Tuesday, April 05, 2005

Why Generic Substitution is Bad for Thyroid Patients

FDA considers generics equal to Synthroid. They are dead wrong. They are using the wrong standards to test the drugs.They used healthy volunteers instead of thyroid patients.They used T4, not TSH as the standard. If a generic was within 33% of Synthroid it was considered equal. Even with the new FDA baseline correction they were still 12.5% difference from Brand, and called equal! Wow, 12.5% is enough to throw your treatment off.If you get generic at the drugstore you would need another test in 6 weeks because it was a different amount, with the same dose on the bottle! How many of you are asked to get retested when they switch on you? The PDR calls for retesting after generic substitution.A recent study found 25% with significant change in there blood TSH tests with generic substitution. The groups most at risk are the elderly, from lipid,osteoporosis and heart complications from over, or underdosing that occurs with generic switching without retesting. Pregnancy also is a dangerous time for generic substitition. Thyroid cancer patients receiving T4 for supression of cancer growth could have either overdose, or underdose if substituted without a retest. T4 suppression is, after total thyroidi9ectomy, the best way to insure a relapse free course of your cancer. In my opinion Synthroid is the only long standing brand name.All the rest are generics to me. However the FDA calls Unithroid, and Levoxyl brands also.What to do if they try to substitute?
Be proactive and say "NO".

Dr.G

Monday, April 04, 2005

Levothyroid not the same drug!

Levothyroid is not the same drug.It is Novothyrox, and is not listed as an AB,1,2,3 drug that can be the same as any branded T4! The FDA allowed them to keep the name even though it was a different drug entirely. It is not listed as an FDA approved generic that is equal to the branded T4's. Consider talking to your doctor, about switching to a branded T4.

Dr.G.

T4/T3 Combination Therapy

The thyroid patients have been told by alternative physicians that recent studies
had proven that T4/T3 combos were better that monotherapy with T4.The New England Journal of Medicine article which sparked the combo idea, has not been confirmed in multiple studies since.Siegmund at al, showed no superior effect over monotherapy.They used 5% T3 substituted for T4. Clin Endo 2004:60,750-757. Also the TSH was more suppressed with the addition of 5% T3! Mood scores,and cognitive function were not inproved with T4/T3 combos. Escobar-Morreale, et al in Annals of Internal Medicine, 2005;412-424, used 7.5 mcg T3 plus 87.5 mcg T4, and compared with straight 100 mcg T4.The results were lower FT4, decreased TSH, unchanged FT3,and no difference in outcomes in the two groups. fatigue,depression,digital span, and general health scores were the same. When your doctor, or a website such as about.thyroid.com talks about the value of combo T4/T3 over T4 alone, quote these articles. Also remember, Armour is the original combo pill with both T4and T3 in a pig's ground up thyroid extract.Avoid that as well as other combo pills, such as Thyrolar, on the market.

D.G.

Rehnquest is still alive

Six months after surgery that did not include removal of his thyroid, but did include
a tracheostomy, he is back on the bench! This is very unusual for most cases of anaplastic Cancer of the thyroid. They are usually dead by 6 months. There has been no public notice of his diagnosis, but experts felt it was anaplastic. Maybe we are wrong.
There are other diseases with longer survival that can present with findings similar to anaplastic. Medullary,Lymphoma,and Tall cell variant of papillary thyroid cancer are examples. He also could have had a rare good response to experimental therapy.
If he lives past one year I will be among the doubters, about the original anaplastic diagnosis.

Dr.G.