Smoking Study

Stop Smoking

STOP SMOKING STUDY IN “THE NEW SCIENTIST”


Smoking cessation is a multi-billion pound industry with an estimated 1.2 billion customers worldwide. Arguably, a market controlled by the powerful pharmaceutical multinationals, which wield such power and influence over the media, television, newspapers, radio, universities, scientific journals, medical associations even government’s. Is it possible to create proactive propaganda to protect and perpetuate a multi-billion pound industry?

NO SMOKE WITHOUT FIRE
By Elliott Wald

Every year four million smokers in the United Kingdom try to kick the habit – with only an estimated 150,000 permanent successes.

Many seek advice from their local G.P or pharmacy; thousands call the national quit line while hundreds contact the government Health Action Zone.

Smokers attempting to quit and contacting one of these organisations will be directed towards the various Nicotine Replacement Therapies (NRT) and encouraged to use one of these products.

Posing as a smoker I contacted the quit line. I gave my my name and post code but declined to give my telephone number. asked if I would like an information pack posted to me. I declined. But guess what, a few days later a NHS quit smoking pack, full of NRT propaganda arrived on my doorstep.

Were hypnosis or acupuncture mentioned? Yes – “other aids to giving up, hypnosis, acupuncture. Some claim very high success rates. Be careful – there is no magic cure and none of these methods have been scientifically proven. If in doubt call us” … it was as if this was reinforce the view that NRT was the only method.

The quit councillor asked what methods I had tried and I listed patches, lozenges, zyban, even claiming to hve tried patches several times but without success. On asking for their ‘expert’ advice they recommended I tried one of the NRT products again.

So I inquired about other methods – perhaps psychological. After all Clive Bates, director of ASH has been quoted as saying a smoker needs to be ‘psychologically ready to give up.’

Was this his way of saying NRT only addressed the physical addiction and did not come close to the second root of smoking the psychological habitual side, such as hypnosis, acupuncture or an alternative method not involving NRT?

The response – “These methods have no evidence to support them. Nicotine replacement products double your success rate.”

“Double your success rate!” I repeated.

Yes I was assured. What a great sales line I thought, muttering to myself – “doubles your success rate”.

“What percentage that equated to,” I asked.

Willpower alone I was informed was one per cent, but with NRT that doubled.

Wow! Two per cent. So NRT is 98 per cent unsuccessful.

I explained I would rather try another form of quitting. Could they recommend a hypnotherapist?

“There is no scientific evidence to support hypnosis”, the expert on the end of the phone retorted.

“Still, I’d like to give it a try” I persisted.

At which I was given the number of British Complementary Medical Association.

On phoning the BCMA I asked for a hypnotherapist in my area. Sorry was the reply, we do not have a hypnotherapist in that area.

So asked for surrounding areas. Sorry, not even in the surrounding areas.

Looking up the website I was hardly surprised to discover that nationwide the BCMA had only 23 hypnotherapists listed. Intrigued at what qualifications they might hold, I tried three of the numbers … they were unobtainable.

Did Quit and the other supposedly independent organisations really not want smokers trying any other methods? They could have given the Hypnotherapy Association, National Council Hypnotherapy or any of the large hypnotherapy associations.

If organisations such as ASH, Quit, and the NHS where making it so difficult to try any method except NRT, it raised one question – why?

Trawling through the Quit website I came across sponsors, Glaxosmithkline, Norvatis pharmaceutical, Pharmacia, Procter and Gamble, Micro medical Ltd.

Could it be that an independent charity, whose main thrust was nicotine replace therapy, was being sponsored by pharmaceutical companies which manufactured those products?

Glaxosithkline supported the ASH conference in Cardiff 2002.

Some of the companies involved

GlaxoSmithKline was created by the merger of pharmaceutical giants Glaxo Wellcome and SmithKline Beecham in December 2000, making the new company the world’s biggest drugs group by sales.

Glaxo Wellcome markets Zyban (buproprion) and SKB markets Nicoderm CQ nicotine patch and Nicorette gum. One of the hold-ups in getting approval for the merger was that both companies marketed smoking cessation products, and even though these accounted for less than four per cent of SK’s sales, neither company was willing for them to be sold to another pharmaceutical company to facilitate the merger.

The UK’s largest pharmaceutical company has been criticised by the advertising watchdog for “misleading” adverts, which claimed a new lozenge could triple a person’s chances of quitting smoking.

The Advertising Standards Authority (ASA) ruled the ads for NiQuitin CQ? lozenges, manufactured by GlaxoSmithKline (GSK), were “misleading” and “exaggerated” the success of a trial study.

Placed in national newspapers and on the London Underground, the adverts suggested the new anti-smoking lozenge “could triple your chances of success” of kicking the habit.

Pharmacia – (Also Pharmacia & Upjohn) makes Nicorette and Nicotrol , “a family of tobacco dependence therapies.” A number of products are also sold globally. Among the company’s largest, most well-known brands is a line of nicotine replacement products, including nicotine gum, transdermal patch, and nasal spray and inhaler.

The Development of Smoking Cessation Drugs

In 1971 Pharmacia developed the first nicotine replacement product for smoking cessation, nicotine-laced chewing gum. The gum was launched for use in Switzerland in 1978, and in 1984 the U.S. Food and Drug Administration (FDA) as a smoking cessation prescription drug approved it. SmithKline Beecham subsequently marketed the gum as Nicorette.

Duke University researcher Jed Rose developed the patch in the early 1980s. Manufactured by Pharmacia, the patch has been marketed in the U.S. as Nicotrol by a Johnson & Johnson subsidiary and as Nicoderm by SmithKline Beecham. The FDA approved Nicotrol and Nicoderm as prescription smoking cessation drugs in 1991, and in 1996 the FDA did away with the prescription requirement for the patches and the gum, approving them for over-the-counter sale directly to consumers.

The nicotine inhaler and nicotine spray have also been approved as smoking cessation drugs by the FDA, but to date the agency has not approved them for over-the-counter sale. The nicotine inhaler evolved from a “smoke-free” cigarette. Sold under the brand name Favor in the 1980s, the cigarette was forced off the market by the FDA in 1987 because it was deemed a “drug delivery device.” Just ten years later the FDA approved Johnson & Johnson’s Nicotrol inhaler as a nicotine delivery device, which could be used for smoking cessation.

Orally ingestible nicotine drugs have been developed but have not yet been clinically tested. One of the two Duke University inventors of this cessation drug is Jed Rose, who also invented the nicotine patch.

Glaxo Wellcome’s Zyban, the only non-nicotine smoking cessation drug currently approved by the FDA, was originally developed as the anti-depressant Wellbutrin. The FDA approved Wellbutrin, the trade name for the drug bupropion, in 1985, but it was subsequently removed from the market because of concerns about drug-induced seizures. Wellbutrin was reintroduced as an anti-depressant in 1989. When researchers noted that some of those taking the drug quit or reduced their smoking, Glaxo Wellcome began clinically testing it as an aid for smoking cessation. The FDA approved Zyban as a prescription smoking cessation aid in May 1997 and approved the combined use of Zyban and the nicotine patch in 1999. Bupropion is currently marketed by GlaxoSmith Kline as an anti-depressant under the trade name Wellbutrin and as a smoking cessation drug under the name Zyban.

The Art Of Manipulation

In order for any drug or drug delivery device to be marketed, the FDA must first approve it. To gain FDA approval, the pharmaceutical company intending to market a specific drug must conduct clinical tests to demonstrate that the drug is both safe for use and that it works for the purpose for which it is intended.

Once clinical testing is complete, the results are presented to an FDA panel of experts for evaluation. If the panel believes the clinical test results demonstrate both safety and efficacy, the drug is recommended for approval, and the pharmaceutical company is then free to market its drug under conditions determined by the FDA (prescription or over-the-counter sales, recommended uses and doses, mandated warnings, duration of use, etc.).

On its face, the system appears to be a good one for protecting consumers from unsafe drugs and fraudulent claims about the curative powers of drugs. However, in practice the system is far from perfect. Sometimes political pressure is brought to bear on the FDA to approve-or not approve-a given drug.

Sometimes there are financial ties between members of FDA panels and pharmaceutical companies seeking drug approval, and occasionally cases of outright graft have been uncovered at the FDA. But even when the approval process is uncorrupted by political interference or competing financial interests on the part of FDA employees or scientific panel members, there is still one major problem: the clinical trials are financed by and heavily influenced by the drug companies themselves.

The FDA itself does none of the testing ; FDA scientific panels merely examine the clinical test results the drug companies present to them, and the companies are not likely to present results which are not favourable to the companies’ products.

In the case of smoking cessation drugs, the results of the company-funded clinical tests had to demonstrate that the drugs were generally safe and that they were effective for smoking cessation. The FDA standard for approval for “efficacy” was that at six weeks the drugs had to show significantly better rates than placebos for 28 days of continuous smoking abstinence in test subjects. The fact that at the end of a year, many of those test subjects were smoking again did not enter into the FDA approval process, and the pharmaceutical companies were able to list the quit rates at six weeks on their drug labels.

To date the FDA has approved only five drugs for smoking cessation:

Nicorette gum Nicoderm and Nicotrol patches Nicotrol inhaler and nasal spray Zyban

Of these, the gum, the patches and Zyban are the most widely used, but just how safe and efficacious are they? By 1997, when it became obvious that the FDA approved nicotine-based cessation drugs were not very efficacious in the long term, an FDA panel urged that the labels for these drugs be changed to reflect the low long-term efficacy. The marketers and manufacturers of the drugs (Pharmacia, SmithKline Beecham, and Johnson & Johnson subsidiary McNeil) argued vehemently against any such labelling changes: “My daughter was fit and healthy before she started taking this drug, but now the doctors say she has to be on medication for the rest of her life. I am blaming Zyban for this,” Susan Sinclair, quoted in “Ban anti-smoking pill that wrecked my life,” Northern Echo (UK), July 23, 2001.

Though the patch and other nicotine-based cessation drugs have few, if any, side effects (a skin rash is the most common negative side effect of the patch), Glaxo Wellcome’s Zyban has many. In addition, it can interact with a number of other drugs. For these reasons, the FDA has approved its use only as a prescription drug.

Included in the long list of drugs that can interact with bupropion are alcohol, cocaine, corticosteroids, kava kava, medications or herbal products for weight loss, medicines for difficulty sleeping, nicotine, phenobarbitol, some medicines for heart rhythm or blood pressure, some medicines for pain, and St. John’s wort.

Among the most common serious side effects are seizures (a dose-dependent risk, according to Glaxo Wellcome), confusion, vomiting, and hives. Less common side effects are blurred vision, difficulty breathing, fast or irregular heartbeat, increased blood pressure, and hallucinations. It can also cause loss of appetite, loss of sexual drive, agitation, anxiety, constipation, wakefulness, dizziness, dry mouth, headache, nausea, tremors, chest pain, and abdominal pain. It may cause changes in menstruation in women and is not recommended for those with liver problems, since metabolites of bupropion may accumulate in the liver.

Despite all these possibly serious side effects, the FDA as a smoking cessation aid approved it. Further, the U.S. Public Health Service Clinical Practice Guidelines released in June 2000, recommend Zyban as “an option for first-line use as an alternative to nicotine-replacement therapy.” It should be noted that Michael Fiore, who was one of the researchers on the pivotal Glaxo Wellcome-funded Jorenby study, which led to FDA approval for Zyban, was also the lead author of the U.S. PHS Clinical Practice Guidelines. Fiore has also received significant additional funding from Glaxo Wellcome and is a paid consultant to the company .

British guidelines released in December 2000 adopted a more cautious approach to Zyban, highlighting the limited evidence about the drug’s effectiveness in the absence of behavioral support. An editorial in the July 8, 2000 BMJ was far more enthusiastic and called for the UK National Health Service to include bupropion on the list of reimbursable prescriptions. The authors of the editorial, John Britton and Martin Jarvis, have both received honoraria and other funding from Glaxo Wellcome, the drug’s manufacturer, and the editorial itself drew some highly critical responses: “Britton and Jarvis could have pointed out that half of patients who successfully stop smoking with the aid of bupropion will start again within 12 months of coming off the drug. They could also have referred in more detail to the side effect profile and the number of patients for whom the drug will be unsuitable. Bupropion may have a 1 in 1000 risk of inducing seizures (product information from Glaxo Wellcome, the manufacturer of the drug). This may be an acceptable risk for drugs to treat disease but is less so for lifestyle drugs.” Harrison C, “Bupropion may not be as good as editorial implies,” Letter, BMJ, Feb 17, 2001. “Britton and Jarvis’s editorial on bupropion does not mention that the drug is an amphetamine derivative…. Bupropion has been released in the United Kingdom on the strength of only two American clinical trials financed by the manufacturer [the highly-positive Jorenby and Fiore study and the Hurt/Sachs/Glover study]…. Bupropion is being foisted on an unsuspecting British public with little evidence that it works much better than placebo.” Kinnell HG, “Drug is almost identical in structure to diethylpropion, a controlled drug,” BMJ, Feb 17, 2001.

In the first year after Zyban was released in the UK as a prescription drug for smoking cessation, 40 people died after taking it and thousands of others reported serious negative reactions. As a result, the country’s Committee on Safety of Medicines ordered changes to the prescribing regimen and stronger warnings about its use (“Anti-smoking drug must carry stricter warnings,” James Meikle, The Guardian, June 1, 2001).

The reported deaths and masses of complaints about Zyban didn’t prevent the BMJ from publishing another editorial in May 2001 supporting the use of nicotine replacement products and bupropion for those who smoke 10 – 15 cigarettes a day or more. Time Coleman and Robert West, the writers of the editorial, both received funding from Glaxo Wellcome and the pharmaceutical companies manufacturing nicotine replacement products. “It is very unusual to get 300-plus adverse drug-reaction reports in the first year of marketing a drug. The question is whether the benefit of the drug justifies the risk…and the answer is no.” Rick Hudson, a medical consultant to British Columbia’s Pharmacare program, quoted in Krista Foss, “The hidden cost of kicking the habit,” Toronto Globe and Mail, Aug. 31, 1999 .

A more recent study funded by Glaxo Wellcome (now GlaxoSmith Kline) found that Zyban was no more effective at helping people give up smoking than the gum or the patch: “Ms Renee Bittoun, director of the Smoking Research Unit at Sydney University [Australia], said she could not reveal the precise results of the study, which was sponsored by the drug’s manufacturer, GlaxoSmith Kline, because her contract would not allow it…. But the study did not show that Zyban was any more effective at helping people give up smoking than the gums or patches, she said.” Judith Whelan, “Anti-smoking drug all puff, says tester,” Sydney Morning Herald, June 1, 2001 .

Recent media attention on political parties accepting donations sprung to mind; do these organisations really want the smoker to quit? Can the government really afford to lose the revenue from taxation if smokers quit? Or is it all a farce, a pretence, the pharmaceutical companies earn millions the government are seen to be doing something, but still collect millions in taxation, with the reality being very few smokers quit, so these organisations thrive.

There are many other alternatives to NRT. Hypnosis has been proven to be the most effective method to stop smoking, yet the NHS or government have not acted upon this, could it be that the hypnotherapy world does not offer the same financial incentive as the giant pharmaceutical companies? Could it be the government cannot afford to lose the massive taxation’s they gain?

“Hypnosis is the most effective way of giving up smoking, according to the largest ever scientific comparison of ways of breaking the habit. Willpower, it turns out, counts for very little.” New Scientist vol 136 issue 1845 page 6

To find the most effective method to stop smoking Frank Schmidt and research student Chockalingham Viswesvaran from the University of Iowa used a meta-analysis, utilising the results of more than 600 studies totalling nearly 72,000 people, the results, which were published in the Journal of applied psychology and included 48 studies of hypnosis covering 6000 smokers clearly showed that hypnosis, to use the same terminology as the quit councillor was three times more effective than NRT. (References – vol 136 issue 1845- page 6 New Scientist) Which again must lead us to ask the question do these organisations really want the smoker to quit? If they do, why are they not utilising other cessation methods, outside of NRT or drugs? “At a time when smoking still causes one in every five deaths in Britain, measures designed to achieve further reductions in smoking are clearly important Effective smoking cessation services should be universally available to smokers.” February 2000 KGMM ALBERTI President, Royal College of Physicians

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