College of American Pathologists Discourages Informing Most Non-Invasive EFVPTC Patients about NIFTP Reclassification

An article published recently in Cap Today Online, a publication of the College of American Pathologists, has opined that most patients who have already been treated for the type of thyroid cancer (noninvasive encapsulated follicular variant) need not be informed that their “cancer” has been reclassified.

The authors, Paul N. Staats, MD and Benjamin L. Witt, MD, write (responding to a hypothetical question) in their article  entitled “Cytopathology in Focus:  The Significance of NIFTP for Thyroid Cytology“:

Should I go back and reclassify all my old thyroid surgical pathology diagnoses?

Probably not. As most patients will have already received definitive treatment of their NIFTP, reclassification is unlikely to have an impact on their management going forward. For patients very recently diagnosed as noninvasive follicular variant PTC, discussion with the treating physicians about reclassification and management options for the patient may be appropriate. Our opinion is that patients were accurately diagnosed within the constructs of the time and that applying new or novel principles to prior diagnoses is not a worthwhile endeavor.

This opinion would appear to be in conflict with that of other authors. For example, an article published last year in Thyroid, advises physicians to retroactively inform such patients that their diagnosis has changed when possible.  See a summary of this article here.

As noted in that post, In the opinion of the Mt. Sinai team who wrote in Thyroid, pathologists are ethically obligated to review cases and contact patients about a  change in diagnosis.  The justification for the widespread adoption of this policy is that a cancer diagnosis causes “clinically significant” stress and also creates financial burdens for patients.  Perhaps most important of all is the primacy of a patient’s basic legal right to information about their own condition.

Advertisements

THYCA INC and the “Myth” of Overdiagnosis

The foremost patient advocacy organization for thyroid cancer in the United States is THYCA INC.  According to its web site, THYCA was founded in 1998, by a group of thyroid cancer survivors and has a mailing address in New York City.  At the time of the group’s founding, there was little information about thyroid cancer available to the public, and apparently there were no support groups.  In 1998, there were approximately 14,000 cases of thyroid cancer in the United States, making it a rare malady at that time.  Nowadays, there are approximately 63,000 cases per year, with thyroid cancer being the fifth most common cancer in women.  The dramatic rise in the number of cases has been attributed mostly to the advent of neck ultrasounds and FNA biopsies by endocrinologists, but also to changing pathology thresholds.  Because the mortality rate for thyroid cancer has remained flat, many doctors and also health organizations such as WHO have posited that the increasing incidence can be attributed to “overdiagnosis”.  Overdiagnosis generally refers to diagnoses that provide little or no net benefit to the patient and which may in fact be harmful both physically and psychologically.  With respect to their pathology, these tumors meet the textbook definition of cancer, yet they are deemed as very unlikely to harm their hosts.

Generally, “overdiagnosis” is said to apply to small papillary thyroid cancers, especially those under  1 or 2 cm which do not exhibit invasive properties.  However, larger noninvasive thyroid cancers may also be candidates for being overdiagnosed.  This was illustrated recently by the NIFTP reclassification, whereby a type of non-invasive thyroid cancer was reclassified as a non-cancer or “borderline” tumor by a multidisciplinary group of pathologists, surgeons and endocrinologists, and reported in the New York Times. There is a general trend today by academic thyroidologists to identify indolent types of thyroid cancer which do not require the radical treatments that were routine in the past, such as total thyroidectomy and routine RAI ablation. But not every case of thyroid cancer is “overdiagnosed”.

About 10% or so of papillary or follicular thyroid cancers may become resistant to RAI treatments  (also known as non-avidity) and persist in the body.  These are the more unusual cases which may eventually prove fatal to patients.  Other types of thyroid cancer, such as  medullary and anaplastic are considered to be serious forms and are also much more rare.  All in all, there are approximately 1800 deaths from thyroid cancer in the USA each year, with about half of these attributed to the papillary or follicular types. Most deaths from thyroid cancer occur in older individuals, although there are rare fatalities among younger patients as well.  The 2015 Guidelines for thyroid cancer by the American Thyroid Association attempt to address overdiagnosis through the implementation of measures designed to reduce the number of ultrasounds and biopsies for patients and also by encouraging the use of a unique risk stratification scheme at the time of diagnosis. There are also efforts underway to identify both indolent and aggressive  tumors according to their molecular characteristics.

THYCA as an organization tends to publicize the more aggressive cases and types of thyroid cancer to the public.  For example, it recently posted an emotionally affecting video about RAI resistant disease to its Facebook page.  The video depicts many graphic surgical images and also memorializes patients who have died of thyroid cancer.  The struggles of these patients and their families are real and should not be minimized; however the fact remains that the vast majority of thyroid cancer patients will never experience their tribulations.  It is these “low risk” patients who have been the subject of controversy about overdiagnosis within medicine.  Because of their sheer numbers (they now constitute the majority of differentiated thyroid cancer patients), they are likely to be exposed to outreach material by THYCA and other similar groups which have in recent campaigns referred to  overdiagnosis as a “myth”.

The motivation to refer to overdiagnosis as “myth” appears to be rooted in a selective use of facts, such as the aforementioned video; but also data on the lived experience of thyroid cancer patients irrespective of what their individual prognosis might be.  Interestingly, one of the rationales which drove the reclassification of noninvasive follicular variant to NIFTP was the psychological impact of a cancer diagnosis on patients which was viewed as being disproportionate to their “benign” outcomes.  Because the concept of overdiagnosis relies upon counter-intuitive  notions about cancer, many patients become indignant when they see articles about thyroid cancer overdiagnosis in the mainstream media, regardless of their actual risk level.

Numerous medical professionals have fallen into the habit of referring to thyroid cancer as “The Good Cancer”; a state of affairs which has made Thyroid Cancer patients of all risk levels and types feel marginalized.   Media campaigns by THYCA to fight the “Good Cancer” perception, have influenced academic studies which have subsequently demonstrated that thyroid cancer patients suffer as much from their diagnoses as do those with other cancer types.  This mixture of circumstances has contributed to opposition by patient advocacy groups such as THYCA to academic and popular media reports about overdiagnosis. For a variety of reasons,  the “cancer” experience is lived by patients on an emotional level that does not always correspond to the facts of their prognosis and likelihood of survival.  In this sense, the world of thyroid cancer patients is influenced by motivations and  medical  controversies of which they are sometimes unaware. For one, there is the motivation of THYCA and other groups to raise awareness and patient dignity, but also to fund research for the deadly but less frequent forms of this disease.  Concurrently,  there is a movement in medicine to curb “overdiagnosis”.   Caught in the middle of these conflicting forces is the “low risk” patient who is also most at risk of being over treated and therefore subjected to unnecessary psychological harm.

Turning overdiagnosis into a “myth”, in contradiction to both the World health Organization and the American Thyroid Association is not only anti-science, but  effectively works against the best interests of many patients whom THYCA  purports to educate and help.

NIFTP Full Disclosure: An Ethical Policy that should be Adopted

An article made available prior to copy editing appeared very recently in the medical journal Thyroid.   Entitled The Ethical Implications of the Reclassification of Non Invasive-Follicular Variant Papillary Thyroid Carcinoma , the article is authored by a group from Mt. Sinai Beth Israel Medical Center in New York City, and also a representative of the THANC Foundation.

This piece is of particular interest because in seeming contradiction to some opinions recently expressed in a CAP Today article regarding the NIFTP reclassification,  these authors state that it’s the physician’s” professional duty to make a sincere and reasonable effort to convey (the) information to the affected patients.”

In the aforementioned piece in CAP Today, an online publication of the College of American Pathologists, noted thyroid pathologist Virginia Livolsi stated that she would not go back and review her past cases of EFVPTC that would now likely be reclassified as NIFTP, a non-cancer.  One of the reasons given was that of differences in techniques for sampling encapsulated tumors.  The diagnostic criteria for NIFTP requires that the entire tumor capsule be submitted by the pathologist.  According to Virginia Livolsi, “older literature” called for the examination of ten sections of a nodule as opposed to the entire capsule.  However, her reasoning seems to be contradicted by Gerard Doherty, surgeon and professor at Boston University, earlier in the same CAP Today article.  According to Doherty, “I think expert pathologists have been examining the entire capsule for some time. That’s not to say it’s been universally done…”

Another of Livolsi’s apparent  objections to reviewing past cases of EFVPTC is her belief that a NIFTP diagnosis cannot be retroactive on principle.  With regard to a case of EFVPTC for which her  patient had requested a review, Livolsi states: “I have refused to revise the diagnosis, and I have refused to look back at the slides. That case was signed out in 2012. In 2012, that was the diagnosis.”  Doherty agrees with her in the article, stating, “We don’t see any clinical reason to go back and tell patients that a group of people has suggested we change the name of a low-risk disease they already knew they had. It doesn’t change clinical management at all. Changing the name doesn’t change the follow-up.”

However, the new article in Thyroid opines that with regard to NIFTP: “… the prudent course would be to attend to the requirements of medical ethics.”  In the opinion of the Mt. Sinai team, pathologists are therefore ethically obligated to review cases and contact patients about a  change in diagnosis.  The justification for the widespread adoption of this policy is that a cancer diagnosis causes “clinically significant” stress and also creates financial burdens for patients.  Perhaps most important of all is the primacy of a patient’s basic legal right to information about their own condition.

Famed Thyroid Pathologist Refuses to Review Possible NIFTP Cases

An article recently appeared in CAP Today,  a publication of the College of American Pathologists about NIFTP, which is a revised designation for a type of thyroid cancer.  Non-invasive encapsulated follicular variant (N-EFVPTC) was reclassified as being nonmalignant, a change which will likely significantly reduce the number of thyroid cancer cases which are diagnosed yearly in the USA and worldwide.

The article gives the views of several well-known pathologists and clinicians about the impact of the reclassification.  Surprisingly, although the reclassification has been touted as being especially beneficial because of its potential to reduce psychological harms to patients, the article suggests that many pathologists and clinicians do not see any reason to inform the thousands of individuals who have already received the N-EFVPTC diagnosis that their “cancer” has been reclassified.

The well-regarded thyroid pathologist and opinion leader, Virginia Livolsi, of the University of Pennsylvania goes so far as to belittle thyroid cancer patients who read the New York Times article about the NIFTP reclassification.  She states:

“They want their tumor from two years ago to be reviewed, which is totally inappropriate”…” Two years ago, the entity and the name did not exist. Patients were treated at the time according to the standards of the time”… “I feel strongly that research results—that’s what these are—do not belong in a patient’s medical record. To go back on the basis of somebody reading something in The New York Times? That’s wrong”.

Ironically, Virginia Livolsi is also quoted in the CAP Today article as having been impressed by a presentation given by Guy Maytal, of Harvard University during the course of the study which resulted in the nomenclature revision for NIFTP.  Dr. Maytal spoke about the psychological impact of a cancer diagnosis. According to the article:

Dr. LiVolsi called Dr. Maytal’s talk “absolutely amazing.”

What could be behind the apparent reluctance of Virginia Livolsi and some other pathologists and clinicians to review past cases of N-EFVPTC and therefore remove the stigma of a cancer diagnosis for these patients?

Keep reading this blog for a future article on this topic.

 

 

 

THYCA’s Grants are Weighted Heavily to Advanced Thyroid Cancer Cases

The Thyroid cancer Survivor’s Association announced the award of six new research grants for thyroid cancer.  The grants are heavily weighted to benefit patients with advanced thyroid cancer. Although advanced thyroid cancer is a worthy cause that is much in need of research dollars, the fact remains that only two out of the six grants may help with the much publicized problems of thyroid cancer overdiagnosis and over treatment.  These two grants may have applications for risk stratification of patients which could potentially help these lower risk patients to avoid being subjected to unnecessary interventions.

Given that the vast majority of thyroid cancer patients are low to intermediate risk following surgery with very low recurrence rates, it seems fair and ethical for THYCA to award more money and to pay more attention  to efforts which would mitigate the widespread over treatment of these patients.  Thyca’s less than enthusiastic response in handling the NIFTP reclassification may indicate a reluctance to address this pressing problem.

The new profile for the typical case of thyroid cancer is a middle aged woman with a microcarcinoma, as was found in this study from Hughes et al in 2011.  These cases are also among those which are the least likely to benefit from aggressive interventions such as total thyroidectomy and radioactive iodine.

Although funding research for Advanced thyroid cancers is an eminently worthy cause, it is troubling that a situation analougous to “robbing Peter to pay Paul” has been allowed to develop within the primary organization for Thyroid cancer survivors in the United States.

 

 

 

 

 

 

 

 

 

 

THYCA’s Feelgood Public Response to the NIFTP Reclassification was Inadequate

THYCA is the acronym for the Thyroid Cancer Survivor’s association. Founded in 1995, its stated mission is to “educate, participate, communicate and support research” in the area of thyroid cancer.  Back in the 1990’s and earlier, thyroid cancer was much rarer than today, and knowledge of the disease was limited.  To that end, THYCA has promoted public awareness and medical knowledge for thyroid cancer which in the past had been considered a rare disease but is now a leading cancer diagnosed in women.

Cancer “awareness”, however, can be a double-edged sword in that awareness activities may become an end in themselves thereby eclipsing the complex realities and heterogeneous nature of cancer.  The Susan G. Komen Foundation has faced criticism over its promotion of mammograms, which have more recently been linked to overdiagnosis and over treatment and are likely saving many fewer lives than had been previously  believed.  Breast cancer awareness activities involving the color pink and merchandise promotion have also been criticized as promoting “survivors” while concealing the realities of those who have either terminal or “overdiagnosed” cases of the disease.  The intimations that mammography has been overly hyped by medical professionals combined with doubts about the public “awareness” campaigns which are spearheaded by organizations such as Komen suggest that there has been simplistic thinking about breast cancer and that a course correction is now underway.

Thyroid cancer has been oft touted as the most rapidly rising cancer for women in the United States.  Although a few studies have asserted that there has been a concomitant “true” increase in incidence, it has now been generally accepted that the dramatic rise in cases is overwhelmingly attributable to opportunistic detection methods and most likely a lowering of diagnostic thresholds by pathologists.  A striking illustration of this reality came to public attention with the recent reclassification of a type of thyroid cancer to a non-cancer, as reported by the New York Times.  Since the identification of noninvasive EFVPTC as a type of thyroid cancer first identified by pathologists in the 1980’s, cases had increased sharply and diagnostic thresholds appeared to drop in a haphazard manner.  Although many pathologists had long suspected that noninvasive EFVPTC was an extremely indolent tumor,a few experts had encouraged an expansion of diagnostic criteria.  In the United States and elsewhere, there are no formal oversight or quality control mechanisms  on the validity of expert opinion in cancer pathology.  Because of this situation a few experts can operate as gatekeepers for an entire disease domain in a largely unchallenged manner. Consequently, it took many years for someone to finally initiate and organize a nomenclature revision for noninvasive EFVPTC. During this period, however, a number of academic articles were published which suggested that the tumor now designated as NIFTP was a problematic diagnostic category.

Although a representative from THYCA, medullary cancer survivor Kathyrn Wall, is listed as a co-author of the JAMA article which proposed the reclassification of noninvasive FVPTC to NIFTP; the THYCA organization had never previously publicized the pending reclassification, nor had it shared any articles about the controversies surrounding the tumor on its official website.  Nothing has yet been published by THYCA about Wall’s participation in the study, nor what type of input she contributed to it.  On the day the study was published (April 14th, 2016), a post appeared on THYCA’s Facebook page announcing the reclassification and which stated in part:

We know many people will be upset that they received RAI as part of their treatment for their encapsulated Follicular Variant of Papillary Thyroid Cancer. Please keep in mind that the care you received was considered the correct standard of care at the time. The care we received has helped contribute to the research which has led to this important change and hopefully many more changes in our care to come.

This comment, appearing in conjunction with the publication of the JAMA study, surely glosses over important facts surrounding NIFTP as a reclassified type of thyroid cancer.   The diagnostic standard for this tumor, although heavily influenced by the opinions of a few “expert” pathologists such as Virginia Livolsi of UPENN, had been contentious for a number of years and as such there was no “standard of care” for the administration of radioactive iodine that had been proven as beneficial or widely recommended. Perhaps more troubling, and given THYCA’s participation in the two- year reclassification effort, its official announcement can be viewed as a lapse in its stated mission to empower patients through “education” and communication.  Had THYCA truly been interested in educating patients with EFVPTC, it had the option of providing information about the tumor on its website or at its annual conferences which are held at various locations in the USA and which are usually well attended by experts on thyroid cancer.  Instead, it held back critical information in favor of promoting “awareness” about thyroid cancer and calling for neck checks. Subsequently, most patients with this diagnosis were taken by surprise when the reclassification was announced.  Many of those that had been treated with radioiodine  may have been spared this intervention had they known of the pending downgrade of EFVPTC by a panel of expert pathologists.

Although THYCA receives donations for its activities from Drug Companies and other corporations, it relies heavily on patient membership in order to support and publicize its awareness activities and to fund research grants.  To this end, THYCA’s web site and other educational materials have usually emphasized that thyroid cancer is the “fastest growing cancer” because the number of cases has been increasing every year for several decades.  Because of the NIFTP reclassification and also other developments, the total number of thyroid cancer cases in the United States and worldwide can now be expected to fall significantly.  Logically, this means that THYCA’s membership is likely to drop because of past cases of thyroid cancer that will now be reclassified and future cases that will no longer be diagnosed as malignant.  Aside from the possible negative financial consequences to THYCA, the reclassification of EFVPTC is also likely to impact the reputation of thyroid cancer itself as serious type of cancer that is worthy of public awareness.

More and more frequently, we are seeing examples of physicians who are becoming attuned to the harms of cancer overdiagnosis, both psychological and physical.  Patient advocacy and awareness organizations have an ethical responsibility to incorporate this growing trend into their activities and materials and to thereby stop promoting uncritical attitudes about cancer as a homogeneous condition.  While it is surely laudable to educate and support those who are suffering from true cancers, it should not be considered expedient for patient advocacy organizations to gloss over or withhold vital information from those patients who are potentially being over treated because of their own ignorance about their condition.

 

NIFTP: Primum Non Nocere – First Do No Harm

The Journal of the American Thyroid Association, Thyroid, has published an editorial ahead of print entitled:  Changing the Cancer Diagnosis:  The Case of Follicular Variant of Papillary Thyroid Cancer-Primum Non Nocere and NIFTP.   Although the full editorial is not currently available to the public, the first page can be viewed on the Journal’s website.

The authors of the editorial are also among the authors of the JAMA article which proposed the reclassification of N-EFVPTC to NIFTP.  They are Steven Hodak of NYU Langone; R. Michael Tuttle of Memorial Sloan Kettering Cancer Center; Guy Maytal of Massachusetts General Hospital and Harvard Medical School;  Yuri Nikiforov of UPMC Pittsburgh; and Gregory Randolph,  Of The Massachusetts Eye and Ear Infirmary, Mass General and Harvard Medical School.

The editorial states that for many thyroid cancer patients, physicians may be violating the important dictum in medicine, “First, do no harm.”  This is because recent studies have indicated that thyroid cancer imposes significant financial and emotional burdens on patients which have apparently gone largely unacknowledged until now.

Instead of recognizing these burdens, physicians have traditionally relied upon a policy of “social utilitarianism”, meaning trying to to the most good for the greatest number of patients through the implementation of cookie cutter treatments.  Under this philosophy, both high and low risk patients have received almost identical interventions for thyroid cancer.

The editorial appears to make a strong case that pathologists, endocrinologists and surgeons who are involved in the field of thyroid cancer have an ethical obligation to their patients with respect to NIFTP.  This means not only an obligation to reduce harm through implementation of the reclassification, but an additional moral imperative to go back and correct past harms by reviewing cases which were classified as N-EFVPTC over the years.