FDA Presentations

FDA Presentations (http://www.fda.gov/cber/summaries.htm)


ICDRA Conference – 9/19/2008

Government Again Concedes Vaccines Cause Autism

Government Again Concedes Vaccines Cause Autism


Mysterious Vaccine Court created in 1986 by the pharmaceutical industry, with the support of Congress, rules in favor of Bailey Banks against HHS.


LOS ANGELES, Feb. 25 /PRNewswire-USNewswire/ — Generation Rescue, Jenny McCarthy and Jim Carrey’s Los Angeles-based non-profit autism organization, today announced that the United States Government has once again conceded that vaccines cause autism. The announcement comes on the heels of the recently unsealed court case of Bailey Banks vs. HHS. The ruling states, “The Court found that Bailey would not have suffered this delay but for the administration of the MMR vaccine…a proximate sequence of cause and effect leading inexorably from vaccination to PDD [Autism].”


In a curious and hypocritical method of operation, the mysterious Vaccine Court not only protects vaccine makers from liability but supports a policy that has tripled the number of vaccines given to U.S. children – all after being made aware of the fact that these vaccines do, in fact, cause autism and repeatedly ruling in favor of families with children hurt by their vaccines.


“It was heartbreaking to hear about Bailey’s story, but through this ruling we are gaining the proof we need to open the eyes of the world to the fact that vaccines do, in fact, cause autism,” said Jenny McCarthy, Hollywood actress, autism activist, best-selling author and Generation Rescue board member. “Bailey Banks’ regression into autism after vaccination is the same story I went through with my own son and the same story I have heard from thousands of mothers and fathers around the country. Our hope is that this ruling will influence decision and policy-makers to help the hundreds of thousands of children and families affected by this terrible condition.”


Banks vs. HHS is the second known case where the Vaccine Court could not deny the overwhelming evidence showing vaccines caused a child’s autism. The first was the case of Hannah Poling in March of 2008, where the court found in her favor and awarded her family compensation.


Jim Carrey, Hollywood legend and Generation Rescue board member, reacted to the news, “It seems the U.S. government is sending mixed messages by telling the world that vaccines don’t cause autism, while, at the same time, they are quietly managing a separate ‘vaccine court’ that is ruling in favor of affected families and finding that vaccines, in fact, were the cause. For most of the autism community the question is no longer whether vaccines caused of their child’s autism. The question is why is their government only promoting the rulings that are in favor of the vaccine companies.”


Why is a secret court, which no one knows about or understands, quietly paying these families for vaccine injuries and autism? Deirdre Imus, Generation Rescue board member and founder of the Deirdre Imus Environmental Center for Pediatric Oncology says, “Over the past 20 years, the vaccine court has dispensed close to $2 billion in compensation to families whose children were injured or killed by a vaccine. I am not against vaccines and my own child has been vaccinated. But, I share the growing concerns of many parents questioning the number of vaccines given to children today, some of the toxic ingredients in vaccines, and whether we know enough about the combination risks associated with the multiple vaccines given to children during critical developmental windows.”


To help spread the word of the Banks ruling, Generation Rescue also bought a full-page ad that will run in the USA Today on 02/25/2009, which has a daily circulation of 2,272,815.


Also see: Generation Rescue Ad in USA Today: Court Again Concedes Vaccines Cause Autism

Alert over tainted meningitis vaccine: 60,000-dose recall after tests uncover bug

Alert over tainted meningitis vaccine: 60,000-dose recall after tests uncover bug

Thousands of doses of meningitis C vaccine were recalled last night after a contamination scare.

The alert was sounded after tests found traces of the bug Staphylococcus aureus, which can cause blood poisoning.

About 60,000 doses are being recalled, a third of which had already been delivered to GP surgeries and health clinics in the past month.

It is not yet known how many have been given to babies.

Government health chiefs said the recall was a ‘precautionary measure’ and no adverse reactions have been recorded in children in the UK.

A spokesman for the Medicines and Healthcare products Regulatory Agency (MHRA) said the decision to recall the two batches was made just to be on the safe side, even though ‘there is no reason for UK children to be at any risk’.

She added: ‘The batches concerned were tested prior to release and complied with all tests, including the sterility test.

‘The tested samples that failed the sterility test were part of a non-routine study undertaken by the company and were not part of the UK market product. This is an entirely precautionary action.

‘There is no reason to believe the UK batches are at risk of the problems of the material that was tested. These batches have been withdrawn to ensure that there are no grounds for anyone to be concerned.’

A Department of Health spokesman said: ‘If people have had this vaccine recently and are concerned contact your GP or NHS Direct. We know which practices have received this vaccine and they will be contacted directly.’

The vaccine, sold under the trade name Menjugate, was manufactured and packed in Italy by Novartis.

A spokesman for the pharmaceutical company said it was working with the MHRA and Italian ministry of health to recall two batches of Menjugate Kit distributed in the UK.

She said: ‘We are investigating a sterility-testing positive result from samples of one lot of aluminium hydroxide solvent which was used for the packaging of two lots of Menjugate.

‘The solvent lot passed all release specifications; the subject result was identified during a special study. Novartis is committed to being a safe and reliable provider of vaccines.’

Millions of jabs for meningitis C are administered every year in Britain as part of the routine immunisation of babies at two, three and four months.

The safety alert affects doses of the vaccine given as boosters at four months.

Meningitis, in which the protective membranes around the brain become infected and inflamed, kills at least one in ten sufferers.

Some survivors suffer permanent complications such as brain damage, epilepsy and deafness.

A decade ago, Britain became the first country to routinely vaccinate against the meningitis C – a move believed to save 150 lives each winter.

The programme was brought in to prevent two out of five cases of the disease – the rest are caused by the B strain for which there is not yet an effective vaccine.

The group C bacteria was regarded as a special threat at the time because it formed a growing proportion of overall meningitis infections in Britain.

Maintaining protection against invasive bacteria with protein–polysaccharide conjugate vaccines

Maintaining protection against invasive bacteria with protein–polysaccharide conjugate vaccines

Polysaccharide-encapsulated organisms are the leading cause of bacterial meningitis and pneumonia in children. The use of protein–polysaccharide conjugate vaccines in developed countries over the past two decades has markedly decreased the burden of disease and mortality from these organisms through direct protection of the immunized and through herd immunity. In the next decade, the widespread use of conjugate vaccines in the developing world should prevent millions of deaths. In this Science and Society article, we describe how vaccine-induced immunity wanes rapidly after vaccination in early childhood and argue that strategies that sustain protection in the population must be considered.

Rethinking Replacement and Resistance

Rethinking Replacement and Resistance  (The Journal of Infectious Diseases 2009;199:771–773)


Before 2000, the year in which the 7‐valent pneumococcal conjugate vaccine (PCV7; Prevnar, Wyeth) was introduced into the US infant immunization schedule, most antibiotic‐resistant strains of Streptococcus pneumoniae belonged to serotypes included in PCV7. During just the first 3 years after vaccine introduction, we observed profound reductions in the incidence of invasive pneumococcal disease (e.g., bacteremia and meningitis) caused by vaccine serotypes and their associated antibiotic‐resistant strains, not only among vaccinated children but also among persons too young [1] and too old [2] to receive the vaccine. The dramatic success of PCV7 in reducing pneumococcal disease in wealthy countries [36]—and the potential benefits to poor countries [7, 8]—have led to World Health Organization recommendations for the global introduction of conjugate vaccines [9] and to extraordinary efforts to finance vaccine purchase and delivery to the poorest countries of the world [10].

At the same time we were heralding the benefits of PCV7, we were alert to the unintended consequence of serotype replacement. This phenomenon, demonstrated convincingly in randomized, controlled trials [11], occurs when serotypes not included in a conjugate vaccine colonize the nasopharynx and “replace” the vaccine serotypes whose colonization is prevented by the vaccine. The net effect is that PCV7 does not reduce the overall prevalence of nasopharyngeal colonization. PCV7 serotypes are, on average, better suited to causing invasive disease than non‐PCV7 serotypes [12, 13]; therefore, vaccine‐induced elimination of PCV7 serotypes from the nasopharynx leads to a net reduction in invasive disease and antibiotic resistance. Of all the serotypes, 19A may come closest to having certain characteristics that make it a successful replacement serotype. First, serotype 19A has relatively high propensities for colonizing the nasopharynx (to maximize transmissibility) and for causing invasive disease. Second, serotype 19A was associated with antibiotic resistance even before the introduction of PCV7; therefore, when exposed to antibiotics prescribed for upper respiratory tract infections, it had a selective advantage over other, more susceptible serotypes. Finally, PCV7 has no efficacy against serotype 19A.

Increases in the incidence of serotype 19A associated with otitis [14], mastoiditis [15], and invasive disease [1618] have been described in multiple US settings since 2000, making it impossible to ignore the temporal association between the introduction of PCV7 and the emergence of serotype 19A. It seemed safe to assume that PCV7 had caused replacement with serotype 19A. There were hints, however, that we might have been presumptuous in attributing the rise of serotype 19A exclusively to the use of PCV7. In multiple studies conducted before PCV7 introduction, serotype 19A was identified as an antibiotic‐resistant serotype, not only in the United States [19] but in other parts of the world as well [20, 21]. Until now, the strongest evidence against PCV7‐induced serotype replacement was that the incidence of serotype 19A seemed to be increasing in Korea [22], France, and Belgium [23] before the introduction of PCV7. The article by Dagan et al. [24] in this issue of the Journal pushes us to question our assumptions about serotype replacement even more forcefully.

The authors describe the emergence of serotype 19A as a cause of otitis media among Bedouin children in southern Israel who, along with their Jewish counterparts, had not received PCV7. During 1999–2006, the proportion of otitis media cases among Bedouin children caused by serotype 19A increased from 8% to 14%. Among Jewish children over the same time period, the prevalence of serotype 19A varied between 8% and 14% without a clear upward or downward trend. These findings are not particularly striking until one examines the susceptibility patterns and clones of serotype 19A strains in these 2 groups. A stable 38% of serotype 19A strains causing otitis in Jewish children from 2002 to 2006 were resistant to penicillin, with very few isolates resistant to macrolides or multiple agents. In contrast, the Bedouin population experienced a dramatic increase in the prevalence of 2 multidrug‐resistant pneumococcal clones (ST‐276 and ST‐2928) of serotype 19A over the same time period. Why the difference?

One hypothesis is that Bedouin children may have had greater exposure to antibiotics than Jewish children. In fact, in the 20% of both populations for whom data were available, modest reductions in overall antibiotic use, including amoxicillin and cephalosporins, were observed. Azithromycin prescriptions, on the other hand, increased markedly in both groups—antibiotic replacement, so to speak. This is important for 2 reasons. First, azithromycin may promote macrolide resistance better than other macrolides because of its long half‐life and low extracellular concentrations [25]. Macrolide resistance often travels with other resistance determinants, so it is plausible that the dramatic increase in multidrug resistance can be attributed to increased azithromycin use. Second, azithromycin use increased dramatically in the United States after its licensure in 1991 at the same time that overall antibiotic use was declining [26] and the prevalence of multidrug‐resistant S. pneumoniae was increasing [27]. This pattern suggests that the appearance of multidrug‐resistant serotype 19A in the United States and southern Israel may somehow have been a response to the introduction and increased use of azithromycin. However, if Bedouin and Jewish children both experienced important increases in azithromycin use, why were the increases in multidrug‐resistant serotype 19A confined to the Bedouin population? A careful look at differences between these populations may shed light on this question.

One important difference relates to seasonal patterns of antibiotic use. Antibiotic prescribing among Jewish children declines substantially in warm months and is accompanied by reductions in antibiotic resistance, whereas, among Bedouins, antibiotic prescribing and the prevalence of antibiotic resistance are more consistent year‐round [28]. This more stable antibiotic pressure may force strains colonizing Bedouin children to maintain multidrug‐resistance determinants despite the fitness costs required to do so [29]. There are also important socioeconomic disparities to consider. According to Dagan et al., Jews and Bedouins live side by side without intermingling. Bedouins have lower family incomes, but their birth rates and family sizes are more than double those of their Jewish counterparts. If living conditions among Bedouins favor more intense transmission, this may be sufficient to overcome any growth costs paid by the organism to sustain multiple resistance determinants [30]. Similar relationships between socioeconomic factors and pneumococcal colonization and transmission have been described in other settings [18, 3134].

Is the emergence of serotype 19A in the PCV7 era entirely attributable to antibiotic use, and is the introduction of PCV7 pure coincidence? It is hard to imagine that increases in serotype 19A causing otitis and invasive disease are not in some way related to the introduction of PCV7, and evidence of increased genetic diversity within serotype 19A, including some antibiotic‐susceptible clones, suggests that a serotype‐specific selection process is at work [16]. But Dagan et al.’s study reminds us to consider how other important factors, such as antibiotics, contribute to well‐documented trends in individual pneumococcal serotypes in the absence of PCV7 [3537]. It is a cautionary note to resist the temptation to attribute all increases in nonvaccine serotypes to the introduction of PCV7, as biologically plausible as that relationship may be. As we prepare for the availability of pneumococcal conjugate vaccines with expanded valency and as the introduction of conjugate vaccine moves forward among vulnerable populations of the world’s poor, Dagan et al. remind us that vaccines do not cause antibiotic resistance, antibiotics do.


See Also:

Introduction and Proliferation of Multidrug‐Resistant Streptococcus pneumoniae Serotype 19A Clones That Cause Acute Otitis Media in an Unvaccinated Population

(The Journal of Infectious Diseases 2009;199:776–785)



On February 12, the federal “Vaccine Court” in Washington issued a sweeping ruling in three highly touted “test cases” against families who claimed that their childrens’ autism had been caused by vaccines. The Special Masters in those three cases found that Petitioners failed to establish causation between MMR vaccines, the mercury-laced vaccine preservative thimerosal, and autism (the court decision, which is under appeal, deferred any finding on a thimerosal-only theory of causation). The rulings could have a significant precedential impact on some 5,000 families who opted to bring their cases in the Omnibus Autism Proceedings (OAP) hoping that the vaccine court would officially hold that the MMR vaccine or thimerosal had caused autism in their children.

The New York Times joined the government Health Agency (HRSA) and its big pharma allies hailing the decisions as proof that the scientific doubts about vaccine safety had finally been “demolished.” The US Department of Health and Human services said the rulings should “help reassure parents that vaccines do not cause autism.” The Times, which has made itself a blind mouthpiece for HRSA and a leading defender of vaccine safety, joined crowing government and vaccine industry flacks applauding the decisions like giddy cheerleaders, rooting for the same court that many of these same voices viscously derided just one year ago, after Hannah Poling won compensation for her vaccine induced autism.

But last week, the parents of yet another child with autism spectrum disorder (ASD) were awarded a lump sum of more than $810,000 (plus an estimated $30-40,000 per year for autism services and care) in compensation by the Court, which ruled that the measels-mumps-rubella (MMR) vaccine had caused acute brain damage that led to his autism spectrum disorder.

The family of 10-year-old Bailey Banks won their case quietly and without fanfare in June of 2007, but the ruling has only now come to public attention. In the remarkably clear and eloquent decision, Special Master Richard Abell ruled that the Banks had successfully demonstrated that “the MMR vaccine at issue actually caused the conditions from which Bailey suffered and continues to suffer.”

Bailey’s diagnosis is Pervasive Developmental Disorder — Not Otherwise Specified (PDD-NOS) which has been recognized as an autism spectrum disorder by CDC, HRSA and the other federal health agencies since at least the 1990s.

In his conclusion, Special Master Abell ruled that Petitioners had proven that the MMR had directly caused a brain inflammation illness called acute disseminated encephalomyelitis (ADEM) which, in turn, had caused the autism spectrum disorder PDD-NOS in the child:

The Court found that Bailey’s ADEM was both caused-in-fact and proximately caused by his vaccination. It is well-understood that the vaccination at issue can cause ADEM, and the Court found, based upon a full reading and hearing of the pertinent facts in this case, that it did actually cause the ADEM. Furthermore, Bailey’s ADEM was severe enough to cause lasting, residual damage, and retarded his developmental progress, which fits under the generalized heading of Pervasive Developmental Delay, or PDD [an autism spectrum disorder]. The Court found that Bailey would not have suffered this delay but for the administration of the MMR vaccine, and that this chain of causation was… a proximate sequence of cause and effect leading inexorably from vaccination to Pervasive Developmental Delay.

The Bailey decision is not an isolated ruling. We now know of at least two other successful ADEM cases argued in Vaccine Court. More significantly, an explosive investigation by CBS News has found that since 1988, the vaccine court has awarded money judgments, often in the millions of dollars, to thirteen hundred and twenty two families whose children suffered brain damage from vaccines. In many of these cases, the government paid out awards following a judicial finding that vaccine injury lead to the child’s autism spectrum disorder. In each of these cases, the plaintiffs’ attorneys made the same tactical decision made by Bailey Bank’s lawyer, electing to opt out of the highly charged Omnibus Autism Proceedings and argue their autism cases in the regular vaccine court. In many other successful cases, attorneys elected to steer clear of the hot button autism issue altogether and seek recovery instead for the underlying brain damage that caused their client’s autism.



How Vitamins and Minerals Can Affect Autism

ADVICE: How Vitamins and Minerals Can Affect Autism

For over a decade, claims have been made that vitamin and mineral supplements may improve the symptoms of autism in a natural way. While not all researchers agree about whether these therapies are scientifically proven, many parents and an increasing number of physicians report improvement in people with ASD when using individual or combined nutritional supplements. Malabsorption problems and nutritional deficiencies have been addressed in several as-of-yet unreplicated studies. A few studies suggest that intestinal disorders and chronic gastrointestinal inflammation may reduce the absorption of essential nutrients and cause disruptions in immune and general metabolic functions that are dependent upon these essential vitamins. Other studies have shown that some children on the autism spectrum may have low levels of vitamins A, B1, B3, and B5, as well as biotin, selenium, zinc, and magnesium; while others may have an elevated serum copper to plasma zinc ratio, suggesting that they may benefit by avoiding copper and taking extra zinc to boost their immune system. Other studies have indicated a need for more calcium. There are several laboratories that test for nutritional deficiencies, but many insurance companies will not pay for these tests. Perhaps the most common vitamin supplement used for individuals with ASD is vitamin B, which plays an important role in creating enzymes needed by the brain. In several studies on the use of vitamin B and magnesium (which is needed to make vitamin B effective), almost half of the individuals with autism showed improvement. The benefits include decreased behavioral problems, improved eye contact, better attention span, and improvements in learning. Other research studies have shown that other supplements may help symptoms as well. Cod liver oil supplements (rich in vitamins A and D) have resulted in improved eye contact and behavior of children with autism. Vitamin C helps in brain function and deficiency symptoms like depression and confusion. Increasing vitamin C has been shown in a clinical trial to improve symptom severity in children with ASD. If you are considering the addition of vitamins or minerals to your child’s diet, a laboratory and clinical assessment of nutritional status is highly recommended. The most accurate method for measuring vitamin and mineral levels is through a blood test. It is also important to work with someone knowledgeable in nutritional therapy. While large doses of some vitamins and minerals may not be harmful, others can be toxic. Once supplements are chosen, they should be phased in slowly (over several weeks) and then the effects should be observed for one to two months.

http://www.autism-society.org By Autism Society of America – February 20, 2009