Reproduced from
an article in the Sydney Morning Herald.
Australia’s
drugs regulators are under fire over the freer
rein given to the advertising
of alternative products. Sydney Morning Herald
Health editor Adam Cresswell reports.
Obesity is a growth industry
in Australia, but if it affects you – or you just need to
shed a few extra pounds – don’t despair,
you are positively spoiled for choice over what
to do. Why not try the herbal preparation Xantrax?
As its promotional blurb shouts from every second
pharmacy window, it’s “recommended
by a doctor” and contains “potent
botanical extracts” that can reduce fatigue,
suppress the appetite and “enhance the
body’s ability to cope with stress”.
A snip at $50 a bottle, you might think, although
it would be only fair to point out that the contents
of these pills are extracts of bitter orange,
guarana, ginseng and green tea, and the (very)
small print reveals that the doctor who so enthusiastically
recommends it is a paid consultant for the makers.
Never mind – you can move on to “new
and improved” FatBlaster Max, which has
tantalising photos of svelte, semi-clad models
on the packaging.
Perhaps you could be fit like the, too, if only
you would lie on the couch and take your herbal
medicine – which in FatBlaster’s
case will also set you back $50 for 60 tablets.
FatBlaster Max leaves Xanthrax’s contents
box in the dust by adding to the herbal cocktail
brindleberry, gymnema, help, yerba mate and cayenne,
and at least a dozen other ingredients. Bargain!
Well, maybe not.
A trip to the website of the advertising regulator
reveals that in December 2005 the company behind
FatBlaster was found to have run advertisements “likely
to arouse unwarranted and unrealistic expectations
of product effectiveness”.
The ads also glossed over the important detail
that to expect good results, anyone shelling
out hard-earned cash for FatBlaster still has
to eat healthily and exercise – in other
words, just like everybody else.
Cat Media, the company that developed and markets
both FatBlaster and Xanthrax, as well as about
20 other complementary medicines, rejects criticisms
of the products. A spokesman told Weekend Health
that natural weight loss products “are
fully backed with scientific, clinical and traditional
evidence” to support their claims. “They
provide an important low-risk alternative to
the potential health risks of pharmaceutical
drugs.”
Wherever the truth lies on that question, Xanthrax
and FatBlaster seem positively respectable when
you look at some of the other things officially “listed” by
the Therapeutic Good Administration, Australia’s
official medicines watchdog, including treatments
for menopause, and “liver tonic pills” that
claim to help “strengthen kidney organ
meridian energy to supply healthy liver Qi”.
It’s an all-too-familiar story for Queensland
scientist Loretta Marron, one of a growing band
of sceptics who say it’s time to blow the
whistle over what they regard as the TGA’s
failure to police complementary medicines.
A tireless advocate for a tougher line, Marron’s
latest media turn was in the pages of this week’s
GP newspaper Medical Observer, where she accused
the TGA of “failing both the public and
the pharmacies badly because it’s listing
products that simply don’t work”.
Marron
told Weekend Health she has “identified
3000 totally useless products” that have
been listed by the TGA.
She says the number of weight-loss treatments
has grown from 15 per cent of total TGA listed
products in 1996 to 5.5 per cent last year – “and
most are based on caffeine or green tea, and
are all useless”.
Fed up with what she sees as the TGA’s
inaction, each month for the past six months
Marron has taken to researching the evidence
(or more usually the lack of) for a specific
treatment, and posting the resulting dossier
to the TGA.
“
I did sex products last month, which was great
fun” Marron confides. “There’s
one amazing device that clamps around the crown
jewels – its costs $606 and claims to
work by inducing a ‘galvanic current’.
It’s the same load of claptrap…but
a lot of erectile problems are in the head,
and the placebo is a powerful force.
"It’s really easy
to make money with the current rules – just
find any garden week that has a traditional use,
put it in
a box with
flowers or a has-been athlete, list it with
the TGA and go on a marketing blitz – and
rake in the money.”
This issue is not new, but hit the headlines
again this week after an outburst by Fred
Nadjarian, the head of Roche Projects, maker
of the weight-loss
drug Xenical.
Xenical, also known by its chemical name
orlistat, used to be a prescription – only drug,
but was allowed to be sold over pharmaceutical
counter last year. It was also reclassified to
allow it to be advertised direct to consumers.
Last week Nadjarian slammed as “just plain
nuts” a recent decision by the TGA’s
National Drugs and Poisons Schedule Committee
to scrap that advertising concession after complaints
by consumer group Choice over Xenical ads screened
during Australian Idol TV Show.
Nadjarian said reimposing the advertising
ban on Xenical left the field open to “hocus
pocus” products “largely based on
green tea extract, eye of newt, wing of bat and
guinea pig tail”. And a number of others
who are normally no friends of Big Pharma have
lined up to agree.
Xenical promotes weight loss by blocking
the absorption of fat in the gut. Even experts
who disapproved of Roche’s TV ads say it is
considered very safe and has a legitimate role
in treating the patients for whom it is approved
= obese patients with a body mass index over
30, or overweight patients who also have other
diseases, side-effects in patients who eat excessive
fat while taking Xenical include oily stools
and “recent leakage”.
“To be fair to Roche,
they do have a product that works, has been clearly
validated by external
people and it does have a small place,” says
Ken Harvey, adjunct senior research fellow at
Victoria’s La Trobe University. “But
by and large, a lot of the alternative products
are crazy”.
Higher –risk drugs – usually prescription
and pharmacy-only medicines – including
Xenical are almost all “registered” by
the TGA, a process requiring the manufacturer
to pay the TGA a hefty fee in exchange for the
TGA evaluating the product for quality, safety
and effectiveness.
“Listing” a lower-risk product, on the other
hand, is simpler. Most complementary products
are listed.
Obtaining a listing is a simple as visiting
the TGA’s website, entering some details about
your product and paying a fee.
No evidence that the product does what
it says it does have to be projected
at the
time of
listing. Officially, sponsors of listed
medicines are
supposed to hold such evidence in case
they are asked for it, which generally
only happens
after
a complaint or when the TGA does random
spot-checks.
Listed products cannot make claims about
curing, treating, managing or preventing
any condition
or disease, and may instead only make
claims related to symptoms and to “health maintenance
and health enhancement”. The TGA says these
measures “ensure that consumers will not
inappropriately self-diagnose or self-treat potentially
serious medical conditions with medications that
have not been established as being effective
by the TGA”. The agency defends the system
as “robust and appropriate”, and
Cat Media says all advertisements have to be
pre-approved before publication, describing the
process as “among the most rigorous and
restrictive in the world”.
The TGA says it does take “regulatory action” when
it finds evidence is wanting. But critics say
the TGA only checks 20 per cent of listed products,
so the chances of getting away with over-the-top
claims are good.
In addition, critics like Harvey say
members of the public do not understand
there is
any difference between registered medicines
and
those that are merely listed, and fears
that a TGA “listing” simply
gives questionable products a sheen of bogus
respectability.
Marron also says the significant fee
income the TGA derives under the existing
system
means the
agency has little incentive to tighten
procedures further.
It costs $950 for an initial application
to list a product, and an annual fee
of $850 thereafter. “In
other words, 3000 dodgy products bring in over
$2.5 million,” says Marron. “There’s
a culture of denial in the TGA-they don’t
want to know what I’m saying.”
Marron also blames some pharmacists for
using TGA listing as carte blanche to
promote products
that as health professionals they ought
to steer clear of. But other pharmacists
are
also just
as critical of quick-fix cures.
“
As pharmacist, we all know that, in the main,
these (weight-loss) products don’t work,” says
Tasmanian pharmacist Mark Dunn, publisher of
the AusPharm suite of websites.
Dunn
says the TGA should “formally assess
the evidence for Aust-L (“listed”)
weight-loss products and if product
sponsors can’t produce good-quality
evidence showing that their products
work, they should not be
allowed to put them on to the market.”
In the meantime, Dunn says products
should be compelled to carry the warning: “The TGA
has not assessed this product for efficacy.” Who uses complementary Medicine?
- 52pc of 3015 people
surveyed used alternative medicines
in 2005
- Use was highest
in younger, educated, city-dwelling,
affluent women born in Australia
- Vitamins were
used by 39pc of all respondents,
followed by herbal medicines
(21pc) and mineral
supplements (14pc)
- Average
spending on alternative medicines
was $21.23 per month – with
the range going from $1 per month
to $650
- About half of those taking alternative
medicines did not tell their GP
- About half of
respondents assumed alternative
medicines were independently tested
by the
government:
of these, 75pc believed they
were tested for quality and safety,
23pc
for what they claimed,
and 19pc for efficacy
Source: Assoc Prof Ken Harvey/MJA
2006; 184(1):27-31
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