‘ Cursed is he who accepts a bribe to strike down an innocent person.’ And all the people shall say, ‘Amen.’
Glaxo Agrees to Pay $3 Billion to Settle U.S. Probe Into Sales, Marketing
By Phil Serafino and Makiko Kitamura – Nov 3, 2011 7:23 AM CT
GlaxoSmithKline Plc (GSK) agreed to pay $3 billion to resolve U.S. criminal and civil investigations into whether the U.K. company marketed drugs for unapproved uses and other matters, its biggest legal settlement.
Negotiations over the terms will be completed next year, the London-based company said in a statement today. The cost is covered by existing legal provisions and will be paid from the company’s cash resources, Glaxo said.
The potential settlement brings Glaxo closer to putting years of legal probes behind it. The company set aside 2.2 billion pounds ($3.5 billion) in the fourth quarter last year in anticipation of reaching an agreement on the cases. Glaxo said it will have about 1 billion pounds of its 2.9 billion pounds in total legal provisions remaining after today’s settlement is completed, and it hasn’t decided what to do with the money.
“This news essentially draws a line under a 10-year legal saga,” Gbola Amusa, an analyst at UBS AG in London who recommends buying Glaxo shares, said in an e-mail. “This removes significant uncertainty on ongoing legal issues.”
Glaxo rose 0.4 percent to 1,361 pence at 11:54 a.m. London time.
The Glaxo settlement would trump the $2.3 billion Pfizer Inc. paid in 2009 over the marketing of its Bextra painkiller and other drugs and the $1.4 billion Eli Lilly & Co. (LLY) paid the same year over sales of its Zyprexa anti-psychotic medicine. The Bextra accord had been the largest pharmaceutical marketing settlement in U.S. history.
Abbott Laboratories agreed to pay at least $1.3 billion to settle claims by the U.S. government and 24 states alleging the company illegally marketed its Depakote epilepsy drug, people familiar with the accords said last month.
“Litigation is an ever-present business risk in the pharmaceuticals industry,” Mark Purcell, a Barclays Capital analyst, wrote in a note to investors today.
Federal prosecutors began an investigation in Colorado in 2004, later taken over by the U.S. attorney in Massachusetts, into whether Glaxo promoted drugs for unapproved uses, and into ways Glaxo potentially influenced doctors. The probe concerns nine of the company’s best-selling products from 1997 to 2004, including the Advair lung treatment, Glaxo said in its annual report.
Today’s settlement also covers a U.S. Justice Department probe of Glaxo and a Medicaid rebate program, and a Justice Department investigation into the development and marketing of the Avandia diabetes drug, the company said.
Drugmakers are required to give rebates to Medicaid, the government health insurance program for the poor. The investigation examined how Glaxo reported prices charged to other payers, which are used in calculating the Medicaid rebates.
Regulators said last year that Avandia would be withdrawn from the market in Europe and sales would be limited in the U.S. because of an increased risk of heart attacks.
“This is a significant step toward resolving difficult, longstanding matters which do not reflect the company that we are today,” Chief Executive Officer Andrew Witty said in the statement. “In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity.”
Earlier this year, Glaxo changed incentive compensation programs for U.S. sales representatives. The company has eliminated the link between sales goals and bonuses, which are now based on selling competency, customer evaluations and overall performance of the representative’s business unit.
Glaxo still faces probes involving the United Nations oil- for-food program, and HIV product sales and marketing in the U.S., JPMorgan Chase & Co. analysts wrote in a note to investors today.
The company agreed to pay more than $250 million to resolve about 5,500 claims related to Avandia to avoid the first trials over claims it can kill users, two people familiar with the accords said in February. Glaxo said in the annual report that it reached agreements to settle the majority of Avandia claims pending as of February, though it didn’t specify how much the settlements would cost.
The legal provision, announced in January, led to a loss for Glaxo in the fourth quarter of 2010. Less than three weeks after the provision was disclosed, the company said it would begin a share repurchase for the first time since 2008 to enhance investor returns.
To contact the reporters on this story: Phil Serafino in Paris at firstname.lastname@example.org; Makiko Kitamura in london at email@example.com
To contact the editor responsible for this story: Phil Serafino at firstname.lastname@example.org
Related… GlaxoSmithKline (and others) knowingly using harmful ingredients in vaccines…
[Squalene is used in Chiron’s MF59 adjuvant, and Glaxo’s Monophosphoryl lipid A (MPL) and is the main factor in Gulf War Syndrome through the Anthrax vaccine. Now they want to poison everyone with squalene in the Swine flu vaccine.]
“3, is the number of diseases that squalene has caused in animals: Adjuvant Arthritis, Experimental Allergic Encephalomyelitis (EAE) and Systemic Lupus Erythematosus.”—Gary Matsumoto
See: Gary Matsumoto
[2011 Jan 9] CHILD FLU VACCINE CONTAINS MERCURY
[Citations] SQUALENE ADJUVANT TOXICITY IN ANIMALS
[2002 pdf] Antibodies to Squalene in Recipients of Anthrax Vaccine Adjuvant disease has been shown to have a latency of onset in humans ranging from 2 weeks to 18 years after exposure (Brawer, 1996).
[2009 oct] Belgian doctors call for sack of government virologist in row over swine flu adjuvant advice The Belgian association of doctors has called for the government’s interministerial commissioner for the flu, the virologist Marc Van Ranst, to be fired after he said on Thursday that the Pandemrix swine flu jab with the adjuvant squalene was safe for pregnant women.
[2009 Aug] What’s the Danger of Swine Flu Vaccinations? by Dr. Anders Bruun Laursen
[Swine flu vax 2009 Aug] Injecting one thing for testing and then adding adjuvant later
[2009 Aug] H1N1 weapon of mass destruction vaccine and human experimentation
 GSK admits in FEB 2009 that it planned on introducing squalene adjuvant ASO3 into regular season flu shots and aware of autoimmune issues!
[2009 July] Squalene: The Swine Flu Vaccine’s Dirty Little Secret Exposed By Dr. Mercola A novel feature of the two H1N1 vaccines being developed by companies Novartis and GlaxoSmithKline is the addition of squalene-containing adjuvants to boost immunogenicity and dramatically reduce the amount of viral antigen needed.
 Formation of Cysts from Squalene Adjuvant?
[Media Oct 2004] Castle insists on response from military, Pentagon asserts vaccine program safe to continue
 A Glimpse into the Scary World of Vaccine Adjuvants By Edda West
ANTI-SQUALENE ANTIBODIES LINK GULF WAR SYNDROME TO ANTHRAX VACCINE
Dr. Robert Garry Testimony, The House Subcommittee on National Security, Veterans Affairs, and International Relations
[Media July 2001] Illegal vaccine link to Gulf war syndrome
Breakthrough on Gulf War Illness By Paul M. Rodriguez
Gulf War Illness Update By Paul M. Rodriguez
Gulf War Mystery and HIV By Paul M. Rodriguez
The Gulf War Mystery By Paul M. Rodriguez
Holmdahl R, Lorentzen JC, Lu S, Olofsson P, Wester L, Holmberg J, Pettersson U. Arthritis induced in rats with nonimmunogenic adjuvants as models for rheumatoid arthritis. Immunol Rev. 2001 Dec;184:184-202. PMID: 12086312 [PubMed – in process]
Rat models are useful for studies of the pathogenesis of rheumatoid arthritis (RA) since rats are extraordinarily sensitive to induction of arthritis with adjuvants. Injection of not only the classical complete Freund’s adjuvant but also mineral oil without mycobacteria and pure adjuvants such as pristane and squalene, induce severe arthritis in many rat strains. Models like pristane-induced arthritis in rats are optimal models for RA since they fulfill the RA criteria including a chronic relapsing disease course. Arthritogenic adjuvants like pristane, avridine, squalene and mineral oil are not immunogenic since they do not contain major histocompatibility complex (MHC) binding peptides. Nevertheless, the diseases are MHC-associated and dependent on the activation of alphabetaTCR (T-cell receptor)-expressing T cells. However, it has not been possible to link the immune response to joint antigens or other endogenous components although immunization with various cartilage proteins induce arthritis but with different pathogeneses. To unravel the mechanisms behind adjuvant-induced arthritis, a disease-oriented genetic approach is optimal. Several loci that control onset of arthritis, severity and chronicity of the disease have been identified in genetic crosses and most of these have been confirmed in congenic strains. In addition, many of these loci are found in other autoimmune models in the rat as well as associated with arthritis in mice and humans.
(American Journal of Pathology. 2000;156:2057-2065.) © 2000 American Society for Investigative Pathology The Endogenous Adjuvant Squalene Can Induce a Chronic T-Cell-Mediated Arthritis in Rats, Barbro C. Carlson*, Åsa M. Jansson*, Anders Larsson , Anders Bucht * and Johnny C. Lorentzen* , From the Department of Medicine,*Unit of Rheumatology, Karolinska Institutet, Stockholm; the Department of Medical Sciences, University Hospital, Uppsala; and the Department of Biomedicine, Division of NBC Defense, Defense Research Establishment, Umeå, Sweden
“Our results strongly suggest that the production of anti-squalene antibodies is linked to symptoms of Gulf War illness and to the presence of squalene found in certain lots of anthrax vaccine…..human exposure to squalene in vaccines has been shown by others to cause immunological symptoms similar to those found in Gulf War illness patients. ……The absence of an association between the presence of Gulf War illness and deployment indicates that the causative agent or factor is not associated with the Persian Gulf. Consistent with this observation are the results of a recent epidemiological study finding that vaccinations that were given to both deployed and non-deployed personnel are associated with ill health. …….The presence of anti-squalene antibodies in ill people and the absence of the antibodies in healthy people is the first hard laboratory evidence that Gulf War illness is what some might refer to as a “real disease.” —-Dr. Robert Garry
GSK’s proprietary adjuvant is called ASO4. It contains alum and MPL. MPL stands for monophosphoryl lipid A. The U.S. Army’s proprietary (unlicensed) adjuvant developed prior to the first Gulf War for use in a second generation anthrax vaccine was called Tri-Mix or Triple Mix. Tri-Mix contained MPL (monophosphoryl lipid A) and squalene. After the war, Army scientists considered MPL to be too toxic, so they began working with Chiron Corporation of Emeryville, CA to develop an adjuvant that contained squalene and water only … on the assumption that adjuvant toxicity with Tri-Mix was due to MPL. This assumption also proved incorrect. There are more than two dozen animal studies that generated data demonstrating squalene’s ability to induce autoimmunity; and there is disputed evidence that nanodoses of squalene in anthrax vaccine sickened countless military personnel who received squalene-tainted vaccine during AVIP.
Back to ASO4 and MPL. MPL was also a component of the Ribi Adjuvant System ( I haven’t checked whether it still is). The Ribi Adjuvant System, or RAS, is a derivative of Tri-Mix, which is approved for use in animals only.
As far as I know, there is no existing data showing whether MPL elicits an immune response specific to it. If MPL is immunogenic, it raises the possibility of a dangerous “cross reaction.” The human body is full of lipids. Antibodies and immune cells responding to MPL might also respond to other lipids in the body, thus breaking tolerance for endogenous lipids (those native to the human body) and initiating autoimmunity. Secret adjuvant in new avian flu vaccine
GULF WAR CORRELATION
In science, a correlation does not prove causation. A correlation, however, is grounds to investigate causation, which has led to some troubling data.
After the first Gulf War, many U.S. and British military personnel said they became sick after receiving anthrax immunizations. Scientists at Tulane University Medical School developed an assay showing a correlation between illness and antibodies to squalene. Although this data did not prove conclusively that Gulf War troops were injected with squalene, the data indicated that injection was the only way to develop these antibodies; the implication being that troops had been injected with a squalene-based adjuvant. This coincided with the fact that at the time, U.S. Army scientists had developed several new and theoretically improved anthrax vaccines that provided more immunity than the licensed vaccine; and did so in less time and with fewer shots. All these new anthrax vaccines contained squalene. I interviewed dozens of Gulf War veterans whose mysterious undiagnosable illnesses were later diagnosed by civilian physicians as autoimmune. Of the sick Gulf War veterans tested by Tulane’s scientists, 95% had antibodies to squalene. Tulane’s data showed another correlation, and this one concerned them even more. Veterans who never deployed to the Gulf had developed chronic and debilitating illnesses too – 100% of sick,non-deployed veterans tested by Tulane had anti-squalene antibodies. When Tulane tested healthy veterans, they found that 0% had the antibodies; that’s zero percent.  Formation of Cysts from Squalene Adjuvant?
In 1998, active duty military personnel deploying to an AOR (Area of Responsibility), which included Saudi Arabia and South Korea, were injected with anthrax vaccine. Many personnel reported sickness after their immunizations, which were later determined by FDA testing to contain trace quantities of squalene. The Department of Defense and the FDA stated that these quantities were too small to harm anyone and that the nanogram quantities of squalene in the vaccine probably came from the eggs in which germs for vaccines are grown. There was a problem with this explanation. Viruses are grown in eggs; bacteria are not. Anthrax is a bacteria. Then the DOD and FDA suggested the squalene came from the bacteria itself. However, scientists had analyzed Bacillus anthracis and proven that it does not produce squalene. DOD then offered a third explanation: the oils in human skin contain squalene; someone’s hands must’ve contaminated the vaccine. The problem with that explanation was that vaccine workers wear gloves and hats and booties. The other problem is that oil and water don’t mix. Nevertheless, trace quantities of squalene had been emulsified in millions of vaccine doses. It wasn’t found smeared on the exterior of glass ware. It was in the vaccine. Special detergents must be added to an oil to break it down sufficiently to mix it with water. What DOD and the FDA left out of their explanations was this. In 1998, the DOD, FDA and NIH formed a Special Working Group to accelerate the development of the Army’s new anthrax vaccine containing squalene. Also that year, NIH scientists published data, which indicated, they said, that animals can become “tolerized” to squalene with micro-dosages. Coincidentally, nanogram doses of squalene, parts per billion, appeared in the military’s anthrax vaccine supply that same year, in 1998.  Formation of Cysts from Squalene Adjuvant?
Military personnel injected with anthrax vaccine containing squalene have been reporting that they developed cysts, appearing all over their bodies. Among the first to report this were Air Force personnel at Dover Air Force Based in Delaware, which had received at least four lots of anthrax vaccine containing squalene. One fellow developed cysts all over his body, including his pericardium. Another fellow developed them on his spinal cord. These cysts were similar to those in British civilians injected with the flu vaccine containing mineral oil, because they were “sterile” – they were not associated with viral or bacterial infection.  Formation of Cysts from Squalene Adjuvant?
TWO LAST CORRELATIONS
Department of Defense and Health and Human Services regulations permit the administration of experimental drugs and vaccines to U.S. military personnel without informed consent. In contravention of the principles memorialized in the Nuremberg Code, the administration of Invesigational New Drugs (INDs) can be done covertly, in clinical trials that are classified. This is stated in unclassified documents issued by the Department of Defense and Department of Health and Human Services.  Formation of Cysts from Squalene Adjuvant?
Since the early 1950s, U.S. military scientists – working in cooperation with scientists with the NIH, FDA, and U.S. Public Health Service – have been testing cyst-producing oil-based vaccine adjuvants on U.S. military personnel.  Formation of Cysts from Squalene Adjuvant?
I discuss the British findings, briefly, in Chapter Twelve, pg 250. A highly regarded British laboratory, Scientific Analyses Ltd. (SAL Ltd.) in Manchester, tested samples of British-made anthrax vaccine for the Granada Television network and found a thirty-six parts per billion concentration of squalene in two lots of the British vaccine. That is a fairly close match for the concentration found in one of the five lots confirmed by the U.S. Food and Drug Administration to contain squalene. Lot #FAV 043, according to the FDA, contained forty parts per billion. What is also noteworthy is the specific test used by SAL Ltd. to detect squalene in anthrax vaccine: flame ionization/gas chromatography. This is the same test used by the FDA. Interestingly, a laboratory the U.S. Army sub-contracted to test the vaccine, SRI, used a much less sensitive analysis called liquid chromatography, which would have been incapable of finding squalene in the concentrations present in either the U.S. or British anthrax vaccines. SRI has a long business association with the Department of Defense and an unanswered question is whether SRI deliberately chose to use a test that would invariably fail to find low concentrations squalene in the vaccine and thus allow the U.S. Department of Defense to declare its anthrax vaccine squalene-free, which it did. Gary Matsumoto http://www.vaccine-a.com/forum.html
According to the World Intellectual Property Organization, which is part of the United Nations, scientists from the organization are developing vaccines specifically to damage fertility as a method of contraception. A suggested ingredient for the vaccine is tween 80 (polysorbate 80): “In a preferred embodiment the vaccine comprises oil, preferably a biodegradable oil such as squalene oil. Typically, the vaccine is prepared using an adjuvant concentrate which contains lecithin in squalene oil. The aqueous solution glycoprotein is typically a phosphate-buffered saline (PBS) solution, and additionally preferably contains Tween 80.” (Fertility Impairing Vaccine And Methods of Use’ This application claims the benefit of U. S. Provisional Application No. 60/070,375, filed January 2,1998, U. S. Provisional Application No. 60/071,406, filed January 15,1998.) Exploring Vaccines
Vaccine A: The Covert Government Experiment That’s Killing Our Soldiers and Why GIs Are Only the First Victims By Gary Matsumoto
1. Many new vaccines feature recombinant DNA. One piece of a deadly germ is inserted or spliced into other organisms, creating bio-engineered microbial molecules. To prompt the body to create antibodies to these recombinants, scientists have created deadly oil-based vaccine additives called adjuvants. Oil-based adjuvants cause extreme inflammation and animals injected with them always develop painful, incurable auto-immune diseases like multiple sclerosis, rheumatoid arthritis or systemic lupus.
2. Since Gulf War I, the military has been secretly putting an oil-based adjuvant called SQUALENE into certain experimental lots of military vaccines. Just like lab animals, thousands of soldiers given SQUALENE- laced vaccines have developed disabling auto-immune diseases. Independent researchers have found SQUALENE antibodies in these sick soldiers. In 2005, the military admitted that 1,200 military personnel who received anthrax vaccine before going to Iraq recently developed serious illnesses, including memory loss and chronic fatigue.
3. The military and federal health agencies have long kept their SQUALENE experiments on U.S. military troops secret because they know that oil-based adjuvants wreak havoc with immune function, causing the body to attack itself. Matsumoto documents how federal and military officials have often been caught lying about the SQUALENE in military vaccines.
4. Matsumoto warns that the National Institutes of Health has funded production of new vaccines for flu, human papilloma virus, malaria, HIV and herpes that also contain SQUALENE. The federal government has been running human clinical tests on these new commercial vaccines and test subjects have not been properly informed of the grave health dangers. Researchers have even found SQUALENE in some of the older vaccines containing tetanus and diphtheria toxoids. Should we wonder why auto-immune diseases like fibromyalgia and chronic fatigue are now rampant?
5. The Bush administration is funding development of new bio-warfare vaccines that will also contain oil- based SQUALENE adjuvants like MF59 or MPL. Because federal officials know that these vaccines may cause disability or death, legislation to protect vaccine makers from lawsuits is expected to be passed by Congress before the end of 2005.* If you become chronically ill from these vaccines, tough luck! Exploring Vaccines
…Our demonstration that an autoadjuvant can trigger chronic, immune-mediated joint-specific inflammation may give clues to the pathogenesis of rheumatoid arthritis, and it raises new questions concerning the role of endogenous molecules with adjuvant properties in chronic inflammatory diseases. The Endogenous Adjuvant Squalene Can Induce a Chronic T-Cell-Mediated Arthritis in Rats
Then a strong angel took up a stone like a great millstone and threw it into the sea, saying, “So will Babylon, the great city, be thrown down with violence, and will not be found any longer. And the sound of harpists and musicians and flute-players and trumpeters will not be heard in you any longer; and no craftsman of any craft will be found in you any longer; and the sound of a mill will not be heard in you any longer; and the light of a lamp will not shine in you any longer; and the voice of the bridegroom and bride will not be heard in you any longer; for your merchants were the great men of the earth, because all the nations were deceived by your sorcery. And in her was found the blood of prophets and of saints and of all who have been slain on the earth.”
Strong’s Concordance #5331
pharmakeia: the use of medicine, drugs or spells
Original Word: φαρμακεία, ας, ἡ
Part of Speech: Noun, Feminine
Phonetic Spelling: (far-mak-i’-ah)
Short Definition: magic, sorcery, enchantment
Definition: magic, sorcery, enchantment…