If Only There Was A Way...

LONDON, Jan 29 (Reuters) - GlaxoSmithKline Plc (GSK.L: Quote, Profile , Research) was accused on Monday of distorting clinical trial results of its antidepressant Seroxat, or Paxil, and covering up a link with suicide in teenagers.

http://www.ahrp.org/cms/content/view/444/29/

A classic study in career survival in the wild kingdom of a global corporation.

E. Howard Hunt,

MIAMI -- E. Howard Hunt, who helped organize the Watergate break-in, leading to the greatest scandal in American political history and the downfall of Richard Nixon's presidency, has died. He was 88.

Hunt eventually spent 33 months in prison on a conspiracy charge, and said he was bitter that he was sent to jail while Nixon was allowed to resign.

Scooter Libby is still alive, awaiting his punishment for carefully following the orders of Karl Rove and Dick Cheney and leaking certain information to the press. Rove and Cheney hatched the idea of outing Valerie Plame as a punishment for her husband Joe Wilson. Wilson, you will recall, had the audacity to release information from his fact finding mission to Nigeria to determine if they sold yellowcake to Saddam Hussein.

It's about dishonesty. Supressing information can be as bad as lying. It all began with supressing Joe Wilsons information. He (Wilson) wrote an article that was published in the New York Times thus working against the white house efforts to start a war. They (the white house) made the decision to release information that we (the American people) need to supress, the identity of our CIA agents. Plame and Wilson and the press wanted to know who released this information to the public. Then Libby and Rove and Cheney and all the rest of them began lying.

It is indeed a tangled web. The lesson for the science minded person is that honesty is not just about fact and fiction. It's about selecting data that fits your bias. You may begin by ingoring a piece of data that doesn't fit your hypothesis. Next you may get more agressive and try to discredit people who disagree with you. If that fails you will end up lying. A true scientist must work very hard from the beginning to stay off of this path. At all points you must keep your eyes open to make sure you haven't strayed onto it. Otherwise you are no better than a politician.

RIP Howard Hunt. Libby will carry the torch of dirty rotten scoundrels like yourself who lie and cheat to protect our highest ranking politicians. Let's hope Scooter gets at least 33 months for his part in starting the Iraq war. At least you, Howard, didn't do as much harm as Scooter.

Dead Investors Walking

The CEO of Cell Therapeutics had a stipulation written into his contract stating that he had to put a drug onto the market prior to 2000 or he would not receive a huge bonus for his services. Just prior to that date Dr. Bianco bought Trisenox, which was destined to be approved but not destined to earn much money. It satisfied Dr. Biancos contract but did not earn the foolish investors of CTI any money.

Now CTI, a desperate company, is vying for DOR BioPharma, Inc.

Under the proposed terms, Cell Therapeutics would issue the Company's shareholders 29,000,000 shares of Cell Therapeutics' common stock, representing 19.9% of Cell Therapeutics' outstanding shares of common stock. Warrant and option holders would receive shares of Cell Therapeutics' common stock in an amount determined using the Black Scholes pricing model. Cell Therapeutics has reserved the right to offer cash as consideration for the warrants instead of Cell Therapeutics' common stock. In addition, Cell Therapeutics is also offering the potential for an additional $15 million payment (in stock or cash at the Company's option) upon receipt of the approval of the U.S. Food & Drug Administration of the Company's new drug application for orBec®. The proposal from Cell Therapeutics is subject to, among other things, the completion of satisfactory due diligence regarding clinical, regulatory, manufacturing and proprietary positioning for orBec®.

What is Dr. Bianco up to now? DOR is trading for less than a dollar a share. They are currently at 40 cents a share, down 27% on the news of being taken over by the esteemed Dr. Bianco. They could make a movie out of CTI. As boring as science is, you could create the greatest film noir out of the life lead by Dr. Bianco. Just don't try to create a profitable investment from this person.

Pfizer Falls

Pfizer came up with a new plan. Take ten percent of the work force and get rid of them. Ten thousand human beings working on the Cargo Cult Airport known as Pfizer are going to be set free.

Pfizer, the world’s largest pharmaceutical company, said it would cut manufacturing sites in Brooklyn and in Omaha and would seek to sell a third site in Germany. It would close three research sites in Michigan and said it hopes to close one in Japan and another France.

Pharmaceutical industry analysts have generally been welcoming cutbacks by Pfizer but have said that while cost-cutting is beneficial, the company needs to resume growth by bringing new products to market. Still, Pfizer’s shares were trading down about 1 percent this afternoon.

Pfizer has been suffering from the loss of patent protection on key drugs like the antidepressant Zoloft and the antibiotic Zithromax. Sales of both drugs plummeted more than 70 percent in the fourth quarter of 2006, the company reported today.

At the same time its laboratories have had difficulty coming up with new hits. The company suffered a huge blow in December when safety concerns prompted it to halt development of torcetrapib, a cardiovascular drug that it considered the most promising experimental drug in its pipeline.

The number one drug company in the world today, with billions and billions of dollars cannot come up with new useful drugs. With all of the advances in biological science over the past few decades you would think it would be easier.

The truth about drug science is that scientists all work in cubicles, attend meetings and write reports. They do not go into the lab. After obtaining their PhDs they go out and do what they do best; they talk. They are trained to write grant proposals. They are trained to defend popular notions that they most likely did not think of themselves. They learn to take a certain tone of voice that makes people think they know what they're talking about.

The Cargo Cult Scientist spent a year interpreting DNA data to PhD scientists in the drug industry. These "experts" were too old to have learned molecular biology software. If, for example, they wanted to know if there was a mutation in a clone they had to ask me. The only way they could know the truth was if I told them. And then they had to trust me. Others, less important, could easily bring up the files in Vector NTI software and compare for themselves. They would be able to come up with the mutation if there was one. It's easy if you take the time to learn new things.

Senior scientists have put themselves in positions where they do not need white lab coats. This disconnect between how data is obtained and how it is talked about has created a lull in the productivity of new drugs. Arrogance is a factor. There is also a culture of accepting failure as the norm. So ten thousand people are losing their jobs at Pfizer. This is perhaps a good thing for the industry. Some of us need to find more productive careers. If that means putting on a Home Depot apron and helping people with home impovement projects, then so be it. Society needs helpers more than they do useless scientists desperately clinging on to their jobs. The receptionists, lawyers, accountants and all of the other "carpet walkers" did their jobs. The scientists did not. They failed and Pfizer has fallen.

Ironically, it will be scientists who help Pfizer get back on its feet. Can Jeff Kindler find the right people? Getting rid of the wrong people is a good start.

Give Til It Hurts

BOTHELL, Wash., Jan. 18 /PRNewswire-FirstCall/ -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) today announced the pricing of an underwritten public offering of 3.25 million shares of its common stock at an estimated total public offering price of up to approximately $42.9 million.

On this news Nastechs stock plunged 94 cents (down 6.69%) to finish the day at 13.12. I'm no stock market genius but offering a stock currently valued at 13.12 for 13.20 might be a hard sell. Time to learn about the old stock market and how it works. Lets keep an eye on this deal.

Think of Nastech as a Cargo Cult airline that carries piles of cash for the investors who are waiting in the Cargo Cult airport lobby. Each of their flights, PYY, PTH, calcitonin, have been delayed. The siRNA airplane is still waiting for take off at an undisclosed location (does this plane really exist?). The investors see someone making their way to the information booth. What could it be? Positive clinical trial results? A new break through in siRNA research? Ewww the anticipation!!!

They want more money? Son of a...

The 6 months stock chart tells the story of investor patience.

P.S. Nastech seems to be good at raising the stock price when it's desparately needed. Day traders should take a risk and buy in the morning and sell by the end of the day.

Baby Chair Research Mistake

Consumer Reports withdraws its recent claim that most infant car seats failed the magazine's front- and side-crash tests.

“Our (the National Highway Traffic Safety Administration) initial review of the Consumer Reports testing procedures showed a significant error in the manner in which it conducted and reported on its side-impact tests. The organization’s data show its side-impact tests were actually conducted under conditions that would represent being struck in excess of 70 mph, twice as fast as the group claimed. When NHTSA tested the same child seats in conditions representing the 38.5 mph conditions claimed by Consumer Reports, the seats stayed in their bases as they should, instead of failing dramatically.”

You've got one job, to smash cars with baby seats in them and report the results!

Is it not possible to visualize the difference between a 70 mph smash versus a 38 mph smash? My guess is that by the time the report was ready to be presented none of the white lab coat scientists were allowed to be seen. It was show time!

Measure of a Measurement

A New York Times analysis of census results in 2005 claims that 51 percent of women in the US are living without a spouse. This is up from 35 percent in 1950 and 49 percent in 2000.

This is a cargo cult analysis!

If there are always 50% men and 50% women then a study of men should also indicate that 51% of men live without a spouse as well. In a third and seperate study of married people we should find that 49% of the people who respond to the survey are married.

It's probably true that a greater percentage of Americans are not married these days. You can just look around however and add up your married and single friends and family. Then go back to a previous generation. What generation had a higher population of married people. Then go talk to everyone you can about why they think they are single. Talk to the old people about why they stayed married or why the never married. Wouldn't that be more informative?

The Duke Lacrosse Story

I watched George W. Bush last night on 60 Minutes. As much as he disgusts me I must listen. I listen because the real threat to our way of life is not swarthy tough guys hiding in caves in the middle east. The threat to the American way of life comes from people like George.

Mike Nifong, the prosecuter behind the Duke lacrosse sexual assault case is the type of person who worries me. He was six weeks away from an election when the Duke case came up. Durham voters are divided between black and white. Nifong promised black voters that he would not let the Duke case drop. He indicted two of the players two weeks before the election and narrowly won.

Nifong had the accuser chose from photos of the 46 white lacrosse players on the team—a multiple-choice test with no wrong answers. He was also aware that there was no DNA evidence linking any of the men to this woman. What he wanted however, was to get re-elected. He acheived his goal.

So how does this relate to Cargo Cult Science. It is about human ambitions. If there is a Cargo Cult airport there are going to people running the airport. How does one get to be an authority when no airplanes have ever landed? In Biotechnology we rely on college degrees, patents, publications and a number of other achievements losely related to scientific work. We often times run into problems discovering new drugs so we change the rules. We set up a long list of candidates and select a few to hammer through. This is just like the 46 pictures of the Lacrosse team. There were no decoys set up to shed light on the decision process. The DNA evidence handling is another method used. When negative data comes up you just don't talk about it. Gone. Simple.

Some people get caught like Mike Nifong. His Cargo Cult leadership skills were too obvious. He wasn't powerful enough to ignore his critics. The lesson is for the public. When we see George and his ilk lying and cheating we must insist that the system be changed. People will never change. If we change the system people like Bush and Nifong will cease to rise up the chain of command.

Cargo Cult President

The decision to send in more troops to Iraq is bad for the future of the USA. It is good for George W. Bush however. The president knows that his plans will not improve the situation in Iraq. It will however improve his chances of getting out of his last term with higher approval ratings. How could he do worse?

If the American public thought like Richard Feynman there would have been a whole bunch of questions after last nights speech. Here is what Feynman thought about a questionable belief systems:

"But then I began to think, what else is there that we believe? (AndI thought then about the witch doctors, and how easy it would have been to check on them by noticing that nothing really worked.) So I found things that even more people believe, such as that we have some knowledge of how to educate. There are big schools of reading methods and mathematics methods, and so forth, but if you notice,you'll see the reading scores keep going down--or hardly going up in spite of the fact that we continually use these same people to improve the methods. There's a witch doctor remedy that doesn't work. It ought to be looked into; how do they know that their method should work? Another example is how to treat criminals. We obviously have made no progress--lots of theory, but no progress--in decreasing the amount of crime by the method that we use to handle criminals."

Does George W. Bush really know what it will take to decrease the violence in Iraq? Should we trust him on this? Why not ask a few questions and make a promise to revisit his decisions six months from now?

I really don't believe that George W. Bush cares about the soldiers in Iraq. His problem is his popularity and his legacy. He wants to leave office on a high note. The surge in troops is buying him time. Can things possibly get worse? If, by the time he leaves office, things in Iraq get better then he can attribute it to the decsions he outlined yesterday. If things get worse it is because the Iraqi government failed on their end. Its a perfect plan.

Biotech Leadership

Biotech Leadership:

BOSTON - Former Massachusetts House Speaker Thomas Finneran on Tuesday resigned from his $416,000-a-year job as president of a biotech industry trade group, days after he pleaded guilty to obstructing justice during a redistricting lawsuit.

The board of the Massachusetts Biotechnology Council accepted his resignation, effective immediately. Finneran had taken the job in 2004 after resigning his legislative position.
In exchange for Finneran's guilty plea, prosecutors dropped three perjury charges.

As part of the deal, Finneran admitted making false and misleading statements under oath during his 2003 testimony in the voting rights lawsuit when he was asked whether he had seen and reviewed a redistricting plan before it was filed with the House clerk. Finneran had repeatedly denied doing so.

Oops

The way to successfully complete a research project for the drug industry is to tell the leaders what they want to hear. It's rare that you'll get caught practicing a cargo cult science. This story is an acception:


WASHINGTON, Jan 10 (Reuters) - The U.S. Food and Drug Administration on Wednesday urged a number of pharmaceutical companies to confirm or repeat some studies done for them by a unit of MDS Inc. (MDS.TO: Quote, Profile , Research) (MDZ.N: Quote, Profile , Research) from 2000 to 2004.

FDA said inspections of MDS Pharma Services had raised questions about the validity and accuracy of studies that measure the level of a drug in a patient's blood and could have been used as part of the basis for FDA approval.

Shouldn't the FDA conduct these types of audits before they approve a drug? Shouldn't they insist that the studies be repeated?

Nobel Prize Winner in Business

A blazing new flame has been put along side the Cargo Cult Airport of Biotechnology. Just check out the scientific advisory board.

LOS ANGELES & WORCESTER, Mass.--(BUSINESS WIRE)--CytRx Corporation

(NASDAQ:CYTR - News) today announced that it has contributed its RNA interference (RNAi) assets to RXi Pharmaceuticals Corporation (RXi), which is co-owned by CytRx and several world leaders in RNAi technology. RNAi has been shown to effectively interfere with the expression of targeted disease-associated genes with great specificity and potency. Subsequent to this contribution, CytRx owns approximately 85% of the outstanding stock of RXi, with the remainder owned by RXi's anticipated scientific advisory team. RXi is a "pure play" RNAi company dedicated to developing proprietary RNAi therapeutics and, in addition to current industry leader Alnylam Pharmaceuticals, RXi will be one of the few companies focused exclusively on developing and commercializing products based on RNAi technology. Pending consent from their research institutions, RXi's scientific advisory board will include four leading scientists who have played major roles in discovering and defining the RNAi field:

Craig C. Mello, Ph.D. received the 2006 Nobel Prize in Physiology or Medicine for his co-discovery of RNAi. He is the Blais University Chair in Molecular Medicine at the University of Massachusetts Medical School (UMMS), a Howard Hughes Medical Institute Investigator and a member of the National Academy of Sciences. His RNAi findings were recognized as the 2002 "Breakthrough of the Year" by Science magazine. Gregory J. Hannon, Ph.D. is a Howard Hughes Medical Institute Investigator at Cold Spring Harbor Laboratory. His laboratory is credited with discovering the mechanism of RNAi in human cells (RISC/siRNA) as well as discovering short hairpin RNAi (shRNAi). Dr. Hannon is also a leading expert on oncogene pathways and was formerly an advisor to Alnylam Pharmaceuticals.

Tariq M. Rana, Ph.D., is Professor of Biochemistry and Molecular Pharmacology and Founding Director of the Program in Chemical Biology at UMMS, and has previously advised a number of biotechnology companies including Sirna Therapeutics, where he served as a member of their Scientific Advisory Board. Dr. Rana discovered key technology for the chemical stabilization of RNAi and has obtained RNAi activity in animals by local and systemic delivery.

Michael P. Czech, Ph.D., is Professor and Chair of the Program in Molecular Medicine at UMMS. He has authored more than 250 papers in the field of insulin action, and was awarded the American Diabetes Association's Banting Medal for Scientific Achievement in 2000 as well as the ADA's Albert Renold Award in 2004. He has used RNAi to discover a number of genes involved in diabetes and obesity.

RXi intends to build on CytRx's RNAi therapeutics programs for the treatment of human diseases, initially focusing on neurodegenerative disease, oncology, type 2 diabetes and obesity. (biotech cargo cult most popular diseases!) The contributed assets from CytRx consist primarily of several key licenses to early fundamental RNAi technologies from the University of Massachusetts Medical School (UMMS) and the Carnegie Institution of Washington, as well as equipment and other tangible assets from CytRx's Worcester, Massachusetts laboratory. The licensed technologies include pending patents on RNAi target sequences, chemical modifications and delivery to cells, and field-specific licenses to a seminal patent application on chemical modification of RNAi filed in 1992 by UMMS and invented by Tariq M. Rana, and to the "Tuschl I" patent. The technologies also include exclusive licenses to patent applications that disclose gene targets for diabetes and obesity, including RIP140, which has been shown to be a master regulatory gene for metabolism in fat cells.

"CytRx has been acquiring, developing and consolidating its RNAi therapeutic assets since 2003. These assets have been created by research performed at UMMS and CytRx's laboratories from 1998 through 2006. We are now moving these assets into an RNAi company exclusively committed to accelerating the commercialization of second-generation RNAi-based therapeutics addressing important diseases, including type 2 diabetes and obesity. We believe this transaction represents the best strategy for CytRx and its shareholders to benefit from the potential value of these RNAi assets, as RXi will have a single, focused purpose positioned to compete directly with other leaders in the industry," said Steven A. Kriegsman, President and Chief Executive Officer of CytRx. The Cargo Cult Scientist believes the CytRx's RNAi program was dragging along with no real results. They are dumping it off in a business way.

Tod Woolf, Ph.D. will serve as Chief Executive Officer of RXi. Dr. Woolf has 20 years of experience developing and commercializing innovative biomedical technologies, and is a recognized leader in RNA therapeutics. He previously worked at numerous biotechnology companies including Ribozyme Pharmaceuticals (now Sirna Therapeutics), where he co-developed a number of lead therapeutic RNA compounds and developed Genbloc(TM) RNA technology, which was spun out to create Atugen. He founded and served as Chief Executive Officer of Sequitur, an RNAi company acquired by Invitrogen in 2003. At Sequitur, Dr. Woolf co-invented and commercialized STEALTH RNAi, one of the most widely used second-generation RNAi research products. Also at Sequitur, he established collaborations with over a dozen major pharmaceutical companies. More recently, Dr. Woolf served as an advisor to Signet Laboratories prior to its acquisition by Covance, and has advised ProNai, Praecis Pharmaceuticals and Invitrogen. Dr. Woolf earned his Ph.D. in biology at Harvard University where he performed seminal work in the then-nascent field of RNA therapeutics. He has recently been serving as a consultant to CytRx in connection with the formation of RXi.
"I have been impressed with Craig Mello's insight and integrity since we met during our graduate program at Harvard and during our work together at Sequitur. It will be an honor to work with him and Drs. Rana, Czech and Hannon. A void was created in the industry by Merck's acquisition of Sirna Therapeutics. RXi intends to fill that void," said Dr. Woolf. "The announcement of our extraordinary scientific advisors and senior management team is the first step in our quest to lead the RNAi therapeutics field," added Dr. Woolf.
RXi has named James Warren, MBA as Chief Financial Officer. Mr. Warren has more than 30 years of experience in financial and general management in rapidly evolving technology-based companies. From 1991 to 1998 he served as Vice President and Corporate Controller for Genzyme Corporation, where he managed an international staff of 120 finance professionals. He also served as CFO of Aquila Biopharmaceuticals, Inc., Harvard BioScience, and ActivBiotics, Inc.. He has been involved in raising over $1 billion at the various biotechnology companies where he was employed. Mr. Warren earned his MBA in operations and research at Boston University, and has recently been serving as a consultant to CytRx in connection with the formation of RXi.

"The clinical potential of RNAi technology is garnering strong attention from the pharmaceutical industry, making the timing excellent to acquire these RNAi assets from CytRx. We believe that RXi's unique assets and pure-play structure make it well-suited to pursue collaborations and compete directly with other leading RNAi companies," noted Dr. Woolf.

So many scientists, so much money, so... where are the drugs?

Another Interview

The interview was not unlike any other. I always think they go well. The uncomfortable part was the last 15 minutes where I talked to the lab staff. Between them they had been in the U.S. for less than a year. The conversation was slow and awkward.

I decided not to drive to the interview. I got a ride and headed downtown afterwards. Rain was coming down sideways as I tried to find windblocks in the wasteland of Paul Allens biotech hub of south Lake Union. I ducked into the Whole Foods at 2200 Westlake. I didn't buy any food or coffee, I just took a seat by the window to watch the rain. I could see that no one had moved in to the biotech hub. The U of W was building and so was Vulcan. Vulcan is Paul Allens company. They are the ones who are to deliver the dream of south Lake Union becoming an urban oasis of affluent people. Above the Whole Foods was the Pan Pacific hotel where rooms start at over $200 a night. The condos at 2200 Westlake went as high as $2 million and they were all sold out. But there were no companies moving in. A little further east is 1616 Eastlake and the Hutch but they too thrive on low paid foreign nationals who did not move to the U.S. to pay $600 per square foot for their home. The oasis was doing okay with affluent people buying up the residential space but those people weren't coming from the biotechnology companies.

The problem is that Paul Allen wanted an industry that will make money and feed into his other plans. Instead he got affluent people who feed on people like Paul Allen. If an engineer develops a new mouse trap and the whole world wants one there will be a lot of jobs. The jobs will put money into the pockets of locals who will spend at the shops. Doctors and dentists and mechanics will have to move in and the next thing you know you've got a community. What we are seeing in South Lake Union is an unbalanced community. The new buildings are soothing to the tastes of Paul Allen but those who work inside are not paid enough to live in the neighborhood. Artists could never live there. Bars and restaurants could never survive. The future is looking dim, but maybe it was just me sitting there in the rain.

The interview was fine. I wouldn't be able to eat at Smoke'n Joes BBQ or have coffee at the corner shop due to the pay. I would be able to stick around and see what will become of the biotech hub of Seattle however. For that reason I hope I do get this job. As for curing Malaria... we'll see about that.