Let Justice Be Done

F. Edward Yazbak, MD, FAAP

“How a legal case could cripple one of modern medicine’s greatest achievements.” (Boston Globe, June 3, 2007) by Paul Offit, MD seems to have miraculously appeared in the IDEAS Section of the Sunday Boston Globe, now a New York Times publication, just a week before an important vaccine injury case is scheduled to be heard.

The editorial staff at “The Globe” did not feel the need to include an opposing view although one certainly would have been included if the article had been written by a vaccine critic. It is unusual for me to disagree with a fellow physician in public but I feel that it is imperative to respond to some specific comments by Dr. Offit (below in Italics) that should not go unchallenged.

Now, massive litigation could force companies to leave the vaccine business. On June 11, in an unprecedented action before a federal claims court, lawyers for 4,800 autistic children will argue that vaccines caused autism.

There has been a National Vaccine Injury Compensation Program (VICP) in the United States since October 1, 1988. The supporters of that program like to say that it was “designed to compensate individuals or families of individuals, who have been injured by covered childhood vaccines, whether administered in the private or public sector”. The truth is that it was created to protect the vaccine manufacturers and the physicians who administer the vaccines from litigation. The result was that many vaccines have been added to the pediatric schedule over the years, some clearly being more beneficial to the maker, the stockholders and those who hold the patents than to the infants who received them.

Before consenting to have an infant vaccinated, the parent or guardian must be given a VIS (Vaccine Information Statement) to read. Whoever administers the vaccine must then certify that the parent /guardian did read the VIS and also record the date the document was printed by the CDC, to show that up to date information was provided for truly informed consent.

The VIS presently provided for the MMR vaccine can be found at http://www.cdc.gov/nip/publications/vis/vis-mmr.pdf

It states under # 5 – What if there is a moderate or severe reaction – that serious reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS). It also states very clearly under # 6 – The National Vaccine Injury Compensation Program – that “A federal program has been created to help you pay for the care of those who have been harmed” and lists a toll-free telephone number and the VICP web site.

The reason why a “massive litigation” was created is because the Office of Special Masters (the judges in the vaccine injury courts) decided in 2002 to put all autism cases together. It certainly is not because the injured children or their parents and advocates wanted or chose to do so.

Now the time has come for the National Vaccine Injury Vaccination Program to work as it was intended to. Whether there is a single vaccine-inured child, or two, or ten or ten thousands, each child needs to be compensated, if entitled. It certainly was never the child’s fault, if he or she was injured by a vaccine that was licensed by the FDA, recommended by The National Vaccine Advisory Committee and the CDC and forced upon him or her by physicians and school authorities. It is also certainly not Michelle Cedillo’s fault that her case was chosen to be heard first, but it is imperative that her personal and constitutional rights be safeguarded.

So starting June 11, everyone, from the judge on down, should remember that this is Michelle’s case.

I happen to know this beautiful girl’s parents and I am well aware of the living hell the child, her parents and her grandparents have been enduring.

Michelle was a normal and healthy baby at birth. At present she has multiple health problems that include severe autism and she will not recover, short of a miracle. She will never jump rope, play basketball, go out on a date, dance at her prom, graduate from college, get married and have children – like other girls her age.

I have reviewed many vaccine injury cases and have testified as an expert witness in a few. I am convinced that Michelle’s present condition is directly due to such injury and that even Dr. Offit will concur, if he took the time to review the case and examine the child.

No single medical advance has had a greater impact on human health than vaccines.

How about nutrition, hygiene, aseptic technique.to name just three! To my knowledge not one of these resulted in thousands of adverse events. Before vaccines, Americans could expect that every year, measles would infect four million children and kill 3,000. There were 441,703 cases of measles with 380 deaths resulting in 1960, years before the measles vaccine. (CDC)

The U.S. population that year was 179 million. Rubella (German measles) would cause 20,000 babies to be born blind, deaf, or mentally retarded. The rubella vaccine was licensed in 1969 when the population of the United States was around 200 millions. According to the CDC’s Pink Book, “Rubella and congenital rubella syndrome became nationally notifiable diseases in 1966. The largest annual total of cases of rubella in the United States was in 1969, when 57,686 cases were reported. CRS surveillance is maintained through the National Congenital Rubella Registry which is managed by the National; Immunization program.

The largest annual total of reported CRS cases to the Registry was in 1970 (67 cases)”. Pertussis would kill 8,000 children. Diphtheria would kill 15,000. There are no available official U.S. statistics on Pertussis and Diphtheria prior to the vaccination era. We will happily publish reliable data confirming the above on this web site. Because of vaccines all of these diseases have been completely or virtually eliminated from the United States. To quote the CDC: “During 2001-2003, the highest average annual pertussis incidence was among infants younger than 1 year of age (55.2 cases per 100,000 population), and particularly among children younger than 6 months of age (98.2 per 100,000 population). In 2002, 24% of all reported cases were in this age group. However, in recent years, adolescents (11-18 years of age) and adults (19 years and older) have accounted for an increasing proportion of cases. During 2001-2003, the annual incidence of pertussis among persons aged 10-19 years increased from 5.5 per 100,000 in 2001, to 6.7 in 2002, and 10.9 in 2003. In 2004 and 2005, approximately 60% of reported cases were among persons 11 years of age and older.” [CDC Pink Book http://tinyurl.com/29olec] Infants usually receive 3 doses of pertussis-containing vaccines by the age of six months.

“On June 30, 2005 the Advisory Committee on Immunization Practices (ACIP) voted to recommend the routine use of Tdap vaccines in adolescents aged 11-18 years. On October 26, 2005 the ACIP voted to recommend routine use of a single dose of Tdap for adults 19-64 years of age to replace the next booster dose of tetanus and diphtheria toxoids vaccine (Td). The ACIP also recommended Tdap for adults who have close contact with infants <12 months of age.” Chickenpox and mumps outbreaks have also recently been reported in highly vaccinated groups. And we’re not finished; vaccines stand as our only chance to prevent pandemic influenza. Good Luck! The seasonal injectable influenza vaccine, that we know so well and that we have had for years does not affect mortality in the elderly according to Simonsen. It also seems ineffective under the age of two according to Jefferson et al who after reviewing the world literature wrote, “There is no evidence of the effectiveness of the vaccine or reduction in symptomatic cases. The efficacy of the vaccine, reduction in laboratory-confirmed cases, is similar to that of placebo.” .and our best chance to prevent certain cancers Good Luck again! The hepatitis B (HBV) vaccine, the “first cancer vaccine”, was supposed to eradicate hepatocellular carcinoma (HCC) or at least that is what we were told when in 1991, we questioned why the first dose was “universally” recommended shortly after birth even though it was not really needed in the overwhelming majority of cases in the US. In a recent study from Taiwan (October 2006) the investigators, who reviewed a total of 18,423 cases of hepatocellular carcinoma over 20 years (1981-2001) concluded: “Our study demonstrates that the percentage of HBV-related HCC has progressively decreased over the last 20 years. The relative decrease in HBV-related HCC was not due to a decrease in HBV-related HCC death. Instead, it was caused by an increase in HCV-related HCC. Prevention of new HCV infection and the treatment of chronic hepatitis C should be the primary goals, which will result in better control of HCC in the future, even in an HBV-endemic area like Taiwan.” (Lu, Su et al) [HCV refers to hepatitis C virus infection. For more on that, see "The First Cancer Vaccine: Facts and Failings" on www.vaproject.org] Lastly, time and space do not allow for a detailed discussion of the “epidemiological studies” that Dr. Offit writes about.

The fact is that they are not worth the paper they are written on and we’ll gladly debate anyone who thinks otherwise. Critiques of some of those epidemiological studies by Stone, Trelka and Yazbak can be found on www.vaproject.org. Dr. Offit and indeed everyone should be reminded that the authors of the 2005 Cochrane MMR Review, the largest epidemiological effort ever undertaken on the subject, concluded that “the design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.” Let us hope and pray that the Court will not be distracted in its efforts to find the truth. This beautiful little girl was severely injured. She deserves justice. and rightfully so.