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.

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Thyca Denies the Existence of “Overdiagnosis” in a Public Statement

Over the past couple of weeks, print and television media have carried several stories about the overdiagnosis of thyroid cancer.  These stories were precipitated by an article about thyroid cancer in the New England Journal of Medicine which was published on August 18, 2016.  The article, Worldwide Thyroid Cancer Epidemic? The Increasing Impact of Overdiagnosis, was written by Salvatore Vaccarella, Ph.D., Silvia Franceschi, M.D., Freddie Bray, Ph.D., Christopher P. Wild, Ph.D., Martyn Plummer, Ph.D., and Luigino Dal Maso, Ph.D. They are epidemiologists from the World Health Organization’s International Agency for Research on Cancer in Lyon, France, and also the Cancer Epidemiology Unit of the Aviano National Cancer Institute in Aviano, Italy.

Their study found that more than 470,000 women and 90,000 men may have been overdiagnosed with thyroid cancer from 1987 to 2007, and articles and news reports appeared in many publications and television programs including NBC Nightly News.  Gina Kolata, of the New York Times, who had recently written another article about the NIFTP reclassification , has also written an article on the new study.  In the midst of all this media attention, The American Thyroid Association issued a statement in reference to the many articles and reports which appeared.  In their statement, the ATA appeared to endorse the conclusion of the NEJM article:

The AMERICAN THYROID ASSOCIATION recognizes that the recent increase in incidence of thyroid cancer in the United States and other countries is, in large part, due to the diagnosis of indolent papillary microcarcinomas that will never result in symptoms or death, and which only rarely will enlarge or spread beyond the thyroid gland. The issues surrounding this problem are twofold: First, medical imaging is identifying small nodules, many that are not clinically significant. Second, these small nodules are subjected to ultrasound-guided FNA, and about 5% reveal cancer cells. The usual next step is surgical removal, often followed by radioactive iodine and life-long thyroid hormone therapy. This approach is costly, creates risks from the treatments, and in most patients offers little or no benefit.

The ATA published a link to this  statement on their Facebook page. It was posted alongside a link to the NBC News report about the overdiagnosis of thyroid cancer, leaving little doubt about ATA endorsement of the study from the World Health Organization which had been published by the New England Journal of Medicine.  The NEJM article, along with the statement from the American Thyroid Association probably represent the most resounding statements yet from influential medical organizations in favor of the overwhelming evidence that thyroid cancer is being overdiagnosed.

On August 19th, THYCA, the Thyroid Cancer Survivor’s Association, which has been previously mentioned on this blog, issued a statement about the “overdiagnosis” articles which had appeared in the media.  Written by Gary Bloom, a survivor of papillary thyroid cancer and the executive director of the organization, the statement appeared on Twitter, Facebook, and THYCA’s website. It opens by asserting:

A number of news articles have recently emerged characterizing the epidemic of thyroid cancer as “overdiagnosis,” typically in reference to papillary microcarcinomas, which are small cancers. ThyCa: Thyroid Cancer Survivors’ Association, Inc. (www.thyca.org), and many of the thousands of survivors we work with, are troubled by this characterization.

The point of these articles should be about the question of treatment, and potentially over-treatment. It is erroneous to classify the situation as one of overdiagnosis, and, more importantly, it is inappropriate to downplay the diagnosis of cancer to the public and those in the health care field. Knowledge is power, and even people with smaller cancers deserve to know what is going on with their bodies.

With his characterization of the concept of “overdiagnosis” as erroneous, Bloom seemed to be taking on the New England Journal of Medicine, the World Health Organization, and The American Thyroid Association in one fell swoop of denial.  For a long time, there have been feelings of anger within the thyroid cancer patient community over the dismissal of thyroid cancer as “the good cancer” by medical professionals, and by extension the mass media and the general public.  THYCA has worked to change this perception with various public campaigns. The characterization of thyroid cancer as “the good cancer” most likely emerged because of the excellent prognosis for most (but not all) thyroid cancers. Only recently has there been a recognition “from within” by endocrinologists and surgeons, that doctors should not refer to any cancer as being “good” to their patients.  For example, an editorial was published on this topic by Future Endocrinology in April of this year.

Whether the “good cancer” label is employed because of  over-confidence by doctors in their own interventions, thereby creating an under appreciation of the natural history of papillary thyroid cancer; or perhaps even due to the sexism of many physicians towards their predominantly female population of patients is not entirely clear.  However, the feelings and experiences of thyroid cancer patients have received a great deal of attention in medical journals over the past two or three years.  The dominant finding of most of these academic articles have contradicted  popular perceptions about thyroid cancer.  In fact,  the research has shown that patients suffer both psychologically and physically at a level on par with those who have cancers which are statistically more lethal.  Therefore, an obvious problem of the “overdiagnosis” narrative is that it appears to marginalize thyroid cancer patients at just the time their disease was seemingly gaining greater respect.

It’s deeply questionable, however, whether THYCA’s statement denying “overdiagnosis” will ultimately help this organization or the patients which is serves, especially because most patients being diagnosed today have “small” thyroid cancers.  The overdiagnosis of thyroid cancer, by all appearances, has been accepted as fact by both the World Health Organization and the American Thyroid Association.  Will denying it as a fact make THYCA appear to be anti-science?   Will THYCA now be able to help future patients by providing an unbiased source of information about incidental or non-palpable thyroid cancers?   These are troubling questions that will not be easily answered.

 

The Antidote to Overdiagnosis – Is it Oversight?

 

“I hope that the investigators are successful in their terminology reform efforts, I encourage them to include among their goals the search for a better understanding of why the specialty of pathology was unable to escape from its stubborn devotion to turning lesions with a low or poorly defined risk into cancer. Also, why is there no backup mechanism analogous to the US Food and Drug Administration’s review to detect and respond in a timely fashion to a systemic problem like hazardous diagnostic criteria becoming the standard of care?”

Pathologist and Author,  Elliot Foucar, addressing the work of Laura Esserman et al in The Lancet

 

In 2014, Dr. Laura J. Esserman and colleagues published an influential paper which proposed a new term, IDLE (Indolent Lesion of Epithelial Origin), for many types of indolent tumors which are currently being labeled as “cancers”.  Among a number of cogent points of the article is this one: ” new guidance is needed to describe and label the heterogeneous diseases currently referred to as cancer.”

As noted by  Dr.Elliot Foucar, a retired pathologist who still publishes papers about errors in pathology, it has fallen to researchers outside of the discipline of surgical pathology to call attention to the problem of cancer overdiagnosis.  Foucar blames the failure of pathologists to challenge and police their system of an expert opinion “gold standard” for the intervention by outsiders such as Esserman et al  into the problem of over treatment of indolent tumors which are labeled as cancers.

Since its publication, Esserman’s article has been cited 274 times, and has brought a significant degree of attention to the problem of overdiagnosis.

 

 

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.

54% of Surgeons and Endocrinologists tell Patients they have “The Good Cancer”

An editorial was published on April 7th, 2016 in Future Oncology about possible Interventions to improve quality of life for Thyroid Cancer Survivors.  The Authors, Raymon Grogan, Briseis Aschebrook Kilfoy, and Peter Angelos; of the University of Chicago write that they polled a group of 105 Thyroid Cancer Specialists and 54% had responded that they used the term “Good Cancer” when counseling their patients about the disease.  Although the data is still under review, the authors suggest the reason so many specialists use this phrasing is the good prognosis of thyroid cancer.

The editorial goes on to state that they can think of no other disease state where physicians “congratulate” the patient.  Additionally, they point out that 3% of thyroid cancer patients do not survive five years, and up to 30% can expect to get a recurrence, depending on how risk groups are stratified.  Certainly, it must be especially distressing for those suffering recurrences or facing death from this disease to hear it designated by medical professionals as being “good”.

Striking also is the fact that other cancers also have very high survival rates, especially in lower risk groups. For example, the five-year survival rate for localized breast cancer is 99%,  and overall for prostate cancer, is “nearly 100%“.  Yet for some unknown  reason, thyroid cancer is singled out as being “The Good Cancer”.  Grogan et al suggest in their editorial that physicians should be more specific with patients about survival rates and recurrence statistics instead of using the generalization “good.”

 

 

 

 

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.