Dr. Bob Sears and Fox Friends

On Saturday, 2 October 2010, Dr. Bob Sears appeared on Fox Friends with Fox News Anchor, Alisyn Camerota (AC) .  Ms. Camerota begins the segment with the question:

AC:  Is there a connection between vaccines and autism?  Thousands of families with autistic kids think there is.  But the Centers for Disease Control has always maintained that no research supports a link.  Now one famous paediatrician has written a book about vaccines who charges the government's studies on vaccines is woefully inadequate.

Ms. Camerota introduces Dr. Bob Sears (BS), author of The Vaccine Book, which was published three years ago. 

AC:  The government says they have studied vaccines and they do not cause autism.  But has the government ever studied the amount of vaccines that our children get in 1 sitting?

BS:  That is what me and my colleagues at SafeMinds are a little worried about...there is a CDC report that says that usually simultaneous vaccination has not been completely studied for safety and that's what we're worried about.  Babies get as many as 6 or 7 vaccines altogether...and the CDC is admitting that they aren't always researched that way.  The prime example is the flu vaccine.  They've researched the flu vaccine in great detail when given alone, but the CDC has never researched it when given in conjunction with all the other shots...and that's what we're worried about.

Interestingly, SafeMinds is a notorious anti-vaccine organisation, also known as the 'mercury militia', that maintains that autism is caused by thimerosal, a preservative used in vaccines that contains ethylmercury.  However, mercury toxicity does not resemble autism, and autism rates around the world have been increasing in spite of thimerosal removal from paediatric vaccines and immunoglobulins starting in 1999 in the U.S. and even years earlier in other countries.  SafeMinds rejects any studies that demonstrate that thimerosal does not contribute to neurological disorders, even going so far as to storm off a study team, in a huff, the day the results were announced and not to their liking.

Dr. Bob alludes to some CDC report that states that simultaneous vaccination has not been completely studied for safety yet doesn't provide any further information about this.  However, the CDC information regarding simultaneous vaccination does not support what Dr. Bob claims.  For instance, from the CDC's Vaccine Safety Page:

Is simultaneous vaccination with multiple vaccinations safe? Wouldn't it be safer to separate combination vaccines and spread them out, vaccinating against just one disease at a time?

The available scientific data show that simultaneous vaccination with multiple vaccines has no adverse effect on the normal childhood immune system. A number of studies have been conducted to examine the effects of giving various combinations of vaccines simultaneously. These studies have shown that the recommended vaccines are as effective in combination as they are individually, and that such combinations carry no greater risk for adverse side effects. Consequently, both the Advisory Committee on Immunization Practices and the American Academy of Pediatrics recommended simultaneous administration of all routine childhood vaccines when appropriate. Research is underway to find methods to combine more antigens in a single vaccine injection (for example, MMR and chickenpox). This will provide all the advantages of the individual vaccines, but will require fewer shots.
Another advantage is that combination vaccines result in fewer shots and less discomfort for children. In addition, spreading out the administration of separate vaccines may leave children unnecessarily vulnerable to disease.

Dr. Bob mentions that influenza vaccine has not been tested with the childhood schedule as the 'prime example', when, in fact, it's the only example.  Vaccine safety studies are addressed later.  Ms. Camerota continues:

AC:  Let me show (CDC Infant Vaccine Schedule) our viewers how many different vaccines some children can get in one sitting.  At two months they get five or six, same at four months.  At six months they get tons!  At 12 months they get up to six, at 15 months they get up to six.  Why isn't the CDC looking at these combinations?

BS:  (Nodding in agreement and not providing any corrections to these assertions.)  Well I think the CDC is just assuming that they are safe.  Because there is no real evidence that they causes [sic] any harm...But I would like to see more research on it and I think that parents want to be confident in vaccines.  And as a paediatrician, I give vaccines in my office every day.  But I want to know that these large combinations are safe.  And what I do as a paediatrician, is I spread the vaccines out.  I give no more than two vaccines at a time to any babies in my office.  It takes longer to vaccinate them that way but I think it's a safer way to go.

Here is the CDC Infant Schedule:

There are not 'tons' of vaccines at six months; actually the same at two and four months and as a matter of course, three or four at 12 months and two or three at 15-18 months.  Dr. Bob not only spreads these out but omits some as well, and not necessarily ones that can or should be omitted and not some that should be as delayed as he has them.  He also eschews combination vaccines which reduce the number of jabs and vaccine constituents, while getting infants protected more timely than his recommendations.  Here are his evidence-free justifications for his recommendations:

• By only giving two vaccines at a time (instead of as many as 6), I decrease the chance of chemical overload from grouping so many vaccines chemicals all together at once. This allows a baby's body to better detoxify the chemicals one or two at a time.
• I give only 1 aluminum-containing vaccine at a time (instead of the recommended 4). Overloading on this metal can be particularly toxic to the brain (See Resources, page 250 of The Vaccine Book to view the research on this).
• I give only one live-virus vaccine component at a time to allow the body's immune system to better handle the live viruses in these vaccines.
• Giving fewer shots at a time may decrease the side effects, in my experience.
• Giving fewer shots at a time also makes it easier to figure out which vaccine a child is reacting to if a severe reaction occurs.

Since Dr. Paul Offit and Dr. John Snyder have already critiqued Dr. Bob's schedules, I don't feel compelled to reiterate their reviews.  However, it does bear repeating that Dr. Bob's schedules have not been tested for safety and efficacy; he merely assumes that his recommendations are better because he has set up numerous faulty assertions that the CDC schedule is bad.  He cannot say that his schedules are safer because he has never put them through the rigours of testing, namely, do they protect infants from vaccine preventable diseases that they would otherwise not have and do his schedules prevent all of the bogey-man disorders that he claims fully vaccinating do or may cause?  He has done nothing to alleviate the fears and concerns that parents have since his book is rife with dubious studies that only serve to incite parental concerns and fears about vaccinating.

Dr. Sears creates controversy surrounding vaccine excipients where there really isn't any, by either misinterpreting or omitting relevant scientific literature.  It is a shame that Dr. Bob has chosen to pander to anti-vaccine rhetoric, for the premise of his book seemed appropriately timely, however his execution was sophomoric and clearly intended to further his own agenda and biases.  Ms. Camerota continues:

AC:  It's interesting that you say that because the CDC in part says that they have combined all these vaccines because parents have clamoured for that...parents say, we don't want to have to keep bringing our kids in every two months and giving them different shots, let's just get it all over with.  So perhaps they have acquiesced to parents desires but in a dangerous way.

BS:  Right, you know 20, 30 years ago we only gave babies two vaccines at a time with a total of about eight injections throughout their childhood.  Now we give babies six or seven vaccines each time and over 50 injections spread throughout their childhood.  So I think parents would rather go the extra mile and and [sic] spread the vaccines out cause [sic] I think parents feel like their babies are being overloaded.

Thirty years ago, infants and children received five DTP, four OPV and one MMR.  The U.S. also had about 20,000 Haemophilus influenzae b (HIb) cases in children annually with about 1,000 deaths each year and approximately 16,000 cases of hepatitis b infection in children less than 10 years old each year.  Twenty years ago, infants and children received 18 vaccinations with four given at visits for two, four, and six month olds, three or four given at 12 -18 months old and three given from four to six years old.  They were DTP, Hib, Hep B, OPV and MMR.  There had also been a huge resurgence of measles during that time with more than 55,000 cases and at least 259 deaths.

Today, children are receiving about 30 vaccines by six years old and three of those are not injections, 36 if parents diligently vaccinate their children for influenza, which are actually very few,  less than 30% most years.  So it is very difficult to determine how Dr. Bob calculated 50 injections, however, his own recommendation to split MMR up into six as opposed to two injections would get children closer to that.

But onto his argument that vaccines have not been tested together.  I don't know how he can make this statement when a quick and easy review of the literature reveals quite the opposite.  There are numerous studies that examine the safety and efficacy of new vaccines with existing ones, for example:
Hexavac with Hepatitis A
Hexavalent vaccine with Rotateq
DTaP with Hib
PCV-13 with all infant vaccines
MMR and Varicella
PCV-7 with MMR, Hib and Varicella
Pediarix with Hib and Infanrix-hexa
New Hib with all infant vaccines
MMR with Varicella
MMR-V with Hib-HepB
MMR-V with all infant vaccines
Meningococcal-C with Hep B and Pentacel
Pentacel with PCV-7
This is not, by far, an exhaustive list.  Additionally, the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) exist to monitor vaccine safety after licensure.   Dr. Bob promotes himself as a vaccine expert yet continues to omit relevant facts.  There are valid criticisms of vaccines and policy that are supported by the scientific literature but  Dr. Bob chooses to raise the spectre of misinformation that he has the solution for. 

AC:  Certainly if they're educated, I think you're right about that.  We asked the CDC for their response to that fact that you say their research has been woefully inadequate, here is their response to us:

 "Vaccination is the single most important step parents can take to protect their children from life threatening diseases which once killed thousands of children each year.  Scientific data from years and years of research show that vaccines are safe and effective.  Vaccines do not overload the immune system.  Vaccines contain only a tiny fraction of the antigens that babies encounter in their environment every day.  We do know that delaying vaccines puts children at known risk of becoming ill with vaccine-preventable diseases."

- Tom Skinner, CDC Spokesperson, 1 October 2010

BS:  Well I agree with most of that, especially you don't want to delay vaccines for very serious diseases like meningitis or whooping cough.  However I think the CDC's argument about the thousands of germs that we can tolerate every day...I think that's scientifically invalid because I think they are talking about germs that we inhale, or germs that we swallow.  Those germs are exposed to our immune system in a natural way, in our intestines and our respiratory passages, our immune system processes those germs.  But when you inject germs directly into the body you by-pass the immune system completely and internal part, the bloodstream immune system has to see the germs and attack them, it's a very unnatural type of germ exposure.

It appears as though Dr. Bob has attended the 'Jenny McCarthy School of Immunology' .  His statements regarding 'natural' versus vaccine immune responses invoke one of the most erroneous and overused canards of anti-vaccinationists.  I can't quite parse what Dr. Bob is saying because his description of immunity isn't corroborated by anything known about how the immune system works.  How could he possibly explain an immune response to antigens (or germs as he puts it) that are introduced 'directly into our bodies' via cuts or insect vectors?  Is this also 'unnatural'?  He also seems to believe that this 'natural way' is completely infallible and compartmentalised such that pathogens cannot breech this.  So how does he explain the fact that pathogens have adapted to evade our innate immune system and requiring our adaptive immunity (perhaps what he is referring to as 'bloodstream immune system') creating antibodies to rid ourselves of them?

Vaccination does by-pass some front line non-specific immune defences, but certainly don't 'by-pass the immune system completely', for if they did, we wouldn't produce antibodies and immune memory defences against pathogens when we encounter them.  The whole point of vaccination is to 'teach' our immune system how to deal with the real thing, by using parts of bacteria or inactivated or attenuated viruses.  And they work!  Which shouldn't be the case according to Dr. Bob's primer on the immune system.  It takes quite a bit of knowledge on a topic to be able to reduce complex concepts down to a few sound bites.  So Dr. Bob's conjecture about vaccine versus natural immunity is the chasmic difference between dumbing something down and just sounding dumb. 

AC:  The CDC also said that they have done lots of research...it's interesting because they, they CDC has long cited 2 studies done by these Danish researchers that show that mercury in vaccines does not cause autism.  Well now the lead researcher is being investigated.  Why?

BS:  Right, he was kind of double-dipping so to speak.  He was taking money from the CDC to do this research, he was also under salary from the Danish Universities [sic] and that was against his contract and apparently that went against the rules and now, according to Danish newspapers, he has skipped town with 2 million dollars worth of Danish research money and that sort of calls into question the validity of his research.

Let's take a look at those publications first:
Madsen KM, Hviid A, Vestergaard M, Schendel D, Wohlfahrt J, Thorsen P, Olsen J, Melbye M. A population-based study of measles, mumps, and rubella vaccination and autism. N Engl J Med. 2002 Nov 7;347(19):1477-82.

Madsen KM, Lauritsen MB, Pedersen CB, Thorsen P, Plesner AM, Andersen PH, Mortensen PB. Thimerosal and the occurrence of autism: negative ecological evidence from Danish population-based data. Pediatrics. 2003 Sep;112(3 Pt 1):604-6.

Notice the dates of publication and the order of the authors.  Ms. Camerota and Dr. Bob have referred to the lead author which is Dr. Madsen for both, well he isn't the author in question.  That would be Dr. Poul Thorsen, the sixth and fourth author, respectively.  Respectful Insolence has explained this relevance in great detail, but an author that far down on the list has not made a very significant contribution.  In fact, Dr.s Madsen and Melbye, the senior authors of the studies released a statement to the Philadelphia Inquirer several months ago regarding Dr. Thorsen's involvement:

"Poul Thorsen had absolutely no influence on the conclusions regarding this paper," wrote Mads Melbye, head of the division of epidemiology at the Statens Serum Institut in Copenhagen and senior author of the study, in response to e-mailed questions.
"Thorsen was not actively involved in the analysis and interpretation of the results of this paper," Melbye said.
The second study, published in Pediatrics in 2003, examined 956 Danish children diagnosed with autism from 1971 to 2000. It concluded the incidence of autism increased in Denmark after thimerosal was removed from vaccines.
Kreesten Meldgaard Madsen, the lead author, said Thorsen played a minor role.
"Dr. Thorsen was not in a position to change or compromise the data," Madsen wrote. "Dr. Thorsen was part of the review cycle, but never very active in giving input. Dr. Thorsen never had access to the raw data nor the analysis of the data."

As for the dates, the studies were published in 2002 and 2003 but Dr. Thorsen's resignation under dubious circumstances did not occur until March, 2009.  Furthermore, the grant money in question was not part of the 2 studies in question at all, but rather part of a cooperative between the US National Center for Birth Defects and Developmental Disabilities,CDC and Odense and Aarhus Universities.  And absolutely nothing at all questionable about that; it was the discovery of forged documents by (allegedly) Dr. Thorsen that may constitute fraud.  Apparently, Dr. Thorsen held a full-time post at Emory University, Georgia, USA while still employed by Aarhus University in Copenhagen, Denmark and that is what comprised of his 'double-dipping', not a grant from the CDC as Dr. Bob stated.  Dr. Thorsen is not missing as he continues to publish studies.  We don't know what the funding irregularity was but we do know it has nothing to do with the 2002 and 2003 studies and we do know that Dr. Thorsen's involvement with those studies is being inflated to extremes for the purpose of disparaging them.  It is as though Dr. Bob read the Huffington Post and Age of Autism, didn't bother to ask himself if it made sense, didn't do a little fact-checking and merely parroted extremely questionable sources. 

But Dr. Bob acts as though these 2 studies were the lynch pins for  exonerating vaccines in the role of autism.  Even if we were to dismiss these studies, Dr. Bob completely ignores the numerous other studies by other investigators, in numerous countries that replicate Madsen et al.'s research and then some.  A hat tip to Chris (comment #63) for putting this list together (I have added some recent studies) Addendum 04.18.11 added more studies:

Lack of Association Between Measles-Mumps-Rubella Vaccination and Autism in Children: A Case-Control Study.
Budzyn D, et al.
Pediatr Infect Dis J. 2010 May;29(5):397-400.
Subjects: 96 children with autism, ages 2 to 15, as well as 192 children in a control group. For children diagnosed before a diagnosis of autism, the autism risk was lower in children who received MMR vaccine than in nonvaccinated children. A similar result was achieved for the single-antigen measles vaccine.

U.S. Court of Federal Claims decision in Omnibus Autism Proceeding
On Feb. 12, 2009, the “vaccine court” ruled in three test cases on the theory that MMR vaccine and the vaccine preservative thimerosal are linked to autism. The court found the scientific evidence is overwhelmingly contrary to this theory.
http://www.uscfc.uscourts.gov/node/5026

Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study.
Hornig M et al.
PLoS ONE 2008; 3(9): e3140 doi:10.1371/journal.pone.0003140
*Subjects: 25 children with autism and GI disturbances and 13 children with GI disturbances alone (controls)

Measles Vaccination and Antibody Response in Autism Spectrum Disorders.
Baird G et al.
Arch Dis Child 2008; 93(10):832-7.
Subjects: 98 vaccinated children aged 10-12 years in the UK with autism spectrum disorder (ASD); two control groups of similar age: 52 children with special educational needs but no ASD and 90 children in the typically developing group

MMR-Vaccine and Regression in Autism Spectrum Disorders: Negative Results Presented from Japan.
Uchiyama T et al.
J Autism Dev Disord 2007; 37(2):210-7
*Subjects: 904 children with autism spectrum disorder
(Note: MMR was used in Japan only between 1989 and 1993.)

No Evidence of Persisting Measles Virus in Peripheral Blood Mononuclear Cells from Children with Autism Spectrum Disorder.
D’Souza Y et al.
Pediatrics 2006; 118(4):1664-75
*Subjects: 54 children with autism spectrum disorder and 34 developmentally normal children

Immunizations and Autism: A Review of the Literature.
Doja A, Roberts W.
Can J Neurol Sci. 2006; 33(4):341-6
*Literature review

Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links with Immunizations.
Fombonne E et al.
Pediatrics. 2006;118(1):e139-50
*Subjects: 27,749 children born from 1987 to 1998 attending 55 schools

Is There a ‘Regressive Phenotype’ of Autism Spectrum Disorder Associated with the Measles Mumps-Rubella Vaccine? ACPEA Study
Richler et al.
J Autism Dev Disord. 2006 Apr;36(3):299-316.
Subjects: A multi-site study of 351 children with Autism Spectrum Disorders (ASD) and 31 typically developing children used caregiver interviews to describe the children’s early acquisition and loss of social-communication milestones. No evidence that onset of autistic symptoms or of regression was related to measles, mumps and rubella vaccination.

No Effect of MMR Withdrawal on the Incidence of Autism: a Total Population Study.
Honda H, et al.
J Child Psychol Psychiatry. 2005 Jun;46(6):572-9.
Subjects: Study examined incidence of Autism Spectrum Disorders (ASD) to age 7 for children born between 1988 and 1996 in Yokohama, Japan. The measles, mumps and rubella (MMR) vaccination rate in Yokohama declined significantly in the birth cohorts of years 1988-92, and no MMR vaccines were administered in 1993 or thereafter. In contrast, cumulative incidence of ASD up to age 7 increased significantly in the birth cohorts of years 1988 through 1996 and most notably rose dramatically beginning with the birth cohort of 1993.

Relationship between MMR Vaccine and Autism.
Klein KC, Diehl EB.
Ann Pharmacother. 2004; 38(7-8):1297-300
*Literature review of 10 studies

Immunization Safety Review: Vaccines and Autism. Institute of Medicine.
The National Academies Press: 2004
(www.nap.edu/books/030909237X/html) *Literature review

MMR Vaccination and Pervasive Developmental Disorders: A Case-Control Study.
Smeeth L et al.
Lancet 2004; 364(9438):963-9
*Subjects: 1294 cases and 4469 controls

Age at First Measles-Mumps-Rubella Vaccination in Children with Autism and School-Matched Control Subjects: A Population-Based Study in Metropolitan Atlanta.
DeStefano F et al. Pediatrics 2004; 113(2): 259-66
*Subjects: 624 children with autism and 1,824 controls

No Evidence for Links Between Autism, MMR and Measles Virus.
Chen W, et al.
Psychol Med. 2004 Apr;34(3):543-53.
Subjects: Study compared 2,407 persons with autism born between 1959 and 1993; to 4,640 Down syndrome subjects born between 1966 and 1993. No increased risk of autism was found following exposures to wild measles and vaccinations with monovalent measles, and Urabe or Jeryl-Lynn variants of measles, mumps and rubella (MMR) vaccine.

Prevalence of Autism and Parentally Reported Triggers in a North East London Population.
Lingam R et al.
Arch Dis Child 2003; 88(8):666-70
*Subjects: 567 children with autistic spectrum disorder

Neurologic Disorders after Measles-Mumps-Rubella Vaccination.
Makela A et al.
Pediatrics 2002; 110:957-63
*Subjects: 535,544 children vaccinated between November 1982 and June 1986 in Finland

A Population-Based Study of Measles, Mumps, and Rubella Vaccination and Autism.
Madsen KM et al.
N Engl J Med 2002; 347(19):1477-82
*Subjects: All 537,303 children born 1/91–12/98 in Denmark

Relation of Childhood Gastrointestinal Disorders to Autism: Nested Case Control Study Using Data from the UK General Practice Research Database.
Black C et al.
BMJ 2002; 325:419-21
*Subjects: 96 children diagnosed with autism and 449 controls

Measles, Mumps, and Rubella Vaccination and Bowel Problems or Developmental Regression in Children with Autism: Population Study.
Taylor B et al.
BMJ 2002; 324(7334):393-6
*Subjects: 278 children with core autism and 195 with atypical autism

No Evidence for a New Variant of Measles-Mumps-Rubella-Induced Autism.
Fombonne E et al.
Pediatrics 2001;108(4):E58
*Subjects: 262 autistic children (pre- and post-MMR samples)

Measles-Mumps-Rubella and Other Measles-Containing Vaccines Do Not Increase the Risk for Inflammatory Bowel Disease: A Case-Control Study from the Vaccine Safety Datalink Project.
Davis RL et al.
Arch Pediatr Adolesc Med 2001;155(3):354-9
*Subjects: 155 persons with IBD with up to 5 controls each

Time Trends in Autism and in MMR Immunization Coverage in California.
Dales L et al.
JAMA 2001; 285(9):1183-5
*Subjects: Children born in 1980-94 who were enrolled in California kindergartens (survey samples of 600–1,900 children each year)

Mumps, Measles, and Rubella Vaccine and the Incidence of Autism Recorded by General Practitioners: A Time Trend Analysis.
Kaye JA et al.
BMJ 2001; 322:460-63
*Subjects: 305 children with autism

MMR and Autism: Further Evidence Against a Causal Association.
Farrington CP, et al.
Vaccine. 2001 Jun 14;19(27):3632-5.
Subjects: Data from an earlier measles, mumps and rubella (MMR) vaccine study (Taylor et al, 2000) were reanalyzed to test a second hypothesis. Results provide further evidence against a causal association between MMR vaccination and autism.

Further Evidence of the Absence of Measles Virus Genome Sequence in Full Thickness Intestinal Specimens from Patients with Crohn’s Disease.
Afzal MA, et al.
J Med Virol 2000; 62(3):377-82
*Subjects: Specimens from patients with Crohn’s disease

Autism and Measles, Mumps, and Rubella Vaccine: No Epidemiological Evidence for a Causal Association.
Taylor B et al.
Lancet 1999;353 (9169):2026-9
*Subjects: 498 children with autism

Absence of Detectable Measles Virus Genome Sequence in Inflammatory Bowel Disease Tissues and Peripheral Blood Lymphocytes.
Afzal MA et al.
J Med Virol 1998; 55(3):243-9
*Subjects: 93 colonoscopic biopsies and 31 peripheral blood lymphocyte preparations

No Evidence for Measles, Mumps, and Rubella Vaccine-Associated Inflammatory Bowel Disease or Autism in a 14-year Prospective Study.
Peltola H et al.
Lancet 1998; 351:1327-8
*Subjects: 3,000,000 doses of MMR vaccine

Exposure to Measles in Utero and Crohn’s Disease: Danish Register Study.
Nielsen LL et al.
BMJ 1998; 316(7126):196-7
*Subjects: 472 women with measles

Immunocytochemical Evidence of Listeria, Escherichia coli, and Streptococcus Antigens in Crohn’s Disease.
Liu Y et al.
Gastroenterology 1995; 108(5):1396-1404
*Subjects: Intestines and mesenteric lymph node specimens from 21 persons from families with a high frequency of Crohn’s disease

Neuropsychological Performance 10 years after Immunization in Infancy with Thimerosal-Containing Vaccines
Tozzi AE, Bisiacchi P, Tarantino V, De Mei B, D'Elia L, Chiarotti F, Salmaso S.
Pediatrics, February 2009, Vol. 123(2):475-82

Mercury Levels in Newborns and Infants after Receipt of Thimerosal-Containing Vaccines
Pichichero ME, Gentile A, Giglio N, et al
Pediatrics, February 2008; 121(2) e208-214

Mercury, Vaccines, And Autism: One Controversy, Three Histories
Baker JP
American Journal of Public Health, February 2008;98(2): 244-253

Continuing Increases in Autism Reported to California's Developmental Services System: Mercury in Retrograde
Schechter R, Grether JK
Arch Gen Psychiatry, January 2008; 65(1):19-24

Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years
Thompson WW, Price C, Goodson B, et al; Vaccine Safety Datalink Team
N Engl J Med, Sep 27, 2007; 357(13):1281-1292

Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links with Immunizations
Fombonne E, Zakarian R, Bennett A, Meng L, McLean-Heywood D
Pediatrics, July 2006, Vol. 118(1):e139-e150

Vaccine Adverse Event Reporting System Reporting Source: A Possible Source of Bias in Longitudinal Studies
Goodman MJ, Nordin J
Pediatrics, February 2006, Vol. 117(2):387-390

Thimerosal in Vaccines: Balancing the Risk of Adverse Effects with the Risk of Vaccine-Preventable Disease
Bigham M, Copes R
Drug Safety, 2005, Vol. 28(2):89-101

Comparison of Blood and Brain Mercury Levels in Infant Monkeys Exposed to Methylmercury or Vaccines Containing Thimerosal
Burbacher TM, Shen DD, Liberato N, Grant KS, Cernichiari E, Clarkson T
National Institute of Environmental Health Sciences, April 21, 2005

Thimerosal Exposure in Infants and Developmental Disorders: A Prospective Cohort Study in the United Kingdom Does Not Support a Causal Association
Heron J, Golding J, ALSPAC Study Team
Pediatrics, September 2004, Vol. 114(3):577-583

Thimerosal Exposure in Infants and Developmental Disorders: A Retrospective Cohort Study in the United Kingdom Does Not Support a Causal Association
Andrews N, Miller E, Grant A, Stowe J, Osborne V, Taylor B
Pediatrics, September 2004, Vol. 114(3):584-591

Thimerosal-Containing Vaccines and Autistic Spectrum Disorder: A Critical Review of Published Original Data
Parker SK, Schwartz B, Todd J, Pickering LK
Pediatrics, September 2004, Vol. 114(3):793-804

The Evidence for the Safety of Thimerosal in Newborn and Infant Vaccines
Clements CJ
Vaccine, May 7, 2004, Vol. 22(15-16):1854-1861

Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases
Verstraeten T, Davis RL, DeStefano F, et al
Pediatrics, November 2003, Vol. 112(5):1039-1048

The Toxicology of Mercury--Current Exposures and Clinical Manifestations
Clarkson TW, Magos L, Myers GJ
New England Journal of Medicine, October 30, 2003, Vol. 349(18):1731-7

Association Between Thimerosal-Containing Vaccine and Autism
Hviid A, Stellfeld M, Wohlfahrt J, Melbye M
Journal of the American Medical Association, October 1, 2003, Vol. 290(13):1763-6

Thimerosal and the Occurrence of Autism: Negative Ecological Evidence from Danish Population-Based Data
Madsen KM, Lauritsen MB, Pedersen CB, et al
Pediatrics, Sept. 2003, Vol. 112(3 Pt 1):604-606

Autism and Thimerosal-Containing Vaccines. Lack of Consistent Evidence for an Association
Stehr-Green P, Tull P, Stellfeld M, Mortenson PB, Simpson D
American Journal of Preventive Medicine, August 2003, Vol. 25(2):101-6

Impact of the Thimerosal Controversy on Hepatitis B Vaccine Coverage of Infants Born to Women of Unknown Hepatitis B Surface Antigen Status in Michigan
Biroscak BJ, Fiore AE, Fasano N, Fineis P, Collins MP, Stoltman G
Pediatrics, June 2003, Vol. 111(6):e645-9

Vaccine Safety Policy Analysis in Three European Countries: The Case of Thimerosal
Freed GL, Andreae MC, Cowan AE, et al
Health Policy, December 2002, Vol. 62(3):291-307

Mercury Concentrations and Metabolism in Infants Receiving Vaccines Containing Thimerosal: A Descriptive Study
Pichichero ME, Cernichiari E, Lopreiato J, Treanor J
The Lancet, November 30, 2002, Vol. 360:1737-1741

An Assessment of Thimerosal Use in Childhood Vaccines
Ball LK, Ball R, Pratt RD
Pediatrics, May 2001, Vol. 107(5):1147-1154

Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism
Price CS, Thompson WW, Goodson B, Weintraub ES, Croen LA, Hinrichsen VL, Marcy M, Robertson A, Eriksen E, Lewis E, Bernal P, Shay D, Davis RL, DeStefano F Pediatrics, October, 2010, Vol. 126(4): 656-664

On-time Vaccine Receipt in the First Year Does Not Adversely Affect Neuropsychological Outcomes
Smith MJ and Woods CR
Pediatrics, June, 2010, Vol. 125 (6):1134-1141

This is, obviously, a lot of reading to do but considering the totality of evidence it is the responsible tact to take when advising the public about vaccine issues.  There are concerns and criticisms regarding the CDC vaccine schedule, but they are rather mundane when compared to the misleading and downright false conjectures that self-proclaimed experts would have us believe.  There seems to be an anti-intellectual movement afoot but with the taskmasters absurdly co-opting the esteem of education and credentials to propagate it.

It is encouraging to see that this interview was done by Fox News since they are renowned for their unapologetic biases and don't even bother to offer up any pretence of presenting a fair balance of issues.  An appearance on Fox News is akin to has-been and never-were celebrities breathing their last gasp on Dancing With the Stars.  It signifies the downward spiral of the anti-intellectual, anti-vaccine movement.  And that is a good thing.

Addendum (16 October 2010):  Rahul K. Parikh, M.D. has weighed in on Dr. Bob Sears' Vaccine Book and appearance on Fox News.

2010-2011 U.S. Influenza Vaccines

Flu vaccines for U.S. use are beginning to arrive in physicians' offices, hospitals and public health departments. The FDA has announced that the following strains will be included in all vaccines for the 2010-2011 season:
* Influenza A/California/7/09 (H1N1)-like virus (pandemic (H1N1) 2009 influenza virus)
* Influenza A/Perth /16/2009 (H3N2)-like virus
* Influenza B/Brisbane/60/2008-like virus
Of the estimated 160-165 million doses of influenza vaccine supplied to the U.S., approximately 74 million (45-46%) will be thimerosal-free.

2010-2011 Influenza Vaccines At-A-Glance
(Adapted from the CDC)

Product: Afluria is manufactured by CSL Limited in Australia but distributed in the U.S. by Merck.
Description: AFLURIA is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Formulated to contain 45 mcg hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the three influenza strains recommended for the 2020-2011 Northern Hemisphere influenza season: A/California/7/2009, NYMC X-181 (H1N1), A/Victoria/210/2009, NYMC X-187 (H3N2) (an A/Perth/16/2009-like strain), and
B/Brisbane/60/2008. A 0.25 mL dose contains 7.5 mcg HA of each of the same three influenza strains.
The single dose presentations do not contain thimerosal. The multi-dose presentation contains thimerosal and each 0.5 mL dose contains 24.5 mcg of mercury.
A single 0.5 mL dose of Afluria contains 4.1 mg sodium chloride, 80 mcg monobasic sodium phosphate, 300 mcg dibasic sodium phosphate, 20 mcg monobasic potassium phosphate, 20 mcg potassium chloride, and 1.5 mcg calcium chloride. Left over from the manufacturing process are residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (≤ 1 mcg), neomycin sulfate (≤ 0.2 picograms [pg]), polymyxin B (≤ 0.03 pg), and beta-propiolactone. The single 0.25 mL dose contains half of all of these quantities.
Indications and Usage: Afluria has been previously approved for the use in children 6 months and older and all adults, however, in light of the risk of febrile seizures observed in Australia and New Zealand in children less than 5 years old, Afluria has been suspended for use in children less than 9 years old, with the exception of 5-8 years olds whose benefit of flu vaccination outweighs the risk and no other vaccine is available. Since CSL will supply only ~12 million single doses to the U.S. (~7% of total supply), it should not be a problem to comply with this recommendation. So, the age indicated for use is ≥ 9 years old.
Contraindications: Individuals with known hypersensitivity to eggs, neomycin or polymyxin, any other vaccine constituent or in anyone who has had a life-threatening reaction to previous influenza vaccine.
Safety and Efficacy: Clinical trials in adults 18 to less than 65 years old demonstrated seroconversion rates of 97.8% (96.7-98.6%), 99.9% (99.5-100.0%) and 94.2% (92.7-95.6%) against H1N1, H3N2 and B influenza strains respectively.

Product: Agriflu is manufactured by Novartis.
Description: Agriflu is prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs inoculated with an influenza virus suspension containing kanamycin and neomycin sulphate. Formulated to contain a total of 45 mcg hemagglutinin (HA) per 0.5-mL dose in the recommended ratio of 15 mcg HA of each of the following three influenza virus strains recommended for the 2010/2011 influenza season: A/California/7/2009, NYMC X-181 (H1N1); A/Victoria/210/2009, NYMC X-187 (H3N2) (an A/Perth/16/2009-like virus); and B/Brisbane/60/2008. Agriflu comes in single dose preparations that do not contain thimerosal.
Each 0.5 mL dose of Agriflu contains 4.0 mg sodium chloride, 0.1 mg potassium chloride, 0.1 mg potassium dihydrogen phosphate, 0.66 mg disodium phosphate dihydrate, 0.05 mg magnesium chloride, and 0.06 mg calcium chloride. Left over from the manufacturing process are residual amounts of egg proteins
Indications and usage: Agriflu is approved for the use in adults ≥ 18 years old.
Contraindications: Individuals with known hypersensitivity to eggs, neomycin or kanamycin, any other vaccine constituent or in anyone who has had a life-threatening reaction to previous influenza vaccine.
Safety and Efficacy: In a clinical trial of adults 18-64 years old, seroconversion rates were 74% (69-78%), 72% (68-76%) and 77% (72-81%) to H1N1, H3N2 and B influenza viruses, respectively. In a clinical trial of adults 18-49 years old, seroconversion rates were 94% (93-93%), 67% (65-70%) and 84% (82-86%) H1N1, H3N2 and B influenza viruses, respectively. Please review package insert for information on adverse events.

Product: Fluarix is manufactured by GlaxoSmithKlein (GSK).
Description: Fluarix is prepared from influenza viruses propagated in embryonated chicken eggs. Formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5-mL dose, in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/California/7/2009 NYMC X-181 (H1N1), A/Victoria/210/2009 NYMC X-187 (H3N2) (an A/Perth/16/2009-like virus), and B/Brisbane/60/2008. Fluarix comes in single-dose preparations that do not contain thimerosal.
Each 0.5 mL dose of Fluarix contains ≤ 0.085 mg octoxynol-10 (TRITON® X-100), ≤ 0.1 mg α-tocopheryl hydrogen succinate, and ≤ 0.415 mg polysorbate 80 (Tween 80). Left over from the manufacturing process are residual amounts of hydrocortisone (≤0.0016 mcg), gentamicin sulfate (≤0.15 mcg), ovalbumin (≤0.05 mcg), formaldehyde (≤5 mcg), and sodium deoxycholate (≤50 mcg).
Indications and Usage: Fluarix is indicated for use in children ≥ 3 years old and adults. Children 3-9 years old who are unvaccinated or have only received a single dose in the previous season should receive 2 doses administered at least 4 weeks apart. Children over the age of 9 years old and adults receive only 1 dose.
Contraindications: Individuals with known hypersensitivity to eggs, any other vaccine constituent or in anyone who has had a life-threatening reaction to previous influenza vaccine.
Safety and Efficacy: Measurements of vaccine efficacy (seroconversion) and effectiveness (how the vaccine actually protected) were performed with the vaccine from the 2006-2007 influenza season for antigenically matched strains and also culture-confirmed flu. The effectiveness for antigenically matched strains in adults 18-64 years old was 66.9% (51.9-72.8%) and for culture-confirmed influenza, 61.6% (46-72.8%). The efficacy in adults 18-64 years old was 59.6% (56-63.1%), 61.9% (58.3-65.4%) and 77.6% (74.4-80.5%) for A/New Caledonia/20/99 (H1N1), A/Wyoming/3/2003 (H3N2) and B/Jiangsu/10/2003 strains respectively. Please review package insert for information on adverse events.

Product: Flulaval is manufactured by ID Biomedical Corporation of Canada, a subsidiary of GlaxoSmithKlein (GSK).
Description: Flulaval is prepared as a trivalent, split-virion, inactivated influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs. Formulated to contain 45 mcg hemagglutinin per 0.5-mL dose in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/California/7/2009 NYMC X-179A (H1N1), A/Victoria/210/2009 NYMC X-187 (H3N2) (an A/Perth/16/2009-like virus), and B/Brisbane/60/2008. Flulaval is a multi-dose presentation so thimerosal is added as a preservative. Each 0.5 mL dose contains 25 mcg of mercury. A complete listing of excipients cannot be found, but left over from manufacturing are residual amounts of egg proteins (≤1 mcg ovalbumin), formaldehyde (≤25 mcg), sodium deoxycholate (≤50 mcg) and phosphate-buffered isotonic solution. Antibiotics are not used in the manufacture of this vaccine.
Indications and Usage: Flulaval is indicated for use in adults ≥ 18 years old. It is estimated that GSK will be shipping ~30 million doses combined of Fluarix and Flulaval to the U.S.
Contraindications: Individuals with known hypersensitivity to eggs, any other vaccine constituent or in anyone who has had a life-threatening reaction to previous influenza vaccine.
Safety and Efficacy: In clinical trials of adults 18-64 years old, Flulaval demonstrated seroconversion in 85.6% (82.7% lower bound of 95% CI), 79.3% (76.1% lower bound of 95% CI) and 58.4% (54.6% lower bound of 95% CI) for A/New Caledonia/20/99 (H1N1), A/Wyoming/3/2003 (H3N2) and B/Jiangsu/10/2003 strains respectively. In a clinical trial of adults ≥50 years old, Flulaval demonstrated seroconversion in 44.8% (39.3% lower bound of 95% CI), 69.1% (63.8% lower bound of 95% CI) and 49.1% (43.5% lower bound of 95% CI) for A/New Caledonia/20/99 (H1N1), A/Wyoming/3/2003 (H3N2) and B/Jiangsu/10/2003 strains respectively. Please review package insert for information on adverse events.

Product: FluMist is manufactured by MedImmune.
Description: FluMist is prepared as a live, attenuated trivalent vaccine for administration by intranasal spray. The influenza virus strains in FluMist are cold-adapted which means that they grow efficiently at 25°C and restricted growth at temperatures of 37°-39°C. Specific pathogen-free (SPF) eggs are inoculated with each of the reassortant strains and incubated to allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled and then clarified by filtration. Each pre-filled refrigerated FluMist sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 10^6.5-7.5 FFU of live attenuated influenza virus reassortants of each of the three strains: A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008. Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, 0.96 mg/dose monobasic potassium phosphate, and less than 0.015 mg/mL gentmicin sulfate.
Indications and Usage: Flumist is indicated for use in individuals 2-49 years old. It is a 0.2 mL dose vaccine that is administered intranasally (0.1 mL per nostril). Children aged 2-8 years old not previously vaccinated for influenza should receive 2 doses, at least one month apart. Children aged 2-8 years old previously vaccinated for influenza and individuals 9-49 years old should receive 1 dose.
Contraindications: Hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine, or life-threatening reactions to previous influenza vaccination. Concomitant aspirin therapy in children and adolescents. Antiviral medications. Anyone with asthma or children less than 5 years old with recurrent wheezing episodes
Safety and Efficacy: In a clinical study of children less than 5 years of age, FluMist demonstrated an effectiveness of 44.5% (22.4-60.6%) expressed as a reduction in culture-confirmed influenza against all matched strains of H1N1, H3N2 and B influenza. In a clinical trial of adults 18-49 years old, FluMist demonstrated an effectiveness of 10.9% (-5.1-24.4%) expressed as a reduction in one or more episodes of febrile illness. Please review package insert for information on adverse events.

Product: Fluvirin is manufactured by Novartis.
Description: Fluvirin is a trivalent, sub-unit (purified surface antigen) influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs inoculated with a specific type of influenza virus suspension containing neomycin and polymyxin. Formulated to contain 45 mcg hemagglutinin (HA) per 0.5-mL dose in the recommended ratio of 15 mcg HA of each of the following 3 viruses: A/Brisbane/59/2007, IVR-148 (H1N1); A/Uruguay/716/2007, NYMC X-175C (H3N2) (an A/Brisbane/10/2007-like virus); and B/Brisbane/60/2008.
Fluvirin comes in single, 0.5 mL pre-filled syringes contain trace thimerosal (≤ 1 mcg mercury per 0.5-mL dose). The 5-mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg
mercury. A complete listing of excipients cannot be found, but left over from manufacturing are residual amounts of egg proteins (≤ 1 mcg ovalbumin), polymyxin (≤ 3.75 mcg), neomycin (≤ 2.5 mcg), betapropiolactone (not more than 0.5 mcg), phosphate-buffered isotonic solution (≤ 1.0 mcg and nonylphenol ethoxylate (not more than 0.015% w/v).
Indications and Usage: Fluvirin is indicated for the use in individuals ≥ 4 years old. Children 4-8 years old who are unvaccinated for influenza or have only received one dose the previous year should receive 2 doses, at least 4 weeks apart. Children 4-8 years old who have previously received 2 doses of influenza vaccine, children ≥ 9 years old and adults should receive 1 dose. It is estimated that Novartis will be supplying the U.S. with ~40 million doses of Fluvirin.
Contraindications: Individuals with known hypersensitivity to eggs, any other vaccine constituent or in anyone who has had a life-threatening reaction to previous influenza vaccine.
Safety and Efficacy: Numerous, small clinical studies conducted on adults 18-64 years old demonstrated a wide range of seroconversion rates depending upon year and strain. The ranges with 95% CI were 55% (44-67%) - 73% (62-83%), 61% (50-72%) - 90% (86-93%) and 56% (45-67%) - 74% (65-82%) for H1N1, H3N2 and B strains respectively. Please review package insert for information on adverse events.

Product: Fluzone is manufactured by Sanofi Pasteur and comes in three presentations. Fluzone High-Dose is new this year.
Description: Fluzone and Fluzone High-Dose are inactivated influenza virus vaccines prepared from influenza viruses propagated in embryonated chicken eggs. They are formulated to contain the amount of HA per dose for each of the three influenza strains recommended for the 2010-2011 Northern Hemisphere influenza season: A/California/07/2009 X-179A (H1N1), A/Victoria/210/2009 X-187 (an A/Perth/16/2009-like virus) (H3N2), and B/Brisbane/60/2008.
Paediatric Fluzone: Is a 0.25 mL dose containing 22.5 mcg HA total; 7.5 mcg each of H1N1 HA, H3N2 HA and B HA. (quantity sufficient for appropriate volume) Sodium phosphate-buffered isotonic sodium chloride solution, ≤50 mcg formaldehyde, ≤50 mcg octylphenol ethoxylate (Triton® X-100) and 0.05% gelatin. Fluzone paediatric comes in single-dose, pre-filled syringes and do not contain thimerosal. Fluzone presented in a multi-dose (for use in individuals ≥ 6 months old) vial does contain thimerosal and contains 12.5 mcg mercury per 0.25 mL dose.
Fluzone: Is a 0.5 mL dose containing 45 mcg HA total; 15 mcg each of H1N1 HA, H3N2 HA and B HA. (quantity sufficient for appropriate volume) Sodium phosphate-buffered isotonic sodium chloride solution, ≤100 mcg formaldehyde, ≤100 mcg octylphenol ethoxylate (Triton® X-100) and 0.05% gelatin. Fluzone comes in single-dose presentations that do not contain thimerosal and multi-dose vials that contain 25 mcg mercury per 0.5 mL dose.
Fluzone High-Dose: Is a 0.5 mL dose containing 180 mcg HA total; 60 mcg each of H1N1 HA, H3N2 HA and B HA. (quantity sufficient for appropriate volume) Sodium phosphate-buffered isotonic sodium chloride solution, ≤100 mcg formaldehyde, ≤250 mcg octylphenol ethoxylate (Triton® X-100) and no gelatin. Fluzone High-Dose comes in a single-dose, pre-filled syringe presentation that does not contain thimerosal.
Indications and Usage: Fluzone is indicated for the use in individuals ≥ 6 months old and adults less than 65 years old. Children 6 - 35 months old, unvaccinated with influenza or receipt of 1 dose in the previous year should receive 2 0.25 mL doses, at least 1 month apart. Children 36 months - 8 years old, unvaccinated with influenza or receipt of 1 dose in the previous year should receive 2 0.5 mL doses, at least 1 month apart. Individuals ≥ 9 years old should receive 1 0.5 mL dose. Fluzone High-Dose is indicated for the use in individuals ≥ 65 years old and should receive 1 dose. Sanofi Pasteur announced that ~70 million doses of Fluzone will be supplied to the U.S.
Contraindications: Individuals with known hypersensitivity to eggs, any other vaccine constituent or in anyone who has had a life-threatening reaction to previous influenza vaccine.
Safety and Efficacy: In one very small paediatric study, children 6 - 36 months old, after 2 doses, demonstrated seroconversion rates of 77%, 77% and 48% to H1N1, H3N2 and B influenza strains respectively. Small, clinical studies of adults 19 - 59 years old demonstrated seroconversion ranges of 49-54%, 72-79% and 38% to H1N1, H3N2 and B influenza strains respectively. In adults 61-86 years old demonstrated seroconversion ranges of 23-38%, 68-70% and 10-11% to H1N1, H3N2 and B influenza strains respectively. Fluzone High-Dose in adults 65-97 years old demonstrated seroconversion rates of 48.6%, 69.1% and 41.8% to H1N1, H3N2 and B influenza strains respectively. Please review package insert for information on adverse events.

Pregnant women or women who will become pregnant during influenza season may be concerned about influenza infection and vaccine safety during their pregnancies. Ideally, women who are thinking about becoming pregnant should consider flu vaccination prior to conception. However, that is not always an option.

In Influenza infection and vaccination in pregnant women, Tamma et al. reviewed numerous studies regarding the effect of influenza infection and vaccination on pregnant women and neonates. Transplacental transmission of influenza virus and teratogenic effects remain unclear, however, there is evidence that an indirect effect of maternal influenza infection on adverse foetal development may occur via the maternal immune response (proinflammatory cytokine production) during hypothermia, particularly in the first trimester. It has been postulated that influenza vaccines could do the same, however first, influenza vaccines administered to pregnant women are inactivated and next, a study by Munoz et al. (2005), failed to find any differences in adverse pregnancy outcomes and infant health (study period of 6 months post-partum) in a cohort of vaccinated pregnant (in second or third trimester) women versus unvaccinated, healthy pregnant women. Additionally, no unusual adverse outcomes occurred in the vaccinated group that could be attributed to influenza vaccine.

There appears to be protective effects for the neonate in influenza vaccinated mothers as well. Zamen et al. (2008) reported a 63% reduction in laboratory confirmed influenza in infants less than 6 months old born to mothers that were vaccinated for influenza during pregnancy as compared to a Pneumovax-vaccinated control group. Although both groups were vaccinated, there were no adverse outcomes that differed from the general population during that time.

Since no vaccine is completely effective, there are a number of precautions that you can and should take regardless of your vaccination choice:

• Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
• Wash your hands often with soap and water. If soap and water are not available, use an alcohol-based hand rub.
• Avoid touching your eyes, nose and mouth. Germs spread this way.
• Try to avoid close contact with sick people.
• If you are sick with flu–like illness, CDC recommends that you stay home for at least 24 hours after your fever is gone except to get medical care or for other necessities. (Your fever should be gone without the use of a fever-reducing medicine.)
  
• While sick, limit contact with others as much as possible to keep from infecting them. Utilise N-95 masks to prevent transmission of flu.
  
• Stay healthy by eating right, this includes supplementation with vitamin D3, which may help to reduce influenza disease effects. Pregnant women need to ensure adequate folic acid intake.
  

(Adapted from the CDC's Seasonal Influenza page)

Cedillo vs. HHS Appeal Denied

Michele Cedillo was selected by the Omnibus Autism Proceeding (OAP) Petitioner's Steering Committee (PSC) as a test case for the 'Thimerosal and MMR Vaccine Autism Causation Claim'. On 12 February 2009, Special Master Hastings denied compensation to the Cedillos on Michele's behalf.

Considering all of the evidence, I found that the petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction, or that the MMR vaccine can contribute to causing either autism or gastrointestinal dysfunction. I further conclude that while Michelle Cedillo has tragically suffered from autism and other severe conditions, the petitioners have also failed to demonstrate that her vaccinations played any role at all in causing those problems.

This decision was upheld on 6 August 2009 by the United States Court of Federal Claims.

After performing this review, the Court is satisfied that the Special Master’s decision is rational and reasonable in all respects, and is in accordance with law. For the reasons addressed above, the Special Master’s decision is AFFIRMED.

Attorneys for the Cedillos filed an Amicus Brief in the United States Court of Appeals for the Federal Circuit on 25 January 2010. The Court of Appeals rendered their decision on 27 August 2010.

In conclusion, we have carefully reviewed the decision of the Special Master and we find that it is rationally supported by the evidence, well-articulated, and reasonable. We therefore affirm the denial of the Cedillos’ petition for compensation.

Part of the Cedillo's arguments relied upon the admissibility of Dr. Stephen Bustin's testimony. While the panel for the Appeals Court of the Federal Circuit found the admission of Dr. Bustin's testimony "troubling", they did not find cause for reversal.

In our recent decision in Hazlehurst, we specifically addressed this question and held that the failure to exclude the testimony and reports of Dr. Bustin did not constitute reversible error. See Hazlehurst, 604 F.3d at 1348-52. In particular, we concluded that the Special Master’s decision to admit and consider Dr. Bustin’s testimony was “in full accord with the principle of fundamental fairness” under Vaccine Rule 8(b)(1) and did not “contravene[] the purpose[] of the Vaccine Act” to avoid proceedings resembling tort litigation.

Curiously, it was the Cedillo's admission of the Unigenitics Laboratory results validity which compelled the HHS to seek rebuttal evidence.

As we noted in Hazlehurst, “[a]lthough not obligated to do so, the petitioners chose to introduce the Unigenetics data and thus placed its validity squarely at issue. Fairness dictated that the government be given an opportunity to refute that critical evidence.” Id. at 1349.

To further the baselessness of this particular complaint by the Cedillos was the fact that they were provided a year to procure relevant documentation from the U.K. regarding Dr. Stephen Bustin's testimony of the Unigenetics Laboratory audit he had conducted, but failed to do so. This, even in light of the fact that Special Master Hastings and the Department of Justice offered their assistance to the PSC.

Second, petitioners did not request that the Special Master apply Rule 26 or order the government to secure the underlying information.
Third, petitioners themselves did not seek to access the data from the UK court, nor did they examine Dr. Bustin as to the current location of the data he relied upon in creating his reports. In the Special Master’s evidentiary ruling denying petitioners’ motion to exclude Bustin’s reports and testimony, he encouraged petitioners’ counsel to seek the underlying data from the UK court, and pledged to join any request. Thereafter, the Special Master then gave petitioners over a year to petition the British court for access to the information. Petitioners also requested that the OAP Special Masters provide a letter supporting a possible request, which the Special Masters did. Petitioners considered making such a request from the UK court, but never did so. They contend that British counsel informed them that it was unlikely that the UK court would permit disclosure of the expert reports without the consent of the experts, which petitioners stated that they could not obtain. But Dr. Bustin did consent to the release of his reports. Once his consent
for the release of his reports had been obtained by the government, there is no reason why the data underlying his reports could not also have been requested.

It appears as though the PSC wilfully shoot themselves in the foot and then expect laws and procedures to change to accommodate their own incompetence. The rest of the frivolity of the claims by the petitioners for a 'do over' and subsequent decision by the Federal Circuit of Appeals is best summed up with the following statement:

Petitioners also contend that the Special Master abused his discretion in “ignor[ing]” certain concessions made by the government’s experts or in “refus[ing] to consider” certain evidence. However, the Special Master did not ignore relevant testimony and explicitly considered the evidence in question with a few limited exceptions. Petitioners primarily argue that the Special Master considered, but erroneously declined to credit, certain evidence, or to draw from it conclusions favorable to petitioners. We have reviewed petitioners’ arguments and we find them to be unpersuasive. In the Special Master’s careful and thorough opinion, he considered, weighed, and stated his reasons for rejecting or discounting each item of evidence in which the petitioners relied. With respect to many of petitioners’ claims of error, no discussion is necessary because there is no possible basis for the claim of error.

In other words, the petitioners' arguments amounted to a lot of foot-stomping because Special Master Hastings did not find their experts nor evidence at all compelling, even in light of the fact that Special Master Hastings qualified each and every statement he made regarding the PSC's expert testimony and evidence.
This case, as with Hazelhurst vs. HHS has been heard 3 times examining various parameters and none have affirmed that the petitioners have presented a compelling case, nor have any reversible legal errors been committed by the presiding Special Masters.

We wish the Cedillos and other petitioners of the OAP the very best and can somehow, accept these decisions in order to move on with their lives. While it is possible that the Cedillos may opt to appeal to the United States Supreme court, it is our rather non-legal opinion that they won't even hear it and it is time for the Cedillos and other families like them to stop being used by interested parties to further their agenda.

Dr. Bob Sears Gets it Wrong Again

This time, about pertussis, pertussis epidemiology, vaccinology and well, just about anything else to do with pertussis. Here is a recent post by him on The Vaccine Book Discussion Forum and his FaceBook page entitled, Pertussis Epidemic 2010: What Should Parents Do? I will break the entire post down point by point. His unedited post appears as indented text.

With the current increase in pertussis (whooping cough), many parents with unvaccinated children are naturally wondering if they need to worry. Here are some of my thoughts:

There IS an increase this year, but pertussis naturally shows a temporary rise for about a year or two every 5 years. The last such increase was in 2004/2005, followed by a decline back to normal. So it’s no surprise that this has happened. It’s not like we are unexpectedly seeing a sudden epidemic. We KNEW this was going to happen. That doesn’t make it any less serious, but it’s important to know that pertussis naturally rises like this.

In past years we’ve had about 15,000 reported cases of pertussis each year. The every-five-year peaks we’ve seen have been about 20 to 25,000 cases. This year we are looking at 30,000 or more. However, these are just the reported numbers. Only about 10% or less of cases are actually diagnosed or reported. So the real numbers are MUCH higher. So, these periodic increases could be mostly increases in reporting, and not much increase in actual disease. Or it could be disease increase. It’s hard to say. One argument if favor of an actual increase is that we do know the actual fatality numbers very accurately. And when that jumps higher, as it has this year, we can take that as a likely indication the disease incidence is higher as well.

Dr. Sears doesn't grasp basic principles of epidemiology such as it isn't the unexpectedness that defines an epidemic, it is the increase in the expected number of cases. Pertussis epidemics occur in 3-5 year cycles, but why? This observation isn't unique to pertussis but many diseases that we are familiar with and have successfully controlled with vaccination, such as measles. Pertussis is cyclical because of highs and lows in herd susceptibility, not due to changes in the bacterium itself. So pertussis infections, such as in 2004/2005, spread through the population because a critical mass of susceptible people have accrued due to births, decreased vaccination rates, primary vaccine failure (the vaccine did not confer adequate antibody titres in the recipient) and secondary vaccine failure (vaccine immunity has waned to below protective levels) and waning natural immunity.

Pertussis is a vastly under-reported disease due to misdiagnosis, underdiagnosis, and asymptomatic and subclinical cases. However, it is under-reported rather consistently so we do know that we are experiencing an epidemic year and not a change in reporting. There is absolutely no evidence that reporting efficiencies would have such a consistent cyclical nature. Case fatality rates are not a consistent indicator of disease incidence rates either.

Is this rise due to so many unvaccinating families? Not in my opinion. The primary reason for the rise is that pertussis is a stubborn germ, and it’s difficult to make a highly effective vaccine against it. The vaccine has an estimated efficacy of 80 to 90%. This is much lower than most vaccines. So outbreaks will occur in both vaccinated and unvaccinated children. Another reason is that the vaccine wears off, so teens and adults can easily catch whooping cough. They might cough for a few weeks without realizing they have it, and spread it around to other adults and children. There are far more teen and adult cases each year than childhood cases.

His opinion should be qualified by evidence and it isn't. Vaccine efficacy has nothing to do with pertussis being a 'stubborn germ'; there is no such accepted or recognised term. The vaccine efficacy, which incidentally is ~63-100%, is due to limitations within the vaccine construct and host immune response. Naturally-acquired immunity does not confer much longer immunity than the vaccine. Which is all more reason why very high vaccine uptake amongst those eligible is crucial to protect vulnerable infants that are too young to receive the vaccine or complete vaccination.

Let's look at some recent figures from the 2010 pertussis outbreak. Here are the California Department of Public Health's pertussis statistics for 2010 by county and here are vaccine exemptions for 2009 kindergarten entry. There has been much finger-pointing at Marin County due to their high rates of vaccine refusal. Not only has their vaccine exemption rate nearly doubled since the last pertussis outbreak to over 7%, but vaccine uptake by kindergartners has steadily fallen below threshold levels to 83%. This is not all though; there is substantial clustering of extremely high vaccine refusal for certain schools. For example, more than half of San Geronimo Valley Elementary and Marin Waldorf School students have vaccine exemptions. Marin County also tops the list for pertussis case rate at 99.8/100,000.

Counties also reporting the highest pertussis case rates/100,000 are San Luis Obispo (98.90), Del Norte (52.23), Madera (37.91), Fresno (31.30) and Colusa (30.04) with respective vaccine exemption rates (%) of 3.92, 5.75, 1.06, 0.98 and 0.54. These counties aren't demographically or socio-economically similar to Marin county at all, so what is going on? With the exception of Del Norte county, the rest are located in California's Central Valley, which is highly agricultural and/or has large sub-populations living at or below the poverty level. This situation translates to disparities in access to health information and services. Numerous San Luis Obispo county schools also have high vaccine exemption rates. Thus, high rates of pertussis infection are still occurring in areas with pockets of low vaccine uptake, but for different reasons than in Marin. It is interesting to note that Del Norte county's pertussis cases for 2010 were all reported prior to May and no new cases have been reported since then following a county-wide immunisation programme.

While it isn't as simple as 'high rates of vaccine refusal linearly corresponds with pertussis cases', as there are numerous factors involved, it is safe to say that vaccine refusal does contribute to increases in pertussis, regardless of the reason. So if Dr. Bob's advice makes him feel uncomfortable about promoting lower vaccine uptake, then perhaps he ought to spend a bit more time investigating the potential ramifications of his advice as should parents taking his advice.

Do unvaccinated children put others at risk? I would have to say that this is true to some extent. An unvaccinated child IS more likely to catch pertussis than a vaccinated child. So it makes sense that the fewer children that are vaccinated, the more likely the disease is to go around. However, this doesn’t mean that anyone has a right to put blame on unvaccinated kids or their parents. Some parents just don’t feel comfortable with vaccines, and they have the right (in this free country) to decline vaccines in most states. Because every vaccine has the potential to cause very severe, even fatal, reactions (which are extremely rare), parents have the right to avoid the vaccine and risk the disease instead. Parents who do feel comfortable vaccinating will get their children protected so they are unlikely to catch the illness if exposed.

Not surprisingly, Dr. Bob contradicts himself by admitting that unvaccinated people do put others at risk and increase disease circulation, but yet are not responsible for the increase in pertussis cases. It doesn't matter why parents are refusing vaccines for themselves and their children; it matters how many and their geographical distribution. So even while parents have the right to refuse vaccinations, that doesn't make them any less culpable for their contribution in the rise in incidence of diseases. Just as it doesn't make any physicians or pseudo-doctors (e.g. chiropractors and naturopaths) any less culpable for promoting vaccine refusal for bogus reasons and deceptively inflated risks.

The children of vaccine refusers are 23 times more likely to contract pertussis infection than in vaccinated. And states that allow easily-obtained vaccine exemptions were associated with a higher incidence of pertussis and numerous other studies have demonstrated that vaccine uptake is inversely correlated with pertussis infection.

How serious is pertussis? The disease usually kills about 20 babies each year in the United States. This year, with the increase, we are headed for about 30 or maybe 40 deaths. These are very tragic. ALL fatalities from pertussis over the last few years have occurred in infants 3 months and younger. For many years before that all fatalities were in infants 6 months and younger. These young babies have about a 1 in 200 risk of fatality if they catch the disease. Fortunately, most babies who catch it will be just fine. Some will need hospitalization, and about 1 in 200 may die. Again, while this is tragic, this is a much lower fatality rate than some of the more serious infant infections such as meningitis.

What about older infants and children? Do parents need to fear for their safety? NO. Infants older than 6 months really have almost zero risk of fatality. Toddlers and preschoolers and older kids virtually always handle the illness without any trouble. Sure, they’ll cough for a month or two, but complications are extremely rare at this age, and hospitalization is unlikely.

Dr. Sears seems to be downplaying the complications associated with pertussis infection by emphasising the only outcome of interest being death. A case fatality rate of 1 in 200 is very serious and that alone puts the risk of disease and death orders of magnitude greater than the risk of death from vaccination. Seventy-nine percent of infants less than 6 months old have required hospitalisation, while 21% of hospitalised pertussis cases have been in > 6 month olds. One in 250 children with pertussis will have permanent brain damage, 1 in 10 will acquire pneumonia. So technically, yes, most children will be fine but why take the chance of risking weeks of very unpleasant illness and having no guarantee that your child will be fine. His comparison to meningitis is also disturbing. If most, if not all future deaths and serious sequelae from pertussis disease can be avoided with increased vaccination then it doesn't matter what statistics other pathogens present. Preventing pertussis disease and meningitis are not mutually exclusive.

One thing that has bothered me is that the media is making it sound like there’s a deadly pertussis epidemic, and that all kids are at risk. This is scaring parents and children of all ages. What the media really should be saying is that parents with new babies need to worry, but parents with older children don’t. There’s very little harm in catching this disease outside of infancy.

Dr. Bob is now instructing 'the media' (although he doesn't specify the sources) to present a portrayal of the current pertussis epidemic that won't make his recommendations look so bad. Who does he think that pertussis reservoir is? How are infants, too young to be vaccinated going to be protected if there are large clusters of unvaccinated or susceptible people surrounding them? The pertussis rate/100,000 in infants and children 6 months to 18 years old is 45; this isn't just a disease in infants. There is very little harm in catching the disease outside of infancy? I beg to differ. Again, it appears as though Dr. Bob's 'feel good' advice about vaccinations is coming back to haunt him and he is rather uncomfortable.

SO WHAT SHOULD PARENTS DO?

First, if you are planning to vaccinate, your infant will receive the DTaP vaccine at 2, 4, and 6 months of age. In certain areas where pertussis is highest, doctors do have the option of vaccinating early – at 6 weeks, 10 weeks, and 14 weeks of age. One dose of the vaccine doesn’t work very well, so the sooner a baby gets the third dose the better he’s protected. Ironically, by the time an infant receives the 3rd dose at 6 months (on the regular schedule), he is beyond the risky age for pertussis. I don’t really have an opinion on whether or not parents who live in high pertussis areas should get the accelerated schedule. That’s between you and your doctor. I have not begun doing the faster schedule, and don’t have any plans to do so at this time.

Six months of age is not "beyond the risky age for pertussis", they are just as susceptible without full vaccination. They are less likely to experience fatalities after 6 months, but they don't magically become risk-free for hospitalisation or serious sequelae. Twenty-one percent of children and infants over the age of 6 months in the current epidemic are still being hospitalised for complications.

Second, because new babies are vulnerable to pertussis in the early months before the vaccine is started and completed, parents and caregivers do have the option of getting the Tdap vaccine (a teen and adult version of the DTaP vaccine). New moms can get this when the baby is born, and dads can too. It’s given as a single dose. It’s ok to get if breastfeeding. You can review the details on this vaccine (how it’s made, what the ingredients are) in The Vaccine Book. I don’t really have an opinion yet on whether or not all parents and caregivers should get this shot. As a pediatrician, I don’t give adult shots, so I don’t have experience on how parents are tolerating the vaccine. But I do feel that the theory of giving parents of new babies this vaccine has merit.

Alas, something that almost makes sense. However, his advice is incomplete as children that have either not received vaccination with DTaP or boosted with Tdap at the appropriate age are not mentioned. The California Department of Public Health is recommending children 7 years and up receive Tdap as a booster so there is no gap in age-appropriate vaccine. So older siblings can be vaccinated either with the primary series or boosted in order to reduce transmission to household contacts as well as the general public.

Third - What about parents who are undecided about giving their new babies this vaccine? Is the current outbreak a concern? There is more risk of catching pertussis this year than last year, and this risk is likely to decline again next year as pertussis naturally wanes (if it follows the pattern of the past couple decades). Parents can review all the pros and cons of this decision in The Vaccine Book.

Nothing like a solid recommendation to try and keep infants safe during a pertussis epidemic. What does such a mealy-mouthed statement do for parents right now? The only reason that pertussis cases will decline the following year is that so many have been infected this year.

Fourth - What about unvaccinated OLDER infants, toddlers, and children? I’ve had a lot of my unvaccinating families call my office and ask if they should NOW get their children vaccinated. Here’s what I’m telling them:

• Realize that pertussis isn’t dangerous beyond infancy. It isn’t fun, and the coughing spells can be tough, but it isn’t dangerous. I can’t say an exact age at which it becomes “safe” to catch pertussis – there’s a gradually decreasing risk once a baby turns 6 months. So, an unvaccinated older infant or child doesn’t necessarily need the vaccine for HIS own protection (see below for other reasons to get the vaccine), and parents don’t need to “fear” this disease beyond infancy.

This is such dangerously bad advice as to be medical malfeasance. Paroxysmal coughing fits can last for weeks and cause cyanosis, vomiting, sleeplessness, rib fractures and cranial bleeding, even in older children and adults. Dr. Bob is contending the sin of omission is better than the sin of commission to validate his evidence-free recommendations. Again, why put children through any amount of misery, that could lead to serious complications, when vaccination can likely prevent that from happening and the risks of vaccinating far outweigh the risks of serious disease sequelae?

• Families with unvaccinated children who have a newborn or young infant should consider vaccinating their older children. Many families who skip vaccines do so because they worry that their little babies can’t handle them as well. Once a child turns two years or older, such parents might become more comfortable and vaccinate the child before a next baby comes along.
• Even without another little baby joining the family, parents could consider giving an unvaccinated older infant or child this vaccine series to help lower the chance that their child might catch it and spread it to other babies in other families.
• Children need at least 3 doses to have useful protection. Any undervaccinated child will have some protection, but should be considered susceptible. It isn’t clear if partial vaccination even helps lower the severity of the disease (as it does in chickenpox, for example).

There is nothing magical about 2 years old as infants respond well to DTaP vaccination and certainly no reason to cater to parental fears about vaccinating. Rather, provide them with accurate information about vaccines and effectively communicating risk assessment.

• In my own office I’ve seen a few patients come in for vaccination because of this outbreak, but I would say most patients who initially skipped the vaccine are not changing their mind now.

A final note: realize that DTaP is only approved for use through six years of age. Once a child turns seven he’s too old for it. Safety and efficacy have not been studied beyond six years of age. The teenage Tdap vaccine isn’t approved until a child turns ten years old. So, children age 7, 8 and 9 can’t get a pertussis vaccine.

Ultimately, I can’t make the decision for you. You need to review that chapter in the book and consider the above information. Then make an informed decision.

Dr. Bob does not seem to be taking this epidemic very seriously. He is essentially suggesting that parents who have chosen not to vaccinate their children have no reason to re-assess the current situation and act accordingly. He is far too interested in coddling and perpetuating parents' emotional beliefs (and maintaining book sales) than he is in acting like the expert he purports himself to be and to also, advise his readers to discuss the matter with their actual physician. Instead, he recommends that you buy his book.

Dr. Bob practises in California and has undoubtedly received the CDPH recommendation for vaccination of 7 year olds with Tdap and safety and efficacy have been determined. How can he advise parents to make an informed decision when he doesn't provide accurate information?

Addendum (added 8.10.2010): Dr. Bob has added a note to his posts regarding Tdap recommendations:

Well, I just got a note from Sanofi-Pasteur announcing that the Califonia Department of Public Health announced that their brand of Tdap (Adacel) has been temporarily approved for use in california children ages 7,8, and 9 years. This wasn't part of the FDA approval process, but the California government feels that the benefit of having a pertussis vaccine for this 3-year age group outweighs the fact that it isn't actually approved or studied in this age group. Just FYI.

The California Department of Public Health issued their recommendation on or shortly after 16 July 2010. While it is true that the use of Tdap has not been FDA approved, it is completely false that its use in younger populations has not been studied for safety and efficacy. The Public Health Agency of Canada recommended the use of Tdap in children 7 years and older in 2006 so it has an established safety profile. In light of pertussis epidemiology in California and elsewhere, it is rather curious that Dr. Bob would not be more abreast on current issues involving pertussis vaccination and appears to be lobbying against the current recommendation with no valid support to do so.

Dr. Bob is attempting to balance his reputation as a non-vax friendly doctor with the very real danger of infants and children suffering pertussis fatalities and serious complications. Instead of providing explicit and accurate recommendations to parents, he invokes abstract dangers of vaccinating and then gives parents the non-advice of, "well it's your decision", thereby freeing himself of any responsibility. Rather than being focused his own image, Dr. Bob should give greater concern to the well-being of the children of those who follow his advice.