Studies Ignite Hope for Long-Acting Allergy Vaccines

SUNDAY, Sept. 28 (HealthDay News) -- A vaccine that protects against the miserable symptoms of ragweed allergy for a longer period of time -- and with fewer injections -- could be available in the coming years.

Unlike traditional allergy vaccines that are given weekly for several months, new formulations would require only a few injections and would offer longer-lasting relief.

"What you would hope is that you would get fewer injections less often, less likelihood of an allergic reaction and the same or better improvement in your symptoms," said Dr. William C. Howland III, an allergist and medical director of Lovelace Scientific Resources in Austin, Texas.

Howland has presented research at an American College of Allergy, Asthma & Immunology meeting showing that just four injections of an investigational ragweed vaccine, called Pollinex Quattro, were safe and effective.

Separately, a research team led by Dr. Peter Creticos, clinical director of the Johns Hopkins Asthma and Allergy Center in Baltimore, has led pilot testing of another ragweed vaccine, called Tolamba, developed by Berkeley, Calif.-based Dynavax Technologies Corp. Those results were published recently in theNew England Journal of Medicine.

"Our study was able to demonstrate that after a concise six-week, six-injection regimen, we were able to shut off seasonal symptoms for at least the two seasons we followed the patients in the study," Creticos said.

Ragweed is a type of weed that grows throughout the United States but is most common in the eastern states and in the Midwest. Among Americans who are allergic to pollen-producing plants, 75 percent are allergic to this particular weed, according to the Asthma and Allergy Foundation of America.

Ragweed season typically runs from mid-August to October and is a significant cause of fall allergy symptoms, says the American Academy of Allergy, Asthma & Immunology.

Antihistamines help some people achieve relief from their symptoms, including runny or stuffy noses, sneezing, and itchy eyes, nose and throat. But when these medications don't work, allergy shots are the next line of treatment.

Allergy vaccines are highly effective but have certain drawbacks, allergists say, including the number of shots required to build up an immune response.

"It takes between six and 18 months of weekly injections to reach the maximum effect, so people are coming in every week, and they get an injection," Howland explained.

In addition, it's recommended that patients wait in their doctor's office 30 minutes after each injection to be monitored for any adverse reactions that may occur.

The new wave of investigational vaccines have been tweaked to be more effective in fewer doses and to reduce the incidence of immediate side effects.

Early results look promising.

Howland and his colleagues, for example, studied different doses of a ragweed extract and their effect on antibodies in the bloodstream. People with allergies produce an antibody called immunoglobulin E, which sets off a cascade of chemicals to fend off a perceived allergen, such as ragweed. This chemical response triggers the allergic symptoms that people experience. Another antibody in blood, called immunoglobulin G, fights infection.

"What the study showed was that the G antibodies increased proportionate to the strength of the injections given," he said. "So, the weaker injection had less of an effect, and then the medium had more, and the highest dose had the highest effect on the G antibodies."

However, don't expect new-and-improved vaccines to pop up in your doctor's office this ragweed season. Vaccine makers have to clear several hurdles first.

Allergy Therapeutics PLC, the U.K.-based maker of the Pollinex Quattro vaccine, reported that the U.S. Food and Drug Administration had placed a "hold" on its clinical studies while the agency reviewed a report of a rare adverse event. The company noted that a physician involved said the event was "possibly related" to the study drug. Last November, the company said it had met with the FDA, submitted information, and would continue to work with the agency to lift the hold.

Meanwhile, Creticos said a large, multi-center trial replicated findings of the Tolamba pilot study that his team led. Additional studies are continuing.

Dr. Thomas B. Casale, chief of the Division of Allergy and Immunology at Creighton University School of Medicine in Omaha, Neb., expects it will take another couple of years for these vaccines to become available, assuming, he added, that the next wave of clinical trials show that these approaches are safe and effective.

Until there are better treatments, people with ragweed allergy can minimize their exposure by keeping windows in their cars and homes closed to prevent pollen from drifting in, according to the American Academy of Allergy, Asthma & Immunology. And take a shower after spending time outdoors, because pollen can collect on your hair and skin.

More information

The Asthma and Allergy Foundation of America can tell you more about outdoor allergies.

SOURCES: Thomas B. Casale, M.D., professor of medicine, andchief, Division of Allergy and Immunology, Creighton University School of Medicine; Omaha, Neb.; William C. Howland III, M.D., allergist, and medical director, Lovelace Scientific Resources, Austin, Texas; Peter Creticos, M.D., clinical director, Johns Hopkins Asthma and Allergy Center, Baltimore; Asthma and Allergy Foundation of America, Washington, D.C.; American Academy of Allergy, Asthma & Immunology, Milwaukee; Allergy Therapeutics PLC, West Sussex, United Kingdom; Dynavax Technologies Corporation, Berkeley, Calif.

By David Olmos

Sept. 26 (Bloomberg) -- Seven instant coffee and milk tea products made in China are being recalled in the U.S. because of possible contamination with melamine, as health fears increased worldwide over the safety of Chinese dairy exports.

The Mr. Brown brand mixes are being recalled by King Car Food Industrial Co., based in Taiwan, and were made by China's Shandong Duqing Inc., the U.S. Food and Drug Administration said today in a statement. The agency said consumers shouldn't use the products.

The recall is the first announced by the FDA since milk tainted with melamine, an industrial chemical, was tied in China to the deaths of at least four babies and the illnesses of an estimated 53,000 children. The 27-nation European Union yesterday banned all imports of dairy-based Chinese food products for children and infants. India also has placed a three-month ban on diary products from China.

``The FDA is still in the process of determining how widespread the distribution is of Mr. Brown products in the United States,'' said Stephanie Kwisnek, an FDA spokeswoman, in an e-mail.

The FDA also warned consumers today not to eat White Rabbit Creamy Candy after New Zealand's food safety authority found the product had high levels of melamine. The agency said it was unaware of any illnesses in the U.S. connected to the candy or to Mr. Brown products.

Asian Store Inspections

U.S. regulators continue working with local and state health agencies to check for Chinese-made infant formula in food markets in communities with large Asian populations, according to the FDA. Inspectors have visited more than 1,400 groceries in Los Angeles, New York, San Francisco, Seattle and other cities without finding any Chinese infant formula.

People who shop in Asian stores should check products for dairy ingredients from China, said Caroline Smith DeWaal, food and safety director at the Center for Science in the Public Interest, a Washington-based consumer group. An investigator from her group found milk from China as an ingredient in yogurt drinks, biscuits, buns and pastries in Asian markets in Arlington, Virginia, she said in a telephone interview.

The FDA ``is starting to catch up with the rest of the world,'' said Tony Corbo, a legislative representative with Food and Water Watch, a Washington-based nonprofit consumer organization. ``The Mr. Brown coffee and tea products were under suspicion in Canada last week.''

Food and Water Watch called on the FDA yesterday to ban imports of all Chinese dairy products and urged foodmakers to test any goods they have already purchased for milk-derived ingredients.

Call for Reform

``The recent scandal involving contaminated milk products from China clearly demonstrates that significant work remains for China to reform its food safety system,'' said Representative Rosa DeLauro, a Democrat from Connecticut, who is chairwoman of the House Appropriations subcommittee that oversees the FDA.

Melamine, used to produce plastic and tan leather, was added by some suppliers to make the protein content in diluted milk appear higher than it was, the Chinese government has said. Melamine traced to Chinese suppliers was also found in pet food that sickened dogs and cats in the U.S. last year.

To contact the reporter on this story: David Olmos in San Francisco at dolmos@bloomberg.net. Last Updated: September 26, 2008 15:37 EDT

By Justin Blum and David Olmos

Sept. 26 (Bloomberg) -- Drug advertisements for five hyperactivity medicines on Web sites including YouTube and in other promotional materials were cited by U.S. regulators as incomplete and misleading.

Johnson & Johnson and Novartis AG were among five companies that received warnings from the Food and Drug Administration on ads for medicines to treat attention-deficit hyperactivity disorder, according to letters posted today on the agency's Web site.

The letters were sent after the FDA reviewed advertising for the class of hyperactivity drugs and found numerous violations, said Rita Chappelle, an agency spokeswoman. Among the ads cited were those for J&J's Concerta and Shire Ltd.'s Adderall XR. The Adderall letter mentioned a YouTube video with Ty Pennington, featured on ABC television's ``Extreme Makeover: Home Edition,'' along with advertising on a Web page.

The letter to Shire says: ``The Web page and video raise significant public health and safety concerns through their overstatement of efficacy and omission of important safety information.''

The FDA also posted today an unrelated warning from August for Novartis's Diovan for blood pressure. That letter cited eight online ``banner'' ads, saying they failed to communicate risks.

The hyperactivity drug warnings, all dated yesterday, also included Eli Lilly & Co.'s Strattera, Novartis's Focalin XR, and Mallinckrodt Inc.'s Methylin.

Shire, Lilly

Matt Cabrey, a spokesman for Basingstoke, England-based Shire, said in an e-mail that the Web posting cited by the FDA ``was made in error'' and the company is ``committed to complying with both the letter and the spirit'' of the agency's regulations. The video posting, removed last year, wasn't intended to appear on its own without additional information on dosing and use, he said.

Indianapolis-based Lilly is reviewing the letter and ``will work with the FDA to address their concerns,'' said David Shaffer, a company spokesman. The agency cited the company for materials used by Lilly employees to market Strattera, saying they overstated the effectiveness and minimized risks.

Tricia Geoghegan, a spokeswoman for New Brunswick, New Jersey-based J&J, said in an e-mail that the company ``will work closely with the FDA to address the issues raised in its letter.'' The agency cited J&J for advertising panels used at conventions, as well as a consumer Web page, saying the materials overstated the drug's effectiveness.

Mallinckrodt, Novartis

Erica Abbett, a spokeswoman for Mallinckrodt, a unit of Hamilton, Bermuda-based Covidien Ltd., said the company is ``preparing a response to address the FDA's concerns.'' The regulators said the company overstated effectiveness and omitted risk information in a patient brochure.

Pamela McKinlay, a spokeswoman for Basel, Switzerland-based Novartis, said the company will review the letters and respond to the FDA. The agency cited material on Focalin, including a company Web page related to the hyperactivity drug and a ``professional slide deck,'' saying they overstated effectiveness.

``Manufacturers will always try to go right to the limit in making their promotional claims to doctors, and doctors tend to follow their claims,'' said Larry Diller, a behavioral pediatrician in Walnut Creek, California, who says the hyperactivity medications are overused though he prescribes them for some patients.

``When claims are overstated, there is both over-prescribing and mis-prescribing and in the end children get hurt,'' Diller said in a telephone interview today.

To contact the reporters on this story: Justin Blum in Washington at jblum4@bloomberg.net; David Olmos in San Francisco at dolmos@bloomberg.net. Last Updated: September 26, 2008 19:07 EDT

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Medtronic catheter faces class 1 recall

Autism Doc's claims led to witch hunt

Sep 28 2008 by Phil Doherty, Sunday Sun

THE man at the centre of the triple jab controversy has accused the Government of conducting a witch hunt against him.

Dr Andrew Wakefield has been pilloried by the medical establishment after he voiced fears 10 yeas ago the Measles Mumps and Rubella inoculation could cause autism in some kids it was given to.

Now working in the USA, he was called back to appear before a General Medical Council disciplinary hearing earlier this year to answer charges of serious professional misconduct.

Speaking for the first time since the hearing was adjourned in July, he said: “What the establishment does is throw stuff at you continuously and then tie you up for years with things like the GMC.

“It is not a question of not vaccinating. I’m not against vaccinations. I don’t know for sure vaccines cause autism but I suspect they do. The opposition just states categorically it does not. But they don’t know either.”

Dr Wakefield and two other colleagues professor Simon Murch and Professor John Walker-Smith, were summoned to the GMC disciplinary hearing over allegations that research they conducted on children breached ethical codes.

If found guilty they face being struck off the medical register.

This follows years of being reviled in parts of the medical world after they published a scientific paper in the Lancet that said there could be a link between the MMR vaccine, and autism and bowel disease.

At a Press conference in 1998 Dr Wakefield said while further research was conducted to see if there was a link, parents should have the single inoculations instead of the triple jabs. At the time of the research it was claimed he had been paid to carry out another study to find out if parents who said their children were damaged by the MMR had a case.

The Lancet said this was a potential conflict of interest and if they had known they would have rejected the research paper.

Dr Wakefield said: “I was accused of going beyond the science when I suggested that parents should have single jabs until the MMR had been properly assessed for risk.

“I had assessed the data and the safety study relied upon by the Department of Health and it was derisory. It was no way as good as the research into the single jabs.

“Bernadine Healy, the former head of the US National Institute for Health, admitted they had altered evidence on the epidemiological studies conducted by the US Government to suit the official line. She admitted the evidence both the US and UK relies on is useless.

“The UK Government has a big dirty secret that it doesn’t want the public to know . . . they agreed to under write any compensation claims for the MMR. This is why they can’t and won’t let their position fail.

“It was inevitable I was going to be dragged in front of the GMC because I dared to question big business. They always come after those who don’t toe their line.”

The environmental group, which focuses on hazards in consumer products, says the study is the first to measure many of these chemicals in this age group. In a study of 20 girls from across the country, researchers found ingredients linked to health problems in animals in the blood and urine of all of the teens, ages 14 to 19.

In the report, author Rebecca Sutton says she found 16 cosmetic-related chemicals in the girls. The ingredients belong to four classes of chemicals. One, triclosan, is a preservative that may affect the thyroid. Three others act like hormones: preservatives called parabens; synthetic musks, which are commonly added to fragrances; and phthalates, also used in fragrances. Ingredients in all four classes have been linked to cancer in laboratory studies, the report says.

The report's authors found two types of parabens — methylparaben and propylparaben — in every girl tested.

Although parabens are typically listed in cosmetic ingredient lists, the dozens of chemicals used to create fragrances often aren't individually listed.

Sutton says scientists are concerned about girls using chemicals that disrupt the hormone system, because children's bodies are still developing. They say that's not surprising that the chemicals are so commonly found, given that the teens in the study used 17 personal care products a day, with a total of 174 ingredients. In comparison, adult women use an average of 12 personal products a day, the report says.

But the report notes that levels of these chemicals in the girls' bodies didn't necessarily match the amount of the chemicals they consumed through cosmetics. That suggests that girls are being exposed through other products, the report says.

The report urges the government to set safety standards for the ingredients in cosmetics.

The Campaign for Safe Cosmetics, an alliance of consumer groups that includes the Environmental Working Group, has criticized many of the ingredients in beauty products, noting that many lipsticks contain low levels of lead. The campaign's website includes a database on the health effects of ingredients in personal care products at safecosmetics.org.

Kathleen Dezio, a spokeswoman for the Personal Care Products Council, says companies test their products carefully before marketing them.

"There are hundreds of scientific studies that have evaluated the health impact of these ingredients," Dezio said in a statement, noting that the council has posted this research on its website, cosmeticsinfo.org. "We stand behind the safety of our products and believe that the consensus of opinion in the scientific community supports the conclusion that our products are safe."

Turning a leaf from cancer-causer to flu-fighter

A $16-million boost from cigarette maker Philip Morris will help a small Quebec vaccine-developer use tobacco as a medium

One of the world's biggest cigarette companies is teaming up with a tiny Canadian biotechnology firm to try to put one of the world's most deadly carcinogens to a healthy use - creating vaccines from tobacco to prevent people from catching the flu.

A $16-million investment by Philip Morris International will help Quebec City-based Medicago Inc. develop its early-stage technology that produces vaccines using tobacco leaves as a medium.

Medicago Inc. is at least a couple of years away from having its first vaccine - for avian flu - on the market, but the shot of capital will help propel it to that stage, chief executive officer Andy Sheldon said in an interview yesterday.

The marriage of a multinational tobacco company with an early-stage Canadian biotech firm may seem unusual, but the union makes sense, Mr. Sheldon said.

Medicago's technology, if successful, will make use of substantial amounts of greenhouse-grown tobacco. For its part, PMI is keen on finding new uses for tobacco beyond making health-damaging cigarettes.

"Philip Morris has made a decision that it wants to look at other business opportunities, and of course this one is just a natural," Mr. Sheldon said.

Executives from the two companies met at a biotechnology conference in Vancouver, he said, and both firms realized they could gain from co-operating.

In the deal announced yesterday, PMI will buy shares and warrants that will give it a 49.9-per-cent stake in Medicago.

The Medicago process does not alter the genetic makeup of tobacco, but involves injecting material into the leaf cells, which then secrete a virus-like protein that can be harvested and used as a vaccine to stimulate immunity.

When injected into humans, the vaccine prompts the production of antibodies that protect the individual from the disease.

Tobacco is used because it has very large leaves and grows quickly, making it an ideal plant to generate the vaccine.

It is also fairly easy to "program" tobacco cells using biotechnology techniques, to get them to produce the vaccine protein.

Mr. Sheldon said Medicago's process will allow the production of vaccines much more quickly than current systems, which use eggs as a medium and take up to eight months to generate a usable vaccine.

A large amount of vaccine can be harvested from tobacco in about three weeks, he said, an especially important quality in the case of a fast-moving influenza outbreak.

Philip Morris, which has been conducting its own biotechnology research to try to eliminate some of the carcinogens from tobacco, will likely have expertise that can contribute to Medicago's work, Mr. Sheldon said.

Ironically, Medicago takes its name from the Latin word for alfalfa, the plant the company initially used for its experiments.

It has abandoned alfalfa, however, and now uses only tobacco.

The avian flu vaccine is now in preclinical trials, and could be licensed as early as 2010, once the clinical trials are complete.

Eventually, the company's process could be used to create large volumes of vaccines for other strains of flu, or other infectious diseases.

"Our technology can be used to manufacture just about any vaccine, from malaria to pneumococcal vaccines... [or] HIV, which is an obvious candidate," Mr. Sheldon said.

MEDICAGO INC. (MDG)

Close: 30 cents, down 6 cents

By Rob Waters

Sept. 22 (Bloomberg) -- The first research to track every prescription drug approved by U.S. regulators over several years concluded that many studies finding the medicines ineffective were not published in medical journals.

To win approval from the Food and Drug Administration, companies must submit at least two studies demonstrating a drug is safe and effective, even if other clinical trials find it is not.

The researchers tracked all studies submitted to the FDA by drug companies seeking approval for new treatments from 1998 to 2000. By 2005, five years after the last FDA approvals of the drugs, most of the studies finding the drugs ineffective hadn't been published in journals. Other trials finding them effective were much more likely to be published.

``We found that there was indeed a pattern that favorable studies were more likely to be published than unfavorable trials,'' said Ida Sim, associate professor of internal medicine at UCSF and the lead author of the analysis published today in the Public Library of Science journal, PLoS Medicine. ``This is something that is essentially structural in the way clinical trial information is disseminated to the public.''

Failure to publish negative and positive results could skew doctors' opinions about a drug, the researchers said. While previous research has examined publication patterns of studies of antidepressants and pediatric drugs, this is the first to look at all drugs approved over a defined time span.

Some critics have said drug companies selectively publish results that show a drug works and fail to publish those suggesting it doesn't.

Relevant Studies

Ken Johnson, vice president of the Pharmaceutical Research and manufacturers Association, said in an e-mail that the FDA incorporates all relevant studies about safety and effectiveness of a drug in its decision to approve. That information is summarized in the drug's prescribing information used by doctors, he said.

Concern that publication bias -- the tendency for positive studies to be more frequently published than negative ones -- may mislead consumers led Congress last year to mandate the creation of a registry of clinical trials. Under that legislation, drug companies must submit the results of all trials they conduct for posting on a government Web site that lists trials and results.

Johnson said his organization supported the new legislation as a way to gain ``more comprehensive information about those trials.''

While the new law may help ensure that studies finding the drugs ineffective aren't buried, a brief summary of study results posted on a Web site isn't the same as full publication in a medical journal, Sim said in a telephone interview today.

Influence of Journals

``Medical journals are one of the most influential ways that clinicians and the public get evidence about which drugs work or don't,'' she said. That's partly because of the attention published studies attract from the media, she said.

The new law may give drug companies less motivation to submit studies to journals because they can argue the Web-site summaries are providing full disclosure.

`` If there's less of an incentive to publish a negative study, the ratio of positive to unfavorable results might actually increase,'' she said.

Sim and her colleagues searched the electronic databases of journals looking for published results of 909 trials submitted to the FDA in support of 90 drugs that were later approved for sale. They found that 57 percent of the trials, 515 in all, were never written about in studies published.

The study didn't examine whether trials were submitted and rejected by journal editors or simply weren't submitted at all. Sim said previous research has shown that the primary reason for publication bias is that companies or investigators don't submit them.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net. Last Updated: September 22, 2008 21:41 EDT

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Mobile phone use 'raises children's risk of brain cancer fivefold'

Alarming new research from Sweden on the effects of radiation raises fears that today's youngsters face an epidemic of the disease in later life

By Geoffrey Lean, Environment Editor
Sunday, 21 September 2008

Children and teenagers are five times more likely to get brain cancer if they use mobile phones, startling new research indicates.

The study, experts say, raises fears that today's young people may suffer an "epidemic" of the disease in later life. At least nine out of 10 British 16-year-olds have their own handset, as do more than 40 per cent of primary schoolchildren.

Yet investigating dangers to the young has been omitted from a massive £3.1m British investigation of the risks of cancer from using mobile phones, launched this year, even though the official Mobile Telecommunications and Health Research (MTHR) Programme – which is conducting it – admits that the issue is of the "highest priority".

Despite recommendations of an official report that the use of mobiles by children should be "minimised", the Government has done almost nothing to discourage it.

Last week the European Parliament voted by 522 to 16 to urge ministers across Europe to bring in stricter limits for exposure to radiation from mobile and cordless phones, Wi-fi and other devices, partly because children are especially vulnerable to them. They are more at risk because their brains and nervous systems are still developing and because – since their heads are smaller and their skulls are thinner – the radiation penetrates deeper into their brains.

The Swedish research was reported this month at the first international conference on mobile phones and health.

It sprung from a further analysis of data from one of the biggest studies carried out into the risk that the radiation causes cancer, headed by Professor Lennart Hardell of the University Hospital in Orebro, Sweden. Professor Hardell told the conference – held at the Royal Society by the Radiation Research Trust – that "people who started mobile phone use before the age of 20" had more than five-fold increase in glioma", a cancer of the glial cells that support the central nervous system. The extra risk to young people of contracting the disease from using the cordless phone found in many homes was almost as great, at more than four times higher.

Those who started using mobiles young, he added, were also five times more likely to get acoustic neuromas, benign but often disabling tumours of the auditory nerve, which usually cause deafness.

By contrast, people who were in their twenties before using handsets were only 50 per cent more likely to contract gliomas and just twice as likely to get acoustic neuromas.

Professor Hardell told the IoS: "This is a warning sign. It is very worrying. We should be taking precautions." He believes that children under 12 should not use mobiles except in emergencies and that teenagers should use hands-free devices or headsets and concentrate on texting. At 20 the danger diminishes because then the brain is fully developed. Indeed, he admits, the hazard to children and teenagers may be greater even than his results suggest, because the results of his study do not show the effects of their using the phones for many years. Most cancers take decades to develop, longer than mobile phones have been on the market.

The research has shown that adults who have used the handsets for more than 10 years are much more likely to get gliomas and acoustic neuromas, but he said that there was not enough data to show how such relatively long-term use would increase the risk for those who had started young.

He wants more research to be done, but the risks to children will not be studied in the MTHR study, which will follow 90,000 people in Britain. Professor David Coggon, the chairman of the programmes management committee, said they had not been included because other research was being done on young people by a study at Sweden's Kariolinska Institute.

He said: "It looks frightening to see a five-fold increase in cancer among people who started use in childhood," but he said he "would be extremely surprised" if the risk was shown to be so high once all the evidence was in.

But David Carpenter, dean of the School of Public Health at the State University of NewYork – who also attended the conference – said: "Children are spending significant time on mobile phones. We may be facing a public health crisis in an epidemic of brain cancers as a result of mobile phone use."

In 2000 and 2005, two official inquiries under Sir William Stewart, a former government chief scientist, recommended the use of mobile phones by children should be "discouraged" and "minimised".

But almost nothing has been done, and their use by the young has more than doubled since the turn of the millennium.

Plastic marine debris destined to worsen

Stealth Viruses - The Secret Face of Autism?

Dr. Martin was concerned because his research suggested that the virus was spreading from infected individuals and causing a wide range of neurological problems. Yet the virus was not activating any of the typical inflammatory markers, thus causing medical practitioners to miss the problem.  He referred to this virus as a “stealth adapted virus” because of its ability to evade the body’s immune responses.

According to Dr. Martin, his unsolicited proposals to the FDA and CDC to test polio vaccine lots for the simian cytomegalovirus were so threatening to the medical establishment that his laboratory at USC was closed and his research funding confiscated.  Despite the great toll this research had taken on his professional life, Dr. Martin continued to pursue these stealth adapted viruses.

Using his own personal support, Dr. Martin was able to identify the presence of a stealth adapted virus in the brain biopsy of a child with neurological problems, who later died.  An account of this can be found in the article “Complex Intracellular Inclusions in the Brain of a Child with a Stealth Virus Encephalopathy” and is available online at www.sciencedirect.com.   

Looking at the samples from this child under a high-powered electron microscope, one thing which was immediately apparent was that these stealth viruses were damaging the mitochondria, the body’s powerhouse for cellular energy.

Dr. Martin first became interested in autism as a result of treating women with chronic fatigue syndrome.  He noted that some of these mothers had children with autism.  Could an infectious agent be passed from mother to child?  Dr. Martin was led further along this path by the reported observation of abnormal head growth during the first year of life in children who were subsequently diagnosed with autism, as well as abnormal neuropeptide levels from cord blood. 

It was apparent to Dr. Martin that these children were entering the world with significant challenges, which may have been exacerbated by their vaccines or other environmental exposures.

Early in his research Dr. Martin worked with Zaki Saluhuddin, a co-discoverer of the HHV-6 virus. They realized that stealth adaptation could potentially occur with all types of human and animal viruses, but that the use of vaccines had likely greatly increased the prevalence of infections caused by such viruses.  Dr. Martin published a study along with Dr. Tom Glass showing that patient-derived stealth-adapted viruses caused severe neurological disease when inoculated into animals, without any accompanying inflammatory reaction, the accepted hallmark of an infectious disease. 

Based on numerous virus cultures, and confirmed by Zaki Salahuddin, direct evidence for a stealth adapted virus infection was seen in the vast majority of patients with autism. A research article describing this finding was published in 1995. In his opinion “an autistic or severely learning disabled child should be considered as being stealth virus infected unless a negative culture shows otherwise.”

Martin believes that these stealth viruses strike at the mitochondria, causing the severe damage of autism and other neurological problems. The mitochondria insufficiency renders the child susceptible to environmental challenges that can place further demands on the body’s energy needs. Unfortunately, the immune system is relatively powerless to deal with stealth adapted viruses.

However, the body can potentially respond through what Dr. Martin calls the alternative cellular energy (ACE) pathway. Martin believes that in addition to food metabolism via the mitochondria, the body has another means of acquiring cellular energy that is somewhat similar to photosynthesis. He compares the ACE pathway to an electrical system of batteries, switches, and currents.

With the help of Mr. BJ McKelvie, Dr. Martin is supporting a transparent double-blind investigational research study to evaluate the safety and effectiveness of a non-drug approach to activate the body’s ACE pathway. Parents participating in the study are openly reporting on their findings and many are seeing quite remarkable improvements. 

The therapy is performed in a child’s home, and consists of putting a dye activated ACE-like material on a thin paper towel placed upon a plastic sheet laid onto the child’s skin. The material is illuminated for 30-60 minutes with an ultraviolet light.  The procedure can be repeated over several days, with many improvements being noted even after the first treatment. The cost for those who can afford to pay for the study is $350, and includes the materials, including the light, training video and compilation of results. Tax deductible donations are being sought for those who cannot afford the present cost.

Parents are required to fill out very detailed weekly journals on their child’s progress and to provide summaries, which can be read in their entirety at www.acepathway.ca.  Parents are claiming that among the documented results are markedly improved social interactions with far better eye contact, verbal speech, reading ability, attention span, and in one patient, the control of previously uncontrollable seizures, allowing for the discontinuation of seizure medication.

Dr. Martin is confident that, although still investigational, this therapy promises a low cost and effective approach to treating children with autism.   Jump starting the ACE pathway can help suppress the underlying viral infection, allowing normal mitochondrial function to resume, along with normal development.  He is aware of reported recoveries of children from changes in diet, chelation, hyperbaric chambers, etc., but feels that these methods only rarely achieve the levels of recovery occurring with direct stimulation of the ACE pathway.

For further information on this approach you can visit www.iminhere.ca. and www.s3support.com.

Wednesday, September 24 at 2:00 PM
210 Cannon House Office Building
Independence Avenue, Washington, DC.

FREE AND OPEN TO THE PUBLIC

Rep. Carolyn Maloney (D-NY) is hosting a special briefing for Members of Congress and their Staff to update them on recent developments in the vaccine-autism debate.

David Kirby, investigative journalist and author of The New York Times bestseller Evidence of Harm, Mercury in Vaccines and the Autism Epidemic – A Medical Controversy, will inform Members and their staff about developments in this debate from science, public policy, politics and law.  Mr. Kirby will be joined Mark Blaxill, Director of the Coalition for SAFE MINDS.

Among the issues to be discussed are:

FDA defends plastic linked with health risks

By RICARDO ALONSO-ZALDIVAR and LINDSEY TANNER – 4 days ago

WASHINGTON (AP) — With scientists at odds over the safety of a chemical found in plastic baby bottles, metal cans and other food packaging, consumers got minimal guidance Tuesday about how to protect themselves.

At a scientific hearing, the Food and Drug Administration defended its assessment that bisphenol A_ or BPA_is safe, even as the first major study of health effects in people linked it with possible risks for heart disease and diabetes. The debate could drag on for years.

"Right now, our tentative conclusion is that it's safe, so we're not recommending any change in habits," said Laura Tarantino, head of the FDA's office of food additive safety. But she acknowledged, "there are a number of things people can do to lower their exposure."

For example, consumers can avoid plastic containers imprinted with the recycling number '7,' as many of those contain BPA. Or, said Tarantino, they can avoid warming food in such containers, as heat helps to release the chemical.

More than 90 percent of Americans have traces of BPA in their bodies, but the FDA says the levels of exposure are too low to pose a health risk, even for infants and children.

However, a study released Tuesday by the Journal of the American Medical Association suggested a new concern about BPA. Because of the possible public health implications, the results "deserve scientific follow-up," the study authors said. Using a health survey of nearly 1,500 adults, they found that those exposed to higher amounts of BPA were more likely to report having heart disease and diabetes.

But the study is preliminary, far from proof that the chemical caused the health problems. Two Dartmouth College analysts of medical research said it raises questions but provides no answers about whether the ubiquitous chemical is harmful.

FDA officials said they are not dismissing such findings, and conceded that further research is needed. "We recognize the need to resolve the concerning questions that have been raised," said Tarantino. But the FDA is arguing that the studies with rats and mice it relied on for its assessment are more thorough than some of the human research that has raised doubts.

The FDA has asked an outside panel for a second opinion on its BPA safety assessment, and the medical journal article was released to coincide with the advisers' hearing.

The FDA has the power to limit use of BPA in food containers and medical devices but last month released its internal report concluding that BPA exposure is not enough to warrant action.

Since then, another government agency released a separate report concluding that risks to people, in particular to infants and children, cannot be ruled out.

Past animal studies have suggested reproductive and hormone-related problems from BPA. The JAMA study is the largest to examine possible BPA effects in people and the first suggesting a direct link to heart disease, said scientists Frederick vom Saal and John Peterson Myers, both longtime critics of the chemical.

Still, they said more rigorous studies are needed to confirm the results.

Vom Saal is a biological sciences professor at University of Missouri who has served as an expert witness and consultant on BPA litigation. Myers is chief scientist at Environmental Health Sciences, a Charlottesville, Va., nonprofit group. They wrote an editorial accompanying the JAMA study.

BPA is used in hardened plastics in a wide range of consumer goods including food containers, eyeglass lenses and compact discs. Many scientists believe it can act like the hormone estrogen, and animal studies have linked it with breast, prostate and reproductive system problems and some cancers.

Researchers from Britain and the University of Iowa examined a U.S. government health survey of 1,455 American adults who gave urine samples in 2003-04 and reported whether they had any of several common diseases.

Participants were divided into four groups based on BPA urine amounts; more than 90 percent had detectable BPA in their urine.

A total of 79 had heart attacks, chest pain or other types of cardiovascular disease and 136 had diabetes. There were more than twice as many people with heart disease or diabetes in the highest BPA group than in the lowest BPA group. The study showed no connection between BPA and other ailments, including cancer.

No one in the study had BPA urine amounts showing higher than recommended exposure levels, said co-author Dr. David Melzer, a University of Exeter researcher.

Drs. Lisa Schwartz and Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice said the study presents no clear information about what might have caused participants' heart disease and diabetes.

"Measuring who has disease and high BPA levels at a single point in time cannot tell you which comes first," Schwartz said.

The study authors acknowledge that it's impossible to rule out that people who already have heart disease or diabetes are somehow more vulnerable to having BPA show up in their urine.

The American Chemistry Council, an industry trade group, said the study is flawed, has substantial limitations and proves nothing.

But Dr. Ana Soto of Tufts University said the study raises enough concerns to warrant government action to limit BPA exposure.

"We shouldn't wait until further studies are done in order to act in protecting humans," said Soto, who has called for more restrictions in the past.

An earlier lab experiment with human fat tissue found that BPA can interfere with a hormone involved in protecting against diabetes, heart disease and obesity. That study appeared online last month in Environmental Health Perspectives, a monthly journal published by the National Institutes of Health.

Government toxicology experts have also studied BPA and recently completed their own report based on earlier animal studies. They found no strong evidence of health hazards from BPA, but said there was "some concern" about possible effects on the brain in fetuses, infants and children.

Several states are considering restricting BPA use, some manufacturers have begun promoting BPA-free baby bottles, and some stores are phasing out baby products containing the chemical. The European Union has said that BPA-containing products are safe, but Canada's government has proposed banning the sale of baby bottles with BPA as a precaution. * * *
http://www.ewg.org/node/27024

FDA’s Flawed Assessment of Bisphenol A Safety Underscores the Need for State and Federal Legislation

An Environmental Working Group (EWG) analysis of FDA’s draft assessment of BPA revealed a number of critical flaws and built in assumptions that biased the agency’s evaluation and ensured that the FDA would find current exposure levels in the population to be safe.

Laboratory studies show BPA harms brain development, raising concerns about its presence in baby bottles and other products that could expose babies and young children.

1. The FDA limited its assessment to studies that conformed to rigid, 50-year old study designs that feed animals high amounts of BPA and analyze the animals for overt signs of poisoning and toxicity. FDA admits in their assessment that the studies they use to set the safety level do not adequately address the impacts of early life exposure to the developing brain, behavior and the reproductive system. Notably, the only studies that conformed to these 50-year old study designs, were those funded by industry.
2. By adhering to what it euphemistically calls studies that follow “good laboratory practices,” the FDA ignores more than 100 studies, including many funded by the National Toxicology Program, showing toxic effects of BPA at very low doses.
3. FDA’s so called 2,000-fold margin of safety evaporates if current exposures are compared to any of the low dose studies, particularly the 12 studies the National Toxicology Program highlights in their April 14, 2008 BPA assessment as raising concerns for the safety of infant exposure to BPA.
4. FDA’s exposure calculations underestimate infant ingestion. They calculate formula intake for the average infant instead of focusing on babies who eat the most, thus underestimating risks for half of all infants. They also assume that liquid formula has 2.5 parts per billion (ppb) BPA, even though their own testing of just 14 liquid formulas found up to 5 times more than this (13 ppb). These errors contradict the accepted risk assessment practice of focusing on risks to the most highly exposed population. FDA claims that its analysis was comprehensive, but in reality it underestimates risks to the most vulnerable infants by a wide margin.

When FDA evaluates new drugs for approval they are required to consider all available evidence of toxicity, not just the findings of studies that conform to standard designs of past decades. In this case they disregard studies showing that BPA exposure harms the developing brain and reproductive system, and encourage parents to continue exposing their children to BPA when safer alternatives exist. Given FDA’s reckless disregard for children’s health, State and Federal actions are needed to protect children from avoidable contaminants in baby bottles and infant formula.

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http://www.ewg.org/node/27075

NIH Refutes FDA’s Claims BPA is Safe for Use

• CONTACT: EWG Public Affairs, (202) 667-6982
• FOR IMMEDIATE RELEASE: September 3, 2008

WASHINGTON – The National Institutes of Health’s National Toxicology Program (NTP) concluded today that bisphenol A (BPA), an artificial sex hormone and chemical used in hard plastic products like baby bottles, may alter brain development and increase the risk of prostate cancer. The NIH review, which contradicts a recent FDA assessment based on chemical industry science, reflects the findings of dozens of independent scientists from around the globe who have raised questions for more than a decade about the chemical’s possible dangers .

NTP’s assessment that BPA exposure is cause for concern directly refutes last month’s announcement by the Food and Drug Administration (FDA), which claimed exposure to BPA is safe for humans. NTP reviewed over 100 independent scientific studies before reaching its conclusion, while FDA relied solely on three chemical industry-funded reports, which gave the toxic chemical the thumbs up for use in consumer products.

“Unlike the FDA, NTP has listened to the nation’s premier scientists and has concluded that the BPA threat to the brains, bodies and behavior of our children must be taken seriously,” EWG Executive Director Richard Wiles said. “The agency’s stance is measured -- and courageous in the face of the slick, relentless publicity campaign from the chemical industry, which seems to be following the tobacco industry’s playbook.”

“The FDA has no credibility when it comes to BPA safety," Wiles added. "The NIH announcement is yet more confirmation that the FDA is in the pocket of industry. FDA ignored the nation’s top public health scientists and instead lauded the benefits of a toxic hormone disruptor found in virtually every infant in America. Now that wrong has been righted.”

The U.S. chemical industry produces an estimated 2.3 billion pounds of BPA annually to make polycarbonates and epoxy resins, tough, light materials that are fabricated into a vast array of products, including airplanes, computer and cell phone parts, paints and coatings, safety helmets and goggles, dental bonding agents, toys, water and baby bottles and food packaging. The global market for BPA is estimated at 6 billion pounds, which translates roughly to $6 billion.

"Consumers deserve straight talk from the government," Wiles said. "The new NTP assessment tells us that we are right to be concerned about BPA and the industry’s ongoing chemistry experiment on our kids."