FDA Accuses Supplement Manufacturers of…Selling Drugs?

FDA Accuses Supplement Manufacturers of…Selling Drugs?

May 17, 2011

Misleading claims vs. legitimate science—getting to the truth can be a minefield! Which is why the Free Speech about Science Act is so important.

The US Food and Drug Administration recently sent warning letters to manufacturers of a number of products—MedaVir, Herpaflor, Viruxo Anti-Viral Support, C-Cure, and Never an Outbreak—for making health claims about treating or preventing sexually transmitted diseases, including herpes.

According to the FDA press release, “While some of the companies market these products as dietary supplements, these products are all drug products under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as they are offered for the treatment of disease. These drug products, which are offered for the treatment of STDs, may not be introduced into interstate commerce without an FDA-approved new drug application (NDA).”

On their websites, the supplement manufacturers make a wide variety of claims. Some of the claims are supported by varying degrees of science; some seem wildly overreaching. But all health- or disease-related claims are currently illegal. And that is precisely the problem: there is no mechanism in place for citing the legitimate science behind a food or supplement’s effectiveness. Many Americans are trying to take charge of their health, and they are desperate for information, so some supplement manufacturers are filling that void by violating current law and making health claims—which makes it even more difficult for consumers to judge a misleading claim from a scientifically valid one.

MedaVir’s website says that research about the product’s ingredients effectiveness has been published in national medical journals, though they don’t link to that research. The website also says MedaVir has been proven effective by an official FDA phase 2 double-blind clinical trial, as well as research at Proctor and Gamble’s laboratories for medical testing and the Cincinnati Children’s Hospital Infectious Diseases Division. Why would FDA warn a manufacturer over health claims when a FDA clinical trial has proven that the product is effective?

Here’s why. The sad truth is, whether the products are effective or not, or whether they have good science to back up their claims or not, is utterly irrelevant to the FDA. Dietary supplements cannot treat or prevent STDs like herpes—only FDA-approved, prescription-only medications can do that. That’s because, as you’ll note above in the FDA’s own words, any product that is offered as a treatment for disease is by definition a “drug product,” and without an NDA, said drug product cannot be sold.

Sadder still, natural substances can be powerful healers, but most of the public will never hear about them. As we have reported in previous newsletters, there are excellent natural treatments for diseases like herpes: vitamin C, selenium, lysine, and especially the powerhouse of the vitamin world, vitamin D. But the FDA says that making a health or disease claim for a supplement instantly and magically transforms it into a drug. It must therefore go through the FDA drug approval process or it cannot be sold. Alternatively, it can be sold, but you can’t tell anyone about its health benefits!

The difficulty, as we have noted many times, is that naturally occurring substances cannot be patented, and without patent protection, few manufacturers will pay the millions—and occasionally billions—of dollars to do the double-blind studies necessary to bring a new product through the FDA new drug approval process.

The long and short of it is this: the current health claim regulation system is broken, and the FDA is exploiting it.

This is why we so desperately need the Free Speech about Science Act of 2011 (FSAS). Passing this bill into law would make a food’s or product’s scientific studies and their implications more transparent and understandable to consumers.

Under FSAS, dietary supplement manufacturers will be able to make well-substantiated disease or health-related claims, based on legitimate scientific research. Because food and supplement manufacturers cannot legally make health claims, it becomes even harder for consumers to make informed and healthy decisions—and consumers are missing out on valuable information. FSAS creates a standard that would weed out junk science and misleading claims, and would provide health-conscious consumers with access to much-needed credible scientific information behind natural products.

We mentioned MedaVir earlier, but some of the other companies targeted by the FDA warning letter also cite scientific evidence to support their claims. The Herpaflor website, for example, cited science behind each of the product’s seventeen different ingredients (or did, before the FDA warning letter made them remove the citations, though we have a PDF of the page in question), supporting the claim that Herpaflor’s ingredients help prevent and treat herpes outbreaks as well as help alleviate some of the side effects such as pain and discomfort. They listed twenty reputable scientific sources for their claims, ranging from NIH studies, The Journal of Dermatology Treatment, The Journal of Medical Sciences Research, and The Journal of Antimicrobial Chemotherapy—though they also listed a number of sources that are not peer-reviewed, like BBC News and Answers.com.

ANH-USA does not, of course, support manufacturers’ misleading or fraudulent claims! We do support, however, the right of consumers to have access to credible, peer-reviewed scientific information about food and dietary supplements. It is difficult for consumers to differentiate what is credible information and what isn’t—because there is no standard in place for citing science for natural products. FSAS would help correct this.

The great irony here is that FDA and FTC absolutely allow egregiously misleading claims—with impunity—so long as they’re made by the major pharmaceutical manufacturers! For example, a full page ad for Astrazenica’s acid blocker drug Prilosec OTC in People magazine says in large type, ZERO HEARTBURN**. If you follow the asterisks down to the bottom of the page, it says in tiny type, “It’s possible while taking Prilosec OTC.” So the actual message is that zero heartburn is possible while taking this drug. Of course, zero heartburn is possible for any other product under the sun! Manufacturers of acid blockers are very careful to avoid saying that their product cures heartburn—because there is no evidence it does. There is abundant evidence, however, that it leads to more infection, pneumonia, bone problems, and a failure to absorb minerals. There is also evidence that it actually makes heartburn worse over time. Yet the FDA and FTC have no trouble with these claims.

Consumers have the right to access this information, and the FDA’s method of barring access to this information in untenable. There must be a system that allows consumers access to credible scientific data, through legislation like FSAS. If you have not already done so, please see our Action Alert and ask Congress to support the Free Speech about Science Act!

AlterNet.org

FOOD

AlterNet / By Ellen LaConte

Garden As If Your Life Depended On It, Because It Does

There are at least five reasons why more of us should take up the spade, make some compost, and start gardening with a vengeance.

March 29, 2011 |

Photo Credit: di the huntress

Spring has sprung -- at least south of the northern tier of states where snow still has a ban on it -- and the grass has 'riz. And so has the price of most foods, which is particularly devastating just now when so many Americans are unemployed, underemployed, retired or retiring, on declining or fixed incomes and are having to choose between paying their mortgages, credit card bills, car payments, and medical and utility bills and eating enough and healthily. Many are eating more fast food, prepared foods, junk food -- all of which are also becoming more expensive -- or less food.

In some American towns, and not just impoverished backwaters, as many as 30 percent of residents can't afford to feed themselves and their families sufficiently, let alone nutritiously. Here in the Piedmont Triad of North Carolina where I live it's 25 percent. Across the country one out of six of the elderly suffers from malnutrition and hunger. And the number of children served one or two of their heartiest, healthiest meals by their schools grows annually as the number of them living at poverty levels tops 20 percent. Thirty-seven million Americans rely on food banks that now routinely sport half-empty shelves and report near-empty bank accounts. And this is a prosperous nation!

In some cases this round of price hikes on everything from cereal and steak to fresh veggies and bread -- and even the flour that can usually be bought cheaply to make it -- will be temporary. But over the long term the systems that have provided most Americans with a diversity, quantity and quality of foods envied by the rest of the world are not going to be as reliable as they were.

What's for Supper Down the Road?

As they move through the next few decades Americans can expect:

• The price of conventionally produced food to rise and not come down again;
• Prices to rollercoaster so that budgeting is unpredictable;
• Some foods to become very expensive compared to what we're used to;
• And other foods, beginning with some of the multiple versions of the same thing made by the same company to garner a bigger market share and more shelf space, to gradually become unavailable.

Tremors in food supply chains and pricing will make gardening look like a lot more than a hobby, a seasonal workout, a practical way to fill your pantry with your summer favorites, or a physically, spiritually and mentally healing activity, or all four. Gardening and small-scale and collective farming, especially of staple crops and the ones that could stave off malnutrition, could become as important as bringing home the bacon, both the piggy and the dollar kind. Why?

Why Is Gardening So Important Now?

There are at least five reasons why more of us should take up spade, rake and hoe, make compost and raise good soil and garden beds with a vengeance, starting this spring and with an eye toward forever.

1) Peak oil. Most petroleum experts agree that we shot past peak oil in the U.S. around 1971. Lest you've missed the raging, that's the point at which more than half the readily, affordably retrievable oil in reserves has been used up, what remains is more expensive to retrieve, and the dregs are irretrievable. We've shot or are about to shoot past peak worldwide, estimates of when ranging from 2007 to 2013, with many oil company execs agreeing to at least the latter. There are no new cheap-easy oil fields coming on line. Any new fields you hear about or new methods, like tar sands drilling are expensive, water guzzling, dangerous, environmentally disastrous and unlikely to produce more than a few years worth of oil, and that a decade or more down the line. That means abundant, cheap oil is about to be history. What difference does that make?

For one thing, there is no replacement for oil that can do all that oil has done as cheaply and universally as oil has done it. I offer an exercise in Life Rules, "The ABC's of Peak Oil" which helps readers imaginatively subtract from their lives everything that depends in one way or another on cheap easy oil. It doesn't leave much. (See Beth Terry's Web site, for example, for what subtracting plastics may entail.)

The global economy that presently supplies us with our food, runs on cheap oil and lots of it. It runs slower and less predictably on expensive oil that's hard to get because it's located in hard-to-reach or high-risk conflict-ridden zones. Cheap, abundant food on the shelves of grocery and big box stores and food banks, on our tables and in our bellies depends on cheap abundant oil for fertilizers, pesticides, and herbicides, and to power farm machinery and transport food from fields to processors and packagers and then to purveyors and consumers, around the world. Past peak, that system's going to have the half-life of the strontium 90 that's escaping the Fukushimi Dai-ichi reactor: 29 years, or thereabouts. One good global crisis, and not that long.

2) Peak soil & space. A couple of links between peak oil and peak soil: First, it matters that one of the proposed alternatives to oil is biofuels. Acreage around the world is being converted from production of corn, wheat and soy for human and animal consumption -- i.e. food -- to production of ethanol and biofuels to put in trucks and cars and ... which makes remaining corn, et al., more expensive. Some energy economy geniuses are proposing that Afghans, for example, convert the fields of opium poppies that are their primary agricultural export, not to growing grains or legumes or other staple foods, but to biofuel, which would, not coincidentally, make the gasoline that goes in American military equipment much cheaper and provide Afghans with a profitable market item rather than food.

According to a 2009 National Geographic staff report, "The corn used to make a 25-gallon tank of ethanol would feed one person for a year." Tell that to Archer-Daniels-Midland, Al Gore's deep-pockets friend and mega-ethanol and corn products producer. Second, the huge oil-gluttonous machinery that has made factory farming possible has compacted soils, literally crushing the life out of them.

Arable land in the developing or so-called Third World has been at a premium since time immemorial, thanks to geographic location and/or persistent plundering by empires old and new. Revolutions in North Africa and the Middle East are occurring not just to obtain more democratic governments but also to obtain more food and more affordable food. Revolutionaries are barking up a tree that's seen better days.

In the United States and elsewhere in the developed, read "First" world, arable land has reached peak production. All those petroleum-based products that fueled the Green Revolution of the last century, also produce so many crops, constantly, with support from toxic chemicals and without concern for the microbes that make soil a live, self-regenerating system, that most American farmland -- if its farmers didn't go organic a while back -- is comprised of dead soils. Peak oil makes a repeat of the petroleum-driven 20th century Green Revolution impossible, which is good for soil and other living things, not so much for food prices and supplies.

After peak, in soil like in oil, comes descent. Adding insult to injury, every year farmers lose thousands of acres of arable land to urban and suburban sprawl and more tons of topsoil than they produce of grain and other field crops to attrition. Half the Earth's original trove of topsoil, like that which once permitted the American Midwest to feed the world, has been lost to wind and erosion. Millions of years in the making, it has been depleted and degraded by industrialized agriculture in only a couple of centuries. China's soils ride easterly winds across the Pacific to settle out on cars and rooftops in California while the American Bread Basket's soils are building deltas and dead zones at the mouth of the Mississippi. Like oil, that soil isn't coming back. We can only build it, help it to build itself and wait.

3) Monoculture. We can cut to the chase on this one. The food we eat is produced on industrial-strength, fossil-fuel-driven super farms. Those farms practice monoculture: the planting one crop, often of one genetic strain of that crop, at a time and sometimes year after year over vast landscapes of plowed field. When thousands of acres of farmland are sown with the same genetic strain of grain, uncongenial bout of weather, disease or pest to which that strain is susceptible can wipe out the whole crop.

At present the Ug99 fungus, called stem rust, which emerged a decade ago in Africa, could wipe out more than 80 percent of the world's wheat crops as it spreads, according to a 2009 article in the L. A. Times. Recent studies follow its appearance in other countries downwind of eastern Africa where it originated, including Yemen and Iran (where revolutionaries are already protesting rising prices and shortages), which opens the possibility of its emergence further downwind in Central and Eastern Asia. The race is on to breed resistant plants before it reaches Canada or the U.S. But it can take a decade or more to create a universally adaptable new genetic line that is resistant to a new disease like stem rust that can travel much faster than that. The current spike in the price of wheat is due in part to Ug99 which might properly be renamed "Ugh."

4) Climate instability. Bad -- uncongenial -- weather has lately devastated crops in the upper Midwest, Florida, Mexico, Russia, China, Australia, parts of Africa and elsewhere. Many climate scientists believe we've passed the equivalent of peak friendly and familiar weather, too. And while increasing heat will bedevil harvests, intense cold, downpours and flooding, drought and destructive storm systems will make farming an increasingly hellish occupation if profit is what's being farmed for.

The transitional climate will be unpredictable from season to season and will produce more extremes of weather and weather-related disasters, which means farmers will not be able to assume much about growing seasons, rainfall patterns and getting crops through to harvest. If the past is precedent, the transition from the climate we've been used to for 10,000 years to whatever stable climate emerges out of climate chaos next, could take decades, centuries or even millennia. Especially if we keep messing with it. When a whole nation's or region's staple crops, especially grains, are lost or on-again-off-again, everything down the line from the crops themselves become more expensive, from meat, poultry and dairy to every kind of processed food. I.e., the food we shop for as if supermarkets were actually where food comes from.

5) The roller-coaster economy. This isn't the place for me to offer my explanation for the probability of global economic collapse. (More on that here.) No pundits, talking-heads or economic analysts (well, very few) deny there are rough economic times ahead. Even many of the cautious among them acknowledge that we may be looking at five or six years of high unemployment and many of the lost jobs won't be coming back. The less cautious, like me, predict the collapse of the whole fossil-fueled, funny-money, inequitable, overly complicated global economic system in the lifetimes of anyone under 50. Well, at the rate we're going in all the wrong directions politically and economically, I hazard the guess, anyone under 80.

Clearly, depending on the present system to provide us with most or all of our food reliably or long-term, is unwise in the extreme. Which is how we get back to why we need to garden as if our lives depended on it. Bringing food production processes and systems closer to home is going to prove vital to our survival. We need to take producing our own and each other's food as seriously as we've taken producing a money income because growing numbers of us won't have enough money to buy food in the conventional ways and there will be less of it to buy. So what's our recourse?

Gardening Like Everybody's Business

Under the influence and auspices of the prevailing economy, most Americans have forgotten how to provide for themselves. We've become accustomed to earning money with which we buy provisions. That process is about to have the legs kicked out from under it. Instead of earning money (or its funny-money kin like credit cards) to buy the things we need, we'll need to start providing more of those things for ourselves and each other locally and (bio)regionally. Gardening -- and small-scale farming -- while they will need to be undertaken in a businesslike fashion will be less about doing business than about everyone's having something to eat and more people being busy providing it. And while not everyone will be able to garden or farm, we are all able to get up close and personal with those who do.

Ellen LaConte, an independent scholar, organic gardener and freelance writer living in the Yadkin River watershed of the Piedmont bioregion of North Carolina, is a contributing editor to Green Horizon Magazine and the Ecozoic. Her most recent book is Life Rules (Green Horizon/iUniverse, 2010). LaConte publishes a quarterly online newsletter, Starting Point.

Bloomberg

Understanding Radiation Poisoning: Questions and Answers

March 14, 2011, 2:52 AM EDT

By Simeon Bennett

March 14 (Bloomberg) -- A potential meltdown at Tokyo Electric Power Co.’s Fukushima Dai-Ichi No. 3 nuclear reactor, which was destabilized by Japan’s strongest earthquake, threatens to release dangerous radioactive materials.

A meltdown may occur should the reactor’s fuel rods remain exposed, Managing Director Akio Komori said at a briefing in Tokyo today.

The vessel containing the reactor’s radioactive core is intact after a blast at 11:01 a.m. local time today, Chief Cabinet Secretary Yukio Edano said. No large release of radiation was detected after the blast at the station, about 220 kilometers (135 miles) north of Tokyo. The possibility of a large radiation leak is very small, he said.

Radioactivity measured at a building that houses the No. 3 reactor containment was less than 2 percent of the level known to harm human health, Hidehiko Nishiyama, deputy director-general at Japan’s Nuclear and Industrial Safety Agency said today.

Here are answers to some frequently asked questions about radiation poisoning. The information is drawn from the Science Media Centre of Japan, the World Health Organization in Geneva, the U.S. Centers for Disease Control and Prevention in Atlanta, and the U.S. Environmental Protection Agency in Washington. Authorities have evacuated people within a 20-kilometer radius.

Q: Should people in Tokyo avoid open air? A: There is no need because Tokyo is far enough away.

Q: What is the worst-case scenario? A: It depends on how much radiation leaks and the prevailing weather conditions. Radioactive iodine, or I-131, is heavier than air and won’t spread far in mild wind. Iodine 131 has a half-life of eight days.

Q: Is there a risk of secondary radiation exposure from contaminated food? A: Based on reported radiation levels, there should be no cause for concern.

Q: How do radioactive materials contaminate food? A: Atomic bomb tests in Nevada during the 1950s and 60s released I-131 into the atmosphere, which was blown thousands of miles away. Animals grazing on I-131 contaminated pastures had the radioactive material in their milk, which poisoned some children who drank it. People exposed to I-131 may have an increased risk of thyroid cancer.

Q: What is ionizing radiation? A: Ionizing radiation is the energy or particles produced by unstable atoms of radioactive materials. Humans are exposed to low levels of radiation naturally from the earth and the sun.

Q: What are the health consequences of radiation? A: Exposure to high levels of radiation can cause acute radiation syndrome, or radiation poisoning, resulting in substantial damage to human body tissues, premature aging, and possibly death. Prolonged exposure to lower levels is also associated with increased risk of ill-health.

Q: What are the symptoms of radiation poisoning? A: The first symptoms of acute radiation syndrome are typically nausea, vomiting and diarrhea. These symptoms start within minutes to days after exposure, and last for minutes to days. A person with acute radiation syndrome may look and feel healthy for a short time, then become sick again with loss of appetite, fatigue, fever, and possibly seizures and coma. This stage may last a few hours or several months. Radiation poisoning also typically causes skin damage.

Q: What level of radiation is dangerous to human health? A: Radiation is measured in sieverts. Exposure to one sievert of radiation can cause hemorrhaging, four sieverts can cause death within two months, and 2,000 sieverts can cause loss of consciousness within minutes and death within hours.

Q: How is radiation poisoning treated? A: Potassium iodide can be used to block radioactive iodine from being taken into the thyroid gland, protecting it from injury. It cannot protect other parts of the body, or reverse damage to the thyroid once it has occurred. Prussian blue, a dye used by artists and manufacturers since 1704, can also be used to remove certain radioactive materials from the body.

--Editors: Jason Gale, Aaron Sheldrick

Radiation Poisoning Possible For Those Aboard U.S. Aircraft Carrier Ronald Reagan

Third Age

International News News Radiation Poisoning Possible For Those Aboard U.S. Aircraft Carrier Ronald Reagan

Radiation Poisoning Possible For Those Aboard U.S. Aircraft Carrier

March 14, 2011 2:18 PM
By Emily Jacobson

Map of the Sendai earthquake
Source: Wikipedia

Click to Enlarge

Radiation poisoning may have hit crew members aboard the aircraft carrier Ronald Reagan, which passed through a radioactive cloud from stricken nuclear reactors in Japan, causing them to receive a month’s worth of radiation in about an hour.

American helicopters flying missions about 60 miles north of the damaged reactors became coated with particulate radiation that had to be washed off.

Despite fears, there was no indication any of the military personnel had experienced negative effects from the exposure.

However, the episodes showed that the prevailing winds were picking up radioactive material from crippled reactors in northeastern Japan. Ever since an earthquake struck Japan on Friday, authorities worldwide have been laying plans to determine what, if any, danger radioactive plumes could pose to people.

"At this point, we have not picked up anything" in detectors midway between Japan and Hawaii, said Annika Thunborg, a spokeswoman for an arm of the United Nations in Vienna that monitors the planet for spikes in radioactivity.

On Sunday, the Nuclear Regulatory Commission said it expected no "harmful levels of radioactivity" to move on the winds to Hawaii, Alaska or the West Coast from the reactors in Japan.

Map of the Sendai earthquake
Source: Wikipedia

Fish Oil May Prevent Alzheimer's

3 Fish Oil Omega:

Do Fish Oils Prevent Alzheimer's Disease?

Another Powerful Study Shows A Markedly Reduced Risk of Alzheimer's with Fish Oils (Omega-3 Oils).

Natural Substances or Prescription Drugs for Alzheimer's Disease?

by Jay S. Cohen, M.D
www.MedicationSense.com

If a drug company announced that a new drug had reduced the incidence of Alzheimer's disease by 60% in a large, impressive study, the news would create a sensation. TV news programs and newspaper headlines would broadcast the discovery everywhere. But what if the discovery wasn't a new drug, but a natural substance: would it get the same attention?

The natural substance is fish oil (omega-3 oils). A growing number of studies are showing that fish oils may help treat mild Alzheimer's disease and may even prevent Alzheimer's from developing. The most impressive study I have seen is a prospective study that followed 815 older people over 4 years.

By following the people prospectively, that is, before any illness had developed, the researchers were able to identify the factors associated with the development of Alzheimer's disease in some participants. The researchers reported:

"Participants who consumed fish once per week or more had 60% less risk of Alzheimer's disease compared with those who rarely or never ate fish.1"

The results were even better for people who ate the most fish. They had a 70% reduction in the risk of developing Alzheimer's disease. The positive results also correlated with people who consumed omega-3 fatty acids, particularly DHA (docosahexaenoic acid), a component of fish oils -- and a major component of human brain tissue.

A Series of Impressive Studies

These findings arrived on the shoulders of other impressive studies. A study published in 2003 found reduced levels of DHA in the blood of people with Alzheimer's disease.2 In 1997, a prospective study of people age 55 and older in the Netherlands found the same thing: an inverse relationship between fish consumption and dementia, especially Alzheimer's disease.3 The more fish people ate, the less the likelihood of Alzheimer's disease.

In 2002, a 7-year study of 1674 people over age 67 found that those who had the greatest fish consumption also had the lowest incidence of dementia. The authors of this study commented:

"Elderly people who eat fish or seafood at least once a week are at lower risk of developing dementia, including Alzheimer's disease.4"

The authors concluded that fish is beneficial because its omega-3 fatty acids reduce inflammation in the brain and assist the regeneration of nerve cells.4

A 2006 study found that supplementation with fish oils could slow cognitive decline in people with mild Alzheimer's disease.5

All of these positive findings may be due to the ability of fish oils to reduce inflammation. Experts believed that much of the degeneration of aging is due to chronic inflammation. The anti-inflammatory effect of fish oils or other forms of omega-3 fatty acids has been proven in studies of people with inflammatory disorders such as rheumatoid arthritis and osteoarthritis.6-8

Natural Substances vs. Prescription Drugs

People's awareness of the benefits of fish and fish oils is rising, but it has taken many years to accomplish this, and many people still have not heard. Many doctors still do not recommend fish or fish oils to patients. There is no national public health initiative to spread the word. Yet, if a drug is ever developed that reduces Alzheimer's risk by 60%, it will receive the full treatment. Headlines. Interviews on television. Full-page print advertisements and unrelenting television ads. Thousands of drug sales reps will inundate doctors' offices, touting the drug's benefits so enthusiastically that they might forget to mention the inevitable side effects and exorbitant cost.

Good alternatives are available today. Fish oils,1-4 folic acid,9,10 alpha lipoic acid,11 curcumin and L-acetyl carnitine12 are believed to offer some benefit for Alzheimer's disease. The evidence is not complete, but it is promising, more promising than many of the drugs that are frequently prescribed today. Moreover, coenzyme Q10 has shown benefit in Parkinson's disease.13

Moreover, a recent study has shown that people who eat a Mediterranean diet have a substantially reduced risk of developing Alzheimer's disease.14 In addition, a Mediterranean diet provides other benefits: reduced cholesterol levels, reduced incidence of heart attacks and hypertension, improved glucose metabolism.

Additional Benefits of Fish Oils

There are other reasons to get enough fish oils in your diet. Studies have demonstrated convincingly that fish oils reduce the risk of sudden cardiac death, which kills 250,000 Americans a year, by 40%-80%.15-17 For this reason, experts recommend that people should eat fish at least once a week or take fish oil supplements (1 gram of omega-3 fatty acids) daily.

Additional benefits of fish oils include reduction of triglyceride levels, improved glucose metabolism, improved vascular flexibility, and reduced blood pressure. Fish oils many also help prevent some cancers. Fish oils also have antithrombotic effects, that is, they cause a slight thinning of the blood. People with bleeding disorders or taking Coumadin (warfarin) or other blood thinners, or even aspirin, should check with their doctors before taking fish oils.

REFERENCES

1. Morris, MC, et al. Consumption of fish and n-3 fatty acids and risk of incident Alzheimer's disease. Archives of Neurology 2003;60:940-946.
2. Tully, AM, et al. Low serum cholesteryl ester-docosahexaenoic acid levels in Alzheimer's's disease: a case-control study. British Journal of Nutrition 2003;89:483-489.
3. Kalmijn, S, et al. Dietary fat intake and the risk of incident dementia in the Rotterdam study. Annals of Neurology 1997;42:776-82.
4. Barberger-Gateau, P, et al. Fish, meat, and risk of dementia: cohort study. British Medical Journal 2002;325:932-933.
5. Freund-Levi Y, Eriksdotter-Jonhagen M, et al. O-3 fatty acid treatment in 174 patients with mild to moderate Alzheimer's disease. Archives of Neurology 2006;63:1402-1408.
6. Cleland L, James M, Proudman S. The role of fish oils in the treatment of rheumatoid arthritis. Drugs 2003;63(9):845-53.
7. Kremer, JM, et al. Effects of high-dose fish oil on rheumatoid arthritis after stopping nonsteroidal antiinflammatory drugs. Arthritis and Rheumatism 1995;38(8):1107-14.
8. Lau, CS, Morley, KD, Belch, JJ. Effects of fish oil supplementation on non-steroidal anti-inflammatory drug requirement in patients with mild rheumatoid arthritis--a double-blind placebo controlled study. British Journal of Rheumatology 1999;32(11):982-9.
9. Seshadri, S, Beisir, A, Selhub, J, et al. Plasma homocysteine as a risk factor for dementia and Alzheimer's disease. New England Journal of Medicine, Feb. 14, 2002;346:476-483.
10. Rydlewicz, A, Simpson, JA, Taylor, RJ, et al. The effect of folic acid supplementation on plasma homocysteine in an elderly population. QJM 2002;95(1):27-35.
11. Hager K, Marahrens A, Kenklies M, Riederer P, Munch G. Alpha-lipoic acid as a new treatment option for Azheimer type dementia. Journal of Gerontology and Geriatrics 2001;32:275-282.
12. Spagnoli A, Lucca U, Menasce G, et al. Long-term acetyl-L-carnitine treatment in Alzheimer's disease. Neurology 1991;41(11):1726-32.
13. Shults, CW, Oakes, D, Kieburtz, K, et al. Effects of coenzyme Q10 on early Parkinson's disease: evidence of slowing of the functional decline. Archives of Neurology 2002;59:1541-1550.
14. Scarmeas N, Stern Y, et al. Mediterranean diet, Alzheimer's disease, and vascular mediation. Archives of Neurology 2006;63:published online 10/9/06, www.archneur.ama-assn.org/cgi/content/full/63.12noc16109.
15. de Lorgeril, M, Salen, P, Defaye, P, et al. Dietary prevention of sudden cardiac death. European Heart Journal 2002;23:277-285.
16. Albert, CM, Campos, H, Stampfer, MJ, et al. Blood Levels of Long-Chain N-3 Fatty Acids and the Risk of Sudden Death. New England Journal of Medicine 2002;346(15):1113-18.
17. Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Lancet 1999;354(9177):447-55.

Copyright 2004, Jay S. Cohen, M.D. All rights reserved. Readers have permission to copy and disseminate all or part of these articles if it is clearly identified as the work of: Jay S. Cohen, M.D., the MedicationSense E-Newsletter, www.MedicationSense.com. You may not use this work for commercial purposes.

Seafood Versus Depression and Inflammation

Omega 3 Depression:

Seafood Versus Depression and Inflammation

Omega 3s Gain Medical Ground

by Craig Weatherby
Courtesy of Vital Choice Seafood

In fall 2004, one “superstar” drug after another fell from its pedestal, the victims of exaggerated claims and unforeseen side effects.

Vioxx was the first to fall, followed quickly by Celebrex. New information showed that each of these “COX-2” anti-inflammatory pain relievers appear to pose greater health risks than the far cheaper generic pain relievers—aspirin, ibuprofen, etc.—they were supposed to improve on. Even the primary reason for their introduction—reduced risk of gastric bleeding in comparison with aspirin and ibuprofen—has since proven false.

Omega-3s discourage depression

Now, the ubiquitous anti-depressant drug Prozac has taken an image hit. First came evidence that Prozac may cause violent and suicidal behavior. In October of 2004, the FDA ordered drug companies to place "black box" warnings on the labels of the most widely prescribed class of antidepressants—serotonin reuptake inhibitors or SRRIs—including Prozac, stating that antidepressants increase the risk of "suicidal thinking and behavior in children and adolescents."

Then, an article in the January 1 issue of the British Medical Journal (BMJ) alleged that Prozac patent holder Eli Lilly & Company had long concealed evidence of this problem. British medical regulators were especially upset over the alleged concealment by Lilly, since they had recommended that many antidepressants not be prescribed for children and teenagers, but had not included Prozac in those advisories.

According to news reports, some of the documents cited by the BMJ article date back to the 1980's and include memos between Eli Lilly employees that show a link between Prozac and violent or suicidal behavior among people taking the drug.

DHA considered vital to mood control

The omega-3 fatty acid known as DHA is a major component of cell membranes in the brain, and dietary DHA has been found to improve the symptoms of bipolar disorder, schizophrenia, and depression. A growing body of evidence indicates that omega-3 fatty acids—especially DHA—offer a promising dietary defense against depression. (DHA is found only in seafood, and is concentrated in fatty, cold water fish like salmon, sablefish, and tuna.)

Research over the past few years yielded these highly suggestive findings:

• People suffering from major depression generally have lower-than-average body levels of omega-3s (especially DHA).
• Omega-3s alleviate major depression, according to the results of the first placebo-controlled clinical trial, published in 2003. As the authors concluded, “From the preliminary findings in this study, omega-3 PUFAs could improve the short-term course of illness and were well tolerated in patients with major depressive disorder.”
• People in geographic areas where consumption of DHA is high enjoy decreased rates of depression, according to most studies. (A recent population study in Finland found no connection.)
• People who typically have below-average tissue levels of DHA—such as alcoholics, and women in the postpartum period—suffer higher than average rates of depression.

This is not to say that people diagnosed with depression can safely toss their prescriptions in favor of eating lots of fish: researchers say that controlled clinical trials comparing DHA against standard antidepressants are required before doctors can prescribe DHA as an effective and safe alternative therapy for depression and related mood disorders, such as anxiety.

That said, increased DHA intake is certainly a safe preventive measure. As researchers at Harvard Medical School noted in a year 2000 review article, “Considering that natural medications generally seem best for treating mild to moderate illness, the role of DHA as a therapy for minor and subsyndromal depression also should be considered.”

Omega-3s seen as anti-arthritis ally

Osteoarthritis affects an estimated 21 million Americans, most of them over the age of 45. This most common type of arthritis is caused by gradual degradation of the cartilage in people’s knees, hips, backs, and ankle joints. Loss of cartilage results in two sources of pain: 1) rubbing of bone against bone, and 2) indirect pain from the inflammatory response the body mounts in response to injury of tissues surrounding the joint. (Cartilage itself has no nerve endings.)

While their modes of action remain a bit of a mystery, aspirin and ibuprofen (Advil), naproxen (Aleve), Vioxx and Celebrex provide effective relief from osteoarthritis pain, primarily through their anti-inflammatory actions. (Vioxx was withdrawn from sale last fall following reports of its risks to heart health.)

Omega-3s also dampen inflammation, but not strongly enough to provide the kind of pain relief people get from taking pharmaceutical drugs.

However, dietary omega-3s exert physiological effects that can help slow the progress of osteoarthritis, and limit related pain and immobility. Test tube studies involving cartilage cells (chondrocytes) show that omega-3s decrease the cartilage degradation and inflammation associated with osteoarthritis. As the authors of one study put it, “… our data provide evidence supporting dietary supplementation of n-3 PUFA [omega-3s], which in turn may have a beneficial effect of slowing and reducing inflammation in the pathogenesis of degenerative joint diseases in man.”

What about the far less common, far more debilitating disease known as rheumatoid arthritis (RA)? This highly painful condition is caused by a mysterious malfunction of the immune system that causes the body to mount an inflammatory attack its own joint tissues. Since omega-3s are anti-inflammatory, it’s no surprise that most clinical studies show that people with rheumatoid arthritis report substantial relief from dietary omega-3s.

Yet, for a purely non-medical reason, omega-3s remain an under-prescribed therapy for either form of arthritis. As the authors of a recent research paper explained, “Since fish oils do not provide industry with the opportunities for substantial profit associated with patented prescription items, they have not received the marketing inputs that underpin the adoption of usual pharmacotherapies.” In other words, drug companies can’t make money selling natural products like omega-3s, because they cannot be patented and, compared with novel drugs, offer little profit potential.

Safety first

Last, but not least, one huge advantage of fish oil over nearly every pharmacological solution is its safety. Only a fishy aftertaste (“repeat”) occurs with some brands, which is completely harmless and usually passes quickly—a very small price to pay for fish oil’s manifold, well-proven benefits.

Sources:

• Mischoulon D, Fava M. Docosahexanoic acid and omega-3 fatty acids in depression. Psychiatr Clin North Am. 2000 Dec;23(4):785-94. Review.
• Su KP, Huang SY, Chiu CC, Shen WW. Omega-3 fatty acids in major depressive disorder. A preliminary double-blind, placebo-controlled trial. Eur Neuropsychopharmacol. 2003 Aug;13(4):267-71.
• Colin A, Reggers J, Castronovo V, Ansseau M. [Lipids, depression and suicide] Encephale. 2003 Jan-Feb;29(1):49-58. Review. French.
• Hibbeln JR. Seafood consumption, the DHA content of mothers' milk and prevalence rates of postpartum depression: a cross-national, ecological analysis. J Affect Disord. 2002 May;69(1-3):15-29.
• Hakkarainen R, Partonen T, Haukka J, Virtamo J, Albanes D, Lonnqvist J. Is low dietary intake of omega-3 fatty acids associated with depression? Am J Psychiatry. 2004 Mar;161(3):567-9.
• Curtis CL, Rees SG, Cramp J, Flannery CR, Hughes CE, Little CB, Williams R, Wilson C, Dent CM, Harwood JL, Caterson B. Effects of n-3 fatty acids on cartilage metabolism. Proc Nutr Soc. 2002 Aug;61(3):381-9.
• Adam O. Dietary fatty acids and immune reactions in synovial tissue. Eur J Med Res. 2003 Aug 20;8(8):381-7. Review.
• James MJ, Proudman SM, Cleland LG. Dietary n-3 fats as adjunctive therapy in a prototypic inflammatory disease: issues and obstacles for use in rheumatoid arthritis. Prostaglandins Leukot Essent Fatty Acids. 2003 Jun;68(6):399-405. Review.
  

AlterNet.org

FOOD

AlterNet / By Ari LeVaux

Organic Meat and Dairy Are About to Be History, But There Are Two Ways You Can Help Stop It

Even as the Obama administration is starting to look like the Monsanto administration, we can still fight back.

February 11, 2011 |

The Obama administration struck a blow to freedom in the realms of food and agriculture late January, when the USDA deregulated genetically modified (GM) alfalfa seed. The agency's decision threatens to deprive farmers of the right to produce GM-free milk and meat and deny consumers the right to purchase it. It also threatens the relevance of the USDA's organic program.

Then, on Feb. 4, the USDA did it again, this time by partially deregulating GM sugar beet seed.

Both announcements were great news for Monsanto, which owns both types of GM seeds -- and USDA chief Tom Vilsack as well, apparently. Vilsack's trips on the Monsanto corporate jet while governor of Iowa are well documented, and his "Governor of the Year" award from the Biotechnology Industry Association was surely well deserved. Indeed, both of Vilsack's recent deregulations were big victories for the biotech industry as a whole. And the sugar beet move is especially chilling to those harboring fears of a GM planet. The USDA's deregulation of sugar beet seed defied an order from a San Francisco District Court demanding an Environmental Impact Statement (EIS) be produced before USDA deregulated the seed.

USDA deregulated it anyway. And even if the agency is ultimately penalized for this intransigence, the seed will have been planted, which is a significant gain of ground for GM agriculture-lovers.

Nearly all the beet seed in the country -- seed for conventional and organic alike, sugar and table beets both -- is grown in Oregon's Willamette Valley. The reason is simple: It's the nation's best spot to grow beets (and chard, too, which cross-pollinates with beets). Once GM beets are planted in the Willamette Valley, non-GM beet (and chard) growers may be forced out or overtaken, voluntarily or otherwise, by genetically modified sugar beet DNA.

In the case of GM alfalfa, even the corporate-rights activist group also known as the U.S. Supreme Court recognized that deregulated alfalfa presented unacceptable risks to the environment, consumers, and business-three pillars of American greatness. Last summer the court ruled that USDA must complete an Environmental Impact Statement (EIS) before deregulating GM alfalfa seed.

In response to this ruling, USDA dutifully held a public comment period and drafted an EIS, which contained plenty of reasons to be wary of GM alfalfa. The agency then proceeded to ignore these warnings and grant full deregulation to GM alfalfa.

In choosing this path, USDA chose against the option of partial deregulation, which would have provided mechanisms for keeping track of what happens to the genes that Monsanto will be releasing into the environment.

Such oversight, at a minimum, is a good idea, since GM alfalfa is to organic dairy what the Trojan Horse was to Troy. Alfalfa is pollinated by bees, which have a five-mile range. When non-GM alfalfa is pollinated with pollen from GM alfalfa plants, seeds containing the lab-modified DNA sequences are produced. Alfalfa is a perennial that can generate 15,000 seeds a year and live for decades, even centuries. Once GM pollen is out of the bag, putting it back in would be like repacking Pandora's box. It's not going to happen. It's a matter of when, not if, GM alfalfa DNA starts showing up in the feed of organic dairy cows. The AP reported on Feb. 7, "Contamination of organic and traditional crops by recently deregulated, genetically modified alfalfa is inevitable, agriculture experts said, despite Agriculture Secretary Tom Vilsack's recent assurances the federal government would take steps to prevent such a problem."

When the genes escape, organic regulators will find themselves in a tricky spot: Either revoke organic certification from the "offender"-who's actually a victim of GM contamination-or broaden organic standards to allow GM in. The latter would be a dream come true for the biotech seed industry. Thus, GM alfalfa may represent a foot in the door of the coveted organic market-the food industry's fastest-growing segment.

The USDA's deregulation of GM alfalfa and sugar beet seed threatens the rights of those in the agriculture business to produce meat and dairy that's free of the mark of genetic modification, and all of the unknown possibility that mark entails. Once the first crop of GM alfalfa goes to seed, the prospects of a future with non-GM meat and dairy will dim considerably, taking with it the consumer freedom to eat non-GM meat and dairy. And once the GM sugar beets go to seed, finding non-GM beets or chard will become difficult if not impossible.

It appears that USDA's goal was getting both alfalfa and sugar beet seed planted as soon as possible. It was able to do so legally, if sleazily, with alfalfa, but not with sugar beets. Perhaps the urgency, from Monsanto's perspective, is that Vilsack only has two more years of guaranteed influence. After the 2012 election, who knows? Since beets take two years to flower, Vilsack's golden window closes this spring. Planting now gives the beets enough time to contaminate the Willamette Valley with their pollen before the possible arrival of a new USDA chief, who might not be in Monsanto's front pocket.

While GM alfalfa threatens to blanket the country with GM pollen that will eventually find its way into dairy and meat supplies, GM sugar beet seed is an efficient surgical strike at beet central. Either way, more genetically modified DNA is poised for injection into the food chain and the environment.

Tom Philpott, food editor at Grist.org, points out that we can find a bit of comfort in the fact that sugar beet seed deregulation is partial, meaning USDA is supposed to monitor where the GM beets are planted and make sure the genes don't spread. But the genes will spread, no matter how carefully USDA and Monsanto try to prevent it.

The genes will spread because that's what genes do.

Those who oppose the planting of GM alfalfa and sugar beet seeds have two significant milestones to consider in their planning. The first is preventing the seeds from being planted. If that fails, the next and final chance will be to make sure the plants are destroyed before they flower. After that, once the pollen gets released, game over. Food and Water Watch has launched a petition to tell the White House how you feel about GM foods. But it may fall on deaf ears. Philpott recently presented evidence that the White House may be even more pro-GM than USDA.

The court system offers the best legal opportunity to achieve one of these defensive stops, and that possibility is real. The Center for Food Safety may be an underdog against Monsanto and USDA on the GM sugar beet and alfalfa fronts, but the nonprofit is, as they say in Vegas, a live dog. CFS is active in both GM alfalfa and sugar beet litigation, and contributing to its legal fund probably provides the most bang for your buck-short of buying land upwind from a Monsanto field and spraying obscene amounts of nasty pesticides on windy days, and then suing Monsanto for stealing the chemicals that land on its plants.

That would be really fun, but my money's on the Center for Food Safety, though. Less potential downside -- blowback, as it were. I'll be including a dollar for every commenter, below, who pledges to donate too.

Ari LeVaux writes a syndicated weekly food column, Flash in the Pan.