Health and Wellness News from the Underground: Blog

What You Didn't Know Was in Your Drinking Water

Wed, 20 Aug 2008 00:58:15 GMT

I gave some money last week to Clean Water Action. I think we should all do the same thing.

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http://online.wsj.com/article/SB121910526011851511.html?mod=hpp_us_inside_today

What's Coming
From Your Tap?

By ANJALI ATHAVALEY
August 19, 2008; Page D1

America's latest drinking problem isn't about alcohol.

Concerned about the cost of bottled water -- and its environmental consequences -- many people are turning back to tap water to quench their thirst. But as evidence mounts of contaminants in public systems, unease about the water supply is growing.

Engineers say that U.S. water quality is among the world's best and is regulated by some of the most stringent standards. But as detection technology improves, utilities are finding more contaminants in water systems. Earlier this year, media reports of trace amounts of pharmaceuticals in water across the country drew attention from U.S. senators and environmental groups, who are now pushing for regulation of these substances in water systems.

Of particular concern, experts say, are endocrine-disrupting compounds -- found in birth-control pills, mood-stabilizers and other drugs -- which are linked to birth defects in wildlife. Also alarming are antibiotics, which if present in water systems, even in small amounts, could contribute to the rise of drug-resistant strains of bacteria, or so-called super bugs.

Many pharmaceuticals taken by humans are excreted into urine, or are flushed intentionally down the toilet. Even though wastewater is treated, trace amounts of the drugs are often not eliminated. Also, drugs found in the waste of animals treated with hormones and antibiotics can eventually end up in groundwater.

The actual health effects of drugs in water systems are unclear. The levels that have been detected are relatively small compared with those of other regulated contaminants, such as mercury and benzene. A 2008 study funded by the Denver-based Awwa Research Foundation -- a nonprofit research group that was established by the American Water Works Association -- concluded that it is "highly unlikely" that pharmaceuticals will pose a threat to human health.

But many medical experts argue that more studies need to be done -- and note that the amount of drugs in the water matters less than who drinks it. Some drugs, even in small amounts, can be especially harmful to infants, pregnant women or those with chronic health conditions, for example.

The publicity has frightened many consumers. Laura Pfeil, 39, a stay-at-home mother with four sons in Mason, Ohio, says it does concern her, "especially when thinking of my children's welfare."

She says she started using bottled water at home 15 years ago when she was pregnant with her eldest son because she thought it was safer than tap water. Three years ago, though, her family switched to a PUR Water Filter System, made by Procter & Gamble Co., to save money and to reduce the waste resulting from plastic bottles. (Environmentalists also point to the energy wasted in transporting bottled water.)

Now, says Ms. Pfeil, she has concerns about consuming trace amounts of pharmaceuticals that the filter may not eliminate. A spokeswoman for P&G's PUR division says it "cannot confirm the reduction of pharmaceuticals in water with carbon filters."

Sales of PUR filters are at an all-time high, says the spokeswoman, an indication of tap water's new popularity. U.S. consumers spent $16.8 billion on bottled water in 2007, up 12% from the year before, according to Beverage Digest, a trade publication. But growth has slowed over the last three years.

Drugs are only one category of contaminants found in tap water. A 2005 study released by the nonprofit Environmental Working Group, a Washington-based research group, found that tap water in 42 states is contaminated with more than 140 unregulated chemicals, including MTBE, perchlorate and industrial solvents.

Protesting a Disinfectant

Even chemicals used to clean and disinfect drinking water are causing worry. Citizens' groups in states such as California, New York and Vermont are protesting the increasing use of chloramine -- a combination of chlorine and ammonia -- to disinfect drinking water. Utilities are using chloramine because of Environmental Protection Agency limits on chlorine byproducts.

Citizens Concerned About Chloramine in the San Francisco Bay Area, an activist group, says that hundreds of residents have had reactions, such as rashes and respiratory problems, to the disinfectant. Some byproducts of chloramine can be more toxic than chlorine byproducts, says Michael Plewa, a professor of genetics at the University of Illinois at Urbana-Champaign who has studied disinfection byproducts.

The EPA says chloramine is safe in drinking water and has been used for decades.

In the absence of federal regulation of certain chemicals in water systems, some states have stepped in. California, for one, has set standards for various compounds that are not regulated by the EPA, including perchlorate, an ingredient used in rocket fuel that was spilled into groundwater during the Cold War and has been found in many water systems. Massachusetts has set standards for perchlorate and requires that water utilities in the state test for MTBE, a gasoline additive.

"What you see in many states is a reaction to the lack of action at the federal level," says Suzanne Condon, director of the Bureau of Environmental Health at the Massachusetts Department of Public Health.

Tap Versus Bottled

Health concerns extend to bottled water, says Sarah Janssen, a science fellow at the Natural Resources Defense Council, or NRDC, a nonprofit environmental advocacy group based in New York. "A lot of bottled water is actually tap water, so there is no assurance that what is coming from the bottle is any safer than what is coming from the tap," she says.

In fact, experts say tap water is held to more stringent standards by the EPA, and tested more often, than bottled water, which is regulated by the Food and Drug Administration.

Utilities are required by law to send annual reports to their customers detailing contaminants found in water systems and whether they exceed levels set by the EPA. They are not required to list unregulated contaminants in these reports.

If a contaminant exceeds the EPA's "maximum contaminant level," the report should detail the potential health effects of the contaminant and a summary of actions the utility is taking. If you do notice a contaminant that exceeds EPA levels in your utility's report, consider installing a tap-water filter, experts say.

Water that is tested by utilities is generally tested at the plant. It still has to travel through your pipes to get to your tap, so if you have pipes that are a couple of decades old, it may be a good idea to get the water from your tap tested in a lab -- especially if you are pregnant, nursing or have small children, says the NRDC's Dr. Janssen. People who get their water from private wells should have their water tested annually.

Water filters aren't foolproof. Those that are certified by NSF International -- a nonprofit group that tests food and water products -- can get rid of unwanted chemicals to EPA's standards, but consumers should be aware that trace amounts of chemicals may still be left in their water.

Carbon filters, which come in the form of a faucet mount or a pitcher, are the most commonly used and cost about $30, says Rick Andrew, operations manager of the drinking water treatment unit program at NSF. These can be fairly effective in removing many contaminants, but need to be replaced about every two months.

Other options -- such as reverse-osmosis systems, which use a semipermeable membrane to remove contaminants, or ultraviolet light treatment, which prevents micro-organisms from reproducing -- can be more effective, but they cost hundreds or even thousands of dollars. Some consumers have found the cost is worth it, especially if members of the family have certain health conditions.

Last April, Elizabeth Beyer, 47, purchased a Kinetico Inc. K5 Drinking Water Station for her father, who had a liver transplant in February. Doctors had advised him to drink only filtered water. The system, which cost $2,100, is meant to remove contaminants ranging from lead to chlorine sediment using reverse-osmosis technology and two additional filters.

Ms. Beyer, who lives in Venice, Fla., says it was worth it. Her water is clearer and crisper. "I can definitely taste the difference," she says. "You can see the difference."

Write to Anjali Athavaley at anjali.athavaley@wsj.com

Thank God for Canada

Wed, 20 Aug 2008 00:51:58 GMT

True, their dollar is stronger than ours, but I almost don't mind, because they help us see what products to avoid, since our own crappy government doesn't see fit to prohibit most of the toxic ingredients in our everyday products.

http://www.cbc.ca/consumer/story/2008/08/18/f-health-chemicals-batch3.html

IN DEPTH

Environment

Next, federal government will weigh in on safety of printer inks, cosmetics

Last Updated: Tuesday, August 19, 2008 | 4:51 PM ET

The federal government is expected to release a draft assessment on Saturday of chemicals that includes a pigment used in some printer cartridges, a colouring agent used in cosmetics, and a dye used in detergents and cleaners.

The review is part of the government's Chemical Management Plan, in which 200 chemicals are assessed in batches. The program, run by Environment Canada and Health Canada, was announced on Dec. 8, 2006.

It was under the same program that Health Minister Tony Clement announced a public consultation on April 18 of the import and sale of polycarbonate baby bottles containing bisphenol A. Clement said the chemical could affect early development in infants and newborns.

Studies in peer-reviewed journals had indicated that even at low doses, the chemical can increase breast and ovarian cancer-cell growth and the growth of some prostate cancer cells in animals.

The plastics industry vigorously defended the safety of the chemical, noting it has been used in a range of products for 50 years.

The U.S. Food and Drug Administration recently said the chemical was safe to use in food containers, as only trace amounts of bisphenol were found to leach into the food. Critics suggested the federal agency relied on industry-funded studies in its evaluation.

The following chemicals, included in Batch 3, are not believed to pose any risks to human health but may pose harm to the environment in low concentrations:

Disperse Red 86 is used in some textile products and Disperse Violet 57 is used to colour certain plastics.
Pigment Red 3 is used in printing inks and cartridges, paints, adhesives, wallpapers, linoleum, carbon papers, typewriter ribbons, artists' materials and grout products.
Pigment Orange 5 is synthetic colorant used in paints, coatings, adhesives and inks.
Pigment Red 4 is a synthetic organic pigment. Environment Canada notes information on use of the chemical is confidential.
Disperse Blue 19 is used in the manufacturing of products including oils, waxes, greases, fats, emulsions and pesticide products.
Pigment Orange 2 is used to colour plastics and inks.
Pigment Red 6 can be found in chemical products including solvents, carriers, strippers and etchers.
Pigment Red 5 is used as a colorant in cosmetic goods, stationary, wood stains, paints, varnishes, latex and synthetic fibres.
Acid Blue 127, a synthetic dye, is used in soap and cleaning products.
Disperse Blue 77 is a man-made organic dye that can be found to make textile fabrics.
PBMBDP is used to make synthetic rubber for hoses, rubber seals and gaskets.
PDDAM, an organic colorant, is used to manufacture pigment, stain, dye and ink.
Acid Violet 48 is used as a dye to colour detergents and cleaners and is used to manufacture textiles.
Pigment Red 251 is used as a colorant in printing ink, pesticides, fuel additives, lubricants, paints, lacquers and construction materials.

Batch 3 also includes these chemicals which are being evaluated for their effect on unborn offspring as well as the environment:

2-Methoxyethanol acetate is used in products including paints, lacquers, glues, adhesives, waxes, oils, textile printing, film, nail polish and dry cleaning products.
2-ethoxyethanol acetate is used as a solvent in paints, varnishes, silkscreen printing inks, wood stain and leather finishing dyes.
2-(2-Methoxyethoxy)ethanol, a synthetic organic chemical, is used in a wide range of products including stamp pads, ball point and felt tip pens, hydraulic brake fluids, wood stains, household and commercial cleaners and cosmetics.
2-Methoxy-1-propanol is used as a solvent or agent in coatings, sealants, adhesives, agricultural pesticides, various types of inks, hydraulic brake fluids and lubricants, and household and industrial cleaners.

Environment Canada and Health Canada are expected to release its draft assessment of Batch 4 chemicals which include an antimicrobial used in some shampoos and deodorants and an organic compound used in certain toiletries on Nov. 15.

Don't Believe the Hype about the Bird Flu Pandemic

Tue, 19 Aug 2008 16:01:33 GMT

Yet more bull**** about the bird flu pandemic that's supposedly coming our way. Scientists have found that people who survived the 1918 flu pandemic still have very strong antibodies against the 1918 flu. Now scientists think that adding these antibodies to a vaccine against the bird flu will make the vaccine stronger and more effective. They are missing two huge points: (1) The 1918 survivors developed these antibodies naturally as a response to natural exposure to the actual disease, not forced intramuscular injection of a manipulated form of the disease; (2) the bird flu only spreads from birds to humans when the humans are immunocompromised by dioxin poisoning (like the dioxin in Southeast Asia from Agent Orange and from industrial waste). The money spent on developing the vaccine would be far better spent on cleaning up Southeast Asia's massive dioxin contamination, because that would help prevent all future animal diseases from infecting humans in this poor, poisoned corner of the world.

Here is the link to (and an excerpt from) my previous blog entry on the subject:
http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!196.entry

Dioxin, influenza and humans: a connection?
In May 2006, Indonesia reported a cluster of human bird flu cases that involved eight family members, seven of whom died. All but one person in the family appeared to have contracted the virus from another family member. This became the first reported incidence of H5N1 spreading from one person to another, and then another. Alarmed officials feared that the bird flu virus had acquired characteristics that would soon allow easy passage from human-to-human.

The members of the deceased family lived in a small village in Karo district located in the Indonesian province of North Sumatra. The Karo highland borders on Lake Toba, the world's largest volcanic lake. The largest lake in Southeast Asia, Toba has been deteriorating since 1998, defenseless against Indorayon, a paper, pulp and rayon manufacturer owned by multinational companies and funded by the World Bank. Untill it was shut down, Indorayon was the largest polluter of Lake Toba in the past decade, dumping tons of chlorine and dioxin into the waters.

Interestingly, hundreds, perhaps thousands, of individuals with H5N1 influenza have not been sick enough to require medical care, as confirmed by Dick Thompson, spokesperson for the WHO in March, 2005.(7) However, between 2003 and April, 11, 2007, there have been 291 cases and 171 deaths, with 61% of the deaths in Vietnam and Indonesia. An investigation, perhaps including a fat biopsy, should be undertaken to determine if those who died had significantly higher concentrations of dioxin in their body than those who have been exposed to H5N1 and remained well or fully recovered.

What can be done?
A global pandemic is brewing, but not because a virus may “jump species” and rapidly circumnavigate the globe, wiping out everyone in its wake. It appears that only those most at risk will be affected. But critically important information is missing: What is each person’s individual level of risk? Beyond spending billions on global bureaucratic preparedness, true prevention is in order through developing tests and detoxification methods for humans.

Instead of funding the development a vaccine that as a marginal chance of being effective, billions of dollars would be better spent funding international environmental clean up programs. Legislative initiatives that put enforcement teeth into international treaties that are already on the books may be the best way of aborting disaster.

(7) 23 Roos, Robert. “Relatives of avian flu patients have asymptomatic cases,” CIDRAP News, 9 March 2005.

Here is the new article about the 1918 flu:

http://news.yahoo.com/s/ap/20080818/ap_on_he_me/sci_flu_protection;_ylt=AtBQxGsbm7ePLeCLl7hlMxtZ24cA

Blood protects against long-gone killer 1918 flu

By SETH BORENSTEIN, AP Science Writer Mon Aug 18, 7:35 AM ET

WASHINGTON - Nearly a century after history's most lethal flu faded away, survivors' bloodstreams still carry super-potent protection against the 1918 virus, demonstrating the remarkable durability of the human immune system.
Scientists tested the blood of 32 people aged 92 to 102 who were exposed to the 1918 pandemic flu and found antibodies that still roam the body looking to strangle the old flu strain. Researchers manipulated those antibodies into a vaccine and found that it kept alive all the mice they had injected with the killer flu, according to a study published online Sunday in the journal Nature.

There's no pressing need for a 1918 flu vaccine because the virus has long since mutated out of its deadly form and is extremely unlikely to be a threat anymore, experts said. What's more important in this research, they said, is that it confirms theories that our immune system has a steel-trap memory.

"It's incredible. The Lord has blessed us with antibodies our whole lifetime," said study co-author Dr. Eric Altschuler at the University of Medicine and Dentistry in New Jersey. "What doesn't kill you, makes you stronger."

This is the longest that specific disease-fighting cells have lasted in people, said study lead author Dr. James Crowe, a professor of microbiology and immunology at Vanderbilt University Medical Center in Nashville, Tenn.

But these antibodies don't just survive; they have mutated tremendously and now bind tighter to disease cells than other antibodies. That makes them more potent, he said.

Crowe said he hopes to use similar techniques to boost the potencies of vaccines that would be more useful now against newer bird flu strains that could become epidemics.

The 1918 flu killed about 50 million people worldwide and nearly everybody else was exposed to the virus, Crowe said. The specific 1918 virus was lost to the world for decades, until it was reconstructed about three years ago using genetic material from victims. When scientists tested the antibodies from survivors on infected mice, they did so in a high level biosecurity lab at the Centers for Disease Control and Prevention in Atlanta.

The idea for the new study came from an old TV show, said Altschuler. In an episode of the since-cancelled TV series "Medical Investigation," a town improbably gets infected with the 1918 flu and the doctors treat everyone with the reluctantly donated blood of an old butler who survived the original pandemic, he said.

That prompted Altschuler, a professor of rehabilitation medicine who doesn't normally study flu, to look into the idea of testing people more than 90 years old for antibodies. The National Institutes of Health, which paid for much of the study, connected Altschuler with experts in the field and he found the elderly antibody donors.

The findings make sense, said Dr. Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases in Bethesda, Md., who wasn't involved with the study. Recent studies have estimated that the human immune system should last many decades, but this gives real proof, he said.

"This is the mother of all immunological memory here," Fauci said.

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On the Net

Nature: http://www.nature.com/nature

Embryonic Stem Cell Treatments a Pipe Dream

Tue, 19 Aug 2008 15:46:42 GMT

After all the griping from celebrities like Michael J. Fox about how scientists need to use human embryonic stem cells (in other words, pieces of babies) to develop cures for diseases like Parkinson's, it turns out that stem cells trigger an immune response that would likely prevent their being used as treatments. Now there's a shocker--that something scientists barely know anything about, turned out not to work after all! I'm sure Michael J. Fox is looking for the next Brooklyn Bridge to buy from the biotech industry...

http://sanfrancisco.bizjournals.com/sanfrancisco/stories/2008/08/18/daily11.html

Monday, August 18, 2008 - 2:05 PM PDT | Modified: Tuesday, August 19, 2008 - 1:00 AM

Stanford scientists suggest stem-cell monkey-wrench

San Francisco Business Times - by Steven E.F. Brown

Researchers at Stanford’s medical school found that human embryonic stem cells — widely touted as the next medical panacea — triggered an immune response in mice, which could limit the effectiveness of treatments derived from them.

The work of Joseph Wu, M.D., and Mark Davis, M.D., showed that the immune system does in fact react to and attack foreign embryonic stem cells.

Antirejection medications, commonly used in organ transplantation, can suppress the immune response, the researchers found. But these drugs, which recipients of donated organs must take for the rest of their lives, carry serious side effects because they are not selective, and suppress the entire immune system. This suppression leaves patients vulnerable to infections the body would normally fight off. The drugs can also weaken the body’s response to cancer.

Because embryonic stem cells are harvested so early in the development of a human being, many scientists supposed that the immune system might not attack them. The assumption was that since a fetus contains genetic material from both its mother and father, yet it is not attacked by the mother’s immune system, embryonic stem cells might elude attack as well. But this research undermines that idea.

“The data is quite convincing,” said Wu, an assistant professor of cardiovascular medicine and radiology at Stanford University School of Medicine. “Based on these results, we believe that transplanting these cells into humans would also cause an immune response.”

Wu and Davis — a professor of microbiology and immunology at Stanford — used new molecular imaging methods to watch cells live or die inside the mice during the experiments. In the past, scientists killed the animals and deduced their conclusions from studies of tissue samples under microscopes.

The work of Wu, Davis and their colleagues at Stanford is being published in the Proceedings of the National Academy of Sciences today.

If You Have Diabetes, Think Twice Before Taking Byetta

Tue, 19 Aug 2008 02:04:57 GMT

http://www.forbes.com/markets/economy/2008/08/18/amylin-byetta-death-markets-equity-cx_lal_0818markets30.html

FDA: Amylin's Byetta Killed 2
Lisa LaMotta, 08.18.08, 4:30 PM ET

The worst thing that you can tell a pharmaceutical investor is that the company's biggest revenue driver might be more harmful than the disease it is meant to treat.

This was the news that Amylin Pharmaceuticals (nasdaq: AMLN - news - people ) shareholder received Monday when the U.S. Food and Drug Administration issued a warning to doctors and patients via its web site stating that six patients taking the company's diabetes treatment, Byetta, have been affected by hemorrhagic or necrotizing pancreatitis since the agency last reviewed the post-marketing material in October. All of the patients required hospitalization; two died.

The news caused investors to pull away from the stock. Shares of Amylin dropped 14.5%, or $4.92, to $29.29, in late-afternoon trading. The FDA said it is working with the company to add stronger warnings to the labels and encourages patients experiencing symptoms of pancreatitis to discontinue use of Byetta, also known as exenatide. Byetta is jointly marketed with Eli Lilly (nyse: LLY - news - people ). Shares of Lilly dropped 1.7%, to $47.95.

Byetta, a twice-daily injection, was approved in 2005 for the lowering of blood sugar in patients with type 2 diabetes. The industry has been awaiting the long-acting release formula that was set to hit the market in 2010. Amylin released positive data from a 52-week study on Byetta Longer-Acting Release at the American Diabetes Association Meeting in June. Yet, analysts fear that a longer-acting drug could lead to harder-to-treat complications. At the least, that would delay the new formula's introduction.

In October, the FDA reviewed 30 reports of pancreatitis in patients being treated with Byetta. Amylin then agreed to add information about the risk to its drug label and to alert doctors about the problem. Prior to the recent report, no one had died from the complication.

Pancreatitis is the inflammation of the pancreas that can cause bleeding. It can also lead to toxins being released into the bloodstream that will negatively affect other organs in the body. It rarely leads to death.

More than 200 million people have diabetes worldwide and between 90.0% to 95.0% have type 2 diabetes, a disease that generally affects overweight people late in life. Byetta had sales of $636.0 million in the United States in 2007, with only $14.2 million elsewhere.

FDA Kisses Big Chemical's Rump on BPA Issue

Tue, 19 Aug 2008 01:53:52 GMT

The FDA apparently says that "trace amounts" (one of my favorite bull**** expressions of Big Pharma and Big Chemical) of bisphenol A (BPA, the plasticizer in polycarbonate plastic--yes, the baby bottles labeled "unbreakable") are not harmful. The myth of "trace amounts" is two-fold: first, it's ludicrous to suggest that every human has an identical immune system, body chemistry, etc., so what might not harm some people could be dangerous to others; second, "trace amounts" add up over time. If a baby drinks formula only, that baby consumes between 1 and 11 micrograms of BPA per kilogram of body weight EVERY DAY. Take a look at the chart of hazardous effects of BPA in my earlier blog post (http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!172.entry) and you'll see that consumption of as little as 0.025 micrograms per kilogram per day cause permanent changes to the genital tract. By 2.5 micrograms per kilogram per day, breast cells become predisposed to cancer. Please do click through the link to my earlier post and read the whole table of awful crap that the FDA says is no problem.

Here's a quick rundown of just a few pieces of actual, non-Big Pharma rump-kissing research:

In 2007, a consensus statement by 38 experts on bisphenol A concluded that average levels in people are above those that cause harm to animals in laboratory experiments,^[27] and a panel convened by the U.S. National Institutes of Health determined that there was "some concern" about BPA's effects on fetal and infant brain development and behavior.^[5] A 2008 draft report by the U.S. National Toxicology Program (NTP) agreed with the panel, concluding that "there is some concern for neural and behavioral effects in fetuses, infants, and children at current human exposures," and that there is "some concern for bisphenol A exposure in these populations based on effects in the prostate gland, mammary gland, and an earlier age for puberty in females." The NTP also concluded that there is negligible concern that "exposure of pregnant women to bisphenol A will result in fetal or neonatal mortality, birth defects or reduced birth weight and growth in their offspring" or that it causes adverse effects in exposed adults.^[28]27. ^ vom Saal, Fred. (July 27, 2007). "Chapel Hill bisphenol A expert panel consensus statement: integration of mechanisms, effects in animals and potential to impact human health at current levels of exposure". Reprod Toxicol..
5. ^ ^a ^b ^c ^d National Toxicology Program, U.S. Department of Health and Human Services (2007-11-26). "CERHR Expert Panel Report for Bisphenol A". Retrieved on [[2008-04-18]].
28. ^ Since you asked - Bisphenol A: Questions and Answers about the Draft National Toxicology Program Brief on Bisphenol A, National Institute of Environmental Health Sciences website.

Now here is the link to the horse**** article planted by the American Chemistry Council: http://www.msnbc.msn.com/id/26223328/

You'll love the part about how the FDA says it's safe, but "parents, politicians, and environmental groups disagree." Actually, Associated Press reporter who can't be bothered to do the simple research of reading the Wikipedia, the National Institutes of Health (NIH) disagree. Real scientists publishing their work in peer-reviewed journals disagree. Anyone with a quarter of a brain and a paycheck that doesn't depend on Big Chemical disagrees, and wants to get this toxic **** out of our food supply.

MSN Reports on Fake Health Food

Sat, 16 Aug 2008 15:10:41 GMT

http://health.msn.com/nutrition/slideshow.aspx?cp-documentid=100212803&GT1=31036

5 Pseudo-Healthy Foods

Pseudo-Healthy Food: Diet Soda

Soda can// © George Doyle /Getty Images

By Cynthia Sass, MPH, RD and Nutrition Director, Prevention

It may seem like the perfect way to save calories and slash your sugar intake, but studies show that diet drinkers actually weigh more than regular soda drinkers. For diet soft-drink drinkers, the risk of becoming overweight or obese tied to a 2-can-a-day habit is 57 percent compared to 46 percent for regular soda drinkers. Diet soda may throw off your natural appetite regulation, causing you to eat more sweets. It may also trick you into thinking it's OK to indulge in high calorie foods because you "saved" by choosing diet soda.

Pseudo-Healthy Food: Pretzels

Pretzels// © Halfdark /fStop/Getty Images

The label may shout 'fat free' and seem like a better alternative to chips, but they're made with refined white flour stripped of its vitamins and antioxidants. They're also dense so they pack a ton of carb calories for a very small amount and they’re not filling. Think of it this way—one 15- ounce bag contains the equivalent of 24 slices of white bread.

Pseudo-Healthy Food: Spinach Wrap

Spinach wrap// © Richard T. Nowitz/CORBISSpinach Wrap

It looks green and good for you but spinach powder is only a scant ingredient. These wraps are typically made from refined white flour and the green hue primarily comes from food colorings (Blue No. 1 and Yellow No. 5.). In other words you can't rely on the immune boosting vitamins A and C found in fresh spinach and it's much higher in calories. One cup of cooked spinach provides 65 calories, 105 less than a spinach wrap, which doesn't count as a veggie serving. Not to mention the fact that the fillings often include ingredients like fried chicken, ranch dressing, cheese and bacon!

Pseudo-Healthy Food: Blueberry Scone

Blueberry scone// © MASH /Getty Images

Even a trans-fat-free wild blueberry scone packs over 400 calories (the amount an entire meal should supply) and over 50 percent of the maximum amount of artery-clogging saturated fat intake for an entire day. They also don’t count as a serving of fruit and they’re devoid of dietary fiber.

Pseudo-Healthy Food: Vitamin Water

Vitamin water// © Tetra Images/Corbis

Yes, it has vitamins, but at up to 200 calories per bottle (50 per serving with 4 servings per jug), just one of these a day can cause a 20 pound weight gain in a year's time if the calories aren't burned off.

X Spine Gets Cited for Dirty Product

Sat, 16 Aug 2008 01:59:18 GMT

...because who needs a device to be sterile when it's going to be inserted into your SPINE?!

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http://www.fdanews.com/newsletter/article?issueId=11864&articleId=109483

FDAnews Device Daily Bulletin

Aug. 15, 2008 | Vol. 5 No. 160

FDA Warns Spinal Implant Company for Supplier Agreement Failures

X Spine Systems’ failure to correct quality problems, document complaint assessment and establish quality requirements for suppliers was cited in a recent warning letter.

When the FDA inspected the firm’s Miamisburg, Ohio, facility April 7–18, it found several GMP violations. The company responded in May, but the agency sent a warning letter July 15, listing a dozen alleged failures X Spine must address.

The FDA had cited the firm for revising a package insert for its Spider Cervical Plating System last September without notifying customers that a previous insert would not guarantee a specified sterility assurance level.

Although X Spine responded that a “field advisory notice” would be sent immediately to customers with unimplanted devices to assure they followed the current package insert, the agency says this response was not adequate. “It does not address how you will assure that the appropriate corrective and preventive action will be taken when a nonconformance is identified in the future,” the letter says.

The agency also had cited the company for failing to establish quality requirements for suppliers and for not having supplier agreements requiring notification about design or manufacturing changes that might affect products. The letter, which was posted recently to the FDA website, is available at www.fda.gov/foi/warning_letters/s6865c.pdf.

One More Blow Against Complementary and Alternative Medicine

Sat, 16 Aug 2008 01:57:28 GMT

...and one more attempt to drive American consumers into the arms of expensive and over-medicating MDs.

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http://www.healthimaging.com/content/view/11811/118/

CMS proposes to eliminate some x-ray reimbursements

The Centers for Medicare & Medicaid Services (CMS) is proposing to eliminate reimbursements to patients for x-rays taken by an MD or doctor of osteopathic medicine (DO), and used by a chiropractor to determine a subluxation.

The American Chiropractic Association (ACA) said it is prepared to fight the change and is urging all chiropractors to submit comments on the proposed regulation. Comments must be submitted by Aug. 31.

In 2000, the requirement for x-rays to justify spinal manipulation to remove subluxation was eliminated. However, the ACA said x-rays remained a covered service if ordered by an MD or DO and the x-ray service is still recognized as an option to identify the subluxation.

As of Jan. 1, radiologists could no longer order x-rays for Medicare patients referred to them by chiropractors in a non-hospital setting.

According to the ACA, by limiting chiropractors from referring to an x-ray study, the costs for patient care will go up significantly because of the necessity to refer patients to another provider for duplicative evaluation prior to referral to a radiologist.

In the Federal Register, CMS said that “the chiropractic exception is no longer warranted. We do not believe it would be necessary or appropriate to continue to permit payment for an x-ray ordered by a non-treating physician when a chiropractor, not the ordering physician, will use that x-ray.”

Bayer Puts Risky Biotech Rice into Food Supply, but Judge Denies Class Action Suit

Sat, 16 Aug 2008 01:54:54 GMT

Good to see the judiciary is also on Big Pharma's payroll. (Also: does anyone remember an uproar about this in the press when it happened? I sure don't.)

http://www.forbes.com/feeds/ap/2008/08/14/ap5325860.html

Judge denies class-action for biotech rice suit
Associated Press 08.14.08, 5:30 PM ET

ST. LOUIS -

A federal judge ruled Thursday that hundreds of farmers will not be able to consolidate their lawsuits against Bayer CropScience AG over the accidental release of experimental genetically engineered rice into the food supply.

U.S. District Judge Catherine Perry denied a motion to certify the farmers' claims into one class-action suit, saying were too different from one another to be lumped into a single case. If the case had been certified, attorneys say thousands of farmers in rice-producing states like Missouri and Arkansas could have joined the action.

The rice farmers are suing Bayer (nyse: BAY - news - people ) CropScience to recoup income they claim to have lost after the release of company's so-called Liberty Link rice into the public food supply in 2006. After the accidental contamination was announced, some foreign countries have temporarily banned U.S. rice exports, drying up key foreign markets and causing the price for U.S. rice to drop.

Judge Perry said in her ruling that even if Bayer CropScience was to blame for the drop in prices, farmers in different states suffered damage that was too different to be tried in one class-action suit.

"Some plaintiffs allege that as a result of this ban, they were forced to plant alternate, lower-yield seed varieties, thereby reducing the size of their harvests," Perry wrote. "Other plaintiffs allege that they were unable to obtain any rice seed because of the ban, and had to plant different crops altogether."

Bayer CropScience said in a statement it "welcomed" the ruling.

"We believe we have acted responsibly and have complied with all relevant regulations and guidelines in our biotech rice development activities," General Counsel Bruce Mackintosh said in the statement.

The ruling doesn't mean farmers will stop their litigation, said Don Downing, an attorney with Gray Ritter and Graham in St. Louis who represents farmers in the case. He said his clients are considering an appeal of Perry's decision.

"I think a lot of farmers were waiting to see if a class was would be certified," Downing said. "I think now that judge Perry has declined to certify that case, then there may well be an influx of a lot more lawsuits."

Downing said all the lawsuits would not have to be tried independently, even if they were not granted class-action status. For example, farmers might choose to litigate a handful of "test cases," and then try to settle based on the verdicts in those cases.

The Liberty Link strain of rice was not considered harmful to humans, but it wasn't approved for human consumption by the U.S. Department of Agriculture. The department determined the rice likely escaped from a corporate-funded test plot at Louisiana State University, where it was grown alongside commercial varieties.

Mackintosh's statement said Bayer CropScience is ready to litigate any further cases that might arise.

(This version CORRECTS that the lawsuit involved hundreds of farmers, not thousands.)

CDC Still Shoving Deadly Rotavirus Vaccine Down the Public's Throat

Sat, 16 Aug 2008 01:44:53 GMT

Not literally, of course, as I believe RotaTeq is injected rather than consumed orally. Here's the deal: just like Paul Offit's (and Wyeth's) previous rotavirus vaccine, RotaShield, Offit's and Merck's RotaTeq kills kids by giving them deadly bowel obstructions. What does the CDC say? The death rate is within an acceptable range. Glad to know the CDC has a set number of kids that it's OK with killing! This is another one for the special room in hell...

Just to clarify for those of you who haven't been following this--rotavirus is extremely rare in the United States, and deaths from it are even rarer. It's basically really bad diarrhea, and it is transmitted via the fecal-oral route. (In other words, it's not airborne, ladies and gentlemen. You have to get it from a sick person's excrement.) Paul Offit is the prostitute of Big Pharma who is always willing to give a pro-vaccine quotation to the press; his last bit of genius was saying that babies can tolerate up to 100,000 (yes, one hundred thousand) vaccines simultaneously. RotaTeq is unnecessary in the United States, and the developing nations where it could do some good would be better served by the United States or UNICEF giving them proper water and sewer systems.

* * *

http://r.smartbrief.com/resp/mbmUtZuPkJjfvzthwj

CDC confident about safety of Merck's rotavirus vaccine
CDC officials expressed confidence in the safety of Merck & Co.'s RotaTeq because the rate of intussusception -- deadly intestinal blockage -- in infants who received the rotavirus vaccine falls within an acceptable range. Health authorities are closely monitoring possible adverse reactions to RotaTeq because Wyeth's RotaShield, the previous vaccine, was withdrawn from the market in 1999 after it was associated with an increased risk for intussusception.

[NOTE: You need to subscribe to the WSJ to read the full article, but the opening paragraphs are printed here]

http://online.wsj.com/article/SB121874889884842037.html?mod=dist_smartbrief

Health Officials Comfortable With Merck Vaccine's Safety

By Peter Loftus

Word Count: 1,214 | Companies Featured in This Article: Merck

U.S. health authorities are increasingly confident that a Merck & Co. rotavirus vaccine taken by an estimated 60% of babies in the U.S. doesn't have the same risk for a potentially life-threatening intestinal blockage that doomed a previous vaccine.

The Merck vaccine -- RotaTeq -- is considered safe because the number of reported cases of that blockage, called intussusception, in babies who have received the vaccine is within an acceptable range, officials say. A Dow Jones Newswires investigation found at least 375 reports of intussusception, including three deaths, among RotaTeq recipients between the vaccine's 2006 introduction and June 2008.

Will Supreme Court Uphold Wyeth Phenergan Ruling?

Sat, 16 Aug 2008 01:41:52 GMT

http://www.boston.com/news/local/vermont/articles/2008/08/15/states_say_drug_ruling_should_be_upheld/

States say drug ruling should be upheld

August 15, 2008

MONTPELIER, Vt.—Vermont and 46 states are urging the U.S. Supreme Court to uphold a Vermont Supreme Court ruling that forced a drug manufacturer to pay $6.8 million to a woman whose arm had to be amputated after she was injected with one of its medications.

A jury awarded the money to Diana Levine of Marshfield who sued Wyeth after she was injected in April of 2000 with its Phenergan nausea medication. The drug was inadvertently injected into an artery, which was seriously damaged. Doctors later amputated her arm.

Wyeth appealed and the Vermont Supreme Court upheld the lower court ruling in 2006.

Now the U.S. Supreme Court has agreed to hear the appeal, which will be argued on Nov. 3

Wyeth contends it should not have been subjected to the lawsuit because the company had the approval of the U.S. Food and Drug Administration for the warning label that accompanied the drug.In a friend of court brief filed Thursday, Vermont Attorney General William Sorrell urged the court to reject Wyeth's argument that it be immune from lawsuits when the FDA approved its labeling.

Step up to the Plate, Mayor Mike

Sat, 16 Aug 2008 01:31:58 GMT

...and deal with the substandard demolition practices of the Sun Chemical plant on Staten Island. Or doesn't the fifth borough matter to you?

* * *
http://www.silive.com/news/index.ssf/2008/08/staten_island_residents_wary_o.html

Staten Island residents wary over chemical plant demolition

by Staten Island Advance
Thursday August 14, 2008, 5:44 PM
Neighbors of Sun Chemical in Rosebank are alarmed that dust from the demolition of the former color pigment plant is continually stirred into the air even as the company insists that strict control measures are in place.
Despite promises to contain dust and ensure that no debris will be dispersed into the air, the company has been neglecting its responsibility to stay on top of the issue, residents say.
However Ed Faulkner, a spokesman for Sun Chemical, said that the demolition plan has been approved by city and state agencies and its details are being followed. Asbestos removal was completed Friday and any leftover drums of color pigment was removed prior to demolition.
"They've seen what we're doing and are in agreement," Faulkner said of the appropriate agencies, adding that all buildings are scheduled to be demolished by Sept. 3 and will be followed by debris removal.
"They did absolutely nothing of what they said [they were going to do]," fumed Chestnut Avenue resident Julie Brown as she watched a huge crane knock down portions of the three-story factory, sending a plume of dust into the air. "They said they were ... going to cover it on parts they couldn't reach with a hose. My kids are out in the backyard. Is it safe to breathe this in?"
During recent days, workers for contractor LVI/Mazzocchi Wrecking Co., of East Hanover, N.J. used a ground-level hose to spray down demolition on the lower floors, Ms. Brown said, but as higher portions of the building came down yesterday, dust visibly spewed into the air. Elected officials and community leaders joined the chorus of people calling for stringent dust control measures and air monitoring around the plant.
Faulkner maintained the company has not heard from concerned residents.
Operations at the 101-year-old plant ceased Jan. 31 after Sun officials announced a year ago that it would close and all 94 employees would be offered severance packages and outplacement services. None of the Rosebank employees were offered jobs at Sun's other pigment plants, in Ohio, South Carolina and Michigan. The site is still owned by Sun Chemical but is listed for sale.
--Contributed by Glenn Nyback

UNICEF Gets Ready to Push More Kids into Autism

Fri, 15 Aug 2008 02:46:27 GMT

"EasyFive" ... it sounds so great, doesn't it? Too bad it's a PENTAVALENT vaccine--five different diseases at once, all loaded into kids in the developing world. We know that getting too many vaccines on one day pushed Hannah Poling into autism--now it's time to do that favor for the developing world! What a great idea, UNICEF! Are you going to pay for their speech therapy and ABA? What makes it even worse is that one of the diseases is hepatitis B, which is a bloodborne pathogen, and is thus avoidable by changing one's behavior (in other words, don't shoot IV drugs and don't have unprotected sex), and is certainly not a risk to any infant (unless, of course, his mother has hepatitis B, in which case he is most likely vaccinated against it at birth). Here is the kicker--the other two vaccines in EasyFive are HiB (a flu variant) and DTwP--diphtheria, tetanus, and WHOLE-CELL PERTUSSIS. Anyone who followed the news at all during the 1990s knows about the deadly effects of whole-cell pertussis vaccine, including seizures, fevers, and tons of deaths that Big Pharma tried to convince us were "SIDS." Believe what you want about Big Pharma, but know this: NO AMERICAN DOCTOR GIVES OUT WHOLE-CELL PERTUSSIS. NONE. (They give DTaP, which includes the acellular pertussis vaccine.) Somehow, though, it's OK for UNICEF to shove it down the throats (quite literally, as it's a liquid vaccine) of children in developing nations. Why is it OK to do things to black and brown people that no one would ever do to white people? (I'm sorry, but someone had to say it out loud.)

Panacea Biotec (great name, eh?) also gives out the oral polio vaccine (OPV), which is the one that is known to give people polio, which is why it is also NOT USED IN AMERICA ANYMORE. In fact, from Panacea's website (http://www.panacea-biotec.com/vaccines1.html), it appears that the company does all of its business selling crappy products to UNICEF for distribution in the developing world. It's great to know that if you turn out a crappy product, you aren't doomed to failure--you just have to sell to a quasi-governmental agency that will force your product on the less fortunate. Excuse me--I have to go and throw up now.

http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aSBX9SQZXOuY

Panacea Biotech Gains After Winning $34.2 Million Vaccine Order

By Paresh Jatakia

Aug. 12 (Bloomberg) -- Panacea Biotech Ltd., the world's biggest maker of the polio vaccine, gained to its highest in almost a month in Mumbai trading after winning a $34.2 million contract from UNICEF.

Panacea rose 2.3 percent to 311.85 rupees, its highest since July 14, at 12:01 p.m. local time after rising as much as 19.8 percent. The benchmark Sensitive Index declined 0.8 percent.

New Delhi-based Panacea won the contract for 2008 and 2009 to supply a vaccine that immunizes children against five diseases to the United Nations' children's charity, the company said in a statement to the Bombay Stock Exchange today.

To contact the reporter on this story: Paresh Jatakia in Mumbai at pareshj@bloomberg.net. Last Updated: August 12, 2008 02:35 EDT

Biotech Bribes Headed to Dems

Fri, 15 Aug 2008 02:30:55 GMT

You could rewrite the first sentence of this article this way: "Biotech execs believe in the power of money to triumph over the public interest." It's not even possible to deny it with a straight face ... sad.

http://blogs.wsj.com/health/2008/08/12/bio-chief-on-the-wisdom-of-giving-money-to-democrats/

August 12, 2008, 2:54 pm

BIO Chief on the Wisdom of Giving Money to Democrats

Posted by Scott Hensley

Biotech execs believe in the power of science to triumph over just about everything but bad public policy.

That’s the view of Jim Greenwood, CEO of BIO, the biotech industry trade group. Unfortunately, he told us during a recent chat at Health Blog HQ, “bad policy comes more easily than good policy.”

BIO is doing what it can to tilt the balance in its favor. In the current election cycle, BIO has stepped up contributions to Democrats, who are getting 51% of the funds doled out by the group’s political action committee for federal office-seekers. That’s quite a change from past elections when Republicans got the lion’s share of donations. Dems got 38% of BIO’s bucks in the 2006 elections and only 24% in 2004.

BIO recognizes the reality that Democrats hold the key leadership positions on Capitol Hill, Greenwood told us. And that’s not all bad as far as the biotech industry is concerned. Democrats have been good on the NIH budget, embryonic stem cells and FDA funding, said Greenwood, who was a Republican congressman from Pennsylvania before taking the helm at BIO in 2005.

As for the presidential campaign, Greenwood said the biotech industry has worries about both candidates. Obama and McCain have supported re-importation of prescription drugs and direct price negotiation by the federal government for Medicare, he said.

On camera, Greenwood talked with us about the industry’s disappointment over a new Massachusetts law that would require disclosure of gifts and payments to doctors, FDA reform and this year’s presidential contest.

Biogen Product May Cause Brain Infection

Fri, 15 Aug 2008 02:27:22 GMT

http://www.reuters.com/article/rbssHealthcareNews/idUSLD44617020080813

EU watchdog assessing Tysabri brain disease cases

Wed Aug 13, 2008 11:32am EDT

LONDON, Aug 13 (Reuters) - The European Medicines Agency said on Wednesday it was assessing two cases of a potentially deadly brain disease reported last month in multiple sclerosis (MS) patients being treated with the drug Tysabri.

The London-based agency said it would then decide whether any changes were necessary to the currently approved label for product, which is made by Elan Corp Plc (ELN.I: Quote, Profile, Research, Stock Buzz) and Biogen Idec Inc (BIIB.O: Quote, Profile, Research, Stock Buzz).

Shares in both companies slumped following the July 31 news of the latest cases of the brain infection known as progressive multifocal leukoencephalopathy (PML).

Tysabri was withdrawn from the market in 2005 after three patients developed PML. It returned in 2006 but the latest cases may prompt physicians to reduce the number of patients they start on the drug, analysts fear.

More than 31,800 patients were being treated with Tysabri as of the end of June and second-quarter sales totaled $200 million. (Reporting by Ben Hirschler; Editing by Paul Bolding)

Toxic-free deodorants

Thu, 14 Aug 2008 03:11:11 GMT

I've gotten a lot of traffic to the blog post where I mention using Herbal Clear deodorant, so I thought I'd update it by saying that we use a few non-toxic deodorants in my house. I still use Herbal Clear (www.herbalcleartoxicfree.com, also available here: http://www.amazon.com/Herbal-Clear-Deodorant-Fresh-1-8-Ounces/dp/B000SSQWNS/ref=pd_bbs_sr_3?ie=UTF8&s=grocery&qid=1218681439&sr=8-3). It has no aluminum, no parabens, and no propylene glycol. Aluminum is a known neurotoxin, parabens are endocrine disruptors, and propylene glycol is toxic to cats and horses--so it may be toxic to humans, too. It is made in Canada.

My husband uses Alba Botanica (http://www.amazon.com/Alba-Botanica-Deodorant-Lavender-2-Ounces/dp/B000SATT0E/ref=sr_1_56?ie=UTF8&s=grocery&qid=1218681776&sr=1-56), which we buy at Giant in the organic and natural aisle, but you can also find it on Amazon. He uses the fragrance-free one (as opposed to the one with lavender essential oil), and he always smells clean and fresh. It is also aluminum-free, paraben-free, and PG-free. It is also made in Canada.

Finally, there is Tom's of Maine, which does contain propylene glycol, but is free of aluminum and parabens. Another very cool thing about Tom's is that the company produces its products in accordance with Islamic guidelines, and has earned Halal certification. You can buy Tom's deodorant at Amazon here: http://www.amazon.com/Toms-Maine-Natural-Deodorant-Unscented/dp/B000FKHO90/ref=pd_bbs_sr_1?ie=UTF8&s=hpc&qid=1218682897&sr=8-1

With all these choices (and doubtless there are more--please add them in the Comments on this blog), there is no reason to use a toxic deodorant. Happy shopping!

Even Prince Charles Knows Frankenfoods Are Bad

Thu, 14 Aug 2008 02:17:38 GMT

http://news.bbc.co.uk/2/hi/uk_news/7557644.stm

Charles in GM 'disaster' warning

Companies developing genetically modified crops risk creating the biggest environmental disaster "of all time", Prince Charles has warned.

GM crops were damaging Earth's soil and were an experiment "gone seriously wrong", he told the Daily Telegraph.

A future reliance on corporations to mass-produce food would drive millions of farmers off their land, he said.

The government said it welcomed all voices in the "important" debate over the future potential role of GM crops.

However, Dr Julian Little, chairman of the Agricultural Biotechnology Council, said he was "disappointed" by the Prince's comments because "they do not seem to be based on any solid evidence".

"Our experience from over 10 years of GM cultivation shows that GM technology has been found to deliver real environmental and economic benefits," he said.

Mr Little added: "At a time when demand for food and fuel is rising and in the face of growing environmental challenges, we need to find ways to feed an ever-increasing global population."

BBC royal correspondent Nicholas Witchell said the Prince's "robust" comments were "likely to rankle with the government", which has given the go-ahead to a number of GM crop trials in the UK since 2000.

"Even for a prince who's a long-established champion of organic farming and critic of GM crops, these are comments which verge on the extreme," our correspondent said.

Prince Charles told the newspaper that huge multi-national corporations involved in developing GM foods were conducting a "gigantic experiment with nature and the whole of humanity which has gone seriously wrong".

Relying on "gigantic corporations" for food would end in "absolute disaster", he warned.

"That would be the absolute destruction of everything... and the classic way of ensuring there is no food in the future."

What should be being debated was "food security not food production", he said.

He said GM developers might think they would be successful by having "one form of clever genetic engineering after another", but he believed "that will be guaranteed to cause the biggest disaster environmentally of all time".

Prince Charles, who has an organic farm on his Highgrove estate in Gloucestershire, said relying on big corporations for the mass production of food would not only threaten future food supplies but also force smaller producers out of business.

"If they think this is the way to go, we will end up with millions of small farmers all over the world being driven off their land into unsustainable, unmanageable, degraded and dysfunctional conurbations of unmentionable awfulness," he said.

The prince also told the Telegraph he hoped to see more family-run co-operative farms, with producers working with nature and not against it.

The Prince's comments come at a time of rising world food prices and food shortages.

The biotech industry says that GM technology can help combat world hunger and poverty by delivering higher yields from crops and also reduce the use of pesticides.

In June, Environment Minister Phil Woolas said the government was ready to argue for a greater role for the technology.

But green groups and aid agencies have doubts about GM technology's effectiveness in tackling world hunger and have concerns about the long-term environmental impact.

Responding to the prince's comments, a spokeswoman for the Department for Environment, Food and Rural Affairs said: "Safety will always be our top priority on this issue."

Vivitrol Causes Abscesses

Thu, 14 Aug 2008 02:12:03 GMT

...so maybe AA is a better choice for treating alcohol dependence. If you're not a religious person, perhaps an alternative therapy is for you: http://www.alternatives-for-alcoholism.com/natural-cures-for-alcoholism.html

* * *
http://news.yahoo.com/s/nm/20080812/hl_nm/alkermes_vivitrol_dc;_ylt=AiKjeeNaam_kpBZ8d3bcFWEQ.3QA

FDA warns of reactions to alcohol dependence drug

By Susan Heavey Tue Aug 12, 5:27 PM ET

WASHINGTON (Reuters) - Nearly 200 patients given Alkermes Inc's drug Vivitrol for alcohol dependence reported complications from the injection, including abscesses requiring surgical drainage, U.S. health regulators said on Tuesday.

Vivitrol, an extended-release version of the generic drug naltrexone marketed by Cephalon Inc, was approved in 2006 to treat alcohol dependence in patients who show they can abstain from drinking prior to receiving the drug therapy.

Since then, the Food and Drug Administration said it received 196 reports of patients who were given Vivitrol and developed swelling, pain, bleeding and other complications. Sixteen required surgery to drain the injection site or to repair damaged tissue, the FDA said.

The problems appeared to arise when doctors did not properly inject the drug into muscle tissue, Cephalon spokeswoman Candace Steele said.

"We believe it's inadvertent," Steele told Reuters.

Vivitrol is injected into a patient's buttock and doctors need to ensure the needle goes past the fat layer and reaches the gluteal muscles when giving the drug.

How deep the needle needs to go depends on a patient's gender and weight, the FDA said, and women may be at greater risk for reactions "due to typically higher gluteal fat thickness."

Cephalon and the FDA could not say how many of the 196 reports were from women. Most of the 16 patients who required surgery were women, Steele said.

The FDA said doctors should make sure they are giving the injections correctly and with the proper needle. They should also advise patients to monitor the injection site and report worsening reactions.

Among other known side effects with Vivitrol are liver damage, nausea, headaches and diarrhea.

It was unclear how many patients have been given Vivitrol since its approval, but Steele said 70,000 doses have been shipped since 2006. The drug is given monthly and is supposed to be used in conjunction with counseling.

On Nasdaq, shares of Alkermes closed down 44 cents at $16.45, while shares of Cephalon closed up 4 cents to $76.92.

Alkermes did not return calls seeking comment.

(Reporting by Susan Heavey; Editing by Brian Moss, Jeffrey Benkoe and Carol Bishopric)

1 in 200 Have Mitochondrial Disorder

Wed, 13 Aug 2008 02:49:06 GMT

Not rare at all, contrary to what the CDC would have us believe about Hannah Poling. What's interesting to me is that the previous estimates were 1 in 4,000 (rather than 1 in 200), which is actually quite a lot of people, in a country of 280 million citizens.

http://www.ajhg.org/AJHG/abstract/S0002-9297(08)00402-3

The American Journal of Human Genetics, Volume 83, Issue 2, 254-260, 31 July 2008

doi:10.1016/j.ajhg.2008.07.004

Article

Pathogenic Mitochondrial DNA Mutations Are Common in the General Population

Hannah R. Elliott¹,David C. Samuels²,James A. Eden³,Caroline L. Relton³andPatrick F. Chinnery¹^,³^,^,

¹ Mitochondrial Research Group, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK
² Virginia Bioinformatics Institute, Virginia Polytechnic Institute and State University, Blacksburg, VA 24061, USA
³ Institute of Human Genetics, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK

Abstract

Mitochondrial DNA (mtDNA) mutations are a major cause of genetic disease, but their prevalence in the general population is not known. We determined the frequency of ten mitochondrial point mutations in 3168 neonatal-cord-blood samples from sequential live births, analyzing matched maternal-blood samples to estimate the de novo mutation rate. mtDNA mutations were detected in 15 offspring (0.54%, 95% CI = 0.300.89%). Of these live births, 0.00107% (95% CI = 0.000870.0127) harbored a mutation not detected in the mother's blood, providing an estimate of the de novo mutation rate. The most common mutation was m.3243AG. m.14484TC was only found on sub-branches of mtDNA haplogroup J. In conclusion, at least one in 200 healthy humans harbors a pathogenic mtDNA mutation that potentially causes disease in the offspring of female carriers. The exclusive detection of m.14484TCon haplogroup J implicates the background mtDNA haplotype in mutagenesis. These findings emphasize the importance of developing new approaches to prevent transmission.

* * *
David Kirby writes about this remarkable finding on the Huffington Post: http://www.huffingtonpost.com/david-kirby/revolutionary-news-from-m_b_118307.html

Wyeth--Sneakier Than You May Have Realized

Wed, 13 Aug 2008 02:22:44 GMT

More investigative journalism from Dan Olmsted. Click through the link to read the entire piece on Age of Autism:

http://www.typepad.com/t/trackback/2465202/32253170

Olmsted on Autism: 1979 Wyeth Memo on DPT

By Dan Olmsted Now that my Age of Autism colleague J.B. Handley has demonstrated the role of Wyeth in funding Every Child By Two (HERE) -- the vaccine initiative that Rosalynn Carter, Paul Offit and Amanda Peet boosted a week ago -- I think it's time to share a piece of paper someone slipped me a while back. It looks innocuous enough -- an inter-office memorandum from 1979 (Click HERE for the pdf)* about distribution of Wyeth's DPT vaccine. But read closely -- a series of SIDS deaths in Tennessee is prompting Wyeth officials to make sure that vials from a single lot don't get distributed to a single state, county or health department.

The memo says "senior management staff" gave the OK to proceed with the plan.

I am going to refrain from interpreting this document -- although, if there is an interpretation besides the obvious one that Wyeth didn't want correlations being drawn between DPT vaccine lot numbers and SIDS deaths, I can't think of it right now.

Watson Fentanyl Patches Could Be Deadly

Wed, 13 Aug 2008 02:09:38 GMT

They cause respiratory depression. I sure hope hospitals throw out the ones with the defects! You go in for surgery, you get a painkiller patch, and then you end up dead. Great job, Watson!

* * *
http://www.fdanews.com/newsletter/article?issueId=11851&articleId=109359

Aug. 12, 2008 | Vol. 5 No. 157

Watson Announces Limited Recall of Fentanyl

Watson Pharmaceuticals is voluntarily recalling one lot of 75 mcg/hr fentanyl transdermal system patches sold in the U.S. from wholesalers and pharmacies.

A small number of patches leaking fentanyl gel have been detected in this lot, which may expose people directly to the gel and lead to serious adverse events such as respiratory depression or possible overdose.

The affected patches were shipped to customers between Jan. 30 and March 19. No other strengths or lots were affected, and the company does not anticipate any product shortages as a result of this recall. The company has notified the FDA, Watson said.

Czech President Kisses Big Chemical's Tush

Wed, 13 Aug 2008 02:04:43 GMT

Nice job, Klaus. I hope you feel good when Czechs die of cancer at a disproportionately high rate, compared to their European peers. Enjoy being a third-rate country.

* * *
http://www.dw-world.de/dw/article/0,2144,3555617,00.html

Business | 11.08.2008

Czech President Rejects EU Chemical Industry Law

Czech President Vaclav Klaus has vetoed a law placing the country's chemical industry under tougher European Union rules, calling it bureaucratic and bad for business.

In a statement released on Monday, Klaus said that neither the Czech Republic nor the whole EU needs such a regulation.

"There is no reason to further toughen legislation in this field. People are not endangered by chemicals," he added.

The bill, passed by parliament last month, implements an EU directive that requires manufacturers and importers to register chemicals with the new Helsinki-based European Chemicals Agency.

Klaus, a free-market proponent and long-time EU skeptic, says the new system is too costly, depriving Europe's chemical industry of competitiveness. The law is "an unprecedented step" that would place the Czech chemical industry "under the direct control of European bureaucrats," he said.

"It amounts to full subjugation of the whole chemical industry," Klaus added.

The new EU agency's tasks are to collect information and run a public database on chemicals as well as to evaluate, authorize and restrict use of substances, so they pose no hazard to humans and the environment.

The European Parliament approved the regulation in 2006. It entered into force in 2007. The 200-seat Czech parliament passed the law on July 18. At least 101 votes are needed to override Klaus' veto.

Dangerous Flame Retardant Is in Your Water

Wed, 13 Aug 2008 02:00:33 GMT

This is why I only buy my mattresses from LifeKind (which uses a fine layer of sand as a flame retardant instead of a toxic chemical). From now on, I am only buying antique furniture and refinishing it myself.

* * *
http://www.insidebayarea.com/localnews/ci_10170552

Fire retardant discovered in wastewater plants that discharge into the Bay

By Julia Scott
San Mateo County Times

Article Last Updated: 08/12/2008 01:32:27 PM PDT

A new fire retardant product with unknown long-term impacts on human health and the environment has been discovered in two wastewater treatment plants that discharge into San Francisco Bay, according to a scientist with the San Francisco Estuary Institute who made the find.

The product, Firemaster 550, is one of California's most widely used brominated fire retardants and is routinely added to the polyurethane foam used in upholstered furniture to meet the state's stringent open-flame household fire protection rules.

Little is known about its chemical components, which were made public for the first time two weeks ago in a study that reported finding large concentrations of it in the dust of 19 Boston homes. But the fact that it is now also being found in wastewater plants has given scientists pause and prompted calls for more testing.

"I'd be willing to say that you could go to every wastewater treatment plant in the Bay Area and you could find the stuff," said Susan Klosterhaus, the San Francisco Estuary Institute environmental scientist who first identified the chemicals in wastewater by comparing them to a sample of Firemaster 550 she obtained from its manufacturer, Chemtura Corp.

"We don't know what the fate of this chemical is. We have no idea what its potential long-term toxic effects are. We don't know whether it metabolizes or degrades into other chemicals that are harmful."

Klosterhaus discovered the chemicals in her own home after having her sofa cushions tested for the presence of brominated flame retardants. The sofa was new, and she found plenty of them.

The information did not come as a surprise to her as an expert in the field, although she was surprised to later discover that Firemaster 550 was being used to coat as much as 50 percent of the foam in all upholstered furniture sold in California.

"The chemicals are used in such huge volumes, we need to know what's in our furniture and the implication of those chemicals we're exposed to on a daily basis," she said.

Firemaster 550 was first marketed in 2004 by Chemtura Corp. as an environmentally friendly replacement for PentaBDE, a former top-selling fire retardant that was phased out in the U.S. that same year due to health concerns.

Firemaster 550 hit the market without testing by the Environmental Protection Agency, which has depended on the company's own test results to determine whether there are any potential risks to aquatic species or human health.

The EPA also honored Chemtura's request to keep the two main ingredients of Firemaster 550 confidential, lest it undercut their market share.

Test data provided by Chemtura to the EPA showed the ingredients were a "high hazard concern" for both short-term and long-term ecotoxicity, meaning they could cause damage to fish, invertebrates or algae if they got into the water. Other human health testing by Chemtura showed there was little or no risk and the EPA downplayed the findings related to aquatic species.

Debra K. Durbin, Chemtura's director of corporate communications, said Firemaster 550 is a safe product and the company tested the product as required by the EPA.

"Chemtura evaluated the bromine component of Firemaster 550 in accordance with EPA guidance for toxicity and submitted the data for the EPA to review. Firemaster 550 was not fully commercialized until the EPA completed their assessment and determined that Firemaster 550 is not persistent, bioaccumulative or toxic to aquatic organisms."

The EPA asked Chemtura to conduct several other tests back in 2005 to determine potential effects on reproduction and development, and to study how easy it would be for the chemicals to migrate out of the foam and into the homes of Americans.

The agency is still awaiting the results, which are due by February 2009, according to Dale Kemery, a spokesman for the EPA's Office of Pollution Prevention and Toxics.

"We have supplied the necessary testing required to date by the EPA and will be submitting additional data early in 2009 in accordance with the terms our consent order," said Durbin.

In the meantime, Firemaster 550 went into wide use and is still considered safe by EPA standards.

"Based upon test data submitted thus far, EPA has concluded that this new chemical component is not expected to be persistent in the environment or accumulate in living organisms," Kemery wrote in an e-mail.

But Linda Birnbaum of EPA's National Center for Environmental Assessment , which does not regulate chemicals, echoed concerns expressed by other scientists that the tests done so far have not adequately addressed the risks of swapping out a controversial product for another, lesser-known one.

"We have no information, and that's a concern. The industry says the tests that they've done say these chemicals are not as persistent or bioaccumulative as the PBDEs, but I haven't seen any of those studies," said Birnbaum.

"Finding them in house dust means that for us as people, there's an opportunity to come into contact with it every day. We're getting it in our hands and into our mouths. If it's in sediment, fish have the opportunity to get it into their bodies, and if the fish are eaten by bigger fish and it's persistent, you have an opportunity for it to spread beyond where it's located."

Klosterhaus said there is potential for at least one of the chemical compounds in Firemaster 550, tetrabromophthalate or TBPH, to accumulate in the sediment of San Francisco Bay.

She is conducting tests to determine whether any component of Firemaster 550 is reaching the Bay from the wastewater treatment plants, and whether Bay-dwelling species have already started to absorb it.

Four years after it was phased out, PentaDBE is still regularly found in wildlife and bird eggs in the Bay in concentrations that are among the world's highest for a single body of water, according to Klosterhaus. PBDEs are still regularly found in breast milk as well.

The TBPH is of greatest concern to Klosterhaus because it has been in wide commercial use for at least two decades as a flame-retardant plasticizer in PVC pipes but has not received extensive testing from the EPA or any other source.

Scientists note that its chemical makeup is very similar to DEHP, a harmful phthalate that Congress banned from use in children's toys just last month.

"TBPH is a phthalate and there is growing concern about some of these phthalates, as quite a number of phthalate compounds are being found to have effects on the male hormone system. I know of no toxicological data on TBPH," said Birnbaum.

How the chemicals came to be discovered in the Bay Area's wastewater is one of the most urgent questions the recent study poses, and it will be one of the hardest to answer.

No one has proven that Firemaster 550, or any other flame retardant chemical for that matter, actually leaches from furniture, mattresses and car seats into the dust that surrounds us. Klosterhaus, a co-author of the Boston study, hypothesizes that the dust is reaching wastewater plants after washing down laundry, sink and shower drains, as well as storm drains in the street.

Bob Luedeka, executive director of the Polyurethane Foam Association, doesn't think anyone can point to the treated foam in couches and car seats as an explanation for finding Firemaster 550 in such high concentrations. He noted that the product has only been in use since 2005.

"The question, is how could it get out there? I don't know where it comes from. I want to find out what other products might contain these same chemical fingerprints," said Luedeka. "Obviously, this has some significant concern for the industry because it could have far-reaching implications."

Still others say the solution to the concerns relating to Firemaster 550 and any other new fire retardant product is to limit them at the state level.

A bill sponsored by Assemblyman Mark Leno (D-San Francisco) would gradually replace the most hazardous brominated fire retardants with a special fabric requirement that would resist smoldering cigarettes.

It would empower the Department of Toxic Substances Control to analyze all chemicals used in fire retardants against their safety benefits and allow the agency to prohibit the most dangerous ones. The toxicity data would likely be provided by the chemical manufacturers, although the state would be able to direct them to do independent testing as well, said Bart Broome, a senior assistant in Leno's office.

The bill, AB 706, failed last year and was amended at the last minute to remove an outright ban on fire retardants. It passed the Assembly and is likely headed for a full Senate vote this week.

In the meantime, Klosterhaus has reluctantly decided to keep her sofa in spite of knowing what's in it.

"I'm holding onto it, for now. How would I replace it? It's not possible to buy a couch in California that does not contain fire retardant chemicals," she said.

Staff writer Julia Scott can be reached at 650-348-4340 or at julia.scott@bayareanewsgroup.com.