November, 2005 -- All out war is being waged between Dr. Steven Hotze, author of a book published earlier this year, "Hormones, Health and Happiness," and the American Association of Clinical Endocrinologists (AACE). The controversy centers on an appearance Dr. Hotze made on the CBS Early Show on September 19, 2005, to discuss his book. In the interview with CBS host René Syler, Hotze made a head-on assault against conventional endocrinology -- along with its main source of funding, Synthroid, one of America's top-selling and most profitable prescription drugs.
In the CBS interview, Hotze took issue with his perceived flaws in how hypothyroidism is diagnosed. Said Hotze:
"This is what I hear from women. "I've been made to feel like a hypochondriac. I've got these problems." What are the problems? Loss of energy, fatigue, hair loss, difficulty with weight, mood swings, can't think clearly, mood swings, go to bed tired, wake up tired, toss and turn all night, sluggish bowel function, joint/muscle aches pains, elevated cholesterol, loss of the lateral third of the eyebrows, enlarged tongue, they don't feel the romantic moods and inclinations, and they go to the doctor, and the doctor does a blood test, and goes 'your thyroid is normal.' How do you think that makes a woman feel? She feels like "well, maybe it's in my mind." The doctor gives her an antidepressant.
Hotze then explained his philosophy of giving a therapeutic trial of Armour Thyroid when a patient presents with symptoms. He said:
Conventional doctors rely strictly on blood tests....That doesn't work. Because 95% of the people alaways fall within the range. That's how they define the range...So in my opinion...we listen to the patient and let her tell us her symptoms. And then we will treat her based upon her clinical symptoms and give her a therapeutic trial of thyroid.
Later in the interview, Hotze took aim directly at Synthroid, while explaining his preference for Armour:
Armour Thyroid's been around for 100 years. Synthroid...synthetic thyroid -- it's not even the active thyroid hormone, nor is Levothroid or Levoxyl. These are synthetic thyroid hormones that the drug companies have perpetrated upon the public, convinced the endocrinologists and doctors to use. And they put the women on these drugs. And I say this...If you're taking a synthetic thyroid preparation and you still have the symptoms of low thyroid, it's not working. And you ought to have a trial of Armour Thyroid.
The AACE clearly disagreed with Hotze's comments, and wrote a letter of response to CBS dated October 18, 2005.
In the letter, Dr. Bill Law, President of the AACE, expressed his "extreme concern and disappointment," calling the interview a "thinly veiled infomercial for his practice and book."
The AACE also criticized Armour Thyroid, saying:
Animal-derived desiccated thyroid, which Dr Hotze endorses and describes as "natural," is not a natural form of thyroid replacement for humans at all. It is an obsolete product obtained from ground-up cattle and pig thyroid glands. The chemical composition is quite variable, since only the iodine content is measured, and the amount of biologically active thyroid hormones in each tablet is not quantified. This makes it extremely difficult for even a trained specialist to properly adjust the dose to fit each patient's needs.
For context, it's important to note that AACE as an organization relies heavily on funding from Abbott Laboratories, manufacturer of Synthroid (See AACE's Corporate Partners list). Many of the members of AACE's leadership, as well as influential general members, are also recipients of hefty grants, speaking fees and honorarium, research funds, free drug samples, free patient literature, logo gift items, and other financial and material support from Synthroid's manufacturer.
It's also important to note that in recent history, whenever Synthroid has been criticized publicly, AACE has come to its defense by issuing public statements, or conducting public relations efforts in support of Synthroid.
For example, Synthroid came under serious fire in 2001 when the FDA refused the manufacturer's request to bypass the required FDA drug approval process, and instead required that the drug receive FDA approval, or phase out manufacturing. In a scathing April 26, 2001 letter to Knoll Pharmaceuticals, Synthroid's manufacturer at the time, the FDA wrote:
The history of potency failures...indicates that Synthroid has not been reliably potent and stable.
The FDA also outlined what they called "a long history of manufacturing problems," including recalls due to potency and stability problems, deviations from good manufacturing practices, and products that were of low dosage.
The AACE President at the time, Rhoda Cobin, had a letter published in the Wall Street Journal in support of Synthroid. Because the manufacturer had failed to bypass the approval process, and was unable to produce a product that met with FDA approval by the FDA deadline, the FDA was recommending production cuts and eventual phase-out of Synthroid, until such time as the manufacturer could produce a product of sufficient quality to receive FDA approval. At the time, Cobin wrote:
...while the American Association of Clinical Endocrinologists does not endorse specific products, the 3,700 physicians in our organization, all specialists in thyroid disease, have found that Synthroid has a long record of safety, efficacy, reliability and consistency...
In June, 2001, AACE also issued a press release in support of Synthroid, titled "Synthroid Should Remain on the Market." ( Read the release now.)
"While AACE does not endorse specific products, it feels that this proposed action is extremely misguided and unwarranted," said Rhoda Cobin, in that release.
Just this past January, AACE launch a questionable campaign to mark the January 2005 "Thyroid Awareness Month." Their campaign, which focused on concerns about bioequivalence and attempts to convince patients not to switch thyroid drugs, also functions as an effort to protect market share for Synthroid. (See more information about the AACE campaign.)
So, it should come as no surprise, then, that AACE has again defended Synthroid against criticisms, in this case, those leveled by Hotze.
What is suprising is that CBS rather quickly agreed to present the AACE perspective, which is not typical for most media outlets. On October 25, 2005, CBS issued a mea culpa to the AACE (Read the entire CBS' response now.) In his letter, Michael Bass, Senior Executive Producer of The Early Show, wrote:
I agree with you that we definitely should have done a better job of challenging his opinions, and also that much of what he proposed falls far outside the accepted norms and, according to our Dr. Emily Senay, could be potentially harmful to some patients. Dr. Hotze is of course entitled to his opinion, but we should have done a better job of countering his perspective and offering more accepted alternatives, so that our viewers would have sufficient information to take with them to their own doctors... As a result, and in light of the concerns you raised, we are airing a segment tomorrow in our Healthwatch on thyroid disease with our own Dr. Senay, which will specifically counter many of the points made by Dr. Hotze...
CBS also blogged this on their Public Eye blog on October 26, 2005, saying: "Kudos to Bass for acknowledging and investigating the AACE's concerns."
CBS's health correspondent, Dr. Emily Senay, then did a segment on October 26, 2005, talking about thyroid disease, offering a straight conventional perspective in line with the AACE positions. You can read the account of her segment at the CBS site or view the segment online. (Click here, and once at the site, scroll midway down the page)
But Hotze is not letting CBS or AACE have the last word. In response, Hotze sent a letter to CBS on November 10, 2005. (Read his entire letter now) In the letter, Hotze said:
The current medical paradigm for diagnosing and treating low thyroid conditions is to rely solely on blood tests, tests which in and of themselves cannot predict patient symptoms...These women with so called normal tests are then routinely sent home with prescriptions for psychiatric drugs, specifically, antidepressants, having been made to feel that they are hypochondriacs, neurotics or hysterics and that their problems have a psychosomatic origin.
Hotze also hit back hard with the following statement:
Many AACE members are guilty of ruining the lives of millions of women whose hypothyroid conditions they leave untreated.
Hotze then concluded:
"May I recommend for your consideration that you host a debate between Bill Law and me over the correct evaluation and treatment of hypothyroidism? Properly advertised it would draw a huge audience of women in mid life who are fascinated by the problem of hypothyroidism. It would compete for the same audience as Desperate Housewives.
Hotze vs. AACE: Who's Right, Who's Wrong?
So, where is the truth in this controversy? A few interesting points to note.
From my perspective as a patient advocate, I absolutely agree with Dr. Hotze that many women are made to feel like hypochondriacs. A quick look at my Thyroid Forums 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 hundreds of letters each week, and the difficulty patients have in getting taken seriously by their physicians is a constant refrain.
Dr. Hotze's assertion that conventional doctors rely strictly on blood tests is also true. Conventional physicians rely almost exclusively on the blood tests, and the TSH test in particular, to diagnose most thyroid conditions.
What is completely perplexing to me is that even with the availability of blood testing, millions of people aren't even able to get diagnosed. The Colorado Thyroid Prevalence Study, published in the Archives of Internal Medicine in early 2000, estimated that nationally, more than 13 million Americans have undiagnosed thyroid disease.
And that number is conservative, given more recent developments. The doctors who rely on blood tests currently don't agree with each other as to what constitutes "normal" test results. For several years, a controversy has been raging among conventional endocrinologists regarding the recommendation to narrow the so-called "normal" range of the TSH test to 0.3 to 3.0, from the current range of approximately 0.5 to 5.0. Such a change to lab values was recommended back in late 2002/early 2003 by both the AACE and the National Academy of Clinical Biochemistry.
One 2005 study reported on in the Journal of the American Medical Association found 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. (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.)
If a simple change to the lab value norms could result in an additional 40+ million people being diagnosed as having thyroid disease, then it's hard to question the argument that current blood tests are not successfully diagnosing everyone with hypothyroidism.
As for Armour, the AACE's condemnation of this drug includes a major medical error. No currently marketed prescription desiccated thyroid drug is made of "ground up cattle thyroid glands," as the AACE stated in their letter. Use of cattle in preparation of prescription thyroid drugs was phased out years ago. Armour Thyroid, and other brands of desiccated thyroid, drugs that are legally sold as prescription pharmaceuticals and regulated by the FDA, are made only of the thyroid glands of pigs. That the endocrinology community does not even know what desiccated thyroid is currently made of raises serious questions about their level of knowledge in their own field, and their motives in disseminating obviously erroneous information to the media.
The argument against Armour also does not have a scientific basis. The preference for synthetic, versus natural, thyroid is opinion. There is no double-blind, peer-reviewed medical research that establishes that today's levothyroxine is superior in treating hypothyroidism as compared to today's prescription desiccated thyroid drugs. The way that thyroid hormone replacement drugs are evaluated and measured for effectiveness is in their ability to restore and maintain a patient to normal thyroid status (euthyroid status), as measured by the thyroid blood tests. A thyroid patient taking an appropriate dosage of Armour Thyroid is, when monitored and properly titrated by their physicians, able to maintain euthyroid levels. If that wasn't so, thousands of responsible physicians across the U.S. would not prescribe it for their thyroid patients. And, in 2004, more than 2 million prescriptions were written for Armour Thyroid. There are clearly many doctors who are able to properly adjust the dose to fit their patients' needs.
All in all, it appears that the AACE, likely at the insistence of Synthroid, is yet again coming to the aid of its main sponsor. Threatened by Dr. Hotze's appearance on national network morning show, and his clear disdain for the conventional endocrinology approach as espoused by AACE, and his criticisms against the drug Synthroid, AACE felt it necessary to defend the conventional medical viewpoint, and, by attacking Armour, to implicitly defend Synthroid.
