Tag Archives: Alternative Medicine

Beware the ELF in the cupboard

Posted in Big Placebo, Health, Scam by

The recent report (2011-12) on the Auditor Generals performance audit into Therapeutic Goods Regulation of complementary “medicines”, is disturbing reading. It confirms that the CAM “industry” if you will may breach the Therapeutic Goods Act with little concern.

Under the authority contained in the Auditor-General Act 1997 the Australian National Audit Office (ANAO) undertook an independent performance audit in the Department of Health and Ageing (DoHA). The Therapeutic Goods Administration – part of the DoHA – has the role of regulating the Therapeutic Goods Act 1989. The Minister for Health and Ageing holds responsibility for the Act.

Back in June this year a Transparency Review of the TGA was published, which you can find in a separate post here. I also outlined the essential gateway that permits the wide scale manufacturing of bogus products, with bogus claims, sold for very real percentages of your hard earned money;

To register a product, sponsors use an electronic listing facility – ELF – by simply going online. Much like filling out a Facebook profile. Ingredients are selected from a drop down list. Near enough is good enough. These ingredients are already deemed riskish free by the TGA. Sponsors “self certify” under GMP requirements. Basically claiming that the goods are produced under Good Marketing Practice. Finally they tick a box indicating that they hold good evidence. Hand on heart no doubt. No checks are ever run. They pay the $600 fee and receive an AUST L number. These goods are then able to be listed on the Australian Register of Therapeutic Goods.

The Electronic Listing Facility software (now version 3) has the power to allow products for sale. It’s no surprise dear reader, to find that our friend the ELF features heavily in the independent audit. The Act was given extra zing in 2001 to allow easy market access of products deemed low risk because they, well, in the main don’t really do anything. It favours “sponsors” (producers) hiding true information from the public. Thus it is open to wide abuse and it seems this opening is a crowded one indeed.

The ELF also provides a free text field for sponsors to wax lyrical about the astonishing qualities and safety of products. Again, like a Facebook profile you may enter whatever you like. Or omit entering what you don’t like. Although introduced in 2003 it can have no impact on products already on the ARTG prior to it’s introduction. True to it’s sleepy nature the TGA have done nothing to check if existing (pre-2003) products comply with present standards. Which may well tell us more about what the TGA think of it’s own so-called standards than the egregious risk to public health it otherwise appears to be.

In respect of “pre-market assessment” on page 77 under 3.44, the ANAO noted four matters “whose consideration could improve their integrity”:

(1) indications and claims in older products have not been checked;

(2) arrangements for scanning free‐text indications are not robust or comprehensive and require manual backup;

(3) the coded indications project—which could address both these issues by eliminating the free‐text field—has been proceeding very slowly; and

(4) some sponsors may, on occasions, be entering incorrect information into the ARTG intentionally.

If a product variation or grouping of products occurs ELF 3 will scan the records from pre-2003. Yet, this is widely known and sponsors avoid updating their records despite new research condemning effects or dismissing efficacy. Thus (for example), St. John’s Wort remains marketed as an effective depression treatment despite having no effect on endogenous depression and a poor effect on clinical depression. Fish oil sponsors continue to boast of success with osteoarthritis (OA) despite the anti-inflammatory effects only showing promise in rheumatoid arthritis. The promised “cartilage regeneration” occurs at a glacial pace compared to loss via OA, rendering it almost meaningless.

The list of “hangers on”, if you like, debunked in any manner of exercise is extensive. “Anti-oxidant” products incapable of meeting claims, detoxification kits that have negative effects actually resulting in jaundice and poor LFT’s, all homeopathic products, echinacea, dedicated preparations containing vitamins or minerals, crystal therapies, energy bands, sexual performance/libido enhancers, cognitive enhancement products, immune stimulants, herbal weight loss products and teas, etc, etc.

The TGA does no manual checking and the software cannot scan existing records for restricted or prohibited terms aiding this pseudoscientific white elephant. This is despite the fact the TGA is regularly adding new terms. So effectively;

  • Any product listed on the ARTG prior to 2003 escapes scrutiny for all restricted or prohibitive terms. Any such product escapes even the dubious self-certification standards by which new products are listed;
  • When the TGA adds a term or word to it’s list of restricted or prohibited words and terms, every single item listed prior to this is not checked for these same words or terms;
  • The TGA’s assessment system is incapable of scanning existing products and thus cannot correct for the impact of emerging research;
  • In the 8 years since implementation of the ELF the TGA has made no attempt to manually check pre 2003 listings;
  • Sponsors intentionally avoid updating information via the ELF, effectively misleading the public to continue to believe a product succeeds where it has been shown to fail;
  • Sponsors may enter incorrect information about a product intentionally and the product may still be approved for listing on the ARTG;
  • Nonetheless the TGA is working to address these shortfalls via a “coded indications” project, which the ANOA has identified at progressing too slowly.

Not surprisingly then when ANAO searched for “TGA Approved” and “safe” – the use of which is unlawful in advertising alternative products – thousands of examples were found. Of these thousands the ANAO provided “three egregious examples to the TGA” (p. 128). The TGA identified other breaches “such as ‘cancer‘”. As of June 20th, 2011 two of these three “egregious breaches” were not rectified.

Okay, so why? Well on page 130-131 we read that prosecution is the only option left to the TGA in these cases. Yet;

The TGA’s Advertising Unit is not aware of having successfully used the full range of sanctions, such as seeking a prosecution for breaches:

Due to the very low financial penalties currently available (a maximum of $6600 for individuals and $33 000 for corporations) for advertising offences in the Act and other investigative priorities for the TGA, it is not cost‐effective for the TGA to initiate a formal investigation of an advertising breach with a view to preparing a brief of evidence for consideration of prosecution by the Director of Prosecutions …

It has never been cost‐ effective for the TGA to initiate a formal investigation of an advertising breach with a view to preparing a brief of evidence.

The size of penalties attached to criminal offences may also mean that it is seen as not in the public interest to proceed. This view is consistent with legal advice provided to the Advertising Unit about specific breaches.

The TGA has also observed that “prosecution is currently the only available option where administrative requests fail to achieve compliance”. There have never been any cases that have been referred for prosecution action and accepted. As a consequence, the prospect of using prosecution action against non‐compliant behaviour, and as a deterrent, seems limited.

Alrighty then. So it’s not cost effective or “in the public interest” to enforce regulations. Sponsors and manufacturers would know of this stunning record of no successful prosecution. They must be trembling in their Whitsunday banana lounges, dear reader. 80 of 82 complaints pertaining to the Advertising Code this year were upheld by the TGA. The two failed complaints were “between” competing companies. Yet there’s no way to follow through and prosecute for non compliance. That’s quite absurd in anybody’s reasoning.

In 2010 a DoHA review found 90% of products reviewed were found to be non-compliant with regulatory requirements. The infamous 31 products selected at random yielded 68 breaches;

  • 20 medicines had labelling issues such as non‐compliance with labelling requirements and/or breaches which may mislead consumers.
  • 12 included incomplete and/or inappropriate information on the Australian Register of Therapeutic Goods (ARTG).
  • 22 were found to have manufacturing and/or quality issues.
  • 14 did not have adequate evidence to substantiate claims made about the medicines.

This comes on top of the 2003 recall of 1600 Pan Pharmaceutical products. In 2006 the TGA found 75% non-compliance with regulations. However, the TGA doesn’t use information gathered from post market reviews to sharpen up the prodding stick for frequent offenders or even the most frequently occurring characteristic of regulatory breaches. This is a major issue in presenting transparency and setting in train practices that would better inform the public.

Since 2005 it’s been government policy for the TGA to collect from sponsors a summary of evidence, for the purpose of informing the public. Sponsors are required to have this summary. The TGA inexplicably assumed this process of collection would be legislated for under the Australia New Zealand Therapeutic Products Agency. The ANZTPA process initially faltered and as the TGA is wont to do it consequently did… nothing.

But by golly, in May this year it “took steps” – yes “steps” dear reader – “to restart implementation of this policy”. Yes! To “restart” the policy. Which to me sounds like bureaucratic blubber indicating a pre-emptive attempt at damage control, if we scrutinise the dates of the auditing process.

So here we are still waiting to know what comes out of those magical places that use our little ELF. On top of the Transparency Review we may conclude there is little transparency for the public. If you’re not in the habit of reading research or taking an intellectual interest in alternative product dynamics (which indicates you’re almost certainly immune to hanky panky), you’d make a perfect customer. Ignorant, misled and unable to access proper information. All in all it’s pretty tragic.

Do be my guest and have a read.

Auditor Generals Report: Therapeutic Regulation of Complementary Medicines

Paul Offit discusses Oscillococcinum

Posted in Big Placebo, Health, Scam by

Oscillococcinum is a homeopathic scam sold as a cold and flu “remedy”. Supposedly made from burberry duck heart and liver because (according to homeopaths), these are “reservoirs” for influenza virus it is in fact, sugar.

It’s an ideal example of the problems Aussies face with homeopathy regulated under our TGA. As we know homeopathic “medicines” are “often so diluted they don’t contain any of the active ingredient”. Australia’s TGA regulations on homeopathic and anthroposophic “medicines” are quite plain in that this fact ultimately dictates that homeopathic products must comply with The Australian Code of Good Manufacturing Practice –  cGMP standards. Overseas sponsors must provide evidence that this standard is met. Whether or not this is actually occurring has no bearing on the rationale.

The rationale for this is that although most homoeopathic (and some anthroposophic) medicines are diluted to the point where it is no longer possible to detect any of the original mother substance, a major factor in ensuring the low risk nature of these medicines is making sure that the mother substances are properly identified, and the dilution and succussion processes are appropriately monitored.

Translation? Some homeopathic products claim to be made from nasty and potentially high risk “mother” substances. The final product from homeo-hokery pokery actually contains no active ingredient, and the TGA is all about preventing risk. So to be certain you’re selling nothing nasty – or rather, nothing at all – your hokery pokery will be subject to cGMP. Efficacy is neither here not there when it comes to alternative “medicines”.

This is rather strange because in 2003 The Expert Committee on Complementary Medicines in the Health System [ECCMHS] recommended that;

Homoeopathic medicines and related medicines making therapeutic claims be regulated to ensure they meet appropriate standards of safety, quality and efficacy.

Efficacy? Quality? Therapeutic claims? Regulation? This is simply not not what we see today, despite the fact 1600 complementary “medications” were recalled in 2003. Recently efficacy was raised again in the transparency review of the TGA. Plainly this is just not good enough.

Remember that a dilution of 1 in 100 is designated by “C” – a centesimal. Oscillococcinum is 200C. In Australia 200C is also known as “bugger all”. Yet, Aussies pay good money for this apparent remedy. This scam.

Paul Offit sums this up nicely in about 2 minutes, and I added some slides for sex appeal.

Paul Offit discusses Oscillococcinum

Chiropractors adjust vaccine truths

Posted in Anti-Vaccination Lobby, Big Placebo, Chiropractic, Health, Scam by

The World Chiropractic Alliance (WCA) have a “journal”, available for free subscription. It doesn’t actually have any peer reviewed studies, but is more a collection of industry positive, competitor negative and hokery pokery articles that deny credibility. Such as Energy Medicine: Futuristic Healing with ancient roots, by Dana Ullman. We know Dana from Twitter as @homeopathicdana

Today I had an article brought to my attention by New Zealand skeptic and critic of anti-vaccination nonsense, @SkepticalSkotty. He’d had the article brought to his attention by a friend. Like many in the developed world outside Sth. Korea, where it’s illegal to practice the scam, the friend had given chiropractic credence. Quite understandable. Unless one’s in a clinical setting or prone to keep an eye on non evidence based trends, chiropractors are the other “doctors” who work on backs and necks and are subsidised by insurance companies and governments.

The September 2010 article Several nations banning flu shots for babies, provides unique insight into bias, deceptiveness and unprofessional standards. Supposedly having no position on vaccination I was intrigued at the effort to mislead readers into forming a negative view of both seasonal influenza and H1N1 vaccination. The article opens with an accurate observation of a QLD infant death following influenza vaccination, but almost immediately begins to blur the lines. Let’s do some housekeeping, remembering that fifteen children in QLD had an adverse reaction to the vaccine.

In WA where babies were given Fluvax – a combination H1N1 and seasonal ‘flu vaccine – febrile convulsions effected 60 and another 200 presented with higher than normal temperatures post vaccination. Well tolerated in teens and adults Fluvax was certainly not tolerated in babies and small children. One small child, Saba Button, fell into a coma and is now struggling with brain damage. It is the type of tragedy health authorities dread. Soon after the reactions WA suspended administering the vaccine to children under 5 and this was also taken up nationally. The TGA had made some noises toward CSL who manufactured Fluvax. However it wasn’t until FDA officials from the USA turned up investigate CSL’s standards of Good Manufacturing Practice (GMP) this year, that one could realistically defend Australian influenza vaccination regimes against quite justified criticism.

These two events were tragic and widespread fevers in vaccinated babies is a huge blow to public confidence. However suggesting that health authorities intend to suppress the truth at the expense of public health is a frequent unsubstantiated claim. Worse is the use of these tragedies by groups like the Australian Vaccination Network – the anti-vax darling of Australian chiropractors – to smear their critics. The day The Australian published Natasha Bita’s article on young Saba Button (May 28th), Meryl Dorey exploited this family to muster anti-vaccination support and to also make false claims about skeptics and Stop the AVN.

Meryl Dorey’s Yahoo! Twitter and Facebook libellous claims

Dorey published an “Action Alert” on Twitter, Facebook and Yahoo! claiming supporters of vaccination were “mobilising” and “organising their forces” to write letters of complaint to The Australian, and thus writing in support was vital. “They do NOT want newspapers or any media outlets to be covering this from a freeedom of choice point of view”, she lied on Yahoo!

Freedom of choice point of view? Since when are facts or a parent’s choice to speak to the media linked to whacky anti-vax lingo’? Dorey was seizing ownership of Saba’s tragedy and using it to engender disgust toward those who criticise her already extensive dossier of lies and deceit. Little wonder many believe she manufactures stories of personal threats.

Not only is this offensive to Saba, her parent’s and those maligned but one must surely question her grasp on reality, not to mention the ethical issues surrounding vaccination, to see a grown woman manipulate her members as pawns in her own delusional neocon’ fantasy. I wrote to Natasha Bita and her colleagues seeking confirmation and on June 21st she confirmed that whilst she had been on holidays no “complaints” had been received, or could be found.

Back to the WCA journal. They failed to stress the vaccine was “suspended” not banned or that other strains would be considered. Onto the second paragraph;

A short time later, Finland also suspended the H1N1 vaccines due to six reports of narcolepsy in children and teens immediately following vaccination. According to The Helsinki Times, “Medical reports suggest that over 750 of those who have been vaccinated have experienced harmful effects.”

Firstly, QLD ADR’s were due to seasonal influenza vaccine. WA’s ADR’s were due to a combination of seasonal and H1N1 vaccines. The vaccine used in Finland was GSK’s H1N1 vaccine Pandemrix. No Australians have been administered Pandemrix and Australia has had no reports of narcolepsy. This distinction wasn’t made by the WCA article. What about those “750 harmful effects” that they quoted. If we read the Helsinki Times piece we see that 2.5 million doses were given. That’s a 0.003% ADR rate. I do rush to add this is not to be dismissed as trivial, but does indicate the risk/benefit ratio. The WCA seems to think that’s an excessively high level for narcolepsy – falling asleep unexpectedly. More so, as we’ll see there are unique Finnish genetic components to this problem that are related to the vaccine.

Yet if we’re talking about removal of insurance coverage for cervical manipulation by chiropractors because of the risk of vertebral/carotid artery tears, stroke and traumatic death – as in the case of Jeremy Youngblood – then an incidence rate of up to 0.005% is a trivial matter. WCA were upset that this brought “…applause from critics who still maintain that chiropractic is linked to strokes”. Chiropractors maintain it’s “a myth”. I hope you got that. Vaccine induced narcolepsy due to genetic predisposition: bad. Higher risk of tearing of the vertebral artery and dying slowly, whilst well documented: is a myth. They write with mind blowing arrogance;

The World Chiropractic Alliance responded by sending the company a copy of its position paper on chiropractic and strokes, and a vast amount of scientifically documented information that dispels the notion that chiropractic is in any way linked to carotid and vertebral artery dissection. “The WCA has been distributing this information ever since the myth about chiropractic and stroke began, and we’ll continue to make sure we counter this campaign of misinformation,” stated WCA founder and CEO Terry A. Rondberg, DC.

Kaiser Permanente, whom I now admire greatly wrote;

Chiropractic manipulation of the cervical spine is associated with vertebral artery dissection and stroke. The incidence is estimated at 1.3-5 events per 100,000 manipulations. Given the paucity of data related to beneficial effects of chiropractic manipulation of the cervical spine and the real potential for catastrophic adverse events, it was decided to exclude chiropractic manipulation of the cervical spine from coverage.

“Paucity of data related to beneficial effects of chiropractic manipulation of the cervical spine and the real potential for catastrophic adverse events”. Damn that reads well. Are chiropractors going to suspend this potentially lethal practice? Hell no – they’ll call it a myth and back that claim with bad science. Are they worried about patient health or patient access to a manipulation that takes seconds? No, they’re upset that they can’t get the big bucks.

Think of how many people around the world would get a cervical manipulation on any one day. At a rate of up to 5 per 100,000 catastrophic injuries and stroke, for no benefit, not to mention all the minor cervical vertebral insults and/or soft tissue injuries you have my permission to feel a little ill dear reader. So, it’s compelling how selective this group of pseudoscientific profiteers can be when it comes to understanding not only risk/benefit ratios but the size of the risk vs the evidence for any benefit.

The WCA article also mentions narcolepsy in Sweden. That also was a rate of 0.003% – a figure they seem intent on not publishing. According to the WHO last April 21st;

The only pandemic influenza vaccine used in Finland and Sweden was Pandemrix, an adjuvanted influenza A (H1N1) 2009 monovalent vaccine manufactured by GlaxoSmithKline.

Narcolepsy is a condition that has a strong genetic linkage, being almost uniquely seen in persons who have the (HLA) DQB1*0602 genotype. Of the cases of narcolepsy tested so far in Finland (n=29), diagnosed during 2009-2010, all have that genotype. The National Institute for Health and Welfare of Finland considers it probable that the Pandemrix vaccine was a contributing factor to this observed increase, and has called for further investigation of other co-factors that may be associated with the increased risk. They consider it most likely that the vaccine increased the risk of narcolepsy in a joint effect in those genetically disposed with some other, still unknown, genetic and/or environmental factors. The final report from the Finnish National Narcolepsy Task Force is expected by 31 August 2011.

Apparently 30% of Finnish have this gene whist 15% of Europeans have it. This wasn’t dismissed as a genetic issue either. There is a nine fold risk in those vaccinated vs unvaccinated. So, GSK aren’t getting any special treatment. Nor does hysteria get to reign. As in Australia it is mainstream medical monitoring and national health responses that ultimately serve to protect the public. But it’ll be late August this year before final European reports are released.

The article goes on to quote a now missing article from the Bharat Chronicle;

The vaccines appear to be causing a pattern of neurological disorders affecting children and teens across the planet

Most facepalmingly, if you pop that sentence into your chosen search facility dear reader, you get over 2,000 hits ranging from Bible prophecy, to natural woo, to wellness, to infant chiropractic to… well you get the idea. Our WCA “journal” is running a junk piece that they probably scavenged from the depths of conspiracy central.

The piece finishes off claiming “Australian authorities” knew of the problem for “several weeks” but withheld the information whilst continuing to encourage vaccination. One assumes they’re referring to WA where ADR’s were reported for two weeks before Saba Button was injured which was around the time the number of ADR’s demanded state wide action. Far better for WCA to publish the insinuation that authorities remained silent about a free vaccine with perhaps the only motivation being to harm the public.

Then it’s back up to QLD for accusatory lies followed by some special pleading;

Health officials at first tried to convince the public that there was no “causal” relationship between the vaccine and the side effects but even the Australian coroner had to admit he couldn’t rule out that the flu shot was responsible for the death of two-year-old Brisbane toddler Ashley Jade Epapara.

Gosh. “Even” the coroner couldn’t rule it out. Appeal to authority also. The truth is no-one can rule it out or rule it in. Period.

Then back to WA with nonsense about attempting to “blame” a bad batch. In fact the possibility of a bad batch must be investigated just as the possibility of the vaccine ingredients and combination was investigated. “This is not a long-term safety issue with vaccines,” University of Western Australia School of Paediatrics and Child Health Associate Professor Peter Richmond told WA today, they add. Quite right. This is most certainly not a problem with vaccines as a long term safety issue. The only long term issue is the capitalisation by anti-vaccination groups.

All in all this is an appalling piece of junk writing that aims only to create the illusion of widespread – or “across the planet” – trends that somehow show vaccines are a health risk. They cant even manage to keep different Australian reports on two very different scenarios straight. Already this year in QLD influenza is back at six times the annual rate. Febrile convulsions and brain damage from vaccine preventable disease are constant realities. It is for this very reason the risk/benefit of vaccination is actually incredibly safe.

No doubt Australia had some serious issues with vaccine manufacture and management of ADR reporting in 2010. This is being dealt with by the proper authorities. The very last thing the present vaccine controversy needs is this band of chiropractic cowboys defending futile and dangerous treatments, whilst attacking sound evidence backed public health measures.

Ultimately there are not any nations “banning” flu shots for babies. Chiropractors have lied again.

Selenium: to supplement or not to supplement

Posted in Alternative "medicine" scams, Health by

Selenium is present in many foods and available as a supplement. Expensive urine however, may not always be the worst case scenario for those duped by the vitamin/supplement industry.

Not to mention the “multi-dose” capers which are almost certainly increasing vitamins and minerals you don’t need, keeping you chronically dosed on those you need in tiny quantities and overdosing you on supplements or fat soluble vitamins you’re getting in sound quantities from your diet. Selenium dietary levels vary due to the origin of the plants or animals in ones diet.

A large, long term Selenium trial had to be suspended due to onset of many adverse effects including diabetes in participating subjects. Now you expect me to say something about supplement-pushing anti-vaccine lobbyists who blame vaccination for diabetes, don’t you? Wouldn’t dream of it.

Consider the poor chap in the MJA document below, who erroneously diagnosed impending prostrate cancer using the internet and natural remedy websites. He then ordered selenium online and with no monitoring from any health professional died from acute selenium poisoning. Serum selenium levels of below 100 ng (nanogram) per ml and above 160 ng per ml can be problematic. Which of course means absolutely nothing to those of us who didn’t get a fully staffed pathology laboratory for Christmas.

So, don’t be swayed by little warnings of doom on supplement bottles. Do appreciate that the range from insufficient to excessive is not only minor but demonstrably unaided by the swallowing of supplements.

Regarding the gentleman below, well he got hold of 200 grams of sodium selenite powder and went to town on it. The authors conclude;

A brief Internet search revealed 287 000 sites discussing the use of selenium in prevention and treatment of prostate cancer. This provides the public with large amounts of information that is not critically evaluated for validity. After reading Internet information on the possible link between selenium and prevention and treatment of prostate cancer, our patient was able to purchase 200 g of sodium selenite powder without adequate instructions.

He selected a dose himself, with catastrophic consequences. This case highlights the risks associated with failure to critically evaluate Internet material and exposes the myth that natural therapies are inherently safe. Internet sites which fail to disclose the potentially fatal effects of advocated treatments are an emerging threat to health. The World Health Organization has devised guidelines to help consumers evaluate medical information on the Internet, which are available online through the Therapeutic Goods Administration.12 Adverse outcomes of complementary and alternative medicines should be better publicised and more stringently reported to the Adverse Drug Reactions Advisory Committee (ADRAC), in tandem with adverse outcomes of conventional medications, to create a database of side effects of all current therapies

This Tonic clip originally aired on the ABC, Sunday August 14th and looks at the rather rash linking of low serum selenium to various cancers – a notable problem in NZ with their low selenium content soils, and high levels of prominent cancers. How ever, the issue of genetics may also play a role. Australia has varying selenium levels in soil.

Be sure to chat to your doctor about using any supplements. Get a blood test if you wish and have the results explained. Try to avoid selenium supplements and the advice of beaming naturopaths.

If you’re worried about selenium scoff down a hand full of Brazil nuts every week rather than popping pills of dubious quality and concentration.

Accidental Death From Acute Selenium Poisoning

Transparency review of the TGA

Posted in Big Placebo, General, Health, Scam by

On July 20th the Review to improve the transparency of the Therapeutic Goods Administration was published.

From an evidence point of view the only game in town is the burgeoning market in what the TGA must only deem to be relatively low risk compounds, sold to a trusting public as alternative or complementary “medicines”. Under present regulations products do not have to demonstrate efficacy. They are thus registered only on a risk basis. Evidence need not be supplied proving claims advertised on packaging. Only an assurance that evidence exists. All that brain developing, flu resisting, sexual performing, “wellbeing” heightening hokudus pokudus has the credibility of a greeting card slogan. So, how does this happen?

To register a product, sponsors use an electronic listing facility – ELF – by simply going online. Much like filling out a Facebook profile. Ingredients are selected from a drop down list. Near enough is good enough. These ingredients are already deemed riskish free by the TGA. Sponsors “self certify” under GMP requirements. Basically claiming that the goods are produced under Good Marketing Practice. Finally they tick a box indicating that they hold good evidence. Hand on heart no doubt. No checks are ever run. They pay the $600 fee and receive an AUST L number. These goods are then able to be listed on the Australian Register of Therapeutic Goods.

Results of a Post-Listing compliance review over 2009-2010 was posted by the TGA on May 11th, 2011:

Between July 2009 and March 2010, the TGA completed 110 compliance reviews of Listed complementary medicines. Of these, 31 were random and 79 were targeted.

Of the 31 random reviews conducted, the following compliance issues were recorded:

  • 20 medicines had labelling issues such as non-compliance with labelling requirements and/or breaches which may mislead consumers.
  • 12 included incomplete and/or inappropriate information on the ARTG.
  • 22 were found to have manufacturing and/or quality issues.
  • 14 did not have adequate evidence to substantiate claims made about the medicines.

Concerning the 79 targeted reviews completed, the reasons for targeting and the data reviewed differed widely:

  • Label reviews were conducted on 52 medicines, of which 34 had compliance issues.
  • Information included on the ARTG was reviewed for all 79 medicines, of which 54 had compliance issues.
  • Manufacturing/quality/formulation reviews were conducted on 50 medicines, of which 30 had compliance issues.
  • Evidence reviews were conducted on 15 medicines, of which 9 had claims that were not substantiated by the evidence submitted.

Clearly then, the system can be abused and often is, highlighting the paper tiger status of the TGA, and the overburdened, under-resourced Complaints Resolution Panel. One issue that has been widely publicised followed a complaint by Dr. Ken Harvey about the SensaSlim weight loss spray. It’s now widely known that con man Peter Foster is indeed behind this global scam, with his name appearing on court documents. When Harvey’s complaint became known Ken was hit with a SLAPP – Strategic Lawsuit Against Public Prosecution. In this case SensaSlim sued for defamation. Under current guidelines all complaint processes must be halted until other lawsuits are finalised. This can take well over 12 months during which time profits continue to roll in. There’s very little in the review below that leads one to conclude such conduct is going to be more effectively dealt with.

Whilst there are naturally occurring OTC products of known efficacy such as Omega 3 fish oil and St. John’s Wort, efforts must be made to seek sources such as Arthritis Australia or Beyond Blue to ascertain effectiveness. In both these cases not all arthritis nor all depression types respectively, respond to either product. A tragedy that has unfolded is the partnering of Arthritis Australia with daylight robbers, Ethical Nutrients. This rather unethical company will charge $70:00 and more for a small bottle of Omega 3 fish oil.

It sits in splendid spotlit glory in a refrigerator in the pharmacy, even though it need not be refrigerated until after opening. Stalk a few shelves and you’ll find another brand for around $20 – 25:00. It’s important to realise the most common form of arthritic aches and pains is osteoarthritis. OA has not been demonstrated to benefit from Omega 3 beyond anti-inflammatory properties, and thence provision of some pain relief in some very few instances. Much is made of the reduction of enzymatic activity responsible for cartilage damage. Less is made of the fact this is not clinically significant.

Rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis inflammation has been shown to respond. Omega 3, available from a number of foods and nuts has a beneficial effect on inflammation. But that hasn’t stopped Ethical Nutrients relentless advertising campaign adorned with the Arthritis Australia logo. If you’re thinking of using these products be sure you have ongoing inflammation or in the case of depression less than moderate. Be wary who you speak to in seeking advice, and please consult your doctor. Promoters of “alternative” income sources operate just as effectively by demoting sound medical treatment.

Also, keep in mind none of these magical concoctions have ever been considered for PBS listing or are cheaper for concession card holders.

Nonetheless, one may take some comfort from recommendation seven below. It directly addresses the absence of evidence loophole, also hinting at public education. Whilst many will hang doggedly onto entrenched habits, this recommendation and the paragraph on page 53 provide a valuable tool for skeptics and evidence based health advocates seeking to educate a largely science illiterate community.

  • Recommendation 7 [Page 5]:

The TGA implement mechanisms to educate and inform the public that listed medicines are not evaluated for effectiveness by the TGA prior to market.

  • Concerns over complimentary medicines and homeopathic products. [Page 53]

The assessment by the TGA of complementary medicines (such as vitamin and mineral supplements, herbal medicines and especially homeopathic products) was raised as an important issue, in both the consultations and the submissions. Contributors were concerned that the recognition of these products by the TGA, and the AUST L number on the label, provided the public with a perception that the claims made for these products had validity.

At both the consultative sessions and in submissions, it was asserted that many therapeutic claims, or claims regarding efficacy and safety made for complementary medicines, cannot be supported from the limited scientific evidence available, while information about possible adverse effects, especially their interaction with conventional medicines, is often lacking. However, complementary medicines are not permitted to state any interactions with conventional medicines in any material that could be considered advertising.

It was accepted that the majority of complementary medicines are low-risk products, but low-risk does not mean no-risk.

Submissions claimed that many complementary medicines are heavily promoted as ‘natural’ or ‘natural alternatives’, with the implication that they are harmless. It was said that this can result in consumers not advising their medical practitioner or pharmacist about their use, and that health practitioners often do not ask about them.

Some submissions sought not just greater transparency on what an AUST L number means with respect to the TGA’s risk-based assessment of safety, quality and efficacy. They asked for changes in labelling and legislation. Some suggested that all labels, promotion and ARTG Public Summary documents of AUST L products should contain the warning, ‘These products have not been evaluated for efficacy by Australian health authorities’.

Other submissions sought changes to the evidence-based requirements for listed medicines, to more clearly distinguish evidence-based complementary medicines from those that were not. Some submissions requested universal evaluation of all therapeutic goods for efficacy, arguing that there was no such thing as complementary medicines, only medicines with evidence of efficacy and those that lacked evidence. In particular, many submissions strongly put the view that the listing of homeopathic products by the TGA be ceased, as it is perceived to provide an unwarranted or inappropriate endorsement of the products that may be no better than a placebo.