Sara Rosenthal Not Interested in Responding to Patient Concerns...

I extended to Sara Rosenthal the opportunity to respond to the patient community's concerns about her controversial article on Patient Misconceptions and Ethical Challenges in Radioactive Iodine Scanning. In that article, Rosenthal claims that the information thyroid patients get online and in books furthers "misinformation" about radioactive iodine (RAI) scanning and treatment.

In a phone call today, Rosenthal conveyed that she has no interest in or intent to respond to patient concerns. (For one letter outlining patient concerns, see Redhen's letter to Rosenthal.) Rosenthal stated that the article was "not intended to be read by a lay, non-medical audience," and suggested that the outcry from patients -- and patient advocates including Elaine Moore and me (Read Elaine's rebuttal) -- was further evidence that we misconstrued her article, and that this sort of journal was meant only for "medical readers," as the patient community clearly "could not properly interpret the information."

It's quite obvious and telling -- even to those of us who do not have an MD or PhD after our names -- what Rosenthal is really saying about patients and to patients in refusing to address our concerns.

In the meantime, here is some additional patient input for Rosenthal to chew on, even if she has refused to respond to it: an excellent, point-by-point analysis from patient and advocate Granny Chris. And even though Granny Chris is just a "lay person," she speaks from experience. She was diagnosed in May 1979 with Graves' disease, and has been taking the antithyroid drug Tapazole for successful management of her condition for 27 years. She raises valid questions that deserve to be considered by compassionate and concerned members of the medical community. (NOTE: As of October 9, 2006, Chris has not received a response from Rosenthal.)

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Preface

Being a 27-year veteran of Graves' and managing well with Tapazole since May 1979, I had a few questions about the article penned by MS Rosenthal, PhD, and recently published in the Journal of Nuclear Medicine Technology, by the Society of Nuclear Medicine. I have posted my response to Dr. Rosenthal below.

MS Rosenthal's rendition of ethics and patients' rights in the Graves' disease setting is a fascinating lesson in contradictions. This "peer reviewed" medical journal contribution is curiously peppered with insinuations, deceptions and exceptions to informed consent for "thyroid patients" everywhere.

Having read patient advocacy thyroid forums for eight years, I fail to see what MS Rosenthal is trying to say. If she had done her homework and truly put some time and effort into researching the internet and patient advocacy groups, she'd have seen there are checks and balances in place, which is more than we usually find in the typical endocrinologist's office. She claims that patient advocacy groups discourage RAI and RAIU scans. However, there are no shortages of *RAI cheerleading* websites to be viewed.

If Rosenthal had spent more than one day accessing patient advocacy forums [referenced sites were "accessed on December 19, 2005" - article submitted for publication on December 20, 2005], she would have seen the gross mismanagement of hundreds, or perhaps thousands of Graves' patients' cases. Many patients are subjected to amazingly uninformed (and disrespectful) doctors, abusing the elusive grasp of PATIENTS' RIGHTS in the thyroid patient setting. I fail to understand how she feels this journal entry is of any help to the Graves' patients and their PATIENTS' RIGHTS. The only thing that will change is that now MORE doctors will feel justified in telling the trusting Graves' patients that RAI is a rapid CURE.

Not sure where she gets the idea that the goal of RAI is to render the Graves' patient euthyroid. Sounds like doc already knows that RAI is a THYROID ABLATION procedure. One patient account after another states the health care provider had informed the patient, "Why not have the RAI and get it all over with?" "One little swallow and 'poof' your thyroid is gone." "One little pill a day [synthroid, etc.] and TSH once a year, and you're all set."

We wondered WHY the standard of care in Graves' treatment in the United States has been *RAI first, refuse to answer questions later* and many patients are not advised of the other options. I think we found out: medical journals!

Far too many Graves' patients are told only of RAI treatment, and the other two options are not discussed. Instead of offering antithyroid drugs to a Graves' patient, the doctors still say, "The antithyroid drugs [ATDs] are toxic and will destroy your bone marrow and rot your liver." "Surgery is too dangerous." Or they "don't believe in" ATDs or surgery.

Today's doctors hide behind the skirts of some worn out RAI-based standard of care, and specious, lame excuses labeled "liabilities." The patients who can think for themselves WILL seek info elsewhere, and should be responsible enough to make their own decisions. MS Rosenthal thinks the result of patient education deserves the tag of "patient misconceptions." Most questions asked of an endocrinologist are usually answered with, "I don't know." Now, THAT'S a big help! It's more than apparent that MS Rosenthal has not walked the Graves' walk if she thinks we can get useful info from the doctor and need to look no further.

There are a few good ideas in her essay, but they are mired in the skewed logic and unfounded barbs lobbed at patient advocates everywhere. RAI is a rapid cure, she says. Then why are most post-RAI patients on replacement hormone? Rosenthal alludes to ATD therapy being a burden. Why isn't this made easier by teaching doctors about PROPER MONITORING and PROPER DOSING of ATDs? There is nothing wrong with lifetime ATD therapy if remission is not accomplished. Other countries have no problem with this approach.

~ Granny Chris

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Granny's response to MS Rosenthal, PhD

September 14, 2006

Dear Dr. Rosenthal:

Re: Your article in the Journal of Nuclear Medicine Technology, received for publication December 20, 2005 and accepted for publication May 15, 2006, entitled: PATIENT MISCONCEPTIONS AND ETHICAL CHALLENGES IN RADIOACTIVE IODINE SCANNING AND THERAPY.

First off, thyroid patients everywhere are thanking you for the *Eureka moments* you have provided for us with your recent article. I have some questions and have numbered them below.

I'd like to address specifically the segments of your article that refer to exceptions to PATIENTS' RIGHTS when it comes to "thyroid patients" and their treatments and options.

It appears that some highly controversial STANDARD OF CARE in the "RAI setting" of a health care provider for the thyroid patient is holding up progress. If patient says "no" to RAI or RAIU, it has to be analyzed to death. What part of "no" do the doctors not understand from a patient who has Graves' and has any types of reservations about a nuclear mode of treatment?

As I would like to fully understand your concept of PATIENT MISCONCEPTIONS, I inquire:

QUESTION No. 1 -

----Where did you get the idea for the first sentence in your article about "patient misconceptions"?:

The use and nature of radioactive iodine (RAI) are complex topics for patients with thyroid conditions to understand.

QUESTION No. 2 -

----Now, regarding the next sentence, I have inserted questions as needed, below:

Fear and anxiety over its [RAI] use, misinformation in patient advocacy books and on the Internet,…

----Your reference #10 - Elaine Moore's Graves' Disease, a Practical Guide is the ONLY book on Graves' disease that ever truly helped me. If one is hypothyroid, your reference #9 - Mary Shomon's Living Well with Hypothyroidism has been a life saver for many thyroid patients.

----There is a wide variety of educational materials "on the Internet," so why do you consider this an obstacle? Each person is responsible enough to decide what to believe and what not to believe, even if that person is a thyroid patient.

QUESTION No. 3

…medical jargon,….

----Why is "medical jargon" listed as a barrier to doctor/patient communications? I can see how it's easier to use the language of the trade amongst yourselves, but when a doctor is explaining a health matter to the patient, why can't doc just explain it in plain English? And if reading "medical jargon" on the internet, a medical dictionary works wonders.

QUESTION No. 4 -

…..confusion regarding postscanning and posttreatment procedures, patient literacy, thyroid health status, and several other socioecomonic factors can create serious barriers to genuine informed consent in RAI scanning and treatment.

. ----Can you please explain how each of these "barriers" to informed consent in RAI scanning and treatment above is a serious barrier?

----For example, why do you list thyroid health status as a barrier? Does this imply a 'thyroid patient' should be regarded differently, even if euthyroid?

----This is why other countries prefer to stablize patient on ATDs first [Escobar-Jiminez, et al., Post Grad Med 2000, Trends in Diagnostic and Therapeutic Criteria in GD] 98 percent of respondents in 10 year study in Spain and other parts of Europe chose ATDs as first line of defense for GD. That's easy to understand. Why can't we change to that in the United States?

QUESTION No. 5 -

Patients with GD represent the most common candidates for RAI, because this condition is far more prevalent in the population than thyroid cancer.

----I'm trying to figure out your logic in this statement. BECAUSE there are more GD patients than thyroid cancer patients, that makes them ripe for RAI ablation?

----Please explain your reasoning and define: "common candidates for RAI".

QUESTION No. 6 -

The majority of these patients are women, are computer literate, and express dissatisfaction with their physicians (5-8), particularly because there is community disagreement regarding the goals of therapy in GD: total ablation and hypothyroidism or an attempt to restore the patient to a euthyroid state. Patients who have GD and who compared their therapies often discovered inconsistencies in approaches that raised questions for them.

----Discovery is GOOD; being left in the dark is BAD. Please describe why patients "express dissatisfaction with their physicians" and why there is "community disagreement" regarding goals of therapy in GD. Is there a problem with discovering "inconsistencies in approaches"?

QUESTION No. 7 -

CULTURAL FEARS OF RAI AND EDUCATION CHALLENGES

There are fears in the general population regarding the words 'nuclear' and 'radioactivity' which conjure up images of hair loss and birth defects. It is clear that patients with low levels of literacy and education, grasping concepts such as 'isotope' and 'half-life' and some understanding of thyroid function are critical for there to be genuine informed consent.

----You cite Veatch's 1995 "Abandoning Informed Consent" as your reference #12, but I can't seem to find an abstract of it online. Since you've taken Veatch's concept and altered it to fit "thyroid function" could you please supply me with a copy so I can understand your interpretation.

----The link that is provided to this abstract misdirects us (As of 9-12-06) to J. Palco's "Doing things with embryos" which I don't believe is relevant to the discussion, or is it?

QUESTION No. 8

ORIGINS OF PATIENT EDUCATION MISINFORMATION

INTERNATIONAL DIFFERENCES IN RAI USAGE FOR GD

----In pointing out that other countries have less of a penchant for rushing into RAI, preferring to try ATDs first, you make this statement:

These differences were related to cultural attitudes and phobias regarding RAI, discussed earlier, particularly in Japan.

----I do thank you for pointing out that other countries primarily start the Graves' patient with ATDs, rather than the USA's preferring to start with RAI. Can you give us a more in-depth reason for these cultural attitudes and phobias? Are you saying these countries' reasons for being hesitant about RAI are unfounded? Just wanted to see if we could get on the same page here.

----FYI: Japan specifically seems to have a better success rate of stabilization or remission, using the least invasive method of controlling autoimmune hyperthyroidism in Graves' with ATDs, "block and replace" therapy, etc., than the USA, from what I understand.

QUESTION No. 9

In Japan, there is a reluctance to use RAI because of safety restrictions applied to RAI pharmaceuticals.

----Do you have a reference to the difference in RAI restrictions among the countries which you associate with the reluctance to use RAI? For example, are these restrictions more stringent in Japan than in the USA? In what ways?

QUESTION No. 10 -

The cost and availability of RAI are the most apparent contributing factors in making RAI the treatment of choice in the United States, as RAI is viewed as providing a cost savings to the patient because of a more rapid cure.

----You cite #19 Wartofsky, 1991 Intl differences, Thyroid, and #20 Tominaga, 1997 Intl differences, Thyroid.

----a. Please describe your interpretation: HOW RAI is a "cure." And more puzzling yet, "a more rapid cure"?

----RAI ablation of the thyroid appears to be a trade-off of autoimmune hyperthroidism for autoimmune hypothyroidism. That's a cure? No, just different pills.

----After one has RAI, the patient is deprived of using AntiThyroid Drugs (ATDs) to try for remission, or to use a low maintenance dose as a lifetime therapy, as in Japan. One Japanese study revealed a patient who went into remission after 20 years on an ATD. [Shizume K, 1978]. Excerpt...

Among the 504 patients with Graves' disease in whom the author initiated antithyroid drug therapy between 1956 and 1968 are 14 to whom the administration of antithyroid drug has been continued for 8 to 21 years because of recurrence shortly after the discontinuation of drugs. During these periods, no side effects were observed and three patients went into complete remission after 8, 9 and 20 years of antithyroid drug administration, respectively. It is suggested therefore that the long term administration of antithryoid drugs can be a useful treatment for intractable cases.

----b. In what ways is RAI a "cost savings to the patient"? RAI therapy can, in fact, come with some costly adverse effects. A number of these adverse effects, especially eye issues, aren't usually found in the majority of post-surgical patients, or those on long term ATDs, or in those who go into remission. Nor are these post-RAI side effects possibilities always revealed by doc.

QUESTION No. 11 -

"Radioactive Fallout"

----Regarding websites you "accessed on December 19, 2005," one day before submitting your article for publication, you remark:

GD patients and patient authors who searched the medical literature with PubMed or Google came across the articles just cited and *misconstrued* the international differences as safety concerns.

----How were the international differences misconstrued as safety concerns?

QUESTION No. 12 -

----Per the example you use regarding the *burdens* of ATD use, I will

quote from your article:

For example statements in the medical literature about RAI facilitating 'rapid improvement of hyperthyroidism,' convenience, and medical cost benefits… [your ref #20, re: Intl differences] …are not interpreted as a medical cost benefit to patients, who otherwise are burdened with the financial and emotional costs associated with antithyroid medications, relapses, prolonged hyperthyroidism, and poorer quality of life.

----Please explain what you're trying to convey with the above statement. Where do you find this particular information re ATD therapy and "financial and emotional costs" associated with it? There are risks with any of the treatments. Why are you calling the alternative to RAI a burden? Burden of ATD therapy? Burden on the patient, or on the doctor? Some who had total thyroidectomy surgery felt better after with that therapy, even after trial run of the ATDs. But it was that patient's INFORMED CHOICE.

----Where do you get the impression that therapy that is alternative to RAI leads to this result? How many ATD therapy cases are mismanaged by the doctor who does not understand the fine tuning of meds and levels with PROPER MONITORING and PROPER DOSING of ATDs?

----ATDs are associated with poorer quality of life compared to what? RAI "treatment"? How do you get "rapid improvement of hyperthyroidism" from RAI but not from ATDs? Please explain. I'm curious.

The next few segments of your article deal primarily with thyroid cancer, so I have no basis for comment on those.

ETHICAL PRINCIPLES INVOLVED IN RAI SCANNING AND TREATMENT

----These 4 core ethical principles are offered:

**Respect for Persons -

----Respecting the patient AND the patient's wishes. Won't do biz with doc without it!

**Beneficence -

In many cases of GD, for example, the use of antithyroid medications or surgical subtotal thyroidectomy may provide appropriate therapy without the use of RAI.

----THANK YOU!!

**Nonmaleficence -

----Don't harm and don't refrain from helping a patient.

QUESTION No. 13 -

**Justice -

----Again you've gone into national assessment of adult literacy, education and

Misinformation about RAI as a result of wide gaps in knowledge and noncritical reading of patient advocacy literature posing tremendous ethical challenges.

----How does "patient advocacy literature" pose these tremendous ethical challenges? Please explain how you arrived at this.

QUESTION No. 14 -

----Below I will insert the question and comments as they apply:

INFORMED CONSENT AND RAI THERAPY -

NINE STEPS OF THE INFORMED CONSENT PROCESS:

----From a 12-year old book on Ethics in a different medical field [your reference #35 McCullough, 1994, Ethics in Obstetrics and Gynecology] you have "culled" an adaptation to the consent for RAI therapy in thyroid patients …. OK, we're back in the "RAI setting," right?

#1. The health care provider starts the process by asking what the patient believes about his or her thyroid condition, ….

----Not always, but that would be nice.

#2. The health care provider corrects factual errors and incompleteness in the patient's fund of knowledge.

QUESTION No. 15 -

----How do you automatically assume that the patient will NEED to be corrected? You're taking a lot for granted assuming the the provider will know more about the nuances of GD than the patient. Strange duck of a disorder.

This does not require that the patient receive a complete medical education.

----Of course doc doesn't have time to give us a complete education, yet we should stay off the internet. Whatever floats your boat.

#3. The health care provider explains his or her clinical judgment about the patient's condition…

QUESTION No. 16 -

----What tests were used to determine the patient's condition? Were these the correct tests, by popular 2006 standards - both in the medical setting AND the patient advocacy setting? What if "clinical judgment" is lacking in accurate data and/or information source, on the medical end?

----Why is doc still being legally or otherwise controlled by peer pressure and the outdated "STANDARD OF CARE" regarding Graves' disease "treatments"?

…and all available management strategies (e.g., B-blockers or antithyroid medications for milder GD)….

QUESTION No. 17 -

"….antithyroid medication for milder GD"?

----Can you please give me your source for this information? Mild, moderate, or severe GD can be treated with antithyroid drugs.

----Look at any monograph for Tapazole, an ATD, either in the mfr's package insert, or ….. dare I say it? …. on the internet: at rxlist.com: Tapazole/methimazole, Indications and Dosage.

DOSAGE AND ADMINISTRATION Tapazole is administered orally. Tablets are usually given in 3 equal doses at approximately 8-hour intervals. Adult – The initial daily dosage is 15 mg for mild hyperthyroidism, 30 to 40 mg for moderately severe hyperthyroidism, and 60 mg for severe hyperthyroidism, divided into 3 doses at 8-hour intervals. The maintenance dosage is 5 to 15 mg daily.

QUESTION No. 18 -

...including doing nothing.

----Yes, "doing nothing" is the epitome of PATIENTS' RIGHTS, but an intriguing usage and placement (each time) in your paper.

----Is this where those thyroid health care providers get, "You must have RAI right away or you will die"? I'm sure your peers know that by doing nothing about Graves' disease, and not offering ATDs and/or beta blockers, hyperthyroid patients can risk various consequences of extreme hypER (extreme: actual thyroid storm) or extreme hypO if proper replacement hormone isn't supplied to patient (extreme: myxedma coma), including death?

----But but patient can also be stabilized per the FREE THYROID LEVELS, and appropriate monitoring might lead to remission, OR if the patient might just have a transient case of thyroiditis, in which case, the overactive problem with the thyroid can go away on its own….. so a patient should be able to choose "doing nothing" as an option.

#4. The health care provider works with the patient as needed or requested to help him or her develop as complete as possible an understanding of his or her condition and alternatives available to manage it.

----Complete as possible would be great, why is it so rare to find a USA thyroid specialist who doesn't harp on RAI?

#5 - The health care provider works with the patient as needed or requested to help identify relevant values or beliefs influencing decision making.

----Promise?

#6 - The health care provider works with the patient as needed or requested to evaluate alternatives in terms of those values and beliefs.

----Yes! When will doctors follow this common sense approach of listening to the patient?

#7 - The patient undertakes to understand his or her condition,..

----Please explain your reservations, if any, about how and where thyroid patients access information about their conditions, and undertake to understand them.

…the available management strategies (including doing nothing), and the prognosis under each alternative, expresses patient's subjective interest-based or deliberative interest-based preferences.

----Please explain your use of subjective or deliberative interest-based preferences. Which do you prefer?

#8. The health care provider makes a recommendation based on the clinical judgment already explained in step 3.

----How much weight should that doctor's recommendation carry? What if the patient already knows what goals he or she wishes to pursue and it conflicts with the doctor's goals? Will the doctor listen?

----What if the patient already knows which tests give him or her the info that's needed, but doc refuses to listen due to "peer-induced" auto-preference for RAI treatment?

#9. A mutual decision is reached and is implemented.

----Yes, PLEASE make that MUTUAL!!

The architects of this list of 9 steps (35) add that the law requires a health care provider to provide an adequate amount of information to the RAI candidate….

QUESTION No. 19 -

----Please cite this law in the United States; and define "adequate" and "RAI candidate."

QUESTION No. 20

… without interfering with his or her exercise of autonomy in choosing or refusing RAI. Thus, information about RAI needs to be supplied only to fulfill the 'reasonable person' standard.

----And how much info is that? Why can't a patient just say no to RAI or RAIU? Why do you have difficulty grasping this?

----You go on to explain this perception of a "reasonable person" - as "an individual capable of thinking things through in a rational manner" but the next line is disturbing:

However, the law does not require that the patient understand well or completely what is disclosed, only that the information be disclosed in a manner and at a level that the patient can reliably be expected to grasp.

QUESTION No. 21-

----Please cite this particular legal reference (United States). The obligation is satisfied in the law even if the patient only *roughly* comprehends the information? So how ROUGH?

----Next we have the 3 components for consent: disclosure, capacity and competency, and voluntariness.

----You cite: [your references #36, #37, and #41] Etchells, et al., 1996, Consent; Disclosure; Voluntariness, but your links take us to abstracts pertaining to CANADIAN law.

QUESTION 22 -

Disclosure, Capacity and Competency, Voluntariness -

----What are the legal protections in the United States federal legal system for Graves' disease patients, or other thyroid patients? I'd like to see some relevance to USA citations we can use here.

----This is your CONCLUSION:

Patients who are inadequately counseled about RAI by either their managing physicians or nuclear medicine practitioners and who may not be offered appropriate alternatives 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. Correcting misconceptions, misinterpreted facts, and even false information and appropriately warning patients about certain risks need to be raised as critical patient education issues for nuclear medicine practitioners.

Patient education materials on RAI that specifically identify myths and facts could become an organized public education mandate of the nuclear medicine community.

It should be appreciated, too, that a substantial number of patients who could benefit from RAI therapy never receive it. In addition to large numbers of patients who have GD and who refuse RAI therapy, some thyroid cancer patients are offered only surgery or do not undergo RAI scanning because of poor physician education, bias, or incompetence. Finally, nuclear medicine technologists must appreciate that thyroid cancer patients may not be sufficiently counseled about the LID. Their colleague physicians may be similarly unaware that stable iodine from radiologic studies carried out with intravenous contrast material can significantly interfere with RAI scans and therapy. It may be prudent to offer counseling with appropriate education materials and, in some cases, reschedule scans or therapy when dietary iodine could seriously interfere with uptake.

----What can I say? Love to see what your plans are for the patient education materials on RAI that specifically identify myths and facts that could become an organized public education mandate of the nuclear medicine community.

IN CLOSING, A SOLUTION:

----Doctors should read patient advocacy literature.

[Your reference #5, Hesse BW, et al., 2005, "Trust and sources of health information: the impact of the Internet and its implications for health care providers--findings from the first Health Information National Trends Survey"]... an excerpt...

In conclusion, evidence from the first administration of the HINTS interview gives credence to the observation that people are turning to the World Wide Web as an information source of first resort, while relying on health care providers as their most trusted arbiter of information quality.

The finding heralds a change in the information role of physicians; physicians may no longer be seen as solitary caretakers but as trusted partners in helping patients sort through information derived from an expanding network of personal and mediated information channels. Although definitive conclusions from the national study are premature—the cross-sectional nature of the survey begs the question of causality—the biennial administration of a survey designed to study the public's use of health information should serve as an important bellwether for dramatic changes in the national health information environment.

Best Wishes,

Granny Chris
(Diagnosed with Graves' disease in May 1979. Taking Tapazole for successful management of Graves' for 27 years.)