Fukushima Thyroid Examination December 2017: 159 Surgically Confirmed as Thyroid Cancer Among 193 Cytology Suspected Cases


Note: Corrections were made on March 8, 2018 regarding an additional surgical case (i.e. confirmed thyroid cancer case) for the second round that was presented during the December 25 Oversight Committee meeting but overlooked in the original version of this post.

Highlights:

  • No new data One new surgical case for the second round since the last report
  • The third round saw no newly diagnosed cases but an addition of 4 new surgical cases means all 7 cases diagnosed so far have been confirmed as thyroid cancer. 
  • Total number of suspected/confirmed thyroid cancer remains the same at 193 (excluding a single case of benign tumor; 115 in the first round, 71 in the second round, and 7 in the third round).
  • Total number of surgically confirmed cancer cases has increased to 158 159 (101 in the first round,  50 51 in the second round, and 7 in the third round)
  • The final report of the second round, released at the Eighth Thyroid Examination Assessment Subcommittee held on November 30, 2017, is essentially identical to the last second round report which is available in English on this web page, other than Table 11 showing the regional comparison.
  • Gen Suzuki was selected as chair of the Thyroid Examination Assessment Subcommittee which convened with new and returning members (information available only in Japanese on this web page).
On December 25, 2017, the 29th Oversight Committee for Fukushima Health Management Survey (FHMS) convened in Fukushima City, Fukushima Prefecture. Among other information, the Oversight Committee released the latest results (as of September 30, 2017) of the third round of the Thyroid Ultrasound Examination (TUE).  Official English translation of the results are to be posted here

Minutes of the proceedings are only released in Japanese, and no official transcript is released for the press conference held immediately after the committee meeting. Information released regarding the TUE at this Oversight Committee meeting was limited, and the narrative below includes pertinent information covered during the committee meeting and the November 30, 2017 Thyroid Examination Assessment Subcommittee as well as respective press conferences.

Overview
This Oversight Committee meeting was held only 2 months after the October 23, 2017 meeting. The final report of the second round released at the 8th Thyroid Examination Assessment Subcommittee on November 30, 2017 was reviewed, but and the latest results from the confirmatory examination of the second round as of September 30, 2017, was NOT presented. Because some participants of the confirmatory examination might postpone biopsy and/or surgery until the summer recess from the last one-third of July through the end of August, data as of September 30, 2017 is considered a critical addition for the second round. Previously, any addition to the final report of the first round results (released on August 31, 2015) such as the number of new cytology-suspected or surgically-confirmed thyroid cancer cases was at least shared orally at subsequent Oversight Committee meetings, with an eventual release of an updated version of the final report (FY2015FY2016) as of March 31—the end of each fiscal year.

The third round saw 4 additional surgical cases, as of September 30, 2017, meaning all cases from the third round have so far been operated on. 

Here's the summary of the latest results as of September 30, 2017.

Below is Table 11 that shows data by four administrative regions. This was the only addition to the final report of the second round that was presented at the 8th Thyroid Examination Assessment Subcommittee. This table is discussed further later.


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: 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 14: 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 15: Iwaki City, Soma City, Shinchi Town
Note 16: 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


Notable information

Toru Takano voiced 3 concerns about the TUE. First was a tremendous amount of overdiagnosis expected from the TUE being planned up to 2036. During the press conference, a freelance journalist Mako Oshidori pointed out a post on Takano's web page stated that autopsy data showed there was no worry about overdiagnosis below age 15. Takano confirmed that students younger than high school ages would not be prone to overdiagnosis based on autopsy data showing no latent cancer below age 15. He stated thyroid cancer cases detected below age 15 are due to reasons other than overdiagnosis.

Takano then questioned if the informed consent form for the TUE is adequate to inform residents about pros and cons of thyroid cancer screening. Takano wondered if parents understand that early diagnosis is not necessarily beneficial or that the TUE is just a survey and not intended to improve their children's health. FMU's Sanae Midorikawa replied that the consent form gained an opt-out option beginning in the third round and the form mentions that screening might lead to some worries. Midorikawa explained that the consent form has no adequate explanation regarding a potential problem of overdiagnosis or lack of merits of early diagnosis. Even when more verbal explanations are offered to parents, it is Midorikawa's impression that those explanations are well understood. Takano suggested that the consent form be reformed.

Takano then questioned about the school-based screening again, after raising the same issue at the November 30, 2017 Thyroid Examination Assessment Subcommittee (see below). He said he understood the school-based screening was conducted between classes (he was previously told it was conducted during classes) which might make students feel that they are forced to take it. Midorikawa explained that screening is conduced during classes. The entire class goes to a room where the screening is conducted, but only those with signed consent forms are screened. The participation rate of the school-based screening exceeds 90% as very few express their intention not to participate ahead of time. Midorikawa states that the school-based screening appears to discourage advanced opt-out.

Kazuo Shimizu raised an interesting point when he revealed that he operated on a Fukushima resident from Koriyama City at his hospital and reported the case to FMU but the case does not seem to be reflected in the official count. The patient apparently participated in the first round screening, evacuated from Koriyama City, and never participated in subsequent screenings. The patient was diagnosed with thyroid cancer at another hospital, and Shimizu learned that the patient participated in the first round the night before he operated on the patient. An FMU official stated that a case would not be included in the official count unless the patient had participated in the second and third rounds.

Kanae Narui, a clinical psychologist, commented on one of the new efforts proposed for the fourth round screening regarding enrichment of psychological support. The proposal will initiate sharing information with facilities conducting the confirmatory examination and strengthen support offered to patients and families regarding worries about the TUE. Narui wanted to know just how the psychological support would be enriched. She went on to illustrate a case of a student she encountered as a school counselor. The student was apparently under clinical follow-up after the confirmatory examination. The student's condition was kept from the school or other students, and it was Narui's impression that the student was not well informed about her own condition. The student stated the only thing she was told by the doctor was that something serious would happen unless she took her medication. When Narui explained to the student that her condition was not as severe as she understood, she felt so relieved that she broke into a big smile and began shaking so badly that she could barely walk. Narui's point was that keeping patient information confidential needs to be balanced with protecting patients' mental/psychological/emotional health. Patients should not feel so isolated and helpless at school. Sufficient information should be shared with school so that patients can receive good support at school.  

Because the rest of data released at this Oversight Committee was essentially similar to what was presented at the last Oversight Committee, the remainder of this post will cover selective information from the 8th Thyroid Examination Assessment Subcommittee, which was held on November 30, 2017.  

(Note: Information presented at the previous Thyroid Examination Evaluation Subcommittees has never been officially translated into English. Some unofficial translation  can be found here and here).

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Thyroid Examination Assessment Subcommittee members
For the new two-year term, the previously 9-member subcommittee was scaled down to 8 members, retaining only one returning member, Ryohei Katoh. Most notably, Kazuo Shimizu, a thyroid surgeon and the former subcommittee chair, was not included on the roster.

Member roster
Hirofumi Ami: Chair, Department of Surgery, Ohara General Hospital, Fukushima City, Fukushima Prefecture (long involved in treating thyroid cancer patients in Fukushima Prefecture; recommended by the Fukushima Hospital Association)
Kota Katanoda: Chief, Division of Cancer Statistics Integration, Center for Cancer Control and Information, National Cancer Center (recommended by the National Cancer Center for his thorough knowledge of cancer registry and cancer statistics)
Ryohei Katoh, M.D., Ph.D.: Professor, Department of Human Pathology, University of Yamanashi (recommended by the Japanese Society of Pathology for his thorough knowledge of thyroid pathology)
Gen Suzuki: Managing Director, IUHW Clinic, International University of Health and Welfare, Tochigi Prefecture (recommended by the Japanese Radiation Research Society for his long involvement with research on radiation effects)
Tomotaka Sobue: Professor, Division of Environmental Medicine and Population Sciences, Department of Social Medicine, Osaka University Graduate School of Medicine (taking part in cancer research from an epidemiological viewpoint; recommended by the Japan Epidemiological Association)
Toru Takano: Instructor, Department of Metabolic Medicine, and Associate Professor, Department of Laboratory MedicineOsaka University Graduate School of Medicine. (long involved in research and clinical management of thyroid diseases; recommended by the Japan Thyroid Association)
Kanshi Minamitani: Clinical Professor, Department of Pediatrics, Teikyo University Medical Center, Chiba Prefecture (long involved in research and clinical management of pediatric thyroid diseases; recommended by the Japanese Society for Pediatric Endocrinology)
Akira Yoshida: Chair, Department of Gynecological Examination, Kanagawa Health Service Association; the former president, the Japanese Society of Thyroid Surgery (An endocrinology and thyroid surgery specialist and the first chair of the planning committee for the Japanese clinical guidelines for treatment of thyroid tumor; recommended by the Japan Association of Endocrine Surgeons and the Japanese Society of Thyroid Surgery)

*****
As written previously, the new roster was a surprise because Kazuo Shimizu—the former subcommittee chair—and Fumiko Kasuga—who one might say acted as "conscience" of the subcommittee—were no longer on it. The Oversight Committee Chair, Hokuto Hoshi, sort of explained their absences that care was taken to avoid dual memberships on the Thyroid Examination Assessment Subcommittee and the Oversight Committee. However, this does not explain the fact that Toru Takano was indeed given a dual membership. Takano advocates fetal cell carcinogenesis as opposed to multistep carcinogenesis, claiming thyroid cancer already exists in childhood which "nicely" explains away a large number of thyroid cancer detected in Fukushima. Takano has called for scaling down Fukushima's TUE in the January 14, 2017 blog post. Takano's presence on both the Oversight Committee and the Thyroid Examination Assessment Subcommittee was recommended by the Japan Thyroid Association, and it is difficult to dismiss it as coincidence.

Gen Suzuki and Tomotaka Sobue have actively participated on various government committees related to health effects of radiation exposure, usually representing the interests of the government. As covered in the previous post, Suzuki is in charge of the government-funded research project on dose reconstruction, effectively reducing exposure doses from the Fukushima nuclear accident: estimated doses (external and internal) for a 1-year-old are now reduced to 7% to 69% of estimated doses in the UNSCEAR 2013 report. Sobue has so far tried to apply pros and cons of adult cancer screening to a unique situation in Fukushima where children were exposed to radiation without the protection of stable iodine tablets. Kota Katanoda, apparently replaced Shoichiro Tsugane, with whom he worked on a document submitted to the Subcommittee in November 2014.

Selection of the subcommittee chair 

When Gen Suzuki was appointed the subcommittee chair by prefectural officials due to lack of nomination from the subcommittee members, a collective gasp was felt in the SNS timeline—across the computer screen—among those who consider him a "master under-estimator" of radiation effects. Added to the absence of Shimizu and Kasuga, installment of Suzuki as chair appeared to effectively set the tone of the subcommittee: a charade. Actual discussions that ensued were productive in some sense and the subcommittee members might be participating earnestly, but Suzuki tactfully and systematically—in his usual manner—dismissed key issues such as the sex ratio and the regional differences in detection rates suggestive of dose-response.

While effectively facilitating discussions amongst the subcommittee members and engaging appropriate officials from Fukushima Medical University (FMU), Suzuki took liberty to utilize his position as chair to infuse the discussions with his own opinions. His nonchalant manner is deceiving, and viewers are almost tricked into accepting Suzuki's opinion as a consensus of the subcommittee. His contemptuous manner sharply contrasts modesty of the former chair Shimizu who refrained from thrusting his own opinions as he presided over the subcommittee, despite his past experience of operating on thyroid cancer patients in Chernobyl.

Adjusted detection rates

Table 11 from the final report of the second round (below) shows cancer detection rates (per 100,000) from four administrative regions (evacuation region, Nakadori, Hamadori, and Aizu) as 49.2, 25.5, 19.6 and 15.5, respectively. 

This sharply differs from the similar table (shown below) from the first round (FY2016 revised version) that shows cancer detection rates (per 100, 000) from the same four regions as 33.5, 38.4, 43.0 and 35.6, respectively. These numbers formed the basis of FMU's claim that there was no regional difference, i.e., dose-response in the first round.



According to Handout 2-3 (in Japanese only) distributed at the 8th Thyroid Examination Assessment Subcommittee, detection rates by region are influenced by factors such as age, sex, interval between screenings, participation rates in the primary and confirmatory examinations by age group. Akira Ohtsuru, head of the Thyroid Ultrasound Examination (TUE), pointed out that the mean age at exposure decreases to the right of the table whereas the mean age at diagnosis increases, and that the proportion of female participants varies by region. It was claimed that further analyses be conducted by making adjustments by such confounding factors, and FMU appeared to be looking to the Thyroid Examination Assessment Subcommittee for guidance on which factors to adjust for. 

As an example, an adjustment was made for the interval between the first and the second round screenings. The table below is an unofficial English translation of the adjusted table: an increase in number is denoted in red, and a decrease in blue. Including only those who participated in both the first and the second round actually increased  detection rates per 100,000 in 3 regions other than Aizu, but the main point made by FMU appears to be the fact that adjusting the detection rates by the interval between the first and second round screenings decreased those numbers from 53.1 (per 100,000) to 21.4 (per 100,000 per year) for the evacuation region, 27.7 to 13.4 for Nakadori, 21.5 to 9.9 for Hamadori, and 14.4 to 7.7 for Aizu.


Essentially, this adjustment proved informative by converting prevalence (per 100,000) to incidence (per 100,000 per year) among those who participated in both the first and the second rounds. As seen on the bottom row of the adjusted table, there is a clear regional difference. There were multiple questions—from members of the subcommittee and the press—about what to make of the regional difference. FMU's answer was that further adjustments were needed to draw any conclusion, and Suzuki stated that the results are likely biased and an adjustment by tumor diameter was due because the average tumor diameter differed between FY2014 (9.4 ± 3.1 mm) and FY2015 (15.8 ± 8.0 mm) (see Table 6 here). 

Handout on sex ratio of thyroid cancer 

Handout 2-2 (in Japanese only) released by FMU contains existing information gathered by FMU regarding the sex ratio of thyroid cancer. This handout consists of 3 parts: 1) sex ratios from the national cancer registry data from 1975 to 2013; 2) past studies on radiation effects, namely the atomic bomb survivor study (Preston et al. 2007), the Belarus study (Zablotska et al. 2011), and the Ukraine study (Tronko et al. 2017); and 3) autopsy studies (JAMA 209, 1969Cancer 36, 1975; and Cancer 65, 1990).

This handout was apparently prepared to present scientific evidence to back up the repeated statement by Akira Ohtsuru—excerpted below from this post—in an attempt to justify the smaller-than-expected female to male ratio (F:M) consistently observed in the TUE (1.97:1 in the first round and 1.22:1 in the second round).

The female to male ratio in Japan's cancer registry data, including all ages, is around 3:1, but it used to be bigger at 4:1 or 6:1 in the 1980's and earlier. In Fukushima, the TUE was conducted in asymptomatic youth around puberty--a different condition than the cancer registry. Yet even in the cancer registry, the female to male ratio tends to be close to 1:1 up to the puberty. Autopsy data of occult thyroid cancer in individuals who died of causes other than thyroid cancer show the female to male ratio of 1:1 or smaller (more males) in adults. This fact indicates that thyroid cancer screening would yield the female to male ratio close to 1:1 even in adults. Thus, it is scientifically expected that thyroid cancer screening in general leads to a smaller female to male ratio.

The cancer registry data from 1975 to 2013 shows the female to male (F:M) ratios of 0.7:1 in ages 5-9, 1.8:1 in ages 10-14, and 4.3:1 in ages 15-19. Considering that 99 of 116 thyroid cancer cases in the first round and 56 of 71 cases in the second round were ages 15 or older at diagnosis, the cancer registry data as presented in the handout merely supports the fact that the female to male ratio observed is indeed smaller than expected.

The handout then refers to three radiation studies which reported "no statistically significant difference by sex in thyroid cancer risks due to radiation." These are the studies of childhood exposure with cancer mostly diagnosed as adults. But this is missing the point: what has been of concern is the actual sex ratio of Fukushima's thyroid cancer cases being diagnosed in youths. In the second round, the FY2015 cohort from supposedly less contaminated municipalities than the FY2014 cohort (see the map on page 3 here) even shows a "flipped" ratio with male dominance (F:M=1:1.38). This flipped ratio raised a question about whether these individuals were potentially exposed to higher radiation doses than estimated from, for instance, more athletic activities outdoors leading to higher inhalation doses.

Needless to say, the autopsy data on usually including older individuals does not offer good evidence for the sex ratio in children and adolescents. 

As asserted by a freelance journalist Mako Oshidori during the press conference, a study such as this shows smaller female to male ratios in radiation-induced thyroid cancer in children. When Oshidori questioned if the sex ratio issue would be pursued beyond the handout in the future, Suzuki kept stating that the sex ratio was "no good indicator" of radiation effects.

A long debated issue that has raised repeated questions and calls for investigation from Oshidori and the former chair Shimizu, the sex ratio issue appears to have been effectively dismissed by Suzuki's arbitrary claim. 

Outdated clinical information 

Also revealed at the 8th Thyroid Examination Assessment Subcommittee was a handout titled "Regarding surgically indicated cases." Disappointingly, this handout comprised outdated information in a collection of power point slides from the September 2016 international symposium that were partly revised and translated into Japanese. The original slides are discussed in detail in this post. The only useful piece of information was a verbal confirmation by Susumu Yokoya, Director of the Thyroid and Endocrine Center at Fukushima Global Medical Science Center, Fukushima Medical University, that 2 of 3 poorly-differentiated thyroid cancer cases from the first round were indeed reclassified as the solid variant of papillary thyroid cancer in accordance with the latest 7th edition of diagnostic guidelines.

Other issues

Other issues that were brought up during the subcommittee meeting include the status of the national and regional cancer registry and the school-based screening.

Sobue explained that the national cancer registry, implemented in 2016, might not be ready for use due to data collection taking time, but that the regional cancer registry by prefecture that was in place prior to 2016 should have data that can be used to gather information on thyroid cancer cases which have been diagnosed and clinically followed outside FMU as well as the FHMS-TUE system. Fukushima Prefecture began the regional cancer registry in 2008. Seiji Yasumura, head of the Public Health Department at FMU stated that FMU has been going over the regional cancer registry data, following trends of various cancers before and after the 2011 nuclear disaster. FMU apparently intends to conduct analyses on not just thyroid cancer but all cancers.

Regarding the school-based screening, a question was raised by Takano as to whether students are examined during school hours which might make the screening appear mandatory. According to Sanae Midorikawa from FMU, the school-based screening is conducted on weekdays year round. Children from elementary school through high school undergo the TUE usually during the first 2 class periods in the morning. (Just like school-based health examinations routinely conducted in Japan). 









Fukushima Thyroid Examination October 2017: 154 Surgically Confirmed as Thyroid Cancer Among 193 Cytology Suspected Cases



Highlights:

  • Only 3 suspected/confirmed cases—all in the third round—were newly diagnosed by cytology since the last report. Total number of suspected/confirmed thyroid cancer = 193 (excluding a single case of benign tumor; 115 in the first round, 71 in the second round, and 7 in the third round).
  • Two additional cases of surgery since the last report, one each in the second and the third round: total number of surgically confirmed cancer cases =154 (101 in the first round, 50 in the second round, and 3 in the third round)
  • The second round screening is nearly complete; the final report to be released at the next Oversight Committee or Thyroid Examination Assessment Committee. 
  • A new two-year term begins for newly appointed and returning members of the Oversight Committee as well as the Thyroid Examination Assessment Subcommittee. Surprisingly, Kazuo Shimizu—former Subcommittee Chair—was not even appointed to be on the Subcommittee
On October 23, 2017, the 28th Oversight Committee for Fukushima Health Management Survey convened in Fukushima City, Fukushima Prefecture. Among other information, the Oversight Committee released the latest results (as of June 30, 2017) of the second and third rounds of the Thyroid Ultrasound Examination (TUE).  Official English translation of the results are posted here. Minutes of the proceedings are only released in Japanese, and the transcript of the press conference held immediately after the committee meeting is not officially released. The narrative below includes pertinent information covered during the committee meeting and the press conference.

Overview
This Oversight Committee meeting was nearly 2 months overdue. In fact, it was held so late that it could have presented data as of September 30, 2017. But no, all that was presented was rather "old" data as of June 30, 2017, which changed very little in terms of the number of cancer cases compared to the previous data as of March 31, 2017. As schools in Japan go into summer recess in the last one-third of July through the end of August, more cancer cases might be included in the next set of data as of September 30.

Here's the summary of the latest results as of June 30, 2017

Notable new members
With the past term for committee members ending on July 9, 2017, this Oversight Committee opened with some new members. (See the Oversight Committee roster in Japanese here). The most controversial might be Toru Takano, an Osaka University physician researcher who advocates fetal cell carcinogenesis as opposed to multistep carcinogenesis. Takano's hypothesis claims thyroid cancer already exists in childhood which "nicely" explains away a large number of thyroid cancer detected in Fukushima. Takano has called for scaling down Fukushima's TUE in the January 14, 2017 blog post. Takano was recommended to be on the Oversight Committee and the Thyroid Examination Assessment Subcommittee by the Japan Thyroid Association.

As for the new roster of the Thyroid Examination Assessment Subcommittee, Kazuo Shimizu—former Subcommittee Chair—and Fumiko Kasuga—who one might say acted as "conscience" of the Subcommittee—were no longer on it. Takano is joined by Gen Suzuki (recommended by the the Japanese Radiation Research Society) and Tomotaka Sobue (recommended by the Japan Epidemiological Association), both of who have actively participated on various government committees related to health effects of radiation exposure. Kota Katanoda from Division of Cancer Statistics Integration, National Cancer Center appears to have replaced Shoichiro Tsugane. Katanoda and Tsugane have worked on a document submitted to the Subcommittee previously.

Interim report on dose reconstruction studies
Most of the meeting time was spent on presentation by Gen Suzuki on a 3-year interim report of "Comprehensive studies on the dose reconstruction for residents in Fukushima nuclear accidents." Suzuki's presentation slides (in Japanese) can be found here, and an English abstract can be found on pages 437-439 (pages 27-29 of PDF) of the interim report to the Ministry of the Environment. 

"Comprehensive studies" consist of 4 separate studies (English abstract page in parenthesis) on 1) updating source term and atmospheric transport dispersion simulations (page 508), 2) retrospective reconstruction of iodine 131 release through iodine 129 (page 516), 3) dose reconstruction of Fukushima residents in early stages (page 528), and 4) prediction of blood deposition and thyroid accumulation of radioiodine (page 542).

Among loads of complicated pieces of information, the take home message was that estimated doses (external and internal) for a 1-year-old are now (successfully?) reduced to 7% to 69% of estimated doses in the UNSCEAR 2013 report. 

Full-Scale Screening (FSS) (second and third rounds)
To be conducted every 2 years until age 20 and every 5 years after age 20, the FSS began with the second round screening (the first FSS) in April 2014, including those who were born in the first year after the accident. There are 381,256 eligible individuals born between April 2, 1992 and April 1, 2012. As of June 30, 2017, 270,516 (5 more than previously) have actually participated in the primary examination. 

A participation rate of 71.0% is lower than 81.7% from the first round screening. Results of the primary examination have been finalized in 270,515 participants, and 2,227 (1 more than previously) turned out to require the confirmatory examination. 

The confirmatory examination appears to be still ongoing for the second round. Of 2,227 requiring the confirmatory examination, 1,844 (12 more than previously) have participated at a participation rate of 82.8%—lower than 92.9% from the first round screening. So far 1,788 have received the final results including 205 (5 more than previously) that underwent fine needle aspiration cytology (FNAC) which revealed 71 cases suspicious for cancer with no new case diagnosed at this time. 

Confirmation of thyroid cancer requires pathological examination of the resected thyroid tissue obtained during surgery. There has been only 1 additional surgical case in the second round since the last reporting. As of June 30, 2019, 50 underwent surgery and 49 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 it has been reported as a differentiated thyroid cancer that is not known to be related to radiation exposure and it is allegedly neither poorly differentiated thyroid cancer nor medullary cancer). 

The third round screening or the second FSS has covered 138,422 or 41.1% of the survey population of 336,631, which excludes those born in FY1992 and FY1993 who are eligible for the age 25 milestone screening. The primary examination results have been finalized in 123,857 or 89.5% of the participants, revealing 754 (63 more than previously) to require the confirmatory examination. Results of the confirmatory examination have been finalized in 367 of 438 (83.8%) that have been examined. FNAC was conducted in 18 (7 more than previously) individuals, and 3 were newly diagnosed with suspected thyroid cancer (2 females and 1 male). There was 1 new surgical case in the third round.  

A confusing issue on composition of target populations
Conducted every 2 years up to age 20, the TUE transitions at age 25 to "milestone screenings" to be conducted every 5 years. Some residents are beginning to participate in the age 25 milestone screening, and if they have never participated in the TUE, their milestone screening results were added to the second round screening results. Thus the number of the second round screening participants kept increasing even though the screening period technically ended in March 2016. 

However, the third round screening survey population excludes the age 25 milestone screening participants: their results will be tallied up separately.

Also in some cases, confirmatory examinations from the second and third rounds might be simultaneously ongoing, or there could be significant delays in conducting confirmatory examinations due to logistical issues such as the lack of manpower. A two-year screening period originally designed for subsequent rounds of the Full-Scale Screening is essentially spread over a longer time period, overlapping with the next round of screening. A precise interpretation of the results from each round of screening might be nearly impossible.

Participants beyond age 23 dropped from released datasets
As mentioned in the previous section, participants eventually move onto the "milestone screening," every 5 years beginning at age 25. No more than 5 years are to pass between examinations up to age 25. 

The chart shown below is the FSS implementation plan from the third round onward (taken from the blue link in this document on the prefectural website on the TUE for residents). It represents ages of participants by their birth years (leftmost vertical column) at particular years of screening (top row). (Years here are "fiscal years" which run from April 2 of one year to April 1 of next year). Darker blue color denotes the milestone screening participants, yellow the participants in the FSS to bridge the gap before the milestone screening, and lighter blue the regular FSS participants. White color denotes no screening during a given fiscal year.


Based on this chart, the third round excludes those who were born in FY1992 and FY1993 as described earlier. This breaks down to 23- and 24-year-olds from the FY2016 targeted municipalities and 24- and 25-year-olds from the FY2017 municipalities. Thus technically, the third round screening includes only half of 23-year-old residents, with the other half of 23-year-olds and all of 24-year-olds not even screened until FY2018.

Although the milestone screening are being tallied up separately, there has been no talk about when and how—or if—the separate results are to be shared with the Oversight Committee.

From the above chart, it should be noted that as the TUE goes on, the age distribution graph will be skewed to younger ages, and the results will not represent all the residents who were 18 or younger at the time of the accident. The "age-at-exposure" distribution graph shows an X-axis up to age 18, but older age group won't even show up there with each successive round of screening: for the third round, that means all residents who were 17 or 18 and some who were 16 on March 11, 2011. 
Fig 3 Age distribution of suspected/confirmed cancer cases (age at exposure)
Second round on left, third round on right

When looking at the age-at-examination distribution graph as below, the "dropping" of older residents as they turn 23 (some) and 24 is something that should be kept in mind.
Fig 4 Age distribution of suspected/confirmed cancer cases (age at confirmatory exam) 
Second round on left, third round on right

Newly diagnosed cases
The second round: No new case diagnosed.

The third round: Three cases were newly diagnosed by FNAC with suspicion of cancer. One was from the evacuation area, and the other two are from Nakadori, the central part of Fukushima Prefecture. Two are males whose ages-at-exposure were 11 and 12, and one was a female who was age 10 at exposure.

Prior diagnostic status of the cases newly diagnosed with cancer
The second round: Of 71 total cases suspected or confirmed with cancer in the second round, 33 were A1, 32 were A2 (7 nodules, 25 other non-nodular lesions), and 5 were B (at least 2 having undergone the confirmatory examination) in the first round. One remaining case never underwent the first round screening (no information such as age, sex or place or residence, is available regarding this case).

The third round: Of 3 newly diagnosed cases, 1 was A1 and 2 were non-nodular A2.

This means at least 63 (34 "A1" and 29 "A2 other") of 78 cases (81%) had no nodules detected by ultrasound in the previous round which could have developed into cancer. Akira Ohtsuru, the head of the TUE essentially reiterated that they were "newly detected" rather than "newly formed." (See this post for details of Ohtsuru's previous claim). 

An issue of the female to male ratio
The female to male ratio of cancer cases warrants a special attention. For thyroid cancer, the female to male ratio is nearly 1:1 in the very young, but it is known to increase with age and decrease with radiation exposure. (See below Slide 2 in this post for more information). In the second round, the overall female to male ratio is 1.22:1, but the FY2015 municipalities have consistently shown a higher number of males than females with the most recent female to male ratio of 1:1.38. For the third round, the female to male ratio started out with 1:1, and now 1:1.33.

What Ohtsuru said about the the female to male ratio is essentially the same as his statement at the previous two meetings, justifying the low female to male ratios observed in this population without concrete scientific evidence. (Refer to this post or the fact sheet for details).

Reporting results by regions, not municipalities
From the third round onward, confirmatory examination results are no longer available by individual municipalities as before. Rather, the results are reported by four regions:
1) 13 municipalities in the evacuation zone (some municipalities only partially evacuated)
2) Nakadori (central region)
3) Hamadori (eastern, coastal region)
4) Aizu (western region)

Reasoning behind this, according to FMU, is to protect privacy and deter discrimination against those from smaller municipalities diagnosed with thyroid cancer. Ohtsuru backed up the new reporting format by explaining how medical data based on the national insurance claim are protected by not disclosing the number of cases in municipalities with population fewer than 2,000, as per the guidelines established by the Ministry of Health, Labour and Welfare. This regional reporting of cancer cases will essentially make comparisons between the second round and the third round data impossible.

New study to document unreported cases of thyroid cancer
It was announced that a new "research" project was to be launched to investigate how many cases of thyroid cancer were not included in the official count (see the document in Japanese here). Currently awaiting approval from the Ethics Board of FMU, this research project is to be conducted through September 30, 2019 by Susumu Yokoya, Director of Thyroid and Endocrine Center at Fukushima Global Medical Science Center, Fukushima Medical University.

The issue of unreported cancer cases came to light back in March 2017, when it was discovered that thyroid cancer diagnosed in a boy (age 4 at exposure) during follow-up medical visits was not included in the official count. The boy apparently had surgery at FMU, but his case wasn't in the official count because he was under regular medical care using national health insurance.

The new research project apparently will go through medical records at FMU to find cases that had positive fine-needle aspiration cytology results and/or surgery. For each case, an inquiry will be made with the Radiation Medical Science Center to see if it's been included in the official count, in order to tally up unreported cases of thyroid cancer.

Just why it would take UP TO SEPTEMBER 2019 to conduct this seemingly simple investigation was the question on everyone's mind. Also, this project would identify unreported cases diagnosed at FMU only.

International Expert Committee
Incidentally, this meeting coincided with the first day of the First Expert Meeting of Thyroid Monitoring after Nuclear Accidents (TM-NUC) by IARC, held on October 23-25, 2017 in Lyon, France. TM-NUC is the final product of a call for a new third-party committee" by Chairman Hoshi at the 26th Oversight Committee held on December 27, 2016. This call for a new "international, third-party, neutral, scientific, up-to-date and evidence-based" expert committee appears to have originated from the October 31, 2016 recommendations (PDF link here) by the 5th International Expert Symposium on Radiation and Health held on September 26-27, 2016. 


Details on circumstances regarding how TM-NUC came about are described in this post.


*****

Below is the summary of the basic information from each round of screening.

First Round Screening (October 2011 - April 2015)
(This is the updated final results as of March 31, 2017).
The number of confirmed and suspected cancer cases remains the same, but some information has been corrected for duplicates.

Total number targeted: 367,649
Number of participants in primary examination: 300,473
Number with confirmed results: 300,473
  • A1   154,605 (51.5%) (no nodules or cysts found)
  • A2   143,574 (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: 2,293
Number of participants in confirmatory (secondary) examination: 2,130
Number with confirmed results : 2,090
Number of fine-needle aspiration cytology (FNAC): 547
Number of cases 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: 381,256
Number of participants in primary examination: 270,516
Number with confirmed results: 270,515
  • A1   108,710 (40.2%) (no nodules or cysts found)
  • A2   159,578 (59.0%) (nodules ≦ 5.0 mm or cysts ≦ 20.0 mm)
  • B        2,227  (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: 2,227
Number of participants in confirmatory (secondary) examination: 1,844
Number with confirmed results : 1,788
Number of fine-needle aspiration cytology (FNAC): 205
Number of cases suspicious or confirmed of malignancy: 71
Number with confirmed tissue diagnosis after surgery: 50
  • 49 papillary thyroid cancer
  • 1 "other" thyroid cancer
Third Round Screening (May 2016 - March 2018) (see report here)
Total number targeted: 336,631
Number of participants in primary examination: 138,422
Number with confirmed results: 123,857
  • A1   43,388 (35.0%) (no nodules or cysts found)
  • A2   79.715 (64.4%) (nodules ≦ 5.0 mm or cysts ≦ 20.0 mm)
  • B          754  (0.6%) (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: 754
Number of participants in confirmatory (secondary) examination: 438
Number with confirmed results : 367
Number of fine-needle aspiration cytology (FNAC): 18
Number of cases suspicious or confirmed of malignancy: 7
Number with confirmed tissue diagnosis after surgery: 3
  • 3 papillary thyroid cancer

Table 6. Cytology results (as of June 30, 2017) 
(including information from Appendix 6: Number of surgeries among cases with malignancy or suspicion of malignancy)

Second Round Screening

Third Round Screening

Age distribution (age at the time of the March 2011 accident)



Circumstances Regarding the Japan-Sponsored IARC Expert Group on Thyroid Monitoring After Nuclear Accidents (TM-NUC)


On October 23-25, 2017, the Expert Group on Thyroid Monitoring after Nuclear Accidents (TM-NUC) met in Lyon, France for the first of two planned sessions (see this PDF for the agenda). The TM-NUC project was established by the International Agency for Research on Cancer (IARC) in order to "develop strategies and recommendations on how to plan and implement thyroid monitoring in populations possibly affected by radiation exposure due to nuclear accidents." 



The aims of the TM-NUC project are to: 
assess the latest scientific evidence on the epidemiology, natural history, and clinical management of thyroid cancer, to develop principles for thyroid ultrasound examinations after nuclear accidents. This includes reviewing the scientific literature and compiling knowledge and experience from relevant countries. 
identify unmet research needs and propose epidemiological study designs to address these gaps in knowledge.          
According to the TM-NUC website
The Expert Group consists of 16 international experts from a variety of fields, including cancer screening, radiation epidemiology, radiation dosimetry, pathology, oncology, endocrinology, and surgery, and is supported by a Scientific Secretariat (Chair and Scientific Coordinator) from the IARC Section of Environment and Radiation 
The primary goal of the Thyroid Monitoring after Nuclear Accidents (TM-NUC) project is to use current scientific evidence and past experience to develop principles for thyroid monitoring in populations possibly affected by radiation exposure due to nuclear accidents. Such principles will help guide policy-makers and health professionals in planning thyroid monitoring in case of nuclear accidents.
The TM-NUC project is funded by the Ministry of the Environment of Japan.     
Next meeting is scheduled for February 21-23, 2018, and the final recommendations are expected by the end of April 2018.

The first day of the first meeting coincided with the 28th Oversight Committee for the Fukushima Health Management Survey (FHMS) held in Fukushima City, Fukushima on October 23, 2017. That the Oversight Committee—nearly 2 months overdue and rumored to have been originally scheduled for October 16—convened on the first day of the TM-NUC Expert Group meeting may be purely coincidental. Nevertheless, circumstances leading to the birth of the TM-NUC are curious enough to warrant further consideration.

At the 26th Oversight Committee meeting held on December 27, 2016, Chairman Hokuto Hoshi stunned everyone by unexpectedly calling for a new "international, third-party, neutral, scientific, up-to-date and evidence-based" expert committee. This expert committee would discuss issues surrounding the Thyroid Ultrasound Examination (TUE) and present information in a manner that would "aid the understanding by Fukushima residents." This proposal apparently originated from the October 31, 2016 recommendations (PDF link here) by the 5th International Expert Symposium on Radiation and Health held on September 26-27, 2016. An excerpt from the item 4 of the recommendations reads as follows:
One possibility would be to convene expert working groups on issues related to the mitigation of health impacts of the Fukushima Daiichi NPP accident, and health monitoring. One of the expert working groups on “Nuclear Disasters and Health Monitoring”, especially focusing on thyroid problems, could provide professional recommendations to the current TUE in Fukushima in future. The international consensus should be shared with all stakeholders, such as national and local governments and public representatives of the affected communities, to improve the current TUE program.
Hoshi's proposal was received skeptically by some committee members as well as journalists but quickly embraced by Tamami Umeda, a committee member representing the Ministry of the Environment (MOE). According to the minutes of the proceedings (in Japanese), a committee member Fumiko Kasuga suggested an expanded role for the Thyroid Examination Assessment Subcommittee (referred as the "Subcommittee" herein) instead, with input from invited international experts, rather than establishing a brand new expert group. Kasuga's suggestion made sense if the new expert group was actually going to focus on Fukushima's TUE, especially when the Subcommittee hadn't met since March 24, 2015 and no official discussion hasn't been conducted beyond the first round results. During the press conference, some journalists questioned why a new committee was even necessary and if the need for a new committee implied that the Oversight Committee wasn't scientific enough.

Two months later, at the 26th Oversight Committee meeting held on February 20, 2017, a prefectural official stated that this "third-party" committee with a neutral standpoint was expected to organize the latest knowledge to be incorporated into discussions at the Oversight Committee and the Subcommittee. He stated that prefectural officials, assisted by the central government, were consulting with international organizations in establishing a third-party committee. Representing the MOE, Umeda stated that she envisioned a new expert group to be separate from yet supplemental to the Subcommittee. 

Three months later, on May 31, 2017, an establishment of a new international expert committee was announced in the Fukushima Minpo article (archived here). According to the article, the international expert committee, established by Fukushima Prefecture and Ministry of the Environment, would investigate causality between the nuclear accident and thyroid cancer. The article stated that selection of the committee members would be based upon recommendations from relevant academic societies within Japan as well as from international organizations specializing in radiation protection or medicine and health. Fukushima Prefecture was to explain about the plan at the June 5th Oversight Committee meeting. 

Five days later, the story took a sharp turn when a new development was revealed at the 27th Oversight Committee meeting held on June 5, 2017. This is described in more detail in this postunder the subheading "The status of the new third-party committee." In short, Umeda was searching for a World Health Organization (WHO) agency that might be a good candidate as an expert committee, when she came across an already planned international expert group by IARC that was tasked with investigation of thyroid monitoring after nuclear accidents. Umeda thought this expert group by IARC might be a good match even though it would not be actually analyzing Fukushima's TUE data(See the minutes of the proceedings in Japanese here). Her fluent explanation of finding a planned IARC expert group made it sound as if it were a happenstance, but the details that emerged 2 days later suggest otherwise: It is very likely that this was a done deal merely being reported to the Oversight Committee.

Two days later on June 7, 2017, Umeda posted on the MOE website an open competitive bidding notice for a commissioned project involving administrative support services for the IARC expert group. A draft contract for the commissioned project (PDF in Japanese available here) is quite revealing and suggests that this might have been planned by the MOE for some time. 

The draft contract explains that IARC has proposed an establishment of an international expert group aiming to offer scientific information and advice on radiation health effects to policy makers and medical professionals in "countries" (probably means "WHO member states"). It claims that the purpose of the commissioned project is to collect information necessary for discussions regarding the FHMS by supporting the IARC expert group. The project is necessary for translation of two reports to be compiled by the IARC expert group and for compilation of a summary report and a manual. The commissioned project is expected to last until the end of December 2018, encompassing two fiscal years—FY2017 to FY2018. 

Two reports to be created by the IARC expert group already have titles: 

  • Report 1: Review the latest scientific evidence and development of principles of TUE as long-term health monitoring instrument for populations possibly affected by radiation exposure due to the nuclear accidents. Research agenda how to address gaps in scientific knowledge. 
  • Report 2: Detailing study and features for activities from the research agenda. 

According to the job description, the commissioned project consists of three parts: 

  1. administrative work related to holding two expert group meetings and translating the final reports into Japanese
  2. administrative work related to a visit to Fukushima Prefecture by the expert group (including a site visit to FDNPP and the TUE facilities, and a panel discussion with domestic experts) and creating a summary report
  3. side-by-side English/Japanese translation of reports from the expert meetings and from the visit to Fukushima, with technical supervision from the standpoint of radiation health effects

The job description also lays out concrete details such as the amount of stipend to be paid to each expert member (17,700 yen or 155 USD daily), and the coverage of reimbursable travel costs (business class tickets on direct flights or flights with the fewest number of connections to Tokyo). Group members are to be about 15—4 from France, 1 from Finland, 3 from the U.S., 1 from Japan, 1 from South Korea, 1 from Germany, 1 from Ukraine, 1 from the U.K., 1 from Italy and 1 from Switzerland. 

Most administrative duties related to the expert group are to be outsourced to the IARC for 281,700 Euro. These duties include member selection and invitation, setting up and running the expert meeting, compiling meeting materials, and making payments to members for travel costs and stipends. Further, one of the FY2018 duties for the commissioned project includes making a payment of 80,700 Euro to IARC to cover the cost of the meeting. In total, the Japanese government is paying 362,400 Euro (over 422,000 USD) to cover the entire cost of the IARC expert group in the TC-NUC project. 

It is doubtful if the TM-NUC project, fully funded by the Japanese government, actually fulfills qualities originally proposed by Chairman Hoshi—international, third-party, neutral, scientific, up-to-date and evidence-based. It certainly is "international." A quick glance at the member list shows some "familiar names" such as Geraldine Thomas, casting doubt on its neutrality. A critical examination of the member composition reveals connections with entities with potential biases such as United Nations Scientific Committee on Atomic Radiation (UNSCEAR), Radiation Effects Research Foundation (RERF), and the 5th International Expert Symposium on Radiation and Health sponsored by the Nippon Foundation. 

The Expert Group may appear "third-party" to Fukushima Medical University (FMU) that conducts the TUE, with an exception of an FMU official, Hiroki Shimura. However, IARC itself has had a close relationship with FMU, visiting FMU as early as November 2012, signing Letter of Collaboration with FMU in January 2013, and conducting a joint workshop at FMU as well as a special seminar to the Fukushima Medical Association in October 2013. A report of the 2013 joint workshop has been published

There is also an inherent problem in the seemingly "closed" field of radiation protection with a premise to allow the use of radiation, medical or industrial. Radiation risk assessment relies on the atomic bomb survivor data as the "gold standard." However, this gold standard is actually far from perfect with missing data and disregard for internal exposure from the black rain and neutron-activated radioactive manganese 56. Any "evidence" built upon faulty assumptions is faulty by default, yet it is exceedingly difficult for "outsiders" to gain insight into such inconsistencies.

Some of the researchers may appear "neutral," yet their research interests might encompass "overdiagnosis" which is what Fukushima's cases are being attributed to by FMU officials despite lacking proper analysis of data with scientific integrity and transparency as described below. 

Included in the TM-NUC agenda is a presentation on Fukushima's TUE by Shimura. Most likely the Expert Group was given only officially released information, which is missing data on at least one unreported thyroid cancer case and potentially more. Existence of the missing data implies any studies published by FMU using the TUE data potentially lack scientific integrity. Consequently, any international organizations—UNSCEAR, WHO, IAEA, to name a few—relying on such studies would not be able to conduct proper analysis on health effects of radiation exposure. FMU officials so far have not documented the issue of missing data in English publications. Long before the missing data surfaced, members of the Oversight Committee and the Subcommittee have repeatedly asked for more detailed information on the TUE data to no avail. It is notable that even UNSCEAR has urged a release of more pertinent information, such as "more detailed breakdowns of the numbers of young people screened, and of confirmed/suspected thyroid cancers by tumour size, and by age at irradiation, and age at screening, and sex," in the 2017 White Paper (see paragraph 123).

The TM-NUC agenda also includes a presentation on EC-funded SHAMISEN project ("SHAMISEN" is a reverse acronym for "Nuclear Emergency Situations Improvement of Medical and Health Surveillance") which issued a recommendation against systematic thyroid cancer screening. (Click on "R25" here for details. See the whole recommendations here). This presentation was given by Evgenia Ostroumova and Ausrele Kesminiene from IARC's Section of Environment and Radiation. Timing of the presentation towards the end of the meeting by members affiliated with IARC—which constitutes the core of the Expert Group—easily leads to speculation that IARC might be facilitating political, rather than scientific, decision-making. 

Even at this point when the first meeting has already occurred, no official announcement has been made in Japan regarding the progress of the IARC Expert Group or its member composition. Moreover, existence of the SHAMISEN project itself has not been officially announced to the general public in Japan. 

The SHAMISEN recommendations are supposedly based on science but actually characterized by a political overtone prioritizing psychological, social, and economic effects. They appear to be directed towards political policy-making. Ironically, contrary to the notion put forth by Umeda that the Expert Group would not be actually analyzing Fukushima's TUE data, the SHAMISEN recommendations, part of the presentation, already incorporate Fukushima's incomplete and biased data. It appears that IARC's TM-NUC Expert Group may be a vehicle for the SHAMISEN recommendations to be distorted into scientifically neutral recommendations to form an international consensus, with a strong potential to influence situations in post-Fukushima Japan where the future of the TUE is in debate.

Chairman Hoshi's original proposal has morphed into something far from the international committee he envisioned. What the MOE and the Japanese government will likely gain from the TM-NUC Expert Group may be an international consensus built on faulty assumptions and biased data, but perhaps that is exactly what is sought by the reconstruction-hungry government and thus totally worth 362,400 Euro.





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