© 2012 Natural Wellness®. All rights reserved.

These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease. Natural Wellness® has developed certain nutritional supplements to meet the specified needs of our customers. These products are not intended to diagnose, treat, cure, or prevent a disease, but rather are dietary supplements intended solely for nutritional support. These statements have not been evaluated by the Food and Drug Administration. Testimonials reflect the personal experience of each person quoted. Individual results may vary. the information provided on this site is not intended as a substitute for advice from your physician or other health care professional or any information contained on or in any product label or packaging. Please consult with a healthcare professional before starting any diet, exercise or supplementation program, before taking any medication, or if you have or suspect you might have a health problem.

U.S. health regulators said on Tuesday they received a report of a multiple sclerosis patient who died within 24 hours of taking the first dose of Novartis AG’s Gilenya.

SUMMARY

The patient, who had been suffering from multiple sclerosis for over 10 years, died on November 23, one day after receiving his first dose of Gilenya, Novartis said.

The U.S. Food and Drug Administration said at this time, it cannot conclude whether the drug, a potential blockbuster, resulted in the patient’s death, but was evaluating the case.

The patient was also treated with two other drugs, and had completed 6 hours of monitoring after the first Gilenya dose without incident.

Last week, the Swiss drugmaker said it was investigating whether Gilenya caused the death of a 59-year-old patient who had just started therapy with the drug.

The patient, who had been suffering from multiple sclerosis for over 10 years, died on November 23, one day after receiving his first dose of Gilenya, Novartis said.

The FDA said healthcare professionals should observe all patients for signs and symptoms of slow heart rate for 6 hours after the first dose of Gilenya.

However, the regulator said it believes Gilenya provides an important health benefit when used as directed, and patients with multiple sclerosis should not stop taking the drug without talking to their healthcare professional.

Fridley-based Medtronic announced results Monday showing a majority of patients in a research study experienced fewer problems with fecal incontinence and a better quality of life for three years after receiving a new medical device treatment.

The device, called InterStim, was approved in March by the U.S. Food and Drug Administration for the treatment of chronic fecal incontinence. a pacemaker-style device that tries to tame symptoms through electrical stimulation of nerves, InterStim has been approved for more than a decade as a treatment for urinary incontinence in certain patients.

Among the 77 study participants who completed three years of follow-up assessments, 86 percent reported at least a 50 percent reduction in the number of incontinence episodes per week. Complete continence – meaning a 100 percent reduction in episodes – was seen in 40 percent of patients, according to the study being published in a medical journal called Diseases of the Colon & Rectum.

“We estimate that about 2 percent of the population has this problem, and it is a hidden problem,” said Dr. Anders Mellgren, lead author of the study and a professor at the University of Minnesota. “This is something you don’t speak so much about.”

Researchers at the U contributed 27 of the 130 patients included in the new study, which was conducted at 16 research centers. All patients had tried more conservative medical treatments, such as physical therapy, without success, or were not candidates for such treatments.

The InterStim products are part of the company’s division in Fridley for neurology devices, which generated about $1.6 billion in revenue during the company’s most recent fiscal year. Medtronic does not break out revenue figures by product line.

The most common adverse events in the study included pain at the site where the device is implanted in the buttocks as well as numbness. both problems usually resolved themselves with time and with tweaks to the level of stimulation provided by the device, Mellgren said. about 10 percent of patients in the study had an infection.

The device is no bigger than a stopwatch and costs between $10,000 and $15,000, Mellgren estimated. the total cost of an implant is $20,000 to $30,000, according to a Medtronic spokeswoman.

Christopher Snowbeck can be reached at 651-228-5479.

Newswise — A warning issued by the Food and Drug Administration regarding the use of atypical antipsychotics for the treatment of dementia was associated with a significant decline in the use of these medications for treating dementia symptoms in elderly patients, according to a report in the February issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

“In 2001, more than 70 percent of U.S. atypical antipsychotic prescriptions were written for off-label indications such as dementia, and atypical antipsychotics accounted for 82 percent of antipsychotic prescriptions written for older patients in Canada in 2002,” according to background information in the article. “In 2005, the Food and Drug Administration (FDA) issued a black box warning that stated, ‘Treatment of behavioral disorders in elderly patients with dementia with atypical antipsychotic medications is associated with increased mortality.‘” Black box warnings are the strongest warnings the FDA issues.

To examine changes in the use of atypical (second generation antipsychotic drugs) and conventional (first generation or “typical” antipsychotics) antipsychotic medications for treatment in patients with dementia, Helen C. Kales, M.D., of the University of Michigan, Ann Arbor, and colleagues reviewed data from more than 250,000 patients with dementia. Data were collected from the national Veterans Affairs (VA) registries maintained by the serious Mental Illness Treatment, Research and Evaluation Center in Ann Arbor, Mich., for veterans age 65 or older who received a dementia diagnosis between April 1999 and September 2007. the overall study period was divided into three sections: no warning (1999-2003), early warning (2003-2005) and black box warning (2005-2007).

At the beginning of the study, 17.7 percent of patients with dementia were using atypical or conventional antipsychotics. overall antipsychotic use began to decline during the no warning period. However, use of atypical antipsychotics increased during the no-warning period, began to decline during the early-warning stage and more sharply declined during the black box warning period.

“In this national VA sample, we found that use of both conventional and atypical antipsychotics for patients with dementia began to decline significantly well before implementation of the black box warning,” the authors write. “In conclusion, use of atypical antipsychotics for patients with dementia began to decline significantly in 2003, and the FDA advisory was temporally associated with a significant acceleration in the decline.” (Arch Gen Psychiatry. 2011;68[2]:190-197. Available pre-embargo to the media at jamamedia.org.)

Editor’s Note: this study was supported by a grant from the National Institute of Mental Health and the serious Mental Illness Treatment, Research and Evaluation Center, Ann Arbor, Mich. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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© 2010 Natural Wellness®. all rights reserved.

These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease. Natural Wellness has developed certain nutritional supplements to meet the specified needs of our customers. these products are not intended to diagnose, treat, cure, or prevent a disease, but rather are dietary supplements intended solely for nutritional support. these statements have not been evaluated by the Food and Drug Administration. Testimonials reflect the personal experience of each person quoted. Individual results may vary. the information provided on this site is not intended as a substitute for advice from your physician or other health care professional or any information contained on or in any product label or packaging. Please consult with a healthcare professional before starting any diet, exercise or supplementation program, before taking any medication, or if you have or suspect you might have a health problem.

Vitamin C is a powerful antioxidant, which helps neutralize cell-damaging free radicals when taken orally. When used intravenously, the vitamin appears to also directly attack pathogens and has shown promise for treating a wide range of infectious diseases, burns and boosting your immune system.

Already intravenous (IV) vitamin C is difficult to come by for some — last year one man’s family had tohire a lawyer to get IV vitamin C administered, which ended up saving his life — but soon it may be banned outright.

The U.S. Food and Drug Administration (FDA) appears to be making vitamin C its latest target, and has notified one pharmacy that it must no longer manufacture or distribute injectable vitamin C.

Their reasoning has nothing to do with safety, as vitamin C has continually proven to be one of the least toxic nutrients in foods and liquid forms have a safe history of use. instead, the FDA is banning IV vitamin C because it can’t be patented, and can’t be taken through the FDA’s approval process for a “new drug.”

The FDA also notified the pharmacy to stop manufacturing injectable magnesium chloride and injectable vitamin B-complex 100, which are often added to IV vitamin C to make the “Myers Cocktail,” used to treat chronic fatigue syndrome and infectious diseases.

Just like they have targeted natural thyroid hormones, vitamin B6, bioidentical hormones and countless other natural products that have threatened the profits of the drug giants, the FDA is now trying to ban IV vitamin C — despite the fact, and more accurately likely because of the fact, that it has shown promise in treating everything from swine flu to cancer.

As the Alliance for Natural Health stated:

“Intravenous vitamin C, administered under the care of a qualified physician, is being studied as an antiviral, antibacterial, anticancer powerhouse.

the FDA suggests it be taken through the full approval process with either a New Drug Application or as an Investigational New Drug, but these can cost billions of dollars, and with NIH refusing to fund any research on IV vitamin C, it’s practically a death sentence for such a vital and life-giving substance.”

Already, a study on the use of high-dose IV vitamin C for the treatment of burns, sponsored by the U.S. Army Institute of Surgical Research, has been terminated because it is waiting for FDA approval of an Investigational New Drug (IND) Application for the vitamin C — and this is only the tip of the iceberg of studies and treatments that will have to be forfeited if the FDA follows through with banning IV vitamin C.

IV vitamin C made headlines last year when the compelling story of Allan Smith, a man conventional doctors claimed “could not survive” after contracting a severe case of swine flu, hit the airwaves.

Allan’s family refused to accept the hospital’s hopeless prognosis and the subsequent decision to turn off his life support. instead, his family insisted the hospital try high-dose IV vitamin C.

Initially the hospital refused, saying they “didn’t think it would work,” until the family enlisted a top legal expert to fight for their right to have vitamin C administered.

What makes this story even more remarkable is the fact that once admitted to the hospital with swine flu, Allan was also diagnosed with leukemia, which dramatically worsened his chances of recovery.

Well, not only did the vitamin C cure Allan’s swine flu infection, but after spending nine weeks in an induced coma, he walked out of physical rehab after 13 days as opposed to the predicted three months.

Even more astounding, just over a year later, he also has no further signs of leukemia …

Vitamin C expert Dr. Thomas Levy, who initially sent me Allan Smith’s case report over a year ago, is the author of several books, including Curing the Incurable: Vitamin C, Infectious Diseases, and Toxins, and Stop America’s #1 Killer, a book about vitamin deficiency and heart disease. He’s also written extensively on topics such as dental toxicity issues from mercury amalgams and root canals, vaccine safety, and the clinical uses of vitamin C for infectious diseases.

Again, vitamin C is a major antioxidant, and antioxidants counter the disease process caused by oxidation (loss of electrons) by supplying electrons. According to Dr. Levy, vitamin C is one of the most important “electron donor” to maintain optimal electron flow in your cells.

Research studies have also shown promising results for vitamin C’s ability to combat infectious disease:

• Journal of Manipulative and Physiological Therapeutics, 1999 found that vitamin C in megadoses administered before or after the appearance of cold and flu symptoms relieved and prevented the symptoms in the test population compared with the control group.
• The Clinical Experiences of Frederick R. Klenner, MD states that cases of influenza, encephalitis, and measles were easily cured with vitamin C injections and oral doses.
• Orthomed.com – Dr. Robert Cathcart, MD, also offers personal case studies where intravenous administration of vitamin C turned out to be lifesaving in cases of acute flu complications.

  “it is not really a matter of medicine; it is a matter of chemistry. Doses of ascorbate which are massive enough to force a reducing redox potential into tissues affected by the disease will always neutralize the free radicals,” he says.

Vitamin C’s role in preventing infectious disease is well-established, but it is also emerging as a potential natural treatment for cancer.

Dr. Ronald Hunninghake is an internationally recognized expert on vitamin C who has personally supervised more than 60,000 IV vitamin C administrations. You can listen to my recent interview with him here.

He got his start in this field about 22 years ago when he joined Dr. Hugh Riordan, who conducted research on IV vitamin C for cancer patients. his clinic is the successor to Linus Pauling and his work on vitamin C, and there is likely no clinic in the world with as much experience as his.

Together, Hunninghake and Riordan conducted studies with a series of patients who had either stage 3 or stage 4 cancer.

“I.V. vitamin C was found to be very beneficial,” Hunninghake said. “It’s not considered a stand-alone therapy for cancer, but it’s a perfect adjunct to any kind of therapy that the cancer patient is receiving at this time.

It will reduce side effects and improve quality of life. There have actually been two major studies now showing how it improves quality of life.”

Most cancer patients experience depression, pain, and tremendous fatigue — all of which can make treatment all the more difficult.

These are all signs of scurvy, which is the result of vitamin C deficiency … and if you actually measure vitamin C levels in cancer patients, especially advanced cancer patients, most, if not all, are vitamin C deficient, Hunninghake claims:

“one of the things that IV vitamin C does is it immediately relieves their scurvy symptoms. So they start having a greater sense of well being. They don’t need as much pain medicine. their appetite improves. their mood improves. They have a better quality of life.”

If you, or someone you know, want more information about using vitamin C as an adjunct to your cancer protocol, please visitRiordanClinic.org, where you can find the Riordan IVC Protocol. That site also contains a number of research articles so that you can review the evidence for yourself.

Dr. Hunninghake has also created a video on how vitamin C fights cancer, available at HealthHunterOnline.org.

This site also contains an informative lecture by Dr. Glen Hyland called IVC, Chemotherapy and Radiation – are They Compatible?Hyland offers compelling evidence showing that not only are they compatible but they are synergistic.

IV vitamin C is relatively inexpensive, safe and very effective for a number of diverse health conditions. and conventional medicine, as a general rule, is notoriously uninterested in solutions that can’t produce profits. So it’s no surprise that vitamin C is on the regulatory chopping block.

If you want to let the FDA know that you want injectable vitamin C, magnesium chloride, and vitamin B-complex 100 to continue being manufactured and sold, you can do so using this form from the Alliance for Natural Health.

The more people who write in the better. together we can let the FDA know that we will fight to protect our right to choose natural alternatives like IV vitamin C!

articles.mercola.com/sites/articles/archive/2011/01/19/now-the-fda-is-going-after-vitamin-c.aspx

EWING, N.J.–(BUSINESS WIRE)–Antares Pharma, inc. (NYSE Amex: AIS) today announced the filing of a new Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Anturol® Gel in patients with overactive bladder (OAB).

“the NDA submission for Anturol represents a significant accomplishment for the Company in 2010. the dedicated efforts of the Antares team allowed us to achieve our goal of submitting the NDA prior to year end and we are pleased with this achievement”

the NDA submission was supported by a Phase 3 clinical trial, which demonstrated a statistically significant reduction in urinary incontinence episodes for both doses studied (56 mg daily or 84 mg daily). the trial was conducted under a Special Protocol Assessment (SPA) with the FDA. in addition, an Open Label Extension study, evaluating long-term safety has been successfully completed.

“The NDA submission for Anturol represents a significant accomplishment for the Company in 2010. the dedicated efforts of the Antares team allowed us to achieve our goal of submitting the NDA prior to year end and we are pleased with this achievement,” said Paul K. Wotton Ph.D., President and Chief Executive Officer.

Anturol Phase 3 Trial

the NDA submission, subject to acceptance by FDA, was supported by a Phase 3 trial conducted under a Special Protocol Assessment (SPA) with FDA. the trial was a double blind, randomized, parallel placebo-controlled multi-center study that evaluated the efficacy and safety of Anturol in 600 subjects with overactive bladder. the primary objective of the study was to demonstrate that daily treatment of 56mg or 84mg dose of oxybutynin applied in the ATDTM Gel technology for 12 weeks was superior to placebo for the relief of OAB symptoms. the study met its primary endpoint of a statistically significant reduction in urinary incontinence episodes for both doses studied (56 mg daily or 84 mg daily, p=0.028 and 0.033 respectively).

Secondary end points included changes from baseline in average daily urinary frequency, void volume, patient perceptions, as well as safety and tolerability including skin irritation. although not the basis for approval, the 84 mg dose provided highly statistically significant results for the secondary end points of urinary frequency and volume while the 56 mg dose did not reach statistical significance. Additionally, Anturol which uses the proprietary ATD Gel technology was well tolerated in the study. No serious adverse events related to the treatment were reported. Anticholinergic side effects such as dry mouth and constipation were low and no CNS side effects were seen compared to placebo. Treatment-related adverse events that resulted in study discontinuation during the double-blind period were low and similar for both the treatment and placebo groups.

About Overactive Bladder

OAB, also called urge incontinence, is a condition marked by a sudden need to urinate that can happen at any time whether or not the bladder is full. OAB is typically caused when the smooth muscle of the bladder undergoes involuntary contractions and may result in uncontrolled leakage. OAB is defined as urgency, with or without urge incontinence and usually includes frequency and nocturia (waking up one or more times during the night to urinate). According to published reports it is estimated that more than 30 million Americans have OAB, and while it can happen at any age is more prevalent among older individuals. It is more common than both diabetes and asthma. According to IMS the annual OAB prescription market in the United States is valued at approximately $2.0 billion.

About Anturol®

Anturol is oxybutynin gel based on the ATD Gel technology platform which is a clear, odorless, hydroalcoholic gel that provides for delivery of oxybutynin in a non-patch transdermal form. the ATD technology is also used in Elestrin®, an FDA approved product for hormone replacement therapy in postmenopausal women. It has been well recognized that transdermal delivery of drugs including oxybutynin is a safe and effective way of delivering certain drugs that undergo first pass metabolism. by delivering oxybutynin transdermally, first-pass gastric and hepatic metabolism is avoided, which is believed to result in lower anticholinergic side effects such as dry mouth and constipation compared to orally administered treatments. these side effects account for a significant level of patient non-compliance among existing oral OAB treatments.

About Antares Pharma

Antares Pharma focuses on self-injection pharmaceutical products and topical gel-based medicines. the Company’s subcutaneous and intramuscular injection technology platforms include VIBEXTM disposable pressure-assisted auto injectors, ValeoTM/VisionTM reusable needle-free injectors, and disposable multi-use pen injectors. in the injector area, Antares Pharma has a multi-product deal with Teva Pharmaceutical Industries, Ltd that includes Tev-Tropin® human growth hormone and a partnership with Ferring Pharmaceuticals. in the gel-based area, the Company’s lead product candidate is Anturol®, an oxybutynin ATD™ gel that has completed Phase 3 studies for the treatment of OAB (overactive bladder). Antares also has a partnership with BioSante that includes LibiGel® (transdermal testosterone gel) in Phase 3 clinical development for the treatment of female sexual dysfunction (FSD), and Elestrin® (estradiol gel) indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and currently marketed in the U.S. Antares Pharma has corporate headquarters in Ewing, new Jersey, with subsidiaries performing research, development and product commercialization activities in Minneapolis, Minnesota and Muttenz, Switzerland.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements related to the potential success or failure of the Anturol NDA and the impact of Phase 3 trials on the NDA. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. these risks and uncertainties include, among others, difficulties or delays in the initiation, progress, or completion of product development, clinical trials, difficulties or delays in the progress or completion of Anturol’s product development or in the success of the NDA and whether or not the Company’s application for marketing approval is accepted for review or at all by the FDA or any other regulatory authority. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2009, and in the Company’s other periodic reports and filings with the Securities and Exchange Commission. the Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

In a U.S. Senate speech this morning in Washington, Sen. Harry Reid, D-Nev., urged passage of a bill to give the Food and Drug Administration more authority to enforce food safety, saying that poisoning can strike anyone, even U.S. senatorsReid recalled he and his wife Landra visited new York some years ago, along with one of their sons and a girlfriend."we were going to go to a play," he said. "we had dinner at a nice restaurant. we both had chicken, the same dish." About 4 a.m., Reid woke up and needed water, but Landra couldn’t get out of bed. They both were ill."we were so sick that day," Reid said "we got out of the room we were staying in, mid-morning. we looked like a couple of homeless people, we were so sick."Landra Reid "never ever got over that completely," Reid said. the incident exacerbated symptoms of ulcerative colitis that she had been suffering from, for which she ultimately was hospitalized for more than a month, he said. "These illnesses affect everyone," Reid said.