Multiple Sclerosis

Thursday, December 17, 2009

PML, MS, Biogen, Polysorbate, Clinical Trials, FDA, pharmacuetical companies, political corruption, lobbying, coverup.

I would be very interested hearing from anyone that has been affected by clinical trials, FDA rules and regulations regarding clinical trials, Progressive Multifocal Leukoencephalopathy (PML), unexplained allergic reactions, hypersensitivity to Polysorbate 80, anaphyalxoid shock, and anaphylaxis.

There seems to be a wide spread belief that Polysorbate 80 is safe for I.V. or injectable use. I believe it is not safe. The US FDA has approved it for oral and topical uses only. It is used in pies, makeup, shampoo and thousands of other products. It is a histamine, so it causes itching, so why is it used to coat Benedryl, an antihistimine?

The JC Virus which causes PML resides harmlessly in up to 80% or more of us, but it is reactivated when drugs with Polysorbate 80 are used. Then the resulting PML, a demyelinating disease (same as MS) attacks the myeline sheath of the axons of the brain resulting in death many times. There have been 24 reported cases of PML in patients taking Tysabri, made by Biogen for MS and Crohns patients.

Biogen warns of hypersensitivity to Polysorbate 80 in their Tysabri marketing, but they did nothing to test it before or during the clinical study. So what goes on here? Why did the FDA fast-track approve Tysabri twice and insist it has a Black Box warning and strict criteria for prescribing it.

A drug called Docetaxel, which is a cancer drug, also uses Polysorbate 80, produced by Sanofi Aventis Pharmaceuticals, used to treat the symptoms of metastatic breast cancer or non small cell lung cancer, but another company has developed the same drug without Polysorbate 80 as the link between PML and PS80 was positive. The cases of PML related deaths or illnesses in patients on Docetaxel (Taxotere) dropped significantly when the PS80 was removed.

Biogen, a for profit pharmaceutical company, knew in 1992 that Tysabri, or as it was known back then as natalizumab or Antegren, was toxic and a member of the original team that developed it said it should not be used in humans. Somehow Biogen has gotten around the FDA and their record of 1 in 1000 MS patients getting Tysabri could get PML seems to be acceptable to them and the FDA.

European authorities are concerned and looking into Tysabri and PML more closely. Biogen made over $229 million profit on Tysabri and even more off their other MS drug Avonex, which contains Polysorbate 20.

Any one that is allergic to PS80 can easily become hypersensitive to PS80, so that if they come into contact with it either from eating or topical use they could get body-wide rashes and very painful intense itching or some other kind or reaction, possibly PML. PS80 breaches the Blood Brain Barrier (BBB) and is used to help other drugs BBB. So it could be possible that the culprit for PML is PS80. It is a known carcinogen and there have been warnings about its uses for over 30 years, but still it goes on.

The route of delivery plays very important part in how PS80 affects the autoimmune system and brings up the question of does it cause the reactivation of the JCVirus causing PML. One manufacturer of PS80 states in its Material Safety Data Sheet MSDS, that it is not intended for injectaible use of any kind. IV injection is the most dangerous route of delivery as it goes straight to the brain.

There is much more to this question than I can write here, so if you have any stories or information regarding Multiple Sclerosis, Tysabri (natalizumab), PML, taxotere, docetaxel, JCVirus, demyelinating diseases, Biogen, Yale University School of Medicine, Yale-New Haven Hospital, clinical trials, the FDA, Institutional Review Boards (IRB), Human Investigation Committees (HIC) I would like to hear from you.

Thank you for taking the time to read this as I think that the use of PS80 in injectibles needs wider discussion and thorough FDA investigation.

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Gloria Larravide February 25 at 11:52pm Report
The Real Gardasil Story

The Reason
This vaccine was created with the motivation of creating a fast return in order to make up for 80 billion dollars or more of fines created by charges made by several states to reimburse medicaid fraud, consumers of Vioxx in a settlement program, pay for fines incurred by dishonest marketing and other violations incurred by the maker Merck and Co, Inc.
Drugmakers Hurry Sales, Delay Safety Studies--Gardasil; Thursday, 08 February 2007
Official Vioxx Settlement; Claims Administrator’s website, Claims Packages,

The Inspiration
The vaccine was an idea that occurred while Dr. D. Harper et al were testing an HPV vaccine. It was later discovered in the testing that the vaccine ''could'' be used to combat cervical cancer, but it was never tested towards this end. The only testing that occurred was to see what if any adverse reactions would be produced at the injection site, since it was the only thing observed. During the testing other adverse reactions presented itself, but were not proactively looked for, as they may have been in biopsied mice to inspect organs and damages made to them if any.
See Interpretation on

The Nightmare
Since it was tested all kinds of adverse reactions have become apparent as caused by the vaccine which even the CDC has finally, 8/18/09, publicly declared. Since testing deaths, clotting and fainting were reported by Merck but the other myriad of adverse effects seen in the product literature was never advertised publicly. However, articles post-vaccine approved started springing up everywhere with declarations from researchers who started to investigate girls and their symptoms came to find they had cutaneous PAN and that hyperpigmentation plaques had formed overlying the vessels of the lower extremities below the knees, thrombosis, nodules, and inflammation. They have also confirmed that vasculitis was associated to the vaccine.
Google "Cervical Cancer Vaccine Linked to Deaths, Incidents of Fainting and Blood Clots;By RADHA CHITALE;ABC News Medical Unit;August 18, 2009" ;
Google "HIGHLIGHTS OF PRESCRIBING INFORMATION;These highlights do not include all the information needed to use GARDASIL safely and effectively. See full prescribing information for GARDASIL."

Because the severe adverse effects had been underplayed and never divulged to the public in the barrage of incessant advertising, something other drug companies adhere to in their marketing, disclosing the adverse effects publicly, Merck soon became the villain coming across like a deception trying to ensnare the girls who were falling prey. Having been charged publicly for dishonest marketing in the recent past helped to create this portrayal. In fact, in May of 2009, Merck was caught paying to create a fake Journal to be published in a Medical Journal forum to advertise the company.
Google "HPV vaccine possibly linked to cutaneous PAN; Publish date: Aug 4, 2009;By: John Jesitus; Source: Dermatology Times"

Discovered Deception
One of Merck's partners GlaxoSmithKline was charged with hiding adverse effects in a trial by the NY Attorney General in June of 2004, so I cannot imagine what made Merck think they could get away with false advertising themselves, but they did. Even to date, 9/7/09, few people, Women in Government(WIG) who have encourage state mandating of the vaccine, cannot believe that Gardasil hurts the youths. They insist that the vaccine is the salvation to the current juvenile female population, contrary to the claims by the injured public that deaths have arisen and thousands of girls are left housebound with paralysis. WIG is determined to stick to their cause and force everyone to take the vaccine under the guise of the state law.