On 24 February 1999, after 3 days of testimony, Alan Raymond Yurko was found guilty of aggravated child abuse and first degree murder in the death of his infant son Alan Joseph, hereafter referred to as Baby Alan. Upon reviewing the case of the State of Florida v. Alan Raymond Yurko (Case No. CR98-1730), it has become apparent that relevant information, which would have affected the decision rendered in this case, was neither presented nor explored. It has become equally apparent that the parents of Baby Alan did not receive adequate professional medical disclosure that may have prevented the untimely death of their infant.

BACKGROUND

Baby Alan was born prematurely, at 35 weeks gestation, to Francine Ream Yurko on 16 September 1997 after a complicated pregnancy. The birth was chemically-induced at that time due to a noted lack of amniotic fluid. During her pregnancy, the mother experienced gestational diabetes, group B Streptococcal vaginal infection, urinary tract infection, Escherichia coli infection, was treated with antibiotics, and failed to gain weight during her pregnancy. In fact, the mother lost 10 pounds during the pregnancy and regained only 10 pounds. She was unable to take prenatal vitamins due to illness. Under such conditions, the child would have been born with severe nutritional deficiencies and under-developed organs.

The 5 lb. 8 oz. newborn was noted to be in respiratory distress, with grunting retractions noted, and infiltrates were observed in the upper left lung. Baby Alan was placed in NICU under an oxyhood; he was intubated and given ampicillin and gentamicin. The child also demonstrated decreased muscle tone and activity and slightly decreased reflexes. Severe hypoxia, acidosis, dehydration, hypoglycaemia, and reduced renal function were also noted. Within a few days of birth, the baby developed jaundice. The baby exhibited no growth over 6 days in the hospital. On 23 September 1997, the child was circumcised, prior to discharge.

Following discharge, the baby continued to experience respiratory problems, with the grunting retractions persisting. Periodic episodes of apnea were observed by his parents. Jaundice was present for a month. Baby Alan received weekly weighing and check-ups. On 10 October 1997, progress notes indicate that the baby was experiencing gas, painful bowel movements, and his stomach looked puffed out. These symptoms are consistent with milk intolerance.

During his 2 November 1997 check-up, Baby Alan was still experiencing congestion and constipation. On 11 November 1997, despite the fact that Francine noted the child was sick, Baby Alan received six vaccines: diphtheria, tetanus, pertussis, haemophilus influenza B, oral polio and hepatitis B. Following vaccination, Baby Alan exhibited lethargy, irritability, inappetence, fever and difficulty sleeping. Approximately 10 days later, he developed a high-pitched cry. Within a few days, on 24 November 1997, Baby Alan began wheezing, vomiting and stopped breathing. Baby Alan was in the sole care of his father at the time. Alan Raymond Yurko unsuccessfully attempted to resuscitate his son. The Baby was brought to Orlando's Princeton Hospital where he was resuscitated approximately 20 minutes after the onset of the apneic episode.

Initial tests revealed anaemia, an elevated WBC count, elevated liver enzymes, bilirubin 0.6, blood sugar 337, a light growth of cocci, etc. Baby Alan was then transferred to Orlando's Florida Hospital where he was placed on life support. He was found to have a small right subdural hematoma, 1-2 sites of intraparenchymal bleeding, retinal haemorrhage, bilateral pulmonary infiltrates (pneumonitis) and small healing fractures on the left 6th and 7th ribs. After 75 hours of hospitalization, Baby Alan was removed from life support and pronounced dead.

Dr. Sashi B. Gore performed the autopsy on 29 November 1997 and brain and spinal cord evaluations were conducted on 19 December 1997 with Dr. Gary Pearl. Significant findings include: minor contusions on both temporal areas of the head (fresh and reasonably resulting from hospital procedures), a small bruise on the lower right eyelid, subdural haemorrhages on both the left and (predominantly) right sides, haemorrhage at the base of the brain and in the lumbar and lumbothoracic region of the spine, partially healed fractures on the 5th, 6th, 7th, and 10th ribs of the left side only, mildly haemorrhagic lungs, pale kidneys, and the absence of the heart, liver, gallbladder, spleen, pancreas, mesenteric lymph nodes and parts of the small intestine due to harvesting for transplant. No toxicology studies were performed, no bodily fluids could be collected, and there was no examination of the meninges or spinal fluid described.

Dr. Gore records the death as a homicide caused by subdural hemorrhage due to Shaken Baby Syndrome. Astoundingly, Dr. Gore concludes his autopsy report by stating that "This 2 month old black male infant died as a result of Shaken Baby Syndrome." (emphasis added). That the child was actually 2.5 months of age at death, versus the 2 months recorded by Dr. Gore, could be disregarded as an estimate but that he incorrectly describes the baby as being black leads one to question whether there may have been some confusion with another case. Additionally, the child Dr. Gore examined had a head circumference of 22 cm whereas Baby Alan's progress notes, recorded during his regular medical check-ups, indicate that on 1 October 97 his head circumference was 33.3 cm and on 10 October 1997 the circumference was 34.5 cm.

COURT PROCEEDINGS

During the trial, the jury heard testimony from six witnesses for the State and only one witness for the defense. The Yurko's were not in a financial position to hire a lawyer and a public defender was assigned to the case. The sheer imbalance of the number of witnesses presenting for the State, as opposed to the sole witness presenting for the defence, in no way indicates that the State's case was more substantial. However, one must question whether the jury would have interpreted the evident imbalance, i.e. the sheer volume rather than the substance of testimony, as being indicative of which side presented the more convincing case.

Having reviewed the testimony, it is clear that much of the information presented would have been extremely difficult for the lay person to understand. Juries are comprised of ordinary citizens and they are not required to understand technical medical concepts in order to serve. In this case, it was apparent that much of the testimony presented would have been beyond reasonable common knowledge. Essentially, the jury could not make a determination of guilt or innocence with any true understanding of the facts, even if they had been presented with all of the information that should have been introduced in court. Nonetheless, significant information, that would have altered the jury's decision, was never presented. In particular, the impact of vaccinating an ill infant, in Baby Alan's condition, was never presented nor explored. This deficiency resulted in the wrongful conviction of Alan Raymond Yurko.

VACCINATION

That vaccine-related injuries and deaths occur is not disputed, rather it is the extent, frequency and causal factors that are argued by scientists and health care authorities. It is well-established through scientific studies and, in fact, on vaccine package inserts, that immunization recommendations are directed at healthy children. It is never advisable to vaccinate a child whose immune system is already compromised in any way because the child will not elicit a strong immune response to the vaccination and because they may be at particular risk of an adverse event. Baby Alan was most assuredly at risk for a serious vaccine-induced adverse event due to a number of preconditions that should have contraindicated vaccination.

As mentioned above, this child was born prematurely and his organs would not have been as well-developed as a child born at term. The mother was unable to gain weight during her pregnancy necessarily indicating that the infant would not have received adequate nutrition. Vitamin deficiency, and particularly vitamin C deficiency, clearly precipitates severe, and often fatal, vaccine injuries. Judging by the greenstick fractures to the ribs, it appears that this child was severely deficient in at least vitamin C and perhaps also vitamin D. Furthermore, it should be noted that correlations between such fractures and apnea, anaemia, and premature birth have been established. That Baby Alan=s physician did not find any evidence of injury during regular examinations, would indicate that these fractures were not trauma-induced, but, rather, induced by vitamin deficiency. The child also was found to have pneumonitis and apnea.

Under these conditions, there is no question that the attending physician should have informed the parents that vaccination was too risky for this child. Even if all of the factors had not been evident at the time, vaccination should at least have been deferred or refused based upon the child's known history. Not only did the attending physician fail to inform the parents of the inherent risks, he chose to administer 6 vaccines simultaneously. It must be understood that this already challenged child was then exposed to 6 different diseases simultaneously as well as a series of toxic and carcinogenic chemicals. The result of which could hardly be expected to improve his health.

Further, Baby Alan had evident gastrointestinal problems, suggestive of milk intolerance, which should have indicated a special risk factor to the physician. In a communication dated 24 July 2001, Francine Yurko stated that both she and her daughter have both had difficulty with milk products so it would not be unusual to find that Baby Alan also inherited this sensitivity. Francine Yurko also stated that she did drink milk during the period when she breastfed and she was also supplementing breastfeeding with a milk-based formula. There is no question, then, that Baby Alan was exposed to milk and, most significantly, to bovine serum albumin (BSA).

BSA sensitivity presents an important health risk to vaccinees. In mouse tests, it has been found that if mice are both sensitized to bovine serum albumin and receive the pertussis vaccine, they exhibit physiological and behavioural changes, suffer encephalopathy and death, resembling the same post-pertussis immunization encephalopathy observed in human infants. This is true even if the pertussis antigen has been genetically-modified. Neither BSA alone, nor the pertussis vaccine alone, could induce encephalopathy in mouse studies. The level to which mice are predisposed to BSA sensitivity directly correlates with their potential to experience brain-injury following vaccination.

Post-mortem examination of the brain [(in experimental mice)] after immunization revealed diffuse vascular congestion and parenchymal haemorrhage in both the cortex and white matter. Cortical neurones showed ischaemic changes. Occasional areas of hypercellularity were evident in the meninges. ...B. pertussis has a wide range of physiological effects including increased IgE production, increased sensitivity to anaphylactic shock, lymphocytosis, and hyperinsulinaemia. Its ability to induce increased vascular permeability may account for the tendency to produce haemorrhage.

Mice, as well as human infants, are susceptible to brain injury if they are genetically predisposed to BSA sensitivity and receive the pertussis vaccine. '"Almost all babies exposed to cow's milk have serum antibodies (IgG, IgA, and IgM) to BSA. Even breast-fed babies have these serum antibodies, which are probably secondary to sensitization to BSA in the mother's milk." That Francine Yurko and her daughter were sensitive to milk, and that Baby Alan exhibited signs consistent with milk-allergy, indicates that this infant was at special risk of pertussis vaccine-induced brain-injury and death. Since the studies describing the link between BSA sensitivity and pertussis vaccine-induced encephalopathy have been available since 1985, there is no justification for professional ignorance or non-disclosure of this special and material risk. Baby Alan's parents should have been informed of this risk and they should have been advised to permanently forego pertussis vaccination for their child. Furthermore, it must be understood that the above effects caused by the pertussis vaccine are the same as one would expect to find in true cases of Shaken Baby Syndrome. That vaccination was never explored in this case constitutes a gross deficiency.

This child also received antibiotics both directly and indirectly through breastmilk. Antibiotic administration has been associated with an increased risk of vaccine reactions, in the form of disease provocation, if administered within a month of vaccination. Antibiotic administration in close proximity with vaccination had been found to induce immunosuppressive effects in the vaccine recipient and to significantly decrease vaccine efficacy. Thus, it is simply not advisable to vaccinate in close proximity to antibiotic therapy. Although Baby Alan directly received antibiotics at birth, which would have been 2 months prior to vaccination, he also received antibiotics via his mother's breastmilk and may not have cleared the drugs from his system as quickly or efficiently as a healthy, term, baby may have.

In many cases, the physician's duty to warn incorporates material and special risks rather than disclosing all possible risks. In this case, it is reasonable to expect that the expert should have been availed of information, and disclosed such information, regarding the material and special risks associated with vaccinating a child in Baby Alan's condition. It is equally reasonable to assert that the particular risks posed by vaccinating the baby were material to the parents in making a decision.

GENERAL FAILURES TO DISCLOSE VACCINE RISKS

Under the 1986 National Childhood Vaccine Injury Act, it is mandatory that health care providers disseminate approved written information describing: the benefits of vaccination; the risks associated with vaccines; the National Vaccine Injury Compensation Program and any other information deemed relevant by the Secretary. The health care provider is also required to document when the information was provided to the patient and/or their legal guardian.

It is, unfortunately, all too common that health care providers fail to follow federal mandates regarding informed consent. In a recent CDC-sponsored study, it was found that 21%-31% of health care workers failed to discuss common vaccine side effects; approximately one third failed to provide mandatory CDC-approved vaccine information sheets; 24%-31% failed to inform parents of when to call the practice about side effects; 38%-46% failed to disclose severe side effects of vaccines; 49%-54% failed to discuss contraindications to vaccination; 66%-70% failed to discuss relevant State Laws and 85%-92% failed to discuss the Childhood Vaccine Injury Compensation Program. Approximately half of the practitioners reported having no written guidelines to screen for contraindications to vaccination. In fact, the self-reported mean time spent conveying risk/benefit vaccine information was slightly >3 minutes while the CDC found, through a time-motion analysis in 7 clinics, that the actual time spent conveying risk/benefit vaccine information ranged between 0-1.9 minutes. The authors of this study noted that these figures may have represented the best case scenario regarding informed consent since respondents were asked to report on their own adherence to a legal mandate and, thus, would desire to be represented as favourably as possible. There is clearly a significant discrepancy between what health care providers are required to disclose, what they feel parents need to know in order to provide informed consent, and what they actually provide in terms of benefit/risk vaccine information. Most providers indicated that time constraints served as the greatest barrier to providing vaccine information and the study authors noted that, since patient education is not "billable time, it is likely that vaccine risk/benefit communication will suffer."

In practical terms, the consequences of uninformed consent, and the lack of screening for contraindications, are that many children will be needlessly harmed by vaccines, practitioners will not recognize adverse events as being causally-related to vaccination, and parents will be wrongfully accused of injuring their children.

Alan Yurko was unable to attend the vaccination appointment due to a conflict with work. Francine Ream Yurko did not receive adequate disclosure regarding potential vaccine-related risks. Mrs. Yurko noted that she had been informed of which vaccines were to be administered on the vaccination day but the discussion on potential reactions was limited only to the potential for fever, reduced appetite, and a transient high-pitched cry. Although it occurs far too frequently, the latter sign, i.e. the high-pitched cry, is not a normal transient reaction but is indicative of neurological injury. According to Mrs. Yurko, there was no mention of potential serious adverse events, no discussion on the vaccines or diseases in question, no discussion regarding pertinent Florida vaccination requirements, no mention of deferring vaccination due to the child's health, and federally-mandated information sheets were not provided. Although Baby Alan's health records suggest that Mrs. Yurko was given the appropriate CDC information sheets, she states that they were never provided. Clearly, there was a gross deficiency regarding informed consent standards in this case which, undoubtedly, had a significant bearing on the outcome of the child and, in fact, the entire family.

Regarding the outcome of Baby Alan, had the parents been adequately informed of contraindications and applicable Florida Law (sec. 232.032), which requires vaccination or exemptions for school children, the parents could reasonably have deferred vaccination until the child was healthy, and when his organs would have been better developed, or their child could have entered school with an appropriate exemption. The parents were never given the opportunity to defer or refuse vaccination and a proper pre-vaccination screening was not performed. When the child began to demonstrate behavioural and physiological changes, they were not recognized as being indicative of a serious adverse event because the parents were informed that such vaccine reactions were merely transient. Vaccine-culpability in the child's death was never entertained by physicians or by the court even though Mrs. Yurko stated that problems began following the baby's vaccination.

BABY ALAN'S VACCINATION

Baby Alan received Connaught Laboratory's DTaP vaccine lot 7H81507 which was cited by the Vaccine Adverse Event Reporting System (VAERS) as having been associated with the most deaths, as well as the highest number of serious adverse events and hospitalizations, of any similar vaccine lot during the period of 07/01/90 through 08/31/99. Further, the VAERS report indicates that the average onset delay for adverse events associated specifically with this vaccine lot was 11.45 days, which corresponds with the onset of signs, at day 10 or 11, observed in baby Alan. In a detailed VAERS report, describing 64 adverse events following the administration of DTaP lot 7H81507, many of the children had received the vaccine within a few months of baby Alan's vaccination date and many had experienced symptoms similar to his, including fever, respiratory distress, poor feeding, vomiting, abnormal high-pitched cry, lethargy/somnolence and encephalitis/encephalopathy.

The degree and timing of the child's behavioural and physiological changes were entirely consistent with a vaccine-induced adverse event. However, a diagnosis of shaken baby syndrome was doggedly pursued at the hospital, by police officers, and by the prosecution attorneys. As a result, the family was separated, the young daughter was removed from the home and subsequently molested, and the father was arrested, tried and convicted of first degree murder. The lack of adequate disclosure regarding vaccine risks, and the apparent inability of experts to recognize or treat serious adverse events, resulted in an avalanche of misdirected presuppositions that culminated in an evident miscarriage of justice. Medically and legally, this case was severely prejudiced because vaccine-injury was never explored.

ETHICAL CONSIDERATIONS

A discussion of the bioethical principles of non-maleficence and beneficence are germane to this case. There is no medical intervention that can claim absolute safety so, in all circumstances, one must consider the benefits versus the risks of any medical procedure. In the case of vaccination, one must consider the risk of contracting a particular disease, available treatments, the expected outcome, the individual's health, family health and vaccination history, and the potential for vaccine-induced adverse events.

The principle of non-maleficence has long been associated with the injunction primum non nocere: "Above all [or first] do no harm."

While it is virtually impossible to guarantee that no harm will result from any medical intervention, it is certainly reasonable to expect that undue harm should be avoided. Clearly, undue harm would result if the risks associated with the preventive or treatment were higher than those associated with the condition itself. The bioethical principle of beneficence incorporates the requirements of non-maleficence but,

The principle of beneficence potentially demands more than the principle of non-maleficence because it requires positive steps to help others, not merely the omission of harm-causing activities.

Taken together, these principles demand not only that undue harm be avoided but that positive action is taken to prevent harm and to provide actual benefits. It is well-established that vaccines can cause permanent injury and death in a percentage of the population but it is assumed that the benefits generally outweigh the risks. The benefits of vaccination are generally defined as the prevention of disease and accompanying morbidity and mortality while the risks can be defined as the potential for adverse events, including permanent disability and death, from vaccination. One must first consider the actual risk posed by the diseases in question and whether vaccination will effectively prevent infection without causing undue harm. In this case, baby Alan received vaccines against diphtheria, pertussis, polio, tetanus, haemophilus influenza b and hepatitis B.

DIPHTHERIA

Reports of diphtheria in the United States are extremely rare and, between 1980 and 1998, the greatest incidence in any given year was 5 cases (average 2.58). Diphtheria is primarily a disease observed during times of war, poverty, migration and over-crowding. The chance of baby Alan contracting diphtheria, and thus warranting vaccination, were non-existent and this is further confirmed by the fact that there were no cases of diphtheria reported in Florida during 1997 or during the years immediately before or after that.

PERTUSSIS

In 1997, there were 6,564 cases of pertussis reported in the United States, of which 90 (1.37%) occurred in Florida. Of the 6,564 cases, 1,978 cases (30.13%) occurred in children < 1 year of age. To be sure, infants < 1 year of age are at greatest risk of serious complications from pertussis but it appears that the incidence of pertussis has actually increased in this age group since the introduction of the vaccine. In a study conducted by the Public Health Laboratory Service, it was noted that prior to general use of the pertussis vaccine, approximately 10% of cases occurred in infants <1 year of age while two thirds occurred in children aged 1-4 years. Following the mass use of the pertussis vaccine, 70% of cases were occurring in infants <1 year of age, accompanied by a 20% mortality rate. When vaccination compliance fell, due to safety concerns, the disease pattern reverted to its original age distribution pattern. Essentially, vaccination was responsible for facilitating infections in the age group that is most vulnerable to complications.

MEASLES, MUMPS AND RUBELLA

Other vaccines have been shown to increase disease-incidence amongst those individuals who are most vulnerable to disease-related complications. Since widespread use of the rubella, measles and mumps vaccines, for example, it has been found that the very groups most in need of protection, are at greater risk of infection.

The rubella vaccine is intended to protect nonimmune mothers in their first trimester of pregnancy when rubella presents a risk of Congenital Rubella Syndrome (CRS). During the years prior to the introduction of the rubella vaccine in the US, there were approximately 10-14 cases of CRS reported annually. In 1969, the year the vaccine was introduced, there were 31 CRS cases. By 1970 and 1971, CRS cases soared to 77 and 68, respectively, and did not return to pre-vaccination rates for an entire decade when the vaccine target group was temporarily changed. Typically one would expect rubella infections to occur in children aged 9-10 but the average age of infection has been climbing steadily so that by 1992, 65% of rubella infections are occurring in individuals >20 years of age. Prior to rubella vaccine use, 80% of these adults would have been naturally immune to the disease. Now the most vulnerable are at greatest risk of infection.

Similarly, measles is relatively innocuous in children aged 4-5, when most natural infections are expected to occur, but the disease can cause complications when contracted outside of the normal pediatric range. Since the introduction of the measles vaccine, we have witnessed a change in the disease's epidemiology. Now, most cases are reported in those >10 years of age and in infants <1 year of age, and most cases are appearing in vaccinated individuals. The increase in infant infections is significant, indicating that vaccinated mothers are not able to provide sufficient passive immunity to their infants via the placenta or breast milk. As vaccine-induced immunity wanes over time, there simply is not enough available immune cells to protect both the mother and the infant.

Mumps primarily presents a risk of sterility (partial) to post-pubescent males. Since the introduction of the vaccine, a large majority of cases appear in those >15 years of age. Again, vaccination has altered the disease's natural target host.

In each case mentioned above, the widespread use of the corresponding vaccine has altered disease-epidemiology in such a way that the groups at greatest risk of complications have become the most susceptible to the diseases. Of course, each vaccine is capable of causing serious adverse events as well.

POLIO

Poliomyelitis is no longer endemic in North America. In fact, between 1980 - 1995, 121 of the 123 confirmed cases of paralytic poliomyelitis in the United States have been caused by the oral polio vaccine (OPV) while the remaining 2 cases were classified as "indeterminate." It is without a doubt that the risk associated with vaccine-induced paralytic poliomyelitis severely outweighed the potential for natural infection. The Advisory Committee on Immunization Practices acknowledged this risk by gradually phasing out the use of oral polio vaccine and, in January of 2000, the oral polio vaccine was removed from the US market. In Canada, 9 of 12 provinces had already phased out the use of the oral polio vaccine in 1996 and the remaining 3 had phased out the OPV by 1998 due to concerns over vaccine-associated paralytic poliomyelitis. The only explanation for the continued use of the OPV in the US was to allow time to use up current stocks to prevent financial losses. The decision to allow use of the OPV until 2000 was not based upon health-related concerns.

Baby Alan and all other North American infants were not at risk of contracting poliomyelitis from the wild virus but many were still given the oral polio vaccine which, in itself, posed the only possible risk of contracting the disease. The World Health Organization has also found that antibiotic use within a month of OPV use increases the risk of vaccine-induced poliomyelitis.

The inactivated polio vaccine has been available in the United States since 1955 and this vaccine has not been associated with provocation poliomyelitis for decades. The inactivated vaccine is considered by international health care authorities to be an acceptable alternative to the OPV in non-epidemic conditions so there is no justification for any country in non-epidemic conditions to accept risks associated with the oral live-virus vaccine. The use of the oral polio vaccine for decades after the disease was no longer endemic was in clear violation of the principles of non-maleficence and beneficence.

TETANUS

Tetanus spores are ubiquitous, meaning that they are virtually everywhere, yet incidence reports are few. Tetanus is not a communicable disease. One must have a route of entry, such as a cut or serious burn, and be exposed to tetanus spores at the same time to cause infection. The spores require an oxygen-free environment in order to live, thus a severe burn, or a cut that does not bleed well, may pose a greater risk of infection. Tetanus is frequently found on farms as it is often a resident in the intestines of horses and cows.

According to MMWR, between 1980 - 1998 there were between 36 - 95 reports of tetanus in the United States accompanied by 1-31 deaths (8 %-43 %) annually. Most cases occur in adults and it is extremely rare for cases to be reported in children <5. Neonatal tetanus, which is known to occur in underdeveloped nations, primarily results from unhygienic birthing practices, such as applying dung to the umbilical stump. Neonatal tetanus is virtually unheard of in developed countries whether the child is vaccinated or unvaccinated due to hygienic birthing practices and, because infants are not mobile, they are unlikely to be exposed to either the spores or conditions required for active infection.

The tetanus vaccine has been associated with severe immune suppression. In a study conducted on 11 healthy adults, it was found that a transient, but significant, drop in helper T cells followed vaccination. In four of the subjects studied, "the helper T cells dropped to levels seen in active AIDS patients."

Deferring this vaccine until a child is of an age where the disease may present an actual threat would be advisable and this is particularly true for the child whose health is already compromised. The risk of contracting tetanus for an infant residing in the United States is extremely remote and vaccination-deferral could certainly be considered without concern. Furthermore, proper wound prophylaxis will prevent infection because tetanus requires an oxygen-free environment in order to survive. Utilizing hydrogen peroxide to cleanse a wound effectively introduces oxygen in the wound destroying tetanus.

HAEMOPHILUS INFLUENZA B

Haemophilus influenza B became reportable in the United States in 1991. From 1991 to 1998, there were between 1,162 and 2,764 cases reported per year, with an average of 1,434 annual cases overall. The average mortality rate fell at 0.6% for reported cases, ranging between 5-17 deaths per year attributed to invasive Hib disease. Haemophilus influenza is frequently found in the throats of healthy people and its presence does not mean that clinical disease will result. The disease presents a greater risk to very young, very old, or immunocompromised individuals. Children in daycare settings are at greater risk of contracting Hib than children who remain at home for the first 12-18 months of life.

In the short time since the Hib vaccine's inception, there have been significant safety and efficacy concerns associated with the various Hib vaccines licenced. Minnesota state epidemiologist, Dr. Michael Osterholm, reported that the PRP Hib vaccine had a minus 86% efficacy rate, meaning that incidence increased following vaccination, and that vaccinees "faced a fivefold increase in the risk that they will be infected by the [HIB] bacteria." Both this vaccine, and the one next-licenced, were found to be completely ineffective in children <24 months of age and < 18 months of age, respectively, when children are most susceptible to infection.

Subsequent Hib vaccines appear to be more effective, even in younger children, but they still induce a negative phase, increasing susceptibility to infection, for at least 1 week post-vaccination. Furthermore, Hib infections continue to occur in adequately vaccinated individuals. The Hib vaccine has been associated with a variety of adverse events including: Guillain Barré Syndrome, transverse myelitis, seizures, muscle weakness/wasting, thrombocytopenia (a decrease in blood platelets responsible for clotting, thus causing bleeding disorders), diabetes and death. In fact, Dr. John Barthelow Classen has stated that his studies have revealed that the "the increased risk of diabetes in the vaccinated group exceeds the expected decreased risk of complications of H. influenzae meningitis." Baby Alan was already at risk for diabetes so it would have been prudent to exclude this vaccine, particularly in view of the low incidence of the disease. Since Baby Alan was not in daycare, and his parents had no intention of enrolling him in daycare, he was not at risk of contracting the disease.

HEPATITIS B

Hepatitis B is generally contracted by contact with infected blood or other bodily fluids. Those who are at greatest risk of contracting hepatitis B are individuals engaging in unprotected sex with an infected partner or individuals who share needles for injectable drug use. Lab technicians are also at an increased risk due to their exposure to bodily fluids. In the United States, from 1991-1998, there were between 10,258 - 18,003 cases reported per year, with numbers steadily declining each year. Of the cases occurring between 1995-1998, 53-81 (0.5% - 0.75%) cases occurred in children <1 year of age. For children <1 year of age, the primary risk factor is perinatal transmission by an infected mother. Hepatitis B status can be determined during pregnancy and, if the mother is HBV-positive, the infant will be treated with active-passive (immune globulin plus active vaccination) immunization shortly after birth. Other than this particular circumstance, there is no justification for vaccinating infants.

Francine Yurko tested negative for hepatitis B so her infant was at no risk whatsoever of contracting the disease. One could not even argue that the vaccine would have protected the child in future, when he may have engaged in risky activities, because it is known that "25% to 60% of adults lose all detectable antibody to hepatitis B vaccine within 6 to 10 years" of vaccination. Thus there is little hope that sufficient antibody titres would have endured long enough to be protective once the child reached an age when he may have engaged in activities (professional or behavioural) that could have placed him at risk of contracting hepatitis B.

In 1997, there was a total of 10,416 reports of hepatitis B disease throughout the United States, only 53 (0.51%) occurred in children <1 year of age, meaning that 99.49% of cases occurred in older individuals. The greatest number of reports (43.74%) occurred in the 25-39 year old group, followed by 40-64 year olds (28.96%), 15-24 year olds (17.18%), 65 and older (5.25%), 5-14 year olds (1.88%) and 1-4 year olds (0.55%). The risk to children, of contracting hepatitis B, is minimal and evidence indicates that risks associated with infant and childhood hepatitis B vaccination are greater than risks associated with contracting the disease.

The hepatitis B vaccine has caused numerous serious adverse events including, but not limited to, encephalomyelitis, optic neuritis, multiple sclerosis, neuropathy, paralysis, transverse myelitis, Guillain-Barré syndrome, liver dysfunction, jaundice, thrombocytopenic purpura, insulin-dependant diabetes myelitis, anorexia, nausea, vomiting, arthritis, arthralgia, myalgia, fever and et cetera. Between 1 July 1990 and 31 October 1998, VAERS received 24,775 hepatitis B vaccine-related adverse event reports, including 9,673 serious events and 439 deaths. In a study done of 8 US States during 1997, it was found that there were 25 cases of hepatitis B amongst children <5 years of age but there were 106 serious hepatitis B vaccine-related adverse events and 10 deaths amongst children < 5 years of age in the same 8 States. Clearly the risk of hepatitis B vaccine-related adverse events outweighs the risk of contracting the disease in children thereby violating the principles of non-maleficence and beneficence. Baby Alan was already struggling with health challenges and the use of this unnecessary, and extremely hazardous vaccine, was completely unwarranted.

CONCLUSIONS

One must consider when and whether to vaccinate a particular child based upon individual risk:benefit assessments. In so doing, one must consider whether the disease in question presents a viable threat: is the disease endemic, is it communicable, what are the chances the child will be exposed, how is the disease transmitted, what is the probable outcome of natural infection, and what treatments are available? One must also consider the health of the child to be vaccinated, any allergies or preconditions that may cause concern, and family history. In weighing these considerations, one must determine whether vaccination is advisable, not advisable, or whether vaccination should be deferred for the particular individual. Essentially, one is weighing the potential for providing actual benefits and reducing harm.

In the case of Baby Alan, the threat posed by the diseases, against which he was vaccinated, was remote. Certainly, based upon US incidence reports to the Centers for Disease Control and Prevention, one can conclude that diphtheria, poliomyelitis, hepatitis B and tetanus posed no threat whatsoever to this child. The threat posed by pertussis and haemophilus influenza B were minimal. Furthermore, Baby Alan did not attend daycare, and the parents state they had no plans to enroll him in daycare, so the chances of his contracting any of the "vaccine-preventable" diseases were even more remote. One would reasonably expect any attending physician to weigh such a minimal risk against risks associated with vaccinating a particular child. Baby Alan was indeed at an increased risk of a vaccine-related adverse event which would have significantly outweighed his risk of contracting the above diseases naturally. Under these conditions, and in the absence of an immediate threat of infection, a prudent physician would have advised the parents to avoid vaccination altogether or, at the very least, to selectively vaccinate only after the child's health became stable.

In view of the fact that Baby Alan's health began to further diminish, culminating in his eventual death, following vaccination, it is astonishing that neither the attending physicians, nor the court, ever entertained vaccine-culpability. This child should never have been vaccinated in his fragile state and he certainly should not have received multiple vaccines simultaneously. The parents should have been informed of the risks involved in vaccinating this child and they should have received considerably more information about signs indicating serious vaccine reactions. Like so many others, they fell victim to a medical system that fails to follow even the minimum standards for informed consent and fails to follow-up on injuries associated with a vaccine lot that has a clear record of causing undue harm.

Signs associated with certain vaccine-related injuries are virtually indistinguishable from those associated with shaken baby syndrome. One cannot help but wonder why the professionals involved focussed upon "shaken baby syndrome" as the absolute cause of Baby Alan's death when they should have also been aware of the potential for vaccines to cause such injuries. As a result, Alan Raymond Yurko was made the target of an investigation that necessarily excluded the true culprit in Baby Alan's death. After carefully reviewing the medical records of Francine Ream Yurko and Baby Alan Yurko, the autopsy report, TransLife Organ Recovery records, and court testimony, I am unequivocally convinced that the jury did not understand the complex testimony presented, that material evidence was never presented nor explored, and that Alan Raymond Yurko did not murder his infant son.