It described research conducted at Columbia and Harvard Universities and findings from three renowned laboratories.

This critique should cast a cloud on the authors’ selection of cases, investigations, results, conclusions and statements to the media.

At the end, the only thing left standing will be the now-undeniable fact that biopsy findings from Dr. John O’Leary’s laboratory are just as reliable as those from two of the best laboratories in the United States.

Keeping that in mind, one must wonder how Dr. Ian Lipkin, apparently speaking for all the authors, could proclaim: "We are convinced there is no link between MMR vaccination and autism."

On a personal note: It has not been easy for me to criticize a publication whose lead author I respect as a person and a pioneering researcher. As it will become evident, Dr. Hornig was not responsible for the part of the study I found most problematic.

*****

Dr. Marie McCormick of the Harvard School of Public Health, the chairman of the Institute of Medicine Immunization Safety Review Committee and the scientist who was supposed to “uncover the truth” about vaccines and autism described the new CDC-sponsored study results as “definitive and significant” adding: "This is the nail in the coffin, the final bit of research we were looking for to finally discredit this link between the measles vaccine and autism." (2)

By her statement, Dr. McCormick disqualified herself as a scientific referee, compromised the Institute of Medicine and confirmed two facts we all very much suspected:

Not to be outdone by a northerner, William Schaffner, MD, chairman of the department of preventive medicine at Vanderbilt University echoed: “It's a "fabulous and terrific study… It is convincing because it takes the original concept of the profoundly flawed [earlier] study and does it the way it should have been done the first time… This really closes the scientific inquiry into whether measles or MMR vaccination causes autism…" (3)

May be Drs. McCormick and Schaffner should read the whole paper a second time.

*****

Internet publication

I frequently publish on the Internet, not because my articles are not good enough to be published in peer-reviewed journals but because I just don’t have the patience, at my age, to deal with the antics of certain editors. (4)

Why was it not in the New England Journal of Medicine (NEJM) where even Danish research is published and protected or …the Journal of the American Medical Association (JAMA) that is always so willing to help “friends in need”?

The answer to these questions is: I don’t know.

I certainly tried but I was unable to find out why reputable medical journals, not only here but also in the United Kingdom, where MMR is a national obsession, refused to publish this CDC-sponsored publication by some of the best names in the business.

Why did all these fearless friendly editors suddenly get cold feet?

I was personally taken back when I read the statement describing the role of the sponsors in the new study. Were the editors of those major publications also concerned enough with the following to refuse to publish the manuscript?

In spite of the heated presidential campaign and a very busy hurricane season, its fallout is guaranteed: The CDC has had a lot of experience circulating and spinning such studies!

*****

Transparency

The statement about the role of the sponsors (above) is strange to say the least. The Food and Drug Administration (FDA) would have never accepted such a statement from the sponsor of a study investigating an arthritis medication, an antihistamine or a vaccine.

One of the best articulations of “Study Transparency” I have ever heard was by Professor Walter O. Spitzer M.D., M.P.H., F.R.C.P.C, Emeritus Professor of Epidemiology at McGill University in sworn testimony at the December 10, 2002 Hearing of the Government Reform Committee of the House of Representatives. The scientific world lost Dr. Spitzer before he could start working on one of his dreams:

An international study of autism rates in developing countries. I can only imagine how interested he would have been in the exploding prevalence of autism among Somalis in Michigan… and its causes.

The study Dr. Spitzer was discussing in 2002 was the CDC-funded “Big MMR study from Denmark” by Madsen, that no one remembers, and that I discussed recently. (4)

Obviously, principles involving the careful harvesting of biopsies from specific pathological areas in a small child and the meticulous reporting of their related findings have to be much more stringent than those related to epidemiological studies.

This is what Professor Spitzer stated in part at the congressional hearing:

For “Total Transparency” Dr. Spitzer advocated:

It clearly seems that “None of the above” took place in this recent study!

*****

When finding nothing is wonderful

Researchers like to discover things and they are very happy when they do.

Scientists charged by the CDC or the U.K. Department of Health to investigate certain aspects of the MMR vaccination-autism puzzle seem on the other hand to be truly elated when they find N O T H I N G because they know that their “achievement” will be enthusiastically applauded.

Our health authorities have somehow convinced themselves and …people that if someone discovers something that does not suit their beliefs, that discovery becomes nil and void if someone else creates a similar study and somehow comes up with N O T H I N G.

Obviously the more difficult the research and intricate the accomplishment, the easier it is for the other camp to fail to duplicate it.

On May 28, 2006, an article appeared in a London paper describing the findings of a study from Wake Forest University School of Medicine in North Carolina titled “Scientists fear MMR link to autism.” According to the report, 275 children with regressive autism and bowel disease were evaluated and 82 were carefully and completely tested. Of those, 70 had evidence of measles virus. The lead author of the study was quoted as saying: “Of the handful of results we have in so far, all are vaccine strain and none are wild measles. This research proves that in the gastrointestinal tract of a number of children, who have been diagnosed with regressive autism, there is evidence of measles virus.” (5)

Dr. Afzal attested that there was no evidence of measles genomic fragments in any of the children examined, in spite of the fact that the methods he used were "highly sensitive, specific, and robust" and capable of detecting "measles virus RNA down to single figure copy numbers per reaction." As expected, the Reuters' report added: “Given the rigorous methods employed, the researchers believe that measles virus material genuinely did not exist in the patient's blood samples”.

Intrigued, I reviewed the literature and discovered that quite often when Dr. Wakefield or a supporter published a paper, Dr. Afzal published one of his own, shortly thereafter. Wakefield and colleagues reported interesting findings and predictably Dr. Afzal always reported finding N O T H I N G, immensely pleasing the U. K. DOH and the vaccine manufacturers.

Wakefield’s publications always made a lot of sense and many are still easily available. (6)

Few remember the “nothing” studies and where they were published

My report “When finding nothing is wonderful” is still accessible. (7)

*****

Many people only read the abstract of a publication and the very first sentence of the abstract of the recent study is wrong:

Wakefield never mentioned measles virus (MV) RNA in his February 1998 landmark article. In addition, the statement does not even adequately summarize the first paragraph of the publication that states otherwise:

A more accurate first sentence would have been:

“In 2002, Uhlmann, Martin, Shiels, Wakefield and O’Leary reported finding evidence of measles virus RNA in 75 of 91 intestinal biopsies from children who developed autism and had certain typical gastrointestinal (GI) findings following MMR vaccination” but that would have obviously created a problem …right off the bat!

For those readers who would have wondered: “How come the U.K. study had 75 positive cases and this CDC-sponsored study from Columbia & Harvard had only one?” the authors of the new study could have certainly not been able to blame O’Leary, his laboratory and his findings.

So …why were the findings so different?

75 out of 91 vs. 1 out of 25

The answer to that question is SELECTION / SELECTION: Selection of the cases and selection of the biopsy site

In Boston (see Subjects Characteristics), “The clinical indications for endoscopic/colonoscopic procedures commonly noted in both AUT/GI and GI groups included recurrent abdominal pain (RAP), gastroesophageal reflux, vomiting, and food allergies.”

In the CDC-sponsored study,

When an attending surgeon supervises a resident performing a surgical procedure such as an appendectomy, he or she effectively “assists” the doctor in training by standing on the other side of the table and helping at every step …sponging, retracting, tying etc

Supervising a colonoscopy with biopsy (s) on a small child is totally different of course. There is not enough room at the foot of the operating table for two adults and all the attending can do is scrub, gown and “supervise”.

The real problems with the site selection were that:

A: All the unwarranted cecal biopsies were effectively useless

I would dare say that when one takes random biopsy samples, one is likely to get random results unless the pathology is diffuse and widely spread.

Lastly, let us look at the very next and even more amazing sentence “Additional specimens were acquired at sites indicative of inflammatory GI lesions, if present” for which the only printable comment is:

“You must be kidding!”

Did Lipkin and friends hope to find evidence of measles virus presence in tissues that were scarcely or not at all inflamed?

Did they seriously want to compare their biopsy results with those obtained by an experienced specialist from the reactive lymphoid expansion of very inflamed intestinal areas?

Are the authors really saying what I think they are saying?

Is that what they are really telling us?

Did the poor sample just happen?

And are we to believe that in spite of all of the above, “LACK of EVIDENCE” after such a study is equivalent to “NO EVIDENCE” just because the authors say so?

Is that how science works nowadays?

As long as you are famous and belong to a prestigious institution, you can do any study and simply anoint it.

*****

Do they really think they replicated the British study when the number of subjects was different, the patient selection was different, the biopsy sites were different…and so much that mattered was different?

If children are required to receive two MMR vaccinations before starting school and their parents are vilified and threatened with police dogs or complaints to social services if they don’t, wasn’t a serious flaw built into the study when 80% of the sample only received one dose of MMR vaccine?

Wouldn’t a better selection, namely the inclusion of cases vaccinated twice, have increased positive yields?

Lastly, why did the Columbia-Harvard researchers not perform serological studies based on those developed by Dr. V. K. Singh? Were they concerned about their results?

In a small but very impressive U. S. study, Bradstreet, El Dahr et al reported the presence of Measles Virus (MV) Genomic RNA in the cerebrospinal fluid (CSF) of three children with regressive autism following MMR vaccination encephalopathy.

The three children also had evidence of MV genomic RNA in their ileal lymphoid nodular hyperplasia biopsies.

In that study, the serological testing performed on the serum and the CSF yielded valuable confirmatory information. (8)

*****

Because this CDC–sponsored study proved that:

The children described in the Uhlmann 2002 study, including my grandson, really and truly had evidence of measles virus genomic RNA in their ileal biopsies as confirmed by the now-vindicated O’Leary laboratory.

Obviously I never doubted that… not for a second.

Andrew Wakefield would have never published doubtful results and he certainly would have never reported findings to me that he was not absolutely certain of.

*****

In the United States, the Vaccine Injury Compensation Program is administered jointly by the U. S. Court of Federal Claims, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ).

The recent Columbia-Harvard study is likely to create difficulties for the DOJ legal team representing HHS in the on-going vaccine-autism litigation.

Not long ago, the team imported a British professor to testify that the O’Leary laboratory findings were not to be trusted. When asked what he was being paid to testify in the Washington DC, the expert said: “It's $250 an hour while I am here and $125 an hour while I'm traveling and nothing while I'm sleeping I think. And also my airfare and hotel are being paid for.”

When asked about his prior work relative to the now defunct United Kingdom MMR litigation and whether he really “spent roughly 1,500 hours at 150 pounds sterling” he answered “Yes that is correct.” He then added that his checks came from the solicitors but that the funds actually came from Merck, Aventis and GSK.

In another exchange with plaintiff's attorney, the expert revealed that his salary was 60,000 pounds sterling. If this is per annum, and if the doctor works 40-hour weeks, then he was making less than 29 pounds sterling an hour at his regular full time job, if my calculator is right.

At the time of this writing, one pound sterling equals $1.77.

A medical writer in the U.K. interviewed the expert upon his return and declared that his report on the O'Leary lab was “…key to the collapse of the anti-MMR litigation in the UK”. He then added that when the lawyers at the Legal Services Commission discovered “this authoritative investigation concluding that O'Leary's findings were unreliable they realised that, putting this together with the wider evidence against the MMR-autism thesis, the litigation had no chance of succeeding.” (9)

As for us in the United States, we are certainly grateful that the recent CDCsponsored MMR study from Columbia and Harvard Universities finally put a last nail in the coffin of the claim that Andrew Wakefield’s work was not to be believed because his biopsy results from Dr. O’Leary’s laboratory were not reliable.