A colleague asked me how to deal with the claims made for this product in a recent Channel 7 Today Tonight segment, “Tips to lower cholesterol”, featuring pharmacists Gerald Quigley and Lesley Braun.
The video voice-over noted that 1 in 2 adults, around 6.5 million Australians have high cholesterol; one of many risk factors for cardiovascular disease and often treated by “pricey cholesterol lowering drugs”. Lesley Braun then talked about how cholesterol can form plaques in your arteries which can cause heart attacks.
The voice-over (not Lesley) went on to say, “Two million Australian take powerful statin drugs to lower cholesterol. But statins can have nasty side-effects” and the screen listed “muscle spasm, memory loss, impotence and diabetes” in large red typeface. The voice-over went on to say, “tonight we reveal other products and one new discovery that reduce cholesterol dramatically”.
Gerald Quigley (holding a packet of Betaglucare) then said, “This is a new way to balance cholesterol and it’s natural”. The voice-over said, “They’re made from beta-glucan a soluble fibre from Nordic oats. Betaglucare cereal is a concentrated form and it can make cholesterol levels plummet”. The video then showed a testimonial from a patient who said, “I just almost halved my level of cholesterol in a matter of 4 months”. A screen shot of her cholesterol results said, “60% lower” reiterated by the voice-over, “60% lower than last year without added exercise or dieting”.
Gerald concluded, “Oats are very good for you. However, we know now that beta-glucan which is in Nordic oats is actually even more powerful in mopping up bile acids and therefore has a profound effect on cholesterol levels”.
The segment ended with Lesley Braun displaying an array of foods that could lower cholesterol levels, saying, “the most powerful foods really are the ones we have right here. The beta-glucan concentrates of the Nordic oats (holding up a packet of Betaglucare), Psyllium Husk, etc”.
So what’s wrong with this TV segment?
First of all it’s primarily a blatant promotion for one specific product: Betaglucare, rather than “Tips to lower cholesterol”.
Second, while Betaglucare may be a new product, the evidence demonstrating a link between the inclusion of oat beta-glucan in the diet and a decrease in serum cholesterol concentration is over a decade old. In March 1995, the Quaker Oats company submitted a petition to the FDA stating that consumption of whole oat products (oats, oat bran, and oat flour) decreases total cholesterol and LDL cholesterol concentrations and reduces the risk of CHD. This claim was approved by the U.S. FDA in 1997 after reviewing 33 clinical studies. In May 2004, the Joint Health Claims Initiative (JHCI) in the United Kingdom also approved a generic health claim for oat beta-glucan and blood cholesterol based on the totality of the evidence. The allowed health claim states that the inclusion of at least 3 g/day of oat b-glucan as part of a diet low in saturated fat and a healthy lifestyle can help reduce blood cholesterol. In 2010, the European Food Safety Authority (EFSA) accepted that oat beta-glucan at doses of at least 3 g/d have shown a statistically significant decrease in LDL-cholesterol concentrations, and that there was strong evidence supporting the biological plausibility of the effect. This also led to approval of a similar high level health claim by the Food Safety Authority Australia New Zealand (FSANZ) for oat bran, wholegrain oats or wholegrain barley containing a dose of 3 g/day of beta-glycan.
Third, the statements that beta-glycan can “make cholesterol levels plummet”, “reduce cholesterol dramatically” and “has a profound effect on cholesterol levels” and the testimonial stating the product lowered one person’s cholesterol by “60%” is not in accord with a 2011 review of the published literature that showed reductions cholesterol of the order of 5%-10% (compared with 30%-50% with statins). I’m not aware of any research that shows that Betaglucare produces a greater reduction in serum cholesterol levels than other beta-glycan containing products that meet FSANZ and other standards.
Fourth, the information on the “nasty side-effects” of statins (muscle spasm, memory loss, impotence and diabetes) is misleading given that all these side-effects were highlighted equally in large red typeface with no information on their varied incidence or severity. Nor was the greater potential for side-effects with statins balanced by pointing out their greater efficacy in reducing cholesterol levels (and cardiovascular events) compared to beta-glycans.
Fifth, while Lesley provides some broad information covering a number of products that was relevant to the topic, Gerald basically just promoted Betaglucare. Given Gerald’s previous coyness about commercial arrangements with the sponsors of products he promoted it would be of interest if he would disclose any financial arrangements he has with the product sponsor &/or distributor of Betaglucare, either for appearing on this program or acting for them in any other capacity.
In short, if this was a promotion for a medicine, in my opinion, it would breach a number of provisions of the Therapeutic Goods Advertising Code. However, beta-glycans are regarded as a food by FSANZ and thus the TGA Complaint Resolution Panel has no jurisdiction. Complaints about the conduct of TV current affairs programs can be sent to the TV station concerned invoking the Commercial Television Industry Code of Practice. Section 4.5 of the latter says, “In broadcasting a promotion for a news or current affairs program, a licensee must present factual material accurately and represent featured viewpoints fairly”. In my view, this segment is in breach of s 4.5 of this Code. In addition, it can be argued that Gerald’s involvement in this misleading promotion is a breach of the Health Practitioner Regulation National Law Act.
In conclusion, it’s appropriate that current affairs programs (and pharmacists) talk to the public about the virtues of natural products to lower cholesterol levels. However, the claims made should be in accord with the scientific literature and comparisons with pharmaceutical treatment should be balanced, factual and objective. In my opinion, this program failed these tests. It is concerning that this program is likely to scare some people into stopping their statin drugs and taking up much less effective beta-glucan products instead. Complaints have been made.
P.S. Gerald was asked, “if he would disclose any financial arrangements he has with the product sponsor &/or distributor of Betaglucare, either for appearing on this program or acting for them in any other capacity.”
His response was, “I act as an independent consultant to a number of companies, and along with Dr Braun, was asked to comment on the sequestant action of Nordic oats in its use for helping balance cholesterol levels.”
Dr Braun commented, “I was not paid for the segment and have no relationship with the manufacturers (don’t even know who they are) – I saw it as an educational piece – as you also know, there is very poor adherence to statin drugs – the question remains why ? we know lowering cholesterol is important so these options were presented as a means of helping people with borderline levels or those who can’t tolerate or won’t take statins.”
In response. I believe Lesley did a good job, in good faith, and the message she gave at the end of the program about how a variety of foods can lower cholesterol is an important public health one. It’s just a pity that Channel 7 and Gerald focused on promoting Betaglucare rather than pointing out that the benefits of lower cholesterol levels can come from a variety of oat, barley and other products that Lesley mentioned. I reiterate, my criticism of this program (and my complaints) are directed at Channel 7 and Gerald, not Lesley Braun.
Finally, this episode shows the dangers of involvement with the media, especially commercial “current affairs” TV programs who may have their own commercial agenda. You can be damned if you get involved because of the danger of misrepresentation through cuts to your interview and the juxtaposition of different views. But you are damned if you don’t because you lose the opportunity to get across important public health messages. My own view is that it’s better to engage (despite the risks) than refuse.