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A fishing expedition at Vaccine Court

Posted Jul 13 2013 8:19pm

The U.S. Court of Federal Claims has a section devoted to adjudicating claims of vaccine injury . This is often referred to as the “Vaccine Court”. Individuals or their families can file a claim (petition) the court for alleged vaccine injury.

Information on individuals who are vaccinated are kept by ten Managed Care Organizations (MCO’s) and the Centers for Disease Control as the Vaccine Safety Datalink (VSD) Project. Researchers working as expert witnesses for families in the Vaccine Court have accessed the VSD in the past, and in one case misused their access . Possibly as a result of this, the MCO’s stopped contributing their data to the CDC for a single VSD database. Hence the reason why there are now 11 separate databases, with each MCO retaining control over their data.

One can see how groups who want to argue vaccine injury in court might want access to the VSD. Mark and David Geier have in the past attempted to use the VSD and they were the ones caught misusing the database. They, together with Heather Young, used an older VSD dataset to produce a paper for the Petitioners Steering Committee (the attorneys arguing for the families in the Omnibus Autism Proceeding). A paper for which the PSC was charged $250,000 . A paper which was of such poor quality that it was not used by the PSC in the Omnibus.

In a recent decision , the Court heard arguments that the information in the Vaccine Safety Datalink Project should be turned over to their expert, Theresa Deisher, for analysis:

Petitioners seek access to data from the Vaccine Safety Datalink Project (hereafter the VSD Project) to allow their expert, Theresa A. Deisher, Ph.D., to conduct an original study comparing the rate of autism disorder incidence among children who received a particular vaccine, with the rate among children who did not receive that vaccine. As discussed more fully below, petitioners’ expert does not seek to study the MMR vaccine at issue in this matter, but rather the varicella vaccine.

That last sentence is important. The Special Master points out the decision to research whether the varicella vaccine (chickenpox) is associated with autism for good reason. The petitioners are not arguing that the varicella vaccine caused their child’s autism. No, they argue that the child reacted to DNA in the MMR vaccine resulting in autism. So, how a study on the chickenpox vaccine would further their case is somewhat unclear. Why they are not asking for data on chickenpox is even less clear.

The petitioners asked for $260,000 up front to fund the study. To my knowledge, the Court does not fund expert witnesses for efforts not yet performed. Aside from that fact, the Special Master noted that Theresa Deisher’s studies on the subject done to date were already funded.

Dr. Deisher notes that this work was funded by the MJ Murdock Charitable Trust, Pet’rs’ Ex. 26 at 18, which according to information on Deisher’s CV, provided her with a $500,000 grant to study “Population, Bioinformatics and In Vitro Studies into the Relationship between Residual Human DNA Vaccine Contaminants and Autism.” Deisher’s CV at 3. Dr. Deisher’s inability to produce a paper of publishable quality, after receiving a substantial grant, does not lend support to petitioners’ claim that she is capable of competently leading a study.

Yes, half a million dollars so far with no papers published. A manuscript was submitted to Autism Research and rejected. My guess is that the manuscript will soon be submitted to a journal (there are those which will welcome this). Or, one of these journals will seek out Ms. Deisher for her work (I could easily see this being published in a certain Polish journal, for example).

One can apply to gain access to the VSD databases. However, Ms. Deisher has not attempted to access the data in this way, opting instead to gain access through a court order.

As discussed in more detail later in this Order, petitioners acknowledge that Dr. Deisher has not followed the CDC’s usual Data Sharing application process and that she has no intention of doing so.

She did, however, apply for an NIH grant to perform this research. The petitioners claim that the controversial nature of the study resulted in it not being funded. The referee reports, however, were clear that the planned study was weak and Ms. Deisher’s skills were not strong in epidemiology and statistics (among other weak points).

Although petitioners make assertions to the contrary, the evidentiary record before the undersigned contains a withering assessment of Dr. Deisher’s ability to competently lead the proposed study. Petitioners here seek extraordinary relief, and the undersigned is reluctant to substitute her scientific judgment for that of the NIH reviewers—a panel of Dr. Deisher’s peers—who have found her proposed study to be critically deficient. In the undersigned’s view, the NIH reviewers’ comments merit weighted consideration.

“Withering assessment”.

The special master also notes that the request for data from the VSD exceeds the data needed to do the proposed study.

The petitioners do not limit their data request to information that is needed for the study they propose:

Despite the stated limits of her study, petitioners’ request for production from respondent and the MCOs lacks correlative limits for patient age and injury. Instead: petitioners seek authority to issue subpoenae to compel [respondent and the MCOs] to grant the petitioners full and unrestricted access to all data collected by the respondent within the VSD related to the administration of vaccines, and the occurrence of neurodevelopment and other disorders from the inception of the VSD to date.

Which, in my opinion, points to this as a fishing expedition. An attempt to gather any and all data and test multiple questions later–with the probability of a chance “hit” going up with the number of questions tested.

Since the Special Master did not grant access to the VSD, the funding request was also denied.

The petitioners asked that the expert witness fees for Theresa Because petitioners’ discovery request is denied, petitioners’ motion for authorization of interim expert expenses is deemed moot.

The decision also includes much discussion of a large, broad request for information from the FDA on the vaccine approval process. Again, this appears as a “fishing expedition”

Petitioners’ motion does not appear to be a well-considered effort to meet their evidentiary burden under the Vaccine Program; but rather appears to be a brazen attempt to gain access to respondent’s comments on the various vaccine licensing applications in the hope that something therein might be of relevance. As presented, there is nothing in petitioners’ briefing or the record showing that the documents under FDA’s control are necessary to a determination of the issues in this matter

Ms. Deisher’s previous research has focused on “changepoint” analysis of autism prevalence data . She follows the method set forth by two people at the FDA who presented such a changepoint analysis previously . I found that analysis lacking and submitted a comment to the journal on it. I find Ms. Deisher’s analysis lacking as well.

In the end, the petitioners shot themselves in the foot, repeatedly. They made an overly broad request for data (essentially the entire VSD database). They requested the funding for the analysis in advance. Their expert witness’ track record was lacking. The proposed a search of FDA documents without providing a good reason why this was important for their case.

They went fishing and they got skunked.


By Matt Carey


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