 |
|
|
Editor's Note: Stuart Adams is a nutritional activist with a passion for evidence-based professional advice.
He has observed the quality of advice some pharmacists give in their daily practice when recommending nutritional supplements, and he finds it lacking.
Given that pharmacy has a commitment to excellence and has been diligently working to raise accreditation standards, what is going wrong in the nutritional advice area?
In a two-part series that commenced in last month's edition of i2P, Stuart talks of his observations and first-hand experiences when working in a pharmacy environment.
This month Stuart is suggesting some potential solutions.
You may disagree with him - that is your prerogative.
But if you catch a glimpse of your reflection within this well researched article, then please take this as an opportunity to raise the barrier.
If Stuart has found these "holes" within the pharmacy profession, others will have surely noticed, and the reputation of all pharmacists declines accordingly .
Shortly after the February edition of i2P was published, a Choice survey concerning the sale of S3 products, specifically Xenical. was published in the daily newspapers.
It confirmed some of Stuart's observations and pharmacists must immediately correct these proven problems.
I value the reputation reported in past surveys of the Morgan Gallup Poll, measuring public opinion for the trust and integrity of pharmacists.
I believe that the ratings were justifiably earned over past years.
I believe that there are many pharmacists letting me down by not being professional.
Please take this as a wake-up call and examine your professionalism against the following commentary.
What are the alternatives?
One might reasonably argue that pharmacists should not be allowed to sell any unproven medicines at.
Unfortunately though this could mean a disaster from public health perspective, as it would mean that people seeking complementary medicines would instead have to go to the health food stores; the advice of which has been shown to be disastrously unreliable. 22
Another suggestion may be to allow pharmacies to sell CAM’s if they have a qualified naturopath working there.
After all, many naturopaths have university science degrees these days, and I’m sure than many naturopathic associations would be equally concerned about people receiving CAM advice from inadequately qualified people such as MLMers and health food store clerks. Unfortunately however, I would have to disagree that a naturopathic university education does much to protect consumers.
Back when I was going my nutrition degree, I decided to do ‘Herbal Medicine’ as an elective (a unit compulsory for naturopathy students).
To give a few examples of what naturopathy students are taught, below are a handful of the ‘immune modulating herbs’ with the appropriate uses, as laid out in our study guide.
Perhaps with the exception of Hypericum (St Johns Wort) for depression, many of these purported indications range from the plausible yet unproven, to the dangerously inaccurate. After sitting through an entire semester of this stuff as well as discussing it with the other students, including a focus group study I conducted using some of them as subjects later on in my degree to canvass their opinions about CAM use in Australia.
Several things were clear (none of which were at all surprising).
- Naturopaths (at least these ones) do not like real doctors or orthodox medicine, and gave the impression that they would not agree with most orthodox medical treatments. (Not very comforting given the high level of people who seek treatment from naturopaths and other CAM therapists, especially cancer patients (given the potential for CAM’s to interact with chemotherapy23,24) many of which do not inform their doctors they are taking CAM treatments.25,26)
- Even at a university level, naturopathy students are taught that modalities such as homeopathy and iridology are not unproven (let alone implausible) hypotheses, but instead that iridology is an effective means of assessing a patients health status and that homeopathy is an incredibly effective means of treating almost every disease in the book. (Suffice it to say, neither is true.27,28) So much for university training ensuring a high standard of healthcare education.
Given the unreliable sources of information Australian naturopaths report using29 (which include ‘professional’ newsletters, seminars run by manufacturers, patient feedback and personal observation of patients, though do not include peer reviewed publish research) together with their unscientific training, I don’t think that placing naturopaths in pharmacies is an appropriate solution – it may even make the situation worse.
Better Regulation
When it comes to protecting the public against useless or potentially harmful listed therapeutic goods, (and the potential for retailers to give misleading advice about them) I think that TGA regulation, especially in regards to labeling, is the most important step in the right direction.
Unlike ‘registered therapeutic goods’(pharmacy only medicines) which need to be proven efficacious and tested for any potential adverse reactions, all you need to say is that something has been used by three generation of people for the TGA to consider it safe enough to be sold as a ‘listed therapeutic good’ (which most CAM’s fall under).
Perhaps most disturbing is that with the exception of supplements containing Retinol (vitamin A) or selenium, no listed therapeutic good must mention any potential side effects or contraindications on its label.
Having dealt with hundreds of pharmacy customers, it is clear that the inadequate labeling regulation and absence of label warnings is responsible for giving many consumers the impression that these products must be ‘natural’, safe and harmless.
Many customers think that the worst case scenario is simply that the product ‘doesn’t help’ and assume that the labels would warn them about any potential adverse reactions
I don’t think it’s too unreasonable to suggest that the absence of label warnings (especially when registered therapeutic goods are often riddled with them) is largely responsible for the widespread misconception that CAM’s must be completely without potential harm.
I also don’t think it’s too far fetched to suggest that the dietary supplement industry is largely dependant on this widespread false sense of security, and consequently remain adamant that things stay the way they are, as warnings might start scaring off customers.
Many CAM proponents argue that concern over the safety of these medicines is unnecessary, as few if any people die or are harmed from their use, as apposed to those who die or are harmed from inappropriate use of prescription medications.
My response is that the only reason that we are aware of the harm associated with certain registered therapeutic goods is because they are constantly studied (though some would argue that they are still not studied enough to identify potential harm, especially in regards to prolonged use).
Just imagine if tobacco (which is also ‘natural’ and stems from many generations of traditional use) had not been studied so extensively.
My suggestion would be not to allow any therapeutic goods to be sold at all without adequate clinical trials to identify any potential adverse effects.
Once any potentially harmful effects have been identified, surely it’s not too much to ask that consumers be warned about them by listing them on the labels.
But who would foot the bill?
Proponents of CAM constantly argue that because ‘natural’ medicines can not be patented, there is no financial interest in studying them.
Although this is true to some extent (though many supplement companies patent their own unique combinations of them, even though most in Australia rarely pay for clinical testing), it doesn’t somehow automatically make them safe and effective.
Australians spend an estimated two billion dollars on CAM each year.1
How wonderful it must be for major supplement companies such as Blackmore’s and Natures Own (not to mention retailers including pharmacies) to be able to take such an enormous piece of this complementary pie, without (unlike makers of registered goods) having to spend a cent on research to assure safety and efficacy.
Even rigorous testing does not guarantee the safety and efficacy of a medicine, but surely it’s better than the alternative.
It’s a win win situation for them.
Unlike makers of registered therapeutic goods, if a listed therapeutic good ends up being safe and effective, then the supplement companies (and retailers, including pharmacies) win.
If they aren’t safe and effective, then they win anyway, because it really doesn’t matter – they will continue to be sold and will never have to bare any warnings on their labels.
Although I know this is a relatively far stretch, the only possible suggestion I could think of would be for the federal government to fund independent testing of supplement product sold in Australia (as the NIH’s National Centre for Complementary and Altenrtive Medicine has done in the United States) only charge anyone selling them (both manufacturers and retailers) some kind of tax or levy to cover the cost.
It’s only fair that the more supplement companies and retailers make by selling these things, the more they should be taxed to help foot the bill for studying them.
Given the enormous fight that anyone associated with the CAM industry puts up when anyone else comes close to infringing on their rights to sell untested medicines without having any objection to it, (including the Complementary Healthcare Council, who I think should replace the word ‘Council’ with ‘Union’ as all they really do is vigorously promote anything CAM related and emphatically reject any criticism of anything CAM related) I doubt that this will ever happen.
Labeling - Safety
Other than mandatory listing of any potential adverse effect, I would suggest that all listed therapeutic goods bare warnings that consumers should inform their DOCTOR that they are taking it.
I once had a chat with the marketing director of a major supplement company who told me how delighted he was that the TGA had allowed them to write ‘health care professional’ instead of ‘doctor’ because ‘health care professional’ could mean a naturopath (or pharmacist) or someone else who would be more likely to recommend the product than a doctor.
Funnily enough, even though they can’t to manage to list any potential adverse effects, Blackmores products do manage to list a 1800 number which you can call to get free advice from one of their naturopaths.
How convenient.
Labeling – Efficacy
The other major change I would propose is that the TGA crack down on loopholes in current legislation which allow supplement companies to make certain health claims on the labels of their products.
Although they can not technically state that their products can treat or cure a specific medical disease, a frequent method of getting around this is to take a physiological process that a particular nutrient or herb may affect, and carefully word the description to suggest that it may somehow be effective for treating conditions which affect that physiological process.
For example, vitamin C is needed for wound healing, though given that it is extremely unlikely that anyone is going to be so deficient in vitamin C that their wound healing abilities would be impaired, it is misleading for supplement companies to mention this physiological function on their labels.
The question we want to know is not what this nutrients (or any others) function is, but whether taking this product is going to make our wounds heal any better or any faster than it would if we didn’t take it.
Zinc may be involved in “maintaining a healthy immune system” and is “essential to maintain healthy skin” but is taking additional amounts of it going to make our immune system work any better or our skin any healthier than if we didn’t take it?
And even if the answer is yes, then is it going to make it work that much better that it will actually have any measurable effect on any specific disease state?
Vitamin E might be involved in “healthy heart function” by “reducing oxidation of LDL cholesterol” and helping to “protect capillary function”, but does it treat or decrease the risk of getting heart disease?
The B complex vitamins may indeed “aid the body during times of stress”, and vitamin B6 may be “necessary for the formation of haemoglobin”, but is taking additional doses of them going to help decrease your stress levels and treat anemia, or will it just change the colour of your urine?
Whilst Milk Thistle may have “traditionally been used in European medicine to enhance liver function, assisting as a natural liver tonic,” will it help effectively treat or prevent any actual disease of the liver?
Although Astragalus may have been “traditionally used to help support a healthy immune system”, will it help prevent or treat any actual medical condition affecting the immune system (let alone HIV and cancer, which university educated naturopaths will be using it to treat).
If the answer to these questions is yes, then they should be saying that they will actually treat or prevent those disease states instead of making vague, non-specific statements about what role they play in the body, or what their ‘traditional; uses are..
If the answer is no (and it generally is) then although these statements may be technically true, they are unnecessary and are deliberately deceptive to the average lay consumer.
The TGA needs to tighten the loopholes they currently have which allow supplement companies to mislead the public with vague and deceptive wording, whilst avoiding the necessity to mention any potential adverse affects they might have.
Clinically proven?
Perhaps the most mind boggling examples are where the labels do not use vague wording at all, but instead make very specific claims about the ‘clinically proven’ efficacy of their product when no such clinical proof exists at all.
The most common examples are where supplement companies will not use systematically reviewed data, but instead selectively cite only supporting studies and ignore the rest (as they did when Choice magazine approached companies selling herbal weight loss supplements some time ago.18)
For example, despite several reviews (including a recent one published in the December 2006 issue of the Journal of the American Dietetic Association17) listing hydroxycitric acid (from the herb Garcinia cambogia,) as being ineffective for weight loss, why is it that Blackmores can claim on the label of their Weightloss Accelerate™ product (which contains only hydroxicytric acid) that its “Clinically proven ingredient” produces “3 times greater weight loss than diet and exercise alone” and that “results [are] usually expected after 4 weeks”?
I’m sure that it’s just a coincidence that they are sold in 4 week packs, and not a marketing ploy to increase the chances of consumers purchasing a second pack even after the first month of disappointment.
Their website cites not a review paper, but only a single small study as justification for this claim.30
The most significant example of recent times was the Tebonin fiasco where Schwabe Pharma Australia Pty Ltd made very explicit claims about the clinically proven efficacy of their Ginkgo biloba product (Tebonin) for the treatment of tinnitus.
Despite a Conchrane review finding that Ginkgo was an ineffective treatment for tinnitus,31 one judge decided that apparently, the public should not be afforded the right to know this, and stopped self appointed consumer watch dogs ‘AusPharm Consumer Health Watch’ (who simply couldn’t afford to fight them any further) from making it publicly known.32
Pharmacist Mark Dunn from AusPharm also sent their report as a complaint to the Therapeutic Goods Advertising Code Council (TGACC) who, only after all the rigmarole, finally decided to change the wording that the Tebonin claims were allowed to make.33
My only suggestion would be that if makers of listed therapeutic goods really do have the hard core scientific data to back up claims of ‘clinically proven’ efficacy, then why not just sell the product as a registered therapeutic good?
As it turns out, makers of listed goods do not need to present supporting evidence before they make claims on their labels.
All they need to do is have the evidence available if by some chance the TGA wants to challenge is, which is probably only likely if someone complains.
What can you do?
Speaking of which, I was pleased to read in last summers issue that skeptic Loretta Marron (‘The Jelly Bean Lady’) has managed to draw enough media attention to these problems (including a regular radio show on which she invited me on as a guest 3 times as well as an article on Australian Doctor) that she inspired Professor Lesley Campbell to write a letter of concern to Tony Abbot, which consequently resulted in a $5 million grant to investigate the use and effectiveness of complementary and alternative medicine in Australia.
Whilst most of us are not professors that government ministers will listen to directly, I would say that the next best thing for the rest of us to do is to submit complaints to the TGACC.
It may be a more economically sensible way to help contribute to consumer protection than by direct public education, which, as we have seen with AusPharm Consumer Watch, can result in costly litigation.
The bottom line
There is no perfect solution to these complex problems.
If however utterly useless products were not available, and those which had at least some use possessed no cleverly yet deceptively worded misleading claims (and this includes their websites and promotional literature as well as the label) and were required to list warnings of any potential side effects or interactions, (as apposed to leaving the customer to discuss it with a ‘health care professional’ of their choice) then I would suspect there would be less potential for pharmacists and pharmacy staff to abuse their position and sell unsuspecting customers products based on false premises.
Until this happens however, from a public health perspective I would strongly object to promoting a message to the public to “ask your pharmacist,” at least when it comes to CAM’s. Whilst I’m sure there are many pharmacists out there providing honest, reliable advice, currently, there is little necessity for them to do so, and just too much room for them to exercise dishonesty and let their critical thinking caps lapse.
Restricting the ability for manufacturers to deceive the public is, in my opinion, the best way to limit the retailer from doing the same.
I’m sure that both supplement companies and their retailers would fiercely object to tighter regulation on the grounds that it may hurt the CAM industries (which include pharmacies), though I really don’t think that protecting the financial status or reputation of any industry should be considered more of a priority than protecting the vulnerable lay public from being mislead and potentially harmed.
I’m all for people using dietary supplements and perhaps even various other CAM’s so long as they do so appropriately, make an informed decision about their use and are not mislead, exploited or unnecessarily harmed.
Surely that’s not too much to ask.
References
1. MacLennan AH, Wilson DH, Taylor AW. The escalating cost and prevalence of alternative medicine. Prev Med. 2000;35:166-73
2. Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids. Washington, D.C.: National Academy Press; 2000.
3. Australian Institute of Health & Welfare. Apparent Consumption of Nutrients Australia 1997-1998. Canberra . December 200
4. Hendler SS, Rorvick D. PDR for Nutritional Supplements. Medical Economics Company. 2001; Montvale , NJ
5. Rumbold A, Crowther CA. Vitamin C supplementation in pregnancy. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD004072.
6. Samborskaya, E.P. The effect of high ascorbic acid doses on the course of pregnancy on the guinea pig and on the progeny. Byull Eksp Biol Med. 1964; 5: 105-8
7. Fahim, MS., Hilderbrand D, Wilson R, Harman JM, and Hall DG. Effect of high doses of ascorbic acid on female reproduction. In. Fifth International Congress on Pharmacology, Abstracts of Volunteer Papers. San Francisco. 1972:66.
8. Blatt DH, Pryor WA. High-dosage vitamin E supplementation and all-cause mortality. Ann Intern Med. 2005;143:150-1;
9. Miller ER 3rd, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E.Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med. 2005;142:37-46.
10. Hu Z, Yang X, Ho PC, Chan SY, Heng PW, Chan E, Duan W, Koh HL, Zhou S. Herb-drug interactions: a literature review. Drugs. 2005;65(9):1239-82
11. Heck AM, DeWitt BA, Lukes AL. Potential interactions between alternative therapies and warfarin. Am J Health Syst Pharm. 2000 Jul 1;57(13):1221-7; quiz 1228-30
12. Izzo AA. Drug interactions with St. John's Wort (Hypericum perforatum): a review of the clinical evidence. Int J Clin Pharmacol Ther. 2004 Mar;42(3):139-48.
13. Henness S, Perry CM. Orlistat: a review of its use in the management of obesity. Drugs. 2006;66(12):1625-56
14. Egger G, Cameron-Smith D, Stanton R. The effectiveness of popular, non-prescription weight loss supplements .Med J Aust. 1999 Dec 6-20;171(11-12):604-8
15. Saper RB, Eisenberg DM, Phillips RS. Common dietary supplements for weight loss. Am Fam Physician. 2004 Nov 1;70(9):1731-8.
16. Pittler MH, Ernst E. Dietary supplements for body-weight reduction: a systematic review. Am J Clin Nutr. 2004 Apr;79(4):529-36.
17. Sharpe PA, Granner ML, Conway JM, Ainsworth BE, Dobre M Availability of weight-loss supplements: Results of an audit of retail outlets in a southeastern city J Am Diet Assoc. 2006 Dec;106(12):2045-51.
18. CHOICE. Test: Slimming Pills. May, 2005. Available at: this link
19. Naidu S, Wilkinson JM, Simpson MD. Attitudes of Australian pharmacists toward complementary and alternative medicines. Ann Pharmacother. 2005 Sep;39(9):1456-61
20. Choice Magazine: Pharmacy Advice in the Spotlight. Online version available at: http://www.choice.com.au/viewPressRelease.aspx?id=104444&catId=100202&tid=100010&p=1
21. Semple SJ, Hotham E, Rao D, Martin K, Smith CA, Bloustien GF. Community pharmacists in Australia: barriers to information provision on complementary and alternative medicines. Pharm World Sci. 2006 Nov 21
22. Barrett, S. Don't Trust Advice from Health-Food Retailers! Quackwatch. See:
http://quackwatch.org/01QuackeryRelatedTopics/hfsadvice.html
23. Meijerman I, Beijnen JH, Schellens JH. Herb-drug interactions in oncology: focus on mechanisms of induction. Oncologist. 2006 Jul-Aug;11(7):742-52.
24. Malekzadeh F, Rose C, Ingvar C, Jernstrom H. Natural remedies and hormone preparations--potential risk for breast cancer patients. A study surveys the use of agents which possibly counteract with the treatment Lakartidningen. 2005 Oct 31-Nov 6;102(44):3226-8, 3230
25. Begbie SD, Kerestes ZL, Bell DR. (1996) Patterns of alternative medicine use by cancer patients. Med J Aust. 18;165(10):545-8.
26. Miller M, Boyer MJ, Butow PN, Gattellari M, Dunn SM, Childs A. The use of unproven methods of treatment by cancer patients. Frequency, expectations and cost. Support Care Cancer. 1998 Jul;6(4):337-47.
27. Ernst E. Iridology: A systematic review. Forsch Komplementarmed. 1999 Feb;6(1):7-9
28. Ernst E. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol. 2002 Dec;54(6):577-82
29. Smith C, Martin K, Hotham E, Semple S, Bloustien G, Rao D. Naturopaths practice behaviour: provision and access to information on complementary and alternative medicines. BMC Complement Altern Med. 2005 Jul 11;5:15..
30. Preuss H, Garis R, Bramble J, Bagchi D, Bagchi M, Rao C and Satyanarayana S Efficacy of a novel, natural extract of (-) hydroxycitric acid (HCA-SX) in Weight Control. Int J Clin Pharm Res.2005; XXV (3):133-144 (N.B – I can’t even find this paper anywhere – it certainly isn’t listed with PubMed)
31. Hilton M, Stuart E. Ginkgo biloba for tinnitus. Cochrane Database Syst Rev. 2004;(2):CD003852.
32. Burton B. Australian court suppresses report questioning effectiveness of complementary remedy. BMJ. 2006 Jul 15;333(7559):116
33. Burton B. Regulator finds advertising of complementary product "misleading".
BMJ. 2006 Dec 2;333(7579):1141.
|
|
|
|
