Brought to you by Mary Shomon Your Thyroid Guide
Letter from Mary Shomon to Sidney Wolfe, MD, of Public Citizen -- September 5, 2003
For background, read:
September 5, 2003
Sidney Wolfe, MD
Health Research Group
Worst Pills, Best Pills / Public Citizen
1600 20th St. NW
Washington, DC. 20009
Dear Dr. Wolfe:
Thank you for responding to my letter, email and phone call. I received your email response today, and would like to respond, point-by-point, to the issues you raised. The parts of your communication to me are in bold to differentiate them.
Mary: This is only a partial response to your letter. Betty Blount, the volunteer nurse who answers some of Public Citizen’s consumer mail has not been in town and we need to talk with her about the concerns you raised about statements in her letter to you. When we have, we will get back to you again.
Dr. Wolfe, I am concerned that this delay in providing a full and adequate response is an effort on the part of Public Citizen to avoid significant, meaningful response to the community of thyroid patients. Serious damage has already been done, in issuing a “Do Not Use” notice for Armour Thyroid, and that damage is being compounded by the dissemination of patently erroneous information about the drug. Consumers have written to your organization – and will continue to write -- to express their concerns about Public Citizen’s position.
Public Citizen cannot continue to defend itself with assertions that Armour Thyroid is an over-the-counter, non-prescription herbal supplement.
It is of the utmost urgency that errors be corrected immediately and publicly. Talking with Betty Blount should not be required in order for your organization to fact-check the misinformation she is disseminating, which include the following most egregious error:
“There are many levels of treating people who do not have the ability to write prescriptions and recommend Armour Thyroid instead which does not require a prescription.“Any PDR or web search can easily verify that Armour Thyroid is in fact a drug that DOES require a prescription.
Betty Blount email August 27, 2003 -- http://thyroid.about.com/cs/thyroiddrugs/a/publiccitizen.htm
Betty Blount letter of July 10, 2003 -- http://thyroid.about.com/library/drugs/blblountletter.htm
Frankly, it does little to help restore Public Citizen’s credibility to avoid the issue of your group’s misinformation about Armour or your plans for correcting misinformation you’ve disseminated.
1. The major issue is the consistency of response to treatment that patients and physicians have a right to expect when thyroid replacement therapy is prescribed.
I would ask, then: how do you account for the circumstances under which 2 million prescriptions for Armour are being written each year? Armour Thyroid is legally on the market, and has been used for more than a century. Most physicians monitor the effectiveness of therapeutic thyroid hormone replacement by measuring TSH, if not T4, T3, and free T4/T3 levels. You seem to suggest that physicians are writing 2 million prescriptions for Armour Thyroid each year, yet are dissatisfied with the consistency of response and ability to achieve euthyroid status in patients. Wouldn’t physicians who found inconsistency of response in their patients simply switch to another type of thyroid hormone replacement therapy until they achieved euthyroid status? You also seem to suggest that the patients receiving those 2 million prescriptions per year are not consistently responding to treatment. Wouldn’t patients who found that Armour was unable to maintain their euthyroid status and resolve symptoms ask to be switched to another thyroid hormone replacement drug?
Are you suggesting that each and every one of those 2 million prescriptions is being written by unscrupulous doctors, who are prescribing Armour Thyroid for weight loss purposes, and not as a hypothyroidism treatment?
There have been some problems with the manufacturing of final finished l-thyroxine dosage forms in the past, for example, changing excipients without prior notification of the FDA by manufacturers that led to recalls.
This is true. In fact, there is a very long history of problems with reliability, potency and stability of levothyroxine products. These problems were the reason behind the FDA’s requirement for New Drug Application for levothyroxine drugs. Interestingly, however, even after new drug approval, there are still numerous recalls of approved levothyroxine drugs regularly taking place. Just a few, for example:
- Levoxyl (Levothyroxine Sodium Tablets), 112 mcg, 2,639 bottles, July 2003 -- http://thyroid.about.com/b/a/011751.htm
- Levoxyl Recall # D-248-3, April 2003 -- http://www.safetyalerts.com/recall/f/02.2/f0002642.htm
- Levoxyl 50 mcg and 100 mcg Recall, June 2002 -- http://www.thyroid-info.com/articles/levoxyl.htm
- Levoxyl Class 2 Recall, October 2001 -- http://www.safetyalerts.com/recall/f/014/f45318.htm
As of June 2001, two levothyroxine products had been approved: UNITHROID, manufactured by Jerome Stevens Pharmaceuticals, on August 21, 2000, and LEVOXYL, manufactured by Jones Pharma. There are now other products with approved New Drug Applications.
Yes. Synthroid, for example, was approved, after a reformulation and numerous extensions of the deadlines. Several generics have also been approved.
2. Shoman [sic] finds fault with the American Thyroid Association’ support of l-thyroxine products neglecting the independence of the Medical Letter and the early editions of the AMA Drug Evaluations.
The American Thyroid Association says at their site, as you quoted:
“There is no evidence that desiccated thyroid, a biological preparation, has any advantage over synthetic thyroxine.”This does not say that Armour is dangerous or should not be used. Simply, they state that their position – their opinion -- is that desiccated thyroid does not have an advantage over synthetic thyroxine.
As for the Medical Letter, and AMA Drug evaluations, the Medical Letter on Drugs and Therapeutics did say in 1977 that synthetic levothyroxine is preferred over other forms of thyroid replacement drugs. And the American Medical Association Drug Evaluations 5th edition also recommended in 1983 that synthetic levothyroxine is the preferred thyroid hormone replacement treatment.
Public Citizen/Worst Pills, Best Pills is, however, relying on quarter-century-old recommendations as justification to a call for physicians to stop prescribing a drug in use today, a move that would create a dramatic upheaval affecting hundreds of thousands of consumers. You seem to be suggesting that this sort of drastic recommendation can reliably be based on outdated recommendations from a time when far fewer patients were even using Armour Thyroid, and less was known about thyroid disease.
As noted, 2 million prescriptions for Armour Thyroid are written each year, and that number is growing. There are no current, peer reviewed, double-blind studies that I am aware of that compare levothyroxine to Armour desiccated thyroid in their ability to maintain thyroxine (T4) levels, which is the current benchmark for thyroid drug therapeutic effectiveness. [Although a Citizen's Petition filed by Abbott Labs in early September of 2003 calls for re-evaluation of the testing methodology for levothyroxine drugs, including consideration of the TSH test as a better means of evaluation than the T4 test.] If you are aware of such studies that would justify Public Citizen’s position, please share them with your me and your other subscribers.
Shomon offers only anecdote in response “... ask the hundreds of thousands of patients who switched from synthetic thyroxine to Armour Thyroid ... “ She says as much that her evidence in anecdotal.
As you know, there is a long history of anecdotal evidence revolutionizing medical treatment. It was the anecdotal observation of the famed Dr. Ignaz Semmelweis that led to the discovery that washing hands reduced post-partum mortality, decades before germs were even “discovered.”
Smart doctors recognize that their own experiences, and the experiences of their patients, are just as essential to good diagnosis, treatment and patient care as are double-blind, peer-reviewed study results.
Power to the people, Dr. Wolfe. Patients now must become educated consumers of healthcare and medicines, and they turn to many places to acquire information. I read the thyroid journals and hundreds of medical journals each month. As a thyroid patient advocate, I hear from more than a thousand thyroid patients each week, and speak regularly with dozens of practitioners around the country each week. Have you or the staff at Public Citizen personally heard the experiences of more than 50,000 thyroid patients in the last year?
You can reject anecdotal evidence with a wave of your hand from your ivory tower, but the real-life experiences of the thyroid patient community cannot be so easily dismissed, and, frankly, should not be dismissed.
Particularly, given that Public Citizen purports to be “an independent voice for citizens in the halls of power," to dismiss and deliberately ignore even anecdotal evidence – evidence that represents the voices of hundreds of thousands of people – seems utterly contradictory to your mission, and hypocritical of you and your organization.
At the same time, if you insist on dismissing the experience of physicians and patients, then I assume you hold yourself to a standard of relying strictly on double-blind, peer-reviewed controlled studies to defend your “Do Not Use” condemnation of Armour Thyroid? In that case, you would of course provide the public with the citations for the double-blind, peer-reviewed research that supports Public Citizen’s condemnation of Armour Thyroid. There were no medical references or citations included in the May 2003 Worst Pills article, and a thorough Medline search did not reveal any comparative research on the effectiveness of levothyroxine versus Armour desiccated thyroid. Would you share those please?
We are well aware of the “Synthroid Affair” and have written about it extensively in Worst Pills, Best Pills News.
You have. At the same time, you have failed to make the obvious connection between that issue, and the influence Synthroid’s manufacturers and the corruptive marketing influence they have wielded for almost 50 years over the medical establishment’s prevailing anecdotal “opinions” about thyroid treatment.
3. Shoman [sic] asks how we know about thyroid hormone and weight loss doctors. There is an extensive history of the inappropriate use of thyroid hormones alone and in combination with other drugs from Congressional hearings that are publically [sic] available. This is why there is a box warning on all thyroid products.
Again, I would caution you to be careful in condemning Armour Thyroid based on “an extensive history of the inappropriate use of thyroid hormones.” You are condemning one particular brand of thyroid hormone, but your justification is that the concern is with all all thyroid hormones. This is simply not logical.
Besides Congressional hearings, which are not considered empirical, scientific evidence, can you provide citations to any research, indicating that, for example, “X percent of the 2 million prescriptions for Armour Thyroid written each year are written inappropriately solely for weight loss, in people who have no serum evidence of hypothyroidism?” I have not been able to uncover any research that validates this particular theory.
4. Shoman [sic] makes the following statement :”The fact that the vast majority of those overweight patients diagnosed with hypothyroidism will leave their doctor’s office with a prescription for levothyroxine – not Armour Thyroid -- seems to have eluded “Worst Pills.”
If the hypothyroidism is correctly diagnosed this would be appropriate therapy and it did not elude us and we are glad Shomon appears to agree.
You are evading the crucial point here. You need to provide evidence that defends your position that somehow, abuse of thyroid hormone for weight loss purposes is more likely with Armour Thyroid than with levothyroxine. Given that the vast majority of thyroid hormone replacement prescriptions are written for levothyroxine, one could logically theorize that in fact,the majority of inappropriate prescriptions of thyroid hormone replacement for weight loss purposes may in fact be written for levothyroxine.
Of course, actual research would need to be done to determine the facts. Until such research is conducted, your hypothesis that somehow, doctors are “inappropriately” prescribing Armour for weight loss (and we have to assume that you mean that they are prescribing Armour to patients who are euthyroid) is just that, an unproven hypothesis. Certainly, a hypothesis is not enough upon which to base such an important decision as a “Do Not Use” warning.
At the same time, if you do believe that unscrupulous doctors are dispensing thyroid drugs for weight loss purposes, and that this particular practice is a valid criterion for a “Do Not Use” warning, then Worst Pills logically and ethically must issue the same “Do Not Use” warning for levothyroxine drugs.
5. Shoman [sic] cites the February 2000 issue of the Archives of Internal Medicine and a cross-sectional study of participants in a statewide health fair in Colorado from 1995 She makes this statement about the study:
“The study found that among patients taking thyroid medication (the vast majority taking levothyroxine), only 60% were within the normal range of TSH. The fact that forty percent of patients, a number that translates to millions of Americans, are taking thyroid hormone – the overwhelming majority taking levothyroxine -- and are still not in TSH range indicates that either vast numbers of doctors do not know how to properly prescribe levothyroxine, or it may not be as effective as its manufacturers and supporters claim.”
This last implication is hardly supportable from the results of a cross-sectional survey.
One looks at a situation, and forms a variety of hypotheses, which need to be tested, of course. A large cross-sectional study found that 40% of the patients on hormone replacement (and we know that the vast majority of patients take levothyroxine) were not euthyroid. Keep in mind that this was before the new lab standards that narrowed the range to .3 to 3.0, which were announced in late 2002. Under the new standards, a larger percentage of that population studied would not be euthyroid.
Hypotheses:
- Doctors are over or underprescribing thyroid hormone replacement drugs
- The thyroid hormone replacement drugs are not consistent, or are of greater or less potency than their stated dosage
- Patients are non-compliant in taking their drugs
And given the poor history of the levothyroxine products in terms of their ability to maintain potency and stability – and the fact that FDA approval does not guarantee safety or quality, as you well know and often remind us in your newsletter – are you confident in asserting that levothyroxine drugs are uniformly safe, potent, reliable and consistent, and that the quality of levothyroxine drugs is not contributing in any way to this issue of erratic TSH levels?
Given your organization’s past concerns about the quality of levothyroxine drugs, do you now stand behind the quality and consistency of today’s levothyroxine drugs enough to say that you can defend removing consumers’ options such as Armour from the market?
Do you stand behind the quality and consistency of today’s levothyroxine drugs enough to call for an action that would interfere with hundreds of thousands of patients’ thyroid treatment now and in the future?
6. Shoman [sic] mentions a New England Journal Medicine study or studies but gives no citation and makes this statement:
And you and your colleagues should also review several back issues of the New England Journal of Medicine, which reported on studies that found that the majority of thyroid patients do not feel well on levothyroxine (which contains only a synthetic version of one thyroid hormone, T4). Rather, these patients felt better and had fewer symptoms with the addition of a second hormone, T3. While the New England Journal articles may be a surprise to “Worst Pills, Best Pills,” they are no surprise to the practitioners and patients who use Armour Thyroid (which contains both T4 and T3).
I believe the citation for this study if N Engl J Med 1999;340:424-9. (attached at the end of this email)
The study involved 33 patients with chronic autoimmune thyroiditis or thyroid cancer treated by near total thyroidectomy. The patients did not receive natural thyroid supplementation they received synthetic thyroxine (levothyroxine) plus T-3. Shamon [sic] appears to be advocating synthetic thyroid hormones produced by Berlin Chemie, Berlin, Germany
First, I am not advocating any particular brand of drug or particular thyroid hormone replacement protocol. I am advocating freedom of choice for the millions of thyroid patients who purchase thyroid drugs each year, and the practitioners who treat them. This is in contrast to Public Citizen’s desire to take away consumer choice and options, by declaring that practitioners “Do Not Use” Armour.
My position has been, and will continue to be that the best thyroid drug for each patient is the drug that works safely and best for each patient, as determined by the patient and his/her physician. I have also remained outspoken in my efforts to ensure that thyroid patients are aware of their various options for thyroid hormone replacement, and the price differences among those drugs.
Second, the fact is that Armour Thyroid contains the natural form of T3. The studies referenced (1-Bunevicius R, Jakubonien N, Jurkevicius R, Cernicat J, Lasas L, Prange AJ Jr. "Thyroxine vs thyroxine plus triiodothyronine in treatment of hypothyroidism after thyroidectomy for Graves' disease." Endocrine. 2002 Jul;18(2):129-33 and 2- Bunevicius R, Kazanavicius G, Zalinkevicius R, Prange AJ Jr. "Effects of thyroxine as compared with thyroxine plus triiodothyronine in patients with hypothyroidism." N Engl J Med. 1999 Feb 11;340(6):424-9. PMID: 9971866) were done using levothyroxine and synthetic T3, but that does not negate the fact that a clear benefit was seen with the addition of T3.
To completely disregard the theory that a similar effect may well be occurring with Armour Thyroid is irresponsible. And to condemn Armour Thyroid, an inexpensive drug that allows patients to obtain T4 and T3 hormone, totally disregards the quality of life of millions of American thyroid patients.
The second study is an editorial in the same issue of the N Engl J Med, Volume 340:468-470. The author of the editorial concludes:
“Finally, it should not be forgotten that the majority of patients taking a dose of thyroxine that satisfies the recommendations of the American Thyroid Association have no complaints about their medication.”
Forgive my lack of citations in the previous letter. The second study, which I cited above, was not the editorial you mentioned. It was in fact an additional study by the Bunevicius/Prange, et. al. team, reported on just last year in a different journal. Here is the citation again: Bunevicius R, Jakubonien N, Jurkevicius R, Cernicat J, Lasas L, Prange AJ Jr. "Thyroxine vs thyroxine plus triiodothyronine in treatment of hypothyroidism after thyroidectomy for Graves' disease." Endocrine. 2002 Jul;18(2):129-33
As for your quote from the editorial, an editorial is, as you know, an article expressing an opinion. It is not scientific fact.
Research from the Thyroid Foundation of America (http://www.allthyroid.org), the nation's largest thyroid patient organization, has found that among patients who were hypothyroid due to treatment for Graves' Disease, the majority did not feel well despite daily treatment with a thyroid hormone replacement pill.
In 2002, I conducted the first quality-of-life survey of almost 2000 thyroid patients, and found that more than 50% of respondents reported that they are not satisfied with their thyroid treatment. Many patients still suffer from symptoms despite treatment, in particular: 92% of those surveyed feel exhausted; 65% are unable to lose weight with diet/exercise; 62% feel run down; 60% have difficulty concentrating; 58% have no sex drive; 51% have pains/aches; 45% feel depressed and 43% are experiencing hair loss.
Were the above two studies double-blind, peer-reviewed and published in a major medical journal? No. But they offer a valid picture of the experience of some thyroid patients.
I would ask you to provide specific citations for the assertion that the majority of thyroid patients have no complaints about their medication, as my research has to date not revealed any such findings.
And again, do you stand behind the theory that the majority of patients are satisfied, to the extent that you feel it’s justified to eliminate a low-cost option that may be the optimal treatment for some patients?
I appreciate the fact that you responded, but I am not satisfied with your response. Public Citizen continues to show disregard for the millions of thyroid patients in America by so casually condemning a drug that has been in use for a century, is far less expensive than its competitors, and contains a second hormone that may greatly aid in quality of life and resolution of symptoms for some.
I maintain that it is irresponsible and indefensible for Public Citizen, with your Health Research Group, "Worst Pills" newsletter, "Questionable Doctors" report, and purported mission of consumer advocacy, to call for the elimination of a drug that is serving many consumers without incident.
And my concern is compounded by your organization’s defense of that opinion with anecdotes, archaic recommendations, and, outright misinformation, such as provided by Betty Blount.
Ultimately, the decision whether or not to use Armour Thyroid should continue to be a matter for patients and physicians to decide – and is certainly not an area where Public Citizen seems qualified to comment or interfere -- particularly if you choose to turn a blind eye to patient and practitioner experience, continue to overlook the corporate influence on research and the politics of medical organizations that are at play in this case, and justify your position based on decades old information, marketing mythology, and various opinions.
For the second time, I publicly call on Public Citizen and Worst Pills to do several things to remedy this wrong and restore your organization's credibility with the 20 million thyroid patients in America:
- Issue a complete clarification and correction in your next Worst Pills newsletter, indicating that Armour Thyroid is NOT an unregulated, over-the-counter herbal or prescription remedy, and correcting the other misinformation being provided in your article and email responses.
- Make the clarification immediately available to readers -- including those without paid subscription -- at your Worst Pills website.
- Issue a press release notifying the public of the error
I hope you do the right thing.
Sincerely,
Mary J. Shomon
cc: Joan Claybrook
