No petroleum, no petrochemical-based fragrances. Just all-natural goodness and moisturizing from LuSa Organics (formerly Queen Bee). This company is a real find--their tangerine and peppermint soap is amazing, too--a great scrubbing soap with no toxic ingredients.

http://www.lusaorganics.com/SearchResults.asp?Cat=23

I don't know if you recall the days before prescription medications were advertised on television, but I do. I also remember the legislation that allowed the advertising to be shown, and it included a provision that any ad in which a product was presented as a treatment for a condition had to list the side effects of the product. Unfortunate for Big Pharma, if the side effects are "an erection lasting longer than six hours" or "in rare cases, death" or "most sleep medicines carry some risk of dependency" or any of the other juicy ones. Anyway, those clever pill-pushers have a new trick up their sleeve, which is to show unbranded advertising that just alerts health care consumers (that's all of us) to problems and conditions they may have. (If you have a problem, and it isn't bad enough for you to ask your doctor about it, then it's probably not bad enough that you need whatever side effect-laden product Big Pharma is pushing. Hell, maybe a lifestyle change is what you need to improve your health. Just my two cents, of course.)

You've probably already seen Sanofi's "silence your rooster" ads for its sleep medication, Ambien. Check out the side effects that Sanofi doesn't have to mention in these ads:

"Some people using sleep medicines have experienced unusual changes in their thinking and/or behavior. These side effects are not common. However, they have included:

• more outgoing or aggressive behavior than normal
• confusion
• strange behavior
• agitation
• hallucinations
• worsening of depression
• suicidal thoughts"

* * *
http://r.smartbrief.com/resp/mhzgtZuPkJlgncLomn

Drugmakers venture into "unbranded product advertising"
Pfizer, Sanofi-Aventis and other pharmaceutical firms are turning to "unbranded product advertising," which involves running TV ads that discuss health problems without mentioning specific medicines. The commercials instead urge people to visit a Web site that contains risk and safety information about certain drugs. This approach does not require "fair balance," allowing drugmakers to maximize their promotional campaigns, an advertising executive said.

...which is great news for the rest of us. Once California bans something, the manufacturers don't find it worthwhile to produce a clean version for CA and a dirty version for every other state, so they just produce the clean version. PFOA is perfluorinated octanoic acid, and it's the same carcinogenic garbage that's in Teflon and ScotchGuard. Thanks, DuPont, for creating a chemical that's persistent in our bodies and carcinogenic to boot! I sure hope your shareholders appreciate your efforts--and I hope they're not using your products!

The second article (courtesy of Environmental Working Group) is better than the first. It gives some good information on the other toxic crap that DuPont will still have in the marketplace, even if the California ban goes through.

* * *
http://www.businessweek.com/ap/financialnews/D92RBHS00.htm

Calif. Assembly OKs ban on chemical in food wraps

SACRAMENTO

The California Assembly has reversed itself and approved a bill that would limit the amount of a chemical that has been linked to cancer and is used in food packaging.

The measure by Sen. Ellen Corbett, a Democrat from San Leandro, would allow no more than 10 parts per billion of a compound known as PFOA in fast-food wrappers, pizza boxes, beverage containers and other food packaging.

The Environmental Protection Agency considers PFOA potentially carcinogenic and says businesses should voluntarily stop using it by 2015.

A Corbett spokeswoman said the bill would make California the first state to essentially ban use of the compound in food containers.

Ten parts per billion is the smallest amount of PFOA that can be detected by tests.

The Assembly rejected the bill last week, but lawmakers reconsidered after Corbett agreed to make a minor amendment.

Wednesday's 42-29 vote returned the bill to the Senate for a vote on Assembly amendments.* * *
http://www.ewg.org/node/27064

News Journal: Calif. Bill Sets Limits on Toxic DuPont Chemical

Wilmington News Journal, Andrew Eder
Published August 29, 2008

Lawmakers in California have voted to limit the amount of a controversial DuPont-produced chemical in food-packaging products.

The California Assembly on Wednesday approved a bill that would allow no more than 10 parts per billion of perfluorooctanoic acid, or PFOA, in stain - and grease-proof items like fast-food wrappers or pizza boxes by 2010.

If the bill is approved by the state Senate, which passed an earlier
version, it would require California Gov. Arnold Schwarzenegger's signature to become law. Schwarzenegger has not said whether he will sign it.

PFOA, also known as C8, is used in the production of DuPont's nonstick
coating Teflon as well as other fluoropolymer products. An advisory panel to the U.S. Environmental Protection Agency has recommended listing the chemical as a likely cancer-causing agent in humans; DuPont contends the evidence shows no health risk to the general public from PFOA exposure.

DuPont, the only U.S. manufacturer of PFOA, is one of eight companies
participating in an EPA program to phase out the use of the long-lived
chemical by 2015.

The chemical is not used in the production of grease-resistant coatings for food packaging, like DuPont's Zonyl line of products, but it shows up in trace amounts as a byproduct.

DuPont spokesman Dan Turner said the California bill sets poorly defined standards for replacement products, establishes an unrealistic time frame and ignores the opinions of federal and state regulators that have approved the food-packaging products for public use.

"Consumer safety is the top priority," Turner said. "The best way to achieve this is to allow and trust the experts and scientists at our public agencies to review and determine the safety of products. SB 1313 does not do that -- it takes the decision out of the hands of these qualified experts."

DuPont is working on a line of replacement products, known as Capstone, that the company says will not break down into PFOA in the environment. Turner said DuPont is seeking regulatory approvals to use Capstone products in food packaging.

Bill Walker, a vice president for the Environmental Working Group, said the "army of lobbyists" employed by DuPont and the chemical industry helped persuade California legislators to amend the bill to exclude the Capstone line, which uses a chemical known as C6.

Walker's organization, which early on questioned the effects of PFOA, also has raised questions about the safety of C6, which has not been studied as extensively as PFOA.

"We don't think they have any credibility when they say we're going to get rid of C8, but you can trust us that C6 is okay," Walker said.

Zonyl and similar products are made at DuPont plants across the globe,
including the Chambers Works in Deepwater, N.J., at the foot of the Delaware Memorial Bridge.

Shawn Gilchrist, a director of strategic campaigns for the United
Steelworkers, which represents about 500 workers at Chambers Works, said the California bill was a victory for workers at the plant who have shown higher PFOA levels in their blood than the general public.

"We're tired of being treated like lab rats," he said. "The USW has
challenged DuPont's lack of accountability on these chemicals for this
reason.

"Since this bill dramatically pushes up the timeline for a phase-out of
these chemicals, over the voluntary EPA stewardship program, we hope to see a similar decrease in the workers' blood in the future," Gilchrist said.

http://www.reuters.com/article/healthNews/idUSCOL76324620080827?sp=true

Fertility treatments induce gene mutations: study

One question: how is it that the company named first and most often in all of these Byetta reports is Amylin Pharmaceuticals, when Eli Lilly is Amylin's partner on Byetta? You never see Lilly in the headlines...

http://www.signonsandiego.com/news/business/20080826-1919-bn26amylin.html

Amylin reports four more deaths tied to diabetes drug

SAN DIEGO – Amylin Pharmaceuticals on Tuesday reported an additional four deaths among patients taking its diabetes drug, Byetta, although the deaths could be attributed to other causes.

Two of the patients died after complications from gallbladder surgery, while a third died after a relapse of leukemia, company officials said. The San Diego company still has not gotten additional information on the fourth death.

It was the second round of negative news in a week for Amylin and its Byetta development partner, Eli Lilly. On Aug. 18, the Food and Drug Administration announced that six people taking the drug had developed acute pancreatitis, and two of them died.

The company had reported the death of all six Byetta patients to the FDA prior to its announcement last week. The regulatory agency did not mention the four cases revealed Tuesday, because it was focusing on the acute cases of pancreatitis, which can cause scarring of the pancreas or bleeding and lead to death, the companies said.

Byetta, the top-seller of Amylin's two marketable products, has not been found to be the cause of any of the deaths or pancreatitis. However, the companies said they are pursuing a review of all the cases, as well as clinical and epidemiological studies to determine whether there is an association.

The additional deaths were revealed on a day the companies held a conference call to try to boost the reputation of its drug for type 2, or adult onset, diabetes, which is responsible for 90 percent of its product revenue.

Amylin's shares have dropped about 20 percent in the past week. The shares fell 53 cents to close at $27.24 Tuesday, then dropped an additional $2.44 to $24.80 in after-hours trading.

Lilly shares fell 52 cents to $46.50.

Prescriptions for the twice-daily Byetta fell 2.1 percent last week, according to pharmaceutical data firm IMS Health.

Byetta has been used by more than one million people and the incidence of people taking it who developed pancreatitis, a painful swelling of the pancreas, is no higher than the incidence of the ailment in the general population, said Orville Kolterman, Amylin's senior vice president of development.

About one in 3,000 people with diabetes develops pancreatitis, and about one in 3,000 people using Byetta developed pancreatitis, Kolterman said.

People with type 2 diabetes have nearly three times as much risk of developing pancreatitis as people without diabetes, Kolterman said. Other known risk factors are a previous history of pancreatitis, gallstone disease, alcohol abuse and high triglycerides, he said.

The companies have a once-weekly version of Byetta under development. In the conference call Tuesday, analysts questioned company executives about whether they thought it now would be harder to get regulatory approval for the long acting version of the drug. The company hopes to file for regulatory approval of that drug in mid-2009.

“We haven't seen a case of pancreatitis in the (long acting version) with over 600 patients exposed now,” Kolterman said.

The companies and the FDA are working together to “ensure thatour Byetta product label continues to provide physicians and patients withinformation about the risk of pancreatitis,” Amylin officials said last week.

The Byetta label was updated in October to include the risk of pancreatitis. The FDA cited 30 reports of pancreatitis in Byetta patients and said the drug was suspected in some cases. Amylin alerted doctors.

Canaccord Adams analyst Adam Cutler said the company was trying to make a case for why pancreatitis is unlikely to be caused by Byetta, “yet the FDA is concerned.”

Given the FDA's concerns, Cutler said: “I'm wondering whether they will have to do longer, larger, safety trials” of the version that is designed to stay in the body for a full week. Such a decision could significantly delay the drug reaching the market.

Interesting...

http://www.washingtonpost.com/wp-dyn/content/article/2008/08/26/AR2008082602785.html?hpid=sec-tech

Novavax Moves Closer to Licensing Bird Flu Vaccine

By Kendra Marr

Washington Post Staff Writer
Wednesday, August 27, 2008; Page D04

Novavax said yesterday that its bird flu vaccine elicited a robust immune response in humans, moving the biotech a step closer to licensing its pandemic vaccine production system.

In the trial, 160 patients received two vaccine injections, of 15 to 90 micrograms, one month apart. Of the patients who received the highest dosage, 94 percent produced antibodies to neutralize H5N1, an Indonesian strain of bird flu that emerged in 2005 and has been linked to 110 deaths.

"These results are strong and very competitive," said Rahul Singhvi, Novavax's chief executive.

Shares of Novavax fell 6 cents, or 2 percent, to $2.91.

Novavax has had a demo of the vaccine manufacturing process set up at its Rockville headquarters since May 1 but does not have a buyer.

There were 385 cases of bird flu in humans, leading to 243 deaths, from 2003 to June 19, according to the World Health Organization's most recent data. Outbreaks have mostly centered on Asia.

Many large multinational biotechs -- GlaxoSmithKline, Sanofi-Aventis, Novartis -- are working on bird flu vaccines in the United States and Western Europe under government contract, said Ken Trbovich, an analyst with RBC Capital Markets.

Novavax has partnered with GE Healthcare to reach the rest of the world by providing other countries a system to quickly mass-produce vaccines.

"If you truly believe a pandemic outbreak is likely, there is reason to believe foreign governments and the U.S. will clamp down and control the supply," Trbovich said. He added, "Other places in the world may have a lot of money, but no amount of money will get you vaccines in the case of a pandemic."

Traditionally, to create flu vaccines, drugmakers grow live virus strains in chicken eggs, which act as incubators. The virus is later killed and bottled into a vaccine. But eggs are a volatile medium, and a scarce supply essentially stops production.

Novavax's bird flu vaccine uses particles that mimic the size and shape of the virus, which trigger an immune response but lack the genetic material to replicate.

Because the particles are produced in more stable insect-cell cultures, yields are seven to 10 times higher than egg-based manufacturing, Novavax said. The vaccine can also be created within 10 to 12 weeks of identifying a pandemic strain -- half the time it takes to make egg-based vaccines.

GE is developing the production equipment, which is cheap to set up and run in case of a pandemic.

In December, Novavax studied low doses of its bird flu vaccine in a much smaller patient population. After tweaking the production process, the biotech was able to elicit a stronger immune response in this recent trial.

Novavax is seeking a governmental or pharmaceutical partner to finance the next set of human trials.

"We see no reason to invest additional money of our own into the pandemic vaccine when we can wait for a foreign government that needs this vaccine to put money in," Singhvi said.

Meanwhile, Novavax will be begin human tests of its seasonal influenza vaccine, using virus-like particles, in the fall. Currently all U.S. flu vaccines are egg-based.

"The pandemic area is difficult to monetize even if you successfully generate a contract," Trbovich said. "There are no reoccurring revenues. Moving a seasonal flu vaccine into clinical trials is their first real commercial opportunity."

...and what I assume, you shall assume--or so Big Chemical hopes.  This article about the Big Chemical museum is just one long pat on the back from the chemical industry to itself.  The Chemical Heritage Foundation (yes, that's its real name) says that the museum "is largely designed for adults who don't remember or understand much about chemistry." CHF CFO Miriam Schaefer is quoted as saying, "I got a C-minus in chemistry at Bryn Mawr — and that was a gift." (Note how she subtly lets you know that she went to a somewhat good college while pretending to be self-effacing--how cute!)

In case the readers of this article and the visitors to this museum get snowed by the smiling villains, here are a few other tidbits to keep in mind about Big Chemical:

* They're responsible for Agent Orange, and three generations of birth defects in Vietnam. (Thanks, Dow and Monsanto!)
* They're responsible for persistent carcinogens like perfluorinated compounds, and they have been prevaricating about the dangers of Teflon and Scotchguard for decades. (Thanks DuPont!)
* They're responsible for Bisphenol A and phthalates, which are endocrine disruptors that increase the risk of breast cancer and reproductive disorders at very low concentrations. (Thanks, Philips and the entire plastics industry!)



* * *
http://www.chron.com/disp/story.mpl/ap/tx/5964007.html

* * *
Update 08-27-08

Nice to see that the CHF has been visiting my blog.  Stop by any time, friends.  You might learn something. 

The FDA says it's OK for producers of produce to irradiate spinach in order to kill E.coli--maybe a better way to kill bacteria is the totally safe (and old-fashioned) way: by freezing. I like Cascadian Farm and Nature's Promise frozen organically grown vegetables, available at Giant and other chains.

http://www.washingtonpost.com/wp-dyn/content/article/2008/08/21/AR2008082103547.html

FDA Allows Irradiation of Some Produce

By Jordan Weissmann

Washington Post Staff Writer
Friday, August 22, 2008; Page D01

Food producers can now use radiation to kill bacteria on fresh spinach and iceberg lettuce because of a new Food and Drug Administration ruling meant to help head off outbreaks of foodborne illness.

This is the first time the agency has allowed produce to be irradiated as a health precaution. Tiny doses of radiation already are used to kill pests on some fruits and vegetables. But the process is most often used on meat -- especially E. coli susceptible ground beef -- and some spices. The food is exposed to just enough radiation to kill off most, though not necessarily all, harmful germs. For instance, the process won't rid the produce of foodborne viruses.

"The ruling is basically giving processors, giving those who deal with providing fresh or minimally processed spinach or lettuce to consumers, an additional tool, another technology to reduce the level of microorganisms that are of concern," said Laura Tarantino, director of the FDA's Office of Food Additive Safety.

The decision, effective today, comes nine years after a coalition composed mostly of food industry groups first petitioned the FDA to expand the number of products that could be irradiated. The original petition had sought to make nearly all foods, from processed grains to seafood, approved for the process.

But in 2006, after an E. coli outbreak traced back to spinach left hundreds ill and three dead, the petitioners went back to the FDA asking the agency to look specifically at iceberg lettuce and spinach.

The FDA is still examining the other foods listed in the original petition.

Bacteria such as E. coli and salmonella can infect produce in a number of ways, including when animal waste makes its way into a farm's water supply, when processing equipment becomes infected or when spread by poor sanitation. Tarantino said that irradiation is not a silver bullet for the problem, and that producers still need sound sanitation practices.

Some health safety organizations questioned the FDA's decision, saying it would give producers a free pass to ignore basic issues.

"Having irradiation of foods provides a disincentive for animal factories and other food production facilities to clean up their act," said Bill Freese, science policy analyst with the Center for Food Safety, a non-profit consumer organization that monitors industrial agricultural practices.

The FDA concluded that irradiating spinach and iceberg lettuce had no toxic effects and did not significantly reduce the nutritional value of the vegetables. While some critics, such as Freese, are skeptical whether irradiation is safe for consumers, most believe the process isn't harmful in the products for which it has been approved.

Food industry representatives praised yesterday's move. "It's a good initial first step for products that have been considered high risk," said Robert Brackett, chief science officer at the Grocery Manufacturers Association. "This is meant as a safety net."

Brackett said his organization was pushing the FDA to enforce better farm sanitation practices, but is hoping that it will add other products to the irradiation list, such as radicchio, romaine lettuce and other greens that are often eaten uncooked.

"There are other products down the line that I think could be thought of as well, such as peppers and tomatoes in light of the salmonella," he said. "But they would have to be evaluated in terms of what the irradiation does to the quality and safety of those products as well."

This is great news. Shocking, but great. See my previous post here: http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!414.entry

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

J&J antibiotic rejected for treating pneumonia
Johnson & Johnson failed to win FDA approval to market Doribax for hospital-acquired pneumonia despite an expert panel's positive recommendation. The agency sought more data on the antibiotic, which is approved for severe cases of abdominal and urinary tract infections. J&J said it is evaluating the FDA's decision "and will work to resolve any outstanding questions."

Now Big Pharma has rounded up some Harvard researchers to say that you have to get Gardasil when you're young in order for it to work. (It's pretty obvious that you have to get it before you start having sex for it to have a better chance of working... I don't know why a study needed to be done to prove this.) I guess the researchers didn't figure out the costs of having to care for a paralyzed daughter, or the costs of burying your teenager.

The article below says that more than half of girls have been exposed to HPV by the time they finish high school. I wonder why it is so much easier for parents to pay $375 for risky shots whose conferred immunity wears off over time than it is for parents to talk to their kids about sex and the importance of using condoms. I also wonder about the parents of the 40% of 11- and 12-year-old girls that the article says have received the vaccine--did their parents also put them on the Pill? Because your odds of getting pregnant by having unprotected sex are 25% (assuming you're not taking your basal temperature with a digital thermometer, monitoring your cervical mucus, and checking the position of your cervix every day--which is a hell of a lot more work than using a condom). Are these parents just holding their breath until there is a vaccine for AIDS, syphilis, and every other STD out there?

http://www.usatoday.com/news/health/2008-08-20-hpv-vaccine-investment_N.htm

Study: HPV vaccine by age 21 a sound public health investment

Authors of the study, in today's New England Journal of Medicine, measured the Gardasil vaccine's value by calculating the cost of giving one person an extra healthy year of life and balancing the expense of vaccinations with the benefits of avoiding cancer, death and related expenses.

The analysis supports some of the Centers for Disease Control and Prevention's guidelines, including its recommendation to routinely vaccinate 11- and 12-year-old girls. Gardasil, made by Merck, is the best bargain if girls are vaccinated before they're exposed to HPV, or human papillomavirus, which is spread through sexual contact, says co-author Jane Kim of the Harvard School of Public Health.

More than half of girls have been exposed to HPV by the time they finish high school, says Carol Baker, professor of pediatrics at Baylor College of Medicine and a member of the CDC's Advisory Committee on Immunization Practices.

Because some women could still be protected, it makes economic sense to offer "catch-up" shots to women up to age 21, but not to older women, Kim says. The vaccine was approved in 2006 for women up to age 26.

About 11,000 Americans develop cervical cancer each year and nearly 4,000 die from it, according to the American Cancer Society. The CDC, which recommends catch-up shots through age 26, has no plans to revise its guidelines, says Dale Morse, chairman of the advisory committee. The CDC considers not just a vaccine's cost, but also its safety and potential to prevent disease, he says.

If the vaccine's immunity fades over time, cervical cancer screening — which has been shown to save lives — could prove to be more cost-effective, says Charlotte Haug of the Journal of the Norwegian Medical Association, who wrote an accompanying editorial in the New England Journal.

About 40% of 11- and 12-year-olds have received the $375 shot, according to Merck. Studies show that Gardasil's immunity lasts at least five years, spokeswoman Amy Rose says. Because the vaccine is new, doctors plan to continue following patients to see how long their immunity lasts. Kim's study was funded by the CDC, the cancer society, the National Cancer Institutes and the Bill and Melinda Gates Foundation.

High blood pressure vaccine, nicotine vaccine, allergy vaccine ... maybe we could all just change our lifestyles a little bit (work out a few times a week, eat better foods) and not succumb to the scare tactics of Big Pharma.

http://www.bloomberg.com/apps/news?pid=20601085&sid=ant2B0klO4IE&refer=europe

Cytos Plans to Sell Rights to Hypertension Vaccine (Update3)

By Dermot Doherty

Aug. 20 (Bloomberg) -- Cytos Biotechnology AG, the Swiss developer of vaccines against allergies and nicotine addiction, expects to sell rights to an experimental treatment for hypertension in the second half of next year.

Cytos is in discussions with several drugmakers on developing and marketing the product, Chief Executive Officer Wolfgang Renner said in an interview at the company's headquarters in Schlieren, Switzerland yesterday. Cytos is talking to all major drugmakers with an interest in the market, including Novartis AG, he said. Novartis makes the best-selling Diovan hypertension treatment.

The experimental vaccine, called CYT006-AngQb, may cut the need for daily blood-pressure medication, Renner said. About 75 percent of people with high blood pressure go untreated or receive inadequate treatment, in part because they don't comply with prescription instructions, he says.

``Everyone who is in the anti-hypertensive field must have an interest in this vaccine because it promises to change the market, and this is what we are hearing from these companies,'' Renner said.

Cytos rose 85 centimes, or 1.4 percent, to 60.1 Swiss francs in Zurich trading. The stock has lost 29 percent this year.

A study published last year found that the hypertension vaccine helped lower patients' blood pressure in the morning, when levels tend to rise and most strokes and heart attacks occur. The therapy works by targeting angiotensin II, a molecule that causes blood vessels to narrow and blood pressure to rise.

Advanced Testing

Cytos expects the results of two further studies of the vaccine in the first quarter of 2009. The company also plans another study comparing CYT006-AngQb against a standard therapy. Advanced testing could begin in 2010 and the product may be introduced in 2013 or 2014, Renner said.

Last year, Novartis agreed to pay Cytos as much as 600 million francs ($548 million) for the rights to a nicotine vaccine that is in the second of three sets of trials needed for marketing approval. Cytos earlier this month reached a research agreement with Pfizer Inc. that is valued at as much as 150 million francs.

Under the accord, the U.S. company will be responsible for preclinical and clinical development of vaccines using Cytos' Immunodrug, or immune-response, technology. The medicines will be developed for diseases not covered by Cytos' own drug development program.

The Pfizer deal ``is a way for us to monetize our technology in a way that we don't give away any assets that we have in- house,'' Renner said.

Allergy Vaccine

Cytos may also license another experimental vaccine for the treatment of allergies, called CYT003-QbG10, next year and is holding discussions with several drugmakers, Renner said. The Swiss company said July 10 the compound performed better than a placebo in a study of people with house dust mite or cat allergies.

Cytos plans to study the drug against hay fever next year and later against food allergies, Renner said. The company also plans to test a nasal spray formulation of the medicine next year.

The treatment doesn't expose patients to severe side effects in the way that standard medicines, which desensitize the body's system, do and may work for people with several allergies, he said.

``With desensitization you have to apply one round after the other and each one takes up to three years, but with our vaccine it should theoretically be possible to cope with multiple allergies in one course of therapy,'' Renner said.

Independent

Cytos plans to remain independent, Renner said. The biotechnology company hasn't received any takeover offers, he added.

In November, Cytos said an experimental skin cancer medicine showed positive results in a clinical trial. Renner said Cytos plans to retain rights to that compound as it would not be a mass-market product.

Renner reiterated the company's guidance of a cash burn, or the amount it spends beyond revenue, of 3.6 million francs to 4 million francs in 2008. The next deal with a major drugmaker is expected to make Cytos ``cash-flow positive,'' he said.

To contact the reporter on this story: Dermot Doherty in Geneva at Ddoherty9@bloomberg.net Last Updated: August 20, 2008 12:17 EDT

Here, I've got an idea: I'll get a Rottweiler and let him roam around my yard unchained. I'm sure I'd reduce my risk of a home invasion or a robbery, but I'd also be putting the general public at risk. Do you think my insurance firm would give me a discount?

http://uk.reuters.com/article/environmentNews/idUKN1928538720080819?sp=true

Farmers using biotech seed may pay less insurance

Just read the highlighted portion to see why I'm so sick over this one.

http://www.timesonline.co.uk/tol/news/world/asia/article4568717.ece

Drug trials in India under investigation after 49 babies die at leading hospital

Forty-nine babies have died in drug tests at one of India’s top hospitals, raising concerns that ethical standards are being compromised as the country becomes the world’s leading destination for clinical trials.

The deaths occurred over a period of 30 months at the Delhi-based All India Institute of Medical Sciences (AIIMS), an elite medical college and public hospital renowned for providing low-cost treatment to the poor.

The victims were among the 4,142 infants who were used in a total of 42 clinical trials — one of the final stages of developing a new drug — at AIIMS since January 2006, many for Western companies. Of the children used in the trials, 2,728 were aged under a year old.

The mortality rate among the babies, many of whom were seriously ill before they became part of the clinical trials, was 1.2 per cent — significantly below the 4 per cent for all patients treated at the hospital.

However the age of those selected for testing has shocked many in India and there are fears that the increasingly lucrative drug-testing industry may be cutting corners because of a shortfall of staff trained in medical ethics and best practice.

Manish Tiwari, a spokesperson for the Congress party, which heads India’s coalition Government, said: “The practice of using infants like guinea-pigs for drug testing must end.”

Campaign groups have voiced concerns that the poor, often illiterate, parents who make use of the publicly subsidised healthcare that is available at institutions such as AIIMS do not understand the implications of putting forward children to test new drugs.

Rahul Verma, of the Uday Foundation for Congenital Defects and Rare Blood Groups, which exposed the AIIMS deaths after a request under freedom of information laws, said: “If you are rich in this country you go to a private doctor. You certainly don’t put your child up to be experimented on.”

India has become the leading destination for international pharmaceutical companies to outsource clinical trials, largely because of the diverse genetic pool offered by its population and the low cost of doing business.

Clinical trials on human beings are forecast to become a £1 billion-a-year industry in India by 2010. According to the Indian Pharmaceutical Alliance, GlaxoSmithKline, the London-listed pharmaceutical giant, and Johnson & Johnson, its US-based peer, are the two leading groups engaged in testing new drugs in India, each conducting 22 trials over the past year.

There is no suggestion that either company is involved in the testing that led to the deaths.

However recent research by the Indian Government’s Planning Commission highlighted a chronic shortage of trained staff. A report found that the country is short of between 30,000 and 50,000 research personnel, including trial investigators, auditors, staff qualified to serve on ethics committees and data safety management boards.

The country’s regulatory infrastructure has been found to be weak and the office of the Drugs Controller, which has to approve drugs trials, including those at AIIMS, is understaffed.

A spokesman for AIIMS, which has a strong international reputation, said that it was important to note that it was not yet known how many of the deaths occurred among babies given drugs and how many among those in control groups, who received placebos. “Many of these babies were very ill,” he said.

It is understood that an inquiry into the deaths ordered by Anbumani Ramadoss, the Indian Health Minister, will focus on two trials carried out at AIIMS funded by the World Health Organisation and the Indian Government. It is not known what treatments were being tested.

Experts said that the entry of large Western drugs developers into India has raised safety and ethics standards but admit that India’s regulatory systems are failing to keep pace with a boom in clinical trials.

Rashma Cama, of the Indian Institute of Clinical Research, said: “Informed consent is now the norm and regulations have become stricter but there is a need for savvier investigators.”

AIIMS denied any slip in standards. It said that illiterate parents have a document approved by the hospital’s in-house ethics committee read out to them that “outlines the risks and benefits and emphasises that parents/guardians can opt out of the trial any time they want”.

About 139 new trials were ousourced to India last year, putting it well ahead of the second-placed China, which had 98. The market value for clinical trials outsourced to India is estimated to stand at about £150 million, having increased by 65 per cent last year. It is expected to hit between £750 million and £1 billion in the next two years.

Documents showed that Shire, the British-based group, was named by the hospital as being among the five leading testers of drugs at AIIMS.

Shire, which is testing a treatment for Gaucher’s disease, a rare inherited disorder, at AIIMS, said that no children had died in its trials.

A spokesman for the company said: “All the patients enrolled in the trials must be at least two years of age and there is a vast age range in the trials.

“This trial has been approved by a local ethics committee and regulatory bodies in India, and follows good clinical practices as outlined by the international conference on harmonisation.”

Trial and error

£500m Average cost of bringing a new drug to market. Human clinical trials are the most expensive phase of drug development

60 Percentage by which costs can be cut by holding trials in India

400 The approximate number of trials under way in the country

£1bn Predicted value of the industry to India by 2010

Source: Times archive

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

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

What's Coming
From Your Tap?

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

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

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.

___

On the Net

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

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

Stanford scientists suggest stem-cell monkey-wrench

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

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.

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.

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


Pretzels// © Halfdark /fStop/Getty Images