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Thursday, May 30, 2013

Niaspan and Chinese IL-6

Right understanding is the most equally divided thing in the world, for everyone believes himself so well stored with it, that even those who in all other things are the hardest to be pleased, seldom desire more of it than they have. Wherein it is not likely that all men are deceived, but rather witness, that the faculty of right-judging and distinguishing truth from falsehood (which is properly called understanding or reasoning) is naturally equal in all men. And as the diversity of our opinions is not, because some are more reasonable than others, but only that we direct our thoughts several ways, neither do we consider the same things. For it is not enough to have good faculties, but the principal is to apply them well. Those who move but very slowly may advance much farther if they always follow the right way.  
Rene Descartes, A Discourse of a Method for the Well Guiding of Reason and Discovery
The "right-judging and distinguishing truth from falsehood" is a curious thing in modern medicine. AbbVie recently got some bad news regarding their "good cholesterol" drug, Niaspan. Two studies involving almost 30,000 people showed that the drug offered no benefit. The first study was halted after the NIH said patients on the medicine had strokes at double the rate of those just taking a companion drug. What did AbbVie do about this? They raised the cost of the pill 37%. What did the FDA do? Nothing.

We can't expect much from the FDA nor the companies who need their approval. The former is poorly structured, lazy and incompetent. The latter is forced to report only the positive news and hide the bad. The non-living entity that is The Corporation must be fed! It is up to great philosophers, such as Descartes and myself, to discuss "right judging and distinguishing truth from falsehood" in these matters. It is no easy task however, to begin to look into the realities of cholesterol medication and the single cause/cures of what ails the modern westerner. Gary Taubes, in Good Cholesterol Bad Cholesterol, dove into the history of the basic cholesterol research. If you believed the facts presented in this book to be "right-judging and distinguishing truth from falsehood", then the outcome of the two studies that pointed out the uselessness of Niaspan was predictable.

Is any of this nonsense getting to our leaders? According to this article from Bloomberg:

 "I don’t know how you can justify it,” Robert Giugliano, a cardiologist at Brigham and Women’s Hospital in Boston and an associate professor of medicine at Harvard. “The balance of the data suggests that niacin has little if any role in” treating patients with cholesterol problems, he said in a telephone interview.

Perhaps our Cargo Cults are running low on faith here in the US and in Europe. The layoffs keep on coming. The money is trickling in at record lows. This sad state of the business of Cargo Cult Science has some saying maybe it's time to head over to China.

Loosely defined, arbitrage is striking a combination of matching deals that capitalize upon an imbalance. Profit is gained from the difference between the market prices. With the Chinese government focusing on innovation through forward-looking national agendas for economic development, the opportunity to apply an “innovation arbitrage” is emerging as an important means to develop novel medicines in China. - Paul Grayson of Cargo Cult RuiYi

Cargo Cult Business? RuiYi hopes to introduce an antibody against IL-6 to protect the indigenous people of China from RA and cancer. IL-6 is one of the latest single cause/drug target being pursued by pharma. The simple side of biotech is to select the target, have some people make an antibody, then set out in your snake oil caravan. The trick is the sale of the product. Beyond showmanship, one must also take into account the audience.

Historically, the potential value of developing a new therapeutic in China was discounted heavily by the potential risk that the therapy would not be used. Chinese healthcare has relied heavily on traditional Chinese medicinal remedies, and the less established intellectual property enforcement did not protect against domestic competition.

There are 1.345 billion people living in China versus 315 million people in the U.S. Imagine how much money we could make if they were simply... us. We make a fortune off of our pills even after studies demonstrate a lack of efficacy and harmful side effects (see above discussion on Niaspan). Are the Chinese people ready for us?

The China Study, by Dr. T. Colin Campbell (controversial as it is here on the CCS) clearly showed a difference between China and the west. Did Paul Grayson of RuiYi take this information into account? A different set of human beings live in China than our current Cargo Cult patients. In order for this latest business model to work we will have to first get the Chinese to eat themselves into the western disease state. The profits made from the Cargo Cult sciences in western pharma were not earned in a day. It takes a long period of time to create the situation that allows for the Niaspan story to A) happen, then B) barely get any attention from the national media. Without the same Cargo Cult Culture, the Chinese may simply ignore the products we bring them. In fact, I predict that is exactly what they will do. While it is true that we have set up many a McDonalds in China, profit from our pills will require that the western diet is first adopted by a certain amount of Chinese people. What is that amount?

We have yet to accept the relationship between diet and illness. The attempt to bring our pills to China is a prime example of how misguided our Cargo Cult leaders have become.

I have been bred up to Letters from mine infancy, and because I was persuaded that by their means a man might acquire a clear and certain knowledge of all that's useful for this life, I was extremely desirous to learn them. But as soon as I had finished all the course of my studies, at the end whereof men are usually received amongst the rank of the learned, I wholly changed my opinion, for I found myself entangled in so many doubts and errors that me thought I had made no other profit in seeking to instruct myself, but that I had the more discovered mine own ignorance. Yet I was in one of the most famous schools in Europe where I thought, if there were any on earth, there ought to have been learned men. - Rene Descartes

Select assets discovered outside China with best-in class-potential that have been passed over due to the competitive landscape could be extremely innovative in China. Identifying, accessing, and partnering such an asset defines an “Innovation Arbitrage” for the arbiter who is prepared for the opportunity. - Paul Gayson

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