White Paper: Fukushima Health Survey Occupies Medical & Legal Conundrum

November 8, 2012November 9, 2012 Editor 4 Comments children, radiation exposure, thyroid

The Fukushima Health Survey recently held a public meeting to address parent concerns about the survey. One of the concerns brought up by the parents was how difficult the survey has made it for parents to obtain the thyroid ultrasound photos of their children. Dr. Suzuki who has been running the Health Survey along with Dr. Yamashita said they would consider releasing the ultrasound photos without requiring a formal request from the parents first. There was no guarantee this would be implemented.

Dr Suzuki also claimed it is unlikely thyroid cancer rates would rise and that the results found so far where over 43% of children had abnormalities were “ordinary”. Sukuki also claimed epidemiological studies on children in Japan had not been performed before. This is known to not be true. Children in Nagasaki were used as a comparison group in a 2001 study by Dr. Yamashita who is now involved with the Health Survey.
“Around 70 Fukushima residents attended the session, during which Suzuki emphasized that it was highly unlikely that thyroid cancer rates would rise at this point, and that the results for children in Fukushima Prefecture were not out of the ordinary. He also sought understanding from residents, saying that epidemiological studies on thyroid tumors in children had never before been conducted in Japan.”

These statements by Suzuki defy the evidence. Over 43% of the children with abnormalities is quite different from the 1.6% or less of children in the Nagasaki study. Suzuki has also held the opinion that thyroid cancers won’t show up for 4 or more years citing Chernobyl. This conflicts with Suzuki’s claim that is it unlikely cancer rates would rise. Further evidence shows thyroid damage was actually occurring right after Chernobyl, it just took years for studies to actually be done. The Health Survey itself has come under fire for a number of statements including admissions by Yamashita that his intention is to deny people compensation to save the government money and that they had been having secret meetings ahead of on the on the record meetings to get their stories together. Even the study’s stated goals are to “calm anxiety” and to “convince doubters” that the nuclear disaster impact would be minor.

During the early days of the disaster, the man who would later be put in charge of the Fukushima Health Survey declared nobody in Japan needed protective iodine tablets. Dr.Yamashita made this declaration March 22nd, 2011. Not that it was too late to give people iodine, but that it was not necessary. He claimed the level were too low to require protective iodine distribution, we know now that this was completely untrue. Dr. Yamashita is still a major part of the survey, he handed off the official “head” of the survey to Dr. Suzuki after considerable public backlash. Most people in the impacted areas did not receive any protective iodine and it was later declared that they should have.

A Different Reality

While the Health Survey claims everything is fine in Fukushima, parents are documenting quite a different reality. Ian Thomas Ash has been producing a serial documentary series on life after the Fukushima disaster. In his most recent filming he has been interviewing parents in Fukushima City and Date City. What he found is astonishing. Children with considerable thyroid abnormalities, some were declared “ok” by the Health Survey only to find out otherwise when they obtained a second opinion from a doctor. That is for those lucky enough to obtain a second opinion, some were denied treatment by doctors after the central government ordered them to stop examining patients for thyroid disorders.

“Mrs. Tsuda’s son Naoki, 11, has thyroid cysts. Her daughter Yuika, 10, has so many thyroid cysts the doctor could not count them all (!).”

“Mrs. Shima showed me the thyroid ultrasound for her daughter Shuri, 11. The government-sponsored test revealed her daughter had NO thyroid cysts, but she went to a private hospital to seek a second opinion. ” The second opinion showed that her daughter indeed did have thyroid cysts.

“Mrs. Kanno’s two children, daughter Yuika, 10, and son Naoki, 11, were both found to have no thyroid cysts in the government-sponsored test. When she went to the private hospital Mrs. Shima recommended for a second opinion, she was told that the hospital had received a directive from the national government to stop providing tests for children it had deemed had no thyroid cysts. Mrs. Kanno was refused a second thyroid test for her children.”

How Can This Be Legal?

It may not be legal. According to Japan’s medical law the refusal of care by doctors around Japan appears to be in violation of those laws.

Fukushima Voice translated the applicable laws from the Medical Act of Japan .
“Article 19　
Section 1. Practicing physicians may not refuse a request for medical examination or treatment, unless there is a just cause.
Section 2. Physicians who performed examination, autopsy or delivery may not refuse a request for an issuance of a medical, autopsy, birth, or stillbirth certificate, unless there is just cause.”

Denying people exams because Dr. Yamashita has requested other doctors not examine patients or as one doctor claimed it was to not interfere with Yamashita’s study would likely not qualify as “just cause”. Another doctor claimed “It will be confusing if our result is different from the result by Fukushima Medical University” as his reason for denying a patient medical care.
Just Cause:
“A reasonable and lawful ground for action.
Appearing in statutes, contracts, and court decisions, the term just cause refers to a standard of reasonableness used to evaluate a person’s actions in a given set of circumstances. If a person acts with just cause, her or his actions are based on reasonable grounds and committed in Good Faith. ” via Free Legal Dictionary

The definition of “just cause” also includes the concept of acting in good faith. Good faith is defined as this.
Good Faith:
“Honesty; a sincere intention to deal fairly with others.
Good faith is an abstract and comprehensive term that encompasses a sincere belief or motive without any malice or the desire to defraud others. It derives from the translation of the Latin term bona fide, and courts use the two terms interchangeably.” via Free Legal Dictionary

While laws vary from country to country the basic legal constructs and definitions remain fairly universal. Most people would find the blanket denial of medical exams and treatment to be not reasonable. The excuse that these doctors are denying care at the request of Dr. Yamashita or to cooperate with his scientific study even for patients that have not chosen to participate in Yamashita’s study fails on both counts of “just cause” and “good faith”. Dr. Yamashita has admitted his goal for the survey is to deny people the proof needed to obtain compensation from the government. These doctors willingness to deny patients medical care because Dr. Yamashita requested it puts them as accomplices in his deception and purposeful injury of those involved.

What Medical Standard?

Dr. Yamashita and the health survey have decided that after the initial thyroid ultrasounds are done only those with extremely large abnormalities will be asked to come in for a re-examination. A very small fraction of those flagged have been re-examined. Most children initially scanned have been told to not come back for 2-3 years for a follow up ultrasound. Those with a nodule larger than 5.1mm or a cyst larger than 20mm would qualify for a second examination. Those exams have been slow to be done and the majority of those who qualified on paper in the report suddenly became not qualified for a second exam. Only 14 of those in the secondary exam category for the first fiscal year have had a biopsy or further exam.

“The 95-page report presenting the survey results reveals a different reality. According to previous results published on 26 April 2012, 35% of the first population of 38,114 children being examined were identified as having nodules of a size under 5 mm and cysts under 20 mm, symptoms that the scientists in charge of the survey considered “normal”. However, one hundred and eighty six children, 0.5%, were identified with nodules over 5mm and cysts over 20 mm. Those children are to receive a second examination (more precise echo examination, blood testing, urine testing, and aspiration biopsy cytology). Yet five months later, only 60 of the 186 children scheduled to receive a second examination have actually received it, and only 38 of those examined actually completed the second examination: 10 of them have been reintroduced into the “normal” cycle of an examination every 2 years; 28 were directed toward a thyroid cytology. Half of those children were finally told that “there is no necessity for an aspiration biopsy cytology” with the result that it was performed on just 14 children. It is thus among those 14 children alone that one thyroid cancer case was officially diagnosed.”

This very confusing mess of classifications and breakdowns by the Health Survey gives a very confident claim of medical standards on the surface but the reality is that of 186 that actually qualified for follow up exams only 60 received an exam but only 38 actually completed the process and only 14 received biopsies.

Of course what the parents are finding is that the Health Survey test results have been inaccurate and under reporting instances or numbers of abnormalities. Some received Health Survey scan results stating they had no abnormalities only to find out they actually did. The Health Survey standard was eroded by the initial under reporting of abnormalities, if these parents second opinions are an indicator. It was further eroded by the elimination of follow up testing for more and more of those in that second examination group. The health survey data also does nothing to address and identify multiple abnormalities. Many have found they didn’t have just a single abnormality but multiple abnormalities and it is unclear if they are being included in the Health Survey in any way. With multiple abnormalities not accounted for, yet another risk factor is missing. Parents interviewed also stated that no medical history was taken nor was there a physical exam a part of the thyroid ultrasounds. They were done in a large room, not a doctors office. Parents received a photocopy form with a classification within the health survey circled on it and no other information about their child’s condition. Those who have ultrasound photos had to formally request them later. The Health Survey on the surface appears to be within the medical standards of nodule classification but in truly fails to meet typical medical standards. Upon close inspection of the actions of the Health Survey, the actual practice uses a less rigorous standard of nodule determination than claimed.

Other Medical Standards

We earlier looked at tumor classification and treatment protocol using German medical standards. What we found indicated that fast growing tumors in children are a warning sign for the need to increase examinations and if tumors are over 10mm they should probably be biopsied. Youth and radiation exposure are also risk factors that increase the medical concern and indicate heightened vigilance. Other thyroid disorders should be ruled out first per what we found. It is unclear if the Health Survey is actually doing this. From what we have found so far they are not.

German Thyroid Protocols:

The German Society for Nuclear Medicine outlines these protocols for thyroid diagnostics and treatment.
palpable (can be felt on exam) nodules are defined as >10 mm
needle biopsy recommended for nodules >10 mm
ultrasound should be capable of resolving (seeing) nodules <3 mm

American Thyroid Protocols:

The 2009 medical protocol standards of the American Thyroid Association suggest these standards of care:
They considered any nodule over 10mm to be a candidate for further examination or testing. Nodules smaller than 10mm require further examination when the ultrasound finds unusual structures or there are additional risk factors. They also confirm that some nodules under 10mm can eventually cause further illness or death. Exposure to fallout as a child puts the patient into a high risk category. US research found about a 2% instance of palpable thyroid nodules in studied US children. Needle biopsy is considered an appropriate and accurate test for diagnosing childhood thyroid tumors. A detailed patient medical history and a variety of other diagnostic tests are needed to make an accurate determination of the patient’s thyroid condition beyond just an ultrasound scan to look at the size of the nodules. So a smaller nodule with unusual structures or composition could potentially be a problem but a diverse set of medical testing is needed to understand this. They found that 49% of tumors found in all age groups were under 10mm, and 87% were under 20mm.

“Generally, only nodules >10 mm should be evaluated, since they have a greater potential to be clinically signiﬁcant cancers. Occasionally, there may be nodules <10 mm that require
evaluation because of suspicious ultrasound ﬁndings, associated lymphadenopathy, a history of head and neck irradiation, or a history of thyroid cancer in one or more ﬁrst-degree relatives.
However, some nodules <10 mm lack these warning signs yet eventually cause morbidity and mortality”
*Further on in the recommendations include exposure to ionizing radiation from fallout as a risk factor for potential cancers. This would put that group of people into a higher risk group..

With the discovery of a thyroid nodule, a complete history and physical examination focusing on the thyroid gland and adjacent cervical lymph nodes should be performed.
Important historical factors predicting malignancy include:

A history of childhood head and neck irradiation,
Total body irradiation for bone marrow transplantation
Family history of thyroid carcinoma,
Thyroid cancer syndrome (e.g., Cowden’s syndrome, familial polyposis, Carney complex, multiple endocrine neoplasia [MEN] 2, Werner syndrome) in a ﬁrst-degree relative,
Exposure to ionizing radiation from fallout in childhood or adolescence
Rapid growth and hoarseness.
Pertinent physical ﬁndings suggesting possible malignancy include vocal cord paralysis, lateral cervical lymphadenopathy, and ﬁxation of the nodule to surrounding tissues.

Thyroid nodules in children:

A US study of children found 20 per 1000 (2%) had palpable (could be found by physical exam) nodules and 7 new cases were found per 1000 in a year.
The iodine consumption of this group of children was not mentioned.
Some studies showed children to have a higher frequency of thyroid cancer compared to adults.
FNA (needle) biopsy is sensitive and speciﬁc in the diagnosis of childhood thyroid nodules

Thyroid ultrasound can answer the following questions:

Is there truly a nodule that corresponds to the palpable (felt on exam) abnormality (lump or unusual feature) ?
How large is the nodule?
Does the nodule have benign or suspicious features?

Thyroid ultrasound should be performed in all patients with known or suspected thyroid nodules.

When to do a biopsy recommendations:

According to the protocols all children exposed in the Fukushima region are considered “high risk”.
Type of nodule point of action
Nodule WITH suspicious ultrasound features >5 mm
Microcalciﬁcations present in nodule ≥10 mm
Solid nodule and hypoechoic (all dark) >10 mm
Mixed cystic(liquid)–solid nodule, WITH any suspicious ultrasound features ≥15–20 mm
Solid nodule and iso- or hyperechoic (all dark) ≥10–15 mm
Mixed cystic–solid nodule without suspicious ultrasound features ≥20 mm
Spongiform nodule (may be able to monitor w/ frequent ultrasound) ≥20 mm

Biopsy and follow up suggestions:

A pure cystic nodule, although rare (<2% of all nodules), is highly unlikely to be malignant (cancerous)
If the nodule is non cancerous on biopsy lab work, further immediate diagnostic studies or treatment are not routinely required.
If there are two or more thyroid nodules >10 mm, those with a suspicious ultrasound appearance should be needle biopsied first.
It is recommended that all non cancerous thyroid nodules be followed with serial ultrasound examinations 6–18 months after the initial biopsy.
If nodule size is stable (isn’t growing significantly) the interval before the next follow-up clinical examination or US may be longer, e.g., every 3–5 years.
If there is evidence for nodule growth of more than a 50% change in volume or a 20% increase in at least two nodule dimensions with at least an increase of 2 mm in solid nodules or in the solid portion of mixed cystic–solid nodules, the needle biopsy should be repeated.

Use of the TSH serum test:

Needle biopsy of nodules is recommended when the serum TSH test shows as elevated in people with Hashimoto’s thyroiditis, as that is an indicator of possibly higher risk of cancer in nodules.
A serum TSH test and ultrasound exam are recommended for the discovery of a thyroid nodule >10 mm in any diameter.
A serum TSH test is recommended. If the serum TSH is below normal, a radionuclide thyroid scan should be obtained to document if the nodule is “hyperfunctioning”
A hyperfunctioning nodule rarely harbor malignancy (cancer), if one is found that corresponds to the nodule in question, no biopsy is necessary.
A serum TSH test is recommended as part of the initial evaluation of the patient with a thyroid nodule. If the TSH is below normal a radionuclide thyroid scan should be performed.

Other suggestions made:

Thyroid replacement pills as a treatment of non cancerous thyroid nodules is not recommended in populations with sufficient iodine intake.
Non cancerous thyroid cysts (liquid filled nodules) can be removed by surgery or an injectable elimination method if the cyst begins to push on or compress parts of the neck or throat or creates a cosmetic problem for the patient.
Routine measurement of serum Tg for initial evaluation of thyroid nodules is not recommended.

UN Involvement In The Issue Of Exposed Fukushima Children:

The periodic UN review of children’s rights in Japan under the UN human rights council included a number of recommendations. The non-binding issues included the right to a healthy life, something that was urged to be added by officials from Futaba in Fukushima prefecture, one of the hardest hit cities by the nuclear disaster.

64. Joint Submission 4 (JS4) indicated that Japan had not taken the necessary legislative, administrative and other measures to protect the right to life, survival and development, the right to health and the right to play of the children of Fukushima. The Istituto Internazionale Maria Ausíliatrice (IIMA) recommended monitoring radiation levels in schools and carry out the proper decontamination, beginning with those places most frequently occupied by children and pregnant women.

66. JS4 stated that Japan should make appropriate compensation health treatment for radiation risks for children of Fukushima and their families. It added that access to accurate information about radiation and its effect was rarely provided by the local authorities and by central government.

68. JS4 stated that local communities in the affected areas had complained about the lack of correct information about radiation and expressed serious concerns regarding impacts of the nuclear crisis. JFBA added that information on evacuation plans was not satisfactory. JNEAGE expressed similar concerns and added that measures to protect children and women from the exposure to radiation were delayed. IIMA criticized some information campaigns promoted immediately after the disaster aimed at reducing the concern about the radiation exposure to children.

What It Means And A Way Forward:

Parents have shown that many of the scans have been inaccurate and underestimate the health damage done to their children creating an incorrect medical diagnosis.

The Health Survey by making the demand all other doctors cease examining, testing and treating all patients for thyroid concerns that may be related to radiation exposure creates an improper authority of a scientific study as a sole medical provider. This is against the consent of all patients in the region. Even those who signed a consent form to be involved in the health survey did not waive their right to second opinions or to seek medical care elsewhere, Those who are not participating in the health survey in no way consented to give up their rights to access medical care that has now been denied to many people. This may also violate some business or trade laws where the Health Survey seized and took away a line of business from doctors by demanding they stop practicing medicine related to certain thyroid problems. Some doctors have ignored this demand but others felt obligated to comply and give up potential business.

The Health Survey demand that patients be denied medical care for thyroid complaints that may or may not be related to radiation exposure likely violates Japan’s medical act. This is not being done in good faith or for a just cause. This denial of care clearly puts patients health and lives at risk as treatment, testing or second opinions are being denied leaving people untreated as their potential health problems progress. The survey itself is operating in an unacceptably slow manner where even those who finally did receive a biopsy for suspect nodules had to wait over a year for a test that should have been done quickly.

The Health Survey insists that they be the sole medical provider for this health issue yet they do not provide appropriate medical care. Most children were ultrasound scanned by lab technicians and did not have an exam or medical history with a doctor from what parents are telling. Patients ultrasounds were read later by the Health Survey and the parents mailed a simple report declaring the size of the child’s nodule and what group they fell into. According to the American Thyroid Association this is insufficient. A medical history, physical exam and various lab work need to be included so a variety of factors can be included in the nodule analysis for every patient. Lab technicians with some additional training to use an ultrasound machine are not a proper replacement for doctors in analyzing structures related to the wide variety of nodule compositions that impact the risks associated with any nodules. The health survey has ultrasound photos they are giving to parents. If only these photos are later given to a Health Survey doctor to look at, important findings related to the thyroid could be missed as inexperienced technicians may not know what is important to save views of. This is insufficient medical care, if a regular doctor in practice were to conduct testing, diagnosis and treatment in a manner that didn’t fully examine the patient, pawned off part of the exam to a lab technician and didn’t do complete expected testing they would likely be in trouble for incompetence. This is the medical care being forced upon the children of Fukushima.

The UN council has pointed out that this violates human rights and they have urged Japan to fix this situation they see as taking away the health and security of the children and adults in Fukushima.

How To Solve This:

The demand that doctors not treat patients for thyroid or radiation related complaints must be lifted immediately. All people should have the ability to seek care with doctors they choose and should not be denied care based on possible exposure or participation in the Health Survey.
All people in the impacted areas of Japan should be issued a personal medical record book to record and track any exposure related testing or scans for their personal use. Doctors should be instructed to record any exams or tests in this book. Patients should be given full copies of all exposure related testing or exams in a timely manner in a usable format.
Those patients willing to continue to participate in the Health Survey must receive any second exams in a timely manner that meets normal medical protocols.
Future thyroid scans by the Health Survey should include informing the patient that the scan is not a comprehensive medical exam and that a personal doctor should be used if a full exam and diagnosis is desired.
Additional funding and training opportunities should be set aside to assist doctors in Japan so they may obtain needed equipment and additional training to help spot signs of thyroid damage in children. Funding should also be prioritized to assist families with out of pocket costs and travel expenses in order for them to obtain proper full screening and exams for their children. Many of the impacted families still struggle with the loss of home, assets and jobs after the 3-11 disaster.

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