Did Pharma Financial Interests Contribute to Decision to Pull Plug on National Children's Study?
For the Duration: A Reflection

The Lady Varnishes: Dorit Reiss Glosses Over Flaws in the Vaccine Injury Compensation Program Identified in a New Government Report

ReissNote: A new Government Accountability Office (GAO)  investigation highlights some of the shortcomings of the Vaccine Injury Compensation Program (VICP) .  AoA publishes David Foster’s submission to the pharma/government funded website Shot of Prevention in response to Dorit Reiss’s duplicitous review of the report.

By David Foster

Dorit Reiss has a history of glossing over vaccine safety issues so her approach taken here in commenting on a new GAO report [1,2] on the National Vaccine Injury Compensation program (NVICP) is not surprising. In the past she has used terms like "plaintiff-friendly", "reduced causation standards" and "relaxed evidence rules" to characterize this program. [3]  I would argue that no one who is actually familiar with this program, or has personally talked with anyone who has had the misfortune to endure it, would consider Dorit Reiss a credible source after reading these comments.

I postulate here that Dorit's conclusions regarding the NVICP are pre-ordained. I do not believe for a second that she had any intention of actually investigating the NVICP or reporting fairly on the GAO report. Why do I say that? Consider the following. She is commenting on a GAO report, and she includes the link to the report's summary in her article, in which she claims:

"Basically, the court removed the requirement of general causation: petitioners no longer have to show that there is scientific evidence supporting a causal connection. If there is a theory that sounds probable to the Special Masters – lawyers, not scientists – and a temporal connection, a case may win even absent scientific support. [...] But it is a very real relaxation of the petitioners’ burden to prove their case, allowing them to win, on occasion, with just a theory supported by one expert." [4]

As is always the case with Dorit Reiss, it is not necessarily what she says that is most important, but what she leaves out. In this case, she neglects to mention the following (which comes from the SUMMARY PAGE OF THE REPORT SHE IS COMMENTING ON):

"Since fiscal year 1999, HHS has added six vaccines to the vaccine injury table, but it has not added covered injuries associated with these vaccines to the table. This means that while individuals may file VICP claims for these vaccines, each petitioner must demonstrate that the vaccine that was administered caused the alleged injury. HHS is considering adding covered injuries associated with these vaccines; but as of September 2014, it had not published any final rules to do so."

Did you catch that?

The NVICP has a list of "Table Injuries" which is essentially a list of injuries for which HHS will presume causation, for each vaccine recommended by the Advisory Committee for Immunization Practices (ACIP). Don't you think it would be important to mention that HHS has neglected (I use that word very much on purpose) to add any new injuries to the table for ALL vaccines added since 1999? For the record, that is 15 years ago and in that time SIX new vaccines, most in multiple doses, have been added to the schedule.

In our online conversation Dorit claims that for "regular" (off-table) injuries "the requirement of general causation is basically waived". [3]  But this is not consistent with the following from the very GAO report she is supposedly commenting on: "Individuals seeking compensation may submit claims for injuries not listed on the table (called off-table injuries) but they need to demonstrate by the preponderance of the evidence that the vaccine caused the alleged injury."

Did you catch that?

Dorit portrays the NVICP as no-fault with relaxed standards of causation even for injuries not covered by the injury table, but this is not the case. For any injuries related to the last SIX vaccines added to the recommended list, plaintiffs are required to demonstrate causation.

In addition, there are two glaring problems I see with the GAO's report, and it does not surprise me one bit that Dorit fails to mention either of them. First, in the summary page under the heading "What GAO Found" [1], the text includes some quite flattering statements like: "In all but 1 year since fiscal year 2009, the program has met the target for the average time to adjudicate claims (about 3.5 years)". Now doesn't that sound like a tortured attempt to find something positive to say? And by the way, doesn't 3.5 years seem like an awful long time to compensate families of children who have died or were permanently disabled and require lifelong medical care?. But please go to the link for the summary [1] and look at the pie chart...the first thing that jumps out at you is that over half of all claims filed since 1999 have taken LONGER THAN 5 YEARS to adjudicate. That would seem like it merits reporting, either in the text of the GAO report or by the likes of Dorit Reiss.

My second problem with the GAO report involves the following two statements contained therein:

"Since fiscal year 1999, HHS has added six vaccines to the vaccine injury table, but it has not added covered injuries associated with these vaccines to the table." [1]

"HHS has authority to promulgate rules to modify the vaccine injury table when certain criteria are met. HHS is also required to amend the table to include a vaccine within 2 years of the Centers for Disease Control and Prevention’s recommending it for routine administration to children." [2]

I mentioned earlier that six vaccines have been added to the Table since 1999, but no injuries associated with those vaccines have been added. I would argue that having a requirement that HHS add a new vaccine to the Table within 2 years of being recommended by ACIP, but not requiring that any associated injuries be added as well, is absolutely meaningless. It's like a Speed Limit sign with no numbers on it. For all vaccines being recommended in the past 15 years, the NVICP no longer has reduced standards of causation, there is no presumed causation and the plaintiffs are instead required to prove causation. This requires expert testimony and can be very expensive.

Dorit Reiss is critical of a report from the AP [5] which claims that claimants are kept waiting by the NVICP. Perhaps if she actually interviewed folks who have been through the program, or looked at case reports, she would have a different understanding of the problems inherent to this program. Instead, she relies on...well...honestly we can't be sure what she relies on because as usual she does not reference the basis for any of her claims.

For example, while discussing a specific NVICP case highlighted in a Northwestern article which also discusses the AP report [6], she claims very matter-of-factly that seizures are not caused by DPT vaccine, but she admits that encephalophy can be caused by the DPT vaccine. See this is the sort of tortured logic that one has to endure when reading anything from Dorit Reiss. Why? Because seizures are one of the symptoms of encephalopathy: "Encephalitis generally begins with fever and headache. The symptoms rapidly worsen, and there may be seizures (fits), confusion, drowsiness and loss of consciousness, and even coma." [7]

This is sheer brilliance right! Because a vaccine can cause encephalopathy, but the encephalophy itself is what caused the seizures, the vaccine is not what caused the seizures. HHS and the CDC uses the same ridiculous logic to deny that any claims have been awarded for cases of autism.

I guess it would have been easier for me to refer to the NVICP Injury Table itself and simply point out that encephalopathy is listed as a "table injury" for DPT vaccine, and note that MRI scans showed brain damage following the vaccine and this suggests some form of encephalophy when seizures are involved.

In my online conversation with Dorit Reiss about the NVICP I had pointed out that the GAO report was critical of the NVICP in a number of ways. She denied this and asked me to please point out the criticisms. They are quite easy to find in the GAO report, as they are in fact the section sub-headings:

- Most Claims Filed Since Fiscal Year 1999 Have Taken Multiple Years to Adjudicate [over half have taken more than 5 years]

- Vaccines Have Been Added to the Vaccine Injury Table since Fiscal Year 1999 without Covered Injuries, Resulting in More Off-Table Claims

- Changes in the Vaccine Injury Table Contributed to More Claims for Off-Table Injuries and for Injuries in Adults

- Information on VICP Petitioner Experience Is Limited

I would argue that this last criticism is perhaps the most significant. For their report on the NVICP the AP conducted over 100 interviews of petitioners to learn about their experiences with this program. Perhaps that is why their report was so critical of the program. Even the GAO report was critical of the NVICP, although it was limited to considering institutional problems rather than the experiences of the petitioners themselves.

Perhaps it would be a good start if all of us, myself included, could stop calling these people "petitioners", and remember that those entering the NVICP are families that have either lost or must now care for a loved one after possibly suffering a severe adverse vaccine reaction in service to the "Greater Good".

David Foster is an IT engineer with BS degrees in Mathematics and Psychology, with respective emphasis on statistical methods and experimental design. He has been following vaccine safety issues for 20 years, first as an obsessive hobby and then as a parent.

[1] GAO Report (summary): http://www.gao.gov/products/GAO-15-142

[2] GAO Report (full): http://www.gao.gov/assets/670/667136.pdf

[3] Comments section of Interlochen Public Radio article "Whooping cough outbreak sparks vaccination debate"

    http://interlochenpublicradio.org/post/whooping-cough-outbreak-sparks-vaccination-debate#comment-1732826133

[4] The Vaccine Injury Compensation Program: What Does the AP Report Really Show?  -Dorit Reiss

    http://shotofprevention.com/2014/11/25/the-vaccine-injury-compensation-program-what-does-the-ap-report-really-show/

[5] AP IMPACT: 'Vaccine court' keeps claimants waiting

    http://news.yahoo.com/ap-impact-vaccine-court-keeps-claimants-waiting-183827288--finance.html

[6] AP IMPACT: 'Vaccine court' keeps claimants waiting

    http://www.thenorthwestern.com/story/news/2014/11/17/vaccine-court/19146311/

[7] What is encephalitis? What causes encephalitis?

    http://www.medicalnewstoday.com/articles/168997.php

[8] NVICP Vaccine Injury Table

    http://www.hrsa.gov/vaccinecompensation/vaccinetable.html

Comments

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Twyla

Vaccine Injury Claims Face Grueling Fight
Victims increasingly view U.S. compensation program as adversarial and tightfisted.
November 29, 2004|Myron Levin
http://articles.latimes.com/2004/nov/29/business/fi-vaccinecourt29

Cynthia Cournoyer

Why add anything to the table of injuries anyway? Most doctors will tell parents that no matter what they report, the vaccine didn't cause it. The push is to make vaccines safe by simply saying it is so. With the push to make the new ebola vaccine no fault, why not just do away with the court altogether? That would be what makers and governments would want in the long run. Just make a sweeping declaration that all vaccines are safe and/or for the greater good, therefore you do not have now, or will ever have a way to make anyone accountable.

Laura Hayes

Superb article, David. I will be sharing this one. A sincere thank you for all of your time, research, and effort that went into this...not to mention having to endure online "conversations" with Ms. Reiss.

Twyla

Thanks so much for writing this, and for your patience in examining Dorit's points. She often sounds so logical until one actually looks at the material she is referencing. Very few types of injury are on the HRSA table. And even for the table injuries, it's not true that no proof is required. If a toddler did not have a scan such as MRI to prove post-vaccine encephalitis, a claim for encephalitis might be turned down. When parents post comments saying that their baby suffered post-vaccine encephalitis, and list the symptoms such as high pitch screaming for hours and arching back, followed by loss of skills, the pro-vaccine commentators say that was just a bad case of colic, or that the mother didn't know how to calm her baby. If a parent was not aware of vaccine reactions at the time of a reaction, the parent may not have obtained necessary evidence at the time. And a court is certainly not going to concede a case based on the parents' recollections. If the baby's father is a neurologist and his/her mother is both nurse and attorney, it is likely that compelling evidence would be gathered, making concession an astute course of action. But for similar cases without that kind of evidence, the case will not be automatically accepted as Dorit would have us believe. Many people with autism have encephalitis, which is defined as inflammation in the brain.* But how many can prove that the encephalitis started with a round of vaccines? If it was really so easy to get compensation, more autism cases would be compensated. We don't have security camera videos showing footage of our children't brains at the time of the vaccines.

re: "has met the target for the average time to adjudicate claims (about 3.5 years)"
Who set that target? It's ok for a family to wait years for care to be funded as long as the average time is 3.5 years? If you sought medical treatment for your child, what would you think if your medical insurance company told you that, "We might pay your claim several years from now"? If you filed for social security disability benefits for your child, what would you think if the SSA admin said, "We'll let you know in a few years"? In exchange for giving up tort liability, with a jury trial and the possibility of huge awards for punitive damages and emotional distress, this system was supposed to provide efficient adjudication. Clearly it has failed in that.

*Brain inflammation a hallmark of autism, large-scale analysis shows
http://www.sciencedaily.com/releases/2014/12/141210073857.htm
“In the autism brains, the microglia appeared to be perpetually activated, with their genes for inflammation responses turned on. ‘This type of inflammation is not well understood, but it highlights the lack of current understanding about how innate immunity controls neural circuits,’ says Andrew West, Ph.D., an associate professor of neurology at the University of Alabama at Birmingham who was involved in the study.”

Neuroglial activation and neuroinflammation in the brain of patients with autism.
http://www.ncbi.nlm.nih.gov/pubmed/15546155

en·ceph·a·li·tis
enˌsefəˈlīdəs/
noun
inflammation of the brain, caused by infection or an allergic reaction

Anne J.

Great article and excellent points!
Whenever I see Dorit Reiss' name attached to a comment, I don't even bother to read it, because it's always the same BS. The sad thing is that people who don't know any better might actually believe some of the vile garbage she tries to put out there as fact (Though, I think so many people point out her obvious conflicts of interest, that her biases are usually transparent enough).

CD

I never read anything she or any of the other vaccine spin doctors (VSDs) have to say. I have them all blocked on social media so I can't see any of their comments. It's simply futile to have a discussion with any of the VSDs or to give their comments my attention. David, I applaud you for your effort....you're a more patient person than I am.

John Stone

"This is sheer brilliance right! Because a vaccine can cause encephalopathy, but the encephalophy itself is what caused the seizures, the vaccine is not what caused the seizures. HHS and the CDC uses the same ridiculous logic to deny that any claims have been awarded for cases of autism."

I have been over and over this with Reiss - if the encephalopathy had no effect what was being compensated? Or how would it work in criminal law? Someone shoots somebody so they are responsible the bullet entering body but not for the tissue damage or the loss of blood? These are unhinged arguments. Also, they are so transparently dumb as to be almost offensive. Really, it is like saying "I'm just trying waste everyone's time, but providing I keep talking most people won't notice".

Thanks, David, for this valuable contribution.

Danchi

I just ran across this in regards to Dorit on another site:

Dorit admits to her family’s owning Glaxo Smith Kline stock (She says she asked her husband.). http://articles.philly.com/2014-10-26/news/55451059_1_hpv-vaccine-hpv-shot-cervarix.

She was running point again for the hpv poison and this is part of the thread:


* DMH Dorit Reiss • 2 months ago

And what would be your conflicts of interest?

-Dorit Reiss DMH • 2 months ago

My family owns, as part of its portfolio, stock of GSK.

I found that out the first time I gave a talk about vaccines - when I looked into that. As a reason to speak up about this topic, from where I stand, it's pretty irrelevant.

What are yours?

*DMH Dorit Reiss • 2 months ago

You didn't know your family own GSK stock?
I have no conflicts.

-Dorit Reiss DMH • 2 months ago

Not until I looked into it. My husband handles our portfolio.

No conflicts? No case before NVICP? No work in alternative medicine, making money off selling alleged alternatives for vaccines?

*DMH Dorit Reiss • 2 months ago

So first you gave a talk about vaccines, then you looked into whether you had stock in a company that makes vaccines, then you became interested in vaccines. Gotcha.
In answer to your questions: no, no, and no.


-Dorit Reiss DMH • 2 months ago

No. First I started talking about vaccines on the internet. Then I wrote blog posts on the topic. Then I scheduled a panel on the topic with several colleagues. As preparation, I was asked if I had conflicts of interests. I knew of none. The form included "do you own stock in pharmaceutical companies". So I asked my husband if we had stock.

I hope that's clear.

-DMH Dorit Reiss • 2 months ago

So, you really should disclose this when arguing for vaccines.

No wonder Dorit is so bully for the HPV shot. She makes money. Every time a child is poisoned a $ shows up in her bank accounts. So as far as a legitimate investigation into the VICP, you can equate Dorit's investigation on the same level as the various grand jury investigations into police killings and abuse running rampant across the US. Her minions came to her rescue of course but how do you defend this kind of conflict of interest.

BoB Moffitt

Unfortunately .. the GAO's report on the NVCIP could just as easily been written about many flawed and failing government agencies meant to protect and serve the people of the United States.

Remember the recent VA scandals .. they were actually committing fraud by collecting bonusus for "hitting their target time" for treating veterans .. when in fact they were simply creating paper work to make it appear they were actually treating these veterans in a timely manner?

OR

NVICP's tampering by removing some troublesome "table injuries" while at the same time failing to provide any additions for vaccines added to the schedule .. sounds a lot like those who promised "if you like your health care insurance, you can keep your insurance .. "if you like your doctor, you can keep your doctor".

Remember .. Prof Gruber .. appearing before a hastily arranged Congressional Hearing? Gruber was quesioned .. under oath .. to explain his numerous vido-taped "candid" admissions wherein he stated the "lack of transparancy" afforded the "debate" over Obamacare was critical in having it pass .. simply because .. the American people were "too stupid" to understand what the reality of implementing Obamacare would cost them.

The really sad .. but .. expected response .. of those most responsible for passing Obamacare were outraged .. not because Gruber told the truth .. but .. that the truth was a "public relations" nightmare for them.

These are just two examples of many flawed .. entrenced government bureaucracies .. whose highest priorities are those that serve the best interest of their own bureaucracy .. rather than the best interests of the people they are sworn to protect and serve.

I suspect too many of these entrenched bureaucrats .. at the highest levels .. believe the American people are stupid.

Why so?

"This is sheer brilliance right! Because a vaccine can cause encephalopathy, but the encephalophy itself is what caused the seizures, the vaccine is not what caused the seizures. HHS and the CDC uses the same ridiculous logic to deny that any claims have been awarded for cases of autism."

I rest my case.

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