FDA Presentations

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

 

ICDRA Conference – 9/19/2008

• Responding to Vaccine Safety Events (PPT – 597 KB) – Karen Midthun, MD
• Post-Marketing Surveillance: Passive and Active Approaches and Use of Electronic Databases (PPT – 411 KB) – Karen Midthun, MD

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 [3–6]—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 [16–18] 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, 31–34].

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 [35–37]. 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)

ANOTHER AUTISM CASE WINS IN VACCINE COURT

ANOTHER AUTISM CASE WINS IN VACCINE COURT

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.

Continued

 

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

Well, Well, Well: Bad is bad

Well, Well, Well: Bad is bad

I’m honoured, and not at all surprised, to hear from Dr Mansi (“Merck Frosst responds,” Letters, Feb 5 – Feb 11, 2009). He obviously cares a lot about Gardasil and has put out some highly sensitive radar for commentary on it, which is good—this is a conversation we need to be having. 

Cervical cancer and other HPV-linked diseases are horrible, on that he and I agree—but that’s probably where our agreement ends. And despite his authoritative tone, I offered no misinformation. 

 

Mansi cites a US Centers for Disease Control (CDC) study that found no significant difference in adverse events between a Gardasil-vaccinated group and a non-Gardasil group. But a very recent study published in the Canadian Medical Association Journal found Gardasil to cause adverse reactions five to 26 times more often than other vaccines. That’s 500 per cent more, at the low end. The study was based on 114 000 young women who had received Gardasil compared to young women who had received other vaccines. 

 

But to bring in the perspective of someone with a little more credibility than I as a journalist might have, I spoke with neuroscientist and UBC professor Chris Shaw. Dr Shaw’s research has turned up some alarming links between aluminum hydroxide (used in vaccines) and neurological damage—something called neuro-inflammation, which is linked to autism, epilepsy, Alzheimer’s, Parkinson’s, ALS and autoimmune disease.

 

Gardasil contains aluminum, and although aluminum adjuvants—the non-viral component of vaccines, designed to stimulate immune response—have been used in vaccines for decades, Shaw says they either haven’t ever been properly tested for safety, or the evidence has been tossed aside. 

 

“Attenuated microbes alone don’t give a sustained immune response, but aluminum does,” he explains. “Without an adjuvant that stimulates a long-lasting immune response, vaccines just don’t work all that well.” 

 

But aluminum generates molecules called tau proteins, which form the clumps in the brain that we see with neurological disease. “What I’ve seen in the lab is the reason my daughter’s never had a vaccine,” he tells me. “The way the aluminum danger is usually dismissed is that we ingest aluminum all the time, but digestive systems have ways to excrete it. When it is injected, it’s an entirely different thing.”

 

Which brings me back to Gardasil and double-blind trials. When we’re comparing two groups, and the control group has been given other vaccines or an aluminum-containing placebo, reactions between the two groups will be similar. And that’s exactly the kind of comparison that has mostly been made in clinical trials. What we need for an accurate picture is to compare vaccinated with completely unvaccinated groups over a long period of time. 

 

As to approval given by Health Canada and other health agencies, we need only to have a look at history, to read accounts like that of former Health Canada employee and whistleblower Dr Shiv Chopra to be reminded of how things work. 

 

“Vaccines are a business, like any other,” the Cochrane Library Review reminds us. “The only difference is that governments are co-sponsors with industry … overestimation of the threat by the target diseases, suppression of data on adverse events and exaggeration of effectiveness are frequent. In the case of population vaccination programs, both governments and industry have conflicts of interest.” 

 

And financial interests, as we all know, tend to trump safety. “Merck lobbied every opinion leader, women’s group, medical society, politician, and went directly to the people—it created a sense of panic that says you have to have this vaccine now,” Dr Diane Harper—cervical cancer researcher, vaccine developer and professor of medicine at Dartmouth Medical School—told the New York Times last August.

 

Mansi insists that the full burden of disease prevented by Gardasil is being overlooked, but we may in fact not be decreasing the burden of disease at all. By continually over-stimulating the immune systems of our children we may be trading one tragedy for another, much greater one. 

As to the comment encouraging readers to consult physicians—absolutely, but it is fair to remind the public where physicians get their information on drugs and vaccines.

SBS and the Vaccine Connection Resources/Articles

Is it Shaken Baby or Barlow’s Disease Variant?

 

C. Alan B. Clemetson, M.D.

ABSTRACT-Retinal petechiae, subdural hemorrhages, and even broken bones do not always indicate trauma or child abuse. Infantile scurvy or a variant form still occurs today and can be mistakenly diagnosed as nonaccidental injury (NAI). Histamine levels, which are characteristically increased in vitamin C depletion, may reach a toxic level owing to infection or the injection of foreign proteins. Histamine intoxication can cause a variant of Barlow.s disease, with weakness of the retinal vessels and the bridging veins and venules between the brain and the dura mater in infants.

 

Elevated blood histamine caused by vaccinations and Vitamin C deficiency may mimic the shaken baby syndrome 

The findings of subdural hematoma and retinal hemorrhages in infants, without any documented history of major trauma, do not always indicate child abuse. A combination of ascorbate depletion and the injection of foreign proteins can cause a very high blood histamine level, leading to capillary fragility and venular bleeding. This can be prevented by the administration of vitamin C. PMID: 15050101 [PubMed - indexed for MEDLINE]

WAS THAT BABY REALLY SHAKEN?

C. Alan B. Clemetson, M.D. Well-meant child-abuse laws have given rise to many inappropriate accusations of shaken-baby-syndrome, without any real evidence that the infants were ever shaken or assaulted in any way.

 

SBS or Vaccine-Induced Encephalitis?

Harold E. Buttram, M.D. The shaken baby syndrome theory, as it stands today, assumes that findings of brain and/or retinal hemorrhages in the absence of known major accidental trauma are diagnostic of shaken baby syndrome (SBS), sometimes also referred to as non-accidental injury. For reasons that will be reviewed in this article, this theory is being increasingly challenged in the scientific literature.

 

Shaken Baby Syndrome on Shaky Ground

Viera Scheibner, PhD. Published in the “Journal of Australasian College of Nutritional & Environmental Medicine”, Vol. 20 No. 2; August 2001.  ABSTRACT -An epidemic of accusations against parents and baby sitters of Shaken Baby Syndrome is sweeping the developed world. The United States and the United Kingdom are in the forefront of such questionable practice. Brain (mainly subdural, less often subarachnoid) and retinal haemorrhages, retinal detachments, and rib and other bone ‘fractures’ are considered pathognomic. However, the reality of these injuries is very different and well documented: the vast majority occur after the administration of childhood vaccines and a minority of cases are due to documented birth injuries and pre-eclamptic and eclamptic states of the mothers.

 

RULES OF EVIDENCE IN THE COURTS

Harold E. Buttram, MD. Court rules of evidence affect SBS defenses. Among the many adversities and difficulties facing the American family today, there is a relatively new and growing hazard — one featuring a parent or caretaker who may be falsely accused of murdering or injuring an infant by shaken baby syndrome, when the true cause of death or injury arises from other sources. Very tragically, child abuse does occur and deserves appropriate punishment. However, it is equally tragic when a family, already grieving from the sudden and unexpected death of their infant, finds a father or mother unjustly accused, convicted, and imprisoned for murder of the infant, a murder of which he or she is innocent. I know of an attorney, an anesthesiologist, a Mormon mother, an Amish mother, and others accused and/or imprisoned (many believe falsely) on charges of injuring or murdering an infant by SBS. It could happen to anyone regardless of race, sex, education, finances, or social status.

 

SBS Defense

 

 

Shaken Baby Syndrome: Pitfalls in Diagnosis and Demographics

F. Edward Yazbak, M.D., FAAP. Medical Studies.

 

Multiple Vaccinations And the Shaken Baby Syndrome 

Child abuse is a terrible crime and the failure to recognize it is unforgivable. An erroneous diagnosis of inflicted head trauma is just as tragic and the resulting destruction of a family is one of the gravest injustices of modern times. Many have recently questioned the existence of the so-called “Shaken Baby Syndrome” and the concept that the last caretaker must have been guilty. Careful reviews often uncover relevant findings that were missed or ignored. Recent pediatric vaccinations have been suspected as precipitating factors. A recent combination of seven antigens is the focus of this investigation. The three vaccines in question were 5 in 1 vaccine combination, HIB conjugate vaccine, 7-valent pediatric pneumococcal vaccine.

 

SUDDEN, UNEXPLAINED INFANT DEATH INVESTIGATION

CDC. I the world of death investigation, infant death investigation is unique. From scene through certification, these investigations require skill and knowledge drawn from disciplines outside those typically considered a part of medicolegal education. This chapter presents an overview of sudden, unexplained infant death, its typical causes, and the importance of the death scene investigation to accurate cause and manner of death determination.

 

Shaken Baby Syndrome and the Death of Matthew Eappen

A Forensic Pathologist’s Response

John Plunkett, M.D.  The American Journal of Forensic Medicine and Pathology 20(1):17-21, 1999.

Subdural hemorrhage, retinal hemorrhage, and cerebral edema have been considered diagnostic for a “shaken infant” since the syndrome was described almost 30 years ago. However, the specificity of these findings has been disputed by defense witnesses in recent U.S. criminal prosecutions. This review examines the scientific basis for the shaken baby syndrome.

 

 

Shaken Babies

Articles by Archie Kalokerinos, MD

 

Sudden Infant Death and the Shaken Baby Syndrome: How They Are Connected!

 

Lecture Was Given by Archie Kalokerinos, MD  

Dr. Kalokerinos believes that the pathologies found at autopsy on many of these “shaken” babies, which include intracranial and retinal hemorrhages and bone changes that can be mistaken for fractures, are due to processes involving infections and toxins produced by the infections, along with an increased utilization of vitamin C.  Dr. Kalokerinos has reasons to believe that there is a relationship between SIDS (sudden infant death syndrome) and the pathologies found in SBS (shaken baby syndrome.)

 

 

The evidence base for shaken baby syndrome

BMJ 2004 328:719-720 Editorial

The phrase “shaken baby syndrome” evokes a powerful image of abuse, in which a carer shakes a child sufficiently hard to produce whiplash forces that result in subdural and retinal bleeding. The theory of shaken baby syndrome rests on core assumptions: shaking is always intentional and violent; the injury an infant receives from shaking is invariably severe; and subdural and retinal bleeding is the result of criminal abuse, unless proved otherwise.¹ These beliefs are reinforced by an interpretation of the literature by medical experts, which may on occasion be instrumental in a career being convicted or children being removed from their parents. But what is the evidence for the theory of shaken baby syndrome?

 

 VITAMIN C and SBS

 

Child Abuse or Life-Threatening Medical Misdiagnosis?

No reliably-witnessed case of shaking in America has ever produced the symptoms associated with SBS, so accusations are based on assumptions, which in turn are based on symptoms alone–symptoms that singly and as a group have medical causes unrelated to abuse. The fact is, there are tests that can separate the innocent from the guilty, but doctors refuse to run them (DIFFERENTIAL DIAGNOSIS–eliminating medical causes to support an assumption of abuse).This only happens in suspected SBS cases in spite of pediatric emergency medical guidelines compelling doctors to do so. The question is, “Why?”

 

Shaken Baby/Impact Syndrome: Flawed Concepts and Misdiagnoses

(Based on a Review of Twenty-Two Cases) Harold E Buttram, M.D.

The following article represents a review of twenty-two cases of shaken baby syndrome (SBS) accusations and/or convictions over a period of approximately three and a half years. Its primary purpose is to offer a composite of information gained from study of these cases to parents or caretakers who have been accused and/or convicted of child abuse in the form of SBS, information which may be of value in their defense. Every effort has been made to maintain simplicity and clarity in the organization of the material. Each section is designed to be complete in itself, and for this reason some portions are repetitious. 

 

In the News:

 

Review of infant deaths urged

 

New look at 142 `shaken baby’ cases over 2 decades justified, Ontario chief forensic pathologist says.

 

MD casts doubt on shaken baby syndrome

 

 

 

KIRK MAKIN/JUSTICE REPORTER/December 6, 2007

The deaths of 142 Ontario babies since 1986 were attributed to a cause many scientists now believe has been discredited – shaken baby syndrome – the province’s top forensic pathologist testified yesterday.

At the time, the fact that most of the injuries were to her neck, shoulders and head was considered highly unusual and suggestive of a homicidal stabbing. However, Dr. Pollanen said that recent studies have shown that, unlike attacks on adults, dogs frequently savage those portions of a child’s anatomy.

 

Michael Pollanen told Mr. Justice Stephen Goudge that skepticism about SBS is so great that he should consider urging a review of the cases when he produces his report next spring.

Dr. Pollanen said he did not know how many of the 142 cases were investigated as suspicious deaths, resulting in criminal charges, convictions or the seizure of siblings from the parents of the pediatric victims.

“To be very straightforward, this would generate a lot of controversy in the community… because it is very polarized,” Dr. Pollanen said.

The inquiry was launched last spring to look at how the province’s former star pathologist, Charles Smith, was able to rise to the top of his profession despite a series of autopsy errors that led to miscarriages of justice.

However, Dr. Pollanen’s revelation yesterday went beyond Dr. Smith to include the work of other pathologists who diagnosed SBS – a conclusion that was typically made upon the discovery of brain swelling and retinal bleeding combined with tissue damage to the linings of the brain.

Dr. Pollanen said that in recent years, a significant segment of the scientific community has come to believe that these symptoms can be found in babies who suffer an accidental blow to the head or an innocent fall.

He testified that Britain took the lead a couple of years ago, systematically re-examining a large number of SBS cases in what became known as the Goldsmith review.

“In the U.K., some of these convictions were quashed,” he said. “The scope of the problem is not clear in Ontario. There needs to be some consideration of whether we should undertake something like the Goldsmith review.”

Similar reviews may follow in other countries, Dr. Pollanen said.

“One of the factors to put fuel on the fire in the U.S. is that traditionally, sentences have been robust in these kind of cases – the death penalty or life imprisonment.

“In the face of what some people believe to be remarkable miscarriages of justice in some of these cases, it really has polarized groups of experts.”

Dr. Pollanen also testified that:

A 1991 ruling by a judge of the Ontario Court of Justice who acquitted a 12-year-old of murdering a baby was “a masterful analysis of the case … that was slightly ahead of its time.” Dr. Pollanen was effectively endorsing the judge, Mr. Justice Patrick Dunn, who rejected Dr. Smith’s testimony in acquitting the babysitter. The inquiry has heard that Dr. Smith often told colleagues that Judge Dunn later confided he regretted the acquittal and should instead have convicted the babysitter.

With not a single medical school in Canada offering forensic pathology training as an area of subspecialty, “I would say we have lagged about 40 years behind in comparison to other systems.”

Forensic pathologists working in provincial coroners’ systems are “prohibitively” underpaid in comparison to their counterparts in the private sector.

Defence counsel in Ontario will never have more than one or two forensic pathologists willing to work on homicides unless legal aid funding improves substantially and experts get over their revulsion for disputing conclusions by colleagues testifying for the Crown.

Advances in forensic pathology have made it even more clear that a Kingston baby known as Sharon definitely died of bites from a pit bull.

 

Controversial doctor admitted his knowledge of forensic pathology was ‘woefully inadequate’

Tom Blackwell / National Post-Canwest News Service   January 28, 2008

TORONTO – Dr. Charles Smith apologized for his mistakes again Monday and admitted his knowledge of forensic pathology was “woefully” inadequate during his years as head of Ontario’s pediatric forensic pathology unit.

Smith began his much-anticipated testimony at the inquiry examining his discredited work by acknowledging and voicing regret for his well-documented failings.

As several of the people wrongly prosecuted for homicide in his cases looked on, he conceded he had little training in the forensic field or in courtroom testimony and sometimes behaved unprofessionally.

“I have come to appreciate mistakes I have made and I am sorry for them,” a solemn-looking Smith told the inquiry. “I also recognize that at times my conduct was not professional and I deeply regret that.

“I do accept full responsibility for my work and for my opinions and for my actions.”

The inquiry was called last year after a panel of international experts found he had made serious errors in 20 of 45 criminally suspicious deaths he helped investigate between 1991 and 2001. Parents or other caregivers were charged in most of the cases, though many have since been cleared.

The outside experts told the inquiry Smith came to conclusions that were clearly unjustified, gave speculative and misleading testimony and seemed to have no training in forensic pathology.

Top officials of the coroner’s office said they generally overlooked the mistakes for more than a decade.

Colleagues testified to Smith’s disorganized, tardy work habits.

Though he was certified as a pediatric pathologist, he conceded Monday he received virtually no formal training in forensic pathology – dealing with cases that have a legal aspect.

“It was self taught, it was minimal,” he said of his knowledge of the field. “In retrospect, I realize it was woefully inadequate.”

He also confessed to receiving little training in being an expert witness at criminal trials, apart from a two-day course he took in the United States.

“I thought I knew it, but I realize now just how profoundly ignorant I was.”

Sherry Sherret, convicted of infanticide in the 1996 in the death of her four-month-old son Joshua, said she has many questions she wants to hear answered by the pathologist, whose evidence was key in her case.

“I would want to ask him . . . why did he do it, how does he feel, does he regret anything that he did,” she said, but conceded that others bear some of the blame for what happened, too.

“In the long run, it’s not 100 per cent his fault, because obviously, someone wasn’t watching him.”

 

Doubts about shaken baby syndrome

…is the science related to it conclusive enough to convict beyond reasonable doubt when there is little other evidence pointing to guilt?

 

Shot in the dark

Heartbroken woman wonders if vaccines killed her infant son

Shaken Baby Syndrome: Debunking the Myth

In 1997 the world held its breath as the media followed closely Louise Woodward’s “nanny” trial. She had allegedly committed the crime of shaking a baby, which resulted in the death of infant Matthew Eappen. Miss Woodward was a 19-year-old British au pair with no criminal record, yet she was “disliked” by the camera and as is often the case in crimes involving children, was presumed guilty. 

Doubt over ‘shaken baby’ theory that has sent dozens of parents to prison

Two British pathologists have found that a combination of injuries used to diagnose abuse, known as the “triad”, can happen naturally.

Dr Irene Scheimberg, from London’s Bart’s Hospital, and Dr Marta Cohen, from Sheffield Children’s Hospital, warn that bleeding on the brain and retinas, swelling of the brain and oxygen deficiency do not only occur through vigorous shaking.

Their discoveries could have a dramatic effect on future child abuse trials and child protection hearings.

Dr Scheimberg said: “When there is no evidence of physical abuse, apart from the haemorrhaging, we may be sending to jail parents who lost their children through no fault of their own.

“As scientists it is our duty to be cautious when we see the triad and to take each case on its merits. We owe it to children and their families.”

The study, published in the journal of Paediatric Developmental Pathology, found that the symptoms of shaken baby syndrome can happen in babies before they are taken home from hospital.

The authors looked at 25 babies who had died shortly before delivery and 30 newborns who had haemorrhages and found similar damage to the brains of all the babies.

The study concluded that the symptoms are common in young babies and could be caused by a traumatic birth or other conditions.

Dr Scheimberg and Dr Cohen believe that what they have found means police and lawyers will need more evidence than bleeding in the brain to prove that a baby has suffered child abuse.

Dr Scheimberg said: “We now know that mothers who have babies through normal vaginal delivery can have a child with a subdural haemorrhage and also retinal bleeding.

“We also know that many of these bleeds resolve themselves – with no outward sign of damage in the first few weeks of life and these children grow up to live a normal life.

“The other group are those children who present with signs of shaken baby syndrome whose bleeding has continued and got worse. These are the children who the courts suspect have been harmed by their parents.”

The evidence could now be used in a string of appeals, including the case of childminder Keran Henderson, who is serving three years for the manslaughter of 11-month-old Maeve Sheppard.

Medical experts argued that Maeve’s injuries indicated that she had been violently shaken.

But Henderson, of Iver Heath, Buckinghamshire, said the baby had a fit while she was changing her nappy.

Her lawyer, leading child abuse expert Bill Bache, said he was “absolutely sure” the research will be used in appeal cases.

“It is very likely we will use it in Keran Henderson’s appeal,” he added.

Mr Bache said the evidence may also be used in at least four further cases.

The “triad” of symptoms first came to public attention in 1998 in the US trial of British au pair Louise Woodward, who was found guilty of the second-degree murder of eight-month-old Matthew Eappen in October 1997. She was sentenced to a minimum of 15 years to life in prison.

Her conviction was then reduced to involuntary manslaughter. Her sentence was also reduced to time served on remand, 279 days, and she was freed.

Around 200 cases of shaken baby syndrome are diagnosed in Britain every year and many accused of abuse strenuously deny any wrongdoing.

 

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