Marijuana derived painkiller seeks FDA approval.

from Everyday Health 

MONDAY, Jan. 23, 2012 — A British company has submitted the first drug developed from marijuana to the U.S. Food and Drug Administration for approval. Called Sativex and administered in oral spray form, the drug contains two of the best-known components of marijuana, delta-9-THC (better known as just THC, the main psychoactive ingredient in marijuana) and cannabidiol, which has been found to have pain-fighting properties.

Sativex has already been approved in Canada, New Zealand, and eight European nations (including the United Kingdom) for relieving muscle spasms associated with multiple sclerosis. According to the Associated Press, the developers of the drug, GW Pharmaceuticals, are hoping to have the drug on the U.S. market by 2013, with an indication for treating cancer pain.

If Sativex is approved in the United States, it could increase pressure on the government to encourage American companies to develop other drugs based on marijuana. A synthetic version of THC, Marinol (dronabinol), is FDA-approved to treatchemotherapy side effects like nausea and vomiting, as well as loss of appetite and weight loss in people with AIDS.

But medical marijuana advocates, like the group Americans for Safe Access (ASA), are worried that having more prescription products available will give the government justification to prohibit marijuana use. Speaking to the Associated Press, Kris Hermes of the ASA said, "To the extent that companies can produce effective medication that utilizes the components of the plant, that's great. But that should not be the exclusive access for people who want to be able to use medical marijuana."

According to a 2011 Institute of Medicine report, about a third of all Americans, or more than 116 million people, are currently living with chronic pain. But despite many studies showing the benefits of medical marijuana in helping pain patients, its use is still a hot topic in the United States — most recently in California, where the state's supreme court will review whether cities and counties can ban medical marijuana stores, despite the drug's legalization there.

http://www.everydayhealth.com/ pain-management/0123/a-marijuana-based-spray-for-pain-treatment-seeks-fda-approval.aspx

Is your Olive Oil really Virgin; or even made from Olives?

In our recent story highlight: Not All Fried Food Is Linked To Heart Disease & Premature Death we discussed how not all fried food is bad for you. Specifically foods cooked in real Virgin Olive Oil. 

Extra Virgin Olive Oil must meet strict quality standards. It means the oil is made only from crushed olives and has not been treated with heat or chemical solvents. To meet the legal definition of "extra virgin" it must also pass a taste test. 

However, in the United States, the FDA allows producers to label their products as heart-healthy without checking what goes into the bottle.

In  author Tom Mueller's, "Extra Virginity: The Sublime and Scandalous World of Olive Oil," a book that reveals that most of the extra virgin olive oils sold in U.S. supermarkets are not what they seem. In fact, in Mueller's new book, he reveals that most of the oils labeled "extra virgin" are probably not the quality, antioxidant rich oils that consumers think they're eating to protect themselves from cancer, heart disease, Alzheimer's and other health problems.

In this expose' Mueller explains how many resellers mix olive oil with lower-quality, lower-priced seed oils that have been extracted using industrial solvents and then pass it off as high-quality olive oil. Oils have even been heated, deodorized and colored to perpetuate the fraud. One of the producers he interviews for the book estimates that some 50 percent of oils sold as "extra virgin" are not.

Mueller lives in Liguria, Italy with his wife and children. His work has also appeared in the New York Times Magazine, Atlantic Monthly and National Geographic.

 "Three weeks after I started (the book), I was sitting in a dark bar talking with this undercover military policeman who was mentioning (Italian Prime Minister Silvio) Berlusconi and wire taps and national criminal conspiracies and I thought, 'What is this? I didn't sign on for heroin trafficking, or uranium or anything like that. This is olive oil.'" Meuller said. 

"I thought it was going to be a happy, upbeat, tasty story. Very, very soon after I realized it was very different than what I expected and much richer," he says. 

"There's no oversight. Just .3 percent of food that comes into America, undergoes any kind of checking whatsoever and that includes barcode scans," Mueller says.

Some Additional Highlights from a recent NPR interview (link below). 

On why 4 out of 10 bottles that say Italian olive oil are not actually Italian olive oil

"A lot of those oils have been packed in Italy or have been transited through Italy just long enough to get the Italian flag on them. That's not, strictly speaking, illegal — but I find it a legal fraud, if you will."

On extra light olive oil

"Extra light is just as caloric as any other oil — 120 calories per tablespoon, but the average person looking at it might say, 'Oh, well, I've heard olive oil is a fat, so I will try extra light olive oil.' ... It's highly, highly refined. It has almost no flavor and no color. And it is, in fact, extra-light in the technical sense of being clear."

On which oil to use while frying or sauteing

"From a health point of view, olive oil is wonderful [for frying]. From a taste point of view, there are times when at really, really high temperatures, an extra-virgin with really bitter flavors and pungency can become a little unbalanced. And the bitterness can become overbearing. And obviously, from an economic point of view, if you're spending a lot of money for an extra-virgin, maybe high-heat cooking in some circumstances really isn't the best thing. But for lower heat, every extra-virgin olive oil is good — it really depends on the dish you're putting together."

Listen to the NPR / National Public Radio interview here: http://www.npr.org/2011/12/12/143154180/losing-virginity-olive-oils-scandalous-industry

UCSF Trial Offers New Hope for Melanoma Patients

New research trials being done at UCSF are showing very positive results for treatment of melanoma. The below excerpt is from the San Francisco Chronicle. 

Shannon Jimerson, an advanced-stage melanoma patient being treated at UCSF, did a little dance this week while still sitting on the exam table after she got the news she desperately wanted to hear.

Nine months after starting a combination drug therapy in early-phase clinical trials, her tumors were continuing to shrink.

"You have very minimal disease left," said Dr. Alain Algazi, a skin cancer specialist.

Algazi told her that her tumors had shrunk by 85 percent, leaving her with just a few "lousy little tumors" he hoped the drugs would continue to target.

Jimerson, 34, of Fairfield has benefited since January from a growing body of research that is giving new hope to patients with melanoma, the most deadly form of skin cancer. Melanoma is diagnosed in about 68,000 Americans annually and kills more than 8,700 each year.

Before entering the trial, Jimerson wasn't sure she'd be alive at this point. Her body had become so riddled with tumors that she was afraid to lay a hand on her own skin for fear she'd find a new lump. She did find a new spot, on her shoulder, and was scheduled for a biopsy two weeks after she started taking the investigational drugs.

"But by the time I got there, there was nothing to biopsy," said Jimerson, the mother of two young daughters and children's pastor at her church. "It was absolutely a miracle, this drug."

The combination of the two oral drugs, both being developed by GlaxoSmithKline, are designed for people who have a genetic mutation that is found in about half of all melanoma cases. The drugs target two different points along a pathway the cancer uses to proliferate.

At least half and up to as many as 77 percent of 71 patients in the earliest phase of the trial experienced reductions in tumor size by a third or greater, researchers said. The company is seeking to enroll about 280 patients in second-phase studies and is already planning for third-phase trials.

The results are promising considering most of the current therapies for melanoma have been found to work in fewer than 20 percent of patients, and often have far lower levels of effectiveness.

"This is definitely a great moment for patients with melanoma," said Dr. Kiran Patel, GlaxoSmithKline's director of oncology research and development. "Our goal is to progress science and really bring new and better options for patients."

Patel said he could not estimate when the company will seek federal approval for the drug combination. "We remain enthusiastic about targeted approaches and will keep doing the right studies so we can get those answers," he said.

Until this year, the last drug approved for melanoma was in 1998. But in August, the U.S. Food & Drug Administration fast-tracked the approval of a drug from South San Francisco's Genentech Inc. called Zelboraf, which targets and inhibits the genetic mutation known as BRAF V600E. The GlaxoSmithKline drugs work on that same pathway, but also targets a second point on the path.

"We haven't had any real breakthroughs since the mid '90s, and now it's like every few months we have something exciting," said Dr. Adil Daud, director of UCSF's Melanoma Program and chief investigator of the trial.

Scientists discovered that when the protein BRAF is mutated, it can become hyperactive and cause cells to grow out of control. The Genentech drug was found to work in about 50 percent of late-stage melanoma patients with the mutation.

While researchers found the results astounding, especially considering that they previously had little to offer people with metastatic melanoma, they quickly realized that the disease started progressing in some patients after several months on the drug. They suspected the cancer was finding a "work-around" in some cases by using a pathway regulated by another protein called MEK.

The GlaxoSmithKline trial drugs Jimerson has been on since January go after both BRAF and MEK. Genentech, for its part, is in clinical trials for its own combination therapy using Zelboraf, its already-approved BRAF inhibitor, and a MEK inhibitor the company is developing. UCSF is involved in that trial as well.

The hope is that patients will be able to stay disease-free longer on a drug that blocks the cancer's pathway in two places rather than just one.

"It's like a river being blocked by two dams," UCSF's Daud explained. "Maybe you'll overflow the first dam, but then the other part will take over."

Daud's colleague, Algazi, said researchers have the challenge of figuring out what other pathways exist and what drugs can be created to fend off those new routes to give the disease a "long-term, knock-out punch."

For Jimerson -- who has experienced few side effects other than a mild rash, some fatigue and an occasional fever -- the trial means she has hope for the future.

c.2011 San Francisco Chronicle

FDA considers walnuts "drugs", censors food distributor.

Walnut Grower Capitulates to FDA Censorship

"Life Extension® has published 57 articles that describe the health benefits of walnuts."

Some of this same scientific data was featured on the website of Diamond Foods, Inc., a distributor of packaged walnuts.

Last year the FDA determined that walnuts sold by Diamond Foods cannot be legally marketed because the walnuts “are not generally recognized as safe and effective” for the medical conditions referenced on Diamond Foods’ website.

According to the FDA, these walnuts were classified as “drugs” and the “unauthorized health claims” cause them to become “misbranded,” thus subjecting them to government “seizure or injunction.”

Despite pleas from health freedom activists to challenge this blatant example of censorship, Diamond Foods capitulated and removed from its website statements about the benefits of walnuts.

FDA thus scored a victory by denying some Americans access to scientific data about a food that can reduce the risk of the most common diseases afflicting aging humans.1-15

http://www.lef.org/featured-articles/Walnut_Grower_Capitulates_to_FDA_Censorship.htm

Shocking news:80% of antibiotics made go to food animals.

The U.S. Food and Drug Administration confirmed numbers this week that indicate animal agriculture consumes 80 percent of all antibiotics used in the United States, more than previously estimated.

Congresswoman Louise Slaughter (D-NY) announced Wednesday that FDA confirmed the numbers with her office for the first time. She plans to reintroduce a bill she crafted in 2009 aimed at preserving the effectiveness of antibiotics important for human health by limiting their use in agriculture.
"Today I confirmed an alarming number that should shock all of us: 4 out of 5 antibiotics sold in this country were for use on animals, many of whom are not even sick, and that is dangerous to all of us," said Slaughter. "We already knew that 13.1 million kilograms of antibacterial drugs were sold for use on animals in 2009.  Recently, I was able to confirm with the FDA that only 3.3 million kilograms were are sold each year for human use in 2009. Using these figures, I have determined that 80 percent of all antibacterial drugs are dedicated to use on animals."

Slaughter's math is on point with December reports from Ralph Loglisci at Johns Hopkins Center for a Livable Future, also published at Food Safety News Dec 27, and Maryn McKenna, an infectious disease journalist and author of "Superbug." 

Asked about the numbers, Sarah Hubbart, a spokeswoman for the Animal Agriculture Alliance, said it was "interesting" that Slaughter does not indicated what percent of the antibiotics given to food animals are the same types used to treat human illness. She noted that "a large percentage of the antibiotics used to treat and prevent illness in animals are ionophores, compounds not used in human medicine."

Loglisci wrote in December that this industry argument--also cited by the National Pork Producers Council--is "inaccurate."

"All uses of antibiotics have the potential to decrease the effectiveness of antibiotics in people. Ionophores are no exception," he added.

Read More at the Below Link:

http://www.foodsafetynews.com/2011/02/fda-confirms-80-percent-of-antibiotics-used-in-animal-ag/

Arsenic agent beats 2 hard-to-treat cancers in new animal experiments.

Washington, DC - Researchers at the Georgetown Lombardi Comprehensive Cancer Center, a part of Georgetown University Medical Center, have found that an arsenic-based agent already FDA-approved for a type of leukemia may be helpful in another hard-to-treat cancer, Ewing's Sarcoma (ES). The research, based on animal studies, also suggests the drug might be beneficial in treating medulloblastoma, a highly malignant pediatric brain cancer (see also Clinical Trials Research).

In the December 22 issue of the Journal of Clinical Investigation, the investigators describe how years of research has uncovered a common pathway in these tumors, known as hedgehog/GLI1. They further detail how they used an existing drug, arsenic trioxide (Trisenox??), to shut down that pathway in mice models of ES and medulloblastoma.

This pathway is also common in other cancers, such as colon, pancreatic, and basal cell skin cancer, among others, says the study's lead investigator, associate professor Aykut Uren, M.D., of Georgetown Lombardi.

"The significance of our finding is that this FDA approved agent can be tested immediately in other cancer types. It is a perfect translational research project," he says. "This laboratory research has immediate clinical implications."

Uren adds that researchers are moving quickly to find an effective inhibitor of the hedgehodg/GL1 pathway because it is so powerful in cancer development. Hedgehog controls cell division in embryonic development, but when it is turned on, and out of control in adult cells, cancer results. Because of that, there are a number of clinical trials underway testing new compounds that inhibit this pathway at the surface membrane of cancer cells, he says.

The compound they tested, however, inhibits the pathway in the nucleus, so it may be effective in cancers that have pathway activation downstream of the membrane molecules, Uren says. "Many of the current clinical trials involve agents that act at the membrane. Ewing sarcoma and colon cancer will not benefit from that approach. Furthermore, medulloblastoma patients treated with hedgehog inhibitors are developing resistance at the membrane level. Therefore, clinical trials can evaluate alternative therapies for patients whose treatment fails with current hedgehog inhibitors," he says.

Arsenic trioxide has been approved for use of acute promyelocyctic leukemia (APL) as a second-line therapy for patients who do not respond to standard therapy.

Arsenic trioxide is generated from processing arsenic compounds, and while a high level of arsenic is known to be carcinogenic, low doses can be therapeutic in selected patients, Uren says. In fact, he says starting in the 17th century, arsenic was the primary therapy for treating leukemia, specifically chronic myelogenous leukemia (CML). He also cites a Dutch population study that concluded low levels of arsenic concentrations in drinking water not only didn't increase cancer incidence in people who drank it, but resulted in a decrease in nonmelanoma skin cancers.

"Like any chemotherapy, high doses of arsenic can be toxic, while lower doses can treat cancer," he says.

In 2009, Uren and his research team, which includes first author Elspeth Beauchamp, Ph.D., showed that the hedgehog/GLI1 pathway is activated in ES. They are now the first to inhibit this pathway by arsenic trioxide in ES, and among the first to show its activity in medulloblastoma.

http://www.lef.org/news/LefDailyNews.htm?NewsID=10621&Section=DISEASE

" The Dutch report shows having minute amounts of Arsenic gives extremely beneficial results against specific cancer cells. The resistance to the logic and reality of dilution is innate in our belief system for some unknown reason. Many people believe diluted substances can not be effective and yet in clinical trials dilution appears to yeild treatments that are highly effective. Classical Homeopathy has been employing highly diluted substances for two centuries with verifiable clinical results. " - Martin Keane, AP, CCH

Homeopathy in Florida

Independent advisory committee grills FDA on genetically engineered salmon

A cast of stakeholders—industry, advocacy groups, academics, and regulators—are writing the storyline, but the climax— a pending decision by the FDA— is still a month or more away.One thing is clear, this FDA decision on GE salmon will set a precedent for other GE food animals in the US, and may influence regulations and practices in other countries already farming or considering farming salmon.

Click to read more ...

FDA Neglect on acetaminophen poisoning

You might be surprised to know that the leading cause of acute liver failure in the United States is not alcohol abuse, nor viral hepatitis.

The number one reason Americans suffer acute liver failure is a drug the FDA has allowed to be sold for decades after its lethal toxicities were known.1

This drug is available over-the-counter and in prescription combinations. In many cases, those ingesting this toxic drug (under various brand names) don’t even know they are taking it.

The FDA has bent over backwards to protect billions of dollars of profits earned annually by pharmaceutical companies who sell this deadly drug.

As the body count mounted in 2009, the FDA was forced to mandate a lower dosage and remove it from prescription combinations that were particularly lethal.

Click to read more ...