The Kevin Trudeau Show: 3-17-10
Today, Kevin explains how far the FDA will go to protect the profits of the precious drug companies and why red bull is banned in France and Demark.
Daily Finance Claims Alternative Medicine is Ineffective… “or Worse”
Over a Million UK Patients Addicted to Pain Killers
Government Workers Feel No Economic Pain
March Madness Membership Drive
Plus, the modern day Nostradamus and founder of The Trends Research Institute, Gerald Celente, stopped by to tell you how he was able to get out of Chile unharmed after the 8.8 earthquake hit the country and to give you his predictions for the next few years.
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Daily Finance: Alternative Medicine is Ineffective…or Worse
February 23, 2010
Daily Finance
By Melly Alazraki
Disturbing news about alternative medicine has been in the air lately. Just the other day, and a few years too late, the Food and Drug Administration issued a stern warning about ear candling — the practice of using lit cone-shaped candles to supposedly draw earwax and impurities or toxins out of the ear canal, marketed for conditions ranging from hearing loss to cancer. Alas, the FDA says that ear candling is not only ineffective but can cause “serious injuries.”
The warning came just weeks after a liquid dietary supplement marketed as suitable for the “entire family,” providing nutrients to “maintain energy and sustain health,” had 200 times the concentration of selenium listed, causing a widespread outbreak of acute selenium poisoning that sickened 201 people. And then there was the Zicam warning last year: a homeopathic nasal-spray and gel cold remedy from Matrixx Initiatives (MTXX), recalled by the FDA after it apparently caused users to lose their sense of smell. Homeopathic remedies are regulated as over-the-counter drugs but aren’t subject to drugs’ safety and efficacy testing.
Poison on the Shelves
Doctors, scientists, and researchers have long warned that most “complementary and alternative medicines,” or CAM — acupuncture, homeopathy, dietary supplements, Ayuverda — are at best ineffective and at worst dangerous. Little scientific evidence suggests efficacy, and many studies backing them lack scientific merit. The 1994 Dietary Supplement Health and Education Act weakened up the regulation of dietary supplements, permitting marketers to promote vitamins, minerals, herbs or botanicals, and amino acids without submitting proof of efficacy or safety to the FDA.
The result is potentially poisonous products on the market, say researchers in the Archives of Internal Medicine. Dietary supplements were considered safe unless proven otherwise by the FDA, through postmarket surveillance: a strategy the General Accounting Offices criticizes for being ineffective. And under the DSHE act, manufacturers of dietary supplements were not required to record or forward to the FDA any reports of illnesses that may have resulted from the use of their products.
In 2007, some 38% of U.S. adults and 12% of children used CAM in the previous 12 months, according to the National Institute of Health’s National Center for Complementary and Alternative Medicine. Those 83 million adults spent $33.9 billion out-of-pocket on CAM: 1.5% of the total spent on U.S. heath care, and 11.2% of what was spent out-of-pocket. Despite evidence that they’re ineffective, such remedies constitute a growing category.
A Senator Backs Faith-Based Medicine
Britain’s House of Commons on Monday dealt a blow to CAM. “Homeopathic products perform no better than placebos,” said the Parliamentary committee’s report, which concludes: “To maintain patient trust, choice and safety, the Government should not endorse the use of placebo treatments, including homeopathy.”
In the face of the looming health-care reform, U.S. Senators have been trying to add various provisions to the bill: Sen. Tom Harkin (D-Iowa) has tried to push insurance coverage for alternative medicines; and Sen. Orrin Hatch (R-Utah) has attached a provision that would cover Christian Science prayer treatments.
It’s unclear whether faith-based medicine has ever been clinically tested, but a spotcheck of the NCCAM Health page and its Office of Dietary Supplement fact sheet shows that many remedies have very limited health benefit, if any. WIth an industry whose products offer a greater risk of danger than a promise of benefit, and as the public keeps buying into these remedies, the U.S. should intervene not to support the trend of their growing use, as Harkin and Hatch would seem to support, but reducing our reliance on quackery.
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Glenmark Gets A Slap on The Hand By The FDA for Selling Unapproved Drug
March 17, 2010
Reuters
* FDA says company sold unapproved nitroglycerin
* Glenmark says evaluating situation
* Company says 2010-11 financial numbers not affected
Glenmark Pharmaceuticals Ltd <GLEN.BO> sold nitroglycerin tablets without approval from U.S. regulators, the Food and Drug Administration said in a letter released on Tuesday.
“Based upon our information, there are no FDA-approved applications on file” for nitroglycerin tablets in doses of 0.3 milligrams, 0.4 milligrams and 0.6 milligrams, the FDA said in the letter.
Glenmark said in a statement that nitroglycerin was an old drug that was previously “grandfathered” in with a category of medicines sold in the United States prior to 1938 without approved applications.
The FDA has made an effort since 2006 to remove older unapproved drugs from the market.
Glenmark said it is “evaluating the situation and will take appropriate measures.”
“We believe that the sales from nitroglycerin tablets will not have a significant bearing on our FY 2010-11 financial numbers,” the company said.
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Former FDA Commissioner Against DSHEA
March 16, 2010 by JP
Filed under Government
March 16, 2010
NutritionNews.com
In an article written for Natural Products INSIDER, Peter Barton Hutt, Senior Partner at Covington & Burling LLP and former FDA Chief Counsel (1971-75), states that the FDA took virtually no enforcement action under DSHEA for nearly a decade as the result of an order from then-commissioner David Kessler, M.D., to not enforce the new law. Hutt writes: “Kessler was so infuriated by the enactment of DSHEA, however, that he ordered FDA not to enforce the new law. Initially, this was not widely understood. As time has gone on, however, former FDA enforcement officials have admitted that, for the first full decade under DSHEA, FDA took virtually no enforcement action because of Kessler’s policy. Kessler was convinced that, if the law was not enforced and the worst elements of the dietary supplement industry were allowed to run wild, Congress would repeal the law.”
For anyone interested in the back story of how we came to this, read on. The article is part of an ongoing series compiled by Natural Products INSIDER called “DSHEA @ 15″ that includes articles and interviews looking at the 15 years since DSHEA was passed in 1994. To read the complete article by Hutt, click here.
So the industry was unregulated because the FDA chose to not do their mandated job of consumer protection. Instead, the nutritional products industry developed “Good Manufacturing Practices” and policed itself.
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The Kevin Trudeau Show: 3-16-10
Today, Kevin explains how low Barack Obama will go just to get his healthcare bill passed and why people in higher power always end up losing their sense of morality.
Plus, get the headlines you aren’t hearing anywhere else:
Vitamin D Proven More Effective Than Vaccines at Preventing Flu
WHO Admits Cell Phones Cause Brain Tumors
Bananas May Prevent HIV Transmission
Former FDA Commissioner ‘Ordered’ Agency Not to Enforce DSHEA
IMF Proposed Plan to Raise Climate Change Funds
Gender-Bender Chemicals Are Turning Boys Into Girls
Dean Foods Pulls Bait-n-Switch!
3D TV May Be The Future Despite Fears of Causing Health Problems
Weed Killer Known to Chemically Castrate Frogs
E.Coli & Chicken Feces Allowed by USDA
Illinois Residents Scared by Local Cancer Study
Heart Treatments for Diabetes Causing Harm
Plavix Gets New FDA Warning
It’s ALWAYS About The Money
Maximize Your Downline
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First Lady to Meet with Food Companies on Anti-Obesity Strategy
March 16, 2010 by JP
Filed under Government
March 16, 2010
Associated Press
Michelle Obama has talked to schools and nutrition groups across the country in her effort to reduce childhood obesity. On Tuesday she will face the food companies that make the snacks and junk food that stuff grocery aisles and school vending machines.
Not that the companies mind. The Grocery Manufacturers Association — which counts Kraft Foods Inc., Coca Cola Co. and General Mills Inc. among its members — invited her to speak at its science forum.
Welcoming the first lady and embracing her campaign for healthier kids, launched earlier this year, could have advantages.
The industry is positioned to take some blows in the coming year, including a child nutrition bill about to move through Congress that could eliminate junk food in schools, digging into some companies’ profits.
The Food and Drug Administration is also beginning to crack down on misleading labeling on food packages, saying some items labeled “healthy” are not, and the Senate last year mulled a tax on soda and other sweetened drinks to help pay for overhauling health care.
That tax did not make it into the health care bill, but it could be seen as an opening shot in a quietly growing effort to target food companies, especially as local, state and federal governments scrounge for revenue in a tight fiscal environment.
Michelle Obama has not previously taken her anti-obesity campaign directly to the large food companies. She said recently, however, that she would like to see more customer-friendly food labels “so parents won’t have to spend hours squinting at words that they can’t pronounce to figure out whether the foods that they’re buying are healthy or not.”
She has also said she will push companies that supply foods to schools to improve nutritional quality. Her campaign is largely focused on school lunches and vending machines, along with making healthy food more available and encouraging children to exercise more.
Scott Faber, a lobbyist for the grocery association, said the industry is open to working with the government on finding ways to produce healthier foods.
“Consumers are demanding more and more healthy choices,” he said. “Our industry will do our part by changing the way we make and market our foods, but government has a big role to play as well.”
This approach is a far cry from the fights consumer groups had with food companies a decade ago, said Margo Wootan, director of nutrition policy at the Center for Science in the Public Interest.
“When I first started working on junk food in schools, it was a very contentious issue where we regularly did battle with junk and snack food companies,” she said. “Now it’s a whole new world, and many of them are supporting updating standards.”
Wootan said she believes that embarrassment is in part fueling the companies’ push, as more attention has been placed on foods’ nutritional values or lack thereof. More uniform federal standards could also be helpful to food companies, she said, as some states and localities are creating their own standards for marketing and making foods.
“When you see the handwriting on the wall, it’s time to get on the right side of the issue,” Wootan said.
Consumer advocates say they are cautiously optimistic about the industry’s involvement, but will wait to see how amenable they are to real change.
“They want to be riding that crest rather than fighting it,” said Jeffrey Levi, executive director of the Trust for America’s Health, a Washington-based public health research organization. “There is a long ways between saying the right things and doing the right thing.”
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Commercial Drug Comparison Studies Non-Existent
March 15, 2010
Reuters
Most of the so-called comparative effectiveness research is done at academic institutions or by other noncommercial enterprises, and less than 20 percent examine the safety of treatments, researchers reported in the Journal of the American Medical Association.
“Most of the comparative effectiveness studies we reviewed simply tested whether medication ‘x’ is better than medication ‘y,’ rather than addressing fundamental questions such as: How can we use this medication more effectively? When is this medication better than surgery? Which among two effective approaches is the safest?” said Dr. Danny McCormick of Harvard Medical School in Boston, who led the study.
McCormick and Dr. Michael Hochman of the University of Southern California in Los Angeles chose 328 studies in major medical journals that evaluated drugs.
About a third, 104 of them, compared a drug to something else. Forty-three percent compared one drug to another, 11 percent compared a drug to a non-drug therapy, 15 percent focused on different dosing schedules, 19 percent looked at safety and just 2 percent included an analysis of cost effectiveness.
While most drug trials are sponsored by companies, noncommercial entities paid for 87 percent of the comparative effectiveness studies, Hochman and McCormick found.
“Many of our nation’s research priorities are driven by the pharmaceutical industry,” Hochman said in a statement.
“These companies, not surprisingly, focus most of their attention on new therapies.”
NEW NOT ALWAYS BETTER
Healthcare reform is U.S. President Barack Obama’s signature political strategy and he has proposed comparative effectiveness research as one big component. Last year Congress approved $1.1 billion for comparative effectiveness research as part of an economic stimulus plan.
“Additional information about existing comparative effectiveness research could help guide policy makers as they determine the amount and types of comparative effectiveness research that are most needed,” Hochman and McCormick wrote.
“In particular, our findings suggest government and noncommercial support should be increased for studies involving nonpharmacologic therapies, for studies comparing different therapeutic strategies, and for studies focusing on the comparative safety and cost of different therapies.”
The Food and Drug Administration should require such studies for drug approvals when possible, they added.
In a separate commentary, Dr. Alec O’Connor of the University of Rochester Medical Center in New York agreed.
“Given the continued progress of science, approval of a new drug or device implies to physicians and the general public that the product represents an advance over older treatments,” O’Connor wrote.
But this is not always true. Recent studies have shown, for instance, that older, cheap drugs such as generic diuretics to treat high blood pressure, or metformin to treat diabetes, work better than newer drugs in many cases.
“For example, if a new medication to treat depression is approved based only on placebo comparisons, it’s very difficult to know how the new drug compares with the dozens of medications already approved for depression,” he added in a statement.
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Food Manufacturer Knew Plant Had Salmonella
March 15, 2010
The Washington Post
By Lyndsey Layton
The company at the heart of a growing recall of processed foods knew that its plant was contaminated with salmonella but continued to make a flavoring and sell it to foodmakers around the country, according to inspectors at the Food and Drug Administration.
Managers at Basic Food Flavors of Las Vegas learned on Jan. 21 that samples taken a week earlier from their Nevada facility tested positive for salmonella, a potentially deadly bacterium, but they kept shipping their product to foodmakers, according to FDA inspection records.
The company makes hydrolyzed vegetable protein, or HVP, a flavor enhancer used in a wide variety of processed foods, from potato chips to sweet and sour tofu. The additive, which comes as a powder or a paste, is mixed into foods to give them a meaty or savory flavor — similar to the use of monosodium glutamate.
Basic Food Flavors tested surfaces near food-processing equipment throughout its plant twice in January and once in February, and each time the samples showed salmonella contamination, according to FDA records. The company continued to ship products and to make more HVP without cleaning the plant or the equipment in a way that would have minimized contamination, the records said.
“The FDA is reviewing the evidence in association with the current inspection of Basic Food Flavors to determine the appropriate regulatory response,” FDA spokeswoman Meghan Scott said.
It is illegal to knowingly sell food products that are contaminated with salmonella.
Officials at Basic Food Flavors did not return calls seeking comment.
No one is thought to have fallen ill from contaminated HVP, and the health risk is considered to be low because most products containing HVP are cooked during processing or carry cooking instructions for consumers, so any salmonella probably would be destroyed before the food was eaten. Ready-to-eat products, such as chips and other snack foods, would carry greater risks.
“It highlights why we need strong rules that would prevent contamination in the first place, so the FDA isn’t swooping in like the cops after the fact,” said Erik Olson, director of chemical and food safety programs at Pew Charitable Trusts.
Legislation that would require companies to take measures to prevent contamination was overwhelmingly passed by the House last year but has been held up in the Senate.
Federal officials were alerted to a problem with Basic Food Flavors in early February by a foodmaker who detected salmonella in one lot of HVP it purchased from the Nevada manufacturer.
Federal inspectors went to the plant within days of the complaint and conducted 14 inspections in the span of about two weeks. They documented dirty utensils and equipment — mixers and tubing coated with brown residue — and cracks and fractures in the floor, as well as standing water on the floor — all conditions where bacteria can breed.
In one area where paste mixers and belt dryers were positioned, FDA inspectors noted “standing, grey/black liquid” in the drain near the area where the hydrolyzed vegetable protein was turned from paste to powder. “We sensed an odor in the vicinity of this drain,” the inspectors wrote.
The company is one of only a handful that manufacture hydrolyzed vegetable protein, and its customer list is extensive. It produces about 20 million pounds of the food additive annually, according to a food industry source.
The contamination is believed to date to September 2009, meaning millions of pounds of potentially tainted HVP — all of which the company has recalled — was shipped in bulk to foodmakers over five months. Many of those companies then sold their products to other clients, complicating the distribution chain and making it hard for federal officials to gauge the scope of the problem.
Food companies had recalled more than 100 products as of Tuesday afternoon, ranging from dips to salad dressings to soup bouillon, and that list is expected to balloon over the next several weeks.
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Bone-Strengthening Drug Linked to Fractures
March 15, 2010
ABC News
BY CHRISTINE ROMO and LARA SALAHI
Sandy Potter, 59 of Queens, New York, was jumping rope with neighborhood children when she felt her thigh bone snap.
“I went up in the air and I came straight down to the ground,” Potter said. “The pain was excruciating.”
Potter, who was diagnosed with osteoporosis at age 48, had been taking the popular osteoporosis drug Fosamax for eight years before her femur literally snapped in two.
Fosamax, one in a class of drugs called bisphosphonates, is supposed to make bones stronger. But now there’s mounting evidence that for some women, taking Fosamax or its generic alendronate for more than five years could cause spontaneous fractures.
“We are seeing people just walking, walking down the steps, patients who are doing low-energy exercise,” said Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center. “Very unusual, the femur is one of the strongest bones in the body.”
Egol said X-rays of some of his patients look more like an injury endured by a car accident than an otherwise minimal fall.
“Over the last 18 months we are seeing this more frequently,” he said.
Sue Heller, 60, of Castle Rock, Colo., had been on Fosamax for almost 10 years. She broke both of her femur bones.
“I’m sure there are a lot of women who have brittle bones right now that maybe are ready to break, and they’re not aware of it,” said Heller. “And my heart aches for them.”
Sales of the popular drug increased when doctors began prescribing it not only to women showing signs of osteoporosis, but also those who were osteopenic, and thus, at risk for the disease. Now some doctors worry that staying on the drug for more than five years can cause some women’s bones to become more brittle.
This is not the first time that many doctors have reported an opposite effect for many people taking the drug. Fosamax has already been linked to severe musculoskeletal pain, as well as to a serious bone-related jaw disease called osteonecrosis.
“In worldwide post-marketing experience with FOSAMAX/FOSAMAX Plus D, rare reports consistent with osteonecrosis of the jaw have been received. Many of these reports lack sufficient clinical details to make definitive assessments and/or are confounded, particularly since a generally accepted definition of ONJ in the general population is unknown,” responded Merck in a written response to the suggested link. “Rare cases of ONJ have also been reported in patients who do not have osteoporosis and who have not taken any bisphosphonate medicines.”
In 2008, the Food and Drug Administration reached out to the pharmaceutical company Merck about the reports of femur fractures. After 16 months, Merck added patients’ reports of femur fractures to the list of possible side effects reported by patients included in the drug’s package insert.
“It took Merck an entire year to respond,” said ABC News senior health and medical editor, Dr. Richard Besser. “Just six words: ‘low energy femoral shaft and subtrochanteric fractures.’”
The FDA has also never made an effort to inform the public or doctors across the country who prescribe bisphosphonates of the possible side effect, said Besser.
Both the FDA and Merck declined ABC News’ request for an interview. The FDA said they are looking into reports of fractures.
“Nothing is more important to Merck than the safety of its medicines,” according to a written statement by Merck to ABC News. A causal relationship between Fosamax and these fractures has not been established, according to Merck.
“The drug companies have to recognize when there is a problem, they have to be up front with the public. If there’s a concern, they have to voice it and at least give everybody a fair chance to look at this carefully,” said Dr. Joseph Lane, orthopedic trauma surgeon at the Hospital for Special Surgery in New York City.
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FDA Adds Boxed Warning To Plavix On Effectiveness
March 15, 2010
Reuters
By Lisa Richwine and JoAnne Allen
The Food and Drug Administration said it was adding a new boxed warning to Plavix, an $8-billion-a-year drug sold by Bristol-Myers Squibb Co and Sanofi-Aventis SA.
The new language will “warn about reduced effectiveness in patients who are poor metabolizers of Plavix,” the FDA said in a notice on its website.
Poor metabolizers are people whose bodies do not effectively convert Plavix to its active form.
“Because the patient makes less of the active form there is less anti-platelet effect in the blood and the patient may not receive the full benefit of Plavix treatment,” Mary Ross Southworth of the FDA’s Center for Drug Evaluation and Research told reporters in a teleconference.
An estimated 2 percent to 14 percent of the population are poor metabolizers of Plavix, the FDA said.
Bristol said published studies suggested the percentage of poor metabolizers is approximately 3 percent. “Patients should continue taking Plavix unless told to do otherwise by their healthcare professional,” the company said in a statement.
The new warning will advise doctors of genetic tests that can identify those patients and to consider alternatives for them.
The length of time it takes to get results of the genetic tests and costs will vary depending on the laboratories used, but the tests are expected be priced under $500, FDA officials said.
Plavix is the second-best selling drug in the world. It loses patent protection in 2012.
Researchers have been studying an alternative drug for patients who cannot benefit from Plavix and details of their findings are expected to be released at a meeting of heart specialists next week.
Plavix reduces the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with heart disease by making platelets less likely to form blood clots.
Plavix does not have its anti-platelet effects until it is metabolized into its active form by the liver enzyme, CYP2C19.
Information about poor metabolizers and diminished effectiveness was first included in the Plavix label in May, 2009, officials said.
“Since that label was approved, further evidence has accumulated to support evidence of an association between CYPC219 type, Plavix exposure and poor treatment outcomes,” Southworth said.
“After reviewing all of that data, we felt like we probably needed to strengthen the warning to include that the provider should consider alternative treatment strategies.”
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