I was following this discussion for a while before my original post. The marketing for Imunozen makes a lot of pseudo medical claims so I wanted to find out what the active ingredients are that cause the effects claimed and how effective they. This included reading through the patent, the Guelph study and a number of other papers at places including Medline Plus which is a standard site for academic research papers for evidence based medicine. I also found a site with questions and answers about plant sterols at http://www.bfr.bund.de/cd/9581 which provides a more objective view than some of the places trying to sell them. It's tricky to get a lot of details because the manufacturers of Imunozen don't list everything that goes into those compounds with names that are trademarks. What I could find out is that Imunozen is not suitable for vegetarians because the ingredient called Cellasate contains fish oil extracts. There may be some confusion because the capsules have a vegetarian coating. Something all the studies into sterol supplements agree on is that they should not be taken by children, pregnant or nursing mothers, people who've had organ transplants, people with diabetes, people with MS or people taking other medication except under the advice of a doctor. This includes the manufacturer's instructions and the Guelph study which included a pregnancy test for the 16 women involved.

One mistake I made in my original post that I'm happy to correct is saying that the sterols in Imunozen come from tall oil. In most food supplements it is but Imunozen comes from processed soya oil. It does however contain other ingredients extracted from pine bark. Actually there is another product that has soya-derived sterols and contains pretty much the same proportion of beta sitosterol as Imunozen. This is called Cholestatin. Each pill contains 400 mg rather than 300 mg of sterols and 160 mg of beta sitosterol. Multiplying this by 3/4 gives you 120 mg which is virtually identical to the 117 mg that Imunozen contains. Cholestatin doesn't contain the fish oils, vitamin C or flavinoids that Imunozen contains and neither does it claim to "modulate" your immune system. On the other hand it only costs US $8 from Amazon. The body is actually pretty good at modulating things on its own: it's a biological process called homeostasis.

I had a read through the Guelph study and there are a few areas that concern me. It only covered 20 people, 16 of them women, and only lasted a month. There were 2 groups, one taking Imunozen and one not. It has been known for some time that plant sterols reduce the absorption of cholesterol: Benecol and Flora Proactive are sterol enriched margarines that have been available for years. The Guelph study tested the hypothesis that sterols reduce the absorption of cholesterol but it did NOT attempt to find out the optimum amount of beta sitosterol required to do this. A more detailed study involving more people for a longer period and trying varying amounts of different sterols ranging from none to the maximum recommended amount of 3000 mg a day would be the way to do this. This one shows a good way how to do it, covering 106 people over a year Another study covering 1,551 people over 12 months also demonstrates some of the methodologies needed for a more conclusive study.

Something else I found out is that big pharma and the alternative health industry are very closely related. Imunozen contains a compound called Enzogenol which is made by Enzo Nutraceuticals Ltd of New Zealand. In the US this is distributed by a company called B&D Nutritional Products (source: http://www.bndni.com/products.html) whose suppliers also include Eastman Chemical Co and Kemin Industries Inc among others. Eastman started off by making photographic chemicals and was spun off from Eastman Kodak in 1994. Kemin is a multinational that makes ingredients for agricultural foodstuffs among other things. Celt Naturals might not see itself as part of big pharma but it buys from a company that is supplied by it. Some of the biggest food supplement manufacturers are pharmaceutical companies. Between 1999 - 2001 Hoffmann-La Roche, BASF, Aventis SA, Solvay Pharmaceuticals, Merck, Daiichi Pharmaceutical, Esai and Takeda Chemical Industries were fined hundreds of millions of pounds by the EU, US, Canadian and Australian governments for operating an illegal cartel to fix the price of vitamins. Merck's vitamin subsidiary in the UK is Seven Seas Ltd.

"Alternative" medicines are not necessarily inherently harmless. As I mention above, there are groups that are specifically told not to take sterol supplements because they can have undesirable effects. Another one is St John's Wort which can have serious side effects if taken with other medicines. Foxglove was also once used as a "natural" medicine until the active compound was identified and synthesised, and obviously the plant is still highly toxic.

The JAMA article isn't really relevant to a discussion on a food supplement made from fish, pine bark and processed cooking oil, but there's a full version at http://silver.neep.wisc.edu/~lakes/iatrogenic.pdf. From reading it I get the impression that Dr Starfield's point is not that doctors are bad but that the US medical system requires reform and that people without medical insurance are more likely to die due to poor medical care and not being registered with a GP. For a start it is entitled "Is US Health really the best in the world?" She says that the Canadian health care system is the 3rd best and the British the 9th best whereas the US system is the 12th out of 13. Germany was the 13th. As the final paragraph says:

Recognition of the harmful effects of healthcare interventions, and the likely possibility that they account for a substantial proportion of the excess deaths in the United States compared with other comparably industrialized nations [my italics], sheds light on imperatives for research and health policy. Alternative explanations for these realities deserve intense exploration.

Strangely enough this paragraph doesn't appear everywhere that quotes the headline figures from the article and it puts a very different emphasis on things. This isn't quite the same emphasis that some places give but it ties in with the research interests and other articles listed on her web pages at Johns Hopkins University. The main point is more "why isn't US health care as good as in other countries?" than "why do doctors kill so many people?"