Dr. Guttler's Newsletter

June 15, 2003

Hello to all my subscribers,

1. 10 million Americans are treated for thyroid dysfunction.
2. Another 13 million are undiagnosed. This group is at risk for adverse heart, brain, and pregnancy outcomes.
3. LT4 is a drug with narrow window of use. This is seen in recent studies showing as many as 60% of patients were on either excess or deficient doses. High-risk patients with thyroid cancer, pregnancy, and the elderly, need to understand that these drugs all are different, and are not equal. The FDA says they are, but the proof is missing.
4. The FDA studies on Generic Equivalence is Flawed. One size does not fit all. The studies were done on normal subjects. The people without thyroid glands were not used. These are the real people you need studied.
5. There was a 12.5-25 % difference between branded and generics. That was called normal!
6. Because there is a tight control of dose by TSH, 12-24% variation is enough to change the whole treatment equation, especially in the high-risk groups mentioned above.
7. For Math people, slight change of less than 12-24%, called not significant to the FDA, will cause a log scale change in TSH. That means control of thyroid cancer would be ineffective if the dose, stopping cancer growth, was 12 24% lower. TSH would go up, and cancer cells would be able to resume growing. That also means the TSH could go above 10, and cause loss of 5 I.Q points in the unborn infant of hypothyroid pregnant woman, who was substituted generic. Elderly patients, switched after testing to generic, with 12-24% increase in dose, could develop Cardiac disease. The FDA would call all these doses equal, by their testing, but in the real patient, 12-24% change in dose can be critical, and life threatening.

Do Not believe the FDA, or the drug company ads claiming their drugs are equal.

Request that your doctor give you a "Do Not Substitute" RX. Make sure your druggist really gives you what the RX calls for and not a generic. Look at the pill, and compare it to the sample given by your doctor.

Special Situations:

Pregnancy
1. Get tested before you get pregnant. High TSH = lower I.Q. child, and maternal complications.
2. The dose of thyroid changes during pregnancy. Check it monthly.
3. Make sure you are on the branded LT4 the whole pregnancy. Do Not allow them to substitute during the pregnancy.
4. After delivery 6 weeks later restore the dose to pre-pregnancy levels
5. Check monthly for 4 months

Thyroid Cancer
1. The hallmark of therapy for cancer is suppression of cancer cell growth by "chemotherapy" with LT4. After surgery, it is the most important treatment for cancer. The dose is higher for cancer, than replacement therapy for the missing gland.
2. For optimal care, Cancer patients SHOULD NOT BE SUBSTITUTED with another LT4 product, no matter what the FDA says about one size fits all.
3. If you have cancer and are switched, you need another testing to assure you are still on a dose of LT4 that stops cancer cells from growing.
4. The lack of true therapeutic equivalence is why you have to insist to not be switched during cancer therapy. Request a branded RX, with a do not substitute on it, and check that the druggist honors the RX. Check the pills to see if they match the samples given by your thyroid specialist.
5. If you have trouble getting what you ask for, see a thyroid consultant. Check www.thyroid.org.

Elderly:
1. The dose of thyroid changes as we age. We need less as we live past 60.
2. 12-24% variation in generics can overdose an elderly thyroid patient.
3. Osteoporosis " brittle thin bones", and increased cardiac deaths, and serious heart abnormal rhythms, can occur when switching of LT4 product occurs.
4. Demand a re-testing if you find out you were switched by druggist or doctor.
5. The FDA is wrong again. 12-24% change in your dose, called normal variation, allowing their one size fits all ruling, is a very significant change when the true therapeutic dose is considered. This is a life and death matter for many thyroid elderly.

What are we doing about this fine mess?

Well, the American Thyroid Association, Endocrine Society, and the American Association of Clinical Endocrinology, are meeting with the FDA to see if they will change their ruling until better studies define true biologic and therapeutic dose equivalence.

THEREFORE, UNTIL MORE RESEARCH CONFIRMS GENERICS ARE EQUAL, BE SKEPTICAL, AND REQUEST TO STAY ON BRANDED PRODUCT AND DO NOT ALLOW DRUGGISTS, OR DOCTORS TO SWITCH YOU. YOUR HEALTH, AND EVEN YOUR LIFE DEPENDS ON A STEADY, UNIFORM DOSE OF THYROID NOT MATTER WHAT THYROID DISEASE YOU HAVE.

Dr. Richard Guttler
Thyroidologist

Call 800-408-4909 for consultation, billing, and details.

Yours truly, and goodbye,

Richard Guttler M.D., F.A.C.E.
The "Doctor Reporter" for
The Thyroid Home Page:
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Sole Thyroid Physician:
Santa Monica Thyroid Center, Founded in 1974
Clinical Professor of Medicine:
USC/Keck School of Medicine - 1974-present

"You are the thyroid patients.......
I am the thyroid doctor"

Thyroid Disease Opinions from the desk of
Richard Guttler M.D., F.A.C.E.

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