How does a drug or vaccine get approved: a description of clinical trials

There seems to be a lot of misunderstanding of the long and complex process that a drug or vaccine has to go through in order to be approved here in the US. Its much more involved than the company just presenting data or applying to the FDA for approval. Drugs and vaccines go through years long testing that while not perfect (see Vioxx) certainly are pretty strict.



These regulations have been in place as we know it currently since 1978 when Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices were established to insure that the testing practices were closely monitored and standardized to some extent.



Initially there is an R+D period called "Discovery" where the basic composition of the product is established. This can be as much as 3-4 years.



Next there is the initial or pre-clinical testing. This is where animal studies are done to establish two things:

A) The properties and reactions of the product, especially what the therapeutic value is.

B)Toxicological studies are done with the animals to see what side effects are possible, and what the safe dosages may be (note: with vaccines toxicity studies are also done with various adjuvant and vaccine combinations to see which works best..therefore anyone who claims that they can't find adjuvant safety study data is looking in the wrong place. Its such standard work that you don't find it in scientific journals but in clinical trial data available from the FDA under the freedom of information act)

This stage can be anywhere form 1-4 years.



Then comes Phase I studies. This is usually the shortest stage of the study. It has a small amount of healthy volunteers to determine the most effective dose, and with drugs it also looks at how the drug is metabolized and excreted. It also looks for acute or harmful side effects. If nothing harmful is seen, this particular phase can be as short as 6 months.



Next is Phase II. Now the clinical trial starts to get into the heavy duty part of the study. The target population for the drug or vaccine is used. The number of test subjects is much larger and the length of the study is much longer than Phase I. It also establishes dose ranges and provides both safety and efficacy studies.



Next is Phase III. This is an even longer term study to get info for dosages and labelling purposes. An even larger group of targeted individuals is used. Critical large scale efficacy and safety studies are completed. The data is compared (if applicable) with standard therapies or perhaps a placebo (note: with vaccines that usually means giving the "placebo" group the adjuvant only to establish that the vaccine is actually creating antibodies to the pathogen it protects against because if it is only giving a generic antibody response, the vaccine is next to useless against the pathogen-this is called vaccine specificity).

Combined Phases II and III can often last between 4-7 years.

After Phase III is completed the data is submitted to the FDA for regulation review. The FDA then looks through and evaluates the data. This process can take anywhere from 6 months to 2 years. The FDA scientific advisor committees then decide whether to recommend the product or not based on the scientific data. If they don't recommend the product 90% of the time the FDA will not market the product. If they do recommend it 90% of the time the FDA will allow the product to be marketed.

Here is where politics come into play in the process. Sometimes political pressure is applied to approve a drug that perhaps should not have been approved (Avandia) and SOMETIMES believe it or not a drug is rejected for political reasons because the FDA is trying to do some PR work to protect its image. For example, recently a new drug of a similar class to Vioxx was rejected by the FDA but many on the advisory committees felt that it was a pretty safe and effective drug and that the FDA was being overly cautious in an effort to not look like they were simply being a rubber stamp for the pharmaceutical industry.

Finally, there is Phase IV- what is commonly known as the post marketing phase. If a drug/vaccine is approved and marketed, it is considered to be in Phase IV clinical stage-INDEFINITELY. In order to insure safety and because clinical trials are somewhat limited in the total amount of people and data they can collect, widespread distribution and use is likely to find what if any flaws there might have been in the trials. Also if there are similar type products on the market this is also when the efficacy of the new compound is compared with the other products. It also looks to see if new labels or warnings for a new drug or vaccine are needed as well as looking to see if its beneficial economically compared to other products.

Gardasil is in this Phase. But this is NOT an experimental phase as some claim (ie, the people now getting their vaccines are NOT guinea pigs). It is merely a recognition that its possible for even perfectly run clinical trial to miss something and this allows the FDA to keep track of new products and either relabel or change recommendation of use, or even yank the the product off the market.

Is this system perfect? No. Certainly there are ways to fudge data but the regulations are pretty tight when enforced. And the FDA has the right (and often does this) to conduct surprise inspections at any time with little or no notice. These days, however the FDA has had its staff and funding cut significantly so they don't have the resources needed to ensure full compliance.
However, most manufacturers have no desire to face multimillion dollar lawsuits so many will voluntarily conform. Also, even just getting a warning letter from the FDA can so damage a companies reputation that it can permanently hurt it (yes, I know of companies who have gone out of business because of this). Also all GLP/GMP companies must by law have a independent QA department whose so job is to make sure that a company is totally compliant with FDA regulations and that also helps keep most companies honest.

Blog Agaisnt Theocracy: How the infusion of religion into education and the public hurts us scientifically

In this day an age with the line between Church and State being made dangerously thin, one of the biggest areas of danger with this is the injection of religion into the last place it belongs..science classes.
There is a push to include Creationism and Intelligent Design as competing "theories" with Evolution. One of the thing that religious fundamentalists don't seem to understand is the difference between a theory and a hypothesis. An hypothesis is an idea that is going to be tested by the scientific method to see if it is valid. A theory while it can apply to unproven data or ideas from time to time (often in an incorrect way) is an idea that has been tested by the scientific method and shown to have scientific validity. That doesn't mean its "the truth" and therefore unassailable, it means that the basic ideas in the theory have shown scientific validity, but theories also can be challenged with new data on the mechanisms of that.
Evolution is an accepted theory, it is not an unproven (and really unprovable) hypothesis like Intelligent Design or the BELIEF of creationism. Neither of these topics have a place in a science or data based/critical thinking arena.
The fundamentalists make the case that science is a "belief" that challenges religion. It is NOT a belief and is a totally separate realm from religious beliefs. Again it seems that many have forgotten the difference between opinion, belief and verifiable facts.
But it isn't just the classroom where religious beliefs hurt our science. Look at the valuable research into such topics as Stem Cells. We have the potential as the wealthiest country in the world to help fight and cure some truly awful diseases like Parkinson's as well as some horrible conditions like spinal paralysis. But because of the religious "beliefs" that a bunch of frozen cells in a petri dish are the equivalent of a human baby (read the scientific definition of life sometime to see how incorrect this "belief" really is), we are terribly hamstrung in this field. Breakthroughs are coming, but its the Europeans and other western countries who don't quite have the resources that we do.
If we can separate out the religious beliefs from the field of science there is so much we as a country can accomplish.

For the Fourth...Freedom to think for ourselves

With the approaching holiday, its time to think about the history of this country and to celebrate what the Founding Fathers accomplished. Well I have some issues with them. I think they left out something when they wrote the Declaration of Independence. They wrote that all citizens have the "Unalienable Right...to Life, Liberty, and the Pursuit of Happiness". Well somewhere in that talk of Liberty they forgot to add something about the right to listen and learn and pursue the truth without hinderance or in other words the freedom to think for ourselves and not what the government WANTS us to think.
More and more it seems like our government likes to play the terrorist card. Much like al-Quaeda its in Bush and Co's best interest to frighten us into unquestioning obdeience. Because if people stop and think about what liberties are now being denied us in the name of being "free from terror" than Bush and friends won't get ANY of the things they want. Some it seems still think for themselves but less and less these days.
And what's worse the backlash from the way Bush and Company behave is making many so paranoid that fear that the government COULD be involved in something is blinding many to the reality of things and again causing an inability to reason things through. For instance a wonderful new vaccine that was recently approved as a way to prevent cervical cancer, a novel new technology, and a scientific breakthrough -never before had it been possible to use a simple vaccine as a preventive measure against cancer. But because of fear and paranoia (and some bad pr and marketing strategies on the vaccine makers ) it became an "untested substance foisted on young girls as a way for Bushie type corporations to make money". This is far far from the truth.
So my wish for the Fourth of July is this: Freedom from fear-mongering and the freedom to think clearly and rationally again without hindrance.

Vaccine FAQ's

Vaccine FAQ’s some basic information ( a series of posts)
So some of you know me some of you don’t so let me say a few words of intro first. There is a lot of misunderstanding of basic vaccinology on DU. I understand, it’s a somewhat complex field. I have numerous years of experience working as a technician in biotechnology lab- bench work is my passion. My work experience is now considered the equivalent of having a Master’s in biotechnology. I have extensive experience in diagnostics, as well as QA/QC type regulatory experience that makes me VERY familiar with the process the FDA uses to approve vaccines and other biologics. However, I recently discovered that my real passion is for vaccine development, it’s a fascinating field for a science orientated person like me. I also had the honor of working at NIH directly underneath one of the world’s foremost experts on malaria vaccines. His passion and dedication to the field infected me with the same enthusiasm. This self same scientist even once infected himself with the malaria parasite in order to produce the needed infected red blood cells for testing. Suffice to say, it was not a pleasant experience for him. That’s the level of dedication I often found in the scientists working both at NIH and at several private biotech companies I worked for. And while many of them made very good money, none of them were really driven by money or greed. It was the passion for science and the desire to help improve mankind that drives the vast majority. The purpose of this post will be to inform all of established scientific facts about this misunderstood field. I am not trying to influence anybody’s personal opinions, merely to inform. All this information is easily found in basic biology, and/or immunology text books. For those who wish to fact check or just learn more, instead of just trying to click on a link to a short article on the internet I would instead go to the library and read one of these types of textbooks. There are many on the subject. Now on to the basic biology of vaccines:
1) There are two basic types of vaccines: virus (attenuated, live etc) that are made directly with the antigen (i.e. virus) and recombinants which are made with small bits of the virus…bits that through extensive testing are determined to be the most likely to provoke the most useful antibody response. Recombinants are considered to be the wave of the future because since its only small bits and not actual virus they are less likely to have side effects.
2) A vaccine is neither a chemical or drug but something entirely different. It is designed to train the immune system into making antigen specific antibodies . Once the vaccine enters the bloodstream it is attacked by the immune system. A good vaccine provokes enough of a response that the immune system will remember it on encountering it again, but not enough that they person actually get sick. Sometimes that happens and people have side effects similar to the actual disease. Sometimes it takes more than one exposure so that the immune system remembers it. Those vaccines require boosters. Vaccines DO NOT linger in the body the way a chemical does. Once the immune system is done “attacking” the vaccine, the now defunct complex of antibody-vaccine(waste product) is removed from the body by the spleen, the same way the body removes the killed virus/bacteria/pathogen of any infection we pick up.
3) Adjuvants. This is actually a technology that has been quite widely accepted and used for years. Some of them have very frightening complex chemical names. In truth, they are small molecules that are attached to the vaccines to “boost” the effect of the vaccine. A good adjuvant can make the need for boosters much less. Some adjuvants work better than others with certain vaccines. A lot of pre-clinical trial work in vaccine R+D is determining what adjuvant works best with a particular vaccine. Since it is attached (or conjugated is the technical term) directly to the vaccine, like the vaccine it is bound tightly in the antibody-vaccine complex which is eventually taken out of the system within a short period of time by the spleen.
4) Side effects- all vaccines have side effects. The thing with vaccines is that they work really really well. However since they stimulate the immune system, autoimmune problems can sometimes result from a vaccine. And sometimes people have undiscovered allergies to some of the compounds and that can cause difficulties as well. As mentioned above sometimes somebody just can’t handle some of the very potent vaccines (the live virus ones usually) and they get sick. Mostly its minor, flu like symptoms aches etc, minor fevers. Sometimes for unknown reasons the reactions are far more severe. No one can predict how individuals are going to react to a vaccine. However the serious reactions are very very small in terms of percentages of overall population. Cold comfort perhaps to the few individuals that have suffered a bad reaction but true none the less. The golden rule on vaccines are this: only healthy individuals are vaccinated. Anything less than healthy is asking for trouble. In fact, it is my OPINION that many of the serious side effects that individuals suffer are due to previously undetected underlying health issues. But that’s only speculation on my part.
Now some of the popular “myths” about vaccines:
1) Vaccines cause autism due to mercury in them. There are two points here a) the scientific community in general does not believe there is any link between vaccines and autism (for various reasons I won’t go into here). This is a scientific consensus. Are there some in the community who believe there is a link? Sure. But the vast majority are skeptical. The mercury in the vaccines was part of the preservative called thimerosol. Preservatives are necessary to keep the vaccines potent enough for storage for a certain amount of time. Thimerosol has been removed from almost all vaccines with the exception of flu vaccines. However thimerosol free flu vaccines are available as well.
My old boss was one who wouldn’t even have thimerosol in the lab for use in non-vaccine related buffers. It is therefore now a non-issue
2) adjuvants are unsafe neurotoxins. Untrue as mentioned before they are an established technology. Before any vaccine+adjuvant gets approved for clinical trials they undergo YEARS of animal testing (usually in both mice, rats, rabbits and monkeys). And its not a few animals but hundreds for each candidate vaccine. Both safety (toxicity) and efficacy (potency) studies are conducted in these animal studies.
3) Vaccines are rushed onto the market before safety testing is finished. For the most part, wrong. Besides the years of animal studies done prior to clinical studies, the clinical trials themselves (usually conducted under very strict regs called Good Laboratory Practices and/or Good Manufacturing Practices) are long (usually in the 10 year area) where again both safety and efficiency are checked. Clinical trials are long enough to establish safety. Sometimes though when the data indicates a problem with the vaccine the study will be ended and the candidate vaccine withdrawn. This happens on a fairly regular basis but usually is not reported in the MSM. Some non-FDA approved vaccines have been rushed onto the market for use by the government from time to time. The anthrax vaccine of the mid to late 90’s is an example of this. Non-FDA approved vaccines are used in private industry for people doing experimental work. But all the vaccines used in the general population and distributed by pharmaceutical companies/biotech firms MUST be FDA approved and therefore must go through the GLP compliant clinical trials, after having extensive pre clinical testing.
4) Vaccines are huge money makers for Pharmaceuticals. Incorrect. Vaccine development and particularly production have such high costs of development and don’t have a large profit margin that many biotech’s and pharma’s do not feel the rewards are worth the risks of investing in a long drawn out research project. The UN is constantly begging Pharmas to invest more in the manufacturing of vaccines as there are constant shortages for them in the third world . Polio might be extinct in this country but it is a HUGE problem in Africa and there is not nearly enough vaccine to go around. In fact most vaccines are made by companies in Europe because laws and regs there with the funding is set up so that making the vaccines is not as expensive. The reason why there has been flu vaccine shortages in the past few years is because only 2 companies make it, and one had production issues that made them not be able to make any.
That’s the basics. Are there problems in the industry. Absolutely. I and other sensible techs/scientists often know what companies are more profit minded than science minded and avoid them like the plague (Pfizer has a real bad reputation in the professional community for example). Are there dishonest scientists? Sure and I have encountered them and fought them to the detriment of my career. Most scientists are more motivated by ego and reputation than greed though. The ability to publish and professional reputations are the big motivations for scientists . Some will massage or manipulate data to protect their intellectual reputations. Very few are motivated by simple greed although there are a few. But the vast majority of scientists and techs are dedicated and hard working and motivated to improving this world. That’s why the vast majority are registered democrats….

Note to science geeks: I am aware that I have very much simplified some very complex science in an effort to communicate and inform

My health issues:Colonoscopy and endoscopy of stomach

So last Friday I had both of these procedures done to see if they can pin down exactly what is wrong with me. By far the worst part was the night before. I had to drink 6 glasses of ginger ale spiked with a phospho soda to clean me out. Ugh. Not only was the drink nasty (and the first 3 glasses did not stay down) but the "cleansing" was not exactly pleasant. For those of you who have heard of the spa treatment called "calonics" thats exactly what that is. A voluntary cleansing. Ugh. Although it did clean me out and I had a couple of days free from the stomach/intestinal problems that had been plaguing me. They seem to be back so it was only a temporary relief it seems. Not something worth doing again if you ask me. Anyway the procedure itself wasn't that bad. I remember watching my doctor gown up in the procedure room and next thing I know I am stirring in bed wondering why I wasn't in my own bed...I didn't even notice them add the sedative to my iv. Anyway, the only noticeable things from the procedure was a bit of gastritus in the stomach. They did a biopsy on that and are testing for H.pylori, the bacteria associated with ulcers. Its possible that I have this bacteria and its irritating the stomach walls which could account for the lack of appetite and the loss of weight AND possibly the vomiting. Its possible then that I caught what might have been the beginning of an ulcer. The doctor is also checking to see if I have IBS (irritable bowel syndrome) something I have suspected for years. The last thing they are checking for is possible Celiac's disease. This would be incredibly ironic if true. Celiac's disease means you can't digest any kind of gluten like wheat rice rye or corn. Yes, the infamous wheat gluten! There is definitely a tinfoil hat part of me that is looking at this being really bad just in the last month or so and wondering! It could be very ironic that I thought I needed to protect my kitties from wheat gluten and it may turn out to be more of a "threat" to me. Ah well. It will be two weeks before I get my results. I would bitch more but I do realize that since they are probably doing a bacterial culture that does take some time. More and more something a friend said to me recently seems to be the case. He said "it seems like since they don't really have a clue what's truly causing everything, the doctors are just going to settle for treating the symptoms". That does seem to be the case. I go to my hematologist on Wednesday and hopefully he will finally green light me going back on my meds for my ET. I think that will really help some....

My health issues

So I keep trying to post info on DU, without soliciting advice, but there is at least one poster on that site that keeps messing me up and getting my threads locked so I will post my stories here.
First of all for the last couple of years I have had a couple of chronic conditions that have been pretty well controlled. One is sleep apnea. Through medications and a CPAP that is under control. The other condition is a rare blood disorder called Essential Thrombocythemia (ET for short). Its part of a group of disorders called Myeloproliferative Disorders (MPD's). Basically its a group of disorders in which the bone marrow makes too much of a particular type of blood cell. In my case, its platelets, which are the cells involved in clotting. Not only does my bone marrow make too many, but they are often made wrong (too big, incorrect structure ect) which can lead to both bleeding and clotting issues. A normal count on platelets runs between 100-400. On meds I am about 450ish. I start feeling unwell at about 700ish. To put things in real perspective on my illness my last count was an all time high of about 974! When it gets this high I get fatigue and headaches and tingling in hands and feet.
A couple weeks ago I started feeling ill. At first I thought it just was a stomach bug but it got worse. Crippling fatigue to the point now that all I can do is work on my computer in bed, just getting up and walking around is exhausting. Trying to run errands is difficult. And my job in the lab..impossible. I have been on indefinite (unpaid) leave for almost 3 weeks. Maybe I could work, but I don't want to push it and I have noticed that I seem to be good for about 2 hours before I wear out and then I pay for it later. Anyway, also I noticed it becoming harder for me to eat and then when I would eat a regular meal, I would vomit it up several hours later. For weeks I had noticed diminished appetite but had attributed that to stress. Now it is much worse and I noticed pain in my left side as well. My first thought is, my ET which I have been off meds for since last July is flaring up, simply going back on my meds (hydroxyurea) will solve it. Called my hem. Had a quick bloodwork exam. The bloodwork at that point was a little elevated (platelets at 630) but aside from the soreness in side there was nothing visibly wrong. My hem sent me for a CT scan to look at my spleen since enlarged spleen could have accounted for the symptoms. Nope. Negative. I went to my GP who had me do some bloodwork. Well my complete bloodwork showed everything is going crazy! Thats where I got the 974 platelet count along with high wbc's, high hemoglobin, high hematocrit, borderline high blood sugar, high blood pressure! My gp has simply given me meds to treat certain symptoms and referred me back to my hematologist and to a GI specialist. After confirming my blood counts with another test (and sitting there literally with his head in his hands in confusion) he also is waiting for my GI results. Finally after talking to my GI specialist he says he needs to look at both my stomach and large intestine. So on Friday I go to get not only a colonoscopy but and endoscopy of my stomach as well. In fact after 8am tomorrow morning (Thursday April 26th) I must start fasting in prep.You do not want to know what I need to do Thursday night to clean myself out in preparation...yuck! And I thought drinking banana smoothie flavored barium was bad...I will update my blog as things go on.

Scientific Bullying

So I recently posted about my experience at NIH. One of the problems there was that governmental employees felt safe and felt like they could get away with anything and therefore felt free to be lazy and dishonest because they "knew" there was no consequences for bad behavior. In order to get anything accomplished my supervisor at NIH had to use aggressive techniques, so aggressive that he was labelled "a bully". I knew he was exceedingly intolerant of bullshit. As a friend of mine who incidentally had followed him up here from Australia said that as long as "you were intelligent, honest, worked hard, and did your job competently you would not have a problem with Allan". In fact because he got tired of banging heads with idiots he brought me in to circumvent them. Which would have maybe worked if some of them hadn't had the ear of higher ups. I think it hurt that while most of the nasties were life long NIH employees, despite being tenured, Allan had only been there for 6 years. That probably didn't help. There were also rumors that he and others in the dept and NIH lost a "harassment" lawsuit about improperly hounding someone into quitting (sound familiar?). I have a feeling it was another less than honest researcher and Allan was doing what he had to get rid of them.
Up until then I always thought that a bully was a bully and it was cut and dry. Its not. I also have heard stories of true bullies who are nasty and vengeful even after people leave their positions. From what I can tell, especially in academia, bullying is very common, and at least in my case a necessary evil. I would be very interested to hear from anyone who has been on either end of a bullying situation.

Why I am uncomfortable with atheism

So I was having a conversation with a science orientated friend about atheism and it occurred to me that while many people in the sciences will identify themselves as atheists, I will not, and am quite uncomfortable with the whole concept for several reasons.
First let me point out, I do dislike organized religion. It certainly has been the root of a lot of evil and irrationality both past and present. And now more than ever we see how it can hinder the progress of civilization. But that's not to say I don't believe in some underlying force. I have always wondered at the efficiency of the human body and just how many things can go potentially wrong yet don't. I feel a sense of awe when I see a large natural feature (a canyon or wide river or the rain forest of Puerto Rico, the astonishing beauty of the desert landscape of Aruba in the middle of the lush Caribbean ocean) and think of all the things that had to happen to "make it so". People can legitimately argue for the sheer randomness of it all. But to me, personally it seems like randomness alone can't explain everything. This is not a rational belief, I know, but despite appearances, I can be far from a rational person, and in fact am considered quite an emotional high strung bundle of nerves by those who know me best (esp my family:)
It is cocksure arrogance to assume that we know everything through science. Things change from time to time. I am wiling to believe that there are things in this world that can't always be explained away scientifically.
Here is my biggest problem with atheists and why they can make me uncomfortable from time to time. The existence of God is something that can never be proven or disproved and many people find faith in God a simple and comforting truth. As long as nobody is attempting to impose their beliefs on others I have no problem with people believing this. However I do have a problem with blind zealotry (personally I believe the difference between a fundamentalist Christian in this country and a fundamentalist Muslim in Saudia Arabia are very minute) and sometimes atheists come across to me as zealots. See the guy who wanted to have the word "God" removed from the Pledge of Allegiance- that was a bit much, to say the least.
It also hurts scientific integrity in the eyes of the general populace to be swept up into the stereotype that we are all "godless" maniacs. There are many, many mainstream folk who are not stupid and not THAT ignorant who are religious and often this misconception leads to the growth of dangerous pseudoscience (once again I was astonished to see how the religious right and the fringe left came together to attack Gardasil, even if they both "claim" to have different reasons). So I would much like to hear other perspectives on this: from those who have managed somehow to reconcile their faith with science, and those who are explicitly atheistic

War on Science pt 3:The dogma of NIH: how internal politics and extreme othodoxy hinder good science

So if you have read about me in this blog you know that I went through a very bad political battle at NIH that pretty much ended in the removal of my boss, a world renowned malaria researcher from his position in the department at NIH, which subsequently made me leave as well. The big problem I saw is that NIH is so wrapped up in its own prestige and appearance that it has become overly political and no longer open to new fresh ways of doing things. And woe to anyone who questions the validity of data collected by "accepted" methods.
The story of my job at NIH was this. The department was moving into Stage 2 clinical trials on their malaria vaccine. They were going to be giving trial vaccines to large populations in Africa and were going to need large scale testing on those vaccines through ELISA to see how potent or effective at different time points the vaccine was. To that end large scale testing with automation was needed. Also it was necessary to move towards GLP (good laboratory practices) compliance since the FDA would be involved in approving the testing methods as well as looking to see the results as well. One group (immunology) had been riddled with issues of laziness and outright lying and incompetence, including getting inconsistent ELISA data. Believing he could never get the right mindset from a group that had time and again failed to produce my boss reached from outside to hire someone who understood not just GLP issues but high throughput ELISA testing I was hired. The old "manual" methods allowed one person to test at Max about 6 plates with 72 samples and controls per day. The new automated methods would increase that number to about 18 plates with 72 samples per day. But it was labor intensive, and certain people felt that a couple hours of concentrated work was "too difficult". My boss is still maybe the most brilliant person I have ever met, and if not a genius surely close. For certain, he was a innovative thinker, a kind of person who "thinks outside the box". Most of his colleagues were incapable of understanding all of his work and I think it made people fearful. I couldn't understand it, at first anyway, but saw the potential. The more we worked the more I understood and the more brilliant I saw his schemes were. However, it became rapidly apparent that my results could not be replicated by the old manual methods. Because my techniques were different than the "standard"way of doing things they tried to attack my results on that basis. My boss however repeatedly said that was NOT the problem as he had observed my techniques and found them acceptable. I became more and more convinced that the old methods were fundamentally flawed. What I did not realize is that would call into question years of data generated by the immunology group and out of the loop or not, they would not tolerate a newbie tech with no phD and no previous research experience doing that. They told lies about me to the other head of the department who was very orthodox but also somewhat senile and not aware of all going on. They made me report to someone else, involuntarily on my bosses part, someone whom my boss and I made the fatal mistake of trusting. She immediately stopped my project because of too many "problems". Yes there were some bugs to be worked out still but overall was going well. Nope. They couldn't reproduce the data he used in his innovated spread sheets for one with their old statistical methods unless they spent hours "fitting the data". How anyone could not understand that this is a form of data manipulation is impossible for me to understand but I think there were some who didn't see it this way. However, I am now convinced that my new boss knew exactly what she was doing with the data and didn't care. Not long after she became my boss she started "retraining me with the correct methods". When I asked why, she said everyone needed to be "certified". When I said the point was to establish new methods she said just in case at first but when pushed I said I had already been certified in methods by my boss she said (to both my and my ex-bosses shock) "Allan (my old boss) doesn't know how ELISA's should be done here". This is a jumped up tech with a Masters saying she knew more than my old boss whom had 26 years of field research including years of lab work both here and in his native country of Australia. How's that for arrogance? Anyway she also told me at one point that even though the stats on my work were perfect that my techniques were still bad even if it didn't show up on paper? Huh? How do you argue with MY WAY IS THE ONLY WAY NO MATTER WHAT THE DATA says. Anyway, there was some other stuff going on including at least one phD pretending to "believe" in my methods (lying to me and Allan) while undermining my work. Finally the deception plus the fact that he was considered a "bully" for strong arming the numb nuts in the department to get things done got him pushed out for "improper behavior" including firing and demoting people improperly. Imagine, trying to get rid of people who weren't doing their jobs! Anyway, when I found out I told everyone I was leaving as soon as I found a new job. That didn't satisfy, and they went out of their way to make my life miserable, and also did things like changing spreadsheets so I was incapable of generating decent data, and then hiding or ignoring my data while generating duplicate data using the "correct manual methods" while reprogramming the robot to fit their beliefs. It came down to me having to leave before I found anything because the stress of the dishonesty and the "tricks" were taking a toll on my health. To this day, I worry about the health of the children being vaccinated. From the little I have heard no valid ELISA data is being generated (although THEY think so) and I worry about the safety of the participants in the clinical trial, since ELISA's are key in establishing both safety and potency of the vaccines. Because I caused a ruckus leaving, screaming long and hard about all the bad science being done, I have now been labelled much like Allan, a troublemaker. Allan has tenure at NIH due to his senior scientific standing so can't be fired but is in essence in exile because they don't believe he can "properly" manage people. He now does several things with NIH including computer modeling on the spread of diseases and it gives him the opportunity to just sit and think which he enjoys. Plus like me the confrontations with the idiots in the department was taking a toll on his health (we once had a conversation where we were competing to see who had the worse BP issues-he won, my values were high but his, pre treatment were much worse!)So while damaged he is okay to some extent. And even though he is persona non grata at the department he still interacts positively with some of the others (and let me say there were MANY fine, fine people who are still there) on occasion. I on the other hand, am blacklisted and although I briefly made an appearance there late, am not welcome by the powers that be as well. Sadly, Allan, who is a fine person, mentor and friend and like a father to me, seems to have so many guilt issues with what happened to me (he always felt it was his fault, what I went through- both of us though made many many mistakes) that he can't bring himself to interact with me directly unless cornered (not a "touchy-feelie" type person doesn't help either I suppose) and won't even discuss me with others because its too painful. I am trying to reestablish contact with him, but its not easy, but someday soon. He will be more than happy to be a good reference for me, but talking or seeing me..to painful. Here is someone who outside of the good natured jokes, was very good at the unreadable detached expression. Except now, when I am brought up...

Anyway, I thought perhaps this awfulness was an exception at NIH. The intensity and level of it perhaps was not typical but this "only one way is correct" type of attitude is common but its also fostered! I heard about similar nonsense with ELISA in a totally different department, and from what I can tell the ELISA's are being manipulated to make the data look better than it really is. To quote a friend of mine who is dealing with that ELISA and knows my story well "I would not trust any so-called breakthrough at NIH until at least 5 other scientific agencies replicate the results". And that my friends, is a very sad state of affairs in a world where the scientific method is under attack from all sides

War on Science pt 2: The right wing/neocons allergy to the truth is leading to the supprssion of good science

So big shocker, Bush and company have been working really hard to implement gag rules so scientists can't actually share "sensitive" (anything that in any small way contradicts the old idiot in chiefs "beliefs") data . It seems that Chimpy was scared by the fact that even the notoriously conservative SCOTUS has ruled that something needs to be done to control greenhouse gasses in this country. I think this is the biggest proof of Bush's autocratic tendencies. Outside of muzzling the press (why does he need to do that when he has Faux (Fox) news to spit out his propaganda) I thing muzzling scientists and their search for the truth and knowledge (which fundamentally is what science is at its heart) is a huge indicator of someone with stong dictatorial inclinations. It seems that truly nothing is illegal to our commander in chief, he seems to think HE is the law in this country and until recently the brown nosing congress let him think that (which is idiotic on so many levels- the most being they willingly let Bush castrate them!) Unfortunately, this has had some really bad side effects outside of just squashing good science (see pt1 about the left's paranoia).
We also have to contend with the Religious fundamental movement who seem to think every frickin world in the Bible is true no matter what scientific evidence shows. Their idiocy is completely obvious to most of the secular left, but it truly does blind mainstream americans (many of whom are christians) to the true issues. Like the fact that they are no pushing that vaccinating agaisnt HPV will increase sexual promiscuity, so we shouldn't do it! Oy. I dread to think what will happen if/when an HIV vaccine comes out. OH NO! It will encourage homosexual behavior, lets ban it!
And if this wasn't bad enough their idiocy about evolution is proof of their DELIBERATE ignorance. This whole thing about intelligent design vs. evolution is so patently inaccurate but not for the reasons most people think. The right has hijacked the theory of intelligent design and equated it with Creationism. The purest earliest ID theory in NO WAY SHAPE OR FORM is Creationism. ID said evolution happens but why? Randomness can not explain it. That in order for the highly sophisticated patterns of evolution to work there must be a guiding force behind it. That's like their OTHER idiotic argument on evolution (and global warming too for that matter) that not all scientists think its occur so therefore it can't be real! Ah yes, one or two loonies disagree with mainstream thought so it must be wrong. The "debate" on evolution they here is this- random or not? and also on how it occurs, slow accumulating mutations over time or short large bursts of mutations.
However that being said about mainstream beliefs vs. a few disagreements by the fringe element, science must also be careful to not let accepted belief on a subject tread into dogmatic orthodoxy and inflexibility in looking at novel concepts and I will address it in my final post about the war on science.

War on Science pt 1: How the anti-intellectual left endangers science and also helps the neocon/Bush agenda

So I keep hearing this crap from the RW/Christian Fundamentalist movement about the war on Christians (the so called "war on christmas" although Stephen Colbert's "war on Easter" is very funny). Utter and complete bullshit. How can there be a war on a group that controls much of the government? But there is without a doubt a war on science and it seems to have not one, not two but THREE major fronts. The threats are from the extreme left, the right (I would have said extreme right but there doesn't seem to be much difference these days) and even within the field of science itself. So I will be posting a series of three blogs on the subject, spaced over the next few days.
Now, because of Bush's allergy to having ANYTHING regulated, and his friendliness with notoriously unethical and greedy corporations anything new on the market scientifically seems to automatically be filed under "unsafe" and "unethical" (see Gardasil- a marvelous new way of looking at a cancer treatment- a vaccine to prevent it has been smeared as an "unsafe" product only put out to make money and is using young girls as guinea pigs. No doubt Merck screwed itself with its shady marketing strategy especially with its connection to the Republican Governor of Texas- but that's another topic.) So now it seems that to the Left any scientist who works for a biotech is a greedy unethical pig only wanting to make money at "innocent" peoples health and safety. And government scientists? They must also be bush dupes because Bush people run EVERYTHING. I am tired of Merck (who again has made its mistakes) being totally trashed (yes, Vioxx is a disaster) but they have done and are doing very helpful research. And the trashing of the FDA! The FDA has built in regs to keep greedy corps from overstepping bounds (Good Laboratory Practices,(GLP) Good Manufacturing Practices (GMP)). I wish people would understand its the lack of ability of the FDA, USDA, and EPA to enforce their own regs that's the biggest problems. Its this unthinking distrust of scientists as "merkies" and "bushie dupes" that not only divides the opposition but actually in some ways empowers this horribly corrupt group of politicians. Its the uninformed that are more easily led and even though the left would deny this, the willful distrust and disinterest in rationale thinking is something the Bush administration promotes. How many people still equate Saddam Hussein with September 11th? The total misuse of the fear in this country after 9/11 made us easily led. Had more people been inclined to think things through instead of just being fearful, we would not now be in the mess in Iraq we are in.
So by discrediting scientists in general, who knows what unsafe crap (both biologically and otherwise) will be foisted on an unthinking populace or to put it a different way, what life saving biologic will be ignored because of the fear of the unknown.

Pet food recall-hysteria is blinding people

So as the mother of two cute not so little cats who USED to eat Iams food including the cuts and gravy style, I have been very concerned about the contamination although my cats are very healthy (driving me crazy at times with their active antics-as I write this I am playing fetch with one and trying to keep the other off the keyboard). Its scary and of course pet owners are very scared but some people seem to be going overboard with the hysterics. Of course the fact that there is a bunch of disagreement on exactly what the toxin is doesn't help. But the hysteria is causing people to forget some facts. It seems that only organic companies/raw pet food suppliers can be trusted while the mainstream companies can't. Now I wouldn't exactly put my faith in Menu foods at this point but these "wholesome" companies are trying to make a profit as well. If you are going to distrust companies be consistant. I am shocked by the people who are quoting company websites as the source of the reasoning why their "diet" is superior. When I reminded someone about an FDA recall for SALMONELLA in a raw food supplier the response was that companies justification for why they felt the FDA was being "too cautious". And the idea of feeding raw food, with all the contamination issues of E.Coli, Salmonella and other bacterial issues is pretty scary. Someone said that "USDA approved meat" is good. Do they not understand that the USDA does inadequate inspections as well? And raw USDA meat even has some allowable contamination because its presumed the meat is going to be cooked? Plus now its led to some nasty insinuations. On DU, I observed a cat vet get attacked again and again as "pushing menu foods" because she, like many vets regard the brand Science Diet for their cats and is skeptical of raw diets. I would think her years of treating animals would be behind her reasoning but NOOO- its all that she is a corporate shill, corrupted by years of "gifts" from Science diet. The nasty attacks that have been aimed at this person are very distressing to me. Once again the person with the scientific knowledge can't actually know what they are talking about. To be fair she has said that homemade diets (which understandably are becoming popul ar) can be done but you have to be careful, and most people don't have the time or money to do it accurately. I would post this on DU, but it would just cause a flame war no doubt.

Why I call myself Miss ELISA

So I am a lab tech who specializes in an assay (test) called ELISA- Enzyme Linked ImmunoSorbant Assay. It basically is a test that is used to detect the amount of antibody in the blood. Someone I think very highly of once teased me that because of the amount of ELISA's I was doing and since I would be very busy with that work (I know how to do other assay's but was doing mostly that test at the time even though it was thought I might cross train with other tests) I would be known as Miss ELISA. I think its a good nickname and in the hope this person actually reads this blog I think he would well understand why I did choose it.
The vaccine job at NIH was so exciting at first, the most intellectually stimulating experience I have ever had. Until the politics interfered. And I discovered that there seems to be a certain dogma on how things are "done" at NIH and woe to anyone with a creative way of solving things. The program me and my boss designed was so efficient and good that the old methods (which I strongly believe were intrinisically flawed) that not only were the "old school " methods shown to be flawed it put into question years of data. And since they couldn't replicate my results they attacked them by saying my methodolgies were flawed (wrong- just different) andthen even resorting to data manipulation. The old school people stabbed both me and my boss in the back (he and I were blatantly lied to on several occasions) and finally outmanuvered my boss and got him ousted.Needless to say that was bad for me and they made me miserable until I left. I earned an undeserved reputation as a troublemaker I believe with the powers that be and believe I am "blacklisted" from NIH employment and maybe places with contracts that relate to my old department.
Anyway, between being horrified by the dishonest and bad science being practiced in a department at NIH that was in clinical trials in Africa vaccinating children, and the rise of Bush and Cos war on the scientific method, I have been very concerned about modern science.
I found a message board group that seemed like a good place to discuss these issues (democratic underground) however the paranoia of the extreme left (the woo-woo tinfoil hat group) along with trouble makers knowingly planting scientific misinformation I found it very frustrating.
So I established this blog and I will exercise my editing powers to weed out the "undesirables" to this blog.