When Dr Ken Harvey spoke to Vic Skeptics earlier this year, a lot of us came away feeling that the Therapeutic Goods Administration was not serious about its role in ensuring that Australians have good information about and acess to reliable and safe over-the-counter medicines and therapeutic devices. An opportunity has since arisen for us to have our “two bob’s worth” before the Federal Government looks at revamping the TGA. Our first of two scheduled submissions is included here.
It has been sent primarily to The Hon Mark Butler in his capacity as Parliamentary Secretary for Health.
The Hon Mark Butler MP, Parliamentary Secretary for Health
Dear Mr Butler,
Australian Skeptics: Submission on the Position Paper on the Promotion of Therapeutic Goods
The Victorian Branch of the Australian Skeptics is part of a loose confederation of groups across Australia that investigates and debates pseudo-scientific and paranormal claims from a responsible scientific viewpoint. The Australian Skeptics publish a quarterly magazine entitled The Skeptic and host an annual national convention which includes prominent scientists, researchers and authors amongst the keynote speakers.
Skeptics encourage thoughtful, rational exploration of the world around us. We do not believe in the paranormal, miracle cures, astrology and the like. We do believe in reproducible results, recognising that sometimes not finding an expected result is an important part of the scientific process. To this end, the Skeptics are keen to promote scientific education and a sense of wonder in the natural world.
Skeptics encourage people to think carefully and seek appropriate evidence before coming to a conclusion on an issue. Things that sound “too good to be true” usually aren’t true! Science has revealed many amazing things, but amazing (unjustified and/or unbalanced) claims are also used to deceive and to defraud innocent people. Unfortunately, this is also true of therapeutic goods; hence our interest in the government’s position paper on their promotion.
We understand that the Government’s aim is ensure that decisions on management (including treatment) options for health needs are based on sound clinical evidence, not driven by incentives or other influences, and that self-regulatory codes of conduct are effective in minimising the potential for any promotional activities to compromise the quality use of medicines and to increase cost pressures on the health system.
Regrettably, there are many examples where therapeutic goods companies have placed their desire for profits ahead of ethical behaviour. One recent example is Merck and rofecoxib (Vioxx). On May 21, 1999, Merck was granted approval by the Food and Drug Administration (FDA) to market rofecoxib. On September 30, 2004, after more than 80 million patients had taken this medicine and annual sales had topped $2.5 billion, the company withdrew the drug because of an excess risk of myocardial infarctions and strokes. By 2001 there had been concern expressed about the potential cardiovascular risks associated with rofecoxib. Merck’s response was to issue a relentless series of publications, beginning with a press release entitled “Merck Reconfirms Favorable Cardiovascular Safety of Vioxx” and complemented by numerous papers in peer-reviewed medical literature by Merck employees and their consultants. The company sponsored countless continuing medical “education” symposiums at national meetings in an effort to debunk the concern about adverse cardiovascular effects. Over the course of this five-and-a-half-year saga, many epidemiologic studies confirmed and amplified the concern about the risk of myocardial infarction and serious cardiovascular events associated with rofecoxib. However, each time a study was presented or published there was a predictable and repetitive response from Merck, who claimed that the study was flawed and that only randomized, controlled trials were suitable for determining whether there was any risk. Meanwhile, Merck was spending more than $100 million per year in direct-to-consumer advertising; a critical mechanism in building the “blockbuster” status of a drug with annual sales of more than $1 billion. The end result was the unnecessary death of thousands of patients around the world and ongoing legal action.
The government has, in the first instance, urged industry to strengthen and standardise self-regulation through developing an industry framework for universal adherence to consistent industry-wide Codes based on a common set of high level principles. It has also noted the need for mechanisms to extend the application of Codes to non-members of industry associations and align industry codes with healthcare professional standards developed in conjunction with national registration.
1. The Vioxx and similar sagas show that self-regulation is not enough; a productive synergy is required between self-regulatory Codes and government regulation so that the strengths of one can cover the weaknesses of the other. For example, a company may not be a member of a self-regulatory industry association or may resign rather than face sanctions.
2. There must be a legislative requirement for industry to commit to transparent self-monitoring, independent monitoring, Code adherence, complaint resolution procedures and education on ethics as a condition of gaining marketing approval from the Therapeutic Goods Administration.
3. Code(s) must be developed co-operatively in genuine partnership with all stakeholders: industry, consumers, health professionals and government in accord with the partnership principle of National Medicines Policy.
4. There must be similar ethical requirements for health professionals’ relationships with the therapeutic goods industry through the Australian Health Practitioner Regulation Agency (it takes two to tango).
5. Skeptics want one high-level Code of conduct for the Therapeutic Goods sector and one transparent system that includes self-monitoring, independent monitoring, complaint resolution, education and review; not eight Codes as at present. This does not pre-empt specific industry sectors formulating additional Code requirements for their members nor the possible formulation of sector specific monitoring and complaint panels.
6. High-level ethical principles should include:
6.1. Active promotion within a country must take place only with respect to drugs legally available in the country. Promotion must be in keeping with national health policies and in compliance with national regulations, as well as with voluntary standards where they exist.
6.2. All promotion-making claims concerning medicinal drugs must be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste. They should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable use of therapeutic goods or to give rise to undue risks. The word “safe” should only be used if properly qualified.
6.3. Comparison of products must be factual, fair and capable of substantiation.
6.4. Promotional material must not be designed so as to disguise its real nature.
6.5. All therapeutic goods clinical trial protocols must be logged onto a public national register at their inception, such as the Australian New Zealand Clinical Trials Registry, to be collated by the World Health Organisation International Clinical Trials Registry Platform (WHO ICTRP).
6.6. The complete and full results of all clinical trials must also be placed in the public domain through publication in peer-reviewed journals and/or on the clinical trials registry web site.
6.7. Scientific and educational meetings and activities must not be used for promotional purposes.
6.8. Promotion in the form of financial or material benefits must not be offered to or sought by health care practitioners to influence them in their use or recommendation of therapeutic goods.
6.9. It is recognised that there are legitimate financial relationships between the therapeutic goods industry and health providers and/or their institutions such as payment for conducting research, consultancy and sponsoring educational activities; in all cases these require public financial disclosure. Thus, therapeutic goods sponsors must publically disclose all payments to individual health care providers and consumer and patient support groups, their institutions or agents whether cash or in-kind transfers including: compensation; food, entertainment or gifts; travel; consulting fees; honoraria; research funding or grants; education or conference funding; stocks or stock options; ownership or investment interest; royalties or licenses; charitable contributions; and any other transfer of value.
6.10. Packaging, labelling and promotional material must place the scientific (generic) name of the active ingredients(s) in a larger and equally prominent type font, in front of, or above the brand name.
6.11. Sales representatives must not receive bonuses and other rewards for merely increasing sales; rather they should be rewarded for achieving quality use of therapeutic goods.
6.12. If industry wishes to contribute to funding the education of health professionals then this money should go to an independent central co- ordinating office to co -ordinate and oversee all requests for, or offers of, industry funding, and to receive and distribute these funds. All industry educational scholarships and travel funding should also be coordinated through this independent office, which would evaluate and choose recipients.
29 July 2010
Australian Skeptics (Victorian Branch)
PO Box 5166, Melbourne, 3001