Stopping clinical trials early

I see the drug companies are coming under fire again, this time for stopping clinical trials of anti-cancer drugs early, because of encouraging signs of benefits.  They have  the bare-faced audacity to claim that their motivation is to get approval as fast as possible – based on short-term effects only – in order to get the drugs to patients without delay.  Even if that were their true motive, it is no excuse for haste in the process of studying real outcomes, which is simply unscientific to the point of being reckless.

But we know, don’t we, that this is not their real motivation. This is an established strategy, they did the same thing with NRT, which was originally passed on the basis of its performance at six weeks!  The fact is, anything that looks like some sort of success is being passed off as the real outcome, in a way that shows a contemptuous disregard for the whole business of approval.  The medical approval bodies are approving drugs on the thinnest of evidence of efficacy, and inadequate evidence of safety. It is dangerous.

The whole system needs to be scrapped, and replaced with an independent academic system that performs real medical trials that take into account all findings, long term results and side-effects, before any medication can be passed as safe and effective.  The current system is corrupt, disreputable and a danger to the public.

the book

Champix/Chantix

The scariest Champix reports were those that involved unexpected changes to mental well-being, including one woman who told me that she stopped taking it because she was having time-lapses in her day she could not account for, including whilst driving. A five-minute journey seemed to have taken twenty-five minutes, for no reason she could remember or explain, and she was deeply concerned.

 

*Update 1: If you or a loved one has suffered a bad reaction to Champix and you are based in the U.K., you can report it to the Medicines and Healthcare Products Regulatory Agency (MHRA) here. The more people do that the clearer the true picture will become. Protect others! Report it.*

**Update 2, 4th November 2011:

The American Food & Drug Administration (FDA) were reported recently in the Business section of the Washington Post as reassuring smokers that Chantix (known as Champix everywhere outside the USA) “does not increase psychiatric problems”, according to two small studies involving 26,000 smokers.  Since this flies in the face of everything else they know about Chantix already, it is surely irresponsible to say such a thing at this time, because the caveats added to the story further down do not carry anything like the weight of the inevitable headline.  Meanwhile, this article in the Daily Mail reports a study which states exactly the opposite.

Why?  Because the Daily Mail is not bending over backward to assist the pharmaceutical industry – even at the expense of smokers’ lives, if that’s what it takes – whereas the FDA very clearly is.  The testing and approvals system is corrupt as hell, using every possible means of dragging their feet so that Chantix/Champix stays of the market and remains ‘approved’ regardless of how many individual smokers’ lives are ruined by the drug.

The Truth Will Out Campaign has been trying to alert smokers (and doctors) to the dangers of this drug since Autumn of 2008, but just imagine the frustration of this commentator on the new Daily Mail report:

“Oh now they make this a huge statement. My mom used it in mid 2007. She ended up in a mental hospital. Thanks Champix. This stuff shouldn’t even be on the market!!! I still can’t understand why it is, with all these accounts of suicide! I read horror story’s back then after this happened to my mom about people killing themselves or having illness such as bi-polar disorder activated in them. My rule with all drugs is, if it hasn’t been on the market for more then 10 years…DO NOT take it. You never want to be the guinea pig. Sorry for all those who ended their lives because they were manipulated this drug.

– Danielle, USA,
3/11/2011 6:08″**

 

Champix/Chantix

by Chris Holmes

*Update: If you or a loved one has suffered a bad reaction to Champix and you are based in the U.K., you can report it to the Medicines and Healthcare Products Regulatory Agency (MHRA) here. The more people do that the clearer the true picture will become. Protect others! Report it.*

 

At the very end of the book Nicotine: The Drug That Never Was, in the final section called A Pause For Breath which you can read here on the site, I mentioned the announcement of the coming of a new magic pill to stop people smoking, which coincided with my completion of the book in May 2007. What I didn’t know at the time I was writing that last section was that the number of smoking clients I was used to getting every week was about to drop by around 50% as thousands of would-be quitters raced off to try the new medication instead.

People want magic pills. They want to believe the doctor can make their problems go away, just by swallowing a little tablet and then getting on with their day. So as soon as the headlines hit – “New Pill to Stop Smoking! Available on the NHS within weeks!” – hypnotherapists like myself who specialise in smoking cessation encountered an unexpected drought that went on from June 2007 right through to the end of the year. Now we’re pretty much back to normal, as everyone has learned that the latest magic pill isn’t magic after all – surprise, surprise – in fact it has turned out to be a horrible nightmare for some.

Champix is supposed to work by ‘blocking the nicotine receptors so that smokers no longer enjoy smoking’, which is actually nonsense because habitual smokers don’t smoke for enjoyment anyway. Some may believe they do, but if you ask any smoker to focus on the pleasure of smoking, and then describe it to you, they will find themselves unable to do that.  Then ask them what their first cigarette was like – most smokers remember that it was disgusting.  So, if there is a pleasure in smoking, how come none of us noticed it straight away?

The truth is that the pleasure is all in the moment, none of it is coming from the cigarette.  Only smoke is coming from the cigarette, which we all found nauseating to begin with, but it’s amazing what you can become accustomed to.  Simply because habitual smokers tend to smoke at moments of repose – which are usually pleasant moments because they are no longer stressed or exerting themselves – many smokers adopt the idea that they enjoy smoking.  Even so, there will be moments when that illusion falters, and the original nausea and disgust becomes noticeable again. Nicotine itself is not pleasant in any way, as all smokers noticed on the first day they ever inhaled the smoke – and apparently, neither is Champix.

Only a few weeks after Champix became available on prescription in the U.K. I began hearing reports from the only people I really trust these days when it comes to quit products: smokers themselves.  The most common remark about the drug was that it caused quite severe nausea, but there have also been much more severe reactions too.  If you have taken Champix yourself, or someone close to you has, feel free to add comments at the end of this post.

Some reports I have heard suggest that although the urge to smoke seems to disappear whilst taking Champix, it returns once the drug is out of your system.

The course of nausea-inducing tablets is twelve weeks, which is a long time to put up with nausea. Not everyone is nauseous for that long apparently, some only reported that for a short period after taking the tablet, but others seem to be regularly heaving or actually vomiting. Since when is medicine supposed to make you ill? Does it really just ‘work’ by making you feel too rough to face smoking, rather like a hangover does? That’s a bit unsophisticated, isn’t it? Sounds a bit dangerous, too. Hypnotherapy – by contrast – isn’t nauseating or dangerous, and the whole process usually only takes a couple of hours. For the majority, that’s it: you’re a non-smoker again. No cravings, no willpower needed, no bad moods and no weight gain. That’s one hell of a lot better than taking tablets that make you ill for weeks on end, isn’t it? Not to mention safer, and with a much higher success-rate, when it’s done properly.

Champix Scary Side-Effects

The scariest Champix reports were those that involved unexpected changes to mental well-being, including one woman who told me that she stopped taking it because she was having time-lapses in her day she could not account for, including whilst driving. A five-minute journey seemed to have taken twenty-five minutes, for no reason she could remember or explain, and she was deeply concerned. A report published in The Telegraph (24.10.07) warned that people taking Champix had been told by the Medicines and Healthcare products Regulatory Agency (MHRA) not to drive when taking the medication, following two accidents blamed on the drug. Dizziness and sleepiness are two side-effects of Champix, made by Pfizer.

Okay, so how is that going to work in reality? Smokers are put on this for twelve weeks, or even twenty-four weeks if they are still smoking after the first twelve. Does the GP say: “By the way, don’t drive for the next six months”? No, they are much more likely to just say: “Don’t drive if you don’t feel well”, but the trouble is, most people on Champix feel unwell daily. Still got to get to work, haven’t they? So the MHRA have issued a warning that few working smokers can possibly heed in practice. How many people are driving about under the effects of a drug that is known to cause dizziness and/or sleepiness – and even memory loss – for anything up to six months?  Given to them by their doctor.

Recent Updated Warnings by Pfizer

At the beginning of 2008 Pfizer added more warnings to the medication suggesting that users should be monitored for erratic behaviour, suicidal thoughts or personality changes whilst on the drug. Okay – by whom? Since the only people likely to see that warning at all are the user and their GP, how is that supposed to work in practice? The people most likely to notice those changes are family and work colleagues – all of whom will probably be unaware of Pfizer’s warning and some of whom may be subordinate to the user in some crucial way which makes swift and effective response unlikely or impossible if indeed any sudden erratic behaviour occurs.

What if the user is a police officer, or in the armed forces? What if they are an air-traffic controller, a crane driver, a rail signalman or a pilot? **Update: Pilots and air-traffic controllers have now been banned from taking Champix** Memory lapses, sudden personality changes or suicidal thoughts take on a whole new angle in such cases, and even the driving issue makes Champix a potential threat to anyone even trying to cross a road. The mass-prescribing of Champix to smokers is actually a gigantic experiment, and what that updated warning from Pfizer really means is this:

“We’ve covered our asses now, you’ll just have to chance it in practice unless you can afford to quit work for a few months… and if anything terrible happens to you or your loved one, and you try to blame the medication, our well-paid legal team will create just enough uncertainty to make sure you get the blame for the disaster, sucker!”

If you have a story to tell about Champix, let us know. If you would like to know more about how hypnotherapy can help with smoking, or any other issue, visit the Central Hypnotherapy Website.

If you wish to comment on this, or any other post on this blog please use the Leave a Reply facility at the end of the list of comments below.

Site Launch!

This campaign is not attacking the medical profession. It is attacking the cosy collusion between medical authorities, the pharmaceutical industry and also the Department of Health, because they are all actively promoting methods that fail the vast majority of smokers, misrepresenting the facts and telling lies about alternative methods like hypnotherapy and acupuncture – all of which is costing lives and wasting resources.

by Chris Holmes

Well now, this should be interesting. It’s not every day a humble therapist takes on the pharmaceutical industry, the Department of Health, the B.M.A. and the Royal College of Physicians… but it has got to be done.

The book was the first step: that had to be written and published initially so that anyone in the world could get hold of a copy and assess the evidence for themselves. I couldn’t just come out and say: “Actually, the whole basis for Nicotine Replacement is false, which explains its abject failure!” …because nobody would have listened. Everyone would assume that it must have been properly tested, surely, in well-designed scientific trials?

Then again, you could just ask yourself: “Who has any faith in nicotine gum these days, really?” And of course, we now know that clinical trials ain’t what they used to be, and the whole process of getting products approved as medicines has been hijacked by the drug companies, who now run all the clinical trials themselves and tend to be very selective about the ‘evidence’ they present to approval bodies.

I challenge anyone – anyone with an open mind, that is – to read the evidence on this site and tell me they are quite happy to have their tax money squandered on the poison nicotine for a few more years. The Department of Health has got the NHS Stop Smoking Services proclaiming ‘success rates’ that bear no relation to the real, long term outcomes – and they know it! They just don’t want the public to know it.

I am quite sure there will be many people working in the healthcare system who will be in full agreement that precious NHS resources should not be wasted on a poison posing as a medication, just because the manufacturers managed to swing it in such a way that the very short-term results were passed off as the real results. That’s bogus, and if you turn a blind eye to things like that, you can hardly be surprised when you later see embarrassing headlines like the ones posted on this site (see Trust me, I’m a Doctor). And if you find yourself doubting that nicotine products could possibly have won approval in that way, you really should read the Daily Mail article there by leading psychiatrist Professor David Healy from February 2007, which is reproduced in that section of the site. In fact everyone should read that, before they allow their doctor to precribe them any new “wonder drug”.

This campaign is not attacking the medical profession. It is attacking the cosy collusion between medical authorities, the pharmaceutical industry and also the Department of Health, because they are all actively promoting methods that fail the vast majority of smokers, misrepresenting the facts and telling lies about alternative methods like hypnotherapy and acupuncture – all of which is costing lives and wasting resources. And all because they don’t want to admit they were wrong, which is a pretty pathetic reason to carry on like that. Or to maintain the status quo because it suits all three parties, which is worse, since it maintains at enormous human cost.

So if you find yourself in agreement with the Truth Will Out Campaign, please help by spreading the word in any way you can! This Campaign is opposed to any kind of violence, intimidation or criminal damage in pursuit of its aims – this is an information war, challenging misinformation and the covering-up of failure on a massive scale. On behalf of smokers everywhere, we welcome all genuine assistance in spreading the word! The Truth Will Out!

the book that blew the whistle on the nicotine scam

hypnotherapy info