Location Location Location

The constant job loss is a part of the cargo cults. They hire with little understanding of what is really needed. In time the lack of cargo leads them to the path of laying off unproductive members of the tribe. Those who make the decisions have to retain their own services because they have a different function. It is their job to keep the cult alive so new ceremonies can be attempted. What Amgen did with their layoffs is no different than all of the other layoffs. In New Jersey, Roche has left enough empty laboratory/biopharma space to fill every floor of the Empire State Building. Seattle has nothing on the state of New Jersey.

Five years ago, Roche acquired Genentech, moved its management to San Francisco and started to slowly withdraw from New Jersey. That's a pretty typical story for what's been happening in the state. In the past 20 years, New Jersey went from having more than 20 percent of U.S. pharma manufacturing jobs to less than 10 percent.

The state of Washington or New Jersey is not the state we need to dissect. The state biopharma is the problem. When it comes to our hopes and dreams about jobs and useful drugs it is going to take more than new surrounding and new money. The constant relocation of the jobs and the shuffling around of the workforce is not working. It contributes to a weaker and weaker workforce. It leads to Yes-men and desperate researchers willing to say what is needed to work another day. If we were to look carefully at the state of biopharma and their scientific method, we would find that it does not vary from one place to the next. Likewise nor do the layoffs.

"Essentially, every time there's a merger or one company acquires another company, there's a reduction in force, and there's been furious mergers and acquisitions in the pharma industry, particularly over the past 10 years," says James Hughes, dean of the school of public policy at Rutgers.

The furious mergers and acquisitions are work functions that keep the leadership away from the higher risk activities of conducting research. It is hoped that someone else will come up with something in the pause created by merging companies, laying off people and articulating the way forward. History has shown that this is not a very effective method.

Business professor Erik Gordon of the University of Michigan says cutting-edge research isn't being done on closed campuses in the suburbs anymore. "The new innovation in biotech, in genomics is happening elsewhere. It's happening in places where there are graduate educational institutions that have research faculty doing that, and New Jersey really doesn't have that," he says.

Again, we see this concept that cutting edge research is done only at certain locations. We've even been given an explanation for why that is. You need to be close to graduate education institutions that have research faculty doing new innovation in biotech and genomics! Take that Rutgers. Serepta had this concept long ago. They moved from Oregon to Bothell WA then to the Boston area. They hired and fired a new Chief Scientific Officer and the CEO and Chairman of the Board had a public spat. Those who think long and hard about what science is know that it is not something that only occurs at certain locations. The natural world can be observed anywhere. A laboratory in Seattle versus a lab in New Jersey or China, is no different. When we want to purify DNA will will all go to the internet to purchase a kit from Invitrogen or some other favorite kit provider. When we want to buy an HPLC we will hold meetings and decide upon our favorite HPLC provider. All HPLCs work the same. They also work the same in Seattle, New Jersey and China. This is the beauty of science. If you are thinking about it correctly, you are thinking about things that do not change from location to location. It can be done anywhere.

"What really sets this site apart is its location," says Tom Stanton of Jones Lang LaSalle, the real estate firm marketing the site. The site is so big that to show it off, Stanton needs a minibus. Looping through a parking lot with thousands of empty spaces, Stanton stresses how close the campus is to Manhattan, Newark's airport and public transit. "Hiring young, talented people is really important to these companies. And that population of upcoming talent is more into the city life," he says.

Positively Sink'n Think'n About Amgen Seattle

An Amgen spokesman told Xconomy its Seattle R&D site and Bothell manufacturing sites employed 660 people combined, with 430 more in Colorado. The facilities will be closed by the end of 2015.

I've extracted this bit of news from an article on Xconomy. The rest of the article depicts the upside that remains in Seattle.

When asked for his reaction to the Amgen news, Washington Biotechnology & Biomedical Association president and CEO Chris Rivera said, “In a word, disappointing.” But Rivera adds he is optimistic that the employees who don’t relocate—Amgen said it would shift jobs to its Cambridge, MA, and San Francisco Bay Area locations—should be able to find jobs in Washington state if they want to.

The Seattle Times reported Riveras' thoughts on the matter this way:

Chris Rivera, president of the Washington Biotechnology and Biomedical Association, said that while the news was a letdown given Immunex-Amgen’s history in Seattle, he is “pretty confident” those employees who want to stay here will be able to find a job in the sector. “There are plenty of opportunities here,” with about 190 biotechnology and pharmaceutical companies in the area, he said.

Next we hear from Bob Nelsen of ARCH Venture Partners, a longtime investor in the Cargo Cults of Seattle: "Amgen’s departure is not good, but the area’s strength in various disciplines will make up for it in the long run.” Oh sure, Amgen in Seattle had 1600 employees in 2004. In 2015 they will have zero. The 750,000 square feet facility will now go on Craigslist perhaps. 'R&D space available. Nice view! DNA bridge included!' The unemployed will take their resumes, many of which will list a degree from UW and one narrowly defined job at Amgen, and go find those jobs that Rivera and Nelsen believe exist. The cargo cults are going to be just fine. The truth is that this is bad. Really bad. We haven't learned anything nor have we admitted that this failure is something worth a concerted effort to prevent in the future. We cannot look past this spectacular failure of the biggest deal in the history of Seattle biotech. The demise was not sudden. There were 1600 jobs in 2004 and only 610 left to eliminate in 2014. The demise was a long slow process. Only one decade after the most grandiose R&D cargo cult was finished and fully staffed, it goes to the Seattle Biotech graveyard. We have seen the loss of many companies large and small. From the tiny 3 people companies at Accelerator to the larger implosions of Zymogenetics and Icos, Seattle biotech workers have had to exist in a minefield. Those losing their jobs must share in the culpability of this minefield. They are cargo cult tribesmen who do not want to speak of that lack of cargo planes landing on their runway. The optimism is always there. The cargo? Now they must be moving on to man the watch tower at the next airport. Once again there will be no gathering of "talent" to put down on paper what was learned. The only writing that will take place comes in the form of CVs depicting only positive information. The leadership that survives will rest assured that they have made the prudent decision and that ten years from now, all will be better. This is the problem with positive thinking. Nothing is gained. As one soon-to-be ex-Amgen researcher said, "I understand from a business angle but I think it is shortsighted." Really? You understand cutting out R&D from a science based company where the kind of research you do can take decades to complete? They shut you down in ten years! Get mad! This is a raw deal. Those who conduct research surely have a thing or two to say about a ten year period where 1600 people lost their jobs. Something was not going well. What was the negative side of your work? Why do you think the executives did not see the value in what you did for their company? Times like these require everyone to face the facts, just as the leadership at Amgen has had to face facts. The value of R&D is just not there. Either it is not very scientific (as the Amgen Study reported) or the leadership is missing its point. Why not make a decision yourself then? Speak out about what you did. I once interviewed for an RNAi job at the Seattle Amgen facility. I learned that it was an RNAi job while on the interview. I told them I would not work with RNAi. We chatted politely but the interview was over for all intents and purposes. I shared what I experienced with RNAi and why I did not believe in the future of the technology. Since then I have witnessed one RNAi company fail after another. Serepta continues to crumble. I gave up biotech entirely in 2010 but I remain loyal to the cause. Not in a positive way like Rivera and Nelsen. I am one of the guys who would have lost his job had I got the RNA job at Amgen. I saw the same value then as Amgen executives see now. The people I interviewed with at some point between my interview and now have lost their jobs. The value of the work we were talking about that day has been decided. It is worth nothing. Now what can we do to find value in ourselves? How can we work towards a brighter future for the next generation or will it be up to them to improve upon what we've been begun? What will become of the unemployed in the next few years? There are many questions but no one is asking them. We don't want to seem negative.

The Trouble With Positive Thinking/Falling From Grace

What is the difference between purposely deceiving an audience and accidentally deceiving yourself? My hero James Randi points out that a magician is the only honest professional, in that s/he sets out to deceive you, tells you that they are going to do it, then does. Contrast that with an advertising professional. They are like magicians except they do not want you to know they are trying to deceive you. A true skeptic however, knows the score. We set our minds to the task of finding the deception, just as Feynman did in the Cargo Cult speech when discussing the Wesson Oil ad campaign.

The easiest way to explain this idea is to contrast it, for example, with advertising. Last night I heard that Wesson oil doesn't soak through food. Well, that's true. It's not dishonest; but the thing I'm talking about is not just a matter of not being dishonest; it's a matter of scientific integrity, which is another level. The fact that should be added to that advertising statement is that no oils soak through food, if operated at a certain temperature. If operated at another temperature, they all will--including Wesson oil. So it's the implication which has been conveyed, not the fact, which is true, and the difference is what we have to deal with.

Imagine Feynman standing in front of the Wesson Oil section of your local grocery store. "Hey, that oil is no different than this one." The would-be purchasers of Wesson Oil would think he is a nut. Yet he speaks the truth. Those who choose to deceive, on the other hand, positively convince the consumer through tv commercials with attractive middle class people that Wesson Oil is a wise choice. The facts thus take a back seat in influencing decisions when more pleasant narratives are in place. Our irrational behavior is our achilles heal. To make matters worse, we have been conditioned to believe that we cannot be so easily fooled. To consider the notion would be to admit a naivete that we don't want to believe. The leaders of biotechnology/pharmaceuticals likewise do not entertain the idea that their selection process has ever been faulty. They have selected for the best and the brightest individuals. Please ignore our history of successes and failures. These individuals simply cannot entertain the notions that luck has anything to do with the fact that they are still employed. Yet lately, even the positive thinkers are starting to have doubts about their chosen profession. In this article we see that people are starting to feel as if we are falling from grace. Grace? Were these people being positive to avoid getting weeded out of our industry? I began this blog with the exact opposite notion about myself and my cohorts. I felt that we were merely watchtower employees of a cargo cult. The layoffs were a part of my industry before I began and after I left. Every time I lost a job I felt that, while I had learned something, the world had not gained much from our efforts. I did not get down on myself because I had learned something. I had grown and every time I found myself at the next cargo cult, I would one day read about the demise of the last one. I made no excuses for myself nor the cargo cult. I failed and they failed because we did not take science seriously. We favored our careers over the thing that made our careers possible. We were standing on the shoulders of giants waiting for them to take us to the land of milk and honey. They didn't budge! As I come back to this blog it is with the purpose to attack the positive thinking that has created four decades of nowhere careers, bad science and the loss of a few hundred billion dollars. In his book, "The Antidote, Happiness for People Who Can't Stand Positive Thinking" Oliver Burkeman describes a study where researchers at a molecular biology lab at UC Berkely were themselves studied. Each time they encountered a result that they had not expected, they first questioned themselves. What had they done wrong. The thought that what they were seeing was to be taken seriously and used to move forward was not entertained. They moved forward in pursuit of the positive result, the one they designed into the experiment. These scientists aspire lead their own labs or groups within biopharma. They want a job! It's not getting harder to have a job as the "Falling From Grace" article suggests. It remains hard to keep a biopharma job. What we are doing is not working. Yet we don't give up. We fight to keep our employment because that one project is your whole job. This is not sustainable. Fight to remain in research, not just the research project you are on. Admit defeat when you know it's time to move on. And move on! It is a cargo cult science out there and that is the problem. Bend over backwards to be honest and leave your hopes and dreams at the door. The scientific method will lead you in directions your positive thinking irrational mind can't imagine.

Biotech Royalty

David Blech earned the title "The King of Biotech". Armed with a Masters degree in Music Education, he became a member of the Forbes 400 investing in companies like Genetic Systems Corporation, Icos, and Celgene. In 1990 he founded D. Blech and Co., a registered broker-dealer involved in underwriting biotechnology issues. On September 22, 1994 the company was deep in debt and ceased operations due to net capital rule violations. The day is known as Blech Thursday.

The uniform net capital rule is a rule created by the U.S. Securities and Exchange Commission ("SEC") in 1975 to regulate directly the ability of broker-dealers to meet their financial obligations to customers and other creditors. Broker-dealers are companies that trade securities for customers (i.e., brokers) and for their own accounts (i.e., dealers).

Blech was given a five year probation sentence in 1998 for criminal fraud. In May 2012 he pleaded guilty to manipulating shares of biopharmaceutical companies Pluristem Therapeutics Inc and Intellect Neurosciences Inc in 2007 and 2008. 

The Cargo Cult message of the story is that success in biotech financial matters does not require a PhD from MIT. It does not require bend-over-backwards scientific honesty. It requires the mind of a gambler. Remember the successes, but not the failures. Remember random events around your successes and tout them as skillful tricks of the trade you are in. 

In Seattle there is a building with four numbers in front. 

Inside this building are people who have chosen the same career path as David Blech. Carl Weissman and Steven Quay have been at the helm of several costly biotech investment decisions. Neither has found themselves on the Forbes 400 but they have had lucrative careers in biotechnology. The investments they have attracted have not been lucrative. Weissman is now the former CEO of Accelerator and Quay is in charge of a sinking ship known as Atossa Genetics. 

I don't want to go into further details about these investment opportunities. I've written about them before. Each man is a leader, as defined by the terms of a CEO. You are investing in them and the decisions they make with your money. Like David Blech, they are not scientists, as defined by the terms of a CSO. They seek money and use it to build biotechnology companies. The science is none  of their  business. Their careers have seen hundreds of millions come and go. They want you to focus in their ability to make the money come, never mind how it goes away.

The takeaway from  Blech, Weissman and Quay is that leadership matters. What makes a good biotech leader? In 1992 David Blech would have been considered a great leader. In their rise, Weissman and Quay were considered worthy of stewardship over millions and millions and the careers of many very smart people. In the ruins of their management is the loss of that money and the ruined careers of too many scientists. True, Blech (the music education master) started companies that made money and continue to do so. But he did not do the work that made these companies long term successes. These three individuals are prime examples of the short term mentality. Start company, get out before the fall. They are prime examples of why we need standardization, certified laboratories with certified lab workers. We need to create an career path for scientists who have the power of science to help investors avoid the song and dance of these three men. One of these men is in prison, one is looking for work, and one is draining $600,000 per year (CEO and CSO salaries for he and his wife) until the latest round of financing is depleted. Be assured that all three will continue to fight for their livelihood and raise money to spend on short term money making biotechnology companies.  

There is a little bakery on the bottom floor is 1616 Eastlake called Grand Central Baking Company. They are the most profitable company that has ever done business out of 1616 Eastlake. They have outlasted all of the Accelerator companies. They have a passion for what they do. 

More than two decades after our founder Gwen Bassetti introduced the Como loaf in Seattle’s historic Pioneer Square, we are still locally owned, led by a unique mixture of family and friends, and dedicated to the craft of artisan baking.

Biotech royalty, like Bech, Weissman and Quay, have a passion for the deal. They love being the biggest boy at the big boy table. But this isn't the craft that makes biotech success stories. The craft of "the deal" has led to many a lawsuit, jail time, and high unemployment. What makes any technology company succeed is a dedication to the science and technology behind the product. For this, you need someone outside the royal families. 

The Narrative of Jack Andraka

I would never do a PhD. I’m sorry, but the lab bench is not cut out for me. I don’t want to do academia. I want to work in the clinical field and do business or public advocacy. - Jack Andraka

When I first saw Jack Andraka on 60 Minutes running down the isle to collect his award at the Intel International Science and Engineering Fair 2012, I thought I was watching someone who had just won the Miss America pageant or a chance to bid on The Price Is Right. His demeanor was that of an attention getter. My bias is that I do not like that kind of personality. Rather I gravitate towards Feynman, who did not like awards. I gravitate towards Frederick Sanger who said, "Scientific research is one of the most exciting and rewarding of occupations." I like Einstein who said that true art and science begins where our hopes and dreams leave off. This 16 year old spent 3 months in the lab and a year on the TEDx talk circuit. He was a media darling, but was he a Cargo Cult Scientist?

I've given my bias. I will try to avoid it when making my argument. 

This article from Mathew Herper in Forbes deviates from the positive spin from the popular media that greeted Jacks entry into the scientific community. The title, "Why Biotech Whiz Kid Jack Andraka Is Not On The Forbes 30 Under 30 List".

But I decided not to include Andraka on the list, overriding the recommendation of an expert judging panel, because the work was not yet published in a peer-reviewed scientific journal. It is by published work that scientists are judged.  I still think this was the right decision. In fact, when Andraka volunteered to share a draft of a paper that he does plan to submit to a scientific journal, my concerns deepened.

Here are a few reasons why he is on the Cargo Cult Scientists list:

1) So we really ought to look into theories that don't work, and science that isn't science.

As Mathew Herper points out in his article, Jack Andraka has not yet published his work. Many scientists that reviewed an early version had their doubts about some of the claims. The question science asks, "Does the theory work?" We don't know.

2) Now it behooves me, of course, to tell you what they're missing. But it would be just about as difficult to explain to the South Sea islanders how they have to arrange things so that they get some wealth in their system. It is not something simple like telling them how to improve the shapes of the earphones. But there is one feature I notice that is generally missing in cargo cult science. That is the idea that we all hope you have learned in studying science in school--we never say explicitly what this is, but just hope that you catch on by all the examples of scientific investigation. 

Jack Andraka is a young man with little experience in science. Something is missing in his foray into science.

3) Details that could throw doubt on your interpretation must be given, if you know them. You must do the best you can--if you know anything at all wrong, or possibly wrong--to explain it. If you make a theory, for example, and advertise it, or put it out, then you must also put down all the facts that disagree with it, as well as those that agree with it. 

Mathew Herpers article highlights some critical details that others have had to point out that throw doubt onto Jack and his mentors interpretation of the lab work.

Andraka’s “168 times faster, 26,667 times less expensive, and 400 times more sensitive” figures are based on a comparison with ELISA. But Church saw problems with the way that Andraka characterizes the ELISA test.

Test speed: Andraka says he compared the speed of his test to the amount of time he spent trying to get results from an ELISA kit he ordered online: 14 hours.  But usually a modern ELISA test takes 1 hour.

Test cost: Andraka is comparing the commercial cost for a test – including the manufacturer’s profit and overhead – to his own materials cost. That’s not a fair comparison. He says the only mesothelin test that he found cost $912 per kit. But other ELISA tests are for sale online for $400 per 60 tests or $600 for 96 tests – in other words, about $6.50 per test run. That still compares favorably to Andraka’s $3 per 10 tests, but remember that there would also be a commercial markup if a company decided to sell his tests. 

4) In summary, the idea is to give all of the information to help others to judge the value of your contribution; not just the information that leads to judgement in one particular direction or another. 

Since the work of Jack Andraka has not been published, we need more information. His mentor, the media and the public all want to believe we have a genius in the wings. The stories and awards provide us with the information and judgement in one particular direction. The truth might fall short of this story.

I agree with Mathew Herper, it was a pretty neat thing for a teenager to do. To take an interest in biotechnology and cancer detection at 15 is remarkable. The tenacity to present his idea to a hundred scientist before getting the attention of one is why I think the kid is going places. His science probably won't go nearly as far.

Which leads me to the conclusion that the boy has merely been a pawn in the Cargo Cults of Biotechnology. His mentor did not discourage the boy nearly as much as those meanies who came later. But that is how science must work. The truly talented scientists have a passion for this pursuit. They do what they do because they are good at it. They want to work in a laboratory, design experiments, observe what  happens, and live a life learning new things that no one else has thought of yet. The details that separate science from Cargo Cult Science are subtle, often times the cause of eye rolling among non-scientists. Where some will say, "big deal" a scientist will demonstrate just how big of a deal a seemingly small detail can be. These people are often introverted, soft spoken, and more focused on petri dishes than their own reputation.

As one commenter said from the Forbes article: "Based on your description, the kid sounded pretty promotional. I don’t know if he will become a scientist. I have a feeling he may become one of those slick biotech CEO in a few years."

A scientist is not a CEO of a biotech company, a bureaucrat at the NIH, or a judge of a science fair. A scientist might hold one of these titles, but the titles do not make you a scientist. Each title may require the holder to have a PhD. But science is bigger than titles and awards and the people who strive for them. A scientist is merely a life long student of the natural world that still has a billion secrets left for us to figure out. 

Through art and science in their broadest senses it is possible to make a permanent contribution towards the improvement and enrichment of human life and it is these pursuits that we students are engaged in.Frederick Sanger 

The Power of Science

I've often cited the Begley and Ellis Nature paper, "Drug development: Raise standards for preclinical cancer research".  Glenn Begley has graced Xconomy with an article on scientific reproducibility. 

The concept that science must be reproducible before you can call it science is a slippery slope to some. A comment from the Nature webpage listed above:

The claims presented here are pretty outlandish. Particularly relevant to "Hematology and Oncology" we now know that mice housed under different conditions with different microflora can have vastly different outcomes in any model, not just cancer. To suggest academic incompetence or outright unethical behavior is offensive, and is a particularly narrow view of why experiments are difficult to reproduce. Further, as indicated in Table 1, the entire definition of not-reproducible hinges on a priori profit motive of "robust" differences (whatever that means). There is always room for improvement in science, but this entire article is disingenuous and belittling to those of us who are on the front lines.

To this I would respond:

"The manager accepts the status quo; the leader challenges it."Warren G. Bennis

Here is the enemy. Feynman described the mouse maze experiment where confounding factors lead many researchers astray. Finding out where we can go astray is an important part of the scientific method. If you don't rule out as many confounding factors, you are subject to making mistakes like those made by not knowing the effect of microflora on mouse experiments. Will a study on microflora get you a tenured position or will it make you a thorn in the side of the scientists who are more concerned about their career in cancer research? Most likely the latter is true. It is the responsibility of leadership to create a more welcoming place for real science, that may not jibe with the career/corporate aspirations of less rigorous scientists.

It is important to realize that this debate, highlighting the deficiencies our scientific process, is taking place openly within the scientific community. This is a sign of the strength of our scientific system.

That is a very important point. People are embracing the conversation about our shortcomings in science. We need more humility, more honesty and less arrogance. A call for increasing the rigors of our soft science is only going to be a positive for the good name of science. The people who will be hurt by a push in the direction of the scientific method are those who do not appreciate what it can do.

The above commenter may believe that any dissenting view of modern science is heresy. (I don't want to create a straw-man argument, thus he may...) If the argument against increasing reproducibility, increasing transparency, and increasing rigor, is that it would make working in science too hard, then I would argue that the power of real science is misunderstood. Your boss may want to see a positive result from your mouse study on his desk prior to his/her next board meeting. You may have just discovered that the microflora is confounding the reproducibility of your experiments. What do you do?  Is it wise to assume that everyone believes that the newfound knowledge of the microflora will be received with open arms from the guy who didn't ask you to look into such details? In this case, the scientific method is in opposition to the political method. The Machiavellian tactics you employ to advance or simply to keep your job are often times jeopardizing future research, yours and those in your field.

The questions Glenn Begley asks:

What constitutes reproducibility?
What, if anything, has changed?
What is driving this?
What is being done and where will this take us?

What Glenn Begley is doing is very important for others who currently work in, or one day hope to work in science.

The majority of scientific discoveries in the biomedical sphere should be sufficiently rigorous and robust to allow other investigators to build on that work and move the field forward. Hopefully the changes instituted as a result of this debate will help further strengthen our discovery processes. - Glenn Begley

Status quo, you know, is Latin for 'the mess we're in'.
Ronald Reagan

If there is dissatisfaction with the status quo, good. If there is ferment, so much the better. If there is restlessness, I am pleased. Then let there be ideas, and hard thought, and hard work. If man feels small, let man make himself bigger.Hubert H. Humphrey 

Marie Hubers SEC Fine

The website Logical Fallacies is an invaluable tool for any scientist or person who wishes to battle the status quo and those who most benefit most from maintaining the status quo.  As stated in the opening paragraph of the website, "Fallacious reasoning keeps us from knowing the truth, and the inability to think critically makes us vulnerable to manipulation by those skilled in the art of rhetoric." Let's look into the logical fallacies surrounding Dendreons Provenge saga.

We have two sides, Dendreon and Marie Huber. One is a once-multi billion dollar biotech company. The other is a private citizen who took issue with the reasoning behind the approval of Dendreons Provenge. Both sides of this story have presented a scientific sounding argument in peer reviewed journals. Both sides appear to have had a monetary motive for practicing the art of deception. Both sides have been accused of some serious shenanigans. In the end, Dendreon is a company on the verge of bankruptcy and Marie Huber has been dragged through the mud.

Here is the final verdict as posted by a pro-Dendreon bully on the Wikipedia site:

Huber's contentions were ultimately exposed as a scheme to profit from speculation in put option contracts in the underlying security of Dendreon Corporation, which would have produced enrichment in the event the stock price were to have declined; the SEC accordingly found in November 2013 that in their reporting of Provenge, she and a colleague, via the dissemination of untrue statements and omissions of fact as a means to obtain money or property, violated Section 17(a)(2) of the Securities Act of 1933 (Securities Act), and imposed against each of them a six-month suspension, a $25,000 civil penalty, and a cease-and-desist order. - Wikipedia entry for Provenge 

"Hubers contentions were ultimately exposed as a scheme to profit from speculation..." The author here is referring to Ms Hubers "Alternative Explanation" as "contentions. This is an important point. The SEC report on Ms. Huber states:

After reviewing and analyzing the FDA documents, Huber concluded that 

the Provenge treatment was hastening the death of patients.  In June 2010, Huber began 

drafting a report for HFA-A, entitled “Provenge PhIII Trials – The Alternative Explanation 

of Survival Results” (hereinafter referred to as the “Alternative Explanation”)

The SEC report later makes the distinction:

A version of the Alternative Explanation was subsequently published in the “Journal of the National Cancer Institute” on February 22, 2012. The findings in this Order do not address the conclusions set forth in the Alternative Explanation. 

The SECs claims against Ms. Huber was that she tried to profit from her June 2010 Alternative Explanation report.

During the period of June 17, 2010 through July 12, 2010, Huber purchased $125,431 in July Dendreon put options and $110,627 in August put options.2 Huber also purchased put options in her mother’s account, and shared her analysis with friends and family who subsequently traded in Dendreon securities. The July put options that Huber purchased were set to expire on July 17, 2010, and had strike prices ranging from $10 to $30. All of the put options were “out-of-the-money” and most of them had strike prices of $25 or less.   Dendreon common stock was selling in the low to mid $30s.

Ms. Huber did her analysis in June 2010 and purchased put options in July. The argument that the Alternative Explanation report is thus a "scheme for profit" might seem logical on the surface. The problem is that the Alternative Explanation exists separately. Was it developed in order to short the stock? Or was it the impetus to short the stock? We don't know nor have we, nor the SEC, attempted to sort that one out.

The logical fallacy is called the Genetic Fallacy. This fallacy is committed when an idea is either accepted or rejected because of its source, rather than its merit. The idea that we are most concerned about here is the truth behind Provenge. Does it work? Is it safe? We mustn't make the Appeal to Authority and accept the FDA ruling, nor can we assume that the demise of Dendreon means Provenge doesn't work. Locially, there is still work to do regarding the Dendreon Provenge saga. One path we should take is in the practice of clinical trials and how a biopharma company interacts with the FDA. But we'll save that for another day.

I think the Genetic Fallacy addresses the Wikipedia damnation, along with all of the other detractors who wish to write off the scientific arguments made in the JNCI paper. The Alternative Explanation and the JNCI paper have not been called into question. The science is not the issue behind the SEC smackdown of Ms. Huber. The scientific method is a journey. It begins one day with a hypothesis. You test your ideas and maybe one day you decide to publish them. The merits of that journey remain untouched by Dendreon bullies and Wikipedia ghost authors.

Now then, as for Marie Hubers SEC troubles. Marie Huber recently made the following comments on the CCS from this post. 

• A trial would have cost me at least a year and $100,000 -$250,000 in legal fees.
• Settling cost me $25,000 and a 6 month suspension.
• My legal defense bill over the 3 years of this SEC investigation has run into SEVEN FIGURES.

The terms of settlement prohibit me from making any statement other than "I neither admit nor deny the SEC's allegations". This means that YOU KNOW NO MORE AFTER READING THE SEC's ALLEGATIONS THAN YOU KNEW BEFOREHAND. An allegation, by definition, need not have anything behind it but the alleger's motivated imagination. Again, "I neither admit nor deny the SEC's allegations".

July 14/15, 2010: An anonymous report that I had written (exposing hidden results from the Provenge trials) was emailed to a bunch of biomedical folks (only 2-3% of whom were investors).

July 15, 2010: my employer files my report with CMS, identifying us as investment advisers.

August 5, 2010: I log the i.p. addresses of Kroll (private investigators) and Marsh McLennan (their former parent company), trawling through decades of archives of my personal website (www.mariehuber.com)

August 10-20, 2010: i.p. addresses from Seattle, WA, hit my personal website.

August 12, 2010: "Someone from Dendreon Corp" browses my LinkedIn Profile.

Sept 14, 2010: Mitch Gold approaches me, out of 300+ analysts who had just listened to his presentation at the Morgan Stanley conference (he does not know me, but I wear my distinctive long, curly hair down in order to lure him, and he obliges). After a little fun, Mitch reveals that he knows that I wrote the anonymous report on Provenge.

October 6, 2010: [I only learned this in 2013] the SEC contacts gmail regarding the account Jess had created to email my report.

The SEC settlement over my friend's distribution of a report I had written in 2010 is unrelated to my JNCI publication.

The JNCI publication occurred 1.5 years after my puts had expired worthless. I had no financial interest, in any way, around the time of the JNCI publication, or which could have been influenced by it. I was completely truthful in my disclosures to the journal, and given that the SEC had been all up in my business from early 2011 onwards, the settlement acts as PROOF of this.

I wished I HAD written in bold at the top of my report: "I believe so strongly in the shocking nature of the data that Dendreon has hidden and the only logical conclusions to be drawn from it, that I have bought thousands of puts betting on a decline of 30-80% in the price of DNDN stock over the next month". Maybe if i'd written that some people might actually have read it.

Anyone that did read it and understand it would have saved themselves from a 66% decline in the value of any DNDN shares they held in August 2011, when the "efficacy" of Provenge spoke for itself.

---------------------------

She ends with a logical fallacy of her own. The stock tanked in August because Mitch Gold made some promises he couldn't keep. He priced his product too high and didn't give his sales team a chance to make money. The efficacy of Provenge may have contributed to the doctors decisions not to prescribe the treatment but a stock price has no logic. 

I believe Ms. Huber and her analysis of Provenge. She was brave to take the journey, even though she may have tried to turn a profit Wall Street style. What matters here is the way in which clinical trials are conducted and reported to the FDA and the rest of us. Big Pharma has the same for-profit motivations as anyone trying to short their stock.

Mala Aria, Italian For Bad Air

When the ancient Romans were conquering the world they became familiar with the disease malaria. They noticed a correlation between thick musky swamp air and the disease. They deduced that the bad air, mala aria in Italian, was the root cause of the disease. Whenever they encountered the disease they drained the nearby swamps. The solution worked. Of course, scientists later honed in on the real culprits, blood parasites transmitted by anopheles mosquitoes.

Rene Descartes said, "Good sense is, of all things among men, the most equally distributed; for every one thinks himself so abundantly provided with it, that those even who are the most difficult to satisfy in everything else, do not usually desire a larger measure of this quality than they already possess."

One of the greatest obstacles of drug research and development is in the assumption that we know how to do it. Coming from the billions and billions of research dollars and the thousands of disparate workers trying to make money for their employers, is the occasional FDA approval. From the approvals we occasionally get a new treatment that is useful. Like blaming the bad swamp air for malaria, we miss the mark when assigning cause and effect. If we dig a little deeper we find that only science brings about real change.

When a company fails to beef up their pipeline, the C-level execs take action to get rid of the dead wood. In the process, they may very well be axing the only chance science has to do what it does. In that moment, where people and ideas turn over, the C-level execs want you to believe that they have done some good. They are draining the swamp. No one has yet figured out how to research disease and develop drugs without simply spending money, starting and ending projects, and hiring and firing the usual suspects. We don't know what it is that made us succeed at the last project nor why we may be failing at the current one. We succeed quite randomly, if we are to be honest about our profession. If that is not true, and we in fact do have drug development experts, where are the lessons offered by the enlightened? Are we not in need of a larger measure of this quality than we already possess?

There are those, however, who lack the skepticism of the scientists. They are the capitalists.  They will soon be gathering at the 32nd annual JP Morgan Healthcare conference in San Francisco, Jan. 13-16. Luke Timmerman, industry cheerleader, announces the upcoming event:

So what about all the healthcare industry capitalists? Are you ready to make the most of this week when all the decision makers and big investors are together in about a five-block radius?

So much for journalism, this is going to be a love fest. The leaders are gathering. It is time for all good soldiers to make a good impression. The healthcare industry however, is one of many elephants in the room when thinking about the next American crisis. Scientifically, we still do not have a viable career path for our scientists. Financially we have a group of fools and fanatics gathering in a five block radius to talk about ways of profiting from a national disgrace, our healthcare industry.

The whole problem with the world is that fools and fanatics are always

so certain of themselves, but wiser people so full of doubts.

-- Bertrand Russell 

Luke has some advice for the decision makers, big investors and those who want to bend their ear.

Don’t get overscheduled. I’ve made this mistake many times. It’s normal to be such an eager beaver that you pack your entire calendar with 1-on-1 meetings, in 30-minute blocks, from 7 am to 6 pm every day. And that’s all before the evening receptions. 

What will the leaders, investors and journalists who reside over our healthcare system discuss. A reproducibility initiative to strengthen the scientific foundation of the industry? New ways of strengthening the scientific labor force? How well things have gone in the last 32 years? The leaders, investors and journalists may simply be there as the proverbial "bad air", dense, powerful, yet not directly responsible for the success of the industry. For 32 years the leaders have been gathering to inspire one another, resulting in a disastrous system of healthcare. But that is not what they are gathering to talk about.

This conference is one of the largest and most informative healthcare investment symposium in the industry, bringing together global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community. 

Approximately 300 companies, both public and private, will deliver presentations to an estimated more than 4,000 investors.

Wouldn't it be interesting if these 300 companies delivered presentations to an empowered, non-biased, career stabilized group of scientists tasked with assessing the science?

Dying Days

Each day my dad awakes to a breakfast of roughly 20 medications. He spent his life smoking, eating a diet of mostly processed food, and not exercising. Now at the age of 72 he is a very sick man. He's had several heart attacks, heart surgery, he has COPD, and his circulation is very poor. He has been in and out of hospitals and nursing homes 13 times. Each time he is released, he goes home and smokes, eats process foods and watches tv until his body gives out again and he has to dial 911. He has racked up bills of well over $700,000.

I've come to live with him to take care of him. Unlike the doctors, I follow the details of my dads end of life experience. His doctors have provided him with the prescriptions. Every now and again he visits them at the various hospitals where they work. They ask him how he's feeling and he tells them he feels terrible. He wants to hide things he thinks will jeopardize his autonomy, like that he has fallen. The brief conversations between the doctor and patient lead to the western solution to every malady, medication. A complex system, the human body at the end of its life, is treated by a simple system. Take old person to doctors work place, read a few vitals, have a talk, prescribe and/or adjust medications that are currently available, and/or maybe schedule a surgery.

The last nursing home experience seemed to transform my dad from a very sick patient to someone whom the authorities deemed acceptable to live on his own, with his sons assistance. Things have gotten worse in this first week. What took place inside his body? The excitement of going home after 2 1/2 months energized my dad. Day one back home he went through his mail, talked on the phone to family, and finished off the day with in his easy chair watching his tv. He also ate a double cheeseburger. The next day he began to feel worse. Since then he's been eating less, sleeping more and he has become far less steady on his feet. Was the cheeseburger a mistake? What took place at the nursing home versus my dads home? The pills and their doses were adjusted, but what was the real change that brought about the improvement?

Confounding factors, such as diet, exercise, and emotional state have not been considered. Some of the pills are simple compounds found in natural food such as KCl and folic acid. What if the patient has decided to give up their wicked ways and eat plenty of fruits and vegetables to get these nutrients? Would that alter the prescription? Then we have the Zoloft to treat depression. It's depressing to be this sick. Perhaps it is unnecessary to pharmaceutically deal with the fact that you are in need of so many pharmaceuticals. Let the patient be sad. Sadness, perhaps, is not a medical condition. To a doctor and the healthcare industry he, as a generic patient, has been understood. Sad? Zoloft. Next problem. To those of us outside looking in, the problem is that he is also a living breathing thinking human being. At the doctors he is probed and interviewed at regular intervals. New paths are set. If he gets worse, its because of the illness or the lack of following the path. If he stays the same or gets better, it's due to the path. Unknown to the doctors is the path outside of their purvey that might have an equal influence on his physical and mental well being.

I think of myself, this blog and why my message does not have an impact whatsoever. I have good points. The industries of biopharma and healthcare are sick. They need to be cheaper, more effective and offer more opportunities. More communication is needed. The science needs to be more rigorous. In spite of my reasoning and the solutions I have proposed, I am not taking into account the confounding factors. Society doesn't like a nattering nabob. An anonymous blog is a poor format to influence others. Just like the doctors and their pills, I am not taking into account the complexity of the system of which I speak. I might have a good remedy, such as the concept of certification of laboratory staff and their work, but I did so here on this blog. Like an ineffectual medicine, I introduced my remedy in the wrong place. It cannot reach the location where it will do the most good. Likewise, a medical remedy may work at a cellular level, in a mouse or culture dish, but how will we get the same mechanism of action to work in a person?

Note: That's just an example of a system that also doesn't bring about change. I write the blog for practice getting ideas out of my head. 

The Cargo Cult message here today is a lesson I am learning as I watch my dad struggle. It is not enough to memorize the parts of an airplane and what they do.

You can learn about the parts, who makes each part, what the name is in Spanish and know nothing about what makes the airplane fly. Now look at the human body:

Each part has its own doctor. The body however is more than parts. That is the area in which the Cargo Cults of medicine must study. What makes a body live, think, age and eventually die?

Doctors and pharmaceutical companies are also mere parts. The leaders of healthcare must invest in understanding the system of healthcare itself. How does the system effect an individual, such as an old man who takes 20 pills every morning. In time we should advance our understanding of life and death, the system we have to  deal with it, reduce the amount of pills, and paradoxically treat the body through all of its stages of life.

Zuckerbergs Nobel Prize in Life Sciences

I don't like honors either. From the Cargo Cult perspective, awards can be given in spite of the arrival of cargo. Imagine an award given to the tribesmen of Vanuatu for best ceremonial dance or best costume. The real award for the tribe would be the cargo. Without the cargo, an award will assuage the tribe and make them feel as though the leaders know what is being done right and what is being done wrong. The truth is that the leaders of Vanuatu do not know right from wrong, as we do in the west. They do not know what makes an airplane fly. Any such award ceremony would simply be another cargo cult ceremony. The people who decide on the winners of any award sell themselves as the deciders of good and bad. That in itself would be a great honor, to be able to tell the world what really matters.

Mark Zuckerberg and Co. have used their money to bestow an award to scientists. The Breakthrough Prize in Life Sciences is no doubt an award that the Silicon Valley gurus hope will solidify their names in the annals of scientific history. The judges who pick the winners will be the previous winners. The first 11 winners were selected by the founders, I assume. You can bet that there is quite a stir among the Nobel committee members over an award given by a group of Silicon Valley rich kids. Who gave these guys the right to create a life sciences prize? Money? Will there be an overlap of Nobel Prize winners and Breakthrough Prize in Life Science winners? Are they suppose to be on par with one another? Money-wise, the new kids on the block offer a better payday. Oh my.

The prize comes with a $3M paycheck, meant to excite young people about a career in science.

The prize is administered by the Breakthrough Prize in Life Sciences Foundation, a not-for-profit corporation dedicated to advancing breakthrough research, celebrating scientists and generating excitement about the pursuit of science as a career.

The next generation of scientists, like the current, is suppose to strive for science that is exciting at the fame and fortune level. The boring details of daily lab work will not get you this prize. The boring narrative of a failed experiment or failed idea will not get you the $3M. It must be exciting, breakthrough and worthy of an award, as decided by others who pursued and won the prize. You must be one of them. In terms laid out from The Amgen Study, you must tell "the best story".

According to the Begley, Ellis paper in Nature:

Some non-reproducible preclinical papers had spawned an entire field, with hundreds of secondary publications that expanded on elements of the original observation, but did not actually seek to confirm or falsify its fundamental basis. More troubling, some of the research has triggered a series of clinical studies — suggesting that many patients had subjected themselves to a trial of a regimen or agent that probably wouldn't work.

This is the kind of research that wins awards unfortunately. If you can spawn an entire field, people are going to take notice. It is known in the scientific community that you can spawn an entire field with a good story, not necessarily good science.

You will not see an award for people who sacrifice their own careers by retracting papers when necessary. You won't see whistle blowers get an award for jeopardizing their careers for the best interest of science. There is no award for "Most Reproducible" or "Best Designed Experiment".
As pointed out in the Begley, Eliis study:

In studies for which findings could be reproduced, authors had paid close attention to controls, reagents, investigator bias and describing the complete data set. For results that could not be reproduced, however, data were not routinely analysed by investigators blinded to the experimental versus control groups. Investigators frequently presented the results of one experiment, such as a single Western-blot analysis. They sometimes said they presented specific experiments that supported their underlying hypothesis, but that were not reflective of the entire data set. There are no guidelines that require all data sets to be reported in a paper; often, original data are removed during the peer review and publication process.

Scientific research that is reproducible, where authors pay close attention to controls and their own biases, is not part of the criteria for a publication, promotion or an award. It is good for your science but it is also a risk. What if your work is not reproducible, as was the case in 90% of the papers looked into by the Begley and Ellis in the Amgen Study? As we learned, nothing will happen. You can still get published, promoted and awarded a prize.

Therein is where we need to see a prize. Take $33M and set up a laboratory where a group of scientists accept "nominations". If you think you've got something that can stand the rigors of another group of scientists looking to poke holes in your theories and evidence, throw your name into the hat. The judges will judge based on communication of ideas, transfer of science, reproducibility and for potential. It is not important what a group of rich kids from Silicon Valley think of your narrative. That is only a story selected on a political level by award committee and their awardees. Something greater than them is happening in science and they are not worthy take interject themselves into this world with another million dollar prize. If only they would use the money for the good of everyone in science and set up a Begley/Ellis-like organization. Select 50 papers to test each year. Award those that are reproducible. Give booby prizes to those that are not.

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.

Marie Huber and Provenge

Oh my! Marie Huber fined $25,000 for making misleading statements about her Dendreon Provenge clinical trial study and violating the Securities Act for her role in disseminating the study! I talked about Marie Huber back in April 2 and April 4 of 2012. She is the former hedge fund financial analyst who walked away from a lucrative career, much like those I discussed yesterday. It's interesting to see this story one day after posting this quote from a government advisor from the tax haven The Isle of Jersey:

One of the things I found most peculiar working in the financial services was the culture of the workers themselves. Many of them are very intelligent people indeed. Lawyers, accountants, bankers, highly trained through Universities. Very privileged people. By and large, they hate their jobs. The jobs are boring, repetitive, stupid, but the money is fantastic. They know that the work they do is without worth. They don't create value in any economic sense of that term. 

Ms. Huber was a biochemist turned financial analyst who walked away from her financial job to use her science education to fight an evil she uncovered while analyzing the statistical analysis of Dendreon. She measured the measurements, something we see missing in the Cargo Cults of Biopharma. What she found was a concerted effort to hide possible harmful effects and spin the data to fit the narrative that originated this drug discovery project. The first rule we must have when working in  medicine (even though we're not M.D.s) is "do no harm". The courage to question Dendreon and the FDA, give up a high paid job, and offer up a scientific argument for all to scrutinize was a breath of fresh air. Not everyone saw it that way.

The SEC, the agency who could not find much of any wrongdoing on Wall Street throughout the economic meltdown the nearly crippled the world economy, felt the Ms. Huber had crossed a line. Read their report here. They fined Ms. Huber $25,000 for her attempts at influencing a lower stock price for the purpose of profiting by shorting the stock.

We at the CCS are not concerned with matters in the trade of biotechnology stocks. Ms. Huber and Jess Jones maneuvers to turn a profit off of the bad science of Dendreon does not diminish the science behind Ms. Hubers analysis of Provenge. In her own words to Pharmalot:

"I have agreed to a settlement with the SEC and I look forward to putting this issue behind me. I stand by the rigor of my scientific analysis and I shall continue to follow-up on the concerns that I expressed with regard to Provenge in the article published in The Journal of the National Cancer Institute ("JNCI") in 2012.

"My primary motivation has always been the well-being of patients and the safety and effectiveness of this treatment. The accuracy of my research and conclusions are not an issue in the SEC settlement; neither my findings on Provenge submitted to CMS in July 2010, nor the concerns set forth by my co-authors and me in the JNCI article were contested by the SEC. Since first submitting the article to the JNCI in 2011, I have had no financial interest in the fate of Provenge."

The SEC has used up their time and effort to correct Ms. Huber. I'm sure this was easier than digging into Goldman Sachs misleading statements to investors whom they encouraged to go long on stocks they were shorting. Who influenced the SEC to take up this small time issue? Perhaps Ms. Huber did practice the art of deception in her financial occupation. This is possibly a fair decision and fine. If only the scientific community had the same"stick-to-it" attitude of the scorned investment community, perhaps we would revisit the effects of Provenge. Did Dendreon practice the art of deception in their scientific work? Most importantly, has the recent introduction of Provenge to the medical community altered the mortality rate of prostate cancer patients.