Wednesday, November 15, 2006

Policosanol Update 2

Does policosanol lower cholesterol or doesn't it?

Thank you to Kharma Dave who provided an update on the policosanol story with this study that appeared in the November issue of the American Journal of Clinical Nutrition:

Lack of cholesterol-lowering efficacy of Cuban sugar cane policosanols in hypercholesterolemic persons

We would benefit from the insight of The Great Speculator as to why 50-odd studies, most originating in Cuba, reported an inverse (beneficial) and dose-dependant relationship between sugar cane policosanol and serum lipids, yet two recent studies support the null hypothesis, that is, intake of policosanol has no effect on serum lipids.

This most recent data point in the policosanol saga is hardly an exclamation point. The dose was small (10mg), the study group was small (n=21), the study length was short (28 days). In the world of studies, this one should have no impact on the accepted efficacy or sale of the product. It shouldn't. But it will. And that's a shame. (Note Kharma Dave's conclusion in the comments of this post.)

Why shouldn't it? Let's compare this recent policosanol study to the study of a mass-marketed pharmaceutical:
  • If this was a study that found no advantage to taking a mass-marketed pharmaceutical (as opposed to a poorly-regulated supplement), it would have no impact on the accepted efficacy or sale of that pharmaceutical.

  • If this was a study that found no advantage to taking a mass-marketed pharmaceutical (as opposed to a poorly-regulated supplement),
    and it included thousands of study participants who were observed over a number of months,
    it would still have no impact on the accepted efficacy or sale of that pharmaceutical.

  • If this was a study that found no advantage to taking a mass-marketed pharmaceutical (as opposed to a poorly-regulated supplement),
    and it included thousands of study participants who were observed over a number of months,
    and it reported harmful, even life-threatening, side effects to taking the drug,
    it would still have no impact on the accepted efficacy or sale of that pharmaceutical.
I reach this conclusion because a popular mass-marketed pharmaceutical used to treat type 2 diabetes, Actos (pioglitazone), was recently reported to be just about useless in improving the quality of life or staving off early death in people with type 2 diabetes:1
"Published studies of at least 24 weeks pioglitazone treatment in [approximately 6200] people with type 2 diabetes mellitus did not provide convincing evidence that patient-oriented outcomes like mortality, morbidity, adverse effects, costs and health-related quality of life are positively influenced by this compound."
And...
"The occurrence of oedema was significantly raised."
(Oedema, or edema, is fluid retention, which, according to Actos' website, "may lead to or worsen heart failure.")
But they conclude...
"Until new evidence becomes available the place of pioglitazone in the treatment of type 2 diabetes mellitus remains unclear."
Unclear. And the occurrence of a side effect which could lead to heart failure was significantly raised. Yet drug companies are still making and project to make big bucks from the sale of Actos:
"Actos generated $77.0 million of revenue for Lilly [in 3 months ending September 30, 2006], an increase of 20 percent compared with the third quarter of 2005."
Lilly only markets the drug. Its manufacturer, Japan's Takeda, does even better with sales topping $1.3 billion in the first half of 2006 - and foresees continued profits. News of the aforementioned and hardly upbeat study came out in October 2006, yet in November Bloomberg.com was reporting that the president of Takeda expected sales of Actos to "increase by at least 20 percent in the year ending March 2007."

What if we took this latest policosanol study, included it in a meta-analysis with those 50 positive studies, and I'll even throw in the negative German study from earlier this year. We could show policosanol good, nice and good, worthy of believed efficacy and increased sales, no harmful side effects - much better than Actos fared in its meta-analysis. Instead, we'll single out this little study and conclude "It does not work." (No offense to Kharma Dave. I think he summed up public impression perfectly.) Sigh. It's all so relative, and profit-based.

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1 The Cochrane Library, 2006, Pioglitazone for type 2 diabetes mellitus.

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