Autism – Cut The Crap

Evelyn Pringle July 31, 2005

In their public statements, officials within the FDA and CDC, are always claiming that researchers and scientists who conduct studies, not funded by drug companies or the government, are making unfounded claims about a link between thimerosal-laced vaccines and autism, and other neurological disorders, which they claim could lead to reduced vaccine coverage, resulting in preventable outbreaks of disease affecting the entire planet.

I say cut the crap.

Think about it. Why would so many highly respected scientists, researchers and physicians go to such great lengths to concoct bogus studies and issue false reports, in essence putting their professional reputations on the line, if their was no connection?

I want these officials to do two things. First I want them to give me one good reason why these professionals would make this up, and two, I want them to give me one logical alternative theory for the current epidemic of disorders.

Let’s look at a few of these experts.

Dr Jeffrey Bradstreet is a practicing physician who treats children with autism and other brain-damage disorders. While in the Air Force, he was trained in toxicology and environmental health. His duties as an Officer included the responsibility for military personnel who had exposure to a wide variety of toxins, including mercury.

Dr Bradstreet has evaluated well over 2000 children with neurological disorders. He also directs a school for children with neurodevelopmental disorders where his responsibilities include supervising occupational therapists, speech and language pathologists, and applied behavioral analysts.

Dr Bradstreet is a Harvard Certified Medical Education Instructor in autism and has written three peer reviewed papers regarding the relationship between thimerosal, developmental disorders and biological markers for Mercury-Susceptibility.

In addition, he has conducted research regarding these disorders and has worked with some of the most highly respected professionals in the country, including Dr Jane El-Dahr of the Tulane University Medical Center; Dr V.K. Singh of the Utah State University Biotechnology Center; the University of Michigan Department of Pharmacology; Dr Vas Aposhian of the University of Arizona; Dr Anne Connolly of the Washington University Hospital; Dr Walter Spitzer of McGill University; the Department of Pediatrics at Robert Wood Johnson Medical School; Dr Jim Adams of the University of Arizona; and Dr Jill James, a former FDA researcher, now with the University of Arkansas, Department of Pediatrics.

Apparently the FDA, CDC, and vaccine makers expect us to believe that this long line of highly respected professionals from Universities all over the country somehow got together and conspired to conduct fraudulent research for decades and then authored 1000s of false reports and other publications.

I don’t buy it. What would be the payoff?

Dr Mark Geier is a medical doctor who holds a PhD in genetics and is board-certified in medical genetics and forensic medicine. He was a researcher at the National Institutes of Health for 10 years and was previously a professor at Johns Hopkins University. He has studied vaccines for more than 30 years and has published over 50 peer-reviewed papers on vaccine safety, efficacy, contamination and policy.

He was instrumental in convincing officials to switch from the whole-cell Diphtheria-Tetanus-Pertussis (DTP) vaccine to the safer version (DTaP). In fact, he wrote the article, “The True Story of Pertussis Vaccination: A Sordid Legacy?” which in 2002, won the first annual Stanley W. Jackson award for the best paper published in the Journal of the History of Medicine and Allied Sciences during the period of 2000 to 2002.

Dr Geier has made several presentations to the Institute of Medicine on the adverse effects of vaccines including one on thimerosal in 2004. He and his son, David Geier, are the only independent researchers who have ever been permitted to study the Vaccine Safety Datalink (VSD) database of the CDC.

Dr Geier has testified before the US House of Representatives Committee on Government Reform Investigating Vaccines and the Autism Epidemic to critique the Hviid study, conducted in Denmark on autism and thimerosal exposure and he has also addressed the FDA Advisory Committee regarding vaccine safety.

Finally, Dr Geier has testified as an expert witness in about 100 cases before the National Vaccine Injury Compensation Program in the US Court of Federal Claims.

In one such case, on November 25, 2003, the Special Master French issued an opinion in which he praised Geier’s credentials and vast experience and said in part:

Dr Geier “ranks high among those who have studied vaccine issues through the medical literature on vaccines, databases, studies, articles and information on vaccine safety and efficacy in vaccine policy.” … “The tenor of his testimony in this case addressed the importance of statistical databases in providing statistical reliability and validity in interpreting the epidemiology and issues relating to autism and various vaccines. . . . Dr Geier has recently proposed a data-sharing process that would improve the reliability of present statistical data that would include the present VAERS statistical database. It would be helpful in interpreting the epidemiology and issues relating to the autism controversy.”

Give me one good reason why this world renowned scientist would put his professional career on the line by lying under oath, not only in court 100 times, but also before a congressional committee?

The drug makers and government officials have waged an all out attack on this particular expert in attempt to discount his opinions because Dr Geier speaks in terms most people understand. He has reported on the staggering statistical numbers showing the rise in brain-damaged kids who were vaccinated with thimerosal compared to the children who received very little mercury, or mercury-free vaccines, and were not injured.

When he speaks, people “get it,” and the powers that be know it.

Then there is, Dr George Lucier, who in the year 2000, retired from the National Institute of Environmental Health Sciences where he was Director of the Environmental Toxicology Program and Associate Director of the National Toxicology Program. In that capacity, he was responsible for coordinating toxicological research and testing across federal agencies as well as conducting risk assessments for exposure to toxic substances including mercury. He has authored well over 200 scientific publications involving toxicology, pharmacology and risk assessment, including ten articles on mercury.

In 1998, Dr Lucier was appointed the Chair of the Organizing Committee for the White House Workshop on Scientific Issues Relevant to Assessment of Health Effects from Exposure to Methylmercury. He has presented his opinions on numerous occasions in various forums and for 28 years, he was the co-editor in chief of the prestigious scientific journal, Environmental Health Perspectives.

Why would this guy lie under oath?

Another renowned scientist expressing the same view on thimerosal, is Dr Boyd Haley, who is currently a Professor and Chairman of the Department of Chemistry with a joint appointment in the College of Pharmacy at the University of Kentucky.

He teaches a class on mercury toxicology and has published more than 110 articles in the peer-reviewed literature including the toxic effects of elemental mercury. Since 1989, his laboratory has been conducting research on the relationship between mercury and neurological diseases, and has performed experiments with thimerosal. In 2001, Dr Haley made a presentation on “In Vitro Studies of Thimerosal Toxicity,” to the IOM.

So why would this guy spend 25 year of his life conducting bogus studies, rendering fraudulent results and authoring a 100 dishonest articles?

An expert I consulted during my initial investigation of this issue was Dr David Ayoub, MD, who when asked how certain he was of the link between autism and thimerosal, told me, “I can state that the certainty of the science supporting mercury as a major cause of autism is probably more overpowering than the science behind any other disease process that I studied dating back to medical school.”

Dr Ayoub is the Director of the Prairie Collaborative for Immunization, an organization that is self-funded, which aids organizations, journalists, and legislators obtain accurate information to assist their work. He is also the author of the report, “Pregnancy and the Myth of Influenza Vaccination-Is it safe, is it effective, is it necessary? What the CDC documents reveal.”

When asked why so many scientist were now conducting research Dr Ayoud said, “I think a disease that effects more individuals than AIDS or cancer, in previously normal infants and children, has created a sense of urgency amongst researchers.”

Flu shots with a toxic dose of mercury are still being given to pregnant women and Rh negative shots with thimerosal are still being given to pregnant women. Even though recent studies have shown that lower IQ levels linked to mercury exposure in the womb costs the US $8.7 billion a year in lost earnings potential, according to a study released in February 2005, by researchers at the Mount Sinai Center for Children’s Health and the Environment, who combined a number of previous studies to determine hundreds of thousands of babies are born every year with lower IQ associated with mercury exposure.

Lead researcher and pediatician, Dr Leonard Trasande, said annually, between 316,588 and 637,233 infants are born with umbilical cord blood mecury levels linked to IQ loss and about 4% of babies are born with mercury levels between 7.13 and 15 micrograms per liter which at that level, causes an IQ loss of 1.6 points.

The drug makers have been marching their own experts into court, so let’s look at the credentials of some of their experts and see how they match up with those listed above.

In the case of Vera Easter verses Aventis Pasteur, although Harvard-educated and the author of some 80 peer-reviewed articles, according to his deposition, Dr Philip Wang’s specialty was epidemiology related to antidepressants. Prior to being retained as an expert for the vaccine makers, Dr Wang had not done any evaluations associated with vaccines, had no specific training whatsoever regarding mercury, and had written no articles on the effects of heavy metal exposure.

Dr Wang has never investigated any illness claimed to be associated with heavy metal exposure and has never been asked to do a formal epidemiologic evaluation of the hypothesis that thimerosal could cause neurological disorders or autism.

He claimed he did know the VAERS database existed prior to being retained as an expert, but he had never conducted any analysis on the Vaccine Safety Datalink.

Dr Wang’s knowledge of vaccines and thimerosal was limited to what he learned in 30 to 35 hours of meetings with defense attorneys and reading the relevant medical literature, most of which was provided by the defense attorneys.

Finally, Dr Wang only offered an opinion on the link between thimerosal and autism and not on the issues relevant to the case relating to other neurological disorders.

For some reason, I don’t think Dr Wang would fare too well if called upon to take the stand to disprove the opinions of the many established experts on the plaintiff’s team with their combined decades of research experience in this area of expertise.

Another drug maker expert was Dr Chris P Johnson, who in her deposition agreed that, prior to this case, her experience with mercury poisoning cases was zero. She has had no experience related to mercury or its neurotoxic effects and conceded that she was not an expert on mercury or the effects of mercury exposure on the human body.

I hardly think Dr Johnson is a match for the experts above. In fact I think it would be grossly unfair to even throw this gal in the ring with those heavyweights. I guess it just goes to show how much humiliation some people are willing to endure to make a buck.

Partnerships Between Industry and Regulatory Officials

In reaching decisions, officials within regulatory bodies seem more concerned about the impact of their decision on global vaccination policies than making an unbiased appraisal of the scientific evidence. In reviewing statements by these agencies, people need to consider the inherent conflicts of interest between the CDC, charged with investigating medical issues; the FDA, charged with regulating vaccines; the Institute of Medicine (IOM), which examines policy issues; and the vaccine manufacturers.

After an on-going investigation of several years, the Mercury in Medicine Report was published on May 21, 2003 by the Subcommittee on Human Rights and Wellness of the Committee on Government Reform, and included testimony from numerous experts. The report rendered a number of specific findings.

Most significant was its statement that, “The CDC in general and the National Immunization Program are particularly conflicted in their duty to monitor the safety of vaccines, while also charged with the responsibility of purchasing vaccines for resale as well as promoting increased immunization rates.”

The report went on to say that the CDC due to its “biases against theories regarding vaccine-induced autism,” had chosen to fund researchers “who also worked for vaccine manufacturers to conduct population-based immunologic studies. . .” But most importantly, it identified Thimerosal as the culprit in plain language and in no uncertain terms:

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

The CDC’s decision to promote the publication of research supportive of the vaccine industry to refute this report by a congressional committee, demonstrates just how far it will go to support its partners in crime.

Blatant evidence of this partnership can be found in a CDC plan to promote flu vaccine sales which detailed a “7 step recipe for generating interest in, and demand for, flu (or any other) vaccination.”

The document discusses the “best recipe” that would foster interest and demand, including use of terms like “very severe,” “more severe,” and “deadly” to “motivate behavior” and increase sales.

For any doubters, this evidence should confirm that the interests of the CDC and the industry are one and the same.

In addition, numerous articles published in medical journals between 2001 to 2004, were cited as key studies relied upon by the Institute of Medicine, which as it turns out, were written by authors and researchers with direct conflicts of interest and real biases in favor of claiming thimerosal did not cause injuries or autism.

Many of the conflicts were not revealed by the authors at the time the articles were written in direct violation of policy rules pertaining to medical journals.

For instance, one article relied upon by the IOM, although not a population study, was Pichichero et al. Mercury concentrations and metabolism in infants receiving vaccines containing Thimerosal: a descriptive study, published in Lancet in 2002.

Pichichero did not declare any conflicts, despite the Lancet’s strict policy requiring that conflicts be disclosed. However, in a subsequent New York Times article, Pichichero admitted that he had done work for Lilly and other drug companies.

But a fact that must have slipped his mind was that in an earlier article in American Family Physician, Pichichero had declarated:

The author has received research grants and/or honoraria from the following pharmaceutical companies: Abbott Laboratories, Inc.; Bristol Myers Squibb Company; Eli Lilly & Company; Merck and Co.; Pasteur Merieux Connaught; Pfizer Labs; Roach Laboratories; Roussel-Uclaf; Schering Corporation; SmithKlineBeecham Pharmaceuticals; Upjohn Company; Wyeth-Lederle.

In defending thimerosal, officials will often refer to the World Health Organization as a body that has found it safe. Well in a June, 2001 WHO report, the agency itself refers to vaccine manufacturers as a full and equal “partner.”

When the WHO was worried that regulations had affected drug maker’s costs, it stressed the need to get them to stay in the market, and even proposed a “communication strategy that would take account of public concern about adverse effects of vaccines.”

So, in a subsequent WHO meeting on April 15-16, 2002, a decision was made to “lobby Ministry of Health and senior regulators” on the thimerosal issue and to “develop a strong advocacy campaign to support the ongoing use of thiomersal.“

It can readily be seen that the WHO has similar reasons to those of the CDC to support the industry’s position.

As thimerosal containing vaccines continue to be shipped to countries all over the world, it’s becoming more and more apparent that these cozy “partnerships” wield a considerable amount of power when it comes to making decisions related to vaccine safety.

Who Knew What And When

The well-documented sordid history of thimerosal, including the continuing misrepresentations by its inventor, Eli Lilly, confirms that the product should never have been used in childhood vaccines, and should have definitely been removed prior to the doubling of the content that resulted from the addition of the HIB and Hepatitis B vaccines in the late 1980’s to mid-90’s.

Mercury in vaccines was tested and shown to be lethal many times over the past 40 years. In May of 1967, an article was published in Applied Microbiology, titled, “Enhanced Toxicity for Mice of Pertussis Vaccine When Preserved with Merthiolate.”

The abstract states: Pertussis vaccines preserved with 0.01% merthiolate (thimerosal) are more toxic for mice than unpreserved vaccines prepared from the same parent concentrate containing the same number of organisms.

In this study, twenty mice were injected with a vaccine with no thimerosal and none died. 30 others were injected with the same vaccines, plus thimerosal, and 5 died. The article stated that “it would not be surprising if injection of this vaccine influenced the susceptibility of the mouse towards a mercurial preservative.“ The authors also noted that “other laboratories” had observed toxicity of final lots of preserved vaccine when the vaccines themselves were “atoxic or only slightly toxic.”

In 1972, Lilly received an article that confirmed that thimerosal had caused 6 deaths when too much of it had been used, which said: “The symptoms and clinical course of the 6 patients suggests subacute mercury poisoning.”

In 1975, autopsies on squirrel monkeys treated with thimerosal-containing nose spray, determined that mercury accumulated in the brain “which may represent a potential hazard in the chronic use of thimerosal as a preservative in products intended for human use.”

By the late 1970’s, vaccine companies realized the need to remove thimerosal because of its poisonous effects. In an October 12, 1979 memo, Merck scientists discussed the “potential problem” of having mercury in its flu and meningococcal vaccines, as well as the Hepatitis B vaccine that was under development and asked: “Should a program of replacement be initiated now to guard against any spontaneous rally to avoid its (thimerosal) use in injectables?”

This memo proves that the industry knew about the dangers long before the mercury-loaded Hib and Hep B vaccines were added to the schedule in the 1980’s and 1990’s.

In 1986, an article titled, “Organic Mercury Compounds and Their Toxicity,” noted that thimerosal had caused problems and stated that it was “now accepted that multidose injection preparations are undesirable, and preservatives should not present in unidose preparations.“

In the early 1990’s, the level of thimerosal in vaccines increased drastically, and in many cases doubled. The drug companies knew that adding 3 or four HIB vaccines and as many as 3 Hep B shots would substantially increase the level of mercury injected into infants at a critical period of brain development.

We now know that by 1991, Merck absolutely knew that the increase was harmful. A 1991 internal memo, recently revealed by the LA Times, concluded that exposure in infants within the first six month of life could be 87 times the level determined safe. The memo‘s damning revelations said:

For babies: the 25 ug of mercury in a single 0.5 ml dose and extrapolated to a 6 pound baby would be 25 times the adjusted Swedish daily allowance of 1.0 micrograms for a baby of that size. The total mercury burden in a baby is unknown, but it has been stated that the blood level of a newborn may exceed that of the mother. If eight doses of thimerosal-containing vaccine was given in the first six months of life (3 DTP, 2 HIB, and 3 Hepatitis B) the 200 micrograms of mercury given, say to an average size of 12 pounds, would be about 87 times the Swedish daily allowance of 2.3 micrograms for a baby of that size.

The memo even acknowledged that “the best way to go is to switch to dispensing the actual vaccines without adding preservatives.”

However, it went on to say that while this was the best solution, there was “a cost consideration the head of Health Services has to consider. Several large ampoules or bottles are more expensive than a smaller number of larger packages.”

So in essence, this Merck memo proves that by 1991, vaccine makers knew they were injecting poison into infants and decided profits were more important than the country’s most precious asset, an entire generation of children.

The vaccine makers are fighting hard against the removal of thimerosal for two reasons. The first is the usual suspect, greed. But the second reason is now higher on their list. The industry knows that if thimerosal were to be completely removed from all vaccines tomorrow, the public would not be able to ignore the corresponding decline, not only in cases of autism, but in the epidemic of all the strange disorders that have engulfed the public school system in all 50 states over the past 15 years. The decline is already happening in California, one of the first states to ban thimerosal.

In attempt to confuse the issue, officials have tried to avoid any discussion of the evidence establishing an association between mercury and a host of other neurological disorders.

In addition to autism, the epidemic includes attention deficit/hyperactivity disorder (ADD/ADHD) and speech or language delay and each has its own spectrum of symptoms. For example, autism is characterized by impairments of social interaction, communication, and behavior. ADD/ADHD is typified by persistent patterns of inattention and/or hyperactivity. Speech and language delay are characterized by sensory and auditory processing disorders impacting on communication. See Immunization Safety Review, Thimerosal-Containing Vaccines and Neurodevelopmental Disorder, IOM 2001.

Officials should quit using scare tactics to infer a threat to the vaccine program as a whole. The issue is not the vaccines, it’s the preservative that has to go. And its not just contained in childhood vaccines. Thimerosal is in other products given to unsuspecting victims.

The flu vaccine is probably the most commonly used product that still contains the preservative, but there are other shots that have it as well.

While adverse effects of vaccines to a small number of susceptible individuals might seem justified in the interest of the greater good to mankind, the brain-injuring effects arising as a result of the government forcing parents to inject a known poison into their precious children should not be tolerated.

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)