The Cover Up Exsposed.

These attached files detail changes to the 2004/5 ESR blood serum dioxin study, that mean the final study was not that described to participants, to gain 'informed consent'. The Taranaki Ethics Committee was mislead over the changes and later the Central Regional Ethics was mislead/deceived over those changes. Both ESR and MoH staff were involved in replying to the Central Regional Ethics Committee and it is clear their actions were intentional. The effect of 'data manipulation' and the changes which breach the ethics agreement, was to downplay historic peak exposures and reported 2005 average levels for the 52 participants. This issue was raised with the Attorney General and Minister of Health on 7.10.2005, noting probable breaches of Nuremberg Code and the Crimes Act. The reply of the Minister of Health dated 11.11.2005 is incorrect, the study was changed and as recognized in June 2007 exposues were most intense prior to 1974. The study was on levels of a toxin known to cause injury and death. There is evidence of manipulation of data to downplay those exposures and that this was intentionally concealled.
Working Draft ; 31.7.2008:The Paritutu Blood Serum Dioxin Study, Altered, Manipulated, and Downplayed.The Honorable Pete Hodgson denies a cover up, yet,The Taranaki and Central Regional Ethics Committee were mislead,the Hon Pete Hodgson refuses to correct his flawed denial and misleading reply of 11.11.2005, which was tabled in Parliament 26.10.2006, documents appear to have been withheld from the Health Select Committee ,and even after the second peer reviews, seven of the eight identified key misrepresentations of data in the 2004/2005 ESR / MoH blood serum study remain uncorrected as at 29.7.2008.After ESR Part I results were received, the serum study methodology, objective, participant selection criteria and purpose were altered, against it's original purpose, as stated in "informed consent" documents to participants and in the original tender document. Ex ESR staff wrote to the Ministry of Health opposing these changes, however the changes were then implemented.
(A) 1. The purpose of the study as stated in the tender document was " to collect and analyse samples of blood serum from selected past and current residents of Paritutu to ascertain possible exposure to dioxins, (foremostly 2,3,7,8 TCDD), related to the historical activities of Dow AgroSciences (formerly operating as IWD) in manufacturing 2,4,5-T at the Paritutu site....In particular, this is to assess the levels of dioxin (esp 2,3,7,8 TCDD) in the blood serum of a group of Paritutu residents living in close proximity to the IWD factory at suspected peak emission times, and therefore most likely to have been highly exposed. Comparisons will be made between this group's results and comparable strata from the 1998 Mfe serum survey."ESR to Ministry of Health.
(B) ESR letter to Serum study applicants, 1 September 2003;"It is very important that the correct group of people is selected for blood testing. These are people *most likely to have had the *greatest exposure to possible dioxin emissions.""Past or current residents of Paritutu *most likely to have had *greatest exposure will be given priority for testing."(*in italics in original letter)ESR to Study Applicants
(C) MoH Media release 10 March 2005;"Director of Public Health, Dr Mark Jacobs said the study deliberately concentrated on people calculated to be the most exposed to dioxins."
(D) 16. The Organochlorines Technical Advisory Group (OTAG) met in November and recommended this two-stage testing procedure with those most likely to be most highly exposed and to show a statistically meaningful result as a group tested first. If this group does show elevated levels of dioxin, then OTAG will reconvene to review the selection criteria and select a second group of people in the most exposed group to be tested. If the blood levels are not elevated then the study will conclude at this point. Health Report; 6.4.2004
(E) ESR Appendix B.Air Dispersion Modelling and Preliminary Assessment of Exposures.5.3 OVERVIEW SUMMARY, page 49.Neither the emissions that have been estimated to have occurred since 1975 from both incinerators, nor the bursting disc release in 1986 can account for the concentrations of 2378-TCDD measured in soils in the vicinity of the IWD plant. The 2378-TCDD emissions that the air-grass-soil pathway modeling suggests would be needed to account for the approximately 30 ng/kg concentration measured in soil at the top of Mt Moturoa are about 150 times the maximum estimates of emissions from both incinerators since 1975 and the bursting disc releases in 1986.Accordingly, it appears necessary to invoke very high 2378-TCDD emissions during the earlier operations of the plant. It is widely expected that the processes were not well controlled from an emissions perspective and the levels of 2378-TCDD contamination in 2,4,5-T produced at the plant are generally considered to have been very much higher during the early period of production. Accordingly it appears credible that the very large 2378-TCDD emissions that are evidently required to account for soil concentrations measured may have in fact occurred.Multipathway Assessment of Exposures from Dioxin Releases in the Paritutu Area. prepared by Air and Environmental Sciences LtdESR 2004 Interim Report,
(F) 2.5. Selection of candidates for Serum TestingObjective: To use predictions of individual TCDD intake, combined with estimated age/sex specific TCDD elimination rates, to derive a list of individuals having the best chance of showing elevations in serum TCDD in 2004 from an exposure *30-40 years ago, in comparison with national averages and estimated variances for the individual age/sex data."page 7.*(1964-1974)
(G) 15. This first group were selected based on their ranking and their homogeneity as a group. Consideration for selection of this group included age, years exposed, gender, soil levels and homegrown poultry and egg consumption. It is expected that if there has been additional exposure above background of the Paritutu community this group will show a statistically significant elevated result compared to the average New Zealand result.Health Report; 6.4.2004
(H) 2. The indicative sample size calculation, based on required power and on anticipated differences between certain groups was 50. It was anticipated that this sample would enable us to observe differences of a certain (statistically significant) magnitude in various age groups. We were subsequently directed by yourselves to divide this into two parts; in the first instance targeting a smaller subgroup with the highest probability of showing an effect should, there be any. The anticipation being at that time that it would require all 50 samples to show a significant effect.ESR to Ministry of Health 2.8.04, 01:43 pmSELECTION OF PARTICIPANTS
(I) January 2007 Ministry of Health:"A potentially highly exposed group of current and former residents were identified from a self selected sample of the population the location and years of residence in relation to various time periods between 1962 and 1987." Summary of Paritutu Serum Dioxin Study (2005):
(J) ESR 2005, page i;Methods"Individuals were selected for testing based on spatial, toxicokinetic, and multi pathway exposure modelling, particularly individuals from different residential periods in order to determine the timing and extent of exposure to airborne emissions of TCDD. The exposure model considered the location and years of residence in relation to various time periods between 1962 and 1987""A second round of testing was conducted in October 2004, the primary purpose being to ascertain the role of more recent years of relevant residence (over the 1972-1986 period) on individual TCDD levels. Twenty-eight participants were selected from the data base (excluding those with occupational exposure) based on age, gender and SURROGATE EXPOSURE VALUES using modelled TCDD soil concentrations and years of residence." Deborah Read Chair Organochlorines Technical Advisory Group (OTAG),
(K) 28.11.2006;�Prior to the study being carried out it had been assumed that based on the production volumes of 2,4,5-T and it�s level of dioxin contamination that 1962-1972 was likely to be the time period of greatest exposure to fugitive emissions. This conclusion was not supported by the blood results from the first 24 people tested.��Consequently study participants for *the second round of serum testing chosen by ESR were the potentially most highly exposed individuals identified from spatial, toxicokinetic and multipathway exposure modelling who lived in Paritutu post 1973.�
(L) ESR to Sally Gilbert, Ministry of Health, 02/08/04 01:43 pm3. The differences between observed and anticipated in the first set of samples were much bigger than anticipated such that the central research question has been answered, and as such, there would appear no justification to sample further residents.5. The results were as you mentioned discussed at OTAG and again, as you say, the advice to the Ministry was that the study be completed before any results are given to participants. We believe, for the reasons outlined above, the study is complete.
(M) Subsequently the second round of blood serum testing retargeted onto those predicted to be least likely to be exposed, this required a change in methodology, SURROGATE EXPOSURE VALUES were used, as the peer reviewed and previously used modelled exposures predicted the post 1974 population to have LOW EXPOSURE. A Gibbs, 2008 (N) 30/7/04 04:22pm"I have been mulling over our chat about the serum dioxin study and your concern that you may not be meeting the requirements of your ethical approval.""I wonder if this has arisen because we have broken the collection and analysis of bloods into two groups, when originally we envisaged that the collection and analysis would all be done in one group? I am not sure how your ethical approval is worded....""I had understood from the OTAG meeting that we cannot adequately interpret the results and what they mean (especially around the time of exposure and therefore the initial burden of exposure and so the subsequent potential health risks) until we have completed the study?""If you do find the wording of the ethics approval is still a concern, you may need to go back to the Ethics Committee to explain the methodology has changed and the wording of the approval may need to be revised to refer to advising the participants (and community and stakeholders) of the results of the study within two months of the results of analysis being available. I strongly recommend you take the chair of OTAG with you to such a meeting so OTAG's advice can be provided and queries answered."Sally Gilbert Team Leader (Environment Team)Environmental HealthPublic Health ProgrammesPublic Health DirectorateMinistry of HealthESR to MoH , 30.7.04 ESR, 14 September 2004
(O) Attn: Catherine Quin (Chair)Taranaki Regional Ethics Committee"Update on Study TRK/03/05/014In accordance with our ethical agreement for the above study, I am writing to inform the committee that we have completed a round of blood sampling and serum testing, which was to target those individuals whom, according to modeled estimates, were most likely to exhibit elevated serum TCDD (dioxin) levels in 2004 if significant exposures were to have occurred. As you probably know, the result of this testing was that there was clear evidence that TCDD exposures had indeed occurred sometime in the past in many of these residents.A decision has been made by the Ministry of Health to continue with further serum testing in the Paritutu community. This is predominantly to address residual questions to do with time periods of exposure. As such, ESR has been asked to sample up to 29 additional individuals. These individuals include seven whom tried to give blood in the last round of testing, but were unable to do so due to medical reasons, or could not be reached at that time. An additional 22 individuals have been identified whom we believe will help us shed light on the question of when the exposures must have happened. We will try to include several (3-4) 'replacement' subjects in anticipation that we will not successfully obtain blood from all 22 of those selected. The results from the next group for testing will be incorporated into a final report to the Ministry of Health which will replace the interim report now available on the internet. *All other methodological aspects of this next phase of testing would be exactly as outlined in the original ethics application, the only exception being that we would no longer propose to include polychlorinated biphenyls (PCBs) in these blood samples as there was no evidence of any increase in PCB levels in the Paritutu subjects (and this reduces the analytical cost substantially.From my understanding, the above-mentioned proposal would constitute an 'add-on' to the existing ethics application. I would like to seek the Committee's approval for such an add-on to be granted as we need to make sure this further testing is completed as soon as possible.In the last round of testing, all of the study participants were met by a scientist from ESR and a public health professional prior to the public release of information. During this visit, individuals received their own individual test results, a copy of the report, a voucher for a free GP visit, answers to anticipated questions, and some general information regarding dioxin. Everyone of us who went to see the participants said it was a positive experience.As before, we will undertake every effort to ensure that individual participants receive their own individual results directly from us, prior to any media release, and in the presence of a public health professional and / or an advocate. We found that this worked well with the previous group of participants, and will appreciate the Committee's guidance about how that process might be improved.I would like to express my personal gratitude for the Committee's support and advice to date in what has been a challenging project." On the 16th September 2004, the chair of the Taranaki Regional Ethics Committee,
(P) Catherine Quin wrote to ESR, "The collection and analysis of blood serum in a selected population to investigate serum dioxin levels in residents who live, or have lived, near the former Ivon Watkins Dow.Investigators: Dr David Philips, Dr Jefferson Fowles, Virginia Baker, Felicity MarriotEthics Reference: TRK/03/05/014The committee met and discussed your 'add on' request to the above study at our meeting held on 15 September 2004. Approval has been granted for this 'add on', however, the committee would like to have the following included in the study:That the local Health & Disability Advocate is part of the process when making decisions about giving the results information to participants. That is, it is not envisaged that she be present when you give results information to 29 participants, (that may be impossible for one person), but she be included in the decision making process.Further it was noted that your next study might be on a family health survey of these participants. That is, a review to establish what, if any, members of these families have medical conditions such as cancer, multiple sclerosis, motor neurone disease, birth defects, etc.AccreditationThis Committee is accredited by the Health Research Council and is constituted and operates in accordance with the Operational Standards for Ethics Committees, March 2002.ReportsThe study is approved until 9 January 2004. A Final Report is required for this study at the conclusion date. You will be sent a form requesting this information prior to 9 January *2004 (*2005?). You can seek an extension if such is necessary. Please note that failure to complete and return this form may result in the withdrawal of ethical approval.AmendmentsAll amendments to the study must be advised to the Committee prior to the implementation, except in the case where immediate implementation is required for reasons of safety. In such cases the committee must be notified as soon as possible of the change."A year later the new Ethics Committee were mislead by ESR and MoH staff.A year later ESR staff and Sally Gilbert from the MoH told the Central Regional Ethics Committee the Part II methodology had not changed, in fact the methodology had been changed, along with the study objective and purpose.ESR staff and Sally Gilbert from the MoH told the Central Regional Ethics Committee the Part II study was not an "add-on", yet on the 14.9.2004 ESR staff had told the Taranaki Ethics Committee "From my understanding, the above-mentioned proposal would constitute an 'add-on' to the existing ethics application. I would like to seek the Committee's approval for such an add-on to be granted as we need to make sure this further testing is completed as soon as possible."ESR to Sally Gilbert, Ministry of Health, 02/08/04 01:43 pm8. The course of action currently proposed raises, as I mentioned to you, a number of concerns, particularly in relation to our existing commitments and obligations, plus some significant challenges for further testing, in particular:. A follow up study as proposed, involves a DIFFERENT OBJECTIVE and hence a DIFFERENT PURPOSIVE SAMPLING DESIGN and PARTICIPANT SELECTION CRITERIA. IT WOULD BE POTENTIALLY MISLEADING FOR THE RESULTS FROM THE TWO STUDIES TO BE COMBINED. (Q) email ESR to MoH, 26/8/05 02:30 pm <<>>ETHICS QUESTION2. On 16 September 2004 the Chair of the Taranaki committee approved the add-on study, with the proviso that the Health and Disability Advocate be involved in the decision making about feedback to participants of results (not as Dr Phillips indicated, to be involved in actually giving feedback to participants. Given that there were several months between conception of the add-on study and the results feedback period, why was the input of the H&Dis advocate not sought?ESR RESPONSE2. Part 2 of the study was a continuation of the study, not an add-on.The study had always intended to take sera from around 50 participants for analysis. The methodology for Part 2 was the same as Part 1, however The elevated results gained from the first round of testing meant that the results of the study assumed more political significance.
(R) email ESR to MoH, 30/8/05 05:07 pm "Dear Sally,has asked me to reply to your recent email.Thank you for your very helpful comments on the draft responses to the Ethics Committee questions. I think they are most useful in clarifying the issues.I have accepted all your suggested changes in the document."<<>>2. On 16 September 2004 the Chair of the Taranaki committee approved the add-on study, with the proviso that the Health and Disability Advocate be involved in the decision making about feedback to participants of results (not as Dr Phillips indicated, to be involved in actually giving feedback to participants. Given that there were several months between conception of the add-on study and the results feedback period, why was the input of the H&Dis advocate not sought?ESR / MoH RESPONSE2. Part 2 of the study was a continuation of the study, not an add-on study.The study had always intended to take sera from around 50 participants for analysis. The methodology for Part 2 was the same as Part 1. The information and elevated results gained from the first round of testing meant that the results of the study assumed more significance.The Ministry of Health / OTAG midstream changes to the study meant the final study significantly differed to that described, to gain "informed consent" from study paticipants. The objective and methodology of Part II was in fact changed after Part I; (S) Selection of Candidates for Serum Testing, Phase II2.51 Part IPart I Objective: To use predictions of individual TCDD intake, combined with estimated age/sex specific TCDD elimination rates, to derive a list of individuals having the best chance of showing any possible elevations in serum TCDD in 2004 from potential exposures beginning from 1962, in comparisons with national averages and estimated variances for the individual age/sex strata.Part I Method: The sum of residential inhalation and dietary intake exposures based on modelled air concentrations of TCDD as described in the multipathway exposure model (above). Subsequently, age/sex specific elimination rates were applied (see toxicokinetic model above), based on assumed TCDD emission period between 1962-1975. Relative TCDD emission rates over the period corresponded to the reported annual production of 2,4,5-T herbicide at the IWD plant.ESR February 2005, page 10.2.52 Part IIPart II Objective: A second round of testing was conducted in October 2004. The four participants who were unable to give blood in part I were invited to give blood in Part II.New participants were selected from the data base, using the same exclusion criteria as described in Part I. The objective of Part II was to select participants from the younger age groups with greatest exposure during the later years of plant operation. people with exposure in 1973 or earlier were excluded from Part II sampling. Part II Method: Surrogate exposure values were calculated for each participant using the following formula:. Soil TCDD (ppt) at location* years at that location (between 1974 and 1987)= exposure surrogate value (ppt-years)......ESR February 2005, page 11.As well as the objective and methodology, the study purpose was also changed after Part I.
(A) 1. The purpose of the study as stated in the tender document was "....In particular, this is to assess the levels of dioxin (esp 2,3,7,8 TCDD) in the blood serum of a group of Paritutu residents living in close proximity to the IWD factory at suspected peak emission times, and therefore most likely to have been highly exposed...."ESR to Ministry of Health 02/08/04 01:43 (C) MoH Media release 10 March 2005;"Director of Public Health, Dr Mark Jacobs said the study deliberately concentrated on people calculated to be the most exposed to dioxins."Ministry of Health 10.3.2005.
(D) 16. The Organochlorines Technical Advisory Group (OTAG) met in November and recommended this two-stage testing procedure with those most likely to be most highly exposed and to show a statistically meaningful result as a group tested first. If this group does show elevated levels of dioxin, then OTAG will reconvene to review the selection criteria and *select a second group of people in the most exposed group to be tested. If the blood levels are not elevated then the study will conclude at this point. Health Report; 6.4.2004*In fact, Part II, post 1974 participants selected were predicted to be a low exposure group.This was confirmed by the result from the Part II group, which did not show a "statistically significant" elevation.
(K) "A second round of testing was conducted in October 2004, the primary purpose being to ascertain the role of more recent years of relevant residence (over the 1972-1986 period) on individual TCDD levels. Twenty-eight participants were selected from the data base (excluding those with occupational exposure) based on age, gender and SURROGATE EXPOSURE VALUES using modelled TCDD soil concentrations and years of residence."Ministry of Health to Hon Minister O'Connor, 03/09/04 04:22 pm"The following is a summary of Ministry of Health approach and a chronology of the events in Paritutu.""Decisions on any further activity/assistance for the community will await the completion of the study that is expected to have occurred before the end of the year, this involves the testing of a further group of about 20 people, as has been *agreed with the community and endorsed by the Organochlorine Technical Advisory Group."(*The Community had not agreed, nor was it informed of, or consulted over changes to the study purpose, participant selection criteria, and the peer reviewed methodology.Serum study tender documents note,�Building in of exit / reassessment points based on acceptability of the project to the community and scientific validity.�) On the 7.10.2005, 13:12 and 13:13 the Attorney General and Minister of Health, the Hon Pete Hodgson were faxed;
(T) Re: Paritutu Serum Dioxin StudyReview of Part I and Part II of the above study have revealed a pattern of data manipulation consistent with an orchestrated attempt to conceal pre 1974 exposure and mislead the affected community over the true historic exposure levels.Particularly the altered years of residence for the 14ppt TCDD 64+ female (short term resident), also anomalies in the 64+ male and female groups.The Part II 50-64 female group also appears to be biased upwards by the inclusion of the 17.9ppt TCDD subject who had a level 5 fold the average of the other 6 subjects in that group.The exposure curves when corrected point to a pre 1974 peak which matches elevated levels *at (typo*of) Neural Tube Defects in Paritutu.There are clearly probable breaches of Nuremberg Code and the Crimes Act: Andrew Gordon GibbsMinister of Health, the Hon Pete Hodgson replied, 11.11.2005;
(U) "Thank you for your letter of 7 October 2005 about the Paritutu Dioxin Serum Study. I do not accept your contention that the study results were in some way fraudulent.I have every confidence in the Integrity of Environmental Science and Research (ESR) and the process followed in the study. This process included community consultation about participant selection, the use of a laboratory accredited by the World Health Organization, and external and independent peer review. The laboratory was selected according to recommendations made by the Paritutu community, and the peer reviewers included organizations nominated by the community.You raise some specific concerns about the study data. The study results were, obviously,* unknown at the time participants were selected, meaning that selection could not have been biased in the way you suggest. Also ESR's report clearly states that the time of exposure is not certain. Exposure times are postulated, based on the evidence in the report.Thank you for writing." ESR to Sally Gilbert, Ministry of Health, 02/08/04 01:43 pm. A follow up study as proposed, involves a DIFFERENT OBJECTIVE and hence a DIFFERENT PURPOSIVE SAMPLING DESIGN and PARTICIPANT SELECTION CRITERIA. IT WOULD BE POTENTIALLY MISLEADING FOR THE RESULTS FROM THE TWO STUDIES TO BE COMBINED.*The Minister's reply is not correct, the participant selection had in fact changed after Part I results were received. The 7.10.2005 fax to the Attorney General, cc to the Hon Pete Hodgson and the 11.11.2005 reply from the Hon Pete Hodgson were tabled in Parliament 26.10.2006. The Hon Pete Hodgson, was subsequently made aware his reply was flawed and not in fact correct, yet he still refused to correct it, "In my last letter of 4 September 2007 to you I made it clear that I am not going to entertain allegations of a Government "cover up" including any sort of "data manipulation" in this matter. Your continuing allegations on this theme are misdirected and are failing to assist progress the Government is trying to make on the basis of known facts."Hon P Hodgson 9.10.2007The evidence in the reports was, the group with pre 1974 exposures had "statistically significant" elevations, the Part II post 1974 group did not.The two data sets were combined, although the Ministry had been warned by the ESR that, "IT WOULD BE POTENTIALLY MISLEADING FOR THE RESULTS FROM THE TWO STUDIES TO BE COMBINED."Data had been manipulated to conceal the combining of two differing data sets which downplayed the average for the 52 participants, also back calculations of peak exposure were downplayed by only back calculating to 1987 not 1974 or earlier. "26.10.2006Parliamentry Questions for Oral AnswerParitutu Dioxin Serum Study-Errors7. TARIANA TURIA (Co-Leader-Maori Party) to the MINISTER of HEALTH:What advice has the Minister received about the nature of the significant errors identified by independent forensic accountant John Leonard in the Ministry of Health's Paritutu dioxin serum study?Hon PETE HODGSON (Minister of Health): I have received advice that the report of the forensic accountant contradicts the findings of the study conducted by Environmental Science and Research that was peer reviewed by scientists at the United States Centers for Disease Control, The Norwegian Institute of Public Health, Massey University New Zealand, and Hatfield Consultants in Canada. However John Leonard has made serious claims and I have instructed the Ministry of Health to have his report independently reviewed. I can advise the house that this review will be carried out by Dr Allan Smith of the University of California at Berkeley.Turiana Turia: Why did the Minister fail to investigate the serious anomalies with the Paritutu dioxin serum study 1 year ago when they were brought to his attention in a letter dated 7 October 2005?Hon PETE HODGSON: I receive some thousands of letters a year and I am afraid I do not recall that one. But I will say the Government has every interest in making sure that accurate information is made available to the people of Paritutu and indeed to the wider public.Barbara Stewart: Has his Ministry considered carrying out DNA tests, similar to those on Agent Orange victims, in order to conclusively identify the effects of exposure to dioxin; if not, why not?Hon PETE HODGSON: My understanding, and I am going from memory, is that Dr Neil Pearce from Massey University is conducting further investigations into various chemicals, including dioxin, and that attached to his study are some DNA disruption studies.Maryan Street: How does the Minister respond to claims that anonymised data from individual patients was withheld from the international peer reviewers of the Environmental Research and Science report, and does he agree that these claims are very serious?Hon PETE HODGSON: I do agree that they are serious claims, and am pleased therefore to inform the house that they are wrong. The anonymised data in question was provided to the international peer reviewers. It has so far been withheld from public release, due to privacy concerns from some in the community and from the ethics committee that approved the study. Regardless, serious claims have been made about the Environmental Science and Research report and I have, as I said in my primary answer, instructed the Ministry of Health to analyse them and respond as soon as possible.""Tariana Turia: What has changed between October 2005, when the Minister denied in writing that there was any evidence of data manipulation to cover up dioxin exposure levels, and the New Zealand Press Association's report of Tuesday, 24 October, in which the Minister is quoted as saying: "It's clear that there's room for doubt so we better have another look at it..."?Hon PETE HODGSON: What has changed is that there was a very long television programme, which spent a long time telling the public of New Zealand that a gentleman thinks there has been a mistake. The gentleman raises valid questions. The fact that he did not know that this stuff has already been peer reviewed several times is perhaps a reflection on the television company. Nonetheless, valid questions have been raised, and we will take another look at the issue.""Tariana Turia: Will the Minister now undertake to review the Taranaki District Health Board's August 2002 birth defects study, as was recommended, in light of the new evidence in John Leonard's report?Hon PETE HODGSON: If the evidence in John Leonard's report stacks up when reviewed by Dr Allan Smith of the University of California at Berkeley, then I think that the Government does need to consider Dr Smith's report when it is received.Tariana Turia: I seek leave to table a letter of 7 October 2005 from Andrew Gibbs to the Hon Pete Hodgson, and a letter from the Hon Pete Hodgson to Andrew Gibbs in response to Mr Gibbs letter of 7 October 2005." On the 29.9.2006, copies of all correspondence between Crown Research Institute (ESR) and the Taranaki Regional Ethics Committee were requested under the Official Information Act.On the 26.10.2006 the reply from ESR informed that under Section 15A of the Act, an extension of 2 weeks from the 26.10.2006 was required to comply with the request. On the 6.11.2006 ESR replied by Facsimile,"Further to #### #####�s letter dated 26 October 2006 and my telephone call on 3rd November 2006, we wish to advise that we are still locating and collating all the documents relating to your client's OIA request. Given that two of the principle investigators/leaders of the project have left the employ of ESR and are now working overseas, it is taking longer than originally anticipated for us to locate all the communications and determine costs.We are commencing the search of out-house and in-house archives (e.g. email and network drives). We have now estimated that it could take up to 35 days (280 hours) to locate and assess all documents and correspondence. Due to the fact the ESR's archive system changed in 2004, we need to rebuild an exchange server to read archived correspondence. This is a monumental task for ESR.This cost will be very significant for your client. Based on standard charge out rates, as determined by the Ministry of Justice, we estimate the cost will be~$21,280+GST. To minimise this cost, we are now meeting with the Central Regional Ethics Committee (CREC) in the expectation they will provide us with copies of the relevant documents and correspondence of the now disbanded Taranaki regional Ethics Committee (TREC)."The OIA file as received, 25 odd pages, and includes no documents to the Taranaki Ethics Committee detailing in full the Ministry of Health / OTAG change in methodology after Phase II Part I to subsequently, target Phase II Part II serum testing of post 1974 low exposure participants. The change in methodology required "surrogate exposure values for candidates" as the altered methodology could no longer use the peer reviewed exposure model, which targeted those predicted to have highest exposures as being 1962 to 1975. Participants understanding of the TCDD test results:1:At least four participants were originally listed in incorrect groups in the ESR 2004/5 studies.2:At least three demonstrably elevated results are misrepresented in the ESR 2004/5 blood serum studies.3:The pre and post 1974 short term residents comparisons fail to factor in the different durations which affect the presented measured 2004 levels 4:One of the eight misrepresentations above was corrected in the second round of peer reviews. Seven remain uncorrected. Three participants I have spoken with were unaware of their actual individual results.Two participants, who were long term breast feeding mothers were unaware of the potential for significant reduction of measured 2004 dioxin levels, due to breast feeding.Participants I have spoken with were unaware their historic dioxin levels may have been at least 4 (1987) to 16 fold (1974), measured 2004 dioxin residue levels in adults.A participant who was retested, received a second ESR serum test result, showing his first serum test to be 67% higher than the second was told by ESR,"We have found that variation in dioxin concentrations as measured in serum can occur as a result of eating habits on the day of measurement."No mention is made in the ESR study of the second test/tests undertaken.Was there ethical approval given/needed for the retesting of participants? Was the same laboratory used?- TV 3, Documentary, "Let Us Spray" goes to air in late October 2006.Subsequently, Appendix O is finally released after a request to the Ombudsman by TV3, earlier OIA requests to the MoH had been denied. Although Appendix O did not contain the disputed years of residence, or other disputed data on individual variables, It did confirm much lower levels in Phase II Part II post 1974 participants, other than 1 outlier participant. When finally released, Appendix O also revealed, elevated PCB levels were more widespread, than just the Phase II Part I participants with PCB elevations, in the 64+ male age group as mentioned in the study text.The change of participant selection, the Hon Pete Hodgson denied, to the period after 1973/4 was made, without community consultation, after the results of Phase II, Part I showed "indications" that post 1974 was influential in determining serum TCDD levels. There was no substantial "evidence" of significantly elevated levels, in post 1973/4 participants in the first round of testing.The study group originally defined by ESR to show statistically significant elevations was 50 participants. An OTAG / Ministry of Health decision, had divided that number of participants in half , 24 participants were tested in Phase II, Part I.The decision to focus on the post 1973/4 exposures as being influential in determining TCDD levels was based on low levels detected in half of the 24 participants. Inter individual variables in, the initial exposures, exposure pathways and well known variable factor's in the breakdown of residues, readily explain those low levels in a group 25% of that originally defined by ESR as necessary to show statistically significant exposures.ESR 2005, page 18;3.2 Role of Timing of Residence"Duration of residence was a key factor in the TCDD elevations found. Clear time periods of particular concern were not evident across the 25-year time period of 2,4,5-T production."ESR 2005, page 24;3.6 Exposure ReconstructionAn attempt was made to ascertain any significant variations in exposure through the 1962-1987 period. However, due to limited data, we were unable to identify confidently any clear time periods as being critical, or to rule out any particular time period within the 25-year 2,4,5-T production history of the plant.""Ideally, identification of critical time periods of exposure would enable a back-calculation of peak body burden for each individual. If it is assumed that exposures were predominantly airborne, then it is reasonable to use either 1987 as the cut-offpoint for significant TCDD exposures or an earlier year if the resident moved away from the area prior to 1987."The ESR Part II, largely post 1974 residents did not show "statistically significant" exposure as a group, therefore post 1974 exposures did not demonstrate significant ongoing exposure after 1974.AG 2008Ministry of Health, mail out,24.1.2007"There were concerns expressed in the media that mistakes in the report by ESR had the effect of minimising the residents exposure. Because of these concerns, ESR had the Ministry of Health commissioned additional reviewers to recheck the study. All three reviews endorsed the study and its conclusions. The reviewers noted that there were minor errors in the study, but these did not affect the findings and the studies conclusions are valid."In April/May 2007 requested information was provide to the MoH and Allen and Clarke detailing the "data manipulation" in the ESR / MoH serum study.Allen & Clarke, Appendix 2"In June 2007, Allen & Clarke called together a technical group to provide expert advice and opinions on defining an exposure group...""The technical group agreed that it was likely that variations in the intensity of exposure occurred and, based on available evidence, it is likely that exposure was more intense for a period in the mid to late 1960's than for any other period. The available evidence included:. Further and ongoing analysis of serum dioxin study results which suggests exposure was most significant in the years 1965 to 1968;. Data on the volume of 2,4,5-T produced at the IWD plant and the concentration of dioxin within this 2,4,5-T that suggests that potential exposure to TCDD was greatest for the years 1962 to 1972."There was no "new information", the earlier exposures had been concealed up to June 2007.Exposure levels still remain downplayed by only backdating to 1987.