Archive | February, 2009

Brian Deer, not a complainant

16 Feb

Just in case you didn’t see it–Brian Deer published more information about Dr. Andrew Wakefield recently. This has caused a lot of furor (we are over 160 comments on that thread already). No surprises there: saying anything which might suggest Dr. Wakefield is anything less than a hero, especially when Brian Deer is doing it, will do that.

Almost all (if not all) of the responses to Brian Deer’s piece has been one big diversionary tactic: attack the messenger. Everyone seems to be studiously avoiding facing the real tough questions. Let’s avoid the ethics questions for the moment. If the details Mr. Deer presented in his article are true, Dr. Wakefield’s autism research has lost any last shred of support. That is a tough pill to swallow for the Wakefield supporters.

David Kirby joined in on the Deer bashing. Seems he read an article by Melanie Philips and rehashed it for his fans on the Huffington Post. He found Ms. Philips’ story to be “very interesting reading”. You see, Ms. Philips postulated:

What the Sunday Times did not report was that the GMC investigation into Wakefield was triggered by a complaint from… Brian Deer, who furnished the allegations against him four years ago.

This was then spun into a story of supposed conflict of interest and a great avoidance of the direct and specific claims of possible misinformation in Dr. Wakefield’s papers.

But, back to Mr. Kirby. He states:

The point is an excellent one. Imagine if a US journalist sued a doctor for libel or misconduct, and then went to the NY Times and asked to be hired as a freelancer to cover the trial that they themselves had instigated in the first place. It wouldn’t happen.

I found that statement very ironic, coming as it did from someone who aided significantly in manufacturing the thimerosal controversy, and who now seems to owe some of his employment to servicing that same controversy.

That said, what about this notion, this postulate as I have called it, that Brian Deer initiated the investigation that he is now reporting on? Well, it turns out that Mr. Deer is not a complainant in the GMC hearings on Dr. Wakefield. Below is a letter to Mr. Deer explaining exactly that.

Strictly Private & Confidential
Mr Brian Deer

25 May 2005

Dear Brian

General Medical Council – Dr Wakefield, Dr Murch, Dr Walker-Smith

I write further to your telephone conversation with Peter Swain last Thursday seeking clarification in relation to your role in the above General Medical Council (“GMC”) proceedings.

I have now had the opportunity to review the GMC’s files. My understanding is that further to your articles appearing in the Sunday Times in February 2004 in relation to your investigation into Dr Andrew Wakefield and the MMR vaccine, you were approached by GMC case officer Tim Cox-Brown, who asked you to supply the GMC with further information regarding this matter.

Your situation as a journalist who has carried out an investigation into the conduct of the practitioners in question is unusual for the GMC. I note from the GMC and FFW’s correspondence files that there does appear to have been some confusion in relation to your role in these proceedings.

In GMC ‘complainant’ cases an individual will have approached the GMC with a complaint against a particular practitioner. If the GMC decides to hold an inquiry, legal representation is offered to the complainant for preparation and presentation of the case before the Professional Conduct Committee.

As stated in Peter Swain’s letter to you dated 16 December 2004, your role in this matter is that of ‘informant’ rather than ‘complainant’. This is due to the fact that the conduct of the practitioners in question has not affected you directly and clearly involves issues of a wider public interest.

As you are aware, your involvement the GMC’s conduct of this case prior to our commencing our investigation and subsequent to our meetings with you on 24 February 2005 and 7 March 2005 has been minimal. We are preparing this case for presentation at the Professional Conduct Committee on the instructions of the GMC. Moreover, we are not able to discuss draft charges with you for reasons
of confidentiality.

We apologise for any confusion in relation to your status in these proceedings and any difficulties this may have caused you. We have made it clear to all parties that your role is that of informant rather than complainant. Please find enclosed a copy of the letter sent to Dr Wakefield’s legal representatives clarifying your status in these proceedings.

We are grateful for information supplied by you and your assistance to date.

Yours sincerely

Matthew Lohn
Partner

So, Brian Deer didn’t initiate the investigation. He wasn’t a complainant. It isn’t like, as in Mr. Kirby’s analogy, Mr. Deer didn’t “sue a doctor for libel or misconduct”.

Let me take a page out of Mr. Kirby’s own playbook:

David, if you read this (and we both know you will), take the message to heart and write a correction to your blog piece on the Huffington Post. Better yet, put up a new one with an explanation and apology.

Vaccines in court, what next?

14 Feb

Lisa Jo Rudy has a post on the “what next question”

On beyond the Vaccine Court: next steps in the vaccine-autism legal process

In it, she quotes from Law.com where they also looked into the question. One of the petitioner’s lawyers is indicating that they may appeal.

I seem to recall there being mention of a possible appeal in the Omnibus Docket, but I can’t find it right now. Basically, the next step would likely be to take the U.S. Court of Appeals. One of the petitioner’s attorneys is indicating that this may happen, with the argument

“I think the special masters were imposing a standard and imposing a burden on this evidence in these cases that was higher than what is called for under the statute.”

Seems a stretch to me. When a Special Master makes a point that it was “not even close”, it doesn’t seem as though it was a matter of changing the standard.

There are many more comments in the decisions making it exceedingly clear that the Special Masters didn’t think these cases had even close to the merit required, but I don’t expect that to stop people from appealing.

After that, or for some people even before the appeal, there is the chance that the cases could be taken to civil court. Similar cases have worked in civil court in the recent past–with cases dismissed before trial even begins based on the lack of evidence. Now, civil court judges will be able to refer to the Special Master’s decisions, which are quite detailed and quite clear.

But, in civil court, will they be able to assemble the “Dream Team” of expert witnesses that the DoJ put together for the Omnibus?

They may not have to.

One of the entries in the dockets for the Cedillo, Snyder and Hazlehurst cases was this:

NOTICE, filed by SECRETARY OF HEALTH AND HUMAN
SERVICES RESPONDENTS CONSENT TO DISCLOSURE OF
EXPERT REPORTS. (Babcock, Alexis) (Entered: 01/30/2009)

Yep, we may get to read the expert reports. It could help slow down any civil cases.

Much more, it could give new families to autism something to read besides the websites of the orgs promoting vaccine causation.

I can’t wait to read those reports.

What you talking about, Safe-Minds?

13 Feb

And the spin continues on the Omnibus decisions. Anyone surprised?

This time, Safe-Minds has chimed in on the Omnibus decisions with:

Federal Vaccine Court Rules Against Autism Families: Government’s Refusal to Fund Sound Science Stacks Deck Against Vaccine-Injured Children.
One more reason to distrust the government’s vaccine program, says SafeMinds

The main theme is a rather contradictory one:

The denial of reasonable compensation to families was based on inadequate vaccine safety science available to the court.

How many times have we all heard from groups like SafeMinds that the science is very conclusive?

If the science is inadequate, why are groups such as SafeMinds and Generation Rescue recommending chelation as a therapy for autism?

As a friend of mine used to say to other drivers while driving down the highway, “Pick a lane, buddy”. Either you got the science or you don’t. Seems like you don’t.

SafeMinds perseverates on the IACC. I do to, so I can’t blame them for that. I can blame them for misrepresenting what happens in IACC meetings:

Last month, the government-dominated Interagency Autism Coordinating Committee blocked critical vaccine-autism research studies from moving forward even though they had been requested by their own scientific advisors and autism advocates.

Uh, one of the BIG problems with the proposed vaccine research was precisely the fact that they were not recommended by the scientific advisory subcommittees. Nice spin, though.

and, again on the IACC, SafeMinds states:

The director of the NIH institute in charge of autism studies, Dr. Tom Insel, has admitted that HHS has a conflict of interest preventing NIH from allowing autism-vaccine science due to the court cases.

Uh, no. He raised the question of whether there is a conflict of interest. He didn’t “admit” to any conflict of interest.

I am actually getting very tired of this claim made about the vaccine court:

Many of these cases were quietly settled by the government so the public is not aware of them.

Sounds oh so conspiratorial.

Of course the government is quiet in the decisions. Quiet in they don’t advertise or call press conferences. What they do is put them on a public website. That is appropriate.

Is it the government’s fault that the vaccine-autism “advocates” never checked? Seriously, you are working on cases costing many millions of dollars and no no seems to have gone through the previous cases searching for the word “autism”?

Is it the government’s fault that the lawyers who worked on the previous cases involving autistics who were injured by vaccines weren’t savvy enough to think of communicating that fact to the Omnibus lawyers? C’mon, at least one of them is working on the Omnibus proceeding!

SafeMinds, you and your sister organizations found out about the other cases from Kathleen Seidel! That’s who is doing your homework.

Even leading vaccine proponents have accused the CDC of carrying out safety research “on the cheap,” and two major systematic reviews of vaccine research by the world renowned Cochrane Collaboration have found studies to be of “poor quality” and “inadequate.”

Who are these “leading vaccine proponents”? And, how many “leading vaccine proponents” think that a lot of time and money is spent on vaccine safety research?

That last sentence is why “..and the whole truth” is included in swearing in witnesses. How many studies did they find to be “poor quality”. The way it is phrased, SafeMinds is trying to make it seem like all the research is substandard. Ironic given that SafeMinds still has the Hornig mouse study on its website with no mention of the MIND study that refuted it.

That said, the Special Masters who wrote the decisions for the Omnibus hearings made it very clear that they had good evidence, good studies to work from.

Here’s a comment that goes to the heart of the future problems:

“The government must fund an extensive vaccine safety program, including studies of the health outcomes of vaccinated and unvaccinated groups,” stated Sallie Bernard, executive director of SafeMinds. “Trust in immunization will continue to deteriorate without the perception of a fair hearing. It is time for a neutral agency to oversee vaccine safety.”

Ms. Bernard: this was a fair hearing. The petitioners were given many years of extra time to get the research that they needed. Much research was done on vaccine safety in regards to autism in that time, and it only helped the defendents.

Also, trust in vaccinations may continue to deteriorate because of the publicity campaigns you and your sister organizations are putting on. Own the responsibility for your own actions.

What you talking about, TACA?

13 Feb

TACA have issued a statement on the Omnibus decisions. We’ve already discussed some of this, but there is something in the TACA statment that is sooo bad that it needs to be pointed out.

TACA states

The VICP was set up for individuals that suffered an “on the table” vaccine injury. That is, an injury that happened within minutes or hours after receiving a vaccine.

What?

But, more importantly…What?

An injury has to be suffered “on the table”? That’s what they think a “table injury” is?

Once again….What?!?

You’d expect TACA to understand that better than I, since I am not involved in the litigation. Sadly, this is not true.

A “Table Injury” is described thus:

The Vaccine Injury Table (Table) makes it easier for some people to get compensation. The Table lists and explains injuries/conditions that are presumed to be caused by vaccines. It also lists time periods in which the first symptom of these injuries/conditions must occur after receiving the vaccine. If the first symptom of these injuries/conditions occurs within the listed time periods, it is presumed that the vaccine was the cause of the injury or condition unless another cause is found. For example, if you received the tetanus vaccines and had a severe allergic reaction (anaphylaxis) within 4 hours after receiving the vaccine, then it is presumed that the tetanus vaccine caused the injury if no other cause is found.

Granted, the definition of “table” in this case is not the most common. It is, in fact, #8 or #9 on the list:

an arrangement of words, numbers, or signs, or combinations of them, as in parallel columns, to exhibit a set of facts or relations in a definite, compact, and comprehensive form; a synopsis or scheme.

So, that was a bit of an “oops” from our good friends at TACA.

Just to be more precise, the VICP was not built just around “table” injuries. Instead, anyone who has read the decisions will be able to tell you that much time is spent deciding cases of possible non-table injuries.

There are more errors in the TACA statement. But, the main one we have already discussed–the fact that the court was very decisive in what they wrote.

Omnibus: the decisions are decisive

13 Feb

The first autism omnibus proceeding decisions are in: MMR does not cause autism, either alone or in conjunction with thimerosal.

Having said that, I can imagine that some of my readers are already accusing me of spinning the conclusions. That’s because the spin has already been put forth that the decisions are weak on the idea of general causation. Another theme is that the decisions only pertain to the test case families. But, as we will see, those ideas are the spin.

Here is a section from the From Autism Speaks statement on the Omnibus:

Today the National Vaccine Injury Compensation Program ruled that the combination MMR vaccine — with and without the preservative thimerosal — did not contribute to three particular children’s autism.

Why did they chose to say “…three particular children’s autism” when they know full well that the point of using “test cases” is to discuss general causation?

TACA is less subtle:

The fact that it took this long for these three decisions has to mean that the vaccine injury evidence had some merit. Poor evidence would have produced a negative decision very quickly.

The fact that they took a long time to decide indicates a tough decision? Either they didn’t read the actual decisions or they are deliberately trying to muddy the waters. Seriously. The comments in the decisions are so clear, so decisive, that one just can not make the TACA statement in good conscious.

Take a look at what the special masters actually said. Granted, there are hundreds of pages of decisions and I am picking a few paragraphs out, but I think you will agree–the statements are very (very!) clear. The decisions were not close. It was not a struggle for the special masters to come to these conclusions.

From the conclusion of the Cedillo case by Special Master Hastings:

This case, however, is not a close case. The overall weight of the evidence is overwhelmingly contrary to the petitioners’ causation theories. The result of this case would be the same even if I totally ignored the epidemiologic evidence, declined to consider the video evidence, and/or excluded the testimony of Dr. Bustin. The result would be the same if I restricted my consideration to the evidence originally filed into the record of this Cedillo case, disregarding the general causation evidence from the Hazlehurst and Snyder cases. The petitioners’ evidence has been unpersuasive on many different points, concerning virtually all aspects of their causation theories, each such deficiency having been discussed in detail above. The petitioners have failed to persuade me that there is validity to any of their general causation arguments, and have also failed to persuade me that there is any substantial likelihood that Michelle’s MMR vaccination contributed in any way to the causation of any of Michelle’s own disorders.

emphasis in the original.

Take a couple of lines out, shall we? Starting with, “…not a close case”. He even emphasized it with italics.

“The overall weight of the evidence is overwhelmingly contrary to the petitioners’ causation theories. “

and

” The petitioners’ evidence has been unpersuasive on many different points, concerning virtually all aspects of their causation theories, each such deficiency having been discussed in detail above. “

This is a clear and decisive decision, not doubts about it.

From another section of the decision, this one entitled Summary concerning general causation issue

For all the reasons stated above, I conclude that the petitioners have failed completely to demonstrate that it is “more probable than not” that the MMR vaccination can be a substantial factor in contributing to the causation of autism, in individuals suffering from regressive autism or any other type of autism. To the contrary, the evidence that I have reviewed makes it appear extremely unlikely that the MMR vaccine can contribute to the causation of autism. It is clear that the causation theories themselves are weak, not just the case in specific for Miss Cedillo.

I expect fragments like “extremely unlikely” to be taken out of context.

An entire section of the decision (page 34) is titled, “I have found above that petitioners general causation theory concerning immune damage is without merit.”

As to part (1) of petitioners’ three-step theory (see previous paragraph), I have already explained in detail, at pp. 22-34 of this Decision, why I have found no merit in the petitioners’ theory that thimerosal-containing vaccines in general can damage infant immune systems.

Doesn’t bode well for the next three Omnibus test cases, does it? The second three focus on thimerosal alone.

Back to MMR, there are two more decisions. From the concluding paragraph to the Hazlehurst decision, by SM Campbell-Smith,

Having carefully and fully considered the evidence, the undersigned concludes that the combination of the thimerosal-containing vaccines and the MMR vaccine are not causal factors in the development of autism and therefore, could not have contributed to the development of Yates’ autism.

Again, for emphasis, let’s pull a phrase out: “the undersigned concludes that the combination of the thimerosal-containing vaccines and the MMR vaccine are not causal factors in the development of autism”

From the Snyder case,

To conclude that Colten’s condition was the result of his MMR vaccine, an objective observer would have to emulate Lewis Carroll’s White Queen and be able to believe six impossible (or, at least, highly improbable) things before breakfast. The families of children with ASD and the court have waited in vain for adequate evidence to support the autism-MMR hypothesis.

Pretty strong words, but I can see some people saying that there is the indication that it is just “highly improbably” raised to the sixth power. “Highly improbably^6 is not zero!” we will hear.

From another section, specifically addressing the general causation question:

However, the problems with the case presented by petitioners for general causation are overwhelming. The quality of the petitioners’ experts paled in comparison to the world-class experts proffered by respondent. The theories petitioners’ experts advanced lacked support in both logic and research. As Dr. Ward testified, an hypothesis has a life span. An hypothesis may be biologically plausible at the time it is first advanced. As evidence accumulates, the hypothesis may be strengthened or weakened. The MMR hypothesis may have appeared biologically plausible at its inception, but the accumulating body of scientific evidence has tipped the scales decisively against it. Snyder Tr. at 975. The weight of the scientific evidence is that the measles vaccine virus plays no role in the pathogenesis or triggering of autism. I thus conclude that petitioners have failed to demonstrate that the MMR vaccine can cause autism, even in the highly circumscribed subset of children with regressive ASD and gastrointestinal symptoms.

Again, for emphasis, here is a line pulled from the above “The weight of the scientific evidence is that the measles vaccine virus plays no role in the pathogenesis or triggering of autism”

It will be frustrating to watch the spin continue. I expect to hear “The decisions weren’t really that decisive” for some time to come.

But, the fact of the matter is that these decisions are clear and, well, decisive.

This is not just a statement about the spin-factor, by the way. The vaccine lawyers have just done millions of dollars worth of groundwork for their appeal and later civil cases on the taxpayer’s dollar. The fact that the Court of Federal Claims has issued such incredibly strong decisions makes it much more difficult for those cases, especially the civil cases, to actually go to trial.

Arthur Allen chimes in on the Omnibus

13 Feb

I hate to give away the title, but I will,

In Your Eye, Jenny McCarthy

here’s the first paragraph. I like the fact that he brings it back to the important question, will this help with vaccine confidence?

The three federal judges who convincingly rejected the theory that vaccines cause autism delivered a devastating blow to crank science today. The battle will go on in the blogs and in the courts. But the most important arena has always been the space between the ears of parents who are deciding whether it’s safe to vaccinate their kids. This decision could do a heap of good by stemming the tide of vaccine-shunning that has led to outbreaks of preventable disease.

Go over, take a look.

Cedillos, Hazlehursts, Snyders

12 Feb

Three brave families who were placed in harms way not by an MMR injection but by a string of bad doctors, worse autism/antivax organisations and really terrible witnesses. A combination of these three factors placed these three families – they who stood for the utterly discredited idea that MMR/thiomersal or MMR alone cause autism – into harm the likes of which said doctors and founders of autism/antivax orgs will never have to face. I recall hearing that the Cedillo’s had taken out a second mortgage on their home to enable them to attend the legal proceedings.

I wonder if the leading autism/antivax groups will have enough about them to pony up to support the Cedillo’s for the rest of their lives? They should, they hung them out like a banner to wave.

This is from the Washington Post:

The decision by three independent special masters is especially telling because the special court’s rules did not require plaintiffs to prove their cases with scientific certainty — all the parents needed to show was that a preponderance of the evidence, or “50 percent and a hair,” supported their claims. The vaccine court effectively said today that the thousands of pending claims represented by the three test cases are on extremely shaky ground.

In his ruling on one case, special master George Hastings said the parents of Michelle Cedillo — who had charged that a measles, mumps and rubella (MMR) vaccine caused their child to develop autism — had “been misled by physicians who are guilty, in my view, of gross medical misjudgment.”

Hastings pinpoints the Geier’s, Krigsman and Wakefield by name in his verdict.

And here’s Special Master Vowell from the Snyder test case:

“After careful consideration of all of the evidence, it was abundantly clear that petitioners’ theories of causation were
speculative and unpersuasive.”

….

To conclude that Colten’s condition was the result of his MMR vaccine, an objective observer would have to emulate Lewis Carroll’s White Queen and be able to believe six impossible (or, at least, highly improbable) things before breakfast.

And here is Special Master Campbell-Smith from the Hazlehurt test case:

Because the linchpin of petitioners’ theory, the finding of persistent measles virus in the biopsied tissue taken from the gastrointestinal lining of autistic children, is glaringly unreliable, the basis for Dr. Corbier’s opinion that the MMR vaccine was causally related to Yates’ autism and his gastrointestinal symptoms is critically flawed and scientifically untenable. Petitioners have failed to prove that their theory of vaccine-related causation is biologically plausible as required by the first prong of Althen. Nor have petitioners demonstrated that the unsupported links of their proposed causal chain cohere to establish a logical sequence of cause and effect as required by the second prong of Althen. Having failed to satisfy their evidentiary burden, petitioners cannot prevail on their vaccine claim.

I should be happy that science has prevailed and I am to a certain degree. The fact that the Vaccine Injury Court demands a very, very low standard of proof should indicate clearly and concisely just how good the rubbish submitted as science was for these kids cases.

I can’t be happy and I can’t take any pleasure in the fact that these kids and their families have been coldly, cynically used by those who demand against all reason that vaccines cause autism. How could any right thinking person? These parents are penniless and will no doubt be coerced into taking part in a shame of an appeal, then civil cases. Civil cases where the standard of science is very much higher. I hope they step back and consider carefully the verdicts of the Special Masters, the horrendous quality of their so-called ‘expert’ witnesses and the utter lack of any science to support them.

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