Worst Pills, Best Pills Warns Against Using Armour Thyroid

But article is long on accusations, short on fact

May 2003 -- I expect a lot from Worst Pills, Best Pills, a newsletter published by the consumer watchdog group Public Citizen, but unfortunately, they have fallen far short this time. The May, 2003 issue of Worst Pills, Best Pills, has an article titled "Do Not Use! Natural or Desiccated Thyroid (ARMOUR THYROID) For Thyroid Hormone Replacement Therapy."

This article fails the American public by mispresenting a shoddy, poorly researched and misguided opinion piece as analysis, capped by a panicky headline.

They are also veering away from their purported mission of helping patients educate and protect themselves, instead proposing that patients limit their options and avoid talking a safe, effective and less costly thyroid drug that may well work better for some.

What happened? Public Citizen is an organization that usually champions the underdog, and cautions consumers to be careful of corporate marketing claims. They are usually the first to point up the cozy relationships between pharmaceutical companies and medical associations. Have they themselves fallen victim to the marketing spiels of the pharmaceutical manufacturers?

Their condemnation of Armour Thyroid reads like a marketing brochure for Synthroid, and it's clear that Worst Pills, Best Pills did little or no research on the subject of desiccated thyroid drugs, their prescription, or their use, as evidenced by the weak and unconvincing arguments they offer in the article.



The first argument the newsletter offers against Armour Thyroid is the following:

The Medical Letter on Drugs and Therapeutics, an independent source of drug information written for physicians and pharmacists that we frequently cite, concluded that synthetic levothyroxine is preferred over other forms of thyroid replacement drugs. This recommendation was made in 1977.



A 25 year old recommendation is not exactly state-of-the-art research. The newsletter article also fails to mention that in 1977, synthetic levothyroxine was not even an FDA-approved drug. Synthetic levothyroxine was introduced in the late 1950s, and at that time, it did not go through an approvals process with the FDA. Rather, its manufacturers claimed it should be grandfathered in, permitted to be sold in the same category as Armour Thyroid. Armour had been safely in use as the only thyroid hormone replacement drug since the early 1900s.

Worst Pills, Best Pills' own editor, Sidney Wolfe, MD, wrote to the FDA in 1996, saying:

In 1978, the last year for which data are available, the FDA estimated that 240 pre-1938 pharmaceuticals were being manufactured. Of these, only 45 had submitted safety and efficacy data in New Drug Applications, in most instances not for all dosage forms of the medication. FDA's failure to conduct such a review has permitted these medications, which include Synthroid, the fourth-most commonly prescribed drug in the United States with annual wholesale sales of $276 million, to remain largely unregulated.



The article's next argument against Armour Thyroid is:

...there is no requirement for the potency of these products in regulating metabolism - the main function of thyroid hormone.

This may be true. But it also applies equally to levothyroxine drugs.

The way that thyroid hormone replacement drugs are measured for effectiveness is in their ability to restore and maintain a patient to normal thyroid status (euthyroid status) as measured by the highly sensitive thyroid stimulating hormone (TSH) blood test. If thyroid patients taking Armour thyroid are, as monitored by their physicians, able to maintain proper TSH levels - then this argument is specious.

If Worst Pills, Best Pills had done its research, they would have first talked to some of the many thousands of physicians who are legally and ethically prescribing desiccated thyroid products to determine if they have success with their own patients, and if patients can be properly titrated to optimal TSH levels. Here at my site, I have articles featuring dozens of nationally known, board-certified MD practitioners who work with desiccated thyroid when appropriate. My support forums feature thousands of patients who are successfully treated using Armour and other desiccated thyroid drugs. As the Worst Pills, Best Pills article itself states, some 2 million prescriptions were dispensed in 2002. There are no studies that indicate that these patients are faring any differently in terms of TSH management than patients taking levothyroxine.

If they'd done any research, they would have also discovered the groundbreaking results of the Colorado Thyroid Prevalence Study. Reported on in the February 2000 issue of the Archives of Internal Medicine, the study found that among patients taking thyroid medication (the vast majority taking levothyroxine), only 60% were within the normal range of TSH. he 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.



The Worst Pills, Best Pills article goes on to argue against Armour Thyroid, saying:

The American Thyroid Association clearly states on its Web site: "There is no evidence that desiccated thyroid, a biological preparation, has any advantage over synthetic thyroxine."

Presenting as factual evidence the opinion of a professional organization that is heavily funded by synthetic thyroxine drug manufacturers, and for that opinion to be that the competitors product has no advantage, is simply inexcusable.

There's a fundamental issue of basic accuracy. The American Thyroid Association's statement should actually read that:

there is no evidence in the form of published, peer-reviewed, double-blind studies that desiccated thyroid, a biological preparation, has any advantage over synthetic thyroxine.

Because if you ask the hundreds of thousands of patients who switched from synthetic thyroxine to Armour Thyroid and find it the optimal thyroid drug for them -- along with the doctors who prescribed the Armour for them -- they can provide volumes of "evidence" of superiority in terms of quality of life and improved health.



It's also important to note that, for accuracy's sake, the opposite of this statement can also be said.

There is no evidence that synthetic thyroxine has any advantage over desiccated thyroid.

What Worst Pills, Best Pills also failed to share is that the American Thyroid Association (ATA), the organization making this declaration, as well as many of its members, have long enjoyed a close financial relationship with the manufacturers of Synthroid, the top-selling levothyroxine drug, and one of the top-selling drugs in the U.S. Abbott Labs, the current manufacturer of Synthroid, has, for example, been a major sponsor of the American Thyroid Association's glitzy annual meeting, and according to their website, was a sponsor of the event in 2001, 2002, and the upcoming ATA meeting in Palm Beach in September, 2003.

Synthroid's manufacturer is also the key funding source for many endocrinologists who receive hefty financial support for everything from their patient literature to attendance at meetings in resort locations and funding for research projects.

Why did Worst Pills, Best Pills - published by a group that claims to be a champion of consumer rights -- also choose to overlook the fact that the market for levothyroxine is nearly monopolized by one drug, Synthroid, which has a questionable reputation? For a complete history of all of Synthroid's legal and product quality troubles, see my Synthroid Chronology. An important part of the story was revealed in 1997, when The Nation chronicled the exploits of Synthroid in an article, "A Year in Corporate Crime.".

The Nation article states:

About 8 million Americans spend $600 million a year on drugs to control hypothyroidism, and Synthroid gets 84 percent of their money. It has been around since 1958 and was the first synthetic thyroid drug. When it came on the market, the F.D.A. approved it without asking for trial data. That oversight has made it extremely difficult for rival thyroid drug manufacturers. Since there is no benchmark data on Synthroid, how could they persuade doctors that their products are just as good and are absorbed into the blood the same way Synthroid is? ...

The article then goes on to describe how Synthroid's manufacturer at the time suppressed research findings that showed that Synthroid was essentially interchangeable with far less expensive competitors, and that use of the cheaper drugs could save thyroid patients $356 million a year. The class action lawsuit against Synthroid that was filed on behalf of patients who overpaid for the drug for the years the research was suppressed is still in the courts, years later, and Synthroid still is substantially more expensive than its competitive levothyroxine products, and far more expensive than Armour Thyroid.



As for the article's suggestion that holistic practitioners are unethically promoting natural thyroid hormone, in some cases as part of a weight loss program, I would first ask, how exactly did Worst Pills, Best Pills come to its expert conclusion that natural thyroid is a "niche market for unscrupulous...practitioners?

Was there research to back up this claim?

As for weight loss, it's no secret that untreated hypothyroidism can cause weight gain and prevent weight loss. Any competent physician consulting with a patient regarding weight loss would include a thyroid function test as part a basic blood workup, and treat any thyroid problems appropriately. Every day, practitioners across the country see patients who want to lose weight, and also complain of fatigue, hair loss, and other hypothyroidism symptoms - and are tested for thyroid disease. The fact that the vast majority of those overweight patients diagnosed with hypothyroidism will leave their doctor's office with a prescription for levothyroxine seems to have eluded Worst Pills, Best Pills.

But the mere fact that Armour carries a warning about improper use for weight loss is a meaningless argument, because the levothyroxine drugs carry the same warnings. Synthroid's package insert, for example, carries the following boxed and bolded warning:

WARNING: Thyroid hormones, including SYNTHROID, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss...

In fact, because levothyroxine is far more familiar and popular with most physicians, it's likelier that a physician prescribing thyroid drugs for weight loss purposes would want to avoid scrutiny by following treatment guidelines for thyroid disease, and would prescribe levothyroxine.



Worst Pills, Best Pills asks why...

after over 25 years of advice to the contrary, is Armour Thyroid in the Top 200 most frequently prescribed drugs in the U.S.?

Clearly, if they had to ask this question, they really weren't doing their homework.

Let's start with one of the most obvious answers: price. In February of this year, I conducted a survey of thyroid drug costs. To briefly summarize, Drugstore.com was selling 90 tablets of .88 Synthroid for $32.14. Unithroid 88 mcg was $28.77. Levoxyl 88 mcg was $22.22. Levothroid 88 mcg was $19.28 (almost half the price of the Synthroid. And 90 tablets of 1 grain Armour Thyroid (which is not directly equivalent to .88 levothyroxine, but is actually a slightly higher dosage size) -- $13.48 -- a third of the price of the Synthroid.

Perhaps just one reason why sales of Armour Thyroid may be growing, given disappearing prescription drug benefits, increasing drug costs, and the fact that the elderly are disproportionately affected by thyroid disease.

And perhaps Dr. Sidney Wolfe needs to re-read his own stern 1996 letter to the FDA. That letter documented a variety of abuses consumers suffered at the hand of levothyroxine manufacturers. It was decades of cavalier manufacturer of levothyroxine, in particular Synthroid, often priced three or more times higher than Armour Thyroid, that forced many physicians and patients to return to Armour, a drug that had been on the market for nearly a century.

And Dr. Wolfe and colleagues also need to pick up a few back issues of the [link url=http://thyroid.about.com/library/weekly/aa021199.htm]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).

The Worst Pills, Best Pills newsletter article concludes:

"if you are offered natural thyroid hormone replacement treatment for any reason, this is a red flag and you should get a second opinion."

Frankly, those who most need a second opinion are the unfortunate readers who are led to believe that the Worst Pills, Best Pills article is anything other than a rehash of tired mythology about desiccated thyroid that has been repeated often enough by the levothyroxine manufacturers and their marketers that it's now mistaken for fact.



Public Citizen states on its website that it is "an independent voice for citizens in the halls of power. We take NO government or corporate money." They urge corporations to stop victimizing consumers and hold government accountable for citizens.

What could possibly motivate such a self-professed champion of the people to turn around and abandon the people, in order to denigrate a safe, effective, 100-year old drug that is serving a portion of the thyroid consumer market, at a third of the price of the top-selling drug?

Some patients do best on a levothyroxine drug like Synthroid, or Levoxyl. Some do best on a combination of levothyroxine and a T3 drug. Others do best on a natural desiccated thyroid drug like Armour Thyroid.

Where Worst Pills, Best Pills ultimately fails its readers, and the American public, is in its inability to recognize that the best thyroid drug for each patient is the drug that safely and effectively works the best for each patient. To suggest otherwise displays a lack of knowledge about the current state of thyroid treatment, and an utter disregard for the quality of life, future, health - and pocketbooks - of millions of Americans.



ACT NOW!!

Write to Worst Pills, Best Pills now and ask them why they have so cavalierly dismissed Armour Thyroid, without any evidence of thoughtful research or inquiry!!

You can email them at: wpbpsupport@citizen.org or write to:

Sidney Wolfe, MD
Editor
Worst Pills, Best Pills
Public Citizen
1600 20th St. NW
Washington, DC. 20009

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