Several days ago, Dr. Ron Cobbs offered his opinion on thyroid hormone replacement therapy. He was very much in favor of using pure t4 therapy, specifically the branded products (Synthroid, Levoxyl). Now Tony Kingkade offers his response to Dr. Cobbs. Read his opinion below:
Mr Kingkade writes:
C’mon Dr. Cobbs…just stop it!
Dr. Cobbs perpetuates the myth that “branded†levothyroxine products (I assume he means Synthroid or Levothroid) are preferable to other manufacturer’s products because the AACE says so. First of all, the AACE statement was published many years ago before ANY levothyroxine product had undergone the FDA approval process. Since then, ALL levothyroxine products on the market today have undergone the same, exact FDA approval process. Some have also demonstrated AB bioequivalency to other “branded†products…ie Mylan levothyroxine is bioequivalent to Synthroid. The generic companies have manufacturing technology, consistency in product and batch-to-batch bioequivalency that rivals or exceeds any branded manufacturer. They know that there can be no variation in their product and they make that a priority.
That thisâ€brand is better†myth continues today is appalling. It was originally promoted by Boots (former Flint and manufacture of Synthroid) and only exposed as false when Boots commissioned a study at UCSF to compare their product to various generic levothyroxine products. When the results of the study showed no difference in blood levels, Boots withheld publishing of the study. A Wall Street Journal article exposed this and the lawsuits from health plans (that paid more for Synthroid than equivalent generics) extracted millions from Boots.
In fact, at one CE presentation, I asked the Boots paid speaker why I should change my generic stabilized patient over to Synthroid since, according to him, there might be huge negative effect if one changes between Synthroid and a generic. He was unable to answer the question (because, to be consistant, it would mean that one should never convert back to Synthroid if already stabilized on another product.)
I know about low therapeutic indexes and the FDA allowable variation in potency for products. I get it! But all these manufacturers get it too. They make sure their drugs are right on, every batch, assay to assay.
So I ask you, Dr. Cobbs, to show us unequivicable proof that this isn’t true. In fact, just show us that the branded products have less variation in their batch-to batch assays than the generics. Give us the proof!
I’m not associated with any generic drug manufacturer. In fact, my wife is employed in a high science position by a major US/worldwide brand name manufacturer. So, if anything, I’m definately pro brand-name. But Dr. Cobb’s support of the AACE recommendations to use only branded versions of levothyroxine is just plain wrong.
From More Attacks on Use of Armour Thyroid, 2009/03/23 at 11:26 PM
