EXPOSING the FDA and the USDA - Broad Casting here the things that they would prefer us NOT to know about our FOOD & DRUGS & Farming.

Saturday, January 31, 2009

They are Hiding Cell Phone Towers in Schools and Churches

From "Mercola.com"

As school budgets shrink, some are getting money from an unlikely and controversial source: cell phone tower installations. Local schools can make hundreds of thousands of dollars from leases on towers.

But some parents say the money isn't worth it. They say the practice is irresponsible and gambling with students' health without conclusive evidence that towers are safe.

More than 262 million wireless subscribers in the U.S. depend on 120,000 towers to route their calls to the appropriate destination. In residential areas, schools are seen as prime locations for towers. They offer a large tract of land in an area that otherwise has smaller tracts and residential uses.

The debate over school-based towers is happening throughout the United States. In September, an Oregon district banned them on school grounds. Los Angeles Unified School District took a similar step in 2000.

Courier-Journal December 16, 2008


The Truth about Trust


An Important Letter About Trust

I recently received the following letter from a Mercola.com reader. The name and specific profession of the writer have been withheld by request.

Dear Dr. Mercola,

Your last newsletter discussed "trust." I'm there on the front lines, providing primary care in an urgent care setting since 1977. In addition to being a licensed health care professional, I've been a serious student of alternative and complementary medicine since 1980’s.

A few years back I saw a gentleman in the clinic with diabetic neuropathy who had no feeling at all below either of his ankles. His feet were OK, free of ulcers or infection. He was on the usual blend of mainstream medications which were not helping.

I'd known him for years, so I suggested that he try two supplements:

* Alpha Lipoic Acid: Standard of care therapy for neuropathy in Europe. In fact, in Germany, it's malpractice NOT to prescribe Alpha Lipoic Acid for a patient with neuropathy.

* Adaptrin (also available as Padma-Basic): This is an ancient blend of 18 herbs which has a remarkable effect on the microcirculation. In other words, it works in the capillaries themselves to improve blood flow and oxygenation. Among its numerous benefits, many neuropathy patients have all feeling returned to their feet after two weeks on this stuff.

He asked me to write them down, so I did, having every expectation that he would be better in two weeks. When he asked his daughter to get these items, she took the list and rushed over to administration and complained. Next thing you know, I'm defending myself in a professional review action. I was condemned, in my own handwriting, by the suggestions I'd written down for the gentleman.

The issue was not the efficacy of the supplements. The committee didn't care whether they worked or not. Alpha Lipoic Acid may be the standard in Europe, but it's NOT the standard here. Their concern was that any deviation from the official mainstream published "standards of care" exposes the facility to liability. And Dr. Mercola, the sad part is, they're right.

By agreeing to stick with the "standards of care" in the future, they decided not to terminate me. I was officially counseled to NEVER discuss that "homeopathic stuff" with any patients. As a result of this experience, when I'm on the clock, I'm totally mainstream.

The take-home lesson of this experience is this: Trust works both ways. All it takes is one complaint from a patient or a family member to shut down an alternative provider. Even praise will do you in. If a patient tells another doctor, "Boy, that Sambucol really works. I never catch a cold." I'm in trouble again.

I'm not totally shut down. If a patient ASKS me about some alternative therapy, I will give them an honest and well-informed answer. But if you don't ask, I cannot tell. Another suggestion for a patient is to ask something like, "If you had my illness, what would you personally use to treat yourself." That I can answer honestly, because I'm not telling you to do anything.

Very few of the 38 percent of American adults that use complementary medicine ever show up here. The reality is that patients who go to mainstream clinics expect mainstream care. That's just the way it is. And I have to meet their expectations. The bottom-line is this: When you're a seeing person in a blind world, it's unwise to rearrange the furniture.

[Name and position withheld by request]


Onyx, a Sweet Deal for Bayer?

Onyx Pharmaceuticals (ONXX)—52-week stock price

By Gene Marcial, Business Week

The German drugmaker already has teamed up with Onyx to sell the smaller company's drug to fight kidney cancer. Could it be the next pharma to make a move?

Big pharmaceutical makers, of late, have dominated the business news as the world's largest drugmaker, Pfizer (PFE), agreed on Jan. 26 to acquire Wyeth (WYE) for $68 billion. Now the buzz on Wall Street is, "Who's next?"

Certainly the Pfizer-Wyeth deal has brought a large dose of excitement to the otherwise moribund world of pharmaceuticals and biotechs. And analysts say the deal has stirred interest among some in the industry to hatch their own buyout or merger plans.

Some targets may be companies still below the radar of most investors, and may already have close partnerships with big drugmakers.

Competing with Pfizer
One such is Onyx Pharmaceuticals (ONXX), which is developing oral anticancer therapies designed to prevent cancer cell proliferation. Sales of Onyx's drug Nexavar have been strong for the treatment of kidney cancer (renal cell carcinoma), and analysts say it has the potential to become a blockbuster.

Interestingly, Nexavar competes with Pfizer's Stutent, which the Food & Drug Administration approved in 2006 for the treatment of both advanced kidney cancer and gastrointestinal tumors. Wyeth also has a new drug for kidney cancer called Torisel, approved by the FDA in May 2007. Onyx's Nexavar, O.K.'d by the FDA in December 2005 for kidney cancer and in 2007 for liver cancer, also got a green light for marketing in the European Union as well as in Japan, China, and South Korea.

Like other small drug companies, Onyx has partnered with a global drugmaker. Germany's Bayer, which trades in the U.S. over-the-counter market under the symbol BAYRY, and Onyx split the development cost of Nexavar and will divide profits on a 50-50 basis worldwide, except in Japan, where Bayer will pay a percentage of royalties to Onyx on sales in that country. In the first quarter of 2007, Nexavar sales produced a $3 million profit for Onyx, making the product a moneymaker for the first time.

Bayer, which offers a wide variety of products, including prescription drugs, diagnostics, and health-care consumer items as well as chemicals and agricultural products, "is the ideal company that could logically acquire Onyx," says Grant Zeng, health-care analyst at Zacks Investment Research, who rates Onyx a buy.

Bayer Gets EntreƩ to Cancer Market
The German company, says Zeng, is starting to shift some of its focus to oncology, where it isn't a big player yet. Buying Onyx would quickly advance its position in the huge cancer market, says Zeng. Onyx and Bayer are working on expanding the application of Nexavar to other cancer indications, including non-small-cell lung cancer.

"Obviously, with its close collaboration with Onyx on Nexavar, Bayer already knows Onyx very well and could easily assess its value to its own operations," says Zeng. He figures that by 2010, sales of the drug will balloon, to $1.1 billion. In the third quarter of 2008, sales totaled $181 million, up 73% from a year ago. Based on Nexavar's strong sales in the first nine months of 2008, Zeng expects Onyx to post its first full-year profit in 2008. He figures the company earned 79¢ for the full year.

Zeng puts the value of Onyx at 45 a share based on his 2010 earnings projection of $2.14 a share. In an acquisition, it could fetch a higher price, says Zeng. Other large drugmakers, he adds, could also be attracted to the company.

Surely Onyx's large institutional investors, which control some 90% of shares outstanding, will back a reasonable deal. The largest holder is OrbiMed Advisors, with a stake of 7.3%, followed by Fidelity Management & Research with 6.7%, Wellington Management, 5.8%, and Barclays Global Investors (UK) Holdings (BCS), 4.3%.

With a market capitalization of $1.8 billion, Onyx would be easily affordable for Bayer, whose market cap exceeds $43 billion. Shares of Onyx hit a 52-week high of 49.97 a share on Jan. 30, 2008, but tumbled to a low of 21 in October. The stock has since recovered, to 31 on Jan. 27. Bayer, on the other hand, has climbed from its 52-week low of 44 in November to 55 on Jan. 27, but is still below its 52-week high of 89 last May.

The recent rebound in Onyx shares is seen by some investors as an indication that the stock may be attracting new buyers, especially in light of Pfizer's acquisition of Wyeth. It would make sense for Bayer to act sooner than later if it is interested in acquiring Onyx, says Zeng.

But will it? Bayer spokesman Guenter Forneck declined comment on Bayer's possible acquisition targets, but says the company will "expand its business through both internal and external growth." Onyx spokeswoman Lori Murray says the company "doesn't comment on market speculation."

Unless otherwise noted, neither the sources cited in Gene Marcial's Stock Picks nor their firms hold positions in the stocks under discussion. Similarly, they have no investment banking or other financial relationships with them.

Marcial writes the Inside Wall Street column for BusinessWeek. In 2008, FT Press published the book Gene Marcial's 7 Commandments of Stock Investing.


Soaring Cancer Drug Costs May Cripple Medicare

Business Week; Jan 28, 2009

Soaring Cancer Drug Costs May Cripple Medicare

A new report says laws crimp Medicare's ability to control costs on cancer, leading to a 267% increase in drug spending over seven years
By Catherine Arnst

Medicare spending on cancer drugs has skyrocketed in recent years, and Congress has severely limited the program's ability to do anything about it, says a report in the Feb. 7 issue of The New England Journal of Medicine.

Although it is not the case with other drugs, Medicare must reimburse doctors or patients for virtually all cancer drug uses, even those not yet approved by the Food & Drug Administration. And it is not permitted to favor the lowest-cost treatment. As a result, says author Dr. Peter Bach of Memorial Sloan-Kettering Cancer Center in New York, "the prices of cancer drugs appear to be rising faster than the health benefits associated with them."

Bach notes that Medicare spending on drugs administered in a doctor's office, the vast majority of which are cancer treatments, rose from $3 billion in 1997 to $11 billion in 2004, a 267% increase. Overall Medicare spending rose by only 47% over the same period. Spending on cancer drugs is likely to rise even faster in coming years since a November decision by the agency that greatly expands patient access to cancer drugs as required by law.

Cost Gains Aren't Necessarily Treatment Gains
Medicare now allows reimbursement for an extremely broad range of "off-label" cancer treatments (meaning the drugs are used in ways that have not yet been approved by the FDA). Off-label uses are incredibly common in cancer therapy because oncologists often try a broad range of drugs against a tumor until they find one that works.

But Bach argues that the high spending on cancer drugs has brought little advantage to patients. Several studies have shown, for example, that the magnitude of the cost increase for each new drug for colon cancer exceeded the magnitude of improvement in efficacy. "It's pretty clear with many of these new drugs, their cost effectiveness is lower than previous drugs," Bach told BusinessWeek. "For each extra day or year of life they give, we're paying more than we did for the last one."

Cancer drugs, long a backwater of the pharmaceutical market, have become incredibly lucrative over the past decade as a new generation of treatments arrived with fewer side effects and better outcomes—but only for some patients. The prices of these drugs, however, are much higher than for cancer treatments in the past because there are few if any competitors for any one drug. Fifteen years ago, Bristol-Myers' (BMY) Taxol was the only commonly used cancer drug that cost more than $2,500 per month. Today, Genentech's (DNA) Avastin, Eli Lilly's (LLY) Erbitux, and Novartis' (NVS) Gleevec, all widely used, can cost $10,000 per month and up.

Medicare Could Negotiate Cancer Drug Prices
Medicare is barred by law from negotiating with drug companies on prices, but it can hold the line when it concludes that several drugs are virtually interchangeable. In that case, the agency can reimburse for the least costly alternative, no matter which drug is used, or choose a weighted average of prices for that class of drug. When it comes to cancer drugs, however, Congress requires Medicare to pay for any drug used "for a medically accepted indication," or for which the treated condition is major or life-threatening.

Bach recommends that Congress rectify the situation by establishing a center for comparative effectiveness—a concept embraced by President Obama's Administration—that would determine when a cancer drug's use is reasonable and necessary, based on clinical research. However, Bach acknowledges that patients may not be keen on this solution, as an authority other than their oncologist would end up restricting their access to some treatments. "This is going to be tough going," he says. "But that is maybe one of the trade-offs we need to make to bring prices under control."

Arnst is a senior writer for BusinessWeek based in New York.


Friday, January 30, 2009

ADHD drugs causing frightening hallucinations in kids

You know by now where I stand on drugs like Ritalin for attention deficit hyperactivity disorder – if I could physically go into millions of American homes and remove these drugs from folks' medicine cabinets, I would.

ADHD has become the "designer diagnosis" of the past decade, and up to 8 percent of all kids have been diagnosed with it at some point or another. Most of them end up on a prescription drug.

I don't have the space here to tell you about all the side effects that come with these drugs… suffice to say, they run the gamut from irregular heartbeats to anxiety and weight loss. But there's a new side effect researchers have uncovered that's cause for serious concern – hallucinations.

A government study that looked at past trials on Ritalin, Concerta and Strattera found that these drugs were sometimes causing frightening hallucinations in kids, who in some cases thought they were seeing bugs and snakes.

Is there anything more frightening to kids than bugs and snakes? Kids are unnecessarily being put on drugs that make it seem like their worst fears are coming true.

The researchers were quick to point out that the side effects only occurs in rare cases. I'm sure it wouldn't seem like such a small issue if it was your kid or grandkid, though.

ADHD is criminally over-diagnosed, and the drugs that treat it are unconscionably over- prescribed. While every kid on an ADHD drug hasn't seen bugs and snakes, these drugs have unleashed other side effects on more children than we can count.

If your kids or grandkids are taking Ritalin, Concerta or Strattera, do them a huge favor – get a second opinion.

Dr. Jon Ingilis

Thursday, January 29, 2009

FDA seeking "do over" on popular blood thinner

Article by Dr. Jon Ingilis, Jan 28, 2009

Of all the laboratories, scientists and technology the FDA has at its disposal, it's the one thing it doesn't have that it tends to need most.

A time machine.

America's favorite bureaucracy seems to constantly be in the business of unleashing some health menace on the American public, and then frantically trying to undo it. The latest FDA "do over" effort involves the blood thinner Plavix.

The FDA announced this week that it was investigating Plavix to see if it is ineffective in patients taking prescription medications for heartburn, such as Nexium (you know, the kind of knowledge it would have been nice to have before millions of Plavix prescriptions were written). The investigation comes on the heels of a study that found people taking heartburn meds with Plavix were far more likely to be hospitalized for heart attacks and strokes, which lead researchers to wonder whether heartburn drugs neutralized Plavix.

But here's the crazy thing – heartburn drugs are often being prescribed with Plavix, because the blood thinner can cause upset stomach.

You heard that right – doctors are prescribing drug combinations without any idea of how those drugs will interact. As shocking as that sounds, it happens all the time. Drug companies are not required to study all the ways their drugs will interact with other drugs… they just wait and see what happens.

In other words, Bristol-Myers Squibb Co. and Sanofi-Aventis SA get to sell $7 billion a year worth of Plavix, while the FDA sits back and waits to see if any carnage results.

There was carnage, of course – and it was completely avoidable. I mean, the majority of folks on Plavix are middle age and older – the same demographic most likely to suffer from heartburn to an extent that would require medication.

You didn't need a crystal ball to understand that these two drugs would be taken together. It was obvious, especially given Plavix's ability to upset your digestive system.

It all goes back to what I've been telling you for years – you can't count on government oversight to keep you safe. The FDA's drug review process is broken and dysfunctional. You need to look out for yourself.

If you're on heartburn meds and Plavix, talk to your doc right away. Better yet, if you're on either of these drugs, have a frank discussion with your doctor about whether you really need them. You might be surprised.


by Tom Laskawy, The Prospect; Jan 28, 2009

It's been a bad week for food safety. First, it was the peanut butter, then it was the High Fructose Corn Syrup and now it's deadly antibiotic-resistant staph bacteria (aka MRSA) in CAFO pigs (and their minders). And of course, as Bill Marler - litigious scourge of the food industry - reminds us, we're continuing to lose the fight against E. coli.

Much has been written about the efforts to track down the sources of contamination. And invariably the companies involved quickly close the their doors (which is how we lost one of the largest ground beef distributors in the country virtually overnight and why the Peanut Corporation of America is no more). But what's truly worrisome is that in each case, the USDA and the FDA (who have joint responsibility for food safety) had information at hand about all of these problems.

In the case of the peanut butter outbreak, the plant in question had a long-documented history of health violations - discovered, not by the FDA, but by local Georgia authorities to whom the FDA had contracted out inspection services. In essence, short of allowing self-regulation, the FDA managed to find an entity that enjoys even cozier relationships with industry than the FDA itself has. In theory, the Georgia Agriculture Department should have forwarded on reports of violations to federal officials. There's no word yet on where in the lines of communication the breakdown occurred.

Meanwhile, the HFCS situation would be comical if not for the fact that mercury is, like, a poison. And, according to a report in Environmental Health (pdf, abstract), it might be in that Coke you're drinking right now. As Tom Philpott dryly points out, despite the fact that HFCS processing requires a witch's chemist's brew of industrial solvents and genetically engineered enzymes, the FDA still considers it a "natural" ingredient. As for the source of the mercury, two of the chemicals used in HFCS manufacturing, caustic soda (aka lye) and hydrochloric acid, are still commonly harvested as byproducts from the industrial chlorine manufacturing process. That process involves forcing mercury through seawater - and now it appears some of the mercury is passed on all the way through to HFCS. The research exposing all this states unequivocally that this discovery represents a "significant additional source of mercury" exposure. But, hey, mercury is natural, too!

And who was the brave investigator toiling in obscurity who uncovered all this? None other than a former FDA scientist who performed the mercury tests way back in 2005 while she was working at the FDA. Oddly, the FDA showed no interest in investigating at the time and it was only after she left the agency that she was able to finalize the research and conclusively demonstrate that mercury contamination in HFCS is a real threat. Another case of food contamination, another potential cover-up.

Finally, we get to the pork problem. This one goes back at least to last spring when a researcher released preliminary results suggesting pigs in CAFOs were contaminated with MRSA. At the time, the FDA issued assurances that there was no evidence that pork sold for retail from any source was infected with MRSA. They could say this with great confidence and no cover-up potential whatsoever. Because, of course, the FDA has never tested for it. And surely, now that the study has been released, they'll start testing? Sadly, no.

If this research is borne out, by the way, it represents a significant threat to public health and safety. MRSA is one of those superbugs that the folks at the CDC lose sleep over. If CAFOs harbor MRSA in any significant numbers, the whole industry, which relies on routine doses of antibiotics to keep animals healthy, faces a serious crisis (which some of us think is a good thing). The FDA, naturally, has repeatedly ruled the practice safe, despite objections from public health officials.

It's understandable then, that USDA chief Tom Vilsack is less concerned with creating whole new regulatory structures for food safety and more concerned with making the ones that we have actually work. But continuing to mix boosterism and regulation - as many of our federal agencies including the FDA and the USDA do - will inevitably lead to these kind of breakdowns. And though you can come up with laundry list after laundry list of changes to penalties, enforcement, inspections and agencies that would improve matters, the frequency and seriousness of each outbreak suggests good intentioned reform may not be enough.

That the output of one contaminated peanut processing plant could require the recall of hundreds of varied and unrelated products and could kill 8 and sicken over 400 in more than 40 states across the country suggests we may have reached the limits of consolidation in the food industry. You'd think that such centralization of food production would make regulation easier. Indeed, the ease of regulation, along with low cost, was one of the prime alleged advantages of consolidation. But we're seeing not just production failures, but the wholesale failure of the regulatory structures themselves. Well, food is cheap anyway.

Posted by on January 28, 2009 3:11 PM | Permalink


SSRI Birth Defects" The Only High Risk Factor I had Was Being on Effexor"

January 15, 2009. By Lucy Campbell

Regina, SA : Pam was told by both her family doctor and her obstetrician that the antidepressant she was taking, namely effexor, was safe for her to continue taking through her pregnancy. But within hours of her son being born, he had been admitted to the natal intensive care unit, suffering from seizures and breathing difficulties.

"My son had a smooth delivery but within 5 hours of being born he began to have agitation seizures and trouble breathing," Pam said. "I was told he was showing withdrawal symptoms. He was put into neo natal intensive care for 10 days. He was suffering from tremors and having difficulty getting enough oxygen. They had him on different stabilizing medications and oxygen and continued to monitor him, and he had another seizure 5 days later. He came home 10 days later.

Shortly after we brought our son home we noticed early symptoms of cerebral palsy – he was not able to raise his head, and there were other tell-tale signs. A year later he was actually diagnosed with cerebral palsy. He's now three-and-a- half and he's in a wheelchair, he can't hold a crayon to draw, or speak properly. The only high risk factor I had was being on the effexor."

Pam was taking half the regular daily maintenance dose of effexor (also called venlafaxine) during her pregnancy. "I was told the risks were minimal - that the baby may have short term effects like tremors and withdrawal symptoms," Pam said. "Since his birth, I've done a lot of reading and it seems that seizures do occur, although it's rare. But I was never told that."

SSRI Birth Defects
Pam was pregnant and saw a specialist in 2004, and gave birth in April 2005. But it wasn't until December 2005 that the first public warnings emerged from the Food and Drug Administration (FDA) about the potential for serious heart defects in babies born to women taking selective serotonin uptake inhibitor (SSRI) antidepressants during pregnancy. Most recently, a study published in the November 2008 issue of the British Journal of Clinical Pharmacology reported a 3 times greater risk for heart defects in babies born to mothers taking either Prozac (fluoxetine) or Paxil.

While the potential for infant heart defects are the primary cause of concern with SSRI use during pregnancy, they are not the only potential birth defect. A study published in the New England Journal of Medicine found that women who took SSRI antidepressants in their third trimester delivered babies who were 6 times more likely to have primary pulmonary hypertension of the newborn (PPHN), or developing a lung disorder, than babies not exposed to SSRIs. And there are also reports of abdominal birth defects, cranial birth defects, club foot, neural tube defects, and Anal Atresia, a congenital malformation of the anus.

"I'm sure that effexor is something pregnant ladies should not be on unless it's really, really necessary," Pam said. "I'm kind of angry that I wasn't warned that the risks were in fact higher than I was led to believe: I would have stopped using the antidepressant. I really think more women need to know about this. I don't know how many women may be affected – but even the woman in the hospital bed next to me, when I had my son, was on an antidepressant."


Wednesday, January 28, 2009

Cultured Meat: How to Grow Your Own

March 27, 2006

Will consumers have a beef with test-tube meat?

Scientists can grow frog and mouse meat in the lab, and are now working on pork, beef and chicken. Their goal is to develop an industrial version of the process in five years.
If they succeed, cultured or in vitro meat could be coming to a supermarket near you. Consumers could buy hamburger patties and chicken nuggets made from meat cultivated from muscle cells in a giant incubator rather than cut from a farm animal.

Home chefs could make meat in a countertop device the size of a coffee maker. Before bed, throw starter cells and a package of growth medium into the meat maker and wake up to harvest fresh sausage for breakfast.

You could feel good about eating a healthy breakfast; the meat would have the fat profile of salmon, not pork. One day, the truly adventurous may be able to grow ostrich, wild boar, or other game.

First, however, meat researchers in the United States and the Netherlands must find a way to replicate on an industrial scale a process that works in a petri dish. The price will have to be right. It is hard to imagine consumers paying more for an in vitro burger than they pay for a regular one.

They will also have to overcome the "ick" reaction. Many find the idea of cultured meat unappealing or downright disgusting. How would it taste?

"I don't find it hard to believe that in vitro meat can be produced that tastes like hamburger or chicken nuggets," said Jason Matheny, one of the founders of Vive Research, a U.S. form working on growing meat for the global market. Most of the flavour in burgers and nuggets now sold in grocery stores or restaurants comes from seasoning or filler, he said.

Researchers have succeeded in growing bits of meat, the type that could be used in burgers or spaghetti sauce.

Growing a test-tube steak or pork roast will be more challenging, said Henk Haagsman, professor of meat sciences at the University of Utrecht. He is part of a team of Dutch researchers who are leading the world in the meat-making field.

He and his colleagues grew mouse meat in their lab because the stem cells they could turn into muscle fibres were easily available. Now they are working on pork.

Australian researchers have grown muscle tissue from a frog, which they served with Calvados sauce at an exhibition in France in 2003. The frog steaks, they said, tasted like jelly on fabric.

In 2001, U.S. researchers, funded by the National Aeronautics and Space Administration, grew muscle tissue from a goldfish -- a kind of carp -- as part of an experiment on whether it is possible to grow fish for astronauts on long space journeys. Morris Benjaminson and his colleagues at Touro College in New York bathed pieces of goldfish muscle in fetal bovine serum -- which contains growth factors that spur muscle growth.

The fish muscle grew nearly 14 per cent over a few weeks. It smelled normal, the researchers reported. But they didn't taste it.

NASA, however, has decided against space burgers -- fish or beef -- for astronauts on long missions.

This has cut off an important funding source for U.S. researchers interested in cultured meat, said Vladimir Mironov, a tissue engineer at the Medical University of South Carolina.

He said mass production of cultivated meat will be difficult, and expensive, at the least in the short term. But smaller, countertop bioreactors, or incubators, could more easily mimic the meat-making experiments scientists have done in petri dishes.

"It would look like a coffee maker -- this is my dream," he said wistfully. "No one wants to fund it."

One group, which he would not name, did offer him money, but they wanted him to grow meat from human cells, so they could grow pieces of themselves to eat.

"I don't want to participate in high-tech human cannibalism," he said he told them.

Theoretically, he said, it would be possible. Researchers have harvested human myoblasts, cells that can grow into muscle fibre.

Even without the stomach-turning notion of a human burger, cultured meat is not an appetizing idea for many people.

"There is no demand," said Mr. Mironov, who came to the United States from Russia. During the Cold War, he said, Soviet scientists developed bacteria that could produce protein. But no one wanted to eat the final product, because it smelled revolting.

Cultured meat burgers will probably taste and smell no different from conventional products, Mr. Mironov said. Eventually, he said, the world will need it.

"I believe it is inescapable."

A public educated about the benefits of in vitro meat might come around to the idea, said Mr. Matheny, a doctoral student at the University of Maryland.

Last year, he and other researchers published a paper on how to grow affordable meat for the modern dinner table.

The health and environmental benefits could be significant, they reported.

Cardiovascular disease and diabetes are associated with the overconsumption of animal fats. Cultivated meats could be engineered to be healthier.

"Using this technology, you could grow ground beef or pork or chicken that had the fat profile of salmon. That would have an enormous public health impact."

Cultured meat could also reduce the risk of diseases such as bovine spongiform encephalitis -- or mad cow disease -- and avian flu.

Growing meat in an incubator would cut down on the cropland, water, fertilizer, pesticides and energy now required to produce animals for slaughter. It would also reduce the millions of tonnes of manure and other waste produced every year in North America.

Demand for meat is growing in the developing countries, and alternative animal farming might help meet that need, Mr. Matheny said.

He and his fellow researchers established a non-profit, New Harvest, as a clearinghouse for information on cultivated meat. Last month, they set up Vive Research, which Mr. Matheny said is backed by angel investors. It involves numerous skeletal muscle tissue engineers in the United States, who plan to collaborate with the Dutch scientists. They want to develop a technology to produce ground meat in vitro in five years.

Most attempts to grow meat require cells cultured from an animal. They can be stem cells, originally taken from an embryo, which can develop into any kind of cell -- skin, bone or muscle fibre, for example. The trick is coaxing them into muscle fibre with special growth factors.

Cells known as myoblasts, which are on their way to becoming muscle fibre, are also being used.

The Dutch researchers have embarked on a five-year state-funded project to cost-effectively produce pig meat.

They face challenges. The first is to isolate the best starter cells for meat production.

They also need to develop a culture medium that doesn't require fetal bovine serum, a blood product extracted from embryonic calves that has a seemingly magical power to make muscle cells grow.

Calf serum is expensive, costing $10,000 (U.S.) per kilogram of cultured meat, according to one estimate. Using it doesn't make sense, Dr. Haagsman said.

"It is ridiculous to make meat using meat products," he said. The whole idea is to reduce the resources that now go into producing the 240 billion kilograms of meat humans around the world eat every year.

The scientists, from three universities in the Netherlands, are also figuring out the best way to exercise muscle fibres to get them to grow. Electrical stimulation works, but so does stretching, then shrinking the fibres.

Taste is another issue. Scientists don't know whether lamb meat tastes like lamb meat because of characteristics of its muscle cells. Perhaps the flavour comes from the grass an animal grazes on, or the food it is given to eat.

They should know in five years whether growing meat on an industrial scale can be done, Dr. Haagsman said. He said he believes consumers are open-minded enough to try cultured meat.

Modern farm factories, he said, have essentially turned animals into meat-producing machines. And avian influenza and other diseases may drive consumers away from conventional sources.

He is hopeful that vegetarians, or partial vegetarians, would give cultivated meat a try.

Charles Miller, part-owner of the Green Door Vegetarian Restaurant in Ottawa, said he wouldn't try a bite.

"It is still an animal product," he said. "I wouldn't touch it. I wouldn't eat it.''

Churchill predicted it

An idea whose time has finally come? In 1932, Winston Churchill predicted that in five decades, people would be eating cultured meat.

"Fifty years hence, we shall escape the absurdity of growing a whole chicken in order to eat the breast or wing by growing these parts separately under a suitable medium."

Researchers say he might have been inspired by Nobel Prize winner Alexis Carrel, who put a hunk of heart muscle cut from a chicken embryo in a bowl of nutrients and kept it alive for more than 30 years.

In the past few years, scientists have grown more than meat in their labs. In 2002, researchers in Japan reported they had grown tadpole eyeballs from scratch. In 2003, scientists in the United States announced that they had successfully grown a rabbit penis in the lab.

Anne McIlroy

How to make your own meat

Vladimir Mironov, a tissue engineer at the Medical University of South Carolina, wants to build a device the size of a coffee maker that would allow people to grow meat in their kitchens.

Here is how it might work.

1. Myoblasts, immature cells that develop into muscle fibre, would be harvested from a pig, cow, chicken or turkey and cultured.

2. Cooks could buy these starter cells, and add them to a growth medium, which would contain water, sugar, salt vitamins, amino acids and growth factors that would stimulate them to reproduce. (Scientists now use fetal bovine serum, but say they would have to come up with a product that was more affordable).

3. The mixture would be put into a counter top incubator, where it would be warmed to encourage growth.

4. The cells would develop into muscle fibre.

5. Hours later, small pieces of meat could be harvested, washed and cooked, either in a patty or a sauce.



Tuesday, January 27, 2009

The USDA / AWEP: More "Pork" for "Producers"

Schafer announces availability of $58 million to producers, entities through new conservation program

Agriculture Secretary Ed Schafer announced that up to $58.4 million in financial assistance is available to agricultural producers and entities through the Agricultural Water Enhancement Program (AWEP), established in the new farm bill to promote ground and surface water conservation and water quality improvement.

USDA is seeking project proposals from potential partners through this program. A Request for Proposals was published in the Federal Register. Proposals must be submitted by March 2, 2009.

The AWEP Request for Proposals can be viewed at the USDA-Natural Resources Conservation Service's (USDA-NRCS) Web site; at the official government regulation Web Site; and at the Federal Register.

The Food, Conservation, and Energy Act of 2008, or 2008 farm bill, established AWEP as a component of the Environmental Quality Incentives Program (EQIP), USDA's largest conservation program on working agricultural lands. All EQIP requirements and policies will apply to AWEP.

USDA-NRCS administers EQIP, a voluntary conservation program that provides technical assistance and payments to help crop and livestock producers address environmental concerns through conservation improvements on agricultural and non-industrial private forests lands.

Farmers and ranchers can use EQIP to farm in an environmentally friendly manner and still meet their agricultural production goals. In addition, it is designed to produce significant environmental benefits to the public, such as improved soil, water and air quality, and enhanced wildlife habitat.

The new farm bill expanded EQIP to include AWEP. AWEP offers financial and technical assistance to help farmers and ranchers carry out water enhancement activities that conserve ground and surface water and improve water quality on agricultural lands such as cropland, pasture, grassland and rangeland.

Agricultural water enhancement activities include:

• water quality or water conservation plan development;

• water conservation restoration or enhancement projects, including

• conversion to the production of less water-intensive agricultural

• commodities or dry land farming;

• water quality or quantity restoration or enhancement projects;

• irrigation system improvement or irrigation efficiency enhancement;

• activities designed to reduce drought's impacts;

• other related activities that will help achieve water quality or water conservation benefits on agricultural land.

Under this new program, USDA-NRCS can contract directly with agricultural producers who are included in approved partner proposals.

Eligible partners include federally recognized tribes, states, units of local government, or agricultural or silvicultural associations.

Producers who apply for AWEP assistance must meet EQIP eligibility requirements. All AWEP funding must go to producers. Like EQIP, contract terms for producers under AWEP run from one year to 10 years.

Agricultural producers in selected project areas can apply for available AWEP funds at their local USDA service center.

For additional information about the AWEP under EQIP, please visit www.nrcs.usda.gov/programs/EQIP or call (202) 720-1845 during business hours.


Big Pharma asks you to trade your heart for your brain

About a decade ago, "atypical" antipsychostic drugs -- such as Risperdal, Seroqueland, Clozaril, Geodon, Zyprexa and Abilify -- flew in on a wave of hope.

But now it looks like they've unleashed a wave of disaster. In the process of helping your brain, these drugs just may stop your heart.

Some trade, huh?

These drugs, used to treat extreme "psychotic" behaviors including those found with bipolar disorder (also called manic depressive illness) and agitation in elderly patients with Alzheimer's dementia, were marketed as "safer" solutions to the "typical" antipsychotic drugs (such as Haldol and Thorazine) that had been in use since the 1950s, and had been linked to heart disease, tremors and other movement disorders.

Turns out, all these new drugs did is add a few billion dollars to the bottom lines of the companies that sold them.

A new study from the Vanderbilt University Medical School found an increased risk of sudden cardiac death from current users of both atypical and typical antipsychotic meds. Interpretation: the atypical drugs didn't make a darn bit of difference.

The study looked at the effects of typical and atypical antipsychotic drugs for tens of thousands of Tennessee Medicaid patients over the course of 15 years. The scientists found users of either class of drugs were twice as likely to die of a heart attack as those who weren't taking the drugs.

You might read that and conclude that the atypical drugs are just as dangerous as the typical drugs. From where I'm sitting, they're actually quite a bit more dangerous. Research has already linked them to an increased risk of diabetes.

It's another case of "meet the new boss, same as the old boss." These newer drugs are asking you to make the same trade as the older ones – your heart for your brain. Do you want to treat your bipolar disorder if it means, for example, doubling your risk of a fatal heart attack?

I'm not convinced you need to make that choice. If you're on one of these antipsychotic drugs, particularly if you suffer from heart disease or diabetes, I'd recommend you talk with your doctor about your treatment options. There are natural cures running the gamut from fish oils to B12 that have shown success with some of the same conditions treated by these drugs.

Dr Jon Ingilis

Friday, January 23, 2009

SSRI Pushers under Fire: Part 2: America’s Most Wanted

January 12, 2009. By Evelyn Pringle

Washington, DC:: Most doctors who attended conferences, medical seminars and other events throughout the 1990s were not aware that the so-called "key opinion leaders" encouraging them to prescribe the new generation of antidepressants for everything under the sun, including to children as young as infants, were nothing more than highly paid drug pushers for Big Pharma.

Dr Daniel Casey was a major player in the SSRI drug-push and useful in many ways to the companies promoting the drugs. He was the chairman of the very first FDA advisory committee that met in 1991, to decide whether a warning about the increased risk of suicide should be added to the label of Prozac, the first SSRI approved in the US, and voted it down. He was also the chairman of the advisory panel that voted to approve Zoloft for Pfizer later that same year.

Bob Sorenson was a sales representative for Pfizer for 21 years. He moved to Oregon shortly before Zoloft was approved. During the first week at his new location, Pfizer’s chief of marketing at the time told him he needed to start calling on a doctor by the name of Dr Daniel Casey at the V.A. in Portland because he was very important to the company.

Dr Casey worked at the V.A., but never treated patients for depression, Mr Sorenson says. "His expertise [was] psychotropic drugs and experimentation."

The chief of marketing said he was interested in finding out what Dr Casey thought of the company's new drug, Zoloft. The company tried to call on him that day, but Dr Casey was not in. Mr Sorenson called on him later in the week and learned that Dr Casey was the lead investigator on Zoloft, which was up for approval by the FDA advisory committee Dr Casey chaired.

"He said I shouldn't be there, but I did ask how it looks for the drug and he said very well," Mr Sorenson recalls.

Dr Casey ended up making a ton of money from Zoloft. "He told me personally one time that he made enough from Pfizer in one year to purchase two cars," Mr Sorenson reports.

Dr Casey became a member of Pfizer's Advisory Board for Zoloft, which meant "all expense paid trips," including honorariums, to anywhere Pfizer wanted him to advise, at any location in the world, Mr Sorenson explains.

"Many speakers were sought out that would only give lectures that put Zoloft in a positive light," he notes, "there was no room for a balanced lecture."

"Dr Casey later became one of the most sought after speakers for the Pfizer promotion of Zoloft," he says, "the reps loved him because of his positioning of Zoloft."

Mr Sorenson was often told to take information to speakers, "including Dr Casey, to have them add the information to their lectures," he reports. "I look back at it now and see how wrong it was," he states.

"As far as the suicide issue," Mr Sorenson says, "the standard company line was that parents and doctors should be monitoring these kids because after being on Zoloft they finally feel good enough that they can carry out their suicide tendencies."

"Another tactic was to blame Paxil and Effexor," he recalls, "it was those drugs that caused suicidal tendencies, not Zoloft."

"Finally," he notes, "the statement was made that if they didn't take Zoloft, they probably would have committed suicide anyway."

Sales reps would practice and rehearse these statements at sales meetings to be able to respond to concerns or objections raised by Doctors about Zoloft’s relationship to suicidality, he says. "There would be contests as to who could detail the drug the best with objections," he recalls.

Pfizer was able to get rid of employees and still keep them quiet, he says, by offering severance packages of up to a year's salary, while forcing them to sign a confidentiality agreement, in which they promised not to sue, or speak adversely about Pfizer, as part of the deal.

Many people were so surprised at being terminated that they felt forced to sign because Pfizer kept the pressure on, he explains. They feared they wouldn’t find another job before financial problems set in, but regretted signing the agreement later, he says.

Mr Sorenson did not sign an agreement when he was fired. His young son had developed cancer, but Pfizer expected him to continue to attend out-of-town meetings and refused to believe that his son was terminally ill, he recalls. After 20 years with the company, Mr Sorenson was let go when he insisted that he needed to remain near his dying son and distraught wife. The Sorenson's son passed away on April 1, 2005.

Evelyn Pringle is a columnist for Scoop Independent News and an investigative journalist focused on exposing corruption in government and corporate America.
(Written as part of the SSRI Litigation Round-Up, Sponsored by Baum, Hedlund, Aristei & Goldman’s Pharmaceutical Litigation Department)


Wednesday, January 21, 2009

Peanut Butter Woes Spreading

CDC, Company Representatives Warn the Salmonella Investigation Could Take Time
ABC News Medical Unit
Jan. 21, 2009

The effects of salmonella contamination of peanut butter may not be quite as pervasive as those of a contaminated water supply, but it's close.

As of 9PM EDT, Sunday, January 18, 2009, 475 persons infected with the outbreak strain of Salmonella Typhimurium have been reported from 43 states and Canada.

Peanut butter reaches so far into the American diet that a single processing plant in Georgia has spread contaminated peanut butter into cafeterias, cakes, cookies, crackers, candies, cereal and ice cream in at least 43 states.

Representatives from the Centers for Disease Control and Prevention and the owner of the Georgia plant, Peanut Corporation of America, told ABCNews.com to expect the investigation to continue to unfold for weeks or months to come.

"It's really on two fronts," said a spokesman for Peanut Corporation of America. "One is on the Georgia facility, then everything after the plant: What do those customers do with those products?" he asked.

News of the outbreak first broke in September, when the CDC traced salmonella to a brand of peanut butter called King Nut, sold to cafeterias and not grocery stores.

Since then, 485 people have fallen ill and an estimated six people have died. As of Sunday, 101 brands of products had been recalled, including popular brands such as Little Debbie, Keebler, Kroger, Famous Amos and, most recently, General Mills and Club Foods.

Only seven states remain free of salmonella reports: Montana, Alaska, New Mexico, Louisiana, Florida, South Carolina and Delaware.

Peanut butter from the Blakely, Ga., plant ships to food companies in 5- to 1,700-pound containers. Once out of those containers, food companies may use the peanut butter in a variety of products.

Studies out of the University of Georgia have shown salmonella can live in the peanut butter paste used in vending machine snacks for months. Once someone eats a contaminated product, it may take the CDC weeks to a month to fully investigate the case.

"There's a lag time of two weeks," said Lola Russell, a spokeswoman for the CDC. Russell explained it takes time for a person to become ill, seek help and get test results. "If you get something that has food-borne illness, there's a wait."

Food safety experts and the spokesman from the Peanut Corporation of America, who declined to be named for this story, used, said it might be easier to find out how the salmonella got into the peanut butter than to track what happened to the peanut butter after it was shipped.

The Source of Salmonella

"If you think about where salmonella comes from, it lives in the intestinal track of warm-blooded animals," said Catherine Donnelly, a professor of nutrition and food science at the University of Vermont in Burlington.

"It's coming from fecal matter," she said.

Donnelly said finding the source of the fecal matter can become quite complicated in a large processing plant. A single worker might contaminate the food, but the ceiling, walls or roof can contaminate the food as well.

"The first (and only) opportunity to kill salmonella lurking around is when the peanuts are roasted," said Donnelly, who explained that cooking temperatures for peanut butter are not high enough to kill the pathogen.

"The nuts are roasted, but the roasted nuts are stored. That leaves a lot of opportunity for the nuts to get salmonella again," she said.

For example, the source of the 2007 outbreak of salmonella in Peter Pan peanut butter turned out to be a leaky roof. Donnelly said vermin and birds lived in the roof, and a leak transferred their salmonella to the peanut products below.

"You have to test the lines themselves, but you also have to test floors and coolers and drains, and walls and roofs," said Donnelly. In the food safety industry, these types of contaminations are deemed "environmental."

The spokesman for PCA said the U.S. Food and Drug Administration found two such environmental sources of salmonella contamination in the Georgia plant.

The PCA peanut butter salmonella recall followed shortly on the heels of the 2007 ConAgra and Peter Pan recall. However, food safety experts said peanut butter has historically been a very safe food.

"It's not a common event," said Michael Doyle, a professor and director of the University of Georgia Center for Food Safety in Griffin, Ga., of salmonella contamination.

"We have had three outbreaks in the world now attributed to peanut butter," said Doyle. The first was in Australia a decade ago, followed by last year's outbreak in the United States and the current salmonella outbreak.

Donnelly worries that consumers will only hear the first reports of the ongoing investigation and not realize the dangers of this recall.

"When you think about salmonella, for most of the population, we're healthy enough that if we get it, it won't likely end in any symptoms," Donnelly said.

However with big cafeterias serving peanut butter in schools, nursing homes and hospitals, it's likely that any contaminated peanut butter will be fed to those most at risk: the sick, the elderly and the young.

"Therein lies the problem," she said.

Donnelly advises the public to pay attention to the food sources of grandparents and children, who may be at risk for salmonella infection.

"When you see recalls happening, in reality only about 20 percent of the recall product comes back to the plant," Donnelly said. "It wouldn't hurt to just check in with the food service director or the school or hospital to make sure they're aware of the recall."

The FDA keeps an updtated list, and a searchable site for recalled peanut butter products on its Web site

Monday, January 19, 2009

A Chocolate that is Good for You

A special report by
Alan Inglis, M.D., "America's Country Doctor"

Introducing a delicious treat that comes with my blessing!

Here's pure chocolate you can eat by the handful and feel good about it!

Introducing a rich chocolate treat that's heart
healthy, cholesterol-FREE and has 540% MORE antioxidant power than organic Blueberries!

I'm the first person to admit it: I LOVE chocolate! In fact, I try new chocolates all of the time, always searching for the best of the best.

But 99.9% of the chocolate you might pick up at the grocery store, convenience store or movie theatre is pure junk.

In fact, I wouldn't feed most of the "name-brand" stuff to my worst enemy!

Milk chocolate, in particular, is full of sugar, and quite often high in fructose corn syrup. What little chocolate it contains is usually "Dutch" processed -- meaning alkali has been added to cut acidity and darken the color.

Even most so-called "dark" chocolate is just as often Dutch processed, and has loads of added sugar!

The result: a sugary, greasy, goopy, calorie-laden mess that will make you fat and stick to your arteries like wallpaper paste!

By the time you bite into most chocolate bars, nearly all of the super-healthy benefits Mother Nature gave the cacoa bean are long gone.

And that's a crying shame, because let me tell you: "Real deal" chocolate is not only delicious and satisfying, it's loaded with more health benefits than you can shake a stick at.

Revealed: Chocolate you
can eat by the handful!

That's why I'm writing you today. I've found a special kind of chocolate that's fit for the gods -- literally. (The Mayan people considered chocolate sacred and used it in their religious ceremonies... But beyond being heavenly, this chocolate is actually healthy!)

And when I say healthy, I mean HEALTHY! This chocolate has everything -- it's minimally processed, has no added fat and only 2 grams of sugar, it's bursting with antioxidants (more on that in a moment) and it tastes GREAT!

The name of my latest discovery is Dagoba Chocolate Nibs. And, I'm pleased to say, I've managed to secure a supply of these delicious, pure chocolate nibs for you.

Now, before I explain just why this chocolate is so special, and so healthy for you (in addition to being so satisfying), I do want to say up front that I was only able to get a limited supply.

So, after you discover all it has to offer and decide you'd like to try some (100% satisfaction guaranteed, of course), you'd best be quick about it. As you'll soon find out, fresh-roasted cacoa nibs from the tiny, family-farmed cacoa plantations in the shrinking rainforests are very hard to get your hands on.

What the heck are chocolate "nibs"?

Most of us eat our chocolate in bars, drops, and other forms of candy -- like the chocolate chips in cookies.

Any chocolate you get that way is virtually certain to be highly processed and full of sugar and additives.

Chocolate "nibs," on the other hand, are almost as close to eating the cacoa bean as you can get, other than crunching down on a whole pod.

You see, the cacoa "bean" is really a pod, and inside are small "nibs." These bits are what cacoa actually comes from. Every piece of chocolate you've eaten started its life as a nib.

But what most people don't know is that you can eat chocolate nibs raw or roasted, just as they are. And that's exactly what Dagoba Chocolate Nibs are -- the pure heart of cacoa, gently roasted and then sweetened with natural cane juice to unlock the taste of chocolate as nature intended.

Pure, 100% cacoa in every mouthful!

Dagoba isn't any old cacoa, either. It meets my strict criteria for chocolate: I look for chocolate that has plenty of pure cacoa -- as close to 100% as possible to get maximum health benefits (more on that in just a minute).

I also look for chocolate that is pure, 100% natural, and minimally processed to maintain that healthy goodness.

Dagoba gently roasts the cacoa bean and then crushes the nibs. The result is something that resembles crushed nuts. They're perfect for eating out of your hand, or in any recipe that calls for nibs. (Mix some in a batch of brownies instead of walnuts and watch kids and adults go wild!)

Dagoba Nibs and Toast

Toast to perfection: Whole grain toast

Spread With: Organic Peanut, Cashew or Almond butter Sprinkle With: Freshly ground Salba seeds

Top with: Dagoba cacao nibs

A friend of mine loves sprinkling them on peanut butter toast. (In fact, I've included her recipe.) And my personal favorite? Sprinkling on homemade vanilla ice cream or orange sherbet!

So...how does it taste? I've tasted nibs that are downright bitter -- probably because the cacoa was inferior to begin with, or it was roasted too long. Like coffee beans, if you apply too much heat, the cacoa is ruined.

Dagoba nibs are perfectly roasted, for a rich, dark taste. They are then soaked in freshly pressed cane juice to provide a slightly sweetened taste. They don't have the very sugary taste that many of us expect in chocolate. So if you're looking for that super sweet, mild, milk-chocolate flavor, you'll be surprised.

Instead, what you get is a pure, almost nutty chocolate flavor, because Dagoba nibs are pure cacoa bean pieces -- literally, the heart of the cacoa bean. If you already love dark chocolate, you'll really love these nibs.

But even more than the taste, the percentage of pure cacoa is critically important when it comes to health benefits (especially for your heart!).

Pure, fresh chocolate is one of the
healthiest treats on earth!

If you're a regular reader of my newsletter, you know I've written reams on the benefits of chocolate. Here are some highlights...

Chocolate: Nature's "health" food treat

Recent studies on chocolate show it's bursting with important nutrients that benefit everything from your heart to your mood. (Keep in mind -- the research revealing all these benefits was on premium dark chocolate, not the highly processed, mass produced, cheap, sugary junk you find in most supermarkets and movie theater concession stands.)

Good, pure chocolate is chock full of flavonoids, which are some of the most powerful antioxidants on earth. And that's the key to their natural goodness. Take a look at these facts:

CHOCOLATE FACT #1: High in antioxidants
Ounce for ounce, chocolate is one of the richest food sources of these crucial substances. Antioxidants neutralize free radicals--rogue oxygen molecules that can accelerate aging and the problems that come with it.

CHOCOLATE FACT #2: Rich in valuable micronutrients
Chocolate supplies meaningful amounts of potassium, zinc, magnesium and iron.

CHOCOLATE FACT #3: Cholesterol "neutral"
Chocolate has been found to help promote healthy cholesterol levels. And, believe it or not, the fat found in chocolate is "cholesterol neutral," meaning that it doesn't have a negative effect on cholesterol levels.

CHOCOLATE FACT #4: Good for blood pressure
People who ate just over 3 ounces of premium quality dark chocolate each day for two straight weeks had an easier time maintaining healthy blood pressure, according to one study. And, according to a 2003 study published in the Journal of the American Medical Association, chocolate helped promote healthy blood pressure levels in the subjects studied. Chocolate helps relax blood vessels so blood can flow through them easier.

CHOCOLATE FACT #5: A safe, mild stimulant
Chocolate actually has relatively little caffeine, but many people notice a quick increase in alertness and improvement in mood that can last hours after eating.

My ticket for good health: Dagoba Nibs!

Now, to be responsible, I also have to say that too much of the wrong kind of chocolate means too many calories. A 3.5-ounce bar can tack on 500 or more calories to your daily diet.

But that makes Dagoba's Nibs even better for you. They are the heart of cacoa beans -- 100% cacoa, no added calories from fat, and just 2 grams of sugar per serving.

That's why, for my money, Dagoba can't be beat. And, when it comes to quality, there's even more good news:

They buy all of their cacoa from small, family-run rainforest plantations.
They're absolutely committed to full-circle, sustainable agriculture. That means that they care as much about the financial health of the family farmers and the plantations as they do their bottom line. That means a lot to me.
Taste. Dagoba wins the prize for what good chocolate should taste like ....
Now, if you enjoy chocolate as much as I do, you're going to love this introductory offer...

Don't spend another nickel on inferior chocolate!

If you want pure enjoyment... don't spend another nickel on inferior chocolate!

Sure, you may be able to buy so-called "gourmet" chocolates locally. But I guarantee they won't come anywhere near to Dagoba's quality or freshness.

Why spend your hard-earned money for less than the best? If I know one thing as I get older, I want only the best. Each box of Dagoba contains 4 ounces of chocolate - bursting with all of the antioxidant goodness and flavor I've described.

Stock Up on Dagoba and Shipping is FREE

For the time being, you can stock up on six or more delicious packages of Dagoba nibs -- plenty to enjoy and share with family and friends -- and we'll pay shipping. That's right: FREE SHIPPING on orders of 6 packages or more.

Our Good Neighbor Guarantee of Satisfaction

I'm a country boy at heart and I believe in being completely straight up with people. That's why I'm backing Dagoba Nibs with my famous Good Neighbor Guarantee: If you don't thoroughly enjoy your Dagoba Nibs, I don't want you to pay.

There is no time limit on my Good Neighbor guarantee!

I don't care if you've gone through the entire package of Nibs. (If you're not thrilled with them, just send me back the unused portion and I'll refund every penny -- less shipping and handling -- no hard feelings.)

Why not stock up on GOOD Chocolate that's GOOD for you...
before we run out?

There isn't much Dagoba chocolate. Because they insist on buying cacoa grown on small, family-run plantations, there isn't much of it.

And as word about all of the health benefits (and great taste!) of Dagoba's nibs get out, I expect their limited supply will sell out quickly. After all...

Per ounce, chocolate has more antioxidants than fruits, vegetables, tea or wine.
In fact, 1.5 oz of quality, pure dark chocolate contains as much antioxidants as 5 oz of red wine.
Dark chocolate has twice the antioxidants of milk chocolate.
Pure cacoa (nibs) has almost twice the antioxidants of dark chocolate.
First come, first served

You can see all the reasons Dagoba Nibs are one indulgence you really shouldn't do without! Each box of Dagoba contains 4 ounces of chocolate - bursting with all of the antioxidant goodness and flavor I've described. I'll bet you'll be back for more!

It's surely the most guilt-free treat you'll ever enjoy.

Yours truly,

Alan Inglis, MD
Pure Country Naturals

Sunday, January 18, 2009

Peanut Butter Recall Broadens


– What began as an investigation of bulk peanut butter shipped to nursing homes and institutional cafeterias has broadened with the Kellogg Co. recalling 16 products and federal officials confirming salmonella contamination at a Georgia facility that ships peanut products to 85 food companies
Kellogg had asked stores earlier this week to pull some of its venerable Keebler crackers from shelves as a precaution. But in a statement late Friday the Battle Creek, Mich., company announced it was voluntarily recalling the crackers and other products in light of the problems in Georgia.
The nationwide salmonella outbreak has sickened hundreds of people in 43 states and killed at least six.
"The actions we are taking today are in keeping with our more than 100-year commitment to providing consumers with safe, high-quality products," said David Mackay, Kellogg's president and CEO. "We apologize for this unfortunate situation."
The recall includes Austin and Keebler branded Peanut Butter Sandwich Crackers, as well as some snack-size packs of Famous Amos Peanut Butter Cookies and Keebler Soft Batch Homestyle Peanut Butter Cookies.
Sandra Williams, a compliance officer with the Food and Drug Administration in Detroit, advised consumers not to eat the products and to contact a doctor if they have any symptoms. She also urged careful disposal of the tainted products to avoid the risk of homeless people finding and eating them.
"Kellogg reacted promptly to this potential public health risk after receiving notification of the potential problem from their supplier," Williams said.
On Capitol Hill, the House Energy and Commerce Committee requested records as it opened its own inquiry.
Although the investigation has gone into high gear, FDA officials say much of their information remains sketchy. And new cases are still being reported.
"This is a very active investigation, but we don't yet have the data to provide consumers with specifics about what brands or products they should avoid," said Stephen Sundlof, director of the FDA's food safety center. Although salmonella bacteria has been found at the Georgia plant, for example, more tests are needed to see if it matches the strain that has made people sick.
The investigation includes not just peanut butter, but baked goods and other products that contain peanuts and are sold directly to consumers. Health officials say as many as one-third of the people who got sick did not recall eating peanut butter.
"The focus is on peanut butter and a wide array of products that might have peanut butter in them," said Dr. Robert Tauxe, director of the foodborne illness division at the Centers for Disease Control and Prevention.
Officials said they are focusing on peanut paste, as well as peanut butter, produced at a Blakely, Ga., facility owned by Peanut Corp. of America. The concern about peanut paste is significant because it can be used in dozens of products, from baked goods to cooking sauces.
Federal officials said they are focusing on 32 of the 85 companies that Peanut Corp. supplies, because of the time period in which they received shipments of peanut butter or paste. The companies are being urged to test their products, or pull them from the shelves as Kellogg did.
The government is also scrutinizing a grower, raising the possibility that contamination could have occurred before peanuts reached the processing plant, which passed its last inspection by the Georgia agriculture this summer.
Peanut Corp. has recalled 21 lots of peanut butter made at the plant since July 1 because of possible salmonella contamination. The company, which suspended peanut butter processing at the facility, said none of its peanut butter is sold directly to consumers but is distributed to institutions, food service industries and private label food companies.
But Kellogg Co., which gets some peanut paste from the Blakely facility, asked stores late Wednesday to stop selling some of its Keebler and Austin peanut butter sandwich crackers. The company said it hasn't received any reports of illnesses.
Peanut Corp. said it is cooperating with federal and state authorities. On Friday, the House Energy and Commerce Committee wrote the company requesting inspection and internal records dating back four years.
Health officials in Minnesota and Virginia have linked two deaths each to the outbreak and Idaho and North Carolina have reported one. Four of those five were elderly people, and all had salmonella when they died, though their exact causes of death haven't been determined. But the CDC said the salmonella may have contributed.
The CDC said the bacteria behind the outbreak — typhimurium — is common and not an unusually dangerous strain but that the elderly or those with weakened immune systems are more at risk.
The salmonella outbreak is the second in two years involving peanut butter. Salmonella is the nation's leading cause of food poisoning; common symptoms include diarrhea, fever and abdominal cramps.
On the Net:
FDA: http://www.fda.gov/
Kellogg's: http://www.kelloggcompany.com

Saturday, January 17, 2009

Audubon Societys Take on Meat & Global Warming

DawnWatch: Superb Audubon article on meat and global warming

The current issue of Audubon magazine includes a terrific
and accidentally animal friendly column about the impact
of diet on the environment. Why do I write accidentally
animal friendly? While there is a common assumption
that environmentalists are concerned with animal suffering,
the assumption is too often false. The Audubon Society
is the perfect case in point. In Thanking the Monkey I refer
to the group as the "Audubowhunt Society" as my tribute
to the method that was chosen to remove 60 deer who
were damaging Audubon's 285 acre reserve. While the
decision to remove the deer may be a more complex
ethical issue, there is no ethical grey area around bow
hunting. The percentage of clean kills is low, with at least
one study documenting that only 50% of deer shot in
bow hunts are recovered by the hunter. Bow hunting is
not a practice that shows concern for animal suffering.

The Audubon society, however, like many environmental
groups, helps save countless millions of animals as it
protects their habitat. So like the article featured in this
DawnWatch alert, the group is accidentally animal friendly --
just as one might say that many people who chose a
plant-based diet strictly for ethical reasons find
themselves accidentally fantastically healthy!

The article, in the Viewpoint section, is headed "The Low-
Carbon Diet" and sub-headed, "Change your lightbulbs?
Or your car? If you want to fight global warming, it's time
to consider a different diet." The writer, Mike Tidwell,
discusses in length how much he loves the taste of meat.
And he writes:

"My carnivore's lust goes beyond the DNA level. It's in
my soul. Even the cruelty of factory farming doesn't
temper my desire, I'll admit. Like most Americans, I
can somehow keep at bay all thoughts of what happened
to the meat prior to the plate."

Then he proposes a change in diet that mercifully
could spare billions of animals the horrors of factory
farming and the slaughterhouse, even though that is
not the concern that drives him.

Tidwell writes,
"So why in the world am I a dedicated vegetarian? Why
is meat, including sumptuous pork, a complete stranger
to my fork at home and away? The answer is simple: I
have an 11-year-old son whose future—like yours and
mine—is rapidly unraveling due to global warming.
And what we put on our plates can directly accelerate
or decelerate the heating trend."

In the discussion that follows we read about the melting
of the Antarctic sheet. We are told that warming
greenhouse gasses from livestock constitute "more
than the emissions of all the world's cars, buses, planes,
and trains combined." We learn that "half of all the
grains grown in America actually go to feed animals,
not people" and "that means a huge fraction of the
petroleum-based herbicides, pesticides, and fertilizers
applied to grains, plus staggering percentages of all
agricultural land and water use, are put in the service
of livestock."

Tidwell writes, "Here's the inconvenient truth about
meat and dairy products: If you eat them, regardless
of their origin and how they were produced, you
significantly contribute to climate change. Period. If
your beef is from New Zealand or your own backyard,
if your lamb is organic free-range or factory farmed,
it still has a negative impact on global warming....
Even poultry, while less harmful, also contributes."

Tidwell tells us that many Americans seem to think
that giving up meat is not an achievable aim, yet
he writes:
"But as a meat lover at heart, I've been a vegetarian
(no fish, minimal eggs and cheese) for seven years,
and trust me: It's easy, satisfying, and of course super
healthy. With the advent of savory tofu, faux meats,
and the explosion of local farmers' markets, a life
without meat is many times easier today than when
Ovid and Thoreau and Gandhi and Einstein did it."

The article is one of the most succinct and compelling
I have read about the impact of animal product
consumption on the environment. Please check it
out and spread the word. You'll find it on line at:

Then please thank the Audubon society for turning its
attention to this vital issue of environmental protection.
While Tidwell has written that the cruelty of factory
farming never tempered his desire for meat, other
Audubon members who read the magazine may feel
differently, so please do include a reference to the
moral issue of animal cruelty if you are so moved. If
you are new to animal advocacy and know little about
factory farming, please go to Farm Sanctuary's site
www.FactoryFarming.com to learn more and to see the
photos, which will tell you more than I ever could on
the written page.

The Audubon Magazine takes letters at
editor@audubon.org and asks that you include your
name, city and state.

Yours and the animals',
Karen Dawn

(DawnWatch is an animal advocacy media watch
that looks at animal issues in the media and
facilitates one-click responses to the relevant
media outlets. You can learn more about it, and
sign up for alerts at http://www.DawnWatch.com.
You may forward or reprint DawnWatch alerts if
you do so unedited -- leave DawnWatch in the
title and include this parenthesized tag line. If
somebody forwards DawnWatch alerts to you, which
you enjoy, please help the list grow by signing up.
It is free.)

Please go to http://tinyurl.com/9mve9r if you would
like to see an NBC news piece on Karen Dawn's new
book, "Thanking the Monkey: Rethinking the Way
we Treat Animals" or go to
www.ThankingtheMonkey.com for reviews and a
fun celeb-studded promo video.

Friday, January 16, 2009

A Real Friend of Animals in DC Politics!

Crossposting from a right-wing conservative pro-slaughter meat-industry rag, and BOY are they scared!

Why the Obama White House May Go to the Dogs
(and the Cows, and the Deer, and the Lab Rats)

Forget about Barack Obama's income tax-challenged Treasury Secretary or the conflict of interest controversy at the State Department. The most outrageous Obama appointee just might be Cass Sunstein, a Harvard Law School professor who's flying under everyone's radar and into a job that hardly anyone has ever heard of.

Cass Sunstein is slated to run the White House's Office of Information and Regulatory Affairs. He's going to be America's chief "regulatory czar." And shocking new research from the Center for Consumer Freedom shows that he's a dedicated animal-rights zealot.

Hold on to your sirloin.

The anti-meat nuts at People for the Ethical Treatment of Animals (PETA) and the anti-hunting lobbyists at the Humane Society of the United States (HSUS) used to think that putting Dennis Kucinich in the White House would be their best hope of wielding real power in Washington . But even they didn't see Cass Sunstein coming. Sunstein has the legal mind of Chief Justice John Roberts and the animal-rights agenda of PETA president Ingrid Newkirk.

We're not talking about animal welfare---the idea of making sure we don't cause animals unnecessary suffering when we use them for food, clothing, entertainment, or lifesaving medical research. Sunstein believes in animal rights---the notion that people shouldn't "own" or "use" animals at all, for any purpose, no matter what the stakes are for mankind.

Cancer research? Not if lab rats are used against their will.

Hunting? Absolutely forbidden, especially if it's for sport.

Leather jackets? The cows need their skin more that you do.

Seeing-eye dogs? They're nothing more than slaves.

And that T-bone steak? Fuhgeddaboudit! If animals have any "rights" at all, the right to not be your dinner is at the top of the list.

All of this makes perfect sense to Cass Sunstein, who organized the "Chicago Project on Animal Treatment Principles" at the University of Chicago. He will soon have the political authority to push for a radical overhaul of the way the federal government regulates everything Americans do with animals.

How radical? Sunstein supports making sport hunting illegal, and completely phasing out the consumption of meat. And if that's not nutty enough, he's actually in favor of giving animals the legal right to sue people.

Think we're joking? Think again. Here's what Sunstein wrote in his 2004 book, Animal Rights: Current Debates and New Directions:

"[A]nimals should be permitted to bring suit, with human beings as their representatives ... Any animals that are entitled to bring suit would be represented by (human) counsel, who would owe guardian like obligations and make decisions, subject to those obligations, on their clients' behalf."

Conservative commentators have been openly fretting that Barack Obama may try to turn welfare entitlements and single-payer healthcare into a new Bill of Rights. But Cass Sunstein threatens to expand the whole concept of "rights" to include the rest of the animal kingdom.

Say No to Industrial GE Corn for Ethanol!

Keep GE Corn for Ethanol Refineries Out of Our Food Supply!

The United States Department of Agriculture is considering a petition from Syngenta Seeds seeking nonregulated status for a new genetically engineered corn seed that is modified to produce an enzyme that facilitates ethanol production. This new industrial GE corn could pose significant threats to the human food supply. Can you tell the new Obama Administration USDA it's time time to stand up for our food supply?

Syngenta is asking the USDA for permission to plant their non-food GE corn without any regulation. The particular genetic change that they've made to this corn is adding a plant pathogen from an exotic enzyme derived from "thermophilic" (heat-loving) microorganisms living near deep sea hydrothermal vents. These exotic enzymes are not currently in the food system. This corn designed for ethanol refineries will almost certainly accidentally enter the food supply as tortilla chips, corn oil and sweeteners. Plus, the leftover corn residues from ethanol production (called distillers grains) are fed to cattle, hogs and chickens that end up on supermarket shelves.

The worst part about this proposal is that we're putting the food system at risk to help the controversial ethanol industry save a few pennies in processing. At best, ethanol has little impact on global warming - and may even make the situation worse. And the rush to ethanol has created a dead zone in the Gulf of Mexico hundreds of miles long where no aquatic life can survive. Fortunately, we've got a new Administration that we can ask to stand up to corporate interests.

Tell USDA to take a stand for food safety by saying no to industrial GE corn for ethanol.

Thanks for taking action,

Sarah, Noelle, and The Food Team
Food & Water Watch

Wednesday, January 7, 2009

388 People Sick Across US with Salmonella

CDC Searching for Source of Contamination

US health officials are reporting that a salmonella outbreak, which began in September 2008, has to date left 388 people sick in 42 states, with 18 percent requiring hospitalization.

The source of the outbreak is not yet known, although the Centers for Disease Control (CDC) are trying to track it. The agency said that the most common sources of this type of salmonella - salmonella typhimurium - are poultry, eggs, and cheese.

JAN-07-09: Salmonella outbreak sickens 388 across U.S. [REUTERS: SALMONELLA OUTBREAK SICKENS 388]

SSRI Pushers under Fire

Well I say its about time!

January 6, 2009. By Evelyn Pringle

Washington, DC: Throughout the 1990's, most doctors who attended conferences, medical seminars and other events were not aware that the so-called "key opinion leaders" encouraging them to prescribe the new generation of antidepressants for everything under the sun, including to children as young as infants, were nothing more than highly paid drug pushers for Big Pharma.

For years, the research that showed SSRI antidepressants (selective serotonin reuptake inhibitors) were dangerous and practically useless was kept hidden, while the studies published and presented to potential prescribers painted a glowing picture of success. These days, a person would be hard pressed to find someone who does not have a family member or friend labeled mentally ill and taking drugs like Prozac, Paxil, Zoloft, Lexapro and Celexa, or their chemical cousins Effexor, Cymbalta and Wellbutrin.

About once a year, a new round of headlines about all the money made by the SSRI pushers comes and goes; but nothing really ever seemed to stick, until now.

The Senate Finance Committee, with the ranking Republican, Senator Charles Grassley, leading the charge, is investigating GlaxoSmithKline. New revelations in a report filed in litigation show that the company manipulated the numbers on adverse events related to suicidality in clinical trials back in 1989, to make it appear that Paxil did not increase the risk of patients experiencing suicidal behavior when, in fact, trial subjects on Paxil were eight times more likely to attempt or commit suicide than patients taking placebos.

Quite a few of the top pushers are also under investigation by the Committee due to revelations that millions of dollars has changed hands between the SSRI makers and the academics who signed off on some of the most fraudulently reported research in the history of modern medicine. A full list of names is easy to compile by scanning the literature on SSRI studies conducted on children. The same names appear repeatedly.

In alphabetical order, the Fortune 500 team of pushers, at a minimum, includes Drs Joseph Biederman, David Brent, Jeffrey Bridge, Daniel Casey, David Dunner, Graham Emslie, Daniel Geller, Robert Gibbons, Frederick Goodwin, Martin Keller, Andrew Leon, John Mann, John March, Charles Nemeroff, John Rush, Neal Ryan, David Shaffer, and Karen Wagner.

Truth Buried in Litigation Graveyard

On February 6, 2007, the world famous historian on psycho-pharmacology, Dr David Healy, published a commentary entitled, "Why you should never trust new wonder drugs," in the UK's Daily Mail stating:

"Ten years ago, I sat faced with boxes and boxes that contained a dirty secret. Inside were thousands of confidential internal company documents about Prozac."

"The secret they revealed was that public statements about the safety of the drug were a lie; that the company knew Prozac was responsible for a raised risk of suicide and was only slightly more effective than a placebo."

Several years later, Dr Healy recounts, he was faced with the secrets of Paxil. "No one outside the two companies, and few within them," he writes, "knew what those boxes contained; I saw them because I was an expert witness in a court case."

"Documents prised out of companies by American court cases," he says, "have become the main way we have of discovering the truth about some of our best-selling drugs."

"The scientific literature, the very place doctors would look for a warning," he writes, "contained barely a hint of problems.”

"What's more, no one seems likely ever to have to answer for what appears to be fraud," he points out.

"In other organizations when evidence of disregard for public safety emerges, heads roll," Dr Healy said. "But there have been no resignations following these drug disasters - barely a flicker of embarrassment."

The UK's medicines “watchdog,” the British Medicines and Healthcare Products Regulatory Agency, he reports, "has never taken any action against the academics who make fraudulent claims in ghostwritten articles, nor doctors working for the companies who repeat such claims, even when they have been shown to be untrue."

"And no one in Britain," he points out, "has any means of finding out why their husband or child might have died."

Seven years before Dr Healy wrote this commentary, in a Prozac case for which he served as an expert witness, the plaintiff's legal team learned that Eli Lilly had withheld evidence in a jury trial when the May 7, 2007 Boston Globe reported that Lilly had agreed to pay $20 million for the rights to a patent on a new version of Prozac that would reduce "akathisia," the very side effect long believed to increase the risk of suicidal behavior, three months before the trial began.

While testifying under oath, Lilly researcher, Gary Tollefson, had told the jury, "there is absolutely no medically sound evidence of an association between any antidepressant medicine, including Prozac, and the induction of suicidal ideation or violence."

When in fact, the wording in the patent for the new formula stated "fluoxetine (Prozac) produces a state of inner restlessness (akathisia), which is one of its more significant side effects," and the "adverse effects which are decreased by administering the R(-) isomer of fluoxetine include but are not limited to headaches, nervousness, anxiety, insomnia, inner restlessness (akathisia), suicidal thoughts and self mutilation."

Patients who lived to talk about a failed suicide attempt have described the SSRI-induced akathisia, as being so unbearable that their only option for relief seemed to be death.

Next Week, part 2: America’s Most Wanted

(Written as part of the SSRI Litigation Round-Up, Sponsored by Baum, Hedlund, Aristei & Goldman’s Pharmaceutical Litigation Department.)

Evelyn Pringle is a columnist for Scoop Independent News and an investigative journalist focused on exposing corruption in government and corporate America.


Tuesday, January 6, 2009

Possible Melamine Contamination Prompts Recall of Topaz Wafer Rolls

Recall is Nationwide
A nationwide recall of Topaz brand wafer rolls, made by National Brands, has been issued due to possible melamine contamination.

The product, distributed through retail stores, comes in 4.76oz (135gm) metal cans and 12.3oz (350gm) metal cans in the following 4 flavors:

Topaz Wafer Rolls with Chocolate Flavored Cream Filling Lot numbers L8085A, L8219A, L8245A

Topaz Wafer Rolls with Hazelnut Chocolate Flavored Cream Filling Lot numbers L8085D, L8219D, L8245D

Topaz Wafer Rolls with Vanilla Flavored Cream Filling Lot numbers L8085B, L8219B, L8245B

Topaz Wafer Rolls with Mocha Cappuccino Flavored Cream Filling Lot numbers L8085C, L8219C, L8245C

JAN-05-09: Nationwide Recall of Topaz brand Wafer Rolls [FDA: NATIONAL RECALL OF TOPAZ WAFER ROLLS]

Possible Listeria Contamination Prompts Recall of Bacon Bit Products

Patrick Cudahy, a Cudahy WI firm, is recalling approximately 3,590 pounds of bacon bit products that may be contaminated with Listeria monocytogenes. The products included in the recall are:

10-pound cases of "Golden Crisp APPLEWOOD SMOKED PRECOOKED BACON TOPPINGS." The products bear the establishment number "EST. 28" inside the USDA mark of inspection as well as a printed Julian date of "8318."

10-pound cases of "John Morrell APPLEWOOD SMOKED PRECOOKED BACON TOPPINGS." The products bear the establishment number "EST. 28" inside the USDA mark of inspection as well as a printed Julian date of "8318."

The bacon bit products were produced on Nov. 13, 2008, and distributed to restaurant and institutional establishments in California, Colorado, Florida, South Dakota, Texas and Wisconsin.

JAN-05-09: Possible Listeria Contamination Prompts Recall of Bacon Bit Products [USDA: BACON BITS RECALL------------------------------------------------------

Friday, January 2, 2009

Burritos Sold at 7-Eleven Recalled for Possible Listeria Contamination

Fresh Sandwich Distributors, Inc, of Denver CO, is recalling approximately 172 pounds of burrito products that may be contaminated with Listeria monocytogenes.

The following product is subject to recall:

5.3-ounce packages of "7- ELEVEN Fresh to Go BURRITO WITH POTATOES, BACON, EGGS, & MONTEREY JACK CHEESE" with a "Best By" date of "Thursday 1225." The products bear the establishment number "EST. 19496" inside the USDA mark of inspection.

The burrito products were produced on Dec. 23, 2008, and sold at retail convenience stores in Colorado. Consumers may have purchased these burrito products on Dec. 24 and 25, 2008.

DEC-31-08: Colorado Firm Recalls Burrito Products For Possible Listeria Contamination [CPSC: COLORADO FIRM RECALLS BURRITOS ]

Legal Help
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FDA Issues Urgent Recall of Healon D

Opthalmic Device Linked to Serious Post Operative Eye Inflammation
The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc (AMO). OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.

On Oct. 30, 2008, AMO voluntarily recalled all 4,439 units of Healon D lot no. UD30654 of Healon D, due to complaints of inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS). At that time, AMO informed customers of the number and nature of adverse event reports associated with OVD from that lot, and included a fax reply form for quick communication.

However, as of December 3, 2008, AMO had retrieved only 964 units of the 1,450 that had been distributed in the United States.

AMO received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.

JAN-02-09: FDA Announces Class I Recall of Ophthalmic Surgical Device [FDA: HEALON D CLASS 1 RECALL ISSUED]

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Possible Link Between Fosamax and Esophageal Cancer

Possible Link Between Fosamax and Esophageal Cancer
23 Cases of Esophageal Cancer Reported to the FDA
A report in the New England Journal of Medicine published December 31, 2008 has raised a red flag over a possible link between Merck's osteoporosis drug Fosamax, and esophageal cancer.

The NEJM article cites an FDA report which states that the agency has received 23 reports of esophageal cancer that may be linked to use of bisphosphonate. The cases were reported between October 1995, when Fosamax became available, and May 2008.

To date, 8 of the 23 patients have died. The FDA report also notes that "no similar US reports for other oral bisphosphonates were retrieved from the FDA's database for adverse-event reporting".

DEC-02-09: Report Links Osteoporosis Drug to Esophagus Cancer [ABC NEWS: FOSAMAX LINKED TO ESOPHAGEAL CANCER]

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