What if you didn't have to make anyone happy with your research? What if you ran a small laboratory with about 10 really smart scientists who conduct research according to a well defined philosophy of science? That means no long winded narratives about your awesome pipeline. You are developing a biotechnology company that sells a service. Research! I am not talking about a CRO here. I am talking about a company that has no bias other than to tell the truth. Who needs such a company?
Those who are embarrassed by the scandals taking place at their organization.
Those who have to retract papers when their chosen peers are led astray.
Those who want to invest in a company but are only getting the input of the people trying to get their money.
How do you make money from a company trying to sell unbiased evaluations? Sell your service. Finance auditing services make money. Why couldn't a science auditing company make money? If it is true that one trillion dollars, (274 million dollars a day) was lost in the past decade on research then we have a business model. One of our original American entrepreneurs, Ben Franklin, told us that a penny saved is a penny earned. We could have earned a whole lot of pennies from that past decade. Of course that money wasn't really lost. It was earned by people who would love to see us continue down the path we are on. David Sinclair is an example. What about those who lost money, such as Roche did with Sinclair? Would they do anything different if they could?
Unlike computer science, engineering or physics, the life sciences do not always have clearly defined tests that lead to predictable outcomes. Medical science is at best soft. At its worst it is a bunch of misleading sciency nonsense that looks for the suckers who are born every minute. The old logic is that the nonsense is snuffed out by wise investors or a team of high powered scientists and lawyers working on the due diligence for a new partnership. That hasn't worked. The product/service of our business model must focus here. Why can't those who are suppose to catch the nonsense do so? How can we succeed where they fail? We will replace faith based methods such as peer review and return to empiricism. The scientific method will be a guiding light.
No matter how good you are in businessman, you can't be an honest success selling broken mouse traps. You can be a dishonest success but those are the guys who profited from the $Trillion dollar loss of others peoples money in the past decade. We are working against them. They have been winning. As of late however we are starting to see new weapons against the Cargo Cults of research. Original online creations like Retraction Watch are pulling the curtain back on the secretive world of research Wizards of Oz. There is a changing attitude towards science. It is fallible. However there is a possibility that Retraction Watch will run it's course and become boring without a greater cause. Abnormal Science blog will start to appear as repetitive because science will always have a dishonest population. The good must also be pointed out as well as the bad, just as it is in the automobile consumer reports. Pointing out that the Honda Accord has bad breaks, for example, is considered useful among car buyers. That doesn't mean that the Honda Accord isn't a nice car, it is. The same may go for a particular field of research or a drug candidate. There may be a highly effective antibody drug available for partnership but it comes with manufacturing issues such as low expression. These are issues that management, investors and future scientists and engineers of the project should know about prior to joining the effort.
Instead of forming an antibody company or an RNAi company, start a research company. Before putting anything on the market, develop the product/service. Like any biotech company, that means spending time establishing the company structure, mission, and financials. Methods must be put in place so that evidence or data isn't accepted without sound basis. Personal relationships must be healthy. Checks and balances can trump supervisors and annual reviews. Ultimately, there must be tests. That means a separate group will offer up several cases each year that should come up as nonsense (a negative control). A positive control will also be required. Each group must specialize in the ways of Cargo Cults.
Human beings have been trying to distinguish shit from shinola. since the dawn of time. We are all consumers of science whether we know it or not. We need better stewards of the information that is out there. Can those stewards be a for-profit organization?
Friday, January 20, 2012
Wednesday, January 18, 2012
Risperdal and Tamiflu Hidden Data
Tamiflu: A new review of the influenza drug oseltamivir (Tamiflu) has raised questions about both the efficacy of the medication and the commitment of its maker to supply enough data for claims about the drug to be evaluated by independent experts.
We looked into our own thoughts on Tamiflu. We talked about it here on our very second post on the CCS.
Risperdal: Johnson & Johnson officials hid three studies showing some patients using Risperdal developed diabetes while claiming the antipsychotic drug didn’t cause the disease, a witness testified.
I'm starting to think there may be some systemic dishonesty in the Cargo Cults.
Type I error and Type II error are precise technical terms used in statistics to describe particular flaws in a testing process, where a null hypothesis that should have been accepted was rejected (Type I error) or where that hypothesis should have been rejected, but was accepted (Type II error).
Clearly Roche and J&J did not make an error. The came to the right conclusions and decided that no one should be allowed to come to the same conclusions. Johnson and Johnson was hit with a $158 million fine this week. Tamiflu and Roche seem to be getting away with their sins against science.
They made billions, for those who don't follow this Cargo Cults. They did not make an error. In the Cargo Cults, Risperdal and Tamiflu are success stories. And they created a lot of jobs in their legal departments.
We looked into our own thoughts on Tamiflu. We talked about it here on our very second post on the CCS.
Risperdal: Johnson & Johnson officials hid three studies showing some patients using Risperdal developed diabetes while claiming the antipsychotic drug didn’t cause the disease, a witness testified.
I'm starting to think there may be some systemic dishonesty in the Cargo Cults.
Type I error and Type II error are precise technical terms used in statistics to describe particular flaws in a testing process, where a null hypothesis that should have been accepted was rejected (Type I error) or where that hypothesis should have been rejected, but was accepted (Type II error).
Clearly Roche and J&J did not make an error. The came to the right conclusions and decided that no one should be allowed to come to the same conclusions. Johnson and Johnson was hit with a $158 million fine this week. Tamiflu and Roche seem to be getting away with their sins against science.
They made billions, for those who don't follow this Cargo Cults. They did not make an error. In the Cargo Cults, Risperdal and Tamiflu are success stories. And they created a lot of jobs in their legal departments.
Saturday, January 14, 2012
Western Blot / The Tool of Scoundrels
The Nobel Prize in Physics 2009 was divided, one half awarded to Charles Kuen Kao "for groundbreaking achievements concerning the transmission of light in fibers for optical communication", the other half jointly to Willard S. Boyle and George E. Smith "for the invention of an imaging semiconductor circuit – the CCD sensor".
The image from a CCD is black and white, but by placing a red, green or blue colored filter over the top of each pixel, color information can be read directly from each pixel — but only for one primary color per pixel. Subsequently, software can also extrapolate the color of adjacent pixels based on their brightness, so that each pixel winds up with its own red, green and blue values. A RAW file is the “raw” color data from the chip before any of the post-processing extrapolation has been done. Cameras usually do all of this processing for you and spit out the result as a JPEG. With the RAW file you actually have all the original sensor data, which is much more information-rich.
So far so good. Here we pack up the Allied forces airport and the Cargo Cult takes over. Next we introduce the western blot. Somewhere between running the western and generating the image of that western we enter the cult.
Post-processing extrapolation was my job for five years. I was a photographer. The original data that I used was a roll of film. I learned how to expose film using f-stops and shutter speed. I learned how to process and print black and white, color and slide film. Interesting things to know but digital technology now takes care of all the things I was doing manually. Post-processing image quality issues like color, contrast, and density are now automatic.
My first few years running western blots were done on film. Then one day we received our first AlphaImager. It is a box with a light table that fold down so you can take pictures of SDS PAGE gels. Fold the light table up and there is a UV light box for DNA gels. Shut off all light and you can take pictures of chemiluminescent western blots. A a RAW file is generated, with all the original sensor data, which is much more information-rich than a processed image.
The western blot has seen some method advancement. There are E-gels and I-blots which speed up the time to transfer the proteins onto the membranes. There are more sensitive reagents for developing the westerns so lower amounts of protein can be detected. Each change challenges the Cargo Cult tribesmen. If a transfer is sped up, they claim, you will get less protein transferring. "How do you know?", I would ask.
Using film, I was told, was superior to digital images when it came time to expose for weak signals. "Can I see the evidence?" I was respond. I wasn't getting a satisfactory answer. I developed a test. I loaded a gel with high to low amounts of protein. The low end concentrations dropped below the level of detection even at maximum exposure time (chemiluminescent probes lose their energy after about one hour). I prepare two identical westerns. One western was visualized by exposing it to film for one hour and the other was visualized using an AlphaImager CCD camera.
Test number one: Hold film in hand and use eyes to compare with digital image on computer screen. Oh the varying opinions! Based on ones bias, a subjective argument would break out. "The film is more sensitive!"
Test number two: Use ImageQuant software from GE Healthcare to quantitate sensitivity. The bias was still there but the data was irrefutable.
Science and technology wins the day.
Next I ran the same western blot and probed it with a fluorescent dye conjugated antibody. I used the CCD camera to capture the image. I also captured the image of the very same western on a lazer scanner. The fluorescent probe provided greater sensitivity measured by the signal from the lowest detectable amount of protein. The scanner produced cleaner data as measured by the correlation coefficient of the linear curve generated by the protein signals. I laid the western in a drawer and let it dry out. Every month for six months I scanned the western. The results did not change.
So I had determined empirically the best way to run one particular western blot. I'm not done yet however. If I am to get reproducible results from my western I must also account for the protein sample I am loading. Purity and stability, for example, must be known. In a proper research organization all of this is known by the QC group. The people who develop the methods take these factors into account. The people who then run the western blots must adhere to the standard operating procedure. They are tracked electronically so that deviations can be accounted for. For example, if a standard curve appears to be lacking in linearity or range, the protein standards can be identified to see if they were used beyond their stability window.
This all leads to the quality control of a cargo cult. I consider a peer reviewed journal to be part of the cult. The tracking of source material, equipment, and technician is not something that a journal editor asks for. It is even rare for immediate supervisors to read over a laboratory notebook, especially when the results turn out in their favor. The cargo cults do not have quality control mechanisms. They rely on their intuition and intelligence. As a result, any questioning of the finalized data is frowned upon. Lower ranking members of the organization are then held accountable for any transgressions, since the scientist above them has such a high standard for their honesty.
If the JPEG or TIFF files were made available we wouldn't have to use our eyes to try and discover fraud. Variances in density, for example, could indicate cutting and pasting. That clear line that gets erased with density adjustment remains on the pre-processed image file. The pre-processed data is what we need, not the post-processed product offered up for publication. The post processing is where the scoundrel plies his/her understanding of imaging and ways of fooling the older generation of leaders. Fortunately, post-processing is tracked by the software. If post-processing takes place, that image must be saved as a new file. The family tree of an image is stored automatically. It all leads back to the pre-processed image.
This is a critical point in the Cargo Cults use of imagery in their ceremonies. The real wealth of the imaging systems comes from the pre-processed data. Office dwelling scientists don't publish relevant information on image enhancements. They offer up aesthetically pleasing images that support their narrative. Orthogonal methods should be required to back up the western analysis, such as the ForteBio.
The image from a CCD is black and white, but by placing a red, green or blue colored filter over the top of each pixel, color information can be read directly from each pixel — but only for one primary color per pixel. Subsequently, software can also extrapolate the color of adjacent pixels based on their brightness, so that each pixel winds up with its own red, green and blue values. A RAW file is the “raw” color data from the chip before any of the post-processing extrapolation has been done. Cameras usually do all of this processing for you and spit out the result as a JPEG. With the RAW file you actually have all the original sensor data, which is much more information-rich.
So far so good. Here we pack up the Allied forces airport and the Cargo Cult takes over. Next we introduce the western blot. Somewhere between running the western and generating the image of that western we enter the cult.
Post-processing extrapolation was my job for five years. I was a photographer. The original data that I used was a roll of film. I learned how to expose film using f-stops and shutter speed. I learned how to process and print black and white, color and slide film. Interesting things to know but digital technology now takes care of all the things I was doing manually. Post-processing image quality issues like color, contrast, and density are now automatic.
My first few years running western blots were done on film. Then one day we received our first AlphaImager. It is a box with a light table that fold down so you can take pictures of SDS PAGE gels. Fold the light table up and there is a UV light box for DNA gels. Shut off all light and you can take pictures of chemiluminescent western blots. A a RAW file is generated, with all the original sensor data, which is much more information-rich than a processed image.
The western blot has seen some method advancement. There are E-gels and I-blots which speed up the time to transfer the proteins onto the membranes. There are more sensitive reagents for developing the westerns so lower amounts of protein can be detected. Each change challenges the Cargo Cult tribesmen. If a transfer is sped up, they claim, you will get less protein transferring. "How do you know?", I would ask.
Using film, I was told, was superior to digital images when it came time to expose for weak signals. "Can I see the evidence?" I was respond. I wasn't getting a satisfactory answer. I developed a test. I loaded a gel with high to low amounts of protein. The low end concentrations dropped below the level of detection even at maximum exposure time (chemiluminescent probes lose their energy after about one hour). I prepare two identical westerns. One western was visualized by exposing it to film for one hour and the other was visualized using an AlphaImager CCD camera.
Test number one: Hold film in hand and use eyes to compare with digital image on computer screen. Oh the varying opinions! Based on ones bias, a subjective argument would break out. "The film is more sensitive!"
Test number two: Use ImageQuant software from GE Healthcare to quantitate sensitivity. The bias was still there but the data was irrefutable.
Science and technology wins the day.
Next I ran the same western blot and probed it with a fluorescent dye conjugated antibody. I used the CCD camera to capture the image. I also captured the image of the very same western on a lazer scanner. The fluorescent probe provided greater sensitivity measured by the signal from the lowest detectable amount of protein. The scanner produced cleaner data as measured by the correlation coefficient of the linear curve generated by the protein signals. I laid the western in a drawer and let it dry out. Every month for six months I scanned the western. The results did not change.
So I had determined empirically the best way to run one particular western blot. I'm not done yet however. If I am to get reproducible results from my western I must also account for the protein sample I am loading. Purity and stability, for example, must be known. In a proper research organization all of this is known by the QC group. The people who develop the methods take these factors into account. The people who then run the western blots must adhere to the standard operating procedure. They are tracked electronically so that deviations can be accounted for. For example, if a standard curve appears to be lacking in linearity or range, the protein standards can be identified to see if they were used beyond their stability window.
This all leads to the quality control of a cargo cult. I consider a peer reviewed journal to be part of the cult. The tracking of source material, equipment, and technician is not something that a journal editor asks for. It is even rare for immediate supervisors to read over a laboratory notebook, especially when the results turn out in their favor. The cargo cults do not have quality control mechanisms. They rely on their intuition and intelligence. As a result, any questioning of the finalized data is frowned upon. Lower ranking members of the organization are then held accountable for any transgressions, since the scientist above them has such a high standard for their honesty.
If the JPEG or TIFF files were made available we wouldn't have to use our eyes to try and discover fraud. Variances in density, for example, could indicate cutting and pasting. That clear line that gets erased with density adjustment remains on the pre-processed image file. The pre-processed data is what we need, not the post-processed product offered up for publication. The post processing is where the scoundrel plies his/her understanding of imaging and ways of fooling the older generation of leaders. Fortunately, post-processing is tracked by the software. If post-processing takes place, that image must be saved as a new file. The family tree of an image is stored automatically. It all leads back to the pre-processed image.
This is a critical point in the Cargo Cults use of imagery in their ceremonies. The real wealth of the imaging systems comes from the pre-processed data. Office dwelling scientists don't publish relevant information on image enhancements. They offer up aesthetically pleasing images that support their narrative. Orthogonal methods should be required to back up the western analysis, such as the ForteBio.
Wednesday, January 04, 2012
Hanging From a Tree in a Forest In Belgrade
You hear about pharmaceutical companies bribing doctors, promoting off-label use of their drugs, cherry picking clinical trial data, ghost writing scientific papers, and all sorts of bad behavior. You rarely hear about the people who do this work for a living. When they get caught the Corporation steps up to the plate and takes the hit. The corporation loses lots of money. The public furls its brow and says, "Bad corporation!". Who are the people who do these bad things? Do they go on to more prosperous positions? Are they ultimately rewarded for their dedication to profits? Or do they succumb to ridicule and ostracism from an honest industry such as biotech/big pharma?
One such person, Nenad Borojevic, a former director of the Serbian Institute of Oncology and Radiology, was found hanging from a tree in a forest in Belgrade. He was charged with supplying drugmakers with information on the amount of cytostatic drugs needed and on public procurement plans. Nenad Borojevic and representatives from several pharmaceutical companies, including AstraZeneca and Roche, were indited on suspicion of accepting and giving bribes totaling about $1.4 million.
Who were the employees at AstraZeneca and Roche who worked with Nedad? According to reports, police also arrested the director of Roche pharmaceuticals office in Belgrade, Vojislav Petrović. Other suspects detained include Director of PharmaSwiss Oncology Sector Andrej Soretić and Predrag Marinković of AstraZeneca bio-pharmaceutical company. Who were their superiors?
How does this relate to a Cargo Cult? The drugs are already approved thus the cargo arrived. I tend to believe however that the drugs are of little interest scientifically to a certain sector of the industry. The drugs are merely widgets that generate profit. With a little help, those profits can go up considerably. The execs with the right credentials, who talk pretty are tasked with making the most money possible from the pills. They have to convince the world of medicine that they need to prescribe the pills. They have to educate. In the process they tend to stretch the truth. And the truth is what we are all about here.
The truth about the pills, in this case, was stretched to the point of criminal activity. One of these leaders was found hanging from a tree in a forest in Belgrade. How can an industry that relies on science employ leaders who have cumulatively created such a corrupt corporate culture? How can such leaders understand how scientific research is conducted? It is fairly easy to deceive ourselves and our fellow human beings. To do so purposely seems to be the skill that the leaders have in spades. Such leaders thrive in Cargo Cults. Sometimes they get caught.
One such person, Nenad Borojevic, a former director of the Serbian Institute of Oncology and Radiology, was found hanging from a tree in a forest in Belgrade. He was charged with supplying drugmakers with information on the amount of cytostatic drugs needed and on public procurement plans. Nenad Borojevic and representatives from several pharmaceutical companies, including AstraZeneca and Roche, were indited on suspicion of accepting and giving bribes totaling about $1.4 million.
Who were the employees at AstraZeneca and Roche who worked with Nedad? According to reports, police also arrested the director of Roche pharmaceuticals office in Belgrade, Vojislav Petrović. Other suspects detained include Director of PharmaSwiss Oncology Sector Andrej Soretić and Predrag Marinković of AstraZeneca bio-pharmaceutical company. Who were their superiors?
How does this relate to a Cargo Cult? The drugs are already approved thus the cargo arrived. I tend to believe however that the drugs are of little interest scientifically to a certain sector of the industry. The drugs are merely widgets that generate profit. With a little help, those profits can go up considerably. The execs with the right credentials, who talk pretty are tasked with making the most money possible from the pills. They have to convince the world of medicine that they need to prescribe the pills. They have to educate. In the process they tend to stretch the truth. And the truth is what we are all about here.
The truth about the pills, in this case, was stretched to the point of criminal activity. One of these leaders was found hanging from a tree in a forest in Belgrade. How can an industry that relies on science employ leaders who have cumulatively created such a corrupt corporate culture? How can such leaders understand how scientific research is conducted? It is fairly easy to deceive ourselves and our fellow human beings. To do so purposely seems to be the skill that the leaders have in spades. Such leaders thrive in Cargo Cults. Sometimes they get caught.
Allozyne Layoffs and Sacrificial Lambs
The last post was about the fallout of a merger that went sour. The CEO and four board members from company A resigned. Company B has possibly laid a few of its 20 employees off but their CEO denies the claim. The details of the merger and the subsequent fallout would be good reading for those of us interested in the business of science. It is not however, what we want to do here on the CCS. What we do here is philosophy. An interesting technology came out of Caltech that enabled one to add a non-natural amino acid to a recombinant protein. That non-natural amino acid would allow for conjugation to other proteins or PEG chains that could add some pharmacokenetic advantages to a protein. Fantastic. What happens next is of interest to the CCS.
What happens next is a business plan is written up and submitted to a venture capital group, a biotech incubator, an angel investor, a rich relative, or whoever has the money that the inventors lack. In a classic "you've got the money, I've got the brains" situation, a relationship is formed. Trust and money is given to the inventors by the investors. A meeting takes place. Where are we going to set up shop? What should we pay for rent. Who do we need to hire? Who can we put on the board and advisory committees to attract other players in the industry? In all of this shuffle it would be easy to lose sight of the original excitement of being able to stick a couple antibodies together and see what happens.
This is of interest to the CCS because what usually happens ends in failure. We ask ourselves how so much interesting science and so much money result in failure? We believe that this is no ordinary business failure. We have recently given a number to the failures of drug research ventures. A trillion US dollars has been lost! That is veritable petri dish teaming with life for a philosopher such as the CCS. I want to put that petri dish under a microscope and watch the interactions and understand what is happening. In one petri dish I have a thousand little companies. 999 of those companies die but one lives. If I look real hard through the microscope I can see a little sign and it says Amgen! What did Amgen do to survive?
What happened at Allozyne is a microcosm of the Trillion Dollar Failure that is drug research. The inventors left the business up to the Cargo Cult Leaders of Seattle and went back to Caltech. One outsider, the CEO, came from the business side of Novartis. The rest of the crew, including the chief scientific officer were selected from the usual suspects of the Seattle Cargo Cult. The CEO and the board are now in charge of turning legitimate science into a profitable business model. They need those Powerpoint slides to tell a story. The story was told to Wall Street but Wall Street didn't bite. Allozyne and Poniard leaders failed. Poniard leadership accepted responsibility and fell on their knives. Allozyne sacked a couple low level techs and offered up soundbites like, "“The syndicate is extremely excited that we are on a Phase III trajectory in 2012” and that their pitch to Wall Street was, "very well received" and that “No one here is in fact at all disappointed. We are very much looking forward to 2012. We are invigorated about the challenge ahead.”
Allozyne began with an initial investment from the Accelerator Corporation. Accelerator usually ponies up around 1 to 2 million dollars. From there Allozyne received 50 million dollars and moved into some rather swanky digs a block away from the Accelerator building. As of June 2011 they were down to 1.4 million cash on hand, leaving 49.6 million to contribute to the lost trillion dollars. I've mentioned that Allozyne is a part of a microcosm. I've mentioned that the microcosm could be thought of as a petri dish teaming with life. 1000 entities begin life in that petri dish. Rather than studying that one Amgen life form that strives, we are looking at one life form that looks sickly. We know that we must add a certain concentration of money into our petri media to keep all of the companies in there alive for a few years. We don't have a good idea what is needed to make the Amgens emerge. In fact, if Amgen were put into a modern biotech microcosm petri dish... it wouldn't survive either. Is Allozyne like an early Amgen? Are they misunderstood yet poised to one day make their detractors very sorry? Or are they dying because the management team is Cargo Cult?
It is hard to study what is happening in our biotech petri dish. Allozyne is a secretive group. One or more people were laid off but according to management it was of no consequence. It was merely a ceremonial sacrifice. Part of the cult rituals is to seek out the members who wear white lab coats and give them pink slips and watch them march out the front door with a box of their meager belongings. These sacrifices take place towards the end of the process. It is believed that the laboratory workers are causing the airplanes to not land. By removing them the investors breathe easier which relieves stress among the managers. The white lab coat clad members of the cult are like lambs. They have no power over the direction of the research they conduct on behalf of their leaders. They do what they are told and they disappear without explanation. It does not however signal the end of another dot in our petri dish. It only signals trouble.
We would like to see a research class that emerges one day with the power to fight. A small biotech is not where that power will come from. It will come from outside of the lab. Slowly people will begin to speak up about the common mistakes that we make in trying to manage science as if it were a business. Firing lab workers is like firing an automobile assembly worker for making a Yugo or an Edsel. The real culpability lies in the minds of those who design the car. The reason the airplanes do not land in our airport is not because the man in the tower is doing his job improperly. It is because Cargo Cults are missing something. That something is unknown or is purposely being ignored by the management class. One thing the are missing is the knowledge that sacrificial lambs make for a dull and timid research staff.
What happens next is a business plan is written up and submitted to a venture capital group, a biotech incubator, an angel investor, a rich relative, or whoever has the money that the inventors lack. In a classic "you've got the money, I've got the brains" situation, a relationship is formed. Trust and money is given to the inventors by the investors. A meeting takes place. Where are we going to set up shop? What should we pay for rent. Who do we need to hire? Who can we put on the board and advisory committees to attract other players in the industry? In all of this shuffle it would be easy to lose sight of the original excitement of being able to stick a couple antibodies together and see what happens.
This is of interest to the CCS because what usually happens ends in failure. We ask ourselves how so much interesting science and so much money result in failure? We believe that this is no ordinary business failure. We have recently given a number to the failures of drug research ventures. A trillion US dollars has been lost! That is veritable petri dish teaming with life for a philosopher such as the CCS. I want to put that petri dish under a microscope and watch the interactions and understand what is happening. In one petri dish I have a thousand little companies. 999 of those companies die but one lives. If I look real hard through the microscope I can see a little sign and it says Amgen! What did Amgen do to survive?
What happened at Allozyne is a microcosm of the Trillion Dollar Failure that is drug research. The inventors left the business up to the Cargo Cult Leaders of Seattle and went back to Caltech. One outsider, the CEO, came from the business side of Novartis. The rest of the crew, including the chief scientific officer were selected from the usual suspects of the Seattle Cargo Cult. The CEO and the board are now in charge of turning legitimate science into a profitable business model. They need those Powerpoint slides to tell a story. The story was told to Wall Street but Wall Street didn't bite. Allozyne and Poniard leaders failed. Poniard leadership accepted responsibility and fell on their knives. Allozyne sacked a couple low level techs and offered up soundbites like, "“The syndicate is extremely excited that we are on a Phase III trajectory in 2012” and that their pitch to Wall Street was, "very well received" and that “No one here is in fact at all disappointed. We are very much looking forward to 2012. We are invigorated about the challenge ahead.”
Allozyne began with an initial investment from the Accelerator Corporation. Accelerator usually ponies up around 1 to 2 million dollars. From there Allozyne received 50 million dollars and moved into some rather swanky digs a block away from the Accelerator building. As of June 2011 they were down to 1.4 million cash on hand, leaving 49.6 million to contribute to the lost trillion dollars. I've mentioned that Allozyne is a part of a microcosm. I've mentioned that the microcosm could be thought of as a petri dish teaming with life. 1000 entities begin life in that petri dish. Rather than studying that one Amgen life form that strives, we are looking at one life form that looks sickly. We know that we must add a certain concentration of money into our petri media to keep all of the companies in there alive for a few years. We don't have a good idea what is needed to make the Amgens emerge. In fact, if Amgen were put into a modern biotech microcosm petri dish... it wouldn't survive either. Is Allozyne like an early Amgen? Are they misunderstood yet poised to one day make their detractors very sorry? Or are they dying because the management team is Cargo Cult?
It is hard to study what is happening in our biotech petri dish. Allozyne is a secretive group. One or more people were laid off but according to management it was of no consequence. It was merely a ceremonial sacrifice. Part of the cult rituals is to seek out the members who wear white lab coats and give them pink slips and watch them march out the front door with a box of their meager belongings. These sacrifices take place towards the end of the process. It is believed that the laboratory workers are causing the airplanes to not land. By removing them the investors breathe easier which relieves stress among the managers. The white lab coat clad members of the cult are like lambs. They have no power over the direction of the research they conduct on behalf of their leaders. They do what they are told and they disappear without explanation. It does not however signal the end of another dot in our petri dish. It only signals trouble.
We would like to see a research class that emerges one day with the power to fight. A small biotech is not where that power will come from. It will come from outside of the lab. Slowly people will begin to speak up about the common mistakes that we make in trying to manage science as if it were a business. Firing lab workers is like firing an automobile assembly worker for making a Yugo or an Edsel. The real culpability lies in the minds of those who design the car. The reason the airplanes do not land in our airport is not because the man in the tower is doing his job improperly. It is because Cargo Cults are missing something. That something is unknown or is purposely being ignored by the management class. One thing the are missing is the knowledge that sacrificial lambs make for a dull and timid research staff.
Tuesday, January 03, 2012
Journalism
The Cargo: Allozyne
The Xconomy Headlines:
* Allozyne, Developer of Multiple Sclerosis Drug in Fewer Shots, Poised to Enter Clinical Trials 10/16/08
* Allozyne’s Next Drug, Made to Kill Two Birds With One Stone, Being Prepped for Clinic 11/16/10
* Allozyne Passes First Clinical Trial, Dreams Big About a Once-Monthly Multiple Sclerosis Drug 1/10/11
* Allozyne Acquires Poniard Pharmaceuticals, Finds Backdoor Route to NASDAQ 6/22/11
* Allozyne Looks to Rustle Up Interest on Wall Street With Backdoor IPO 7/13/11
* Allozyne, Poniard Scrap Plan to Merge Amid Investor Apathy 12/22/11
* Allozyne Raises More VC Cash, Looks to FDA Meeting After Poniard Deal Fizzles 12/23/11
One final headline by the Wall Street Journal: Poniard CEO, 4 Board Members Resign In Wake Of Merger Collapse
Xconomy missed that story.
The unfettered enthusiasm remains a mystery. The journalistic approach to the story is non-existent. A balance comes in the comment section of a few articles. A reader who goes by the moniker Nanostring added a few points on the Poniard deal that the article does not mention:
1. Based on today’s price of PARD, the merger values Allozyne @ ~$20 M ($11M*65/35).
http://finance.yahoo.com/q?s=PARD&ql=1
That is: they took valuable technology from Caltech + $43M in investor money and ended up with $20M in value. You do the math.
2. Even that $20M may be too rich, considering that PARD got immediately hit by two lawsuits for agreeing to the terms of the merger.
http://yhoo.it/qbHfKv
http://yhoo.it/mOWjQe
3. As of now PARD shareholders have twice rejected the reverse stock-split, which is a prerequisite to the merger:
http://biz.yahoo.com/e/110725/pard8-k.html (second graph)
Nanostring sounds like an interested party with ties closer to the money than the science. He was correct about the market value falling short. He is no fan of the Xconomy cheerleading.
Keeping the positive spin on the disastrous management of Allozyne is worthy of journalistic coverage all by itself. Meena Chhabra is very attractive. Yet she was unable to attract the kind of attention needed among the geniuses of Wall Street. While she continues to go unscathed in Xconomy and among her local peers, her counterparts at Poniard suffered a different fate.
Will Allozyne survive? With plans to skip phase II trials and sign up only 700 people in a phase III, funded by Allozyne alone, all carried out by a management team that orchestrated the Poniard fiasco... we think this plane won't land. And all of this for the hope of a longer lasting form of a drug already on the market.
Will Xconomy cheer leading continue, leaving in the good and leaving out the bad? Unfortunately we think they will. They are a part of this Cargo Cult.
Biologic therapeutics represent the vanguard of innovation. By 2006 they had captured a $30 billion dollar market with forecasted growth to $60 billion by the end of 2010. Although the creation and adoption of biologics has been rapid, the markets that they serve are still burgeoning with unmet medical need. We, a privately held and clinical stage biopharmaceutical company, have rapidly developed a number of protein therapeutics product candidates through its next generation protein engineering technology in order to serve unmet medical need in various autoimmune diseases and cancer.Ka-Ching!
The Xconomy Headlines:
* Allozyne, Developer of Multiple Sclerosis Drug in Fewer Shots, Poised to Enter Clinical Trials 10/16/08
* Allozyne’s Next Drug, Made to Kill Two Birds With One Stone, Being Prepped for Clinic 11/16/10
* Allozyne Passes First Clinical Trial, Dreams Big About a Once-Monthly Multiple Sclerosis Drug 1/10/11
* Allozyne Acquires Poniard Pharmaceuticals, Finds Backdoor Route to NASDAQ 6/22/11
* Allozyne Looks to Rustle Up Interest on Wall Street With Backdoor IPO 7/13/11
* Allozyne, Poniard Scrap Plan to Merge Amid Investor Apathy 12/22/11
* Allozyne Raises More VC Cash, Looks to FDA Meeting After Poniard Deal Fizzles 12/23/11
One final headline by the Wall Street Journal: Poniard CEO, 4 Board Members Resign In Wake Of Merger Collapse
Xconomy missed that story.
The unfettered enthusiasm remains a mystery. The journalistic approach to the story is non-existent. A balance comes in the comment section of a few articles. A reader who goes by the moniker Nanostring added a few points on the Poniard deal that the article does not mention:
1. Based on today’s price of PARD, the merger values Allozyne @ ~$20 M ($11M*65/35).
http://finance.yahoo.com/q?s=PARD&ql=1
That is: they took valuable technology from Caltech + $43M in investor money and ended up with $20M in value. You do the math.
2. Even that $20M may be too rich, considering that PARD got immediately hit by two lawsuits for agreeing to the terms of the merger.
http://yhoo.it/qbHfKv
http://yhoo.it/mOWjQe
3. As of now PARD shareholders have twice rejected the reverse stock-split, which is a prerequisite to the merger:
http://biz.yahoo.com/e/110725/pard8-k.html (second graph)
Nanostring sounds like an interested party with ties closer to the money than the science. He was correct about the market value falling short. He is no fan of the Xconomy cheerleading.
Will this FAIL be covered at Xconomy? What happens next? Will we hear again from OVP’s Carl on how proud he is with Allozyne, now that PARD shareholders have flipped a middle finger to this merger? Why are comments disabled on the other Xconomy article?
Unfortunately, (as I have complained to Luke and Buderi on numerous occasions), Xconomy again wants to be more of a PR shop for the local VCs rather than a real news-reporting blog with journalistic integrity…
Keeping the positive spin on the disastrous management of Allozyne is worthy of journalistic coverage all by itself. Meena Chhabra is very attractive. Yet she was unable to attract the kind of attention needed among the geniuses of Wall Street. While she continues to go unscathed in Xconomy and among her local peers, her counterparts at Poniard suffered a different fate.
Will Allozyne survive? With plans to skip phase II trials and sign up only 700 people in a phase III, funded by Allozyne alone, all carried out by a management team that orchestrated the Poniard fiasco... we think this plane won't land. And all of this for the hope of a longer lasting form of a drug already on the market.
Will Xconomy cheer leading continue, leaving in the good and leaving out the bad? Unfortunately we think they will. They are a part of this Cargo Cult.
Sunday, January 01, 2012
Friend or Foe
Retraction Watch estimates close to 400 papers were retracted in 2011. A couple comments came up with retraction numbers below 100 for the year:
Thanks so much for providing this valuable service. Of interest, a PubMed search for “Retracted Publication” or “Retraction of Publication” for 2011 yields only 35 papers. So if you and your colleagues weren’t on the job, we’d be missing out on ~1 in 12 of these papers!
Pat French
“Retraction notice” gives 63 hits. Still, the problem is exactly that it is not clear how to retrieve all the retractions, which may well be in the PubMed database. There should be a standard tag!
Jon Beckmann
We think that retractions are important pieces of scientific information. Unlike a Friday night bar conversation where you make the claim that the Buffalo Bills won the Superbowl back in 1995, the accuracy of claims made in science matters. When the folks at Nature faced the prevalence of chicanery taking place in big science labs and big science journals they concluded:
The peer review process employed by science journals is the opposite of the scientific method. Peer reviewers don't repeat any experiments thus their judgments are not empirical. Peers have a bias that is not eliminated by the process. The authors and their organizations carry with them a cache that brings with it bias that is also not eliminated. The science isn't the only thing being evaluated. In a perfect world a journal would publish articles and offer only minimal interference into what the authors intend to say. Once published the true peers can evaluate the paper and agree or disagree with it. Scientists after all, are the peers.
The question that peer reviewed journals have to wrestle with is whether or not Retraction Watch is their friend or enemy. With over 1.5 million hits online Retraction Watch is clearly popular among scientists. Who else would read about retractions? It appears that the demand is there for more information. Transparency is our friend.
Thanks so much for providing this valuable service. Of interest, a PubMed search for “Retracted Publication” or “Retraction of Publication” for 2011 yields only 35 papers. So if you and your colleagues weren’t on the job, we’d be missing out on ~1 in 12 of these papers!
Pat French
“Retraction notice” gives 63 hits. Still, the problem is exactly that it is not clear how to retrieve all the retractions, which may well be in the PubMed database. There should be a standard tag!
Jon Beckmann
We think that retractions are important pieces of scientific information. Unlike a Friday night bar conversation where you make the claim that the Buffalo Bills won the Superbowl back in 1995, the accuracy of claims made in science matters. When the folks at Nature faced the prevalence of chicanery taking place in big science labs and big science journals they concluded:
these days image detection software and the vigilance of media outlets such as Retraction Watch can catch irregularities—be they due to innocent error or misconduct—much sooner. The ability to track these changes provides benefits to biomedicine, as experiments in the scientific literature lay the foundation for future experiments.
The peer review process employed by science journals is the opposite of the scientific method. Peer reviewers don't repeat any experiments thus their judgments are not empirical. Peers have a bias that is not eliminated by the process. The authors and their organizations carry with them a cache that brings with it bias that is also not eliminated. The science isn't the only thing being evaluated. In a perfect world a journal would publish articles and offer only minimal interference into what the authors intend to say. Once published the true peers can evaluate the paper and agree or disagree with it. Scientists after all, are the peers.
The question that peer reviewed journals have to wrestle with is whether or not Retraction Watch is their friend or enemy. With over 1.5 million hits online Retraction Watch is clearly popular among scientists. Who else would read about retractions? It appears that the demand is there for more information. Transparency is our friend.
Wednesday, December 21, 2011
The Arrivals
If you've made up your mind
to test a theory, or you want to explain some idea, you should
always decide to publish it whichever way it comes out. If we only
publish results of a certain kind, we can make the argument look
good. We must publish both kinds of results. -RF
If we could make one change that could turn the cargo cults into real airports it would be to create a place where the results of all experiments are published. In Cargo Cult Airplane terms, what cargo planes were scheduled to land and did they report on the landing? If you are looking for a big deal struck between big pharma and biotechnology (the departure) you will have no problem finding the publicity. If you are looking for the results of a big pharma/biotech deal you will have to begin conducting research.
Let's look at a deal between Pfizer and Scripps back in 2006.
Under the terms of the agreement, Pfizer will pay Scripps Research $100 million over a five-year period, during which time scientists from Pfizer and Scripps Research will work together to identify and perform specific projects of mutual interest.
Pfizer will pay Scripps Research milestones and royalties on therapeutic compounds created through the collaboration. In addition, Pfizer will have the first right to license many discoveries made at Scripps Research during the agreement.
This particular deal was given journalistic coverage by the San Diego Union Tribune. (Beware the trade PR publications such as Fiercetech and Xconomy)
Pfizer would pay Scripps $20 million a year for five years, he said. Scripps would have full control over how the money is spent.
In return, Scripps would give Pfizer the right to review all of the institute's discoveries, plus the right to license up to 47 percent of them. Pfizer would be able to make such actions only during the five-year funding period.
In order to evaluate the results of this collaboration it is important to know that Pfizer was given access to all of Scripps publicly funded research, not just the work initiated and researched during the five year $100 million deal. It makes the 2011 arrival time even more interesting.
The Pfizer deal replaced Scripps' controversial 10-year alliance with Novartis. The institute came under scrutiny in the early 1990s after the NIH questioned aspects of its initial deal with Sandoz Pharmaceuticals Corp., who later became Novartis. According to the Union Tribune:
During a congressional inquiry, federal officials said the agreement gave Sandoz too much control over Scripps' research priorities, stifled academic freedom and prevented smaller biotechnology companies from competing for access to Scripps' scientific discoveries. The partnership allowed Sandoz to license nearly all of the institute's inventions.
Some legislators suggested that the Scripps-Sandoz deal made the federal government, through its grants to Scripps, a patron of a foreign corporation.
We certainly don't want that to happen. We want pills that make people better when they get sick. After the Scripps-Sandoz partnership, the NIH established policies to clarify how institutions that receive its funds should enter into licensing agreements with for-profit companies.
The institutions' responsibilities include:
Preserving the academic freedom of its scientists.
Ensuring that findings based on taxpayer-funded research are disclosed in a timely manner.
Not entering into agreements that permit a corporate partner to acquire exclusive licensing rights to a discovery without plans to actively develop and commercialize it.
Promoting the manufacturing of its products in the United States.
That is a positive outcome, although not the one intended. A cargo plane landed here, bringing with it a new set of rules. If you are a drug exec or a politician in charge of funding massive organizations like the NIH, this is cargo. This set of rules effects how you do your job. It effects how scientists do their jobs.
What did we get from this deal? What did Pfizer get? One benefit was offered up from the citizens of Palm Beach County Florida. They ponied up $310 million to get Scripps to set up shop in Florida and bring with them high paying jobs. A quick Google search finds a story of hope via the Pfizer deal and an unrelated spin-off from Scripps, Xcovery. On their website Xcovery lists one job. Scripps Florida lists 3 jobs. 4 jobs currently available after $410 million. Are both investments drying up or was there a surge in hiring and thus scientific progress is ? We can't say.
Another potentially related story, "Scripps Research/Pfizer Team Produces a Potential New Painkiller". The team reports on the promising new compound in the April 24, 2009 issue of the journal Chemistry & Biology. The Cravatt group began collaborating with Pfizer in 2003 however to pursue, among other goals, development of fatty acid amide hydrolase (FAAH) inhibitors. This collaboration (began in 2003) led to the discovery of a promising class of inhibitors known as piperidine ureas. This potential painkiller appears to have been sold off as a research tool and can be purchased at various chemical companies. Although not a blockbuster, this is scientific progress. This is a cargo plane that landed with an alternative cargo. It all began in 2003 however.
What really became of this deal? The extensive Pfizer pipeline may contain candidates from this collaboration. Novartis may have picked over the carcass leaving little behind after their ten year manipulation of scientific activity at Scripps. For the Cargo Cult Scientist, this is where research begins. If you want to know what the leaders have been up to you start with a press release. You wait the advertised amount of time and you draw a conclusion on what happened. It really is no different than a laboratory experiment. But who is conducting this research? The NIH and Pfizer executives are the foxes guarding the coup. Quite often a failing project begins to lose favor and piece by piece it begins to disappear. Which brings us back to Feynmans rule of reporting results regardless of outcome. By simply trying to evaluate the outcome of a $100 million dollar deal, we begin to see the complexity of such a human undertaking. Yet we know it is being done everyday by some group of people. They are who we are studying in this research project. What did they do with the money and how are they reporting the value of the investment?
If in fact the drug industry has lost over a trillion dollars in the past decade, this $100 million deal is small potatoes. It tells a story however. Each deal tells a story that is fascinating and worthy of research. There is the psychology of the major players. The structure of scientific research organizations can be studied. Did the Pfizer/Scripps deal solve the productivity issues facing big pharma/biotech R&D?
Greatest Loss of 2011
Daily Hitchens: UK Channel 4 Tribute
Imagine an articulate curmudgeon who would dedicate his career to fighting the abuses of scientific authority. Who is the Christopher Hitchens of the scientific community?
While Hitchens was no scientist, he was a brave man who derived his courage from the truth. When you believe you are on the side of the truth, regardless of the accuracy of your assumption, you are empowered to speak up. Hitchens relished a good argument and made a living out of speaking up. I don't believe he engaged in any Cargo Cult intellectualism.
We could use a man like him in our ranks. It would be amusing, as we look to the sky for our Cargo planes, to hear a lone voice, slightly inebriated with a British accent... "They're not coming you God-damned fools!"
Imagine an articulate curmudgeon who would dedicate his career to fighting the abuses of scientific authority. Who is the Christopher Hitchens of the scientific community?
While Hitchens was no scientist, he was a brave man who derived his courage from the truth. When you believe you are on the side of the truth, regardless of the accuracy of your assumption, you are empowered to speak up. Hitchens relished a good argument and made a living out of speaking up. I don't believe he engaged in any Cargo Cult intellectualism.
We could use a man like him in our ranks. It would be amusing, as we look to the sky for our Cargo planes, to hear a lone voice, slightly inebriated with a British accent... "They're not coming you God-damned fools!"
"Beware the irrational, however seductive. Shun the 'transcendent' and all who invite you to subordinate or annihilate yourself. Distrust compassion; prefer dignity for yourself and others. Don't be afraid to be thought arrogant or selfish. Picture all experts as if they were mammals. Never be a spectator of unfairness or stupidity. Seek out argument and disputation for their own sake; the grave will supply plenty of time for silence. Suspect your own motives, and all excuses. Do not live for others any more than you would expect others to live for you.” ― Christopher Hitchens
Sunday, December 18, 2011
Most Signficant Fire Burning Out in 2011
In January of 2010 Alan Sachs of Merck was interviewed about SIRNA, a subsidiary of Merck who specialized in RNA interference. SIRNA was purchased for 1.1 billion dollars. Before the end was announced they had burned through 1.5 billion dollars. Alan Sachs was their leaders and well aware of the hype:
All of the companies mentioned have ended their RNAi programs, including Alan Sachs' Merck. Alan was correct, It was a huge promise. A huge investment followed and a huge fall from grace has finally been completed. Among the Cargo Cults, Merck had the biggest RNAi airport.
Some investors still believe there is a pot of gold at the end of this rainbow. Here is why the CCS places the science into question.
The talking point among RNAi sympathizers is that monoclonal antibodies had likewise been left for dead back in the 90s. The difference however is that RNAi is a nucleic acid therapy like gene therapy. It is different than protein therapy. The diagrams and animations that depict the mechanism of action (MOA) of RNAi failed to depict the delivery of the small RNA pieces to the gene expressing cell targets. It offered a crisp clean MOA that had the same end result of monoclonal antibody therapy, a reduction in the amount of a specific protein. Without changing the highly simplified approach to biotech research, office bound PhDs ordered their white lab coat staff to run the same ELISAs and western blots to demonstrate knock-down. As a white lab coat staff member, I worked through a microcosm of what was to come back in 2002. My first blog post on RNAi was on May 10, 2006. After four years of thinking about RNAi, working with RNAi, watching others work with RNAi, and most importantly, watching the Cargo Cult leaders deal with the lack of efficacy in RNAi, I had come to the conclusion that this stuff is snake oil. That was several months before Merck bought SIRNA.
Since RNAi didn't work very well in the laboratory, it seemed preposterous that it would work in the clinic. The pharmaceutical industry relies heavily on pharmacy and much less on pharmacology. The two main areas of pharmacology are pharmacodynamics and pharmacokinetics. The former studies the effects of the drugs on biological systems, and the latter the effects of biological systems on the drugs. In broad terms, pharmacodynamics discusses the interactions of chemicals with biological receptors, and pharmacokinetics discusses the absorption, distribution, metabolism, and excretion of chemicals from the biological systems. In contrast, pharmaceutical research is primarily concerned with preparation, dispensing, dosage, and the safe and effective use of medicines. Biotech and Big Pharma leaders put up the money to put RNAi through the latter forms of research. The lack of efficacy left RNAi companies scrambling to explain why RNAi wasn't panning out as a drug. Delivery of the little pieces of RNA to a cell that was actively translating the drug target became a hot topic. In other words, they needed to get a handle on the pharmacology. Delivery of the little pieces of RNA was the reason the leaders decision making had hit a snag.
Currently, delivery of little RNA pieces remains the missing link to the promise. It keeps the promise alive. If the pharmacology techniques were in place we could check on the likes of Alnylam and Tekmira. We should not take their word for the promise of SNALPs, Stable-Nucleic-Acid-Lipid-Particles. We should have a separate organization that works for the FDA and the NIH. This group of scientists would development methods ahead of time to test the claims of for profit organizations who can both profit and cause harm. Other possibilities with RNAi is that they can do no good or they can help what ails us. The important thing for scientists to work on is in the development of a science that will help evaluate claims.
In July of this year Merck ended their RNAi efforts after 5 years and $1.5 billion. They claimed that this was a difficult decision based not on science but on financial needs for the Merck corporation. As usual a learning opportunity was lost. As Feynman said;
It is our biased opinion here at the CCS that 2011 witnessed a most significant ending to biotechnology's biggest promise of the past decade. I didn't present any data that might have suggested that RNAi works. I left that up to the experts who still claim that RNAi works. As far as putting ones money where ones mouth is, the verdict is in. RNAi is not moving forward in the world of BigPharma.
Here at the CCS we began in 2006 with a strong opinion and we end in 2011 with the same opinion, backed by a huge failure of RNAi in biotechnology and BigPharma. Alan Sachs was right, the promise was huge. That is why the failure is also huge. Huge shifts in thinking are fun places to be in science. Not just in the beginning, like those who jumped on the RNAi bandwagon, but in the end like those who kept the story of N-Rays and cold fusion alive. We have much to learn in the psychology of Cargo Cults. It remains and area in the philosophy of science that is itself a mystery. How do these things happen and why are so many people successful leading failures? What RNAi has taught us is that, in fact, science corrects itself. How do we stray from the truth and how much work goes into correcting ourselves?
Don't believe in the hype of a trendy science story. Believe in the truth. As Alan Sachs would say, there is power in the long term potential of the modality.
My background in molecular profiling was around when the Human Genome Project sequence came out in 2000 and 2001, and living through that bubble. What you realize is that the essence of the excitement is correct, and the reduction to practice may make it less-than-anticipated, but it’s still real. The same thing will be true of the RNA therapeutics space. There is a lot of expectation and anticipation. The reality will be somewhere between that and zero. We’d like to think because of the experience we have in our company that we have a clear line of sight on what’s practical within a certain time frame.
This will settle down. The acquisition of Sirna by Merck really set this thing off. We’re three years past that. I think in two more years, you’ll see this settle down, much like in the genomics space. In genomics, many of the opportunities consolidated into a few big players. The same thing will happen here. But the big companies like Merck, Roche, Novartis and Pfizer, that have committed to do this, ultimately will be there. Because of the long-term potential of the modality, not the immediate potential, but the long-term potential. It’s huge.
All of the companies mentioned have ended their RNAi programs, including Alan Sachs' Merck. Alan was correct, It was a huge promise. A huge investment followed and a huge fall from grace has finally been completed. Among the Cargo Cults, Merck had the biggest RNAi airport.
Some investors still believe there is a pot of gold at the end of this rainbow. Here is why the CCS places the science into question.
The talking point among RNAi sympathizers is that monoclonal antibodies had likewise been left for dead back in the 90s. The difference however is that RNAi is a nucleic acid therapy like gene therapy. It is different than protein therapy. The diagrams and animations that depict the mechanism of action (MOA) of RNAi failed to depict the delivery of the small RNA pieces to the gene expressing cell targets. It offered a crisp clean MOA that had the same end result of monoclonal antibody therapy, a reduction in the amount of a specific protein. Without changing the highly simplified approach to biotech research, office bound PhDs ordered their white lab coat staff to run the same ELISAs and western blots to demonstrate knock-down. As a white lab coat staff member, I worked through a microcosm of what was to come back in 2002. My first blog post on RNAi was on May 10, 2006. After four years of thinking about RNAi, working with RNAi, watching others work with RNAi, and most importantly, watching the Cargo Cult leaders deal with the lack of efficacy in RNAi, I had come to the conclusion that this stuff is snake oil. That was several months before Merck bought SIRNA.
Since RNAi didn't work very well in the laboratory, it seemed preposterous that it would work in the clinic. The pharmaceutical industry relies heavily on pharmacy and much less on pharmacology. The two main areas of pharmacology are pharmacodynamics and pharmacokinetics. The former studies the effects of the drugs on biological systems, and the latter the effects of biological systems on the drugs. In broad terms, pharmacodynamics discusses the interactions of chemicals with biological receptors, and pharmacokinetics discusses the absorption, distribution, metabolism, and excretion of chemicals from the biological systems. In contrast, pharmaceutical research is primarily concerned with preparation, dispensing, dosage, and the safe and effective use of medicines. Biotech and Big Pharma leaders put up the money to put RNAi through the latter forms of research. The lack of efficacy left RNAi companies scrambling to explain why RNAi wasn't panning out as a drug. Delivery of the little pieces of RNA to a cell that was actively translating the drug target became a hot topic. In other words, they needed to get a handle on the pharmacology. Delivery of the little pieces of RNA was the reason the leaders decision making had hit a snag.
Currently, delivery of little RNA pieces remains the missing link to the promise. It keeps the promise alive. If the pharmacology techniques were in place we could check on the likes of Alnylam and Tekmira. We should not take their word for the promise of SNALPs, Stable-Nucleic-Acid-Lipid-Particles. We should have a separate organization that works for the FDA and the NIH. This group of scientists would development methods ahead of time to test the claims of for profit organizations who can both profit and cause harm. Other possibilities with RNAi is that they can do no good or they can help what ails us. The important thing for scientists to work on is in the development of a science that will help evaluate claims.
In July of this year Merck ended their RNAi efforts after 5 years and $1.5 billion. They claimed that this was a difficult decision based not on science but on financial needs for the Merck corporation. As usual a learning opportunity was lost. As Feynman said;
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.
It is our biased opinion here at the CCS that 2011 witnessed a most significant ending to biotechnology's biggest promise of the past decade. I didn't present any data that might have suggested that RNAi works. I left that up to the experts who still claim that RNAi works. As far as putting ones money where ones mouth is, the verdict is in. RNAi is not moving forward in the world of BigPharma.
Here at the CCS we began in 2006 with a strong opinion and we end in 2011 with the same opinion, backed by a huge failure of RNAi in biotechnology and BigPharma. Alan Sachs was right, the promise was huge. That is why the failure is also huge. Huge shifts in thinking are fun places to be in science. Not just in the beginning, like those who jumped on the RNAi bandwagon, but in the end like those who kept the story of N-Rays and cold fusion alive. We have much to learn in the psychology of Cargo Cults. It remains and area in the philosophy of science that is itself a mystery. How do these things happen and why are so many people successful leading failures? What RNAi has taught us is that, in fact, science corrects itself. How do we stray from the truth and how much work goes into correcting ourselves?
Don't believe in the hype of a trendy science story. Believe in the truth. As Alan Sachs would say, there is power in the long term potential of the modality.
Tuesday, December 13, 2011
RNAi Strikes Again
It appears that the only thing RNA interference has accomplished thus far is a whole lot of disappointment. After my first RNAi experiment worked I was on board. We knocked out IL2 which led to an inhibition of osteoclast formation. Of course that was early on in the research. I later came to the conclusion that the inhibition of osteoclast formation was a fluke. Did I forget to add RANK-L? Would another day of observation have resulted in a full bloom of osteoclasts? As is normal in unreported science, the result was unclear. The probability of what we were hoping for (RNA interference) seemed to diminish with each new attempt at repeating the IL2 knockout.
The company I was working for soon ran out of cash and shut down having never repeated that experiment. Many laboratory workers tried but none could reproduce the results of that simple experiment. The way this type of science works is to have a desired result or even better, a one time observation, and force it to be the truth. The Beer and Pizza diet began. What concentration of RANK-L was used? Where did you buy the cells? Different technicians were brought in to overcome the incompetence of the last. All the while our successful experiment was presented to the investment world in 3 perfectly understandable slides. Just add RNA and away goes osteoclastogenesis.
The reason we went after IL2 was because we were a Bioinformatics company. We alone made the connection of IL2 to the RANK pathway using Bioinformatics. For that brief moment of success, we had added laboratory evidence. It brought out the worst in everyone. We needed this to be true. Our company was hurting and eventually filed for Chapter 7 bankruptcy. If IL 2 had become a drug target for Osteoporosis it would have changed everything.
RNA interference and IL 2 research continue however, with expected outcomes. AVI Biopharma (self proclaimed global leader in RNA based therapeutics) is axing 28% of its staff after missing out on a potentially huge federal contract to make an RNA-based treatment against pandemic flu. RNAi is also used by Dr. Steven Elledge.
IL 2 is in the news lately with a new retraction from the Bulfone Paus saga.
RNAi and IL2 research could one day lead to important information that will advance the life sciences. What I do is merely research. We find pieces of evidence and we try to figure out what is really going on. The complexity of a pathway is not simply understood by knocking out one of the many proteins involved. Nor is the complexity of RNAi understood by witnessing the many cases of gel manipulation in major publications from Harvard professors. It is odd but not direct evidence that RNAi does not work. IL2 is involved in a few sketchy cases of misconduct as well. It proves nothing.
All we have here is job loss and possible scientific misconduct associated with a couple areas of popular research being conducted by highly successful scientists. Are they Cargo Cult leaders? No comment. Is science correcting itself? Yes.
The company I was working for soon ran out of cash and shut down having never repeated that experiment. Many laboratory workers tried but none could reproduce the results of that simple experiment. The way this type of science works is to have a desired result or even better, a one time observation, and force it to be the truth. The Beer and Pizza diet began. What concentration of RANK-L was used? Where did you buy the cells? Different technicians were brought in to overcome the incompetence of the last. All the while our successful experiment was presented to the investment world in 3 perfectly understandable slides. Just add RNA and away goes osteoclastogenesis.
The reason we went after IL2 was because we were a Bioinformatics company. We alone made the connection of IL2 to the RANK pathway using Bioinformatics. For that brief moment of success, we had added laboratory evidence. It brought out the worst in everyone. We needed this to be true. Our company was hurting and eventually filed for Chapter 7 bankruptcy. If IL 2 had become a drug target for Osteoporosis it would have changed everything.
RNA interference and IL 2 research continue however, with expected outcomes. AVI Biopharma (self proclaimed global leader in RNA based therapeutics) is axing 28% of its staff after missing out on a potentially huge federal contract to make an RNA-based treatment against pandemic flu. RNAi is also used by Dr. Steven Elledge.
Using the power of small interfering RNAs (siRNAs) to silence gene expression, we are now undertaking loss-of-function screens in mammalian cells.Why is such a powerful research tool involved in such a curious story as the one coming from Dr. Elledge's laboratory?
IL 2 is in the news lately with a new retraction from the Bulfone Paus saga.
RNAi and IL2 research could one day lead to important information that will advance the life sciences. What I do is merely research. We find pieces of evidence and we try to figure out what is really going on. The complexity of a pathway is not simply understood by knocking out one of the many proteins involved. Nor is the complexity of RNAi understood by witnessing the many cases of gel manipulation in major publications from Harvard professors. It is odd but not direct evidence that RNAi does not work. IL2 is involved in a few sketchy cases of misconduct as well. It proves nothing.
All we have here is job loss and possible scientific misconduct associated with a couple areas of popular research being conducted by highly successful scientists. Are they Cargo Cult leaders? No comment. Is science correcting itself? Yes.
Friday, December 09, 2011
A Trillion
One of the interesting 2011 reports on the drug industry came from Burrill and Company. They made the claim that Big Pharma hasn't been doing very well.
We lost a trillion bucks in a decade? Those of us who enjoy math will stop and reflect on that number. For example, a million seconds lasts about 11 days. A billion seconds lasts about 31.5 years. To be exact, a trillion lasts 31688 years, 269 days, 1 hour, 46 minutes, 40 seconds.
In order to have lost a trillion dollars in ten years we would have to lose $100 billion each year or about $274 million a day.
What does it mean to lose that much money? In that decade I received some of that money in the form of an income. I also spent that money buying reagents and equipment. We paid Retrogen to sequence our DNA and Alphalyse for protein sequencing. While that money was being "lost", others were finding it. Some companies, like Retrogen and Alphalyse, were smart businessmen and women and they positioned themselves to be in line for some of the biopharma largesse.
My car has aged and is now worth less. The value was in fact lost. During the course of the devaluation I enjoyed the usage of my car. It had value and still does, just not as much. Likewise, BioPharma has aged and decreased in value. Unlike my highly reliable Honda Accord however, this baby was a lemon. One of the experts you would trust to make sure you don't pick a lemon is Cargo Cult leader biotech visionary G. Steven Burrill. As the industry was busy losing a trillion dollars G. Steven Burrill was succeeding.
During the course of the trillion dollar loss G. Steven Burrill must have given a warning. Leaders know that losing a trillion dollars is not the goal of any investment. We couldn't actually find any warnings that a trillion dollars was going to be lost. Did G. Steven Burrill succeed in spite of the loss or as a result of the loss? Was the industry loss his gain? How do the Cargo Cults select their leaders when the planes never land?
Prior to the loss of a trillion dollars there were warnings.
Biotech losses 94 to 04
biotech losses 90 to 93
Then came the new millennium.
biotech job losses 00 to 11
To G. Steven Burrill I offer up a different kind of award. The first ever Lifetime Achievement Cargo Cult Leader Award.
The first ever Annual Cargo Cult Scientist Awards are coming! Silvia... you're getting one. The rest of you will have to wait and see.
During the past decade large pharmaceutical companies have pursued an aggressive strategy of mergers and acquisition in an effort to grow their businesses. But an analysis from Burrill & Company suggests the approach has been a failure as these companies have seen the loss of $1 trillion in value during the past decade.
We lost a trillion bucks in a decade? Those of us who enjoy math will stop and reflect on that number. For example, a million seconds lasts about 11 days. A billion seconds lasts about 31.5 years. To be exact, a trillion lasts 31688 years, 269 days, 1 hour, 46 minutes, 40 seconds.
In order to have lost a trillion dollars in ten years we would have to lose $100 billion each year or about $274 million a day.
What does it mean to lose that much money? In that decade I received some of that money in the form of an income. I also spent that money buying reagents and equipment. We paid Retrogen to sequence our DNA and Alphalyse for protein sequencing. While that money was being "lost", others were finding it. Some companies, like Retrogen and Alphalyse, were smart businessmen and women and they positioned themselves to be in line for some of the biopharma largesse.
My car has aged and is now worth less. The value was in fact lost. During the course of the devaluation I enjoyed the usage of my car. It had value and still does, just not as much. Likewise, BioPharma has aged and decreased in value. Unlike my highly reliable Honda Accord however, this baby was a lemon. One of the experts you would trust to make sure you don't pick a lemon is Cargo Cult leader biotech visionary G. Steven Burrill. As the industry was busy losing a trillion dollars G. Steven Burrill was succeeding.
During the course of the trillion dollar loss G. Steven Burrill must have given a warning. Leaders know that losing a trillion dollars is not the goal of any investment. We couldn't actually find any warnings that a trillion dollars was going to be lost. Did G. Steven Burrill succeed in spite of the loss or as a result of the loss? Was the industry loss his gain? How do the Cargo Cults select their leaders when the planes never land?
Prior to the loss of a trillion dollars there were warnings.
Biotech losses 94 to 04
biotech losses 90 to 93
Then came the new millennium.
biotech job losses 00 to 11
To G. Steven Burrill I offer up a different kind of award. The first ever Lifetime Achievement Cargo Cult Leader Award.
A leader is a dealer in hope.
Napoleon Bonaparte
The first ever Annual Cargo Cult Scientist Awards are coming! Silvia... you're getting one. The rest of you will have to wait and see.
Thursday, December 01, 2011
Don Polderman
One of the things I do from time to time is check the stats on my blog. Most recently I've been getting a lot of hits from people typing Don Polderman into their search engine. There are people who want information. What has Don been up to lately? Has he found a new job, issued some statement regarding his dismissal, published a new paper, invented a new drug, started a biotech company... But a curious thing is happening. If you type Don Polderman into Google, the Cargo Cult Scientist is third on the list!
Are people concerned about the impact of a scientist who published over 500 articles and was fired for scientific misconduct? Are they willing to talk about it? Why hasn't this incident generated a public discussion?
My answer to that question would be cynical. I would cast dispersions on the world of science. I will join the rest of the scientific community who type his name into Google and stumble across this crazy blog. I will skip a detailed research project into the impact of Dons Sins Against Science.
This blog is really about the scientific method. The method can be applied to finding out whether or not your kid is lying to you about brushing their teeth. It can be used to find out if a drug can be manufactured at a 50,000 liter scale or if that drug is useful in treating human disease. The method can be used to find out how much BS Don Polderman has put into the scientific discourse. But professional scientists talk like Don. Judging by the amount of publications, Don was very good at talking. Now we have more information on Don however. Somewhere between the proper application of the scientific method and the kind of scientific misconduct Don Polderman is accused of lies the truth. Was he an outright fraud? Did he really make unintentional mistakes? Is it worth finding out? What about those 500 papers. If they were worth publishing in the first place, is it worth revisiting them? Why, at this point in Dons career, are we abandoning the scientific method? In our opinion now is the most important part of a scientists career to be analyzed using the scientific method. Instead we will brush this one under the rug.
Don Polderman will fade away. But here at the Cargo Cult Scientist, we will hold him in high regard as one of our leaders. Our airports do not bring in cargo. Our airport is a place where people who have no idea how airplanes operate (or even where airplanes come from) become experts in airports and airplanes. The tribesmen are suppose to be obedient and not talk about embarrassing moments experienced by our leaeders, best described in The Emperors New Clothes. We don't know where airplanes come from. But some of us know that our leaders don't either.
Are people concerned about the impact of a scientist who published over 500 articles and was fired for scientific misconduct? Are they willing to talk about it? Why hasn't this incident generated a public discussion?
My answer to that question would be cynical. I would cast dispersions on the world of science. I will join the rest of the scientific community who type his name into Google and stumble across this crazy blog. I will skip a detailed research project into the impact of Dons Sins Against Science.
This blog is really about the scientific method. The method can be applied to finding out whether or not your kid is lying to you about brushing their teeth. It can be used to find out if a drug can be manufactured at a 50,000 liter scale or if that drug is useful in treating human disease. The method can be used to find out how much BS Don Polderman has put into the scientific discourse. But professional scientists talk like Don. Judging by the amount of publications, Don was very good at talking. Now we have more information on Don however. Somewhere between the proper application of the scientific method and the kind of scientific misconduct Don Polderman is accused of lies the truth. Was he an outright fraud? Did he really make unintentional mistakes? Is it worth finding out? What about those 500 papers. If they were worth publishing in the first place, is it worth revisiting them? Why, at this point in Dons career, are we abandoning the scientific method? In our opinion now is the most important part of a scientists career to be analyzed using the scientific method. Instead we will brush this one under the rug.
Don Polderman will fade away. But here at the Cargo Cult Scientist, we will hold him in high regard as one of our leaders. Our airports do not bring in cargo. Our airport is a place where people who have no idea how airplanes operate (or even where airplanes come from) become experts in airports and airplanes. The tribesmen are suppose to be obedient and not talk about embarrassing moments experienced by our leaeders, best described in The Emperors New Clothes. We don't know where airplanes come from. But some of us know that our leaders don't either.
Wednesday, November 30, 2011
A Tale of Two Janets
Janet had an important job. Unfortunately, just as she was about to wrap up the show, her boob fell out. The exposure was an embarrassment to those who placed their confidence in her. The exposure of that one boob led to a Congressional investigation!
Of course I'm talking about Janet Jackson, not Janet Allen the director of research at the Biotechnology and Biological Sciences Research Council. Janet Allen had an important job as well, director of research for the Biotechnology and Biological Sciences Research Council. She finished her career there with a boob exposed in the form of a former PhD student and world class Cargo Cult Scientist Alirio Melendez. There was no federal government investigation into her culpability in this boob incident however. She let this boob out into society. This boob should have turned her face red and sent her scrambling to find a solution to reversing the damage that was done. Instead:
Contrast this praise with the fallout from Janet Jackson boob falling out. The NFL Commissioner Paul Tagliabue was apologetic before Congress! How much control would he have over such an incident? How much warning did he have that this boob would be exposed? Perhaps we need science commissioners to apologize and help make sense of our own boobs.
What Janet Allen did was have a successful career. She did increase her organizations grants and their duration. Who could ask for more? Well... I could. Did the planes land? What was the outcome of those longer more expensive grants? Who benefited most? I would have to say that it was the brass at the BBSRC.
Those of us who watched Janet Jacksons boob falling out at halftime of the superbowl on national tv had something to talk about the next day. It was funny to me and I knew there would be outrage amongst our conservative branch of society. Yet in science, we are not seeing that branch who are outraged by people who direct bogus research. We don't think they have any responsibility controlling rogue scientists who blatantly manipulate data and spin yarns in scientific journals.
And so we continue on with another saga in the Cargo Cults of Biotechnology. A director of scientific misconduct offers no apology. Janet Allen stepped down as director citing personal and private reasons. Her relationship to Melendez and the research they did together is not something she wants to revisit. Another unsatisfactory ending to a possible learning experience. I'm guessing we will see many more cases of scientific misconduct before we see another female breast on mainstream TV.
Of course I'm talking about Janet Jackson, not Janet Allen the director of research at the Biotechnology and Biological Sciences Research Council. Janet Allen had an important job as well, director of research for the Biotechnology and Biological Sciences Research Council. She finished her career there with a boob exposed in the form of a former PhD student and world class Cargo Cult Scientist Alirio Melendez. There was no federal government investigation into her culpability in this boob incident however. She let this boob out into society. This boob should have turned her face red and sent her scrambling to find a solution to reversing the damage that was done. Instead:
Douglas Kell, chief executive of the BBSRC, publicly thanked Professor Allen for her work at the research council. He said her "leadership and personal drive" had led to "noteworthy" contributions to the delivery of every aspect of the organisation's strategic plan, including multipartner programmes and the move to longer, larger grants.
Contrast this praise with the fallout from Janet Jackson boob falling out. The NFL Commissioner Paul Tagliabue was apologetic before Congress! How much control would he have over such an incident? How much warning did he have that this boob would be exposed? Perhaps we need science commissioners to apologize and help make sense of our own boobs.
What Janet Allen did was have a successful career. She did increase her organizations grants and their duration. Who could ask for more? Well... I could. Did the planes land? What was the outcome of those longer more expensive grants? Who benefited most? I would have to say that it was the brass at the BBSRC.
Those of us who watched Janet Jacksons boob falling out at halftime of the superbowl on national tv had something to talk about the next day. It was funny to me and I knew there would be outrage amongst our conservative branch of society. Yet in science, we are not seeing that branch who are outraged by people who direct bogus research. We don't think they have any responsibility controlling rogue scientists who blatantly manipulate data and spin yarns in scientific journals.
And so we continue on with another saga in the Cargo Cults of Biotechnology. A director of scientific misconduct offers no apology. Janet Allen stepped down as director citing personal and private reasons. Her relationship to Melendez and the research they did together is not something she wants to revisit. Another unsatisfactory ending to a possible learning experience. I'm guessing we will see many more cases of scientific misconduct before we see another female breast on mainstream TV.
Thursday, November 24, 2011
Geron Research
What is research? Wiki says, "Research can be defined as the scientific search for knowledge, or as any systematic investigation, to establish novel facts, solve new or existing problems, prove new ideas, or develop new theories, usually using a scientific method."
Geron conducted research into the use of human stem cells for use in spinal cord injuries. What we at the CCS would like to spend our days doing is conducting research into research. Measuring the measurements. We would love to learn everything we could about stem cell research. That is to say, we want to research the research. A prime target of our research would be the Roslin Institue and Geron.
The curiosity of Keith Campbells departure prior to the Roslin Institute selling their cloning technology to Geron followed by the failure of Geron to reproduce the work needs to be understood. Why couldn't Geron scientists do what Campbell could do? Campbell left the Roslin Institue in 1997. In 1998 Campbell in collaboration with PPL (Pharmaceutical Proteins Limited) created another sheep named 'Polly'. She was made from genetically altered skin cells containing a human gene. In 2000, after joining PPL Ltd, Campbell and his PPL team (based in North America) were successful in producing the world's first piglets by somatic cell nuclear transfer (SCNT), the cloning technique. The PPL teams based in Roslin, Scotland and Blacksburg (USA) also used the technique to produce the first gene targeted domestic animals as well as a range of animals producing human therapeutic proteins in their milk.
Geron finally called it quits last month. What went wrong? That is the research question is ask. What were there success stories and how did it all lead to nothing? My hypothesis is that scientists and businessmen do not think the same way. Both groups of thinkers wish to hold the title of scientist. The former adopt the title to help others identify their chosen profession. The latter want to make others think they are like the former.
Ultimately I am trying to get at the understanding of the thinking that separates a scientist from the rest of the human race. An example of scientific thinking comes from a comment given on the link to Gerons decision to hang up the stem cell research.
Then comes a concept straight out of the Cargo Cult Science speech.
Indeed in the research of the research, the data must be seen. We must present all of the data, not just the stuff we want people to see. How could a researcher of research gain access to the data? Who would pay such a person to conduct such research?
The data is piled high but in that pile is Dr. Campbell and his successes. Geron scientists couldn't pull out what was necessary to reproduce the work. The executives steered the research into a profit driven R&D project that failed. The connection between cloning an animal and using stem cells for regenerating human tissue, organs and whole beings is there. That is a separate research project. What I am interested in is how we miss that connection and veer off into the cargo cults.
Like Poldermans 500 papers, the quantity of research is great. The quality is suspect. Stem cell research was and is overhyped. "Embryonic stem cells are not ready for 'prime-time,'" said Dr. Bryon Petersen, professor in the Institute for Regenerative Medicine at Wake Forest Baptist Medical Center. "There are too many variables about these cells that we just don't know about." How do we get to "know about" the variables? Certainly not by starting a biotech company and hoping to make drugs out of the cells. Science conducted honestly will eventually spit out a useful medical application. Pursuing a useful (profitable) medical application will most often not produce anything resembling science.
Geron conducted research into the use of human stem cells for use in spinal cord injuries. What we at the CCS would like to spend our days doing is conducting research into research. Measuring the measurements. We would love to learn everything we could about stem cell research. That is to say, we want to research the research. A prime target of our research would be the Roslin Institue and Geron.
The curiosity of Keith Campbells departure prior to the Roslin Institute selling their cloning technology to Geron followed by the failure of Geron to reproduce the work needs to be understood. Why couldn't Geron scientists do what Campbell could do? Campbell left the Roslin Institue in 1997. In 1998 Campbell in collaboration with PPL (Pharmaceutical Proteins Limited) created another sheep named 'Polly'. She was made from genetically altered skin cells containing a human gene. In 2000, after joining PPL Ltd, Campbell and his PPL team (based in North America) were successful in producing the world's first piglets by somatic cell nuclear transfer (SCNT), the cloning technique. The PPL teams based in Roslin, Scotland and Blacksburg (USA) also used the technique to produce the first gene targeted domestic animals as well as a range of animals producing human therapeutic proteins in their milk.
Geron finally called it quits last month. What went wrong? That is the research question is ask. What were there success stories and how did it all lead to nothing? My hypothesis is that scientists and businessmen do not think the same way. Both groups of thinkers wish to hold the title of scientist. The former adopt the title to help others identify their chosen profession. The latter want to make others think they are like the former.
Ultimately I am trying to get at the understanding of the thinking that separates a scientist from the rest of the human race. An example of scientific thinking comes from a comment given on the link to Gerons decision to hang up the stem cell research.
This company would not walk away from this trial in the absence of an unexpected complication or safety concern, if there was any evidence that it was working," said Dr. Daniel Salomon, associate professor in the department of molecular and experimental medicine at the Scripps Research Institute in San Diego. "The assumption has to be that they designed a study with a purposeful plan to complete it to a certain benchmark of efficacy and that they had the funds for that effort in hand.
Then comes a concept straight out of the Cargo Cult Science speech.
Without seeing the data, one cannot be certain that there was not a clinical reason for stopping the trial," said Dr. Robertson Parkman, professor of pediatrics at the University of Southern California.
Indeed in the research of the research, the data must be seen. We must present all of the data, not just the stuff we want people to see. How could a researcher of research gain access to the data? Who would pay such a person to conduct such research?
The data is piled high but in that pile is Dr. Campbell and his successes. Geron scientists couldn't pull out what was necessary to reproduce the work. The executives steered the research into a profit driven R&D project that failed. The connection between cloning an animal and using stem cells for regenerating human tissue, organs and whole beings is there. That is a separate research project. What I am interested in is how we miss that connection and veer off into the cargo cults.
Like Poldermans 500 papers, the quantity of research is great. The quality is suspect. Stem cell research was and is overhyped. "Embryonic stem cells are not ready for 'prime-time,'" said Dr. Bryon Petersen, professor in the Institute for Regenerative Medicine at Wake Forest Baptist Medical Center. "There are too many variables about these cells that we just don't know about." How do we get to "know about" the variables? Certainly not by starting a biotech company and hoping to make drugs out of the cells. Science conducted honestly will eventually spit out a useful medical application. Pursuing a useful (profitable) medical application will most often not produce anything resembling science.
Sunday, November 20, 2011
Avastin Oh Avastin
"Sometimes, despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing." FDA Commissioner Margaret A. Hamburg
Hamburg said the choice was difficult because so many women and their doctors have put their faith in the drug and lobbied hard on its behalf.
"It does not improve survival," said Dr. Joanne Mortimer, director of the Women's Cancers Program at City of Hope in Duarte, who served on two of the three FDA advisory panels that debated Avastin's use for breast cancer. "Yes, it keeps your cancer under control longer. But … the risks are pretty huge."
They claim that Avastin will keep your cancer under control but you will have a higher risk of death from stroke or heart attack. The medication raised blood pressure and increased the risk of congestive heart failure. The risk of serious bleeding was five times higher among users of Avastin than it was for those on chemotherapy only. What about survival?
Hopes that Avastin could prolong life for patients with advanced breast cancer rested on a 2007 study in the New England Journal of Medicine. Researchers found that patients who took the drug in combination with the chemotherapy agent paclitaxel experienced an 11.8-month window, on average, during which their cancer was not growing. That compared with an average of 5.9 months of progression-free survival in patients receiving standard chemotherapy alone.
Alas you would think that an interesting cancer research project would be born. Using tumor growth as an end point to a cancer drug development program is flawed. What could be a better approach? Avastin generated about $3.5 billion in sales in the United States in 2010. Sales have dropped since the FDA made it known that they were concerned about the risks and the lack of efficacy on survival.
That plane did not land. People still want to take it. At $5oK per year, that cargo plane should land and bring with it plenty of health and happiness for those running short due to breast cancer. Since it doesn't, we have to say good by. The choice should not be difficult for the FDA boss. Ah but how reluctantly the mind consents to reality!
Hamburg said the choice was difficult because so many women and their doctors have put their faith in the drug and lobbied hard on its behalf.
"It does not improve survival," said Dr. Joanne Mortimer, director of the Women's Cancers Program at City of Hope in Duarte, who served on two of the three FDA advisory panels that debated Avastin's use for breast cancer. "Yes, it keeps your cancer under control longer. But … the risks are pretty huge."
They claim that Avastin will keep your cancer under control but you will have a higher risk of death from stroke or heart attack. The medication raised blood pressure and increased the risk of congestive heart failure. The risk of serious bleeding was five times higher among users of Avastin than it was for those on chemotherapy only. What about survival?
Hopes that Avastin could prolong life for patients with advanced breast cancer rested on a 2007 study in the New England Journal of Medicine. Researchers found that patients who took the drug in combination with the chemotherapy agent paclitaxel experienced an 11.8-month window, on average, during which their cancer was not growing. That compared with an average of 5.9 months of progression-free survival in patients receiving standard chemotherapy alone.
But even in that study, patients on Avastin did not live longer, said Dr. Kerin Adelson, a medical oncologist at Mount Sinai School of Medicine in New York.
A later study confirmed Avastin's failure to extend survival, and brought the drug's risks into better focus, Adelson said. (One of her own breast cancer patients who took Avastin had a massive stroke, she said.)
"Many drugs will improve the amount of time it takes for a cancer to grow but don't improve the amount of time a patient lives," she said.Alas you would think that an interesting cancer research project would be born. Using tumor growth as an end point to a cancer drug development program is flawed. What could be a better approach? Avastin generated about $3.5 billion in sales in the United States in 2010. Sales have dropped since the FDA made it known that they were concerned about the risks and the lack of efficacy on survival.
That plane did not land. People still want to take it. At $5oK per year, that cargo plane should land and bring with it plenty of health and happiness for those running short due to breast cancer. Since it doesn't, we have to say good by. The choice should not be difficult for the FDA boss. Ah but how reluctantly the mind consents to reality!
Friday, November 18, 2011
500 Papers
Retraction Watch posted the story yesterday of Dr. Don Polderman who was fired from Erasmus University in Rotterdam for scientific misconduct. He studied the risk of complications during cardio-vascular surgery. According to the DutchNews website, "In particular, he failed to obtain patient consent for carrying out research and recorded results ‘which cannot be resolved to patient information."
Having a forum like Retraction Watch allows for a conversation that doesn't always take place among people interested in science. We know people cheat. We know all of us are prone to fooling ourselves. What a forum such as Retraction Watch does is provide a journalistic approach to the fallout of being wrong. You might be purposely wrong or accidentally wrong. Being wrong however is nothing to be ashamed of. In fact finding out that you were wrong is how some of us learn. The greater our concern over right and wrong, the greater our desire is to understand why something is true or false. Retraction Watch opens up room for a conversation on the way in which scientists communicate (publish their work) and how flawed the system can be.
Our analogy of the Cargo Cults provides another way of looking at modern science. We like the philosophy of right and wrong and how subjective the two can be among mere mortals. Let's take two of the four comments currently up on Retraction Watch's story on Dr. Polderman.
These two concerned scientific people seem to be at odds in their philosophy. Dr. Seitz suggests that the quantity of publications is not important. He suggests reviewing each paper. Jey suggests that 500 papers in 30 years is too good to be true. Looking at the quantity of publications versus the quality of them seems to be a part of the culture of success in clinical medicine.
When I was a boy in Boy Scouts we had a contest of who could hold their breath the longest. The winner went about 4 minutes. Of course the winner and everyone who made it past the first minute were cheating. We didn't really need to follow each boy scout to see when they took in a fresh lung full of air. We didn't need to hold a mirror under every kids nose to see if they were breathing. We knew that the max of holding ones breath lasts about a minute. Jey is very astute in his observation regarding the number of papers Dr. Polderman has his name on. Jey goes on to say "Only possibility I can think of is that everyone in the building have been putting his name as a co-author. It’s even difficult to make up over 15 papers/year".
It is very difficult to take a single paper and reproduce the entire set of experiments and come to the same conclusion as the lead author. The list of authors on a paper haven't even taken the time to verify (in the lab) what is being reported. Therefore Dr. Seitz has proposed a far more difficult way of resolving this situation. Rather it would be of some value to assess the main thrust of what Dr. Polderman has put forth for the medical profession and to first look into the papers that support those ideas. Along the way perhaps a pattern will emerge that will lead us to pull out other papers that may contain false information.
The fact of the matter remains, a successful doctor/scientist has been caught cheating once again. As Jey pointed out, one would have to publish 15 papers a year. In 2001 Jan Hendrik Schon of the infamous Schon Scandal was listed as an author on an average of one newly published research paper every eight days. A pattern is thus already apparent for scientists. The quantity of ones publications may be inversely correlated to the quality.
I have my name, as an author, on a paper that was "published" in the Journal of Biological Chemistry. In fact, that paper is listed as a paid advertisement.
Those who work inside the laboratories are usually too young, scared and otherwise unfit to take on the likes of a powerful doctor such as Dr. Polderman. It takes a lot to correct someone who has captured the attention of the scientific community. My thanks go out to Retraction Watch for the valuable service they are providing to help shine a light on the dark side of science. We, who have worked or currently work inside the laboratories know all about the pressure to obtain publishable results. It is the Cargo Cult Culture. It is not important whether or not the planes land. Our careers present a conflict of interest in the pursuit of the truth.
Having a forum like Retraction Watch allows for a conversation that doesn't always take place among people interested in science. We know people cheat. We know all of us are prone to fooling ourselves. What a forum such as Retraction Watch does is provide a journalistic approach to the fallout of being wrong. You might be purposely wrong or accidentally wrong. Being wrong however is nothing to be ashamed of. In fact finding out that you were wrong is how some of us learn. The greater our concern over right and wrong, the greater our desire is to understand why something is true or false. Retraction Watch opens up room for a conversation on the way in which scientists communicate (publish their work) and how flawed the system can be.
Our analogy of the Cargo Cults provides another way of looking at modern science. We like the philosophy of right and wrong and how subjective the two can be among mere mortals. Let's take two of the four comments currently up on Retraction Watch's story on Dr. Polderman.
Polderman has “some 500 publications to his name”; does that number, 500, alone incite incredulity? A vast undertaking would be to review all of those publications to determine just how unique and how reliable was each study. Conrad Seitz M.D.
It’s a culture in clinical medicine to just look at the quantity, not the quality. You need to get more than 15 publication/year in order to reach 500 in a 30 year career span and this is a theoretically impossible task if you’re doing real science. Jey
These two concerned scientific people seem to be at odds in their philosophy. Dr. Seitz suggests that the quantity of publications is not important. He suggests reviewing each paper. Jey suggests that 500 papers in 30 years is too good to be true. Looking at the quantity of publications versus the quality of them seems to be a part of the culture of success in clinical medicine.
When I was a boy in Boy Scouts we had a contest of who could hold their breath the longest. The winner went about 4 minutes. Of course the winner and everyone who made it past the first minute were cheating. We didn't really need to follow each boy scout to see when they took in a fresh lung full of air. We didn't need to hold a mirror under every kids nose to see if they were breathing. We knew that the max of holding ones breath lasts about a minute. Jey is very astute in his observation regarding the number of papers Dr. Polderman has his name on. Jey goes on to say "Only possibility I can think of is that everyone in the building have been putting his name as a co-author. It’s even difficult to make up over 15 papers/year".
It is very difficult to take a single paper and reproduce the entire set of experiments and come to the same conclusion as the lead author. The list of authors on a paper haven't even taken the time to verify (in the lab) what is being reported. Therefore Dr. Seitz has proposed a far more difficult way of resolving this situation. Rather it would be of some value to assess the main thrust of what Dr. Polderman has put forth for the medical profession and to first look into the papers that support those ideas. Along the way perhaps a pattern will emerge that will lead us to pull out other papers that may contain false information.
The fact of the matter remains, a successful doctor/scientist has been caught cheating once again. As Jey pointed out, one would have to publish 15 papers a year. In 2001 Jan Hendrik Schon of the infamous Schon Scandal was listed as an author on an average of one newly published research paper every eight days. A pattern is thus already apparent for scientists. The quantity of ones publications may be inversely correlated to the quality.
I have my name, as an author, on a paper that was "published" in the Journal of Biological Chemistry. In fact, that paper is listed as a paid advertisement.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.Other than that paragraph, the paper looks like a normal peer reviewed article. It is listed on the authors resumes. I did the work, my supervisor wrote the paper, our CSO signed off on it and a couple others got their names on it as well. And of course it is part of the art of deception.
Those who work inside the laboratories are usually too young, scared and otherwise unfit to take on the likes of a powerful doctor such as Dr. Polderman. It takes a lot to correct someone who has captured the attention of the scientific community. My thanks go out to Retraction Watch for the valuable service they are providing to help shine a light on the dark side of science. We, who have worked or currently work inside the laboratories know all about the pressure to obtain publishable results. It is the Cargo Cult Culture. It is not important whether or not the planes land. Our careers present a conflict of interest in the pursuit of the truth.
Sunday, October 23, 2011
The Art of Journalism
Bill Moyers recently quoted a mentor of his: "News is what people want to keep hidden; everything else is publicity."
Does science truly have a journalistic style publication? Does anyone report on the ebb and flow of information being put forth by scientists? Xconomy sponsors the "Biotech is Back" conference. The WBBA organization holds an annual meeting. "This intense program will be a celebration of our successes, and a discussion of the industry’s current challenges and coming opportunities locally, nationally and globally." One of the speakers is the CEO of Eli Lilly who took control of Washington's largest biotechnology and fired the vast majority of its employees in 2007.
This is of course an example of publicity. The public relations groups include WBBA, Xconomy and the governor. They are the leaders. Who could report on their activity? Objective journalism should come from somewhere but who could gain access into these leaders and tell the story of what they do? This is science and the leaders have set up a system that excludes the sharing of information.
It would go something like this: WBBA hosts annual meeting. Guest speakers include governor Gregiore and the CEO of Eli Lilly. In 2007 Eli Lilly gained complete ownership of Cialis, and promptly shut down Icos operations and laid off Icos personnel, except for 127 employees working at the biologics facility. Icos was the largest biotechnology company in the state of Washington at the time of the acquisition, and employed around 700 people. In December 2007, CMC Biopharmaceuticals A/S, a Copenhagen-based provider of contract biomanufacturing services, bought the Bothell biologics facility and retained the existing 127 employees.
In addition to the layoff of Icos employees, other aspects of the acquisition were equally controversial, such as assertions that Icos was being sold too cheaply and that conflicts of interest existed. The latter related to Icos senior executives, who – despite poor stock performance, in part from failed clinical development programs and an inability to successfully license drugs over the preceding years – were to be massively compensated upon a successful acquisition.
Senior executives at Icos received cash payments worth a combined $67.8 million for selling the company to Eli Lilly. Icos chairman, chief executive, and president Paul Clark received "a 'golden parachute' worth $23.2 million in severance pay, cashed-out stock options, restricted stock awards and other bonuses for retention and closing the deal." Nine senior Icos executives received similar packages, each worth more than $1 million.
Does science truly have a journalistic style publication? Does anyone report on the ebb and flow of information being put forth by scientists? Xconomy sponsors the "Biotech is Back" conference. The WBBA organization holds an annual meeting. "This intense program will be a celebration of our successes, and a discussion of the industry’s current challenges and coming opportunities locally, nationally and globally." One of the speakers is the CEO of Eli Lilly who took control of Washington's largest biotechnology and fired the vast majority of its employees in 2007.
This is of course an example of publicity. The public relations groups include WBBA, Xconomy and the governor. They are the leaders. Who could report on their activity? Objective journalism should come from somewhere but who could gain access into these leaders and tell the story of what they do? This is science and the leaders have set up a system that excludes the sharing of information.
It would go something like this: WBBA hosts annual meeting. Guest speakers include governor Gregiore and the CEO of Eli Lilly. In 2007 Eli Lilly gained complete ownership of Cialis, and promptly shut down Icos operations and laid off Icos personnel, except for 127 employees working at the biologics facility. Icos was the largest biotechnology company in the state of Washington at the time of the acquisition, and employed around 700 people. In December 2007, CMC Biopharmaceuticals A/S, a Copenhagen-based provider of contract biomanufacturing services, bought the Bothell biologics facility and retained the existing 127 employees.
In addition to the layoff of Icos employees, other aspects of the acquisition were equally controversial, such as assertions that Icos was being sold too cheaply and that conflicts of interest existed. The latter related to Icos senior executives, who – despite poor stock performance, in part from failed clinical development programs and an inability to successfully license drugs over the preceding years – were to be massively compensated upon a successful acquisition.
Senior executives at Icos received cash payments worth a combined $67.8 million for selling the company to Eli Lilly. Icos chairman, chief executive, and president Paul Clark received "a 'golden parachute' worth $23.2 million in severance pay, cashed-out stock options, restricted stock awards and other bonuses for retention and closing the deal." Nine senior Icos executives received similar packages, each worth more than $1 million.
Wednesday, October 19, 2011
Pharmaplasia and Us
What ails the pharmaceutical industry? There are many perspectives. The one from the leaders of Seattle is that nothing ails us. We're doing fine. Then there are the others.
I've just started reading Pharmaplasia by Mike Wokasch. He is coming from the executive level in business and marketing. He has worked as a pharmacist, a pharmaceutical sales representative, marketing manager for blockbuster products, and he has held corporate officer positions at large and small companies. He is passionate about the need for expertise and professionalism in any career choice or job function.
Having yet to read the book, I am skeptical about the marketing side of pharmaceuticals. In Cargo Cult terms, his job is to make people believe that the planes are coming. He does not need to have any idea how a real airport works. After all of the business and marketing meetings are over, you still know absolutely nothing about the natural world or how the human body lives and dies. Yet M. Wakasch has taken an important step. He has admitted that there is a problem. In Cargo Cult terms, he acknowledges that the planes aren't going to be landing as advertised.
There is a distinction that has to be made however. A laboratory scientist is not considered a professional. We do not have the same kind of career paths as executives or marketing professionals. We do not make as much money. We are not expected to grow as laboratory professionals. The layoffs, such as Amgens announcement today, make laboratory workers who serve the R&D side of the industry less than professionals. We learn a skill such as running an ELISA and that becomes our "profession". We serve a piece of the puzzle being assembled by higher ranking PhD scientists who work out of offices. When they fail, we fail. A true professional must have some control over their livelihood. The laboratory professional lives each day in fear of the layoffs that result from not curing cancer. The marketing professional at least has some control over how a product sells, whether is works or not.
The current system is based on the assumption that leaders are the creative types who innovate. Pharmaplasia at least takes on the notion that we have not done well as of late. Here at the Cargo Cult Scientist, we believe that human beings have always had a problem with new and powerful ideas. New and powerful ideas upset the status quo. They elevate true innovators above those who sit comfortably in powerful positions. There is resistance. Imagine sacking the staff who makes the decisions and leaving behind the professionals who can take direction and quickly test the ideas of any leadership. Imagine a research staff held accountable only for executing the experiments set forth by them by the leaders. The outcomes of the experiments must be dealt with intelligently and scientifically by the leadership. When they fail, they shouldn't be allowed to wash it all away by laying off the laboratory staff.
As I read on in Pharmaplasia, I am certain I will find new things to write about. As a former "professional" who was placed into various silos and pigeon holes, I am certain I will be receiving an education as to how those who put me there think. My own inability to effectively communicate with the leaders of my cults is of little concern to me. I see the fallout everyday when I read about "massive layoffs, slowing revenue growth, a major blockbuster “patent cliff”, disappointing R & D productivity, never-ending product liability lawsuits, allegations of illegal marketing and sales activities that lead to billion dollar fines and settlements, and the list goes on" (as stated on the Pharmaplasia website) I know I wasn't exactly wrong about my predictions. I feel we in the industry are average people convinced that we are Einsteins. Certain things prevent us from succeeding but those things can be overcome. You do not hire a group of recent college grads and tell them to go make an airplane. You need experience and not just any experience. You need professionals. Those professionals must then produce new professionals. The most important thing is that the airport works.
I no longer work in the industry. I've moved far from the hubs of biotechnology. Yet I still care. The complexity of the human body makes R&D the most perilous profession out there. Research and development remains an area where human beings will always attempt to employ the scientific method. It is that method and the Cargo Cult Science approach that keeps my interest. I long for the day when we begin to face our failures and learn from them. You can layoff the laboratory staff but you are left with a poorly educated (and I'm not talking about the University education) group of professionals who do the bidding of those who never seem to suffer the consequences of bad science. Good luck to the Amgen R&D folk who have lost their jobs. You are tribesmen. Learn from your experience. Speak out. Tell us what you think went wrong. Read Pharmaplasia. Read. Write. Think. Talk.
I've just started reading Pharmaplasia by Mike Wokasch. He is coming from the executive level in business and marketing. He has worked as a pharmacist, a pharmaceutical sales representative, marketing manager for blockbuster products, and he has held corporate officer positions at large and small companies. He is passionate about the need for expertise and professionalism in any career choice or job function.
Having yet to read the book, I am skeptical about the marketing side of pharmaceuticals. In Cargo Cult terms, his job is to make people believe that the planes are coming. He does not need to have any idea how a real airport works. After all of the business and marketing meetings are over, you still know absolutely nothing about the natural world or how the human body lives and dies. Yet M. Wakasch has taken an important step. He has admitted that there is a problem. In Cargo Cult terms, he acknowledges that the planes aren't going to be landing as advertised.
There is a distinction that has to be made however. A laboratory scientist is not considered a professional. We do not have the same kind of career paths as executives or marketing professionals. We do not make as much money. We are not expected to grow as laboratory professionals. The layoffs, such as Amgens announcement today, make laboratory workers who serve the R&D side of the industry less than professionals. We learn a skill such as running an ELISA and that becomes our "profession". We serve a piece of the puzzle being assembled by higher ranking PhD scientists who work out of offices. When they fail, we fail. A true professional must have some control over their livelihood. The laboratory professional lives each day in fear of the layoffs that result from not curing cancer. The marketing professional at least has some control over how a product sells, whether is works or not.
The current system is based on the assumption that leaders are the creative types who innovate. Pharmaplasia at least takes on the notion that we have not done well as of late. Here at the Cargo Cult Scientist, we believe that human beings have always had a problem with new and powerful ideas. New and powerful ideas upset the status quo. They elevate true innovators above those who sit comfortably in powerful positions. There is resistance. Imagine sacking the staff who makes the decisions and leaving behind the professionals who can take direction and quickly test the ideas of any leadership. Imagine a research staff held accountable only for executing the experiments set forth by them by the leaders. The outcomes of the experiments must be dealt with intelligently and scientifically by the leadership. When they fail, they shouldn't be allowed to wash it all away by laying off the laboratory staff.
As I read on in Pharmaplasia, I am certain I will find new things to write about. As a former "professional" who was placed into various silos and pigeon holes, I am certain I will be receiving an education as to how those who put me there think. My own inability to effectively communicate with the leaders of my cults is of little concern to me. I see the fallout everyday when I read about "massive layoffs, slowing revenue growth, a major blockbuster “patent cliff”, disappointing R & D productivity, never-ending product liability lawsuits, allegations of illegal marketing and sales activities that lead to billion dollar fines and settlements, and the list goes on" (as stated on the Pharmaplasia website) I know I wasn't exactly wrong about my predictions. I feel we in the industry are average people convinced that we are Einsteins. Certain things prevent us from succeeding but those things can be overcome. You do not hire a group of recent college grads and tell them to go make an airplane. You need experience and not just any experience. You need professionals. Those professionals must then produce new professionals. The most important thing is that the airport works.
I no longer work in the industry. I've moved far from the hubs of biotechnology. Yet I still care. The complexity of the human body makes R&D the most perilous profession out there. Research and development remains an area where human beings will always attempt to employ the scientific method. It is that method and the Cargo Cult Science approach that keeps my interest. I long for the day when we begin to face our failures and learn from them. You can layoff the laboratory staff but you are left with a poorly educated (and I'm not talking about the University education) group of professionals who do the bidding of those who never seem to suffer the consequences of bad science. Good luck to the Amgen R&D folk who have lost their jobs. You are tribesmen. Learn from your experience. Speak out. Tell us what you think went wrong. Read Pharmaplasia. Read. Write. Think. Talk.
Monday, October 17, 2011
Why Quit Now?
I've reached my new location. I'm in a secret hiding place where I have decided to keep taking shots at the Cargo Cults of Science.
First news item. Bristol Myers Squibbs drug, Yervoy, has been rejected by the UK Health Cost Agency.
Has Dendreon tried to get approval in the UK? Would it prove to be cost effective? Should the U.S. form a Cost Efficacy Agency within the FDA? Step A, approve or reject a drug. Step B, decide if the government is going to pay for it. If not, let the drug maker sell the approved drug on the free market. As BMSs mission statement goes, "Bristol-Myers Squibb is a global BioPharma company firmly focused on its Mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases." It is their job to deliver $100K+ drugs to people without government or insurance assistance.
News item number 2: Cargo Cult Scientst #1, Hwang Woo Suk has cloned a coyote.
What did we learn from his stem cell scandal? The disgust we may have for him is merely a personal feeling. It is not what motivates science. Yet we are now faced with a profound skepticism that will bring about the scientific method. Did he clone or not? How do we find out? At least we know that a peer review process isn't enough.
Time to grow. Biotech/Pharma drugs are getting too expensive. They are asking the sick and dying to assist them in extracting undue amounts of money from our government and insurance agencies. Hwang Woo Suk is claiming to have cloned again. They have cloned a dog and it is said that this was verified. It is time to see him hired by Geron. Assemble the same people who gave him the stamp of approval for his stem cell work and let them try again.
First news item. Bristol Myers Squibbs drug, Yervoy, has been rejected by the UK Health Cost Agency.
About 30 percent of patients treated with the drug would have improved survival, with 10 percent potentially experiencing long-term benefits, the National Institute for Health and Clinical Excellence said in a statement today, citing clinical specialists.
The drug costs about 80,000 pounds ($125,600) per patient, said the agency, known as NICE, which advises the National Health Service on whether drugs provide value for money. Yervoy is the first medicine proven to extend the lives of patients with advanced melanoma, the most deadly form of skin cancer.
Has Dendreon tried to get approval in the UK? Would it prove to be cost effective? Should the U.S. form a Cost Efficacy Agency within the FDA? Step A, approve or reject a drug. Step B, decide if the government is going to pay for it. If not, let the drug maker sell the approved drug on the free market. As BMSs mission statement goes, "Bristol-Myers Squibb is a global BioPharma company firmly focused on its Mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases." It is their job to deliver $100K+ drugs to people without government or insurance assistance.
News item number 2: Cargo Cult Scientst #1, Hwang Woo Suk has cloned a coyote.
What did we learn from his stem cell scandal? The disgust we may have for him is merely a personal feeling. It is not what motivates science. Yet we are now faced with a profound skepticism that will bring about the scientific method. Did he clone or not? How do we find out? At least we know that a peer review process isn't enough.
Time to grow. Biotech/Pharma drugs are getting too expensive. They are asking the sick and dying to assist them in extracting undue amounts of money from our government and insurance agencies. Hwang Woo Suk is claiming to have cloned again. They have cloned a dog and it is said that this was verified. It is time to see him hired by Geron. Assemble the same people who gave him the stamp of approval for his stem cell work and let them try again.
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