Following on from previous posts, here is another letter to Parliamentary Secretary for Health, Mark Butler, from Ken Harvey today (and copied to Graeme Samuel at the Australian Competition & Consumer Commission).
Will he get a response this time?
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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
Goodluck with that Ken, sounds to me like the FDA and the TGA are twins.