Fw: [ThyroidNews] Sticking Out Our Necks

[Guest guest]

Any sisters interested in this???? Carolyn

----- Original Message -----

From: Shomon thyroidnews

Sent: Friday, July 06, 2001 9:53 PM

Subject: [ThyroidNews] Sticking Out Our Necks / June-July 2001 / # 51

- - - - - S t i c k i n g O u t O u r N e c k s !! - - - - - -The Thyroid

Disease News Reportby Shomon " We're Patients...NOT Lab Values!! " Issue

#51 June /July 2001=================================================THIS

IS THE JUNE/JULY SUMMER EDITION: Please note that this special expanded

issue is a June/July summer edition. There will not be a separate July

issue of Sticking Our Necks. The next issue will be distributed in August

of 2001.

Welcome to the fifty-first issue of " Sticking Out Our Necks! " my thyroid

disease news report. This newsletter is copyright Shomon, and cannot

be legally reproduced without permission. Feel free, however, to forward a

single copy to someone who might be interested in reading the newsletter or

subscribing to it in the future.ON THE WEB: My Thyroid Disease Information

Source and News Report home page is located at http://www.thyroid-info.com'>http://www.thyroid-info.com

, and I also run a comprehensive Thyroid Disease site at About.com, which

you can visit at http://thyroid.about.com . SEND NEWS! If you see something

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tomailto:ThyroidNews-unsubscribe . To contribute information,

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alseMY BOOK: " Living Well With Hypothyroidism: What Your Doctor Doesn't

Tell You...That You Need to Know, was published March 2000, by

Harper, and is a bestseller in its eighth printing. The Los Angeles

Times calls it " a first-rate book. " The book is available in your local

bookstores. FOR MORE INFORMATION, AND ONLINE ORDERS, see

http://www.thyroid-info.com'>http://www.thyroid-info.com/booktoc.htm . FOR PHONE ORDERS IN THE U.S.,

call Politics and Prose Bookstore, 800-722-0790.

=================================================SHARE YOUR AUTOIMMUNE

DISEASE STORIES FOR MY NEW BOOK!!I'm very excited to announce that I'm at

work on a new book for national publication in 2002! The new book is all

about autoimmune diseases, and the conventional AND complementary/holistic

ways to help treat them, and in some cases, potentially even cure them! If

you have stories you would like to share about autoimmune disease, I would

LOVE to hear from you by email, as your story could be featured in the

book, and help others in their efforts to find practitioners, get diagnosed

and properly treated, and live well. If you or a family member have an

autoimmune disease, your stories would be of GREAT help to me. Stories that

would be helpful include:* difficulties, frustrations and challenges

finding the right doctor to recognize/diagnose your autoimmune disease*

what you did to find a doctor who recognized your autoimmune disease* being

misdiagnosed, or misunderstood by doctors, while you were trying to be

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treatment* your frustrations about having an autoimmune disease* what's

working for you * what's not working for you* your advice to other patients

with your condition* names and contact info for doctors and alternative

practitioners who you've found are fantastic in their abilities to diagnose

and treat autoimmune disease* anything else you'd like to shareYour

information can be as short or as long as you'd like. You don't have to be a

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it...bullets, notes, etc. The conditions I'm covering include, among

others: Lupus, Reiter's Syndrome, Sarcoidosis, Sjögren's Syndrome, Graves'

Disease, Hashimoto's Thyroiditis, Autoimmune 's Disease, Premature

Ovarian Failure, Autoimmune Oophoritis, Polyglandular Syndromes,

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Shomon, " P.O. Box 0385, Palm Harbor, FL 34682, or you can fax me at:

301-493-5224. Your privacy will ALWAYS be respected, so unless you

specifically request it, your real name will NOT be used in the book.

Practitioners who would like to be interviewed, please drop me an email

with your phone number, so we can set up a time to talk.Also, please feel

free to forward this to any organizations, patients, or practitioners you

think would be interested in sharing their stories and experiences.

=================================================NOTIFICATION REGARDING NEW

BOOKIf you would like to be notified as soon as the new autoimmune book is

available for purchase, please drop me a one-time email, and I'll make sure

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=================================================NEW EMAIL NEWSLETTERSI'm

launching two new email newsletters -- Autoimmune Update, and Thyroid Diet

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=================================================SYNTHROID AND

LEVOTHYROXINE -- BASIC INFORMATIONSynthroid Information CenterDespite what

some doctors and pharmacists are still insisting, Synthroid is, as of July

7, 2001, NOT an approved levothyroxine drug. There are two FDA-approved

drugs -- Levoxyl and Unithroid. It's a complicated, political battle, and

to stay up on the coverage about Synthroid and what you need to know, visit

the Synthroid/Levothyroxine Information

Center.http://thyroid.about.com/blsynthroid.htmPatient FAQ About the

Levothyroxine Drugs, Including SynthroidA patient-oriented list of

Frequently Asked Questions regarding levothyroxine drugs and Synthroid,

including information about the current FDA controversy, and what patients

may want to discuss with their healthcare

providers.http://thyroid.about.com/library/weekly/aa061301a.htm=============

====================================MARY SHOMON SPEAKS OUT ON BEHALF OF

THYROID PATIENTS IN THE MEDIA Wall Street Journal -- " FDA Could Make Abbott

Pull Synthroid, Popular Thyroid Drug, >From the Market " On Friday, June 1,

2001, the Wall Street Journal published an article on the front page of the

Marketplace section, titled " FDA Could Make Abbott Pull Synthroid, Popular

Thyroid Drug, From the Market. " I was interviewed for this story, and am

quoted discussing the patient perspective on this controversial issue. The

full text of this article was republished by MSNBC at their site, and can

be read online. http://www.msnbc.com/news/581223.asp'>http://www.msnbc.com/news/581223.aspCanadian'>http://www.msnbc.com/news/581223.asp'>http://www.msnbc.com/news/581223.aspCanadian Radio

Interview Re: Synthroid BattleOn Monday, June 4, 2001, I was interviewed by

the Canadian Broadcasting Company's program " As It Happens, " talking about

the Synthroid/FDA battle in the U.S. " As It Happens " has posted the

interview online in

RealAudio.http://radio.cbc.ca/insite/AS_IT_HAPPENS_TORONTO/2001/6/4.htmlTamp

a Tribune's " Synthroid Under Siege " I was interviewed by the Tampa Tribune

for an article that appeared in their Sunday, June 17, 2001 edition. It's a

very patient-oriented article, talking about hypothyroidism, patient

concerns about the levothyroxine controversies and deadlines, Armour

thyroid, and other important issues.Multimedia Version:

http://multimedia.tbo.com/multimedia/MGA4QN7H1OC.htmlHTML Version:

http://health.tbo.com/health/MGA4QN7H1OC.html===============================

==================SPECIAL REPORT: THE SYNTHROID FDA APPROVAL ISSUE IN-

DEPTHAs of the end of June of 2001, there are really only a few facts of

which we can be certain. Synthroid, the top-selling levothyroxine drug, and

number three selling drug in the United States, is not FDA-approved, and

has not yet applied for FDA approval. Two levothyroxine drugs are

FDA-approved -- Levoxyl and Unithroid. And in the meantime, the questions,

accusations, and concerns continue unabated, and are likely to continue

until the August 14, 2001 FDA deadline for levothyroxine drugs. Just what

does that deadline mean for Synthroid and the millions of patients taking

it? To attempt to answer that question, let's take a look back at how we

got to the current situation.Back in 1997, the FDA ruled that due to

concerns over safety and stability, all the levothyroxine products were

classified as " new drugs, " and would be required to go through the new drug

application process in order to receive FDA approval. The approval deadline

was August of 2000 in order to continue to legally market a product. In

between the FDA announcement and the August 2000 deadline, many things took

place. Synthroid's manufacturer at the time, Knoll Pharmaceuticals,

submitted to the FDA requests for numerous documents related to

levothyroxine, under the Freedom of Information Act. The company also filed

a citizen's petition for Generally Recognized as Safe and Effective

(GRAS/E) status, an alternative to the new drug application process, and

one that would allow Synthroid to remain on the market without going

through new drug application. Along the way, because of various

administrative issues, the FDA extended the August 2000 deadline to August

of 2001. In the meantime, three drugs applied to the FDA for approval --

Levoxyl, Levothroid and Unithroid.In August of 2000, the first new drug

application for levothyroxine was approved by the FDA. The product,

Unithroid, was manufactured by a small company, Jerome s, and later

it was announced that distribution would be handled by

Pharmaecuticals. Synthroid's manufacturer, Knoll Pharmaceuticals, was

purchased by pharmaceutical giant Abbott Laboratories, which officially took

over in Spring of 2001. On April 26, 2001, the FDA sent a letter to

Synthroid's manufacturers, officially denying the request for GRAS/E status.

The nine-page letter outlined various concerns regarding Synthroid's past

stability, potency and reliability, stating that " The history of potency

failures...indicates that Synthroid has not been reliably potent and

stable. " The FDA also wrote to Synthroid's manufacturers, " Although you

claim that Synthroid has been carefully manufactured, the violations of

current good manufacturing practices discussed above indicate that Knoll

has not always manufactured Synthroid in accordance with current standards

for pharmaceutical manufacturing. " Abbott announced that in light of the

GRAS/E denial, they would be filing a new drug application before the

August 2001 deadline. In articles at my website, I raised some questions,

pointing out that the typical new drug application for levothyroxine was

requiring nine to ten months, and that the FDA was not clear about the

deadline, having pointed out that in some official communications, the FDA

seemed to indicate that the deadline was for approval of a new drug

application, and not submission. The Stop Patient Abuse Now Coalition and

Gray Panthers got into the situation in May when they announced that to

help " shift the balance of power >from drug industry executives and their

friends in Congress to the consumers who need relief, " they were calling

for campaigns against several drugs, including Synthroid. The strategy was

intended to, as they put it, " raise the financial stakes for drug

manufacturers that engage in anti-competitive or anti-consumer behavior in

order to avoid competition. " On May 25, 2001, Levoxyl became the second

levothyroxine drug to receive FDA approval. Friday, June 1, 2001, the Wall

Street Journal published an article on the front page of the Marketplace

section, titled " FDA Could Make Abbott Pull Synthroid, Popular Thyroid

Drug, From the Market. " (Note: The full text of this article was

republished by MSNBC at their site, at http://www.msnbc.com/news/581223.asp'>http://www.msnbc.com/news/581223.asp.

In that article, reporter wrote: " a spokeswoman for the FDA

said the regulatory notices the agency has published on Synthroid and its

competitors 'don't include a provision' related to simply submitting an

application by Aug. 14. The agency has not decided what it would do if the

Aug. 14 deadline came and went before the drug received approval. But it

would not rule out asking for the drug's removal and noted that there are

two other approved drugs in Synthroid's class that could fill any void left

by Synthroid. " I was also interviewed for that article.The Wall Street

Journal coverage opened up a firestorm of coverage and controversy. I was

interviewed as a patient advocate by CBS radio news network, the ABC radio

news network, WebMD, CBS radio in New York, ABC World News Tonight, the

CBC, and Tampa Tribune.In the meantime, on Friday, June 1, Abbott issued

its own press release, stating that " the safety and efficacy of Synthroid

has been extensively studied and validated. " Abbott's release quoted:

" Synthroid is a tried and trusted product with decades of use and

physicians and patients should continue to have confidence in Synthroid, "

said Leonard Wartofsky, M.D., chairman, Department of Medicine, Washington

Hospital Center, Washington, D.C. " It would be dangerous for patients if

Synthroid were removed from the market. " Leonard Wartofsky, M.D. is an

official representative of Synthroid and affiliated with the manufacturer.

He was in fact in attendance at meetings with the FDA regarding Synthroid,

and FDA records list him as a representative of Knoll/Synthroid. On June 1,

2001, a segment of the endocrinology community also issued a press release,

weighing in on the issue. " Synthroid Should Remain on the Market, Says the

American Association of Clinical Endocrinologists (AACE). " In this release,

AACE objected to the idea of Food and Drug Administration (FDA) withdrawing

Synthroid from the market, stating " AACE is greatly concerned that the

precipitous removal of the drug would create a massive and expensive burden

for both patients and physicians alike. Synthroid patients would have to

visit physicians for an alternative medication. This would also require a

significant change in pharmacy orders. Moreover, patients will be confused

and unnecessarily alarmed over the safety of the drug. Dr. Cobin noted that

clinical endocrinologists have not encountered unusual problems in

prescribing Synthroid and, in fact, count on its reliability. " (Dr. Cobin is

Rhoda H. Cobin, MD, FACE, AACE's President.) Later in the release, Dr. Cobin

says: ``This is not about favoring one product over another, but what is

best for our patients and the least costly and burdensome for our health

care system. " This release did not, however, disclose the relationship

between AACE and Synthroid. Synthroid is prominently listed on the Sponsors

Page of the American Association of Clinical Endocrinologists. Also on June

1, 2001, the Gray Panthers issued another release, " Gray Panthers Challenge

Abbott Labs and American Thyroid Association To Answer FDA Concerns

Regarding Safety and Effectiveness of Synthroid. " Their release reported on

a letter sent to Abbott asking the company to respond to FDA concerns

regarding the safety and effectiveness of Synthroid. Gray Panthers

Executive Director Tim Fuller said in the release " We should not allow

Abbott to ignore the law for its own convenience while patient safety is at

risk, especially since safe, effective, and approved alternatives are

available. " The debate continued on Monday, June 4, with another press

release. " American Thyroid Association, The Endocrine Society, and ThyCa

Call for Continued Availability of Thyroid Hormone Products. " In this

release, The American Thyroid Association, The Endocrine Society, and

ThyCa: Thyroid Cancer Survivors' Association urged the FDA to maintain the

uninterrupted availability of Synthroid. Said the release: " The American

Thyroid Association, The Endocrine Society, and ThyCa recognize that the

reason that Synthroid and some other thyroxine preparations have not yet

received FDA approval is logistical, not medical. " The initial release

failed to disclose that all three organizations are recipients of funding

and support from Synthroid/Knoll. The American Thyroid Association

prominently lists Synthroid on its Sponsors Page. According to a phone call

on Monday, 6/4/01 with Chill, Director of Development and Client

Services for the Endocrine Society, the Endocrine Society is a recipient of

corporate support from Synthroid. And the Thyroid Cancer Survivors'

Association has received funding and support >from Synthroid, including a

booth presence at its annual conference for thyroid cancer survivors.

Things calmed down for about a week, until June 12, 2001, when Abbott

announced that they had filed suit against Pharmaceuticals,

distributor of Unithroid. According to Abbott's press release, Abbott was

asking a Federal court to stop alleged advertising activities by

against Synthroid. Abbott was also asking the court to order to run

an advertising campaign to, as Abbott claims in their release, " correct the

deliberate misinformation it has created within the medical community. "

Abbott's press release alleged that is " inundating patients with

alarming, medically-inaccurate information. " In an telephone interview with

Pizzuti, M.D., Abbott's Vice President, Global Medical Affairs on

June 12, 2001, Dr. Pizzuti told me the information of concern included:

" press releases issued by , some before the GRAS/E (Generally

Recognized as Safe and Effective) petition was denied; a promotional

mailing that contained statements such as 'the FDA is threatening to remove

Synthroid due to questionable quality' which misstates the facts; and

verbal concerted actions by the sales force. " Rob Funsten, Senior

Vice President and General Counsel for Pharmaceuticals told me by

phone that based on the press release, " Nothing that has come to my

attention would say there is any merit to this whatsoever. It strikes me as

an act of desperation. " According to Funsten: " The whole motivation behind

this lawsuit may say more about Abbott and the fact that Synthroid is

unapproved than about . " Funsten added: " One of the things that

surprised a lot of people was the June 1st Wall Street Journal article.

Until then, a lot of people weren't aware of that FDA letter, they weren't

aware that Synthroid hadn't received approval. It strikes me that Abbott is

afraid of people becoming more informed about this issue. " Synthroid's

representatives have a different perspective. " The FDA letter is not saying

that Synthroid not safe, " said Pizzuti, " It is saying 'we think you need to

file the NDA, we can't approve the GRAS/E.' " According to Pizzuti, " We

thought it was irresponsible and medically incorrect to imply that the drug

is not safe and effective. " In June 6 and 7, 2001 letters from Abbott to

patients, pharmacists and healthcare practitioners, Abbott wrote: " Abbott

wants to reassure physicians and patients that the safety and efficacy of

Synthroid has been extensively studied and the results have been published

in peer-reviewed journals such as the New England Journal of Medicine. " In

addition, they wrote: " Recently, FDA informed Abbott that it would not

grant GRAS/E status for Synthroid under Knoll's citizen petition. This only

means that an NDA will be required for Synthroid. This is not a reflection

of the safety and efficacy of the product, but a regulatory issue. " The

Abbott letters do not address the FDA's nine page GRAS/E denial letter, or

why the FDA would choose to so extensively outline these concerns, and when

asked, Dr. Pizzuti had no comment regarding why the FDA chose to deny

Synthroid's request with a detailed and extensive nine-page accounting of

product problems, rather than a simple denial of the GRAS/E request and

statement that the new drug application would need to be filed. One key

point in the lawsuit, and an unresolved question that is facing doctors and

patients alike, is the issue of whether Synthroid will be unavailable after

the August 2001 FDA deadline. The original FDA notice calling for all

levothyroxine products to go through the new drug application process,

which was issued in 1997, stated: " After August 14, 2000, any orally

administered drug product containing levothyroxine sodium, marketed on or

before the date of this notice, that is introduced or delivered for

introduction into interstate commerce without an approved application,

unless found by FDA to be not subject to the new drug requirements of the

act under a citizen petition submitted for that product, will be subject to

regulatory action. " That notice was later amended to extend the deadline one

year until August 14, 2001. With a nine to ten month typical timeframe for

approval of a levothyroxine product, Synthroid, which according to Pizzuti

will apply " sometime before August 14th, " is clearly not likely to obtain

approval by the August 14, 2001 deadline. However, " subject to regulatory

action " does not necessarily mean that a product will be pulled from the

market, an interpretation Abbott is clearly counting upon. Dr. Pizzuti says

that Abbott has interpreted the FDA to mean that the act of applying before

the August 14, 2001 will ensure that Synthroid remains available on the

market with no interruption. Says Pizzuti, " We are working directly with

the FDA to clarify exactly what to do to keep it on the market. " While the

initial Federal Register notice threatens " regulatory action " against any

unapproved products being marketed after the deadline, in a letter dated

April 26, 2000 to Synthroid manufacturer Knoll Pharmaceuticals, the FDA

makes it clear that they viewed the August 14, 2001 deadline is a firm one,

saying: " The FDA denies Knoll's request to set a date by which NDAs must be

submitted rather than approved...We believe the additional year the Agency

is allowing for all sponsors to obtain NDA approval grants in substantial

part Knoll's request for additional time to comply with the 1997 notice.

(To read the full letter, download the Portable Document Format (PDF)

version at the FDA website:

http://www.fda.gov/ohrms/dockets/dailys/00/may00/050400/pav0001.pdf ) Later

clarification by the FDA, issued in its " Guidance for Industry,

Levothyroxine Sodium Questions and Answers, "

http://www.fda.gov/cder/guidance/3609fnl.htm, stated: " After August 14,

2001, what will happen to a 505((2) application that has been filed, but

not yet approved? What if the application was submitted, but not filed?

A[nswer]: If the application has been filed, FDA will continue to review

it. If the application has not been filed, FDA will refuse to file it. "

This guidance, however, is not considered official correspondence, and is

prominently labeled, " This guidance represents the Food and Drug

Administration's current thinking on this topic. It does not create or

confer any rights for or on any person and does not operate to bind FDA or

the public. An alternative approach may be used if such approach satisfies

the requirements of the applicable statutes and regulations. " Verbal

statements by the FDA have been vague, and this ambiguity leaves open the

question of whether the deadline will be interpreted as applying to

approval and not application, or whether an unapproved Synthroid product

will be allowed to continue to be marketed, but with some sort of

restrictions or oversight until such time as FDA approval is granted. Tim

Fuller, Executive Director of the Gray Panthers, has said in a press

release in May, " The FDA clearly stated that a New Drug Application for

Synthroid must be approved by August, not just submitted. We should not

allow Abbott to ignore the law for its own convenience while patient safety

is at risk, especially since safe, effective, and approved alternatives are

available.'' The battle over FDA approval for Synthroid was a hot topic at

the Endocrine Society annual meeting, Endo 2001, which took place >from June

20-23, 2001 in Denver. With representatives of the various levothyroxine

manufacturers in attendance, as well as the Gray Panthers, the key players

in the drama were well represented. Yet another controversy took place when

the Gray Panthers announced a June 21, 2001 Town Hall meeting titled

" Synthroid: Addressing consumer concerns about safety and efficacy. "

Synthroid declined to attend the forum, however, offering to meet privately

with the Gray Panthers instead.As July begins, we're presently awaiting a

number of potential developments, including:* the possibility of

clarification from the FDA as to what the deadline actually means for

patients* further word on the Abbott lawsuit against * further

response from the Gray Panthers* the actual submission of the new drug

application for Synthroid by Abbott Laboratories* FDA approval for

Levothroid, a levothyroxine drug submitted, but still awaiting -- FDA

approval *******************************WHAT SHOULD PATIENTS DO?

*******************************If you are a new thyroid patient who is

being prescribed levothyroxine for the first time, or a thyroid patient who

is not feeling well despite treatment, you may wish to ask your doctor to

prescribe an FDA-approved levothyroxine product, or you may wish to

investigate other options with your physician, such as the addition of T3

drugs, or a switch to natural desiccated thyroid drugs. If you are a

thyroid patient who is taking Synthroid and you are stabilized and not

experiencing fluctuations or symptoms, then you should first talk with your

physician about any concerns you may have about developments, stay up on

the latest news concerning Synthroid's approval and availability, and

consider developing a contingency plan with your physician in the unlikely

event that the FDA does take some sort of action in August and availability

of Synthroid is called into question.*******************************MORE

REFERENCES ONLINE*******************************Synthroid Information

CenterFor continuing coverage, check back regularly to the Information

Center.http://thyroid.about.com/blsynthroid.htmAugust, 2000 -- Unithroid

Approvedhttp://thyroid.about.com/library/weekly/aa082400a.htmApril 26,

2001 -- FDA Letter to Synthroid, Denying GRAS/E

Statushttp://thyroid.about.com/library/news/blfdaletter.htmApril 30,

2001 -- Abbott Laboratories Forced to Submit New Drug Application for

Synthroidhttp://thyroid.about.com/library/weekly/aa043001a.htmMay 3,

2001 -- Synthroid Has a Long History of Problems, Says FDA, in Denial

Letterhttp://thyroid.about.com/library/weekly/aa050301a.htmMay 14, 2001 --

National Organization of Women, Gray Panthers, and Stop Patient Abuse Now

to Take Action Against Pharmaceutical Market

Abuseshttp://thyroid.about.com/library/weekly/aa051401a.htmMay 25, 2001 --

Levoxyl Approvedhttp://thyroid.about.com/library/weekly/aa052501a.htmJune

1, 2001 Wall Street Journal Article, online

http://www.msnbc.com/news/581223.asp'>http://www.msnbc.com/news/581223.asp June 1, 2001 -- Gray Panthers

Challenge Abbott Labs and American Thyroid Association To Answer FDA

Concerns Regarding Safety and Effectiveness of

Synthroidhttp://thyroid.about.com/library/news/blspanjune1.htmJune 1,

2001 -- Press Release: Synthroid Should Remain on the Market, Says the

American Association of Clinical

Endocrinologistshttp://thyroid.about.com/library/news/blaacejune1.htmJune

1, 2001 -- Abbott Response to News Reports on

Synthroidhttp://thyroid.about.com/library/news/blabbottjune1.htmJune 4,

2001 -- Press Release: American Thyroid Association, The Endocrine Society,

and ThyCa Call for Continued Availability of Thyroid Hormone

Productshttp://thyroid.about.com/library/news/blatajune4.htmJune 4, 2001 --

Press Release: Gray Panthers Says Consumer Concern Increasing Over Abbott

Labs Missteps on Synthroid; Abbott Response Avoids Critical Issues and

Relies on Contract

Physicianhttp://thyroid.about.com/library/news/blgraypanthjune4.htmJune 12,

2001 -- Press Release: Federal Court to Help Protect Patients Against

Misleading Information About Synthroid®, Company Seeks Injunction to Halt

'Orchestrated Campaign of Fear And Confusion' by

Pharmaceuticalshttp://thyroid.about.com/library/weekly/aa061201a.htmJune

15, 2001 -- Press Release: Gray Panthers Invites Abbott Laboratories to

Public Forum On FDA's Synthroid Safety and Efficacy

Concernshttp://thyroid.about.com/library/links/bljune21forum.htmJune 21,

2001 -- Abbott seeks meeting with group over SynthroidAbbott Laboratories

declined to attend the Gray Panthers scheduled public forum to discuss

Synthroid, instead offering to meet privately.

http://biz./rf/010621/n21580452.htmlJune 21, 2001 -- Gray

Panthers, Consumers to Seek Help with Questions Left Unanswered; Abbott

Laboratories Avoids Public Discussion of Synthroid Safety

http://thyroid.about.com/library/news/blgraypanthers2.htm===================

==============================ENDOCRINOLOGISTS DEFEND SYNTHROID IN THE WALL

STREET JOURNAL In a letter to the editor, responding to the June 1, 2001

Wall Street Journal article about concerns regarding Synthroid, Rhoda H.

Cobin, M.D., President of the American Association of Clinical

Endocrinologists again publicly defended the drug. In the letter, Cobin

states: " 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... " She also states that " careful

laboratory assessment rarely confirms that inconsistency in the drug is

responsible for the multitude of symptoms reported by the 'patient activist'

in your article. " To see the full letter from AACE to the Wall Street

Journal, go to:http://www.aace.com/pub/press/lettertoedWSJ.htmlI've written

a letter in response to Dr. Cobin's letter, which I've reproduced here.

June 23, 2001Letters to the EditorThe Wall Street Journal200 Liberty St.New

York, N.Y. 10281By E-mail: letter.editor@... Editor:In her letter

to the editor ( " Synthroid Has Record of Safety and Efficacy, " June 20,

2001) Dr. Rhonda Cobin, President of the American Association of Clinical

Endocrinologists states: " 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... " It's important to mention, however, that in this apparent

endorsement, Dr. Cobin failed to note that her organization has a

long-standing financial relationship with the manufacturers of Synthroid, a

levothyroxine drug that has not yet applied for or received FDA-approval.

(Synthroid's sponsorship of AACE can be verified at the AACE website

sponsor page, http://www.aace.com/sponmain.htm ). Synthroid also

prominently features a supportive press release issued by AACE on the home

page of their promotional www.synthroid.com website. As the patient

advocate quoted in the original article ( " FDA Questions Safety and

Efficiency of Abbott's Popular Thyroid Drug, " June 1) and referred to in

Dr. Cobin's letter, ensuring that the millions of thyroid patients in the

U.S. get the unbiased information they need to live and feel well is my top

priority. To that end, patients need to be aware that there are already two

FDA-approved levothyroxine products available on the market -- Levoxyl and

Unithroid. Patients may wish to note that the manufacturers of these

FDA-approved thyroid drugs are not listed as sponsors of AACE.

ShomonThyroid Patient AdvocateAuthor: " Living Well With Hypothyroidism:

What Your Doctor Doesn't Tell You...That You Need to Known (Harper,

2000)********************************'NOTE TO READERS: My letter has not

yet been published by the Wall Street Journal, nor have I received notice

of their intent to publish it. I would encourage others with interest in

the issue to write the Wall Street Journal about their decision to publish

Dr. Cobin's letter without also disclosing her financial ties to Synthroid.

To write the Wall Street Journal, email letter.editor@... (

mailto:letter.editor@... )=============================================

====ABBOTT/SYNTHROID NEWSWATCHSynthroid's Price Up 22.6% in 2000, One of

Biggest JumpsAccording to a Reuters article, the prices of the 50

top-selling drugs used by America's seniors rose 6.1% over the one year

period ending in January of 2001, compared to an inflation rate of 2.7%.

Says Reuters: " The biggest price jumpers included Knoll's synthetic thyroid

agent Synthroid, up 22.6%, or more than eight times the rate of inflation

over the 1-year

period... " http://thyroid.about.com/library/links/blsynthroidprice.htmAbbott,

Under Probe by Justice Dept, Cuts PricesNow that it's one of 20 companies

targeted in a U.S. Justice Dept. pricing investigation, Abbott, whose

Synthroid product was identified as one of the drugs that had the biggest

price jumps in 2000, announced sudden price cuts, but wouldn't respond to

questions about whether the investigation is a

factor.http://thyroid.about.com/library/links/blabbottcut.htmAbbott Plans

Bigger Role as DrugmakerIn the midst of all a Justice Department

investigation into its pricing policies, and FDA controversy over the lack

of approval for Synthroid, Abbott Laboratories Inc., fresh from its $6.9

billion purchase of Knoll Pharmaceuticals, has announced its strategy for

becoming a top competitor among the world's largest

drugmakers.http://biz./rf/010621/n2176728.htmlAbbott Labs,

University of Washington, Hit With $16.2 Million VerdictA Seattle area jury

awarded $16.2 million to a woman who had unnecessary chemotherapy, a

hysterectomy and part of her lung removed partial lung after test results

erroneously showed her as having cancer. Abbott Laboratories, manufacturer

of the test kits, blames the University, claiming its doctors misused the

kit. The University claims Abbott's kits falsely showed high hormone levels

that indicated

cancer.http://biz./rf/010629/n29154653.html========================

=========================TSH TESTS AREN'T ENOUGH, SAY RESEARCHERSAccording

to findings reported at the 83rd Annual Meeting of the Endocrine Society in

Denver, Colorado in June of 2001, it is more accurate to evaluate

peripheral organs for levels reflective of the severity of hypothyroidism

rather than blood tests for thyroid stimulating hormone (TSH) levels. The

researchers looked at TSH levels, investigating 58 women who had full-scale

hypothyroidism, and 153 women who were mildly hypothyroid, with elevated

TSH levels but normal T4 levels. The most hypothyroid patients had no

correlation between common tissue markers of hypothyroidism and the TSH

levels. Free thyroxine (known as Free T4) levels, however, did correlate

with the metabolic assessment tests. What they found was that worsening

tissue hypothyroidism, which could be evidenced by worsening of ankle

reflex test values, did not show a significantly corresponding increase in

TSH. The researchers told DG News, " Serum TSH is a poor test to estimate

the severity of tissue hypothyroidism. This is in direct contrast to the

generally accepted view that TSH is the best and most reliable screening

test for assessing routine thyroid

function. " =================================================HOW TO GET YOUR

THYROID TESTED WITHOUT A DOCTOR 13 million people have undiagnosed thyroid

disease in the US, and 40% of treated patients are not at the proper TSH

level. To deal with these challenges, you can now order your own bloodwork,

at prices less than many labs and doctors' offices, and have the results

mailed directly to you -- all without a doctor's prescription or

pre-approval. The service, known as " Healthcheck USA, " allows you to order

the same thyroid lab tests ordered by doctors. Results are analyzed by an

accredited medical reference laboratory. Healthcheck USA has three key

thyroid test options, including: Comprehensive Thyroid Profile: T3 Uptake,

T4 Total, T7, and TSH -- $40 ; Thyroid Stimulating Hormone (TSH) Test:

$27.00; Comprehensive Thyroid Profile II: T3 (Triiodothyronine) Free, T4

(Thyroxine) Free, and TSH - Thyroid Stimulating Hormone -- $65.00. At the

Healthcheck USA website, after you identify the tests you want to order,

you fill our registration information, and then pay by online check or

credit card. After you've filled out your order, a representative from

Healthcheck USA will call you to review your order and procedures.

Paperwork will be sent to you, which you will need in order to have your

bloodwork conducted at the lab. Once you receive the paperwork, you can go

to the laboratory at your convenience, and no appointment is necessary. Test

results are sent out the next business day after your test, with an

explanation of results. Healthcheck USA urges that any abnormal results on

any of their blood tests be evaluated by your own physician. In addition to

thyroid tests, a variety of other popular blood tests are also available

through Healthcheck USA. For more information, visit the HealtcheckUSA

website, or contact the company by calling 800-929-2044, or call their

Customer Service line: 800-925-7901, Address: 8700 Crownhill #506, San

, Texas 78209. Phone: (210) 929-2044, Fax: (210) 820-

0750=================================================ROUTINE THYROID DRUGS

TO SHRINK NODULES MAY NOT BE NEEDEDResearchers have found that " routine

administration of TSH suppressive thyroid hormone therapy to prevent growth

is unwarranted. " According to findings reported at the 83rd Annual Meeting

of the Endocrine Society in Denver, Colorado in June, the standard use of

thyroid hormone replacement drugs to shrink nodules in patients who have

otherwise normal thyroid function may not be necessary. The research found

that only a small percentage of nodules in patients with normal thyroid

function appear to grow. Dr. Poj Tannirandorn from the University of

Pennsylvania School of Medicine studied more than 100 benign thyroid nodules

in patients who were not on any thyroid hormone drugs. The study found that

60 percent of the nodules did not change size, 34 percent decreased in

size, and only 6 percent increased in size. All the nodules that grew

underwent fine needle aspiration, and all were benign. Based on these

results, the researchers have stated that " routine administration of TSH

suppressive thyroid hormone therapy to prevent growth is unwarranted. "

=================================================ESTROGEN THERAPY MAY

INCREASE THYROID DOSAGE NEEDS According to the June 6, 2001 issue of the

New England Journal of Medicine, women with hypothyroidism who are taking

thyroid hormone replacement medication may need an increased dosage if the

begin estrogen treatment after menopause. The study found that the

additional thyroid medicine needed was " small but potentially clinically

important. " Because women with hypothyroidism who are taking thyroxine may

need more thyroxine when they are treated with estrogen and may need less

thyroxine after estrogen is discontinued, it is prudent to reassess their

thyroid function several months after estrogen therapy is either initiated

or discontinued. The researchers advised women who are hypothyroid to have

their thyroid function tested 12 weeks after they begin estrogen therapy,

to assess if additional thyroid medicine is needed.

=================================================SUPPLEMENTING WITH

SELENIUM MAY HELP THYROIDITIS According to findings reported at the 83rd

Annual Meeting of the Endocrine Society in Denver, Colorado in June of

2001, supplementing with selenium may help to slow down the progression of

autoimmune thyroid disease -- and may be particularly effective during the

onset of thyroiditis. The findings were reported by Munich, Germany

physician Barbara Gasnier, of the Medizinische Klinik University. The

researchers believe that a deficiency in selenium may contribute in part to

development of autoimmune thyroid problems because of selenium's impact on

certain immune system enzymes. The study looked at 72 women at an average

age of 42, all who had autoimmune thyroiditis. In all the women, thyroid

peroxidase (TPO) antibodies and/or thyroglobulin (Tg) antibody levels were

greater than 350 U/mL. Half the patients received selenium supplementation

for three months, the other half received a placebo. All patients were

normalized on their thyroid hormone treatment. At the conclusion of the

three month period, autoantibody levels were measured. Interesting, nine of

the patients taking selenium supplementation had antibody levels that

returned completely to normal. Two members of the placebo control group had

antibodies return to normal. Among those in the selenium group, the mean

TPO antibody levels decreased significantly in the selenium group. The

higher the TPO at the onset of the test, the greater the reduction was seen

in the TPO antibody levels at the end of the three months. It was reported

in DG News that the researchers stated: " Selenium substitution with 200 mcg

(micrograms) of sodium selenite may improve the inflammatory activity in

patients with autoimmune thyroiditis, but whether this effect is specific

for autoimmune thyroiditis or may also be effective in other organ-specific

autoimmune diseases has to be investigated. " Dr. Gasnier has indicated that

the selenium may be increasing peroxidase activity, lowering free radicals,

and reducing inflammation.

=================================================TREATMENT FOR THYROID

ANTIBODIES AND NORMAL TSH? The practice of treating patients who have

Hashimoto's thyroiditis but normal range TSH levels is supported by a new

study, reported on in the March 2001 issue of the journal Thyroid. In this

study, German researchers reported that use of levothyroxine treatment for

cases of Hashimoto's autoimmune thyroiditis where TSH had not yet elevated

( " euthyroid " ) beyond normal range could reduce the incidence and degree of

autoimmune disease progression. In the study of 21 patients with euthyroid

Hashimoto's Thyroiditis (normal range TSH, but elevated antibodies), half of

the patients were treated with levothyroxine for a year, the other half

were not treated. After 1 year of therapy with levothyroxine, the antibody

levels and lymphocytes (evidence of inflammation) decreased significantly

only in the group receiving the medication. Among the untreated group, the

antibody levels rose or remained the same. The researchers concluded that

preventative treatment of normal TSH range patients with Hashimoto's

disease reduced the various markers of autoimmune thyroiditis, and

speculated that that such treatment might even be able to stop the

progression of Hashimoto's disease, or perhaps even prevent development of

the hypothyroidism. Journal Reference: Thyroid, 2001 Mar;11(3):249- 55,

" One-year prophylactic treatment of euthyroid Hashimoto's thyroiditis

patients with levothyroxine: is there a benefit? "

=================================================POLYCYSTIC OVARY SYNDROME

MAY UP RISK OF AUTOIMMUNE THYROIDAccording to findings reported at the 83rd

Annual Meeting of the Endocrine Society in Denver, Colorado in June, the

condition known as polycystic ovarian syndrome (PCOs) may carry with it as

much as a four times greater than normal risk of also having autoimmune

hypothyroidism.Munich, Germany researcher Dr. Roland Gaertner found that

among the women with PCOs they studied, 17 percent of them had clinical

autoimmune thyroiditis. Talking to DG News, Dr. Gaertner has said that the

researchers are not sure of the mechanism behind why the risk is increased.

But they speculate that female hormones may be influencing the immune

system, and that low levels of progesterone are causing an increase in

stimulatory effects of estrogen on the immune system. Dr. Gaertner also

recommended that women with PCOs talk about the possibility of autoimmune

thyroid problems with their doctors.

=================================================QUICK NEWS RECAPSIodine

Intake Affects Type of Thyroid DiseaseYou face an increased risk of thyroid

disease from both low and high iodine intake. Researchers, reporting in the

journal " Thyroid, " have found that proper monitoring and control of the

population's iodine intake level is a cost-effective alternative to

diagnosing, therapy and control of the many individual cases of thyroid

diseases that might have been prevented. (Journal Reference: Thyroid 2001

May;11(5):457-69). High-Dose IV Steroids for Graves' Eye DiseaseResearchers

have found that high-dose IV steroid therapy provides efficient and stable

improvement in Graves' ophthalmopathy, along with a lower incidence of side

effects, when compared to oral steroids. (Journal Reference: J Endocrinol

Invest 2001

Mar;24(3):152-8)=================================================RIC BLAKE,

THYCA FOUNDER, NEWSPAPER PROFILE CONTINUESThe extraordinary and moving

profile of Ric Blake, thyroid cancer patient and founder of the Thyroid

Cancer Survivors' Association, continues in the Eagle Tribune. In Part 5,

Ric Blake heads off to the National Institutes of Health for possible

surgery.http://www.eagletribune.com/news/stories/20010603/FP_003.htmIn Part

6, despair leads to renewed hope for Ric, as he receives startling news

>from some of the nation's top doctors.

http://www.eagletribune.com/news/stories/20010617/FP_001.htmAnd in Part 7,

Ric seeks a miracle from the 'wizard'.

http://www.eagletribune.com/news/stories/20010617/FP_002.htmFor links to

the entire series, see

http://thyroid.about.com/library/news/blricblake.htm========================

=========================CHIA: ANCIENT FOOD AND MODERN FATIGUE FIGHTER You

may have seen ads for ChiaPets, those fuzzy creatures that are so popular

at the holidays, but did you know that chia seeds are actually an ancient

food making a modern comeback? Chia seeds are the subject of Scheer's

exciting new book, " The Magic of Chia. " These seeds turn out to be a

low-calorie, nutritional powerhouse food that can help you fight fatigue

and exhaustion, increase endurance, balance blood sugar, and lose weight.

I've tried chia, and think it's really quite remarkable, and you might too.

Find out whether it's time to add chia to your diet by reading my in- depth

article about chia. http://thyroid.about.com/library/weekly/aa061101a.htm

And if you want to pick up a copy of Jim Scheer's new book, pop on over to

Amazon.com,

http://www.amazon.com/exec/obidos/ASIN/1583940405/scratcthenetwebs=========='>http://www.amazon.com/exec/obidos/ASIN/1583940405/scratcthenetwebs==========

=======================================LISA LORDEN TO HEAD UP NATIONAL

FIBROMYALGIA AWARENESS CAMPAIGN NEWSLETTER AND WEBSITEMany of you join me

in being fans of my colleague and friend Lorden, who was been

About.com's guide to Chronic Fatigue Syndrome and Fibromylagia for three

years. Despite struggling herself with her own health, has tirelessly

given of herself on behalf of her fellow patients, and kept us up on the

latest on CFS and FMS. has left her position as site guide, and

sharing her tremendous passion and advocacy in a new position with a non-

profit organization called the National Fibromyalgia Awareness Campaign,

where she will be Editor of their new Fibromyalgia magazine, among other

key activities. Keep up with , and sign up for a free first issue of

this magazine, at http://lisalorden.com. From the bottom of my heart, I

wish the greatest success with her new endeavor. She built a fantastic

resource at About, and I know her knowledge and commitment will now be a

great asset to the National Fibromyalgia Awareness Campaign. Best of luck,

!! =================================================BOOKS OF

INTERESTThyroid Power, by Drs. and Karilee ShamesFor more

information, see http://www.thyroid-info.com'>http://www.thyroid-info.com/thyroidpower.htm or go

tohttp://www.amazon.com/exec/obidos/ASIN/0688172369/scratcthenetwebsTired

of Being Tired: Rescue, Repair, Rejuvenate, by Hanley, DevilleAn

excellent look at adrenal

burnout.http://www.amazon.com/exec/obidos/ASIN/0399147497/scratcthenetwebsHo

rmones and the Mind, by L. KlaiberA psychoneuroendocrinologist's

look at the relationship between hormones and the brain.

http://www.amazon.com/exec/obidos/ASIN/0060193735/scratcthenetwebsHormone

Heresy: What Women Must Know About Their Hormones, by Sherrill

SellmanRevelations about your

hormones.http://www.amazon.com/exec/obidos/ASIN/0958725209/scratcthenetwebsS

olved: The Riddle of Illnessby Langer, MD Langer and F.

Scheer An excellent look at thyroid disease and its relationships to many

other

conditions.http://www.amazon.com/exec/obidos/ASIN/0658002937/scratcthenetweb

sThe Magic of Chia, by ScheerThe ChiaPet seed turns out to be an

ancient fat- and fatigue- fighting wonder food!

http://www.amazon.com/exec/obidos/ASIN/1583940405/scratcthenetwebs=========='>http://www.amazon.com/exec/obidos/ASIN/1583940405/scratcthenetwebs==========

=======================================LINKS WORTH SURFING Low Sex Drive:

Most Men Don't Talk About ItA national survey has shown that men with a low

sex drive -- a symptom more common with thyroid disorders -- are reluctant

to talk about it with their physicians. With many new treatments to help,

it's time to take a private self-test that tell you if it's time to talk to

the doc.http://thyroid.about.com/library/news/bllibido.htmCourt Says No to

DownwindersThe 9th Circuit Court of Appeals decided against Hanford

downwinders who are trying to force the federal government to pay for

medical monitoring. A California attorney and activist who lost her father

to a rare thyroid cancer, and who herself was exposed to radioactive iodine

as a child, sued the Department of Energy under the provision of the

Superfund law that requires DOE to pay for programs to monitor the thyroid

health of " downwinders, " people exposed to Hanford

radiation.http://thyroid.about.com/library/links/bldownwind.htmGenzyme

General Announces Results from Study of ThyrogenThyrogen is a drug used by

thyroid cancer survivors to avoid the effects of hypothyroidism when they

have to stop taking their regular thyroid prior to a body scan for

recurrence. New research now shows that Thyrogen may also increase the

sensitivity of the thyroglobulin (Tg) test, a key cancer marker, making it

easier to identify those at highest risk of

recurrence.http://thyroid.about.com/library/news/blthyrogen.htmStudying the

Autoimmune Disease PuzzleA look at the latest findings on autoimmune

diseases, including why 80% of the sufferers are women, new immunotherapies,

estrogen/testosterone/DHEA theories, and the role of fetal cells. A good

summary of the state-of-the-art

thinking.http://thyroid.about.com/library/links/blautoimmune.htmThyroid

Cancer Rates Rise, While More Common Cancers DropAccording to the National

Cancer Institute, thyroid cancer rates are on the rise, while the overall

rates for cancer are on the decline. Find out more about this good news for

the general public, but bad news for thyroid

patients.http://thyroid.about.com/library/news/blcancerstudy.htmAutoimmune

Hypothyroidism: A Mind-Body Exploration The effects of the mind and stress

on the immune system are explored in this interview with Drs. and

Karilee Shames. Find out more about autoimmune hypothyroidism, including

practical suggestions that you can follow so that your mind can positively

influence your health.

http://thyroid.about.com/library/weekly/aa060901a.htmAre You Being Duped by

Pharmaceutical Companies?The May 2001 edition of Pharmaceutical Marketing

magazine thinks you are. " How Pharmaceutical Companies Manipulate Doctors, "

a review in the British Medical Journal, focuses on how pharmaceutical

companies manipulate doctors and use them to push their

products.http://thyroid.about.com/library/links/blbmjpharma.htmThyroid

Cancer is Main Health Result of ChernobylA report issued by the Russian

Academy of Sciences' Nuclear Safety Institute has found that thyroid cancer

is the major health legacy of the 1986 accident at the Chernobyl nuclear

power station in

Ukraine.http://thyroid.about.com/library/links/blthycauk.htmIncreasing Your

Metabolism With ExerciseWill exercise help keep your metabolism >from

slowing down on a low-calorie diet? Find out from the

experts.http://thyroid.about.com/library/links/blexercise.htmIs Your Heart

Skipping Beats? It May Be PVCsThe sensation of skipped heartbeats,

palpitations or " thumps " can be frightening. How do you know when they're

are a sign of heart disease, or when they might be premature ventricular

contractions (PVCs), which are common and usually benign? Take a look at

this issue that frequently plagues thyroid

patients.http://thyroid.about.com/library/links/blpvcs.htmMichigan Thyroid

Support Group Leader FeaturedRead all about leader Michigan Thyroid Support

Group founder Green, who was featured in the Detroit

News.http://detroitnews.com/2001/health/0106/06/h07-232723.htm==============

===================================A CODE OF ETHICAL BEHAVIOR FOR PATIENTS

Traveling around the internet via email forwarding is the following

hilarious -- but unfortunately all too true -- set of guidelines for

patients. (No author credit was attached to this email, but if you know who

wrote it, please let me know. He/she deserves a medal!!)1. DO NOT EXPECT

YOUR DOCTOR TO SHARE YOUR DISCOMFORT.Involvement with the patient's

suffering might cause him to lose valuable scientific objectivity.2. BE

CHEERFUL AT ALL TIMES. Your doctor leads a busy and trying life and

requires all the gentleness and reassurance he can get.3. TRY TO SUFFER

FROM THE DISEASE FOR WHICH YOU ARE BEING TREATED. Remember that your doctor

has a professional reputation to uphold.4. DO NOT COMPLAIN IF THE TREATMENT

FAILS TO BRING RELIEF.You must believe that your doctor has achieved a deep

insight into the true nature of your illness, which transcends any mere

permanent disability you may have experienced.5. NEVER ASK YOUR DOCTOR TO

EXPLAIN WHAT HE IS DOING OR WHY HE IS DOING IT. It is presumptuous to

assume that such profound matters could be explained in terms that you

would understand.6. SUBMIT TO NOVEL EXPERIMENTAL TREATMENT READILY.Though

the surgery may not benefit you directly, the resulting research paper will

surely be of widespread interest.7. PAY YOUR MEDICAL BILLS PROMPTLY AND

WILLINGLY. You should consider it a privilege to contribute, however

modestly, to the well-being of physicians and other humanitarians.8. DO NOT

SUFFER FROM AILMENTS THAT YOU CANNOT AFFORD. It is sheer arrogance to

contract illnesses that are beyond yourmeans.9. NEVER REVEAL ANY OF THE

SHORTCOMINGS THAT HAVE COME TO LIGHT IN THE COURSE OF TREATMENT BY YOUR

DOCTOR. The patient-doctor relationship is a privileged one, and you have a

sacred duty to protect him from exposure.10. NEVER DIE WHILE IN YOUR

DOCTOR'S PRESENCE OR UNDER HIS DIRECT CARE. This will only cause him

needless inconvenience and embarrassment.

=================================================BOOK NEWS -- AN EIGHTH

PRINTING!!!!In early May, two months after its seventh printing, my book

" Living Well With Hypothyroidism " went to an eighth printing! The book is

now 16 months on Amazon's Top 25 " This Week's Health Bestsellers " list. If

you don't already have your own copy, it's a one-stop source for information

on how to get properly diagnosed and treated for hypothyroidism (whether

autoimmune, or due to surgical removal or radiation of the thyroid), plus

help on how to live well, with tips on alternative medicine, other

medicines, depression, weight loss, pregnancy, and other issues. It also

features a huge Resources chapter featuring organizations, books, websites,

TV/radio shows, support groups and more that can help you get information

and support...and live well! Here's the info on how to get it: Title:

" Living Well With Hypothyroidism: What Your Doctor Doesn't Tell You. . .

That You Need to Know " Author: J. Shomon ISBN number: 0380808986List

price: $13.50 (US dollars)Published by: HarperTO GET A

COPY:Available at your local bookstore everywhere in the U.S. and if they

don't have a copy, ask them to order you one! Online at Amazon.com:

http://www.amazon.com/exec/obidos/ASIN/0380808986/scratcthenetwebs Phone

Orders: Politics and Prose, 800-722-0790In the UK: http://www.amazon.co.uk

, or by order in bookstores More Online Information:

http://www.thyroid-info.com'>http://www.thyroid-info.com/booktoc.htm=====================================

============NOTES >FROM MARY: AN IMPORTANT MESSAGE ABOUT THIS NEWSLETTERAs

I mentioned last month, this issue is " Sticking Out Our Necks' " fourth

anniversary issue! Every month since July of 1997, I've been researching

thyroid disease, autoimmune disease, and bringing you the latest news on

conventional and alternative diagnosis and treatment options. Each issue

has included the news that the pharmaceutical industry and medical

establishment frequently don't want you to hear. If you have been reading

" Sticking Out Our Necks, " you knew back in 1997 that Synthroid and its

competitive levothyroxine drugs were not FDA-approved -- you didn't have to

wait until the recent spate of national media coverage to find out this

crucial information. If you have been reading " Sticking Out Our Necks, " you

knew a year ago about the FDA's first approval of a levothyroxine drug,

Unithroid. And if you have been reading " Sticking Out Our Necks, " you have

known all along about the use of T3 drugs, the connection between thyroid

problems and chronic fatigue, fibromyalgia, carpal tunnel syndrome,

depression, miscarriage, hair loss, and more. You've learned about low-

glycemic diets and CLA, long before they were talked about in the popular

press as effective ways to lose weight with thyroid problems. One of the

only ways I've been able to keep bringing you this independent information

for free for the past four years is that my work has been supported by

online publishing. While I have always had to work full-time on a

non-thyroid-related job, the minimal but steady compensation I earned from

my thyroid sites made it possible for me to do the extra hours of research

every week, the many interviews with doctors I do each month, and answer

what has ended being more than a thousand of your personal email questions

every single week -- and still be able to help support my family. But

unfortunately, things have changed. The downturn in the dotcom Internet

economy means that publishing opportunities and income online are rapidly

dwindling. But I want to be able to keep bringing you the same

up-to-the-minute thyroid and health information as always -- information

that you simply will not find anywhere else.But I also do not want to take

advertisers or sponsors in my newsletter. Believe me, almost every

pharmaceutical company has asked to advertise in Sticking Out Our Necks, as

have numerous other companies who want to sell you something. I've always

said no, and will continue to say no. Because I don't want to go down the

road of the patient and professional organizations who accept money from

drug companies and other vendors, and then end up losing credibility, and

losing the ability to speak honestly to you about what really matters. I

don't want to end up having to issue press releases supporting particular

drugs because the company that makes the drug gives me a big chunk of

advertising or funding every year and I am beholden to them. I want to be

beholden only to YOU-- the thyroid patients, the people who need and want

the information I share. I want " Sticking Out Our Necks " to remain the YOUR

ONLY TRULY INDEPENDENT PATIENT-ORIENTED THYROID INFORMATION SOURCE. I want

to be able to bring you the information you need -- without worrying about

what advertisers or funders or pharmaceutical companies will say or do

about what I've written. But I simply can't do it for free anymore, as I've

been doing for four years. I wish I could, but like most of us, I have to

hold down several jobs to make ends meet.So, beginning with the September,

2001 issue, I will be moving the full-text of my present e-mail newsletter

format to my hardcopy newsletter, and I am asking that you become a

subscriber. Your subscription support -- only $25 a year -- will make it

possible for me to find and send out the same quality information as in the

past -- without my having to become a mouthpiece for advertisers, while

claiming to be supporting patient concerns. Because I believe in the

importance of empowered and informed patients, I will still continue to

make available a highlights version of " Sticking Out Our Necks " for free by

email, so that even those of you who choose not to receive a subscription

will continue to receive a summary of important health information. But

each bimonthly issue of the print newsletter, which will be expanded to 12

pages from 8 beginning with the September/October issue, will offer the

in-depth versions of the stories, along with news you won't find anywhere,

including at my website. (Please note that this current expanded issue is a

June/July summer issue. There will not be a July email issue of " Sticking

Our Necks. " The next e-mail issue will be August of 2001, and that will be

the last issue in which full text of all articles is featured. Starting in

September, Sticking Out Our Necks e-mail edition will feature news

highlights.)In each print issue, you'll get in-depth feature stories, such

as the May/June 2001 cover story, which is an original article you won't

find anywhere else, titled " Eleven Important Pieces of Advice >from the

Experts About Your Thyroid Problems. " This article covers the following

important points, and offers experts' advice and information to help,

including:-- Difficulty Sleeping at Night May Be a Symptom of Thyroiditis--

Some Menopausal Symptoms Can Be Relieved by Thyroid Treatment-- Heart

Palpitations May Point to a Vitamin Deficiency-- Fluoride May Be

Compounding Your Thyroid Problems-- You Should Always Keep Track of Your

Own Health Information and Medical Records-- There are Options to Consider

for Better Care if You're in an HMO-- Thyroid Patients Should Consider

Supplementing with Coenzyme Q-10 to Help Prevent Heart Disease-- To Lose

Weight, Exercise May be a Requirement for People with Hypothyroidism--

Graves' Patients with Eye Involvement (Exophthalmus) May Benefit From

Pregnenolone-- Armour Thyroid May Work Better for Some Thyroid Patients--

How You Take Your Pills May Affect How They WorkPlus, many other news

stories, questions and answers, exclusive practitioner interviews, and much

more. It's information that you won't find anywhere else, for example, not

in the Thyroid Foundation of America's newsletter " The Bridge, " or in the

drug company's marketing-oriented newsletters. Only with your help can I

can continue to independently bring you, and the rest of our thyroid

community the information on how to live well with thyroid disease.

DEADLINE FOR OUR SPECIAL DEAL: I'm extending our special deal. If you order

a print subscription by mail by July 31, 2001, you'll get a free report,

" 10 Vitamins and Supplements Thyroid Patients May Need, " valued at $15, PLUS

a one-year subscription, with 6 bi-monthly 12-page issues of Sticking Out

Our Necks, AND, we'll give you a $3 discount, so all this, a $40 value, for

only $22. For the online subscription form, see

http://www.thyroid-info.com'>http://www.thyroid-info.com/subscribe.htmOR, you can print out the order

form on this page.I look forward to continuing to bring you the best

independent information, news, interviews and ideas on thyroid disease, as

together, we continue to live well! Thanks in advance for your support.Live

well, = = = = = = = = = = = = = = = == =

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==================================================MORE NOTES >FROM

MARYIt's been a busy month for thyroid news, hasn't it! Stay tuned,

because it looks like it's going to get even more interesting in weeks

ahead, and will keep heating up all summer well past the August 14, 2001

FDA deadline. Will Synthroid get submitted by the deadline? Will Synthroid

stay on the market? Will more companies get sued? Will patient and

professional organizations keep jumping in to defend their favorite drugs?

Will other players get involved? Will the FDA clarify whether their

deadline is for submission of a new drug application, or for final

approval of all applications? As for the deadline, only the FDA knows its

own intentions, and so far, they're not clarifying it, leaving it open for

everyone else to interpret what they mean and guess at the outcome. It's

certainly a soap opera that has the attention of millions of people whose

health is at stake.The most critical question of all is what would happen

if all the drug companies, professional organizations, patient groups, and

the FDA started focusing their efforts exclusively on what is the best and

right thing for US, the thyroid patients...Not likely to happen, though,

is it...unfortunately? But we can still have

hope!*****************************************************COMING IN THE

AUGUST ISSUE: MY LUNCH WITH

SYNTHROID*****************************************************I had a very

interesting lunch with several company representatives from Abbott

Laboratories, the manufacturer of Synthroid, including Pizzuti, M.D.,

Vice President of Global Medical Affairs for Abbott. Stay tuned to the

August newsletter for a recap of my lunch meeting. [And just for the

record, I of course paid for my own lunch!]Live

well,================================================= " Sticking Out

Our Necks " email edition is published monthly by Shomon. Please invite

your friends to subscribe! Send them a copy with your recommendation.

" Sticking Out Our Necks " is copyright 1997-2001 by Shomon. Web:

http://www.thyroid-info.com'>http://www.thyroid-info.com Email: mshomon@...,

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Palm Harbor, FL 34682.=================================================