There is a lawsuit being reported in the Hartford Courant, “Ex-Pfizer Worker Cites Genetically Engineered Virus In Lawsuit Over Firing” that bears close follow-up. A former Pfizer scientist, Becky McClain, says she was fired from her job in the vaccines and genetic engineering division after she was inadvertently infected and subsequently debilitated by a genetically engineered lentivirus used in vaccine research. According to the article, the alleged infection left McClain with an “acute intermittent paralysis” described in the article as “a condition that causes complete paralysis as many as 12 times a month.”
I know a little about rare diseases and off the top of my head there just aren’t that many things that would account for such a clinical picture, one might think of a new onset of petite mal or absence seizures but that doesn’t seem to quite fit the description. There are some very rare genetic diseases of sodium, calcium or potassium ion channels that cause a periodic paralysis. However, the key word here is genetic, these are genetic diseases, how would one have them their whole life, be healthy enough to attain a demanding research job in a highly respected pharmaceutical company only to be suddenly debilitated while still a relatively young woman. If this were not a court case, such a finding would be well worth a case write-up as something strange and unusual for a medical journal.
Of course, especially given the bizarreness of the claims, one reasonable theory is that she is malingering, a medical euphemism for lying for some sort of gain, in this case a pot of gold at the end of a medical disability claim. Such things have certainly happened before. And clearly this is the position that Pfizer is taking by claiming that there was no workplace infection and McClain was dismissed for not showing up to work. However, it is not just McClain who is saying there is something wrong with her health and that she has this bizarre syndrome of new onset acute intermittent paralysis, medical experts gave her this diagnosis and suspect that she has some type of dysregulation of her potassium ion channels.
Perhaps the most disturbing part of this court case to me is that, so far, Pfizer has refused to release the genetic sequence of the lentivirus that McClain alleges infected her, citing that they are not required to release intellectual property. While this may be true under the law, I would also think this must be balanced against concerns of public health. If the viral sequence were released it would be possible for other scientists to study it, speculate about and research its human effects, and quite possibly get to the bottom of whether it might be responsible for the health effects claimed by McClain. While there may be no law that covers this area, commonsenically what right does Pfizer have to withhold this information, especially when it is being requested by her physicians.
If we accept Ms. McClain’s (I don’t know whether she is married) testimony there are a number of disturbing related questions that spring to mind. This workplace mishap happened at one of largest and most respected pharmaceutical companies in the world. Genetic engineering is going on all over the world, if this happens at Pfizer how often are similar genetically engineered pathogens escaping containment and even infecting humans? The virus Ms. McClain believes infected her is a lentivirus. Lentiviruses, or slow viruses, as they are called are retrovirurses that are useful in genetic engineering because they are able to integrate directly into the DNA of a host’s genome, so they might, for instance, be used to try and deliver a new gene into an organism’s DNA. They are also sometimes used to try and block the expression of a particular gene. Lentiviruses, as some of you may know, are a family of viruses that also includes viruses such as Simian Immunodeficiency Virus and Human Immunodeficiency Virus (HIV). Because Pfizer has not released the genetic sequence of the specific lentivirus we don’t know anymore. If there is nothing to hide just release the sequence already, it makes one think maybe there is a gene for a protein that blocks potassium channels attached to that lentivirus, really who knows.
Retroviruses, because they integrate into a host genome might be able to cause long term effects even if the virus itself never regained the ability to reproduce and multiply. However, the safeguards for inactivating viral replication are very far from fool proof. Really I would hardly call them safeguards at all more like most of the time the virus won’t replicate but if it is used enough it will probable regain the ability to replicate. Does Becky McClain have a replicating virus in her? Again, if the viral sequence were released it would be a trivial thing for a diagnostic lab to develop a PCR test to look for the presence of the virus, without this it could be very difficult. This is not just an academic question, let me rephrase it, is Becky McClain infectious? AIDS has apparently killed in excess of 40 million people in the past 40 years or so. Here you have someone who believes she is infected with a virus from the same family which her physicians suspect is causing her to have repeated and frequent episodes of complete muscular paralysis. Is Becky McClain infectious? Is she the potential index case for a plague of millions? I really think she and the rest of us would like and deserve any and all information related to this question. Tom Clancy or Michael Crighton would never have come up with something like this. Truth is stranger than fiction,
As I have pointed out in a previous post, genetic engineers in Australia when attempting to create a mouse contraceptive completely by accident created an incredibly lethal version of mousepox virus. Such researchers are unable to see where their actions might lead and when dealing with replicating organisms are like Goethe’s parable of the Sorcerer’s Apprentice who tried to stop the enchanted broom by breaking it in two only to end up with two enchanted brooms. To purposefully release self propagating genetically modified organisms into the wild is reckless, stupid and insane.
I’ve attached a copy of the court affidavit (if that’s the correct legal term) related to her suit if anyone wishes to go through it.
Also below is a half hour video of Ms McClain from 2009 talking about her situation and the problems in the genetic engineering industry.
Personal Comments: You know I have to wish for really everyone’s sake, except her own, that Ms. McClain is malingering, but I must admit I really don’t think so and that is sad and frightening. I can’t comment on any of the industry safety claims made but I will say when she described in general the potential dangers of genetic engineering my BS meter never even went into the yellow. While I don’t have her specialized experience, she is correct, as far as I can see, about what she is saying. One quick anecdote to illustrate this, she talks about changing the tropism of viruses, i.e. what types of cells they infect, in the example she provides by altering a viral coat. When I worked at FDA in the rare diseases office there was an application for support from researchers. I can’t remember all the specifics which is for the best but the general idea was as follows. They wanted to treat malignant glioma, which is to say brain tumors. So they would take a virus – again I can’t remember and I’m not going to look it up- but it was some sort of airborne virus like chickenpox and do two things to it. First they would disable the virus from replicating, then through genetic engineering they altered the tropism, this time in a different way, but again through genetic engineering of the virus so that it now also infected brain cells. It was known that this virus would then infect brain tumor cells because of a protein that was highly expressed in brain cancer cells. There were just a couple problems. One) Though the protein leading the virus to the brain tumor cells was more highly expressed in cancerous cells it was also expressed at a lower level in normal brain tissue. Two) viruses are very promiscuous about exchanging genetic material, what if one of these non-replicating viruses recombined with a “wild type” replicating virus and regained the ability to replicate. When I tried to quantify this risk I actually found that the process they were intending to use had been documented to show that, I don’t know, something like one in a million modified viruses would revert to wild type and regain the ability to replicate. When you have billions or trillions of viruses then it would be expected that some of the modified viruses would be able to replicate. I presented my concerns to the researchers and rejected them on safety grounds, which fortunately they didn’t argue. But to sort of bottom line this for you what I would have liked to have put in the letter was something along the lines of, “Are you people frickin insane, do you have any idea what you are doing? Do you have any idea what you are talking about? You want to take a common virus make it highly pathogenic for brain tissue give it to potentially thousands of people with incurable brain tumors and if it ever reverts to wild-type, which is what we can expect from previous research, we would then have an air-borne highly infectious virus that eats people brains.” Yes, truth is stranger than fiction.
That's spooky stuff. Speaking of lab accidents,
http://socioecohistory.wordpress.com/2009/03/07/live-avian-flu-virus-placed-in-baxter-vaccine-materials-sent-to-18-countries/
remember that one during the swine flu madness last year?
"The contaminated product, a mix of H3N2 seasonal flu viruses and unlabelled H5N1 viruses, was supplied to an Austrian research company. The Austrian firm, Avir Green Hills Biotechnology, then sent portions of it to sub-contractors in the Czech Republic, Slovenia and Germany."
Yeah that's right, super flu…..
Thanks well written and informative article. Thanks excellent article. Unfortunately many people are not aware of the clandestine activities that go on in the Big Pharmaceutical companies.
It looked like recombinant viruses were an issue with the H1N1 to create an epidemic for monetary gain. What do you think?
Thanks, Caroline Heinemann
She was given the sequence, and her claims in regard to the workplace exposure were thrown out of the lawsuit.
I doubt the pharmaceutical industry is competent enough to release a recombinant virus and keep it under wraps. It's much more likely that the industry was simply reacting to a random mutation resulting in a mild but unique strain of flu. The hype machine in the media and government helped tremendously but despite all that less than half of the US population complied with H1N1 vaccination. I think that these corporations are just so focused on profit that they make dumb errors and contaminate their workers and accidentally ship bird flu across the planet. If they caused a genuine deadly pandemic, there would be profits to make for sure but the remaining corporations would probably ban together temporarily condemning the act while everyone of them made windfall profits on the untested vaccinations and treatments. With the pandemic definition changes made by the WHO, we shall have a pandemic each year with the routine seasonal circulation of flu strains, so there's no need now to manipulate anything. Much more effective than releasing something which wipes out 30-50% of the population.
@Caroline,
Thanks for the compliment. As regards whether H1N1 is synthetic, I don't know. Let me add a bit to that answer though. If you ask me is it feasible, absolutely. That was one of the big concerns when the genetic sequence of the 1917 flu was published a few years back, that anyone with the means to could then recreate it. As for it having segments from varied species, I'm not qualified to say how odd it might be, influenza does rearrange itself a lot through recombination, maybe an expert in virology would know more though it is also possible no one knows whether this is really odd or about par for the course.
Also, to say the H1N1 virus is synthetic is to accuse a nebulous and unidentified group of bioterrorism against the world (sort of similar now that I think about to critiques of recent motivations for US wars). I'm not throwing stones at anyone and that would be a boulder with zero evidence. I've changed my position on a lot of things over the past few years its probably not a good idea to spout off with false certitude that, "be angry, be fearful, they're trying to kill you, flee, flee for your lives" only to realize shortly after that geez I've changed my mind again. Besides there are enough voices saying things like that. I know about medicine not politics why should I get drawn into their game whatever it might be.
There's also another side to this H1N1 story. If the preliminary evidence about vitamin D holds up the history being written now might read, "All epidemic infectious disease need now be a thing of the past".
@ Anon, Thanks for the update, Wow you're smart or must have lots of insider knowledge. There is nothing about this in the news. Either that or you're lying out of your elbow. How bizarre, how bizarre.
@ RC
Your link is spookier, I had come across that and sort of put it out of my mind, but yes Baxter shipped vaccine with live virus, that's well documented it seems. I also tend to side with incompetence or stupidity over malice but one thing I am trying to avoid on this site is trying to figure out people's motivations. It would be more difficult then just figuring out what is going on. I don't know and unless there were a compelling reason I don't want to know, life's too short.
While I don't want to become sensationalist, if we just want to consider what is technically feasible, I'll give you a fireside camp story, one very disturbing thought occurred to me that I don't even see discussed on the internet. Have you ever looked at WHO's research into contraceptive vaccines? They have had success with this as far back as the late 1980s early 90s. Won't dig out the links but you can easily confirm. The anti HCG vaccine was associated with few side effects and no disturbance of the menstrual cycle. In other words the person wouldn't know they were infertile if they weren't told. The effects, I believe, began to wane after about a year or so. Now you can vaccinate for more then one thing at once. And there have already been allegations of tetanus vaccine adulterated with HCG antigen. Of course you wouldn't want to have all of, I don't know some yearly vaccine, combined with the anti HCG vaccine as no one would get pregnant, maybe 3 or 4%, just to "regulate fertility." This is science fiction on my part but entirely possible from the technical end. But to even consider it would be like supposing people could get away with adulterating the water supply with a known toxin. Now you see why I don't want to get sensationalist. Besides we can already blow ourselves up ten times over so why create possibly phantom problems. Still, maybe I'll try to expand it into a post sometime.
One poster, who possibly may be connected to Pfizer, said in a previous post that McClain did receive the sequence to the lentivirus that she is infected with. The poster insinuated that this is why the claim was thrown out of court.
Ms. McClain has received some general information concerning the virus but needs more detailed genetic information to be able to determine her future state of health, to determine if she is infectious and to be able to try and better figure out a cure.Pfizer refuses to give the more detailed info.
The lentivirus is such an integral issue in the case that its very difficult to understand how they can get away with keeping it a secret. Evidently the current laws protect big industry and not the workers or the public.
I was present at the trial. Every time McClain's lawyer mentioned the word virus, the judge called the lawyers to the front of the courtroom for 15 minute pow wows. It was very difficult for McClain's lawyer to avoid the subject of contamination in the lab….as it is directly related to McClains health and safety complaints. The whole thing is ludicrous.
McClain vs Pfizer is a landmark case and is getting quite a bit of attention. I would think that Pfizer would want to show good faith, handle this issue with more care, compassion and humanity….otherwise their reputation will suffer severe consequences. The biotech industry is getting out of hand. There needs to be more regulation and oversight.
Do those people who work for Pfizer realize that their decisions concerning the health and safety of their workers and the public….will ultimately affect these decision makers and their families?
"Do those people who work for Pfizer realize that their decisions concerning the health and safety of their workers and the public….will ultimately affect these decision makers and their families?"
I can assure you those people realize their decisions concerning the health of the company affect their family's wealth and health immediately AND ultimately. Most people will compromise their integrity for job security; even the so called whistle blowers tell stories of benign neglect if not overt complicity for months to years before they finally blow the metaphorical whistle. If it is so heinous what companies like Pfizer do, then customers will have to stop rewarding them by participating.
And maybe more efficacious would be looking at the root system(s) which results in such widespread corruption. Pfizer isn't the exception to the rule here, they are typical of the pharmaceutical industry. And just who finances the majority of our clinical trials? Clinical trials which make up the bulk of the medical knowledge base.
Pharmaceutical corporations have built diseases and syndromes from the ground up to match their new products. Most of the DSM is invention of the industry, each arbitrary cluster of symptoms and signs attached to a pill or set of pills. Our definitions of things like hypertension and hyperlipidemia are moulded by research paid for by industry. Heart burn becomes GERD. Shyness becomes social anxiety disorder.
You don't get to 18% GDP by sitting back and letting the body heal itself.
The reason Pfizer and all the rest do such sick corrupt things is because it is incredibly lucrative. And profit, in our current social order, equals survival.
Those who are very good at playing the game tend to be corrupt for the simple reason:
they tend to win the game.
My Point is that they may appear to win but in the end they very well may lose when their family suffers and becomes ill from lack of oversight in the biotech industry. They must not see the direct connection of genetically engineered viruses getting loose and perhaps infecting them.Either that ot they're stupid
I agree with your statements concerning the creation of real diseases AND creating disease labels for the purpose of profit and control. Here is an article I wrote a few years back. "The Disabling Of A Nation. http://lymesentinel.blogspot.com/2009/09/disabling-of-nation.html
Your side discussion on vaccines and infertility reminded me of some research I did maybe a year ago on a related subject. A good summary can be found in Dr. Mercola's article of Oct. '08 found here:
http://articles.mercola.com/sites/articles/archive/2008/10/25/prominent-scientist-warns-of-hpv-vaccine-dangers.aspx
I don't know much things about rare diseases. In fact, i think i don't know much of them.
@anon
Thanks for the update, while I haven't seen anything in the news can you also confirm that the claims "weren't thrown out of the court"
As far as characterization of the virus, yes absolutely the genetic code is needed. It is a single base pair difference that is the cause of diseases such as sickle cell anemia or cystic fibrosis. A single nucleotide difference can be quite a change.
I am no expert on the legal end. But my understanding, if it hasn't changed is that genes i.e nucleotide sequences can be patented. "Don't it turn your brown eyes blue?" If this is still the case it is becoming quite ridiculous in light of $5,000 dollar whole genome sequencing. Does the diagnostic lab get a patent on you? So I am guessing the lentivirus is patent protected.
If this is the case, I don't know if the judge might try to turn the whole genomic patent idea upside down, but I would at least hope that if physicians or similar experts request the information this would supersede the patent. It really is an interesting case. Keep me posted, if you will.
@ Scott
Thanks, Dr. Mercola has looked into this and went a lot further than me on the topic, I hadn't known anyone was even speculating on such ideas. Thx for the read. While I hadn't seen that I have been following Gardasil, chk out the Health around the Web segment.
Paul
yikes. great piece, thanks for the info. Pfizer is defying logic.
Reminds me a little of Stephen King's "the Stand" – where a superflu gets out of a government lab and a malfunctioning gate allows an infected soldier to flee…starting a chain reaction that infects the country.
Ironically, on the same day the New York Times article, “Safety Rules Can’t Keep Up With Biotech Industry” broke, the scientific watchdog group, The Council for Responsible Genetics-GeneWatch Magazine submitted the electronic version of the print subscription; March-April 2010 issue titled, “BioLab Safety”.
The Editor of GeneWatch, Sam Anderson stated in the Editorial Section, ” This may be one of the most important GeneWatch issue in recent memory”.
The electronic version of GeneWatch magazine; BioLab Safety is available free online at http://issuu.com/genewatchmagazine/docs/genewatch23-2?mode=embed&layout=http%3A%2F%2Fskin.issuu.com%2Fv%2Flight%2Flayout.xml&showFlipBtn=true This 28 page electronic version can be read as you would a “printed” magazine issue.
March-April 2010 issue; “BioLab Safety” articles:
A Cruel and Unusual Corporation
By Ralph Nader
A Roach in the Kitchen
By CRG staff – interview with Becky McClain
Commentary: GM Crops
By Eric Hoffman
Dedication: Tony Mazzocchi
By Jeremy Gruber
Give Them an Inch…
By Michael Siciliano
One Bug, One Drug
By Lynn Klotz, Edward Sylvester
The Lab in My Backyard
By Beth Willis
Teatime in the Lab
By Sam Anderson
Book Review: Breeding Bio Insecurity and Germs Gone Wild
By Andrew Thibedeau
Flushing It Down the Rabbit Hole
By Andrew Thibedeau
Topic: Genetic Discrimination
By Jeremy Gruber
Topic: Forensic DNA Databanks
By CRG Staff
The Case of Dr. Malcolm Casadaban
By CRG Staff
Thx
Am looking forward to reading the link.
It's always nice when you can not only be informed, but also entertained! I'm sure you had fun writing this article.