Tony Kingkade Responds to Dr. Cobbs

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 this”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

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  • Ronald K. Cobbs, MD

    Mr Kingkade has a very interesting opinion. I prefer to deal with the facts. First, the AACE position was posted after not before the FDA approved other brands of levothyroxine. Second, the FDA has stated that they do not use TSH to assess equivalence of levothyroxine preparations. They use area under the curve concentration which is not as accurate. Endocrinologists use a sensitive TSH assay which is more precise.

    There is no myth if you read the literature. Since so many people misunderstand the facts, a joint position paper was published on the internet.
    AACE, The Endocrine Society and the American Thyroid Association published the joint statement. The statement was published after the FDA refused to listen to the opinions of all three groups of endocrinologists. The joint statement is the one that states that branded levothyroxine should be used instead of generics. And it was issued in 2004

    Also for the record, the FDA allows for significant variance from the stated dosage. Some generics are more “bioavailable” and others are less available resulting in differing thyroid function test results despite all claiming to be the exact same strength using FDA standards. Differing manufacturing techniques account for the differences.

    As for the Boots paper, Boots was wrong in withholding their paper however a careful review of the other published literature reveals many other papers that demonstate differences in blood levels of different brands even when the dosage claims to be the same.

    For the record, I am not a paid speaker for any pharmaceutical company. I have taught and continue to teach endocrinology to residents, attending physicians and medical students for more than 20 years. I prefer to deal with facts as represented in the published literature. A drug company paid speaker gives a promotional lecture. Don’t expect facts from them.

    The facts stand for themselves. The recommendation to use branded levothyroxine is that of AACE, The Endocrine Society and the American Thyroid Association. I stand by the recommendation of all three associations of endocrinologists. The facts speak for themselves.

  • Amy

    “The recommendation to use branded levothyroxine is that of AACE, The Endocrine Society and the American Thyroid Association”

    Perhaps Dr Cobbs can elaborate on the relationships that the AACE, The Endocrine Society, and the American Thyroid Assn share with Abbott Labs, the makers of Synthroid? Just a cursury search online brings up a whole host of examples of just how Abbott supports all these societies and helps them to stay in business.. Are we really supposed to believe that these endocrine societies are going to bite the hand that feeds them and, god forbid, promote or even give equal time to either natural desiccated thyroid or generic brands? And I assume that you, Dr Cobb have never attended a drug sponsored lunch, dinner, or any event designed to promote their products? Nor ever invited an Abbott Labs drug rep into your office with the resultant pens, mugs, pads and other goodies?
    There has been too much exposed about Big Pharma’s cozy associations with the organizations, societies and doctors that help promote their products. The facts, indeed, stand for themselves.

  • christie pontello

    hhmm, drug companies that release drugs must show that they work, and must show they do not kill you first. While I do NOT trust big Pharma, makers of generics DO NOT HAVE TO PROVIDE PROOF OF EFFICACY , EVER.

    Additionally if I owned a fruit store and my scale was off to the degree a pharma scale is allowed to be I would be fined for every pound of bananas I sold, plus everything else I sold. I never take a generic if I can afford it because I never know if one , they will work, or 2) if the meds are perfect raw but the various binders prevent the release of the product in the proper place, like say only in intestines not the stomache or reverse, 3) meds may be perfect and perfectly pressed, but not be enough to be efficatious. ADHD (ADD) meds are the best example. the right amount works wonders, too little and they are pointless. You may have to titrate a person for two months if you can afford the copays till you figure out what to give the kid.

    Additionally, I do not know the time frame, but the pens/mugs/10 dollar lunches are out now and have been for a while. I have neighbors who are both drug reps, I know a well respected medical chemical engineer as well as several doctors all of whom I have discussed drugs with over the past 30 years. Interestingly the Chemical engineer explained to me in extreme detail how stuff is made and the differences between generics (in general) and very specific ones and makers. Would he take a generic, admittedly there were few.

    And self regulation is a big issue as well. Vitarene on Long Island was falsefying documentation for years and they finally were closed maybe 10 years ago. A certain big pharma company wasn’t seeing the increase in profits fast enough from a certain statin and then came up with the idea that more statin reuced the levels better. They went out and pushed this idea through the reps. Sales went wild, duh it only works in a small percent of the users, and it only decreases it by a tiny amount.

    S otony I do blieve you mean well, but, I think you are off base here.

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