| |
Since completing my article on dietary
supplements there has been a major crisis in the world of alternative medicine in
Australia due to the recalling of more than 1500 different products from the shelves of health food stores, pharmacies, and supermarkets
(1,2,3,4,5). These products
were predominantly alternative medicines and over the counter drugs produced by the Sydney company Pan Pharmaceuticals which exports to more than 40 countries
(6).
The magnitude of this disaster and the tendency of some to see it as an
opportunity to condemn the alternative medicine industry underlines the
importance of a factual unbiased analysis of the entire incident. This is
the purpose of this article.
The following account of this crisis is divided into five sections. In the first section I chronicle the events which led
up to the current situation and the nature of the resultant recall. The second section will consider much of the "hype" which has surrounded this issue and the
ways in which it has been handled by the media and health authorities. For
balance, the third section will briefly detail some examples of the
dangers of prescription drugs. The fourth section will consider the
implications of the Pan crisis for the future of alternative medicine. In the final section I will summarise the data and
make some concluding remarks.
Visitors to this web site are reminded that this site is primarily
intended to represent the interests of patients and consumers of
pharmaceuticals and alternative therapies. Both the medical profession and
the pharmaceutical industry are well represented by many capable, and
frequently very outspoken, spokespersons. The alternative medicine
industry is also represented by many capable, although perhaps less
outspoken, representatives.
I am concerned that comprehensive changes are occurring to our health
care system with little or no consumer involvement (see Alternative
to Mainstream?). Extremely disturbing changes to the alternative
medicine industry are now taking place on a global scale (see TGA
and the Pan Crisis, The Codex and the Pan Crisis). Many in orthodox medicine would like to see holistic
medicine replaced by a reductionist
medicalised form of alternative medicine where herbs are purified to form
concentrated drugs and treatments focus upon suppression of symptoms (see Symptom
Suppression) as is the current practice in orthodox medicine (see Orthodox
Medicine). While a minority of those within alternative medicine may
support these types of changes, and the abandonment of the holistic roots
of alternative medicine, the popularity of such changes amongst consumers
has not been established.
These changes, and their ultimate goal, are occurring with no official
notification to consumers. Consumers by and large, have not been invited
to participate in this process or even made aware of what the ultimate
goals are. I believe the cards should be placed squarely on the table, the
whole process formalised, and consumer involvement invited. Not to do so
is to promote values which are the very antithesis of democracy. From my
view, what is required is a form of integrated medicine (see Integrated
Medicine) where both holistic medicine and orthodox medicine continue
to be utilised independently so that the strengths of both are preserved and
any takeover is prevented.
In January 2003 the Therapeutic Goods Administration (TGA) of Australia recalled the travel sickness product Travacalm, manufactured by Pan Pharmaceuticals
(7,8,9). Travacalm
was reported to have resulted in almost 100 people being seriously affected, including 19 who required hospitalisation
(1,2,3,4,5). Many of these victims reported very disturbing symptoms including, agitation, dizziness, confusion, delirium, hallucinations, and an inability to speak or
walk (1,2,3,4,5). Pan Pharmaceuticals produced three separate Travacalm products, each with a different formulation. Only one of these,
Travacalm Natural (10), which merely contained 500mg of the herb ginger, could be described as an alternative medicine product. The other two products, Travacalm Original and
Travacalm H.O., contained over the counter drugs and therefore could not be considered as natural or alternative products. Travacalm Original contained dimenhydrinate (an antihistamine),
hyoscine hydrobromide (an anticholinergic drug) and caffeine while Travacalm H.O. only contained
hyoscine hvdrobromide (10),
It must be emphasised that the products which caused the adverse reactions were Travacalm Original and Travacalm
H.O. and it was these products which were initially recalled (7,8,9,11). The ginger containing product, Travacalm Natural, was not observed to cause ill effects and was not
initially withdrawn (7,8,9,11).
When subsequent investigations were carried out it was found by the TGA that the affected
Travacalm products contained inconsistent levels of the active ingredients, some tablets containing
up to seven times more than those specified (4,12). The symptoms caused by
Travacalm products were symptoms which would normally be associated with an overdose of
the drug (13), particularly the ingredient hyoscine hydrobromide
(14). Interestingly, some consumers had used the drug for years with no problems
and yet just one tablet from a new packet caused severe consequences (12,15).
The Travacalm incident passed quietly with little publicity and few repercussions. It
was after all, just another drug which had produced severe ill effects. Three months later however, on the 29th of April, the TGA suddenly initiated the largest recall of therapeutic products in Australian history
(1,2,3,4,5,9,31,32). The 219 products initially recalled rapidly increased to
more than 1500. This time the recalled products were primarily dietary supplements although some over the counter drugs were also affected. Unlike in the case of Travacalm, in this instance the products were NOT withdrawn
because they had caused adverse reactions (3,31,32) but rather because
inspections of the company had led to concerns that some products may be of inconsistent
quality(31,32). According to the TGA there were nine major problem areas including fabrication of test results, data manipulation, substitution of substances, unsatisfactory cleaning and quality control, insufficient testing of raw ingredients and other manufacturing problems
(5,17). According to Dr McEwen of the TGA
(1,2,5) "our
great worry is that a product may not be true to label."
What is absolutely astonishing is that the TGA claimed that Pan Pharmaceuticals was endangering the lives of consumers
(2)
and therefore all "consumers should avoid taking herbal and
vitamin preparations and complementary medicines" (2,5). This same type of
warning did not occur three months earlier when the drug Travacalm put 19 people into hospital. When Pan Pharmaceuticals products were known to be dangerous and of inconsistent quality no such warnings or general recalls were issued. The comparison between these two recalls is of fundamental importance. The Travacalm drug recall in January was a Class 1 recall
(8) meaning that there was a risk of serious or fatal reactions. In stark contrast, the general recall of complementary medicines in April did
not even rate a Class 3 recall (8,31,32) but yet this recall, unlike the first,
was accompanied by a media frenzy driven by TGA warnings that all
complementary medicines should be avoided.
The apparently fraudulent and shoddy practices used by Pan Pharmaceuticals should never be tolerated
and should attract extremely, severe penalties. Having said this however, it is essential to have complete consistency and freedom from bias. The actions of health authorities such as the TGA should never be seen to favour drugs as compared to dietary supplements.
Bearing these facts in mind there are serious questions which need answering regarding the
actions of the TGA. Why for instance did the TGA wait for 3 months after the Travacalm incident before recalling other Pan products (16,18)? When Travacalm
was found to be dangerous
why were no other drugs withdrawn and no general warnings or recalls issued regarding other Pan products? Why on the other hand were such extreme warnings issued 3
months after the dangerous products had been recalled when some dietary supplements were found to be of inconsistent quality even though no adverse reactions had been reported
(3)? Why were no such warnings issued when Travacalm was classified as a Class 1 health risk, a classification which is reserved for the most dangerous and potentially lethal products
(8,12)? Why
was there so little publicity for the initial Class 1 recall and yet so much media exposure and panic during the later recall when there was no Class 1 health risk?
The point cannot be overemphasised that the dietary supplements which were
withdrawn were not classified as a Class 1 health risk. These products were withdrawn
because they may not have been "true to label" (2,5) even though the Health
Minister indicated that (19) "there may be nothing wrong with many of the health supplements withdrawn from
sale." These products had been in use for 9 months with no reported
adverse reactions ( 20).
For more than 200 years mainstream medicine has felt the need to run alternative practitioners out of
town. They have sought to humiliate them, outlaw them, imprison them, and deny them publication and research
funds (see Alternative
to Mainstream?, Medical Bias, Genetic
Nutrition). These methods
have been considered necessary to enable medicine to survive and to protect it from the popularity of alternative medicine. While medicine feels sufficiently insecure so as to abandon science and reason in favour of these types of campaigns of persecution, then health care has a dismal future. Let us see if medicine has learned from the past and has adopted a more scientific patient oriented approach.
In spite of the terrible intolerance of the past, it seems little has changed. It is most disturbing to witness the way various health authorities and media outlets have treated the current pharmaceutical crisis. While largely ignoring the Class 1 health risk caused by the drug
Travacalm, there has been a media frenzy regarding the possibility that certain complementary medicines may not be "true to label." It is absolutely astonishing that some people have used this as an opportunity to bash alternative medicine. Martyn Goddard of the Australian Consumers Association even went so far as to suggest it was an example of
"quackery" and "snake oil salesman" (3,21,24): "we have more
quackery and more snake oil salesman now than we did in the 19th century,
and consumers are being conned into paying through the nose for this stuff." Goddard claimed that "consumers should be asking
themselves whether they needed complementary medicine at all." Goddard also referred to the
alternative medicine industry as a (25) "smoke and mirrors
industry."
Dr Robyn Napier of the Australian Medical Association also expressed her concern that
(22)
"the recall of Pan products demonstrates that labelling for
complementary medicines cannot necessarily be trusted" and the "regulation
of complementary supplements is nowhere near as thorough as for
prescription medicines." Perhaps this is why orthodox medicine is only responsible for around 10,000 deaths annually in Australia
alone (see Holistic
Medicine Sets the Standard for Safety).
While the concerns expressed by Goddard and Napier are indeed commendable they are
somewhat late as far as the victims of Travacalm are concerned. They are also rather misplaced.
Both Goddard and Napier seem to confine their concerns to "complementary
medicines" even though the only products to cause adverse reactions in
the current crisis were drugs, not complementary medicines. Notably, they
fail to express concern about over the counter or prescription drugs. In fact, of the three Travacalm products the only one
which did not cause adverse reactions was a complementary medicine containing ginger
(7,8,11). This fact has not been widely publicised either by the media or health authorities. It is another clear example of the safety of alternative medicines. In this instance, although a manufacturer failed to adhere to ingredient specifications and quality standards, the resultant adverse reactions were confined to the company's drug products while complementary medicines produced
under the same conditions produced no adverse reactions. So often we find that the concern expressed by certain authorities
is not consistent with the scientific facts but is confined to the quality of complementary medicines
while little or no concern is expressed about drugs which cause infinitely more suffering (and death).
The snake oil theme was continued by Professor MacLennan (69)
who claimed that the Pan affair had exposed the "nakedness" of
alternative medicine and "opened its merits up for scrutiny".
According to the Professor(69):
"It has given an opportunity for people to say - we're not really
having to debate how much snake is in the snake oil, or whether there is
goanna contaminating the snake oil. We are really having to debate -
should you be on snake oil at all, and is this snake oil doing you any
good, or, more of a worry, is this snake oil doing you harm?"
In an article in the Australian newspaper entitled (23) "Alternative medicines industry out of
control" Clara Pirani claimed that the Pan crisis "shows the nation's
alternative healthcare market is woefully under regulated, and raises serious questions about
the TGA's powers to police the $2.3 billion industry." Pirani continues:
"complementary and alternative medicines should be subject to the same testing as prescription drugs. In fact, CAMS should
arguably undergo even more rigorous testing than drugs consumers can only obtain on
prescription." These same concerns, as is the case with Goddard and Napier, were not expressed when consumers were poisoned
with drugs such as the Travacalm products.
Somehow it seems, if someone is poisoned by a DRUG, it must be the fault of alternative medicine. Apparently drugs are poisoning people because alternative medicines are not tested or
labelled correctly. Those who expressed these public health concerns should have expressed proportionately greater concerns 3 months earlier when people were being poisoned by the Travacalm drugs. The casual nature of the industry's response (and the media's) to the Travacalm poisonings is highlighted by the fact that this drug was still available for sale in March even though it was recalled in January (12). In stark contrast, more than
1500 complementary medicines which had not been reported to have made anyone ill, were withdrawn from shelves in days. Unlike the procedure which apparently is normally followed in regard to drugs, when it was found that certain complementary medicines
were not "true to label", the media was informed by the TGA before any official notification to
industry (26).
Another interesting article was entitled (27) "Natural Disasters" and
subtitled
"alternative medicines have become our latest religion, but should we put our faith in untested
panaceas?"' In this article Professor MaClennan, who is interested in
"evidence based medicine", claims that
"in virtually all cases alternative products have not been shown to be any better than a
placebo or dummy tablet, and in cases where they have been trialed they
have been shown not to work." In the same article however, Dr Ramesh
Manocha, a clinical researcher at the Sydney Royal Hospital for
Women, claims that alternative medicine "was a fringe area and wasn't
respected by mainstream society until halfway into the 80's, when the
scientific evidence started coming out." As is clearly acknowledged by
Manocha, there is rapidly increasing scientific evidence in support of nutrition and alternative therapies (see
Nutrition and Megavitamins, B
vitamins), a fact which should be of interest to anyone concerned with
"evidence based medicine."
The fact that alternative medicine is backed up by considerable scientific evidence has also been confirmed by Professor Cohen who states
(34)
"there is overwhelming evidence of the benefits of complementary
medicine here and overseas." This has recently been confirmed again by Dr Brighthope who notes that (44)
"there is a wealth of scientific evidence to support the use of
natural health products." Brighthope goes on to cite various scientific studies
which confirm the effectiveness of alternative medicines. Brighthope comments that although the current Pan crisis was caused by a drug and not an alternative medicine, it nevertheless has
"flushed out the detractors of natural medicine who have hijacked
the situation to criticise the efficacy of complementary medicine."
In spite of MaClennan's concerns about lack of scientific evidence, according to Robotham
(28):
"but despite such tough talk, the orthodox
medical community has actually been softening its stance towards alternative medicine.
In interviews with 80 doctors, Heather Eastwood, a social science lecturer at the
University of Queensland's School of Population Health, found GP's
were attracted to offering complementary therapies because they resented their role as prescription writers
and Medicare gatekeepers. 'They became disenchanted with their
biomedical training.....they want to get back to their role of
being a healer', she said. The AMA last year issued a broadly
supportive position paper on complimentary
therapies. Pointing to research
findings that four out of five GPs refer patients for an
alternative therapy at least occasionally, and that one in five practises
one or more techniques, it said the most important thing was to
make sure such therapies were being offered responsibly and with the knowledge of the GP (MaClennan's study found
more than half would not reveal this to their doctor). 'The AMA
acknowledges the growing use of complementary medicines and therapies by the Australian population. It recognises
that evidence based aspects of complementary medicine are part of the repertoire of
patient care and may have a role in mainstream medical practice', the statement
said." |
Unlike the TGA, which describes complementary medicines as "low risk" (33), Professor MaClennan also expresses concern that alternative medicines are dangerous (28) even though he expresses no concern whatsoever about the current epidemic of iatrogenic diseases and the fact that such diseases are responsible for more than 10,000 deaths annually in Australia alone ( see
Holistic Medicine Sets the
Standard for Safety). He emphasises that the Australian public are
"gullible" (27) and they "love to self medicate" (27,28). In regard to alternative medicine MaClennan concludes (27):
"its quite a religion. When I suggest that alternative medicines
should be subject to the same rules as any medicine, I offend many peoples religion,
but particularly those who are making a commercial killing from that
religion."
While the TGA (33) and others (see Holistic
Medicine Sets the Standard for Safety, Dietary
Supplements) may be well aware of the enviable safety record of
alternative medicines, especially when compared to what mainstream
medicine and the pharmaceutical industry have to offer, the accuracy of
the following editorial in the Australian newspaper is cause for alarm
(16): "sure, there is irony in the fact that consumers have
been drawn to 'alternative' medicines by fear that 'conventional'
medicines are bad for you, only to end up taking what are potentially much
more potent and harmful drugs." Precisely which alternative
"drugs" are more potent and harmful than say steroids or NSAID's
is not mentioned in the editorial.
As if all this is not bad enough, according to Professor Simon Chapman of Sydney University (28), when it comes to alternative medicines,
"there is an awful lot of expensive urine being flushed down
Australian toilets." Similarly, Professor John Dwyer (30) expressed his concern about expensive although usually "harmless" alternative medicines which were
"destined to go straight down the consumer's toilet." Although Dwyer correctly points out that the Pan Pharmaceuticals crisis (30)
"stems from quality control issues, not the therapeutic claims
made for its products by the company or its contractors", he then makes the following astonishing claim:
"nonetheless, the toxicity associated with the consumption of one of its products brings into focus
the need to pay more attention to the risk-versus-benefit ratio associated with
consuming 'complementary' medicines." Here again we have an
example of the strange reasoning that if a drug can be shown to be
toxic then there are general implications for "complementary" medicines. Professor Dwyer, like many others, fails to point out that the only products
which have been shown to be toxic during the current crisis are drugs, not
complementary medicines.
Even the Australian Skeptics have got in on the act claiming the
Travacalm incident (64)
"has served to educate those who have been tricked into
believing that 'natural' equals 'harmless'." It seems
that the Skeptics believe, since Travacalm was a drug,
drugs-equals-natural-equals-harmless, although they fail to supply any
scientific evidence for this claim. I would be somewhat sceptical about
such a claim.
Confusion about the difference between complementary medicines and over the counter drugs also extends to the
Pharmaceutical Society of Australia (PSA). According to Geraldine Moses of the PSA
(53) "Travacalm is the kind of synthetic-looking medicine which people are used to attributing unusual symptoms to potential adverse drug
reactions." Moses continues: "the drug was withdrawn from the
Australian market in January 2003, but if it weren't for the Travacalm reactions, it would have taken much longer to discover Pan's infidelity to the Code of Good Manufacturing Practice, because people generally do not report adverse reactions to complementary
medicines." Although Moses refers to Travacalm as a "synthetic looking
medication" and a "drug", she nevertheless claims that the adverse reactions caused by this product
have emphasised the need for more stringent regulations of complementary medicines. As far as people not reporting adverse reactions is concerned,
this is clearly a consequence of the severity of the reactions. She fails to mention that in the case of prescription drugs patients frequently do not need to report adverse effects because they are
automatically recorded when the ambulance delivers the victim to hospital.
In spite of the concerns expressed by the PSA, according to Professor Dwyer the attitude of some pharmacists is aggravating the problem (30):
"for economic reasons too many pharmacists are willing to turn their back on their scientific training to obtain the dollars available from unsuspecting consumers buying expensive products pharmacists know to be
useless." The fact that many doctors also use these "useless" products is not mentioned by Dwyer.
Professor Dwyer goes on to suggest that herbal medicines should be (30)
"supplied in a standardised
format to provide maximum benefit." Interestingly however, Professor Dwyer fails to mention the fact that scientific evidence has recently demonstrated the dangerous effects of
standardisation of the herb Kava Kava (see
Nutrition and Megavitamins). Standardised forms of Kava Kava were reported to be liver toxic whereas even the TGA acknowledges the fact that natural forms of Kava have not been associated with liver disease (see
Nutrition and Megavitamins), a fact which
has recently been confirmed again (65). Concerns about toxicity should be consistent
with evidence of known risk and should not be confined to the least toxic (alternative) products.
Even though the evidence indicates that the process of standardisation has
made Kava more toxic, it nevertheless is probably far safer, as is noted
by Naiman (54),
than virtually any prescription drug on the market: "if kava kava
can be yanked from the market because someone complained of liver
problems, then there is hardly a single pharmaceutical drug on the market
that could pass the standard being held as appropriate for kava kava."
When it comes to liver disease the official drug industry and
regulatory attitude to the rheumatoid arthritis drug leflunomide is
much more casual than their attitude to Kava, even after 8 deaths and 54
cases of liver failure which have been attributed to it (67).
According to the manufacturers of Arava (67):
"Causality is not easy to determine," said Dr. Francois Nader
of Aventis Pharmaceuticals, Arava's maker. Meanwhile, "the physicians
need choices, and the patients need choices." Rather than
withdraw Arava from the market its continued use has been endorsed by the
FDA.
The medical profession is clearly in complete disarray. Although some medical experts claim that there is no scientific evidence to substantiate the use of alternative medicines and all such products achieve is to create "expensive urine", other experts claim that the scientific evidence has been accumulating for decades. So much so that such therapies have even received support from the AMA. Even the TGA, which has noted that complementary medicines are
(33)
"developed with an emphasis on health and wellness rather than
disease", emphasises the fact that such medicines are used just as much by
doctors themselves as they are by the wider community. Although there
is no reason to think that doctors who use alternative therapies are not
making an informed choice, according to NSW Premier, Mr Bob Carr (29),
consumers are being "exploited" by the Alternative medicine industry. Mr Carr,
who seems to disagree with the stance of the AMA, the TGA, and other medical experts, claims that alternative medicines are (29)
"not much more advanced than the medicine men hucksters of the
19th century."
Mr Carr further claimed (70):
"This scandal ought to be an opportunity to assess some of the
exploitation of gullible people that takes place under the guise of
alternative therapy and complementary medicine. Some of them may work, but
there's not much scientific basis for popping pills that change the colour
of your urine but do no demonstrable good."
So what is going on? Is the AMA simply comprised of "medicine men hucksters"
"gullible people", and "snake oil salesman" whose ambition is to create "expensive urine"? Are they simply imagining the last few decades of scientific evidence as some other experts seem to believe? Or, on the other hand, are these critics of alternative medicine genuinely unaware of the available scientific evidence? Or do they, for some reason, prefer to conceal this evidence and pretend it does not exist? Do such critics prefer to keep complementary medicines to themselves, fearing that if patients are permitted unlimited access to such products they may become well or fail to become ill?
Another anomaly with regard to critics of alternative medicine is their often expressed concerns that many patients do not inform their doctors which alternative medicines they are taking,
estimates claiming that 50%-66% of patients would refuse to reveal this
information (28,52). Are they serious? For more than 200 years doctors have been trying to persecute and ridicule alternative practitioners, calling them "quacks" and "snake oil salesman", and have even attempted to have them arrested.
Some authorities even today still maintain this
type of attitude, claiming that alternative medicines are useless. MaClennan claims that "alternative products have not been shown to be any better than a placebo or dummy
tablet" (27). MaClennan apparently believes that people who use alternative therapies are (27) "gullible" people who "love to self medicate" (27).
To "medicate" of course, one must use a medicine, not
just a dummy tablet.
It must be admitted that doctors have created an environment wherein open
communication with patients about alternative medicines is most unlikely. Doctors who have traditionally rejected alternative medicines as useless now wonder
why patients do not tell their doctors which useless medicines they are taking.
Although hopefully only representative of a minority of medical
practitioners, according to the attitude displayed by some experts during the current crisis,
it seems there may be some doctors who might say to any patient who
utilises alternative medicines: 'you are a gullible person who loves to self medicate with
dummy tablets which do nothing more than create expensive urine. But why
won't you tell me which products you are taking?'
Many doctors have traditionally failed to display interest, knowledge, or respect for patients, when it comes to alternative
therapies. Patients who simply wish to take a few vitamins have in the
past been
criticised by doctors on the basis of the uselessness of these products. It is absolutely astonishing just how out of touch some doctors are. Where is the science in all of this? Why
do scientifically trained people feel the need to behave in this way?
While I am personally aware of doctors who adopt a very positive
supportive attitude when it comes to alternative medicines, I also know of
others whose attitude is overwhelmingly negative. They tend to scoff at
the slightest mention of such products. Still others claim that 'alternative
medicines definitely will not help you but if you believe they will help
then you may take them'. Patients who experience such attitudes soon
learn it does not pay to mention alternative medicines, a decision which
not surprisingly, has been made by the majority of patients.
For all the mystery surrounding this issue the answer is simple indeed.
I would suspect that doctors who have a positive attitude to alternative
medicines would have very little trouble in this area, most patients
readily revealing which supplements they are taking. If this is so, which
can be easily ascertained, then the solution is simply to correct the
attitudinal problems within medicine. It is always best to address the
underlying cause rather than simply conceal the symptoms.
Since various authorities have sought to question the safety of alternative medicines as a result of the Pan crisis, forgetting of course to mention the dangers of prescription drugs, I will now seek to address this bias by a brief description of the toxicity of prescription drugs.
The same day the TGA was busy recalling alternative medicines which had harmed no one, the ABC, on its Four Corners programme, was screening a show about the dangers of the antidepressant Seroxat, otherwise
known as Aropax or Paxil (35,36,37,38). One of the world's top selling antidepressants, Aropax has been reported to cause aggressiveness, hostility, violence, and suicidal behaviour, one patient reported by the programme having killed his wife, his daughter, and his
granddaughter after taking two tablets of Paxil (35,36,37,38). This is in spite of the fact that he had no history of violence or aggressive behaviour prior to taking Paxil. A subsequent court case which
was won by the family of the victim revealed that the manufacturer of the drug had concealed evidence of the dangers of Aropax for 15 years. The information was kept under lock and key. Astonishingly, although a doctor was permitted access to the information as a result of a court order, he was prevented from discussing or publicising the notes
he had taken.
This drug, which was not withdrawn by the TGA, attracted no official public warnings in Australia as the products of Pan Pharmaceuticals did.
Last year, my father, who is a patient in a nursing home, suddenly experienced a dramatic deterioration in his condition. When I queried nursing staff about this sudden change I was told that the only thing wrong with him was his "age".
I knew he had just commenced a new tablet, a
Non Steroidal Anti-inflammatory (NSAID), and it seemed like he was having a severe drug reaction. I immediately contacted the doctor who promptly
discontinued the drug. The problem was subsequently diagnosed as drug induced kidney failure. This was further confirmed by a kidney specialist who stated that the drug had caused
complete kidney "shutdown", a relatively common effect of this type of drug in the elderly. Although his kidneys recovered, he has never been the same since this occurred. Statistically, it is as
though this entire event did not occur.
This family of drugs, the NSAIDs, have a very bad reputation. NSAID's cause gastrointestinal ulcers to such a degree
that more than 100,000 people require hospitalisation in the U.S. alone
every year (39,40). Of these from 10,000-20,000 will die
(39,40). Kidney failure is also another hazard with these drugs
(43). Although it was first claimed that the
newer drugs Celebrex and Vioxx would be free of these problems, these drugs are now also known to cause kidney failure
(41,42).
In spite of the considerable safety problems with the NSAIDs they have not been withdrawn and the TGA has not even issued a safety warning or a media alert.
My father's abovementioned drug reaction provides an excellent insight
into the attitude of the medical profession to drug reactions, as distinct
from reactions to alternative medicines. While there are so many doctors
who express public concern about reactions to alternative medicines which
are not severe enough to require hospitalisation, doctors on the other
hand, who express equal public concern about life threatening drug
reactions are rather thin on the ground. This is odd since the degree of
compassion and concern should be proportional to the severity of the
suffering and the seriousness of the reaction.
Reporting of significant adverse prescription drug reactions should be compulsory
and failure to do so should incur very heavy penalties. Unless this is
done, the full magnitude of this problem will remain unknown.
When it comes to adverse drug reactions Eve Hillary has recently drawn
attention to the pro drug bias of government regulators (see TGA
& the Pan Crisis): "Even
more incredibly, no large multi-national company has ever been shut down
by a government regulator after one of its products has been recalled,
even if deaths have occurred as a result of using the drug or chemical."
Hillary also cites the most disturbing story of the drug bupropion (Zyban)
which the TGA approved for sale in Australia after it had
apparently caused 245 deaths overseas
(see TGA & the Pan Crisis).
In an attempt to explain the prevalence of adverse reactions in modern
medicine, Hassed has recently posed the following questions (62):
- "Has medicine become overly sophisticated and
interventionist?
- Is it understandable that increasing numbers of
people look outside the medical system for health care?
- Should the potential for human error be taken
more into account when framing medical protocols and systems?
- Do we pathologise and treat too many conditions
unnecessarily?
- Have we done enough cost-benefit analysis to see
whether the net effect of many interventions warrants their use?
- Do we always prescribe with clear indications in
mind rather than to suit patient expectations or feel like we are
doing something?
- Do we need to be more aware of safe and
efficacious alternatives?"
Regardless of the huge safety problems associated with prescription drugs ( see
Holistic Medicine Sets the Standard for
Safety, Dietary Supplements, Science or
Progress?, Asthma) and the continuing prevalence of anti-nutrition bias (see
Medical Bias), these problems are apparently generally considered quite acceptable to modern science. This it seems is due to the risk/benefit of these products. Strangely, if toxic drug reactions are due to problems in manufacturing or quality control rather than the inherent toxicity of the drug then this is not the case.
This safety bias has been dramatically exposed yet again during the current Pan crisis. Early in the crisis,
before the full list of affected products had been discovered, sources within the medical and pharmaceutical industries stated confidently that consumers should have absolutely no doubt about the quality of prescription medicines as these were not
affected (46,47,48). According to Health Minister Kay Patterson
(46):
"the recall affects only complementary preparations and not
prescription medicines recommended by your doctor. I would like to
reassure everyone that all prescription medicines, including generic
medicines, are safe and people should continue taking them."
Interestingly, Kay Patterson was blatantly wrong on two counts. Firstly
of course, especially since it was an over the counter drug which
triggered the entire crisis, the suggestion that the recall only applied
to "complementary medicines" was nonsense. She was wrong also
with respect to prescription drugs since a prescription antidepressant was
subsequently withdrawn (49,50).
There has been much hype over the Pan crisis, many untrue, misleading
or irresponsible statements having been made by people who should have
known better. Sadly, many within the medical or pharmaceutical industries seem to have regarded it as an opportunity to condemn alternative medicines and promote their own agendas. While this is disappointing, it is not surprising. There have always been those
within the mainstream medical and pharmaceutical industries who have their own
agenda.
The current crisis has underlined the importance of an effective
monitoring system to ensure drug companies adhere to acceptable quality
control and ethical standards. With all the hysteria about alternative
medicines as a result of the Pan crisis, many seem to have forgotten that
it is the effectiveness of the pharmaceutical industry's Code of Good Manufacturing
Practice which has been bought into question. Should this code be more
rigidly supervised and enforced or should it be left to industry "self
regulation"? In this connection the comments of Toohey regarding the
current crisis are of interest (51): "the need for regulatory
change is clear. The public has every right to reject the dominant
approach which encourages the TGA to let manufacturers 'self assess'
whether they meet the proper standards until the inevitable disaster
strikes." As was noted by Toohey (51) "if the TGA had an
adequate system in place to monitor quality control, such a sweeping range
of product recall notices should not have been necessary."
4. Future Shock: implications for the future of alternative medicine
Unfortunately, the plight of those who were poisoned by the Travacalm drugs has largely been forgotten because of the screams about "snake oil salesman",
"quackery", and "expensive urine". There has been a vicious attempt to hijack the debate and turn the whole matter into an alternative versus orthodox debate and promote the desires of those who seek to ban or take control of alternative
therapies (see Alternative
to Mainstream). Public health concerns are to some, unfortunately, no
more than an excuse to promote a global takeover of the alternative
medicine industry and ensure that dietary supplements become prescription
items.
The matter has been summarised by Benson and colleagues (45): "but
there can be no doubt that the alternative therapy industry has been in
the sights of regulators and the conventional medicine industry for years.
To use similar language to that used by the industry's inquisitors, it has
an element of a witch hunt about it.......the question now is whether this
is the thin end of the wedge and the ammunition the regulators need to rip
into the industry as a whole."
There is absolutely no doubt that orthodox medicine is working towards increased control over alternative therapies. In view of the fact that such a move would be decidedly unpopular
with many in the industry and also many consumers, there is only one way that such a move could ever be justified and that is to convince the public that alternative medicines are dangerous. Moves are underway in Australia and around the world to encourage consumers to report
to their doctor the slightest adverse reaction that may be associated with alternative medicines
(52,53,54,55,56,57,59,60 - see also
Dietary Supplements). As Moses has recently pointed out
(53), "the way the complementary medicine industry is regulated in Australia, it is only through such complaints or adverse reaction reports that changes in the industry are
activated." The AMA has even lobbied the Government (58)
"to provide $1 million in research funding to evaluate potential benefits and adverse effects of
complementary medicines and therapies."
If this money is intended for the alternative medicine industry so
they can conduct their own research then it is a positive step indeed.
Astonishingly, according to orthodox medicine's definition, when it
comes to alternative therapies an adverse event is an adverse event
(59,60) "whether or not it is confirmed to be related to the
therapy." It is absolutely amazing, and extremely disturbing, that such a definition could ever be regarded as being scientific. We are talking about scientists, people who always stress the importance of scientific evidence. Yet, when it
comes to alternative medicines any new symptom is an adverse effect, regardless of its cause. The standards for scientific evidence have
been clearly established - the future of science is obviously very grim indeed.
When it comes to knowledge of the adverse effects of alternative
medicines, the confession by orthodox medicine that they are totally
dependent upon voluntary anecdotal reports from patients is a clear
admission of the infrequency of any serious reactions to such products.
It is abundantly clear that orthodox medicine is clutching at every straw in an attempt to label alternative medicines as dangerous. Anything will do. Real or imaginary, it doesn't matter when it comes to scientific evidence. As if the validity of the "evidence" is not disturbing enough, perhaps even more disturbing is the reason this campaign of misinformation has been deemed necessary. Modern medical science is quite simply attempting to
mislead consumers because they realise their position is fundamentally unpopular and flagrantly undemocratic. They know they must falsely convince consumers that alternative medicines are dangerous if they are to have any hope of obtaining the legislative changes they are seeking. As was recently stated by Kerryn Phelps
(57): "we need to counter the common belief out there that anything herbal is
safe." Or, in the words of Moses (53), complementary medicines
"are presumed to pose little risk-the old 'if its natural it must be safe'
assumption....... we live in blissful ignorance that complementary medicines cause few adverse
events."
Conspicuously absent from all these alleged concerns however, is any concern at all about the much greater dangers of prescription drugs. In America 106,000 people die every year because of adverse drug reactions (see
Science or
Progress?) and adverse drug reactions outnumber herb reactions by 99 to 1 (see
Holistic Medicine Sets the Standard for
Safety). In Australia, every year 80,000 people are hospitalised because of drug reactions and iatrogenic
diseases claim more than 10,000 lives (see Holistic Medicine Sets the Standard for
Safety). As I have already indicated, the NSAID's alone cause much more suffering and fatalities than all the alternative medicines in the world combined.
With all the paranoia about the dangers of alternative medicines however, the safety of prescription drugs is not even considered worthy of mention. Sadly, if you happen to become a victim of a serious adverse drug reaction, history shows that the medical profession and the pharmaceutical industry will seek to frustrate your every attempt to obtain
not only justice or compensation, but also recognition. As has recently
been noted by AMA President Kerryn Phelps (63):
"as a community we need to put an end to the notion that
patients have the basic right to sue their doctors."
Although doctors clearly regard protection from their patients as a
priority, they do not express the same concern about the reasons why they
consider this
protection is necessary. There will likely be little or no
concern about those who suffer an adverse drug reaction or about the
implications of such reactions as far as public health is concerned. We
can see a clear example of this with the Travacalm incident. On the other hand it seems, if you
suffer a significant adverse reaction to an alternative medicine you will be welcomed - and the implications for public health will likely become headline material.
Once again the Travacalm incident reveals that alternative medicines
may be blamed for adverse reactions even if they are caused by drugs!!
This incredible double standard represents one of the most preposterous insults to the collective intelligence of the community ever imagined.
Unless claimed public health concerns can be shown to be proportional to evidence of known risk then quite clearly these 'concerns' are motivated by other factors. Regardless of the source of the data (see
Holistic Medicine Sets the Standard for
Safety, Science or
Progress?, Dietary Supplements), the incredible safety record of alternative medicines compared to prescription drugs is a simple scientific fact. Prescription drugs after all, are classified under the poisons schedule as being too dangerous to be sold over the counter. Alternative medicines on the other hand, as has been confirmed by Professor Dwyer (30), are "usually harmless". Why would anyone suggest that
an unrestricted dietary supplement is more toxic than an S4 poison?
It is abundantly clear from the above facts that any health authority who expresses concerns about the alleged dangers of alternative medicines while failing to express
proportionately greater concerns about the dangers of prescription drugs is simply not expressing an attitude which is in the best interests of public health. As I have indicated elsewhere (see
The Nature of Scientific
Evidence): "the determination with which health authorities avoid publicising the increasing incidence of iatrogenic diseases and the scientifically proven dangers of prescription drugs is a measure o f their disinterest in genuine science and public
health."
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.
One of the most disturbing aspects of this agenda is that it is not evidence based. It is an agenda which very largely will take place in the media rather than in laboratories. As can be seen from the eagerness to establish a connection between Travacalm poisonings and the need for tighter regulatory controls of alternative medicines, it has clearly been decided to throw any reasonable standards of evidence out the window. This is further confirmed by the fact that adverse reactions to alternative medicines do not have to be actually caused by the alternative medicine
(59,60),
the Travacalm incident being a clear example of this reasoning. Obviously evidence
of significant adverse reactions to alternative medicines are not only exceedingly difficult to come by (see
Dietary Supplements), but further there is little need for
evidence of such reactions in the public arena.
The subject of evidence is of vital importance since according to Kerryn Phelps
(57): "the key to acceptance of complementary medicines and therapies is having an evidence
base." Since, as I have indicated above and also elsewhere (see Medical
Evidence, The Nature of Scientific
Evidence, Dietary Supplements, Medical
Bias), medicine itself does not conform to any reasonable standards of evidence, it seems that what is required of alternative medicine has yet to be attained by orthodox medicine.
This has recently been confirmed by Hassed of the Royal Australian College of
General Practitioners ( 61)
who claims that in "both orthodox and unorthodox medicine it
would seem there is no evidence for many commonly used practices and
little evidence for others". It appears, according to Hassed ( 61 ), that
standard medical practices are "only loosely based on evidence".
Medicine obviously has enormous problems. Those at the top of the medical hierarchy are undoubtedly only too well aware that conventional medicine is rapidly becoming outdated. Unless something drastic is done quickly to enable medicine to takeover alternative therapies then very soon conventional medicine will be seen as applying
predominantly to trauma and acute care. Alternative therapies will continue to emerge as being the treatments of choice for many chronic diseases, for prevention, and for maintenance of
optimum health. This will continue to provide considerable motivation for
medical authorities to obtain more "evidence" of the health risks of alternative therapies.
Doctors it seems, will encourage patients to report any symptom that can
possibly be blamed on alternative medicine, irrespective of its actual
cause. But if patients report definite positive effects of
alternative medicines this would probably be dismissed as
"anecdotal".
As part of this scare campaign there will probably also be a
proliferation of highly publicised but poorly researched or biased
studies (see Dietary Supplements) aimed at
linking alternative medicines to adverse effects. If medicine is
successful in its bid to create widespread paranoia about alternative
medicines, then the alternative medicine industry as we currently know it
will cease to exist. It will become just another branch of medicine.
As we have been graphically reminded by Eve Hillary, the future of
the alternative medicine industry, and the freedom of consumers, are both
at considerable risk (see TGA & the Pan
Crisis).
5. Concluding Remarks
The Pan Pharmaceuticals fiasco, according to the TGA, is the result of a shameful abandonment of
quality control and the falsification of data. This is absolutely inexcusable. Pharmaceutical companies should conform to the highest quality standards and the highest ethical standards and any breaches of these standards must be severely penalised. Having said this however, safety standards and quality control standards, as distinct from efficacy standards, must be consistent and apply to all companies and all products. There
should be no bias or preferential treatment. As many experts have stated, the same safety standards should be applied to both alternative medicines as well as drugs. If it is acceptable for drugs to cause thousands of fatal reactions every year, then according to this standard,
with which of course I vehemently disagree, it should be acceptable for alternative medicines also.
Contrary to the impression created by the media hype, the Pan crisis confirms again the safety of dietary supplements and alternative medicines as compared to drugs. While alternative medicines were
withdrawn because of fears some products may not have been true to label, Travacalm drugs on the other
hand were withdrawn because there was a fear of severe or fatal reactions.
Even though Pan Pharmaceuticals were producing tablets that contained up to 7 times the normal level of active ingredients, the only products to cause ill effects were
drugs. In spite of the huge number of alternative medicines which were
withdrawn, the only products which required a Class 1 health warning were
also drugs. These facts clearly illustrate the safety of alternative medicines compared to drugs.
We should not be distracted from the real issue by those who wish to
avoid responsibility and turn the Travacalm tragedy into an alternative
medicine witch hunt. The real issue is the fact that people have been
poisoned by drugs due to the manufacturing processes (and ethical conduct)
which have been utilised in a pharmaceutical company which produced over
the counter drugs as well as prescription medicines and alternative
products. It is the manufacturing procedures, quality control and ethical behaviour of
those in the pharmaceutical industry which is in question. In spite of
these facts, the health authorities and the media have largely succeeded
in creating the false perception that responsibility for the current
crisis falls squarely on the shoulders of the alternative medicine
industry. It is up to the industry to correct this misperception and
publicise the enviable safety record of alternative medicines.
According to abundant evidence there are gross deficiencies in the
pharmaceutical industry, especially in regard to ethics and quality
control. There is also overwhelming evidence that prescription drugs and
pharmaceuticals generally, cause far too many adverse reactions and even
fatalities. Reporting systems for adverse drug reactions should be strengthened
and reporting of adverse drug reactions in death certificates should be
mandatory. Current proposals to encourage reporting of adverse reactions
to alternative medicines should be extended to include all drugs until the
drug industry has achieved a level of safety similar to that which has
already been achieved by the alternative medicine industry.
The same rules
of evidence should of course be applied in both instances. Any symptom,
even if only vaguely related to a prescription drug, should be immediately
reported and recorded by doctors and alternative practitioners. We must
all strive to reduce the unnecessary suffering caused by prescription
drugs. We should also strive to produce a genuine form of integrated
medicine where the independence of alternative medicine is preserved,
and its strengths maintained. We should never accept the use of scare
tactics to justify a takeover of the alternative medicine industry.
I look forward to the time when our health care professionals no longer
feel the need to indulge in insults and
name calling and they begin to work together to eliminate deficiencies in our health
care system for the betterment of human health.
Addendum
In keeping with the oft stated desire of authorities to establish a
connection between the safety of over the counter drugs and the use of
alternative medicines as a result of the Pan crisis, scientists now want consumers to be more wary
about alternative medicines (but not over the counter drugs such as
Travacalm) (68).
According to Pengelley (68):
"When the dust settles from the Pan
Pharmaceuticals recall, scientists want users to be more discerning about
natural medicines." Pengelley cites Geraldine Moses from the
Pharmaceutical Society of Australia (68):
"We have to educate people to be a bit nitpicky and stop just
acting on blind faith because it's on the label. There are a lot of things
that are only there for historical reasons. They've kind of been
grandfathered on to the shelves. It's really true there are lots of things
that get marketed but don't work."
Predictably, as a result of the Travacalm DRUG scare, government
authorities have now promised to clamp down on complementary medicines.
According to O'Malley (66):
| "A panel of experts will be given the job
of scrutinising the complementary medicines industry after the Pan
Pharmaceuticals recall. Parliamentary health secretary Trish Worth
said the panel would also focus on the maintenance of a
responsible and viable complementary medicines industry.' The Pan
Pharmaceuticals recall has highlighted the importance of
preventing or deterring deliberate or reckless breaches of
standards and conditions,' she said.".................."Australian
Medical Association president Kerryn Phelps has welcomed the
committee and urged it to focus on restoring consumer faith in
evidence-based complementary medicines. 'Complementary medicines
and therapies that have been shown to work should not be dragged
down by the Pan scandal,' Dr Phelps said." |
According to Parliamentary Secretary for Health, Trish Worth (78),
"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." As a result of
these concerns about the Pan recall, Trish Worth announced the formation
of a committee to conduct an inquiry into "complementary medicines"
(78).
Trish Worth continues (78):
"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."
It seems that since we have now proven that a certain pharmaceutical
drug was toxic we must take urgent action to ensure the safety of vitamins
and dietary supplements and we must "examine the role of
complementary medicines in the health care system." Furthermore, as has been correctly pointed out by
Phelps, the reputation of vitamins and supplements should not be
"dragged down" simply because of the "Pan scandal".
The Pan scandal, as I have indicated above, provided further evidence of
the safety of alternative medicines as compared to drugs. Did I miss something? Are we having an inquiry into drugs or
vitamins?
Interestingly, Professor MacLennan, who reportedly regards alternative
medicines as "snake oil"(69),
has been appointed to the Committee to assist in determining the role
of complementary medicines in the health care system. Professor
MacLennan was described by Paul Heinrichs (69)
as " someone with a long-standing interest in querying the
worth of alternative medicine."
But the Pan crisis is also being used to justify the control of dietary
supplements in New Zealand by the Australian government (71,72,73).
According to Middleton (71):
| "Up to ninety (90) percent of all
traditional Chinese Herbal Medicine and as much as forty (40)
percent of New Zealand, Canadian and the U.S.A made Dietary
supplements will be banned from New Zealand if the New Zealand
LABOUR party's proposed Trans Tasman Agency to Regulate Dietary
Supplements( Chinese Herbal Medicine) is passed into law early
2003"......"The proposed Authority will be based in
Canberra, set up under Australian Law, and staffed primarily by
Australians . Every single herb or vitamin that is sold in New
Zealand will have to be registered and licensed with this new
Authority run by the Australian Therapeutic Goods administration(
TGA) which is recognised internationally and by the American
Nutritional Foods Association as having the most draconian
regulatory regime for dietary supplements in the world , being
highly restrictive, bureaucratic, cumbersome and costly." |
As I have indicated above, the desire of the medical establishment to
control dietary supplements has accelerated the need for increased
publicity aimed at causing fear and anxiety regarding the safety of all
alternative medicines (74,75,76,77).
There will be an increasing number of poorly conducted and biased studies
(see Dietary Supplements) which will seek to
draw attention to any alleged dangers, real or imaginary, of alternative
medicines. Such studies are made more urgent as scientists and doctors
advise the public that anyone who does not take nutritional supplements is
risking serious diseases such as heart disease and cancer (see Nutrition
and Megavitamins 2, Nutrition
is for the Birds, B vitamins). As more and
more doctors are themselves taking vitamins there is an increasing need to
convince the public of the safety of prescription drugs and the dangers of
vitamins.
Not surprisingly, as a result of the Pan crisis the Australian
government is now seeking to begin a process of dramatic regulatory reform
of the alternative medicine industry to enable it to take full control of
the industry with greatly enhanced power to cancel licences of
manufacturers of alternative products. These changes are expected to be
implemented in 2005 ( see page 165 of the Report)
For those who wish to see Holistic Health
Topics response to the Australian Government Inquiry into
Complementary and Alternative Medicine please click
here.
Links and References
1. http://news.ninemsn.com.au/Health/story_48067.asp
2. http://www.news.com.au/common/story_page/0,4057,6349938%5E2,00.
See: Judy Skatssoon, Safety
breaches force recall, April 28, 2003.
3. http://finance.news.com.au/common/story_page/0,4057,6359090%5E462
See: Simon Benson, Pan Boss Suspended Before, 30th April, 2003.
4. http://www.stuff.co.nz/stuff/0,2106,2437692a6026,00.html
See: Australia launches its biggest medical recall, 30
April 2003
5. MaGuire, T., Largest Ever Drug Recall, Daily
Telegraph, 29th April 2003.See : http://www.dailytelegraph.com.au
6. http://www.panlabs.com.au/html/body_company_profile_.html
7. http://www.health.gov.au/tga/docs/html/mediarel/mrtravac.htm
See: Media release, TGA intensifies warning about Travacalm
Original travel sickness tablets, TGA, 22nd January.
8. http://www.health.gov.au/tga/recalls/travac300.htm
See: Urgent Medicine Recall, Travacalm HO hyoscine hydrobromide 300
micrograms tablets strip pack, TGA, 30 January 2003.
9. http://www.recalls.gov.au/recalls_therapeutic.cfm
10.http://www.keypharmaceuticals.com.au/TravelCalm.htm
See: Key Pharmaceuticals
11.http://www.guild.org.au/public/currentissues/travacalm220103.pdf
See: Pharmacy Guild of Australia, Sonya Sparre, Quality Assurance Manager,
Urgent Medicine Recall, 20th January, 2003, Key Pharmaceuticals.
12.Needham, K., p5, Sydney Morning Herald, 30th April,
2003.See: http://www.smh.com.au/
13.http://healthanswers.telstra.com/drugdata/appco/00016952.asp
14.http://www.drugs.com/xq/cfm/pageID_0/kw_hyoscine/kws_4262/gtype_
15.Schubert, M., p6, The Australian, 30th April, 2003. See: http://www.theaustralian.news.com.au/
16.A Dose of Their Own Medicine (editorial), p12, The
Australian, 30th April 2003. See: http://www.theaustralian.news.com.au/
17.Sexton, J., O'Keefe, B., The Australian, p6, 30th April
2003. See: http://www.theaustralian.news.com.au/
18.The Daily Telegraph (editorial), p30, 30th April 2003. See :
http://www.dailytelegraph.com.au
19.http://www.abc.net.au/news/newsitems/s843371.htm
See: ABC News, Heads to Roll at Pan, 30th April.
20.Gottliebsen, R., The Australian, p6, 30th April 2003. See: http://www.theaustralian.news.com.au/
21.http://www.thewest.com.au/20030429/business/tw-business-home-sto9
See: Pan Pharmaceuticals vows to return, The West Australian, 29th
April.
22.http://www.upi.com/view.cfm?StoryID=20030429-011654-1923r
See: Australia issues biggest medical recall, UPI, 29th April.
23.Pirani, C., The Australian, p6, 30th April 2003. See: http://www.theaustralian.news.com.au/
24.Benson, S., The Daily Telegraph, p6, 30th April 2003. See : http://www.dailytelegraph.com.au
25.Patty, A., MacGuire, T., pp1,6, The Daily Telegraph, 30th April
2003. See : http://www.dailytelegraph.com.au
26.The Australian, p6, 30th April 2003. See: http://www.theaustralian.news.com.au/
27.Tobler, H., The Australian, p11, 30th April 2003. See: http://www.theaustralian.news.com.au/
28.Robotham, J., Sydney Morning Herald, p16, 30th April 2003.See: http://www.smh.com.au/
29.The Daily Telegraph, p8, 30th April 2003. See : http://www.dailytelegraph.com.au
30.Dwyer, J., Doctors and Chemists should tell the Truth about
Natural Medicines, Sydney Morning Herald, p17, 1st May
2003.See: http://www.smh.com.au/
31.http://www.health.gov.au/tga/recalls/nonpanrec.htm
See: Urgent Medicine Recall - Products manufactured by Pan Pharmaceuticals
Limited and supplied by various sponsors and distributors, TGA, 4th May,
2003.
32.http://www.health.gov.au/tga/recalls/pan.htm
See: Pan Pharmaceuticals Limited - Regulatory Action and Product Recall
Information,
33.http://www.tga.gov.au/docs/pdf/cmfact3.pdf
See: Fact Sheets on Complementary Medicines, TGA: Please note that the
original document has been moved and classified "historical" - go to
http://www.tga.gov.au/docs/html/cmfact1.htm
34.http://www.theage.com.au/articles/2002/09/20/1032054963271.html
See: Wendy Tuohy, Why complementary therapies are winning
patients
, The Age, 21st September 2000.
35.http://www.abc.net.au/4corners/content/2003/20030428_happy_pill/default
See: Hazards of the Happy Pill, Four Corners, ABC Australia.
36.http://news.bbc.co.uk/1/shared/spl/hi/programmes/panorama/transcripts/ser
See: Panorama The Secrets of Seroxat, BBC.
37.http://news.bbc.co.uk/1/hi/programmes/panorama/2310197.stm
See: The Secrets of Seroxat, BBC News.
38.http://www.a-paxil-lawyer-source.com/html/updates/glaxo.html
See: Glaxo 'played down Seroxat side effects',Sarah Boseley, health
editor, Saturday October 12, 2002, The Guardian
39.http://www.healthsentinel.com/NSAIDs/
40.http://www.cpmission.com/main/NSAIDs.html
41.http://my.webmd.com/content/article/33/1728_83308
42.http://www.viox-heart-attack.com/pages/vioxx_lawsuits.html
43.http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed
See: Griffin MR, Yared A, Ray WA, Am J Epidemiol 2000 Mar
1;151(5):488-96
44.Brighthope, I., Script Addicts Loathe to Admit Natural Medicine
is Effective, Sydney Morning Herald, p17, 2nd May 2003.See: http://www.smh.com.au/
45.Benson, S., Sofios, S., Cazzulino, M., "Hunt for the Bad
Medicine", The Sun Herald, pp 24, 4th May, 2003.
46.http://www.theage.com.au/articles/2003/05/02/1051382070157.html
See: Doctors' medicines all safe: govt, The Age, 2nd May 2003.
47.http://www.themercury.news.com.au/common/story_page/0,5936,63590
See: Michelle Pain, Shops left in pill ban
muddle, The Mercury, 30th April 2003.
48.http://dubbo.yourguide.com.au/detail.asp?class=news&subclass=local&cat
See: Nikki Roberts,
Prescription medicines safe, The Daily Liberal, 30th April.
49.http://www.health.gov.au/tga/docs/html/mediarel/mrpan6.htm
See: Media release, Allegron 25MG Subject to PAN Pharmaceutical Recall,
TGA, 2nd May 2003.
50.http://www.theage.com.au/articles/2003/05/03/1051876890610.html
See: Prescription drug in Pan recall, The Age, 3rd May.
51.Toohey, B., The Daily Telegraph, pp 28-29, 3rd May, 2003.
See : http://www.dailytelegraph.com.au
52.http://www.ama.com.au/web.nsf/doc/SHED-5FK4YN/$file/healths_gd_p
See: AMA Position Statement on Complementary Medicine, 2002.
53.http://web.archive.org/web/20030608102915/http://www.abc.net.au/public/
See: Geraldine Moses, spokeswoman for the Pharmaceutical Society of
Australia, Drug recall should be used as industry wake-up call,
Public Record, ABC, 8th June, 2003.
54.http://www.soaringspiritwithtears.com/healthcare/rebuttal.html
55.http://www.soaringspiritwithtears.com/healthcare/regulations.html
56.http://www.cspinet.org/reports/wh_statement020702.html
See: Bruce Silverglade, Director of Legal Affairs, Comments on the Draft
Recommendations of the White House Commission on Complementary and
Alternative Medicine that Pertain to Dietary Supplements, 7th Feb., 2002.
57.http://www.ama.com.au/web.nsf/doc/WEEN-5GB44J
See: Speech to the Natural and Complementary Healthcare Summit Canberra, 1
March 2001 President of the AMA, Dr Kerryn Phelps.
58.http://www.ama.com.au/web.nsf/doc/WEEN-5GB4A6
See: Media Release, AMA adopts progressive policy on complementary
medicine, 28th Feb 2002.
59.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.
60.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.
61.http://www.racgp.org.au/document.asp?id=2037
See: Craig Hassed, What is Orthodox Medicine?, 6th Dec., 2000.
62.http://www.racgp.org.au/document.asp?id=1664
See: Craig Hassed, Do No Harm, Journal of the RACGP - 28(11)
November 1999.
63.http://domino.ama.com.au/AMAWeb/MediaRel.nsf/a9aea78b666d4f9e4
See: Phelps, K., Address given to National Press Club, Canberra, 17th
July, 2002.
64.http://www.skeptics.com.au/features/spoon/bs-03pan.htm
See: Ian Pavey, Bent Spoon Nomination, Australian Skeptics Inc., 30th
April, 2003.
65.http://www.mja.com.au/public/issues/178_09_050503/cur10189_fm-1.ht
See: Currie, B.J., Clough, A.R, MJA
2003; 178
(9): 421-422.
66.http://www.theage.com.au/articles/2003/05/12/1052591741123.html
See: Sandra O'Malley
, Pan recall sparks regulation, The Age, May 13 2003
.
67.http://archive.mail-list.com/hbv_research/msg04713.html
See: Lauran Neergaard, AP Medical Writer, Gov't
Debates Risks of Arthritis Drugs, Wed, 5 Mar 2003 09:34:31 -0500.
68.http://www.theadvertiser.news.com.au/common/story_page/0,5936,6481
See:
Pengelley, J., Watch the
pills you take, The Advertiser, 24th May 2003.
69.http://www.theage.com.au/articles/2003/05/03/1051876900577.html
See: Paul Heinrichs, Can natural remedies recover?,
The Age, 4th May, 2003.
70.http://www.smh.com.au/articles/2003/04/29/1051381933062.html
See: "Time to end the alternative health hype: Carr
", Sydney Morning Herald, 29th April, 2003.
71.http://health-search.com/threat.htm
72.http://health.nzoom.com/health_detail/0,2811,187745-399-404,00.html
73.http://www.healthcrusador.co.nz/
74.http://www.msnbc.com/news/925713.asp?0dm=C19OH
75.http://straitstimes.asia1.com.sg/health/story/0,4395,194730,00.html
See: The Straits Times, 16th June 2003.
76.http://www.medscape.com/viewarticle/457204?WebLogicSession=Pu0n
See: Karla Gale, Beta-Carotene Supplements May Increase Mortality
Risk, Reuters, 12th June, 2003; See also: Lancet
2003;361:2017-2023.
77.http://news.bbc.co.uk/1/hi/health/2986922.stm
See: BBC, Friday, 13 June, 2003.
78.http://www.health.gov.au/mediarel/yr2003/tw/tw03023.htm
See: Trish Worth,
Final List of Members for Expert Committee on
Complementary Medicines, Media Release, 27 May 2003.
|
|
