Fukushima Thyroid Examination April 2019: 168 Surgically Confirmed as Thyroid Cancer Among 212 Cytology Suspected Cases

*Table for The latest overall results including "unreported" cases was replaced with a corrected version showing that Age 25 Milestone Examination was conducted in FY2017, not FY2016 as stated in the original version.

Highlights 

• The third round: 3 cases newly diagnosed as suspicious or malignant, and 2 new cases surgically confirmed.
• The fourth round: 2 cases diagnosed as suspicious or malignant
• Total number of suspected/confirmed thyroid cancer is now 211 excluding a single case of benign tumor: 115 in the first round, 71 in the second round, 21 in the third round, 2 in the fourth round, and 2 in Age 25 Milestone Screening.
• Total number of surgically confirmed thyroid cancer cases has increased by 2 to 168 (101 in the first round, 52 in the second round, and 15 in the third round).
• Report of the 12th Thyroid Examination Assessment Subcommittee held on February 22, 2019 shows a "new" regional (dose-response) analysis and a disagreement on incorporation of TM-NUC recommendations into a new informed consent form. 

The latest overall results including "unreported" cases

(See this post for the details of the "unreported" cases.)

Delayed timing
     On April 8, 2019, the 34th Oversight Committee for Fukushima Health Management Survey (FHMS) convened in Fukushima City, Fukushima Prefecture. This was the "later-than-usual" first meeting of the quarterly Oversight Committee meetings to be held in 2019: first meetings of each calendar year which correspond to last meetings of each fiscal year ending March 31 have mostly been held in February (one in early March) reporting results as of December 31 of the previous year. Fiscal reports as of March 31 are usually released at the second meeting of each calendar year corresponding to the first meeting of each fiscal year usually held in mid-May to mid-June. There is a concern that delayed timing of the 34th Oversight Committee meeting could interfere with "timely" reporting of the final results of the 3rd round.
     Among other information, the Oversight Committee released the latest results (as of December 31, 2018) of the third and fourth rounds of the Thyroid Ultrasound Examination (TUE). Official English translation will be available here in the hopefully "near" future. (Note: English translation for the December 27, 2018 meeting was posted online on April 5, 2019.)

Summary on the current status of the TUE
     A five-page summary of the first through fourth rounds as well as the Age 25 Milestone Screening, "The Status of the Thyroid Ultrasound Examination," was also released, listing key findings from the primary and confirmatory examinations as well as the surgical information. This summary is not translated into English officially, but here's an unofficial translation. 

Status of the Thyroid Ultrasound Examination (April 8, 2019) on Scribd

Report from the 12th Thyroid Examination Assessment Subcommittee
     Chair of the Thyroid Examination Assessment Subcommittee (herein, subcommittee), Gen Suzuki, reported the content of the 12th subcommittee held on February 22, 2019. Suzuki's report is summarized here.
     Notably, Fukushima Medical University (FMU) reported a new analysis on associations between thyroid cancer occurrence in 2 age groups (6-14, ≥15) and minimum and maximum values of estimated thyroid absorption doses by UNSCEAR, concluding no observation of dose response. (However, an astrophysicist Junichiro Makino has questioned scientific validity of the analysis itself in April-June 2019 issues of Kagaku, pointing out inconsistencies between the original data and the 95% CI shown in graphs and between the results of this analysis and a previously published paper.)
     Discussions regarding risks and benefits of the TUE have long been incongruous. On September 28, an IARC expert group, Thyroid Monitoring after Nuclear Accidents (TM-NUC) released the first report as an IARC publication, followed by an article in the October 1, 2018 issue of the Lancet Oncology and the second report in March. (See this post on the "birth" of TM-NUC.) 
    The TUE informed consent form is currently undergoing revision to better inform participants of the risks and benefits. During the 12th subcommittee meeting, the discussion reached a new level of dichotomy between pubic health specialists wanting to use as the TM-NUC recommendations (summarized here) as evidence for overdiagnosis risks and clinicians doubting the evidence level of the TM-NUC report which is built on known-to-be-scarce evidence of pediatric thyroid cancer.
     As a matter of fact, TM-NUC's first report is not intended to guide how Fukushima's TUE should be implemented as described by TM-NUC chair Joachim Schüz during the press conference after the March 7, 2019 symposium in Tokyo sponsored by Ministry of the Environment and moderated by none other than Shunichi Yamashita to introduce the report. 
    The first report does incorporate findings from Fukushima's TUE by necessity, as data from one of the three nuclear accidents. Its section on "Overdiagnosis in Pediatric Thyroid Cancer" relies heavily on published papers on Fukushima's TUE, yet most of the published papers on the TUE are inherently biased. This is partly because the publicized data itself is incomplete and lacks transparency and partly due to the premature and scientifically unfounded premise by FMU to dismiss effects of radiation exposure before conducting a proper analysis on data beyond the first round. This topic is to be covered in a separate post, time permitted.

Implementation Status of the Support Program for the Thyroid Ultrasound Examination in Fukushima

Fukushima Prefecture offers a financial support program for the Thyroid Ultrasound Examination (TUE) of the Fukushima Health Management Survey (FHMS) as described on their website (Japanese only).  The TUE support program (herein, "the support program") was begun on July 10, 2015, after financial assistance was recommended by the Thyroid Examination Assessment Subcommittee in their March 2015 interim report, in order to lessen residents' financial burden from medical costs related to thyroid ultrasound findings.  

Since the 2011 nuclear accident Fukushima Prefecture has offered free medical care to those younger than 18, but as soon as they turn 18, they must pay 30% of costs of medical care related to thyroid nodular diseases diagnosed from the TUE. The support program is offered for for thyroid nodules suspected or confirmed of malignancy but excludes non-cancer thyroid diseases even when diagnosed through the TUE because the fundamental purpose of the TUE is to detect thyroid cancer which is known to occur in children after radiation exposure as in Chernobyl.

The support program was created to offset the out-of-pocket expenses as long as patients were not receiving any other public assistance including medical. However, the assistance was conditional: applicants to the program were to 1) be the TUE participants, 2) be receiving care from either FMU or medical facilities approved by FMU to offer the confirmatory examination (FMU-approved facilities), and  3) provide clinical information related to medical care rendered at the FMU-approved facilities which otherwise are not reported to FMU or Fukushima Prefecture.

In December 2018, condition 2) was dropped in order to expand the assistance to those who have sought medical care related to thyroid ultrasound findings completely outside of the FMU framework. However, the eligible applicants still had to have participated in the TUE at some point, reinforcing the original premise that the support program was to act as a feedback mechanism for improving the FHMS.

However, it was revealed in May 2018 that Fukushima Prefecture has done very little with the clinical information collected from the applicants, other than releasing a brief fiscal report on the implementation status (FY 2016, FY 2017) which included general information on the cumulative number of disbursements as well as the actual number and the age range of recipients. For the surgical cases, the same information was provided with an addition of the number of cases for each post-surgical pathological diagnosis.

For instance, the FY 2017 report shows 313 (121 in FY 2015, 104 in FY 2016, and 88 in FY 2017) disbursements were made cumulatively for 233 individuals during FY 2015-2017 for ages 18-25. Of 313, 82 (42 in FY 2015, 25 in FY 2016, and 15 in FY 2017) disbursements were made cumulatively for surgeries to 82 individuals, including 77 thyroid cancer cases (76 papillary and 1 poorly-differentiated) and 5 non-cancer cases such as follicular adenoma. It was not known how many of 82 surgical cases were actually included in the official count, and it became clear that the collected information never was or was to be cross-checked with the official data in order to assess which "supplementary" information might have been obtained. 

On December 12, 2018, it was reported that chief of the FHMS department in the prefectural government, Yoichi Suzuki, stated during a prefectural assembly session that almost all 233 individuals receiving assistance, including 151 that haven't undergone surgeries, had thyroid cancer. At the 33rd FHMS Oversight Committee meeting on December 27, 2018, Suzuki was grilled on the actual number of thyroid cancer cases among recipients of the assistance, but he would only repeat that the number of thyroid cancer cases was 77, and declined to elaborate any further. At the March 7, 2019 prefectural assembly session, Suzuki officially recanted his previous statement. 

Because the support program is for thyroid nodules suspected or confirmed of malignancy diagnosed after FNAC (fine-needle aspiration cytology), which as part of the TUE should not incur any out-of-pocket expenses, almost all recipients of the support program would have suspected or confirmed thyroid cancer by default, with some exceptions such as follicular adenoma that is difficult to distinguish from follicular cancer. Yet diagnosis is provided only for surgical cases, which is somewhat understandable because a definitive diagnosis of thyroid cancer requires pathological examination of thyroid tissues excised during surgery. On the other hand, applicants must submit clinical information including a given diagnosis, which Suzuki confirms with the medical facility where the applicant is receiving care.

Suzuki was no where in sight at the 34th Oversight Committee meeting held on April 8, 2019, having been replaced by another official through a routine, fiscal personnel reshuffling. New chief, Tatsuya Sugano, provided an updated report as of December 2018 (hence not a fiscal report) with an additional information such as breakdown of recipients by region and sex. 

Between July 10, 2015 and December 2018, 375 cumulative disbursements were made for 257 (90 males and 167 females; 47 from Hamadori, 165 from Nakadori, 25 from Aizu, and 20 from the evacuation zone; ages 18 to 26) individuals. This represents an addition of 62 disbursements in FY 2018 (through December 2018) and 24 individuals since the FY 2017 report. For surgical cases, 95 cumulative disbursements were made to 93 (38 males and 55 females) individuals, reflecting a FY 2018 increase of 13 disbursements. 

A discrepancy between the cumulative disbursements, 95, and the number of individuals, 93, means two extra surgeries conducted in FY 2018, suggestive of completion thyroidectomy following a lobectomy and/or surgery for a recurrence. Pathological diagnoses for 93 surgical cases include 87 thyroid cancers (85 papillary, 1 poorly-differentiated, and 1 follicular) and 6 non-cancer cases such as follicular adenoma, reflecting an additional 9 papillary thyroid cancers, a newly diagnosed follicular cancer, and an additional non-cancer case in FY 2018.

The updated report with a few additional details did nothing to resolve the fundamental issue of the support program data not being compared with the official count, failing to offer a more comprehensive picture of the current status of thyroid cancer in Fukushima. Granted, there are other factors contributing to incompleteness and lack of transparency in the official data: failure to report thyroid cancer cases diagnosed during clinical follow-up visits or even collect cases diagnosed at non-FMU facilities inside or totally outside the TUE framework. 

With dramatically declining participating rates in successive rounds of the TUE for ages 18 and older who might seek medical care outside Fukushima as they move on with their lives, the support program could be a valuable source of otherwise unavailable information for this age group, as in the actual number of suspected or confirmed thyroid cancer cases. Yet no matching or comparison with the official data has been conducted, and diagnoses provided by the participants themselves remain under the veil unless they had surgeries. Whatever this lack of transparency is suppressing must be very inconvenient.