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Medco Thyroid Scandal – from Mary Shomon’s site

Posted By on August 7, 2009

This is from Mary Shomon’s About.com site, and her letter to Medco demanding answers to their scandalous (and entirely unethical) letter distributed to doctors nationwide regarding dessicated thyroid products.

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Medco Thyroid Scandal: Thyroid Patients Demand Answers Regarding Misleading Thyroid Drug Shortage Notices
Thursday August 6, 2009
Major mail-order pharmacy Medco Health has recently been disseminating a misleading and highly suspicious notice to doctors, suggesting that no natural desiccated thyroid drugs are available, that the FDA intends to take these drugs off the market, and suggesting that doctors switch patients to levothyroxine. I have obtained a copy of the notice, and have written a letter to the heads of Medco, asking them to explain why they would be telling doctors that natural desiccated thyroid is not available — when it is — and why a pharmacy has taken it upon themselves so suggest to physicians what drugs the doctors should be prescribing to their patients. You can see the Medco notice (PDF), and read my letter now, and talk about it on the Thyroid Forum.

SENT BY FAX AUGUST 6, 2009

August 6, 2009

David Snow, Chairman and CEO
Kenneth Klepper, President and Chief Operating Officer
Medco Health
100 Parsons Pond Dr
Franklin Lakes, NJ 07417-2604
Fax: 201-269-1109

Dear Mr. Snow and Mr. Klepper:

It has come to my attention that you have recently sent out a notification to doctors (see attached), under the heading “Thyroid Products Shortage,” suggesting that there is “a nationwide shortage of products including porcine-derived desiccated thyroid and liotrix.” Your notice states: “These medications do not have U.S. Food and Drug Administration (FDA) approval, and we expect that the FDA will eventually require these products to be approved and may remove any remaining unapproved products form (sic) the market. Supplies of these products are now limited, because of this uncertainty.”

Your notice then lists all known of natural desiccated thyroid, and indicated that all sizes are “unavailable.”

You then go on to indicate, “When prescribing thyroid therapy consider using levothyroxine.”

Frankly, patients around the United States — and in particular, customers of Medco — are asking themselves what motivation Medco has to provide incorrect and misleading information about thyroid medications. Because your notification is patently incorrect.

Let’s look point by point at Medco’s inaccuracies and misleading statements:

1. Medco states: “there is a nationwide shortage of products including porcine-derived desiccated thyroid and liotrix.”

This is incorrect. There is a nationwide shortage of Armour Thyroid, one brand of porcine-derived desiccated thyroid produced by Forest Labs. And there is a nationwide shortage of Thyrolar, the brand name for liotrix (a synthetic combination thyroid drug), produced by Forest Labs. There is, however, NO nationwide shortage of RLC Laboratories’ natural desiccated thyroid drug, Nature-Throid.

2. Medco states: “These medications do not have U.S. Food and Drug Administration (FDA) approval.” It’s true that natural desiccated thyroid does not have FDA approval.

Medco’s statement is misleading, however. Natural desiccated thyroid was in use long before the FDA was created, and was “grandfathered in.” Natural desiccated thyroid is a legal, FDA-regulated prescription medication.

3. Medco states: “…we expect that the FDA will eventually require these products to be approved and may remove any remaining unapproved products form (sic) the market.”

This is pure speculation. Medco has no basis on which to “expect” this. Millions of prescriptions each year are written for natural desiccated thyroid, and the FDA has not indicated any intent to remove natural desiccated thyroid from the market, especially given that it has been safely used for more than 100 years.

4. Medco states: “Supplies of these products are now limited, because of this uncertainty.”

This is again speculation, with no basis in fact. Forest Laboratories recently reformulated Armour Thyroid, and has been on backorder since the reformulation. During this time, many patients using natural desiccated thyroid turned to Nature-Throid as a substitute, which created a short-term backorder of Nature-Throid with distributors, which is now being resolved.

5. Medco states, regarding natural desiccated thyroid, that all dosage sizes are “unavailable.”

This is absolutely untrue, as Nature-Throid has availability of all but its 3 grain size. Instead of obtaining the readily available Nature-Throid, Medco is instead misleading doctors by suggesting that no natural desiccated thyroid drugs are available, and that patients should be switched to levothyroxine.

6. Medco states: ” When prescribing thyroid therapy consider using levothyroxine.”

Since when is it the business of a pharmacy to recommend to doctors one particular drug over another, as treatment for patients? If a doctor has prescribed natural desiccated thyroid to his or her patients, it is for a reason, and for those doctors, synthetic levothyroxine is not considered a substitute for therapy with natural desiccated thyroid. Is Medco presuming to know what will treat thyroid patients better than the doctors writing prescriptions?

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Frankly, as a thyroid patient advocate, I find Medco’s conduct entirely unacceptable. It raises the question as to whether Medco is financially benefiting from promoting levothyroxine over natural desiccated thyroid drugs. Given that natural desiccated thyroid is available, unless there is some financial motivation, what reason would Medco possibly have to mislead doctors by suggesting to them that natural desiccated thyroid is unavailable for patients, when that is categorically not the case?

It’s clear that thyroid patients deserve answers to the following questions:

1. Why is Medco unable to obtain Nature-Throid, when other pharmacies are able to obtain it, and the company itself has indicated that supplies are available for immediate shipment to distributors?

2. Why is Medco disseminating incorrect information to doctors, suggesting that there is a nationwide shortage of natural desiccated thyroid drugs, when the shortage is only in one brand?

3. Why is Medco trying to mislead doctors, saying that natural desiccated thyroid does not have U.S. Food and Drug Administration (FDA) approval, when the company should be well-aware that like many older drugs, natural desiccated thyroid does not require FDA approval, given its grandfathered status and 100 year history of safe use?

4. Why is Medco making predictions about FDA activities when the FDA itself has not discussed any intent to regulate natural desiccated thyroid drugs?

5. Why is Medco trying to link Forest Labs reformulation and backorder difficulties, with FDA plans for natural desiccated thyroid, when no such link is established?

6. Why is Medco saying that no natural desiccated thyroid is available, when Nature-Throid has availability of all but the 3 grain size, and is considered an equivalent to Armour Thyroid for patients taking natural desiccated thyroid?

7. Why is Medco recommending levothyroxine to doctors who have prescribed natural desiccated thyroid for their thyroid patients?

I look forward to Medco’s prompt response to these concerns.

Sincerely,

Mary J. Shomon
Thyroid Patient Advocate

Full article here

http://thyroid.about.com/od/thyroiddrugstreatments/l/MedcoLetter.pdf


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