Here's a Nice Example of What Happens

[Minimalist]

when you let the 'profit-is-everything' crowd run wild....and the libertarians would make sure the Food and Drug Administration was crippled so these fuckers could kill more people marketing their poison.

http://www.msnbc.msn.com/id/43187290/ns/...alth_care/

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.”

Some 150 suicides — more than doubling those previously known — were among 589 delayed reports of severe issues turned up in a new analysis by the non-profit Institute for Safe Medication

[Shell B]

My doctor would not prescribe me Chantix because of that, because I had an adverse emotional reaction to beta blockers. He was concerned that I would see negative side effects from that, as well. Good guy.

[Tiberius]

Hate to burst your anti-capitalist bubble, but:

Federal Food and Drug Administration officials acknowledged that they asked Pfizer to resubmit thousands of records after realizing that the company was sending required reports in an inappropriate format that could not be added to the agency’s Adverse Events Reporting System, or AERS.

“Last year, FDA became aware that a few manufacturers were submitting adverse events reports to FDA through improper channels,” the agency said in a statement.

Pfizer officials said they were submitting reports as required and that when the FDA asked them to change, they did so immediately.

So the company were sending reports of these incidents, just in the old format, which the FDA took ages to notice (i.e. a failure on their part). When they did finally notice, they requested that the reports were resent in the correct format, and only then did they find out the extent of their failure.

Whichever way you look at it, the company was abiding by the law here. It was sending the reports as the FDA had instructed, and had not been told of the format changes. Once it was informed, it resent the reports. This is just another example of a government organization failing to do what it was set up to do, because once you get bureaucracy into the mix, efficiency goes down the plughole.

Oh, and I thought this was quite important as well, although you didn't seem to think so when you tried to make this about blaming an innocent company:

FDA officials said the new reports did not change the agency’s position on the risks and benefits of the controversial drug, which received a black box warning that included suicide — the strongest caution possible — in 2009, according to agency officials who would not speak on the record.

(bolding mine)

So, a company makes an experimental new drug that tries to help stop people smoking. They file reports to the FDA about the risks, and the FDA puts a caution on the drug. The company continues to report the incidents to the FDA, although for some reason they are not informed by the FDA about the change in format, which the FDA also doesn't pick up on for some reason. When the FDA finally get off their lunch break and realise they've fucked up big time, they ask the company to resend the reports in the new format. The company complies, and the FDA stick to the same caution they put on the drug 2 years ago...

...and you say the problem is with the corporation and not the FDA?

[Minimalist]

Yes because they tried to hide the bad data...as these fuck wit corporate pricks will do if they think it will hurt their bottom line.


And, libertarian assholes who want to gut the FDA simply want to make it easier for them.


http://columbialibertarians.blogspot.com...h-fda.html

Many economists have studied the FDA. Their diagnosis is well expressed by Nobel-winning economist Milton Friedman: “The FDA has done enormous harm to the health of the American public by greatly increasing the costs of pharmaceutical research, thereby reducing the supply of new and effective drugs, and by delaying the approval of such drugs as survive the tortuous FDA process.”

By all means....let's let them pour poison on the market. So what if some people die? Anything for corporate profits!!!!

[Tiberius]

Yes because they tried to hide the bad data...as these fuck wit corporate pricks will do if they think it will hurt their bottom line.

Are you going to be a man and admit that this statement is pure speculation, with absolutely no solid evidence to back it up?

[Dean-o]

By all means....let's let them pour poison on the market. So what if some people die? Anything for corporate profits!!!!

People are a lot smarter than you seem to give them credit for. If a company is poisoning their products no one will buy them. If the large corporations refuse to stop, they will either go bankrupt or get another charity check from the government.

[Faith No More]

People are a lot smarter than you seem to give them credit for. If a company is poisoning their products no one will buy them. If the large corporations refuse to stop, they will either go bankrupt or get another charity check from the government.

Prescription drugs are different though. When you are prescribed one you should be secure knowing the risk of side effects are minimal and that all precautions were taken by the companies to make sure the drug is safe. If a prescription drug is bad, chances are you've already taken it too long by the time you realize it.

[Zen Badger]

That champix(the Oz branding) is bad shit. Kichi was on it for a while and she became quite literally suicidal.

Although she didn't attempt anything, she kept saying that she really felt like killing herself.

Fortunately she stopped taking it quickly after she did some research on the net.

The interesting thing is that it is heavily funded and promoted by the government.

A one month course costs $300.00 of which the government covers $270.00.

The statistics show a 6% success rate, which is less than people just going cold turkey.

Yet despite the information freely available on the net etc. the gov. is still promoting it.

Hmmm........

[tackattack]

I tried Chantix, I dind't have any suicidal tendencies, but it gave me serious stomach cramps. Seeing what my wife goes through, I'd compare them to a mild menstrual cramp. I had to stop,other than that they worked great though, much better than Zyban

[KichigaiNeko]

The craziest thing is that 'Zyban' was initially an anti-depressant, the stats showed that it also stopped those taking it from smoking. 'Chantix' (Champix) is second generation of that compound sans the anti-depressant. Make no mistake you are dealing with a psychotropic medication and as such it is on prescription only here in Australia. My objection is that the medicos are so gun-ho ready to dole the drug out to all and sundry with no investigation done on the patient; the fixation of the planetary wide 'quit smoking at any cost' mantra by the medical profession and governments who are convinced that smokers are costing billions of dollars in lost revenue; and finally the fact that whilst the paltry 44% of viable "success" stories seems impressive the fact that the other 56% have NO "success" in quitting smoking a significant number of that majority are dead or loopy costing MORE $$$ to governments and the medical profession in terms of hospital care and government funded medication is ignored. Governments (being full of politicians) just want to look good to be 'seen' to be doing something...even if it is just questioning someones birthcertificate. Is it any wonder that WHO has labeled Mental Health the biggest global issue?

For your reading pleasure:-

http://www.truthwillout.co.uk/2010/03/ch...champix-6/

http://champixsideeffects.com/champix-reviews/

http://www.smokingproducts.youruserrevie...r-champix/

http://healthinfostat.com/category/stop-smoking

While it can be argued that IN SOME patients Champix is THE quit-smoking aid. 44% is a piss poor success rate to be doling this drug out like paracetamol or ibuprofen (both of which have very obtuse effects on yours truly- 500mg paracetamol will put me to sleep, ibuprofen has no effect on the pain but makes me "stoned" is the best I can come up with) Unfortunately the "success rate does not follow up on patients 1-2 years down the track where they have taken up smoking again hence the adjusted figure of 6% is deduced.

I am still battling depression and constant headaches and diarrhoea. At times it is very bad and I must resort to Cognitive therapy techniques to get myself out of it. I still smoke (though am having some success in reducing the use of tobacco) but the constant nausea I think is helping there and no... having food snacks or meals do not help much. I still think it would have been easier to just walk off the 10th floor of my apartment block on some days it gets that bad, and this is 12 months after stopping the "Champix" wonder drug treatment.

I would say that the only quit smoking "aid" you really need is the strong desire to "Not Smoke Anymore" other than that I can only say that I enjoy smoking (keeps people away from me when I've had enough of society) and that smokers aren't costing the medical budget $$ pharmaceutical companies just might be. The whole system is just one big con-derrived mess imho ...why do we NEED to have vitamins?? Look at that little $$ earner for pharmaceutical companies.

I remain very sceptical.