The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

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

Merck Caught Misrepresenting Vioxx Risks Again

May 17, 2006

Evelyn Pringle

Although Merck has long maintained that the risks associated with Vioxx occur after long-term use, a recent study in the Canadian Medical Association Journal, says the drug may raise the risk of heart attack for patients taking Vioxx for less than 2 weeks.

The study published online this month, found that more than 25% of 239 patients who had heart attacks did so in less than 13 days of being on the drug.

The study followed patients for about two and a half years and included 30,200 Vioxx users and 45,000 Celebrex patients. It found no statistically significant increase in heart attack risk with Celebrex patients.

In addition, on May 12, 2006, Dr Steven Nissen, interim chairman of cardiology at the Cleveland Clinic in Ohio, said Merck recently misrepresented an analysis of data from a follow-up review of patients who participated in the 3-year study called, Approve, that led to Vioxx being pulled off the market on September 30, 2004.

“It’s important that we inform people about this because patients who have taken the drug will need increased surveillance by their physicians and increased awareness of their risks in the year subsequent to stopping the drug. And that risk may extend beyond a year; we simply don’t know,” Nissen told Reuters in a telephone interview.

“In the one year after Vioxx was stopped there was a 75 percent greater risk of having an adverse event,” he said.

“What this means is that, surprisingly, in the year following discontinuation of Vioxx the relative risk remains approximately as high as it was when people were actually taking the drug,” Dr Nissen explained. “That is very clear from the data,” he said.

Critics say the cozy relationship between the pharmaceutical industry and the FDA is evidenced by the large number of industry connected members on the agency’s advisory panels. A study conducted by the Public Citizen’s Health Research Group in the April 26, 2006 issue of the Journal of American Medical Association analyzed the transcripts of 221 FDA drug advisory panel meetings that involved 16 committees, listed on the agency’s web site as taking place between January 1, 2001 and December 31, 2004.

The analysis revealed that in 73% of the meetings, at least one member of the panel or one voting consultant disclosed a conflict, and yet only 1% of the members recused themselves from participating.

In all, 28% of committee members and voting consultants disclosed a conflict, the most common involving substantial financial dealings from consulting agreements, contracts or grants, and investments. For instance, the study found that 19% of the consulting agreements were worth over $10,000, 30% of the investments involved over $25,000, and 23% of contracts or grants exceeded $100,000.

In the case of Vioxx, ten of the 32 members on the FDA advisory committee that voted to allow the continued sale of Cox-2 pain drugs, including Vioxx, had previously acted as paid consultants for the drugs’ manufacturers.

And true to form, the members with industry ties voted to return Vioxx to the market. Dr Marcia Angell, a senior lecturer in social medicine at Harvard Medical School and author of “The Truth About the Drug Companies: How They Deceive Us and What to Do About It,” said in a March 10, 2005 editorial in the Boston Globe: “It is hard to see how the panel could have concluded that the benefits were worth those risks, especially given the fact that taking over-the-counter Prilosec in addition to an older pain reliever would probably have provided as much protection from stomach ulcers.”

Dr Angell says advisory committees should not include paid consultants for drug companies. “Their conflict of interest is real, not ‘potential’,” she wrote.

“The excuse that they are indispensable,” she says, “is not only self-serving but insulting to the experts who don’t consult for industry.”

However, in what critics call a rare occurrence, and no doubt because the agency was under intense public scrutiny, in this instance the FDA did not follow the recommendation of its advisory panel and Vioxx was not approved for a return to the market.

In light of the evidence of Merck’s total disregard for patient health that has surfaced in Vioxx litigation thus far, the public needs to take a good hard look at any proposed legislation or action by Congress or the FDA that would shield drug companies from accountability based on the FDA’s approval of a drug.

According to Attorney, Karen Barth Menzies, a partner in the Los Angeles based Baum Hedlund law firm, “the Vioxx public health debacle, has served to highlight deep-seeded problems within the FDA.”

She says, “drug companies are profit-driven and are loath to issue warnings about risks associated with their drugs, even those that become quite clear.”

“And it is precisely for this reason,” Ms Menzies says, “that the public is in such desperate need for an agency that advocates for them, rather than the drug industry.”

The FDA played a big part in the Vioxx disaster and allowed Merck to get away with murder. A new report released on April 24, 2006, by the Government Accountability Office is deeply critical of the FDA’s approach to drug safety and specifically Vioxx, and lists organizational dysfunction, bureaucratic politics, and ineffective enforcement over drug companies as factors compromising drug safety.

The report was commissioned by Senator Charles Grassley (R-Iowa), in response to findings at a November 18, 2004, Senate Finance Committee hearing titled, “FDA, Merck and Vioxx: Putting Patient Safety First,” where reports of mismanagement surfaced regarding the FDA’s failure to implement safety measures to protect the public against the dangers of Vioxx.

Citing “recent controversy about drug safety,” the report illuminates the weaknesses of the FDA in monitoring the safety of drugs once they are approved.

The report states that the FDA “lacks a clear and effective process for making decisions about, and providing management oversight of, postmarket drug safety issues.”

It highlights the communication problems between the two FDA offices that handle postmarket safety concerns and advises that “insufficient communication” between the Office of Drug Safety and the Office of New Drugs “has hindered the decision-making process.”

“Specifically,” the GAO wrote, “ODS management does not always know how OND has responded to ODS’s safety analyses and recommendations.”

Ms Menzies says the FDA has sided with industry for years. “The recent GAO report,” she says, “confirms many of the problems that we have been shouting about for years and illustrates that, contrary to FDA’s preemption arguments, FDA’s decisions must be second-guessed for the safety of the public.”

The report comes almost two years after the hearing that revealed the FDA had not acted promptly to protect the public when it first became aware of information that Vioxx might pose risks to cardiovascular health.

The Senate Finance Committee got involved in the Vioxx matter because it has jurisdiction over the Medicare and Medicaid programs. “Accordingly,” Senator Grassley informed the audience at the start of the November 18, 2004 hearing, “the committee has a responsibility to the more than 80 million Americans who receive health care coverage — including prescription drugs — under these programs.”

“Of the 20 million Americans who reportedly took Vioxx, an untold number are Medicare and Medicaid beneficiaries,” he advised. “I was told that the Medicaid program paid in excess of $1 billion for Vioxx while Vioxx was on the market,” he said.

To demonstrate the value of government payments to Merck, at the beginning of the hearing, Senator Grassley described a June 4, 1999 Merck document titled “IN IT TO WIN IT” that said: “As of yesterday, Vioxx became reimbursable on Medicaid in 42 states with the other 8 states close behind.”

“The Medicaid market was clearly going to be a money maker for Merck,” he said, “and Medicaid has paid Merck well for Vioxx.”

When the FDA approves a drug, Senator Grassley said, it’s considered a “Good Housekeeping Seal of Approval.”

“However,” he told the audience, “what’s come to light about Vioxx since September 30th makes people wonder if the FDA has lost its way when it comes to making sure drugs are safe.”

It looks like the FDA, he said, allowed itself to be manipulated by Merck on labeling changes that became necessary after a review by Merck that’s known as the VIGOR trial.

He explained how Merck completed the VIGOR trial in March 2000 and gave the findings to the FDA in June 2000, and was the subject of an advisory board meeting in February 2001. “But it was April 11, 2002,” he told the audience, “before the Vioxx label was actually changed.”

“During these 22 months,” Senator Grassley said, “Merck aggressively marketed Vioxx, knowing that consumers and doctors were largely unaware of the cardiovascular risks found in the VIGOR trial.”

The bottom line is, consumers should not have to second guess the safety of what’s in
their medicine cabinets,” he said. “The public should feel confident that when the FDA approves a drug, you can bank on it being safe, and if a drug isn’t safe, the FDA will take it off the market.”

The first witness called to testify at the hearing, was Dr David Graham, a scientist with an 18 year career at the FDA, who blew the whistle on the FDA’ s handling of the safety issues related to Vioxx.

Right off the bat, he warned the committee: “we, are faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world.”

He called the Vioxx tragedy “a profound regulatory failure.”

“It is important,” Dr Graham said, “that this Committee and the American people understand that what has happened with Vioxx is really a symptom of something far more dangerous to the safety of the American people.”

“Simply put,” he told the panel, “FDA and its Center for Drug Evaluation and Research are broken.”

Dr Graham discussed the studies that demonstrated that Merck and the FDA were aware of the Vioxx risks since before the drug was approved.

He told the panel of a Merck study named 090, that found a nearly 7-fold increase in heart attack risk with low doses of Vioxx conducted before the drug was approved and yet the labeling at the time of FDA approval said nothing about the risks.

In November 2000, he said, the VIGOR study found a 5-fold increase in heart attack risk with high-doses of Vioxx and yet the company said Vioxx was safe.

In fact, it was not until about 18 months after the VIGOR trial was published, that the FDA made a label change to include the heart attack risk, but even then the agency did not place it the “Warnings” section.

“Of note,” Dr Graham told the committee, “FDA’s label change had absolutely no effect on how often high-dose Vioxx was prescribed, so what good did it achieve?”

He informed the panel that a large study in 2002 also reported a 2-fold increase in heart attack risk with high-doses of Vioxx.

In March of 2004, he said another study determined that both high-dose and low-dose Vioxx increased the risk of heart attack and sudden death.

In this study, users of Vioxx were compared with users of another COX-2 inhibitor, Celebrex. The analysis found that Vioxx at doses of 25 mg or less daily was associated with a 50% increase in the risk of heart attack; and doses of greater than 25 mg daily were associated with a 370% increase in the risk of heart attacks.

Yet a report describing these findings was not posted on the FDA website until November 2004, on election day.

“In my opinion,” Dr Graham said, “the FDA has let the American people down, and sadly, betrayed a public trust.”

In regard to injuries, Dr Graham told the panel that Dr Eric Topol of the Cleveland Clinic estimated that there were up to 160,000 cases of heart attacks and strokes due to Vioxx, in an article published in the New England Journal of Medicine.

“This article,” Dr Graham said, “lays out clearly the public health significance of what we’re talking about today.”

At the November 18, 2004 hearing, to illustrate the significance of 100,000 people being affected by Vioxx, Dr Graham presented charts to show that when looking at Florida or Pennsylvania, it would mean that 1% of the entire population would have been affected. For Iowa, the charts showed it would be 5%, for Maine 10%, and for Wyoming 27%.

“If we look at selected cities,” Dr Graham told Senator Grassley who resides in Des Moines, Iowa, “67% of the citizens of Des Moines would be affected, and what’s worse,” he continued, “the entire population of every other city in the State of Iowa.”

The VIGOR study started in January 1999, and included patients over 40, with rheumatoid arthritis who were given either Vioxx or Naproxen. Patients with recent cardiovascular events and patients taking aspirin were excluded from the study.

In the combined outcome of all cardiovascular deaths, heart attacks and strokes, Vioxx patients had higher rates than Naproxen patients. For the outcome of heart attack alone, the rate was five times higher in Vioxx patients than in Naproxen patients

In 1000 patients followed for one year, Vioxx treatment was found likely to be associated with 6 more heart attacks than Naproxen treatment.

Dr Graham said he became concerned about the public health risk after the VIGOR study indicated that the heart attack risk was increased 5-fold in patients who used the high-dose strength of Vioxx.

The safety question was important he explained because (1) Vioxx would be used by millions of patients; (2) heart attack is a fairly common event; and (3) even a small increase in risk could mean that tens of thousands of patients might be seriously harmed or killed.

“If these three factors were present,” Dr Graham said, “I knew that we would have all the ingredients necessary to guarantee a national disaster.”

To get answers, he worked with Kaiser Permanente in California to perform a study that took nearly 3 years to complete and concluded that high-dose Vioxx significantly increased the risk of heart attacks and sudden death and should not be prescribed or used by patients.

“This conclusion,” Dr Graham said, “triggered an explosive response from the Office of New Drugs, which approved Vioxx in the first place and was responsible for regulating it postmarketing.”

The response from senior management in the Office of Drug Safety was equally stressful he said. “I was pressured to change my conclusions and recommendations,” he told the panel, “and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference.”

In fact, one Drug Safety manager recommended that he should be barred from presenting the poster at the meeting, and also said that Merck needed to know about the study results.

Finally, he said they wrote a manuscript for publication in a peer-reviewed medical journal and senior managers in the Office of Drug Safety would not grant clearance for its publication, even though it was accepted by a prestigious journal after rigorous peer review.

“Until it is cleared,” Dr Graham told the panel, “our data and conclusions will not see the light of day in the scientific forum they deserve and have earned, and serious students of drug safety and drug regulation will be denied the opportunity to consider and openly debate the issues we raise in that paper.”

As for the FDA conduct in responding to the studies that showed the dangers of Vioxx, Dr Graham discussed what he referred to as two “revelatory milestones,” in 2004.

“In mid-August,” he said, “despite our study results showing an increased risk of heart attack with Vioxx, and despite the results of other studies published in the literature, FDA announced it had approved Vioxx for use in children with rheumatoid arthritis.”

“Also, on September 22,” he told the committee, “at a meeting attended by the director of the reviewing office that approved Vioxx, the director and deputy director of the reviewing division within that office and senior managers from the Office of Drug Safety, no one thought there was a Vioxx safety issue to be dealt with.”

At this meeting, the reviewing office director asked Dr Graham why he had even thought to study Vioxx and heart attacks because the FDA had made its labeling change and nothing more needed to be done.

At the same meeting, a senior manager from ODS labeled the latest Vioxx study conducted by Dr Graham’s team, “a scientific rumor.”

“Eight days later,” Dr Graham told the panel, “Merck pulled Vioxx from the market.”

“My experience with Vioxx is typical of how CDER responds to serious drug safety issues in general,” he said.

On December 31, 2004, Dr Graham told Inter Press Service that the Vioxx debacle did not phase the FDA. “You have an agency in denial,” he said in the interview with IPS, “the FDA still maintains it made no mistake in the approval or regulation of Vioxx.”

He said, “intimidation of scientists who threaten the status quo at FDA is routine,” and described how, his FDA superior reacted after he sought withdrawal of another arthritis drug called Arava.

“The division director spent the first 10 minutes of that meeting screaming at me,” he said. “Basically, standing up, jugular veins bulging in his neck, eyes sort of bugging out of his head, screaming,” he recalled, “basically trying to intimidate me so that I’d change my conclusion.”

In fact, once Dr Graham went public, history shows that there was a full-court press by FDA officials against the agency Whistleblower.

Dr Steven Galson, the acting director of the FDA drug-evaluation division at the time, told reporters that Graham’s work “constitutes junk science,” and sent an email to an editor at the British medical journal The Lancet, questioning the “integrity” of Dr Graham’s data.

Acting FDA commissioner, Dr Lester Crawford, accused Dr Graham of evading the agency’s “long-established peer review and clearance process,” and another agency official made calls to a Senate staffer, disparaging Dr Graham personally and professionally.

Before the testimony even began at the November 18 hearing, Senator Grassley responded to comments issued the night before by Dr Crawford against Dr Graham.

“News reports today,” Senator Grassley noted, “say the FDA is calling Dr. Graham a “a maverick who did not follow Agency protocols.”

Dr. Graham, he explained, completed an FDA sponsored three-year study under FDA guidance and with Drs. Campen, Levy, Shoor, Ray, Cheetham, Spence and Hui. Dr. Graham’s immediate supervisor said the paper that formed the basis of the study was “… an excellent study and analysis of a complex topic.”

“So the clarifications provided last night by Dr. Crawford,” Senator Grassley said, “appear intended to intimidate a witness on the eve of hearing.”

Dr Crawford knows there’s a problem, he told the audience, “and would better serve the FDA by spending time on the problem rather than going after congressional witnesses who helped identify the problem in the first place.”

Earlier in the year, on March 10, 2005, Senator Grassley gave a speech to the Consumer Federation of America and praised the FDA whistleblower and described how the FDA stonewalled concerns raised by Dr Graham after a study found an increased risk of heart attacks and strokes with Vioxx and said:

“Dr. Graham warned the FDA of the cardiovascular risks of Vioxx, the FDA approved the use of Vioxx for children. The director of FDA’s office of new drugs suggested that Dr. Graham water down his Vioxx conclusions. Dr. Graham replied that in good conscience he could not. When Dr. Graham was asked to present his findings at my committee’s Vioxx hearing, he was also undermined.

“Dr. Graham did testify before the advisory committee and his science was subjected to public scrutiny from his peers. … In the end, the scientific process prevailed. But again, not before Dr. Graham’s supervisors attempted to intercede.”

In the speech, Senator Grassley said FDA whistleblowers are patriots.

“Think about the guts it takes to undermine your career,” he said, “and to go against your supervisors at a huge federal agency, and in this case, the multi-billion-dollar drug companies.”

“Whistleblowers are the rare birds who refuse to go along to get along,” he told the audience. “The only thing they’re guilty of is “committing truth,” he said.

“Unfortunately,” Grassley told the audience, “it appears that some drug companies are placing greed ahead of drug safety. In this fraudulent environment, the FDA’s mission is more important than ever before. The FDA absolutely has to do a top-notch job on ensuring drug safety,” he said.

The FDA “needs to demonstrate that it is unequivocally committed to the scientific process – and those who speak up on its behalf — when it comes to drug safety and that nothing gets in the way of that, whether it’s pressure from profit-oriented drug makers or institutional ego that doesn’t want to admit a mistake,” Grassley warned.

“The one and only client of the FDA must be John Q. Public,” he declared.

Four months later, on July 18, 2005, Senator Grassley took to the floor of the Senate to explain why he would vote against the nomination of Dr Crawford to head the FDA, and gave a caustic speech about the FDA’s relationship with drug companies as a whole, and Dr Crawford’s conduct in the position of a temporary commissioner, and said in part:

“During the last 18 months, this country’s confidence in the FDA has been shaken. It has been shaken not because of one isolated incident or one isolated whistleblower. It has been shaken because multiple drug safety concerns have been exposed by more than one courageous whistleblower.

“My oversight of the FDA leads me to the conclusion that there are cultural and systemic problems at the FDA. Unfortunately, Dr. Crawford has long been part of that same culture and system. The evidence is overwhelming that the FDA must change to better protect the American people. Dr. Crawford does not appear willing to be the man to change the FDA.

“During Dr. Crawford’s tenure, I have witnessed the suppression of the scientific process and the muzzling of scientific dissent. First, with Dr. Mosholder finding a link between anti-depressants, children and suicide. And second with Dr. Graham’s allegations regarding the FDA, Vioxx and post-marketing safety generally.

“Dr. Graham’s testimony before the Finance Committee suggests that the problems are systemic. Oversight of the FDA exposed the cozy relationship that exists between the FDA and the drug industry. It revealed that the FDA negotiated for almost two years with Merck about how to change the Vioxx label so people would know about the risk of heart attacks.”

In the end, Dr Crawford did become the FDA Commissioner in July 2005, but not for long. This Lester Crawford saga gives to new meaning to the phrase of “what goes around comes around.”

After less than 3 months on the job, in a September 23, 2005 letter to President Bush, Crawford announced his resignation from the FDA and said it was “effective immediately.”

In public, Crawford explained his departure by saying it was time for someone else to lead the agency. On September 28, 2005, Forbes.com reported that Crawford said he decided to leave the agency because he was tiring after three years at the agency. “He denies that financial conflicts of interest had anything to do with his decision to resign,” Forbes noted.

However, Senators Mike Enzi (R-Wyo) and Edward Kennedy (D-Mass) disputed that claim and asked the HHS Inspector General to investigate Crawford’s resignation to see whether he left due to an undisclosed financial conflict of interest.

Less than a month later, on October 26, 2005 the Wall Street Journal reported that as late as 2004, Crawford or his wife “owned stock in companies that make or distribute products regulated by the agency.”

According to the Journal, Crawford or his wife held shares in several companies whose business is regulated by the FDA, as late as 2004, when Crawford was acting commissioner, quoting financial disclosure forms obtained by the Journal.

When Crawford began work at the FDA in 2002, the Journal said, he held stock in many companies, including Merck, Pfizer, and Johnson and Johnson. But he told ethics officials that he sold those stocks in 2002, along with stock he held in Kimberly-Clark, which makes medical devices.

Crawford also reported the sale of his stock in the company Teleflex Inc in 2002, which also makes medical devices, although “later forms show that he or his wife continued to own some shares,” the Journal reports.

On the same day that the Journal’s article was published, the Kaiser Daily Health Policy Report reported that the HHS Inspector General had confirmed that it had launched an investigation into Crawford’s departure from the FDA.

About 3 months after that, on February 8, 2006, Crawford’s new employer was revealed when the Washington Post reported that Crawford, “whose sudden resignation last fall after less than three months in office remains a mystery, has joined a lobbying firm that specializes in food and drug issues.”

“Crawford is listed as “senior counsel” to the firm Policy Directions Inc.” the Post said.

A few of the firm’s clients listed in the article, include Merck, Altria Group Inc, formerly Philip Morris Companies, and the industry’s trade group, the Pharmaceutical Research and Manufacturers of America.

According to the Post, “Crawford is barred from lobbying former colleagues at the FDA for a year, but he can give clients strategic advice about food and drug issues and can lobby members of Congress.”

Less than a month later, on March 3, 2006, the Houston Chronicle reported that before he abruptly resigned, Crawford sold more than $50,000 in shares of Teleflex Inc, “a company that makes medical devices, according to financial disclosure forms” obtained by The Associated Press.

“As head of the FDA,” the Chronicle noted, “Crawford oversaw the regulation of medical devices.”

And on April 29, 2006, the Washington Post reported that the “former commissioner of the Food and Drug Administration is under federal investigation amid accusations of financial improprieties and making false statements to Congress.”

The criminal investigation was disclosed at a hearing in a civil suit filed against the FDA over its handling of the emergency contraceptive Plan B, according to the Wall Street Journal on May 1, 2006. It seems Crawford was scheduled to be questioned under oath in the trial, but his attorney Barbara Van Gelder asked for a delay, saying she would instruct Crawford to invoke his Fifth Amendment rights.

Van Gelder said that Crawford is under criminal investigation and that the issue of his financial disclosures “is within the grand jury.”

As for how things are going these days for Dr Graham, in April 2006, he was interviewed by Life Extension Magazine and described his life as “surreal” since the Vioxx scandal broke and discussed what its like to face the same people every day who tried to destroy him for simply telling the truth.

“It’s very difficult,” he said. “I periodically have to sit down with supervisors who I knew in November were lying to Congress about me, lying to The Lancet about me, and who tried to prevent my getting protection as a government whistleblower.”

“They were doing hateful things,” he explained, “and now they pretend nothing happened.”

Dr Graham did say that the mistreatment comes only from senior management. “At the staff level,” he said, “I’m very respected and supported.”

“If anything, esteem for me has increased because they realize I told the truth,” he told Life Extension. “They know the reality of what we’re dealing with.”

In April 2006, in what has to be one of Merck’s worst nightmares, a federal judge ordered Dr Graham to testify at a deposition in the Vioxx multidistrict litigation. The MDL was created to consolidate pretrial proceedings for the thousands of lawsuits filed by users of Vioxx.

The FDA attempted to block Dr Graham’s testimony by filing a motion to quash the Plaintiff’s subpoena on grounds that his deposition would divert the agency’s time and resources, and cripple its ability to fulfill its statutory mandate, and said there was no need to depose Dr Graham, given his public statements already made.

However, Judge Eldon Fallon denied the motion and said: “This court does not see how the deposition of one employee during nonworking hours would cripple the FDA’s ability to function.”

He also noted that none of the documents in the public record could “express Dr. Graham’s opinion with the clarity and tone as he personally can in his deposition.”

Filed under: 2006, FDA, FDA Crawford, FDA hearing, GAO, Graham, Judge Fallon, Merck, NSAIDs, Vioxx, whistleblower

Halliburton Contracts Illegal – Bush Says So What

Evelyn Pringle February 2005

After millions of tax dollars were spent investigating how Halliburton ended up being awarded billions of dollar worth of no-bid contracts in Iraq, the Government Accounting Office determined that the company should never have been awarded the contracts in the first place.

In response to those findings, Cheney and Bush both, as much as thumbed their noses at tax payers as if to say “so what, what are you going to do about it?” Well, it’s beginning to look like they were right, there is nothing we can do about it.

According to the GAO’s report, Rebuilding Iraq: Fiscal Year 2003 Contract Award Procedures and Management Challenges, contracts worth billions of dollars were awarded without full and open competition, including Halliburton’s oil infrastructure contract.

The GAO found that the Bush Administration violated procurement law when it issued various task orders under existing contracts. Of the 11 task orders examined, more than half were awarded outside the scope of their contracts, according to the report.

As an example of the inept procurement process, the GAO told how “a military review board approved a six-month renewal contract with Halliburton worth $587 million in just ten minutes and based on only six pages of documentation,” the report said.

Once and For All – How Did Halliburton Get Those Contracts?

Remember back when Cheney appeared on NBC’s Meet the Press on Sept 14, 2003, and said, “And as vice president, I have absolutely no influence of, involvement of, knowledge of in any way, shape or form of contracts led by the Corps of Engineers or anybody else in the federal government.”

And remember when he was asked whether he had known about Halliburton’s noncompetitive contract, and he said, “I don’t know any of the details of the contract because I deliberately stayed away from any information on that.”

Those statements were proven false by a June, 2004, article in Time Magazine entitled, “The Paper Trail: Did Cheney Okay a Deal?” As it turns out, Bush and Cheney both were informed that Halliburton would get the contract before it was awarded. Time quoted an email sent by the Army Corps of Engineers, that said the contract for construction of oil pipelines was approved by Under Secretary of Defense Douglas Feith “contingent on informing WH tomorrow. We anticipate no issues since action has been coordinated w VP’s [Vice President’s] office.”

This email totally contradicts Cheney’s nationally televised assertion that he had no involvement in Halliburton’s contracts whatsoever. It proved once and for all that Cheney and the White House had played a key role in making Cheney’s ex-employer the number one war profiteer in Iraq.

The email was dated March 5, 2003, and Halliburton was awarded the contract three days later without any bids by other companies.

The administration tried to dismiss the email by saying the employee at the Corp was just trying to give the Vice President’s office a heads-up on the process. Now I suppose opinions on what the email mean could differ. However, people’s opinions on what it means are likely based on what their definition of co-or-di-na-ted IS.

No Political Appointees Involved – None

Some people may recall the news conference, where State Department spokesman, Richard Boucher, explained who makes the decisions on contracts. “The decisions are made by career procurement officials. There’s a separation, a wall, between them and political-level questions when they’re doing the contracts,” he maintained. Boucher lied.

Then there was the time that the chief counsel of the Army Corp of Engineers appeared on “60 Minutes” and denied that there was any involvement by political appointees in the Halliburton contract. He specifically said: “The procurement of this particular contract was done by career civil servants.” Well, I hate to be the bearer of bad news, but this guy is a liar too.

Major Joseph Yoswa, a Department of Defense spokesman, also claimed safeguards existed to insure that the process was free of favoritism. “Most important,” he said, “career civil servants, not political appointees, make final decisions on contracts,” according to The New Yorker. As it turns out, the Major has a problem telling the truth as well.

Then back in August, 2003, there was Halliburton spokeswoman, Wendy Hall, who said the company’s military contracts were awarded “not by politicians but by government civil servants, under strict guidelines.” I for one, would like to see the list of strict guidelines, and then, I’d like to have the names of the civil servants Wendy dealt with.

Finally, during a March 11, 2004, hearing before the Government Reform Committee, six senior officials from the CPA and DOD testified under oath, and were asked to answer the following question by Republican Committee Chairman, Tom Davis:

“I want to get this on the record, and everybody is under oath. Have you or anyone in your office ever discussed with the Vice President or with his office the award of a contract for Iraqi reconstruction prior to any contract being awarded?”

Every single one of those six officials said “no sir,” which means every single one of them lied under oath. So how Cheney could pull this off? How could he get all these people to lie? I may not know how he did it, but the fact is he did it and nothing has been done about it.

Because, according to the June 14, 2004, LA Times, “The Pentagon admitted that a $7 billion no-bid contract to extinguish oil fires in Iraq was awarded to Halliburton after a political appointee from the Bush administration recommended the company for the job. … the political appointee was Michael Mobbs — a special assistant to Undersecretary of Defense Douglas Feith. During the Summer of 2002, Mobbs was in charge of the Pentagon’s Energy Infrastructure Planning Group (EIPG) to develop a plan for reconstructing Iraq’s oil industry,” the Times reported.

For obvious reasons, contracting experts say political appointees like Mobbs should not decide which companies compete for contracts. “The suggestion that political appointees would be directing that type of investigation does not seem consistent with maintaining the appearance of propriety,” expert Steven Schooner told the Times.

How Could They Pull This Off?

In November 2002, long before the war began, a Pentagon group led by Mobbs, deceded to pay Halliburton $1.9 million to develop a secret contingency plan for handling the Iraqi oil industry.

Tax payers need to understand that it was this initial task order to develop a plan, that led to the company being awarded the $7 billion oil infrastructure contract.

Remember the strategy that Cheney’s developed back when he was secretary of defense under the first President Bush. It goes like this, you give Halliburton funding so it can create a market for its services and then its the logical company to hire to carry out the plan when it comes time for contracts to be awarded.

In this particular instance, according to testimony by GAO investigator, Willim Woods, at a House oversight hearing, Mobbs even acknowledged in a memo that the $1.9 million task order would uniquely position Halliburton to win the far larger sole-source contract to actually do the restoration work to Iraqi oil fields.

So once again, Cheney’s contract manipulation strategy worked like a charm.

Mott described the Halliburton contingency plan in a meeting of the Deputies Committee. Those attending the meeting included Cheney’s chief of staff, Lewis Libby, the deputy national security adviser, Steven Hadley, the deputy secretaries of state and defense, and deputy director of the CIA.

On March 8, 2003, Halliburton was chosen to carry out the plan. When the contract came up in the media, Bush claimed the contract was merely a deal to put out oil well fires. However, it wasn’t long before Pentagon officials were forced to admit that it was a big deal and would involve billions of dollars. But even then, they said that the contract was only temporary and would be replaced by competitively bid contracts shortly.

After umteen delays, new contracts were finally awarded on Jan 16, 2004 and surprise, surprise, Halliburton won the big prize again. An $800 million contract went to the Parsons Corporation, and a $1.2 billion contract went to Halliburton.

Bush and Cheney In Up To Their Necks

During a June 8, 2004 briefing to staff members of the House Committee on Government Reform, Pentagon officials, including Mobbs, were asked about the specific details of the contracting procedure that was employed with Halliburton.

Before making a final decision, Mobbs admitted that he briefed top officials from several executive agencies, in the Deputies Committee, to make sure they had no objections. According to Mobbs, White House Staff members were among those at the meeting.

So, we’ve got Cheney’s top dog, Libby, and Rice’s second in command, Hadley, and White House staff members, and political appointee, Mobbs, leading the pack. And Bush and Cheney want us to believe that not one of these officials uttered a word about Halliburton contracts to either one of them. Yea right.

Following the June 8th Mobb’s briefing, Waxman sent a letter to Cheney and gave reporters a copy. “These new disclosures appear to contradict your assertions that you were not informed about the Halliburton contracts,” Waxman wrote. “They also seem to contradict the administration’s repeated assertions that political appointees were not involved in the award of the contracts to Halliburton,” he said.

The letter described the briefing at which Mobbs acknowledged that he chose Halliburton. After that meeting, Mobb’s said that a White House official told Douglas Feith the group did not object, according to Waxman’s letter.

Waxman also raised questions about the March 5, 2003, e-mail that Cheney received. The author of that email, Stephen Browning, said in an interview that he wrote the memo after he and retired Lt Gen Jay Garner met with Douglas Feith about plans to declassify the earlier $1.8 million contract with the Halliburton.

According to Browning, Feith told him that he had already informed Cheney’s office. Three days later, Halliburton got the $7 billion contract and the war began March 20, 2003. At the briefing, “Browning repeated his story,” Waxman wrote.

“These disclosures mean that your office was informed about the Halliburton contracts at least twice at key moments,” Waxman wrote.

When Waxman tried to investigate the matter further, Cheney simply refused to respond to a request for records of any communications he and his staff had with Halliburton, or actions they took on the contracts. And in what has by now become a pattern when it comes to Cheney, Congress did nothing about it.

The Whistleblower

Finally, in October, 2004, Bunnatine Greenhouse, a top official responsible for making sure the Army Corps of Engineers complies with contracting rules, came forward and revealed that top Pentagon officials showed improper favoritism to Halliburton.

Greenhouse said that when the Pentagon awarded the company a 5-year $7 billion contract, it pressured her to withdraw her objections, actions that were unprecedented in her experience, she said.

The Greenhouse allegations were first reported by Time Magazine. In a letter, Greenhouse told members of Congress that the Army gave the no-bid contract to Halliburton for political reasons. She also said the Army altered documents in order to justify the company’s contract work in the Balkans.

Federal contracting rules say contracts must be awarded by career civil servants, not political appointees. Greenhouse said the Army ignored this requirement when giving contracts to Halliburton. She said the Army violated “the integrity of the federal contracting program as it relates to a major defense contractor.”

“Employees of the U.S. government have taken improper action that favored KBR’s interests,” Greenhouse said in the letter. “This conduct has violated specific regulations and calls into question the independence” of the contracting process.

Bush and Cheney Are Busted – So What?

The media chased after that dumb 20-year-old Whitewater story (hardly the crime of the century) for 8 years To this day, I still don’t know what they were trying to prove exactly. I do know it wasn’t that the Clintons and their cronies had scammed billions of dollars from tax payers. Yet now with Bush administration, the media spends little or no effort exposing crimes involving real fraud and corruption even though the schemes are costing tax payers billions of dollars.

Has the mainstream media been bought off entirely?

Filed under: 2005, Bush, Cheney, Feith, GAO, Greenhouse, Halliburton, Iraq, Mobbs, war profiteers, whistleblower

Free Travel for Military Personnel with Prescribing Power

Evelyn Pringle June 2009

From 1998 through 2007, there were 8,700 trips by Department of Defense personnel paid for by the healthcare industry, with a price tag of more than $10 million, according to a new report titled, “Pentagon Travel,” by the Center for Public Integrity.

In a joint project with Northwestern University’s Medill School of Journalism, the Center reviewed travel disclosure forms filed by DOD personnel, and found the medical industry was the largest sponsor of free travel, accounting for about 40% of all trips.

The sponsors included drug and device makers as well as health foundations and trade groups often funded by those companies.

“Drug companies and device manufacturers spent about $1.7 million for more than 1,400 trips taken by DOD doctors, medical researchers, pharmacists, and other health care employees over the decade, creating relationships that pose serious conflict of interest issues, according to medical ethics experts,” the Center said in a June 9, 2009 summary of the study on its website titled, “Medical Industry Showers DOD with Free Travel.”

“Of special interest to the industry were DOD employees who prescribe, purchase, or recommend the use of drugs or medical equipment,” the summary notes.

DOD’s pharmacy system employees, who can influence which drugs are selected at base pharmacies, took more than 400 trips, worth over $400,000, from medical industry sources, according to the Center’s analysis.

The review found drug companies paid more than $115,000 for trips to destinations that included Orlando, Las Vegas, San Diego, New York City, New Orleans, Paris, and Rome.

“They pay for them because it works,” says Thomas Murray, president of the Hastings Center, a nonpartisan bioethics research institute, in the summary. “Trust me, their marketing departments are paying very close attention to cost benefit analysis for these kinds of gifts.”

Shahram Ahari worked as a sales representative for Eli Lilly in 1999 and 2000, and described how he used free meals, trips, and unrestricted grants to subtly seduce civilian physicians into prescribing Lilly’s drugs.

The strategy, he explained, is to make friends with doctors and pharmacists to get them talking about the drugs or devices, and then reward them with additional perks for prescribing the drugs.

“The return on dividends is phenomenal,” Ahari said in the summary. “If it costs them a thousand dollars for a dinner, that’s a [patient’s drug] payment for one month.”

“If they fly you on the Concord to Paris for five grand, even if they get one patient out of it, it’s a lifetime of cash,” he pointed out.

From fiscal year 2000 to fiscal year 2006, the Pentagon’s prescription drug spending more than tripled from $1.6 billion to $6.2 billion, according to an April, 2008 Government Accountability Office report.

The head of the DOD’s pharmaceutical program, Rear Admiral Thomas McGinnis, banned his own staff from going on company-paid trips, but other military pharmacy staff took about 400 trips, the Center points out.

Drug spending hit $6.8 billion in 2008, said McGinnis, and “the GAO expects DOD pharmaceutical spending to reach $15 billion by 2015,” according to the summary.

Filed under: 2009, anticonvulsants, antipsychotics, GAO, military, SSRIs, suicide, veterans

Autism – Worst Welfare Disaster In History

Evelyn Pringle April 19, 2006

Scientist and medical experts say that unless the government forces the pharmaceutical industry to pay for the damage caused by mercury-laced vaccines, in the not too distant future, Americans will experience the worst welfare disaster in the history of this country.

No doubt with that in mind, eight members of Congress are calling for a new investigation into the link between the autism epidemic and the mercury-based preservative, thimerosal, that children received in vaccines during the 1990s, and that some children received as late as 2003.

After six years of hearings, and testimony from medical experts, scientists, special education teachers, school nurses, and parents of autistic children, several lawmakers say they are convinced that a review of the vaccine database will show a causal link between autism and thimerosal.

Throughout the 1990s, when thimerosal was most heavily used, the number of children diagnosed with autism reached epidemic proportions. During this period, the levels of mercury that children received were 120 times greater than safety standards set for oral ingestion of mercury in food, according to the lawmakers.

In 1999, public health officials began asking vaccine-makers to eliminate the preservative from childhood vaccines. But seven years later, word got out that the preservative is still in the flu vaccine recently added to the childhood immunization schedule, and parents, medical experts, and scientists are outraged.

In seeking an independent review, the lawmakers basically told the Centers for Disease Control to butt out. They maintain that previous research conducted by the agency is flawed because it “was based on data collected prior to the removal of thimerosal and failed to explicitly compare the outcome of children who received thimerosal-containing vaccines with those who did not,” they said.

The group has also criticized the Institute of Medicine for its 2004 public announcement that there is no link between vaccines and autism, because the conclusion for the most part, was based on European studies, when American children had been injected with 75% higher levels of mercury than the European children in the studies were exposed to.

In March 2006, the lawmakers sent a letter to the National Institute of Environmental Health Sciences, asking their agency to conduct a study of the CDC’s Vaccine Safety Datalink, which contains records on 7 million children vaccinated since 1990.

“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,” the lawmakers wrote in the letter.

Although the debate over the cause of autism may rage on indefinitely, the rising costs to society of caring for and educating the children afflicted with the disorder can not be ignored.

On January 4, 2005, the Government Accountability Office advised the Subcommittee on Human Rights and Wellness Committee on Government Reform, that the average per pupil cost for educating a child with autism was estimated to be over $18,000 during the 1999-2000 school year, the most recent year in which data were available at the time of the report.

That means that six years ago, the GAO’s estimate for educating autistic children was nearly 3 times the cost of educating a normal student. The amount of money needed to educate autistic children is the highest per pupil cost for children receiving special ed services.

The epidemic does not discriminate, its happening in every state in the nation, due to the fact that under the mandatory vaccine schedule, children in every state received the same mercury-laced vaccines.

From December 1998 to December 2002, the autism population in California’s Developmental Services System nearly doubled and the 97% increase in 4 years did not include children less than 3, persons classified with less common forms of autism, or persons who are suspected of having autism but are not yet diagnosed.

The total number of autistic students served statewide in creased from 10,360 in December 1998 to 20,377 in December 2002.

Over the last 6 years, the state of Ohio experienced more than a 1,000% increase in students with autism, with 5,406 reported cases for the 2003-2004 school year, according to the Ohio Legislative Office Of Education Oversight.

This year, the Pennridge School District in Pennsylvania, expects to only receive about $1 million in federal funding, and only $2.8 million from the state, to cover its $11 million special ed budget. This means about 60% of the total cost will have to be paid by local taxpayers.

In recent years, the average age of autistic children entering the school system has shifted to much younger children. Under federal law, public schools must provide appropriate education for all children with disabilities, starting at age 3, and many autistic children remain in the system until age 21.

For very young children, the recommendation for early intervention has created an increased demand for more intensive behavioral therapy and educational services in general. However, the federal government only partially reimburses the states for the cost of educating autistic children, even though early intervention means that the services required for each child must now be provided for a much longer period of time.

And on the other hand, as more autistic children reach late adolescence, the need for out-of-home residential services is beginning to have a heavy impact on state budgets.

There is also an increase in public health care costs associated with the growing number of autistic children. For instance, according to state government records, South Carolina has an estimated 2000 children under the age of 18 with autism, and the great majority of these children are eligible for at least some services covered by Medicaid.

During the fiscal year 2005, according to the Department of Health and Human Services, South Carolina paid out more than $20 million for autism care, in large part, because most insurance companies do not cover the high cost of the specific therapies that have been found to be the most successful in treating children with autism.

A group of South Carolina lawmakers are trying to pass a bill that would require private insurers to cover services for all autism patients regardless of age. Industry lobbyist, Larry Marchant says that if passed, the bill would cause the health insurance premiums that individuals or families pay to increase 25%, and would average out to an extra $200 a month for those enrolled in family plans, according to State.com on March 26, 2006.

In addition, the financial burden that a disorder like autism takes on families is absolutely devastating. Upon becoming autistic after receiving vaccines at 16 months, Laura Bono says her son, “Jackson’s medical and therapy needs began taking every bit of money we had saved or ever would have saved.”

“The total we have paid for Jackson’s medical, nutritional and private therapy expenses so far,” Laura says, “is roughly $685,000 since August 1990.”

That amount averages out to well over $50,000 a year.

There is no escaping the fact that the epidemic is having a profound impact on society; not only on autistic children and their families, but on our public health care programs and school systems as well. And, until vaccine-makers are held accountable, taxpayers will continue to carry the full burden.

Filed under: 2006, autism, CDC, GAO, thimerosal, vaccines

FDA Feeling The Heat

January 19, 2007 Evelyn Pringle

Over the past year, the Bush administration’s FDA has been the focus of non-stop investigations and with the Democrats in control of Congress, a long overdue overhaul of the agency is in the cards.

The Government Accountability Office has identified serious problems within the FDA. In an April 21, 2006, report, the GAO found the FDA’s performance “disorganized,” “bureaucratic,” and undermined by infighting between drug evaluation administrators whose allegiance is with the pharmaceutical industry, and the Office of Drug Safety.

According to the GAO, the drug safety office is under-funded, lacks independence and lacks decision-making responsibility. It also criticized the way FDA scientists were prevented from speaking at advisory committee meetings on drugs they were studying.

Investigators point to a major conflict within the Office of New Drugs because it is not only responsible for approving a drug in the first place, it is also responsible for taking regulatory action related to the safety of drugs once they are on the market.

The GAO report said that day-to-day oversight of safety issues is still hampered by poor information, lack of legal authority to order drug company studies, and bickering between the powerful FDA bureau that reviews drugs for approval and a smaller safety office.

To improve postmarketing safety, the GAO recommends that Congress expand the FDA’s authority to require drug companies to conduct studies when additional data is needed.

Another report was released on June 26, 2006, titled, “Prescription for Harm: The Decline in FDA Enforcement Activity,” after an investigation was commissioned by the House Committee on Government Reform to evaluate the FDA’s enforcement activities related to the pharmaceutical industry under the Bush administration.

When requesting the investigation, Rep. Waxman, wrote to the committee Chairman specifically asking for “attention to cases where career investigators believed official action to protect the public health was warranted but could not proceed.”

For the investigation, in addition to reviewing the FDA documents, the investigators obtained information from current and former FDA officials and independent experts.

The experts consulted included Dr. Jerry Avorn, Professor of Medicine at Harvard Medical School; Dr. Michael Wilkes, Vice Dean of Medical Education at the University of California at Davis School of Medicine; and Sammie Young, former Director of Compliance at FDA’s Bureau of Biologics and a 29-year veteran of the agency.

As to methods available for enforcement, when a serious violation of FDA standards is found during an inspection, the FDA has the statutory authority to seize or recall products, impose civil fines, or initiate criminal action.

However, most often the FDA will send the manufacturer either a “warning letter” or a “notice of violation,” which is also called an “untitled letter.” A warning letter notifies a company of violations, requires a written response, and warns that failure to correct the violations can lead to additional enforcement action.

Under FDA procedures, the agency must evaluate the response to a warning letter to determine whether the violations have been corrected. If the firm’s response is inadequate, the agency must take other enforcement action “as necessary to achieve correction.”

An untitled letter is less serious and informs a company of the violations but does not require a written response or warn that enforcement action may follow if violations are not corrected. An untitled letter also does not require an FDA follow-up.

The Prescription for Harm investigation found that there has been a sharp decline in FDA enforcement actions against pharmaceutical companies since December 2001. After reviewing the records, in a May 25, 2006, letter, Dr. Avorn told the Reform Committee, “In all of FDA’s once-proud recent history, I cannot recall a time of greater concern about its work on the part of doctors, patients, and policy researchers.”

“In overview,” he said, “there appears to have been a sharp drop-off in the number of warning letters FDA has issued in recent years, from an average well over 1,000 for the period 1992 – 2001 to an average of only about 700 for the years 2002 – 2004.”

“It is unlikely,” Dr Avorn advised, “that the behavior of the regulated industries improved so much during these years to account for a reduction of 300 warning letters per year.”

Another expert consulted for the investigation, Dr. Wilkes, stated in a June 10, 2006, letter to Rep. Waxman:

“Today the snake oil salesman need not travel in horse and cart nor even in automobiles — they use the internet and the mail to make the same outrageous claims with products that contain sometimes dangerous ingredients and often inert useless ingredients.

“And the Food and Drug Administration seems unable and unwilling to step in to protect the American public.”

The Report cites examples of serious problems that were ignored, including a GlaxoSmithKline plant in Puerto Rico, where the FDA’s field inspectors found several violations between 2002 and 2004, and even recommended that the facility be closed. Yet it was not until 2005, that the FDA censured Glaxo, and even then it did not impose a fine, shut down the plant, or order a recall of the products it was unable to seize.

In some cases, the Report states, FDA headquarters rejected the recommendations of field inspectors despite findings that violations led to multiple deaths or serious injuries. Internal agency documents obtained during the investigation reveal that in at least 138 cases over the last 5 years, the FDA failed to take actions recommended by field inspectors.

The problems identified by inspectors in these cases included 110 where drug labeling and new drug application requirements were violated; 99 cases where manufacturing standards were violated; and 2 cases where firms failed to report adverse drug events. And over 40% of the files, the report said, involved multiple types of violations.

In nearly half of the cases, the FDA took no enforcement action against the firm and in the remaining cases, it took action that was weaker than recommended by the field inspectors.

Most interesting is the fact that during the Congressional investigation, the FDA provided no records from the Office of Chief Counsel, even though a previous investigation had attributed a sudden decline in enforcement actions to the issuance of a change in FDA policy by then Chief Counsel, Mr Daniel Troy, in September 2001, that required all warning letters and untitled letters to be approved by his office before being issued.

According to the revised procedures, the Chief Counsel is required to “state in writing the reason for nonconcurrence” whenever it objects to an enforcement action. Yet when the FDA was asked to explain why there were no records from Mr. Troy’s office, FDA staff claimed that the Office of the Chief Counsel does not maintain copies of its decisions or recommendations, or even a record of which files it has reviewed.

The FDA was slammed again when the Institute of Medicine released a September 22, 2006, report that said that the nation’s drug safety system is impaired by “serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture in [FDA] that is not optimally functional; and unclear and insufficient regulatory authorities particularly with respect to enforcement.”

The report listed the agency’s lack of stable leadership in recent years, and the detrimental effect on personnel; the failure to provide the agency with the necessary authority to regulate post-marketing assessments and enforce compliance; the undue influence caused by the agency’s dependence on user fees; and the impact of stacking advisory committees with members that have clear conflicts of interest.

A recent session of the Senate Committee on Health, Education, Labor, and Pensions, gave the Democrats the first opportunity to show how they intend to deal with the major problems at the FDA, so aptly identified by investigations over the past year.

A November 17, 2006, hearing was held to push forward Senate Bill 3807, the “Enhancing Drug Safe and Innovation Act of 2006,” previously introduced by outgoing chairman, Senator Michael Enzi (R-WY), and incoming chairman, Senator Edward Kennedy (D-MA), who began working on the bill shortly after the Vioxx disaster.

At the hearing, critics called for stricter conflict of interest rules for advisory panels. Merrill Goozner, Director of Integrity in Science Center for Science in the Public Interest, testified about the conflicts of interest involving the expert panel that reviewed the COX-2 inhibitors, and how the panel decided that Vioxx was safe enough to stay on the market, even though its maker, Merck, had already removed it from the market.

Mr. Goozner told the Senators that ten of the 32 scientists on the committee had financial ties to the drugs’ makers. “Had their votes been eliminated,” he said, “two of the drugs in the class would have been voted down by the panel.”

The president of Consumers Union, Jim Guest, testified that improvements are needed to prevent future disasters like Vioxx and called for a rule requiring that at least 90% of the members who decide whether a drug should be approved be free of conflicts of interest.

Dr. Steven Nissen, of the Cleveland Clinic, who has served on advisory panels, testified to “a crisis in public confidence in the FDA following an unprecedented series of revelations about drug and device safety” and called the Senate reform bill a “major step forward.”

“I served on a 2001 Advisory Panel that recommended a warning label for Vioxx,” he told the Senators, “but it took 14 months before the FDA could secure agreement from the company to accept a weakly written warning.”

Dr. Nissen also said improvements “in the Advisory Committee process will help to ensure that FDA consultants are less likely to be influenced by financial conflicts of interest.”

In 2005, a law was passed that required panel members to make full disclosure of all financial ties to Big Pharma. However, after reviewing the disclosure forms submitted, the FDA is still permitted to grant waivers that allow experts to sit on panels even if they have financial ties to a drug company.

On April 21, 2006, the Boston Globe discussed the practical effects of the law since it was enacted and quoted FDA critics as saying “the new transparency has changed little, and scientists who have conflicts of interest can still guide FDA decision making.”

In less than 6 months, the Globe determined, close to 100 waivers had been granted.

Congressman Hinchey is the author of an amendment to the spending bill that funds the FDA, which would ban waivers. “Plain and simple,” he says, “if a doctor or scientist has a personal, financial stake in a drug they should not be allowed to sit on an FDA advisory panel and determine whether that drug is safe.”

In response to the FDA’s renewed push to maintain its ability to grant waivers, on July 24, 2006, Rep Hinchey released a statement stating, “The FDA continues to demonstrate a lack of commitment to ensuring that all of its advisory panels are filled with members who have no conflicts of interest with the drug or device being reviewed.”

“Saying that there are not enough potential advisory panel members available without conflicts, as the FDA argues, is an empty claim,” he said.

Most disturbing, he said is that the FDA denies only 1% of the waivers requested. “When the FDA is handing out waivers 99 percent of the time,” he states, “it is a clear sign that the system is broken.”

No doubt in attempt subdue the hornet’s brought on by the investigations into the approval of Ketek based on fraudulent studies, in late July 2006, the FDA announced a series of changes it plans to make in the methods used to evaluate clinical trials.

One would require a company to notify the FDA immediately if it believes a researcher has committed fraud during a clinical trial. As it is now, drugs companies are trusted to remove unreliable data and are not required to report any fraudulent activity to the FDA until they actually submit the new drug application.

The agency also says it plans to clarify which adverse events must be reported to the review boards that monitor the studies and standardize the forms used to collect information and revise the rules on how patients may qualify to participate in clinical trials.

The new FDA commissioner was confirmed on December 7, 2006, but critics say the agency is incapable of change under the Bush regime. Rep. Hinchey released a statement stating: “Unfortunately, the Senate’s confirmation of Dr. Andrew von Eschenbach represents anything but a fresh start for one of the most troubled agencies in the federal government.”

“I have not seen anything substantive from Dr. von Eschenbach,” he stated, “to make me believe that the mismanagement, misplaced priorities, and ineptitude of the agency’s leadership will change during his tenure.”

“Among many other things,” he said, “Dr. von Eschenbach has presided over the FDA as it issued a new rule that prevents Americans from filing lawsuits against drug companies if they or a loved one become seriously ill or die as the result of a particular drug.”

“And in just the last few days,” Rep. Hinchey reported, “the FDA has approved numerous waivers for panelists on its advisory boards who have financial conflicts of interest with drugs and devices they are reviewing.”

Houston attorney, Robert Kwok, makes the point that “fortunately, there are just two years left in this administration, so Dr von Eschenbach’s term may be short.”

“But he can still do a lot of damage in that time,” he warns, “to the rights of Americans, their health, and their privacy.”

(This article is written as part of a series on pharmaceutical litigation and is sponsored by Robert Kwok & Associated, LLP)

Filed under: 2007, FDA, GAO, Glaxo, IOM, Ketek, Kwok, Troy

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