Tuesday, June 29, 2010

Andrew Moulden and his junk science in Vaccine Court - Veryzer v. HHS

Ideology is not science – which it pretends to be. Science accepts the results of the experiments it devises, whereas ideology systematically rejects empirical evidence.... All ideologies are aberrations. A sound and rational ideology cannot exist.

- Special Master Richard B. Abell in
Veryzer v. HHS, quoting Jean-François Revel

In a decision filed on June 15, 2010 - Veryzer v. HHS, US Court of Federal Claims, No. 06-0522V - Special Master Abell considered whether expert evidence may be excluded under the Daubert standard in a Vaccine Injury Compensation Program proceeding. These vaccine injury cases are handled at the trial level by the Office of Special Masters in the US Court of Federal Claims. The program is sometimes referred to as "Vaccine Court." In Veryzer, faced with the prospect of having to consider opinion evidence from the petitioner's expert, anti-vaccine crank and germ theory denialist Dr. Andrew Moulden, the special master ruled that he could exclude that evidence from consideration under Daubert.

The Daubert standard was developed by the US Supreme Court as a means of determining the admissibility of scientific and other expert opinion evidence in federal courts. In US District Court, the Daubert standard serves a gate-keeping function by allowing the trial judge to apply various factors to determine the reliability of proffered evidence before it is put before a jury. If the judge determines that the evidence isn't reliable, he or she can refuse to admit it. That way, the jury isn't presented with junk science. The Daubert standard is supposed to be flexible enough to allow admission of novel scientific evidence, as long as the evidence is reliable.

There is no jury in Vaccine Court, however, so there is no need for a gate-keeping function. Nevertheless, special masters have used the Daubert standard to assess the reliability of expert opinion evidence that they have admitted and are considering. An example of this use of Daubert can be seen in Cedillo v. HHS, US Court of Federal Claims, No. 98-916V (appeal pending in the US Court of Appeals for the Federal Circuit).

In Veryzer, the special master ruled that Daubert could also be used to exclude evidence, but only in the most extreme cases. "In the Vaccine Program, then, exclusion from the record is an exceptional remedy, and should only be applied by the Court where the material sought to be excluded is so unreliable, it patently forfeits every trace of being helpful to the Court’s consideration of the facts of the case."

Andrew Moulden's proffered testimony fits the bill. Dr. Moulden has been described by ScienceBlogs blogger Orac at Respectful Insolence as having "plumbed depths of crankery that few pseudoscientists can even dream of plumbing." Although this sounds like hyperbole, Special Master Abell drew a similar conclusion after applying the Daubert factors to Dr. Moulden's expert report in Veryzer. Here are excerpts from the special master's analysis:

More than any arguments made by Respondent, or any failures to rebut by Petitioner, Dr. Moulden himself openly flaunts that he does not follow generally accepted medical science. He believes that none of the several theories found reliable by this Court over the years, none of the mechanisms identified by the IOM, and none of the medical literature on vaccine injury are correct. Even if this is not the heresy which Respondent would ascribe, it is undeniably a heterodoxy that veers sharply from the orthodox universe of accepted medical science. Similar to this is his belief that “all vaccines are useless,” and that vaccines are the primary pathogen in the world. It seems incredible that Dr. Moulden would find vaccines more destructive than smallpox, polio, measles, or tetanus. Without being hasty, it may be fair to say that this diverges from the understanding of acceptable medical science, not least in the field of immunology. And it is hard to conceive of a belief that would diverge more from modern medical science than his rejection of germ theory. On a fundamental level, Dr. Moulden breaks notably from medical science as it is practiced today. These are not prudential matters of opinion; these affect the very fiber of scientific methodology. As the Supreme Court stated in Kumho Tire, a reliable expert must adhere to “the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” 526 U.S. at 152.
...

However, inasmuch as he has publicly released none of the results of his research, his toil in the laboratory does not bolster the reliability of his opinion either. One is left to assume that his experiments have followed the pattern of hypothesis, testing, theory, duplication of results, and falsifiability. However, the lack of published results leaves this supposition as a mere article of faith. Furthermore, as Respondent pointed out, the absence of publication within the medical field also makes testing, duplication of results, and falsifiability impossible for any others to perform. One of the identifiable hallmarks of science is the requirement of theoretical falsifiability; even if an individual theory has not undergone sufficient testing to prove or disprove its viability, the requirement remains that it must be falsifiable under some potential (even if not yet discovered) rubric, else it cannot bear the name “scientific” but is an article of faith. Petitioner even hoisted himself by his own petard by his citation to Paoli (supra at note 14), which states that an opinion is only reliable when premised upon “good grounds,” by which that court described an expert theory and conclusion that was “based on the methods and procedures of science.” 35 F. 3d at 744. There is a word for a postulated system that purports to be a unified theory of everything, explaining all phenomena by its one, reductionist theory: ideology. Indeed, Dr. Moulden’s seraphic vision of a MASS response smacks of a pensée unique, perhaps even devolving into an idée fixe. To be so engrossed in one way of perceiving reality, so as not to recognize the distinction between congenital defects and infection, is not helpful to understand reality, and it cannot prove helpful to the Court’s understanding. Thus, the Court stares askew at Dr. Moulden’s statements such as “Pasteur’s germ theory of mammalian disease is both incorrect and inaccurate [because] disease is not being caused by any particular pathogen or strain of pathogen [but] is the non-specific immune response to foreign substances [in] the body and blood stream that causes disease–all diseases.” Moulden Report at 90-91.
...

Given that Dr. Moulden diverges (even veers) from accepted medical science on such a fundamental level in his methodology, that there is no single indicium of reliability that would bolster his opinion, and that the fact that his opinion would manifestly be unhelpful to the Court’s resolution of the issues presented in this matter, the Court rules that Dr. Moulden’s opinion shall be excluded from the record to be considered in ruling on the Petition, and that he shall not testify at any hearing held herein.

The special master also excluded evidence from petitioner's other expert witness, Huffington Post blogger and anti-vaccine activist Dr. Sherry ("Become a Vaccine Refusenik") Tenpenny. He found that she didn't have the expertise to give the opinion that was offered in the case, and that, even if she did have the qualifications, her opinion was not reliable. The special master found that Dr. Tenpenny's report "is thoroughly worthless to the Court, and is not helpful enough, not relevant enough, to be admissible, considering the strong arguments against its admissibility."

In the end, the special master found that neither Dr. Moulden nor Dr. Tenpenny "should be permitted to waste the Court’s (or counsel’s) time at a hearing held merely to endure testimony that is patently unreliable," and ordered the petitioner to "seek out a credibly qualified, methodologically reliable expert witness to opine on the specific matter at issue in this case: namely, can the Hepatitis A vaccine cause Petitioner’s injury, and if so how; and did the Hepatitis A vaccine follow such a process in Petitioner’s case, with reference to his medical records."

58 comments:

  1. What a great find. I didn't realize that Moulden was connected with Thoughtful House.

    I'm surprised at Dr. Tenpenny. I thought she was smarter than to put herself forward as an expert before the vaccine court, especially where Hepatitis A is involved.

    I've signed up for the feed from your blog.

    sheldon101
    www.vaccineswork.blogspot.com

    ReplyDelete
  2. I read your comment on SBM and enjoyed your post on this. I think it is a much-needed smack for bloviated, self-appointed pundits like Moulden and Tenpenny to have received. I'm sure they won't be advertising this, but I will certainly be using this document to signify their utter lack of competence.

    ReplyDelete
    Replies
    1. Perhaps you might listen to Doctor Moulden's words. Like many brave people opposing the Industrial Medical juggernaut this man is now dead. Just a coincidence I am sure.

      http://healthyprotocols.com/2_Dr_Moulden.htm

      Delete
  3. Thanks for your comments, Sheldon and Science Mom. Sheldon, Dr. Tenpenny has appeared a few times in Vaccine Court, usually testifying as a petitioner's treating physician rather than as an expert witness.

    ReplyDelete
  4. Dr. Tenpenny is one of few medical professionals who are willing to stand up against corrupt interests that would practice eugenics on the population.

    She is my doctor and I trust her far more than I do the CDC and FDA who are more interested in accepting kickbacks from the pharmaceutical companies than they are in watching out for those who count on them for UNBIASED advice.

    ReplyDelete
  5. Leave it to an anonymous commenter to attempt to prop up "Dr." Tenpenny. The only thing Tenpenny is good at is selling DVDs and tickets to her seminars, or $200 "wellness kits" that are supposed to protect you from the flu.

    Does Tenpenny have any peer-reviewed research or studies published? Nope. Has she participated in any double-blind clinical trials in an effort to prove her opinions? No.

    What exactly does she do other than sell supplements and DVDs? Based upon this post, it sure doesn't seem she is going to be called upon to be an "expert witness" in many more vaccine injury cases, so maybe she can get together with Moulden and they can do a 75 city tour with Jenny McCarthy trying to convince mothers to skip vaccinations for their children.

    Yea that will end well.

    ReplyDelete
  6. I can appreciate the importance of having rules of evidence in various courts but who writes the rules and for what purpose and for whom?

    I agree that this Dr ought to do a proper study of what he claims so other scientists can review it but there is dogma in science about topics such as this.

    My concern here is that Big business and big insurance companies along with lobbyist groups have an obvious agenda in preserving their various money streams. This directly pertains to the marketing and administration of vaccines on a global scale.

    I am glad that this Dr Moulden is attempting to help protect the rights of children that are damaged by vaccines.

    ReplyDelete
  7. Thank you for this post. I know it's a little late, but I'm adding you to my faves. I love how both of them were given a professional "f" you for all the scientific community to see!

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