the family sit back acting passive? Heck no! Get a lawyer! File for damages if one can prove that company knew about those brakes and did not disclose to consumers with recall. It takes allot of folks to complain to get things right!
No, of course I don't believe that, and I didn't mean to imply it. I don't think there's much question, though, that some lawsuits are frivolous and opportunistic. Having reviewed the stated side-effects of Chantix firsthand, I feel like it's possible these folks are disregarding their own responsibility to monitor the effects of the drug on themselves. It's also possible that those suing are right and the drug needs to be taken off the market or regulated more carefully. I just don't know, and I'm not sure we'll really find out through this particular legal mechanism.
As for your Somalia bit, I can only say that I find the whole genre of "if you don't love it, leave it" rhetoric a little facile. I'm more in the vein of "if you don't love it, talk about it and figure out if there's a better way."
"Love it or leave it" was not the point I was trying to make. I was responding to your "over-regulation, and limited choice" argument by pointing out that there are countries without regulation & what the implications of that are. Personally, I want my medicine, food, water, automobile safety, workplace safety, etc. to be regulated. I just want it done wisely.
I have a question... Considering the officials of our regulatory agencies are unelected
and in the case of the FDA, uncountable to anyone except the drug industry...
Is it possible to expect wise regulation?
and in the case of the FDA, uncountable to anyone except the drug industry...
Is it possible to expect wise regulation?
I disagree. When Pfizer tested the drug to gain approval, they specifically excluded patients with depression and other mental disorders. Here is one example. See the exclusion criteria:
An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking - Full Text View - ClinicalTrials.gov
When the problems began emerging in the after-market surveillance, Pfizer began setting up studies specifically for patients with various types of cognitive and mood disorders. Some of these have been discontinued. Usually a study is not discontinued unless they have seen too many adverse events going on.
Terminated Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD) Conditions: Attention Deficit/Hyperactivity Disorder; Smoking Cessation
Intervention: Drug: Varenicline (Chantix)
Withdrawn Treating Schizophrenic Smokers: Effects on Craving, Cues and Withdrawal Condition: Tobacco Use Disorder
Interventions: Drug: varenicline; Behavioral: Adaptation of Motivational Interviewing
Is Pfizer totally to blame? Well it seems to me that if they had scientists on staff who understood the effects of nicotine withdrawal, it should have occurred to them to not exclude people who were already prone to some of the more troublesome nicotine withdrawal symptoms (e.g., depression, anxiety, cognitive impairments), since the goal of treatment is nicotine abstinence. If they didn't think of it, shame on the FDA for not requiring those tests prior to drug approval! Shame on doctors who prescribe drugs without reading about the side effects first. Shame on pharmacists who don't catch these things.
The last person who should be held accountable is the patient, who trusts the pharmaceutical companies not to screw them over, trusts the FDA to do a good job of protecting public health, and trusts their doctor and their pharmacist.
A much higher percentage of smokers have less education than the rest of the population. The majority of smokers I know would not even understand half the words in the patient warnings distributed with their medication. Even well-educated people sometimes have troubles with these.
The FDA is bought and paid for by the drug industry. FDA approval means nothing more then you can legally obtain the drug. But I still believe in personal responsibilities. I once took percocet after surgery, and had the most wild dreams that continued even after I woke up. Is percocet a bad drug--no, but it was not good for me. I am sure that had I continued to take it. I would have become depressed because of poor sleep. The responsible thing for me to do would be to stop taking it. And I believe if I had ever taken Chantix and felt suicidal, I would have stopped taking it. I would deduce that smoking was better for me than Chantix.
And class action law suits are a completely different animal than individual personal injury lawsuits. Class action lawsuits are only to line lawyers pockets.
In most cases, all you have to do is stop taking a drug when you have a bad reaction. Unfortunately, with Chantix some of the effects continue after you stop taking it. Now that is scary!
Petrodus: Regarding regulatory agencies. We have to hold our elected officials accountable for the regulatory agencies that they oversee. The lack of meaningful regulation is due to the fact that many of our elected officials do not believe in regulation, or have been bought off by the companies being regulated. They, for example, undermine regulatory agencies by cutting their funding, or under funding, which reduces the number of inspectors & inspections, the ability to independently test products, etc., so that the agencies have to rely on self-reporting and self-testing by the companies they regulate. And, our elected officials need to establish meaningful penalties for those individual & companies that skirt the regulations and cause public harm. Yes! I think we can have meaningful & wise regulation. Do we have it at present? No! If we did 110,00 people wouldn't die every year in the US due to medical malpractice. We wouldn't have 76 million illnesses, 325 000 hospitalizations and 5 000 deaths in the United States each year due to food poisoning. We wouldn't have workers dying in mines, etc.
devilock76
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As someone who worked for a company that did pharmaceutical sales (reps going to the docs, I was in IT) I take a good note of the decor of my doctors office. What drugs or companies have their displays and such on the wall. New docs I ask who makes what drug and is there a generic and if there is not what is a more generic alternative. My doc has learned not to push a name brand at me unless he can back up why.
Ken
For those who say "they should have known" you are wrong. Chantix was never tested on people with depression or other mental disorders. In fact, they specifically EXCLUDED those people from studies. It wasn't until it was released onto the unsuspecting public and people started killing themselves or raging that the warnings were issued. So, those early victims had no way of knowing how it could affect them and they have every right to be upset and get compensation.
That's one reason why I balk at the idea that "clinical studies" on e-cigarettes would prove anything. First off, they won't know long-term effects until they've actually been used long term and secondly, artificial testing environments can only give scientists an educated guess about products for the general population. The only way these companies ever know the true side effects of their products is after it's been released and has real-world use. And the FDA makes the companies do the testing and only "reviews" the reports. So, studies/tests of pharmaceuticals are no more "unbiased" than the tests and studies which e-cigarette manufacturers have done.
E-cigarettes have been on the market in the U.S. for over 3 years and on the world market for nearly 7, with no reports of serious adverse affects. Compare that to FDA-approved and clinically-tested Chantix - which had adverse affects within months of release.
There is simply no test or study which can replace real-world use and e-cigs have had 3 years absent serious adverse affects.
That's one reason why I balk at the idea that "clinical studies" on e-cigarettes would prove anything. First off, they won't know long-term effects until they've actually been used long term and secondly, artificial testing environments can only give scientists an educated guess about products for the general population. The only way these companies ever know the true side effects of their products is after it's been released and has real-world use. And the FDA makes the companies do the testing and only "reviews" the reports. So, studies/tests of pharmaceuticals are no more "unbiased" than the tests and studies which e-cigarette manufacturers have done.
E-cigarettes have been on the market in the U.S. for over 3 years and on the world market for nearly 7, with no reports of serious adverse affects. Compare that to FDA-approved and clinically-tested Chantix - which had adverse affects within months of release.
There is simply no test or study which can replace real-world use and e-cigs have had 3 years absent serious adverse affects.
Kristin, I agree with all of your points, but I also acknowledge the fundamental conflict there: pharmaceutical companies don't test thoroughly enough (Chantix); pharmaceutical companies can't test thoroughly enough (e-cigs).
Obviously, we can't have it both ways, so it's a matter of finding balance. (And that balance won't be found in a jury's deliberation room, though outright negligence might be.)
Obviously, we can't have it both ways, so it's a matter of finding balance. (And that balance won't be found in a jury's deliberation room, though outright negligence might be.)
If a product is a drug, regulatable under the FDCA, the FDA should not approve it for sale until after it has been given a reasonable test for safety. IMHO, it is not "reasonable" to exclude the types of people who make up a large portion of the target population for the drug. Research conducted over 20 years ago showed that about 20% of smokers had symptoms of depression. I would guess that this percentage has grown a lot--it now might be 40 or 50%--because it is very difficult for people prone to depression to stop smoking. When you add to that the well-known fact that nicotine withdrawal often triggers serious depression in folks who never were depressed before, THERE IS NO EXCUSE for excluding depressed people from the tests. If Pfizer failded to conduct safety tests that accepted all types of people who were smokers, the FDA should have said, "wait a minute...."
It is our position that e-cigarettes are not a drug and that they should not be subject to the same types of clinical trials required of drugs. If I invented a "near beer" that alcoholics found to be an acceptable substitute for getting drunk on real beer, would that be a drug, or would it simply be a new consumer product? The courts would say that it's the latter, as long as I don't market it as a treatment for alcoholism.
But in addition, as Kristin has pointed out, and as I have pointed out many times as well, in the case of a drug or device that can be regulated under FDCA, we don't know the true safety profile until the product is in use with no restrictions on who can use it.
The point is that if anybody is worried about e-cigarettes being dangerous, we have much MORE information about the safety profile on these than Pfizer had on Chantix when the product was released onto the market, because we already have several years of widespread use behind us. So it isn't a matter of "having it both ways." It's a case of "look at our track record."
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