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

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 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.

Ethics, Transparency, and “The Good Cancer”

 

If someone were to compile a list of phrases guaranteed to bring an emotional reaction from thyroid cancer patients, at the top of the list would be, “The Good Cancer”.   Internet patient forums and columns across the web are rife with anecdotes about the use of this expression by medical professionals and the subsequent confusion and distress which it causes in the afflicted.  Those who have been diagnosed and treated for this condition will typically relate that, for them, thyroid cancer is “anything but good”. This is in spite of the generally high survival rate for papillary thyroid cancer, its most common form.   Among the many reasons given by patients for the label’s inappropriateness are the necessity of lifelong hormone replacement therapy, inconvenient (and sometimes incapacitating) follow-up testing and the specter of “recurrence” that is never completely lifted; all of these oftentimes experienced by younger women in the prime of their lives.

How could any of these things be considered as “good”?  Indeed, a recent journal article from Otolaryngology –Head and Neck Surgery , found that  more than half of thyroid cancer patients experience a level of distress that “does not correlate” to their prognosis.  One wonders if this finding is suggestive of patient “over-reaction” or whether an alternative explanation is more plausible.  Perhaps not surprisingly, there is evidence in support of the latter explanation.  According to many experts, thyroid cancer patients who are lower on the risk spectrum are being subjected to  an outmoded and increasingly discredited treatment paradigm.  Many of these patients are not even aware that they are likely being over treated.

Alongside the voluminous research literature on the pathological definitions and best treatment of thyroid cancer over the past forty or fifty years, a parallel universe of articles warning of “over diagnosis” has also emerged.  Generally corresponding to the advent of FNA (fine needle aspiration) biopsies and ultrasound technology, the incidence of the disease has been noted to have had a 4.6 fold increase since 1973, mostly in small papillary cancers, with a coexistent stable mortality rate. For some authors, this suggests the detection of a disease reservoir that has always been present, yet has gone undetected.  Other studies have found that pathological definitions have been expanded, particularly for low-grade encapsulated tumors which in the past would have been diagnosed as adenomas. Additionally, thyroid cancer pathology has been plagued by problems of inter-observer diagnostic disagreements and a lack of expert consensus, even extending to doubts about the existence of a reliable “gold standard” for diagnosis . All of these factors lead to serious questions about the underlying rationales and even the appropriateness of current diagnostic criteria and subsequent treatment protocols for thyroid cancer, particularly for those  deemed as “low risk” with a very low recurrence rate and very high survival rate.

Critiques of the  standard of care for papillary thyroid cancer have historically focused upon extent of surgery and have  questioned whether radioactive iodine ablation should be routine for low and intermediate risk patients as defined by various staging schemes for the disease.  In the past, follicular and papillary thyroid cancers have been grouped together for treatment and statistical purposes, perhaps inappropriately , and in the USA, mostly only the smallest cancers have been spared from total thyroidectomy and radioactive iodine treatment.  Just as the burgeoning number of cases and high survival rates for prostate and breast cancers precipitated a questioning of treatment modalities and scrutiny of histopathological thresholds for those diseases, thyroid cancer has increasingly been placed under a similar umbrella of suspicion by epidemiologists and some clinicians.

Until fairly recently, medicine has espoused an attitude of paternalism with presumptions that the superior medical knowledge of physicians qualifies them to make authoritarian and opaque decisions in service to the patient’s best interest. The foundation of medical decision-making resides in the discipline of Pathology. The “faceless” nature of  transactions between pathologists and patients means that this aspect of patient care effectively operates in a shadow zone.  Typically (and sometimes even by legal mandate), the pathologist makes his or her diagnosis in the relative obscurity of the laboratory; leaving the nuances of transmission to the surgeons and clinicians who interface with patients.  In this regard, the specialty of pathology and its often subjective diagnostic thresholds has been insulated from oversight, and driven by “expert” opinion. With a few exceptions, most of its recent critics have originated from outside its purview.  Elliot Foucar, a pathologist from New Mexico, wrote in The Lancet that the “Gold Standard” of expert pathological opinion had failed to adapt to the newer epidemiological data which has revealed the deleterious effects of cancer screening and new detection technologies on unsuspecting patients.

But who decides which opinions are “expert”?  In this vein, it seems self-evident that a “gold standard” which is based upon such expert opinion cannot be immune to political machinations within a given field.  Perhaps with this problem in mind, a new proposal to reclassify a type of thyroid cancer was recently published in JAMA Oncology and its recommendations were subsequently accepted by the World Health Organization.  The reclassification was unique because of its adoption of an evidence based approach in order overturn  the “expert opinion” diagnostic standard for malignancy.  It’s thought that this bold initiative will likely serve as a model for similar reforms in other overdiagnosed subtypes of cancer.  The impetus for renaming a type of encapsulated thyroid cancer (noninvasive encapsulated follicular variant, or N-EFVPTC) as NIFTP  reportedly came to fruition when the University of Pittsburgh Pathologist, Yuri Nikiforov was motivated to act on the dilemma  of over treated patients with N-EFVPTC at his institution. As an “adaptation” to recent insights about thyroid cancer, it was both a deeply ethical response and a blueprint for accountability in medicine.

As epidemiological and other research data show, the detested “Good Cancer” label for papillary thyroid cancer is used by doctors because of its generally  indolent nature, but is also very likely  attributable to an exaggerated confidence in their own interventions.  A perfect storm of early detection dogma, enthusiasm for new technologies, and artificial  shifts in diagnostic thresholds was mostly ignored until an article by Esserman et al garnered a great deal of media attention in 2014.  The reclassification of a type of thyroid cancer to benign NIFTP is a startling leap towards more accurate diagnoses.    But a permanent retirement of “The Good Cancer” label can only come about when its roots are laid bare for  patients to see.  The roots may begin with pathology but they extend to patients kept in the dark about doubts regarding the extent of surgery ( or even the necessity of surgery), and the appropriateness  of RAI ablation and therapy.  Transparency from medical professionals about conflicting evidence is an ethical responsibility that will help patients make decisions and possibly alleviate their distress.

 

Why Many Patients are Angry about the NIFTP Reclassification – and why they may be Wrong

Soon after the announcement of a proposal to reclassify a type of thyroid cancer (noninvasive encapsulated follicular variant or EFVPTC) as a non-cancer, there were some angry reactions on the web from thyroid cancer patients.  An article appeared in the New York Times on April 14, 2016 which gave background information about EFVPTC and relayed the main reason that Dr. Yuri Nikiforov, a pathologist at the University of Pittsburgh, had initiated the study which lead to the proposal.  According to Dr. Nikiforov’s statement in the article,  he felt “a responsibility to stop the madness” of over treatment for an indolent tumor.

In a different  article about the reclassification  which came out a few days later in Medscape, Dr. Nikiforov was quoted as saying that many thyroid cancer patients were confused and had not realized that the reclassification only applied to a very specific type of FVPTC, rather than to all thyroid cancers.  This misconception apparently  became a source of anger for a segment of patients who are being treated or followed for various types of thyroid cancer.  On the Thyroid Cancer Survivors’ Organization‘s Facebook page, and other thyroid cancer related Facebook sites, some patients expressed anger and disbelief about the reclassification.  Many were confused; some felt upset about having received unnecessary treatment, and a number distrusted the nomenclature change.

Other patients, such as the thyroid cancer patient and veterinarian, Sarah Boston, were angered by the New York Times article for a different reason.  On her blog, Boston wrote that the New York Times article was actually doing a disservice to thyroid cancer patients because the reclassification only affects approximately 10,000 people a year in the United States.  The remaining thyroid cancer patients must struggle with the public perception of thyroid cancer as “the good cancer”, which might even be exacerbated by the publicity which the reclassification would now receive. Boston  movingly conveyed her experience as a patient with an “imposter” cancer. She did not consider the reclassification as newsworthy and opined that the information about EFVPTC should have remained in the peer-reviewed journal which published it.

As noted in the Pittsburgh Tribune Review, this is the first time that a type of cancer has been reclassified as a non-cancer.  This reclassification could possibly have far-reaching effects for other types of cancer which are also thought to be “overdiagnosed”.  In this respect the reclassification will likely serve as a model for future efforts which will seek to curb the growing problem of indolent tumors.  Therefore, the publication of the NIFTP article is an event which could have very far-reaching consequences beyond the world of thyroid cancer.

Many people have difficulties in understanding the concept of “overdiagnosis”.  The term does not refer, as many think, to the diagnosis of a disease that isn’t there, nor does it mean “misdiagnosis”.   The indolent tumors, such as noninvasive EFVPTC, which are being diagnosed as cancers do meet pathological definitions of cancer.  The problem lies with the growing realization that many of these “cancers” are not destined to progress. This turns the traditional definition of cancer on its head.  The phenomenon of overdiagnosis has been discovered mostly due to epidemiological studies which show steadily rising rates for certain cancers such as thyroid cancer, while the death rate remains the same.

Overdiagnosis hurts patients in two different ways.  First, it hurts the “overdiagnosed” who have been exposed to unnecessary medical interventions and the accompanying psychological harms of a cancer diagnosis.  Secondly, it hurts patients who have a “true” cancer because the overdiagnosed cases are distorting the overall statistics for the specific cancer.  The survival statistics which include the indolent cases will mask the rate for the truly life-threatening and potentially life-threatening cases.  Doctors also will likely make inferences that their interventions are more successful than they actually are.

Many cancer patients, and also the general public, intuitively reject the notion of overdiagnosis. One of the biggest reasons is  the historic concept of cancer as a relentlessly progressive disease which will kill us if  we do not intervene.  The study by Nikiforov et al, which subjected both invasive and noninvasive FVPTC to an unprecedented degree of scrutiny will  likely bring a new public focus to thyroid cancer and to other cancers with similar epidemiological profiles. The concept of cancer reclassification as a tool to counteract overdiagnosis may at first seem antithetical to the goals of the survivors’ organizations which promote disease “awareness”. But in the long run the public perception of thyroid cancer may be transformed, and the disease  taken more seriously once the “imposter” cases have been peeled away.

The literature about thyroid cancer overdiagnosis foreshadows the increasingly contradictory goals of  survivors’ organizations as compared to progressively-minded medical researchers.  Cancer survivors’ organizations have traditionally sought to expand ” disease awareness” by promoting  activities such as “neck checks” for thyroid cancer and mammograms for breast cancer.   But it’s becoming more evident with each passing year that these measures may only be subjecting greater and greater numbers of the healthy to a questionable enterprise.

Attempting to put a lid on the public’s knowledge of important medical advances by confining them to often pay-walled medical journals is both ethically problematic and ultimately harmful to the credibility of survivors’ organizations.  The empowered patient is the informed patient, and the informed patient is less likely to be overdiagnosed and over treated.