Why Did Sara Rosenthal Attack Thyroid Advocacy and Patients?

Patient Misconceptions and Ethical Challenges of Radioactive Iodine

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Bioethicist M. Sara Rosenthal wrote a controversial article, published in the September 2006 issue of the Journal of Nuclear Medical Technology. The article, titled "Patient Misconceptions and Ethical Challenges in Radioactive Iodine Scanning and Therapy," claimed that the thyroid information patients get online and in books furthers "misinformation" about radioactive iodine (RAI) scanning and treatment.

In the past, Rosenthal wrote and self-published several supposedly "patient-oriented" publications through her Sarahealth and YourHealthPress web sites, along with several other books that claim to help patients make "informed decisions" and "self-educate about a variety of health conditions," including thyroid problems. She has presented herself as qualified to write on thyroid disease because two decades ago, she survived thyroid cancer in her early 20s.

Yet Rosenthal wrote the article not as thyroid patient or patient advocate, but rather in her role as bioethicist. Rosenthal completed a Ph.D. in bioethics, moved to the U.S. from Canada, married University of Kentucky endocrinologist Kenneth Ain, and started a job teaching bioethics at the university where Ain is on the faculty.

She summed up her premise in the following quote from her article:

Patients who are inadequately counseled about RAI...will self-educate about RAI, relying on patient-generated books and Web sites to ''translate'' the medical literature for them as well as anecdotal accounts by patients about the health effects of RAI. As a result, the complexity of RAI as a health topic for patients with no medical background is wide open for misinterpretation.... Additionally, patients who are appropriately counseled may still be vulnerable to misinformation that they read in patient advocacy literature...(1)

Are Web Sites, Books and Advocacy Materials Sources of Misinformation?

In accusing Web sites, books and advocacy materials of providing misinformation, Rosenthal abandoned a patient advocacy perspective, choosing to adopt the defensive posture and anti-advocacy argument typical of many of today's physicians.

Rather than encourage empowerment and education, her argument is that the "Doctor" must better educate patients regarding their options, because self-education for patients leads to misleading books, Web sites, patient advocacy literature, and anecdotal accounts. Rosenthal also suggests that even when information is correct, those without a medical education are unable to understand what they read.

Rosenthal footnoted her article with references to a number of popular books and web sites that discuss thyroid disease and RAI treatment. (Rosenthal failed, however, to footnote her own web sites, books and self-published pamphlets on thyroid disease.)

Clearly, there are errors and misinformation to be found in books, Web sites, and other materials that discuss thyroid disease. But errors and misinformation -- not to mention glaring omissions -- are rampant on professional organization Web sites, in medical journals, and at medical meetings as well.

One can't forget, for example, the makers of Synthroid's efforts to suppress journal publication of research showing the bioequivalence of Synthroid to its competitors.

Or the obvious influence of various thyroid drugmakers on the public positions of various thyroid organizations. Dr. Sidney Wolfe of Worst Pills/Public Citizen's misinformation and inexplicable call for a ban on Armour Thyroid, claiming that it was made of cow thyroid and sold over the counter. And perhaps most egregious is the endocrinology community's obvious inability to agree on what is their most basic diagnostic and treatment management tool: what is a normal TSH? The debate over the TSH reference range has been going on for almost 4 years, and shows no signs of resolution. A patient can get a TSH test result of 4.0, and be told by one doctor that she is hypothyroid, and be told by another that she has normal thyroid function.

When it comes to misinformation, the medical community is contributing more than its fair share.

Do Doctors Agree that Hypothyroidism is the Goal of RAI Therapy for Hyperthyroidism?

Rosenthal based her argument on a number of questionable premises, including this one: "According to GD listserves, hypothyroidism is not entirely expected and is seen as proof that RAI is risky or improperly dosed. This misinformation originates with inadequate patient counseling regarding the goals of therapy and informed consent." (1)

Patient-oriented Web sites and books point out a fact that Rosenthal skims right by: The problem is not only inadequate patient counseling, but it's a fundamental lack of agreement in the medical community over whether hypothyroidism is even the goal -- and not just a side effect -- of RAI.

In fact, hypothyroidism is not clearly the standard goal of RAI for a number of prominent medical authorities, including the American Thyroid Association itself, whose "Treatment Guidelines for Patients with Hyperthyroidism and Hypothyroidism" clearly state: "The treatment of Graves' hyperthyroidism is directed toward lowering the serum concentration of thyroid hormones to reestablish a eumetabolic state." (2) This indicates that the goal is euthyroidism -- a normal TSH level -- and not hypothyroidism.

The other leading professional organization for thyroid care, the American Association of Clinical Endocrinologists, reinforces this, saying in their "Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hyperthyroidism and Hypothyroidism" that "...some [clinical endocrinologists] prefer use of a small dose [of radioactive iodine] in an attempt to render the patient euthyroid ." (3)

It's not just the endocrinologists who aren't all on the same page. Family physicians, who treat the majority of people with thyroid disease, recently published in their journal American Family Physician, that "the goal of hyperthyroidism] therapy is to correct the hypermetabolic state with the fewest side effects and the lowest incidence of hypothyroidism ." (4)

And finally, there's the granddaddy of thyroid references.

Werner & Ignbar's The Thyroid: A Fundamental and Clinical Text, Ninth Edition as late as 2005 wrote: "Some have suggested that large doses should be given to most patients and that hypothyroidism should be accepted as a desired consequence, rather than as a side effect, of [RAI] therapy." The implication here is that hypothyroidism is viewed as a side effect, and not the goal. (5)

The bottom line: Rosenthal has it wrong. It is not agreed-upon fact that hypothyroidism is the intended goal after RAI.

Do Conventional Thyroidologists Mismanage Hypothyroidism?

Rosenthal is clearly of the opinion that conventional thyroidologists do not mismanage hypothyroidism. But where is the research to support her opinion?

The Colorado Thyroid Prevalence Study found that the majority of people being treated for diagnosed thyroid disease were outside the normal TSH range, and were therefore not at optimal therapeutic range. That same study estimated that millions of Americans had thyroid disease, but were not diagnosed. Various studies, including ones conducted by the Thyroid Foundation of America, have shown that patients -- and some studies report a majority of patients -- do not feel well when they become hypothyroid after a period of hyperthyroidism.

Clearly, someone is mismanaging hypothyroidism...but none of these studies pinpointed the specialization of the practitioners involved.

But until such time as studies have been done to compare and contrast the diagnosis and treatment success rates -- including qualify of life and patient satisfaction surveys -- of patients being managed by a thyroidologist/endocrinologist, versus other types of practitioners, there is no objective way to know who is mismanaging hypothyroidism . Until such studies have been done by unbiased researchers, it's all anecdotal discussion.

Is RAI Use Less Outside the U.S Because of "Cultural and Attitudinal Barriers?"

Rosenthal herself summarizes the dramatic differences in RAI usage in the U.S., as compared to other countries:

  • 69% of the members of the American Thyroid Association use RAI as the treatment of choice, 30.5% used antithyroid medications
  • Only 22% of the members of both the European Thyroid Association and the Chinese Thyroid Association use RAI as the treatment of choice, 77% used antithyroid medications
  • In Japan and Korea, only 11% of members of the corresponding associations reported that RAI was the treatment of choice, and 88% used antithyroid medications
  • Among members of the Latin American Thyroid Society, 15.3% chose RAI as the treatment of choice, 83% chose antithyroid medications
  • In Australia, 19% chose RAI, compared to 81% for antithyroid drugs(1)

Yet, Rosenthal dismisses these dramatic differences as a result of "cultural and attitudinal barriers," in particular, the Asian fears of "radiation" in general after the atomic bombs of the 1940s.

Claiming that only cultural and attitudinal barriers are at play overlooks the serious medical concerns some practitioners have -- including some in the U.S. -- regarding RAI. And in particular, they do not explain why, even when practitioners outside the U.S. do use RAI, they rarely use it on women under 40, and almost never on children, citing concerns about the risks of cancer and genetic mutations, as well as potential impact on fertility.


Are Thyroid Patients Unable to Make Informed Decisions Because We're Depressed, Tired, Not Thinking Clearly, or Anxious?

Rosenthal seems to be arguing that patients aren't able to make appropriate decisions -- or to genuinely consent to particular treatments or procedures -- because of the mental impact of thyroid problems.

She writes:

When people do not understand the information relevant to a decision, do not appreciate the reasonably foreseeable consequences of a decision or lack of decision, or are not able to decide about a procedure because not enough information has been disclosed, they are considered to lack a genuine capacity to consent. For patients with thyroid conditions, fear of RAI, hypothyroidism, or thyrotoxicosis clearly can become a barrier to capacity. Depression, unclear thinking, and fatigue are common features of hypothyroidism, and extreme anxiety is a common feature of patients with thyrotoxicosis. Depression and anxiety also are common in patients with thyroid cancer. (1)

It's true that the mental symptoms of thyroid disease can have an impact on the decision-making abilities of some patients. But what percentage of patients actually fail to proceed with RAI because their depression and anxiety makes them unablel to "understand the information," versus those who patients who do their research, and forego RAI because they have legitimate concerns about the side effects, long-term effects, or in the case of hyperthyroidism treatment, resulting lifelong hypothyroidism .

The answer is, we don't know. Those studies have not been done.

Rosenthal does not address this, preferring to adopt the patronizing tone of some physicians who view patients as too muddled, depressed, or fuzzy-thinking to be able to make good decisions.

What Do the Advocacy Books REALLY Say?

Rosenthal mischaracterizes a number of patient advocacy books, charging that they "assert that the TSH test is 'inappropriate' for detecting hypothyroidism" and that they presents levothyroxine sodium (i.e., Synthroid) as a "harmful therapy," that "desiccated thyroid hormone confers greater benefit," and that "triiodothyronine [T3] is appropriate therapy for the long-term management of hypothyroidism, and that "the TSH test is inappropriate for detecting thyroid function."

Unfortunately, Rosenthal's accusations are not based on fact, and are exaggerations and generalizations rather than an accurate reflections of the contents of these books. And, by misstating the actual contents of some of the books, and failing to include her own non-medical books on thyroid disease, Rosenthal appears to have as her goal to discredit the works of other patient advocates, including my book Living Well With Hypothyroidism, Elaine Moore's Graves' Disease: A Practical Guide, the National Graves' Disease Foundation's Graves' Disease: In Our Own Words , and several others.

It's particularly curious that she attacks Moore's Graves' Disease: A Practical Guide. After the success of Moore's book, Rosenthal herself went on to personally commission Moore to write a book that Rosenthal subsequently published as part of her commercial/for-profit publishing company, Sarahealth. The book is called Thyroid Eye Disease: Understanding Graves Ophthalmopathy . (Read Elaine Moore's September 5, 2006 rebuttal letter responding to Sara Rosenthal's article now.)

[A Telling Error: Footnote #15 in Rosenthal's article is one example of the general carelessness of this article, and her unfamiliarity with the sources she is criticizing. The footnote states that Elaine Moore's website is at http://www.elainemoore.com, and states that the site was "accessed December 19, 2005" -- yet for several years, this site has been the home page of a children's book writer also named Elaine Moore, and is currently not "unavailable." (The site appears to have been taken offline in Spring of 2005. The Internet Way Back Machine shows what the site last looked like.) The Elaine Moore to which Rosenthal refers -- and whose work Rosenthal herself has published -- has a web site located at http://www.elaine-moore.com.]

In the case of my own advocacy efforts, a careful reading of my book makes it clear that my perspective is straightforward: patients deserve to know all of their options when it comes to treatment for both hyperthyroidism and hypothyroidism.

Many patients who receive RAI treatment are never even told of the option to go on antithyroid drugs, or the fact that some patients who go on antithyroid drugs have the possibility of complete remission without lifelong hypothyroidism. I feel that this failure to disclose key information is highly unethical, and an issue I am attempting to address in my writing and advocacy.

And when it comes to thyroid hormone replacement, I do not favor synthetic over natural thyroid, nor do I suggest that levothyroxine is harmful, or that desiccated thyroid is better.

Rather, my perspective is that the "best" thyroid drug is the one that works best, and safely, for each patient, as decided by that patient and his/her practitioner.

The problem is that, because many physicians are biased by the financial and advertising influence of Synthroid -- the profitable, top-selling thyroid drug, and one of the most prescribed drugs in America -- many patients never learn that there is any other option besides Synthroid. I find it highly unethical for doctors to fail to make patients aware of the options, even more so if the practitioners have a financial incentive to promote one drug over another.

It's worth noting that when attempting to educate regarding medical ethics, Rosenthal owes it to readers to disclose her family connections to drug companies. For example, her husband Kenneth Ain has personally been beneficiary of financial support from Abbott Laboratories, manufacturer of Synthroid, a levothyroxine drug.(7) Both Rosenthal and Ain also participate in a number of professional groups that similarly receive major drug company funding, including from Abbott. Readers deserve to know about such an intimate personal connection with the top-selling thyroid drug in America.

Thyroid Facts and Fiction

By criticizing patient advocacy books as offering misinformation, Rosenthal is implying that there is somehow agreement and consensus among experts about what even is considered misinformation. The fact is, there is no consensus . Instead, there is controversy amongst practitioners over the most basic facts regarding thyroid diagnosis and treatment.

Certainly, Rosenthal is entitled to her opinion about others' work, but any scholarly critique of advocacy publications -- especially when her own works are noticeably absent -- should at least reflect a thorough knowledge and understanding of the source material she is criticizing.

For example, as mentioned earlier, endocrinologists do not even agree as to how to use the TSH test to detect hypothyroidism, or what levels constitute "normal." This alone means that the foundation upon which all conventional hypothyroidism diagnosis and treatment rests on is shaky at best.

Varying studies have been published presenting opposing perspectives on the usefulness of T3 treatment for hypothyroidism. Some studies have found that normal TSH, with elevated antibodies, is evidence of disease that warrants treatment, and may even prevent overt hypothyroidism.

These are just a few points that refute Rosenthal's charges of "misinformation." For a charge of misinformation to be more than just an opinion, there must be agreement. And since we fail to see agreement on many basic issues, it's clear that thyroid disease diagnosis and treatment is not black and white. Like much of medicine, the study of the thyroid is an evolving body of knowledge, filled with controversies and explorations.

The Bioethical Implications of Thyroid Treatment

Bioethical princples say that practitioners should have as their goals to avoid harming a patient, and to proactively provide help to a patient -- in essence, they should not pass up an opportunity to help a patient if such an opportunity is presented.

In the case of RAI, is it ethical for a practitioner to fail to discuss options such as antithyroid drugs that might prevent a permanent, lifelong chronic disease -- hypothyroidism -- or to inordinately push patients toward a permanent, more invasive option in the absence of overwhelmingly compelling medical reasons?

Respect for the autonomy of patients is another fundamental bioethical principle. And fundamentally, I believe that patients deserve to know their options -- levothyroxine, natural desiccated thyroid, supplemental liothyronine (T3), and/or compounded thyroid drugs -- and deserve a practitioner willing to work with them to find the treatment approach that safely works best for them.

Respect for the autonomy of thyroid patients is crucial. In the end, Rosenthal's article raises a key question for me: How does denigrating patient advocacy web sites, listserves and books -- or suggesting that patients are so muddled or anxious that they can't even make their own decisions -- ethically contribute to the welfare or autonomy of thyroid patients?


1. Rosenthal, M. Sara. "Patient Misconceptions and Ethical Challenges in Radioactive Iodine Scanning and Therapy," Journal of Nuclear Medicine Technology Volume 34, Number 3, 2006 143-150, Web

2. Singer, Peter M.D. et. al. "American Thyroid Association Treatment Guidelines for Patients with Hyperthyroidism and Hypothyroidism." Journal of the American Medical Association (JAMA) 1995;273:808-812, Web

3. Baskin, Jack MD et. al. "Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hyperthyroidism and Hypothyroidism," American Association of Clinical Endocrinologists 

4. Reid, Jeri, MD et. al. "Hyperthyroidism: Diagnosis and Treatment," American Academy of Family Physicians, American Family Physician, August 2005, Web

5. Cooper, David. "Treatment of Thyrotoxicosis," in Werner & Ignbar's The Thyroid: A Fundamental and Clinical Text, Ninth Edition. Editors: Braverman, Lewis & Utiger, Robert. 2005.

6. Shomon, Mary J. Living Well With Graves' Disease and Hyperthyroidism, HarperCollins, 2005. Web.

7. Frontiers in Thyroid Cancer, April 2005 Agenda

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