Fukushima Thyroid Examination September 2016: 135 Thyroid Cancer Cases Confirmed (101 in the First Round and 34 in the Second Round)

135 Thyroid cancer cases confirmed in Fukushima as of June 30, 2016--101 in the first round and 34 in the second round (Total of 174 cases including suspected cancer cases--115 in the first round and 59 in the second round).


The 24th Prefectural Oversight Committee for Fukushima Health Management Survey convened in Fukushima City, Fukushima Prefecture, on Wednesday, September 14, 2016. 

Among other information, the Oversight Committee released the latest results (as of June 30, 2016) of the second round screening, which was conducted over a two-year period from April 2014 to March 2016. The second round screening is still ongoing in terms of the confirmatory examination, so the results are not complete.

An official English translation of the results is available here. The narrative below contains some information gathered from the live webcast of the Oversight Committee meeting and the subsequent press conference. 

Overview
As of June 30, 2016, there are 2 more cases with malignancy or suspicion of malignancy from the second round, for a total of 174 (175 including the single case of post-surgically confirmed benign nodule). The number of surgically confirmed cancer cases, excluding the aforementioned case of benign nodule, now totals 135 (101 from the first round and 34 from the second round), and the remaining 39 (14 from the first round and 25 from the second round) await surgical confirmation. 

Although the final results of the second round screening were widely anticipated at this Oversight Committee meeting, it turned out only two-thirds of those who were eligible for the confirmatory examination actually participated as of June 30, 2016. (Many of them might have undergone the confirmatory examination during the summer break, typically from late July through August).

Since the last results were released, only 4 additional cases from the second round have been operated on. Post-surgical pathological examination of the resected thyroid gland tissue confirmed 3 as papillary thyroid cancer and 1 as "other thyroid cancer" according to the classification in the seventh revision of Japan's unique thyroid cancer diagnostic guidelines released in November 2015.

Full-Scale Screening
To be conducted every 2 years until age 20 and every 5 years after age 20, the Full-Scale screening began with the second round screening in April 2014, including those who were born in the first year after the accident. There are 381,281 eligible individuals born between April 2, 1992 and April 1, 2012. As of June 30, 2016, 270,378 actually participated in the primary examination at the participation rate of 70.9% (lower than 81.7% at the first round screening). 270,327 have received confirmed results of the primary examination, and 2,217 (increased by 156 since the last Oversight Committee meeting) turned out to be eligible for the confirmatory examination. 

The confirmatory examination is still only about two-thirds complete. Of 1,476 who actually underwent the confirmatory examination, 1,379 received confirmed results including 176 that underwent fine-needle aspiration cytology (FNAC). FNAC revealed 59 cases suspicious for cancer. Confirmation of thyroid cancer requires pathological examination of the resected thyroid tissue obtained during surgery. As of June 30, 2016, 34 underwent surgery and 33 were confirmed to have papillary thyroid cancer. One remaining case was confirmed to have "other thyroid cancer" according to the classification in the seventh revision of Japan's unique thyroid cancer diagnostic guidelines. A specific diagnosis was not revealed, but Akira Ohtsuru, in charge of the thyroid screening, confirmed that it was a differentiated thyroid cancer that is not known to be related to radiation exposure.

Newly diagnosed cases in the second round
In the second round, 2 cases were newly diagnosed by FNAC to be malignant or suspicious of malignancy. They were 2 females (age at exposure: 12 and 14). Their places of residence at exposure were Iwaki City and Tadami Town, both of which are FY 2015 target municipalities.

In relation to the still ongoing confirmatory examination, special attention should be paid to the participation rate in Iwaki City. Of 45,228 Iwaki City residents who participated in the second round screening, 376 were eligible for the confirmatory examination. Only 172 have actually participated in the confirmatory examination as of June 30, 2016, and 134 of them have confirmed results. Thus, more confirmatory examination results are expected from Iwaki City, the largest of the FY2015 target municipalities. 

Prior diagnostic status of the cases newly diagnosed in the second round
Of 59 total cases with malignancy or suspicion of malignancy in the second round, 28 were A1, 26 were A2, and 5 were B in the first round.  

28 cases that were A1 in the first round screened suspicious for malignancy in the second round. This would appear to be a new onset after the first round since A1 cases by definition have no ultrasound findings of cysts or nodules.

In 26 cases that were A2 in the first round, 7 were nodules and 19 were cysts. (Two cases with malignancy or suspicion of malignancy reported this time are deduced to be A2 cysts in the first round). Thus the majority of the second round cases appeared to have developed thyroid cancer in 2 to 3 years since the first round. However, Ohtsuru explained this time that at certain ages in children, existing ultrasound lesions may not be visible until a few years later, suggesting there might have been invisible lesions in the first round which only became visible as the child aged.


First Round Screening (October 2011 - April 2015)
(This is the final results as of March 31, 2016. It is unchanged from the previous report).

Total number targeted: 367,672
Number of participants in primary examination: 300,476
Number with confirmed results: 300,476

• A1   154,607 (51.5%) (no nodules or cysts found)
• A2   143,575 (47.8%) (nodules ≦ 5.0 mm or cysts ≦ 20.0 mm)
• B        2,293   (0.8%) (nodules ≧ 5.1 mm or cysts ≧ 20.1 mm)
• C               1   (0.0%) (requiring immediate secondary examination)

(Note: Cysts with solid components are treated as nodules).

Number eligible for confirmatory (secondary) examination: 2,294

Number of participants in confirmatory (secondary) examination: 2,128

Number with confirmed results : 2,086

Number of fine-needle aspiration cytology (FNAC): 545

Number suspicious or confirmed of malignancy: 116 (including one case of benign nodules)

Number with confirmed tissue diagnosis after surgery: 102

• 1 benign nodule
• 100 papillary thyroid cancer
• 1 poorly differentiated cancer

Second Round Screening (April 2014 - March 2016) (see report here)

Total number targeted: 381,281

Number of participants in primary examination: 270,378

Number with confirmed results: 270,327

• A1   108,619 (40.2%) (no nodules or cysts found)
• A2   159,491 (59.0%) (nodules ≦ 5.0 mm or cysts ≦ 20.0 mm)
• B        2,217   (0.8%) (nodules ≧ 5.1 mm or cysts ≧ 20.1 mm)
• C              0   (0.0%) (requiring immediate secondary examination)

(Note: Cysts with solid components are treated as nodules).

Number eligible for confirmatory (secondary) examination: 2,217

Number of participants in confirmatory examination: 1,476
Number with confirmed results: 1,379

Number of FNAB: 176

Number of cases with malignancy or suspicion of malignancy: 59

Number with confirmed tissue diagnosis after surgery: 34

• 33 papillary thyroid cancer
• 1 "other thyroid cancer"

Third Round Screening (May 2016 - March 2018) (see report here)

Total number targeted: 381,172

Number of participants in primary examination: 17,481

Number with confirmed results: 0

Unofficial translation of selected tables

Second Round Screening

Table 1. Primary examination coverage as of June 30, 2016

Table 2. Number and proportion of children with nodules/cysts as of June 30, 2016

Table 3. Participation rates by age group as of June 30, 2016

Table 4. Comparison with the Initial (Preliminary Baseline) Screening as of June 30, 2016

Note 1: Top line refers to the results of the Preliminary Baseline Screening for confirmed results of the Full-Scale Screening.

            It is not the breakdown of the total Preliminary Baseline Screening results, 300,476.

Note 2: Top line refers to the breakdown of the Full-Scale Screening results in a given category of the Preliminary Baseline Screening results. 

            Bottom line shows the proportion in %.

Table 5. Confirmatory testing coverage and results as of June 30, 2016

Table 6. Cytology results (including information from Appendix 6: Number of surgeries among cases with malignancy or suspicion of malignancy) as of June 30, 2016

Figure 3. Distribution of cases with malignancy or suspicion of malignancy by age (as of March 11, 2011) and sex (females in white and males in gray)

Figure 5.  Estimated external effective doses of those who submitted basic survey questionnaire as of June 30, 2016 (females in white and males in blue) 

Third Round Screening

Table 1. Primary examination coverage as of June 30, 2016

【Thyroid Cancer in Fukushima】Fukushima Thyroid Examination Under Dual Review

Below is unofficial translation of two Fukushima Minyu articles regarding the review of the thyroid examination, published on August 8, 2016 (archived here) and July 4, 2016 (archived here). The August article is based on an interview of Hokuto Hoshi, Chair of Oversight Committee for the Fukushima Health Management Survey. It might be tied to this post. The July article covers the launch of an independent exploratory committee by Fukushima Pediatric Association. 

Interestingly, a telephone inquiry by a concerned citizen revealed the Division of the Fukushima Health Management Survey at the Fukushima Prefectural Office was unaware of the content of the August article before its publication in newspaper. They declined to comment on the issue for the time being while contacting Oversight Committee Chair Hoshi to confirm facts and discuss the issue internally.

On September 26-27, 2016, the 5th International Expert Symposium “Chernobyl+30, Fukushima+5: Lessons and Solutions for Fukushima’s Thyroid Question” will be held in Fukushima, organized by Nippon Foundation and co-organized by Fukushima Medical University, Nagasaki University and Sasakawa Memorial Health Foundation. Judging from the symposium theme, there seems to be a rush to bring closure to the thyroid cancer issue even before the final results of the second round screening are released. A glance at the program is quite revealing.

*****

Oversight Committee for the Fukushima Health Management Survey Plan to Review the Thyroid Examination: Reduction in Target Population Considered

August 8, 2016 

Oversight Committee for the Fukushima Health Management Survey, engaged in discussion on the status of the survey to examine the health effects due to the nuclear accident, will begin discussions as early as September to consider reduction in target population as well as review of the screening procedure.

The thyroid examination that targets all residents who were age 18 or younger at the time of the accident will face a big turning point, as revealed by the Oversight Committee Chair Hokuto Hoshi in the interview with Fukushima Minyu as of August 7th.

The thyroid examination targets about 380,000 residents. Thyroid cancer cases detected by the examination are considered “unlikely to be the effect of radiation exposure at this time” by the Oversight Committee.

What lies behind starting the discussion to consider review of the examination is the concern about detection of “latent cancer” cases, which exist at a constant rate regardless of radiation exposure, by screening with high sensitivity. 

Thyroid cancer is curable in many cases, and the across-the-board cancer screening is unlikely to give rise to the merit of “reduced mortality.” Thus thyroid cancer screening is not globally recommended. This has led medical providers to voice concerns that “participation in the examination alone can be detrimental to the participants.”

Under the circumstance, the Oversight Committee is expected to begin discussions on issues such as: 1) Whether residents older than age 18 should be included in the target population in the future; and 2) Whether to change the method of mass screening currently conducted in school settings which has been pointed out to interfere with the participant’s wish not to participate.

*****

“Thyroid Examination” Should Be Reviewed: Fukushima Pediatric Association to Establish an Independent Committee

July 4, 2016

Fukushima Pediatric Association (president: Kazuhiro Ohga) adopted a general assembly statement incorporating the establishment of its own exploratory committee to consider the status of the thyroid examination on July 3, 2016 at the general meeting held in Kooriyama City. The thyroid examination, part of the Fukushima Health Management Survey that investigates health effects of the Tokyo Electric Fukushima Daiichi nuclear power plant accident, is conducted by the prefecture targeting residents who were age 18 or younger at the time of the accident. The association deems necessary to review the thyroid examination, taking a fresh look at part of it. This is the first time the association expresses the need to review the examination.

Five years have passed since the nuclear accident, a question was raised about the status of the thyroid examination mainly by pediatricians performing medical examinations on residents who are targeted for the thyroid examination.

According to the Fukushima Pediatric Association, there are 172 individuals (as of the end of March 2016) who have been diagnosed with thyroid cancer or “suspicion of cancer.” Thyroid cancer is curable in many cases, and the screening is unlikely to give rise to the merit of “reduced mortality,” while there is a mental detriment when diagnosed with cancer. Thus thyroid cancer screening is not globally recommended.

The general assembly statement referred to health worries experienced by children participating in the thyroid examination and their guardians as well as residents, stating “It is necessary to explain (the results) to the participants with care and compassion and offer an easily comprehensible explanation to residents.”

President Ohga stated, “The thyroid examination was started in order to alleviate anxiety of residents, but it is possible the examination created (new) anxieties. It is necessary to review the examination from the standpoint of the participants.”

The Exploratory Committee, comprising the association members, is scheduled to begin discussions this fall. It will take up opinions of those diagnosed with thyroid cancer and intend to set directions before next year’s general assembly. In addition, the content of the general assembly statement will be sent to the prefectural government as a request in the future.


The statement also incorporates items regarding the response to health effects on children, long-term health management, and continuing support for children and their families who are evacuated or returning.

【Thyroid Cancer in Fukushima】How the Thyroid Examination Should Be: “Respecting a Wish Not to Participate in the Examination”

On June 15, 2016, Fukushima Minyu, one of the major regional newspapers in Fukushima Prefecture, published an article featuring Sanae Midorikawa, M.D., Ph.D., an endocrinologist who has been making school visits in Fukushima Prefecture to educate children regarding the thyroid examination they participate in. Midorikawa is also an associate professor in the Radiation Health Management at Fukushima Medical University and tasked with communication with residents. (Note: the article has been deleted from the Fukushima Minyu website. See the archived version).

The article (archived here) describes how Midorikawa is "accommodating" wishes of those children who do not want to participate in the thyroid examination that might lead to "unreasonable diagnosis of thyroid cancer." The "unreasonableness" is apparently based on the opinion of Fukushima Medical University that the thyroid cancer cases found during the first 4 years after the Fukushima Daiichi nuclear power plant accident are not due to radiation effects but simply a result of mass screening. In other words, these diagnoses are considered "unreasonable" because these cancers might never have been found until later in life without the mass screening.

It is true that cancer diagnosis can cause mental anguish and stress. When it happens to children, it is even worse since children usually do not get cancer. However, it also seems unreasonable that Fukushima Medical University is prematurely declaring "no radiation effects" for thyroid cancer cases in Fukushima children only based on the results of the first round screening. In fact, the second round screening—just completed but some results still pending—is showing more cases of thyroid cancer than explainable by "screening effect" which should not even be an issue during the second round. (See this post for the latest results.)

Although it is important to address the anxiety and fear felt by children (and their loved ones) who participate in the examination, they and their families also deserve to receive unbiased, realistic information regarding radiation risks. Yes, their exposure doses might not be as high as the Chernobyl population, but there are many uncertainties about the actual exposure doses in Fukushima. It is inferred in the recent paper by Fukushima Medical University published in Thyroid that radiation-induced thyroid cancer is not likely to appear in Fukushima because the exposure doses do not exceed 100 mSv, but this so-called 100 mSv threshold discourse has been scientifically disproven by recent studies such as the Australian CT study and the Swiss background radiation study.

The unofficial English translation of the Fukushima Minyu article  (archived here) is presented below in an attempt to share with the international community the view of a Fukushima Medical University researcher. (Addendum: FMU released an official English translation here.)

*****

Milepost Towards Reconstruction: Five Years of History
How the Thyroid Examination Should Be: “Respecting a Wish Not to Participate in the Examination”

“Should we leave alone the unreasonableness of being diagnosed with cancer in rare occasions after participating in an examination with unclear purposes?” 

   Beginning the last fiscal year, Sanae Midorikawa (age 48), an associate professor in the Department of Radiation Health Management at Fukushima Medical University who is in charge of communication regarding the thyroid examination, started the “demae jugyou” (translated to “delivered class” in English) geared towards children. It is because she felt it was unreasonable for many children to participate in the examination without knowing the purpose of the examination: watching over health.

   The thyroid examination targets Fukushima residents who were 18 or younger at the time of the nuclear accident. Cases of thyroid cancer have been detected among the participants, but the Fukushima Health Management Survey Oversight Committee, comprising physicians and experts, has consistently expressed an opinion that, “At the present time, they are unlikely to be due to the effect of radiation.” A possibility has been pointed out that a sensitive mass screening has detected many cases of cancer which were not previously found.

   Against the backdrop of parental concern, most children in Fukushima underwent the examination. However, Midorikawa thinks, “It is important to offer options to participate or not participate in the examination, after parents and children reach the understanding about the meaning and limitations of the examination.”

   In general, most cases of thyroid cancer are curable, and it is unlikely that thyroid  screening will lead to the merit of “reduced mortality. On the other hand, thyroid screening is not globally recommended due to the demerit of mental effects of being diagnosed with cancer. “Considering these merits and demerits, we have reached a point in time, now that five years have passed, when we need to consider how the thyroid examination should be.”

   At the delivered classes, Midorikawa explains to children about the possibility of the examination detecting cancer and tells them, “For those of you who ‘don’t want cancer diagnosis,’ your wish not to participate in the examination will be respected.” 

   In the past five years, anxiety about radiation amongst Fukushima residents took precedence over addressing the need by children to agree to participate in the examination or securing sufficient understanding of the demerits of the examination. Midorikawa reflects back, “It is not surprising that residents thought, ‘Our children should participate in the examination” after the nuclear accident. It also makes sense they connected the results with radiation and felt anxious. However, looking back, all of that was an irrational experience.”

   Unreasonableness experienced by parents and children in Fukushima Prefecture is not limited to the thyroid examination. Immediately after the accident, Chiharu Itoh (age 44), the vice principal of Fukushima Mebae Kindergarten (Fukushima City), established a one-on-one counseling room to address concerns of the mothers, dealing with various worries such as, “Should we evacuate outside Fukushima?” and “Should we avoid Fukushima products?”

   Now that five years have passed, some are beginning to voice positive opinions about the experience. “Mothers are interested in applying their experiences in adverse circumstances to the rest of their lives.” 

   Coming in contact with children during the delivered classes, Midorikawa hopes, “In the future, they will have to make important decisions regarding health risks other than radiation. It is my hope that, at such times, they will take their experiences in the past 5 years as helpful information in making a decision.

Fukushima Thyroid Examination June 2016: 57 Cases Suspicious or Confirmed of Thyroid Cancer in the Second Round Screening

131 Thyroid cancer cases confirmed in Fukushima as of March 31, 2016--101 in the first round and 30 in the second round (Total of 172 cases including suspected cancer cases--115 in the first round and 57 in the second round).


The 23rd Prefectural Oversight Committee for Fukushima Health Management Survey convened in Fukushima City, Fukushima Prefecture, on Monday, June 6, 2016. 

Among other information, the Oversight Committee released the latest results (March 31, 2016) of the Full-Scale thyroid examination, or the second round screening, which was conducted over a two-year period from April 2014 to March 2016. The second round screening is essentially ongoing in terms of the confirmatory examination, so the results are not complete.

For the Initial (Preliminary Baseline) Screening, or the first round screening, the updated, corrected version of the results was released. 

There has been no updated information on clinicopathological details of the surgical cases since August 2015 that showed 74% lymph node metastases post-surgically. The most recent publication in Thyroid by Fukushima Medical University covering the first round screening results as of the August 2015 report only includes older information from the November 11, 2014 Thyroid Examination Evaluation Subcommittee meeting available here.

An official English translation of the results is available here. The narrative below contains some information gathered from the live webcast of the Oversight Committee meeting and the subsequent press conference. 

Overview
As of March 31, 2016, there are 6 more cases with malignancy or suspicion of malignancy from the second round, for a total of 172 (173 including the single case of post-surgically confirmed benign nodule). The number of surgically confirmed cancer cases, excluding the aforementioned case of benign nodule, now totals 131 (101 from the first round and 30 from the second round), and the remaining 41 (14 from the first round and 27 from the second round) await surgical confirmation. Since the last results were released, 14 additional cases from the second round have been operated on and confirmed as papillary thyroid cancer by post-surgical pathological examination of the resected thyroid gland tissue.

For the first time, there was a case of age 5 (male) at the time of the accident. This did not get a special mention during the committee meeting, but various domestic and international experts have used the absence of age 5 or younger at exposure as one of the reasons why Fukushima cancer cases were unlikely to be related to radiation exposure. There were a few questions during the press conference regarding how the committee perceived this particular case. The answer was evasive: the single case of age 5 at exposure would not mean much, especially without the exposure dose information.

Initial (Preliminary Baseline) Screening (a.k.a. the first round)
The first round targeted about 368,000 individuals who were age 18 or younger, residing in Fukushima Prefecture at the time of the Tokyo Electric Fukushima Daiichi nuclear power plant accident on March 11, 2011. There were 300,476 actual participants in the primary examination, giving rise to the participation rate of 81.7%. As of March 31, 2016, there are 116 cases with malignancy or suspicion of malignancy, including a case of the post-surgically diagnosed benign nodule: 102 underwent surgery and 101 were confirmed with thyroid cancer (100 papillary thyroid cancer and 1 poorly differentiated thyroid cancer). 

An additional, updated information from the first round
Details of the three cases orally presented previously were revealed: 2 females (ages 13 and 18) and 1 male (age 17) with their municipalities of residence including Yabuki Town, Hanawa Town, and Aizumisato Town, all FY2013 target municipalities.

There are about 160 who did not participate in the confirmatory examination, but about 60 went through the second round examination and have been reclassified as the A assessment.

Another notable update for the first round was the number of poorly differentiated thyroid cancer, which was decreased from 3 to 1 in accordance with the November 2015 revision of Japan's unique thyroid cancer diagnostic guidelines. No specific details were given regarding the reclassification of 2 (1 each from FY2011 and FY2012) of the 3 cases of poorly differentiated thyroid cancer as papillary thyroid cancer. According to some of the abstracts from the Japan Association of Breast and Thyroid Sonology meeting in late May 2016, it seems that according to the previous guidelines, poorly differentiated thyroid cancer was diagnosed if there was even a small portion of tumor showing poorly differentiated features, whereas the new guidelines requires poorly differentiated features to compose more than 50% of the tumor.

Full-Scale Screening (a.k.a. the second round)
To be conducted every 2 years until age 20 and every 5 years after age 20, the second round screening additionally targets those who were born in the first year after the accident, eventually aiming to examine 381,286 individuals in a 2-year period. As of March 31, 2016, 267,769 have participated in the primary examination of the second round at the participation rate of 70.2%. 256,670 have received confirmed results of the primary examination, and 2,061 turned out to be eligible for the confirmatory examination. 

The confirmatory examination is only two-thirds completed. Of 1,345 who actually underwent the confirmatory examination, 1,242 received confirmed results including 169 that underwent fine-needle aspiration cytology (FNAC). 57 cases had FNAC results suspicious for cancer. Confirmation of thyroid cancer requires pathological examination of the resected thyroid tissue obtained during surgery. As of March 31, 2016, 30 underwent surgery and all 30 were confirmed to have papillary thyroid cancer.

Newly diagnosed cases in the second round
In the second round, 6 cases were newly diagnosed by FNAC to be malignant or suspicious of malignancy. There were 4 males (age at exposure: 5, 8, 14 and 15) and 2 females (age at exposure: 10 and 15). Their places of residence at exposure include 4 municipalities: FY 2014 target municipalities such as Okuma Town and Koriyama City (2 cases); and FY 2015 target municipalities such as Iwaki City (2 cases) and Kagamiishi Town. (In the first round, Okuma Town was included in the FY 2011 target municipalities; Koriyama City in the FY 2012 target municipalities; and Iwaki City and Kagamiishi Town in the FY 2013 target municipalities). 

Cytology results show the 5-year-old (age at exposure) to be from FY2015 screening. His municipality is deduced to be Iwaki City based on the confirmatory examination implementation status by municipality (not translated in this post). Of 44,143 Iwaki City residents who participated in the second round screening, 322 were eligible for the confirmatory examination. Only 105 have actually participated in the confirmatory examination as of March 31, 2016, and 74 of them have confirmed results. Thus, more confirmatory examination results are expected from Iwaki City, the largest of the FY2015 target municipalities. 

Prior diagnostic status of the cases newly diagnosed in the second round
Of 57 total cases with malignancy or suspicion of malignancy in the second round, 28 were A1, 25 were A2, and 4 were B in the first round. (In the 6 cases with malignancy or suspicion of malignancy reported this time, 3 each were classified as A1 and A2 in the first round). 

28 cases that were A1 in the first round screened suspicious for malignancy in the second round. This would appear to be a new onset after the first round since A1 cases by definition have no ultrasound findings of cysts or nodules.

In 25 cases that were A2 in the first round, it is not clear how many were cysts, but 15 of 22 were cysts in the last report. Thus the majority of the second round cases appeared to have developed thyroid cancer in 2 to 3 years since the first round.


First Round or Initial Screening (October 2011 - April 2015)

Total number targeted: 367,672
Number of participants in primary examination: 300,476
Number with confirmed results: 300,476

• A1   154,607 (51.5%) (no nodules or cysts found)
• A2   143,575 (47.8%) (nodules ≦ 5.0 mm or cysts ≦ 20.0 mm)
• B        2,293   (0.8%) (nodules ≧ 5.1 mm or cysts ≧ 20.1 mm)
• C               1   (0.0%) (requiring immediate secondary examination)

(Note: Cysts with solid components are treated as nodules).

Number eligible for confirmatory (secondary) examination: 2,294

Number of participants in confirmatory (secondary) examination: 2,128

Number with confirmed results : 2,086

Number of fine-needle aspiration cytology (FNAC): 545

Number suspicious or confirmed of malignancy: 116 (including one case of benign nodules)

Number with confirmed tissue diagnosis after surgery: 102

• 1 benign nodule
• 100 papillary thyroid cancer
• 1 poorly differentiated cancer

Second Round or Full-Scale Screening (April 2014 - March 2016)

Total number targeted: 381,286

Number of participants in primary examination: 267,769

Number with confirmed results: 256,670

• A1   102,870 (40.1%) (no nodules or cysts found)
• A2   151,739 (59.1%) (nodules ≦ 5.0 mm or cysts ≦ 20.0 mm)
• B        2,061   (0.8%) (nodules ≧ 5.1 mm or cysts ≧ 20.1 mm)
• C              0   (0.0%) (requiring immediate secondary examination)

(Note: Cysts with solid components are treated as nodules).

Number eligible for confirmatory (secondary) examination: 2,061

Number of participants in confirmatory examination: 1,345

Number with confirmed results: 1,242

Number of FNAB: 169

Number of cases with malignancy or suspicion of malignancy: 57

Number with confirmed tissue diagnosis after surgery: 30

• 30 papillary thyroid cancer

Unofficial translation of selected tables

Full-Scale Screening

Table 1. Primary examination coverage as of March 31, 2016

Table 2. Number and proportion of children with nodules/cysts as of March 31, 2016

Table 3. Participation rates by age group as of March 31, 2016

Table 4. Comparison with the Initial (Preliminary Baseline) Screening as of March 31, 2016

Note 1: Top line refers to the results of the Preliminary Baseline Screening for confirmed results of the Full-Scale Screening.
            It is not the breakdown of the total Preliminary Baseline Screening results, 300,476.
Note 2: Top line refers to the breakdown of the Full-Scale Screening results in a given category of the Preliminary Baseline Screening results. 

            Bottom line shows the proportion in %.

Table 5. Confirmatory testing coverage and results as of March 31, 2016

Table 6. Cytology results (including information from Appendix 6: Number of surgeries among cases with malignancy or suspicion of malignancy) as of March 31, 2016

Figure 3. Distribution of cases with malignancy or suspicion of malignancy by age (as of March 11, 2011) and sex (females in white and males in gray)

Figure 5.  Estimated external effective doses of those who submitted basic survey questionnaire as of March 31, 2016 (females in white and males in blue) 

Initial (Preliminary Baseline) Screening
(updated information marked with yellow highlights)

Table 1. Primary examination results (final results from October 9, 2011 to April 30, 2015)

Table 2. Number and proportion of children with nodules/cysts

Table 3. Confirmatory testing coverage and results as of March 31, 2016

Table 4. Cytology results (including information from Appendix 7: Surgical cases of suspicious or malignant cases) 

Table 9. Proportion of B or C test results, and suspicious or malignant cases                   As of March 31, 2016

Note 10: Excluding duplicates.

Note 11: Excluding unconfirmed results. 

Note 12: The number of FNAC, out of (c), including those who were reclassified as A1 or A2.

Note 13: Excluding one suspected case found benign after surgery.

Note 14: Tamura City, Minamisoma City, Date City, Kawamata Town, Hirono Town, Naraha Town, Tomioka Town, Kawauchi Village, Okuma Town, Futaba Town, Namie Town, Katsurao Village and Iitate Village

Note 15: Fukushima City, Koriyama city, Shirakawa City, Sukagawa City, Nihonmatsu City, Motomiya City, Koori Town, Kunimi Town, Otamamura Village, Kagamiishi Town, Tenei Village, Nishigou Village, Izumizaki Village, Nakajima Village, Yabuki Town, Tanagura Town, Yamatsuri Town, Hanawa Town, Samegawa Village, Ishikawa Town, Tamakawa Village, Hirata Village, Asakawa Town, Furudono Town, Miharu Town, and Ono Town

Note 16: Iwaki City, Soma City, Shinchi Town

Note 17: Aizuwakamatsu City, Kitakata City, Shimogo Town, Hinoemata Village, Tadami Town, Minamiaizu Town, Kitashiobara Village, Nishiaizu Town, Bandai Town, Inawashiro Town, Aizubange Town, Yugawa Village, Yanaizu Town, Mishima Town, Showa Village, and Aizumisato Town

"Strict" Management of the Fukushima Health Management Survey Data by Fukushima Medical University

The Interim Report released in March 2016 by the Oversight Committee for Fukushima Health Management Survey called for the need to establish the rules of management and provision of the data so it can be widely utilized by domestic and international experts. Accordingly, the Subcommittee to Review Provision of Data for the Purpose of Academic Research met in Fukushima City, Fukushima, for the first time on May 31, 2016. Subcommittee members were selected by the Fukushima prefectural government in order to address the role of the subcommittee in establishing technical rules in provision of data and include specialists in epidemiology, information technology, law, and legal sociology. Also included are members of the Oversight Committee for Fukushima Health Management Survey, Shoichiro Tsugane and Hokuto Hoshi, and the Health Survey Support Department Head and the Department of Epidemiology Chair at Fukushima Medical University, Tetsuya Ohira, representing the Fukushima Health Management Survey. Noteworthy was the absence of a medical ethicist.

The subcommittee meeting, streamed live online by independent journalists, revealed important facts that warrant sharing with the English-speaking community.

First, even those of us who have been following activities of the Fukushima Health Management Survey from the beginning did not realize Fukushima Prefecture has actually commissioned academic presentation and paper publication of the data to Fukushima Medical University in addition to collection of data. Apparently, data analysis is one of the commissioned tasks assigned to Fukushima Medical University, and as a result, end products of data analysis such as presentations and published papers are considered part of the commissioned tasks. 

(Note: It is a public knowledge that Fukushima Medical University is commissioned by Fukushima Prefecture to conduct the Fukushima Health Management Survey using the 78.2 billion yen "Fukushima Resident Health Fund" established in late 2011 by the Japanese government. However, it might not be as well known that the 78.2 billion yen came from the Ministry of Economy, Trade and Industry, whose Agency for Natural Resources and Energy is tasked with promoting construction of nuclear power plant facilities in Japan via its Nuclear Facilities Development and Nuclear Fuel Cycle Industry Division of the Electricity and Gas Industry Development Department).

Second, it became apparent that the Fukushima Medical University has such strict management guidelines for the Fukushima Health Management Survey data that there is tight control over presentation and publication of the analyzed data via an internal peer review process which approves or disapproves the work. 

For information, the purposes of the Fukushima Health Management Survey are stated on the website of the Radiation Health Science Center: 

     "The primary purposes of this survey are to monitor the long-term health of residents, promote their future well-being, and confirm whether long-term low-dose radiation exposure has health effects."

*****

According to Ohira's statements, summarized below and shown in the video recording of the subcommittee meeting (from 25 minutes 57 seconds, in Japanese), this is what Fukushima Medical University researchers have to go through: 

Those interested in analyzing data would have to submit a request for data analysis specifying the type and purpose of the analysis. The request is then examined by the review committee. If the review committee deems appropriate, the data is provided to the applicant who signs an agreement on data handling. Thus the data is strictly managed. When it comes to presenting the analysis at an academic meeting or publishing the analysis, another request for presentation must be filed with the review committee. The presentation or publication of the analysis can only proceed if the review committee approves it as appropriate. 



A question was posed by a Fukushima University professor and legal sociologist, Hiroyasu Shioya, 

"For the third party use, would the review be a matter of formality or more substantial?"

Ohira answered,

"At the Radiation Medical Science Center for the Fukushima Health Management Survey at Fukushima Medical University, the content (substance) of the analysis itself is examined. In the case of publication of a paper, we conduct what is called an internal peer review, where the paper is distributed to reviewers for examination of the content. Then it is further discussed at the review committee and approved if it is determined appropriate."

Chair of the Subcommittee to Review Provision of Data for the Purpose of Academic Research, Shoichiro Tsugane, wondered how the third-party use review might actually proceed, indicating that would be a future topic of the subcommittee.

A question arose to the viewers' mind as to what is considered "appropriate" by the review committee and who constituted such committee. Answers were found in a document distributed at the February 15, 2016 Oversight Committee Meeting by the Prefectural Department of Fukushima Health Management Survey describing the details of the review committee. 

In summary, any research conducted at Fukushima Medical University must be approved by the Ethics Review Committee as well as the Conflict of Interest Committee. Then, within the Radiation Medical Science Center for the Fukushima Health Management Survey, there is a special review committee, the Review Committee for the Use and Analysis of the Fukushima Health Management Survey Data (referred to as "the Review Committee" hereafter).  Below is a translation of page 4 of the document.

**********

Review procedures for research at Fukushima Medical University

Procedures within Fukushima Medical University

1. Ethics Review Committee (description not translated)
2. Conflict of Interest Committee (description not translated)

Procedures within the Radiation Medical Science Center for the Fukushima Health Management Survey

3. Review Committee for the Use and Analysis of the Fukushima Health Management Survey Data

Reviews appropriateness in the use, analysis, and report of the Fukushima Health Management Survey data.

(1) Eligibility for application
a. Fukushima Health Management Survey expert committee members 
b. Equivalent to the above, with approval by the expert committee

(2) Items to be reviewed
a. Study title, applicant name
b. Type and range of data to be used
c. Purpose of data use
d. Plan for analysis
e. How the analytical result will be publicized
f. Items regarding the use and storage of data

(3) Review criteria
a. Whether the use and report of data will be appropriate according to the Report of Review Committee Regarding Handling of Research and Development Results (Ministry of Education, Culture, Sports and Technology, May 20, 2002).
b. Whether the use follows one of the purposes of the Fukushima Health Management Survey, "to monitor the long-term health of residents."
c. Whether there is any problem if data is used, analyzed and reported according to the review application.
d. Whether there is any problem with qualifications and credentials of the person handling data.
e. Whether data is properly handled.
f. Any other issues with data use.

(4) Review Committee members 
Chair: Executive Director of the Radiation Health Science Center
Members: Deputy Directors, Department Heads, Division Chiefs, Deputy Administrative Director (in charge of reconstruction) of the Radiation Health Science Center; others considered necessary by the Review Committee

**********

According to the information provided on the Japanese website and English website of the Radiation Medical Science Center, Chair of the Review Committee is Masafumi Abe, executive director of the Radiation Medical Science Center for the Fukushima Health Management Survey, and a vice president of Fukushima Medical University.

Below are the Review Committee members whose names and titles are publicly available on the Japanese website. 

Vice Directors: Koichi Tanigawa, Shunichi Yamashita, Kenji Kamiya.
Department Heads: Akira Ohtsuru (Thyroid Examination Department), Masaharu Maeda (Health Survey Department), and Tetsuya Ohira (Health Survey Support Department)

(Note: Names of the above individuals often appear as co-authors of papers published using the Fukushima Health Management Survey data, such as this, this, and this.

***********

Page 3 of the document shows a flow chart of the review procedures at Fukushima Medical University. Use of any data outside the Fukushima Health Management Survey, including the clinical data, only goes through steps 1 and 2, ethics review and conflict of interest review. Use of the Fukushima Health Management Survey data additionally goes through step 3, with details outlined above, except that the review process is different for the publicized data and the unpublicized data.

Use of the publicized data can be requested through the Review Committee in three ways: use, use and academic presentation, or use and academic paper writing. A request for use alone is simply approved or disapproved. If a request for an academic presentation using the publicized data is approved by the Review Committee, the applicant must report back to the Review Committee whether the presentation was accepted at the academic meeting or not. If a request for writing an academic paper using the publicized data is approved by the Review Committee, the completed paper must go through an internal peer review followed by examination of the content at the Review Committee before the paper is approved to be published. 

The review process for use of the unpublicized data is more rigorous. After the application to use and analyze the unpublicized data is approved by the Review Committee, another request must be filed for the result of the analysis to be presented at an academic meeting. If the Review Committee approves the request, the applicant must report back whether the presentation was accepted or not. If the applicant wishes to write a paper using the analyzed result of the unpublicized data, a request must be filed before writing the paper. If the Review Committee approves the request, the paper can be written. Once complete, the paper goes through an internal peer review followed by examination of the content at the Review Committee before the paper is approved to be published (just as in the case of the paper using the publicized data).

**********

Comment: The extent that the data use is "managed" seems extraordinary. Specifically, one of the review criteria regarding whether the use follows the purpose of the Fukushima Health Management Survey, "to monitor the long-term health of residents," is unique to this review process. However, exactly how this is determined and applies as a criterion is unclear. During the Subcommittee meeting, "promotion of health and the well-being of residents" was mentioned multiple times by various committee members as the primary purpose of the Fukushima Health Management Survey and as the reason to guard the data so closely. Certainly, one could imagine the "misuse" of data, as internally determined by the Review Committee, might be detrimental to the well-being of someone--whoever that might be. 

This unusually strict management of data raises questions such as: neutrality of the internal review of academic papers which list the Review Committee members as co-authors; potential biases in the conclusion of the academic presentation or paper; and missed opportunities in pursuing scientific knowledge of health effects of radiation exposure in Fukushima residents. 

What the Subcommittee decides on the third-party use of the data is to be closely followed.