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.

Ian Hay Addresses “Overdiagnosis” of Thyroid Cancer at the ATA Meeting

Dr. Ian Hay, a renowned expert on thyroid cancer from the Mayo Clinic in Rochester, Minnesota, gave a talk entitled “Changing Attitudes to the Most Common Endocrine Malignancy, T1 PTC” in one of the opening sessions of the 86th annual meeting of the American Thyroid Association in Denver Colorado. The meeting is being held from September 21st through the 25th, and is attended by thyroid experts from all over the world. Dr. Hay’s talk was covered on the Healio website, which gave a summary of what he said.

According to the article, Dr. Hay stated:

“The major burden of overdiagnosis has fallen on women”… “Patients, particularly women, need protection from the harms of unnecessary diagnosis.”

The article from Healio also quotes  Dr. Hay  as stating “smaller thyroid cancers will most likely never result in symptoms or death.”  Within the thyroid cancer medical community, Dr. Hay is probably best known for his research demonstrating a lack of beneficial impact for radioactive iodine ablation on low risk thyroid cancer.  Studies from the Mayo Clinic found that patients with a MACIS score of less than 6 do not benefit from RAI ablation in terms of  their survival or their likelihood of experiencing a recurrence.

A few doctors attending the ATA meeting expressed an apparent dissatisfaction with the word “overdiagnosis” through their Twitter accounts. However, it is uncertain what impact these opinions will ultimately have within the ATA.  One of the motives for the recent reclassification of non-invasive encapsulated  follicular variant to NIFTP was to reduce the psychological impact of a cancer diagnosis on patients.  The issues surrounding patient distress from thyroid cancer have received considerable attention in recent medical literature.

 

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.

 

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.

 

 

 

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.”