EECAP Blog

Developments, problems, and thoughts on the implementation of EEOICPA  

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 Sherrie Neff Memorial

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Radioactive Daughter

Thoughts on EEOICPA and America's history of atomic weapons

 

Ignoring the Evidence Scuttles Claim

 


A big part of an EEOICPA claim is proving that a worker’s illness was caused by his work at a covered nuclear weapons facility.  For Part E claims, according to EEOICPA Bulletin 08-38, if a DEEOIC Claims Examiner (CE) does not find a link in the Site Exposure Matrix (SEM) between the worker’s illness and his toxic exposure the CE sends a letter to a claimant stating that “available evidence does not demonstrate a known link between the condition being claimed and exposure to a toxic substance.”  The letter then gives the claimant 30 days to provide evidence making the link, although the claimant may request more time if needed.

There are two types of evidence a claimant may supply.  One is claim specific evidence, which includes things like additional medical records or doctor reports.  The other is what DOL calls Programmatic Evidence, which the Bulletin defines as being based on “studies that are occupational in nature, cover a statistically significant human population, and be published in a peer reviewed journal. This would include, for example, large-scale studies conducted by a university regarding occupational or environmental etiology.  Animal and environmental studies may also be useful in certain circumstances.”  08-38 also states that “Evidence not warranting a referral includes: 

  • unsubstantiated statements of causal relationship;
  • speculative or equivocal medical/specialist opinions;
  • scientific literature or other documents that do not provide reference to the illness under evaluation; and
  • general news articles from print or the Internet.”

The Bulletin also states that the CE MUST follow the guidance quoted above when evaluating Programmatic Evidence.  The Bulletin states that when such evidence is submitted, “If the evidence is of such a nature that it establishes, in a logical way, a causal relationship between a disease and an exposure, a review by the National Office toxicologist might be in order.  Similarly, if the opinion relates to a chemical about which little is known, a toxicologist review might be necessary.”

It makes good sense that a CE would request help evaluating whether a submitted study or evidence is applicable to a claim.  Medical studies are tricky for lay people to understand and it makes sense to have an expert to evaluate the evidence.  Without a medical background chances are someone will not be able to grasp a study in its entirety.

This was brought to mind last week when a very experienced advocate and Authorized Representative sent me a copy of a Recommended Decision she had received.

The Authorized Representative had sent the following peer reviewed studies to DEEOIC support of a claim she was working:

  1. Exocrine pancreatic pathology in female Harlan Sprague-Dawley rats after chronic treatment with 2,3,7,8-tetrachlorodibenzo-p-dioxin and dioxin-like compounds
  2.  Low-level arsenic impairs glucose-stimulated insulin secretion in pancreatic beta cells: involvement of cellular adaptive response to oxidative stress
  3. Cadmium exposure and cancer mortality in the Third National Health and Nutrition Examination Survey cohort
  4. Occupational exposures and pancreatic cancer: a meta-analysis
  5.  Chronic cadmium exposure in vitro causes acquisition of multiple tumor cell characteristics in human pancreatic epithelial cells
  6.  Occupations with increased risk of pancreatic cancer in the Swedish population

She also submitted:

  1.  Information from the well-respected Collaborative on Health and the Environment’s Toxicant and Disease Database on Pancreatic Cance
  2. US Government’s National Library of Medicine’s Hazardous Substances Data Bank fact sheet linking to an animal study connecting Cadmium Chloride to metallothionein synthesis in rat pancreases. (See what I mean about needing an expert’s evaluation of studies?)
  3. Hazmap’s Agents Results for toxins that can cause pancreatic cancer.  It is important to remember that HazMap is the only source of information that DEEOIC allows to supply information to their Site Exposure Matrix (SEM) that CEs use to evaluate claims’ exposure.
  4. The National Toxicology Program’s Final Report on Carcinogens Background Document on Formaldehyde

The Claims Examiner working this claim searched the SEM and found no links between the worker’s job and illnesses.  Although the Authorized Representative had submitted studies 1 and 2 neither of these were submitted to the DEEOIC toxicologist nor was any reason for this was given.  The claim was denied.  The Authorized Representative requested a hearing.  After the hearing the claim was remanded (sent back) to the Denver District Office requiring that “all new evidence, from the oral hearing. (along with the previously submitted articles) be forwarded to the DEEOIC Toxicologist and possibly the DEEOIC Medical Director and other policy makers, as outlined in EEOICPA Bulletin No 08-38”.  Seven questions were developed for the Toxicologist and submitted to the National Office for review.  The National Office Policy Branch (not the Toxicologist or Medical Director) instructed the Denver Office to limit the questions and “determined most of these articles were not sufficiently convincing to bring into question the scientific association between the diagnosed pancreatic cancer and toxic substance exposure.”

Ignoring the directive in the Remand Order, only studies 3 and 6 were submitted to the Toxicologist ignoring eight other pieces of evidence that the Remand Order had said needed to be reviewed by the DEEOIC Toxicologist.  Interestingly enough, one of the pieces of evidence the National Office Policy Branch determined was not acceptable was the printout from HazMap National Institute of Health website.  Hazmap is the only source of information for DEEOIC’s SEM.  The Policy Branch stated, about Hazmap: “This submission is an online list of data without any scientific validity or context.”

DEEOIC’s Toxicologist reviewed the two submitted studies and determined that they did not offer any additional proof of links between cadmium and pancreatic cancer and the claim was denied.

Who knows how different this might have been if DEEOIC had done what they were instructed to do in the Remand Order?  And if DEEOIC really considers HazMap without any scientific validity or context EEOICPA claimants are in REAL trouble.

 

 

 

 

 

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Hacked Off

Two separate computer security software firms, Invincea and Alien Vault, reported on May 1st that DEEOIC’s Site Exposure Matrix (SEM) public website had been hacked and malware was installed on the SEM webpage.  This was confirmed by DEEOIC.  Obviously this is very concerning to many claimants, advocates, and public users of the SEM.  I’m not a computer expert by any means, but I will try to explain the situation as I understand it. Be aware that the situation is still being uncovered and things may change.

The attack exploited a previously unknown vulnerability in Internet Explorer.  This is known as a zero-day attack because before this attack this vulnerability was unknown.  Microsoft confirmed that the vulnerability was in Internet Explorer 8 and says that versions 6, 7, 9 and 10 were immune to the attack.  It is thought that computers running Windows XP were the main target but other versions of Windows such as Vista and Windows 7 may be vulnerable as well.  At this point it looks like 9 other websites were attacked in the same way.

I believe this means if you are using a browser other than IE8 your computer could not have been affected by the malware, but as I said, I am no expert. 

At 10:56 AM EDT Terrie Barrie received an alert from Google News that the SEM had been hacked. Apparently DEEOIC received an alert about the same time. Terrie quickly contacted DEEOIC to let them know and verify the information. DEEOIC responded quickly (11:13 am EDT) that they were checking into it.  When she didn’t hear back from DEEOIC she sent out a notice, at 11:37 am EDT, to let people know there might be a problem.  One person receiving Terrie’s warning was on the SEM at the time the warning was received.  So we know the SEM was still available to the public until at least 11:37 am EDT.

So when did the attack actually occur? A report from URLQuery shows that the attack was first detected by their system on April 30, 2013 at 2:55 AM Central European Time which is 9:55 PM EDT on April 29th.  This report shows that the SEM webpage was infected from this time until May 1st at 11:46 AM EDT.  The 11:46 AM EDT time is about 45 minutes after Terrie asked DOL if there was a problem.  I want to thank Terrie for being so quick to let us all know of the problem.  This might well have been a lot worse if she hadn't taken action.

I’d also like to point out that Terrie is a volunteer who works to improve the implementation of EEOICPA.  DEEOIC is comprised of paid staff.  In my mind this makes Terrie the hero of the day.  She was under no obligation to notice the problem or let anyone know, but she did it because it was the right thing to do.

The SEM is currently offline and DEEOIC is working hard to resolve the problem.  I'm sure they will make the SEM available again as soon as they can assure its security.  EECAP thanks DEEOIC officials for keeping us updated on the situation.

However, this attack raises several important questions.  Who is in charge of DEEOIC’s cyber-security and how did they miss this attack?  Why did two private computer security firms find that the SEM website was infected and possibly spreading malware without DOL being aware of it?  We know that millions of dollars have been spent developing and maintaining the SEM and that Paragon Technical Services is the contractor who developed and maintains the SEM.  Is Paragon also in charge of cyber-security or does DOL have this responsibility?  Either way, why wasn’t the attack found sooner?  And most importantly how will DOL insure that such an attack is not missed in the future?


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More on DEEOIC Administrative Costs

Yesterday we took a look at how the DOL’s administrative cost of each Final Decision issued has risen.  Another picture is seen when you compare the DOL yearly administrative costs to the number of yearly claimant payments.  Over the past nine years the percentage of DOL administrative costs has decreased in Part B claims from 11% to 10%, with a hiccup in 2005 of 19%.  I would have expected the administrative costs of the Lump Sum Payments to be about the same as the Final Decisions since each Payment must first have a Final Decision issued, but this is not the case.  Again, as is often the case with DEEOIC’s statistics, I’m not sure why.  There may be a problem with the numbers or it may be something I just don’t understand.


But while Part B DOL administrative claim payment costs have decreased, Part E DOL administrative costs have increased from 18% to 25%. I would think that paying 25% of each payment in administrative costs is pretty high and I’m curious as to what is driving the costs.

The Part E chart below shows the cost per claim dropping in 2012.  I’m not confident that this is correct as the only reason for the drop is that the number of Final Decisions issued in 2012 was almost double what it was in 2010 and 2011.  This may well be because of the suspected problem with the 2012 statistics.  I’d hoped to hear back from DOL on this issue last week but that didn’t happen.  I’ll post the information here as soon as I hear from them.


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DOL Administrative Costs Rise-Why?

The old adage, “A picture’s worth a thousand words”, is even more necessary with numbers than it is with words.  I’ve spent the last week pouring over Department of Labor’s budgets and trying to make sense out of the EEOICPA data.  I don’t know about you, but I can’t keep several years’ worth of data in my head so instead I used the data to draw pictures.  Much easier on the brain!

So, what do the pictures tell us?  I’m not sure.  The statistics are all from DOL sources but not all DOL sources report the same numbers.  And I still haven’t heard back from DOL on what (or if) the problem is with the 2012 statistics.  Still there seems to be a clear trend shown here.

The charts below were made using DOL’s data on DOL’s yearly administrative costs and the number of Final Decisions issued each year.  With these I can compute how much DOL is spending each year on administrative costs for both a Part B and a Part E claim.  As you can see the administrative costs have been increasing over time.  While it’s a little hard to tell by the squiggly lines the straight red trend line clearly defines the upward trend.  These charts do not consider NIOSH’s costs.

I don’t have enough information available to explain why the costs have been rising.  I’ve asked DOL and will report back when I have an answer. 

The Part E chart below shows the cost per claim dropping in 2012.  I’m not confident that this is correct as the only reason for the drop is that the number of Final Decisions issued in 2012 was almost double what it was in 2010 and 2011.  This may well be because of the suspected problem with the 2012 statistics.  I’d hoped to hear back from DOL on what is going on with the 2012 statistics last week but that didn’t happen.  I’ll post the information here as soon as I hear from them.


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Did DEEOIC Mislead Us Again?


The March 27th Institute of Medicine’s (IOM) Review of the Department of Labor’s (DOL) Site Exposure Matrix (SEM) lists strengths and weaknesses of the SEM.  One of the strength’s discussed is:

Includes all DOE facilities covered by EEOICPA Part E, even those that are no longer in operation. The database lists 116 DOE sites and 4,122 RECA sites (DOL, 2012a; Stalnaker, 2012), including sites that have been closed for decades, such as Sacandaga Facility that was in use from 1947 to 1953 (DOE, 2012), sites that are currently being remediated under Superfund (Rocky Flats in Colorado and sites that are currently in operation such as Savannah River in South Carolina).” 

That does seem pretty great.  All DOE facilities have their own SEMs? Terrific!  Too bad it’s not true.  We’ll probably never know whether the person who passed this incorrect information to IOM was being misleading or just confused.  But it’s shameful that it happened.

Why is it important for a DOE site to have its own SEM?  Because the SEM is an important tool in EEOICPA claim development both for claimants and for DOL’s claims examiners.  It’s a good place to begin gathering evidence of what toxins a DOE worker might have been exposed to.  The majority of sites do have a SEM and workers from sites without a SEM are at a distinct disadvantage.

There are SEMs for 113 DOE sites plus a SEM for construction workers.  But it’s a far stretch to say that ALL DOE facilities are covered by SEM.  There are actually 40 DOE sites where workers are eligible for Part E coverage but do not have DOE Facilities SEMs.  That’s 65% of the sites, not 100%.  Big difference.  Especially if you are a worker or claims examiner working on one of the sites without a SEM.

But this story, as usual, is not that simple.  Some of the DOE facilities without SEMs actually have different SEMs with no link to the DOE SEMs.  Confusing?  YES! 

Time for some Show and Tell.

Let’s say the widow of a worker from the Climax Uranium Mill has filed a claim after her husband’s death.  She knows he worked for a DOE facility.  She goes to DOL’s SEM DOE Facility page and searches for “Climax Uranium”.  Nothing there.  However, if she had clicked on the button, “Show uranium mills” rather than the ”Show DOE facilities” button she might have found the information she was seeking after running through a confusing maze of drop-down menus.  I suspect that what happens to most people when they don’t find the site they were looking for on the DOE Facilities SEM is that they just give up.

This brings up another issue.  Except for the DOE Facilities SEMS, all the other SEMs are built backwards.  Rather than starting with the name of the site, you have to start with the state the site is in, and sometimes the county, and work back to the name of the site.  I suspect a moderately clever programmer could correct this easily.  Or at least provide a link between the DOE Facilities SEMs and uranium mills SEMs.  This was done with the Ore-buying stations.  You can find the DOE covered Ore-buying stations listed on both the DOE Facilities SEM and the Ore-buying station SEM.  They are linked together so the DOE site webpage takes you to the Ore-buying site webpage.

And this still leaves us with 23 DOE facilities without any SEMs at all.  Why in the world would DOL tell the IOM Committee that all DOE facilities have a SEM when it isn’t true?  Your guess is as good as mine. 

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How are the SEM and HazMap Related and Why should I care?


DOL, in its Response to the March 27th IOM Report, describes HazMap as the “database that forms the foundation for the causative links in the system.”  This is not putting it too strongly.  The Site Exposure Matrix (SEM) bases its illness/exposure data on HazMap data. In Terrie Barrie’s April 3rd blog, Terrie points out that Claims Examiners are not allowed to use anything in HazMap beyond what has been incorporated into SEM and asks why this is.

Although HazMap is used for SEM it was not designed for a compensation program.  HazMap contains only some the exposure information needed to evaluate toxic exposures of an EEOICPA claim since it contains only chemicals that cause an occupational illness.  HazMap is silent on whether chemicals can aggravate or contribute to illnesses.  And as we all know for an EEOICPA claim to be approved the claimant must prove that worker’s exposure to a toxic substance at work must have significantly “caused, aggravated, or contributed to” his illness.  By linking only causal agents to illnesses, HazMap begins the process by missing two thirds of the exposure links which need to be evaluated.

The March 27th IOM Report states that HazMap should “not be the sole source of such links for SEM” (page 76).  The IOM Report also made specific recommendations on what is needed for sources to provide scientific viable evidence for the SEM including:

  • Weight-of-evidence evaluations for occupational health effects and exposures
  • Peer review
  • Easy to use
  •  Transparent with methods clearly described
  • Field contents appropriately referenced Communicative so that toxic substance–disease linkages are clear and accessible to non-expert audience
  • Publicly available for free or minimal cos
  •  Is comprehensive.

The IOM Report also notes that HazMap lacks transparency in several crucial areas including,

  • Lack of formal criteria for determining the hazardous agent–occupational disease links
  • Lack of transparency about what information is reviewed, its sources, and how it is evaluate
  • Lack of peer review
  • Lack of adequate oversight or content review by external, independent experts because the Haz-Map developer is solely responsible for its conten
  • Lack of  disclaimer on the Haz-Map home page at NLM indicating that it is not peer-reviewed or that NLM is not responsible for its content
  • Relies heavily on textbooks, which are never peer reviewed

So why does it matter to a claimant trying to get an EEOICPA claim approved what is in HazMap?  It matters because HazMap feeds information into SEM.  If the information going into SEM is inadequate there is no way to evaluate if the information in SEM is valid.  If we don’t know if the SEM is valid or not, there is no way to evaluate whether a claim has been accurately determined. Claims Examiners can only use the information within the SEM.  They cannot use any of the sources HazMap uses or any of the other well-regarded, scientifically valid references available.  They can’t even use the references Hazmap uses. Their hands are tied unless they consult with costly experts to help them understand the claimant’s exposure and illness.

Other than describing HazMap as the foundation of SEM’s causal links, what does the DOL response to the IOM report say about HazMap?  DOL acknowledged that the IOM Committee provided recommendations for “data sources, in addition to Haz-Map, that could be utilized to provide a more comprehensive picture of the adverse effects that may be associated with exposure to the toxic substances.”  The Response also noted that the IOM report called for an Expert Advisory Board to “review of new links in SEM that are based on Haz-Map and supplemental information, and identify potential new links”. (The emphasis is mine.)  The above quote also neglected to mention that the IOM Committee strongly recommended the Expert Advisory Board be an External or Independent Board and called for a review of all links.

Because Hazmap is the foundation for proving exposure/illness links I agree it is imperative to follow the IOM Report’s recommendations and am glad DOL sees the seriousness of this issue.  However, just reviewing new SEM links will not be enough on its own to shore up the foundation.  It’s a systemic problem.  Fixing one or two minor glitches is not enough.  A foundation must be strong enough to hold up a building or the whole structure comes crashing down.  The IOM Report pointed out that the EEOICPA claims process has a shaky foundation at best.  And we all know what happens when you build on a shaky foundation.

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What's the Big Deal about Peer-Review?


The March 27, 2013 IOM Report talks a lot about how the SEM and HazMap need to be peer-reviewed.  What does “peer-review” mean and why is it important?

I’ll answer the last question first.  Without peer-review there is no way to determine if a source is valid or not.  A document which has not been peer-reviewed could be the truth or a fabrication.  There is no way to tell.  Pretty important, right?

The IOM Report gives the National Research Council’s definition of peer-review on page 45 of the report. Basically what it comes down to is “peer-review” is a way for independent experts in a field to review whether information being presented is factual and unbiased.  The peers doing the review need to have no conflict of interest and need to be free of bias from personal, work, or financial concerns.  One of the best known sources of peer reviewed medical research articles is PubMed.  This is a resource that many claimants and advocates turn to when they need to research links between occupational illnesses and toxic exposures.  These articles are then sent to DOL to evaluate whether they are useful for a specific claim. 

As we have seen in the IOM Report neither the Site Exposure Matrix (SEM) nor HazMap have been peer-reviewed.  The SEM contains information from HazMap on illness and exposure, as well as data from DOE on DOE facilities.  Evidence sent to DOL to be reviewed for the SEM is currently evaluated by Paragon Technologies, the contractor whom DOL pays to manage the SEM.  The information in HazMap is evaluated by Dr. Jay Brown, a Paragon contractor.

The IOM Report leaves no doubt that the SEM and HazMap, as SEM’s only source of illness/exposure information, need to be peer-reviewed. The report states peer-review is “critical if the SEM is to provide both DOL claims examiners and claimants with comprehensive, accurate, and understandable information.”  This is a very strongly worded recommendation and DEEOIC cannot afford to ignore it.  The report explains that the need for peer-review has increased over time because the “claims process has evolved and new claims have continued to be submitted to DOL”. (Page 10)

And the IOM Report points out that there is no need to reinvent the wheel on peer-reviewing SEM data as other agencies have already addressed the issue, “DOL need not develop its peer review process de novo. Other federal agencies (EPA in 2006 and the Office of Management and Budget in 2004) have prepared guidance on the peer review process for scientific documents. DOL may use this guidance for the SEM or require that Haz-Map use a similar process before the agency can import Haz-Map information into SEM.” (Page 105)

This is important and DOL needs to follow this guidance rather than try to cobble something together on its own.

And, as always, the IOM Report contains valuable suggestions of the approaches DOL might choose to use to accomplish its peer-review process, including the Independent Advisory Board reviewing the Contractor’s assessments of toxic substance evidence and an internal expert advisory panel assessing the toxic substance evidence and then having independent external experts review the internal expert advisory panels assessments.

The IOM Report also makes clear its thoughts about how this would best be done when it says, “the committee believes that the primary function of the advisory panel would be a peer review of its toxic substance–occupational disease links”. (Page 103)

What does the DOL Response say about the need for peer-reviewing of the SEM and HazMap?  DOL says, “There are a number of mechanisms through which OWCP could obtain the peer review recommended by the IOM. OWCP will determine whether it should obtain such peer review by contracting with a scientific or academic organization or another scientific or academic organization, by utilizing the services of scientific experts employed by other Federal agencies, or by creating a peer review process by individually selecting individuals with recognized scientific expertise to independently review the SEM.”

For the buzzword unenabled, OWCP is the Office of Worker Compensation Program, of which DEEOIC is a department.  So DOL is saying that OWCP will decide if the SEM/HazMap will be reviewed by a scientific or academic organization, or Federal agency employees or independent expert to do the review.  

It is good that DOL has agreed with the IOM for the need for a peer-review of SEM/HazMap.  However, neither DEEIOC nor the public will be served if DOL chooses to do a hidden review process using either federal employees, creating a new peer-review process from scratch or setting up and doing the peer-review process in a non-transparent way.  DEEOIC needs to be open and transparent about the process and follow the IOM Report’s recommendations.  And, it seems to me that an integral part of this will be involving help from an Independent Advisory Board.  This will go a long way in beginning to improve DEEOIC’s credibility.

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Was DEEOIC Confused or Misleading? Either Way Problems need to be Fixed

 

As we saw a few days ago the contract DOL made with IOM states that “the committee will identify strengths and weaknesses of the SEM and make recommendations for addressing any weakness.”  The IOM report goes into great detail on what needs to be done for the SEM to function as it was meant to.

IOM’s second recommendation was for improvements to the structure and function of the SEM. Terrie Barrie addressed some very important points from this in her April 3rd ANWAG Blog and as always gave clarity to the issues.  But what else did the IOM recommend for improving the SEM and how does DOL say the issues should be addressed?  Today I’ll just deal with just one—whether the National Library of Medicine is responsible for the data in the SEM.

The IOM Review pointed out that DOL is misleading the public and DEEOIC personnel about how the National Library of Medicine is involved with the SEM (Page 101).  This issue has been raised multiple times by the Alliance of Nuclear Workers Advocacy Groups (ANWAG) with DEEOIC continuing to insist that peer review of the SEM is not necessary because the National Library of Medicine (NLM) reviews it. 

On July 16, 2009 ANWAG and DOL had a tele-meeting in which Director Leiton answered questions from the advocates.  Ms Leiton stated, “…we rely on experts from National Library of Medicine (NLM) to review and confirm such links.” and, “Again, Hazmap is evaluated by NLM and the SEM disease linkages come from Hazmap. We depend on their expertise.” and, “We rely on Hazmap and NLM experts, as above. NLM provides a review process prior to publication of Haz-Map.”

The IOM Review of the SEM makes it clear that this is not true.

Far be it from me to try and decipher whether DEEOIC’s position on the NLM reviewing data in HazMap and the SEM is confused or misleading.  However, the IOM Report definitively answered the question.  HazMap and SEM have NOT been reviewed by the National Library of Medicine.  Nor has either of them has been peer-reviewed.  All NLM does is publish HazMap on their website and copyedit the agent profile fields.  For the SEM to stand up to scientific scrutiny the SEM needs to be peer reviewed rather than just being reviewed by one person.

If the SEM is not peer-reviewed is it scientifically viable?  If it is not scientifically viable then how can it meet the requirements for determining exposure under the law?  As we all know one of the determining factors for an EEOICPA claims is that it must be, “at least as likely as not that exposure to a toxic substance at a Department of Energy facility was a significant factor in aggravating, contributing to, or causing the illness”.  Where does this leave us if one of the main tools for determining this exposure is not based on peer reviewed science?

DEEOIC also needs to remove the misleading statements pointed out in the Report and properly train their staff on this issue. 

What did DOL say about either their confusion or misleading statements on NLM reviewing the SEM in their Response to the National Institute of Medicine’s Report?  Nothing.  Zip.  They didn’t discuss the issue.  They talked around it a bit when they said, “We recognize the value of a process for review of the SEM links and substances by a panel of scientific and medical experts. Over the course of the coming year, we will evaluate the options for developing such a process.”  But is this good enough for a department that was either confused about or making misleading statements?  There is enough wiggle room in the statement to allow no improvements to strengthen the SEM .  And that is not acceptable.  I hate to say it, but this is yet another reason that an Independent Advisory Board is necessary.  The changes recommended in the IOM Review need to be implemented, not “evaluated”. 

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What about that external Advisory Board?


As Terrie Barrie said in her March 30th blog, DEEOIC and the IOM report, Part 1 we’re working together to try to help the public understand the Institute of Medicine’s (IOM) report on DOL’s Site Exposure Matrix (SEM).  She gave us all a good history of the SEM, how it came about and what it was designed to do. So here goes on my first part!

I first heard that the Institute of Medicine  would review the Site Exposure Matrix on an October afternoon in 2011.  Terrie Barrie, Dr. David Manuta, Faye Vlieger, and I were meeting with DEEOIC Director Rachel Leiton, Acting Director Gary Steinberg, and DOL’s attorney Jeff Nesvit.  The meeting was scheduled after it came to light that DEEOIC was using Freddie Krueger and similar names to represent claimants in their Claims Examiner training manual.  Ms. Leiton sincerely apologized for the insulting names and the names were subsequently changed.  She then told us, as an example of how DEEOIC was working to improve the program, about the SEM review. When we reviewed the mission and reputation of the Institute of Medicine we were greatly pleased that such an august organization would be reviewing the SEM and offering their expert opinions on how the SEM could be improved to better serve claimants.

This report is now out and DEEOIC has responded to it.  According to the contract the IOM would “provide a scientific assessment to identify strengths and weaknesses of the SEM and make recommendations for addressing links to chemical usage/exposure.”  The total amount of this contract was $1,082,762 so it was a major outlay of money, but when DOL makes the improvements the review recommends it will probably save enough money to pay for itself as well as greatly improving the implementation of EEOICPA.

So for today, let’s take a look at one area of improvements the IOM Review recommends and what DOL is proposing to do.

The IOM report makes 3 “overarching” recommendations to improve the SEM.  Just for fun, let’s start with Number three.

RECOMMENDATION 3: Establish an expert advisory panel for the Site Exposure Matrix database.

The IOM report states: “the committee recommends that DOL establish an expert advisory panel. This is not the first time that such a panel has been suggested (e.g., 2010 GAO report; H.R. 1030), and there is a precedent for such a panel as required for EEOICPA Part B, that is, the Advisory Board on Radiation and Worker Health (see Chapter 3). The proposed EEOICPA Amendment Act of 2011 (H.R. 1030) would have required the president to establish an Advisory Board on Toxic Substances and Worker Health to review and approve the SEM.

An expert advisory panel could perform several important functions with regard to SEM, but the committee believes that the primary function of the advisory panel would be a peer review of its toxic substance–occupational disease links. The expert advisory panel should be broad based, external to DOL and its current SEM contractor, and its membership should include such expertise as epidemiology, occupational medicine, toxicology, and industrial hygiene. The committee also recommends that the advisory panel include claimants and advocacy organization representation.”

DOL’s press release addresses Recommendation 3 by stating: “We recognize the value of a process for review of the SEM links and substances by a panel of scientific and medical experts. Over the course of the coming year, we will evaluate the options for developing such a process. There are a number of mechanisms through which OWCP could obtain the peer review recommended by the IOM. OWCP will determine whether it should obtain such peer review by contracting with a scientific or academic organization or another scientific or academic organization, by utilizing the services of scientific experts employed by other Federal agencies, or by creating a peer review process by individually selecting individuals with recognized scientific expertise to independently review the SEM.”

So are how are the two statements the same and where do they differ?

IOM Recommendations

In the IOM Report

In the DOL Proposal

Peer review of its toxic substance–occupational disease links.

Yes

No

Broad based Expert Advisory Panel

Yes

No

Expert Advisory Panel external to DOL.

Yes

No

Expert Advisory Panel also external to current SEM contractor.

Yes

No

Membership should include experts in epidemiology, occupational, medicine, toxicology, industrial hygiene, claimants, advocacy organization representation.

Yes

No

Expert Advisory Panel  would establish the criteria for the evidence base for causal links between exposure to a toxic substance and an occupational disease.

Yes

No

Expert Advisory Panel  would determine the information sources that might be reviewed to identify information on possible links.

Yes

No

Expert Advisory Panel  would develop a worksheet or other documentation to capture the evidence taken from each information source, including Haz-Map.

Yes

No

Expert Advisory Panel  would oversee revisions of SEM to add appropriate fields for capturing supplemental information.

Yes

No

Expert Advisory Panel  would peer review all new links in SEM that are based on both Haz-Map and the supplemental information.

Yes

No

Expert Advisory Panel  would assess occupational diseases that might result from complex exposures.

Yes

No

Expert Advisory Panel  would identify potential new links and track them for possible future inclusion in SEM.

Yes

No

Expert Advisory Panel  would review existing causal links in SEM that are based solely on Haz-Map.

Yes

No

Expert Advisory Panel  would do periodic review of a sample of the toxic substance–disease links from both accepted and rejected claims to determine whether SEM links are actually assisting in the claims process.

Yes

No

 

DOL Press Release

In the IOM Report

In the DOL Proposal

DOL suggests having a panel of unnamed scientific and medical experts review the SEM links and substances.

No

Yes

DOL suggests possibly contracting with an unnamed scientific or academic organization to do the work.

No

Yes

DOL suggests possibly utilizing the services of scientific experts employed by other Federal agencies to do the work.

No

Yes

DOL suggests possibly creating a peer review process by unnamed individuals with recognized scientific expertise to independently review the SEM.  Didn’t IOM just do this?

No

Yes

So what can we observe from the differences? 

  1. The IOM report makes very detailed recommendations which would improve the SEM’s accuracy.
  2.  DOL makes vague suggestions that they might or might not want to act on.
  3. IOM finds major issues that need to be corrected for the SEM to do what it was meant to do.
  4. DOL does not see a need for any major corrections to the SEM.
  5. IOM recommended an EXTERNAL advisory board.
  6. DOL would prefer to do the work in house or by individuals of their choosing.
  7. IOM recommended claimants and advocates be part of the advisory board.
  8. DOL did not discuss a place for claimants and advocates on the advisory board.

I’m afraid that I think as Terrie does that it feels like DEEOIC would rather stick with the status quo than make the improvements the IOM report recommends.  I’ve been wrong before and I hope I’m wrong this time.  The contract for the IOM report was for over a million dollars if used in its totality.  It seems to me that after spending that much money it would be a terrible waste to just sweep the report under a rug.  SEM needs to be improved to function as it was meant to.  The IOM is not some Mickey Mouse organization to be ignored.  We need to listen to them and DEEOIC needs to enact their recommendations.  I suspect that doing so will end up saving money in the long run.  I’m sure an external advisory board will result in savings.

 

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