Avandia Law Suit Brings Out the Opportunists

The lawsuits against Avandia are being prepared and opportunists are lining up for a payday. Unfortunately, everyone else will wind up a loser, and here’s why.

Avandia, one of only two available medicines with unique properties to treat diabetes, was approved in 1999. From the very first day Avandia was approved a heated debate arose whether Avandia or its sister drug, Actos, was the better drug for diabetes treatment. Both had similar abilities to lower blood sugar and both had the same downside of causing significant weight gain and fluid retention. Avandia showed a slightly worse effect on cholesterol profiles which convinced many diabetes specialists to choose Actos over Avandia. The choice between drugs has also been heavily influenced by cost considerations such as whether the drug was covered by the patient’s insurance carrier. I personally treated numerous patients with both drugs and found them about equal in all respects.

The lawsuits against Avandia will contend that the medication caused heart attack or stroke. The truth of this contention is very much in question, but the murkiness of the water doesn’t stop the lawyers from trying to take a bite out of the flesh of GSK (GlaxoSmithKline), the maker of Avandia.

Several years ago research studies seemed to indicate a small increased risk of heart attacks in users of Avandia. Ever since there has been a heated debate about whether this was a true risk or just the result of overly aggressive interpretation of the available data. There are two major analyzes on the subject of heart attack risk with Avandia. One, written by a doctor on the payroll of a competing drug company, looked at results from 14 thousand patients on Avandia and found a small increased risk of heart attack or stroke and the other study analyzed another 14 thousand Avandia users and found no such association. Under pressure from the public, in 2007 the FDA placed a strong warning on the label of Avandia regarding the possibility of the drug causing heart disease, but Avandia was permitted to remain on the market. The FDA warning was updated and upgraded in 2010. The publicity surrounding Avandia’s potential risks basically halted the use of the drug in the U.S.

Now enter the opportunists. Advertisements fill my email in-box from lawyers looking for customers who want to sue the drug manufacturer in class action law suits. Try goggling “Avandia side-effects” and you will find the first several pages of results are ads looking for lawsuit clients. In the last month I received two requests for patient records from these lawyers. Both patients had heart disease at the time they started the medication. One patient who recently died was over 80 years old, and the other who had significant heart disease and other diabetes complication to begin with, is still alive more than 7 years after treatment with Avandia. I wonder how much benefit these patients received from the medication which allowed them to survive as long as they did despite all the other problems they had related to their diabetes.

Why should you care about whether a small army of opportunists each get a few thousand dollars from the drug manufacturer and a few lawyers become millionaires? Because it is just this sort of legal action which is convincing drug makers to back away from developing other potential diabetes treatments. It takes a decade and a billion dollars to bring a new drug in front of the FDA. This doesn’t include the cost of developing drugs which fail to even make it to FDA review. Then the FDA approval process is tortuous and uncertain. Passing this hurdle, any new drug can come under attack (like Avandia) for “possible” side effects making the company vulnerable to devastating legal costs and bad publicity. It isn’t economically feasible to develop new diabetes drugs in the United States. As a result, new drug development is grinding to a halt. We will all suffer due to lack of innovation, not only for diabetes treatment but for treatment of many other dangerous diseases.

Gary Pepper, M.D.
Editor in Chief, Metabolism.com

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  • Leslie Denoff-Sanders

    Dear Dr. Pepper, Greetings to you. I am an American lady, living in London. I have been living here since ’95. Today, I came across an article you wrote, regarding Cytomel, and I would very much like to discuss my case with you, especially as it is somewhat atypical. Are you in private practice in the U.S? I found two listings for physicians with your name-one in Jupiter, FL, and one in Brooklyn, N.Y. The Florida listing is an Endocrinologist, so I’m guessing that may be the correct listing. Could you possibly email me your contact details? I have recently had a Near-Total Thyroidectomy, due to having had medically intractable Thyrotoxicosis, with an episode of Neutropenia Sepsis, in Dec 2010, which was due to a rare side effect of the drug, Carbimazole. Also, it was discovered post-op via the histology report, that the ‘nodes’ on my thyroid, were Follicular Adenomas, and that the surgeon accidentally removed one of my Parathyroid glands. Now, almost 5 months post-op, I am unable to take any higher dosage than 25 mcg of Levothyroxine, as it makes me feel extremely unwell, yet my T4 remains quite low, and symptomatically, I am still significantly hypothyroid. I will be in the U.S shortly, and would like to have a consultation with you, if possible, hopefully with a view to starting Cytomel. I must note that Cytomel is not yet licensed in the U.K. Ok, well, I hope to hear back from you via email. Thank you, in advance for taking time to read this, and reply. Best Regards, L. D-Sanders

  • Leslie Denoff

    Dr. Pepper,

    I wanted to update my comment with regard to Thyroid post op presentation.
    I am now on 120 mg of Armour thyroid, and have been since about July of 2012.
    Since that change, my clinical presentation has improved dramatically and I am now back in the USA and completing my medical degree.
    Prior to Armour, I was almost completely non functional following thyroidectomy in Feb 2011, and was unable to take the synthetic thyroid meds which are normally prescribed, such as Synthroid and Cytomel.
    If Armour were to vanish from the drug market, I dread to think what my life would than be like.
    I have read countless articles and postings from patients who are unable to convince doctors to prescribe Armour, and I must say how sad this makes me, and that i have utmost empathy for these patients.

    I can not begin to comprehend the reasons any physician would have for refusing to prescribe this drug, and it concerns me greatly that practitioners are knowingly preventing patients from regaining their health and ability to live a happy and useful life.
    I know that I was, prior to Armour, totally incapable of participating in any kind of activity beyond laying on bed and reading, and sometimes, I was too exhausted to even read.

    I would be very interested to know how the refusal of prescribing Armour, when indicated, is justified by these doctors.
    IF you have any information on this, please do email me.

    Thank you very kindly and I appreciate the metabolism site, as I would have been unaware of Armour had I not come upon the site 2 years ago.

    Best Personal Regards,

    Leslie Denoff