During my research for an article on Cuba (coming later today, stay tuned), I stumbled across the strange case of a drug called Policosanol, a sugar-cane derivative and "nutritional supplement" that apparently lowers "bad" LDL cholesterol and increases "good" HDL cholestoral... or does it? The Wikipedia entry for Policosanol rapidly degenerated into an edit war, so let's see if we can help them out a bit. It's also an interesting case study of junk-science arguments in action.
The next entry in my "Junk Science in the Axis of Evil" series will be about Cuba's use of questionable and alternative medicine in its world-famous healthcare system. As you'll see, Cuba is under very heavy trade sanctions, meaning that many basic drugs are unavailable. To counter this, Cuba has had to be become much more self-sufficient, manufacturing its own versions of drugs to supply its population, and raising much needed cash by selling some of them abroad. As I'll discuss in my next post some of these are good, and some of these are, well, not so good.
Policosanol consists of very-long-chain aliphatic alcohols purified from sugar cane wax. It is widely used in Cuba, and across the world, as a "natural" way to reduce cholestoral levels. A clue as to how dodgy this claim is comes from the fact that even Ray Sahelian, the "bestselling author of Mind Boosters" and "The Stevia Cookbook and several other books" and "also a superb herbal product formulator with such popular products as Diet Rx, Passion Rx, Mind Power Rx, and others" and owner of "RaySahelian.com, the most visited website in the world on natural supplements maintained by a medical doctor", isn't convinced. Indeed he states that there "is no strong evidence at this time that policosanol helps lower cholesterol levels. The research has provided mixed results with some studies showing certain benefits while other studies claiming that policosanol has no benefit in cholesterol management. I have included both positive and negative findings on this policosanol page. I am as confused as most everyone else regarding the role of this nutrient in health and disease."
Helpfully he also sells the supplement from his website.
If you really want to know anything about anything in the brave new world of Web 2.0, you need to visit Wikipedia, which helpful provides an entry for Policosanol. Except... oh dear... it's all gone a bit wrong...
Looking back through the edit history, it seems that the entry was created on 20th February 2006 by one "AED". This original entry makes a whole range of claims stating that "there have been a number of clinical studies, with both human and animal subjects, on the effects of policosanol and on its major component, octanosol. They have found that it can lower cholesterol, act as an anticoagulant, and inhibit atherosclerosis", but unfortunately providing no supporting references.
Four months later, an anonymous user comes across the article and adds a paragraph stating intriguingly that: "Policosanol, touted as a natural way to treat high cholesterol levels, appears to be useless, German investigators reported in The Journal of the American Medical Association. In a new study, participants were randomly assigned to policosanol at doses of 10, 20, 40 or 80 milligrams daily or placebo. After 12 weeks, the researchers saw no statistically or clinically significant effect on LDL cholesterol at any dose. Almost all of the former studies, as referenced below, came from one group in Cuba, whose research was funded by Dalmer Laboratories, which markets policosanol."
The article now contains two halves - one saying the drug doesn't work, followed by several more paragraphs stating that it does. Fortunately, an editor spots that the supporting "evidence" is actually swiped from http://www.pdrhealth.com/drug_info/nmdrugprofiles/nutsupdrugs/pol_0207.s... and deletes it.
At this point, somebody evidently feels the need to rebalance the article, helpfully adding that "the "Lightning Bolt" energy drink, endorsed by the magnificent Steven Segal contains traces policosanol. Those crazy asians.". Sadly, this magnificent revision lasts only 7 minutes before a watchful editor reverts it.
Clearly some "NPOV" is called for. By October, editor "SlashMe" manages to create a reasonably balanced article, providing for the first time proper references for both the positive and negative studies, and explaining that "published studies have come to conflicting conclusions regarding the efficacy of policosanol". Both sides now have equal weight, which may not be clinically accurate but satisfies the hive mind's need for "NPOV".
It may have satisfied the Wikipedia editors, but it certainly didn't leave the nutrition junkies happy. Some six months later, in April 2007, an anonymous user lets rip on the article, and anti-Cuban racism in general: "However some US backed studies have challenged the the wider consensus on the efficacy of policosanol in lowering LDL (i.e., "bad cholesterol") or raising HDL (i.e., "good cholesterol"). The initial studies that found the positive effects of policosanol came from the National Center for Scientific Research in Havana, Cuba. Resistance to the acceptance of Policosanol has been driven by two factors (i) heavy investment in the marketing of competitor drugs (Lipitor and Zocor) and (ii) the US economic embargo/blockade of Cuba, as well as general prejudice against Cuban technology." As proof of this, he references some, er, nutritional supplement sites.
In a spectacular display of an editor not having a life, the edit is reverted by Z.E.R.O. just one minute later. An edit war continues for the next week or so, until thanks to a combination of sheer persisance, obsession with NPOV, and high-speed broadband connections we have an article that tells us (and I'm paraphrasing slightly) that Policosanol is a drug that may or may not lower Cholesterol levels that has had "lots" of trials done on it, that the trials supporting the drug are part of a Cuban conspiracy to make money, and that the trials against the drug (including a German one) are part of a general problem with American anti-Cuban racism, and Big Pharma.
It's the kind of crisp, concise and useful information that Wikipedia is renowned for. Frankly, I'm surprised we still need text books at all. The net result of the edit war is a mess of an article containing a list of several references all supposedly supporting the drug, and one that apparently concludes that it doesn't work. The talk page simply displays an editor's lonely plea... "NPOV!!!"
So... what's the truth? A quick look at the references speaks volumes. The Berthold study debunking Policosanol seems like a perfectly valid trial [1]. It is registered, and concludes that "in patients with hypercholesterolemia or combined hyperlipidemia, the sugar cane–derived policosanol in usual and high doses does not demonstrate a reduction in lipid levels beyond placebo". Then we have the Havana trials. The original Cuban study [2] and seven of the nine references provided anonymously at the end of the last "edit war" supporting Policosanol [2,4,5,6,8,9,10, and 11] have come from Havana, Cuba, many of them from the National Center for Scientific Research (CNIC) - the same center that set up Laboratorios Dalmer to promote/market/sell Policosolanol [12]. The two remaining references supplied that are actually independent of the reach of CNIC are a meta-study which simply repeats their conclusion (not a study as the Wikipedia editor claimed), and brilliantly/bizarrely, a paper that actually states that Policosanol doesn't work [7]!
So, in summary, Policasonol was invented by Dalmer, a branch of CNIC, and the data showing it works is from CNIC., and attempts by others to repeat the trials seem to have failed. In effect, the Cuban government manufactures, trials and sells the drug, so no possible conflict of interest there. As for the wikipedia proponents, they really need to learn that quoting fancy scientific references means nothing unless you actually read and check them.
The only question remaining is, can I be bothered to edit the Wikipedia entry?
[1] Berthold, H.K. et al, 2006. "Effect of Policosanol on Lipid Levels Among Patients With Hypercholesterolemia or Combined Hyperlipidemia". Journal of the American Medical Association 295 (19): 2262-2269.?
[2] Pons P., Rodriguez M., Robaina C., Illnait J., Mas R., Fernandez L., Fernandez J.C., 1994. "Effects of successive dose increases of policosanol on the lipid profile of patients with type II hypercholesterolaemia and tolerability to treatment". International Journal of Clinical Pharmacology Research 14 (1): 27-33. PMID 7927958.
[3] Chen J.T., et al, 2005. Meta-analysis of natural therapies for hyperlipidemia: plant sterols and stanols versus policosanol. Pharmacotherapy. 2005 Feb;25(2):171-83.
[4] Castaño, G., et al, 2004. Long- term effects of policosanol on older patients with Type 2 diabetes. Asia Pacific Journal of Clinical Nutrition. 13(Suppl):S101.
[5] Castaño, G., et al, 2004. Effects of policosanol and ticlopidine in patients with intermittent claudication: a double-blinded pilot comparative study. Angiology. 2004 Jul-Aug;55(4):361-71.
[6] Castaño G., et al, 2004. Concomitant use of policosanol and beta-blockers in older patients. Int J Clin Pharmacol Res. 24(2-3):65-77.
[7] Varady K.A., Wang Y., Jones P.J., 2003. Role of policosanols in the prevention and treatment of cardiovascular disease. Pub Med Nutr Rev. 2003 Nov;61(11):376-83.
[8] Menéndez, R., et al, 2000. Effects of policosanol treatment on the susceptibility of low density lipoprotein (LDL) isolated from healthy volunteers to oxidative modification in vitro, Br J Clin Pharmacol, 50, 255-262.
[9] Davalos J.M., Mederos H., Rodriguez J., et al. (1996) Effect of policosanol in hypercholesterolemia due to nephrotic syndrome. X Latinciamerican Congress of Nephrology and Hypertension, 14 September, Santiago de Chile, Chile.
[10] Arruzazabala M. L., Carbajal D., Mas R. and Valdes S., 1997. Comparative study of policosanol, aspirin and the combination therapy policosanol-aspirin on platelet aggregation in healthy volunteers. Pharmacol Res 36(4):293-7.
[11] Stusser R., Batista J., Padron R. et al., 1998. Long-term therapy with policosanol improves treadmill exercise-ECG testing performance of coronary heart disease patients. Int J Clin Pharmacol Ther 36(9):469-73.
[12] Laboratorios Dalmer is a subdivision of CNIC.
Edit: I fixed the Wikipedia entry for the drug in the end... We'll have to see if the edit sticks.
