The Price of Saving Face By F. Edward Yazbak , MD , FAAP

On June 12, 1999, Brent Taylor, Elizabeth Miller and others published “MMR vaccine and autism: no epidemiological evidence for a causal association” in The Lancet in an attempt to contradict research and findings presented by Andrew Wakefield and others, seventeen months earlier, in the same journal.

Two important statements by Taylor were downplayed:

A. “There was a steady increase in cases (of autism and autistic spectral disorders) by year of birth with no sudden "step-up" or change in the trend line after the introduction of MMR vaccination”

B. “No significant temporal clustering for age at onset of parental concern was seen for cases of core autism or atypical autism with the exception of a single interval within 6 months of MMR vaccination.”

So here was a study directly or indirectly funded and authored by the U.K. Department of Health (DOH) that proclaimed that autism increased after the launch of the national MMR vaccination initiative and that autistic regression occurred within six months of said vaccination and yet, no one questioned their significance or challenged the authors about them.

Because parents were requesting the monovalent vaccines for measles, mumps and rubella vaccines in increasing numbers, the DOH had decided that the best way to improve MMR vaccination rates was to de-license the available single vaccines. The impending publication of the Taylor/Miller study and its surrounding publicity provided the perfect occasion for a “Question and Answer” session that was pl ann ed for June 11, 1999 at and by the Royal Free and University College Medical School .

It is almost certain that Drs. Taylor and Miller wrote or approved every answer including:

All the evidence indicates that MMR provides better protection than single vaccines.” [http://black.book.users.btopenworld.com/id72.htm]

To provide “better protection” a vaccine must protect more individuals and protect them for a longer time.

It should be stated unequivocally that neither the creator of the MMR vaccine nor its manufacturer EVER stated that the triple vaccine “provided better protection than single vaccines”.

***

Maurice Hilleman, who passed away in April 2005 at the age of 85, was a very well-known vaccine expert who developed at least three dozen animal and human vaccines, including 8 of the 14 routinely given today to young children in the U.S.A. Among those vaccines were the measles, mumps, rubella and MMR vaccines.

In addition Dr. Hilleman made substantial contributions in the fields of immunology, cancer research and virology and although he did not win a Nobel Prize, which is reserved for basic research, he received the U.S. highest science honor from President Ronald Reagan: The National Medal of Science.

The World Health Organization also bestowed upon Hilleman its own top award: The Special Lifetime Achievement Award. The renowned scientist received the Albert B. Sabin Hero of Science Award and was honored by the creation of The Maurice R. Hilleman Chair in Vaccinology at the University of Pennsylvania .

Relative to the present situation in the United Kingdom , it would be safe to say that Maurice Hilleman was and remains the world's foremost expert on measles, mumps, rubella and MMR vaccines.

Hilleman published over 300 scientific papers including the following two that are pertinent to the present discussion and co-authored with epidemiologists from the Centers for Disease Control and Prevention. (CDC)

I. Weibel RE, Buynak EB, McLean AA, Hilleman MR. Long-term follow-up for immunity after monovalent or combined live measles, mumps, and rubella virus vaccines.
Pediatrics. 1975 Sep;56(3):380-7. PMID: 1161394

“Antibody in human subjects persisted without substantial decline for 8 years after mumps vaccine (Jeryl Lynn), for 6 years after measles (Attenuvax), for 5 1/2 years after rubella vaccine (HPV-77 duck), for 5 years after measles-mumps-rubella and mumps-rubella combined vaccines, for 4 years after measles and rubella, and for 2 years after measles-mumps vaccines, the longest periods tested.”

 

II. Weibel RE , Buynak EB , McLean AA , Hilleman MR . Persistence of antibody after administration of monovalent and combined live attenuated measles, mumps, and rubella virus vaccines. Pediatrics. 1978 Jan;61(1):5-11. PMID: 263873
“Hemagglutination-inhibiting antibodies were retained in comparable levels eight years after vaccination with Enders' original Edmonston and more attenuated Moraten (Attenuvax) and Schwarz line measles vaccines. Neutralizing antibody persisted without substantial decline in titer for at least 9.5 years after administration of Jeryl Lynn mumps virus vaccine (Mumpsvax). Antibodies were retained without important decline in children and adults for at least 7.5 and 7 years, respectively, after administration of HPV-77 duck-modified rubella vaccine (Meruvax). The patterns of antibody persistence 7.5 years after administration of combined measles-mumps-rubella (M-M-R) and mumps-rubella (Biavax) vaccines, 6 years after administration of measles-rubella vaccine (M-R-VAX), and 4 years after administration of measles-mumps vaccine (M-M-VAX) were the same as for the monovalent vaccines, indicating no alteration in the retention of immunity. Subclinical reinfection evidenced by increase in homologous antibody titer was observed to follow vaccination the same as occurs after natural infection.”

So, in summary, the man who developed the MMR vaccine after developing the monovalent measles, mumps and rubella vaccines did NOT say that the triple vaccine provided better or longer-lasting immunity than its single components.

Merck & Co

MMR II contains Attenuvax, Mumpsvax and Meruvax II, all registered trade marks of Merck and Co.

According to Merck and as listed under Attenuvax in the 2000 Physicians Desk Reference (PDR), page 1748: "A single injection of the vaccine has been shown to induce measles hemagglutination-inhibiting (HI) antibodies in 97% or more of susceptible persons. Vaccine-induced antibody levels have been shown to persist for at least thirteen years without substantial decline".

 

Also on the same page: "If the prevention of sporadic measles outbreaks is the sole objective, revaccination with monovalent measles vaccine should be considered".

 

In the same issue of PDR, under MMR II on page 1819, Merck states:

"Clinical studies …demonstrated that MMR II is highly immunogenic and generally well tolerated. In these studies a single injection of the vaccine induced measles hemagglutination-inhibition (HI) antibodies in 95%" and "Vaccine induced antibody levels following administration of MMR II have been shown to persist to 11 years without substantial decline".

The same claims are repeated in the 2005 Physician's Desk Reference (PDR), a single injection of MMR II vaccine, the presently available product, induced measles hemagglutination- inhibition (HI) antibodies in 95 %, of susceptible individuals (p. 2075) while Attenuvax induced measles HI antibodies in 97% or more of susceptible individuals (p. 1995).

Pre-MMR licensure, Merck and Co had to conduct safety and efficacy studies.

While there were few small safety studies, all of short duration, there were many more efficacy studies performed “because of fear that combining the three live attenuated vaccines would result in decreased effectiveness of one or more of the components”.

Merck has never claimed nor reported any synergistic effect when the single vaccines were combined.

***

 

In addition to his now famous open letter to Dear Sir/Madam that was co-signed by several supporters [See Blame Is The Name Of The Game] , David Elliman co-authored a recent major review with R. Booy, N. Singupta and Helen Bedford that was published in Clinical Evidence , the international source of the best available evidence for effective health care (BMJ). [ http://www.clinicalevidence.com/ceweb/conditions/chd/0316/0316_I1.jsp ]

 

The summary of the review started “ We found no systematic review or RCTs comparing the protective efficacy against measles of combined measles, mumps, and rubella (MMR) versus no vaccine or placebo.”

An RCT is a randomized control study, a study in which people are allocated at random (by chance alone) to receive one of several clinical interventions. It is in fact a quantitative, comparative and controlled experiment in which investigators study interventions in a series of individuals who receive them in random order. The RCT is one of the most powerful tools available in clinical research.

So to repeat: Booy, Singupta, Bedford and Elliman after reviewing every available study and investigation could not find a SINGLE systematic review or a single randomized control study that compared the effectiveness of the MMR vaccine in preventing measles with placebo or no vaccination altogether.

In their summary, the authors go on “One quasi-randomised trial, one large retrospective cohort study, and several large observational studies found that measles vaccine (monovalent or MMR) reduced the incidence of measles. Mass population cohort studies and other observational studies also consistently found important reductions in child mortality after measles vaccination.”

In other words, the authors found studies that documented a decrease in the incidence of measles after both, the single measles and MMR vaccination. Why the authors mentioned “monovalent or MMR” when talking of incidence and failed to mention MMR vaccination in the following sentence when they discussed infant mortality is not clear.

One must also note that at this critical time, the authors reviewed everything about MMR and single measles, mumps and rubella vaccine EXCEPT comparing their efficacy and the protection they provided.

Dr. Elliman wrote several scholarly papers about vaccinations. His first measles vaccine-related study was published in the British Medical Journal (BMJ) Clinical Research Edition in June 1986 and titled “ Antibody response and clinical reactions in children given measles vaccine with immunoglobulin”.

His first paper on the safety of the MMR vaccine (with B. Dhanraj) was published in The Lancet in February 1991 “ Safe MMR vaccination despite neomycin allergy”.

Elliman jumped into the MMR and Autism controversy on March 7, 1998 , just a week after Andrew Wakefield published his well-known study of 12 in The Lancet. In a BMJ article with lead author A. Nicoll and co-author E. Ross, Elliman discounted any triple vaccine – autism connection.

There were three Elliman “MMR” publications in 2001.

In January, “ MMR vaccine: the continuing saga” in the BMJ (with Helen Bedford), possibly intended to rebut Andrew Wakefield and Scott Montgomery's hard-hitting “ Measles, mumps, rubella vaccine: through a glass , darkly .

In October: “ MMR immunisation. Health professionals should strongly recommend this immunization” in the BMJ and “MMR vaccine--worries are not justified” in the Archives of Diseases of Children , both with H. Bedford.

The three Elliman publications of 2001 appeared to reflect his fears and concerns about falling vaccination rates. Because the U.K. Department of Health (DOH) had not renewed the licenses of the single (monovalent) vaccines for measles, mumps and rubella – effectively outlawing them, the confused parents had been left with 3 difficult choices:

  • No vaccination
  • Expensive single vaccines from private clinics
  • The NHS-provided MMR vaccine that was under scrutiny

Elliman and Bedford broached the subject of autistic gut disorders in 2002 when they published “Measles, mumps and rubella vaccine, autism and inflammatory bowel disease: advising concerned parents” in Paediatric Drugs.

Following is the abstract that was provided with the publication. Whether it convinced parents and professionals that indeed the MMR vaccine never caused autistic regression or specific gut findings in a small cohort of genetically-predisposed children is not known.

“Measles, mumps and rubella (MMR) vaccine has been used for almost 30 years in the US , 20 years in Sweden and Finland , and over 10 years in most of the rest of Europe . During this time, it has brought about a dramatic reduction in the morbidity and mortality due to measles and mumps, as well as a considerable reduction in the number of babies with the congenital rubella syndrome. In spite of extensive evidence confirming the efficacy and safety of the vaccine, concerns have recently been raised about a possible link with autism and bowel problems. These arose principally from a research group in the UK , but have now spread to other countries. In the UK this has caused a fall in the uptake of the vaccine with fears of possible outbreaks of measles and mumps in some groups of children. Over the last 3 years a number of studies have addressed this possible link between MMR and autism and inflammatory bowel disease. Studies from the US , UK , Sweden , and Finland have all failed to demonstrate a link. Amongst others, the American Academy of Pediatrics, the Royal College of Paediatrics and Child Health, the Institute of Medicine , and the World Health Organization have all considered the evidence and endorsed the continuing use of the vaccine. No regulatory body in the world has changed its policy as a result of this hypothesized link. Professionals and parents can be assured that MMR is well tried and tested and one of the most successful interventions in healthcare.”

Elliman co-authored three publications on measles and measles prevention with Bedford , Booy and Singupta in 2005.

***

Summary

  • In spite of what the vaccine creator and manufacturer say, the medical authorities in the U.K. still state that “MMR …is the safest way to protect your children against these diseases.” [http://www.mmrthefacts.nhs.uk/basics/whatismmr.php]
  • If 95% of all children in the United Kingdom whose parents did not trust the MMR vaccine, had received the single measles vaccine starting in 1999 and the rubella then the mumps vaccine, 6 or 12 months later, the present situation would have never happened and there would be no crisis today. 
  • Protection from measles is important and most urgently needed
  • Delaying mumps and rubella vaccination a while, and even until the age of 9 or 10, does not carry a great risk and may actually offer some benefits
  • The time has indeed come to draw a line, to do what is right and to re-license the single measles, mumps and rubella vaccines before children start dying as a result of unfortunate and ill-advised decisions made by stubborn men and women who are determined to save face at any cost.

F. Edward Yazbak , MD , FAAP

TL Autism Research, Falmouth , Massachusetts















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