Violent insurrections, refugees clinging to life rafts and hand rolled cigars comprise the average Westerner’s view of Cuba in the 21st century. Sure, Cuba grapples with a crushing trade embargo and brutal poverty but, behind Castro’s cigar smoke, lies the occasional bright spot – at least relatively speaking.
Michael Moore’s Sicko documentary briefly brought up a lesser-known aspect of Cuba to the Western audience – the Cuban health care system. With their communist form of government, Cuba has forged ahead with a strong-armed approach to socialized health care, for better or worse depending on your political persuasion. Disputed statistics are thrown around in the debate – have a look at John Stossel’s interviews with Michael Moore for a reference on the political situation:
Like it or not, one positive aspect of this socialized approach to medicine in Cuba has been a series of government mandated medical research programs. Immediately after Castro came to power in 1959, the Cuban Institute for Research on Sugar Cane Derivatives (ICIDCA) was formed and began studying – as you might imagine from the name – products that could be derived from sugar cane. They found one compound – called policosanol – that showed promise.
On the Road Towards Acceptance…
Soon after its discovery, policosanol was heralded as a major advance against heart disease by its creators. The Cubans demonstrated that it was made up of long-chain ‘fatty alcohols‘ found in the cell walls of sugar cane plants. Among these alcohol compounds, roughly 60% of policosanol was reportedly made up of octacosanol – the physiologically active compound found in the supplement version according to the Cuban scientists.
Initial studies sponsored by the Cuban company responsible for its introduction into the Western world, Dalmer Laboratories of Havana, found policosanol inhibited LDL cholesterol production and potentially promoted HDL production , .
From this start, science slowly leaked out of Cuba that continued to show policosanol could lower LDL cholesterol while raising HDL cholesterol with no side effects. Subsequent studies – nearly 30 in all - demonstrated policosanol’s efficacy among all kinds of different test cases with control groups [see a good source list here].
Coming to America in a Big Way
While these studies were pouring out of Cuba, the US National Heart, Lung and Blood Institute’s cholesterol-lowering campaign was in full swing. The mantra of reducing meat consumption for a high carbohydrate diet as a way to lower cholesterol was in force during the early to mid-1990s. These developments – a cholesterol lowering campaign and what looked like solid science behind a cholesterol-lowering supplement – was creating a perfect storm of acceptance for policosanol.
Consequently, many supplements like multivitamins started to include policosanol. Even the household name Bayer advertised their One-A-Day Cholesterol Plus product as having policosanol. From the press release [emphasis ours]:
“MORRISTOWN, N.J., May 16 /PRNewswire/ — Bayer HealthCare’s Consumer Care Division today introduces One-A-Day Cholesterol Plus, the first and only leading complete multivitamin specially formulated with heart-health supporting ingredients, including policosanol — which, along with diet and exercise, can help keep cholesterol and blood pressure levels within the normal range.
One-A-Day Cholesterol Plus is the only leading complete multivitamin to contain policosanol, an ingredient derived from sugar cane, that clinical research has shown can help maintain healthy cholesterol levels. One-A-Day Cholesterol Plus also contains folic acid and calcium, both of which have been shown to help maintain healthy blood pressure levels.”
There were some rumblings aired about the fact that basically all science known about policosanol was published by the same Cuban group that had made a sizeable investment in the space. Newer non-Cuban reviews advocated for more studies to be performed on a larger scale – a call that would go unanswered for a number of years.
This conflict of interest we see here is akin to what happened with Merisant and Nutrasweet back in the 1980s or the studies Monsanto published about GMO corn in the 1990s; companies with a new product and a massive stake in its survival are generally the ones to fund the first research about it. This is the primary reason why its prudent to wait for consensus to develop about research findings – with greater numbers the ‘noise’ of sponsored science gets turned down.
The upside of policosanol’s moment in the sun was that larger studies could now be justified on a cost basis because of policosanol’s deeper penetration into the American supplement market.
A Day of Reckoning
By 2006, some of the major journals started to weigh in on the scientific side – and what they found did not support the Cuban research team’s sponsored science in any way.
The Journal of the American Medical Association (JAMA) came down hard on policosanol and said that neither standard nor high dosing has any effect on cholesterol levels. This was a double-blind, placebo-controlled trial – the gold standard of research – and it was published in one of the most prestigious medical journals in the world. This was a damning finding if there ever was one – but still it was just one finding.
A follow-up study with good design in another prestigious journal – The American Journal of Clinical Nutrition – found much the same as the JAMA investigation. Policosanol did little to lower LDL or raise HDL cholesterol. From that study:
“In conclusion, our study showed that a 20-mg dose of sugar cane-derived policosanol, with a chemical composition similar to that of the originally developed product from Cuba, did not lower LDL cholesterol. This finding corroborates the data from several other independently performed clinical trials. We would like to highlight the inconsistency between the negative results now published from 5 independent laboratories and the data published from Cuba, Argentina, and Russia before 2004. We hope to bring this discrepancy to the attention of healthcare providers and consumers of health supplements as a caution to use healthy skepticism when choosing supplemental products for lipid-lowering purposes.”
Now, with six months since the JAMA study, we see five non-sponsored studies by other non-Cuban researchers that have also found policosanol does nothing for cholesterol. In January 2009, one study in Japan showed pigeons had some benefit from policosanol but that had been one of the few positives since the Cuban studies. These findings form the basis of a consensus – a consensus that would see policosanol lose favor with Bayer, among others.
The initial pushback on these non-Cuban studies suggested that the type of policosanol used in these particular studies is what caused the conflicting results. Cuban policosanol comes from sugar cane because of its wide availability there but, in the US, policosanol tends to be sourced from beeswax or wheat. Although this appears as if it would be a significant difference, policosanol sourced from either sugar, wheat or beeswax has been shown to result in very similar levels of circulating octacosanol, the bio-active compound in policosanol. In short, the source does not matter.
Policosanol On the Brain
The cannon of policosanol research we have is sharply divided but in a way that allows us to quickly come to a conclusion. A massive amount of studies found policosanol to be highly effective but those studies were all funded by a Cuban study group with a significant interest in pushing the supplement into the marketplace. Follow-up studies performed by non-biased scientists using good design refute the Cuban findings with authority. Because of this, it appears policosanol does not aid in cholesterol management.
Now, it should be noted that this does not rule out policosanol’s usefulness in the future. It could turn out that current research was focused on the wrong physiologically active compound and future avenues of research could yet prove its effectiveness. But, as far as we know now, policosanol does nothing for heart disease.
Aside from the science, it may seem odd that Cuba, a communist country, would actively be marketing a supplement product to its sworn enemy, America, in such a capitalist way. Part of their rationale is that the revenues generated by the ICIDCA’s corporate arm – Dalmer Labs – can be reincorporated back into the socialized medical system. Along those same lines, Cuba also runs a series of higher-end hospitals for foreigners as past of a ‘health tourism’ initiative – another revenue generating scheme for their medical system.
We find it interesting that even across two countries with radically different values and political systems, the constant of financial corruption unites them together.
Be it Cuba, the US – even Mars for all we care – sponsored science is a broken modality for determining the efficacy or safety of drugs and supplements. It is nearly impossible for an entity whose livelihood is on the line to produce findings that will endanger its survival. Examples of companies halting research that would damage their bottom line do exist – read Marion Nestle’s Safe Food for a couple examples – but once a product is fully developed, so much money has been sunk into it that it is statistically unlikely these rare bright spots in sponsored research will become common.
A new model where regulatory agencies demand that products demonstrate their safety and efficacy before they reach the market would benefit customers and manufacturers greatly. Creating a system of trust between manufacturers and consumers would generate more sales than this smoke and mirrors routine we have today. Hopefully, we will see regulatory reform but until then we will do our best to keep you informed about as many of these issues as we can possibly cover.