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Mary Shomon Letter to Michael Bass, November 18, 2005
from Mary Shomon, Your Guide to Thyroid Disease |
The following is the text of the letter sent November 18, 2005 to Michael Bass, Senior Executive Producer at CBS' Early Show. Note: You can also view this letter as a PDF file.
Patient Advocate, Author
November 18, 2005
Mr. Michael Bass
Senior Executive Producer
CBS / The Early Show
524 W. 57th St.
New York, NY 10019-2902
Fax: (212) 975-2115
Dear Mr. Bass,
I am writing in regarding to Dr. Bill Law's letter to you of October 18, 2005 regarding the Early Show's interview with Dr. Steven Hotze, and CBS' subsequent response to the issue.
It's important to clarify some issues for CBS regarding AACE, the validity of its information, and its authority to speak on behalf of the thyroid patient community.
First, Dr. Law claimed that in the interview with Dr. Hotze, certain statements made about hypothyroidism and its treatment are "readily refuted by a large body of solid scientific evidence."
As a thyroid patient advocate for the past decade, I feel it necessary to point out that Dr. Law's claims reflect his opinion, but there is no "large body of solid scientific evidence" to support a number of his claims about hypothyroidism and Armour Thyroid. I have written to him to request the specific citations -- if any -- regarding the supposed scientific evidence to support his position, and am awaiting his response.
For example, Dr. Law claimed that while "such symptoms are also very common in the general population, most of who [sic] do NOT have hypothyroidism and will NOT experience any sustained improvement in their symptoms with thyroid hormone therapy." Actually, just this year, a study reported on in the highly respected Journal of the American Medical Association (JAMA), found that changes to the blood tests that have been urged by the AACE actually mean that many millions of Americans are hypothyroid, but not diagnosed. Three years ago, Dr. Law's own group, the American Association of Clinical Endocrinologists (AACE) themselves recommended the narrowing of the so-called "normal" range of the Thyroid Stimulating Hormone (TSH) test from its range of 0.5 to 5.0, to a new, narrower range of approximately 0.3 to 3.0. They have called on the endocrinology community and laboratories to accept and practice according to these new ranges. The JAMA study I referenced reported that using a TSH upper normal range of 5.0, approximately 5% of the population is hypothyroid. However, if the upper portion of the normal range was lowered to 3.0, approximately 20% of the population -- as many as 59 million people -- would be hypothyroid. (1) Since it's currently estimated that less than 10 million people have been diagnosed and are being treated, many millions of people are, by the AACE's own standards, hypothyroid, likely symptomatic, but not diagnosed.
Second, Dr. Law claimed that "Inappropriate thyroid hormone treatment with ANY preparation can lead to thin bones, known as osteoporosis..." This claim is not backed up by a large body of solid scientific evidence. Dr. Senay, or any competent medical researcher, can verify this with a simple Medline search. The issue of the osteoporosis risk of thyroid hormone replacement treatment is an ongoing and clearly undecided controversy amongst endocrinology researchers. Many experts believe that only prolonged periods of hyperthyroidism that results from a disease state, and NOT suppressed TSH or elevated T4 or T3 levels due to excess exogenous thyroid hormone replacement, is an increased risk factor for osteoporosis. There is, therefore, no conclusive evidence that definitively establishes that inappropriate thyroid hormone treatment can lead to osteoporosis.
Third, Dr. Law claimed that "Animal-derived desiccated thyroid...is not a natural form of thyroid replacement for humans at all." This argument is fundamentally misleading. Since Armour is derived from the thyroid glands of pigs, it is true that it is not "natural" to humans. But the favored drug of endocrinologists, levothyroxine, is synthetically manufactured. Synthroid and levothyroxine, therefore, are not a natural form of thyroid replacement for humans either. I'm not sure if Dr. Law is suggesting that levothyroxine is somehow natural to humans, or "more natural" than desiccated thyroid, but in any case, this is a very misleading point.
Fourth, Dr. Law refers to desiccated thyroid as "an obsolete product." You should know that this is an opinion, not a scientific fact. There is no specific "solid scientific evidence" that has established that natural desiccated thyroid is "obsolete." I am not aware of any double-blind, peer-reviewed, journal published research that establishes that today's prescription desiccated thyroid drugs are obsolete, or anything less than equally effective as synthetic thyroid drugs.
In a particularly egregious error, Dr. Law claimed that desiccated thyroid is "obtained from ground-up cattle and pig thyroid glands." Frankly, it's surprising that as the head of one of the nation's leading endocrinology professional groups, Dr. Law has made a major mistake on such a simple fact. Armour Thyroid, as well as the other leading brands of prescription desiccated thyroid that are regulated by the Food and Drug Administration, are all made of the thyroid glands of pigs. Cow thyroid has not been used in prescription desiccated thyroid drug preparation for years.
Dr. Law claims that it's "extremely difficult for even a trained specialist to properly adjust the dose to fit each patient’s needs." Yet, I can personally provide you with the names of hundreds of thyroid patients who have taken Armour for years, with little fluctuation in their dosage, and picture perfect lab tests. I can provide you with the names of physicians who treat hundreds of patients in their practices with Armour thyroid, and these physicians are able to treat their patients with no difficulty. In fact, if it was difficult to maintain euthyroid levels, thousands of responsible physicians across the U.S. would not prescribe it for their thyroid patients. And, as you should know, in 2004, more than 2 million prescriptions were written for Armour Thyroid by physicians around the country. There are clearly many doctors who are able to properly adjust the dose to fit their patients' needs, and do not, as Dr. Law does, consider it extremely difficult.
Dr. Law also encouraged you to "view AACE’s guidelines on thyroid disorders at www.aace.com." After revisiting these guidelines for hypothyroidism and hyperthyroidism -- located online at http://www.aace.com/clin/guidelines/hypo_hyper.pdf and dated November/December 2002 -- I feel it important to point out to you that AACE has not updated these outdated guidelines in three years, despite numerous important research findings and advancements in the treatment of these conditions, advances that impact quality of care. The information on hypothyroidism and fertility and hypothyroidism and pregnancy for example, is seriously out of date. Physicians following these guidelines will compromise a woman's ability to get pregnant, and should she become pregnant, she is at increased risk of miscarriage if these guidelines are followed, rather than newer recommendations for early testing, dosage increases, and frequent monitoring of more than just TSH levels in pregnant patients. I find it irresponsible that AACE is suggesting to you that their guidelines are the last word on hypothyroidism and hyperthyroidism treatment, when they have failed to even keep them updated to current standards of medicine.
It is also a serious oversight that, in publicly criticizing Armour Thyroid, Dr. Law did not publicly disclose AACE's close financial relationship with Abbott Labs, the manufacturer of Synthroid, a product that is a direct competitor to Armour Thyroid. AACE has a very obvious interest in protecting the market share and profitability of Synthroid, given that AACE as an organization receives substantial funding from Abbott. In addition, many members of AACE's leadership, as well as the group's membership, are recipients of grants, speaking fees, honoraria, research funds, free drug samples, free patient literature, logo gift items, and other financial and material support from Synthroid's manufacturer. This sort of financial relationship must be disclosed to allow for CBS viewers to evaluate the validity and motivations behind AACE's attacks on drugs competitive to Synthroid, and their attacks on doctors who publicly criticize Synthroid. Yet, nowhere in the Public Eye blog postings about the incident, or in the letters exchanged between you and Dr. Bass, is this financial relationship ever discussed. This failure to disclose the financial ties does a serious disservice to CBS viewers, and to the millions of thyroid patients in the U.S. who watch your program.
AACE plays a key role in making Synthroid the top-selling thyroid hormone replacement drug on the market. And while many people don't take thyroid particularly seriously, in 2004, a total of 44,056,176 prescriptions were written for Synthroid(2), making it the fifth most prescribed drug in the United States, generating $950 million in sales.(3)
Synthroid is a highly profitable drug as well. According to one Congressional report, a senior citizen in the U.S. who pays for his or her own prescription drugs must pay, on average, more than twice as much for the drugs as the drug companies’ favored customers (i.e., HMOs or the federal government). The Congressional report found, however, that "the drug with the highest price differential was Synthroid." Said the report:
For this drug, the average price differential for senior citizens was 1,566%. A typical prescription for this drug would cost the manufacturer’s favored customers only $1.75, but would cost the average senior citizen over $29.00.(4)Since it's estimated that even the favored customer price builds in profit for the manufacturer, given that many patients are paying price markups over 1500%, there is clearly a great deal of profit in Synthroid.
Is it any wonder that the patient community is left to speculate about the lengths to which Synthroid's manufacturer, and those who are recipients of the company's largesse, such as AACE, will go to defend the drug's market dominance?
For the record, I do not have any relationship with Armour Thyroid or any drug company.
I also wanted to note some points brought up In your October 25, 2005 response to Dr. Law and AACE. In that letter, you wrote, regarding Dr. Hotze, that "much of what he proposed falls far outside the accepted norms." As I outlined earlier, given the vast underdiagnosis of hypothyroidism, even according to the AACE itself, and the lack of scientific evidence against Armour Thyroid, I fail to see how many of the Dr. Hotze's ideas fall far outside the accepted norms.
In your response, you said: "...we should have done a better job of countering his perspective and offering more accepted alternatives..." The question here is, are you talking about offering alternatives that are more accepted by pharmaceutical companies and the large professional organizations receiving their funding, alternatives more accepted by doctors who treat patients fairly and independent of drug company influence, or alternatives accepted by patients who are desperate to feel well? Because I assure you, if you ask these different groups, you will get very different responses.
From my perspective as a patient advocate, I absolutely agree with Dr. Hotze that many women are made to feel like hypochondriacs, and are often shuttled off with antidepressants, rather than being tested for thyroid disease, properly diagnosed, and treated. A quick visit at my heavily trafficked online Thyroid Forums at About.com, located at http://forums.about.com/ab-thyroid, and it's easy to see that many thyroid patients are not getting properly diagnosed, and are made to feel like hypochondriacs by their physicians, including endocrinologists.
I receive nearly a thousand letters each week, and most of them tell of the extreme difficulty patients have in getting their physicians – including endocrinologists – to take their thyroid symptoms seriously. Many women do in fact get dismissed with a prescription for an antidepressant, instead of getting a thyroid test.
In writing my books on thyroid disease, which include Living Well With Hypothyroidism, The Thyroid Diet, Living Well With Graves Disease and Hyperthyroidism, and Living Well With Autoimmune Disease, I have talked with thousands of thyroid patients and practitioners around the world. The message is clear.
We are patients -- we are NOT lab values. Many of us are NOT being properly diagnosed or adequately treated, and the current thyroid dogma may serve Synthroid, but it does NOT serve many patients.
As a thyroid patient, and someone who also cares deeply about the welfare of my fellow thyroid patients, I believe that you should hear all sides of the story, particularly when it deals with a condition as overlooked, underdiagnosed, and poorly treated as hypothyroidism.
At the same time, you have a responsibility to your viewers not to assume that simply because someone has initials after their name, that they are offering unassailable or indisputable facts.
I urge you to review some of the referenced materials, so you can get a true picture of the current state of hypothyroidism, and the gaps in diagnosis and treatment patients are currently experiencing.
We look forward to more balanced CBS coverage of thyroid disease in the future, and hope that future programs will also seek to include the all-important patient perspective that has been so lacking in this entire debate.
Sincerely,
Mary J. Shomon
Patient Advocate, Author
Citations
1 Fatourechi V, Klee GG, Grebe SK, et al. Effects of reducing the upper limit of normal TSH values. Journal of the American Medical Association. 2003;290:3195-3196.
2 RxList.com -- http://www.rxlist.com/top200.htm
3 RxList.com -- http://www.rxlist.com/top200_sales_2004.htm
4 Prescription Drug Pricing in the United States: Drug Companies Profit at the Expense of Older Americans, Prepared for Rep. Henry A. Waxman, www.democrats.reform.house.gov/Documents/20040629104049-62473.pdf
Read the Article Now:
Dr. Steven Hotze vs. the Endocrinologists: The Battle Over Hypothyroidism Diagnosis and Armour Thyroid
