| |
Following the rejection of the Therapeutic Products Bill and the
proposed Trans Tasman agency by the New Zealand Parliament (Therapeutic
Products Bill),
widespread agreement about the best way forward has apparently been
agreed by the natural products industry in NZ (1,2,3).
According to a press release issued by NZ Health Trust (1,2)
more than 150 businesses and organisations have signed the agreement
which rejects the government promoted pharmaceutically based control system of complementary
medicines which was intended to be administered by the
Australia New Zealand Therapeutic
Products Authority (ANZTPA) in Australia (3).
The new agreement, which is yet to be accepted by government, exempts complementary medicines and natural products from the
control of the joint agency and is therefore consistent with the widespread feelings
demonstrated by the alternative health community in NZ (Therapeutic
Products Bill). Exempting complementary medicines and natural
products from the control of the proposed Trans Tasman
Therapeutic Products Authority is
not only popular amongst the alternative health community but should
also prove very popular with the medical profession who were concerned
about the complete failure of the Bill following the refusal of the
Australian and New Zealand governments to proceed unless complementary
medicines were included in the Bill (Misinformation
About Pan, & Increased Regulatory Control of Alternative Medicines in
Australia & NZ,
Therapeutic
Products Bill). Since it was felt by doctors that the failure of the
Bill would make it more difficult to access new drugs (Misinformation
About Pan, & Increased Regulatory Control of Alternative Medicines in
Australia & NZ) the proposal to exempt complementary medicines from
the Bill removes the only obstacle preventing passage of the Bill
through NZ parliament, an outcome that clearly should be welcomed by
doctors concerned about access to new drugs. Additionally, given the
widespread community support base for such a proposal, it should also be
popular amongst those who expressed a desire to see a more democratic
outcome (Misinformation About Pan, & Increased
Regulatory Control of Alternative Medicines in Australia & NZ).
Notwithstanding the popularity of this proposal amongst the alternative
medicine community however, there are still those who oppose such a
seemingly democratic solution. Taking an opposite stance for instance,
is Natural Products New
Zealand (NPNZ), who have recently complained about advertisements
opposing the Bill and
supporting the complementary medicine industry in NZ (Misinformation
About Pan, & Increased Regulatory Control of Alternative Medicines in
Australia & NZ). NPNZ continues to support the control of
complementary medicines by the proposed Trans Tasman Authority even in
spite of the divisive nature of such a proposal amongst the alternative
medicine community (Therapeutic
Products Bill). NPNZ apparently feel the potentially unsafe or
dangerous nature of complementary medicines (Misinformation
About Pan, & Increased Regulatory Control of Alternative Medicines in
Australia & NZ) justifies the control of such products by the
Australian based ANZTPA although strangely, when I recently requested
evidence of their claims about the dangers of such products they refused
to comply with my request (Misinformation
About Pan, & Increased Regulatory Control of Alternative Medicines in
Australia & NZ). It seems that though many people claim alternative
medicines are dangerous, when they are asked to provide scientific proof
or cite placebo controlled randomised controlled trials they become
extremely evasive. This is not too surprising given the fact that the TGA and medical experts in
Australia have repeatedly drawn attention to the safety of such products
(Pan Crisis,
Alternative Medicine Takeover,
Response
to Government Inquiry,
Therapeutic Products Bill, Misinformation About
Pan, & Increased Regulatory Control of Alternative Medicines in
Australia & NZ). As I have stated elsewhere (Misinformation About
Pan, & Increased Regulatory Control of Alternative Medicines in
Australia & NZ):
| "Usually experts consider that adverse reactions
to pharmaceutical drugs outnumber adverse reactions to
complementary medicines by around 99 to 1 or, at worst, 98
to 2 (Alternative
Medicine Takeover,
Response to Government Inquiry), a fact which clearly
indicates, given the claimed risk based nature of
legislative reforms, that safety legislation should be at
least 49 times more strict for pharmaceutical drugs than for
alternative products." |
Recently, in a letter to members dated 13th August 2007 (4), Michelle
Beckett of NPNZ outlines the position of the executive and refers again
to the concerns of NPNZ about the safety of complementary medicines and
the need for the proposed ANZTPA:
| "With the recent scandals of contamination of
toys, toothpaste and other products from China, one must
reflect on where else these contaminations may occur. When
one then reflects that many of the vitamins, minerals,
herbal extracts, excipients and processing aids are now
manufactured and supplied from India, China and other third
world or developing countries, it is clear that relying on
documentation without actual test screening is possibly
quite high risk behaviour. At the very least it would seem
that some kind of identity test must be performed, and
further testing undertaken on an at least rotational testing
basis for other attributes and possible contaminants." |
While scientific evidence of the dangers of any therapeutic product,
drug or vitamin, is vitally important, it seems resort is given here to
incidents which might happen in the future. Having said this however,
Michelle Beckett is perhaps making a very good case here for
restrictions upon international trade. Why should therapeutic products
be imported when they can be manufactured under more closely supervised
conditions in Australia or New Zealand? Surely there should be effective
government incentives to ensure such therapeutic products are produced
within Australia or NZ or countries which utilise effective safety
standards. The suggestion that NZ may be
importing dangerous products because of inadequate safety standards and
production facilities in certain countries is an excellent point and one
which NPNZ could take up with the NZ government.
Meanwhile, the TGA in Australia has apparently decided to apply more pressure to NZ
manufacturers by imposing tighter controls following the rejection of
the Therapeutic Products Bill by NZ Parliament (5,6).
It was expected that governments would apply further pressure to the
industry following failure of the Bill, perhaps even resorting to the
same type of scientifically unsubstantiated claims which were employed
so successfully during the Pan drug debacle (Therapeutic
Products Bill). The reader is reminded that the current legislative
campaign in Australia and NZ is the result of the Pan drug debacle which
demonstrated the safety of complementary medicines as compared to drugs
(Pan Crisis,
Alternative Medicine Takeover,
Response
to Government Inquiry,
Therapeutic Products Bill, Misinformation About
Pan, & Increased Regulatory Control of Alternative Medicines in
Australia & NZ).
New Zealanders have consistently demonstrated their opposition to
regulation of complementary medicines by the proposed ANZTPA, a fact
which has been confirmed by the results of the political enquiry and the
rejection of the Bill by parliament (Therapeutic
Products Bill). Surely it is time to move on now by adopting a more
democratic and scientifically justifiable attitude by ceasing the
divisive attempts to force complementary medicines to be regulated by
the pharmaceutically based ANZTPA. The medical profession wants the Bill
passed to enable access to new drugs but the NZ government stubbornly refuses to
pass it unless complementary medicines are included (Misinformation
About Pan, & Increased Regulatory Control of Alternative Medicines in
Australia & NZ). A more conciliatory and scientifically justified
approach by both Australian and New Zealand governments is desperately
needed so that access to new drugs in NZ will not be impeded.
References
1.http://www.nzhealthtrust.co.nz/pdf/Press%20Release%20Joint%20position%20statement%20Aug%2
Amy Adams, Natural Health sector agrees the way forward for
regulation, press release, NZ Health Trust, 13th August 2007.
2.http://www.scoop.co.nz/stories/BU0708/S00272.htm
3.http://www.nzhealthtrust.co.nz/pdf/position_statement_140807.pdf
JOINT INDUSTRY POSITION STATEMENT REGULATION OF THERAPEUTIC PRODUCTS
IN NEW ZEALAND, NZ Health Trust.
4.Michelle Beckett, Re: Regulation of New Zealand Therapeutic
Products (letter circulated to members and interested parties),
Natural Products New Zealand, 13th August 2007.
5.http://www.tga.gov.au/manuf/gmpsom.htm
Guidance on the GMP clearance of overseas medicine manufacturers,
TGA, August 2007, Canberra.
6.http://www.tga.gov.au/manuf/gmpsom.pdf
Guidance on the GMP clearance of overseas medicine manufacturers,
TGA, August 2007, Canberra.
For the past few decades confusion has reigned in the world of
mainstream medicine and nutrition as scientists struggled to explain the
link between nutrition and chronic diseases (Nutrition and Megavitamins,
B Vitamins,
Nutrition Breakthroughs,
Experts say dietary supplements may save $billions in health care
costs!!). Although the epidemiological evidence of this link is
indisputable (Nutrition and Megavitamins,
B Vitamins,
Nutrition Breakthroughs,
Experts say dietary supplements may save $billions in health care
costs!!), scientists are constantly frustrated by their inability to
pinpoint the precise reasons for this link by simplistic clinical trials
(When There is
Evidence for Nutrition but Little Evidence for Evidence Based Medicine).
In fact, scientists only recently discovered that there is no precise
scientific means of diagnosing vitamin deficiencies or determining who
will benefit from supplements of simple vitamins such as folic acid and
therefore they have recommended supplements of this vitamin or the
addition of this vitamin to staple foods (The
Folic Acid Lesson,
Nutrition Breakthroughs, Dietary
Supplements or Functional Foods). To date, the principles of (When
There is Evidence for Nutrition but Little Evidence for Evidence Based
Medicine) evidence based medicine and (Holistic or
Reductionist) reductionism have completely failed to meet the
challenge of complementary medicine. The effects of the confusion
resulting from the failure of scientific reductionism and evidence based
medicine are clearly manifested by the continual disagreements and
conflicts which are so prevalent in the medical world.
Recently for instance, university courses in complementary medicine have
been described in the U.K. as (1,2)
"anti-science" and "scandalously unacademic". David
Colquhoun, professor of pharmacology at University College London,
described universities conducting courses in complementary medicine thus
(1,2):
| "Universities that run them should be ashamed of
themselves. They are cashing in on people's wishful thinking
when there is no evidence that complementary medicine works.
They might as well offer degrees in astrology." |
In further support of this view, Edzard Ernst, professor of
complementary medicine research at the Peninsula College of Medicine and
Dentistry (1,2),
described most complementary medicine degrees as "scandalously
unacademic". Supporters of such courses however, have branded
critics as (1,2)
"out of step with the times".
Meanwhile, in Australia, governments are contributing millions of
dollars (3,4)
to the establishment of the National Institute for Complementary
Medicine at the University of Western Sydney. The National Institute
for Complementary Medicine is intended to (4)
"broaden the scientific community's understanding of complementary
therapies and alternate medicines". In New Zealand the
appointment of a new Chief Advisor to assist in the integration of
complementary medicine and conventional medicine has heralded a (5)
"New era for complementary medicine" while the purpose of the
National Center for
Complementary and Alternative Medicine in the U.S. is to (6)
"Explore complementary and alternative healing practices in the
context of rigorous science". And in Malaysia complementary
medicine is being integrated into public hospitals (9).
But there are still those who seem to prefer to adhere to a simplistic
and rigid reductionist view of
reality where yesterdays scientific 'facts' are very quietly discarded like
out of date fashions (Science Today, Quackery
Tomorrow, Darwinian Medicine) and who still
unscientifically generalise about alternative therapies which they
describe as unscientific or quackery
(7,8).
Of course even such persons eventually accept the importance of vitamins
like folic acid, even though scientists still have no means of
determining precisely who will benefit from supplements of such
vitamins. Perhaps they would suggest we need double blind trials of
various levels of dietary folic acid intake to determine the precise
intake needed to prevent birth deformities. To them it seems, folic acid is different to other vitamins,
although they seem unable to supply scientific proof that this is so.
Of course the problem for scientists and EBM advocates (When There is
Evidence for Nutrition but Little Evidence for Evidence Based Medicine)
is that reality or real life experiences always precedes scientific
evidence. The full benefits of food and folic acid were not discovered
by double blind trials so those who claim that EBM is the only way of
knowing (When There is
Evidence for Nutrition but Little Evidence for Evidence Based Medicine)
will always be the last to learn the truth. Governments and public
health authorities around the world are currently responding to
increasing scientific evidence that the epidemic of chronic diseases,
which are the main causes of morbidity and mortality today, are linked
to nutrient poor diets and therefore diet or nutritional treatments
offer considerably more therapeutic or preventative potential than any
other treatment science has so far been able to offer. This is a simple
fact. Sceptics or EBM advocates however, seem determined to maintain the
status quo and usually have little or no positive suggestions to make
regarding the current epidemic of chronic diseases (10).
They seem to be motivated by an obsession with arbitrary and ever
changing simplistic rules of evidence rather than the suffering caused
by iatrogenic or chronic diseases (Health Trends).
Should we turn a blind eye to the suffering caused by chronic diseases
until EBM advocates are happy that nutritional supplements conform to
their requirements for the rules of evidence? Should we deny real life
experiences in the absence of randomised controlled trials? If the
sceptics wish to avoid taking dangerous nutrients they should be
permitted to do so - unless and until such actions forces the remainder
of the community to pay because of further increases in the huge costs
of chronic diseases!
As the world moves forward there will always be those at the forefront
of research and those who lag behind.
References
1.http://www.dailymail.co.uk/pages/live/articles/news/news.html?in_article_id=471045&in_page_id=1770
Laura Clark, Row over surge in 'scandalously un-academic' university
courses, Daily Mail, 26th July 2007.
2.http://www.dailymail.co.uk/pages/live/articles/news/news.html?in_article_id=471124&in_page_id=1770
Laura Clark, Dons in revolt over 'unacademic' degrees, Daily
Mail, 26th July 2007.
3.http://www.bordermail.com.au/news/bm/national/853706.html
Complementary medicine boost, The Border Mail, 7th July
2007.
4.http://www.theage.com.au/news/National/Alternative-medicines-get-funding-boost/2007/07/06/1183351
Alternative medicines get funding boost, The Age, 6th July
2007.
5.http://www.nzdoctor.co.nz/news?article=1d4afc1d-7a5a-48f9-bd3f-0c46dad5e781
New era for complementary medicine; Media release from health
minister Pete Hodgson and Green Party health spokesperson Sue Kedgley,
4th July 2007.
6.http://nccam.nih.gov/about/ataglance/
7.http://www.quackwatch.org/01QuackeryRelatedTopics/nccam.html
Wallace I. Sampson, Why the National Center for Complementary and
Alternative Medicine (NCCAM) Should Be Defunded.
8.http://www.geocities.com/healthbase/camufo.html
Paul Lee, Is Complementary & Alternative Medicine a UFO?
Skeptic Report,
July 2003.
9.http://thestar.com.my/news/story.asp?file=/2007/7/18/nation/18334698&sec=nation
Vicki Hyde, Complementary and Alternative Medicine
-
Current Policies and Policy Issues in New Zealand and Selected Countries,
Submission to the
Ministerial Advisory Committee on Complementary and Alternative
Health (MACCAH),
New Zealand Committee for the Scientific Investigation of Claims
of the Paranormal,
NZ
Skeptics.
|
"There is a world of
difference between potentially harmful nonbiological drugs
and innocent - if sometimes misapplied -
nutrients.........alien chemicals and natural nutrients
should not be treated alike, and if medical education
were on the ball, they never would be."
Roger Williams, Nutrition
Against Disease, Pitman Publishing Co., 1973. |
Bill Defeated in NZ Parliament but Australian Government Expects Legislation to be Passed
this Year - Recent Developments.
The Australian
government, like other governments around the world (see
Misinformation About Pan, & Increased Regulatory
Control of Alternative Medicines in Australia & NZ,
Pan Crisis, TGA &
Pan,
Codex in Australia,
Pan Crisis
& Future of Alternative Medicines,
Alternative Medicine Takeover,
Response
to Government Inquiry), continues to
seek to
impose restrictions on vitamins and supplements with the
Therapeutic Products Bill 2007 which
is intended to control the industry in New Zealand (1,2,3,4).
According to Adams (5):
| "New Zealanders face losing their access to thousands
of safe and effective natural supplements if the Therapeutic
Products and Medicines Bill is passed. That is the
inescapable reality.
This bill would hand over all rights New Zealand has
to control its own health-products laws to an Australian
corporation which will apply the same style of rules that
have seen the Australian natural-products industry crippled
over the past 15 years." |
These changes are understandably causing considerable concern in New
Zealand (5,6,7,8,9,10,11)
as trends in Australia and around the world reflect a movement to restrict health freedoms by
imposing increasingly draconian restrictions on the marketing of
vitamins and dietary supplements (see
Misinformation About Pan, & Increased Regulatory Control of Alternative
Medicines in Australia & NZ, Pan Crisis, TGA &
Pan,
Codex in Australia,
Pan Crisis
& Future of Alternative Medicines,
Alternative Medicine Takeover,
Response
to Government Inquiry). It is history
now that the Pan crisis in Australia (Pan Crisis)
was just a devious and scientifically baseless excuse to introduce
draconian controls over the vitamin and supplement industry (Misinformation
About Pan, & Increased Regulatory Control of Alternative Medicines in
Australia & NZ,
TGA &
Pan,
Codex in Australia,
Pan Crisis
& Future of Alternative Medicines,
Alternative Medicine Takeover,
Response
to Government Inquiry).
After considerable opposition to the Australian
government's moves to restrict health freedoms in New Zealand, on the
15th June the Committee established by the New Zealand government to
look into the Therapeutic Products and Medicines Bill tabled
their report in Parliament (12,13,14).
After receiving 895 submissions the Committee found that they could not
reach agreement on the Bill and therefore (13,14)
"cannot recommend that the Bill be passed." The Committee
noted that the alternative medicine industry was generally strongly
opposed to the Bill with contributors questioning the need to apply
prescription drug type regulations to dietary supplements (13):
| "Much of the opposition to the regulation of
complementary healthcare products through
the joint scheme centred on their comparative safety, the
perceived high cost of the proposed regime, and the argument
that it is thus inappropriate to impose a pharmaceutical
model of regulation and licensing upon them." |
According to National Party members (13):
| "The level of search and seizure power in regard
to complementary medicines seems to be
well out of line with the potential risk. In other words the
powers given are more
commensurate with risks associated with dangerous high-level
drugs than they are with
herbal tea." |
The Committee also noted various other concerns of those
opposed to the legislation (13):
| "Recurring concerns were that the costs and
other consequences of complying with the new
regulations could reduce choice for the consumer, that the
products remaining on the
market might become more expensive, the new Authority might
undermine New Zealand’s
sovereignty, and that small and innovative New Zealand-based
businesses might be
adversely affected." |
Especially since the government has provided no
scientific justification for the proposed legislation it is hardly
surprising that the Bill has been described as (14)
"deeply divisive" as the Australian government seeks to impose
its will upon the New Zealand people primarily for commercial purposes and
in utter disregard of the health and freedom of New Zealanders.
In a major embarrassment for those promoting the erosion
of health freedoms in New Zealand however, on 15th of July the New
Zealand government accepted defeat of the controversial Therapeutic
Products and Medicines Bill, reluctantly admitting they did not have the
numbers to get it through parliament (50,51,52,53,54).
Although the New Zealand government proposed a compromise involving the
exemption of complementary medicines from the Bill, such was the
attitude of the Australian government that apparently they preferred to
see the entire Bill fail rather than exclude complementary medicines (54).
According to New Zealand State Services Minister Annette King however (53,54,56,57),
the Therapeutics Products and Medicines Bill would merely be "postponed"
until there was more support in parliament for the scheme. The New
Zealand government has refused to permanently bury the Bill (50,52,53,54,55,56,57).
In a consideration of why the Bill was defeated Ms King claimed that the
(56,57)
"complementary health manufacturers" did not have sufficient
influence. But the insufficient influence referred to by Ms King was the
result of widespread community concern across NZ, a process often
described as democracy.
This point was made by Marcus Blackmore who drew
attention to the extent of community concern in New Zealand (58):
| "The New Zealand Bill did not pass through
parliament due to a consumer protest in that country because
there was the perception that it would create a regulatory
environment that is not relative to the low risk nature of
complementary medicines. There is always a risk of this when
government categorises complementary medicines under the
same banner as drugs." |
Following the failure of the Trans Tasman Bill, the New
Zealand government have signaled their intention to pursue tighter
national controls over supplements (54,55)
and apparently warned that (54)
"it will not be business as usual for the complementary medicines
industry." According to Young (55):
"the Government is set to look at using ministerial powers to create
domestic regulations for complementary medicines after it conceded
defeat yesterday on a transtasman regulatory agency. So while the
New Zealand government are crossing their fingers and hoping for
sufficient support to pass the Trans Tasman Bill they will pursue their
own national crackdown on alternative medicines. And following defeat of
the Bill, the Parliamentary Secretary for Health in Australia, Senator
Brett Mason, stated that the Australian government (59)
"will now proceed in a way that allows both countries to explore
other options for harmonisation", although he avoided spelling out
exactly what these new options may be. In view of the tactics
utilised in the past, it would not surprise if there were further
attempts to exploit community fear about the safety of therapeutic
products by vague allegations about the 'dangers' of
complementary medicines, not drugs (Misinformation
About Pan, & Increased Regulatory Control of Alternative Medicines in
Australia & NZ).
Amazingly, as I indicate below,
all this recent legislative interest in complementary medicines apparently
resulted from the Pan witch hunt which demonstrated the safety of
complementary medicines as compared to pharmaceutical drugs! Strange
that the toxicity of pharmaceutical drugs which was demonstrated again as a
result of the Pan debacle resulted in so much subsequent DISINTEREST in
strengthening drug safety regulations!
In spite of these developments however, the Australia New Zealand Therapeutic Products
Authority (ANZTPA) has recently stated they expect legislation to be passed
this year regardless of the divisive nature of the proposals and in
spite of New Zealand opposition (15).
According to Phil Davies, transitional director of ANZTPA (15),
apparently the unpopular and divisive nature of the Bill was "not
necessarily unexpected" and progress is continuing with the Bill now
"in the hands of the New Zealand Government". According to Davies
(15),
both Australian and New Zealand governments "have announced that they
are working to establish ANZTPA in 2007" and "the new regulatory
scheme itself would then come into operation some time in 2008."
Apparently it seems, opposition to the Bill is
irrelevant as authorities have already decided to implement their
policies irrespective of the effects on freedom and public health.
Why the Public Needs Protecting from Vitamins - how to
justify an industry takeover.
While government
authorities pretend that the Therapeutic Products and
Medicines Bill is necessary to protect
the public from the safest therapeutic or preventative health promoting products on the
market (Dietary Supplements,
Holistic Medicine Sets the Standard for Safety), thousands of patients continue to suffer or die as a result of
the toxicity of government supported pharmaceutical drugs. Yet the
government seeks to apply these same safety standards, which result in
thousands of deaths every year, to alternative medicines. Most
conspicuous throughout this entire process is the fact that these
changes, though consistent with profits and commercial considerations,
are completely out of step with the available scientific evidence (Dietary
Supplements,
The Folic Acid Lesson,
Holistic Medicine Sets the Standard for Safety). As is the case in
Australia, in New Zealand too (43)
the safety levels achieved by the alternative medicine industry
absolutely dwarfs the achievements of the much more dangerous and highly
regulated pharmaceutical drug system.
If concern about the safety of therapeutic substances
is genuine of course, then safety requirements will be prioritised in
direct accordance with scientific evidence of the toxicity or known health risk of each
particular product. The persistent refusal to adopt a structured and
scientifically based safety system where regulatory safeguards are
focused especially upon those specific products that are known
to pose the greatest risk (ie. drugs), is of course ample proof that their true
concerns have nothing to do with their publicly stated concerns about
safety.
The current global push to takeover the supplement industry (Alternative
Medicine Takeover)
correlates with several very important facts.
Firstly, the
pharmaceutical industry is suffering as the toxicity and limitations of
drug treatments are being exposed throughout the world (Holistic
Medicine Sets the Standard for Safety,
Science or Progress?, Dietary Supplements,
Global
Trends in Health Care). As adverse drug
reactions continue to hit the headlines and the bank balance of drug
companies (16,17), medical experts are increasingly realising that toxic
pharmaceutical drugs have little to offer for the prevention of chronic degenerative
diseases (Global
Trends in Health Care), the most important causes of morbidity and mortality today
(Health
Trends). In fact, the proliferation of pharmaceutical drugs during
last century correlated with a phenomenal increase in the incidence of
heart disease, cancer, and other chronic diseases (Health
Trends). The past 100 years of attempts to cure chronic diseases
with drugs has not only been a catastrophic failure, but furthermore,
this obsession with toxic drugs has created a whole range of new diseases called
iatrogenic diseases (Holistic
Medicine Sets the Standard for Safety) as doctors succumbed to the influence of the
drug companies. It has also created a global dependence upon
pharmaceutical drugs as drug companies reveled in their ever increasing
profits (Integrated Medicine). Politicians
and drug industry puppets have permitted this disgraceful situation to
continue for the past century.
The ever increasing global incidence of drug induced
iatrogenic diseases demonstrates indisputably the failed and hopelessly
ineffective safety requirements used for the marketing of pharmaceutical
drugs, yet the powers that be seek to apply this same failed system to
the marketing of health promoting supplements. And drug companies have
responded by criticizing public concerns about drug safety pointing out
there is no such thing as a totally safe drug and consumers have
"unrealistic expectations" (16).
Secondly, as concern spread regarding
the proliferation of chronic diseases and the obvious failings of drug
treatments (Health
Trends), people around the world increasingly resorted to using vitamins
and dietary supplements as doctors offered little assistance for their
various chronic illnesses (Holistic
or Reductionist?). This lead to a global boom in alternative
therapies as people sought therapies which were safer and more
effective, especially preventatively, than toxic pharmaceutical drugs (Holistic
or Reductionist?).
As a result of these trends, drug companies and health authorities have
sought to cash in by increasingly researching natural supplements
and alternative therapies while at the same time seeking to monopolise
these treatments so that any effective natural treatments could
ultimately only be dispensed by doctors (Pan Crisis, TGA &
Pan,
Codex in Australia,
Pan Crisis
& Future of Alternative Medicines,
Alternative Medicine Takeover,
Response
to Government Inquiry). Pharmaceutical companies and
health authorities have increasingly become aware of the enormous
potential of vitamins and dietary supplements (The
Folic Acid Lesson,
Doctors Discover
Malnutrition in the Elderly, Nutrition
Breakthroughs). In fact, modern scientific medicine now predicts
that
individualised nutrition or megavitamin therapy will be one of medicine's
main tools in the 21st century for the prevention of chronic
degenerative diseases (Nutrition Breakthroughs).
Additionally, governments and health funding organisations have been steadily accumulating evidence that billions of
dollars in health care costs may be saved if everyone used dietary
supplements (Experts
say dietary supplements may save $billions in health care costs!!,
The Folic Acid Lesson).
In other words, medical science has done a complete about face and begun
to endorse therapies which they callously dismissed as quackery only a
few years ago (But
isn't Holistic Medicine Quackery?,
Science
Today, Quackery Tomorrow,
The Folic Acid Lesson). Such is this amazing revolution in health
care, but yet it is still only in its early stages!
The direction in which modern medicine is progressing
is very clear. There is an increasing recognition that toxic drugs will
never prevent most chronic degenerative diseases. On the other hand,
individualised nutritional therapy or megavitamin therapy (nutrigenomics)
is considered to be a modern scientific breakthrough which has the
potential to prevent chronic diseases, reduce the ever increasing global
dependence upon drugs, and reverse the current epidemic of chronic
diseases and drug caused iatrogenic diseases.
This is the modern scientific
environment which has created the single minded determination of the
pharmaceutical industry and health authorities to takeover the dietary
supplement industry.
How to Simultaneously 'Pan' Dietary Supplements and
Increase Confidence in the Industry - the public will believe anything.
Although evidence of a global push to control the
alternative medicine industry is overwhelming, there are still those who dispute that current
legislative changes are intended to enable a virtual takeover of
alternative medicines and eventually restrict their availability in
retail stores. The TGA for instance, claims that (18)
"the proposed Codex Guidelines for
Vitamin and Mineral Food Supplements will NOT apply in Australia and
will have NO IMPACT on the way these types of products are regulated in
Australia," although the TGA does point out it is only the
(18)
"the current Australian regulatory framework for
complementary medicines under Therapeutic
Goods Act 1989" which is "not subject to the standards and
guidelines of the Codex Alimentarius Commission" ( notice the TGA
strictly
avoids any future or long term commitment).
Especially since the Australian government has already
warned that some alternative medicines will be withdrawn from sale or
reformulated (26)
the intention to reduce supplement availability is quite clear. The TGA describes the regulation of dietary supplements in
Australia thus (18):
| "The regulation of vitamin and mineral
supplements in Australia The Australian
Government acknowledges and supports the right of consumers
to be able to make informed choices on matters related to
health, and to expect that medicines available in Australia,
including vitamin and mineral supplements, will be safe and
of high quality.
Australia has a risk-based system where the level of
evaluation and regulatory control of a medicine is based on
the relative risk of the product and the seriousness of the
condition for which it is intended to be used. All
therapeutic goods must be entered in the Australian Register
of Therapeutic Goods before they can be supplied in, or
exported from, Australia, and must be manufactured in
accordance with the principles of Good Manufacturing
Practice, which ensures they are of acceptable quality." |
So what has the Australian government done to support
"the right of consumers to be able to make informed choices on matters
related to health, and to expect that" (alternative?)
"medicines" (will always be available in retail outlets) "
in Australia." What has the Australian government done to
protect the retail availability of dietary supplements and prevent a
takeover by pharmaceutical companies? And have they demonstrated in
practice that "Australia has a risk-based system where the level of
evaluation and regulatory control of a medicine is based on the relative
risk of the product and the seriousness of the condition for which it is
intended to be used." Have they devoted most of their legislative
attention to the most hazardous therapeutic products (ie drugs)?
Similarly, according to the
ANZTPA fact sheet on the
proposed regulatory scheme for complementary medicines (19):
| "Will consumers still be able to buy a range of
complementary medicines? Yes. Under the proposed
joint regulatory scheme consumers will continue to have
access to a wide range of complementary products, with the
sort of products currently sold through retail outlets such
as supermarkets and health food stores continuing to be
available in this way.
In Australia complementary medicines are already
regulated by the Therapeutic Goods Administration (TGA) and
Australian consumers have a choice of over 17,000
complementary medicines containing around 2,200 active
ingredients
Under the proposed joint regulatory scheme consumers
would have an assurance of the quality and safety of
complementary medicines and would be provided with truthful
information about a product's therapeutic health benefits to
help them make more informed choices."
"Dietary supplements should not be
regulated in the same way as over-the-counter medicines and
prescription medicines
The proposed joint regulatory scheme is a based on
categories or scales of risk. In simple terms this means
that a lighter level of regulation is being proposed for
lower risk therapeutic products, which includes most
complementary medicines. Tighter regulations are being
proposed for higher risk therapeutic products such as
prescription medicines and some medical devices such as pace
makers and heart valves which would go through pre market
evaluation by the Authority.
It is also proposed that for lower risk complementary
medicines, suppliers and manufacturers will be able to self
assess or certify their products by entering information
into an online web based data base to gain a product licence.
The declarations made about a product would be subject to
audit. There would be a separate office of complementary
medicines within the joint Authority, which will have
offices bases in Wellington and Canberra."
"Consumers have rights to access natural
health products and complementary medicines
Consumers will continue to have access to a wide range
of complementary medicines, with the sort of products
currently sold through retail outlets continuing to be
available in this way. When purchasing these products,
consumers have a right to expect they will be safe and of
high quality, while maintaining choice. The main aim of the
proposed joint regulatory scheme for therapeutic products is
to safeguard public health and safety." |
ANZTPA has carefully avoided any suggestion that they
will ensure the current range of retail complementary medicines, and in
the currently available potencies, will continue to be available. So
what protections has the government included in the proposed legislation
to ensure that the potency and range of currently available retail
dietary supplements will not be reduced? Do their actions back up their
words? Where are the legislative protections ensuring the
retail availability of the current range and potency of dietary
supplements? Of course there are
no such protections since the government has already stated their
intention to withdraw or reformulate supplements and reduce consumer
choice (26). Especially since the Australian government has repeatedly stated they wish to "restore confidence"
in the alternative medicine industry (Misinformation
About Pan, & Increased Regulatory Control of Alternative Medicines in
Australia & NZ), how have they expressed this wish
in proposed legislation? What legislative steps have they taken to
ensure retail dietary supplements will not have their potency or availability
reduced or restricted? Especially
since it was the government's own false statements regarding Pan which
had a negative impact on confidence (Misinformation
About Pan, & Increased Regulatory Control of Alternative Medicines in
Australia & NZ), do their actions confirm their
honesty and sincerity?
Interestingly, this same type of refusal to guarantee
the continued availability of the currently available range of dietary
supplements is also occurring in New Zealand. When Annette King, the Minister for State
Services in the New Zealand government and the Minister in charge of The
Therapeutic Products and Medicines Bill, was asked in parliament whether
there would be reduced availability of complementary medicines following
implementation of the Therapeutic Products Bill she chose to completely
avoid the question. The following question was put to her by Sue Kedgeley (20):
| "Can the Minister confirm that once the proposed
agency is operational and the transitional period completed,
an effective traditional remedy or dietary supplement that
is not on the approved list will be illegal and not be able
to be sold in New Zealand, even if it has been safely used
for centuries and has had overseas regulatory authorities'
approval, such as that of the American Food and Drug?" |
Ms King completely avoided the thrust of the question
and responded thus (20):
| "One of the big issues in terms of this
regulator is to ensure that we could have some mutual
recognition with other countries. What we will not have now
is an agency like the FDA agreeing to anything being safe in
New Zealand, because there is nothing for it to be able to
acknowledge. What we are trying to stop is that in the
future we have a country like the United States and its
regulator the FDA making decisions for us. What we want is a
joint regulator between two friendly nations. We are looking
at some countries having to make decisions for other
countries because those countries are unable to have the
quality assurance themselves." |
Similarly, Tony Ryall also sought an assurance from Ms
King about the continued availability of the current range of complementary medicines (20):
| "Can the Minister understand why New Zealanders
are so strongly opposed to her plan to cover natural health
products when the Government's own papers state that 60
to 65 percent of the products that are currently on shop
shelves now will be wiped from those shelves under this
proposal* and when the advice of one of New Zealand's
leading natural health products companies is that the cost
of regulating a product will go from $2,700 to $64,000 under
her plan-a plan that she has mucked up completely?"
* Emphasis added |
But once again the Minister gave a completely dismissive
response (20):
| "I would much rather have had the opportunity to
do something positive than to sit where that member has for
7 years doing absolutely nothing but whinge. To answer the
member's question, he has totally misinterpreted the
consultation document on fees and charges, and I am happy
for officials to give him a personal briefing. But this is
not the first time the Opposition has misinterpreted an
official document. Another example of misinterpretation was
that of the Australian regulatory impact statement. Those
members opposite got that wrong as well, and they were shown
to have got it wrong. The member got this wrong, as well." |
It is abundantly clear that government authorities
and bureaucrats in both Australia and New Zealand are determined to
completely avoid any discussion of, or commitment to, the continued
retail
availability of the currently available range of dietary supplements and
alternative medicines. Amongst all the inconsistencies and
contradictions this refusal to guarantee the future availability of
supplements is conspicuously consistent. Of course this is also
consistent with global trends and the requirements of Codex (Misinformation
About Pan, & Increased Regulatory Control of Alternative Medicines in
Australia & NZ).
It is imperative that we explore in more detail the true
attitude of government authorities and the TGA towards alternative medicines and
since the government's current legislative campaign to crack down on
alternative medicines began with the Pan crisis (see Pan Crisis,
Alternative Medicine Takeover,
Response
to Government Inquiry),
this provides an appropriate starting point for examining the
governments attitude and motivation. It should be realised of course,
that if the government wishes to control alternative medicines on behalf
of drug companies then
the only way they could possibly achieve the drastic legal reforms
they seek is on the basis of public health and safety. Put bluntly, the public must
somehow be convinced that health promoting nutritional supplements are
more dangerous than toxic pharmaceutical drugs which are listed on the
poisons schedule. In this regard it should be noted that the
government is simultaneously pursuing a policy aimed at adding these
same dangerous dietary supplements to foods (Dietary
Supplements or Functional Foods).
At the outset it should be made abundantly clear, given the stated aims of the TGA are to
"restore confidence" in the industry and ensure the safety of
alternative medicines (
Misinformation About Pan, & Increased Regulatory
Control of Alternative Medicines in Australia & NZ,
Pan Crisis,
Alternative Medicine Takeover,
Response
to Government Inquiry), that the government must provide scientific
evidence that the Pan crisis has proved the unsafe nature of all
alternative medicines (since the governments legislation is not product
specific there must be scientific evidence that all alternative
medicines are unsafe - if one drug is found unsafe the TGA does not take
action against all drugs) and a consequent loss of consumer confidence. These are the often
stated requirements the government has used to justify a legislative
"crackdown" on
alternative medicines (
Misinformation About Pan, & Increased Regulatory
Control of Alternative Medicines in Australia & NZ,
Pan Crisis,
Alternative Medicine Takeover,
Response
to Government Inquiry). When considering the comments of the TGA
it should be realised that the only product reported to make anyone ill during
the Pan crisis was in fact an over the counter drug containing the toxic
chemical hyoscine hydrobromide ( Pan Crisis).
The Pan crisis therefore proved once again the safety of
complementary medicines as compared to drugs since not one person was
made ill by complementary medicines during the Pan crisis even though
both complementary medicines and drugs were produced under the same
conditions ( Pan Crisis).
Comments made by the TGA or the Australian government
in regard to the Pan crisis should also be considered in light of
the fact that the government's legal action against Pan Pharmaceuticals
has recently been dismissed by the Supreme Court of New South Wales
(22,23).
Let us examine the recent actions of the Australian
government and the TGA as a result of the Pan crisis.
Initial statements made by the TGA regarding the
consequences of the Pan crisis and reported in the media on the 28th and
29th of April 2003 (39,40) claimed that Pan Pharmaceuticals was
endangering the lives of consumers and therefore all "consumers
should avoid taking herbal and vitamin preparations and complementary
medicines". Notice that the TGA specifically targets complementary
medicines here and not the withdrawn prescription drugs and over the
counter drugs which precipitated the entire crisis and
which caused serious adverse reactions (Pan Crisis,
Alternative Medicine Takeover,
Response
to Government Inquiry). But Dr McEwen of the TGA also added that the
main concern of the TGA was not safety but rather (39,40): "our great
worry is that a product may not be true to label." The Health
Minister also confirmed this stance saying (31) there may be nothing
wrong with many of the health supplements withdrawn from sale". But
on the 2nd of May the Health Minister made the following astounding
false claim (24):
"The recall affects only complementary preparations and not
prescription medicines recommended by your doctor," she said. I would
like to reassure everyone that all prescription medicines, including
generic medicines, are safe and people should continue taking them."
This is an absolutely astonishing claim since it was an over the
counter drug, Travacalm (hyoscine hydrobromide), and not complementary medicines, which triggered the
entire Pan crisis (Pan Crisis). This trend of
resorting to false claims about the safety of complementary medicines is
clearly a common theme for the TGA and the Australian government.
These untrue comments were followed up on 28th May by
Trish Worth, the Parliamentary Secretary for Health (25):
"the Pan Pharmaceuticals recall has highlighted the importance of
preventing or deterring deliberate or reckless breaches of standards and
conditions applicable to the manufacture of medicines in order to
protect the health and safety of the Australian public" Trish
Worth describes the committee set up by the government to examine
alternative medicines as a result of the Pan crisis (25):"the
establishment of this committee and amendments to the Therapeutic Goods
Act go a long way towards giving the public and all health care
practitioners confidence that the Government has taken the necessary
steps to examine the role of complementary medicines in the health care
system." So according to Trish Worth, "the role of complementary
medicines in the health care system" must be examined because
of the
Pan crisis which revealed the toxicity of drugs and the safety of
alternative medicines!! This is the reasoning which
is consistently used by the Australian government and the TGA throughout
their current push for legislative reforms of alternative medicines.
Amazingly, in New Zealand the same attitude was
expressed by Annette King, the Minister for State Services, who stated (42),
"it
is because of the Pan Pharmaceuticals situation that this Government has
decided to move, in conjunction with Australia, to regulate
complementary and therapeutic dietary supplements." Once again,
because the Pan debacle demonstrated the safety of complementary
medicines as compared to drugs we are expected to believe, for some
reason, that this justifies the need for increased regulatory control of
all complementary medicines! Such statements seem to say more
about politicians views of the collective intelligence of the community
than about the safety of vitamins.
So the Australian government subsequently established a
committee to allegedly examine the "safety" of alternative medicines and
"restore confidence" in
the industry because alternative medicines, unlike drugs, had been shown
to be totally safe during the Pan crisis. As headlines such as (26)
"Strict New Rules Curb Herbal Drug Sales" and (27)
"Red Tape Forcing Up Medicine Prices", appeared in
March - April 2005, all under the guise of "restoring confidence", the government responded to the Report of the Committee of
enquiry (28) in a
most predictable fashion by warning that alternative medicines may be
withdrawn from sale (26):
"many products would have to be reformulated or relabeled, and some may
need to be removed from the market". The Parliamentary health secretary was
apparently not aware of this however (26):
"the parliamentary secretary responsible for complementary medicines,
Christopher Pyne, said he had not been told about the possible
withdrawal of products. 'Australia is very fortunate to have such a
high-quality complementary medicines industry,' he said, adding that the
Pan scandal had shown that the TGA was 'on top of the industry'."
Close examination of details surrounding the Pan crisis
demonstrates quite clearly the desperation of authorities who were
pushing for a takeover of the supplement industry with many authorities
apparently feeling the need to resort to false or unscientific claims (Misinformation
About Pan, & Increased Regulatory Control of Alternative Medicines in
Australia & NZ, Pan Crisis,
Alternative Medicine Takeover,
Response
to Government Inquiry). Some authorities were apparently so desperate that they
even resorted to complete lies or wild exaggerations (Pan Crisis,
Alternative Medicine Takeover,
Response
to Government Inquiry). Some even went so far as
to suggest that a
dangerous over the counter drug was an alternative medicine or
supplement and therefore all supplements were dangerous. Even
politicians made untrue statements claiming that only complementary
medicines were withdrawn from sale and not prescription drugs when the
truth is that both over the counter AND prescription drugs were
withdrawn (Pan Crisis). As I have stated
previously (Pan Crisis):
| "It is obvious from comments made by a range of
health authorities during the Pan crisis that there is an
extraordinary eagerness amongst members of both the medical
profession and the pharmaceutical industry to establish a
link between, on the one hand, poisoning caused by over the
counter drugs, and on the other, regulatory controls for
alternative medicines. This clearly represents a
considerable degree of desperation about the progress of
what is obviously an ongoing agenda to convince the public
of the dangers of alternative therapies and thereby justify
increased regulatory controls." |
This desperation to establish a link between adverse
reactions to drugs like hyoscine hydrobromide and the
need for increased regulatory control over complementary medicines
is so extreme it seems, that some traditional opponents of complementary
medicine have even sought to establish some vague kind of link between this drug and
natural herbs, apparently because hyoscine hydrobromide was
derived from a plant. Hyoscine hydrobromide is however, an S2 or S3
poison or drug (National
Drugs and Poisons Schedule Committee, 2002) and not a complementary
medicine which can be purchased from health food stores. Since the drug
morphine is derived from the opium poppy, perhaps these critics would
therefore conclude that morphine is a complementary medicine! It is sad
to see so many people have abandoned the scientific facts in their
apparent eagerness to justify increased regulatory control of
alternative medicine.
As has recently been pointed out by McEwen and
colleagues of the TGA (46),
the "Travacalm Episode" was caused by "widespread hyoscine
hydrobromide toxicity." In fact, the Travacalm incident is
top of the TGA's list of (47)
Australian reports contributing to the
early global recognition of a drug-related problem." Strange
indeed that the toxicity of this drug led the TGA to warn consumers to
stop taking hundreds of complementary medicines for which there was no
evidence of a safety threat (39,40): "consumers should avoid taking
herbal and vitamin preparations and complementary medicines." Since
the hyoscine hydrobromide containing Travacalm was a drug
rather than a complementary medicine, why was the TGA so determined
not to issue a general warning about the consumption of drugs which
after all, they knew to be much more dangerous than complementary
medicines? Why did they choose to warn the public about the least
dangerous products? The fact that that so many health authorities,
bureaucrats, and even politicians, joined forces in the intense campaign
of misinformation about the Pan debacle is most disturbing.
In November 2006 the Australian government was
continuing to destabilise and discredit the industry by announcing yet another
study, this time to determine if alternative medicines "really work" (29,30),
pretending of course that the vast scientific literature on the subject
does not exist (Nutrition and Megavitamins,
B Vitamins,
Nutrition Breakthroughs, Holistic or
Reductionist,
Experts say dietary supplements may save $billions in health care
costs!!).
Additionally, this is in spite of the fact that according to the TGA alternative
medicines are intended for (34)
"health maintenance, health enhancement and risk reduction" and
are (32) "often developed with an
emphasis on health and wellness rather than disease". Just how the
TGA proposes to test how effective alternative medicines are for "health
maintenance, health enhancement and risk reduction" and restoring "health
and wellness" will indeed be interesting to see. And in spite of
claims by the government's own expert committee of enquiry that (33)
"compared with other medicines, complementary medicines may offer
lower risk and more cost-effective options for the prevention and
treatment of some diseases, conditions and disorders," the TGA
claims alternative medicines cannot be labeled as suitable for
prevention or to treat any serious disease (34)
even in spite of extensive scientific evidence indicating otherwise (Nutrition
and Megavitamins, B Vitamins,
Nutrition Breakthroughs,
Holistic or Reductionist,
Experts say dietary supplements may save $billions in health care
costs!!).
In other words, it seems it would be illegal to claim supplements are
suitable for treating malnutrition or thiamine may be used to treat or
prevent beri beri, or folic acid could be used to prevent neural tube
defects or other birth defects (35). In many instances, according to the TGA,
it will be illegal to state truthful (scientifically verifiable) claims
(35).
All this in the guise of restoring confidence.
Why do Australian authorities such as the TGA pretend
that nutritional supplements do not "really work" and blatantly
contradict leading world nutrition experts such as Professor Bruce Ames
(45)?:
| "It is inexcusable that anyone in
the world should have an inadequate
intake of a vitamin or mineral, at
great cost to that person's health, when a
year's supply of a daily
multivitamin/mineral pill as insurance against
deficiencies costs less than a few
packs of cigarettes.......A metabolic tune-up is
likely to have enormous health benefits,
particularly for those with inadequate
diets such as many of the poor and
the elderly who need improvement the most,
although it is currently not being
addressed adequately by the medical
community. The issues discussed here highlight
the need to educate the public about
the crucial importance of optimal nutrition
and the potential health benefits of
something as simple and affordable as
a daily multivitamin/multimineral supplement.
Tuning up metabolism to maximize the human
health span will require scientists,
clinicians and educators to abandon outdated
paradigms of micronutrients merely
preventing deficiency disease and
explore more meaningful ways to prevent chronic
disease and achieve optimal health
through optimal nutrition." |
|
Why are statements by the Australian government and the
TGA so irresponsible and inconsistent with the public health point of
view demonstrated by world leaders in nutrition research like Professor
Bruce Ames? Why is the Australian government lagging so far behind,
still stumbling about in the dark ages of vitaminphobia? At a
time when the benefits of nutrition are now known, why are Australian
authorities still refusing to encourage the use of supplements as
recommended by world experts?
Sadly, those who cannot embrace new
discoveries continue to obstruct advances in human knowledge and health
care. It seems they have learned nothing from past attempts to prevent
the widespread use of vitamins such as folic acid and thereby sentence
millions to unnecessary birth deformities. Scientific progress has
always been impeded by such closed minded people who seek to impose
their rigid draconian ideas upon others. Such persons are generally
seen to oppose dramatic innovative new discoveries, irrespective of
scientific evidence. They are the last people to accept breakthroughs in
research. And they can be easily identified by the eagerness with
which they seek to attack and insult, perhaps becoming exceedingly
hostile and irrational with anyone who does not agree with their rigid
view of reality. Their extreme reluctance to apologise is also most
conspicuous. They usually seem almost totally preoccupied with a
negative approach to life characterised by insults and criticisms.
Most noteworthy is the fact that they seldom seem to offer positive
suggestions on how to reduce human suffering from the current epidemic
of chronic diseases or drug induced diseases. Their comments seem to
reveal a desire to preserve the status quo rather than promote positive
changes in health care. They seem to be prone to all sorts of
misconceptions of reality which they seem to perceive as some kind of
threat to their particular belief system. According to this type of
belief system common sense does not exist until it can be demonstrated
by a meta-analysis of randomised controlled trials!
As has recently been pointed out by Rosemary Stanton,
the mistake littered record of nutritional research emphasises that (48)
"we should have learnt that sometimes we don't even know what we
don't know" and "we should be humbled by our lack of knowledge of
food and human nutrition." However, like a mental straightjacket,
arrogance is not conducive to the learning of new concepts let alone an
accurate perception of one's own ignorance, since to the arrogant, it is
most important that their views prevail, regardless of truth (Science
Today, Quackery Tomorrow). Not surprisingly, the greatest
scientists tend to be the most humble since they have a more accurate
perception of the limitations of their own knowledge (49). In
the words of Kothari (49):
| "some of the greatest
people who are very learned, are almost painfully humble.
You almost get irritated that this man knows so much and yet
he pretends to be humble. But in the depths of his heart you
see, he knows that he doesn't know!
" |
I appeal to those who have traditionally been more
interested in insults and opposing positive change to adopt a more
positive caring attitude and join the effort to reduce human suffering by
promoting positive change in our health care system (Integrated
Medicine).
The TGA's determination to prevent claims about
prevention or treatment of serious diseases flies in the face of all the
available evidence (Nutrition and Megavitamins,
B Vitamins,
Nutrition Breakthroughs, Holistic or
Reductionist,
Experts say dietary supplements may save $billions in health care
costs!!). Suggestions by the TGA that supplements can only be used
for treating symptoms are in stark contrast with the scientific facts
which reveal that nutrients frequently have a curative effect unlike
most drugs which merely suppress symptoms (
Nutrition and Megavitamins,
Nutrition is for the
Birds,
Symptom Suppression,
Response
to Government Inquiry). As I have indicated elsewhere (Response
to Government Inquiry), if we are to go by the scientific facts then
most drugs should carry the label "For Suppression of Symptoms Only"
while nutritional supplements should be labeled "For Disease
Prevention and Optimum Health". Although this would be consistent
with the available scientific evidence the TGA has chosen to adopt a
position which is completely at odds with the scientific facts. There
is absolutely no evidence to show that all drugs have a curative effect
and all nutrients have a symptomatic effect yet this is the amazing
proposition being proposed by the TGA.
At every turn the government and the TGA have
contradicted their own words. When a drug was found toxic during the Pan
crisis they condemned alternative medicines - not drugs. When a drug was
found toxic they said we need more stringent regulations to control
alternative medicines - not drugs. After falsely condemning alternative
medicines they then suggested they
wanted to restore confidence in the alternative medicine industry. And
after claiming they have a risk based approach to safety, they then
targeted the safest therapeutic products on the market and ignored the
most hazardous. All this when they repeatedly admitted that alternative
medicines are "low risk"(18,
34).
Obviously the Australian government and the TGA have their own agenda,
an agenda which they are strenuously seeking to hide.
As I have summarised elsewhere (Alternative
Medicine Takeover):
| "It is indeed interesting to note that the TGA
is also now attempting to dispel fears regarding the Codex
in Australia (20)*.
Yet the TGA has been responsible for the Pan witch hunt and
the unjustified condemnation of alternative medicines when a
DRUG was found to be toxic (3,4)*.
It is history now that this witch hunt was the first step in
the TGA's current campaign to dramatically reform the
alternative medicine industry in this country, including
proposed restrictions on factual information, guarantees of
market exclusivity, withdrawal or relabelling of products,
and increased power to cancel licences of manufacturers (4,6,8,9,13,19,23)*.
Amazing how these changes are so in line with changes being
promoted by Codex. The Australian
government, the TGA, and other bureaucrats who were
involved, have an extremely serious credibility problem. Why
should anyone believe them now when they went to such
incredible lengths to conceal the truth, and their long term
agenda, during the Pan crisis and its sequel.............................
When our national drug regulator seeks
to abandon the available scientific evidence relating to
public health and adopt a stance instead which is consistent
with the commercial interests of multi-national drug
companies then an urgent inquiry is obviously needed.
If the TGA really wished to dispel fears
about Codex in Australia they would obviously have called
for the government to enshrine health freedoms pertaining to
alternative medicines in legislation. Why was it decided to
omit such vitally important matters from the terms of
reference of the recent inquiry? When does the government
intend to act to protect and preserve the current health
freedoms of consumers? It is all very well to adopt an
entirely negative position and state that Codex does NOT
apply to Australia, how about a detailed picture of what
DOES apply to Australia? What is the eventual aim of their
current anti-alternative medicine campaign? What is the
underlying agenda? Why have they gone to so much trouble
to mislead the public about the consequences of Pan?
What possible reasons could the government have for being so
determined NOT to make any such assurances or adopt
legislative reforms to protect the freedom of choice of
alternative medicine consumers?"
* For references see
Alternative Medicine Takeover |
The determination with which government authorities have
refused to provide legislative protections to protect and preserve the
current freedom of choice which consumers of dietary supplements enjoy
is most noteworthy and consistent in both Australia and New Zealand. The
following concerns expressed by Sue Kedgley of the Greens Party in New
Zealand regarding the proposed legislative changes remain unanswered (21):
- "it would impose an inappropriate,
pharmaceutical model for low risk healthcare products,
and would result in increasing pharmaceutical control of
natural health products
- natural health products would become more
expensive and difficult to access
- small New Zealand businesses would go to the wall
as a result of excessive compliance costs
- there would be reduced consumer choice as many
ingredients would not be available in the future
- some traditional remedies that have been safely
used for centuries, such as Chinese herbs and Ayuvedic
medicine, would become illegal in a few years time
- our sovereignty and control over medicines and
natural health products would be undermined, and
Parliament would effectively hand over jurisdiction for
these products to the Trans-Tasman regulator. "
|
Sue Kegley further documents the concerns of the Green
Party regarding the proposed legislative changes (41):
"We note that no justification is provided in the
legislation for the government's decision to include dietary
supplements in a trans-Tasman regulator. Nowhere in the bill
does the Government explain why it believes the natural
health products industry in New Zealand should be subjected
to this heavy-handed regulatory regime. We believe it is
crucial that this is clarified before Parliament begins to
consider the bill.
Further concerns about the bill:
• The proposed regulatory framework for therapeutic goods
has failed in Australia. Far from being ‘international best
practice’ as the government alleges, reputable Australian
sources claim that the Australian regulatory system for
complementary medicines (through the existing Australian
Therapeutic Goods Authority) has done considerable harm to
the Australian natural health industry in terms of
increasing compliance costs for dietary supplements
businesses and therefore the cost of natural health
products, reducing innovation in the industry, the range of
products available to consumers.
• Val Johansen, a key player in the complementary medicines
industry in Australia, says the Therapeutic Goods
Authority’s excessive and bureaucratic regulatory system has
hamstrung and hobbled the industry there. She says the
excessively high compliance costs (which have been
increasing by more than 15% a year) are driving many dietary
supplements businesses offshore.
• One of the problems the Australian natural health industry
is experiencing is the high cost of getting a product or new
ingredient licensed. According to Val Johansen and others,
there have been very few new products coming into Australia
and consumers there have access to a much restricted range
of supplements which are mostly produced by multinational
corporations who can afford the high compliance costs,
rather than by small businesses. Increased compliance costs
will inevitably be passed onto the consumer in terms of
higher costs for supplements.
• The proposed agency will undermine the sovereignty of our
Parliament. If passed into law, control of dietary
supplements, pharmaceuticals and medical devices industries
in New Zealand will transfer to the Australia New Zealand
Therapeutics Products Authority –an offshore entity that
will be set up under Australian law, and will be
headquartered in Canberra, with an office in Wellington. It
will be the first time entire industries in New Zealand will
be controlled by an off-shore entity headquartered in
another country. Documents I have obtained under the
Official Information Act indicate that about 93% of the
staff of the agency will be Australians, and just 7% New
Zealanders. This speaks volumes about how ‘equal’ this
agency will be.
• We acknowledge that there will be a Ministerial Council
comprising the Ministers of Health of New Zealand and the
Federal Government of Australia, who will oversee the
agency. But the two Ministers will meet in private. While
the agency is subject to the Official Information Act, it
appears that the Ministerial Council may be exempt, which
would mean that the public will have no way of knowing what
the two Ministers discuss or approve in the Ministerial
Council, beyond what they choose to make public. I note that
the Minister has turned down repeated requests I have made
under the Official Information Act for minutes of
Ministerial Council meetings and other information relating
to the establishment of the agency. The Minister has also
refused requests to provide this information to the Health
Select committee.
• The two Ministers, meeting in private, not our Parliament,
will review the agency. And while a report on the agency
will be tabled in Parliament each year, there is no
provision for the report to be considered by a select
committee, or for other recourse or scrutiny in the event
that MPs have concerns about aspects of the report. The
agency is not subject to key legislation such as the Public
Finances Act. And the main powers of the agency, to issue
Orders on all manner of issues, will be delegated to an
unelected and unofficial Managing Director who will have
statutory powers of delegated legislation presently
exercised by the Minister of Health, as well as powers to
enforce and police regulations.
• The agency will have unprecedented police powers of search
and seizure. This means that inspectors or police from the
off-shore entity will have the power to issue warrants and
prosecute people and organisation here in New Zealand and
close down dietary supplements companies they believe to be
non-compliant.
• The agency will also have the power to issue civil penalty
and other offences, and to impose instant fines of up to
$550,000 on a company. As well as instant fines, penalties
for offences range up to $5.5 million for companies.
• Rules and Orders issued by the proposed agency will have
the force of law in New Zealand, but will not require the
approval of our Parliament. The Managing Director of the
proposed agency will have the power to enforce and police
Rules and Orders in New Zealand, even though they will not
have been voted on by our Parliament.
• Technically the Rules and Orders could be challenged by a
‘disallowance motion’ in Parliament, but the committee
should note that a disallowance motion has never passed in
the 153 year history of our Parliament. This means that the
power to challenge regulations in our Parliament is
essentially illusory.
• The definition of what is a ‘therapeutic product’ is vague
and it would be left to the Managing Director to decide, on
a case by case basis, what should constitute a therapeutic
product.
• Once the new agency was fully in place, in about five
years time, any ingredients that had not been been approved
and included on a so-called ‘positive list’ would become
illegal.
• The agency will circumvent the Treaty of Waitangi and
reduce the access of Maori to their traditional medicines
and herbs, guaranteed by the Treaty of Waitangi. Since
traditional herbs are part of the ‘flora fauna’ guaranteed
to Maori by the Treaty of Waitangi, requiring Maori who wish
to commercialise their traditional herbs to apply to get it
licensed to an off-shore entity, would seem to be a breach
of this treaty commitment." |
As Kedgley points out (41),
the risk based changes being thrust upon the people of New Zealand
by the government completely ignores the known benefits of dietary
supplements at a time when surveys have proven that nutritional
deficiencies are commonplace amongst the New Zealand people. Why are
governments so opposed to people experiencing the well known health
benefits of health promoting dietary supplements?
Interestingly, at the same time as the Minister for
State Services in New Zealand was pushing for the Australian government
to control vitamins and supplements in New Zealand, supposedly because
the toxicity of drugs during the Pan debacle demonstrated the dangerous
nature of supplements, she was also supporting the mandatory
fortification of bread with one of these dangerous supplements, folic
acid (44).
Of course doctors have refused to endorse the use of folic acid
supplements for decades because, unlike drugs, it was considered too
dangerous (The Folic Acid
Lesson, Nutrition and Megavitamins,
Nutrition Breakthroughs,
Nutrition is For the
Birds,
Dispelling the Vitamin E Myths). While the public should apparently
be protected from those substances that made no one ill during the Pan
debacle, it is nevertheless acceptable to add one of these dangerous
substances to bread where individual dosage levels are impossible to
determine. In fact, the mandatory fortification of bread with folic acid is described by
Ms King as (44)
"a triumph for humanity and common sense." But just who was
responsible for delaying or preventing this triumph was not mentioned by
Ms King. Also not mentioned was whether this "common sense" applies to
other nutrients and adulterated nutrient impoverished foods and the
general nutritional state of New Zealanders or whether folic acid is
absolutely unique amongst nutrients (The
Folic Acid Lesson).
Meanwhile, in the real world, doctors are becoming increasingly aware of the very serious
consequences of malnutrition and its increasing prevalence (Doctors
discover malnutrition in the elderly.......again!), and scientists
are discovering the enormous potential of individualised nutritional therapy or megavitamin
therapy (Nutrition Breakthroughs) and the
addition of dietary supplements to foods (Dietary
Supplements or Functional Foods), which
are expected to be at the forefront of medicine's fight against chronic
diseases this century (Nutrition Breakthroughs,
(Dietary Supplements or Functional Foods).
And health authorities around the world now realise that billions of
dollars in health care costs could be saved if everyone took vitamins (Experts say dietary supplements may save $billions in health care
costs!!). While there is so much concern about cost savings let us
not forget that this translates into a huge reduction in human
suffering, something which governments traditionally express little
concern about. As the Australian government pretends that these health
promoting substances which could produce such enormous benefits to
public health are in fact so dangerous urgent regulations are needed, so
they simultaneously ignore human suffering. But this is normal. How
many millions have suffered and are still suffering while governments
and health authorities argued about the terrible dangers of folic acid
and other supplements (The
Folic Acid Lesson)? And have they apologised, offered
compensation, or changed their ways? But in the world of multinational drug companies and their
bureaucratic puppets and
covert agendas, politicians and health authorities seek to convince the
public that nutritional supplements are so dangerous they should not be
so commonly available.
The current attitude of the Australian government is
grossly irresponsible as they deliberately, for their own devious
purposes, refuse to publicly endorse the widespread daily use of
nutritional supplements as has been recommended by health experts around
the world. Although they know the suffering caused by the past refusal to
acknowledge evidence relating to the importance of folic acid, still
they persist with this nutritional recklessness and indifference to
human suffering. How else could the intense campaign of deceit and
misinformation about Pan be explained other than by a desire to
camouflage what were known to be shameful and potentially extremely
unpopular legislative reforms?
Strange as it may
seem, science has provided a precedent for this ridiculous situation.
The twentieth century was the century during which all
the vitamins were discovered and yet in this same century, following the
discovery of the vitamins, scientists developed the food processing
industry to remove these essential health promoting nutrients from foods
more effectively than ever before in human history (Nutrition
and Megavitamins). They called it scientific progress. Over time of
course, as people became sick from nutritional deficiencies, even the
scientists learned the foolishness of food processing. As a result,
science came to the rescue again however, and developed ways of
manufacturing synthetic vitamins and adding these back to the foods from
which they had previously been removed. This was a great scientific
breakthrough indeed and everyone was happy. Science had created two new
highly profitable industries which could coexist quite happily together.
Meanwhile, health conscious consumers were forced to
purchase "whole" grain or "natural" foods from health food stores to
avoid the latest food processing discoveries of scientists. While
science was busy destroying or "dismantling" natural nutrient rich whole
foods, the astute consumer was forced to try and "reassemble" these
foods by purchasing the separate constituents from health food stores.
For instance, the wheat grain could be "reassembled" by purchasing the
separate parts of the wheat such as the germ, the bran, and vitamins. In
this way the health conscious consumer could overcome the advances of
modern science and do his or her bit to prevent malnutrition. Sadly
however, such consumers incurred the wrath of doctors who sought to
prevent healthy eating and who therefore referred to such people by derogatory terms such as "food faddists" or "health
nuts" who believed in "nutrition quackery" (Dietary
Supplements or Functional Foods). As is now apparent to
doctors however, the food faddists were decades ahead of medicine in
their attempts to prevent malnutrition (Dietary
Supplements or Functional Foods). The bran and whole foods favoured by food faddists and ridiculed as quackery by doctors are now
recommended by doctors (11,36,37,38). If only they had listened to the food faddists
all those years ago they could have prevented so much suffering! Sadly
however, unlike the food faddists who seem to possess a degree of common
sense and inherent wisdom, the scientists needed to experiment with the
general public and observe malnutrition by double blind studies before
they realised the foolishness of processing the nutrients out of foods.
This precedent demonstrates quite clearly that yes,
politicians and health authorities could indeed be so stupid, callous,
and uncaring as to
reduce the availability of nutritional supplements at a time when
malnutrition is becoming increasingly prevalent - but it also
demonstrates that new highly profitable industries, such as the addition
of dietary supplements to foods (Dietary
Supplements or Functional Foods), are likely to
develop as a direct result of this action!
But the
Folic Acid Lesson teaches us that vitamins cannot be too freely
available and should be subsidised by governments because of their
fundamentally curative cause based nature, unlike modern symptom
concealing drugs.
As far as Australia and New Zealand
are concerned, it would seem unlikely that the Australian government
would seek to implement full control over alternative medicines
before gaining legislative control over New Zealand. Once the
necessary legislation is in place then it will be up to the Australian
government to decide the nature and timing of the changes they wish to
implement.
Since the campaign of misinformation about Pan has
been so successful we can no doubt look forward to more exercises in
mass deceit.
Those who put profits and personal gain ahead of health
and caring will continue to resort to any means possible to enforce
their will upon the majority. It is up to all of us to be vigilant and
ensure that caring and compassion do not give way to greed. We owe it to
the aged community, and we owe it to our children, and to every
following generation. Do not let them down.
References
1.
http://www.health.gov.au/internet/wcms/publishing.nsf/Content/7D33BF39495CAA19CA2572AE001C
Therapeutic Products Bill 2007: Guide to the exposure draft,
2007, Department of Health and Ageing, Australian Government,
Canberra.
2.
http://www.health.gov.au/internet/wcms/publishing.nsf/Content/7D33BF39495CAA19CA2572AE001C
Therapeutic Products Bill 2007: Guide to the exposure draft, 31st
Jan 2007, HOUSE OF REPRESENTATIVES, The Parliament of the
Commonwealth of Australia, Canberra.
3.
http://www.aar.com.au/pubs/bio/fohapr07.htm, Przemek Kucharski, A
review of the exposure draft of the Therapeutic Products Bill 2007 (Cth),
Focus: Health – April 2007, Allens Arthur Robinson.
4.
http://www.claytonutz.com.au/uploads/Therapeutics%20Product%20Bill_104168857_1.pdf
Summary of key provisions in the exposure draft of the Therapeutic
Products Bill 2007 ("the Bill"), Clayton UTZ, Australia.
5.
http://www.stuff.co.nz/stuff/4055356a12935.html Amy Adams, Health
products: the great Aussie takeover, The Press, Friday, 11
May 2007.
6.http://www.nzhealthtrust.co.nz/news.html
NZ Health Trust
7.
http://www.scoop.co.nz/stories/PO0705/S00230.htm ‘Anti-Vitamin
Bill’ protest at Parliament Tomorrow, Press
Release: Red Umbrella Vigil, 14 May 2007.
8.http://www.nzherald.co.nz/topic/story.cfm?c_id=204&objectid=10440849
Health law threatens '1000 products', NZ
Herald, 21st May 2007.
9.
http://www.scoop.co.nz/stories/PO0705/S00167.htm
Trans-Tasman Medicines Regulator a ‘Trojan Horse’,
Press Release: Medical School and College of Law,
10 May 2007.
10.
http://www.stuff.co.nz/stuff/sundaystartimes/auckland/4040477a6016.html
Stephen Forbes, Bitter pill to swallow, Western Leader,
28 April 2007.
11.
http://www.nytimes.com/2007/05/15/health/nutrition/15nutr.html?_r=1&oref=slogin
Eric Nagourney, Nutrition: A Cardiovascular Argument for Eating Whole
Grains, The New York Times, 15 May 2007; See also
Philip B. Mellen, Thomas F. Walsh,
David M. Herrington
Nutrition, Metabolism and Cardiovascular Diseases .
12.http://www.parliament.nz/en-NZ/SC/Reports/0/e/9/0e9c2505c5084f0fa20509afba8967ae.htm
Therapeutic Products and Medicines Bill 103—1, Report of the
Government Administration Committee, New Zealand Parliament, 15th
June 2007.
13.http://www.parliament.nz/NR/rdonlyres/B9BAD06B-FDF0-4A55-8F20-3E8E096A9BA6/56884/D
Therapeutic Products and Medicines Bill 103—1, Report of the
Government Administration Committee, New Zealand Parliament, 15th
June 2007.
14.http://www.nzherald.co.nz/section/story.cfm?c_id=204&objectid=10445946&pnum=2
Sophie Hazelhurst, Committee fails to reach agreement on therapeutics
bill, The New Zealand Herald, 15th June 2007.
15.http://www.anztpa.org/newsletters/2007/0707newsletter.pdf
Philip Davies, Newsletter Number 3, The Australia New Zealand
Therapeutic Products Authority Project, July 2007.
16.http://www.ahrp.org/infomail/05/11/14.php
Vera Hassner Sharav, Loss of Trust: Big Drug Makers See Sales Decline
With Their Image, Alliance for Human Research Protection, 14
Nov 2005; see also, Alex Berenson,
Big Drug Makers See Sales Decline
With Their Image, New York Times, 14 Nov 2005.
17.http://www.businessweek.com/magazine/content/05_02/b3915433.htm
Amy Barrett, John Carey, Michael Arndt,
More Bitter Pills For Big Pharma,
Business Week, Jan 10 2005.
18.http://www.tga.gov.au/cm/fs_codex.htm
Fact sheet - Codex, TGA, Canberra,
19.http://www.anztpa.org/cm/fs-cm.htm
The proposed joint regulatory scheme for complementary medicines,
Fact Sheet, Australia New Zealand Therapeutic Products Authority,
Jan 2007.
20.http://theyworkforyou.co.nz/portfolios/state_services/2007/mar/14/o01#23
Questions to Ministers, New Zealand Parliament, 14th March 2007; see
also
http://www.hansard.parliament.govt.nz/hansard/Final/FINAL_2007_03_14.htm#_Toc163464757
.
21.http://www.greens.org.nz/searchdocs/other10437.html
Sue Kedgley MP, Green Party,
Trans Tasman Shenanigans,
Complementary Health Newsletter,
1st December 2006.
22.http://www.democrats.org.au/news/index.htm?press_id=5806
Senator Lyn
Allison, Democrats Demand Howard Apologise for Pan
Pharmaceuticals Witch Hunt,
AUSTRALIAN DEMOCRATS PRESS RELEASES, 18th April 2007.
23.http://www.theaustralian.news.com.au/story/0,20867,21578443-2702,00.html
Tracy Ong, Pan Pharmaceuticals boss acquitted, The Australian,
18th April 2007.
24.http://www.theage.com.au/articles/2003/05/02/1051382070157.html
See: Doctors' medicines all safe: govt, The Age, 2nd May 2003.
25.http://web.archive.org/web/20030622072144/
http://www.health.gov.au/mediarel/yr2003/tw/tw03023.
See: Trish Worth, Final List of Members for Expert Committee on
Complementary Medicines, Media Release, 27 May 2003.
26.http://www.smh.com.au/news/National/Strict-new-rules-curb-herbal-drug-sales/2005/03/09/11103160
Mark Metherell, Strict new rules curb herbal drug sales, Sydney
Morning Herald, 10th March 2005.
27.http://www.theage.com.au/news/National/Red-tape-forcing-up-medicine-prices/2005/04/23/111415
Phillip Hudson, Red tape 'forcing up medicine prices', The Age,
24th April 2005.
28.http://www.tga.gov.au/cm/cmresponse.htm
See: Australian Government response to the recommendations of the Expert
Committee on Complementary Medicines in the Health System, Department of
Health, Canberra, March 2005.
29.http://www.theage.com.au/news/National/Govt-launches-alternative-medicine-study/2006/11/23/116387
Govt launches alternative medicine study, The Age, 23rd
Nov 2006.
30.http://www.theaustralian.news.com.au/story/0,20867,20809394-29277,00.html
Alternative medicine to be put to the test, The Australian,
23rd Nov 2006.
31.http://web.archive.org/web/20040426071749/http://www.abc.net.au/news/newsitems/s843371.htm
See: ABC News, Heads to Roll at Pan, 30th April.
32.http://www.tga.gov.au/docs/html/cmfact1.htm
Complementary medicines reform package - an overview Complementary
medicines information sheet, 20 April 1999, TGA, Canberra.
33.Bollen, M., Chairman, Report of the Expert Committee on
Complementary Medicines in the Health System, Canberra, September,
2003.
http://www.tga.gov.au/docs/pdf/cmreport.pdf
34.http://www.tga.gov.au/cm/cmreg-aust.htm
The regulation of complementary medicines in Australia
An overview, April 2006.
35.http://www.bmj.com/cgi/content/full/328/7433/180
MB Katan, (Edit) Health claims for functional foods, BMJ 2004;328:180-181 (24 January).
36.http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15195181&
Jacobs DR, et al, Consumption of whole grain foods and chronic
disease,
Tidsskr Nor
Laegeforen.
2004 May 20;124(10):1399-401.
37.http://www.jacn.org/cgi/content/full/19/suppl_3/291S?maxtoshow=&HITS=10&hits=10&RESULTFO
James W. Anderson et al,
Whole Grain Foods and Heart Disease Risk,
J Amer Coll Nutr, 19, 291S, 2000.
38.http://www.jacn.org/cgi/reprint/19/suppl_3/289S.pdf
Leonard Marquart et al, Whole Grains and Health: An Overview,
J Amer Coll Nutr, 19, 289S, 2000.
39.http://www.news.com.au/common/story_page/0,4057,6349938%5E2,00.
See: Judy Skatssoon,
Safety breaches force recall,
April 28, 2003.
40.MaGuire, T., Largest Ever Drug Recall, Daily
Telegraph, 29th April 2003.See :
http://www.dailytelegraph.com.au
41.http://www.greens.org.nz/searchdocs/other10593.html
Sue
Kedgley MP, SUBMISSION: THE THERAPEUTIC PRODUCTS AND MEDICINES
BILL, Parliament, 20th February 2007.
42.http://www.hansard.parliament.govt.nz/hansard/Final/FINAL_2003_12_04.htm
Annette King, NZ Parliament, 4th Dec 2003.
43.http://www.naturopath.co.nz/assets/File/Natural%20Medicine%20The%20Safest%20Way%20to%20Avoid%20Death.pdf
Natural medicines – the safest way to avoid death in NZ, The
Naturopaths, New Zealand, 12th October 2006.
44.http://www.nzherald.co.nz/topic/story.cfm?c_id=294&objectid=10447345
Bread to be fortified with folic acid, New Zealand Herald,
22nd June 2007.
45.http://jn.nutrition.org/cgi/content/full/133/5/1544S
Bruce Ames, The Metabolic Tune-Up: Metabolic Harmony and Disease
Prevention, J. Nutr. 133:1544S-1548S, May 2003.
46.http://www.ingentaconnect.com/content/adis/dsf/2007/00000030/00000005/art00002?crawler=true
McEwen, John et al, Widespread Hyoscine Hydrobromide Toxicity
Due to Contract Manufacturer Malpractice: The Travacalm Episode,
Drug Safety, Volume 30, Number 5, 2007 , pp. 375-378(4).
47.http://www.australianprescriber.com/magazine/28/6/140/2/
Kerri Mackay, Showing the blue card: reporting adverse reactions,
Aust Prescr 2005;28:140-2.
48.http://www.natsoc.org.au/html/papers/stanton.pdf
Rosemary Stanton,
Who's Driving the Food Supply?,
Food for
Healthy People and Healthy Planet Conference ; see also Bryan
Furnass (Ed), Good Grub - food for healthy people and a
healthy planet,
Nature and Society Forum Inc ABN 52 456 986 523 People and Nature (PAN)
Perspectives book (267 pp), published by Nature and Society Forum and
the Mulanggarri Foundation.
49.http://aidsmyth.addr.com/articles/medicalignorance.htm
Manu Kothari, Medical Ignorance & The Democracy of Intellect,
12th June 2000.
50.http://en.epochtimes.com/news/7-7-23/57900.html
Barry Mills, Relief over Natural Products Bill Defeat, The
Epoch Times, 23rd July 2007.
51.http://www.nzdoctor.co.nz/news?article=8489bfc2-9080-4143-8e45-99c3df93fb6d
Therapeutic Products and Medicines Bill Shelved and Sedated,
Media release from the New Zealand Society of Anaethetists, 19th
July 2007.
52.http://www.smh.com.au/news/World/Joint-therapeutic-agency-plans-on-hold/2007/07/16/118455967
Joint therapeutic agency plans shelved, Sydney Morning Herald,
16th July 2007.
53.http://www.theage.com.au/news/World/Joint-therapeutic-agency-plans-shelved/2007/07/16/11845596
Joint therapeutic agency plans shelved, The Age, 16th July
2007.
54.http://www.newswire.co.nz/main/viewstory.aspx?storyid=382883&catid=33
Time Runs Out For Joint Medicines Agency, Newswire NZ,
16th July 2007.
55.http://www.nzherald.co.nz/author/story.cfm?a_id=164&objectid=10451961
Audrey Young, Government defeat on medicines spurs 'lame-duck' jibes,
New Zealand Herald, 17th July 2007.
56.http://www.parliament.nz/en-NZ/PB/Debates/Debates/Speeches/3/9/2/48HansS_20070717_00000
English, Bill: Questions for Oral Answer — Questions to Ministers,
New Zealand Parliament, 17th July 2007.
57.http://www.scoop.co.nz/stories/PA0707/S00273.htm
English, Bill: Questions for Oral Answer — Questions to Ministers,
New Zealand Parliament, 17th July 2007.
58.http://www.blackmores.com.au/News/Detail.aspx?ArticleId=8979
Marcus Blackmore, Blackmores’ perspective: Trans-Tasman Harmonisation
on hold, 24th July 2007.
59.http://www.theaustralian.news.com.au/story/0,25197,22141485-23289,00.html
Adam Creswell, Drug regulator collapse dents patient hopes,
The Australian, 28th July, 2007.
The FDA in America, like
the TGA in Australia (see above), moves to restrict health freedoms and tighten
control over alternative medicines.
As Europe leads the way (1,2,3,4,5,6)
in restricting health freedoms by imposing draconian restrictions upon
the alternative medicine industry and the marketing of dietary
supplements, so the FDA in America (1,7,8,9,10,11,12,13)
and the TGA in Australia (see above)
are also moving in the same direction. Evidence reveals these changes
are commercially based with the eventual intended goal of establishing a
protected monopoly in alternative medicines for drug companies.
In spite of these trends there are many commentators who
contradict current claims about impending vitamin restrictions and loss
of health freedoms, however, it seems to me that most if not all of such
persons prefer to avoid looking at the "big picture", preferring instead
to confine their analysis to very specific legislative changes. This
tunnel vision approach ignores global changes, general trends and the
profit motive of drug companies and their puppets. I have
always made it clear that my concern is with these general trends and with
the end results as well as the credibility and track record of those
proposing the changes (see Pan Crisis, TGA &
Pan,
Codex in Australia,
Pan Crisis
& Future of Alternative Medicines,
Alternative Medicine Takeover,
Response
to Government Inquiry). For instance, if doctors who have
traditionally regarded vitamins as useless, harmless, placebos suddenly
want new legislation because vitamins are so dangerous, then there
clearly is a massive credibility problem. This is also true when we see
politicians and health authorities abandoning scientific evidence and
resorting instead to lies and wild exaggerations in an obviously
desperate attempt to justify proposed changes, as occurred during the
Pan witch hunt. Let us not let the detail
blind us to the truth. Greed is a huge motivator.
Currently there is much concern in America about the
direction in which legislators are moving and the continuing erosion of health
freedoms (1,7,8,9,10,11,12,13).
Like Australia, America is moving in a direction which is consistent
with global trends and the requirements of Codex and Big Pharma. While
current legislative proposals may not necessarily be the "knockout
punch" that so many are expecting, they are nevertheless causing
widespread confusion and alarm (1).
According to Adams however, the knockout punch is on the way, it just
has not landed yet (11):
"the FDA is about to deal a final, fatal blow to the alternative
medicine industry, outlawing nutritional supplements, functional foods,
homeopathy and natural therapies all at once." Adams lists the
following possible consequences of this proposed legislation (11):
| "Things that will be regulated out of
existence It is very clear that the FDA is
intending to regulate and ultimately destroy the entire CAM
industry (Complementary and Alternative Medicine). Based on
the explanations in the FDA's own document, the following
things are likely to occur:
- All vitamins, nutritional supplements and functional
foods will be stripped of their structure & function
claims, reducing them to empty labels where virtually
nothing at all is allowed to be stated.
- Vegetable juice will be regulated as a drug. Raw
juice retreats will be raided or shut down.
- Growing and selling common garden herbs will get you
arrested as a drug dealer.
- Massage oils and handheld massagers will be
regulated as "medical devices."
- Yoga props, pilates machines and weight machines
will be regulated as "medical devices" and require FDA
approval before being sold or used.
- Raw sprouts and other anti-cancer foods will be
regulated as drugs.
- Bottled water that "treats" dehydration will be
regulated as a drug.
- Massage therapists who use hot rocks as part of
their therapy will have the ROCKS regulated as medical
devices! (It's true. The FDA will actually look at a
pile of rocks and declare, "Those are medical devices!")
- Functional foods, supplements, vitamins and
homeopathic remedies will disappear from store shelves,
pending FDA "review." (The only things remaining will be
processed junk foods and pharmaceuticals, which is
exactly what Big Business wants.)
- Therapeutic tea products, such as green tea, will be
outlawed and confiscated.
- Vitamin store owners will be arrested and prosecuted
for "practicing medicine without a license."
- Citizens owning personal inventories of "unapproved
drugs" (vitamins and herbs) may have their homes raided
at gunpoint and their inventories confiscated by armed
law enforcement agents.
- The importation of herbs and functional foods from
all countries may be banned."
|
Adams continues (11):
"Keep in mind that the FDA is the same agency that:
- Wants to label irradiated foods as "pasteurized."
- Voted to put the deadly drug Vioxx back on the
market after tens of thousands of deaths, even after its
own manufacurer pulled it from pharmacies.
- Raided a church at gunpoint, confiscating
biofeedback machines and charging that they were
"practicing medicine" by counseling church members on
issues like depression.
- Openly allows corrupt, "on the take" experts to vote
on new drug approvals, even when those experts are
taking money from the same companies impacted by their
votes.
- Refuses to legalize stevia, the safe, natural herbal
sweetener that's used virtually everywhere else in the
world. The agenda? Protect the profits of aspartame and
other chemical sweeteners.
- Openly allows the mass poisoning of the public with
cancer-causing food additives such as sodium nitrite.
- Refuses to enforce its own laws regarding unsafe
chemical toxins in personal care products, allowing
perfume and lotion companies to continue poisoning the
public with cancer-causing chemicals that don't even
have to be listed on the label, nor proven safe.
- Ordered the destruction of recipe books that
mentioned stevia. (A campaign to keep the public
ignorant of the herb.)
- Does everything in its power to protect drug company
profits, including discrediting herbs, supplements and
alternative medicine."
|
While authorities may disagree about the immediate
significance of this legislation as far as the alternative medicine
industry is concerned (1),
there is little disagreement about the intended or eventual end results
and the motivations behind this legislation (1,7,9,10,11,12,13).
One of these concerns relates to the push to define alternative
treatments as "drugs" so that even treatment with vegetable juices could
be regarded as "drug" treatment (1,7,9,10,11,12)
and suffer the same restrictions as toxic pharmaceutical drugs.
Paradoxically however, there is a simultaneous global push to add
dietary supplements to foods (Dietary
Supplements or Functional Foods).
These proposed powers are consistent with powers already
conferred upon the FDA by the
Trilateral
Cooperation Charter (TCC) to enable them to redefine the term
"health fraud" so that (1)
"any product that is both safe and gives rise to beneficial effects
on health i.e. the vast majority of dietary supplements, become
potential subjects of health fraud." According to the Alliance
for Natural Health, ANH (1):
"The most worrying aspect of the TCC is the way in which
the three counties have agreed to define ‘health fraud’. In
essence, they have provided such a wide definition of health
fraud that it potentially allows the regulators in each of
the three countries to go after any company making
therapeutic natural health products – even if they present
no harm to consumers and contain no false or misleading
information on their labels or associated marketing
material. In fact the FDA
claims over 730 prosecutions since the TCC’s inception
in 2003 through to just October 2005.
The TCC defines health fraud as follows, but note in
particular the second part of the definition we have bolded
for emphasis:
“The false, deceptive, or misleading promotion,
advertisement, distribution, sale, possession for sale,
or offering for sale of products or provision of
services, intended for human use, that are represented as
being safe and/or effective to diagnose, prevent, cure,
treat, or mitigate disease (or other conditions), to
rehabilitate patients or to provide a beneficial effect on
health." |
Interestingly, the Natural Solutions Foundation
in America recently reported that their web site supporting alternative
medicine was recently blocked for mysterious reasons (29). These
restrictions on free speech are very similar to
changes in Europe (1)
and in Australia where the Australian government also seeks to prevent
truthful claims about vitamins or natural health products (Alternative
Medicine Takeover). And in the UK opponents of alternative medicine
are so vocal and organised that the national press has refused to
publish an article supporting complementary medicine (14,15,16,17,18),
while in Wales, a supplier of vitamins was made a criminal following a dawn raid
of his premises by the British Medicine's Regulator (19,20).
Just as in Australia, the FDA in America is merely
attempting to justify a complete takeover of alternative medicines on
the basis of false or wildly exaggerated unscientific claims about safety (30,33,34,35,36),
precisely the same tactics used by the TGA as a result of the Pan witch
hunt. According to Byron Richards (30):
| "The FDA has conveniently used the excuse of looking
out for consumer safety to increase their perverse
regulatory power, undermine free speech, disrupt commerce,
and generally get in the way of helping people improve their
health. The “half-truth” of the safety issue is used as a
ploy to reduce the rights of Americans, one freedom at a
time. Once again, the FDA is seeking more police power to
intimidate supplement companies. This is one step in an
overall FDA master plan to eliminate therapeutic nutritional
supplements from the free market. Those who lose are the
American public." |
Richards continues (30):
| "The PR spin suggesting a “need” for this legislation
is to protect consumers and give consumers confidence in the
supplement industry. The only reason for any lack of
consumer confidence is due to a relentless and fraudulent
persecution of supplements by the controlled media acting on
behalf of the sickness industry. It is an attempt to divert
public attention from the real safety issue of dangerous
drugs that kill several thousand Americans per week." |
Once again these tactics are exactly the same as those
employed by the TGA in Australia, who, while destroying the supplement
industry, pretended they were building consumer confidence in the
industry (Pan Crisis, TGA &
Pan,
Codex in Australia,
Pan Crisis
& Future of Alternative Medicines,
Alternative Medicine Takeover,
Response
to Government Inquiry). Richards draws attention to the fact that
since evidence of serious adverse reactions to supplements is so rare
the legislation has been deliberately structured so as to permit side
effects of pharmaceutical drugs to be blamed on supplements (30):
| "The bill says, “The term adverse event means any
health-related event associated with the use of a dietary
supplement that is adverse.” This is far different than a
serious adverse event. In another words, any symptom a
person associates with taking a vitamin that in their
opinion is improper will need to be recorded as an adverse
event. Such reports need to be open for FDA inspection at
any time. This legislation is nothing more than an FDA
harassment vehicle."........"The way
the legislation is written a person could blame vitamins for
almost anything, even if they are on multiple drugs or have
pre-existing serious health problems." |
Once again these identical trends are occurring in
Australia where experts have also suggested, when it comes to
alternative therapies, an adverse event is an adverse event (31,32)
"whether or not it is confirmed to be related to the therapy,"
a fact I drew attention to in my article about the Pan witch hunt (Pan Crisis).
If you are taking pharmaceutical drugs and vitamins at the same time the
vitamins can therefore be blamed for any adverse reactions. Amazing
how, like puppets, the ramblings of Australian authorities reflect so
closely the words of the FDA. Is the FDA making Australian policy? Or is
the policy in both countries determined by Big Pharma?
Richards continues (30):
| "Adverse event reporting is addressing a non-existent
problem. It is seeking to shift the legal burned of proof to
supplement companies. It is targeted to harass small and
truly helpful nutritional companies. It plays on the false
need for improved safety as the excuse to gain further
regulatory control of the supplement industry. It is a ploy
by the FDA and various bought-off members of Congress to
further harass supplement companies, setting the stage for
Codex implementation and overturning U.S. law that gives
consumers access to a wide variety of supplements." |
Richards sums up the consequences of adverse event
reporting (AER) legislation(36):
| "Adverse Event Reporting legislation will enable
doctors to viciously attack vitamin supplements based on Big
Pharma propaganda, and with the help of the FDA have
effective dietary supplements removed from the
market..................AER legislation for dietary
supplements is best understood in the context of Big Pharma
and FDA efforts to brand dietary supplements as dangerous
and categorize them as drugs. This effort is taking place
internationally, regionally, and within the United States.
Many FDA actions in this campaign are blatantly illegal and
undermine American sovereignty........Big Pharma will pay
for fraudulent science,
as was done to attack vitamin E, and doctors across the
country will tell their patients to report any symptom as an
adverse event relating to vitamin E (or anything else),
simply because the person is taking vitamin E. Then, the
FDA will apply drug-like risk analysis to the information
they collect from vitamin companies, and slant statistics
with a goon-like twisted “public health” perspective. They
will then rule numerous vitamins to be unsafe at various
levels of intake." |
It seems that in America time is running out to prevent
the takeover of the dietary supplement industry which is being sought by
those who oppose health freedoms and the availability of dietary
supplements, such as the FDA and Big Pharma (37,38).
Step by step Big Pharma and its puppets are continuing their relentless
march towards the global takeover of vitamins and supplements and their
desire to deny citizens the right to rectify malnutrition and vitamin
deficiencies with supplements. According to Richards (37):
| "Your right to have free access to safe and
highly effective dietary supplements is under an intense
multi-pronged FDA attack. On May 14, 2007 the Supreme Court
sided with the FDA by deciding not to hear the case of
Nutraceutical v FDA, letting stand a federal appeals court
ruling that permits the FDA to use drug-related risk/benefit
analysis to determine if a nutrient is safe. This is the
exact same point the FDA is trying to get put into law
through Senate bill S.1082 and HR.1561, which consumers have
flooded the Senate on over the past few weeks. And it is the
same point the FDA is seeking to help implement on an
international basis through Codex. The Supreme Court denial
to hear this case is a dramatic turn of events that means
there is very little time left to act to preserve free
access to dietary supplements............................"
"You may find it hard to believe that the FDA would
follow this path when so many people are in need of natural
and safe health options. Yet, the FDA is already working
with Codex on an international basis to help establish risk
analysis (toxicology) for dietary supplements. FDA
scientists are heavily involved with the Codex Committee on
Nutrition and Foods for Special Dietary Uses (CCNFSDU). In
the upcoming meeting in Germany in Nov 2007 an
FDA-supported plan will be presented in an effort to
help establish the application of risk analysis to guide
CCNFSDU to set “Safe Upper Limits” for dietary supplements.
Safe Upper Limits, as currently viewed by Codex, are a
public health scam; they are a politically correct strategy
for branding dietary supplements as drugs based on
drug-related risk analysis technology. The FDA and Codex
goal is to remove therapeutically useful dietary supplements
from the free market so they don’t compete with drugs.
Another goal is to make all useful nutrients into
prescriptions to give Big Pharma a total monopoly on all
health options." |
Perhaps one of the most disappointing aspects of
this whole matter is the fact that some supposed supporters of
alternative medicines, and even some suppliers of alternative medicines, have
been persuaded to 'change sides' and support the push to control
alternative medicines. I have previously drawn attention to this
occurrence in Australia (Alternative Medicine
Takeover) and according to Richards (Big
Pharma Trojan Horses Permeate Supplement Industry), it is also
occurring in America (35,36).
According to Richards (35),
"Unfortunately, it is up to 'we the American people' to save the
supplement industry from traitorous groups pretending to be on your side."
Although legislators have managed to confuse the debate
about Codex and controls over marketing of vitamins, the general
direction of, and motivation behind, these changes, should be abundantly
clear to everyone. As I indicated elsewhere (Alternative
Medicine Takeover, Alternative Medicine
Enquiry) , it would be very easy for governments to adopt a
scientifically based attitude, in response to proactive pressure from
lobby groups, and move to strengthen health freedoms in current
legislation in accord with the available scientific evidence which shows
the safety and effectiveness of supplements (Dietary
Supplements, Dietary
Supplements or Functional Foods,
Nutrition Breakthroughs). Legislative safety
amendments clearly should reflect evidence of known toxicity and
relative risk of therapeutic substances and therefore the more hazardous
pharmaceutical drugs should be receiving the most legislative attention
(Dietary Supplements).
This is in accord with all the available scientific evidence.
Proactive action would involve interest groups lobbying government to
subsidise nutritional supplements and make them more available to all.
The right to proper nutrition, using supplements if desired, should be
enshrined in our constitutions. At the same time governments should be
urged to introduce new labeling and grading for pharmaceutical drugs
according to scientific evidence of known risk. Additionally,
unless a drug is known to have a "curative" effect it
should be labeled accordingly as a symptomatic treatment (Alternative
Medicine Enquiry):
| "Regulations should formally acknowledge the
different efficacy standards for alternative medicines and
pharmaceutical drugs by requiring that the former,
particularly nutritional supplements, are labeled "For
Disease Prevention and Optimum Health" or similar, while
drugs should be labeled "For Suppression of Symptoms"
or similar. Exemptions could of course be granted in
specific cases where this is warranted. Such a system would
be totally consistent with all the available scientific
evidence. This distinction must be formally acknowledged in
the interests of public health." |
The fact that governments are moving in the opposite
direction, and the fact that interest groups are generally silent on
such proposals, is most conspicuous and incriminating. I issue a
challenge to those who say there is no threat to supplement availability
intended by currently proposed legislative changes to publicly endorse
the above suggestions and endorse and enact a risk and toxicity based
approach to legislation of therapeutic products in accord with
scientific evidence (Dietary Supplements).
While all these changes are occurring it is business as usual for
the multinational drug companies. Even former editors of the New
England Journal of Medicine draw attention to the corruption and
fundamental profit motive of drug companies (21,22,23,24).
Although the New England Journal of Medicine recently relaxed its
guidelines to permit more potential conflict of interest amongst
submitting authors (25)
there is continuing unrest amongst doctors about the corrupt influence
of Big Pharma upon the medical profession (26,27).
And in America claims are being made that senators are being bought off
by Big Pharma as the drug companies attempt to steamroll their
opposition (27,28).
At the same time the food industry is continuing its relentless campaign
to add dietary supplements to foods (Dietary
Supplements or Functional Foods).
But as the potential benefits of nutrition are becoming
increasingly obvious, at the same time drug industry profits and the
production of innovative "blockbuster drugs" are in significant
decline as the drug industry is forced to depend increasingly upon
production of "copycat" or so called "me-too drugs" which
offer no clear therapeutic advantage (39,40,41,42,43,44).
Additionally, according to Humer (45),
who cites figures from the Pharmaceutical Research and Manufacturers
Association of America , "USD100 million are wasted every year
in the United States alone because patients take drugs that are
ineffective or have serious side effects."
With the assistance of politicians, the medical profession,
and even deserters in the alternative medicine industry, it is hardly
surprising that Big Pharma is seeking to "cash in" on the current boom
in alternative medicines. Politicians, bureaucrats, and doctors have joined forces, as
we observed as a result of the Pan witch hunt, to
try and convince consumers that health promoting nutrients are so
dangerous nothing but complete government control will save the human
race. They tell us that in order to protect us they need the same control over
vitamins as has resulted in
thousands of deaths from pharmaceutical drugs every year. And they
tell us that as
malnutrition becomes more prevalent vitamins are too dangerous to
take. And as scientists discover the need for
megavitamins vitamins should be restricted. And of course it should
be against the law to say that nutritional supplements alleviate
malnutrition. And anyone who suggests megadoses of nutrients could be
used to treat genetic diseases - surely they should be arrested! But we
will need extremely big gaols - but then again.......if we privatise the
gaols......
References
1.
http://www.alliance-natural-health.org/index.cfm?action=news&ID=278
ANH PRESS RELEASE: FDA Guidance for CAM, CAM THERAPIES IN
THE USA IN TURMOIL FOLLOWING RELEASE OF FDA DRAFT GUIDANCE DOCUMENT,
Alliance for Natural Health, 2nd May 2007.
2.
http://www.alliance-natural-health.org/_docs/ANHwebsiteDoc_272.pdf
ANH puts spotlight on EU procedures for food supplements following
European Court judgment, Alliance for Natural Health, 16
March 2007, Dorking, United Kingdom.
3.
http://www.alliance-natural-health.org/index.cfm?action=news&ID=275
ANH PRESS RELEASE: ANH responds to EFSA accusation of legal threat,
Alliance for Natural Health, 27 March 2007, Dorking, United Kingdom.
4.
http://www.alliance-natural-health.org/index.cfm?action=news&ID=274
ANH PRESS RELEASE: ANH puts spotlight on European Commission over
food supplement procedures, Alliance for Natural Health,
16 March 2007, Dorking, United Kingdom.
5.
http://www.staffnurse.com/nursing-news-articles/euro-court-backs-vitamin-restrictions-1348.html
Euro-court backs vitamin restrictions, July 18th 2005.
6.
http://www.theecologist.org/archive_detail.asp?content_id=202
Hidden Agenda, The Ecologist,
01/06/2003.
7.
http://www.healthfreedom.net/index.php?option=com_content&task=view&id=217&Itemid=251
FDA CAM Regulation Guidance, Health Freedom Foundation.
8.
http://www.healthfreedom.net/index.php?option=com_content&task=view&id=209&Itemid=244
Upcoming legislation that will severely affect your health choices,
Health Freedom Foundation.
9.
http://www.anxiety-and-depression-solutions.com/articles/news/FDA_alt_med_0407.php
FDA Seeks Stricter Regulations for Alternative Medicines,
Insight, Apr 24, 2007.
10.http://www.mediaisland.org/en/cam-practices-products-and-fda-regulation-updated-threat-assessment
Ralph Fucetola JD -
www.vitaminlawyer.com,
CAM Practices, Products and FDA Regulation: Updated Threat Assessment,
Media Island International, 04/24/07.
11.http://www.newstarget.com/021789.html
Mike Adams, Health freedom action alert: FDA attempting to regulate
supplements, herbs and juices as "drugs", News Target, April
11, 2007.
12.http://www.healthfreedomusa.org/index.php/?p=354
Comments on FDA Guidance to Regulate CAM, Natural Solutions
Foundation, 04/06/07.
13.http://www.healthfreedom.net/storage/aahf/documents/HFF_dietary%20supplement.pdf
$100 For a Single Vitamin C Tablet, Health Freedom Foundation.
14.http://www.alliance-natural-health.org/index.cfm?action=news&ID=266
Read and forward this - the press won't publish it!, Alliance
for Natural Health, 14 Dec 2006, Dorking, United
Kingdom.
15.http://www.alliance-natural-health.org/_docs/ANHwebsiteDoc_262.pdf
Robert Verkerk, Who’s confused about alternative medicine?,
Alliance for Natural Health, 14 Dec 2006, Dorking,
United Kingdom.
16.http://www.alliance-natural-health.org/index.cfm?action=news&ID=265
UK anti-comp med campaign given another stab by Prof Ernst,
Alliance for Natural Health, 12 Dec 2006, Dorking,
United Kingdom; see also,
http://www.dailymail.co.uk/pages/live/articles/health/healthmain.html?in_article_id=422017&in_page
Barbara Rowlands, Complementary medicines are useless and dangerous,
says Britain's foremost expert, Daily Mail, 12 Dec 2006.
17.
http://www.alliance-natural-health.org/index.cfm?action=news&ID=262
Furious UK debate on comp med continues, Alliance for Natural
Health, 01 Dec 2006, Dorking, United Kingdom.
18.
http://www.alliance-natural-health.org/index.cfm?action=news&ID=259
Leading UK professor accuses alternative medicines industry of 'vile
and cynical exploitation', Alliance for Natural Health,
24 Nov 2006, Dorking, United Kingdom; see also,
http://press.psprings.co.uk/bmj/november/pv1129.pdf , Prof Jonathan
Waxman, Personal View: Shark cartilage in the water,
BMJ 2006; 333: 1129.
19.http://www.alliance-natural-health.org/index.cfm?action=news&ID=267
Vitamin seller made a criminal, Alliance for Natural Health,
15 Dec 2006, Dorking, United Kingdom.
20.http://www.alliance-natural-health.org/_docs/ANHwebsiteDoc_263.pdf
Vitamin seller made a criminal, Alliance for Natural Health,
15 Dec 2006, Dorking, United Kingdom.
21.http://www.americanscientist.org/template/BookReviewTypeDetail/assetid/39097;jsessionid=baa9...
Arthur L. Caplan, Indicting Big Pharma, American Scientist Online,
Jan-Feb 2005; see also, The Truth about the Drug Companies: How They
Deceive Us and What To Do about It. Marcia Angell. xx + 305 pp.
Random House, 2004, On the Take: How Medicine's Complicity with Big
Business Can Endanger Your Health. Jerome P. Kassirer. xx + 251 pp.
Oxford University Press, 2005, Powerful Medicines: The Benefits,
Risks, and Costs of Prescription Drugs. Jerry Avorn. viii + 448 pp.
Alfred A. Knopf, 2004.
22.http://www.motherjones.com/news/qa/2004/09/09_401.htm
Peter Meredith, The Truth About Drug Companies,
September 7, 2004; see also,
The Truth About Drug Companies: How They Deceive Us and What to Do
About It.
23.http://www.newstarget.com/021795.htm
Mike Adams, Americans fed up with drug industry influence, FDA
corruption, reveals remarkable Consumer Reports survey, April 16,
2007.
24.http://www.truthout.org/cgi-bin/artman/exec/view.cgi/61/20823
Dean Baker,
Prescription Drug Scams, 29 June 2006; see also
http://www.nytimes.com/2006/06/28/business/28foundation.html?ex=1309147200&en
Reed Abelson, Charities Tied to Doctors Get Drug Industry
Gifts, NY Times, June 8 2006;
http://www.washingtonpost.com/wp-dyn/content/article/2005/11/29/AR2005112901650.html
Jonathan Weisman, Drugmakers Win Exemption in House Budget-Cutting
Bill, Washington Post, November 30, 2005;
http://www.nytimes.com/2005/11/28/business/28cheer.html?ex=1290834000&en=1f0e2dde86b6
Stephanie Saul, Gimme an Rx! Cheerleaders Pep Up Drug Sales,
NY Times, Nov 28 2005.
25.http://www.freerepublic.com/focus/news/726423/posts
Nathan Newman, Big Pharma, Bad Science; see also New Eng J Med,
June 2002.
26.http://www.medicationsense.com/articles/jan_apr_06/conflict_of_interest_020306.html
JS Cohen, THE MEDICAL PROFESSION'S CULTURE
OF CORRUPTION, PART 1: MedicationSense E-Newsletter,
www.MedicationSense.com,
2006; see also, Brennan TA et al, JAMA, Jan. 25,
2006;295(4):429-433.
27.http://www.medicationsense.com/articles/may_aug_06/conflict_of_interest_060306.html
JS Cohen, THE MEDICAL PROFESSION'S CULTURE
OF CORRUPTION, PART 2: MedicationSense E-Newsletter,
www.MedicationSense.com,
2006.
28.http://www.americanchronicle.com/articles/viewArticle.asp?articleID=25995
Senators Bribed By Big Pharma vs. Senators Not Bought Off, Byron
Richards.
29.http://www.healthfreedomusa.org/index.php/?p=349
FAQ RE: Site Blocked, Natural Solutions Foundation, March
16 2007.
30.http://www.newswithviews.com/Richards/byron1.htm
Byron J. Richards, THE F.D.A. - A WOLF IN SHEEP'S
CLOTHING, NewsWithViews, July 7, 2006.
31.http://apsu.inopsu.com/cam2001.pdf
See: Dr Mike South, et al, Adverse Effects Associated with the use of
Complementary or Alternative Medicine, Australian Paediatric
Surveillance Unit, 2001.
32.http://apsu.inopsu.com/CAMprotocol.pdf
See: Dr Mike South, et al, Adverse Effects Associated with the use of
Complementary or Alternative Medicine, Australian Paediatric
Surveillance Unit, 2001.
33.http://www.thenhf.com/government_affairs_117.htm
Scott C. Tips, A Night At The Opera -
The Debate Over Mandatory Adverse Event Reporting, National
Health Federation, October 19, 2006.
34.http://www.newswithviews.com/Richards/byron14.htm
Byron J. Richards, THE POLITICS AND PROFITS IN KEEPING
AMERICANS SICK, NewsWithViews, November 12, 2006.
35.http://www.newswithviews.com/Richards/byron16.htm
Byron J. Richards, BIG PHARMA TROJAN HORSES PERMEATE
SUPPLEMENT INDUSTRY, NewsWithViews, December 5, 2006.
36.http://www.truthinwellness.com/articles/health_freedom_reels_pt2.php
Byron J. Richards, Big Pharma Juggernaut Rolls
To Victory – Health Freedom Reels – Part 2, Truth in Wellness,
2006.
37.http://www.newswithviews.com/Richards/byron30.htm
Byron J. Richards, UNDERSTANDING THE THREAT TO DIETARY
SUPPLEMENTS PART 1, NewsWithViews, May 15, 2007.
38.http://newswithviews.com/Richards/byron31.htm
Byron J. Richards, UNDERSTANDING THE THREAT TO DIETARY
SUPPLEMENTS PART 2, NewsWithViews, May 16, 2007.
39.http://stanmed.stanford.edu/2005summer/drugs-metoo.html
Rosanne Spector, Me-too drugs Sometimes they're just the same old,
same old, Stanford Medicine Magazine, Summer 2005.
40.http://www.time.com/time/nation/article/0,8599,1572974,00.html
Douglas Waller, Too Little Bang for the Buck in Drug Research?,
Time, 27th Dec 2006.
41.http://www.gooznews.com/archives/000573.html
Merrill Goozner, GAO: Drug Innovation Lags Despite High Drug Prices,
Gooznews, 19th Dec 2006.
42.http://www.bmj.com/cgi/content/full/331/7520/0-b
"Me-too" drugs drive the rise in drug expenditure, BMJ 2005;331 (8 October).
43.http://www.motherjones.com/news/qa/2004/09/09_401.html
44.http://www.washingtonpost.com/ac2/wp-dyn/A43257-2003Nov14?language=printer
Peter Lansbury, An Innovative Drug Industry? Well, No,
Washington Post, 16th Nov 2003.
45.http://www.roche.com/fbh_zvg05_e.pdf
Innovation in the Pharmaceutical Industry — Future Prospects,
Talk by Dr Franz B. Humer, Chairman of the Board of Directors and CEO of
F. Hoffmann-La Roche Ltd, to the Zürcher Volkswirtschaftliche
Gesellschaft Zurich, 16 March 2005
How many times must doctors
discover malnutrition in the elderly before they discard their anti-nutrition bias (see
Medical Bias) and take action
to reverse the starvation of our elderly citizens rather than just
filling them with drugs? Now doctors have made this same astonishing discovery
yet again as a result of the recent study by Professor Bolin at Sydney's
Prince of Wales Hospital (1,2,3,4)
as well as studies in Britain (5,6),
though they seem to pretend this is a new discovery. Of course this is
the opposite of the truth, doctors having known for many years about the
widespread prevalence of malnutrition, even in hospital or nursing home
patients where nutrition is controlled (7,8,9,10,11,12,13,14,15,22,24:
see also; Nutrition and
Megavitamins,
B Vitamins,
Nutrition is for the Birds,
Do
Not Resuscitate). Malnutrition in hospitals or aged care facilities
is so common in fact that it has been termed "iatrogenic
malnutrition" or doctor caused
malnutrition (15,16;
Do
Not Resuscitate). In spite of this it has been claimed that this
most recent Australian study (3)
"is believed to be the first randomised study of its kind examining
malnutrition in a clinical setting with control and intervention
groups", a disgraceful admission indeed given past evidence of the
prevalence and importance of malnutrition (Do
Not Resuscitate, Nutrition and
Megavitamins). Although doctors have traditionally regarded
malnutrition as being unimportant, accumulating evidence of the
consequences of malnutrition (7,9,10,14,17,18,19,20,21,22)
seems to be very slowly convincing doctors of the importance of adequate
nutrition.
Particularly enlightening is the following report from
The New York Times taken more than twenty years ago (10):
| "MALNUTRITION may account for a substantially
greater portion of illness among elderly Americans than has
long been assumed, according to several medical experts on
aging........Most recently, many gerontologists have been
both alarmed and excited by evidence that malnourishment may
cause much of the physiological decline in disease
resistance seen in elderly patients, a weakening of
immunological defenses that has commonly been blamed on the
aging process.......In experiments that have captured the
attention of many gerontologists, Dr. Chandra has shown that
nutritional supplements can partly restore the immune
systems of malnourished elderly patients and can also
improve their responses to vaccines for influenza, tetanus
and pneumonia. A lack of immunological reaction in the aged
often undercuts the benefits of vaccines, which work by
triggering the body's defenses." |
But 7 years later, in 1992, the following report also
appeared in The New York Times (9):
| "Dr. Howard Fillit has come up with a low-cost
way to fend off, and even reverse, what most people view
simply as the inevitable ravages of age: He feeds
people.........Up to 40 percent of the scores of very sick,
elderly patients Dr. Fillit sees at Mount Sinai Medical
Center are malnourished, he said, even though they -- and
their families and nursing aides, when they are lucky enough
to have either -- usually do not realize it. In many cases,
he said, their bad diet has caused, or at least severely
worsened, their pneumonia, their heart trouble or even their
dementia...'If they were objective, they would see
themselves as skeletons,' said Dr. Fillit, who runs Sinai's
Geriatric Evaluation and Treatment Unit. 'But they just see
themselves as old.'..................Hence the living
skeletons that keep turning up on Dr. Fillit's doorstep.
'Every day they come in, and the primary diagnosis from a
geriatrician's point of view is malnutrition and social
impairment,' he said. 'What good is it going to do to give
them the right antibiotic for pneumonia and send them back
home?. 'It's All Reversible' ...People often have weakened
their immune systems, already slipping as a natural
consequence of age, by not eating properly. 'These people
are dying from infections,' he said. 'That's how people in
Somalia are dying.' Sometimes the old people he sees are
confused, displaying what look like the symptoms of
Alzheimer's Disease. But on closer examination, he has
discovered that they were simply lacking adequate amounts of
B12, a vitamin commonly found in meat, fish and milk. 'It's
all reversible,' he said." |
The fact that
malnutrition continues to be so prevalent is due to the preference for
drug treatments and the consequent low priority given to malnutrition by
doctors. According to Professor Bolin in this regard (1,3):
"Unfortunately, nutrition and malnutrition are not priorities for
physicians and surgeons and only come to notice when a patient's
recovery is not progressing. Often this is too late." So even
in 2007 nutrition is still not a priority for doctors, but perhaps this
is not too surprising given the claim by Professor Dwyer that (23),
"vitamin deficiency is rare in Australia since so many of the
foods we consume contain vitamin supplements."
In his article entitled (23)
"Serving up
nonsense in the form of pick-me-up pills",
Professor Dwyer even contradicts nutrition research from around the
world indicating the benefits of nutrition and vitamin supplements,
especially in regard to chronic diseases like heart disease (see
Nutrition and Megavitamins,
B Vitamins,
Nutrition is for the
Birds, Dietary Supplements or Functional
Foods?). According to Professor Dwyer (23):
| "A consumer who takes the Nature's Own
advertisement for vitamins at face value is likely to
conclude that everyone should consume a daily multivitamin
preparation to help avoid heart disease. The truth is
different, and this again highlights the fact that
self-imposed standards for advertisers, and the media
outlets that present their information, are failing
consumers." |
As I indicated elsewhere (Do
Not Resuscitate), such is medicine's disregard for malnutrition that doctors refused to give vitamin injections to my
father even though he was dying from starvation. The traditional medical
bias against nutrition is well known (Medical Bias)
with some authorities even claiming that nutritional supplements are so
useless they do no more than enrich our sewerage (Pan
Crisis). Such is medicine's traditional contempt for nutrition that
pregnant women have even been advised by doctors in the past to
deliberately starve themselves in order to produce a smaller baby and
have an easier delivery (Medical
Rationing):
| "One of the most tragic
examples of iatrogenic diseases may well be the current
epidemics of heart disease, syndrome X, diabetes, adrenal
disorders, and respiratory diseases (see
Health Trends) which may all share a common cause.
According to increasing scientific evidence all these
diseases may result from low birth weight caused by
inadequate nutrition during pregnancy (96,97,98,99,
100,101,102,103,
104,105,106,107)*.
But 50 years ago modern medical science was advising women
to deliberately practice semi-starvation during pregnancy to
ensure they would give birth to a smaller baby and hence
have an easier delivery (108,109)*. And medical experts
continue to wonder why there has been such an epidemic of
chronic diseases in the latter half of the 20th century. And
medical bioethicists, bureaucrats, and economists seek to
withdraw treatment from the chronically ill because of
costs.
There is no better example of the possible tragic
consequences of medicine's short sighted symptomatic
approach to "health care". The fact that deliberate
iatrogenic foetal malnutrition may be a significant factor
in the current epidemic of chronic diseases should be
headline material, but yet it rarely receives any mention
whatsoever. The "costs" of this irresponsible nutritional
advice would be expected to be most prominent in those who
are now 50 years of age or older. Unfortunately we must all
pay the price for the disruption of the learning process
which occurs when health authorities seek to deny or conceal
the truth."
*See
Medical Rationing for references. |
Another suggestion made as a result of the Bolin study is the
possibility that malnutrition may not be caused only by insufficient
nutrient intake, but additionally, inefficient absorption or metabolism
of nutrients may also play a key role, a possibility according to Bolin,
that warrants further research (3):
| "Malnutrition is not simply caused by lack of access
to food – we believe other factors such as malabsorption
play a key role"......."An extension of the study
will look at malabsorption rates in the community by using a
dual sugar absorption test ." |
This is all very interesting but malabsorption and
problems with nutrient utilisation have long been known to be a
significant factor in nutritional status and malnutrition (Nutrition
and Megavitamins, B Vitamins). In
fact, according to the Genetotrophic Concept and
Nutrigenomics (Nutrition
Breakthroughs,
Genetic
Nutrition), common genetic deviations in people cause various
inefficiencies in nutrient utilisation and the need for megadoses of
nutrients if malnutrition is to be avoided. The Genetotrophic
Concept was developed by Roger Williams more than 50 years ago
as a result of his research which indicated that inefficiencies in
nutrient utilisation were commonplace, a discovery which was
rejected by the medical world which based its belief on the
assumption that efficiency of nutrient utilisation is identical in
nearly everyone (Nutrition
Breakthroughs).
While progress in nutrition is to be welcomed, how
about giving credit to past researchers who made these discoveries
years ago. And instead of talking about the terrible prevalence of
malnutrition, why not do something about it?
References
1. Clara Pirani, Malnutrition
widespread in elderly patients, The Australian, 9th May
2007.
2. Julie Robotham, Elderly patients risk malnutrition,
Brisbane Times, 9th May 2007.
3. Kate McEvoy, New Study Reveals High Rates of Malnutrition in
Elderly, WestEnder, 10th May 2007.
4. ABC News Online, Elderly patients need greater
nutritional care: study, 9th May 2007.
5. We are eating ourselves ill: Treating malnutrition costs NHS
more than obesity, The Independent (UK), 6th May 2007.
6. Junk Food Nation, The Independent (UK), 6th May
2007.
7. Chen CC, Schilling LS, Lyder CH., A concept analysis of
malnutrition in the elderly,
J Adv Nurs.
2001 Oct;36(1):131-42.
8. Peter Ellingsen, Scandal of the elderly who go hungry,
The Age, 4th Dec 2005.
9. James Bennet, Hidden Malnutrition Worsens Health of Elderly,
The New York Times, 9th may 2007.
10.Erik Eckholm, MALNUTRITION IN ELDERLY: WIDESPREAD HEALTH
THREAT, The New York Times, 13th Aug 1985.
11.Elderly in British hospitals malnourished,
30th Aug 2006.
12.Seiler, WO, Clinical
pictures of malnutrition in ill elderly subjects, Nutrition,
Volume 17, Issue 6, June 2001, Pages 496-498.
13.Azad, N. et al, Nutrition survey in an elderly population
following admission to a tertiary care hospital, CMAJ •
September 7, 1999; 161 (5).
14.Malnutrition in the elderly – a more significant global
problem than obesity, Novartis press release, 13th Nov
2006.
15.Wendland BE, Malnutrition in institutionalized seniors: the
iatrogenic component.,
J Am
Geriatr Soc. 2003 Jan;51(1):85-90.
16.http://webhost.sun.ac.za/nicus/Factsheets/updated2006/Hospital%20Malnutrition%20(2004)%20SC.doc.
Hospital Malnutrition: European Union
moves to address the "skeletons in the hospital cupboards,
Nutrition Information Centre University of Stellenbosch.
17.Raynaud-Simon A, Lesourd B., Malnutrition in the
elderly. Clinical consequences,
Presse Med.
2000 Dec 16;29(39):2183-90.
18.Lesourd B., Immune response during disease and recovery
in the elderly,
Proc Nutr
Soc. 1999 Feb;58(1):85-98.
19.Harris CL, Fraser C, Malnutrition in the
institutionalized elderly: the effects on wound healing.,
Ostomy
Wound Manage. 2004 Oct;50(10):54-63.
20.Zazzo JF., Physiopathology and consequences of malnutrition,
Rev Prat. 2003
Feb 1;53(3):248-53.
21.Pamela Mason, Undernutrition in Hospitals - causes and
consequences, Hospital Pharmacist, 13, 358, 2006.
22.Barry Jones, NHS Patients 'Risk Complications And Death'
Because Of Poor Nutrition In Hospitals, British Society Of
Gastroenterology, 23rd March 2006
23.http://www.smh.com.au/news/opinion/serving-up-nonsense-in-the-form-of-pickmeup-pills/2006/01/24/1
John Dwyer, Serving up nonsense in the form of pick-me-up pills,
Sydney Morning Herald, January 25, 2006.
24.http://www.jacn.org/cgi/content/full/19/5/613
DL McKay et al, The Effects of a Multivitamin/Mineral Supplement
on Micronutrient Status, Antioxidant Capacity and Cytokine
Production in Healthy Older Adults Consuming a Fortified Diet,
Journal of the American College of Nutrition, Vol. 19, No. 5,
613-621 (2000).
Four years ago, following a severe respiratory
infection, I developed severe
shingles in the ear. The initial outbreak
was characterised by intense pain in the ear, neck, throat and scalp,
high fever, copious discharge from the ear, serious loss of hearing
in the affected ear, severe headache, and symptoms of encephalitis. I responded quickly
to Zovirax (Acyclovir) but the course of treatment
only lasted one week. When I finished this course of treatment the
shingles returned (recurrent
shingles) almost as severe as it had been a week earlier but the
GP I was attending could not believe the shingles could return even
though he saw it with his own eyes. When I emphasised my CFS and poor
immunity to him and asked if perhaps I needed a longer course of the
drug he replied most emphatically that it is impossible for shingles to
come back and therefore I did not need any further doses of the drug. He
said this even though he saw with his own eyes that the weeping blisters
in my ear had returned and I was once again complaining of intense pain.
He adopted a dismissive attitude and said it was best that I just try to
forget about it although he referred me to a neurologist and an ear
specialist..
In the meantime, while waiting to see the
specialists, I was forced to continue enduring a continuing attack of
shingles because the GP did not believe it was possible for it to
return. While this attack continued more damage was being done to the
affected nerves in my ear, around my scalp and face, and in my head.
When I saw the ear specialist he took one look at my ear
and said he could not help me but said he would have to ring the
infectious diseases specialist. Very promptly it was arranged for me to
see the infectious diseases doctor who immediately told me the shingles
had returned (this was no secret to me...in spite of what the GP said!)
and prescribed Valtrex to treat it. He advised me that because of my CFS
and immunity problems I would need to take this drug for a considerable
time until my body was strong enough to stop the shingles. He was right.
As it turned out I had to take the drug for 4 months. Unfortunately
though, my recovery from this second attack of shingles was much slower
than the first time because the nerves around my ear, face, scalp, and
brain, had been more severely damaged because the GP refused to give me
further treatment. Eventually however, the pain settled and I was was
lucky enough to recover much of my lost hearing.
This year however, 4 years later, I contracted a gastric
infection which was followed by the return of shingles again in the same
ear although this time the attack was not as severe as previously. The
doctor prescribed Zovirax which I responded to very quickly but once
again I found if I stopped the drug the shingles returned. After about 6
weeks however I was temporarily able to stop the drug. It was not long
however before I developed another viral respiratory illness which was
very persistent although it did respond to
astragalus (huang qi). The
damage was done however and the shingles returned forcing me to
take the Zovirax again.
A new problem emerged however, increasing intolerance of
shingles drugs. Although the drugs often made me feel sick the
biggest problem and a problem which became worse the longer I took the
drugs, was severe heart palpitations. I could not tolerate this. I also
found that Zovirax seemed to depress my immunity and make me susceptible
to constant colds and viral infections. For months after commencing
Zovirax I experienced constant colds, chills, and viral infections and
the only way I could control these constant infections was to take
astragalus. I could not stop astaragalus for more than one day without a
return of these infections and this continued until 3 weeks after I
ceased taking Zovirax.
I searched the
internet for natural remedies for herpes or shingles and I tried many
without success. Astragalus, although extremely effective for many
viruses was no help for the shingles. Other well known treatments such as Lysine, Olive
Leaf, Red Marine Algae, Lactoferrin, Echinacea, vitamin C, and other
immune tonics, were all useless. The only herb which seemed to help was
Camu Camu but I cannot be definite about this because the shingles may
have been weakening when I took it. However, after taking 2.5g of
Camu Camu for a short period the shingles has not returned
My message from this experience is twofold. Firstly I
plead with doctors not to be so closed minded and to use more common
sense and compassion in their diagnoses. Just because they did not read
about it in a book does not mean it does not exist. How many times must
this same lesson be learned by doctors? Medical science is always
learning so why pretend otherwise? How can anyone learn with such a
closed mind? The tragedy here is that shingles often causes chronic pain
after the infection has gone and this leads closed minded doctors to
suggest a reactivation of shingles must be nothing more than chronic
shingles pain. Additionally, most doctors will not prescribe antiviral
drugs for shingles if the symptoms have been present more than 48-72
hours, falsely believing that such drugs are ineffective beyond this
time. This is a statistical decision, but when an attack continues for 4
months such statistics merely sentence a patient to continued suffering. Incidentally, apart from CFS, doctors have so far found
no diagnosable reason for my poor immunity. I do not have AIDS or any
other detectable immune disease.
Secondly, I merely wish to pass on my experience with
various shingles treatments in the hope it may benefit others. I would be
interested in hearing of others who have shared my experience.
Recently, in an
absolutely shameful demonstration of the ineffectiveness of normal
public health watchdogs and the reliability of self testing by drug
companies, two New Zealand schoolgirls discovered the inaccurate claims made
by the drug company Glaxo Smith Kline (GSK) regarding the vitamin C
content of their fruit drink, Ribena (1,2,3,4,5).
That the scientific testing carried out
by school students has been shown in this instance to be more accurate
and reliable than the combined resources of public health authorities,
consumer organisations and one of the largest drug companies in the
world, is absolutely disgraceful and cause for alarm. Most people would
assume that scientific testing by drug companies and public health
authorities would be more accurate and reliable than testing carried out
in school laboratories but this is apparently not necessarily the case. In the words
of Burke regarding the misleading claims made by GSK (6);
"After 55 years of telling porkies, Ribena has finally sent
itself to the naughty corner."
As a result of the school science experiments in New
Zealand and the resultant impending legal action against GSK in that
country (1,2,3,4,5,6),
GSK assured Australian authorities it would also change product
advertising in Australia so as not to mislead consumers with false or
misleading advertisements (
6,7,8,9).
Apparently the impending legal action in New Zealand prompted GSK
to approach the Australian Competition
and Consumer Commission (ACCC) (6,9)
who subsequently emphasised that since GSK had "self-reported
the discrepancies" (9), the ACCC considered further legal action
unnecessary, even in spite of actions occurring in New Zealand. Would
GSK have taken this action if they were unsure of a favourable response
from the ACCC?
Subsequent to events in New Zealand, GSK Australia issued
this statement (10);
"On the nutritional information panels on some Ribena Ready to Drink
products, Ribena claimed an amount of Vitamin C that could not be
substantiated by acceptable testing methods. As a result, Ribena Ready
to Drink products no longer make any claims regarding the Vitamin C
content and any claim made in the future about the Vitamin C content
will be substantiated by validated testing methods."
Mr Graeme Samuel, Chairman of the ACCC,
justified the refusal of the ACCC to take legal action in this case of
misleading advertising by a major drug company by stating (9);
"where a company cooperates
with the ACCC, this is taken into account when determining what further
action is appropriate." So in
Australia it seems, false advertising for a few years by large
drug companies may not be considered sufficiently important to warrant legal
action
as long as 'mistakes' are eventually "self-reported" to the ACCC.
This situation needs urgent clarification. Is there any duty to
abide by current advertising laws or has the act been structured in such
a way as to minimise mandatory duties and maximise the
discretionary powers of the ACCC?
In this instance
we have two New Zealand students to thank for apparently testing this
product more accurately than could be achieved by the combined resources
of public health authorities, consumer organisations and one of the
largest drug companies in the world. In fact, thanks to these students
GSK has promised to develop new testing methods for vitamin C (11);
"Since the NZCC
brought its concerns to our attention, GSK has already:
Revised all advertising to ensure there were no claims in regard to
Vitamin C that could potentially be misleading to consumers
Modified Ribena labels on the RTD products so that the labels made no
reference to Vitamin C
Implemented a plan to reformulate RTD Ribena products with new
methods for testing Vitamin C
GSK Consumer Healthcare in both New Zealand and Australia sincerely
regret any confusion caused to customers in relation to these Ribena
products.
Perhaps if GSK
were to ask the two New Zealand schoolgirls for advice on accurate tests
we may not see a repeat of this problem.
References
1.
Ribena Vitamin C claims false and misleading, Media Release,
Release no. 112, Issued 27 March 2007, NZ Commerce Commission.
2. Jeevan Vasagar,
Schoolgirls rumble Ribena vitamin claims, The
Guardian, Tuesday
March 27, 2007.
3. Carolyn Churchill,
School science test exposes false Ribena vitamin C claims,
UK Herald,
27
March 2007.
4. Schoolgirls find there's no C in Ribena, Sydney
Morning Herald,
27
March 2007.
5. NZ vitamin C row hits Ribena firm, BBC News,
27
March 2007.
6. Kelly Burke, Ribena to withdraw vitamin C claims,
Sydney Morning Herald,
22
March 2007.
7. Valarie Tan, AVA confirms Ribena drinks sold here are "rich in
Vitamin C", Channel NewsAsia, 29
March 2007.
8. Australian watchdog squashes Ribena health claims ,
Yahoo News,
21
March 2007.
9. Ribena Vitamin C claims 'may have misled consumers',
Media Release 075/07,
Australian Competition and Consumer Commission, 21st
March 2007 .
10. A correction from Ribena, Glaxo Smith Kline,
Australia.
11. GSK Consumer Healthcare statement on Ribena, Glaxo
Smith Kline, Australia, 28th March 2007.
Adverse Drug Reactions Hotline
to Close as Government Withdraws Funding from Hotline to Spend More
Money Controlling Alternative Medicines.
It seems there is no rush of funding support for
Australia's Adverse Medicine Events Line which played such a
vital part in the Stilnox story (1,2).
Apparently the TGA, the Commonwealth government, and drug companies,
just cannot find the money to support those who suffer adverse drug
reactions. In spite of alleged increasing concerns about the safety of
dietary supplements (Pan Crisis,
Therapeutic
Products Bill), the withdrawal of funds for the Adverse Medicine Events Line
by the government seems destined to force closure of a valuable public
health watchdog at a time when more and more people are suffering
adverse drug reactions. In fact, in the Daily Telegraph on the 9th July
2007 (p10), appeared 2 articles side by side indicating the current
attitude of the Australian government to public health. The first
article, entitled "Cures
Killing Hundreds - Anti-psychotics prove grim trip, described
the tragedy of government supported modern drug therapies which continue
to destroy so many lives. The second, but much smaller adjoining article
entitled "Drug Hotline Out of Funds" underlined the priorities of
the Australian government which is currently spending millions of
dollars taking control of the alternative medicine
industry.
References
1.
http://choice.com.au/viewArticle.aspx?id=105298&catId=100386&tid=100008&p=1&title=Consumer
Consumer reporting of adverse drug reactions, Choice Magazine
Online, Australian Consumers Association, 6th June 2006.
2.
http://www.news.com.au/couriermail/story/0,23739,21757617-953,00.html
Janelle Miles, Drug hotline may close, Courier Mail, 19th
May 2007.
In his book Happy Accidents: Serendipity in Modern Medical
Breakthroughs (1,2),
Dr. Morton Meyers, Emeritus Professor of Radiology and Medicine,
demonstrates that many medical discoveries have resulted from just plain
old fashioned good luck or what he terms "serendipity". According to
Meyers (1),
"Many of the pivotal discoveries of the past century, which have
saved or enhanced innumerable lives, came about as a result of
happenstance. Scientists with open, creative minds stumbled across
surprising results, and found what they were not looking for."
As is pointed out by Meyers (1),
in stark contrast with the results of good luck in medical research, the
results which have been achieved by deliberated directed research are
very poor: "One approach to medical discovery is the centralized
management of directed research. The experience of more than 3 decades
with a War on Cancer directed and funded by the federal government has
shown the futility of this approach. The better approach is based on
independent, creative, curiosity-driven research that liberates
serendipity. It is this approach that has brought us the bountiful
results mentioned previously. We need to be sound in our judgment of the
allocation of funding and resources.Fostering an openness to serendipity
has the potential to accelerate medical discovery as never before."
Meyers recommends individuality, open-mindedness,
and freedom from bias in medical research and training (1):
"students, particularly in science and medicine, must be taught about
the role of serendipity and be prepared to recognize and exploit
departures from expected results. Indeed, chance does favor the prepared
mind...........The process of peer review should be modified to reduce
the inherent bias toward prevailing concepts and to welcome mavericks
and outsiders."
References
1.
http://www.medscape.com/viewarticle/555061?src=mp Morton A. Meyers,
Eureka! When Scientists Find What They're Not Looking For,
Medscape, 05/07/2007; see Happy Accidents:
Serendipity in Modern Medical Breakthroughs, Morton A. Meyers,
Arcade Publishing; 1 edition (March 9, 2007).
According to latest research the amount of fat in the diet has no
effect on obesity. In fact, reducing dietary fat may even aggravate the
obesity problem. In the U.S., two decades of significant reduction in
dietary fat consumption has corresponded with "massive"
increases in obesity. Willett, W.C., Obesity
Reviews, 3, 59, 2002.
It has long been known that the side effects of new drugs are only
revealed by long term use by the general community. Short term clinical
trials involving a few chosen participants do not necessarily reflect the
long term effects in the wider community. The real clinical trials do not
begin until new drugs are marketed in the general community, although
patients may not be aware of this. Temple, R.J., Himmel, M.H., JAMA
(editorial),
Vol. 287, 1st May, 2002.
See also Lasser, K.E. et al, JAMA,
2002;287:2215-2220.
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