Novartis Pays $422M For Off-Label Marketing

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Pharmalot
By Ed Silverman
September 30th, 2010

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Another week, another drugmaker agrees to settle off-label marketing charges brought by the federal government. This time, Novartis will pay $422.5 million for illegally promoting its Trileptal epilepsy med for unapproved uses, such as bipolar disorder and neuropathic pain, along with five other drugs - Diovan, Zelnorm, Sandostatin, Exforge and Tekturna.

The fine includes roughly $237 million to settle four lawsuits brought by whistleblowers, while $185 million goes toward criminal penalties. One of the lawsuits was filed by Jeremy Garrity, a former cardiovascular sales rep, who worked for Novartis between 2002 and 2008 before being fired (you can read it here, and another whistleblower suit here, and you can read the settlement here. Oh, and this is the guilty plea).

This is the latest in a stream of settlements involving big drugmakers. In recent weeks, Allergan paid $600 million for illegally marketing Botox and Forest Laboratories paid $313 million for improperly promoting three meds. Other marquee names to run afoul of the law: Pfizer, which paid a $2.3 billion fine; Eli Lilly paid $1.4 billion; AstraZeneca paid $520 million and Bristol-Myers Squibb paid $515 million.

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The Italian daily La Repubblica reports about some new research that could revolutionize cancer therapies. We believe this news to be relevant outside of the national (Italian) context as well. Here is a link to the original Italian article, and a summary of the Italian research mentioned in the report.

Could bicarbonate, antiacid medicines replace chemotherapy drugs?

Proton pump inhibitors, generally used to treat stomach ulcers, could perhaps replace chemotherapy drugs. This is the direction of new research several Italian scientists are pursuing. Those products could be effective without damaging side effects and at a cost that is much lower than conventional cancer meds. The research was illustrated by scientists of the Institute of Health at the first symposium of the International Society for Proton Dynamics in Cancer (ISPDC).

This new therapy is based on a different approach - starting out from the consideration that all tumors are acid. "Acidity is a mechanism used by cancers to isolate themselves from everything else, including pharmaceutical drugs", explains Stefano Fais, president of the ISPDC and head of the pharmaceutical department of the Institute of Health. "But tumor cells, in order to defend themselves in a highly acidic environment, are relying heavily on up-regulated protein pumps moving those H+ protons. If those pumps are blocked, the cancer cells remain defenseless in the acid medium they created, and they eventually die.

Therefore, using those antiacids, even generic protein pump inhibitors generally used against gastric ulcers, cancer could be cured. "These drugs do not have side effects like those used in chemotherapy", explains Fais, "and they are much lower cost. Consider that the drugs used in target therapy, which are toxic and provoke patient resistance, cost 50 to 60 thousand Euro per patient every year. With this therapy instead, the cost would be 600 Euro using generic drugs or 1200 Euro for those still covered by patents. But pharmaceutical manufacturers aren't interested in this kind of approach today." Resistance notwithstanding, the Institute of Health succeeded to get the first two trials underway in Italy. One trial of 30 patients with melanoma was run by the Milan Cancer Institute and the University of Siena, another trial involving 80 patients with bone cancer was run by Bologna University.

"The results are very encouraging", continues Fais, "because these drugs, used together with chemotherapy, have improved patient response to therapy, even in cases where previously drugs were no longer working, in cases of metastases and in cases where cancer had re-appeared. But those data have to be confirmed with additional studies on more patients, and for that we need the support of pharmaceutical manufacturers."

The same kind of approach has also been used at the Fudan University of Shanghai for breast cancer, while the Tampa Florida Cancer Center is experimenting with oral doses of bicarbonate. In Tokyo instead, Edobashi University is studying an older molecule, acridine orange, which gets attracted to acidic organules of the cell and which, after a luminous X-ray stimulous turns into a compound that is highly toxic for tumor cells. "But the real change", says Fais in closing, "will come when we get the ok for a clinical study in which we will use only protein pump inhibitors, without the chemotherapy drugs. This way we will be able to show their efficacy and the possibility to use them as an alternative to chemotherapy."

www.repubblica.it/salute/

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In Praise of Hemp

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For OpEdNews: Jim Prues - Writer
September 27, 2010

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Hemp is the common name for cannabis, the first plant cultivated by humanity as we crept from being Neolithic to becoming Agrarian. Likely this was due to a few reasons. First, hemp is an extremely versatile plant, with leaves, seeds and stalks all capable of creating useful products. Second, it's particularly easy to grow, needing little in the way of fertilizer or pest control. And finally, hemp is native to many parts of the world, particularly The Fertile Crescent, where some of the first agriculture happened early in our civilization.

Hemp use predates the Agrarian Age, as hemp fibers have been found in pottery in China and Taiwan dating to 7,000 years ago. The classical Greek historian Herodotus (ca. 480 BC) reported that the inhabitants of Scythia would often inhale the vapours of hemp smoke, both as ritual and for their own pleasurable recreation. So presumably the Scythians were the first recorded stoners.

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US Govt Hearings Go Swimmingly for GM Salmon

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Scoop
September 27, 2010

US Government Hearings Go Swimmingly for Genetically Engineered Salmon

by Martha Rosenberg Rockville, MD

Even though the US Food and Drug Administration (FDA) held hearings about how AquAdvantage Salmon should be labeled the day after hearings about if it should be approved this week, it said it has not decided yet about the genetically engineered fish.

Unfortunately, its invited speakers didn't get the memo.

Presenting to the Veterinary Medicine Advisory Committee (VMAC) on Monday, Yonathan Zohar, from the Center of Marine Biotechnology at the University of Maryland, extolled the "promise" of aquaculture and bashed Greenpeace and other groups who are against growing "fish in cages."

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Prozac for children - what happened with the follow-up?
By Janne Larsson

Reporter - investigating psychiatry

September 21, 2010

Prozac was approved for children in Europe in 2006. [1, 2] Several countries were strongly opposed, but the UK and Swedish medical agencies pushed to get the drug approved. They thought it was a good idea to first approve Prozac and afterwards do the needed safety studies.

So what happened to the needed studies and the careful monitoring which were a requirement - a condition - for the approval of Prozac for children in Europe?

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First read Part I of this sordid story, Prozac - how could it be approved for children in Europe? http://jannel.se/prozac.childrenEU.pdf

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Colloidal Silver Secrets

September 22, 2010


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The following is a list of pathogens and conditions successfully treated with colloidal silver, as documented in medical texts prior to the advent of prescription antibiotic drugs in the 1940's.

Many of these citations are from the following books: The Use of Colloids in Health and Disease (1919) by Alfred B. Searle; Colloids in Biology and Medicine (1919) by H. Bechhold; and Index-Catalogue of the Library of the Surgeon General’s Office United States Army (1931) U.S. Printing Office, Washington, D.C.

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by Sami Grover, Carrboro, NC, USA on 09.23.10
Food & Health (food) Treehugger
September 23, 2010


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Image credit: Chow Down

"I have $60,000 in this attache case and I want to give it to you if you will leave the word cancer out of any mention in the Red Cross course."

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VOICE
Press Release
September 21, 2010

International scientists, health and environmental campaigners have presented detailed evidence of the adverse effects of adding fluoride to drinking water at an EU public hearing held in Brussels. Its effects on bone and tooth enamel, the brain, kidney, thyroid function and the endocrine system regulating the body’s hormones were confirmed by reference to extensive scientific research.

Ireland and the UK are the only EU member states to deliberately fluoridate their citizens. The European Commission’s scientific committee on health and environmental risks (SCHER) is critically reviewing fluoride and fluoridation chemicals following repeated questions from Irish and UK MEPs. The committee’s preliminary opinion has already stated that water fluoridation is ‘a crude and rather ineffective form of systemic fluoride treatment to prevent dental caries without a detectable threshold for dental and bone damage’.

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The One Click group
Organic HealthSeptember 21, 2010

201009221705.jpg201009221707.jpgWould you feel comfortable being injected with a vaccine that contains a substance that has been strongly linked to infertility? Well, if you take the Fluarix swine flu vaccine manufactured by GlaxoSmithKline or any of the other swine flu vaccines that contain Polysorbate 80 that is exactly what you will be doing. If you are considering getting the swine flu vaccine, or any other vaccine for that matter, perhaps you should educate yourself about EXACTLY what is in these vaccines before you allow them to be injected into your body.

Perhaps you think that linking the swine flu vaccine with infertility is quite a stretch. Well, let's take this one step at a time.

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Atmospheric Geoengineering

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Institute of Science in Society

ISIS Report 20/09/10

Anonymous report confirms climate and weather manipulation experiments conducted by the US and its allies over the past decades Julian Rose

Chemtrails unveiled

Much suspicion has been aroused by unusual cloud formations and abnormal jet trails in the upper atmosphere over the past decade. I have personally witnessed hundreds of days of 'engineered'' jet trails and clouds, both in the UK and in Poland. However, it has proved extremely difficult to obtain any information about the phenomenon from official sources. When challenged, the normal answer is "nothing unusual is happening."

This turns out to be very far from the truth. While I concentrate most of this article on just one recent example of professional research on the topic, there have been hundreds of both official and unofficial documents exploring and exposing the military and civil aviation antics responsible for spraying layer upon layer of toxic aerosol "chemtrails" in the sky above our heads on an almost daily basis for the past ten years.

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