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Dan Olmsted: Age of Autism Index

Evelyn Pringle Autism Related Articles

David Kirby on
Huffington Post

Wednesday, November 30, 2005

The Age of Autism: Nuts

By DAN OLMSTED
UPI Senior Editor

You may have seen the brief news stories this week: A 15-year-old Canadian girl with a severe peanut allergy kissed her boyfriend -- and died.

The New York Post perfectly captured the tabloid pathos. The headline: "Allergy teen's fatal kiss." The lead: "Her allergy to peanuts may have been the kiss of death for a Canadian 15-year-old who died after smooching with her boyfriend, who'd just had peanut butter, authorities said.

"Christina Desforges died last Wednesday in a Quebec hospital, where she was being treated for the allergic reaction to the kiss the weekend before. The fact is that even a trace amount can cause a severe reaction."

A CNN reporter asked: "Could it really have been ... the kiss of death?" (Could it really have been ... a crass cliché worth avoiding?) The network quoted three people -- ages 13, 15 and 20 -- who all have severe peanut allergies and recounted near-death experiences as a result. It quoted a doctor as saying, "I've lost three patients due to anaphylaxis (severe allergic reaction). They're all teenagers. One was a baked good, one was Chinese food, one was a candy. None of them had epinephrine (antidote) available."

Now, why are so many young North Americans suddenly at risk of death from eating common foods or kissing those who have?

"Food allergy such as peanut allergy is an immune response," explains foodconsumer.org. "It differs from food intolerance which causes discomfort without provoking the immuno-response. What causes peanut allergy remains largely unknown. A study, published in the March 13 issue of New England Journal of Medicine, linked the acquisition of the condition with babies' using skin preparation containing peanut oil. Peanut allergy was also found associated with intake of soy milk or soy formula."

Other possible factors cited in press accounts include more peanut-eating by pregnant and breast-feeding women and earlier peanut consumption by young children. That, it is surmised, could predispose them to severe allergic reactions later.

Maybe. But omitted from the speculation is one other possibility, which explains why peanuts are the subject of this column about autism: There are studies and informed observations suggesting that a rise in peanut allergies -- and other severe allergic and autoimmune reactions in young people, both acute and chronic -- are associated with a rise in childhood vaccinations in the 1990s.

Are you rolling your eyes yet? Please bear with us. Our purpose here is not to propose this as the most plausible hypothesis, but simply to point out -- yet again -- how nutty the discussion of the horrifying rise in childhood medical problems becomes when it does not look squarely at all possibilities.

And vaccines are among those possibilities -- certainly right up there with peanut eating during pregnancy, to say the least. We refer you to this posting on the Web: www.vaccinationnews.com/DailyNews/March2002/Anaphylaxis&Vaccines.htm.

It is a Nov. 6, 2001, letter from Rita Hoffman of Stirling, Ontario, to the Immunization Safety Review Committee of the U.S. Institute of Medicine, part of the prestigious National Academies.

"Re: Epidemic of Children with Anaphylaxis," it begins. "Thank you for the opportunity to submit the following information for your review of the possible association between multiple immunizations in newborns and infants and immune system dysfunction. We are writing in particular about the potentially life threatening allergic response called anaphylaxis."

The letter, which Hoffman wrote on behalf of the group Anaphylaxis Action, sure looks like a serious piece of work to us. It cites one scientific journal study after another, beginning with the Archives of Internal Medicine, which reported in 2001 that "The occurrence of anaphylaxis in the US is not as rare as is generally believed. On the basis of our figures, the problem of anaphylaxis may, in fact, affect 1.21 percent (1.9 million) to 15.04 percent (40.9 million) of the US population."

That's something that should trigger urgent research and -- despite the cluelessness of the press accounts about the 15-year-old's kiss of death -- it has indeed.

Hoffman quotes from a paper in the journal Pediatric Allergy Immunology from 1994 that says that "the role of immunization for the development of allergy merits further study."

A 1997 article in Immunology Today: "Modern vaccinations, fear of germs and obsession with hygiene are depriving the immune system of information input upon which it is dependent. This fails to maintain the correct cytokine balance and fine-tune T-cell regulation, and may lead to increased incidences of allergies and autoimmune diseases."

From the Journal of Manipulative and Physiological Therapeutics in 2000, Effects of diphtheria-tetanus-pertussis or tetanus vaccination on allergies and allergy-related respiratory symptoms among children and adolescents in the United States: "The odds of having a history of asthma was twice as great among vaccinated subjects than among unvaccinated subjects. The odds of having any allergy-related respiratory symptom in the past 12 months was 63 percent greater among vaccinated subjects than unvaccinated subjects."

We could go on, but we refer you to Hoffman's excellent summary. Of course, there are countervailing studies and theories that find no such link between immunizations and allergic reactions, anaphylaxis and asthma (not to mention autism). But the point is this is a serious, ongoing debate with immediate, life-and-death consequences.

Too bad the mainstream media doesn't take it seriously. Christina Desforges and her generation deserve better -- and they deserve it now.

--

E-mail: dolmsted@upi.com
© Copyright 2005 United Press International, Inc.


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An Ill Wind Blows into a Child's Life

Bioaccumulation of heavy metals in autistic children

By James Ottar Grundvig
Special to The Epoch Times

Most Americans remember with clarity where they were when they first heard the news of the September 11 attacks on the World Trade Center.

Life-defining moments like 9/11 are those rare events that reshape society and culture, forever changing how people take stock of their lives. This holds especially true for those who witnessed the tragedy firsthand.

For me, a rooftop witness to the fire and smoke that poured out of the Twin Towers, the day after 9/11 has lingered in my mind with equal brilliance and anxiety. Confined at home with work closed, my son and I appeared safe in the shutdown city with Navy jets flying over the empty skyline. And why shouldn't I have felt that way? We lived Uptown at 94th Street and Third Avenue on the opposite end of the island, six miles away from the smoldering ruins of the collapsed buildings that made up the World Trade Center complex.

Yet what happened that morning unnerved me. With our 14th floor living room window ajar, I began to smell an acrid, burning smoke that I had never smelled before. I raced around the apartment looking for the source of the fire. I found nothing. Watching my son, Fridrik, play by the open window, wondering where the pungent odor was coming from, I had a delayed reaction. The smoke that I saw drift east to Brooklyn on 9/11, blew north as the wind changed direction the next day. I closed the window. But my gut feeling told me it was too late.

A Child Sickens

By the next morning, Fridrik began to cough. It was a dry, hacker's cough as if he had smoked cigarettes for twenty years. Within a week, he developed an acute ear infection—the only one of his life. On the 25th of September, my wife and I took Fridrik to see his pediatrician. This was the same doctor who told us one year before that an infant's lungs develop over the first three years. So when we inquired about taking him swimming the only restriction the doctor emphasized was "no dunking." With the cough still persisting weeks after the insult, the pediatrician gave Fridrik his only prescription of penicillin in his life. It wasn't for the cough, but the ear infection. Although the cough dissipated over time, the thought about what toxic chemicals had invaded my son's lungs never left me.

If pool water is bad for an infant, then how much worse would be the scorched air emanating out of Ground Zero? The answer came more than three years later, and almost two years after Fridrik had been diagnosed with autism.

On Valentine's Day, we decided to forego the ritual romantic dinner and took Fridrik to see a doctor. The results were in for his red blood cell analysis test, which profile the metal makeup of a person's body—from essential (good) metals, like zinc and iron, to heavy metals that can be harmful. When we learned that our son was carrying high amounts of mercury, lead, cadmium, and arsenic in him, we were at a loss. How did he become so "dirty" at such a young age? Having done extensive research into the vaccine-thimerosal (a mercury-based preservative used in many vaccines), we knew we would find mercury in him, but not the other three neurotoxins.

The Danger of Ground Zero

It took only the subway ride home from the doctor's office for the burnt smell of 9/12 to come racing back. We began to research and interview people, including several New York journalists, to see if those heavy metals in Fridrik were present in the World Trade Center. In short, we discovered that computers carry high amounts of mercury; cadmium can be found in light fixtures; and arsenic and lead in the steel. The World Trade Center, which comprised a small city of 60,000 people, with computers on every desk and light fixtures in every room and corridor, became the focus for the secondary source of heavy metal poisoning.

We learned that the EPA air monitoring stations were setup at the northern-most limit of 14th Street—a good eighty blocks from where we lived—but a poor location to get a true sampling of what was airborne. More research brought home a frightening fact. The intense fires, which appeared to vaporize everything in their path, released the superheated heavy metals into the air. And when the particles of lead and arsenic cooled off, far from the source of the heat, they shrank in size and collected on the dust and drifted, in Fridrik's case, uptown into our home and in his lungs.

I was never concerned about asbestos or other PCB, cancer-causing chemicals harming him. His exposure was limited in time. But after learning that mercury from the baby vaccines had shutdown Fridrik's glutathione, or his ability to filter out neurotoxins, I knew that he had more than enough exposure to ingest the bad stuff—something far worse than being dunked in a pool.

The Metals Around Us

What parents of autistic spectrum disorder (ASD) children need to know is that heavy metals, which come from the earth's crust, cannot be destroyed, incinerated, or broken down any further. Once inside an ASD kid, mercury and the rest can stay there for up to a third of his or her life if not treated.

Fridrik wasn't the only child on the spectrum, a "human" magnet collecting heavy metals in the city when 9/11 occurred. And the Upper East Side wasn't the only area in the city to be hit by the poisonous air that cooked for more than a month after the towers collapsed. There are other children who were insulted, adding to the "bioaccumulation" problem that impacts their speech, amplifies their senses, and zaps their nervous system.

Finally, there are other 9/11-like events that put ASD children in harm's way: the fires in the wake of Hurricane Katrina; the cities that burned in the riots that plague France. There are also more innocuous sources, from the water we drink to the air tainted by industrial plants.

For children like Fridrik, the struggle has not only been treating him for toxins that have made a home in his body and brain, but trying to prevent primary (vaccines) and secondary sources of heavy metals from leeching again into his body and not out.

James Ottar Grundvig lives and works in New York City. He is the father of an autistic child.

Please also read Autism's Razor: Epidemic's Cause Found, and How Can a Child Forget a Parent's Face?.


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Tuesday, November 29, 2005

Critics question provision in vaccine plan

Source: 13 Eye Witness News
Tom Walker/Washington Bureau Chief

Washington D.C., Nov. 29 - The government's strategy for fighting bird flu includes doing everything possible to keep it from becoming a pandemic in the first place.

President George W. Bush has said, "The best way to deal with it is to isolate and contain it in the region in which it begins."

In case that fails, Congress is working up a $7 billion plan to encourage production of potentially life saving vaccines.

But critics are now taking aim at a part of the plan they say would also give drug makers sweeping new protection from lawsuits, protection they say goes beyond bird flu.

"A couple of cases of measles could be considered an epidemic that then would be covered under this legislation." Barbara Loe Fisher runs the watch-dog group National Vaccine Information Center that she founded after her son developed learning disabilities she believes were related to childhood vaccine.

She and other critics of the pharmaceutical industry, including Indiana Congressman Dan Burton, are gearing up to oppose the liability provisions.

President Bush and others say the number of makers of vaccine has plunged, largely because of fear of lawsuits. And they argue that without protection companies won't make the drugs.

But there is growing opposition from groups, including the politically powerful Association of Trial Lawyers, that say

fear of pandemic should not close the courthouse door to those injured.

"Certainly when it happens to you or to a loved one," says Fisher, "when you're the one that gets hurt, things look very different."

This is shaping up as a bitter struggle that could have an impact on drug makers like Eli Lilly and Company that don't make vaccines, but could be ramping up production of other medicines that might be needed in a bird flu pandemic.

Legislation drafted by Republicans would only allow lawsuits against makers of pandemic vaccines if there were willful misconduct.


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A New Ultra-Secret Government Agency

Source: OMB Watch

Legislation is moving in the Senate to create a new government agency to combat bioterrorism that will operate, unlike any other agency before it, under blanket secrecy protection.

Sen. Richard Burr (R-NC) has introduced the Biodefense and Pandemic Vaccine and Drug Development Act of 2005, S1873, that would create a new agency in the Department of Health and Human Services (HHS) to research and develop strategies to combat bioterrorism and natural diseases. While Congress has created several agencies recently in response to homeland security concerns, most notably the Department of Homeland Security, Burr proposes for the first time ever to completely exempt this new agency from all open government laws. The legislation has already passed out of the Committee on Health, Education, Labor, and Pensions and is now before the full Senate.

The Act creates the Biomedical Advanced Research and Development Agency (BARDA) to work on countering bioterrorism and natural diseases. Apparently in an attempt to protect any and all sensitive information on U.S. counter-bioterrorism efforts or vulnerabilities to biological threats, Burrs has included in the legislation the first-ever blanket exemption from the Freedom of Information Act (FOIA). The legislation states that, "Information that relates to the activities, working groups, and advisory boards of the BARDA shall not be subject to disclosure" under FOIA "unless the Secretary [of HHS] or Director [of BARDA] determines that such disclosure would pose no threat to national security."

Neither the CIA nor the Defense Department has such an exemption. Burr’s spokesperson argues that the exemption is necessary to protect national security claiming that "there will be times where for national security reasons certain information would have to be withheld." For instance, the BARDA should not, according to the spokesperson, be required to publicly disclose information pertaining to a deadly virus.

FOIA, however, already includes an exemption for national security information, as well as eight other exemptions ranging from privacy issues to confidential business information and law enforcement investigations. If the public disclosure of information would threaten national security, then the government may withhold the requested information. "The well-established and time-tested FOIA provisions already address Burr's concerns," explains Sean Moulton, OMB Watch senior policy analyst, "thereby making the blanket exemption for BARDA unnecessary and unwise."

Congress established and strengthened FOIA over the years to create a reasonable, consistent level of accountability among government agencies. Under FOIA, when the public requests agency records, the agency is compelled to collect and review the requested information. The only decision for the agency is whether specific records can or can not be released under the law based on the exemptions from disclosure written into the law. However, the Burr legislation reverses the process: it does not require BARDA to collect or review the requests for disclosure. Instead, the agency can automatically reject requests. Still more troubling, the law prohibits any challenges of determinations by the Director of BARDA or Secretary of HHS, stating that the determination of the Director or Secretary with regards to the decision to withhold information "shall not be subject to judicial review."

Mark Tapscott at the Heritage Foundation writes that "BARDA will essentially be accountable to nobody and can operate without having to worry about troublesome interference from courts or private citizens like you and me."

This move to restrict the reach of FOIA appears in stark contrast to the recent Senate vote to strengthen open government. Sens. John Cornyn (R-TX) and Patrick Leahy (D-VT) co-sponsored FOIA reform legislation, passed by the Senate in June, that "will bring additional sunshine to the federal legislative process, and was another step toward strengthening the Freedom of Information Act."

The Biodefense and Pandemic Vaccine and Drug Development Act also exempts BARDA from important parts of the Federal Advisory Committee Act, which requires public disclosure of advice given to the executive branch by advisory committees, task forces, boards and commissions.

Other provisions of the bill compound the troubling secrecy provisions. They include:

The FOIA exemption in combination with these provisions would prevent the public from knowing whether BARDA is effectively completing these duties. Only information on agency actions could establish if the new agency is protecting the public from bioterrorism and infectious disease or if it is simply providing handouts to drug companies that creates no added security.

"It is essential that open government safeguards remain in place for all agencies," Moulton continues. "It is extremely important to ensure that the nation is protected against pandemics and bioterrorist attacks, but such efforts must not be excluded from open government. By providing the mechanisms for government accountability, these safeguards ensure that the government meets its responsibility to protect the public. In the end, an accountable government is a stronger government which acts to effectively meet all threats, including pandemics and bioterrorism."

Burr is still in the process of revising the Biodefense and Pandemic Vaccine and Drug Development Act, and, with the Senate's incredibly tight schedule, the timing of the bill's introduction on the floor remains uncertain. In the meantime, supporters are rumored to be seeking out a Democratic cosponsor to give it momentum.



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Monday, November 28, 2005

The Sickening Politics Of Vaccine Legislation

By Richard S. Dunham
Business Week Online


Even in an era of hyper-partisanship, it should have been easy. Everyone on Capitol Hill, Republican and Democrat, understands that the U.S. needs emergency legislation designed to speed production of new vaccines aimed at combating future pandemics. Everyone knows drugmakers need a liability shield to protect against the lawsuits that will inevitably spring up when a vaccine is rushed to market. And nearly everyone wants Washington to help Americans who are injured by their shots.

But in Washington nothing is easy, especially when it involves a clash between two bitter enemies -- Hill Republicans and the trial lawyers. The GOP and pharma lobbyists charge that the lawyers and their allies are pulling out all the stops to prevent any erosion of their cherished right to sue at the drop of a hat. But the plaintiffs' attorneys see the Republicans pushing broad relief from lawsuits under the guise of public health. "It's cynical to claim that this is what's needed to deal with avian flu," says Senator Edward M. Kennedy (D-Mass.). "The Republican leadership is trying to do another favor for the drug companies."

Obscured by the overheated rhetoric, however, is a key issue: How much compensation should people damaged by these vaccines collect? Kennedy and the trial lawyers say they can support liability protections for drugmakers only if victims are promised full government indemnity. "We are not in any way trying to undermine the vaccine program," says Association of Trial Lawyers of America lobbyist Linda Lipsen. "In the event that individuals are injured [or] killed, there should be... compensation."

Full indemnity could be a trillion-dollar commitment, but that's completely impractical and unaffordable, Republicans say. During negotiations between Kennedy and Mike Enzi (R-Wyo.) on indemnity, Senate Majority Leader Bill Frist (R-Tenn.) summoned senators to his office to call off the talks. Indemnity will never fly, he said.

Vague Compensation
Instead, Industry and Frist are backing an effort led by Senators Richard Burr (R-N.C.) and Judd Gregg (R-N.H.). They would limit liability to vaccines designated as essential to fighting pandemic flu or other deadly new diseases and would direct the Secretary of Health & Human Services to create a compensation program, with details and funding to be determined later. "We just don't have enough information to set one up now," argues a GOP staffer.

The pharmaceutical industry, not surprisingly, is firmly behind the GOP. Trial lawyers, advocates for vaccine victims, and others counter that a vague plan for a future compensation program is tantamount to none at all. Somewhere in the middle are public health experts. They want Congress to spur vaccine production while assuring the public it will have a safety net.

When all the smoke clears, that's likely to happen. Supporters plan to attach the Burr liability provision to a spending bill that just enough Democrats -- especially those like Senator Hillary Rodham Clinton (D-N.Y.), who have already backed some form of liability protection -- will be loath to oppose. It won't be pretty, it won't be easy, and it won't be truly bipartisan. But "it's all going to work out, despite the big bad trial lawyers," says a pro-industry lobbyist.

By Richard S. Dunham and John Carey, with Lorraine Woellert and Eamon Javers


CAPITAL WRAPUP
Business Digs Deep For Pro-Trade Dems

Union leaders vowed to shut the fund-raising spigots for 15 House Democrats who broke ranks with their party in July to vote for the Central America Free Trade Agreement. But new Federal Election Commission reports indicate that business has more than compensated for labor's closed wallets.

A BusinessWeek analysis of political action committee receipts for the first nine months of 2005 finds that unions provided an average of 16.1% of the PAC money raised by CAFTA Dems -- down from 22.1% in the 2004 election. But business donations surged to 76.7% of the CAFTA 15's PAC money, from 66.3% that these pro-business Dems received in 2003-04. Corporate interests have already pumped more than $100,000 into the coffers of 10 of the 15 Democrats.

Business efforts included a September fund-raiser hosted by leaders of the Business Roundtable, the National Association of Manufacturers, and the Electronic Industries Alliance. Bernadette Budde, senior vice-president of Business Industry PAC, says executives also will hold local events to make sure that Democrats "do not suffer for the [pro-trade] positions they have taken." First up: helping friendly Democrats such as Representatives Henry Cuellar of Texas and Gregory Meeks of New York, who face primary races against labor-backed foes.


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Sunday, November 27, 2005

Pharma's Poisoned Generation

by Evelyn Pringle
OpEdNews.com


A growing number of professionals in the health care field are reporting that a relationship exists between the epidemic in neurodevelopmental disorders of autism, attention deficit hyperactive disorder, and speech or language delay all across the country, and the use of thimerosal, the mercury-based preservative used in childhood vaccines.

Vaccines are the only medicines that Americans are mandated to receive as a condition for attendance in school and day care, and for some types of employment. Parents who receive federal assistance are also required to show proof that their children have been vaccinated.

While the mandate for which vaccines must be included on the vaccine schedule is a state mandate, it is the Centers for Disease Control and Prevention (CDC) and its Advisory Committee that make the recommendations to which the majority of states adhere when determining mandates. The current epidemic actually began in the late 1980s when a large number of new vaccines were added to the schedule.

The blame is at least partially attributable to the failure of government officials to keep track of the cumulative amounts of mercury as they added triple-dose-vaccines to the schedule and the amount of thimerosal was multiplied by three.

Each new vaccine contained 25 micrograms of mercury and according to Professor Lynn Adams, of Radford University, who specializes in autism, by 1999, a study determined that the average child received 33 doses of 10 different vaccines by the age 5.

Elected lawmakers first became aware of the problem in 1999, when the House Committee on Government Reform initiated an investigation into the dangers of mercury exposure. An alarm rang early about the exposure of children to thimerosal.

By October 25, 2000, Committee Chairman, Dan Burton (R-IN), was trying to get the substance out of vaccines as quickly as possible and sent a letter to the Department of Health and Human Services, asking the director to get the FDA to recall all vaccines with thimerosal.

“We all know and accept that mercury is a neurotoxin, and yet the FDA has failed to recall the 50 vaccines that contain Thimerosal,” Burton wrote. “Every day that mercury-containing vaccines remain on the market is another day HHS is putting 8,000 children at risk,” he said.

“I implore you to conduct a full recall of these products,” he wrote. “If the only action ... is a gradual phase out, children will continue to be put at risk every day,” Burton warned. “These vaccines will continue to be injected in children for years to come - putting our nation's most vulnerable population ... at risk for mercury poisoning," he added.

The Reform Committee soon discovered that regulatory agencies were still allowing thimerosal to be used decades after the recognition that it was harmful. The Committee was told that the Food and Drug Administration, (FDA), uses a subjective barometer in determining when a product that has known risks can remain on the market. According to the agency:

"at the heart of all FDA’s product evaluation decisions is a judgment about whether a new product’s benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. The FDA will allow a product to present more of a risk when its potential benefit is great—especially for products used to treat serious, life-threatening conditions."

The argument that the known risks of infectious diseases outweighs any potential risk of neurological damage is one that has continuously been used by officials. The FDA claims that any risk from thimerosal is theoretical because no proof of harm exists.

However, after its review of scientific literature and listening to the testimony of witnesses, the Committee found plenty of evidence to support the fact that thimerosal posed a grave risk. "The possible risk for harm from either low dose chronic or one time high level (bolus dose) exposure to thimerosal is not "theoretical," but very real and documented in the medical literature," the Committee said.

The Committee also discovered that regulatory agencies have never required drug companies to conduct studies on the use of thimerosal. During a June 20, 2002, hearing, Burton questioned officials from the FDA and CDC and said, "You mean to tell me that since 1929, we've been using Thimerosal and the only test that you know of is from 1929, and every one of those people had mennigitis, and they all died?"

In his opening statement at a July 18, 2000, hearing, Burton said:

"We assume that the FDA would protect our children from exposure to any level of mercury through drugs. But that hasn’t been the case. Thimerosal was first marketed in 1930 and has become the most widely used preservative in vaccines. It is present in over 50 licensed vaccines."

"The FDA recently acknowledged that in the first six months of life, children get more mercury than is considered safe by the EPA," Burton noted. "The truth is that sometimes kids go to their doctor’s office and get four or five vaccines at the same time," he added.

"My grandson received vaccines for nine different diseases in one day," Burton said. "He may have been exposed to 62.5 micrograms of mercury in one day through his vaccines."

"According to his weight, the maximum safe level of mercury he should be exposed to in one day is 1.51 micrograms," Burton advised. "This is forty-one times the amount at which harm can be caused," he added.

In his opening remarks at a June 19, 2002, hearing, Burton described the devastation of witnessing the correlation between vaccines and autism.

"My only grandson became autistic right before my eyes – shortly after receiving his federally recommended and state-mandated vaccines. Without a full explanation of what was in the shots being given, my talkative, playful, outgoing, healthy, grandson Christian was subjected to very high levels of mercury through his vaccines. He also received the MMR vaccine. Within a few days he was showing signs of autism."

People often wonder why regulatory officials would protect drug makers. In large part, because the CDC and FDA policy decisions are made through advisory panels whose members have financial relationships with the same companies they are charged to regulate.

The decisions of the 300 experts who sit on the FDA's 18 advisory committees affect billions of dollars in sales. The panel members play a crucial role in determining what drugs will be approved and participate in just about every major decision related to industry regulation.

When it comes to vaccines, the large population in the USA transforms into a lucrative customer base when our government makes vaccines mandatory and keeps adding more and more to the list. Between 2003 and 2006, it was predicted that the annual global market for vaccines would rise from $6 billion to $10 billion, by Mark Benjamin for United Press International on July 21, 2003.

Investors follow the decisions made by the advisory panels closely. A favorable vote by a committee can add hundreds of millions of dollars to a company's stock value which also means the potential for corruption in the panels is enormous.

In a July 18, 2000 hearing, Burton mentioned the problem. "We have a lot of doctors who serve on Federal advisory committees who have serious conflicts-of-interest problems. They’re allowed to vote on vaccines made by companies that they get money from."

An analysis conducted by USA Today, of 159 FDA advisory committee meetings that took place between January 1, 1998, and June 30, 2000, revealed conflicts of interest were wide-spread:

At 92% of the meetings, at least one member had a financial conflict of interest.

At least one committee member had a financial stake in the topic under review at 146 of 159 advisory committee meetings.

At 55% of meetings, half or more of the FDA advisers had conflicts of interest.

At the 102 meetings dealing with the fate of a specific drug, 33% of the experts had a financial conflict.

Many parents are now refusing to vaccinate their children because they believe there is an on-going conspiracy by government officials and the pharmaceutical industry to boost profits by mandating unnecessary vaccines, while at the same time, denying their potential for harm. Congressman Burton addressed this issue in a June 19, 2002 hearing:

"Parents are increasingly concerned that the Department may be inherently conflicted in its multiple roles of promoting immunization, regulating manufacturers, looking for adverse events, managing the vaccine injury compensation program, and developing new vaccines. Families share my concern that vaccine manufacturers have too much influence as well."

Burton also noted the need to get honest about the current epidemic. "As representatives of the people, we have a responsibility to ensure that our public health officials are adequately and honestly addressing this epidemic and its possible links to vaccine injury," he said.

In May 2003, the Reform Committee, released a report that said the "FDA and the CDC failed in their duty to be vigilant as new vaccines containing thimerosal were approved and added to the immunization schedule."

As an example the report cited the Hepatitis B vaccine. "When the Hepatitis B and Haemophilus Influenzae Type b vaccines were added to the recommended schedule of childhood immunizations, the cumulative amount of ethylmercury to which children were exposed nearly tripled." The report identified thimerosal as the cause of the autism and chastised the FDA:

“Thimerosal used as a preservative in vaccines is directly related to the autism epidemic. This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding a lack of safety data regarding injected thimerosal and the sharper eyes of infant exposure to this known neurotoxin. The public health agencies failure to act is indicative of institutional malfeasance for self protection and misplaced protectionism of the pharmaceutical industry.”

Many people have not yet recognized the seriousness of the epidemic, largely because the majority of people have not seen many autistic children due to the fact that parents seldom take their affected children out in public because of the difficulty in trying to control them in a strange environment.

However, the rising numbers in special education classes in the nation's public school system provides a clear measurement of how wide-spread the epidemic has become. State by state statistics for students with autism from the Department of Education for the 12-year period between 1992-93 and 2003-04, are almost unbelievable. For instance, in Ohio in 1992-93, there were only 22 cases of autism, by 2003-04 there were 5,146. In Illinois, there were only 5 cases twelve years ago and 6,005 in 2003-04. Wisconsin had 18 cases of autism in 1992-93 and the numbers rose to 3,259 in 2003-04.

The true reality of these statistics will register in the not too distant future. "With eighty percent of autistic Americans under the age of 18, the dramatic impact of this crisis will be felt by taxpayers in the coming years when these autistic children become adults," says Anne McElroy Dachel, Media Relations Coordinator for the National Autism Association.

Most vaccines on the immunization schedule now are said to be thimerosal-free but some still do contain trace amounts. "An exception is the flu shot, which the Centers for Disease Control and Prevention recommends for pregnant women and for infants 6 to 23 months old,” advises Don Olmsted in United Press International on November 19, 2005.

For 6 to 23-month-old infants, the schedule calls for two flu shots that contain 12.5 micrograms of thimerosal each to be given a month apart. “That total of is the same amount that was in vaccines some parents believe triggered their child's autism," Olmsted advises. "And some of them believe in utero exposure to mercury via the pregnant mother might be the most dangerous exposure of all,” he said.

When deciding whether mercury-laced flu vaccines are safe for children, parents had better think long and hard before rolling the dice.

Evelyn Pringle
epringle05@yahoo.com

(Evelyn Pringle is a columnist for Independent Media TV and an investigative journalist focused on exposing corruption in government)


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Investigate This

by Rich Tucker
Townhall.com

Oh goody.

Patrick Fitzgerald, the special prosecutor who’s been investigating the supposed outing of a CIA operative, plans to present evidence to another federal grand jury. “The investigation is continuing,” Fitzgerald announced, just weeks after most assumed it -- almost two years old and counting -- had finally ended.

This will be the second grand jury called to investigate whether or not Joe Wilson’s wife Valerie Plame was outed. In the long run, though, few Americans will care about -- or even be aware of -- the outcome of Fitzgerald’s probe (assuming it eventually ends). But as long as we’ve got a grand jury impaneled, let’s have it ask some questions about something that actually affects countless American lives. Autism Spectrum Disorder (ASD).

There are more questions than answers about autism. But unfortunately, it’s no longer unusual. In her new book about manners, author Lynne Truss writes that we’re living in “an age of social autism, in which people just can’t see the value of imagining their impact on others.”

Imagine reading that sentence two decades ago. In 1985, an estimated 4 in 10,000 children were diagnosed autistic. Most people went through life without meeting an autistic person. Autism then was similar to schistosomiasis -- even if you had heard of it, you probably didn’t know what the symptoms were. Today the Centers for Disease Control says as many as 1 of every 166 children is on the autism spectrum. Autism today is something that afflicts a son, nephew or cousin.

Everyone knows what it means to be “autistic.”

Still, the government seems stumped. “There are no effective means to prevent the disorder, no fully effective treatment and no cure,” the National Institute of Mental Health admitted in its February 2005 annual report on autism to Congress. And on its Web page, the CDC lists three things it is “doing about ASDs.” Two are studies tracking the number of children with autism in the Atlanta area and in Brick County, New Jersey. The third is funding various state projects. “These state projects look at how common ASDs are in children. Some of the projects also study what factors make it more likely that a child will have an ASD,” the CDC says.

Well, that’s a start, but a slow one.

Let’s use the grand jury to dispell some of the fog and ask some difficult questions. For example, in his book “Evidence of Harm” author David Kirby writes that thimerosal, a preservative long used in many vaccines, “never underwent any of the rigorous safety trials now required for FDA approval.” Thimerosal is 50 percent mercury, and mercury is a known toxin.

A grand jury could subpoena records to find out if the government (which approved thimerosal) or drug companies (which included the preservative in their vaccines) ever ran any tests to determine if it really was safe to inject it into infants. And if there were no such tests, perhaps a grand jury could find out why not.

This isn’t simply an academic exercise. While it’s been removed from most childhood inoculations, thimerosal remains in one vaccine: The flu shot we’ve heard so much about.

The American Academy of Pediatrics says flu shots are critical. “Since young children are at such high risk of getting the flu, the AAP recommends the flu vaccine regardless of whether it contains thimerosal, a mercury-containing preservative,” the group says on its Web site. “To date, there is no scientific proof that mercury in vaccines caused autism despite years of study.” That’s true, but it’s also true that thimerosal has never been proven safe, either. Our grand jury could ask the AAP if medical standards have changed -- is it now all right to inject a substance that may be dangerous, as long as it hasn’t been proven dangerous?

The jurists might also want to hear from some experts who question the use of thimerosal. Michael Wagnitz is a senior chemist for the state of Wisconsin. He’s urging his state to stop giving thimerosal-containing flu shots. “Liquid waste needs to go to a hazardous site if it contains more than 200 ppb mercury. Is it really safe to inject people with a level of mercury 250 times higher than hazardous waste?” he asked in a recent letter republished by the UPI wire service’s “Age of Autism” column.

It’s said that Nero fiddled while Rome burned. Today our government spends time and money investigating whether or not a CIA officer’s name was leaked to a reporter. Meanwhile, tens of thousands of children have descended into autism, with no apparent hope of a cure.

Wouldn’t it be grand if a simple grand jury investigation could help change that?

Rich Tucker is an editor in Washington D.C. and a columnist for Townhall.com. You can email him here.


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Thursday, November 24, 2005

Mercury in vaccine poses a danger

Journal Standard.com
Opinions

Dr. Amy Johnson's comments in The Journal-Standard on the mercury-containing flu vaccine for children contain serious flaws.

Dr. Johnson may say that "there is no evidence of harm," but she's basing that on the CDC's easily flawed and manipulated population studies to "prove" mercury is safe when injected into babies. What about the government's own testing of thimerosal?

Introduced by Eli Lilly in 1930, thimerosal was tested only once, on 22 adult patients suffering from meningitis. There was no chance for follow-up to observe long-term effects, as all of the patients in this "study" died. Even if follow-up had been possible, damage to the developing brains of very young children would have remained an unknown. Thimerosal was pronounced "safe" and later grandfathered in when the FDA was created.

Starting in the late 1980s more and more vaccines with mercury were added to our children's list of required vaccines, without any regard for the total mercury exposure children were receiving. Finally in 1999, the federal health agencies and the American Academy of Pediatrics added up all the mercury children were receiving and realized it was over 100 times EPA limits for mercury exposure. They then urged vaccine makers to stop using it. In 2004, the AAP put out an "autism alarm" because of the epidemic increase in autism.

In 20 years, the rate has gone from one in 10,000 to one in every 166 children. Furthermore, one in every six schoolchildren now has a diagnosis of attention deficit or some other learning disability.

The medical community seems to focus on denying that this is in any way related to mercury in vaccines.

The first 11 cases of autism ever documented, in 1943, were in children who were among the first to be vaccinated with mercury. The federal government has never conducted specific tests on the neurotoxicity of thimerosal, although hundreds of published studies and documents attest to its extreme toxicity. Our CDC and FDA should be utterly embarrassed to make safety claims based on such a pathetic history of oversight.

Our federal health agencies are also the ones whose members have over 700 conflict-of-interest waivers for direct financial ties to the vaccine makers.

Evidence of Harm is the new book by David Kirby on the autism controversy. Mr. Kirby spent two years researching the history of thimerosal use and its relationship to thimerosal. He writes, "... many research) documents dating back to the 1930s, each raising a red flag about thimerosal." (EOH 207-209). Mr. Kirby chronologically lists over 70 years of scientific research on the damaging and deadly effects of thimerosal that was willfully ignored by Eli Lilly and the CDC. http://www.evidenceofharm.com/

We need to take a serious look at the generation of American children exposed to mercury. A person would need to weigh 275 pounds by the EPA's own standards to be able to eliminate the 12.5 mcg of mercury in the children's flu vaccine for this year.

This is hardly a "low dose" of mercury. By anyone's standards, it is unconscionable to inject a known neurotoxin into babies and toddlers.

Anne McElroy Dachel
Chippewa Falls, WI


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Pharma To Republicans - Time To Pay Up Again

By Evelyn Pringle
Scoop Independent News

The generation of children injured by vaccines containing the mercury-based preservative thimerosal is now reaching puberty. Many of these children will require life-long care and support. The cost to their parents by today's standards, will reportedly exceed $2 million dollars for each child.

An ever-growing number of health care professionals point to thimerosal as the culprit behind the explosion in cases of autism and other neurological disorders. The only common thread connecting these damaged children to one another is their exposure to mercury through childhood immunizations.

Accountability from vaccine makers is something that parents of injured children have been seeking for years; but accountability appears more illusive with each year's passage. On October 27 2005, the Hartford Courant reported that "Congress is considering a bill that would allow the government to order that vaccines be given to every U.S. citizen in a national emergency, even if a vaccine has previously harmed some people."

The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (S 1873), is being pushed through Congress without giving voters the chance to make their objections known to their elected officials.

Nicknamed "Bioshield Two," the bill's primary sponsor, Senator Richard Burr (R-NC), claims the Act will give the Department of Health and Human Services "additional authority and resources to partner with the private sector to rapidly develop drugs and vaccines."

Co-sponsored by Senators Bill Frist (R-TN), Mike Enzi (R-WY), and Judd Gregg (R-NH), the Act will in truth, eliminate current regulatory and legal safeguards applied to vaccines.

What kind of profits need protecting? A good example is GlaxoSmithKline, which predicts that some of its new vaccines will become blockbusters with projected sales of more than $1 billion a year, according to Reuters on June 30, 2005. Glaxo aims to launch five major vaccines by 2010, it said.
ADVERTISEMENT

Another example, for people who believe there’s no profit in vaccine making, “tell it to Wyeth, a big drug maker whose vaccine Prevnar ... costs more than $250 for the four-dose treatment given to infants,” says Kristine Severyn, PhD, author of the report, Profits, Not Science, Motivate Vaccine Mandates Vaccine Policy Institute.

Despite the price, "the government has recommended that all infants get the vaccine, and insurers generally pay for it - as does the federal Vaccines for Children program for low-income families. Prevnar, with sales expected to top $1 billion this year," says Severyn.

Severyn's predictions were right on. According to Wyeth's 2005 first quarter earnings report, Prevnar achieved net revenue of $391 million, more than double the first quarter earnings in 2004.

Bush’s FY2006 budget proposes to improve access to vaccines by allowing underinsured children to receive Vaccines for Children at state and local health clinics. The Department of Health and Human Services estimates that cost of the proposal will be $140 million in 2006, and $700 million over the 2006-2010 period.

How much does this sort of government protection cost? For starters, according to the Center for Public Integrity, the Pharmaceutical Researchers and Manufacturers of America (PhRMA), is the industry's trade organization and it has topped the list of pharmaceutical lobbying spending since 1998, shelling out $74 million. Its members include 16 of the industry's 20 largest companies and their subsidiaries and its current president is Billy Tauzin, is a former Republican congressman from Louisiana.

In the 2002 election cycle, PhRMA gave $3,505,052 with 95% going to Republicans. The top recipient in the Senate was none other than Senator Richard Burr, who received $288,684, according to the non-partisan Center for Responsive Politics. So far in the 2006 cycle, Gregg has received over $106,000 and Enzi has taken in $21,000 in pharma money.

Frist is a real piece of work. He has been trying to get a law passed to protect the drug companies for years. In 2002, he was behind the dead of night insertion of a provision into the Homeland Security bill that would have immunized vaccine makers from lawsuits related to thimerosal.

Frist has made millions upon millions profiting off human misery. The basis of the family fortune is the Hospital Corporation of America, the largest for-profit hospital conglomerate in the nation. However, the corporation also paid the largest health care settlement in history of more than $1.7 billion in civil and criminal penalties to settle charges of massive Medicare and Medicaid billing fraud.

Until recently, Frist and his wife owned $26 million worth of HCA stock. They are currently being investigated on charges of insider trading in the sale of HCA stock in the weeks immediately before the stock's value plummeted, and conflict of interest charges involving his ownership of HCA stock which he had previously claimed he knew nothing about because in accordance with ethics rules, it was in a "blind trust."

According to the Center for Justice and Democracy, Frist has received more than $2.3 million from doctors, health insurers, drug companies and others in the health care industry, raising more cash from health-care interests than 98% of his colleagues. In return, his legislative work in the Senate consists of almost nothing but trying to push through laws to increase profits for his number one backer.

Its worth noting that while Frist was its chairman, the pharmaceutical industry was also the largest single contributor to the National Republican Senatorial Campaign Committee, doling out about $4 million, with Eli Lilly, the company that invented thimerosal, being the single biggest contributor, giving $1.6 million.

The National Vaccine Information Center (NVIC), a watchdog advocacy group, is highly critical of the pending protection legislation. According to the group's President, Barbara Loe Fisher, "It is a big lie that drug companies have been driven out of business by lawsuits in the past two decades.” The NVIC calls the Act "a drug company stockholder's dream and a consumer's worst nightmare."

According to NVIC, currently there are at least ten different bills pending in Congress that will contain provisions to shield drug companies from lawsuits including S3, S975, S1437, S1828, S1873, S1880, HR650, HR3154, HR3970, and HR4245.

"This proposed legislation," Fisher told UPI, "is an unconstitutional attempt by some in Congress to give a taxpayer-funded handout to pharmaceutical companies for drugs and vaccines the government can force all citizens to use while absolving everyone connected from any responsibility for injuries and deaths which occur."

The bill establishes the Biomedical Advanced Research and Development Agency (BARDA), as the single authority for the advanced research and development of drugs and vaccines and grants the Secretary of the Department of Health and Human Services, the sole authority to determine whether a drug maker violated drug safety laws. In addition, the Act specifically bars citizens from challenging the Secretary's rulings in court.

BARDA will be exempt from the Freedom of Information Act and the Federal Advisory Committee Act, to ensure that no evidence related to injuries caused by vaccines classified as "countermeasures" will become public.

"It means that, if an American is injured by an experimental flu or anthrax vaccine he or she is mandated to take," Fisher told UPI, "that citizen will be banned from exercising the Constitutional right to a jury trial even if it is revealed that the vaccine maker engaged in criminal fraud and negligence in the manufacture of the vaccine."

In a November 15, 2005, letter to Senator Burr's staff director, Fisher describes S 1873 as "arguably unconstitutional" because it (1) lacks transparency into the research, development, licensure and post-licensure surveillance of vaccines and drugs used in public health emergencies; (2) lacks accountability for either manufacturers of these products or government health officials who mandate their use without informed consent; and (3) lacks justice for those who will inevitably die or suffer chronic illnesses after being compelled to take these products.

“It is exactly this type of legislation that leads to civil disobedience and many times in the extreme form,” Dr Boyd Haley, a well-known expert on heavy metal toxicity, told this author, “I am very fearful of how certain segments of our society will respond to any mass vaccination program---especially if it does cause a problem like the thimerosal/autism situation,” he said.

As it stands today, if the Bush administration and its puppets in Congress achieve their common goal of protecting pharma profits by shielding vaccine makers from lawsuits, tax payers will have to foot the bill for the life-long costs of caring for millions of injured children.

Tax payers are already funding their special education needs. In a January 14, 2005, letter to a Congressional Subcommittee on Human Rights, the Government Accountability Office (GAO), informed committee members that the number of children diagnosed with autism served under the IDEA has increased by more than 500% in the last decade and that "about 1.5 million Americans are currently living with some form of autism."

In a recent interview with Teri Small published in the journal, Medical Veritas 2 (2005), Dr Geier said that he believes that this may be the greatest iatrogenic epidemic in history. "The damage already done to our society is already in the trillions of dollars," he warns. "The damage of the 9/11 terrorist attacks, and that of the AIDS epidemic pale when compared to the current epidemic of autism," he told Veritas.

"All of us alive," Dr Geier says, "will have to bear its effects both in the lifetime care of the damaged children and the loss of what they otherwise might have contributed to our society."

*************

Evelyn Pringle
epringle05@yahoo.com

(Evelyn Pringle is a columnist for Independent Media TV and an investigative columnist focused on exposing corruption in government."


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Tuesday, November 22, 2005

Protective mind coating

UCLA researchers learn how a nerve-tissue wrap in the brain, myelin, impacts behavior

BY JAMIE TALAN
Newsday

Abnormal development of the protective insulation that wraps around the wiring of the brain's nerve cells could result in a range of behavioral problems - including autism, attention deficit disorder, drug abuse and schizophrenia, according to a new study.

Dr. George Bartzokis and his colleagues at the University of California in Los Angeles have studied brain scans in living humans and autopsied brains to unravel the role of myelin, the insulation material. The thicker and heavier the wrapping, the faster and more effective nerve cells can communicate.

Bartzokis is the scientist who first discovered that myelin production continues to grow throughout the first four decades, then peaks at 45 and goes down from there. "We are truly adults at our 50th birthday," he said.

In his latest study, published in Adolescent Psychiatry, Bartzokis and his colleagues map out a picture of the younger brain undergoing myelination and what can happen if those connections don't develop normally.

He believes that humans myelinate different circuits at varying points throughout life, which could explain why the brain diseases of young people are so different from those of older ones.

For instance, if myelin is disrupted early in life, basic circuits that govern language and social communication might not develop normally, hence autism.

If the problems develop in school-age children, the inability to process information fast and effectively could pave the way for attention deficits. Even later in adolescence, problems with myelin can impair a person's ability to think clearly, a common feature of schizophrenia.

So what's a brain to do?

Myelin is a fatty acid, and Bartzokis said that there may already be medicines, certain foods and fish oil supplements high in fatty acids that promote myelination. He likens it to a high-speed Internet connection. Without proper myelination, the brain "can't get online," he said.

Only vertebrates have myelin, and humans have the most - about 20 percent more than chimps. It increases the speed of transmission of information, expands the brain's bandwidth and allows the brain to go online.

The California scientist said that this finding could explain why it is virtually impossible to see any obvious brain damage in many of these developmental disorders.

"There's no dead anything on autopsy," Bartzokis said. "Those brain connections just never developed normally."

If people are working offline because of myelination problems, Bartzokis said, "it's not that they are bad or dumb. It's that they are not able to bring all of their knowledge to bear."

That's why a teenager's knowledge about the dangers of driving while drunk might not help when he or she is in a high-risk situation.

Barzokis' brain scans of healthy people from 19 to 76 show a myelination growth curve. In middle age, when myelin is on the decline, a number of new brain diseases emerge.

Genes, environmental toxins and even diet appear to influence the myelination process, Bartzokis said.

Good news for the female brain: His studies show that female brains are making better myelin, which could explain why young boys are at greater risk for problems.


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Saturday, November 19, 2005

The Age of Autism: Flu shot flashpoint

By DAN OLMSTED
UPI Senior Editor

It's flu shot season, and that simple fact is sharply focusing the debate over a possible link between vaccines and autism. The reason: Most flu shots contain thimerosal, the mercury-based preservative that some suspect caused a huge rise in autism cases beginning in the 1990s.

Federal health authorities say science has ruled that out. But to be on the safe side, the U.S. Public Health Service -- along with groups representing pediatricians and family doctors -- urged manufacturers in 1999 to phase thimerosal out of childhood vaccines as soon as possible.

Most such vaccines are now thimerosal-free or contain trace amounts. An exception is the flu shot, which the Centers for Disease Control and Prevention recommends for pregnant women and for infants 6 to 23 months old.

The counter-argument: Why take a risk when thimerosal-free shots are also available and cost just three or four dollars more? The CDC has declined to express a preference for those shots on the theory that there wouldn't be enough to meet demand.

On Monday, as this column reported, a New Mexico pediatrician appeared before the state Board of Pharmacy to urge it to immediately warn residents that most flu shots do have mercury. He also wants the state ultimately to ban it from vaccines for kids and pregnant women, something six states have already done -- with bans taking effect in future years. A dozen states are actively debating the issue.

The pediatrician, Dr. Ken Stoller, said the board decided to seek an advisory opinion from the New Mexico attorney general about its jurisdiction in the matter. It meets again in two months.

"The recent meeting was, I have to confess, a little disappointing from the standpoint of truth-in-labeling as set out in the New Mexico Drug Act," Stoller wrote the board in a follow-up letter.

"I presented clear, accurate and precise information on how a preservative that contains the known neurotoxin, ethylmercury, exists in the flu and other vaccines at a level that exceeds several safety limits as set forth by more than one Federal agency."

Perhaps because of the growing number of state bans -- which mean, self-evidently, that they don't want their children and pregnant women exposed to mercury in flu shots -- the issue is percolating this year in a way that it simply hasn't before.

In a Chicago Tribune piece titled, "A contradiction taints flu shots among infants," writer Julie Deardorff said that as a mom, she was concerned that health experts are now recommending a shot that in most cases contains an ingredient they suggested removing six years ago.

"It was eliminated from nearly all vaccines with one exception: the flu vaccine. Now the academy (American Academy of Pediatrics) wants us to immunize infants with a vaccine that contains an ingredient that it suggests should be removed," Deardorff wrote.

She quotes an Illinois AAP spokesman about the apparent contradiction:

"The amount (of thimerosal) in the multidose influenza vaccine (12.5 micrograms) is well below even the most conservative standards for mercury exposure. ... There's no evidence that thimerosal in vaccines is dangerous, and the benefits kids get from being protected against the flu are substantial."

Still, it needs to be noted that the immunization schedule calls for two 12.5 microgram shots a month apart for the 6-to-23-month olds. That total of is the same amount that was in vaccines some parents believe triggered their child's autism. And some of them believe in utero exposure to mercury via the pregnant mother might be the most dangerous exposure of all.

Directly to the north, a senior chemist at the University of Wisconsin has been trying to get the attention of the Wisconsin Department of Agriculture, Trade and Consumer Protection.

"Unfortunately, in the 35 days that have passed since my original letter, thousands of Wisconsin's most vulnerable citizens have been exposed

to this material (mercury in flu shots)," Michael Wagnitz wrote the department in a letter this week.

"As I explained in my original letter, liquid waste needs to go to a hazardous site if it contains more than 200 ppb mercury. Is it really

safe to inject people with a level of mercury 250 times higher than hazardous waste?

"What exactly is the (department) working on that is more important than stopping the injection of mercury directly into the bloodstreams of its

citizens? Could you give me some examples? Again, I ask that you issue an immediate mercury warning for pregnant women and infants who plan on getting the flu shot."

This looks to be an issue that won't go away.

--

E-mail: dolmsted@upi.com

© Copyright 2005 United Press International


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Thursday, November 17, 2005

EMERGENCY ALERT, DAY 2!

POWER OF PARENTS CALL-IN CAMPAIGN

WITH YOUR HELP, WE JAMMED PHONE LINES ON CAPITOL HILL YESTERDAY TO PROTECT VACCINE-INJURED CHILDREN’S RIGHTS—WE MUST KEEP UP THE PRESSURE!!!




HERE’S WHAT WE NEED TO DO:
THE POWER OF PARENTS CALL-IN CAMPAIGN, DAY 2




Time is of the essence and it ties up their phone lines.

The results are immediate.

If you have time for faxing, below is a sample letter you can change to fit your situation, or just write your own brief note.

We need everyone possible to get involved—in-laws, neighbors, friends, and anyone else you can think of. Send this action alert to everyone in your address book. This is their best chance. WE MUST STOP THEM!

A-CHAMP will send out updates on the situation on Capitol Hill as they receive them.

________________________


Dear Senator (or Representative) _________:

Re: SAY NO TO UNFAIR AND UNNECESSARY LIABILITY PROTECTION FOR VACCINE MANUFACTURERS

I respectfully request that you act to protect the rights of vaccine injured children by blocking the unfair liability immunity giveaway proposed for pharmaceutical companies.

There are ten bills that we know about that contain language that unnecessarily limits the rights of children injured by vaccines. These include S3, S975, S1437, S1828, S1873, S1880, HR650, HR3154, HR3970, and HR4245. I am shocked to learn that similar provisions are being slipped into proposed legislation, including Appropriations bills, in a manner similar to the provisions snuck in the dead of night into the Homeland Security bill in 2002. If any of these provisions is enacted, a vaccine-injured child's right to have his or her day in court will be unnecessarily and unfairly taken away. Enactment of this legislation will be a dark day for the tradition of fair play and equity in the American justice system.

As a voter and one who cares deeply about children injured by vaccines, I oppose legislation that provides unprecedented immunity to a vaccine industry that has caused tragic injury to some children. Such liability protection is unnecessary.

Current laws adequately protect vaccine manufacturers. There have been very few vaccine injury claims against vaccine makers over the past 30 years. The true reason for the apparent lack of vaccine manufacturing capacity is the pattern of merger and consolidation in the pharmaceutical industry and market factors unrelated to liability concerns that make vaccines economically difficult to produce. National health authorities such as Dr. Anthony Fauci and Dr. Walter Orenstein have said that the liability concerns are not causing the problems. The Government Accountability Office ("GAO") and other respected authorities said the same.

I urge you to place the interests of injured children above those of the pharmaceutical industry. Along with hundreds of thousands of voters across the country, I am deeply concerned that vaccine manufacturers will cease to have an incentive to make their products safe, should unnecessary liability protection be enacted.

I know that families of vaccine injured children and their friends are watching the actions of legislators very closely. As a legislator you must choose whose interests you protect: the interests of injured children, or the financial interests of the drug industry.

Please do all in your power to see that none of the provisions that take away children's rights are enacted.

Sincerely,


________________________


CALL ALL of these Senators (and three House Members) ASAP!!! Our sources in Washington tell us that Senators Frist, Santorum, and Graham, and Congressmen Hastert and Barton are especially important for us to focus on right now.

Senator Bill Frist (TN) Phone: (202) 224-3344 Fax: (202) 228-1264

Senator Rick Santorum (PA) Phone: (202) 224-6324 Fax: (202) 228-0604202-224-3344

Senator Thad Cochran (MS) (Chairman) Phone: (202) 224-5054 Fax: (202) 224-9450

Senator Ted Stevens (AK) Phone: (202) 224-3004 Fax:(202) 224-2354

Senator Arlen Specter (PA) Phone: 202-224-4254 Fax: 202-228-1229

Senator Pete Domenici (NM) Phone: (202) 224-6621 Fax: (202) 228-3261

Senator Christopher Bond (MO) Phone: (202) 224-5721 Fax: (202) 224-8149

Senator Mitch McConnell (KY) Phone: (202) 224-2541 Fax: (202) 224-2499

Senator Richard Shelby (AL) Phone: (202) 224-5744 Fax: (202) 224-3416

Senator Judd Gregg (NH) Phone: (202) 224 – 3324 Fax: (202) 224 - 4952

Senator Kay Bailey Hutchison (TX) Phone: 202-224-5922 Fax: 202-224-0776

Senator Conrad Burns (MT) Phone: 202-224-2644 Fax: 202-224-8594

Sen. Daniel Inouye (Ranking Member) (HI) Phone: 202-224-3934 Fax: 202-224-6747

Senator Robert C. Byrd (WV) Phone: 202-224-3954 Fax: 202-228-0002

Senator Patrick Leahy (VT) Phone: 202-224-4242 Fax: 202-224-3479

Senator Tom Harkin (IA) Phone: (202) 224-3254 Fax: (202) 224-9369

Senator Byron Dorgan (ND) Phone: 202-224-2551 Fax: 202-224-1193

Senator Richard Durbin (IL) Phone: (202) 224-2152 Fax: (202) 228-0400

Senator Harry Reid (NV) Phone: 202-224-3542 Fax: 202-224-7327

Senator Dianne Feinstein (CA) Phone: (202) 224-3841 Fax: (202) 228-3954

Senator Barbara Milkulski (MD) Phone: 202-224-4654 Fax: 202-224-8858

Sen. Edward Kennedy (MA) Phone: 202-224-4543 Fax: 202-224-2417

Sen. Olympia Snowe (ME) DC Phone: 202-224-5344 Fax: 202-224-1946

Sen. Susan Collins (ME) Phone: 202-224-2523 Fax: 202-224-2693

Sen. Debbie Stabenow (MI) Phone: 202-224-4822 Fax: 202-228-0325

Sen. Lincoln Chaffee (RI) Phone: 202-224-2921 Fax: 202-228-2853

Sen. John McCain (AZ) Phone: 202-224-2235 Fax: 202-228-2862

Sen. Lindsay Graham DC Phone: 202-224-5972 Fax: 202-224-3808

Congressman Dennis Hastert (IL) Phone: 202-225-2976 Fax: 202-225-0697

Congressman Joe Barton (TX) Phone: (202) 225-2002 Fax: (202) 225-3052

Congressman Jerry Lewis (Chair, House Appropriations) Phone: 202-225-3801 Fax: 202-225-0351

Think Autism. Think Cure.


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Some responses to Paul Offit

LETTERS TO THE EDITOR
The HILL

In response to an article by Paul Offit.

Mercury-autism link can’t be dismissed so easily
From Anne McElroy Dachel, media-relations coordinator, National Autism Association:
Dr. Paul Offit promotes the success of vaccines in eradicating diseases and lightly dismisses the growing controversy linking the mercury-based neurotoxin thimerosal to the epidemic of autism in the United States (“Vaccine history shows need to update VICP law,” Nov. 15). Nowhere, however, does Dr. Offit note the explosion in the rate of autism that directly coincides with the increase in mercury-containing vaccines in the childhood schedule.

In the past 20 years, autism has increased from 1 in 10,000 to 1 in every 166 children. Furthermore, one in every six schoolchildren now has a diagnosis of attention-deficit or some other learning problem. The best our federal health agencies can tell us is that it’s all due to “better diagnosing.”

Dr. Offit may think that science disproves any link between mercury use and neurological disorders, but our Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) can only point to easily flawed and manipulated population studies to “prove” mercury is safe when injected into babies. What about the government’s own testing of thimerosal?

Introduced by Eli Lilly in 1930, thimerosal was tested only once, on 22 adult patients suffering from meningitis. There was no chance for follow-up to observe long-term effects, as all of the patients in this “study” died. Even if follow-up had been possible, damage to the developing brains of very young children would have remained an unknown. Thimerosal was pronounced “safe” and later grandfathered in when the FDA was created.

The first 11 cases of autism ever documented, in 1943, were in children who were among the first to be vaccinated with mercury. The federal government has never conducted specific test on the neurotoxicity of thimerosal, although hundreds of published studies and documents attest to its extreme toxicity. Our CDC and FDA should be utterly embarrassed to make safety claims based on such a pathetic history of oversight. Our federal health agencies are also the ones whose members have over 700 conflict-of-interest waivers for direct financial ties to the vaccine makers.

The Hill article describes Dr. Offit as “the chief of infectious diseases at the Children’s Hospital of Philadelphia,” but it should be noted that he is also someone who’s been on the vaccine approval board of the CDC and is himself is a vaccine patent holder. In addition he is paid by Merck Pharmaceutical Corp. to promote vaccines. His conflicts should be noted in any article where he is cited as an expert.

Chippewa Falls, Wis.

Children need answers
From Liz Birt:
As a parent of a child who has documented measles vaccine in his gastrointestinal tract and his cerebral spinal fluid, as well as immune-system and metabolic disorders, I find Dr. Paul Offit’s recent article disturbing.

It is very difficult, as the parent of a child who has been injured from vaccines, to get a decent remedy from our system. To do away with the current “opt out” system would protect the vaccine manufacturers from liability associated with known problems from their products.

We must have a counterbalance in our system; if not, then those that are in power and have the most influence in Congress will be protected in spite of those who are suffering.

We are suffering today in this country with an epidemic of children with neurological disorders. This is not the luck of the cards. This increase is directly related to the increasing dose of mercury that was injected to our children.

The only study conducted to this date by the Centers for Disease Control not only serious has flaws but the raw data have been hidden from independent researchers who have no vested financial interest in the outcome.

Many, many children are suffering needlessly and deserve answers as to why suddenly they failed to progress, regressed and are so ill. This is inhumane.

Our country, our culture must do better; if not, then we are no better than animals. I am sorry, but this is the truth. Perhaps your editorial board can’t deal with it. Who knows? By now everyone has a child with autism.

Oakwood, Ill.


Listen to this article Listen to this article | Posted by Becca




Wednesday, November 16, 2005

Frist Inoculates Drug Makers for Any Vaccine Liability

Frist Inoculates Drug Makers for Any Vaccine Liability After Industry Won Him Senate & He Himself Said Anthrax Was Problematic

To: National Desk

Contact: Jamie Court, 310-874-9989; Carmen Balber, 310-392-0522 ext 324

SANTA MONICA, Calif., Nov. 16 /U.S. Newswire/ -- Senate Majority Leader Bill Frist is seeking a last-minute amendment to an appropriations bill that would remove legal liability from a drug company if the Bush Administration declares its vaccines are needed to respond to a public health threat. The Associated Press reports Frist is behind the eleventh-hour change.

The pharmaceutical industry that makes the vaccines was the largest industry donor to Frist's National Republican Senatorial Committee, the political arm of Senate Republicans that was key to winning a GOP majority in the Senate. The Foundation for Taxpayer and Consumer Rights (FTCR) called on Frist to withdraw the amendment based on his own conflict of interest - the industry he is helping is his biggest donor and he has himself condemned the safety of the anthrax vaccine.

"How can we trust an administration that does not know what a weapon of mass destruction is to take away our legal rights when it sees a so-called public health threat?" said Jamie Court of the Foundation for Taxpayer and Consumer Rights. "This is a total giveaway to the GOP's biggest donor using national security as cover. It's a terror dividend for Big Pharma, which handed Senator Frist and the GOP the third branch of government."

Under the legislation the Frist amendment is based on, the Bush Administration could declare a real or potential public health emergency, classify any vaccine or product as necessary to respond to a public health threat and provide its manufacturer almost virtual immunity from prosecution. The immunity provisions are so broad that any product that can be considered a "countermeasure," not just vaccines, would be included under its protection.

Frist himself has acknowledged problems with the anthrax vaccine: "The (anthrax) vaccine is a dated vaccine, it's an old vaccine. There are very real and potentially serious side effects from the vaccine and anyone who elects to receive the vaccine needs to be made aware of that."

"I do not recommend widespread inoculation for people with the vaccine in the Hart Building," Frist said. "There are too many side effects and if there is limited chance of exposure the side effects would far outweigh any potential advantage." (CNN.com, 12/20/01, http://archives.cnn.com/2001/US/12/18/anthrax/ )

After a secret attempt to provide liability protection for the makers of Thimerosal in 2002 under the cover of an amendment to Homeland Security legislation, Congressional leaders are again promoting sweeping protections for the drug industry while no one is looking. Frist denied involvement in the Thimerosol amendment in 2002 but the backlash forced the Senate to remove the immunity provision. The 2002 amendment was based on parallel legislation Frist carried.

Frist's blind trust listed personal investments with Abbot Labs and Johnson & Johnson, each in the $15,000 to $50,000 range, through 2004. Frist himself had a close relationship with Eli Lilly, maker of Thimerosal, which not only topped the list of drug maker contributors to the Senator's PAC but also bought 5,000 copies of Frist's book on bio-terrorrism.

FTCR filed an ethics complaint with the Senate Select Ethics Committee last April charging Senate Majority Leader Frist (R-TN) with a conflict of interest for promoting medical malpractice liability limits while retaining stock worth millions in HCA. The Frist family-founded hospital chain owns HCI, the nation's fourth largest malpractice insurer. The committee dismissed the complaint, ruling that Frist's millions did not constitute a conflict. The Senator sold the stock this summer just before the stock price plummeted and is under investigation by the SEC for possible insider trading.

For more on FTCR's complaints about Senator Frist's ethics, visit http://www.consumerwatchdog.org/corporate/Frist/

http://www.usnewswire.com/
© 2005 U.S. Newswire 202-347-2770/

See also:
"Forced To Withdraw Drug Company Immunity From 2002 Homeland Security Bill After Outcry...."
Agency Would Be Exempt from FOIA
Open Secrets - PoliticiansProtection for vaccine makers debated
Frist Secretly Pimps For Drugmakers Again!!


Listen to this article Listen to this article | Posted by Becca




Lawmakers weigh preventing drugmaker suits

By KEVIN FREKING
Associated Press Writer

Last Updated: November 16, 2005, 12:33:42 PM PST

WASHINGTON (AP) - People injured by a vaccine against bird flu or anthrax would have to prove willful misconduct to bring a claim for damages against drug manufacturers or distributors, according to legislation being drafted behind the scenes by Republicans.

A 10-page draft of the legislation obtained by The Associated Press says it would be up to the Health and Human Services secretary to declare that such misconduct occurred. If that declaration is made, the case must be heard in federal court.

The measure, which would be included in a spending bill, would bar any punitive damages and limit awards for physical and emotional pain and suffering and other noneconomic damages to a maximum of $250,000.

The draft legislation was provided to the AP separately by two parties opposed to its provisions, who did not want to be identified.

An aide to Sen. Bill Frist, R-Tenn., confirmed the majority leader was looking to add the liability protections to a spending bill.

Amy Call said the legislation is important because "it would be a pity to appropriate $7.1 billion to purchase vaccines and antivirals but have no capacity to produce them."

She said Frist is seeking clearly defined standards for an industry that is already heavily regulated.

"We would only provide liability protection in a serious situation and for a set period of time and for a specific purpose," Call said. "The protection would only go into effect if the secretary makes a declaration that we are grave danger and the public is advised to take the product."

President Bush's plan for dealing with a flu pandemic called on Congress to give drug manufacturers sweeping immunity against lawsuits. "In the past three decades, the number of vaccine manufacturers in America has plummeted, as the industry has been flooded with lawsuits," Bush said last month. "Today, there is only one manufacturer in the United States that can produce influenza vaccine."

Lawmakers from both political parties also have cited a need to grant the industry some protections. However, the protections described in the draft are quite broad, and some say they would make it extremely difficult for those harmed by a medicine to get any financial compensation.

"The Republican leadership in Congress is trying to do another special favor for the drug companies by slipping a provision into a massive spending bill to absolve the pharmaceutical industry of any responsibility to patients injured by dangerous drugs or vaccines, with no compensation for those who are harmed," Sen. Edward M. Kennedy, D-Mass., said in a statement.

He called for an open debate on the issue.

Sen. Mike Enzi, R-Wyo., chairman of the Senate's health committee, favors liability protections for drug manufacturers, but not as part of an appropriations bill, according to spokesman Craig Orfield.

"He does not want to address biodefense in a piecemeal fashion," Orfield said.

Trial lawyers said they oppose having to prove "willful misconduct" to get financial compensation from an injury.

"Basically, as an average person, I would have to prove some scientist at Merck or some CEO somewhere had made a determination to hurt me," said Chris Mather, a spokeswoman for the Association of Trial Lawyers for America.

Willful misconduct, according to the draft legislation, would occur if manufacturers or distributors of a particular product knew that it presented "a significant or unreasonable risk to human health" and there was a "conscious failure to act" to avoid that risk.

If the HHS secretary rules against the petition, then those claiming to be harmed could seek judicial review from the U.S. Court of Appeals.

Rep. Dave Weldon, R-Fla., a doctor who said he is involved peripherally in the talks, said he doesn't want protections so broad that people might be unwilling to take medicine in the event of a flu pandemic.

"The way it's being discussed is lacking," Weldon said.

Meanwhile, House GOP leaders have delayed until December any action on President Bush's $7.1 billion request to prepare for a potential bird flu pandemic. The development came as negotiators on a huge spending bill covering health care and education programs met Monday night.

The House rejected an almost $8 billion Senate plan to fight the flu, saying it will revisit the issue next month as it also turns to Bush's request to direct emergency funds already enacted for victims of Hurricane Katrina to new purposes such as rebuilding highways, levees and federal facilities damaged by the storm.

--

Associated Press writer Andrew Taylor contributed to this report.


Listen to this article Listen to this article | Posted by Becca




CHEAP TRICK! LEGISLATORS ARE TRYING TO SNEAK IN UNFAIR LIABILITY PROTECTION – AGAIN!

STOP THE NEW "ELI LILLY RIDER" LEGISLATIVE GAMBIT Take Action!

STOP THE LATEST CHEAP LEGISLATIVE TRICK THAT AIMS TO GIVE LARGE CORPORATIONS UNFAIR AND UNNECESSARY LIABILITY PROTECTION

CALL, FAX, and SEND AN EMAIL THROUGH A-CHAMP'S AUTOMATED SYSTEM.

FAX & TELEPHONE Numbers of key legislators are Listed Below. Call and send faxes to them and send emails to your Senators and Congressman through A-CHAMP's system.

THIS TIME YOU NEED TO DO ALL THREE TO SEND A STRONG MESSAGE!

POWER OF PARENTS CALL-IN CAMPAIGN

WITH YOUR HELP, WE CAN SWARM WASHINGTON WITH PHONES CALLS TO PROTECT VACCINE-INJURED CHILDREN’S RIGHTS!!!



HERE’S WHAT WE NEED DO:


Time is of the essence and it ties up their phone lines.

The results are immediate.

If you have time for faxing, below is a sample letter you can change to fit your situation, or just write your own brief note. In addition, use our automated email system to send messages to your representatives and other key Senators.

We need everyone possible to get involved—in-laws, neighbors, friends, and anyone else you can think of. Send this action alert to everyone in your address book. This is their best chance. WE MUST STOP THEM!

We will send out updates on the situation on Capitol Hill as we receive them.
____________________________________


Dear _________:

I respectfully request that you act to help protect the rights of vaccine-injured children by blocking the unfair liability immunity giveaway proposed for pharmaceutical companies.

There are ten or more bills that contain language that severely limits the rights of children injured by vaccines. I am shocked to learn that similar provisions are being slipped into proposed legislation-including Appropriations bills- in a manner similar to the provisions snuck in the dead of night into the Homeland Security bill in 2002. If any of these provisions is enacted, a vaccine injured child's right to have his or her day in court will be unnecessarily and unfairly taken away. If it occurs this will be a dark day for the tradition of fair play and equity in the American justice system.

As a voter and one who cares deeply about children injured by vaccines, I oppose legislation that will provide unprecedented immunity to a vaccine industry that has caused tragic injury to some children. Such liability protection is unnecessary. There have been very few vaccine claims over the past 30 years--current laws adequately protect vaccine manufacturers. There are other reasons for the apparent lack of vaccine manufacturing capacity, such as merger and consolidatin in the pharmaceutical industry and market factors that make vaccines economically difficult to produce. Liability concerns have little to do with vaccine manufacturing problems--Dr. Anthony Fauci and Dr. Walter Orenstein have said so. Liability is not the problem.

I urge you to place the interests of injured children above those of the pharmaceutical industry. Along with hundreds of thousands of voters across the country, I am deeply concerned that vaccine manufacturers will cease to have an incentive to make their products safe, should unnecessary liability protection be enacted.

Sincerely,


____________________________________


CALL ALL of these Senators (and one House Member) ASAP!!!
Senator Thad Cochran (MS) (Chairman) Phone: (202) 224-5054 Fax: (202) 224-9450

Senator Ted Stevens (AK) Phone: (202) 224-3004 Fax:(202) 224-2354

Senator Arlen Specter (PA) Phone: 202-224-4254 Fax: 202-228-1229

Senator Pete Domenici (NM) Phone: (202) 224-6621 Fax: (202) 228-3261

Senator Christopher Bond (MO) Phone: (202) 224-5721 Fax: (202) 224-8149

Senator Mitch McConnell (KY) Phone: (202) 224-2541 Fax: (202) 224-2499

Senator Richard Shelby (AL) Phone: (202) 224-5744 Fax: (202) 224-3416

Senator Judd Gregg (NH) Phone: (202) 224 – 3324 Fax: (202) 224 - 4952

Senator Kay Bailey Hutchison (TX) Phone: 202-224-5922 Fax: 202-224-0776

Senator Conrad Burns (MT) Phone: 202-224-2644 Fax: 202-224-8594

Sen. Daniel Inouye (Ranking Member) (HI) Phone: 202-224-3934 Fax: 202-224-6747

Senator Robert C. Byrd (WV) Phone: 202-224-3954 Fax: 202-228-0002

Senator Patrick Leahy (VT) Phone: 202-224-4242 Fax: 202-224-3479

Senator Tom Harkin (IA) Phone: (202) 224-3254 Fax: (202) 224-9369

Senator Byron Dorgan (ND) Phone: 202-224-2551 Fax: 202-224-1193

Senator Richard Durbin (IL) Phone: (202) 224-2152 Fax: (202) 228-0400

Senator Harry Reid (NV) Phone: 202-224-3542 Fax: 202-224-7327

Senator Dianne Feinstein (CA) Phone: (202) 224-3841 Fax: (202) 228-3954

Senator Barbara Milkulski (MD) Phone: 202-224-4654 Fax: 202-224-8858

Sen. Edward Kennedy (MA) Phone: 202-224-4543 Fax: 202-224-2417

Sen. Olympia Snowe (ME) DC Phone: 202-224-5344 Fax: 202-224-1946

Sen. Susan Collins (ME) Phone: 202-224-2523 Fax: 202-224-2693

Sen. Debbie Stabenow (MI) Phone: 202-224-4822 Fax: 202-228-0325

Sen. Lincoln Chaffee (RI) Phone: 202-224-2921 Fax: 202-228-2853

Sen. John McCain (AZ) Phone: 202-224-2235 Fax: 202-228-2862

Sen. Lindsay Graham (DC) Phone: 202-224-5972 Fax: 202-224-3808

Congressman Jerry Lewis (Chair, House Appropriations) Phone: 202-225-3801 Fax: 202-225-0351



Listen to this article Listen to this article | Posted by Becca




Bird Flu Over the Cuckoo’s Nest

In the middle of the night, without a hearing or debate, friends of big drug companies have plans to attach to an unspecified conference report a pandemic disease proposal that instead of protecting the public health and safety would award special interest protections to the pharmaceutical industry.


If their proposal is so essential to the public health, why are proponents attempting to add it stealthily, while the American public isn’t watching? The truth is their proposal has nothing to do with public health and safety and everything to do with unnecessary giveaways to drug companies. The proposal includes language not included in any House or Senate passed bill—language that provides the drug companies with sweeping legal protections, releasing them from virtually all accountability. The proposal is so broad that it applies to a wide range of commercial drugs and products that may have nothing to do with bioterrorism or a potential pandemic. It even applies to commercial drugs already on the market for which drug companies are making billions of dollars.

Under the proposed language, drug company immunity is triggered if the Secretary of Health and Human Services (HHS) 1) declares an actual or potential public health emergency and 2) declares a drug, vaccine, or device a “countermeasure” or qualifying “pandemic or epidemic product.” Once this occurs, drug companies are virtually immune from all liability. The proposal:

Applies to a wide range of drugs, vaccines, and other products. The proposal provides that any “drug, biological product or device that is used to mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such pandemic or epidemic might otherwise cause…” may be covered and given immunity. The proposal does not, in any way, limit its application only to new drugs or vaccines used in a pandemic context. The scope of the proposal is so broad that it could include drugs like Tylenol, Advil or Vioxx.

Immunizes drug companies by erecting insurmountable barriers to the court system. Citizens can’t go to court unless the Secretary of HHS gives them permission. The proposal bars injured individuals from filing a claim against a manufacturer of a covered product, even in cases of gross negligence. The only exception to the grant of wholesale immunity is in the case of “willful misconduct.” An injured person may ask the Secretary of HHS to find that the manufacturer acted with willful misconduct and allow a case against a drug company to go forward. The Secretary has the sole discretion to investigate or to simply decline the petition. Because the Secretary is bound by an entirely new definition of “willful misconduct” it is virtually impossible for the Secretary to ever allow a claim to go forward. The proposal mandates the Secretary of HHS, together with the Attorney General, promulgate regulations defining what is meant by “willful misconduct” and requires them to find that the drug company had actual knowledge that their product would harm the petitioning individual. This requirement means that only conduct that would also constitute assault, battery or murder would be sufficient for the Secretary to find “willful misconduct.”

Includes severe restrictions even if a claim is allowed. In the unlikely event the Secretary allows a claim to go forward because he has found sufficient evidence a drug company intentionally and willfully injured or killed a person, the following restrictions would still apply:

Includes provisions of the so-called “Lawsuit Abuse Reduction Act” (LARA). Proponents have even dumped into this proposal provisions of LARA, a bill which has twice passed the House but has never been considered in the Senate. Among other things, the proposal would amend the Federal Rules of Civil Procedure without following the normal rule-making processes.

Fails to specify any time limitation for application of immunity. Under the plan, immunity may be triggered at any time because the Secretary of HHS is given broad and unfettered discretion to declare a “public health emergency” when he or she decides there is an actual or potential threat of a pandemic occurring. This could occur tomorrow in light of new risks posed by such diseases as avian flu. Once this declaration occurs, anything deemed a “countermeasure” under the proposal receives wholesale liability protection. A drug or vaccine is shielded from liability whether or not it is actually given in response to a flu pandemic health emergency.

Fails to provide any alternative compensation remedy and is therefore wholly unconstitutional. This proposal sweeps away a host of rights under state and federal law for persons who may be injured by drugs and vaccines. Yet the proposal neither establishes nor provides access to an alternative compensation system. The Supreme Court of the United States has repeatedly made clear that constitutional rights, including specifically an injured person’s right to a jury trial, may not be simply eliminated. The legislature must offer a reasonably equivalent right to a remedy.

Without a safety or compensation component, the proposal asks the American public to trust the pharmaceutical industry to keep them safe. And if that trust is broken, Americans are left with no place to turn for a remedy—no access to the court system and no access to any compensation system when they or their loved ones are injured or killed by a covered countermeasure.


Listen to this article Listen to this article | Posted by Becca




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