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

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. 


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 Kagakupointing 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-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.

Where to Find Fukushima Radiation Health Survey Information: : Fukushima Medical University's Radiation Medical Science Center Website



Where to Find Fukushima Radiation Health Survey Information: Fukushima Medical University's Radiation Medical Science Center Website 

Fukushima Medical University's Radiation Medical Science Center opened a new website on January 10, 2019. The original English website, "Office of International Cooperation," is still active, although it seems to be updated at a lot slower pace nowadays. (It took 2 months for them to post English translation of the reports from the September 2018 Oversight Committee meeting, which used to come out in 3-4 weeks.)

The top page looks like this:



When you scroll down, 4 blue rectangles appear: 

  1. Radiation Medical Science Center: scrolls down the screen to show a greeting and organizational information. 
  2. Fukushima Health Management Survey: shows the report of the Fukushima Health Management Survey, with the current version being the "revised version" as of December 5, 2018. (The "original" version appears to have been deleted. For record, the current version is stored here.)
  3. Research/Publication: jumps to the Publications page of the Office of the International Cooperation
  4. Office of International Cooperation: jumps to the original website where official English translation of selected reports presented at the Oversight Committee meetings (here) and links to past conference and workshops (here) can be accessed.


If you are interested in information available in Japanese, click "Japanese Website" in the right upper corner of the top page. There are 3 blue rectangles with Japanese/English labels. 

Radiation Medical Science Center: scrolls down to the greeting and organizational information. 
Fukushima Health Management Survey: jumps to the top page of the Japanese website for the Radiation Medical Science Center's Fukushima Health Management Survey, which functions as an information hub for the Fukushima residents and includes all the basic information about each survey.
Research/Publications: jumps to the publications page of the above Japanese website.

*If you are specifically looking for information on the Oversight Committee for the Fukushima Health Management Survey where the results of the Thyroid Ultrasound Examination (TUE) are reported, the Fukushima Prefecture website offers an easier access here (in Japanese). 

Here's the screenshot of the partial list of the Oversight Committee meetings: 
Dates for each Oversight Committee meeting (First through thirty-third at this time) are shown, and the right column has links to the details of each meeting including links to all the handout materials as well as the meeting minutes. 

For instance, the 32nd Oversight Committee meeting details look like this:
The first section has a link to the meeting notice. The big middle section shows a list of the materials handed out at the meeting, not all of which are officially translated into English. The bottom section has a link to the meeting minutes.

Information on the Thyroid Examination Assessment Subcommittee can be similarly accessed here (in Japanese).



Shin-ichi Kurokawa Sets Straight Dishonesty and Misrepresentation in the Hayano Statement Regarding the Radiation Dose Study with Alleged Misconduct


This is an unofficial English translation of the article that originally appeared on the HARBOR BUSINESS Online (HBOL) website on February 11, 2019, posted here with permission from the HBOL. The English translation is supplemented with additional information as needed, enclosed in square brackets.

*February 20, 2019 update: PDF link for translation of the article co-authored by Kurokawa and published in the February 2019 issue of Kagaku is inserted in appropriate places. This translation is available in Kagaku's e-publication page and citable in AMA style as: Kurokawa S, Shima A. A Glass Badge Study That Failed and Betrayed Residents —A Study with Seven Violations of Ethical Guidelines Can Be No Ground for Government Policies. Kagaku. 2019;89(2):e0017-e0024.

Urgent Report: Professor Emeritus Kurokawa sets straight dishonesty and misrepresentation in the "statement" by Ryugo Hayano, the author of the radiation dose study with alleged misconduct


Written by Shin-ichi Kurokawa

 
   On January 8, 2019, Ryugo Hayano posted "A position statement regarding the external dose study in Date City residents" (herein, "statement") at the Ministry of Education, Culture, Sports, Science and Technology press club. He also tweeted it as below.
(Translation of Hayano’s tweet itself: Today, on January 8, I posted a “position statement regarding the external dose study in Date City residents” at the MEXT press club. It describes: the serious error which undercalculated the 70-year cumulative doses by a factor of 3; the reason for the error; unintentionality of the error; and apology to the Date City people.)


   This "statement" describes the "facts" surrounding the allegation made to the University of Tokyo for research misconduct as well as falsification regarding two studies (herein, Hayano-Miyazaki Papers I & II) co-authored by Makoto Miyazaki (Fukushima Medical University) and Ryugo Hayano (Professor Emeritus, University of Tokyo) and published in a British journal, Journal of Radiological Protection (herein, JRP), which is a journal for the Society for Radiological Protection (SRP):“
The "statement" is also said to describe Hayano's views as the person mostly in charge of the data analysis. Incidentally, the "statement" shows an incorrect title for Paper II, but the correct title is shown above. The "statement" consists of two pages: the first page includes four items of explanation and a closing remark, and the second page is an attachment that explains the calculation error allegedly discovered by the authors (Hayano and Miyazaki).


English translation of the first page of the "statement" by Hayano from Hayano's tweet

The second page of the "statement" by Hayano from Hayano's tweet
(Numbers added in reference to Japanese translation of text shown below.)


A Figure 6 shows “measurements over a 3-month period represented by a single data in the central month.” However, in our data analysis program to calculate the cumulative dose, we failed to recognize that each period is “3-month long”. As a result, the cumulative doses were underestimated by a factor of 3.
B Figure 6, Paper II (excerpted for explanation), Distribution of individual doses by the glass badge measurement period (µSv/h)
C Figure 7, Paper II (excerpted for explanation), Cumulative doses (mSv)
D Glass badges were worn for 3 months. Figure 6 shows the 3-month average (dose rate) represented by the central month.
E In (this portion of) Figure 6, the data are shown only for the 7th and 10th months after the accident. However, the first measurements are for the 6th, 7th and 8th months, and the second ones for the 9th, 10th, and 11th months. The figure below exhibits these situations.
F Added up to calculate the cumulative doses
G Error: Data in Figure 6 were simply added.
H To be correct, the data should have been tripled as above. There is a similar error in the integrated theoretical curve, which should also have been tripled. Figure 5 also includes a similar error.


   Item 1 on the first page of the "statement" mentions "S. Kurokawa," which is me. It was my submission of a Letter to the Editor to JRP criticizing Paper II that triggered the sequence of events leading to this incident [of the allegation of research misconduct and falsification]. Not only does Hayano's explanation in the "statement" use vague and arbitrary expressions, but it also includes multiple falsehoods. I am greatly concerned that many people who read this "statement" might believe Hayano's words and gain a false notion of the circumstance. It is because of this concern that I decided to write this critique.
   

Timeline of how the Letter criticizing the Hayano-Miyazaki Paper was accepted

   A critique of a paper published in an academic journal usually takes a form of a paper called a Letter to the Editor. It is a rule in the world of science to criticize an academic paper with another academic paper, and it is also a rule to reply to the criticism with an academic paper.
 
   The status of My Letter to the Editor,
ʻComment on ʻIndividual external dose monitoring of all citizens of Date City by passive dosimeter 5 to 51 months after the Fukushima NPP accident (series): II. Prediction of lifetime additional effective dose and evaluating the effect of decontamination on individual doseʼ(shown in the arXiv site
follows the timeline shown below:

        August 17, 2018: The Letter is received by JRP.
        September 13, 2018: First revision submitted.
        November 5, 2018: Second revision submitted.
        November 16, 2018: The Letter "is ready to accept," and it was sent to the authors.

   The expression, the Letter "Is ready to accept" means that my Letter will be accepted when the original authors write and submit their reply: Both my Letter and their reply will then be published in the same issue. The November 16, 2018 email I received from the Editorial Office informing me that the Letter "is ready to accept" explained that the process of receiving the authors' reply usually takes about a month.

   My Letter to the Editor points out about 10 simple errors or inconsistencies between the numbers and graphs. The Letter was also peer-reviewed by two referees before attaining the "is ready to accept" status.

"Deceptions" seen in the Hayano "statement"

   
    Now, I am going to examine the content of the "statement."

   First, Item 1 states, "I was contacted by JRP to 'comment on Letter by S. Kurokawa with academic inquiries regarding the contents of Paper II.'" To those who might not be familiar with rules of academic journals, the expression, "Letter with academic inquiries," might be misunderstood as if I sent a letter of inquiries to JRP. What I did was not conducting academic inquiries nor sending a letter. Rather, what I did was submitting a form of academic paper called a Letter to the Editor. When the Letter became "ready to accept" on November 16, the authors were asked by the Editorial Office to reply. In explaining such a simple fact, Hayano's uses inappropriate and vague expressions.

   Next, I am going to examine the part, "When the main author and I reviewed the data analysis program made by myself for the study, we realized for the first time that we made a serious error in miscalculating the 70-year cumulative doses, underestimating the doses by a factor of 3."
   My Letter points out that even though Figure 7 should correspond to Figure 6 in Paper II, the  actual values [cumulative doses] in Figure 7 are only half of the values expected from calculation of the values [dose rates] shown in Figure 6. It also points out that this discrepancy between Figures 6 and 7 is due to the fact that Figure 7 is shrunk by half while Figure 6 is correct. 
 The miscalculation discovered by Hayano does not explain the discrepancy raised in my LetterThus, the phrase, "I would like to express a deep gratitude to S. Kurokawa who gave me an opportunity to find the error," only leaves me perplexed.
 
   Next, Item 2 says, "Regarding the error, I contacted JRP on November 28, 2018 stating, 'It is necessary to comment on the Letter and make corrections in the paper due to a serious error that has been discovered.' JRP responded on December 13, 2018 and told us to 'submit a corrected version.'" This phrase has two major problems. First, the part, "It is necessary to comment on the Letter and make corrections in the paper" is a false statement.

   In mid-December 2018, I received an email from the JRP Editorial Office including the authors' response.
   The authors' response stated, "We believe it is appropriate to publish a corrigendum rather than point-by-point replies." Here "We" refers to the authors, Hayano and Miyazaki. The authors "believe it is appropriate to publish a corrigendum rather than point-by-point replies" to my Letter. In other words, the authors are essentially saying they have no intention to "comment on the Letter." It is quite obvious that the Hayano "statement" contains a falsehood.  

   It should be noted that Corrigendum is equivalent of "seigo-hyo" (which means "erratum") in Japanese. In fact, the authors have issued the corrigendum regarding Paper I. (See Corrigendum: Individual external dose monitoring of all citizens of Date City by passive dosimeter 5–51 months after the Fukushima NPP Accident (series): I. Comparison of individual dose with ambient dose rate monitored by aircraft surveys.)
Corrigendum: Individual external dose monitoring of
all citizens of Date City by passive dosimeter 5–51 months after
the Fukushima NPP Accident (series): I. Comparison of
individual dose with ambient dose rate monitored by aircraft
surveys (2016 J. Radiat. Prot. 37 1)
(Excerpted from the IOP Science website.)


   This shows what a corrigendum looks like. In this corrigendum, the year "2011" is corrected to be "2012." The serious error of miscalculation underestimating the 70-year cumulative doses by a factor of 3 is not something that can be corrected with a corrigendum in the first place.

   Also, please pay particular attention to the fact that the "statement" uses the term "revision" rather than "erratum" or "correction" in place of corrigendum. "Correction" means fixing a sentence and can be equivalent of a corrigendum, but "revision" has a broader meaning, as in the case of "revising a plan." Hayano's use of the word "revision" could be construed as a way to manipulate people's perception with an arbitrary use of the broad meaning of the word.
 

Slickly replacing JRP's request for a corrigendum with a rewrite

   Also, as will be described later, it is clear what JRP requested from the authors is not a rewrite but a corrigendum. However, the "statement" says, "JRP responded (...) and told us to 'submit a revised version.'" This "revised version" is supposed to be a corrigendum, but Item 4 suggests otherwise.

   Item 4 states, "We believe that, in order for us to submit a revised version, it will be necessary for Date City to re-supply us with only data with appropriate consent so we can re-conduct the analysis. However, whether or when this is possible is to be discussed in the near future between Date City as the contractee and Fukushima Medical University as the contractor. When the decision is made, we will do our best to follow it."
 
   It was originally supposed to be a corrigendum, but somehow "a revised version" has morphed into re-writing the paper after the data is re-supplied by Date City. All that JRP requested is submission of a corrigendum. Replacing that request with rewriting the paper would have to be considered a fraud. 
 
   Item 4 also states, "The data used in the two papers have been deleted, in accordance with the research protocol approved by the Ethics Committee at Fukushima Medical University."
 
   Deletion (more appropriately called "destruction") of data is a violation of the Ethical Guidelines which would be considered research misconduct, as pointed out in the article that I co-authored with another person in the February issue of Kagaku [Note: English translation of an abridged version of the article will be is now available on the Kagaku website soon. PDF download link.] I will not go into the details of the article here, but "data deletion" in the "statement" refers to destruction of all the data as reported in the Status Report on the Maintenance of Materials and Data which is attached to the Research Completion Report that was submitted to Fukushima Medical University (FMU).

   The "statement" only refers to destruction of the data, but actually the research itself was completed as of October 31, 2018. There is no way to rewrite a paper when the research has already completed and all the data have been destroyed. Even if Date City were to re-supply the data to FMU, it would be considered new research and a new research proposal would have to be submitted to the Ethics Review Committee at FMU. A resulting paper would no longer be a revised version, but an entirely different paper based on new research. A scientist should never conceal such information, let alone pretend as if what was requested by JRP was a rewritten paper when it was a corrigendum that was actually requested.

  Item 3 states that the authors "discovered for the first time through a media report" that the data used included data without appropriate consent of Date City residents, but the previously mentioned article in the February issue of Kagaku clarifies that is not true. The Kagaku article also shows the authors committed six more violations of the Ethical Guidelines in addition to the data destruction. If you are interested in more details, please refer to the Kagaku article.

Hayano avoiding discussions in an academic setting

   Lastly, I would like to express my opinion regarding the part, "As described above, the serious error in the study is advancing to be addressed in discussions in an academic setting of JRP." that appears on the first page of the "statement."

   Academic discussions mean nothing other than advancing the cycle of criticisms  of papers and replies by authors. Yet Hayano is refusing to take the initial step, that is, replying in a point-by-point manner to the Letter criticizing his paper. Then, how can he say, the situation is "advancing to be addressed in discussions in an academic setting"? Regarding this, Hayano owes a clear explanation.
 
*****
Note: In the Retraction Watch article that reported that JRP issued Expressions of Concern (EOCs) to both Paper I and Paper II, a spokesperson from Institute of Physics (IOP) that publishes JRP is quoted to have said, 
"(...) due to the nature of the investigation(s) the authors would need to await the outcome prior to re-analysing the data to correct the mistake by way of a potential corrigendum."
As described in the main body of this article, a corrigendum is a simple erratum, not a rewrite of the paper. (An EOC is issued when an editorial office of a journal alerts readers regarding a potential issue in credibility of a paper.)

*****

Supplementary information regarding the reference to Paper I in the "statement":

   Item 1 in the "statement" says, "It should be noted that this error is limited to the calculation of the cumulative doses in Paper II, and no analytical error has been found in Paper I." This phrase strikes as bizarre.
   It was in Paper II that the cumulative doses were calculated, and Paper I says nothing about the cumulative doses. Of course there is no analytical error in Paper I as in Paper II
   Researchers submitting papers to journals do so because they believe their papers contain no errors. After a paper is published, it is not the author(s) but a community of scientists that determines whether or not the contents of the paper are correct. An Inclusion of such an uncalled-for phrase in the "statement" could be considered a message directed towards those outside the scientific community.
   Sure enough, the "statement" was read aloud during the January 25, 2019 session of the Radiation Council of the Japanese government. The secretariat of the Radiation Council went on to explain that Paper I "is not something to be completely disapproved in terms of its academic significance." For more details on this matter, please refer to the HBOL article by Junichiro Makino (available here only in Japanese).



Shin-ichi Kurokawa is Professor Emeritus at the High Energy Accelerator Research Organization. Born in 1945. Graduated with a major in physics from the University of Tokyo in 1968. Withdrew from Department of Physics, Graduate School of Science, the University of Tokyo in 1973. Doctor of Science. After joining the High Energy Physics Research Institute (currently the High Energy Accelerator Research Organization) as a research assistant, Kurokawa advanced to positions of assistant professor and professor, retiring in 2009. Awarded the Rolf Widerøe Prize by the European Physical Society in 2011 and the People's Republic of China International Science and Technology Cooperation Award in 2013. Specializes in accelerator physics.




(Translation by Yuri Hiranuma)

Citation in AMA style for the article co-authored by Kurokawa and published in the February 2019 issue of Kagaku: 
Kurokawa S, Shima A. A Glass Badge Study That Failed and Betrayed Residents —A Study with Seven Violations of Ethical Guidelines Can Be No Ground for Government Policies. Kagaku. 2019;89(2):e0017-e0024.


Fukushima Thyroid Examination December 2018: 166 Surgically Confirmed as Thyroid Cancer Among 207 Cytology Suspected Cases


♦Note: This post is likely to be updated with key points from the meeting in the near future.
♦The February 21, 2019 update begins below the embedded file, "The Status of the Thyroid Ultrasound Examination."
♦On April 9, 2019, links to the third round, fourth round, and Age 25 screening reports in Japanese were replaced with links to English versions.

For more detailed information on the Fukushima Thyroid Examination itself, see the September 2017 fact sheet (long version, or e-published PDF)

Highlights: 
  • The third round: 3 cases newly diagnosed as suspicious or malignant, and 2 new cases surgically confirmed.
  • The fourth round: No cytology conducted yet as of September 30, 2018.
  • Age 25 Milestone Screening for those born in FY1992: 2 cases diagnosed as suspicious or malignant. No surgery yet.
  • Total number of suspected/confirmed thyroid cancer is now 206 (excluding a single case of benign tumor; 115 in the first round, 71 in the second round, 18 in the third round, and 2 in Age 25 Milestone Screening).
  • Total number of surgically confirmed thyroid cancer cases has increased by 2 to 166 (101 in the first round, 52 in the second round, and 13 in the third round).
The latest overall results including "unreported" cases:
(See this post for the details of the "unreported" cases.)

On December 27, 2018, the 33rd 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, 2018) of Thyroid Ultrasound Examination (TUE) including the third and fourth rounds as well as the Age 25 Milestone Screening for those born in FY1992. Official English translation will be available here in the near future. (Note on April 9, 2019: Official English translation was finally posted here on April 5, 2019.) 

A five-page summary of the first through third rounds, "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. In particular, any update to the number of surgical cases is reflected in this summary before such information is compiled in the fiscal year update as of March 31. This summary is not translated into English officially, but here's an unofficial translation. 

 
Updated on February 20, 2019
Other topics covered at this Oversight Committee meeting include:
  1. Publication report of a paper in Scientific Reports.
  2. A report from the Eleventh session of the Thyroid Examination Assessment Subcommittee held on October 29, 2018.
  3. Recommendations by the IARC Expert Group on Thyroid Monitoring after Nuclear Accidents (TM-NUC). (See this post on what TM-NUC is all about.) 
  4. A compilation of surgical and pathological features of 125 thyroid cancer cases.
  5. A revision of the TUE support project provisions.
1. Publication report of a paper in Scientific Reports

   An FMU official reported publication of a paper, "Spatial analysis of the geographical distribution of thyroid cancer cases from the first-round thyroid ultrasound examination in Fukushima Prefecture." (link)  The paper concluded that the thyroid cancer cases detected in the first round are unlikely to be attributable to regional factors, including radiation exposure due to the Fukushima nuclear accident.

2. A report from the Eleventh session of the Thyroid Examination Assessment Subcommittee 

   The subcommittee chair, Gen Suzuki, went over the report including the materials handed out at the October 2018 subcommittee meeting as well as previous meetings. The report (only in Japanese) can be accessed here. (The list of the materials handed out at the subcommittee meeting is available here, and the detailed summary of this subcommittee meeting is included in pages 6-16 of the Japanese article e-published on the Kagaku website.)
   Analyses conducted by FMU on the second round results only include data from those who participated in both the first and the second rounds, consisting of analyses by age groups, regions, the first round results, and the length of time elapsed since the first round screening (aka screening interval). The detection rates of suspected/confirmed thyroid cancer increased with age and the length of screening interval. The screening interval was naturally the longest in the evacuation area and the shortest in Aizu, corresponding to the order of screening in the first round. When the detection rates of "B" test result and suspected/confirmed cancer in the second round were split up by the screening year of the first round (Table 4 on page ①-8 of the report), FY 2011 showed the lowest percentage of the first round "B" among the second round "B" at 19.5%. This was related to the low detection rate of "B" and "C' among the FY 2011 participants in the first round, which in turn was attributed to a unique circumstance of initial chaos and lack of examiners under which the FY 2011 was conducted. 
   Some of the subcommittee members cautioned that interpretation of apparent regional differences in cancer detection rates as dose response must take into consideration regional differences in factors such as participation rates, screening interval, circumstances and results of the first round, and FNAC rates. 
   According to FMU, these analyses were intended to offer to the Subcommittee some materials for reviewing the second round data. This appeared to be an attempt to fulfill the request from the subcommittee members to make data available in actual numbers rather than just percentages in FMU's partial analysis of some of the first and second round data (available only in Japanese here and also included in the report from the 11th subcommittee meeting) released at the 10th subcommittee meeting on July 8, 2018 (described in this post). However, this attempt was still clearly inadequate: Kota Katanoda from the National Cancer Center Japan requested more detailed distribution of tumor diameter in order to evaluate differences in detection rates by the screening year. 
   Subcommittee Chair Suzuki announced that thyroid doses by municipality and age group estimated by UNSCEAR will be used to conduct an analysis of the second round data. Katanoda warned that results from such an analysis should be interpreted with caution due to unadjustable confounders. Suzuki also revealed his intention to eventually shift from a cross-sectional ecological study currently conducted to case control studies in a cohort that has some degree of post-accidental dietary and behavior record (to be used to reconstruct individual thyroid doses).
   Regarding the TUE conducted in a school setting (herein, school screening), it was revealed to have been requested by municipalities and municipal boards of education in order to ensure equal opportunities for participation, lessen families' burden in taking children to the designated TUE facilities, and prevent absence from classes. 

   After Suzuki's reporting on the 11th subcommittee meeting, several points were raised by the oversight committee members. Shoichiro Tsugane from the National Cancer Center Japan remarked that conducting analyses by adjusting for biases and confounding factors is easier said than done. He continued to point out that detection biases were so strong that adjusting any dose response which might be shown for the biases by statistical modeling could be impossible. Noboru Takamura from Nagasaki University brought up uncertainties associated with the UNSCEAR thyroid doses.
   Toru Takano of Osaka University, who is also a subcommittee member (he is the only dual member) and a vocal opponent of the school screening, explained that, in accordance with the Declarations of Helsinki, the adverse effects of the TUE warrant that the school screening be not compulsory. When asked to describe the adverse effects of the TUE, Takano gave examples of psychological distress, commonly experienced by cancer patients, voiced by some patients that have come to see him. Kanae Narui, a clinical psychologist, responded to Takano that such distress was anticipated even before the TUE started, and it is something that can be clinically dealt with psychological care, not something that should be used as a reason to stop the TUE or the school screening. 

Table 1: Detection rates of suspected/confirmed thyroid cancer in the second round by age group

Table 3: Detection rates of suspected/confirmed thyroid cancer in the second round by region

Table 4: Detection rates of suspected/confirmed thyroid cancer in the second round by screening year for the primary examination in the first round


3. Recommendations by the IARC Expert Group on Thyroid Monitoring after Nuclear Accidents (TM-NUC)
   
   An official from Ministry of the Environment (MOE) presented a Japanese translation of the TM-NUC recommendations, which is actually a translation of an article published in the Lancet Oncology, "Long-term strategies for thyroid health monitoring after nuclear accidents: recommendations from an Expert Group convened by IARC." Translation had been commissioned to the Nuclear Safety Research Association (NSRA), along with some clerical work, by the MOE which fully financed this "project." (Read more on the "birth" of the TM-NUC project in this post.) The entire report, "Thyroid health monitoring after nuclear accidents," issued as "IARC Technical Publication 46" can be accessed from the TM-NUC website or the IARC website (or from this PDF link.) For clarification, the TM-NUC recommendations are not meant to be applied to the TUE already undergoing in Fukushima. 
   As described in this summary, the IARC Expert Group recommends against population thyroid screening, defined as actively recruiting all residents of a defined area to participate in thyroid examinations and subsequent diagnostic or follow-up tests as indicated. The Expert Group recommends a long-term thyroid monitoring program in higher-risk individuals. A thyroid monitoring program is defined as an elective activity including education to improve health literacy, registration of participants, and centralized data collection from thyroid examinations and clinical management. Higher-risk individuals are defined as individuals who received a thyroid dose of 100-500 mGy in utero, childhood, or adolescence. Note that screening is distinguished from monitoring. The recommendations do not preclude lower-risk individuals with lower doses from participating in the monitoring program after fully informed of pros and cons of thyroid examinations.

   Despite the clarification that the TM-NUC recommendations are not meant to evaluate Fukushima's TUE, Tsugane remarked that the recommendations were formed after discussions were carried out by the experts who "learned and understood all that has happened in Fukushima's TUE," and that the considerations included thyroid cancer screening in children and adolescents. The rest of his remarks about high survival rates of childhood thyroid cancer and harms of screening on asymptomatic individuals concluding with a plea to the committee members to "think hard" about the TUE on Fukushima children made it sound as if Tsugane was suggesting the TUE conform to the TM-NUC recommendations.
   However, there are major differences in thyroid cancer management between Japan and western countries that make make reliance on data from western studies tricky. For instance, hemithyroidectomy is the surgical method of choice in Japan for preservation of natural thyroid function unless total thyroidectomy is absolutely called for, and almost all cases undergo extensive lymph node dissection. Whereas in the US, total thyroidectomy and radioiodine treatment is considered the mainstream management, which might lead to high survival rates, but QOL (quality of life) might suffer from lifetime thyroid hormone supplementation as well as side effects of radiation treatment including an increased risk of secondary cancer.
   Use of survival rates as the end point (i.e., as in conventional cancer screening) has been a point of contention during both the oversight committee and the subcommittee meetings, with some members (esp. Takano and Tomotaka Sobue, both of Osaka University) calling Fukushima's thyroid cancer cases "overdiagnosis" and even recommending a switch of diagnostic modalities from ultrasound to palpation based on a high survival rate even when diagnosed after symptoms appear. 
   Other members, including a thyroid surgeon, a pediatrician and a pathologist, have cautioned against relying on survival rates and placed importance on high QOL achieved by early diagnosis and treatment. It was also explained that, given the fact that the TUE was started against the backdrop of the Fukushima nuclear accident, the TUE should not be considered as a conventional cancer screening but as a health examination to assess potential effects of radiation exposure. (Note: This was also stated by Shinichi Suzuki, a thyroid surgeon at FMU, at the 2nd subcommittee meeting in 2014. In Japanese, "cancer screening" and "health examination" are both called "ken-shin" but use different kanji characters for "ken.")
   Another issue with Tsugane's remark about how the experts "learned and understood all that has happened in Fukushima's TUE" is that the information about Fukushima's TUE included in the TM-NUC report appears to be mostly limited to the official TUE results that have been released publicly. Lack of transparency has always been an issue with the TUE data, but we now know the official data does not include any cancer cases diagnosed during clinical follow-up ("unreported cases") or undergoing surgery at non-FMU medical facilities. Thus, TM-NUC could not have "learned and understood all that has happened in Fukushima's TUE," as recognized by Tsugane. (This "recognition" by Tsugane was strange, considering Tsugane's criticism when the existence of the "unreported cases" was revealed. Tsugane stated that any paper written excluding the "unreported cases" would not be able to be accepted by journals as international or scientific paper and that it was scientifically expected for cancer screening data to include all cases diagnosed during a given period.)
   Further, review of some of the academic papers used by TM-NUC as references on the TUE also reveals their conclusions of denying radiation effects are mostly based on analyses of the first round data. This "denial" has to be considered too premature, given the second round data have yet to undergone analyses for potential dose response.

4. A compilation of surgical and pathological features of 125 thyroid cancer cases

   This handout titled "Regarding surgical cases at Fukushima Medical University hospital" is a compilation of clinical information already released and included in the following four references:
   Basically, there is no new information in this report that hasn't been released up to now. It's that all the clinical and pathological information released so far—albeit limited—is complied in one handout with an additional information about TNM and Ex classifications and an anatomical classification of regional lymph nodes as designated in the seventh edition of the Thyroid Cancer Management Guidelines. Chairman Hoshi commented that this report was put together to address repeated requests by the committee member Fumiko Kasuga of the National Institute of Environmental Studies. Kasuga politely thanked for the report, apparently without realizing it does not contain what she has been asking for: an additional set of information such as a more detailed distribution of tumor diameters.
   More information about inconsistencies of the second and third references will be added at the end of the current post.

5. A revision of the TUE support program provisions

   As explained in the July 2018 post, the TUE support program offers reimbursement for out-of-pocket medical expenses (30% copay) incurred while undergoing follow-up observation or medical treatment for thyroid nodules diagnosed during the TUE. The revision, effective December 12, 2018, retroactively removes one of the previous eligibility criteria requiring participation in the confirmatory examination of the TUE at the FMU-authorized medical facilities. This revision, explained in this handout and read aloud by Yoichi Suzuki, chief of prefectural department of Fukushima Health Management Survey, was called for in order to expand eligibility to those receiving medical care outside FMU or FMU-authorized facilities for various reasons. As laid out on the Fukushima Prefecture website, the revised eligibility criteria are as simple as 1) participation in the TUE and 2) receiving medical care for thyroid nodular lesion(s) at medical facilities. The criterion 1) can even be waived under compelling circumstances such as evacuation. 
   The TUE support program offers financial support in exchange for some clinical information. The revision also calls for an additional collection of clinical information, such as the presence of distant metastasis, which is necessary for continuous support.
   In Fukushima Prefecture, children aged 18 or younger receive free medical care until the end of fiscal year when they turn 18. The TUE support program excludes those receiving free medical care from Fukushima Prefecture or those on welfare. There are also municipal and prefectural medical expense assistance programs with various coverage and age limits throughout Japan, so those who moved out of Fukushima Prefecture receiving such assistance will not qualify for the TUE support program, either.
  
   There were questions from the committee members regarding the actual number of thyroid cancer cases in relation to the statement made by Suzuki to the December 13, 2018 Fukushima Prefectural Assembly. Suzuki stated that all 233 receiving payments from the TUE support program had thyroid cancer, whereas it had previously been reported that 233 received payments including 82 that underwent surgery and 77 of 82 were confirmed with thyroid cancer. This discrepancy caused a confusion, leading some to criticize "underreporting." Suzuki never said his statement at the prefectural assembly was incorrect, but he did clarify that there were indeed 77 cancer cases.
      


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

Highlights   The third round: 3 cases newly diagnosed as suspicious or malignant, and 2 new cases surgically confirmed. The fourth round:...