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:
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:
