How can clinical biochemists help or harm thyroid patients?

Economic pressures on health care systems worldwide have led to government-funded and medical-association supported campaigns like Choosing Wisely that offer “toolkits” promoting the cancellation of laboratory tests and treatments.

These cancellations affect a wide variety of patients with many health conditions, not just thyroid patients.

However, thyroid patients are being hit hard by test cancellations.

Ours is a condition that is frequently overtested in screening for thyroid disease outside of the context of thyroid therapy. The monitoring of our highly sensitive, individualized lifelong therapy is being shoe-horned into the same bare-bones test algorithm as screening before therapy.

These test-limiting campaigns, funded by provincial ministries of health, have given up on the idea that merely persuading and training doctors to order tests wisely is going to be enough to save money. Persuasion is too weak. Medical education isn’t enough to arm a doctor against the compassion they may feel for a suffering patient.

A major player in these campaigns is the clinical biochemist who serves as a medical laboratory chief or administrator. Their role includes serving on Laboratory Operations Committees (LOCs) (p. 113) that approve new laboratory tests and cancel existing tests, and they are the ones who implement the directives of toolkits like Choosing Wisely’s thyroid test cancellation program, Understand the Gland.

The clinical biochemist, armed with the citation of a few guideline documents, now has the role of vetoing the wise choices of physicians who order a test and the patients who agree with them in ordering a test.

The clinical biochemist also has the power to even cancel a patient-pay thyroid test that causes no financial harm to the taxpayer-funded health care system.

The clinical biochemist can persuade a laboratory committee to strike a supposedly insignificant thyroid hormone test off the roster entirely, thus affecting all thyroid patients in an entire region from accessing it.

This post examines how our laboratory testing care system is being shaped by the clinical biochemist and what’s at risk when they lack professional ethics and systemic checks on their power.

I start with the definition of the Clinical Biochemist offered by the Canadian Society of Clinical Chemists (CSCC).

Then I provide an open letter I wrote last week to the CSCC to ask for their code of ethics (in the wake of the abrupt patient-pay Reverse T3 cancellation in Alberta in January 2020 and my correspondence with the clinical biochemist who cancelled it).

I conclude by reflecting on whether the clinical biochemist is a mere pawn in a web of professional and institutional powers, and whether a clinical biochemist has the insight and the moral integrity to listen to thyroid patients.

The role of the clinical biochemist

The Canadian Society of Clinical Chemists has a web page that answers the question, “What is a Clinical Biochemist?” They explain:

“Clinical Biochemistry is the division of laboratory medicine that deals with the measurement of chemicals (both natural and unnatural) in blood, urine and other body fluids. These test results are useful for detecting health problems, determining prognosis and guiding the therapy of a patient.

Clinical Biochemists are PhD level scientists with specialized post-doctoral training in laboratory medicine. All hold certification from the Canadian Academy of Clinical Biochemistry or equivalent. Ongoing professional competence is ensured through participation in the Maintenance of Competence program offered by the Academy.

Clinical Biochemists ensure that consistent high quality, accurate and precise biochemical test results are provided so that high quality care can be provided to the patient.” 

The primary responsibilities of a Clinical Biochemist include:

  • Interpretation of patient laboratory tests for screening, diagnosis, management and monitoring of disease processes.
  • Development of interpretive guides for other professionals using the laboratory service, through the selection and validation of reference intervals, interpretive comments and critical values.
  • In consultation with clinical colleagues, development, implementation and monitoring of testing algorithms, appropriate testing turnaround times, practice guidelines and care pathways.
  • Provide oversight and guidance for point-of-care testing programs both in hospital and community settings.
  • Development and implementation of policies and procedures to ensure the laboratory produces high quality information, and meets regulatory requirements and standards of practice.
  • Selection of test methods and instrumentation.
  • Assessment of the scientific and medical value of potential new tests, evaluation of the ongoing value of existing tests, in order to optimize patient care and the use of health care resources.
  • Teaching and research.

Clinical Biochemists work in a variety of settings, including hospital, community and reference laboratories and in industry. The Clinical Biochemist interacts with many of other professionals, including physicians, nurses, technologists, administrators, government officials, students (medical and technical), and business personnel.”

No accountability to the patients?

Early in this definition, we are told that the aim of testing is “so that high quality care can be provided to the patient.”

However, patient health competes with economic priorities when the definition later articulates a combined goal “to optimize patient care and the use of health care resources.

The words “patient” and “care” seems to be the emphasis, but if you look closely, they’re not really interested in patients. The grammar makes the “quality care” and the “patient care” the main subject at hand.

The patient is the mere object of this thing they deem “high quality care.”

The rest of the definition of the clinical biochemist’s role supports this interpretation of their distance from the patient.

In fact, these people are separated from patients by a powerful set of professionals whom they either control or are controlled by.

We are told that these PhD-holding authorities interact with and are primarily accountable to:

  • “Other professionals” whom they address with their interpretive guides for lab test results,
  • “Clinical colleagues” involved in the writing of “practice guidelines”
  • The authorities responsible for “regulatory requirements and standards of practice” that they read.

They rarely seem to interact with patients, or if they do, we’re not important enough to mention.

Instead, the website boasts that clinical biochemists rub elbows with “other professionals, including physicians, nurses, technologists, administrators, government officials, students (medical and technical), and business personnel.”

This profession is embedded in a web of professional politics.

Therefore, it may be very difficult for a clinical biochemist to conceive of a situation in which health care economics and research exclusion conspire with self-interest to ignore the health needs of an individual patient or an entire class of patients, and yet this is happening.

[Read about the British Columbia thyroid test cancellations in 2019: https://thyroidpatients.ca/2019/10/04/lifelabs-bc-handout-reveals-thyroid-testing-policy-failure/ ]

Asking for a code of ethics

Dear CSCC,

I would like to know if your society has a code of conduct or ethics statement to which you hold your members accountable. Perhaps you may provide ethics training or guidelines to clinical biochemists that can support them when public disputes arise regarding their decisions.

Some of your members are invested with a high level of authority to make decisions that can adversely affect the health of patients, such as abrupt cancellation of tests. I would like to know what checks and balances there are in place to moderate their sweeping powers over all patients who live in a province or region. What is their responsibility to patients and to the public when there is an outcry against a sudden policy decision? In the search for efficiency, what can restrain decision making from going too far? 

What responsibilities do laboratory committees have to the public to reveal their literature review efforts when they make sweeping “evidence-based” decisions? Should not the search for “evidence” of the value of a test include more than a cursory look at outdated clinical guidelines? What about obtaining some input from stakeholders who may have access to more relevant evidence than the biochemist has been able to find? How about transparency in decision making? Should one interpret guideline silence or even dismissal as equivalent to meaning a test is useless or unnecessary in all clinical cases?

Economic and ideological factors are also at play. What if the blood sample has long been shipped to a US lab and has been routinely paid for by the patient, and what about other tests that, instead of being cancelled, could be offered on a patient-pay basis? Where ideologies of taxpayer funded versus private health care are at play, how is one to decide what is in the public’s best interest over the long term as fiscal pressures push some services beyond our public health care system?

As you may suppose from my questions, I am dealing with a test cancellation this month. I am a leader of a federal nonprofit organization whose patient group is affected by the test cancellation, and I myself am a patient in the region whose health has benefited from the test in question. I would appreciate very much seeing such a code of conduct that addresses this matter at the level of your profession as a whole. It is my hope that a robust enough code may provide some support for a timely dispute resolution.

Thank you for your time,

Sincerely,

Tania S. Smith 

If you want to send your own thoughts via email, letter, or phone call to the CSCC, here is their contact form: https://www.cscc.ca/en/contact-us.html

Is a clinical biochemist a mere pawn?

Can’t the PhD-educated clinical biochemist see how they can become a mere lever in a system that might not be worthy of their trust?

When cancelling Free T3 tests and Reverse T3 test, have PhD-educated biochemists never learned that a lower T3 and higher RT3 are biochemical features are associated with higher risk of death and morbidity even in people with healthy thyroids?

Can’t a clinical biochemist realize something is very strange about policies that would prevent health practitioners from testing and alleviating a thyroid-disabled patient’s chronic lower T3 and higher RT3 levels — wouldn’t anyone want to help a person recover rather than stay in the realm of risk?

And further, do clinical biochemists not know that it takes a rise in TSH stimulating a healthy enough thyroid to recover naturally from this biochemistry?

Did anyone tell the biochemist that this medical field (thyroid endocrinology) has never bothered to assess the risk of non-recovery from high RT3 and low T3 in thyroidless people?

How can guidelines be trusted when vulnerable thyroid patients have been excluded from most studies of nonthyroidal illness (a.k.a. Low T3 syndrome) and when it is often assumed that central hypothyroidism (inappropriately low or normal TSH) does not occur during therapy for thyroid failure? How can we recover (other than by a therapy adjustment) if we don’t secrete enough TSH and/or have no living thyroid tissue to be stimulated by TSH?

Have clinical biochemists ever been taught about the discordant TSH-T3 relationship in thyroid therapy, which is extremely different from the TSH-T3 relationship in healthy controls? It makes thyroidless patients with a normalized TSH more likely to have a Free T3 level that drops below the population mean. Free T3 levels below the mean are associated with increasing hypothyroid symptoms (Larisch et al, 2018).

How can an intelligent clinical biochemist believe that an “adequate” TSH-normalizing dose of T4 hormone will be effective while abnormally larger amounts of FT4 are being daily converted to Reverse T3 instead of T3?

Narrowing tests = Narrowing therapy

What a society does not measure, it begins not to value.

When you can’t measure the thyroid hormones that correlate with human suffering and health risks during thyroid therapy, that suffering can become invisible and worthless, easily blamed on other health conditions when all aspects of health can be worsened by suboptimal thyroid therapy.

Conversely, as most clinical biochemists should know, laboratory tests become popular when they lead to the prescription of a drug. 

The test then becomes useful for optimizing the dosage of these test-result-altering pharmaceuticals.

Thyroid therapy “by the guidelines” has become pipeline for thyroid “care” that narrows it down to one laboratory test that leads to one test-normalizing pharmaceutical.

Why would a medical field so resolutely bar the door against testing for aberrations in T3 and RT3 unless they do not wish doctors to see the need for T3 pharmaceutical alternatives?

The narrowing of thyroid testing occurs at a time when new tests are being added to the marketplace.

This narrowing and cheapening of thyroid therapy is occurring at the same time as other diseases are getting more expensive pharmaceuticals.

Biologics like Humira now make far more money for AbbVie than sales of Synthroid. “HUMIRA accounted for approximately 61% of AbbVie’s total net revenues in 2018,” (p. 14) according to their 2018 financial statements. Beyond AbbVie, Synthroid is no longer a monopoly in thyroid therapy — since the early 2000s, the generic levothyroxines and other brands have entered the marketplace in force.

When profit is not the major driver of maintaining a test-to-therapy pathway, the parties with the most to benefit from test cancellations are 1) a medical association who wants to keep its practices and beliefs from changing — and 2) a health care system that wants to avoid prescribing slightly more expensive T3-based options for thyroid conditions such as liothyronine and desiccated thyroid, which have long been approved and regulated for their quality by Health Canada.

The irony is that a few more tests for patients that are already on thyroid therapy can optimize all types of thyroid therapy (LT4, synthetic T3-T4 combo, desiccated thyroid) and could save lives by aiding recovery in critical illnesses. It may lead some patients to the T3-containing thyroid medications they need, and their health is a far cheaper option for society in the long run.

Compare the cost of healthy thyroid patients to what the health care systems already spend on more expensive therapies and tests for patients who are suffering more deeply with their diabetes, heart disease, or cancer because of their poorly optimized thyroid therapy.

It’s potentially very costly not to listen to thyroid patients’ side of the story regarding test cancellations.

[ Read the letter from Tania S. Smith to a Laboratory Chief in Alberta — download the PDF from the introduction to this post https://thyroidpatients.ca/2020/02/21/think-twice-about-cancelling-patient-pay-reverse-t3-tests/ ]


Categories: Testing policy

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