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30 avril

Merck 15 Days from Shutdown

Finally, someone at the FDA grows a spine. Let's hope this is a trend.
 
 
FDA warns Merck to clean up violations at vaccine plant

By LINDA A. JOHNSON, AP Business Writer Wed Apr 30, 11:58 AM ET

TRENTON, N.J. - The Food and Drug Administration is warning drugmaker Merck & Co. to fix problems at its main vaccine plant.

The agency on Wednesday released a warning letter sent to Merck's chief executive that says FDA inspectors determined manufacturing rules are not being followed at the plant in West Point, Pa., just outside Philadelphia.

The plant makes a number of popular children's vaccines, as well as Gardasil, which protects against cervical cancer. Last year, it recalled 1.2 million vaccine doses because of a sterility problem.

The nine-page warning letter gives Merck 15 days to tell the FDA how it will correct the violations. Otherwise, the FDA says it could suspend the plant's manufacturing license and seize products.

Merck Vaccine Kills ... But Docs Can Get 2 Percent Back If They Buy More Now!

rotateq
This isn't a surprise, really, but it's incredibly sad. Merck's rotavirus vaccine (RotaTeq, brought to you by Paul Offit) has just killed someone via intussusception (bowel obstruction). It's not a surprise because Wyeth stopped making its rotavirus vaccine (RotaShield, also brought to you by Paul Offit) because it killed too many people (via, you guessed it, intussusception). Rotavirus is very rare in the US and almost never results in fatalities (65 last year nationwide, I believe). It's a problem in developing countries without access to clean water, because it is spread through the fecal-oral route (not airborne). Still, Merck and the CDC are forcing it down our kids' throats. I hope Merck chokes on this news.
 

If you read this post (or perhaps the related Wall Street Journal article) and were surprised by it, then you obviously need to read some of my previous posts:

 

Merck’s fish kill in the Delaware:

http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!213.entry

 

Merck’s Gardasil deaths:

http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!185.entry

http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!180.entry

 

Big Pharma’s PAC contributions:

http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!183.entry

http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!182.entry

 

Merck’s MMR (mumps, specifically) foibles:

http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!178.entry

 

Merck’s HiB contamination:

http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!177.entry

 
 
Merck & Co Inc Update: FDA reports a death after vaccination with Rotateq - death from intussusception (bowel obstruction) will be added to prescribing information for doctors
 
  • [MRK] Today 10:54am
    Merck & Co Inc FDA warning letter will not hamper ability to sell currently marketed vaccines - wire headline - Merck notes that the FDA letter involves 12 remaining quality control observations from 49 original more...
     
  • [MRK] Today 10:03am
    Merck & Co Inc FDA sends warning letter about vaccine production at Pennsylvania plant - Inspectors note they found significant objectable conditions at the Merck plant.
     
  • [MRK] Yesterday 06:20am
    Merck & Co Inc Price target cut to $53 from $58 at Lehman

  • 27 avril

    Wal-Mart To Stop Selling Bisphenol A (BPA)

    This is great news! Wal-Mart, retailing giant, is going to stop selling baby products with bisphenol A (BPA) in them. Bisphenol A is a known endocrine disruptor that greatly increases your chance of developing (for example) breast cancer. Toys R Us, as I reported earlier, has already pledged to stop selling BPA products by the end of 2008, and Health Canada is on the verge of banning BPA in Canada. The US FDA is, of course, dragging its feet, because the people who make these products (Philips, maker of Avent, I'm looking at you!) pay lots of taxes and probably spend lots of money on lobbying.

    What I love is that ABC News reports this story as "debate rages over plastic bottle chemical's safety." How hilarious! Scientists say it causes cancer, and companies that make it say that it's safe to use. Is that really a debate? I'm sure Saddam Hussein used to say that gassing Kurds to death was a good thing for Iraq--would we really call that a "debate" as to whether Saddam was a good leader? ABC News, the Al-Jazeera of the US, probably would.

    Quote

    ABC News: Wal-Mart Joins BPA Battle

    Debate Rages Over Plastic Bottle Chemical's Safety

    Canada Moves Toward BPA Ban; Wal-Mart Pledges to Phase Out BPA-Containing Baby Bottles

    By Will Dunham

    Reuters

    WASHINGTON

    Canada is moving to get rid of products with a chemical common in plastic baby bottles, the United States is expressing concern over its safety and some retailers are planning to stop selling these items.

    But whether the chemical bisphenol A poses genuine health risks in people remains a matter of debate, with industry groups defending its safety and environmental activists saying studies involving animals show otherwise.

    Bisphenol A, or BPA, is used to make polycarbonate plastic, a clear shatter-resistant material in products ranging from plastic baby and water bottles to sports safety equipment and medical devices.

    It also is used to make durable epoxy resins used as the coating in most food and beverage cans.

    People can eat or drink the chemical when it leaches out of the plastic into liquid such as baby formula, water or food inside the container.

    "At this point, the writing is on the wall for bisphenol A. Major retailers and governments all across the country and the world are now recognizing that this chemical is extremely toxic at very low levels of exposure," Michael Schade of the U.S. environmental group Center for Health, Environment and Justice said in a telephone interview.

    Critics of BPA said more than 150 scientific studies involving laboratory rodents show BPA to be harmful at even low levels. But some experts are not convinced.

    "For me, the big question is: what levels of exposures are we getting and are those levels of exposure sufficient to cause harm?" Carl Winter, director of the Food Safety Program at the University of California-Davis, said in a telephone interview.

    "There still does not exist strong evidence supporting significant impacts on human health for bisphenol A," he said.

    "NEGLIGIBLE RISK"

    Steven Hentges of the American Chemistry Council downplayed the animal studies, saying they "have not been corroborated between labs and the entire data set is not coherent."

    He added: "We do believe that bisphenol A poses negligible risk to human health."

    On Tuesday the National Toxicology Program, part of the U.S. government's National Institutes of Health, issued a draft report expressing concern that BPA could cause neural and behavioral problems in fetuses, infants and children.

    Relying on the results of animal studies, it expressed concern about possible links between BPA exposure and early puberty and prostate and breast cancer.

    Dr. Anila Jacob of the activist Environmental Working Group said using rodent studies to assess toxicity is a well-established practice given that scientists cannot expose humans to possible toxins in research for ethical reasons.

    Canadian Health Minister Tony Clement said on Friday his country intends to become the first to ban the import and sale of some types of plastic baby bottles because they contain BPA. He expressed concern that overexposure at an early age could cause later behavioral and neurological symptoms.

    Wal-Mart, the world's largest retailer, announced on Thursday it plans to offer more BPA-free products and intends to stop selling baby bottles made with BPA early next year.

    Rochester, New York-based bottle maker Nalgene said on Friday it will phase out production of bottles made with BPA. Nalgene is owned by Thermo Fisher Scientific Inc.

    U.S. states including California, Maryland, Minnesota and Michigan are considering bills to ban or restrict bisphenol A in children's products.

    In Washington, Democratic Reps. John Dingell and Bart Stupak have been investigating BPA in products intended for use by infants and children. They are calling on the Food and Drug Administration to reconsider its view that it is safe.

    (Editing by Maggie Fox and Xavier Briand)


     

    Pampers, UNICEF, and You -- Giving African Babies Autism Together

    You've probably seen the ads--buy a pack of Pampers, save a child's life. Here's how it works: you buy a pack of Pampers, and Pampers donates money to UNICEF's fund for vaccinating "at-risk" pregnant women in developing countries. What you don't know is that the vaccines that we give people in developing countries are the ones that we won't allow our own children to take--yes, that's right, the ones with mercury (thimerosal) in them. If you don't believe me, check the CDC's list of contaminants and read about Td (Decavac and Massachusetts labels), which is the tetanus and diphtheria vaccine:

    http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-1.pdf

    http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf

    Now check the FDA's full list of all vaccines manufactured (http://www.fda.gov/cber/vaccine/thimerosal.htm#t1) , and keep in mind the frequent statement that "Today, with the exception of some flu vaccines, none of the vaccines used in the U.S. to protect preschool aged children against 14 infectious diseases contain thimerosal as a preservative" (http://www.cdc.gov/vaccinesafety/concerns/thimerosal_faqs_thimerosal.htm#4). Note that "TT" (which is the standalone tetanus vaccine) still contains thimerosal--25 micrograms of mercury per dose!

    Yeah, we're totally OK with poisoning foreigners--just like we're OK with them plowing under their own food crops to grow corn to sell us ethanol. If you're NOT OK with  giving mercury poisoning to African babies, then consider Seventh Generation diapers, which are chlorine-free (http://www.diapers.com/Shop/Brands.aspx?CategoryID=1&CategoryName=DIAPERS&BrandCode=7thG&BrandName=Seventh%20Generation) or Tushies diapers, which are polyacrylamide gel-free (http://www.diapers.com/Shop/ProductDetail.aspx?ProductID=5468&From=Brand).

    The problem with "life-saving" programs like the one from Pampers and UNICEF is that they're cheap. It takes more than buying the diapers you were going to buy anyway to fix the problems of developing countries. It takes big money--and I'm looking at you, celebrity spokesperson Salma Hayek and big corporation Procter & Gamble--the kind of money that can build a hospial in Africa and staff it with doctors to treat diseases, or the kind of money that can put in modern plumbing and sewage so that the "flying toilet" phenomenon (http://en.wikipedia.org/wiki/Flying_toilet) becomes a thing of the past--along with the diseases that accompany it. Have some guts and pony up the real dough, and if you're a regular Joe who can't afford to make a donation that can really help, for God's sake don't give Africa new problems like autism.

    Quote

    Vaccines for Pregnant Women Provided by Pampers® and UNICEF
    26 avril

    Autism Risk Linked To Distance From Power Plants, Other Mercury-releasing Sources

    More evidence against environmental mercury...

    Quote

    Autism Risk Linked To Distance From Power Plants, Other Mercury-releasing Sources

    Autism Risk Linked To Distance From Power Plants, Other Mercury-releasing Sources

     

    ScienceDaily (Apr. 25, 2008) — How do mercury emissions affect pregnant mothers, the unborn and toddlers? Do the level of emissions impact autism rates? Does it matter whether a mercury-emitting source is 10 miles away from families versus 20 miles? Is the risk of autism greater for children who live closer to the pollution source?

    A newly published study of Texas school district data and industrial mercury-release data, conducted by researchers at The University of Texas Health Science Center at San Antonio, indeed shows a statistically significant link between pounds of industrial release of mercury and increased autism rates. It also shows—for the first time in scientific literature—a statistically significant association between autism risk and distance from the mercury source.

    “This is not a definitive study, but just one more that furthers the association between environmental mercury and autism,” said lead author Raymond F. Palmer, Ph.D., associate professor of family and community medicine at the UT Health Science Center San Antonio. The article is in the journal Health & Place.

    Dr. Palmer, Stephen Blanchard, Ph.D., of Our Lady of the Lake University in San Antonio and Robert Wood of the UT Health Science Center found that community autism prevalence is reduced by 1 percent to 2 percent with each 10 miles of distance from the pollution source.

    “This study was not designed to understand which individuals in the population are at risk due to mercury exposure,” Dr. Palmer said. “However, it does suggest generally that there is greater autism risk closer to the polluting source.”

    The study should encourage further investigations designed to determine the multiple routes of mercury exposure. “The effects of persistent, low-dose exposure to mercury pollution, in addition to fish consumption, deserve attention,” Dr. Palmer said. “Ultimately, we will want to know who in the general population is at greatest risk based on genetic susceptibilities such as subtle deficits in the ability to detoxify heavy metals.”

    The new study findings are consistent with a host of other studies that confirm higher amounts of mercury in plants, animals and humans the closer they are to the pollution source. The price on children may be the highest.

    “We suspect low-dose exposures to various environmental toxicants, including mercury, that occur during critical windows of neural development among genetically susceptible children may increase the risk for developmental disorders such as autism,” the authors wrote.

    Study highlights

    • Mercury-release data examined were from 39 coal-fired power plants and 56 industrial facilities in Texas.
    • Autism rates examined were from 1,040 Texas school districts.
    • For every 1,000 pounds of mercury released by all industrial sources in Texas into the environment in 1998, there was a corresponding 2.6 percent increase in autism rates in the Texas school districts in 2002.
    • For every 1,000 pounds of mercury released by Texas power plants in 1998, there was a corresponding 3.7 percent increase in autism rates in Texas school districts in 2002.
    • Autism prevalence diminished 1 percent to 2 percent for every 10 miles from the source.
    • Mercury exposure through fish consumption is well documented, but very little is known about exposure routes through air and ground water.
    • There is evidence that children and other developing organisms are more susceptible to neurobiological effects of mercury.

    Implications

    “We need to be concerned about global mercury emissions since a substantial proportion of mercury releases are spread around the world by long-range air and ocean currents,” Dr. Palmer said. “Steps for controlling and eliminating mercury pollution on a worldwide basis may be advantageous. This entails greener, non-mercury-polluting technologies.”

    The U.S. Environmental Protection Agency (EPA) estimated environmental mercury releases at 158 million tons annually nationwide in the late 1990s, the time period studied by the Texas team. Most exposures were said to come from coal-fired utility plants (33 percent of exposures), municipal/medical waste incinerators (29 percent) and commercial/industrial boilers (18 percent). Cement plants also release mercury.

    With the enactment of clean air legislation and other measures, mercury deposition into the environment is decreasing slightly.

    Limitations

    Dr. Palmer and his colleagues pointed out the study did not reflect the true community prevalence rates of autism because children younger than school age are not counted in the Texas Education Agency data system. The 1:500 autism rates in the study are lower than the 1:150 autism rates in recent reports of the U.S. Centers for Disease Control and Prevention.

    Furthermore, the authors note that distance was not calculated from individual homes to the pollution source but from central points in school districts that varied widely in area.

    Data sources

    Data for environmentally released mercury were from the United States Environmental Protection Agency Toxics Release Inventory. Data for releases by coal-fired power plants came from the same inventory and from the Texas Commission for Environmental Quality. Data for school district autism came from the Texas Education Agency.

    Journal reference: Palmer, R.F., et al., Proximity to point sources of environmental mercury release as a predictor of autism prevalence. Health & Place (2008), doi:10.1016/j.healthplace.2008.02.001.

    Adapted from materials provided by University of Texas Health Science Center at San Antonio.

     
    (APA-format citation) University of Texas Health Science Center at San Antonio (2008, April 25). Autism Risk Linked To Distance From Power Plants, Other Mercury-releasing Sources. ScienceDaily. Retrieved April 26, 2008, from http://www.sciencedaily.com­ /releases/2008/04/080424120953.htm


     

    25 avril

    Merck Vaccines Contaminated ... Again

    Check out the graphic below: Note that nearly $1.5 BILLION of Merck's money came from Gardasil in 2007--thank God for Texas and mandatory vaccination, right, Merck? Also note that Merck made 18% of its money from vaccines in 2007, up from 5% in 2005. Anyone (NY Times, I'm looking at you) who discounts Jenny McCarthy's opinion in favor of these jerks doesn't know how powerful a motivator money can be.

    Quote

    FDA report shows problems at Merck vaccine plant | Philadelphia Inquirer | 04/24/2008

    FDA report shows problems at Merck vaccine plant

    By Karl Stark

    Inquirer Staff Writer

    Federal inspectors documented unwanted "fibers" on the stoppers of vaccine vials at Merck & Co. Inc.'s vast vaccine plant in Montgomery County.

    They also found instances of contaminated children's vaccines and complaints that were not always investigated at the West Point plant.

    Inspectors from the U.S. Food and Drug Administration spent 30 days at the plant between November and January and cited 49 areas of concern, including a failure to follow good manufacturing practices.

    The findings are detailed in an unpublished 21-page FDA report obtained by The Inquirer under the federal Freedom of Information Act.

    Slideshow element

    Independent experts who reviewed the report say it documents serious concerns in one of the country's premier vaccine plants. They suggested the problems could be a symptom of Merck's cost cutting in the face of rapid growth of its vaccine business.

    "I would fault the management for not providing enough resources to do the work that needs to be done," said Scott M. Wheelwright, a biotech manufacturing expert and chief executive officer of the biotech consulting firm Strategic Manufacturing Worldwide, of Saratoga, Calif.

    John T. McCubbins, who heads Merck's Global Vaccine Manufacturing and West Point Operations, disputed that assessment. He maintained that the division's employment had kept pace with vaccine production. He stressed that no contamination was found in finished vaccines and that Merck was addressing all the problems.

    McCubbins stressed that Merck's own technicians - not FDA inspectors - had detected and reported most of the problems, which were found in the manufacturing process, not in vaccines themselves.

    "We are absolutely confident in the quality of the product," McCubbins said.

    The plant continues to operate, and the FDA has not ordered Merck to stop production or to recall any products.

    The report comes as demand for Merck's vaccines is surging. The company began selling four new vaccines in 2005 and 2006, pushing up total vaccine sales from $1.1 billion in 2005 to $4.3 billion in 2007.

    The West Point plant, where Merck makes most of its vaccines, has had issues before. Bulk production of varicella-related vaccine for chicken pox has been down for many months, leading to shortages. The supply of Vaqta for hepatitis A also has been disrupted.

    In June 2006, the company paid $20 million in a consent decree with authorities after a chemical spill shut down recreation on the Wissahickon Creek and closed water-intake pipes on the Schuylkill.

    In December 2007, the company voluntarily withdrew 1.2 million doses of the childhood vaccines PEDVAXHIB and COMVAX because executives said they could not guarantee the products' sterility.

    In contrast to pills, vaccines are harder to make because they are produced by living organisms that must be grown under precise conditions and kept from contamination.

    In their report, FDA inspectors criticized the company for making a manufacturing change involving the withdrawn vaccines in mid-2006 and later reversing course and citing the change as the cause for the withdrawal.

    McCubbins said the recall showed the company's quality-control systems were effective. All the recent problems reflect the inherent difficulty of working with living organisms to make vaccines, he said.

    "The primary driver when we get here is the quality of the products we produce," McCubbins said. Merck will resolve the agency's concerns, he said.

    FDA inspectors spent a total of 30 days at the West Point plant between Nov. 26, 2007, and Jan. 17, 2008. The agency could go on to issue a warning letter and take other actions if its concerns are not addressed. The FDA declined repeated requests to comment.

    The report cites cases where bulk lots of PEDVAX and ProQuad were contaminated. Unwanted "fibers" were found on the vial stoppers of MMR, the measles, mumps and rubella vaccine, among others. They were caused by "lesser quality" supplies from a vendor, the FDA report said.

    The report noted defective vials had to be rejected twice to be discarded, and that one internal quality investigation went on for more than a year.

    Several experts said no single finding was horrendous but that the overall pattern was troubling. "It's the sum of many small things that puts the whole operation in question," said consultant Wheelwright.

    Merck is a fabled name in vaccines. It was at Merck that microbiologist Maurice Hilleman developed many of the most common childhood vaccines, which are credited with saving millions of lives.

    Richard T. Clark, Merck's current chief executive, started as a quality inspector in 1972 and held several key manufacturing positions at West Point before his rise to the top.

    That Merck would be having problems with FDA inspectors surprised several longtime company observers.

    Sammie Young, a retired FDA deputy director, inspected the West Point plant early in his career and for many years oversaw vaccine-plant inspections for the entire agency.

    "There are a lot of violations there [in the report]," Young said, after reading the report. "I'm surprised."

    He said vaccine-makers were supposed to investigate vaccine lots if their use was associated with a death or a life-threatening event.

    Merck failed to investigate two such cases, the FDA report said. A patient treated with the pneumococcal vaccine Pneumovax developed a half-dollar-size abscess and needed intravenous antibiotics to contain the infection. A pregnant woman who took the HPV vaccine Gardasil lost her baby, the FDA report noted. The Gardasil packaging warns against its use for pregnant women.

    "I am concerned about the adverse-event reporting system," Young said. "It looks like the people didn't know when they were supposed to report. I find that hard to believe."

    Wheelwright, a consultant with 25 years' experience in vaccine manufacturing, suspects that the workload could be overwhelming.

    "I would not judge the plant as being out of control," he wrote in an e-mail. "There are numerous issues where they failed to comply with their own documentation and SOP [standard operating procedure] requirements. This suggests insufficient staff. There are other instances where the validation was insufficient. This also looks to me like overwork of the available crew. Sometimes in a plant where everyone feels overburdened . . . they give up trying to do everything and just try to keep their heads above water."

    McCubbins disputed the criticism, saying the staff follows its procedures and investigates complaints. "There's always a level of interpretation," he said.

    McCubbins said he feared the FDA report could create unwarranted "panic" about the firm's vaccines.

    The plant would make changes, he said, "where we believe that the agency may have a point and often they do. Nobody's perfect."

     


    Contact staff writer Karl Stark at 215-854-5363 or kstark@phillynews.com.

    The Next Hannah Poling

    Well, look at that. Another one of the kids suing the Department of Health and Human Services has a mitochondrial disorder. It turns out that the current vaccine schedule (including the insanity of the "catch-up" schedule) is grossly unsuited to a significant percentage of children and can send them into regressive autism. Wake up, Julie Gerberding! It's time to do what's right for the next generation of children.

    Quote

    spectrumpublications.com - The Next Hannah Poling

    The Next Hannah Poling Print
    Written by David Kirby   

         In February, I leaked news of the Federal government’s admission that vaccines had triggered autism in a little girl named Hannah Poling. The stunning revelation, though still reverberating around the world, was roundly downplayed by US officials, who insisted that Hannah had an extremely rare, genetic case of “aggravated” mitochondrial disorder, with zero bearing on other autism cases.
         Dr. Julie Gerberding, Director of the US Centers for Disease Control and Prevention (CDC), rushed to the airwaves, exhorting parents to adhere to the nation’s intensive and virtually mandatory immunization schedule, and brushing off their legitimate anxieties by saying: “We've got to set aside this very isolated, unusual situation.”
         Well, the days of setting aside are over: Hannah Poling is neither isolated nor unusual.
         In fact, the boy who was selected to replace Hannah Poling as the first-ever thimerosal “test case” in so-called Vaccine Court, has just been found with many of the same unusual metabolic markers as… you guessed it, Hannah Poling.
         Hannah’s case was scheduled to be heard in Federal Claims Court on May 12 -- as one of three “test cases” of the theory that thimerosal (a mercury-based vaccine preservative) can cause autism.
         Test cases will help address general causation issues in all 4,900 autism claims now pending in Vaccine Court. But following the government concession, Hannah was withdrawn as the first test case of the thimerosal theory, and attorneys scrambled to find a replacement: a young boy from New York.
         Last week, however, the court announced that the replacement thimerosal test case was also being withdrawn, in order to “proceed to an individual hearing on a different theory of causation.”
         That theory, which applies to Hannah as well, maintains that children with dysfunctional mitochondria (the little batteries within each cell that convert food into energy) are susceptible to autistic regression, triggered by a vaccine-induced overtaxing of the immune system.
         “We want to pursue an additional theory, not a different theory,” the boy’s father told me. “We are by no means abandoning the thimerosal theory of causation but, in the context of the test case, the thimerosal theory would have eclipsed our other evidence, including evidence of metabolic dysfunction,” such as impaired mitchondria and low cellular energy.
         Following the Poling concession, he said, “I saw right away that we needed to pursue the mitochondrial theory,”but the lead attorneys did not see it that way. “Perhaps they did not properly understand the concession, and believed the finding was of a rare, genetically caused mitochondrial disorder,” as the government contends. “I think they rightly want to keep clear focus on thimerosal in the test case, and not muddy the presentation with other theories.”
         The court’s test case process is unusual and unwieldy. “They limit the cases to one theory at a time, when the theories are not mutually exclusive,” the father said. “For example, thimerosal could cause, contribute to, or aggravate mitochondrial dysfunction. These cases can't be wrapped into neat little packages.”
         The unexpected withdrawal of two test cases in a row – both because of their apparent mitochondrial underpinnings – is sure to have larger ramifications in the Court of Federal Claims, as well as the much larger court of public opinion.
         A new, additional theory of causation is about to be introduced in Vaccine Court: Vaccines can trigger a chain of events in children with mitochondrial dysfunction that causes autism.
         But the US Government now has a major quandary to deal with. Federal officials already conceded that, far from being “theoretical,” this chain of events already happened to Hannah Poling. This will make it difficult, if not impossible, to argue against compensating the boy from New York, when compensating a nearly identical case – Hannah Poling – was already deemed appropriate.
         Some estimates of mitochondrial dysfunction in children with autism range as high as 20%-30%. But among the regressive subset of cases (virtually all of the claims in Vaccine Court) up to half of the children might show signs of it.
         No one knows how many of those families will pursue a similar strategy of individual hearings on causation, based on the mitochondrial concession in the Poling case. But my guess is that there could be hundreds of them, following in the precedent of this case’s footsteps. The legal ramifications, inside Vaccine Court and throughout the judicial system, remain incalculable at this point.
         Still, when the American public finds out that the exceedingly “rare” Poling case was replaced by what is shaping up to be yet another exceedingly rare case – they will follow the lead of all three presidential candidates and finally reject the tired mantra that, “there is no link” between vaccines and autism.
         Then perhaps will end, “One of the most vitriolic debates in medical history,” as it is called by Dr. Bernadine Healy, former head of the NIH and the Red Cross. “At some level,” she said, the Poling case “was a vindication for families,” adding that, “vaccines as a trigger carry a ring of both historical and biological plausibility.”
         The government is currently examining the national vaccine schedule to see if we are, perhaps, immunizing children too early and too often (and with too much thimerosal from the flu shot).
         I personally thought that one Hannah Poling emerging out of Vaccine Court would be enough to change the way we vaccinate in this country. But now we have two. And there are many more Hannah’s out there, waiting to be counted.


    24 avril

    Aluminum, everyone's second-favorite neurotoxin

    As I've mentioned before on this blog, aluminum is linked to Alzheimer's disease and may be implicated in other neurological disorders. It's definitely not something you want in your body. So how does it get there, and what are the alternatives to the poisonous products you're likely to find in your home?

    - Baking powder and baking soda: sodium aluminum phosphate is used as an anti-caking agent. Calcium phosphate is non-toxic, but more expensive, so most brands don't use it. Try Bob's Red Mill (www.bobsredmill.com) for the good stuff.

    - Antiperspirant: aluminum makes you not sweat. Think about it, though: would you rather be a little sweaty, or have Alzheimer's disease? Try Herbal Clear (www.herbalcleartoxicfree.com, also available on www.amazon.com) for a deodorant without aluminum, parabens, or propylene glycol.

    - Cookware: many pots and pans are made of aluminum, which leaches into food when it's cooked. Try cast iron or stainless steel instead.

    - Vaccines: aluminum is used as an adjuvant. Not sure if there's any alternative to this one, which is why we all need to show up at Jenny McCarthy and Jim Carrey's "Green the Vaccines" rally in Washington, DC, on June 4th.

    Quote

    http://www.bobsredmill.com/
    22 avril

    Pneumonia vaccine causes rise in pneumonia in Scotland

    So you vaccinate against a few strains of pneumonia, and then the other strains get more powerful, and they come and get you. Brilliant! Vaccinating for pneumonia is one of the dumbest ideas I've ever heard. This (http://www.youtube.com/watch?v=zDkothz4lV4) is a much better idea:

     

    Quote

    Sunday Post Online

    Fears as child chest infections rocket

    By Iain Harrison

    THE number of Scots children rushed to hospital with pneumonia has rocketed by more than 50 per cent in three years.

    This coincides with the introduction of a new vaccination against the condition in 2006.

    While a child health expert insists there’s no connection between the two, the Scottish Government has ordered an urgent investigation after we presented the findings to them.

    Newly released NHS Scotland data shows 2454 children were hospitalised for pneumonia in 2006/07 — compared with 1620 in 2003/04.

    Under-fours

    The problem is especially pronounced in infants, with 65 per cent of emergency hospital admissions for the condition involving under-fours.

    Statistics also reveal the number of under-15s dying from all respiratory illnesses has climbed from seven in 2004 to 12 in 2006 — a rise of 71 per cent.

    Last night, Dr Richard Simpson, Labour’s shadow minister for public health, described the figures as “worrying”.

    He said, “In 2006 a vaccine against the pneumococcal infection was introduced into the childhood immunisation schedule and the uptake has been very high.

    “This will go some way to reducing the numbers of children from future generations who are admitted to hospital with pneumonia.

    “But it may be necessary to consider a catch-up programme for older children, an appropriate course of action if there were serious concerns about an epidemic.”

    No link

    Dr David Spencer, a consultant respiratory paediatrician in Newcastle, insists the rise in hospital admissions is not linked to the UK-wide introduction of the pneumococcal vaccine.

    But he said it might be down to an increase in the number of children being struck down with more complicated strains of the illness.

    “The pneumococcal vaccine has had a dramatic beneficial effect in reducing hospital admissions,” he added. 

    “The vaccine protects against seven common pneumonia strains and has been very successful in reducing cases among children.

    “It was introduced into the US around seven years ago and was responsible for about a 40 per cent decrease in admissions for pneumonia in infants and young children, so it’s a very good thing.

    “But the vaccine doesn’t presently cover serotype one, which infects the lining of the lungs and can cause a great deal of pain.

    “Years ago, serotype one was not common in the UK, but over the last 15 years we’ve seen an increase in the number of cases of the strain.

    “Last year we saw 70 cases of serotype one at our Newcastle centre alone. This rise may explain the increase in hospital admissions in Scotland.”

    Concern

    Despite this, Dr Spencer admitted the introduction of the vaccine could potentially lead to increases in cases involving serotype one.

    “The pneumonia bug lives in peace with us for most of the time, but it does not like a vacuum,” he explained.

    “If you take away one of the types of serotype by vaccination then another may then take its place.

    “I contacted the Health Protection Agency 18 months ago and expressed concern there was a potential for the vaccine to make things worse.

    “A new version of this vaccine, which will probably be introduced in about two years, will address this.”
    A recent study by Emeritus Professor George Knox, of Birmingham University, found an “exceptional” link between an increase in pneumonia deaths in England and car exhaust fumes. 

    He said, “The number of children being hospitalised with pneumonia in Scotland is very concerning.”

    Investigating

    A Scottish Government spokeswoman said they’d be probing the rises.

    “There may be a number of reasons for these increases and we’ll be investigating this,” she added.

    “A range of initiatives are under way to reduce respiratory conditions, including pneumococcal vaccinations as part of the childhood vaccination programme and also for the elderly, and a seasonal flu vaccination programme every year. 

    “Further research is needed to establish whether the concentrations of pollutants of the order present in Professor Knox’s findings can be linked to increases in deaths from pneumonia.”

    Pneumonia, or inflammation of the lungs, is usually caused by an infection and symptoms include chest pain, high fever and breathlessness.

    Antibiotics can often control it, but complications can be life-threatening.

    Toys R Us Bans BPA

    The FDA doesn't care. They say they're not sure Bisphenol A (a known endocrine disruptor) is bad for you. The major baby bottle makers don't care. They say they're only selling something that is FDA-approved. (Avent "Naturally," I'm looking at you!) It's up to the consumers and the channel (bravo, Toys R Us!) to keep these cancer-causing plastics from our kids.

    I like that Toys R Us is getting rid of BPA bottles by the end of the year, even though manufacturers like Avent (http://www.aventamerica.com/support/tipsfaqs/bottlefeeding.asp#bisphenola) are clinging to the FDA's November 2005 claim that BPA is safe. How totally lame that Avent (and parent comparny Philips) can't just get its act together and make a safe product like the one from Born Free (www.newbornfree.com) or Foogo (http://www.thermos.com/SubCategoriesCatalog.aspx?CatCode=Foog&SubMenuID=0)? How hilarious that Avent feels the need to assert, "Our products have been and will continue to be used by millions of healthy babies in over 70 countries worldwide." Not in Canada, and not at Toys R Us, they won't. Let's watch the rest of the dominos fall.

    Quote

    http://www.nypost.com/seven/04222008/news/nationalnews/baby_bottle_chem_ban_107519.htm

    April 22, 2008 -- Toys "R" Us plans to phase out all baby bottles containing a chemical that is facing safety questions.

    The retailer said yesterday that it hopes to have all baby-feeding products containing bisphenol-A, or BPA, off its shelves by year's end.

    The National Toxicology Program said last week that there was "some concern" about BPA. It cited experiments on rats that linked the chemical to changes in behavior and the brain, to early puberty and, possibly, to precancerous changes in the prostate and breast.

    Canada has said it may ban the use of BPA in baby bottles.


     

    21 avril

    Canada Proposes Banning Bisphenol-A Baby Bottles...

    ... while the US FDA sits on its ass. Nalgene is voluntarily withdrawing its product from the market--thank God some manufacturers have more spine than our government does.

    Quote

    Canada says chemical in hard plastic bottles may be unsafe: Associated Press Business News - MSN Mon

    April 18, 2008

    TORONTO (AP) - An ubiquitous chemical found in hard plastic water bottles, DVDs, CDs and hundreds of other common items came under increased pressure Friday when Canada said it's potentially harmful and may ban its use in baby bottles.

    Health Canada made the announcement shortly after a U.S. company said it would stop selling hard-plastic Nalgene water bottles made with bisphenol A because of growing consumer concern over whether the chemical poses a health risk.

    Health Canada's action could be the first step toward Canada banning the chemical altogether.

    Earlier this week, the U.S. government's National Toxicology Program said that there is "some concern" about BPA from experiments on rats that linked the chemical to changes in behavior and the brain, early puberty and possibly precancerous changes in the prostate and breast. While such animal studies only provide "limited evidence" of risk, the draft report said a possible effect on humans "cannot be dismissed."

    With more than 6 million pounds produced in the United States each year, bisphenol A is found in dental sealants, baby bottles, the liners of food cans, CDs and DVDs, eyeglasses and hundreds of household goods.

    In Canada, Health Minister Tony Clement said a draft report on bisphenol A has found the chemical could endanger people -- particularly newborns and infants -- and the environment.

    "To be prudent, the government of Canada is proposing to reduce bisphenol A exposure in infants and newborns by proposing a number of actions: to ban polycarbonate baby bottles; to develop stringent migration targets for bisphenol A in infant formula cans; to work with industry to develop alternative food packaging and develop a code of practice; and to list bisphenol A under Schedule 1 of the Canadian Environmental Protection Act."

    Ottawa is giving the public 60 days to comment on the report and Clement said it will ban its use in baby bottles if no new relevant information comes forward.

    "It is our intention to ban the importation, the sale and advertising," Clement said of its use in baby bottles. "Canada will be the first country in the world to take such action to limit exposures to bisphenol A."

    Earlier this week, Wal-Mart Canada and other major retailers in Canada began removing BPA-based food-related products such as baby bottles and sipping cups from store shelves.

    Wal-Mart Stores Inc., the world's largest retailer, said in a statement Friday that the Bentonville, Ark.-based company expected its entire assortment of baby bottles to be BPA-free early next year.

    Highly durable and lightweight, resistant to stains and odors, and able to withstand extremes of hot and cold, screw-cap Nalgene bottles have been marketed as an environmentally responsible substitute for disposable water bottles.

    Citing multiple studies in the United States, Europe and Japan, the chemicals industry maintains that polycarbonate bottles contain little BPA and leach traces considered too low to harm humans.

    But critics point to an influx of animal studies linking low doses to a wide variety of ailments -- from breast and prostate cancer, obesity and hyperactivity, to miscarriages and other reproductive failures.

    "I think the writing's on the wall for this chemical," said Aaron Freeman, policy director of Toronto-based Environmental Defence Canada. "You've got major retailers with huge market clout pulling BPA products ... and you've got consumers in droves who are opting for alternatives. They're a bit late to the game, but they are responding to that consumer demand."

    In Washington a key Democratic Senator said the chemical should be banned from all children's products and food-packing containers. Sen. Charles Schumer of New York blasted the U.S. Food and Drug Administration for signing off on bisphenol A, despite dozens of studies suggesting it may interfere with hormones and other biological functions.

    "At best FDA gave Americans a false sense of comfort about a questionable substance. At worst, they put millions of Americans directly at risk," Schumer said.

    Schumer plans to introduce a bill Monday banning the chemical and funding a public health campaign on its potential risks to infants. Other lawmakers are expected to propose similar measures.

    An expert panel of 38 academic and government researchers who attended a U.S. National Institutes of Health-sponsored conference said in a study in August that "the potential for BPA to impact human health is a concern, and more research is clearly needed."

    Nalge Nunc International, a division of Waltham, Mass.-based Thermo Fisher Scientific Inc., said Friday it will substitute its Nalgene Outdoor line of polycarbonate plastic containers with BPA-free alternatives.

    "We continue to believe that Nalgene products containing BPA are safe for their intended use," Steven Silverman, general manager of the Nalgene business, said in a statement. "However, our customers indicated they preferred BPA-free alternatives and we acted in response to those concerns."

    Nalge Nunc was founded in 1949 by Rochester chemist Emanuel Goldberg. The lab-equipment supplier's product evolved in the 1970s after rumors spread about its scientists taking hardy lab vessels on weekend outings. That led the company to form a water-bottle consumer unit targeting Boy Scouts, hikers and campers.

    In 2000, a new sports line of Nalgene-brand bottles offered in red, blue and yellow hues quickly became the rage in high schools and on college campuses.

    18 avril

    Standing Orders from the Immunization Action Coalition

    Read these PDFs. They are un-****-ing-believable. They are standing orders to doctors, nurses, and pharmacists to give infants immunizations with or without parents' consent for no reason other than to give money to pharmaceutical companies. For example, read the one for Hep B. Read the guidelines for babies born to mothers who are HEP B NEGATIVE. Read where it tells nurses to give baies who weigh 4.4 POUNDS a full dose of Hep B vaccine before they leave the hospital, even if their mothers DO NOT HAVE HEP B, which is a blood-borne pathogen.

    Then ask yourself who the "Immunization Action Coalition" is. I'm glad you asked. It's a couple of doctors at some hospital in Minnesote acting as a mouthpiece for Big Pharma (see "IAC Funding," on this page: http://www.immunize.org/aboutus/funding.asp where the following donors are listed: Merck, Sanofi Pasteur, Wyeth, MedImmune, and Baxter). It's also a direct line from Big Pharma to the CDC to your doctor. Big Pharma pays the IAC. The IAC develops "standing orders" (like the one telling nurses to give Hep B shots to 4.4-pound preemies born to Hep B-negative mothers) for use in hospitals. The CDC promulgates these standing orders, urging physicians to use them (see the "Recommendations" section here: http://cdc.gov/vaccines/vpd-vac/rotavirus/default.htm#concerns). Your physician, who is basically someone who can memorize well (because that's what gets you through medical school--not intellect or ingenuity), forces your kid onto a ridiculous immunization schedule, often against your will or without your full knowledge or consent. It's time to Just Say No.

    Try this thought experiment: Imagine if ArmaLite (who makes guns) gave money to me and a friend of mine. Then my friend and I wrote up some PDFs called "Standing Orders to Defend Your Liberty" stating that every high school principal should give every high school senior a rifle upon graduation. Then the Department of Education promulgated my PDFs to all high school principals everywhere. Then all high school principals everywhere gave rifles to all high school seniors everywhere, resulting in big profits for ArmaLite (and--coincidentally? who knows?--a skyrocketing of the teenage murder rate). You would be horrified. Horrified. That's how you should feel about Immunize.org, the CDC, and the whole Big Pharma shell game.

    Quote

    Educational Print Materials from IAC: Standing Orders

    Autism is Reversible

     

    Quote

    YouTube - "Autism Yesterday" Autism is Reversible

    View the clip:  


     

    16 avril

    Join Jenny McCarthy and Jim Carrey in DC on June 4th 2008

      

    Great New Book from Deirdre Imus: Growing Up Green: Baby and Child Care: Volume 2 in the Bestselling Green This! Series $G

    Lots of great info on safe and green ways to raise your child, from pregnancy through adolescence. Wyatt Imus is lucky to have such a great mom. Check out this book for information on why you should avoid fish, cleaning products to use (and those to avoid), and why not to give your kid tons of plastic junk to chew on and play with. I live a pretty green life, but this book had plenty of information in it that I didn't already know.

    Quote

    Amazon.com: Growing Up Green: Baby and Child Care: Volume 2 in the Bestselling Green This! Series $G

    The second volume in the New York Times bestselling Green This! series, Growing Up Green: Baby and Child Care is a complete guide to raising healthy kids. Environmental activist and children's advocate Deirdre Imus addresses specific issues faced by children in every age group -- from infants to adolescents and beyond. With a focus on preventing rather than treating childhood illnesses, Deirdre concentrates on educating and empowering parents with information such as:

    • How to make sure your child is vaccinated safely

    • Which plastic bottles and toys are least toxic

    • How to lobby for safer school environments and support children's environmental health studies

    • Advice from leading "green" pediatricians and nationally recognized doctors such as Mehmet C. Oz, M.D.


     

    9 avril

    Vaccinations Cause Diabetes

    Just in case you weren't sure whether it's a good idea to overstimulate the immune system, here's more evidence that it's not.
     
     

    Discontinuation of BCG Vaccination Precedes Significant Drop in Type 2 Diabetes in Japanese Children. Role of Inflammation and Cortisol Activity as a Cause of Type 2 Diabetes 

    pp.1-4 (4) Author: John B. Classen

     

    doi: 10.2174/1874216500802010001

     

    Abstract: 

    BCG immunization was routinely given to elementary and junior high school students in Japan until it was abruptly discontinued after 2002. Data on the incidence of type 2 diabetes was analyzed to see if there was a change following discontinuation of BCG. The incidence of type 2 diabetes dropped by over 50% in children from Tokyo following discontinuation of BCG immunization, the relative risk reached 2.78 (95% confidence interval 1.03 - 7.480). This drop appears to be more significant given the epidemic of type 2 diabetes in children around the world. The increased secretion of cortisol following immunization is thought to result in metabolic syndrome and type 2 diabetes. Japanese children produce larger amounts of cortisol following immunization than White children. This increased production of cortisol may explain why Japanese children have a high risk of type 2 diabetes but low risk of type 1 diabetes compared to White children. The proposed mechanism may explain the epidemic of obesity which starts in children under 6 months of age.

    Hope You Didn't Need Any Heparin

    http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2008/heparin_nth-aah_e.html

     

    The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

     

    NOTICE TO HOSPITALS

    Health Canada Issued Important Safety Information on

    HEPARIN 

     

    March 27, 2008

     

    To: Hospital Chief of Medical Staff

     

    Please distribute to the relevant Departments of Pharmacy, Surgery, Emergency Medicine, Pediatrics, Geriatrics, Internal Medicine, Intensive Care, Nephrology and Dialysis Units and other involved professional staff and post this NOTICE in your institution.

     

    Subject: Contaminant associated with serious allergic adverse reactions in the United States found in some Canadian HEPARIN products 

     

    As per the advisory posted on Health Canada MedEffect's website on March 20, 2008, Health Canada's testing of heparin has identified the presence of a substance similar to the contaminant, oversulphated chondroitin sulphate, identified by the FDA, in some lots of the active pharmaceutical ingredient of heparin from B. Braun Medical Inc. In the US, use of heparin products contaminated with oversulphated chondroitin sulphate has been associated with an increase in reported serious allergic and anaphylactic reactions and possible lack of effect. B.Braun is recalling the affected lots of unfractionated heparin for intravenous use on the Canadian market.

     

    Health Canada testing of other heparin products available in Canada is ongoing. Health Canada is requiring all Canadian distributors and manufacturers of heparin to implement additional tests in all lots of heparin active pharmaceutical ingredient. Pending results, regulatory action will be taken as appropriate. Health Canada will continue to inform health care providers and the public as soon as new information becomes available, please monitor our website for updated information.

     

    Health Canada is recommending the following:

     

    Ensure that the recalled lots of B. Braun Medical Inc's unfractionated heparin for IV injection are not used and are returned as instructed in the company's recall letter. Other unfractionated heparin products for IV use are available;

     

     

    Use the lowest dose necessary at the slowest infusion rate acceptable to obtain the desired effect;

     

     

    Administer infusions without using a bolus dose whenever possible;

     

     

    Carefully monitor patients during and immediately following heparin administration for signs of allergy or anaphylactic reaction;

     

     

    Monitor anticoagulation parameters as the possible presence of a contaminant may affect the efficacy of the product;

     

     

    Ensure that this information is communicated accordingly if you are aware of any use of the above recalled products outside the hospital setting.

     

     

    Background

    On January 18, 2008, Baxter Healthcare and the U.S. FDA notified American healthcare professionals of a recall of all of their multi-dose and single-use vials of heparin, due to an increase in reports of allergic adverse reactions. The last reported number in U.S. is approximately 785 adverse reactions and 19 deaths associated with use of certain heparin lots in which the contaminant was found. FDA revealed that the contaminant is a substance called oversulfated chondroitin sulfate. However, the causality between the contaminant and the adverse reactions has not been established.  Consult the US FDA.

     

    Adverse reactions reported to Health Canada do not show an increase in allergic reactions related to heparin in 2007. In Canada, there was only one report of an allergic adverse reaction related to heparin from January 1, 2007 to March 6, 2008.

     

    The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse reaction reporting programmes. Any occurrences of allergic/anaphylactic reactions or other serious and/or unexpected adverse reactions in patients receiving heparin should be reported immediately to Health Canada at the following address:

     

    Any suspected adverse reaction can also be reported to:

    Canada Vigilance Program

    Marketed Health Products Directorate

    HEALTH CANADA

    Address Locator: 0701C

    Ottawa, Ontario, K1A 0K9

    Tel: 613-957-0337 or Fax: 613-957-0335

    To report an Adverse Reaction, consumers and health professionals may call toll free:

    Tel: 866 234-2345 Fax: 866 678-6789

    CanadaVigilance@hc-sc.gc.ca

     

    The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

     

    For other inquiries related to this communication, please contact Health Canada at:

    Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)

    E-mail: bcans_enquiries@hc-sc.gc.ca

    Telephone: 613-941-1499

    Fax: 613-941-1668

     

    8 avril

    What Big Tobacco and the Gunmakers Could Learn from Big Pharma

    How to bribe government officials, I think. What else could explain the fact that the Supreme Court seems likely to give pharmaceutical firms pre-emption--a legal term for "you can't sue us"--because the FDA approves all pharmaceutical products in the marketplace? Let's just ponder a few facts here, shall we?

    1. All companies, other than non-profits, exist to make money. If you're not the Peace Corps or Legal Aid, you exist to make money, no matter how enjoyable or helpful your product(s) may be. Merck is in business for the same reason as R.J. Reynolds and ArmaLite.

    2. All cigarettes have carried the warning of the Surgeon General since 1969, but are sold legally in the United States. Despite this message of "OK, go ahead" by the US government, cigarette companies were sued for cigarette-related health care costs, and settled--to the tune of 246 BILLION DOLLARS--in 1998. (See here: http://www.cbsnews.com/stories/2006/03/09/business/main1384910.shtml)

    3. According to the press, cigarette companies funded the 246 BILLION DOLLAR settlement by raising prices on cigarettes--which are paid for by smokers, not all Americans. Again according to the press, these higher prices are causing a drop in cigarette sales; thus, FEWER PEOPLE ARE SMOKING or PEOPLE ARE SMOKING LESS.

    4. Pharmaceutical firms have already won pre-emption in the case of vaccine injuries. Individuals who are injured by vaccines are forced to seek remedy in the US Court of Federal Claims, where the defendant is the Secretary of Health and Human Services. This means that every payout to a vaccine-injured individual is FUNDED BY TAXPAYERS. That's right, EVERY AMERICAN PAYS when Big Pharma's vaccines harm someone.

    5. Cigarettes carry a "black box" warning label that they are hazardous to your health, may cause cancer, etc. Cigarettes are restricted for sale to adults. Cigarettes carry a huge price tag, none of which can be reimbursed by insurance (of course).

    6. Vaccines are MANDATORY for entrance into public school (unless an individual obtains a medical or religious exemption, which are rare--only 2.5% of children currently have these exemptions). Vaccines are covered by health insurance. Therefore, 97.5% of American children buy vaccines, and EVERY HEALTH INSURANCE PLAN MEMBER PAYS FOR THEM.

    7. Big Pharma's other products (besides vaccines) harm and kill people. Ortho Evra alone has killed 23 people since 2002. (See here: http://orthopatchlawsuit.lawinfo.com/contact-an-ortho-evra-lawyer.html) Big Pharma lies about the content of its products (see the NYT article below) and about their efficacy (see here: http://www.nj.com/business/ledger/index.ssf?/base/business-1/1203226564272060.xml&coll=1). The FDA is not doing a good job protecting the public from harmful drugs, but NEITHER IS BIG PHARMA.

    Now ask yourself whether pharmaceutical firms deserve pre-emption for all their products. It just doesn't make sense. Pre-emption means that you, the taxpayer, will cover the cost of all drug injuries and deaths. You already cover the costs of vaccine injuries (through your tax dollars). You already cover the cost of everyone's drugs and vaccines (through your insurance company premiums). Should you really cover ALL of their legal costs?

    Here are a couple more facts to help you decide:

    8:

    Leaders in Market Capitalization          

    JOHNSON AND JOHNS DC [JNJ]: $186.2 B

    PFIZER INC [PFE]: $144.3 B

    GLAXOSMITHKLINE PLC [GSK]: $121.8 B

    NOVARTIS AG ADS [NVS]: $118.0 B

    SANOFI-AVENTIS SA [SNY]: $102.6 B

    MERCK CO INC [MRK]: $86.6 B

    ABBOTT LABORATORIES [ABT]: $84.8 B

    ASTRAZENECA PLC ADS [AZN]: $61.3 B

    LILLY ELI CO [LLY]: $59.4 B

    WYETH [WYE]: $55.6 B 9. These aren't even all American companies. Do you like seeing your tax dollars and health insurance premiums go to Switzerland? Neither do I.

    http://www.nytimes.com/2008/04/06/washington/06patch.html?_r=1&ex=1365220800&en=b573b011dd3b8321&ei=5089&partner=rssyahoo&emc=rss&oref=slogin

    April 6, 2008

    Drug Makers Near Old Goal: A Legal Shield

    For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

    But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

    This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

    The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.

    More than 3,000 women and their families have sued Johnson & Johnson, asserting that users of the Ortho Evra patch suffered heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the food and drug agency received reports of at least 50 deaths associated with the drug.

    Documents and e-mail messages from Johnson & Johnson, made public as part of the lawsuits against the company, show that even before the drug agency approved the product in 2001, the company’s own researchers found that the patch delivered far more estrogen each day than low-dose pills. When it reported the results publicly, the company reduced the numbers by 40 percent.

    The F.D.A. did not warn the public of the potential risks until November 2005 — six years after the company’s own study showed the high estrogen releases. At that point, the product’s label was changed, and prescriptions fell 80 percent, to 187,000 by last February from 900,000 in March 2004.

    Gloria Vanderham, a Johnson & Johnson spokeswoman, said the company acted responsibly.

    “We have regularly disclosed data to the F.D.A., the medical community and the public in a timely manner,” Ms. Vanderham said. “Ortho Evra is a safe and effective birth control option for women when used according to the labeling.”

    But Janet Abaray, a plaintiff’s lawyer from Cincinnati, said that Johnson & Johnson took advantage of an agency overwhelmed by its many responsibilities.

    “Johnson & Johnson knew that F.D.A. does not have the funding or the manpower to police drug companies,” Ms. Abaray said.

    A series of independent assessments have concluded that the agency is poorly organized, scientifically deficient and short of money. In February, its commissioner, Andrew C. von Eschenbach, acknowledged that the agency faces a crisis and may not be “adequate to regulate the food and drugs of the 21st century.”

    The F.D.A. does not test experimental medicines but relies on drug makers to report the results of their own tests completely and honestly. Even when companies fail to follow agency rules, officials rarely seek to penalize them. “These are scientists, not cops,” said David Vladeck, a professor at Georgetown Law School.

    Last month, at a trial over the schizophrenia drug Zyprexa, Dr. John Gueriguian, a scientist who worked at the F.D.A. for two decades, testified that the agency did not always ask for strong warnings even if it believed a drug was risky. Companies typically oppose warnings, and the agency knows it must compromise on its requests or face years of delay, Dr. Gueriguian said.

    “We at the F.D.A. know what we can obtain and we cannot obtain,” Dr. Gueriguian said. “We have many, many problems, and we have a management system — what we can’t obtain we will not ask.”

    For years, top officials at the agency acknowledged that lawsuits could aid the agency’s oversight of safety issues. In the last decade, suits over Zyprexa, the withdrawn pain pill Vioxx, the withdrawn diabetes medicine Rezulin, the withdrawn heartburn medicine Propulsid and several antidepressants have shown that companies played down the risks of their medicines and failed to disclose clinical trials to the public even as they have aggressively marketed their drugs.

    But now, the agency says a proliferation of lawsuits could lead to an overlapping patchwork of rules that would burden companies and might discourage patients from taking useful medicines.

    The Ortho case, however, suggests that Johnson & Johnson, like other drug makers, is not always quick to tell the F.D.A. about potential problems with its medicines.

    In 1996, the company told the agency it planned to develop the Ortho Evra patch in part because it would be likely to expose women to less estrogen than pills. The company suggested that the body would not break down hormones delivered via the patch as readily as the pill, so lower doses could be used to achieve contraception. And unlike the pill, which must be taken daily, the patch is changed weekly.

    High doses of estrogen are known to raise the risk for blood clots that can cause heart attacks and strokes.

    But a crucial trial completed in 1999 showed that the patch delivered 30 to 38 micrograms of estrogen into the bloodstream each day, according to company documents.

    Because up to half of the estrogen in pills is lost in the digestive tract before it reaches the blood, the study suggested that the patch delivered an amount of estrogen that could be as high as a pill containing 76 micrograms of estrogen. In 1988, the F.D.A. banned birth control pills with more than 50 micrograms of estrogen.

    But the study’s author, Dr. Larry Abrams, who has since retired from Johnson & Johnson, decided to apply a “correction factor” to the results of the 1999 trial, according to documents. He claimed that the patch actually delivered about 40 percent less estrogen than the trial results showed — about 20 micrograms a day.

    Dr. Abrams made the change, according to his deposition, to adjust for the different ways the body metabolizes hormones from pills and patches. This adjustment was never part of the study protocol, a plan filed with the F.D.A..

    “The judgment was made by the pharmacokeneticists at the time that in doing the calculation, it was probably appropriate to make that correction,” Bob Tucker, a lawyer representing Johnson & Johnson, said in an interview Thursday. “Later on when people looked at it in a different time frame, they concluded that probably the correction shouldn’t be applied.” The company mentioned its decision to use the “correction factor” only once in a 435-page report filed with the F.D.A., and then only in a complex mathematical formula. When the study was published in 2002, there was no reference to the alteration.

    Mr. Tucker said that the F.D.A. was aware of the “correction factor.”

    Clinical trials conducted before the patch was approved raised other red flags, as patients complained of breast soreness and nausea. “The side effects seem related” to high estrogen doses, one company scientist wrote in an e-mail message.

    Two other studies, one conducted in 1999 and another in 2003, confirmed that the patch released more estrogen than the pill. Still, Johnson & Johnson delayed reporting those results to the food and drug agency, according to documents that have been made public in lawsuits.

    After the patch was approved, the company marketed it as releasing 20 micrograms of estrogen to the blood every 24 hours, a figure it now acknowledges was inaccurate. It also acknowledges that the patch releases more estrogen than the pill but says that the estrogen released under the two methods cannot be directly compared.

    The New York Times provided the drug agency with a copy of a court brief and asked whether agency medical reviewers were aware of the “correction factor.”

    Rita Chappelle, an F.D.A. spokeswoman, replied, “At present, we are reviewing the allegations and cannot comment further at this time.”

    Prescriptions for the patch grew rapidly after its introduction, reaching more than 900,000 by March 2004, according to data from Wolters Kluwer, a company that tracks prescription trends. But as the use of the patch rose, so did reports of side effects.

    By 2004, after the death of Zakiya Kennedy, an 18-year-old college freshman in New York, food and drug officials had become concerned.

    In November 2005, the agency announced that it had placed a warning that the patch “exposes women to higher levels of estrogen than most birth control pills.”

    Since then, an epidemiological study has shown that women on the patch can have as much as double the risk of blood clots than those taking pills. And prescriptions for the patch have fallen 80 percent.

    Still, lawyers for Johnson & Johnson say that patients should not be allowed to sue the company because the F.D.A. approved the patch and its label.

    “F.D.A. is responsible for making those decisions,” said John Winter, a lawyer for the company.

    Judge David A. Katz of Federal District Court for the Northern District of Ohio is expected to rule soon on whether any of the lawsuits against Johnson & Johnson can go forward.

    In the fall, the Supreme Court will hear a separate pre-emption case involving Wyeth, another drug company. Chris Seeger, a plaintiffs’ lawyer who has about 125 Ortho Evra cases, said he expected the court to rule in Wyeth’s favor.

    “Our lawsuits are the ultimate check against the mistake made by the government, or fraud made by the companies against the government, or just an underfunded bureaucracy stretched thin,” he said.

    Janet Roberts contributed reporting.


    7 avril

    No-VOC Paint

    We just bought a house, and we'll be doing some painting with this:
    FreshAire paint, available at Home Depot, has no VOCs in the paint or in the colorant.
     
    GreenDepot stores sell other no-VOC brands, but they're not in every town. Benjamine Moore makes a paint called EcoSpec with no VOCs, but it's not available near us.

    Artificial food colors and preservatives bad for kids...

    ...and probably not great for adults. Just say, "No" to anything not colored with annatto or other natural colors.
     

    http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2008/04/07/nfood107.xml

     

    Artificial colourings as harmful as leaded petrol for children

    By Graham Tibbetts

    Last Updated: 2:45am BST 07/04/2008

     

    Artificial colourings could be removed from hundreds of food products after researchers found that they may be almost as harmful to children's development as leaded petrol.

     

    The additives, found in a host of sweets and soft drinks, have been linked to behavioural problems. But a team at Southampton University, carrying out a £750,000 study for the Food Standards Agency, (FSA) suggested seven colourings, including tartrazine and sunset yellow, could also affect children's intelligence by up to five IQ points.

     

    The board of the FSA, the industry's governing body, will meet on Thursday to consider recommendations from its officials that manufacturers should voluntarily remove six of the E numbers from their products while further research is carried out on the seventh, sodium benzoate. They would be urged to use natural replacements.

     

    The Southampton study was published in September but the FSA ignored calls for swift action after the Committee on Toxicology said additives had only a moderate effect on some children.

     

    Claims that the colourings were virtually as damaging as lead emerged when the leader of the research, Professor Jim Stevenson, wrote to the FSA demanding immediate action.

     

    "The position in relation to AFCs [artificial food colours] is analogous to the state of knowledge about lead and IQ that was being evaluated in the early 1980s... Needleman [a researcher] found the difference in IQ between high and low lead groups was 5.5 IQ points... This is very close to the sizes obtained in our study of food additives," wrote Professor Stevenson.

     

    Leaded petrol was phased out from petrol stations in 2000, two decades after the warning. The letter added: "We would argue that the findings from our own study... would lead to the same conclusion... that there is 'justification for action now'."

     

    The letter was sent to the FSA last month and published at the end of last week.

     

    A spokesman for the Food and Drink Federation, which represents the industry, said that food additives were properly tested before they were allowed to reach the public.

     

    "The use of food additives is strictly regulated under European law and they must be approved as safe by the appropriate European scientific committee before they can be used..."

     

    The additives linked to hyperactive behaviour are:

     

    • Tartrazine (E102): Yellow food colouring found in mushy peas and candy floss, banned from all foods and drinks for under-threes.

     

    • Quinoline yellow (E104): Food colouring found in squash, flu capsules

     

    • Sunset yellow (E110): Orange yellow colouring found in bubble gum and jelly babies.

     

    • Carmoisine (E122): Red food colouring found in throat lozenges

     

    • Ponceau 4R (E124): Red food colouring found in pear drops and bombay mix

     

    • Allura red (E129): Red food colouring found in fruit jelly sweets and lollipops.

     

    • Sodium benzoate (E211): Artificial preservative found in squash, fizzy drinks and cough syrup