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Thursday, December 12, 2013

Enzyte, Religion and Juno Therapeutics

Enzyte is an herbal supplement that some claim promotes natural male enhancement. It is suppose to make your penis bigger. Its effectiveness has been celled into doubt. The original businessmen who marketed this product knew that there was no scientific logic behind the claim. That doesn't mean you have to throw in the towel. What made the leaders successful businessmen was the selection of the product, clever marketing, and the passive nature of some people who accept getting ripped off when it doesn't involve a lot of money. Because Enzyte is an herbal supplement no testing by the FDA is required. The company selling Enzyte, Berkeley Nutraceuticals Inc., went a little too far however. CEO, Steven Warshak was found guilty of 93 counts of conspiracy, fraud and money laundering, sentenced to 25 years in prison and fined $93,000. Berkeley Nutraceuticals had to forfeit $500 million. Several other executives were convicted of crimes but the company lives on. It is now called Vianda LLC and they still sell Enzyte. Hamilton County (Cincinnati OH) commissioners approved a $195,000 property tax break to the "new" company based on projected employment opportunities. They continue to receive customer complaints on the efficacy of the product and improper billing issues. 
During the Middle Ages there were all kinds of crazy ideas, such as that a piece of rhinoceros horn would increase potency. Then a method for separating the ideas--which was to try one to see if it worked, and if it didn't work, to eliminate it. This method became organized, of course into science. And it developed very well, so that we are now in the scientific age. It is such a scientific age, in fact, that we have difficulty in understanding how witch doctors could ever have existed, when nothing that they proposed ever really worked-- or very little of it did. - R. Feynman, Cargo Cult  Science
This little passage only applies to the efficacy of Enzyte. We know that profit is why government agencies support the continuation of this job creating business. Science and business/government in this case, are in opposition to one another. The former is only concerned with the claims of "male enhancement". The latter is only concerned with the interests of the company and the local economy. The customer is offered a useless product and freedom of choice. Scientifically it is a bad choice to pay for and use the product. It is snake oil. From a business and local government perspective, why not make a few bucks off of the naive? It's not a much money and it might even give the men a brief moment of hope.

This leads me to the concept of religion and science. When you really want something to be true, you put your money where your heart is. Churches all over the world make money. They build buildings, pay their leaders and even do a little charity work. Yet religion is snake oil for the soul. There is no God yet every Sunday/Saturday and several times a day somewhere in this world, a preacher will stand up and go on and on about new thoughts they alone have dreamed up regarding their religion. Biopharma, likewise, sells hope, builds buildings, pays its leaders and does a little charity work. Oh yes, we have our charismatic leaders who could have just as easily made a fortune from Enzyte. What makes a biotech different from religion is the component of science. Unlike Enzyte, biopharma drugs must be approved by the FDA. The efficacy must be proven. Although not impossible, science makes FDA approval a complicated problem.

I did not say that the formation of a biotechnology drug company is approved by the FDA. Biotechnology drug companies are approved by investors. Investors really really want to make money, just like the leaders of Berkeley Nutraceuticals/Vivandia and local officials of Cincinnati OH. They do not follow the organized methods of science. Only some of the people at a biotechnology drug company must follow the scientific method.

Which leads me to Juno Therapeutics. This is the latest Seattle based biopharma company. Is it science or is it business? Is it a combination of the two? Is this of little interest to the locals in Seattle who see the $120M investment and call it a success?

According to Xconomy:
The company doesn’t intend to make a conventional pill in a bottle or targeted antibody drug in a vial. Instead, it plans to withdraw blood from individual cancer patients, re-engineer certain immune T-cells from each patient to turn them into super-aggressive cancer cell killers, and then re-infuse the “killer” T-cells back into the body. The great future ambition is to wipe out the tumors and create ongoing immune system memory and surveillance that can potentially keep cancer at bay for years.
Juno Therapeutics is an off-shoot of Dendreon. The CEO of Juno, Hans Bishop, is the former COO of Dendreon. The manufacturing and logistics skills learned through Dendreon will now be parlayed into Juno. The difference will be in the choice of immunogens/cancers Junos induced immune response will attack. In a Utopian world, Dendreon technology would have been the main interest in Dendreon, not Provenge. In a profit motivated world such as ours, a new company has to be formed to remove the stench from Dendreons financial failures. The technology of taking blood from a patient, sending it to a lab to generate an out-of-body anti-cancer immune response, then putting the cells back into the body, is indeed an advanced biotechnology. But so is making a pill.

In the Cynefin system of thinking, this technology is complicated. What is happening on the cancer cell side of the equation however, is complex. Juno has not solved the problem of understanding the cancer cell. Rather they have made the assumption that a cancer cell will have an Achilles heal. One Achilles Heal target means that the cancer cell side of the equation, according to the cynefin framework, is simple. Highly unlikely.
The big idea is in exploiting advances in understanding how to manipulate T cells to fight cancer,” said Larry Corey, the president of the Fred Hutchinson Cancer Research Center and co-founder of Juno.
What I am suggesting is that an even greater understanding of the cancer is required before you apply your T cell/immunology understanding. There is a leap of faith taking place.

Are the investors of Juno like the moneyed interests behind Enzyte? We all want to believe. There is a history of investments. Efficacy has long been an issue. In spite of the troubled past of immunotherapy for fighting cancer, the investments continue to pour in. Fortunately, biotechnology has its scientific side, along with the religious followers (investors) and the great story tellers. I want to follow this company carefully. Their claims have not been submitted to peer review nor have they signed up to present at any conferences. Rather than take the old fashioned science route (peer review) they have started a biotech company and not in a shy way. From my perspective as a long time student of the Cargo Cults, I find this to be suspicious. From a scientific standpoint, they aren't much more Berkeley Nutraceuticals at this point. They have a lot of money, a good story, and people who need what they are promising. The path forward will be beaten down for easy passage by those who want to believe, want to profit and those who want Seattle to take another run a becoming a biotech hub. I will hold onto my skepticism as always and keep my eye on Juno as much as possible. They have moved into the old VLST space, a place where a $50M biotech company once disappeared and no one knew about it for several months! That should not happen to Juno. The bold burst onto the scene should be followed up with an equal amount of attention to what comes next.


Northgate Nan said...

I like your perspective - you dig deep and tell it straight. The question always remains - so what the f do we/can we do about it?

My grandma, born somewhere in the 1880s was a very ethical, courageous and smart woman who turned to religion in her later years - mostly, I think, to cope with the myriad disappointments in her life. I remember her saying many a time: "It's a wicked system, a wicked system" When one gets the "faith" maybe it takes a load off while they look to eternal salvation or Armageddon or the maybe even the Rapture. Drink it, just drink it! he he

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