We’ve already heard buckets of criticism of the deal between the Pharmacy Guild and Blackmores, which would have seen pharmacists prompted to promote Blackmores products as “companions” to certain popular medications.
In the article below (first published in Medical Observer), Dr Ken Harvey, Adjunct Senior Lecturer, School of Public Health at La Trobe University, looks at some of the broader issues involved.
He calls on the TGA to provide information about whether specific complementary medicines have been evaluated, and for the National Prescribing Service or similar groups to provide more independent information about evidence-based complementary products that have not been registered.
(Update: On 26 October, a related article, from Carol Bennett of the Consumers Health Forum, was added to the bottom of this post).
***
A call for independent information about complementary products
Ken Harvey writes:
The Pharmacy Guild says its deal to promote Blackmores complementary medicines (CMs) has been withdrawn in view of “media reporting of the endorsement which was ill-informed and inflammatory”.
My own view is that the deal itself was ill-informed and inflammatory. It involved an undisclosed payment by Blackmores to enable GuildCare dispensing software to prompt pharmacists entering prescriptions to on-sell Blackmores “Companion” products.
The four Guild-endorsed Blackmores products were a probiotic to be promoted with antibiotics, zinc with blood pressure drugs, coenzyme Q10 with vitamin D3 for statins and magnesium with proton pump inhibitors.
The National Prescribing Service (NPS) and others have pointed out that there is no good evidence to support the routine use of these supplements with the prescription drugs targeted.
In addition, this practice would unnecessarily add to the “medication burden” experienced by many patients taking multiple drugs, including compliance difficulties, increased cost and potential drug interactions.
Finally, it presents ethical problems for GuildCare (who were recommending one brand only) and for individual pharmacists (who would benefit financially if they went along with prompts that may not be in their patient’s best interest).
Several polls have shown that the deal diminished the standing of pharmacists in the eyes of consumers and medical practitioners.
This cancelled deal brings back memories of another: pharmaceutical advertisements in prescribing software.
Health professionals and consumers also raised strong concerns about this practice and subsequently the Medicines Australian Code of Conduct was changed to include the clause:
“Advertisements for prescription products must not be placed in any section of prescribing software packages.”
The Code of Practice of the Complementary Health Care Council of Australia would benefit from proscribing similar deals.
The NPS evaluation of the Blackmores Companion products highlights the need for more independent information about complementary medicines, as does the increasing number of upheld complaints about their promotion and post-marketing data from the Therapeutic Goods Administration (TGA), showing high rates of regulatory non-compliance.
The recent Australian National Audit Office report titled, Therapeutic Goods Regulation: Complementary Medicines, said (paragraph 43):
“It would enhance transparency and help inform both consumers and healthcare professionals if the TGA were to place the summary of evidence it collects from sponsors, as received, on its website – with a clear indication of whether it had been assessed or evaluated by the TGA.”
There are a small number of registered CMs on the Australian Register of Therapeutic Goods (ARTG). If these products were registered recently, they have been thoroughly evaluated for quality, safety and efficacy (unlike listed CMs which predominate on the ARTG).
Examples include Blackmores Flexagil pain relief cream (a clinically proven comfrey root extract) for the topical treatment of sprains and osteoarthritis, and Flordis Iberogast (a clinically proven nine-herb mixture) for irritable bowel syndrome.
Unfortunately, some registered CMs were “grandfathered” into the ARTG without proper evaluation. At this point in time, there is no way the ARTG can be searched to obtain a list of registered CMs, let alone those that have been properly evaluated as distinct from grandfathered.
The TGA should be encouraged to include a list of properly evaluated, registered complementary medicines to help consumers and doctors separate the wheat from the hype-driven chaff.
In addition, the NPS (or other independent groups) should be encouraged to provide more independent information about evidence-based CMs that have not been registered.
However, this information needs to be product specific, not generic. Not all herbal products (or other CM formulations) are phyto or therapeutically equivalent.
***
(Added to post on 26 October, following publication yesterday in the Crikey bulletin)
The public deserves better information about complementary medicines in light of new safety concerns
Carol Bennett, Chief Executive Officer, Consumers Health Forum of Australia, writes:
We all like to have some control over our own health which is one of the strong appeals of complementary medicines. You can readily find complementary medicines carefully categorised by disease or symptom in one of the larger sections of your local pharmacy or health food store.
There are vitamins and other products claiming to help you lose weight, be in a better mood, experience less digestive problems, feel stronger, more sexual, help prevent or treat the symptoms of colds and flus, even have more energy. Many Australians say yes please to these products, with over a billion dollars being spent on complementary medicines each year.
Health professionals have generally adopted the view that although there are many unanswered questions about whether complementary medicines actually offer any real health benefits, these products are fairly harmless. Some consumers believe they feel better by using complementary medicines and perhaps they do, even if some of the effects may be a result of their belief in the products.
There is good clinical evidence supporting the prescription of a limited number of complementary medicines for very specific symptoms, but these are unusual cases which often involve some form of severe deficiency and they make up a very small minority of the vast numbers of consumers of these products.
The ‘largely harmless’ view of complementary medicines is now being challenged by emerging international research.
A US study published in the Archives of Internal Medicine looked at the use of vitamin and mineral supplements in relation to total mortality in 38,772 older American women (with an average age of 62) and found that the use of multivitamins, Vitamin B6, folic acid, iron, magnesium, zinc and copper were associated with an increased risk of total mortality when compared with corresponding non-use.
The study controlled for key health factors and concluded that the regular use of complementary medicines is a direct contributor to poorer health outcomes. This follows on from another study showing that healthy men who take Vitamin E have an increased risk of prostate cancer.
In Australia it is the Therapeutic Goods Administration (TGA) that is responsible for regulating complementary medicines. Over 10,000 complementary medicine products are listed on the TGA Aust-L list.
For most Australians, this is a source of some comfort. However, the reality is that the TGA does not test complementary medicines to see if they do what they claim to do. Nor do they test every product to see if it is safe.
The listing is largely a self-report process and the only real check is the occasional audit of the information provided by manufacturers on the forms. Less than 5% of products are audited and the last time such an audit was conducted on a limited number of complementary medicines, over 90% failed to comply with the regulations.
Complementary medicine manufacturers go to some lengths to create the illusion that their products have been tested by authorities for efficacy, that is, whether or not they work as they claim to. Complementary medicine manufacturers also draw on well targeted marketing, product placement, celebrity and sports hero endorsements to give the impression their products really work.
Australia is not as litigious as the United States where the need to protect governments from legal action has informed labelling decisions. This does not mean Australian authorities should ignore their responsibilities.
We need to adopt a sensible approach to the labelling of complementary medicines based on the principle of consumers having the right to know whether or not a product has been properly tested.
Australia should follow the lead of the United States and clearly label all complementary medicines: ‘This product has not been tested by Australian authorities.’
Labels may not significantly change consumer behaviour in purchasing and using complementary medicines. At the same time, it is not acceptable that complementary medicines are able to imply through their packaging and marketing that they have been tested or endorsed by the TGA or other authorities.
The complementary medicines industry will resist the labelling of their products, but given emerging concerns about the possibility that some of these products may cause harm, it is almost inevitable that governments will be forced to protect their own interests as a regulator of medicines.
The reality is that many of these products have very little clinical evidence to support the claims they make, they have not been tested by the TGA or any other government authority, and they adopt misleading marketing strategies to imply their clinical effectiveness has been established.
At the point where there is evidence that some of these products may be contributing to a reduction in life span or harming people’s health, it is time consumers were given the information they need to make an informed choice.
Anything less than full disclosure about the lack of testing compromises the capacity of health consumers to appropriately purchase and use complementary medicines.
The government can no longer put the complementary medicines industry into the harmless category and ignore their responsibility to properly inform Australia’s health consumers.
***
Previous Croakey posts on the Guild/Blackmores deal
The TGA is not capable of assessing complementary medicines, much as it would like to. Best it sticks to assessing patent medicines – the ones that cause far more issues with un-expected interaction and debatable efficacy. That said, it would be good to have guarantees as to the contents of the bottles etc. But leave the consumers to tinker. No harm done unless people are so stupid as to drink a litre of olive oil or some-such. Not even the TGA can stop the Darwin Effect.
For the most part there are few consequences for leaving the punters to fiddle about with herbs and vitamins … the worst that happens is that they quite literally flush their money away each morning.
But there are some instances where specific complimentary medicines can have a dramatic interaction with prescribed medicine…. one being St John’s Wort and it’s reaction with anti-depressants. There have also been a few instances where traditional Chinese concoctions – taken by enthusiastic amateurs have led to death.
A few years back as a newly appointed member of the Science Faculty Board, – and coming from a background not too far from the TGA – I found myself suggesting that rather than establishing a proposed School of Traditional Chinese Medicine for fee-paying undergrads, the more rational approach would be to establish a centre for evaluating complimentary medicines at a post-grad level and seek government and industry funding. Money was available and the project would have indeed been most welcome to the then Federal Minister.
Unknowingly I had wandered into a tense no-man’s land between the biological sciences (who had a host of nursing lecturers facing imminent redundancy) and the so called “hard scientists” who believed that such potions were barely removed from witchcraft and astrology. Not much wiggle room.
The School was of course established – saving the university a bucket of money, keeping a lot of redundant staff employed and pulling a stream of cash from offshore. And leaving the scientists appalled at being associated with a faculty that taught techniques based on unproven assertions, folktales and myths.
Such is the way these decisions are made, that legitimacy is conferred. And still the claims go unchecked. What a waste.
Colin, why would efficacy evaluation for CMs be different in any way whatsoever to evaluation of patent medicines? If medicine works, it works, regardless of whether its genesis is in a lab or a herb.
If I’m buying a bottle that’s labelled “Flower Extract – cures diabetes!” I don’t just want to know that its contents are 100% extracted from flowers. I also want to know that the medical claim has been properly tested, that the stuff in the bottle does what it says on the bottle.
Alternative medicine methods are diverse in their foundations and methodologies. Methods may incorporate or base themselves on traditional medicine, folk knowledge, spiritual beliefs, or newly conceived approaches to healing.-Guy Riordan
Seems pretty simple to me. Double blind, or meta-epidemiology. Long term studies. Hang on.. didn’t the Scandanavians just do that on mega- and multi-vitamins for women, and didn’t they find they actually *cut* life expectancy, not increased it…
oh dear.