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

Profit Driven Swine Flu Propaganda – Pump Up the Volume – Part Five

Evelyn Pringle October 2009

In the video commentary titled, Mild Swine Flu & Over-Hyped Vaccine, on the website for the National Vaccine Information Center, the group’s co-founder and president, Barbara Loe Fisher, reports:

“We are witnessing a roll-out of the largest, most expensive mass vaccination campaign in the history of our nation. A rollout that is bigger than even the polio vaccine campaigns of the 1950’s.”

“If you or your child are injured from getting a flu swine flu shot, you are on your own,” Fisher warns.

“Because Congress shielded the vaccine manufacturers and any person giving swine flu shots from lawsuits if people get hurt,” she says. “There is no funded government vaccine injury compensation program for swine flu vaccine.”

“Doctors are telling some children under 10 years old to get 3 to 4 flu shots this year – 2 shots for seasonal flu and one or two more for swine flu,” Fisher points out.

“We have never given young children 3 to 4 flu shots in a single year and there is no information about how safe it is to do that,” she advises.

On October 18, 2009, the Wall Street Journal advised that: “Children ages six months to nine years who have never received a flu vaccine before are recommended to receive two doses of both the H1N1 and seasonal-flu vaccine about a month apart,” citing Paul Offit, chief of infectious disease at the Children’s Hospital of Philadelphia, as the source, without letting readers know how rich he has become profiting off the vaccine industry.

Eight months ago, on February 16, 2009, “Age of Autism” published a report titled, “Voting Himself Rich: CDC Vaccine Adviser Made $29 Million Or More After Using Role to Create Market,” by Dan Olmsted and Mark Blaxil, for an investigation that found:

“Dr. Paul Offit of the Children’s Hospital of Philadelphia (CHOP) took home a fortune of at least $29 million as part of a $182 million sale by CHOP of its worldwide royalty interest in the Merck Rotateq vaccine to Royalty Pharma in April of last year.”

“Based on an analysis of current CHOP administrative policies, the amount of income distributed to Offit could be as high as $46 million,” the report noted.

“In a Moody’s report dated June 2008, CHOP reported net proceeds from the Rotateq transaction of $153 million, a deal basis that would put the value of Offit’s 30% share at $45.9 million,” the authors wrote.

“Unlike most other patented products, the market for mandated childhood vaccines is created not by consumer demand, but by the recommendation of an appointed body called the Advisory Committee on Immunization Practices (ACIP),” the AoA report states. “In a single vote, ACIP can create a commercial market for a new vaccine that is worth hundreds of millions of dollars in a matter of months.

“For example, after ACIP approved the addition of Merck’s (and Offit’s) Rotateq vaccine to the childhood vaccination schedule, Merck’s Rotateq revenue rose from zero in the beginning of 2006 to $655 million in fiscal year 2008,” the authors explain.

“When one multiplies a price of close to $200 per three dose series of Rotateq by a mandated market of four million children per year, it’s not hard to see the commercial value to Merck of favorable ACIP votes,” the authors point out.

From 1998 to 2003, Offit served as a member of ACIP. As a member of the ACIP, Offit “voted to include the rotavirus vaccine in the Vaccines for Children program, which ultimately made his Rotateq product worth hundreds of millions of dollars to Merck,” the National Autism Association reports.

Offit also holds a “$1.5 million dollar research chair at Children’s Hospital, funded by Merck,” according to a July 25, 2008 report by CBS News titled, “How Independent Are Vaccine Defenders?”

Calling them “the most trusted voices in the defense of vaccine safety,” CBS reports that the American Academy of Pediatrics, Every Child By Two, and pediatrician Dr Paul Offit, have something else in common – “strong financial ties to the industry whose products they promote and defend.”

“The vaccine industry gives millions to the Academy of Pediatrics for conferences, grants, medical education classes and even helped build their headquarters,” CBS found. Totals were secret, but documents cited by CBS reveal the following:

A $342,000 payment from Wyeth, maker of the pneumococcal vaccine – which makes $2 billion a year in sales.

$433,000 from Merck, the same year the academy endorsed Merck’s Gardasil vaccine – which made $1.5 billion a year in sales.

Another top donor was Sanofi Aventis, maker of 17 vaccines and a new five-in-one combo shot added to the childhood vaccine schedule in June 2008, CBS said.

“Every Child By Two, a group that promotes early immunization for all children, admits the group takes money from the vaccine industry, too – but wouldn’t tell us how much,” CBS investigative correspondent Sharyl Attkisson reports.

In April 2009, the AAP even filed a friend of the court brief (amicus) with the US Supreme Court in support of a petition for a writ of certiorari from vaccine makers Wyeth and GlaxoSmithKline to overturn a unanimous ruling by the Georgia Supreme Court that decided a civil lawsuit filed by Marcelo and Carolyn Ferrari on behalf of their autistic son was not barred by the National Childhood Vaccine Injury Compensation Act.

The Georgia decision noted that recognizing presumptive preemption would “have the perverse effect of granting complete tort immunity from design defect liability to an entire industry.”

The Farrari family alleges that the vaccine makers could have manufactured safer childhood vaccines without the mercury-based, thimerosal, that caused their son’s autism. The Georgia court’s ruling would allow a jury to decide the case.

On September 9, 2009, the National Autism Association issued a press release with a headline: “Offit’s Failure to Disclose Jeopardizes Swine Flu Vaccine Program,” referring to his recent appearance on a segment of NBC’s Dateline.

“As autumn approaches and millions of Americans consider taking an H1N1 Swine Flu vaccination, the integrity of all vaccine developers has been called into question by the financial relationship of a leading vaccine advocate and a pharmaceutical manufacturer,” NAA advised.

“If people are to have confidence in the integrity of the Swine Flu vaccination program this fall then we need full disclosure of all financial relationships between proponents and manufacturers on every vaccine on the market,” said Jim Moody, attorney for the NAA, in the press release.

“Who has an objective opinion about a company that has made them rich?” he said.

“Offit has zero credibility in matters of vaccine safety,” says Wendy Fournier, president of the NAA. “Not only does he advance the absurd suggestion that children could safety get 100,000 vaccines at a time, he opposes any studies of the comparative health of unvaccinated children that could shed light on the extent and nature of vaccine-caused injuries, leading to their prevention.”

Beyond Offit’s financial conflicts, autism advocates are also dismayed about his credibility on speaking about autism in general, as he does not treat patients with autism.

“It’s a mystery how such an inexperienced and financially conflicted man has become the go-to guy for information on autism,” Ms Fournier says. “Here’s a man with no real knowledge about autism that again and again appears in media coverage.”

“Not only is he completely unqualified to address autism from a medical standpoint, his financial conflicts of interest disqualify him as a credible source for vaccine safety commentary as well,” she points out.

Too many shots

“Today’s immunization schedule now calls for kids to get 55 doses of vaccines by age 6,” according to the CBS News report.

The four flu shots recommended this year will be in addition to all the other vaccines children receive in complying with the mandatory childhood vaccine schedule.

On the “Age of Autism” website, Mary Podlesak warns that the flu vaccines still contain mercury. “I was reading the package inserts for the H1N1 vaccines from Novartis, Sanofi Pasteur and CSL last night,” she said. “All three state the vaccine contains 25mcg of mercury — not 25mcg of thimerosal — 25mcg of mercury.”

“When I checked the package inserts for the seasonal flu vaccine, they read the same as the H1N1 description,” Podlesak wrote.

The package insert states: “The 5-mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury.”

Smaller amounts of thimerosal also remain in some other vaccines, even those marketed as “preservative-free,” according to Age of Autism.

The H1N1 vaccine insert also states: “Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A”

“(H1N1) 2009 Monovalent Vaccine or AFLURIA. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed. “

Back on May 20, 2003, after a three year investigation of pediatric vaccine safety, initiated in the US House Committee on Government Reform, the “Mercury in Medicine Report,” was placed in the Congressional record.

“Thimerosal used as a preservative in vaccines in likely related to the autism epidemic,” the report concluded.

“This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding the lack of safety data regarding injected thimerosal and the sharp rise of infant exposure to this known neurotoxin,” the Committee advised.

“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,” the report pointed out.

“At the same time that the incidence of autism was growing,” the Committee said, “the number of childhood vaccines containing thimerosal was growing, increasing the amount of ethylmercury to which infants were exposed threefold.”

Vaccine makers and conflicted public health officials are always claiming that studies show vaccines did not cause the autism epidemic. In a February 24, 2009 Huffington Post article, Robert F Kennedy, Jr, pointed out “that for sixty years the tobacco industry successfully defended a product that was killing one out of every five of its customers against thousands of legal actions brought by its victims and their families.”

“Big tobacco prevailed for six decades,” he said, “even without the help of supportive government agencies deliberately suppressing real science and research.”

“In that sense vaccine victims must leap a much higher hurdle,” he added.

Filed under: 2009, autism, CDC, flu, front groups, Offit, Supreme Court, thimerosal, vaccines, WHO

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