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Sabin Russell, San Francisco Chronicle Medical Writer

Under U.S. Food and Drug Administration rules that place much of the responsibility for product safety in the hands of manufacturers, Chiron Corp. shipped 6 million doses of its now-suspect flu vaccine from its British plant to the United States before the company's own tests uncovered evidence of bacterial contamination.

The Chronicle has learned that vaccine shipped across the Atlantic has been sitting since August in the warehouses of American drug distributors, under a Chiron-imposed "quarantine,'' but outside the direct control of the company or U.S. regulators.

Now, Chiron's entire production of at least 48 million doses of flu vaccine has been rendered useless after British regulators abruptly suspended the license of the Emeryville-based company's Liverpool factory Tuesday, cutting the U.S. supply of flu shots in half.

In this case, Chiron employed the little-known quarantine process under which drugmakers can ship products to distributors before final safety tests are completed.

Norman Baylor, deputy director for the FDA's vaccine unit, said it was not unusual for manufacturers to ship vaccine under quarantine. The quarantine is lifted by the manufacturer when the company's final tests confirm that the product is safe and the distributor is free to sell it. "I think the system works,'' Baylor said in an interview in September shortly after Chiron's contamination problem first surfaced. "The system did what it was supposed to do.''

Baylor also confirmed that 27 bulk lots -- nearly half of the 60 produced by the Chiron plant -- had been "released" by the FDA prior to the company's discovery that some finished product was contaminated. The actual number of doses that can be produced from each lot varies.

Although the federal agency does not conduct tests on the final product, companies are liable for the safety of their medicines and have powerful incentive to test them thoroughly before releasing them from quarantine, Baylor explained.

Chiron shipped its first million doses of vaccine to distributors in late July, trumpeting its first-to-market achievement in a July 23 press release. At that time, the company explained that "in the coming days," it would "complete its internal release procedures, allowing distributors to begin shipping vaccines to customers.''

Any optimism at Chiron evaporated with Tuesday's ruling. "We consider the Fluvirin season to be over, for all intents and purposes,'' Chiron spokesman John Gallagher said Wednesday.

He also confirmed that the initial crisis had been triggered when tests detected serratia bacteria in a small number of lots. Serratia bacteria are often implicated in episodes of hospital-acquired infection and can be deadly in the bloodstream.

The company has yet to reveal when it discovered the contaminated lots, but having found a problem, Chiron never lifted its quarantine. Although no Chiron vaccine was shipped to clinics, some drug industry experts acknowledge that its presence at multiple U.S. distributor warehouses poses a potential security problem.

"Because of the shortage, the spot market for flu vaccines is going to go through the roof,'' said David Webster, a health care consultant in Lehigh Valley, Penn. "Any time there is an extremely valuable commodity, the potential exists that it will work its way on to the black market. It is a legitimate cause for concern.''

Chiron chief executive Howard Pien said Tuesday that all of the Fluvirin doses "would be destroyed in due course.''

Top FDA officials are meeting in Britain today in an attempt to learn why their British counterparts suddenly and unexpectedly pulled the license for the Liverpool plant, where Chiron had brewed nearly 50 million doses of flu vaccine.

American distributors had been gearing up to ship their stocks of Chiron vaccine after the company and U.S. health officials expressed optimism last week that the cause of the contamination had been found and that the problem was confined to a small amount of vaccine.

Secretary of Health and Human Services Tommy Thompson said Tuesday he was surprised by the British decision. "We were assured by Chiron that everything was OK,'' he said, adding that U.S. officials had been in contact with British regulators, who had made no indication as recently as last weekend that Chiron's license was in jeopardy.

He said FDA regulators would be visiting the Liverpool plant this weekend and would try to determine whether some of the Chiron vaccine could be released.

"It does not look promising at this point,'' Thompson said Wednesday.

Tuesday's British action not only cut the U.S. flu vaccine supply in half, it raises serious concerns about whether drug safety regulation in Britain is overly cautious -- or whether American oversight is too lax.

When British regulators suspended the license of Chiron's Liverpool factory Tuesday, they shut down a facility that had been cleared by U.S. inspectors one year earlier, and they apparently have blocked for good the sale of 27 lots of vaccine that had already been released by the FDA.

According to FDA spokeswoman Lenore Gelb, the agency's direct role in the testing of flu shots ends with the production of bulk quantities of vaccine. The final manufacturing steps, such as filling vials and syringes, are regulated through bi-annual inspections to assure that companies are adhering to "good manufacturing practices" that are the basis of their licensure.

Manufacturers are required to conduct their own tests for sterility, and it was one of these quality-control tests by Chiron that spotted the serratia in August.

The current crisis was triggered when British regulators re-inspected the Chiron plant and concluded that it did not meet British standards for good manufacturing practices.

U.S. health officials, meanwhile, continued to counsel calm about the instant shortage of flu vaccine, calling on the public to cooperate with efforts to steer vaccine toward those most in need.

Thompson said vaccine maker Aventis Pasteur would be able to produce 1 million more doses than initially predicted, bringing its total production this year to 55 million.

Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention in Atlanta, said it was "not a realistic strategy" for the federal government to seize the vaccine produced by Aventis and direct its distribution.

She said the CDC was in the process of establishing a toll-free hot line for consumers to report shortages, so the agency can steer privately held surpluses of vaccine to regions that need it. She described it as a collaborative process.

The newly revised guidelines no longer recommend vaccine for healthy adults. Programs that provide flu shots to that population -- and had purchased large quantities of Aventis vaccine -- are likely to find they have too much on hand. The CDC will facilitate the sale of that vaccine to needier clients.

The current flu vaccine shortage, Gerberding added, underscores the need for "a comprehensive national strategy" to build up America's domestic flu shot manufacturing capacity.

"Our entire vaccine production system is fragile in this country,'' she said.

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A controversial preservative will be hard to avoid in this season's severely reduced supply of vaccines.

By Robyn Shelton | Sentinel Medical Writer
Posted October 10, 2004

The government's push this year to vaccinate young children against the flu has triggered new interest in banning a mercury-based preservative found in most influenza shots.

Called thimerosal, the preservative was used in many children's vaccines until manufacturers began phasing it out in 1999 amid concerns that mercury might contribute to autism and other developmental disorders.

America's reduced supply of about 54 million influenza vaccines this flu season still includes 4.6 million shots that are free of thimerosal. The nation's total supply of almost 100 million doses was slashed nearly in half last week after the British government withheld a major manufacturer's shipment because of quality concerns.

In the ensuing pinch to get a vaccine in coming weeks, parents might not have the luxury of requesting doses without the preservative. Some are worried about exposing their children to thimerosal in that instance. But most doctors think there's a much greater risk in forgoing the vaccination.

Influenza caused a startling string of children's deaths early last season, prompting a run on flu shots and panic among parents in some hard-hit states such as Colorado.

"Get the vaccine," said Dr. Douglas Short, a pediatrician at Arnold Palmer Hospital for Children & Women in Orlando. "No one has ever been proven to have been harmed by thimerosal, while lots and lots of babies get really sick from the flu every year, and a few will die from it. It's an obvious risk versus a theoretical one."

But even so, some parents, doctors and, now, members of Congress are calling for more research on thimerosal. U.S. Rep. Dave Weldon, R-Palm Bay, thinks the federal government should ban the substance in all vaccines or at least keep it out of all children's doses.

He sits on a congressional subcommittee that held a hearing on thimerosal last week in Washington.

Weldon is not convinced by U.S. and European studies that have found no link between thimerosal and autism, nor by the expert panels that have drawn similar conclusions.

He says the studies have been so flawed in their designs or otherwise limited that they are evidence of the halfhearted, dismissive attitude by the scientific community toward the topic.

"My biggest complaint is they have never taken this issue seriously and funded the necessary research" to truly study thimerosal, said Weldon, a medical doctor.

Thimerosal contains a little-understood form of mercury called ethylmercury. It has been used in vaccines for more than 50 years as a way to prevent contamination in vials that contain more than one dose. Children's vaccines are now sold in single doses, eliminating the need for the preservative.

But influenza shots -- which just this year became a routine recommendation for babies ages 6-23 months -- historically have been focused on adults. Most say thimerosal is not a threat to adults, who are larger in size and fully mature.

Experts say children, with their small bodies and rapid, ongoing development, are more vulnerable to potential toxins such as mercury.

Governmental and professional organizations such as the American Academy of Pediatrics joined in 1999 to support removing thimerosal from children's inoculations.

The move came after the Food and Drug Administration discovered that some children were receiving enough thimerosal in vaccines during their first six months to exceed Environmental Protection Agency limits on a similar form of mercury called methylmercury, which can be found in mercury-contaminated fish.

The EPA doesn't have enough data to establish limits for ethylmercury. But its cousin methylmercury has been linked to problems with vision, learning and coordination. Health officials said the decision to remove thimerosal from childhood vaccines was strictly precautionary.

Several large studies within the past couple of years have not found any evidence that thimerosal is linked to autism, a complex developmental disorder that affects a child's ability to communicate and interact with others.

For example, Danish researchers in 2003 found the rates of autism continued to rise in that country seven years after thimerosal was removed from vaccines.

In May, a panel from the prestigious Institute of Medicine reviewed a number of studies and concluded that thimerosal is not linked to autism, though it did not rule out a connection to other developmental disorders such as speech delay and attention-deficit disorder.

Cindy Smith's two children went through the regular regimen of childhood vaccinations, but the Longwood mother will pass on the influenza shot this year.

Her plan is to keep Nicholas, 18 months, and Matthew, 5 years old, as healthy as possible with a wholesome diet and overall healthy lifestyle. Knowing that thimerosal might be in the vaccine is one of her reasons.

"If I knew that was in a vaccine, I definitely wouldn't do it," Smith said.

Parents who are concerned about the preservative should ask their doctors, who will know whether it is contained in the vaccines they're using.

Weldon, who supports vaccinations for children, also faults the government and industry for failing to ramp up production of thimerosal-free doses so that parents don't have to worry about them. He said regulators are dragging their feet on the issue because of the implications of problems with thimerosal.

"If this is ultimately proven, this is going to be a huge, colossal liability for a lot of people," he said.

Weldon said he would not want to deter parents from getting children vaccinated. They should get information on the issues and make an informed decision for themselves, he said.

Many pediatricians, the Centers for Disease Control and Prevention, the FDA and other groups do not hesitate to say that vaccination is the right decision.

By the end of last year's flu season, 153 influenza deaths in children had been reported to the CDC. Five of the youngsters were from Florida.

The agency can't say whether that is a high number, because child flu deaths have never been tracked nationally.

Short, from Arnold Palmer, said doctors have noticed increasingly that children younger than 2 are among the most vulnerable to flu's serious complications.

"The rate of hospitalization for young babies is almost as high as the rate for older folks over 65," he said.

The vaccine is not approved for children younger than 6 months, which is why the government recommends that all caretakers of infants in that age group get vaccinated. If everyone around the baby has been inoculated, the child has less of a chance of picking up the virus.

Robyn Shelton can be reached at rshelton@orlandosentinel.com or at 407-420-5487.

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Flu Shots Can Be Dangerous to Your Health

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by: Dr. Edward F. Group, III

Every year about this time doctors around the world are recommending that people go in and get their annual flu shot. What most people don’t know or understand is just how dangerous this could be, especially for children under the age of 12. When people call and say “My doctor is telling the family to go in and get a flu shot. Should I do it?”…I tell them they should learn about the side effects and decide for themselves…as a chiropractor and naturopathic physician I don’t’ have the time or energy to argue with family practitioners or family doctors who are obviously uneducated on the possible side effects or detrimental effects flu shots or vaccinations in general can have on the body.

I personally have never received a flu shot and have never been ill during the flu season. In my personal opinion I don’t think toxic chemicals and strains of different viruses growing on living tissue belong inside the body. Because of the demand, I want to share with you some of the research that we have found in the latest flu shot trend and the by-products of these supposedly sterile and non-harmful solutions.

I don’t know about you, but I sure would not want any of the following compounds in my bloodstream or deposited in my body. Let’s look at what we have found in the common vaccinations:

Ethylene Glycol: Ethylene Glycol is nothing more than the technical name for anti-freeze, the same stuff that you put inside your car engine. I don’t think I have to tell you what would happen if you ingest antifreeze.

Thimerosal: This is a mercury derived disinfectant and preservative which is used in a majority of the vaccinations and can result in brain injury over a long period of time leading into Alzheimer’s or Parkinson’s Disease, lack of memory, sluggish brain performance and also is known to induce auto-immune diseases such as lupus, rheumatoid arthritis, ALS as well as altering and depleting the immune system from working efficiently.

Phenol: Phenol is most commonly used as a disinfectant, also used as a dye, is listened as a carcinogenic agent (cancer-causing) agent and is also known as carbolic acid.

Neomycin and Streptomycin: These compounds are used as antibiotics which have side effects to include severe allergic reactions in some people. It always puzzled me why they are putting two different forms of antibiotics in a viral vaccine.

Aluminum: Aluminum accumulates in the skin, bones, brain and kidneys and can cause Alzheimer’s and Parkinson’s disease. Aluminum has also caused cancer in laboratory mice. It is commonly used as an additive in most vaccinations.

Formaldehyde: Formaldehyde is used as a preservative. It is also classified as a carcinogenic (cancer-causing agent) and causes the body fluids to become acidic in nature. Formaldehyde will start to preserve your tissues within the body.

I hope that when your doctor starts telling you that it is time for your annual flu vaccine you will present this material to him and ask him how all of these ingredients are going to prevent you from getting the flu. I’ll be very interested in knowing what his answer is to that question. As a side note just to let you know what is being injected to your body, these vaccines are strained through animal or human tissues like chicken embryos, monkey kidney tissue and embryonic guinea pig cells, to name a few.

So what am I supposed to do if I don’t listen to my doctor and I decide not to get an annual flu shot? Well, you have probably made the smartest decision you have ever made in your entire life. So let me give you 5 Simple Secrets and Bonuses to Sailing Through The Flu Season:

Secret #1: Reduce your intake of caffeine, alcohol and carbonated beverages and replace with purified water with addition of organic apple cider vinegar added. Two tablespoons per gallon or a capful per glass. Ideally, you should drink at least ½ gallon of water each day.

Secret #2: Reduce intake of refined white sugar, white flour, sweets, refined grains and hydrogenated oils. Try not to over-eat, especially during the holidays. Try to get adequate exercise—at least 3 times per week. The more you move, the better your lymph system is able to move toxic materials out of the body.

Secret #3: Zinc. In a majority of the studies that have been done during the flu season many people have prevented the flu by taking supplements of zinc. Zinc is one of the most powerful immune stimulants and is powerful anti-viral. There are a lot of different forms of zinc and you have to be careful on which one you choose. Therefore I recommend the best and most absorbable form of zinc which is zinc orotate. If you cannot find this form of zinc at your local health food store or natural health care practitioner contact Global Healing Center at 713.476.0016 or staff@ghchealth.com. Do not take zinc at the same time you eat or drink citrus fruits or juices. It will diminish the effectiveness of the zinc.

Secret #4: Eat as close to nature as possible. This means to eat food that is considered “live.” Include raw fruits (seasonal), vegetables and nuts and seeds as much as possible in your diet. If possible, buy organic or from a local farmer’s market. Make sure that you thoroughly wash your fruits and vegetables before consuming. Vegetables may be steamed lightly or used in nourishing soups and stews. Adding fresh garlic to your diet is also recommended.

Secret #5: Eliminate stress and negative emotions. Being negative and allowing stress to affect you can quickly bring down the immune system. Learn to say no to activities that will over-tax your schedule. Spend time alone each day and read positive books, listen to good music or practice meditation. Train your mind to find the positive or good in every situation and treat all of these situations as a learning experience. Don’t go around playing the “victim” in life.

BONUS! Secret #6: Colloidal Silver, Oxygenator and Oregano Oil: Colloidal silver has been around for hundreds of years and has been used as a natural antibiotic which promotes healing. It can also be used as a nasal spray and as eardrops. Oxygenator is a safe, stable, inorganic compound of oxygen and chlorine-containing products, in a colorless and odorless aqueous medium. Oxygenator is known to release chlorine dioxide (CL02), and the product has demonstrated efficacy as an anti-inflammatory, broad spectrum, bactericidal, fungicidal, as well as a virucidal agent. The Chemistry Literature verifies this triple-threat ability of CL02. Oregano Oil is a powerful germ and painkiller. An article published in Phytotherapy Research describes how oregano oil superceded anti-inflammatory drugs in reversing pain and inflammation and is nearly as powerful as morphine as a painkiller. The oil also possesses significant antioxidant powers. Furthermore, it stimulates the flow of bile, which greatly aids digestion. Keep these three products in your medicine cabinet at all times. All three are available from www.ghchealth.com or by callling 713.476.0016.

SUPER BONUS!! Extra Tips and Suggestions:

~~ Get adequate sleep and rest. The body does the most healing between the hours of sundown and midnight. It is impossible to “catch-up” on sleep.

~~ Wash your hands frequently. Rinse and dry your hands thoroughly and keep them away from your eyes, nose, and mouth. If you sneeze use a tissue and throw it away as soon as possible.

~~ Buy a new toothbrush frequently. Toothbrushes can harbor viruses and prolong an illness.

~~ Eucalyptus Oil is good for relieving congestion. Put 6 drops in a hot bath or in boiling water, put a towel over your head and inhale the vapors. You can also diffuse it through an essential oil diffuser.

~~ Dairy Products. Dairy can be very mucous causing not to mention the fact that many people have an allergy to cow’s milk and don’t even know it.

~~ 3 Drops of 3% Hydrogen Peroxide in each ear 3x daily for 5 days helps relieve flu symptoms.

With many flu seasons ahead I felt it was finally time to break the silence and reveal these secrets to as many people as possible. I have come to the conclusion that your Dr. doesn’t want you to know about the detrimental effects of flu shots and vaccinations. Please feel free to share this article with your friends, family and loved ones. I wish you a happy and healthy holiday season. Don’t forget to check all the information and research articles on our continually updated website: www.ghchealth.com.

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Editor-In-Chief: Dr. Edward F Group III, DC, PH.D, ND, DACBN
Executive / Managing Editor: Dr. Loretta Lanphier, ND, CN, HHP


Published monthly by:
Global Healing Center, Inc.
2040 North Loop West Suite 108
Houston TX 77018
713.476.0016
www.ghchealth.com
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Questions or Comments? staff@ghchealth.com

Check out our websites for more advice and information on improving your health at www.ghchealth.com, www.oxypowder.com, or www.colon-cleanse-constipation.com.

Required disclaimer: Any statements in this newsletter have not been evaluated by the U.S. Food and Drug Administration. Our products are not intended to diagnose, cure, treat, or prevent any disease.

“Your body wants to take care of itself and if you reward it with good nutrition/supplementation, exercise and a calm emotional state it will reward you with vibrant health and energy. Take time to focus on your health every day.”
--Dr. Edward F. Group, III