Crucial Evidence for Vaccine Safety is missing-the Giant has been sleeping

David Denton Davis MD, a graduate from The George Washington University School of Medicine, a Charter Member of the American College of Emergency Physicians. He is the author of Dancing Cats Silent Canaries, a story about his career and his viewpoints about what parents can do to lessen the risks of their babies succumbing to the epidemics of SIDS and Autism.

While writing my book, I came to the realization that I have been part of what might be described as a sleeping giant—an organization known as the American College of Emergency Physicians (ACEP). In drawing this analogy, I believe it is fair to say a significant percentage of parents with sick infants seek immediate medical care at sites other than their primary care locations. Many of these infants and children will have received a recent immunization. Unless doctors working in emergency and urgent care fully understand and appreciate the objectives of the National Childhood Vaccine Injury Act (NCVIA) and the requirements of the Vaccine Adverse Event Reporting System (VAERS), the majority of adverse events will go unreported.

This organization, which I helped create, has perhaps unknowingly, failed to assume responsibility for adhering to the requirements of this 25 year old law designed to protect children and vaccine makers. Without doubt injuries have been caused by vaccines; otherwise there would never have been need for a law and a compensation mechanism. To date more than $2 billion has been paid to victims and their families. Through education and a minor procedural change I believe this giant can awaken and reaffirm a leadership role through reporting compliance.

This means infants, children and adults who arrive at acute care facilities within four to six weeks of an immunization with any illnesses characterized by vaccine manufacturers as a possible adverse event will be recognized and reported. Typically seizures, fevers, rashes, vomiting, irritability, lethargy, weakness, numbness and even death will be found in vaccine literature. According to law physicians should consider these illnesses as adverse vaccine events until proven otherwise and initiate a report. Due to the passive nature of the system submission of adverse event reports is the only method for determining the actual safety of vaccines. Therefore VAERS reports are of critical importance for identifying any that may be harmful. Evidence suggests these reports have been overlooked in most acute care settings.

An actual survey of emergency and urgent care providers failed to identify significant knowledge of either the NCVIA or VAERS. A twelve month extrapolation of the estimated daily missed adverse events points to an annual non-reported number greater than the cumulative twenty-five year total. As a consequence actual vaccine safety appears to be based on a very small percentage of adverse events. Missing reports, including deaths, will be misconstrued as evidence they never happened. Without enforcing physician compliance the NCVIA is inadequately protecting babies. Unless the number of adverse reports reaches a critical high figure the real danger may never become known.

In testimony before Congress Michael Belkin, the father of a five week old baby who died 18 hours after receiving her Hepatitis B vaccine estimated 95% of all adverse events are going unreported. This may be an underestimate. I did not complete a VAERS report during the first 35 years of my career. Sadly, a survey of my colleagues revealed I was not alone. Once aware I soon began noticing the need for one to two possible VAERS reports each week. The only possible conclusion is vaccine related illnesses have, and if nothing is done, will continue to go unreported. Acute care provider compliance will is essential for uncovering the missing information.

The first implication of the current non-reporting phenomenon is vaccine manufacturers are not receiving important information necessary for determining the actual safety of their products. This places many infants in potential jeopardy. Secondly parents may never learn a vaccine may have been the cause of their child’s illness and subsequent injury. For example, recent VAERS reports revealed the MMRV (Measles, Mumps, Rubella and Varicella) combination vaccine was associated with more febrile seizures than the MMR. Many more thousands of seizures related to these polyvalent vaccines have likely gone unreported meaning the MMRV combination may be far more dangerous than either parents or physicians have been told. Trying to fathom the long-term effects of vaccine induced seizures is virtually impossible. Not attempting to attribute a seizure to a vaccine may be even worse.

Physicians were given a warning about the MMRV without significant comment. Astonishingly, a short time later a Febrile Seizure article for physicians made no mention vaccines could be the cause. The authors either did not know or chose not mentioning a possible correlation. An assumption might be other more dangerous than suspected immunizations or combinations are flying below the radar. The giant must be aroused and begin surveillance participation before an unsafe vaccine remains and becomes mandatory. The benefits of vaccines must far outweigh their risks in the name of the public good.

In addition to the lack of physician understanding parents are also contributing to the under-reporting problem. A brief survey of mothers of children receiving the MMRV revealed they neither asked for nor received verbal or written warnings mentioning seizures or other illnesses. Recently a mother brought her child to urgent care not suspecting his illness was related to a vaccine. Following my history and exam I contacted he child’s pediatrician informing her that this child had a fever, rash and was according to his mother, showing “tic” like seizure activity five days following his MMRV. When a VAERS was mentioned the doctor replied a report would not be necessary. In this case the mother appropriately insisted upon a report. Although most parents are not being told enough about adverse events, if one is suspected a report should be completed in spite of doctor disagreement. If neither parents nor providers suspect a vaccine responsible, it will never appear in the record. Some physicians may unwisely choose to ignore pleas to consider a vaccine cause and veto the possibility. This is not excusable especially when the law has already dismissed liability for both physicians and manufacturers.

The NCVIA, in point of fact, requires healthcare personnel to provide Vaccine Information Statements (VIS) which state the risks and benefits to recipients, their parents or legal guardians. Multiple immunizations require a VIS for each component. Symptoms associated with vaccine adverse events are found in package inserts. If parents or legal guardians are not provided with inserts the issue of informed consent may become a future cause for litigation.

Non-reporting means the actual safety of vaccines, combinations and “cocktails” will possibly remain unknown to manufacturers and vaccine experts. Continuing to rely on the current VAERS makes no sense unless these forms are completed for every illness within the manufacturer’s adverse event “window.” Few will argue driving through red lights is not dangerous. Violations, if detected, are punishable. Likewise the present law should not allow a large percentage of doctors to go unpunished for failing to obey. Missing evidence for safety is placing babies and infants in harm’s way. Physicians refusing to inform their patients or failing to complete VAERS forms may be more dangerous to society than those who are refusing vaccines.

At best the current system is woefully inadequate. Injuries will continue to occur if cause-effect relationships are allowed to remain unidentified. Comprehensive detection of adverse events must become a much higher priority. The Sabin Polio vaccine, designed to prevent Infantile Paralysis, caused deaths and injuries for more than 18 years before the government, rather than the manufacturer or medical community, intervened and removed it from the market. Similarly, it is reasonable to presume there are dangerous vaccines in current use. Before mandatory immunizations are considered there must be mandatory reporting. Acute care providers can make an immediate difference in distinguishing between adverse vaccine events and coincidence. The missing evidence, in my opinion, is readily visible in acute care settings every day.

In conclusion everyone deserves to know more about missing evidence. Discovery may reveal a more sinister side to the controversy. What we do not know will, in all likelihood, continue to cause harm. My intention is to introduce a resolution that asks for the help of ACEP and more than 25,000 members. I will ask for documentation of the date the last immunization. Any illness occurring within the “window” will automatically “trigger” a request for VAERS completion. I am hopeful publicity will encourage many thousands of additional doctors to learn about the importance of their roles and support my resolution. Actively opposing compliance is not in the best interest of manufacturers, patients or the public good.