Brought to you by Mary Shomon Your Thyroid Guide
Letter from Mary Shomon to Sidney Wolfe, MD, of Public Citizen / Worst Pills, Best Pills
For background, read:
August 29, 2003
Sidney Wolfe, MD
Health Research Group
Worst Pills, Best Pills / Public Citizen
1600 20th St. NW
Washington, DC. 20009
Dear Dr. Wolfe:
I wrote to you back in May, and also emailed, but received no response. I am writing again to call your attention to major inaccuracies being disseminated via your "Worst Pills, Best Pills" newsletter, and through email responses to my readers that have been sent out by your organization’s volunteer, Betty Blount, RN, BSN on behalf of Public Citizen.
I have always expected a lot from Public Citizen, and "Worst Pills..." has, until recently had a good reputation for consumer advocacy. Unfortunately, your newsletter and organization have fallen far short, and is now doing a disservice to the more than 2 million patients taking Armour Thyroid, and the more than 20 million thyroid patients in the U.S.
May 2003 Worst Pills, Best Pills" Article
Your May, 2003 issue of "Worst Pills..." article titled "Do Not Use! Natural or Desiccated Thyroid (ARMOUR THYROID) For Thyroid Hormone Replacement Therapy" contained numerous inaccuracies. And now, in defending your position to people who have written challenging that article, your organization is disseminating more erroneous -- and potentially dangerous -- information to thyroid patients.
It appears that that "Worst Pills, Best Pills," and later, Betty Blount, have done minimal research on the subject of desiccated thyroid drugs, their prescription, regulation, or use. This is evidenced by the erroneous arguments offered in the article, not to mention the grievous errors offered by Ms. Blount in her email response as defense of Public Citizen’s position.
Your “Worst Pills…" article states:
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 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.
You personally 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.Your 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 all thyroid hormone replacement drugs, INCLUDING 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.
To properly research your article, your organization should 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 research had been done, you 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. 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.
The “Worst 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 inexcusable. This is especially surprising from a group that supposedly savvy to the cozy relationships between medical organizations and the drug companies that fund/control them.
There's also 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 anecdotal "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" 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 online at http://thyroid.about.com/blsynthroid.htm. 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 your 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" come to the conclusion that natural thyroid is a "niche market for unscrupulous...practitioners?" Was there research to back up this claim? It appears to be simply your opinion. And if 2 million patients are being prescribed Armour Thyroid, does that suggest that the practitioners who prescribe it all fit into your category of unscrupulous practitioners?" Because there are many leading practitioners in the field who use Armour, and would no doubt take exception with that sort of categorization.
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 – not Armour Thyroid -- seems to have eluded “Worst 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.
In your article, 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 this question had to be asked, it's more evidence that you weren't doing your 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. 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 you might want to revisit your 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 manufacture 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 a century.
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).
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."The authors of this article clearly are in need of a second opinion – perhaps the PDR would be a good starting point -- to obtain accurate information about prescription desiccated thyroid.
Betty Blount’s Email Response
One thyroid patient who wrote to complain about the inaccuracies in your "Worst Pills" article did receive a response from your volunteer, Betty Blount, on August 27, 2003. I am reprinting it here for you, to help clarify the additional misinformation that Public Citizen is disseminating about Armour Thyroid products. This email has provided incorrect details on even the simplest information about Armour Thyroid. Of greatest concern to me, my fellow patients, and the doctors who work with this product is the fact that you are basing your concerns on an incorrect belief that Armour Thyroid is an unregulated, over-the-counter dietary supplement. Armour Thyroid is a prescription drug that is regulated by the FDA.
The following is Public Citizen's email response regarding the "Worst Pills" article that condemned Armour Thyroid.
From: public_citizen@citizen.orgWhile the entire email is filled with misrepresentations and inaccuracies, the most dangerous are outlined here.
Sent: Wednesday, August 27, 2003
We have received your e mail disagreeing with our article on Armour Thyroid. It would seem that we must agree to disagree.
A big reason we say do not use is that the standards set for this product are based only on iodine content and not potency-there is no requirement for the potency of these products in regulating metabolism (the main function of thyroid hormone). 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. If you watch the research carefully, you will also note that the levels of TSH requiring treatment have been dropping and many physicians and labs have not readjusted their numbers - often resulting in dosage levels being inadequate.
Our work is concentrated on those drugs that have undergone testing and clinical trials before being approved by the FDA - herbal products and food supplements have not undergone the same level of scrutiny or are they approved or regulated by the FDA.
In order to understand the problems one must know the different ways in which the law deal with herbals, etc. as opposed to the responsibility for prescription and over the counter drugs. The FDA must pre-screen all prescription and over the counter drugs with peer reviewed science that demonstrates they are safe and effective. A 1994 federal law, pushed by the industry, exempted supplement companies from federal regulation, including the reporting of adverse reactions. The FDA must prove that one of these products is dangerous before it can be removed from the market - the reverse of normal drug approvals that, first, must prove safety before the drug is available.
The following list itemizes some of the specific problems with unregulated products:
1. Tests of many of these products reveal dangerous contaminants such as lead, arsenic, or mercury.
2. Poor quality control - often every container has a different strength and different ingredients.
3. The potency of the pill may not match what the label says.
4. The supplements industry has almost no accountability and can almost do anything it wants.
5. Pharmaceutical companies manufacturing prescription and over the counter drugs can not advertise a medical benefit that research does not support. Supplement companies have a great deal of leeway in their advertising. In our book Worst Pills Best Pills we stated "the promotion of nutritional supplements is now reminiscent of the 'snake oil' sales seen at the beginning of the 20th century."
It is of concern to us that we are receiving more and more mail with people describing negative effects from herbals or dietary supplements they are using. Poison control centers are also reporting increased adverse reactions to a broad range of supplements and a disturbing trend of increasing numbers of children being adversely affected. A guiding rule is that everything reacts to everything else and one must make decisions with their physicians of the risks and benefits of any particular product. Never assume because something is natural or over-the-counter that it is safe. A common misconception is that some people believe if a product weren't safe, the government would not allow it to be sold. Never use these products without your doctor's knowledge- they may react or interact with prescription drugs you are taking.
We believe the public has a right to a marketplace free of untested products that can be sold for unsubstantiated uses. The passage of the Dietary Supplement Health and Education Act (DSHEA) stripped the FDA of any authority to act proactively to ensure the public's safety. The DSHEA has left American consumers almost without protection in the anarchistic dietary and herbal supplement marketplace. With the proliferation of dietary supplements, the public seems to have forgotten the basics - proper diet, exercise, and a lifestyle compatible with good health - supplements can't take their place.
The goals of the Health Research Group are to educate the public about critical health issues, and to monitor the state and federal agencies which regulate the delivery of health care and the safety of drugs, medical devices, food, and environments. Our small staff's time is spent pursuing these goals, and we are unfortunately not able to respond in detail to questions raised in the tremendous amount of mail we receive.
Betty Blount, RN BSN
Public Citizen Volunteer
PUBLIC CITIZEN ERROR: "Armour Thyroid...does not require a prescription."
FACT: Armour Thyroid is a prescription drug, requires a prescription, and is FDA-regulated.
PUBLIC CITIZEN ERROR: "If you watch the research carefully, you will also note that the levels of TSH requiring treatment have been dropping and many physicians and labs have not readjusted their numbers - often resulting in dosage levels being inadequate."
FACT: This development has nothing to do with Armour Thyroid, and is an issue that affects ALL thyroid hormone replacement drugs, including levothyroxine and liotrix.
PUBLIC CITIZEN ERROR: "In order to understand the problems one must know the different ways in which the law deal with herbals etc. as opposed to the responsibility for prescription and over the counter drugs."
FACT: Armour Thyroid is a prescription drug, and not an over the counter or herbal remedy.
PUBLIC CITIZEN ERROR: "The following list itemizes some of the specific problems with unregulated products..."
FACT: Like any other prescription drug, Armour Thyroid is regulated and overseen by the FDA.
PUBLIC CITIZEN ERROR: "It is of concern to us that we are receiving more and more mail with people describing negative effects from herbals or dietary supplements they are using."
FACT: Again, Armour Thyroid is not an herbal or dietary supplement. It is a prescription thyroid hormone replacement drug.
PUBLIC CITIZEN ERROR: "We believe the public has a right to a marketplace free of untested products that can be sold for unsubstantiated uses. The passage of the Dietary Supplement Health and Education Act (DSHEA) stripped the FDA of any authority to act proactively to ensure the public's safety. The DSHEA has left American consumers almost without protection in the anarchistic dietary and herbal supplement marketplace. With the proliferation of dietary supplements..."
FACT: Again, Public Citizen and its representative, Ms. Blount, are incorrectly characterizing Armour Thyroid as a dietary supplement. Armour Thyroid, being a prescription product, IS subject to the authority of the FDA.
PUBLIC CITIZEN ERROR: "The goals of the Health Research Group are to educate the public about critical health issues..."
FACT: The goal of education is correct information. Unfortunately, in this case, Ms. Blount, the Health Research Group, and Public Citizen appear to be the ones in most dire need of basic education on thyroid drugs, you are providing incorrect and potentially dangerous information to thyroid patients around the country.
You state on your website that Public Citizen is "an independent voice for citizens in the halls of power. We take NO government or corporate money." You urge corporations to stop victimizing consumers and hold government accountable for citizens.
I am an independent voice for thyroid patients. I take no pharmaceutical company money. And I urge YOU to stop victimizing thyroid patients by disseminating this erroneous information.
What could possibly be the reason for abandoning millions of consumers in order to denigrate and spread misinformation about 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?
The fact is that 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.
It is irresponsible of a group such as Public Citizen, with your Health Research Group, "Worst Pills" newsletter, "Questionable Doctors" report, and reputation for consumer advocacy, to stand by clearly erroneous information that does such a tremendous disservice to thyroid patients. And to continue to do after receiving the correct information calls into question the integrity of your organization, and displays a disregard for the quality of life, future, health – and pocketbooks – of millions of Americans.
You have been contacted by me, and by numerous physicians and patients, all providing citations to the correct information. At this stage, it is indefensible to continue to stand by and disseminate incorrect and potentially dangerous information.
At minimum, I would call on Public Citizen and Worst Pills to do several things to remedy this wrong:
1. 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.
2. Make the clarification immediately available to readers -- including those without paid subscription -- at your Worst Pills website.
3. Issue a press release notifying the public of the error
As a health writer and thyroid patient advocate for more than 7 years, I’ve worked with various organizations and media to advocate for various patient issues. Along the way I've had the opportunity to be interviewed for television, radio and newspaper stories hundreds of times, to help expose various coverups and issues affecting the population of millions of thyroid patients. I have in the past, and will in the future continue to publicize issues that put my fellow thyroid patients at risk. In addition to my media advocacy, I communicate via my websites, and my email and print newsletters’ readership, and my bestselling thyroid book, "Living Well With Hypothyroidism," (HarperCollins), currently in its 17th printing.
I feel strongly that patients deserve the correct information and ask that Public Citizen and "Worst Pills..." issue an immediate public correction of this erroneous information. I look forward to hearing from you regarding what actions your organization plans to take to help ensure that no further damage is done by the misinformation in your newsletter, website, and being disseminated by email.
Sincerely,
Mary J. Shomon
cc: Joan Claybrook
Betty Blount, RN, BSN
