David Kirby: What if The Parents Win?

I had honestly not thought that far ahead. I am so used to having all our points ignored, I think I just assumed that no matter how good the Cedillo's case was, that of course the court would not want to set the prescient.

If Parents Win in Vaccine Court, What Do We Tell the World?
David Kirby
HuffPo

Will parents win their case against the government in Vaccine Court by convincing three federal judges that there's enough evidence to support a link between the MMR vaccine, thimerosal and autism spectrum disorders?

I, for one, am not placing any bets. But several thimerosal defenders are now dispatching dire warnings about the looming decline of the nation's public health -- and the pharmaceutical industry's corporate health -- should any of the 4,800 families win their vaccine/autism case in federal court.

"Massive litigation could force companies to leave the vaccine business, threatening the future of one of medicine's greatest achievements," Dr. Paul Offit, chief of infectious diseases at the Children's Hospital of Philadelphia, wrote in the Boston Globe on June 3rd.

If the claims are successful, Dr. Offit wrote, they "could exhaust the pool of money currently set aside to compensate children who have been hurt by vaccines," and would open the floodgates for private litigation directly against the drug companies, threatening their financial viability and compelling them to abandon the vaccine business.

(It should be noted, at this point, that Vaccine Court claims are awarded in just one third of the cases, and payouts average about $800,000 -- which might cover the proper care, treatment, and special education of an autistic child for maybe a decade. Victory in this particular court does not get you a condo in Maui, just a little temporary financial relief from endless costs).

Critics of the autism claims also contend that a victory in court by any of the families would drive panicked parents away from immunizing their children at all, resulting in new epidemics of infectious disease and lots of sick and dying youngsters

Maybe that's why Dr. Offit -- who incidentally stands to make some money from the recently approved rotavirus vaccine he co-developed with Merck -- referred to the court as a "circus" in his Boston Globe Op-Ed.

While this gives us insight into one pediatrician's contempt for the American legal system, it is somewhat puzzling, given that the first "test case" has proceeded with nothing but respect, decorum and a sobering sense of the Herculean task at hand.

It's entirely possible that all 4,800 cases will go down in flames. But what if some of the parents and their attorneys can beat the tough odds, and make a good enough case to convince the judges?

Irrespective of one's views on the merits of these cases, I think everyone needs to stop and think about dealing with the ramifications -- on a worldwide scale -- of any family victory in Vaccine Court.

Yes, some drug companies would likely face some big lawsuits in civil court. But in the age of Vioxx and Avandia, that almost seems to be a routine cost of doing business.

And let's face it; neither the American government, nor its people, would stand for the wholesale collapse of the pharmaceutical industry -- which does, after all, keep millions of people alive each year. No, I am reasonably sure that Big Pharma, somehow, would muddle through and survive (possibly with a major assist from you, the taxpayer, so think about that one as you stand in the pharmacy prescription line).

But what about vaccination rates? Wouldn't they tumble?

Not if we start to educate parents now about the thorny issues that could arise with a decision in favor of the plaintiffs.

First of all, it's important to remember that thimerosal has been in the news since 2005, when Don Imus began to not shut up about it. Later that year, I appeared on "Meet the Press" to discuss the controversy, and the subject has been raised in innumerable media outlets ever since.

And what happened? Immunization rates rose to new record levels.

We need to show a little more faith and confidence in young parents. If causation from thimerosal is found, new parents might actually breathe a sigh of relief, knowing that childhood shots now contain only residual amounts of mercury (with the glaring exception of 90% of the flu shot, so they might want to put in their order soon for mercury-free influenza vaccine for the 2007-2008 season).

If the MMR triple-live-virus vaccine, which never contained thimerosal, is implicated, then we as a society might want to consider having those shots administered separately. Even though that would mean two more jabs for the baby, it might also calm a lot of jittery parental nerves, and keep immunization rates robust.

Meanwhile, none of the other vaccines that children receive today are on trial here, and parents will almost universally understand that.

I am sure that critics will deride this scenario as being far too rosy, and I hope they are wrong. Nobody wants to see measles, or mumps, or polio sweep the country. But I don't think that will happen.

But I do wonder about the ramifications overseas.

The US has largely removed thimerosal from the routine shots we give our own kids (out of an "abundance of precaution," we are told), but children in the developing world are afforded no such consideration.

Today, millions of children in Latin America, Asia and Africa are receiving American-export vaccines that still contain the full battery of ethylmercury -- in amounts that put children dozens of times over the US EPA maximum daily limit on vaccination days.

Immunization rates are rising in many developing countries, but so are the reported rates of autism. In Mexico, for instance, vaccine rates are now about 92%, UN figures show, while reported cases of autism are also moving upward (proof of nothing, but interesting and disturbing nonetheless).

Several well-placed sources have told me that the CDC and FDA will never agree to an outright ban on thimerosal in vaccines, due to pressure from the World Health Organization, and because the message this would send to developing nations would be untenable: "Yes, thimerosal might cause harm, but we are going to give it to you anyway, for your own good. Trust us. We're Americans. We know what we're doing."

Talk about driving people away from vaccines in droves. The result could be catastrophic, with rising rates of infectious diseases and child mortality to follow.

In other words, we can probably convince American parents to keep on vaccinating, because the mercury here has largely been removed. But what do we tell parents in South Korea, or Brazil, or Nigeria?

Thimerosal is not a necessary ingredient in vaccines. We can still ship multi-dose vials -- which require a preservative but are cheaper to buy and administer -- to poor countries, a noble goal indeed. But the preservative does not need to be based on a deadly neurotoxin.

The MMR shot itself is preserved not with thimerosal (which would kill the live viruses) but with a type of phenol. Why can't we find a non-mercury based preservative for all vaccines? I have never been able to get a satisfactory answer to that question.

But even if we could switch to alternative preservatives tomorrow, and boost global confidence in vaccines, we might still inherit another, more sinister problem to deal with.

On the very last page of my book, Evidence of Harm, I close with these words:

"If thimerosal is one day proven to be a contributing factor to autism, and if U.S.-made vaccines containing the preservative are now being supplied to infants the world over, the scope of this potential tragedy becomes almost unthinkable. The United States, at the dawn of the 21st century, is not exactly the most beloved nation on earth. What if the profitable export of our much vaunted medical technology has led to the poisoning of tens of millions of children? What then?"

We need to prepare for at least the possibility of a parental victory in vaccine court. We need to prepare our own parental population, and we need to think about what we are going to tell the rest of the world.

Vietnam just suspended a certain US-made MMR vaccine after some patients died from it. This could be the tip of the iceberg in terms of social, economic, and physical retribution against the United States.

What do we tell the Chinese and their hundreds of millions of vaccine consumers? What will we say to people in booming India, or next door in Mexico? Will our immigration policy bar parents of autistic kids from coming to America, even if American shots might have made their kids sick?

And then there is the Middle East.

Osama, for one, has a very extended family. We are exporting thimerosal containing vaccines to many Muslim nations. Some vaccines contain not only mercury, but products derived from pigs.

I don't need to tell you where I am going with this train of thought. You already know.

I do not think these court cases should be decided on the larger ramifications. That is just not the way our legal system works. Still, a victory for the families -- justified or not -- will produce endless headaches for the pharmaceutical industry, the US public health establishment, and the WHO.

If just one family wins their case in that Washington courtroom, then we, as a nation, have a lot of explaining to do.

6 injured, 1 dies after US Made MMR

HCMC Suspends US-made Vaccine After Worker’s Death

The Ho Chi Minh City Health Department has or­dered city hospitals and health centers to stop using a batch of US-made vaccines after a worker died and five others fell ill after getting vaccinated.

Six women workers from the Tango Candy Company were hospitalized Tuesday 30 minutes after be­ing getting a shot of MMR, a vaccine to protect people against measles, mumps, and rubella (German measles).

One worker, Huynh Thi Kim Hoa, experienced breathing difficulties and a fall in heart rate, and she later fainted and slipped into a coma. Hoa was taken to Gia Dinh Hospital where doctors said she had suffered a brain hemorrhage.

The 20-year-old died Friday morning.

Hospital director Do Hoang Giao said Hoa's condition was not caused by the vaccination but was the result of defective blood vessels around her brain. The bleed­ing could have been trig­gered anytime.

The five others also suffered breathing difficul­ties and were also taken to the hospital. Doctors discharged them that evening.

The batch in question, H1666, was manufactured by American drug company Merck Sharp & Dohme Inc. on October 24, 2004, and expires in November this year.

The city Preventive Health Center said it im­ported 10,000 doses of the vaccine, more than 1,000 of which had already been used.

The idea that the MMR had nothing to do with her death is just a little difficult to swallow.

She fell ill 30 minutes after the following the vaccine. Since she was 20 years old, she had lived through 350,400 (actually more since this was following her birthday) - 30 minute intervals without her "defective blood vessels" in her brain hemorrhaging.

That means that when she collapsed, she less than a 1 in 350,400 chance of this happening to her at that moment.

So we are to swallow that it was just coincided with the vaccination by chance and was completely unrelated?

More importantly, we are to believe that the docs actually believe that themselves?

Kirby on HuffPo: See You In (Vaccine) Court

See You In (Vaccine) Court
by David Kirby
The Huffington Post
Posted June 7, 2007 | 07:05 PM (EST)


On Monday, one of the most important legal proceedings in American medical history will get underway at the U.S. Court of Federal Claims in Washington. There, a special panel of three judges will begin hearing evidence to support -- and refute -- the hypothesis that mercury in vaccines and/or the live-virus measles-mumps-rubella shot caused autism or autism-like symptoms in some American children.

Monday will mark the first time ever that evidence of autistic harm from childhood vaccines is examined and cross-examined in a court of law. This is far from a slam dunk case for either side, and the stakes - professional, financial, emotional - could not be more intense.

These three judges from the federal "Vaccine Court," as it is called, are about to dip into the raging, contradictory waters of the vaccine-autism contretemps, knowing they must emerge on the other side, each with their own acutely anticipated decision about causation. Ultimately, they must deliver judgment on some 4,800 claims that have been languishing in the system for years.

I do not envy them their task.

Technically, at least, this is not a trial at all; it is an "Autism Omnibus Proceeding" in a no-fault, supposedly non-adversarial adjudication. The judges are not judges, but "Special Masters;" plaintiff families and their lawyers are called "petitioners," and the defendant, called the "respondent," is not some drug giant, but the Department of Health and Human Services, represented by well-funded attorneys at the US Justice Department.

Any claims awarded in Vaccine Court are paid from a 75-cents-per-vaccine tax footed by consumers, leaving vaccine makers free from liability.

But if even one case of causation is determined, then private lawsuits in civil courts - where the drug makers themselves are on trial - would soon flood the dockets. (Ironically, if families lose in Vaccine Court, they are free to sue in civil court. Having autistic kids appear before sympathetic juries is Big Pharma's big nightmare, and it's why a secret rider was attached to the Homeland Security Act of 2002 to bar thimerosal cases from civil court and force them into Vaccine Court).

Over the next three weeks, evidence on both sides of the first "test case" will be picked apart to its bare bones, with one gaping exception. Petitioners were just denied access to the government's vast vaccine safety database of HMO patients, which was used by CDC officials to conduct a four-year study that ultimately found no link between thimerosal and autism. Earlier versions of the study, obtained through the Freedom of Information Act, however, clearly showed increased risks for many neurodevelopmental disorders, depending on the dose of thimerosal administered.

No wonder a special panel convened by the NIH recently issued a harsh critique of the CDC's data collection and management, saying the study contained "several serious problems... weaknesses and limitations" that "reduce its usefulness" in proving or disproving causation.

And so, numbers culled from the government's massive database will be submitted as Exhibit A for the defense, though the other side will be forever barred from seeing the actual raw data, in order to replicate what the CDC researchers found. (Exact replication is impossible because original datasets, culled at taxpayer expense, somehow "went missing" and are no longer available for re-analysis - a possible felony violation of the federal Data Quality Act).

On the other hand, the burden of proof for plaintiffs is lower in Vaccine Court than other federal courts, which could even things out a little.

Nearly all of the government's evidence will be "epidemiological" in nature - based on large population studies of computerized data. These include the CDC study, plus similar research done in Sweden, Denmark and the UK which found that, if anything, thimerosal had a "neuro-protective" effect on children by apparently reducing their risk of autism.

Petitioning attorneys will counter that Federal Court rules regard epidemiology alone as being "insufficient" to disprove causation, and will surely use the NIH panel's critique of the government's own database as a roadmap toward defanging the CDC's conclusions. To begin with, the CDC found an autism rate of just 11-per-10,000 children at the largest participating HMO, where the actual rate is currently 73-per-10,000. Why so many excluded children, they will likely ask, and how did this affect the rate of outcomes?

As for Denmark, petitioning lawyers will argue that autism case numbers increased after 1992, when thimerosal was removed from childhood vaccines, mostly because the Danish government happened to switch from counting inpatient-diagnosed cases only - about 13% of the total - to counting all inpatient AND outpatient cases nationwide. By 1999 the total number had "gone up" to about 200 children a year, in a nation of 6.2 million people - well below the current US rate of 1-in-150 kids, and not exactly a raging epidemic.

The lawyers might also point out that incidence and prevalence rates of autism actually declined in Denmark during 2000, and again (we now know, only through FOIA) in 2001. And they could cite a media quote from Dr. Irva Hertz-Picciotto, professor of public health at UC-Davis School of Medicine and chair of the NIH panel that critiqued the CDC study. Flawed as the CDC analysis was, she called it "an improvement on other studies, including the two in Denmark, both of which had serious weaknesses in their designs."

For their side of the argument, family lawyers will present thousands of pages of published "biological" science, as opposed to epidemiology. They will examine data from animal models, test tube studies, and examinations of children with autism; they will try to present a plausible biological mechanism by which mercury (and to a lesser extent, MMR) could cause autistic-like symptoms -- at the molecular, cellular, and clinical level.

Among this evidence is research suggesting that:

1) Many children with autism, probably due to genetics, are deficient in certain sulfur-based proteins that defend against heavy metal accumulation in humans. The proteins, which include glutathione, are called "thiols," and sometimes "mercaptans," from the Latin mercurium captans, or literally "mercury capturers."

2) Many children with autism show signs of heavy metal accumulation, including elevated levels of proteins called "prophyrins" a bio-marker of lead and mercury toxicity. They also present with low levels of mercury in baby haircuts, (versus control children) suggesting a heavy metal "efflux disorder" that prevents the proper metabolism and excretion of heavy metals.

3) Exposure to extremely low doses (micromolars) of thimerosal, previously thought to be safe, shut down 25% of brain stem cells, in one lab study.

4) In another, low-level exposures of a few minutes duration killed many of the immune system's "dendritic" cells, disrupted production of immune-system messenger chemicals called "cytokines," and caused inflammation.

5) Meanwhile, many children with autism show signs of immune deficiency AND hyperactivity, as well as cytokine imbalances and inflammation, (they also show signs of chronic autoimmunity, where the immune system attacks the body and brain).

6) Organic ethylmercury from thimerosal crosses the blood-brain barrier in primates, where it quickly converts to inorganic mercury, which can remain trapped in the brain for decades.

7) Inorganic mercury trapped in primate brains caused neuro-inflammation (ie, rapid brain growth) by activating "glial" cells in the brain.

8) Autopsies on autistic human brains found chronic inflammation, apparently linked to the brain's immune system and produced by activation of its "glial" cells.

9) Another autopsy study also showed ongoing neuro-inflammation, possibly from heavy metal exposure, and signs of autoimmunity. (Other studies have found rapid brain growth in infants with autism.)

10) Thimerosal can disrupt a chemical process called "methylation," critical for gene expression, neural function, memory and attention, and the production of sulfur-based "thiol" proteins like glutathione.

Plaintiff lawyers will also show data from a study of birthday videos proving that many kids with autism were meeting or exceeding developmental milestones at age one, only to have tumbled into a wordless, autistic world by age two. They will also show home videos of plaintiff children, before and after their own regression, and in many cases, of the same children a few years after experimental treatments - including chelation (for heavy metal removal) and methyl B-12 (for repair of methylation) - that seem to have vastly improved their condition.

At this point, government lawyers will surely try to discredit these biological studies, one-by-one. They could succeed, though it will be tough, given the data's provenance. Lead authors come from institutions such as Harvard, Northeastern, Columbia, UC Davis, Johns Hopkins, and the Universities of Washington, Arkansas, Kentucky and Rochester, and their papers were published in peer-reviewed journals such as Molecular Psychiatry, and the NIH's Environmental Health Perspectives.

The defense also has a few biological studies to support its side, including one showing no difference in the mercury levels of blood and hair of typical vs. autistic kids. But the mean age in this study was four years old, and mercury does not linger around in blood or hair for that long.

Another study showed the thimerosal containing drug Rho-Gam (given to pregnant women, and not a vaccine) did not increase the risk of autism in children, though this study was funded by Johnson & Johnson, the product's manufacturer and a potential thimerosal litigation defendant.

Likewise, the plaintiffs might offer some epidemiology, including one study from the University of Texas showing increased rates of autism in school districts near mercury-emitting coal power plants, and another, funded by the CDC itself, where children with autism in the SF Bay Area were 50% more likely to be born in the region's most mercury-polluted tracts, suggesting "a potential association between autism and estimated metal concentrations."

Finally, expect to hear hours of testimony about California. Mercury was phased out of childhood vaccines (except the flu shot) a few years ago, the argument goes, so there should have been a drop in autism rates by now, especially in California, which keeps the most reliable autism statistics. It's a very powerful contention, but it may be too early to make any final conclusions.

Among the youngest children, 3-to-5-year-olds, the number of cases was still increasing after the first quarter of 2007. These kids were born and vaccinated between 2002 and 2004, after thimerosal was removed from vaccines, right?

It's true, most companies started making preservative-free vaccine in 2001, but they also continued making product with thimerosal, as a backup during the transition period. Little, if any of those mercury-containing vaccines were ever recalled: They remained on the market, until they were finally used up or expired, in 2003.

Government lawyers will likely point to a 2002 survey of vaccine providers, conducted by the CDC, showing that just 2% of the pediatric shots contained thimerosal. But this was a survey of providers under CDC contract only, and CDC had a record of buying mercury-free vaccines for its clients (ie, state, county and other public health clinics) even before 1999, when the federal government called for the removal of thimerosal from the pediatric schedule "as soon as possible."

It's not clear how many of the CDC contract providers surveyed were in California, where the vast majority of children receive care in private practices and large HMOs. Moreover, the CDC survey was merely a "convenience sample," which are so inaccurate in representing the general population they are virtually never used in published data. In fact, the US DOJ itself defines them as "rarely useful in evaluation and usually hazardous."

Meanwhile, the state has quietly been tracking the number of autism cases by birth year, as well as age group, meaning we can look at the very youngest children entering the system. In the first quarter of 2003, there were 170 children with autism in the state system born in 2000 (or, roughly, three-year-olds). In the first quarter of 2004, the number of three-year-olds increased 8.2% to 184. In 2005 the same number went up 13%, to 208, and in 2006 it jumped nearly 27% to 264. But this year, among kids born in 2004, it was 251, a 5% drop.

This could be attributable to some quarterly reporting glitch, and the caseload could easily be made up in the next quarter (that data will be out in mid-July). But if the deficit continues, the 2004 birth cohort could finish out as the first in which case numbers actually fell. (A similar trend might be emerging at Northern California Kaiser, a major HMO).

Of course, it would take tremendous resources to get to the bottom of this, lawyers might argue. One would need full medical records on each of those 251 kids born in 2004. Did any receive thimerosal still left in California vaccines (or prenatally via Rho-Gam)? How many were exposed to mercury in flu shots during pregnancy and as infants? And in a population that is now one-quarter foreign born, how many children immigrated from countries where immunization with thimerosal is now routine? (Vaccination coverage in Mexico is now 92%).

Is immigration helping keep the California numbers up? We don't have that data. But we do know that, since 2003, the rate of increase among white and black children was 48.6% and 51.6%, respectively. Among Asian children, however, it was 79%, and among Hispanics, 84.2%. Probably something worth looking into (as well as the effect of aggressive early intervention campaigns, which have consistently brought down the average age of diagnosis and would likely drive up the number of three year olds in the system).

But again, this is epidemiology coming out of California, and the Special Masters are looking at specific children with specific claims before their court. Officials from the state have been warning all of us (and that includes me) not to read too much into these numbers.

At the International Meeting For Autism Research last month, California health officials presented their data along with this caveat: "Limitations of the database and lack of individual exposure data prevent conclusions, based on these data, about thimerosal as a cause or modifier of autism in a specific subgroup or child."

It is entirely possible that thimerosal itself did not cause the autism epidemic, but that is not what is on trial here. Even so, for the sake of argument, let's say that a "specific subgroup" of people with autism, maybe 1%, was affected by mercury in their vaccines. With an estimated 1.5 million Americans with autism, that would mean 15,000 people severely impacted by thimerosal.

But, if causation can be shown in even 1% of cases, this would provide tremendous hope for the other 99%. Yes, some cases may be purely genetic in nature. But for everyone else, if we can show how thimerosal caused "autism," we might be able to do the same for, say, pesticides, PCBs, flame retardants, jet fuel, environmental mercury in air, water and fish, or any combination thereof.

It's a tough call and, like I said, I don't envy these Special Masters, though I do thank them for opening the proceedings to the public.

And I will see you in Vaccine Court.

----------------

David Kirby is author of the book "Evidence of Harm." Many of the studies cited here can be found on his Powerpoint slides at www.evidenceofharm.com

Conflict of Interests in the Wakefield Conflict of Interest Case

As I have mentioned before, I have not focused on the Andrew Wakefield/MMR controversy because Chandler never got the MMR and so that research is on the back burner for me. This article was just to much for me to pass up posting though.

The Wakefield Case is a carnival of conflict of interests with his accusers breaches vastly eclipsing those that they accuse Dr. Wakefield of. The irony would be hilarious were it not destroying a good man who has gone above and beyond for our kids, and holding at bay progress that would be made in understanding our children's illnesses.

I have heard Dr. Wakefield present three times, and have been impressed. He is a humble man, he backs up what he says with research, he is reticent to make claims about topics that are not fully explored yet, and most importantly, he presents case after case of successfully treated autistic children who came to Thoughtful House with horrible bowel issues and who became healthier and more functional when they were able to resolve those issues.

If we could afford it I would be in Texas getting Chandler scoped.

Good thing that these kind of secret hearings and dual relationships shenanigans don't exist here in the US.

GMC Challenged On MMR Inquiry Chief's Vaccine Firm Links

London, England & Scotland/29 May 2007/JWock/ The Chairman of the General Medical Council's inquiry into MMR vaccine doctor Andrew Wakefield, Professor Dennis McDevitt, is being challenged over undisclosed personal interests. On 11th July this year an unprecedented 14 week GMC hearing chaired by Professor McDevitt was due to commence into charges against Dr Andrew Wakefield of the Royal Free Hospital relating to the controversial vaccine. However, previously secret government minutes reveal Professor McDevitt was himself a member of a 1988 government safety panel which approved Pluserix MMR as safe for vaccine manufacturer Smith Kline & French Laboratories (see first .pdf attached). Pluserix MMR (measles, mumps and rubella) vaccine was introduced in 1988 but the Government was forced to withdraw it in November 1992 after large numbers children suffered suspected adverse vaccine reactions.

This development follows the recent discovery that High Court Judge Sir Nigel Davis, who in a secret hearing rejected the MMR childrens' appeals against withdrawal of legal (see second .pdf attached), failed to disclose his brother was main board director of the MMR vaccine manufacturer's parent company GlaxoSmithKline (more below).

The GMC hearing against Dr Wakefield relates to events in 1998, seven years after legal investigations into the MMR childrens' ailments first started. Dr Wakefield angered MMR vaccination proponents and created a furore in 1998, when he suggested offering single vaccines alongside MMR - albeit that is current official Conservative party policy.

Nearly 2000 children alleged to be suffering from autism, deafness, bowel disorders and other serious injuries caused by the vaccine filed legal claims against manufacturer Smith Kline & French Laboratories Ltd. Investigations into the claims started in 1991 when applications for legal aid were first being filed. The vaccine was given to 85% of MMR vaccinated children between 1988 and 1992. Labour MP Jack Ashley said at the time of the 1992 withdrawal that correspondence with Minister Virginia Bottomley MP confirmed government knew of the problems in March 1991, some 18 months earlier.

The GMC's inquiry into Dr Wakefield is said to include conflicts of interest alleged by the Sunday Times in 2004. Dr Wakefield was retained as an expert witness in the legal claims. It was alleged Dr Wakefield failed to disclose payments made by lawyers to the Royal Free when his team published a paper in the Lancet medical journal concerning medical investigations into the children's illnesses. Final charges have yet to be published. GMC hearings are often less than a day and usually no more than two or three days.

Other safety panel members who approved the vaccine included controversial paediatrician Professor Sir Roy Meadow, Government vaccination supremo Dr David Salisbury, Dr Elizabeth Miller of the Health Protection Agency, and Joint Committee on Vaccination and Immunisation member and Chairman Professor Sir David Hull.

Dr Miller is also an expert witness for the Glaxo companies defending the children's claims. She has stated "there can be no conflict of interest when acting as an expert for the courts, because the duty to the courts overrides any other obligation, including to the person from whom the expert receives the instruction or by whom they are paid ". Dr Miller has also published in The Lancet without disclosing funding from drug companies and still without complaint from the Editor. Wakefield disclosed his status as an expert witness funded by legal aid in a letter to the Lancet in 1998 - six years earlier so this was known to The Lancet.

Barrister Robert Hantusch in a letter to the Times of 24 February 2004 said "The courts do not consider that the engagement of someone to act as an expert witness in litigation has the effect that that person is then biased. Indeed, if this were the legal position, no paid professional could ever at any time give evidence to a court."

A challenge is also being mounted against the withdrawal of the childrens' legal funding in 2004 concerning High Court Judge Sir NigelDavis failure to disclose his brother was main board director of the MMR vaccine manufacturer's parent company GlaxoSmithKline plc and Chief Executive of the Lancet medical journal. Judge Davis' brother is Sir Crispin Davis (57).

Furious parents who filed complaints with MPs and the Office for Judicial Complaints, which investigates the conduct of judges and coroners are told to expect a response this week..

Judge Davis' spokesman Peter Farr of the Judicial Communications Office said "The possibility of any conflict of interest arising from his brother's position did not occur to him. If he was wrong, any possible remedy must be sought from the Court of Appeal.".

Multinational drugs giant GlaxoSmith Kline appointed Sir Crispin Davis as non executive director 1 July 2003. Three months later the Legal Services Commission were due to decide on the MMR childrens' funding and made the contested decision on 4th October 2003. Five months later Judge Davis rejected appeals against the LSC's decision. The reasons remain secret. Parent Ann Hewitt claims " We have been dumped. Legal advice says Thomas has a strong case, but legal aid was mysteriously taken away." However, parent Marion Wickens, who also claims her severely injured 13-year-old daughter's legal case was strong, said in a later open court hearing that a senior LSC official admitted the decision to stop Legal Aid " came from the government" (see third .pdf attached).

Sir Crispin Davis is unlikely to be a stranger to controversy over the MMR vaccine. He is Chief Executive of the owners of the "The Lancet" medical journal. In 1998 The Lancet published the now controversial study by Dr Andrew Wakefield's Royal Free Hospital London research team into links between autism and the MMR vaccine. Wakefield sparked a furore with the government later to involve Prime Minister Tony Blair when at a March 1998 press conference he suggested single measles jabs be made available alongside MMR.

Six years after the publication of the Lancet paper, in February 2004 and only a week before Judge Nigel Davis's rejection of the childrens' funding appeal, The Lancet Editor, Richard Horton disclaimed the Royal Free paper, claiming Wakefield had failed to disclose a conflict of interest over funding by the Legal Services Commission. Premier Blair was quoted at the time " There's absolutely no evidence to support this link between MMR and autism". Horton expressed public regret for publishing the Royal Free paper and Sir Crispin Davis was knighted three months later.

Parent John Stone comments "A major unexplained mystery is why the issue of what measles vaccine was given to children should have been so political. There was, after all, a perfectly acceptable, cheaper and more effective measles vaccine then available. "

Current Conservative Shadow Health Minister Andrew Murrison says "The last time we commented on this we said that MMR would be routinely recommended (the CMO believes it to be safe) but if refused the single jab would be available. We haven't changed that position. "

Today the issue remains mired in confusion and contradictions. Parent Elaine Butler demands an inquiry "We believe the evidence shows very clearly that our children were damaged by this vaccine. If it was so important to the government, then they should have ensured the case went to trial with full funding so everyone could see the evidence in open court. The additional amount that would cost compared to all the money spent by the government and NHS on attacking Wakefield and promting MMR is trivial . And the irony is, we now learn that 2007 is the year the chance of anyone catching measles and dying became vanishingly small. People in the UK are 60 times more likely to be hit by lightning than killed by measles and the official government
figures show that disparity will continue to increase over time ".

INFORMATION FOR EDITORS:

For the curious politics of MMR see - Top doctor wades into MMR debate BBC - Monday, 23 February 2004

Some of the MPs known contacted by parents include:-
Norman Baker
Stewart Jackson, Peterborough,
Shona Robinson (SNP health minister with autistic daughter)
Sir Robert Smith, Aberdeenshire West & Kincardine
Lynne Featherstone
Alex Salmond
Chris Mullin

For in-depth analysis of the controversy see:-
"MMR - SCIENCE AND FICTION": the Richard Horton story BMJ John Stone
24 Sep 2004
"MMR - SCIENCE AND FICTION": the Richard Horton story II BMJ John
Stone 26 Sep 2004
"MMR - SCIENCE AND FICTION": the Richard Horton story III BMJ John
Stone 30 Sep 2004
"MMR - SCIENCE AND FICTION": the Richard Horton story IV BMJ John
Stone 1 Oct 2004
"MMR - SCIENCE AND FICTION": the Richard Horton story V BMJ John Stone
1 Oct 2004
"MMR - SCIENCE AND FICTION": the Richard Horton story VI BMJ John
Stone 3 Oct 2004

========== Contact information
Peter Farr
Judicial Communications Office
Thomas More Bldg 11.07
Royal Courts of Justice
Strand, London WC2A 2LL

www.judiciary.gov.uk