The Bitter Pill

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Lawmakers Sever Ties Between CDC and Big Pharma

Evelyn Pringle August 21, 2006

In the wake of overhauling the FDA, lawmakers are also cracking down on conflicts of interest within the Centers for Disease Control.

Last month, Representatives, Dr Dave Weldon (R-FL), and Carolyn Maloney (D-NY), held a press conference to announce the introduction of a bill that would give responsibility for vaccine safety to an independent agency within the Department of Health and Human Services, and remove most vaccine safety research from the CDC.

Specifically, they said on July 26, 2006, the “Vaccine Safety and Public Confidence Assurance Act of 2006,” will create an independent office to address, investigate, and head off potential safety problems like the use of mercury in vaccines, in an objective and non-conflicted office whose sole purpose is vaccine safety and evaluation.

According to Dr Weldon in a prepared statement, Federal agencies charged with overseeing vaccine safety research have failed. They have failed to provide sufficient resources for vaccine safety research. They have failed to fund extramural research and they have failed to free themselves from conflicts of interest that serve to undermine public confidence in the safety of vaccines, he said.

“The American public deserves better,” Dr Weldon stated, “and increasingly parents and the public at large are demanding better.”

“There’s an enormous inherent conflict of interest within the CDC,” he said, “and if we fail to move vaccine safety to a separate independent office, safety issues will remain a low priority and public confidence in vaccines will continue to erode.”

He said that similar conflicts have been remedied in other federal agencies, but in the vaccine program the conflicts persist unchecked. “This bill will provide the independence necessary,” Dr Weldon said, “to ensure that vaccine safety research is robust, unbiased, and broadly accepted by the public at large.”

“Vaccines do wonders for public health, but when the government requires them, it must also ensure that they’re safe,” Ms Maloney said in her statement. “We need adequate, unbiased research on vaccines, and this legislation would deliver that.”

She applauded Dr Weldon for his tremendous commitment and leadership on the issue. “He is truly dedicated,” she said, “to protecting our children and the public at large.”

While announcing the new bill, Dr Weldon and Ms Maloney were joined by several groups advocating vaccine safety reform, including the National Autism Association, A-Champs, and safeMINDS.

According to the National Autism Association: “This landmark legislation will provide critical government agency oversight and implementation of vaccine safety research, which has not kept pace with the rise in the number of vaccines routinely prescribed to consumers including pregnant women and young children.”

Additionally, the Act calls for $80 million in funding to conduct vaccine analysis and safety research.

Currently the CDC oversees vaccine research, safety and promotion, a situation that has been drawing more and more public criticism in recent years. The CDC compiles the list of vaccines that doctors are to give all children in the US, based on the recommendations of an advisory panel, and in many states kids can not attend day care or public schools unless they have received the CDC-endorsed vaccines.

A recommendation by the CDC guarantees a huge market for a vaccine and enables the drug company to use the government as a marketing device for its product. The annual global market for vaccines is expected to be over $10 billion this year.

On July 21, 2003, United Press International published a report based on a four-month investigation that found a pattern of problems linked to vaccines recommended by the CDC, as well as a web of close ties between the agency’s advisory panel and the pharmaceutical industry.

By investigating members of an advisory panel of outside experts that make vaccine recommendations, UPI found that members of the panel received money from vaccine makers through relationships that included: sharing a vaccine patent; owning stock in a vaccine company; payments for research; money to monitor vaccine testing; and funding for academic departments.

In fact, according to UPI, the CDC itself is in the vaccine business. Under a 1980 law, UPI found the CDC had 28 licensing agreements with drug companies and one university for vaccines or vaccine-related products and eight ongoing projects to collaborate on new vaccines.

For instance, the CDC and SmithKline Beecham worked together on the Lyme-disease vaccine. A 1992 CDC activity report, obtained by UPI, says the agency had an agreement “with SmithKline Beecham that currently funds three positions at (the CDC) for the purpose of providing information of use in developing advanced test methods and vaccine candidates.”

In June 2001, the General Accounting Office delivered a report on the issue to Senator Chris Dodd, (D-Conn), that noted that CDC employees “are listed on two Lyme-disease related patents” including “a 1993 joint patent between CDC and SmithKline Beecham Corporation.” The report also said that six of 12 consultants working for the CDC on Lyme vaccines “reported at least one interest related to a vaccine firm.”

According to CDC meeting transcripts where the committee weighed its recommendation, 3 had conflicts of interest with SmithKlineBeecham. The LYMERIX lyme-disease vaccine was approved by the CDC on February 18, 1999, and by October of 2000, more than 1.4 million people had received the vaccine.

But 18 months later, according to UPI, in February 2002, SmithKline Beecham pulled the vaccine off the market claiming that sales of LYMERIX were insufficient to justify the continued investment. However, according to UPI, the company also faced hundreds of lawsuits by people who said they suffered side effects from the vaccines.

The government’s database at the time, listed possible side effects from LYMERIX as 640 emergency room visits, 34 life-threatening reactions, 77 hospitalizations, 198 disabilities and six deaths after people took the shots since the CDC endorsed it, according to UPI.

UPI also found other cases where vaccines endorsed by the panel were pulled off the market after a number of people suffered devastating side effects, and some died.

Congressman Dan Burton, (R-Ind), had already been investigating the advisory panel for several years, and told UPI that the conflicts of interest were a major problem. “This presents a real paradox,” he said, “when the CDC routinely allows scientists with blatant conflicts of interest to serve on influential advisory committees that make recommendations on new vaccines, as well as policy matters.”

“All the while these same scientists,” Representative Burton said, “have financial ties, academic affiliations, and other vested interests in the products and companies for which they are supposed to be providing unbiased oversight.”

An August 2001 report on the investigation by Rep Burton’s House Government Reform Committee, stated that “four out of eight CDC advisory committee members who voted to approve guidelines for the rotavirus vaccine in June 1998 had financial ties to pharmaceutical companies that were developing different versions of the vaccine.”

Critic say the conflicts of interest of Dr Paul Offit while sitting on the advisory panel could not be more blatant. He was part of the team that mandated the use of the RotaVirus vaccine, even though he received a $350,000 grant from Merck to develop the vaccine, shared the patent, and was paid to go around the country teaching doctors that vaccines were safe, according to the Wall Street Journal.

UPI discovered that Merck also had bought and distributed copies of a book written by Dr Offit titled, “What Every Parent Should Know About Vaccines,” to physicians with a Dear Doctor letter that stated:”Merck Vaccine Division is pleased to present you with a copy of the recent publication, ‘What Every Parent Should Know About Vaccines.'”

“The authors designed the book,” Merck’s letter told doctors, “to answer questions parents have about vaccines and to dispel misinformation about vaccines that sometimes appears in the public media.”

The book had a list price of $14.95, and Dr Offit told UPI that he did not know how many copies Merck had purchased.

In 2001, Congressman Burton’s investigation also found conflicts of interest with the then chairman of the advisory panel, Dr John Modlin, a Professor at Dartmouth Medical School, who owned $26,000 worth of Merck stock.

In a phone interview in 2003, Dr Modlin told UPI that he had sold the Merck stock, but that he had recently agreed to chair a committee to oversee Merck vaccine clinical trials.

“Meeting transcripts over the past decade,” UPI says, “showed that at some meetings, half of the members present had potential conflicts with vaccine manufacturers.”

For instance, at a June 2002 meeting, four of the 11 members on the panel acknowledged conflicts with Wyeth, GlaxoSmithKline, Merck, Pfizer, Aventis Pasteur, and Bayer. Two of the four conducted research or vaccine trials and one member was a co-holder of a patent.

The agency is currently facing a major credibility crisis over the issue of whether vaccines containing the mercury-based preservative, thimerosal, are responsible for the epidemic of neurological disorders ranging from ADHD to autism in children all across the country.

The CDC is being accused of research manipulation and cover-ups of vaccine maker culpability by an ever increasing number of activist groups and is also facing tough questions from some of the powerful members of Congress, both Republicans and Democrats alike.

The CDC continues to claim that there is no evidence to support a connection between the epidemic and thimerosal, which they say is no longer used in most pediatric vaccines.

It is however, included in the flu vaccine currently recommended for all pregnant women and children more than 6 months old.

Earlier this year, a group of lawmakers initiated a new investigation of the matter and basically directed the CDC to butt out. On February 22, 2006, they stated in a letter: “If the federal government is going to have a study whose results will be broadly accepted, such a study cannot be led by the CDC,” in a letter to Dr David Schwartz, Director of the National Institute of Environmental Health Sciences.

The letter was signed by Senators, Joe Lieberman (D-Conn) and Debbie Stabenow (D-Mich), and members of the House Representatives including, Dr Dave Weldon, (R-Fla) Chris Smith, (R-NJ), Carolyn Maloney, (D-NY), Dan Burton, (R-Ind), Joseph Crowley, (D-NY), and Maurice Hinchey, (D-NY).

The Institute of Environmental Health Sciences is part of the National Institutes of Health, and was asked to convene a panel to decide how to analyze the CDC database to determine whether autism rates have dropped since thimerosal was removed from most vaccines.

The controversy picked up traction in April, “National Autism Month,” when world renowned heavy metal experts, researchers, and physicians traveled to Washington and rallied on Capital Hill moving the debate beyond just the parents of autistic children.

This spring, a full-page ad appeared in USA Today, the most widely-circulated newspaper in the US, and accused the CDC of “causing an epidemic of autism” by recommending that kids receive a series of vaccinations that contained thimerosal at least as late as 2001.

The ad quoted one of the most recent and famous advocates to join the cause, environmental lawyer, Robert F Kennedy Jr, as saying: “It’s time for the CDC to come clean with the American public.”

The ad was funded by a coalition of advocacy groups led by Generation Rescue, and directed readers to the web site, http://www.PutChildren First.org, to view internal CDC documents, many of which were obtained under the FOIA, that includes transcripts of meetings and e-mails that the groups contend support their allegations of a CDC cover-up.

Congressman Weldon has a theory about why the CDC continues the charade of denying the link between vaccines and autism. “If it is eventually determined that an entire generation of kids was essentially poisoned,” he says, “a class-action suit against the federal government could be on the order of hundreds of billions of dollars, and so there’s very good reason for them to try to cover this up.”

And Dr Weldon’s prediction is proving true. Vaccine injury lawsuits are being filed and won against the vaccine makers and the government. Implemented in 1988, the National Childhood Vaccine Injury Act of 1986, established a mandatory, federally administered no-fault claims process for individuals who allege that they were harmed by the administration of childhood vaccines.

The vaccine compensation fund was created to supposedly ensure an adequate supply of vaccines, and to stabilize vaccine costs. A small fee charged on each vaccines funds the program. According to statistics on the vaccine compensation web site, in fiscal year 2006, a total of $38.2 million has been paid out in cases involving 47 awards.

In what is reported to be one of the largest settlements ever, in July 2006, a quadriplegic boy was awarded $43.1 million. The case alleged that now 7-year-old, Mario Rodriguez, became a quadriplegic after receiving a measles, mumps and rubella vaccine on January. 25, 2000.

Under the guidelines of the vaccine compensation fund program, the lawsuit was filed against the Department of Health and Human Services. Kansas City attorney, Leland Dempsey, who represented the child, told the Kansas City Star: “One unusual aspect of the case is that Mario is expected to have a normal lifespan, and therefore will require more years of care that will cost more money.”

“He will need round-the-clock care, including extensive medical intervention, throughout his life,” Mr Dempsey said.

Many other vaccine related lawsuits have been filed against drug makers. For instance, Eli Lilly, the company that invented thimerosal back in the 1930s, informed its shareholders in its 2005 Annual Report filed with the SEC on April 1, 2006: “We have been named as a defendant in approximately 340 actions in the U.S., involving approximately 1,020 claimants, brought in various state courts and federal district courts on behalf of children with autism or other neurological disorders.”

Lilly also stated, we believe that “the majority of the cases should not be prosecuted in the courts in which they have been brought because the underlying claims are subject to the National Childhood Vaccine Injury Act of 1986.”

Under the Act, claims must first be brought before the US Court of Claims for an award determination under the guidelines established by the Act. However, as Lilly points out in its filing, “Claimants who are unsatisfied with their awards under the Act may reject the award and seek traditional judicial remedies.”

Filed under: 2006, autism, CDC, CONFLICTS OF INTEREST, GAO, Offit, prices, rotavirus, thimerosal, vaccines

End Profit Driven Mandatory Vaccination Racket

Evelyn Pringle February 12, 2008

The push to keep adding more vaccines to the mandatory schedules comes directly from a purely profit motivated industry and a recent investor report estimates that the world-wide market will quadruple from about $4.3 billion in 2006 to more than $16 billion in 2016, with the biggest boost coming from kids in the US.

A November 2007 report entitled, “Pipeline and Commercial Insight: Pediatric and Adolescent Vaccines,” authored by vaccine analyst, Hedwig Kresse, for the independent market analyst Datamonitor discusses the future outlook for vaccine profits.

The report provides an assessment of products and a patient-based forecast of market size and coverage rates to the year 2016, and predicts that the introduction of high price vaccines will induce rapid growth in the pediatric and adolescent vaccines market.

The report predicts that due to the “promising commercial potential” of new, high-price vaccines, the pediatric and adolescent market will quadruple from approximately $4.3 billion in 2006, to over $16 billion by 2016, across the US, the EU-five including France, Germany, Italy, Spain, and the UK, and Japan.

The crucial factor for success in the pediatric market, the report notes, is the introduction of a product into national vaccination schedules. “Along with reimbursement, this virtually guarantees the rapid uptake and continuously high coverage rates in the target population,” Ms Kresse states.

As an example, she cites Wyeth’s Prevnar, as the first premium price vaccine launched in the US in 2000 for vaccinating infants against pneumonia and meningitis.

Since then, Prevnar has been added to the childhood vaccination schedules in the US and EU-five despite its high price of nearly $320 for the 4-dose regimen. In 2006, Global sales reached almost $2 billion, making Prevnar the first vaccine to attain blockbuster status, according to the report. By 2016, Datamonitor expects the total value of the infant market for pneumococcal vaccines to increase to $2.3 billion.

In June 2006, Merck’s Gardasil was approved for cervical cancer. Because it was the first vaccine offered as a preventive measure for a form of cancer, its approval generated tremendous public attention along with pressure for healthcare authorities to make the vaccine available to teenage girls at a cost of $360 for 3 doses.

“Although most cases of cervical cancer in the developed world can be prevented through the existing pap smear screening programs, the expensive HPV vaccination has been recommended and is reimbursed for teenage girls across the US and Europe,” Ms Kresse reports.

She notes that this decision is driven more by public pressure and excitement about the opportunity to vaccinate against cancer rather than by real need. The widespread publicity has led to a good uptake in the target group of adolescent girls, which is usually hard to reach for vaccination, Ms Kresse points out to investors.

Datamonitor sees a huge commercial opportunity in HPV vaccines, with annual sales of $1.4 billion in teenage girls for the seven major markets by 2016 and a cumulative catch-up opportunity in women aged 13-26 that could add up to over $17 billion until 2016.

But Ms Kresse warns investors that the “lack of medical need” for rotavirus vaccines such as RotaTeq will limit their uptake in most markets. RotaTeq is advertised to combat diarrhea that usually affects infants under the age of two, and was introduced by Merck in the US in 2006, at a price of $200 for the three-dose regimen.

According to Ms Kresse, many countries, but not the US, have refused to add the vaccine to their schedules due to cost-benefit reasons. “In the developed world, rotavirus diarrhea is rarely severe for small infants and quick and efficacious treatment is already available,” she writes. “Consequently, healthcare authorities see no need to widely introduce a very expensive vaccine.”

Datamonitor estimates that annual sales will remain limited to approximately $1 billion across the 7 major markets by 2016 and predicts that the US will account for the majority of sales, being the only country to have recommended the rotavirus vaccine for all infants.

Wyeth’s Prevnar vaccine came on the market in 2000 and is recommended for children under 2. The vaccine was hailed as a breakthrough and had sales of more than $1.5 billion in 2006. Prevnar is given as four shots to children between 2 and 15 months.

On September 18, 2007, NewsMax reported that the vaccine has dramatically curbed pneumonia and other serious illnesses in children but is also having an unfortunate effect: “promoting new superbugs that cause ear infections.”

According to NewsMax, doctors reported finding the first such germ that is resistant to all drugs approved to treat childhood ear infections and 9 toddlers in Rochester, N.Y., have had the bug and that it also may be turning up elsewhere.

It is a strain of strep bacteria not included in the pneumococcal vaccine. Prevnar prevents seven strains responsible for most cases of pneumonia, meningitis and bloodstream infections. But dozens more strains exist and some have become resistant to antibiotics since the vaccine combats the more common strains.

If the new strains continue to spread, “it tells us the vaccine is becoming less effective” and needs to be revised, Dr Dennis Maki, infectious diseases chief at the University of Wisconsin-Madison Hospitals and Clinics, told NewsMax.

A new study in the November 8, 2007 New England Journal of Medicine by researchers at Oregon Health & Science University, supported by the United States Public Health Service, suggests that the schedule for vaccinating and revaccinating against diseases should be reevaluated and adjusted.

The study found that in many cases, the established duration of immunity for vaccines is greatly underestimated, which means that people are getting booster shots when their immunity levels do not require it and those antibody responses caused by viruses such as measles mumps, and rubella remained at protective levels for several decades and in most cases, for life.

The research also reconfirmed a previous finding by Slifka and his colleagues: that the duration of immunity after smallpox vaccination is much longer than previously thought. In that earlier study published in the journal Nature Medicine in 2003, these OHSU researchers observed surprisingly long-lived antiviral antibody responses but they were unable to measure the slow rate of decline.

The study indicates that the duration of immunity after smallpox vaccination is maintained with a calculated half-life of 92 years and that a person who has received the primary series of tetanus vaccine is likely to be protected for 3 decades.

Experts say we have allowed ourselves and our children to be overdosed through a culture dominated by industry marketing influence which has now become dangerously out of control and detrimental to our children’s health. “In the 21st century, it is unacceptable to be marketing medication to infants and children that may not work,” Dr Steven Czinn, chair of the department of pediatrics at the University of Maryland School of Medicine, told Reuters on October 11, 2007.

In the November 19, 2007 Huffington Post article, “Over Medicated and Over-Vaccinated: The Unintended Consequence of Medicines Meant to Protect,” Deirdre Imus asks, “Where are the conflict-free studies that prove giving infants and children 49 immunizations – most of them by age 5, are safe and effective?”

She points out that studies have provided evidence that the over-vaccination of dogs and cats can result in numerous maladies including cancer, skin and ear conditions, arthritis, allergies, diabetes, aggression, behavior problems and other immune system dysfunctions. “There is even a name for the conditions caused by animal over-vaccination, vaccinosis,” she notes.

Ms Imus also points out that the mercury-containing preservative, thimerosal, used in vaccines for over 50 years was removed from animal vaccines in 1992.

“Unfortunately for the kids,” she writes, “it remained in children’s vaccines for another decade and remains in some vaccines like the influenza (25 micrograms) and tetanus vaccine (25 micrograms) today and in trace amounts (3 micrograms) in some immunizations.”

She says most people do not realize is that any liquid waste containing more than 200 parts per billion (ppb) mercury must be deposited at a hazardous waste site and that drinking water cannot exceed 2 ppb mercury.

“But when the influenza vaccines arrive and are injected into pregnant woman and infants as young as six months, those vaccines contain 50,000 ppb mercury,” Ms Imus notes.

This amount of mercury is 250 times higher than hazardous waste, she notes, and according to EPA guidelines, this amount can only be considered safe if a person weighs 550 pounds. “Even trace amounts of mercury in vaccines can be anywhere from 600 to 2000 ppb,” she warns.

On November 13, 2006, PutChildrenFirst.org, a parent-led organization advocating vaccine safety, issued a press release to announce the results of a survey conducted October 27-30, 2006, by Zogby International of over 9,000 Americans to learn their plans for getting flu shots, their knowledge of its ingredients, and who they hold responsible for making sure vaccines are safe.

The survey showed that an overwhelming majority of Americans were unaware that most flu shots contain mercury and that they would refuse a shot with mercury. After learning that mercury is an ingredient, 74% of those polled said they were less likely to get a flu shot and 86% of parents said they were less likely to allow their child to get a shot.

Lisa Handley is a founding parent of PutChildrenFirst.org, whose son Jamison had an adverse reaction to a flu shot with mercury in 2003. “I know firsthand how life-changing a flu shot with mercury can be, since our son began his regression into autism after his flu shot,” she states.

“With everything we know about the dangers of mercury and the havoc it can wreak on young, developing brains, there is no excuse for any vaccine to contain mercury,” says Lyn Redwood, RN, MSN, President of SafeMinds, a nonprofit organization committed to ending mercury-induced neurological disorders.

“The survey reveals that Americans are overwhelmingly in the dark about what is in most flu shots,” Ms Redwood stated in the press release.

“They do not want a known neurotoxin injected into their children, and they believe Congress and medical professionals must be more vigilant about keeping vaccines safe and mercury-free,” she added.

PutChildrenFirst also advises that two recent studies in leading medical journals admitted that limited data exists to support the effectiveness of flu vaccines. One study, in the Journal of the American Medical Association, noted that, “there is scant data on the efficacy and effectiveness of influenza vaccine in young children,” the release notes.

According to Ms Imus, we are beginning to see prescribed vaccines, like the whole cell DPT and Rotovirus, which are later found to be unsafe.

“While physicians warn the public about the over use of antibiotics,” she points out, “it is the physicians themselves that over-prescribed these antibiotics for every ailment under the sun.”

“And like antibiotics,” she writes, “every time a new vaccine was developed, it quickly found its way onto the immunization schedule along with the recommended booster shots.”

“We are now reaping the unintended consequences of the overuse of these medical interventions,” she states. “Instead of being healthier, we have a nation of very sick children.”

Forcing parents to inject poisonous concoctions into innocent, helpless children against their will is a gross violation of their most basic parental rights.

Filed under: 2008, autism, flu, Gardasil, Prevnar, rotavirus, thimerosal, vaccines

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