At the risk of a gratuitous self-plug, the use of these medicines in young children was one of the issues of concern that Ray Moynihan and I highlighted in our book, Ten Questions You Must Ask Your Doctor (Allen & Unwin, 2008). We came across several references raising concerns about these products’ use in children when researching the book back in 2007.

So the TGA is certainly not rushing the jump.

Nonetheless, the move will be such a challenge to accepted practices that it will need to be backed by a long-term educational campaign. So argues Ron Batagol, a Pharmacy and Drug Information Consultant.

He writes:

“In a move that is likely to provoke much spirited debate amongst doctors, pharmacists and, most importantly, the parents and carers who look after the day-to-day health issues of  young children in their care, the Therapeutic Goods Administration (TGA) has given notice that it is intending to  “upschedule” over-the-counter cold and cough products to Prescription Only for children under six years and Pharmacist Only for children aged between six and 12 years.

As part of the upscheduling exercise, the TGA has also recommended cough and cold medicines should not carry dosage instructions for children under six years old. The TGA says that this approach would bring the regulation of cough and cold preparations in Australia into line with measures in place in the UK and Canada.

After extensive  internal and external reviews of the evidence surrounding both  efficacy and safety in use, the proposed changes are stated by TGA to have been made ” in light of the current lack of evidence of efficacy and the historical profile of adverse drug reactions (ADRs) in Australia and overseas”.

It is certainly true, that the  consensus of informed opinion amongst paediatricians about the usefulness and propensity of side-effects of these products is in concurrence with the TGA assessment.

Now I must say that there is a whole fascinating social phenomenon associated with parents and carers buying cough ands cold products for children in their care.

This has, in fact,  been noted in the TGA External Review, where they raise the concept of  “social medication” which researchers have found is, in part, aimed at modifying child behaviour to more acceptable patterns, and in part a ‘coping strategy, and that cough and cold medicines were a common “social medication” in this respect’. Pharmacists at the “coal face” will be very familiar with this belief amongst their clients and the associated behaviour patterns.

Presumably, in recognition of  the social behavioural re-scheduling moves would certainly make them feel to some extent disenfranchised, turning on its head as it does, a long-held, even if erroneous, understanding that recommending a suitable cough and cold product for use by children served both a therapeutic and, as discussed, also a “social” function.

It seems to me that there will need to be long-term educational campaign on this issue, if the  proposed changes are adopted.

Indeed, TGA has said that the changes recommended would need to be widely promoted and explained to medical practitioners, pharmacists, parents and caregivers, and that particular efforts be directed towards educating consumers, medical practitioners and pharmacists that OTC cough and cold medicines have not been shown to be effective, and are potentially harmful in children under 6 years of age.

From recent discussions of this issue, when I raised it on our major pharmacy internet discussion website Auspharmlist, I have no doubt that at all that education and explanation will certainly be needed for many of my pharmacist colleagues, and their professional organizations!  This is, of course, quite understandable.

After all, on the face of it, the proposed issue is somewhat analogous to the lengthy but ultimately quite successful campaign over the past 5-10 years, to “educate” doctors and inform the broader community that antibiotics are not required to treat a whole range of common infections, and may ultimately promote bacterial resistance.

Five to ten years ago, of course, patients virtually demanded an antibiotic from their doctors in such situations.  These days, most patients are aware of this or, at least, do understand the situation when it is explained to them.

But, with TGA inviting responses from  stakeholder organisations, it is going to  require a huge effort to achieve the aims of broader community understanding of the rationale for the move by TGA to restrict availability of this group of widely-used, and generally well-regarded  infant and childrens’ medicines.”

Regular readers may remember that earlier this year Michele Kosky, executive director of the Health Consumers’ Council in WA, asked the TGA and Medicines Australia to investigate whether the consumer advertisement breaches the ban on direct-to-consumer advertising of prescription medicines.

In June, Croakey reported back that Kosky had not had any response from the TGA. Now it is October and, when I checked recently, she still had not had a response. Perhaps someone from the TGA might like to enlighten us about why the long delay?

Meanwhile, in case you missed her story in the Crikey bulletin last week, Dr Agnes Vitry, from the University of South Australia, has been examining some of the broader issues around direct-to-consumer advertising.

“Pfizer is running a big marketing campaign for its combination heart pill, Caduet. Medical magazines have been carrying full-page advertisements, advising doctors that “patients will soon be asking about their suitability for combination heart medications”.

The advertisement includes a sample from a consumer advertising campaign, which advises readers to talk to their doctor about a combination heart pill if they’re taking multiple medicines for their heart. The consumer ad incudes a rip-out section to take to the doctor, which carries a Pfizer logo and says “I’d like to discuss my treatment for high blood pressure or high cholesterol. Please advise me if a combination heart pill is suitable.”

This is occurring despite a Medicines Australia Code of Conduct, which complements the Australian legislation that prohibits direct-to-consumer advertising of prescription medicines. However, the code has several loopholes that allow pharmaceutical companies to subvert the ban on DTCA.

Unfortunately, direct-to-consumer advertising of Caduet is not an isolated case.

De facto direct-to-consumer advertising increasingly occurs in the form of “unbranded” advertisements or campaigns about specific diseases and conditions, which do not mention of the name of a specific medicine, but may include the company name or their logo.

Famous examples of unbranded marketing campaigns include the Viagra “Welcome Back Tiger” campaign. Pfizer, the maker of Viagra, simultaneously advertised to GPs and to consumers in popular magazines. The only difference between advertisements was the “omission” of the product name and product information in the consumer version. The tiger character became prominent in subsequent campaigns, making it synonymous with the product.

There are multiple examples of ongoing de facto DTCA campaigns in Australia. For example, Pfizer is currently running the “Master” marketing campaign for Champix (varenicline), a new drug marketed for smoking cessation.

The consumer campaign includes TV, radio, outdoor and online advertising. The “Master” is featured by a pack of cigarettes, “representing the manipulative inner voice of nicotine addiction”. This campaign encourages smokers to seek healthcare professional advice and visit outsmartcigarettes.com, a commercial website listing websites for smoking cessation products such as nicotine replacement product. At the same time, Pfizer is promoting Champix towards doctors and pharmacists and give them promotional leaflets to distribute to their patients.

Wide-scale advertising to the public of new medicines, whose long-term health effects are still unknown, is a threat to public health as two-thirds of the medicines that are withdrawn from the market due to safety concerns have been on that market for less than three years.

While advertising a medicine for smoking cessation such as Champix may seem a laudable objective, Champix is a new drug and as such, may cause severe adverse effects that may only be discovered post-marketing. No surprise, it is actually what happened with Champix.

Since the initial marketing of Champix, medicine agencies around the world have issued stronger and stronger safety alerts. In the United Kingdom, 1241 reports of suspected adverse reactions were received during the first year of marketing, mainly psychiatric adverse effects with headaches, abnormal dreams and nightmares, depressions and depressed moods and suicidal ideations.

In December 2008, the Australian Adverse Drug Reactions Advisory Committee (ADRAC) bulletin stated that they had received 339 adverse reaction reports with varenicline up to October 2008, more than 72% being psychiatric symptoms including depression, aggression, agitation, abnormal dreams, insomnia, hallucination and anger. There have also been reports of suicidal/self-injurious ideation or behaviour.

In July 2009, the US Food and Drug Administration required Champix to carry the agency’s strongest safety warning over side-effects including depression and suicidal thoughts. Despite the new, stricter warnings, the FDA said consumers and doctors still have to weigh the benefit versus the risks when taking the drug. “The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, the director of the FDA’s Centre for Drug Evaluation and Research.

Another ongoing DTCA campaign is the Bayer’s campaign on how “low testosterone can take the life out of you” (for example, full-page advertisement in the  August 22-23 Weekend Australian Magazine). This campaign encourages men to see their doctors if they have any symptoms such as “lack of vitality, reduced sex drive, mood swings, poor concentration and reduced strength”.

Bayer’s low testosterone campaign is typical of a disease awareness campaign that is used as a strategy to extend the boundaries of illness and to expand markets for new products. In the case of Bayer’s campaign, men are told to view non-specific and common symptoms that may occur in ageing as a treatable disease that could be cured. It is similar to the promotion of hormone replacement therapy (HRT) for menopausal women.

And when you have the “disease”, look out for the drug! A single internet search showed that Bayer was marketing in Australia a range of testosterone products, such as Reandron 1000 and Testogel. The use of testosterone products (androgens) in men outside very limited indications is not a harmless measure.

Severe adverse effects from inappropriate use of androgens include sodium and water retention, oedema, acne, gynaecomastia, impotence, testicular atrophy, priapism, inhibition of spermatogenesis, degenerative changes in seminiferous tubules, impaired glucose tolerance, hypercalcemia, polycythaemia, decreased clotting factors, increased LDL cholesterol, aggressive behaviour, psychotic symptoms, physical and psychological dependence, withdrawal symptoms etc.

The ban on DTCA is related to the ban on direct sales of prescription medicines. It a health protection measure to prevent unsafe and unnecessary medication use. The ban on DTCA is consistent with regulatory aims to protect health and with the National Strategy for Quality Use of Medicines to encourage appropriate medicine use. DTCA may pretend to be information, but its primary objective is to increase sales of one particular medicine without any consideration for the public health issues.

Unbranded product advertising and disease-awareness campaigns are two of the most common forms of DTCA that should not be allowed in Australia if the current regulatory ban was properly enforced.

Over the past 20 years, several complaints have been sent to Medicines Australia about unbranded product advertising and disease-awareness campaigns. To our knowledge, they have never been upheld if the name of the advertised product was not explicitly mentioned in the advertising campaign. Any further complaint to the TGA would just remain ignored because of their absolute “trust” in the efficacy of the self-regulatory system for the control of drug promotion.

In the past few years, the successive waves of international scandals have revealed to a wide public that misleading drug promotion and unethical behaviour of top international drug companies were systemic problems and not isolated cases. The passive attitude of regulatory agencies will have to change if they want to keep the trust of the Australian public.

Parliamentary Secretary for Health Mark Butler recently declared that the government has begun to conduct a complete review of how the relationship between pharma companies and doctors is regulated. We hope that the Australian government will take vigorous steps to enforce the ban of DTCA in Australia including unbranded product advertising and disease-awareness campaigns. We hope that we will regain confidence in the Australian regulatory agencies to achieve what they are meant to achieve: preventing unsafe and unnecessary medication use and protecting the Australian public from the harm of misleading drug promotion.”

• Dr Agnes Vitry is a member of Healthy Skepticism and Health Action International

But the gardener’s delight may be a patient’s peril – recent tests suggest some ginkgo products in Australia have been adulterated and that consumers are being conned.

Dr Ken Harvey, Adjunct Senior Research Fellow in the School of Public Health at La Trobe University, has been investigating the issue over the past year, and has some questions for the Therapeutic Goods Administration.

He writes:

“Ginkgo biloba (the Maidenhair tree) is a deciduous tree native to China, Korea and Japan. Ginkgo leaves and seeds have a long history of use in traditional Chinese medicine for a range of conditions. Ginkgo is one of the most widely used herbal medicines in Europe and the United States of America.

There are currently more than 400 products that contain Ginkgo on the Australian Register of Therapeutic Goods (ARTG). These are listed medicines and are commonly indicated for stimulating blood circulation.

On 2 October, 2009 the TGA noted (on their web site) that they had recently conducted tests on twenty-two (22) batches of herbal medicines containing Ginkgo biloba, covering twenty (20) products.

The TGA said:

“In some of the samples tested, elevated levels of quercetin and rutin were noted. These are naturally occurring components found in Ginkgo and many other plants. Variation in the content of these components may occur due to natural variation in the plants or the processing and storage of the herbal material. The TGA is currently working with its expert advisory committees and the complementary medicine industry associations to refine the quality standards for Ginkgo extracts used in medicines available in Australia.”

What the TGA neglected to point out was that one third of the samples tested had, in fact, failed the United States Pharmacopoeia (USP) identity test for Ginkgo biloba (Test B) because they had ratios of flavonoid components that were consistent with adulteration, not natural variation (for more info, see here and here).

It is common knowledge that some Chinese suppliers of cheap Ginkgo use only a little genuine leaf extract and spike it with less expensive sources of flavonoids, such as rutin (from buckwheat). This tricks standard tests that looks only at the total amount of flavonoids, not the spectrum specific to ginkgo. The concept is not dissimilar to
the scandal about melamine being added to milk in China although, fortunately, the compounds used to adulterate ginkgo do not appear to be harmful.

Nevertheless, consumers unknowingly purchasing adulterated ginkgo products are being hoodwinked, sponsors of products who have sourced genuine (but more expensive) extracts of Ginkgo biloba are being disadvantaged and those responsible for supplying adulterated products are clearly engaged in deceptive and misleading conduct as defined in the Trade Practices Act, 1974.

Eleven months ago, on 21/10/2008, I submitted a Freedom of Information (FOI) request to the TGA. I said, “I wish to know if the TGA has ever tested Australian complementary medicines containing Ginkgo biloba for adulteration with added flavonol glycosides or aglycones such as rutin from buckwheat”.

On 04/12/2008 I received a telephone call from Dr David Briggs (then Head of the Office of Complementary Medicines, TGA). He said, “the TGA was looking into this matter”. Subsequently, I heard no more.

On 11/05/2009 I became aware that the TGA had found that a random sample of 20 Australian herbal products containing Ginkgo biloba had failed United States Pharmacopoeia (USP) Identification Test B.

On 13/05/2009 I telephoned the TGA to inquire why I had not been informed about these results. I was told to submit a new FOI request.

On 14/05/2009, I submitted another FOI, “From testing documents held by the TGA, I request the brand and sponsors names of the 20 products tested and the identification of those products that passed and those that failed USP Identification Test B”.

On 01/10/2009, I received a letter from the TGA refusing my FOI request on the grounds that the documents contained information that:

* could adversely effect business (of third parties) if disclosed;

* if disclosed could prejudice the future supply of information from industry.

I have written to relevant government Ministers (Butler and Ludwig) expressing my concern that the TGA had failed to properly balance the public interest for disclosure against commercial interests that support suppression.

This matter is now open for public debate.”

***

Croakey will send Dr Harvey’s article to the TGA’s media people and ask for a response. We will keep you posted.

Update…and here it is:

From a spokeswoman for the TGA:

“It is important to note first that the TGA has been provided with no evidence of significant safety matters related to Ginkgo products by Dr Harvey.

While presented as a consumer interest matter, this issue appears to have been raised to allow certain companies to attempt to gain a commercial advantage by claiming other products are not meeting standards that are not
actually part of Australian regulatory requirements.

The reasons the TGA is not releasing the information requested under FOI to Dr Harvey include the facts that:
1) no products breached applicable Australian standards at the time of testing,
2) exemptions apply under the FOI Act that exclude the documents from release  as there is the potential for damage to occur to the legitimate interests of third parties, and
3) to release the information to Dr Harvey may be detrimental to the public interest by discouraging future cooperation with TGA testing programs aimed at raising standards of therapeutic products available to the Australian people.

The TGA has released information on its website about Ginkgo and TGA’s ongoing work on this issue.

In order to ensure that the Australian public continues to have access to the highest quality Ginkgo products the TGA is working with its expert scientific advisory committees to clarify appropriate Australian requirements for the composition of Ginkgo products so that there is no ongoing confusion about this matter.”

• a lot of people must be working pretty hard and wondering how on earth they’re going to pull it all off

• we will be hearing and reading plenty of reports emphasising the potential benefits of vaccination and maximising concern about the impact of swine flu.

In one sense, this is what happens whenever there is a roll out of a new health program or intervention; the advocates talk it up. But this time, they will no doubt be even more determined to do this, given the questions that are being asked about the merits of the campaign and its timing.

In light of this second point, you might be interested in this piece calling for a “common sense” response to swine flu, recently published by Healthy Skepticism, a group which is not known for being overly enthusiastic about medical marketing.

It is by Juan Gérvas, a rural GP in Spain, and a Visiting Professor, Primary Care, International Department, National School of Public Health (Madrid), Spain. He is also Honorary Professor, Public Health, School of Medicine, Autonomous University (Madrid).

Will he get a response this time?

**

Dear Mr Butler,

Re: Media release, 8 September 2008, “Ethical Promotion of Therapeutic Goods”

I have written to you previously about this topic in a letter dated 8 July, 2009. On 19 August, 2009 I asked for an appointment to discuss these matters with you (via Carla Macreadie in your Canberra Office). Despite several follow-up telephone calls, I have yet to receive a response either to my letter or my request for an appointment. However, I was sent your media release dated 8 September, 2009.

Your media release upset me. While I appreciated the government commitment to pursue, a level playing field on marketing obligations within the therapeutic goods industry” I was perturbed by your apparent reliance on a meeting with the TGA and industry associations, “to discuss their respective codes and consider potential strategies for a way forward” and “ensure that self-regulation retains public and Government confidence”.

Regrettably, it is my experience that neither Australian industry “self-regulation” or government “co-regulation” has protected consumers and health professionals from unethical promotion of therapeutic goods. In addition, I have no confidence that further bilateral discussions between the TGA and industry will improve the situation.

My interest in this area extends over many years. I was a member of the World Health Organisation group of experts that formulated the 1988 WHO “Ethical criteria for pharmaceutical promotion”. I am currently involved in two international projects: “Practical Implementation of the WHO Ethical Criteria for Medicinal Drug Promotion”1 and “Measuring the Impact of Pharmaceutical Promotion regulation”. I have submitted numerous complaints about unethical promotion and I have written a number of academic and lay articles about the deficiencies my experience has shown. I have suggested improvements in industry codes of conduct that have not been implemented.

I summarise the problems of therapeutic promotion in Australia below:

1. The focus on self-regulation has produced a plethora of industry codes and complaint systems which makes it difficult for complainants to know where to send a complaint (see flow chart attached).

2. As noted in my previous letter, there are different standards and gross inconsistencies between various codes, their complaint processes, timeliness, transparency, sanctions, monitoring and effectiveness.

3. Self-regulation has not worked as evidenced by companies both large and small continuing to re-offend against various codes of conduct.

For example:

• Pfizer Australia has had 17 complaints against Medicines Australia (MA) Code of Conduct upheld during 2005-09. Although one of these complaints received the maximum fine of $200,000, over this time the fines only averaged $50,000. There is no evidence that such modest fines have reduced Code violations by Pfizer or other
member companies. In contrast, U.S. regulators recently fined Pfizer $2.8 billion; a sanction much more likely to concentrate their mind. This is why Choice (the Australian Consumers Association) and others have argued that MA should increase the maximum fine for Code transgressions to $1 million in their submissions to the
recent Code review. Not surprisingly, this was rejected by MA who went on to make a token increase in fines of $50,000 only taking the maximum fine to $250,000.

• Cat Media produces products such as “FatMagnet”, “Fatblaster”, “FatblasterMax”, “Xantrax”, “Diuret” and “Horney Goat Weed”. They have had at least 18 complaints upheld by the Complaint Resolution Panel (CRP) over the last few years with more in the CRP’s overloaded queue. They have consistently ignored CRP determinations
(as have other companies) because the CRP has no power to enforce their “requests”.

4. Co-regulation is also ineffective. In theory, if self-regulation fails, our “co-regulatory” system provides a backstop in the Therapeutic Goods Administration (TGA). In practice, this backstop appears to be asleep on the boundary fence.

For example:

• I have had at least 20 complaints upheld by the CRP, refered on to the TGA, about which no more is ever heard. The consequence of this inaction is that sponsors know they can re-offend with impunity, complainants get disillusioned and the public continues to be hoodwinked by unethical promotion.

• Analysis of successful complaints (for complementary medicines) showed they clustered around product categories such as weight loss, memory enhancement and arthritis relief. In 2007, the TGA was asked to review the efficacy of all ingredients used in weight loss products in the hope that up-stream evaluation would reduce the need for downstream complaints. It is my understanding that industry concern watered down the scope of this review to a anodyne review of the evidence required to make claims for weight loss (with no implementation plan). This document was put up for comment by the TGA earlier this year and was extensively criticised by
many concerned parties. Subsequently no more has been heard.

• In addition, despite complaints, the TGA has failed to take action on misleading weight loss product and pack names such as “Fat Blaster”, “Fat Blaster Max”, “FatMagnet”, “Slim Me”, “Weight Loss Accelerate” and “Xantrax (High Potency Weight Loss Formula)”.

• I wrote to your predecessor, Senator Jan McLucas, about these matters on March 2, 2009. The letter was titled, “Failure of the “integrated three-tier system of controls” for the advertising of therapeutic goods in Australia – a case study of FatMagnet (ARTG: 145959, Cat Media Pty. Ltd.)”.  I have yet to receive a response.

• I was concerned that some Australian sponsors are promoting products containing Ginkgo biloba that had been adulterated (spiked) with cheaper compounds that were unlikely to be clinical active. I first submitted a Freedom of Information (FOI) request to the TGA about such adulteration on Oct 21, 2008 arguing that this
information was in the public interest. I am still waiting for an outcome.

In conclusion, Australian Medicines Policy is meant to be a partnership between all players including health professionals and consumer groups; not a bilateral arrangement between the industry and the TGA.

I am aware of a number of ongoing confidential discussions between the TGA and industry on matters such as the labeling of homoeopathic products and advertising requirements for complementary medicines. These bilateral consultations by the TGA are not in accord with the spirit of Australian Medicines Policy. The lack of input from key health professional and consumer groups ignores the important contribution these groups can make and destroys their confidence in the outcomes. It creates the unfortunate perception that the TGA is more concerned with industry protection than consumer protection.

The end result is a weak, dysfunctional and inconsistent co-regulatory system which fails to protect consumers (and health professionals) from unethical and misleading promotion. I and many others, believe a new approach is required as outlined in previous correspondence.

Once again, I request a meeting with you to discuss these important matters.
Yours sincerely,
Dr. Ken Harvey

Instead, he seems to have added fuel to the fire – at least, according to Dr Ken Harvey, who argues that the Government and TGA are making things all too cosy for the industry, at the expense of the public interest.

Harvey writes:

“Australian Medicines Policy is meant to be based on partnership with all the players, including consumers and health professionals. It is not meant to be a bilateral relationship between the Therapeutic Goods Administration and industry.

Yet, once again (see Mark Butler’s press release):

“The TGA is meeting with all the therapeutic industry associations next week to discuss their respective codes and consider potential strategies for a way forward.”

and Mr Butler said:

“I look forward to receiving advice on industry agreed options for working together to strengthen codes of conduct, provide a level playing field, and ensure that self-regulation retains public and Government confidence.”

In my opinion, these bilateral consultations between the TGA and industry are not in accord with the spirit of Australian Medicines Policy and the debate on ethical promotion must be opened up to include health professional and consumer groups as well.

Self-regulation is ultimately self-serving and these matters should not be left solely to the pharmaceutical industry.

If you agree, I suggest you communicate your concern to Mark Butler (as I have done).”

• Dr Ken Harvey is Adjunct Senior Research Fellow, School of Public Health, La Trobe University

The Food and Drug Administration says the supplements have been associated with serious side effects, including liver toxicity.  In Canada, a class action law suit has been filed.

Harvey, Adjunct Senior Research Fellow School of Public Health, La Trobe University, says the key issue is why do the company &/or the TGA believe that Australian products are safe when some of those withdrawn in the US appear to be the same as those available in Australia; see here.

He says: “To-date, the TGA has only warned consumers not to purchase US productsvia the Internet! The assumption is that the Australian products have a different formulation and that makes them safe. No evidence has yet been provided to support this assumption.”

Here is Harvey’s letter with some questions for the Federal Government:

6 May 2009

Senator Jan McLucas
Parliamentary Secretary to the
Minister for Health and Ageing
Parliament House
Canberra ACT 2600

Dear Senator McLucas,

Re: TGA warning issued on complementary medicines weight loss products  (Hydroxycut)

Adam Cresswell reported today that “AUSTRALIA’S drug watchdog has warned consumers to stop using a range of weight-loss products bought on the internet from the US, after 23 reports of serious liver problems, including one death” .

“A TGA spokeswoman said last night it had been informed by the Australian sponsor, Export Corporation (Australia) Pty Ltd, that the four Hydroxycut products approved for sale in Australia had a different formulation to the products sold in the US, as some of the US ingredients were not permitted here”.

I am unclear why the TGA warning is restricted to US products bought on the Internet and why the TGA has accepted the sponsor’s advice that the Australian listed products differ from those removed in the US and Canada.

I have appended the names of Hydroxycut products (and their ingredients) listed on the ARTG as sponsored by Export Corporation (Australia) Pty Ltd.

I have attached printouts of three current Australian advertisements for Hydroxycut products from:
http://www.mrsupplement.com.au/

One advertisement promotes Hydroxycut (ARTG No: 154243) as “America’s #1 selling weight-loss supplement. The ingredients in this product appear to be the same as those in product removed from sale in the US and Canada. In particular, they include Garcinia quaesita (cambogia) . The latter ingredient has been associated with hepatoxity .

I have also attached the detailed US Health Hazard Evaluation Board Report concerning Hydroxycut, “Liver toxicity following consumption of dietary supplement”.

I have the following questions:
1.     In what way does the formulation of Hydroxycut product (ARTG No: 154243) differ from those removed from sale in the US and Canada?
2.    Why has the TGA not withdrawn this product from the Australian market as has occurred in the USA and Canada?
3.    Does the TGA agree that the claims made for these products in the attached advertisements breach the Therapeutic Goods Advertising Code? If so, what action will be taken?

Yours sincerely,

Dr. Ken Harvey
Adjunct Senior Research Fellow
School of Public Health, La Trobe University
http://www.medreach.com.au

Pharma Focus recently reported the ASMI’s concerns about “mischievous misrepresentation” of the guidelines.

The discussion continues below. Read on…

Part 1
From: Ken Harvey, Adjunct Senior Research Fellow
School of Public Health, La Trobe University
To: Deon Schoombie, Australian Self-Medication Industry

Dear Deon,

It has been reported (in Pharma Focus) that, “Negative media reaction to the new guidelines has irritated the Australian Self Medication Industry (ASMI)”.

In response to queries from a colleague the TGA has stated, “It has not yet been proposed that all products would be scientifically tested for the evidence. The [draft] guidelines simply outline scientific evidence considered acceptable to support claims so that sponsors are aware of the type of evidence they should hold”.

In short, the TGA will continue to rely on sponsors doing the right thing or consumers and health professionals challenging the claims made.

While I accept that members of your association may respect the revised guidelines, you are well aware that there are many other non-ASMI sponsors who have consistently ignored the previous TGA’s “Guidelines for Levels and Kinds of Evidence to Support Indications and Claims,2001.” Why would they change what is obviously a profitable approach?

In addition, industry personnel who “pre-approve” advertisements (only in specified media) do not have the time to routinely ask for, and checkclaims against the evidence, as shown by successful complaints against advertisements with CHC pre-clearance numbers.

Furthermore, you cannot expect consumers and health professionals to continue to submit complaints when the CRP now merely forwards these to the TGA whereupon they disappear into a black hole and are never heard of again!

I (and others) would be much more positive about responding to these draft guidelines if the TGA had announced any intention of implementing them!

With best wishes,
Ken
–

Part 2
From: Deon
To: Ken

Dear Ken

Thank you for your email.

In our view there are 2 aspects to the issue of supporting evidence for indications and claims – the first is setting the rules (through regulatory requirements and/or guidelines) and the second is ensuring compliance with those rules. The guidelines address the first aspect and we believe it to be a major step in clarifying the required standards.

On the issue of compliance (and bearing in mind that the draft is still subject to public consultation and amendment) I believe it won’t be too difficult to request sponsors (at the time of pre-approval of ads, or when dealing with complaints or at the time of post-market audit – which could perhaps be stepped up in specific areas like weight loss as ASMI has been advocating for some time) to submit the “piece of paper” which supports weight loss of 5% and 3% above placebo in 2 – 6 months in the intended target population – no less and no more. Issues arising from sample size and research methodology (outlined in the guidelinesdocument) will also become evident straightaway and should result in a simple pass/fail conclusion.

The message will get out soon enough and most sponsors will get their houses in order. The others will get caught through the complaints process and post-market audits (increased targeted audits). In addition penalties and sanctions should be heavy enough to act as effective deterrent.

Kind regards
Deon
***

Part 3: PostScript from Ken

While I accept that the draft guidelines COULD be implemented along the lines Deon suggests, the TGA has shown no inclination to do so. In addition, there are still loopholes in the draft for claiming “traditional use” and using non-randomised, non-placebo controlled trials.