Tag Archives: Ken Harvey

Science or Snake Oil: will horseradish and garlic really ease a cold?

The Conversation

File 20171123 6013 1vm5e9b.jpg?ixlib=rb 1.1
Horseradish hasn’t been studied, and studies on garlic found it probably does nothing. from http://www.shutterstock.com

Ken Harvey, Monash University

Some of us may have heard that horseradish and garlic supplements help ease cold and flu. Blooms High Strength Horseradish and Garlic Complex claims it has

a soothing antimicrobial action that helps fight off the bugs that can cause colds and flu and provides symptomatic relief from upper respiratory tract infections.

Others, such as those promoted by Swisse and Blackmores, claim to be “traditionally used in Western Herbal Medicine to provide symptomatic relief of sinusitis, hay fever and upper respiratory tract infections”. And the Swisse and Blackmores products (and many others) add additional ingredients, commonly vitamin C, which is claimed to be beneficial for “immune health”.

There are two categories of “evidence” allowed by the Therapeutic Goods Administration (TGA) to validate indications or claims made for complementary medicines: scientific or traditional.

Scientific evidence is based on the scientific literature, such as trials in humans. Traditional evidence is based on theories outside modern conventional medicine, such as Western herbal medicine, traditional Chinese medicine and homeopathy.

Read more – Science or Snake Oil: can turmeric really shrink tumours, reduce pain and kill bacteria?

So, what does the research say?

A search of the medical journal database PubMed failed to find any clinical trials on the combination of horseradish (Armoracia rusticana) and garlic (Allium sativum), with or without vitamin C. Nor were any clinical trials found on horseradish alone.

The authors of a 2014 Cochrane review concluded there was insufficient clinical trial evidence supporting garlic in preventing or treating the common cold. A single 2001 trial (from the Garlic Centre in the UK) suggested garlic may prevent the common cold, but more studies were needed to validate this finding. Claims of effectiveness appear to rely largely on poor-quality evidence.

A 2013 Cochrane systematic review explored whether taking vitamin C (0.2g a day or more) reduced the incidence, duration or severity of the common cold. The 29 trial comparisons involving 11,306 participants found taking vitamin C regularly failed to reduce the incidence of colds in the general population.

Supplements can claim they’re a traditional medicine, meaning they don’t have to prove they’re effective. Screenshot, Author provided

Regular supplementation had a modest effect in reducing the duration of common cold symptoms by a few hours. The practical relevance of this finding is uncertain. The authors felt this level of benefit did not justify long-term supplementation. Finally, taking vitamin C at the onset of cold symptoms was not effective.

Vitamin C deficiency can impair immune function, but this is uncommon in Australia and best prevented by eating fruit and vegetables.

Read more – Monday’s medical myth: vitamin C prevents colds

The TGA accepts a traditional indication if that use has been recorded in internationally recognised traditional sources for a period of use that exceeds three generations (75 years). Traditional indications or claims don’t mean a product actually works – that requires scientific evidence.

What’s the verdict?

Products such as Blooms High Strength Horseradish & Garlic Complex claim they fight off bugs, but those claims that lack scientific validation. This breaches many provisions of the Therapeutic Goods Advertising Code 2015.

Products such as Swisse Ultiboost High Strength Horseradish + Garlic + Vitamin C, claiming horseradish and garlic have been “traditionally used in Western Herbal Medicine”, have correctly invoked the TGA’s “traditional paradigm”. But it’s important to remember this doesn’t mean these products work.

What’s the implication?

Recently, more and more purveyors of complementary medicine have been making “traditional” claims for their products.

If consumers are to make an informed choice about medicines claiming traditional use, a mandatory statement is required on the label and on all promotion explaining what this means. It should be explained to consumers the “tradition” is not in accordance with modern medical knowledge, and there is no scientific evidence the product works.

Without such a disclaimer, consumers will be misled and the TGA will be seen to be endorsing pseudoscience. But to date, industry, the TGA and government have refused to take on-board such proposals.

The ConversationRead more: Which supplements work? New labels may help separate the wheat from the chaff

Ken Harvey, Associate Professor, School of Public Health and Preventive Medicine, Monash University

This article was originally published on The Conversation. (Reblogged by permission). Read the original article.

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Which supplements work? New labels may help separate the wheat from the chaff

The Conversation

Ken Harvey, Monash University

New proposals from Australia’s drug regulator should give you a better idea if your complementary medicines do what they say on the packet.

One change proposed by the Therapeutic Goods Administration (TGA) is a “stamp of approval” on the packaging and promotional material of some vitamins, minerals, herbs and other supplements to tell you there is enough evidence to back health claims.

Other proposals include reducing the number of often unsubstantiated indications that manufacturers of complementary medicines currently make on their TGA application, which are then used as the basis for advertising claims.

The TGA also proposes incentives for companies to develop and market products with new active ingredients, or make new claims based on research.

The proposed changes, which are out for public consultation, follow the recent ABC Four Corners program, which highlighted long-standing problems with the way complementary medicines are currently regulated.

ABC Four Corners’ documentary “Swallowing it” highlights the shortcomings of how complementary medicines are regulated in Australia.

What’s the problem?

The TGA’s proposals are urgently needed to fix three major shortcomings of the current regulatory system.

First, consumer organisations and health professionals have lost confidence in the complementary medicines industry’s ability to regulate its own advertisements, and in the TGA’s ability to apply adequate sanctions when companies don’t follow the rules.

Second, there is little incentive for the manufacturers of complementary medicines to research new innovative products or prove existing ones work.

There are about 11,000 listed complementary medicines on the Australian Register of Therapeutic Goods (indicated by Aust L on packaging). Listed medicines are meant to contain pre-approved, relatively low-risk ingredients, produced with good manufacturing practice and only make “low-level” health claims for which evidence is held. However, the TGA does not check these requirements before the product is marketed; post-marketing surveillance and upheld complaints show high levels of regulatory non-compliance.

But there are only 35 registered complementary medicines (indicated by Aust R on packaging) the TGA says have been thoroughly assessed for safety, quality and efficacy (there is also debate about whether many of these older products should still be on this TGA list). There are fewer products on this list because research to meet registration requirements is expensive, the public doesn’t understand the subtleties between an Aust L and Aust R product and a better return on investment comes from promotional hype and celebrity endorsement of listed products.

Third, the TGA provides only limited transparency about companies and products that fail post-marketing evaluation or have complaints upheld. This information is currently regarded as commercial-in-confidence, fuelling the perception the TGA is more concerned with helping industry than protecting consumers.

How could the new measures help?

The proposal to restrict companies to only making pre-approved, “low-level” indications and claims for a product, such as, “may relieve the pain of mild osteoarthritis”, will minimise the risk of misleading consumers. But it is not yet clear how the list of allowed indications will be established nor how a specific product will be matched with an appropriate allowed indication.

The regulator also proposes manufacturers apply for “intermediate-level” health claims falling outside the permitted list (outlined above). An example might be, “our formulation of cranberry reduces the frequency of recurrent urinary infections in women”. For this, the TGA would have to assess the evidence substantiating the claim for a particular product. If the evidence stacks up (and there’s a debate about the type of evidence needed), the product could then carry a TGA “stamp of approval” on the label and any promotional material. But it is not clear what this “stamp of approval” will be. Is it text, a symbol or both?

Not everyone agrees a TGA ‘stamp of approval’ should be in the form of a symbol, like this.
(Unofficial mock-up created by Ken Harvey)

In preliminary TGA stakeholder consultations, consumer representatives supported a prominent visual identifier (like a logo or symbol) because of the failure of the existing Aust L and Aust R labelling to inform consumers. But industry representatives were concerned a highly visible identifier for a small number of evidence-based complementary medicines might affect sales of the bulk of listed products without one.

The TGA’s proposals encourage innovation because they will stimulate companies to engage in research to qualify for a TGA “stamp of approval”. The proposal also suggests companies that develop a TGA approved evidence-based claim would be awarded a three-year period of data protection to stop others freeloading on their research.

But the proposed changes do not yet address the need for greater transparency in the regulatory process. For instance, it is not clear whether the TGA’s assessment of evidence to back higher-level health claims for complementary medicines will be publicly available, as they are for prescription medicines.

What happens next?

These proposed changes, which are out for public consultation until March 28, 2017, sit alongside other recommendations aimed at improving the advertising complaints system.

If the TGA implements this package of recommendations, Australia will be a world leader in how complementary medicines are regulated. Despite the substantial and increasing use of supplements, no other country has developed a system that helps consumers and health professionals separate the evidence-based wheat from the chaff, improves confidence in the industry, stimulates more evidence-based products and has the potential to boost exports.

The ConversationKen Harvey, Adjunct Associate Professor, School of Public Health and Preventive Medicine, Monash University

This article was originally published on The Conversation. (Reblogged by permission). Read the original article.

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Chemmart’s myDNA test offers more than it can deliver

The Conversation

Ken Harvey, Monash University and Basia Diug, Monash University

When you enter a Chemmart pharmacy, it’s hard to miss the posters and brochures promoting its “revolutionary myDNA test”. The brochure states it’s “personalised medicine”, where “your DNA results … can help guide your future health and lifestyle choices”.

It’s an enticing promise. Knowing your genes unlocks a healthier future. Right?

The myDNA advertising, also on the Chemmart and mydna.life websites, claims that “70% of people who take a myDNA test have a finding that could affect current or future medications”.

Chemmart myDNA brochure front page.
Freely available from Chemmart pharmacies

The promotional materials suggest taking the test if you’re using antidepressants, pain or reflux medication. The test also covers the common, but difficult to manage, blood thinner warfarin, which is prescribed to approximately 30% of patients over the age of 70 years.

Chemmart says it’s particularly relevant if you have a history of not responding to common drugs, you experience side-effects from your medication, you take multiple medications, you have children on prescribed medication, or you are pregnant or planning pregnancy.

But some of Chemmart’s claims may be misleading for consumers who lack detailed knowledge of DNA testing and may produce unrealistic expectations of the product’s effectiveness. In so doing, Chemmart appears to have breached a number of provisions of the Therapeutic Goods Advertising Code 2015.

The test

The test costs A$149 and is not covered by Medicare or private health insurance rebates. It involves a cheek swab taken by a trained pharmacist, which is sent to Australian Clinical Labs (formerly Healthscope Pathology) for DNA analysis.

The results are delivered by personal consultation with the pharmacist and are also sent to your nominated doctor. If the pharmacist recommends changes to medication, you are referred to your doctor.

As part of their training, participating pharmacists are encouraged to explain the test to local doctors, both to educate them and prepare them for pharmacist referrals or enquiries from patients.

The test identifies common variations in four genes that are involved in processing a number of drugs. For example,

  • CYP2C9 and VKORC1 affect the metabolism of the blood-thinning drug warfarin
  • CYP2D6 is involved in the metabolism of the pain killers codeine and tramadole, as well as antidepressants
  • CYP2C19 affects the metabolism of antidepressants, the newer blood thinner clopidogrel and drugs taken for reflux, such as esomeprazole.

The science

The term pharmacogenetics was first coined in 1959 but it is only recently that pharmacogenetic (PGx) tests have moved from the lab to the clinic.

Researchers have now identified inherited variation in approximately 20 genes affecting around 80 medications, which are potentially actionable in the clinic.

Genetic variations may predict, for example, that a patient is at increased risk of experiencing the side-effects of certain drugs because they metabolise it slowly and high concentrations can build up on a normal dose.

Other genetic variations may cause a particular drug to be metabolised too rapidly, so patients may need a higher dose of the drug to achieve a therapeutic effect.

But a “normal” PGx test doesn’t mean you’re not at risk of drug-related side-effects or of not responding to a drug. Current tests only capture known variants of known genes.

And even if the test shows gene variants that impact on a certain drug’s metabolism, this is only one of many patient characteristics and factors that influence how they respond to drugs. Others include interactions with other drugs, allergies, and kidney and liver function.

As a result, the cost-effectiveness and clinical utility of PGx tests is still uncertain.

Case study: warfarin

Warfarin is a commonly prescribed blood-thinning drug that prevent strokes in patients who have an irregular heartbeat or whose heart valves have been replaced. However, it must be monitored closely with regular clotting tests to ensure it is at the right therapeutic level to prevent bleeding or stroke.

Variations in the genes VKORC1 and CYP2C9 can either slow warfarin metabolism, thereby increasing the risk of bleeding, or increase sensitivity, which may require a lower dose to produce the required effect.

However, in practice, the clinical implementation of genetic testing for warfarin dosing has been disappointing. The current consensus guidelines by the American College of Chest Physicians actually warn against the routine use of genetic data to guide dosing because of its poor predictive value for large populations.

In Australia, GPs manage warfarin dosage via regular monitoring of the clotting test. This allows GPs to adjust the patient’s dose, taking into account all important patient risk factors.

The promotion

Chemmart claims “myDNA is a genetic test that identifies which medications will work best for you”. This overstates the role and value of this test.

It has limited applicability only to certain drugs in particular situations.

We do not believe the test is “particularly relevant” to those who “take multiple medications, have children on prescribed medication”, or “are pregnant or planning pregnancy” because of the extremely limited applicability of the test to these patient groups.

We also have problems with the claim that “the myDNA test covers 50% of the most commonly prescribed medications”. This is not in accord with data from the United States, which shows that just 7% of approved medications and 18% of outpatient prescriptions are affected by actionable pharmacogenes (genes you can test for and alter medication around). Nor is it in accord with Australian data on the top ten drugs prescribed.

We have submitted our concerns to the Therapeutic Goods Advertising Complaint Resolution Panel for an independent determination.

More research (and GP training) will be required to determine if PGX tests improve patient care and are cost-effective. In the meantime, marketing claims should reflect the current uncertain clinical role of these tests.

The role of test providers, pharmacists and doctors

Before undertaking PGx tests, which are also available from other providers, the National Health and Medical Research Council recommends discussing their value and applicability with your GP.

Pharmacists play an important role in engaging with consumers and doctors to achieve better use of medication. But the current model of pharmacist “detailing” PGx tests has several problems. “Detailers” are not welcomed by all GPs. Some clinics have demanded the pharmacist bring a free lunch (often provided by drug reps) before they will schedule a visit.

Finally, the national prescribing service NPS Medicinewise has an important role to play in developing a pharmacogenetic education campaign. This could still involve trained pharmacists but NPS Medicinewise authority would provide greater access to GPs without the demand for lunch as the price of entry.

The ConversationKen Harvey, Adjunct Associate Professor, School of Public Health and Preventive Medicine, Monash University and Basia Diug, Senior Lecturer & Deputy- Head of the Medical Education Research Quality Unit, School of Public Health and Preventive Medicine, Monash University

This article was originally published on The Conversation. (Reblogged by permission). Read the original article.


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Krill oil marketing: a case study of Australia’s broken regulations

The Conversation

By Ken Harvey, Monash University; Aaron Kovacs, Monash University, and Grace Jackel, Monash University

Two out of three Australians regularly use complementary medicines, which constitute a A$3.5 billion domestic market. But the industry’s marketing strategies are a source of ongoing controversy and pose a significant challenge for regulators.

Products containing containing krill oil provide a good example of the kinds of extravagant claims made by supplement manufacturers. The oil is derived from a tiny, shrimp-like crustacean and, like fish oil, contains omega-3 fatty acids.

Company claims include krill oil’s capacity to “relieve arthritic symptoms [of osteoarthritis and rheumatoid arthritis] within a short period of 7 to 14 days”, as well as its “superior absorption” and the curiously ambiguous “9x [strength]” of the less expensive fish oil. Such claims are found on product packs and manufacturers’ websites, as well as the websites of third-party stockists.

Few companies provide links to research supporting such claims. What research does exist is not easily accessible to most consumers, who, at any rate, can rarely assess its validity.

Claims and science

The widely used claim that krill oil relieves the symptoms of arthritis within seven to 14 days appears to be based on a small 2007 study. The research focused on one specific formulation of krill oil, produced by a Canadian company. Possible conflicts of interest, including the source of funding for the study, are notably absent from the paper.

The study recruited 90 people with a confirmed diagnosis of one or more of cardiovascular disease, rheumatoid arthritis (ten people) and osteoarthritis (30 people). They were compared to placebo groups of 12 and 26. Three patients pulled out of the trial before completion, and 12 didn’t have a diagnosis of either osteoarthritis or rheumatoid arthritis.

While some results at seven and 14 days were deemed statistically significant, the meagre number of people involved raises questions about the clinical significance of its conclusions.

Snake oil for what ails you? Speedy fixes sound great, but don’t be taken in by claims on labels.
Tim & Selena Middleton/Flickr, CC BY

Regardless of this and other details of the report that suggest only people with very severe cases of illness were included, the findings of this early and isolated study can, at best, be considered preliminary. And a search of a comprehensive research database found no evidence that the results had been replicated independently.

The claim of krill oil having “superior absorption” is also dubious and not supported by research evidence. A 2014 review of krill oil absorption actually concluded there was no evidence for krill oil being more easily absorbed by the human body.

Regulatory challenges

Companies that market complementary medicines in Australia are legally required to comply with standards set by the Therapeutic Goods Administration (TGA). These standards relate to both the quality of the product and advertising claims.

But manufacturers self-certify their compliance with TGA requirements. Limited, as well as poorly targeted, post-market surveillance of complementary products means they can contravene standards without fear of reprisal. Then there’s the lack of effective penalties to deter companies from breaching TGA regulations.

In May 2013, the Therapeutic Products Advertising Complaint Resolution Panel determined claims such as “9x stronger” and “reduce[s] pain, stiffness and inflammation caused by arthritis, within a short period of 7 to 14 days” breached a number of sections of the Therapeutic Goods Advertising Code 2007.

It said such statements:

“ought to be supported by a wide body of scientific evidence involving a number of independent studies.”

But the claims continue to be made, even by companies asked to withdraw them.

Numerous reports over the last decade have recommended that the lack of effective penalties for offending companies be redressed. But it seems unlikely any changes will be implemented any time soon as both the industry and government support a deregulation agenda.

Meanwhile, consumers continue to be ripped off by products that cannot deliver on the promises they make.

The ConversationThis article was originally published on The Conversation. (Reblogged by permission). Read the original article.

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