Glaxo goes on the offensive
In football some believe that the best defense is to play an aggressive offense, this appears to be GlaxoSmithKline’s (NYSE:GSK) approach to the Avandia controversy. In what is setting up to be a battle between statisticians and a debate over meta-analysis both Avandia detractors and supporters are set to bring out the heavy artillery. While this debate is needed and no one would argue that change is needed, this debate will only further confuse the general public. Like it or not the public wants simple answers to complex questions.
The majority of Avandia users are just regular people, not experts on diabetes. The honest truth is they really don’t care what a meta-analysis is or its shortcomings. They don’t want to hear about the difference between absolute numbers and percentages. To the everyday Avandia user they only care about one thing; Is Avandia safe or not. This is their bottom line and they don’t want a lot of mumbo jumbo complex explanations. All they want is a simple yes or no.
Those of us who follow the industry realize that there are no simple answers. Even under the best of circumstances there is no exact way of knowing that a drug will develop complications six or seven years after it has been on the market. New drug innovation would come to a halt if the FDA required companies to run clinical trials for 5 or more years. The drug approval process is already lengthy and expensive. Can you imagine what the cost of drugs would be if the FDA required even longer clinical trials. True the FDA has the power to ask for post-market studies unfortunately few get completed and the FDA appears powerless.
The reality of the situation is there are no guarantees that a drug which originally looked safe and effective during clinical trials won’t have a long term adverse effect. This is the inherit nature and risk associated with drug development. There are few, if any, absolutes. Still this does not change the realities of the situation where the general public wants simplicity and they want it yesterday. This is particularly true for people with diabetes who are dependent on their medications each day of their lives. Patient compliance is already woefully inadequate and an unfortunate consequence of the Avandia controversy is that it gives patients another excuse not to take their medication. Diabetic Investor will skip our rant on the lack of patient education and how this contributes to the problem. However, the lack of patient education is a contributing factor that cannot and should not be ignored.
Avandia patients are being told to consult with their physicians before making any changes to their daily therapy regimens. Physicians who must consider more than just whether or not Avandia is working for their patients. In the back of each physicians mind is the chance they may be sued at some point down the road should they keep their patient on Avandia and that patient has a heart attack. Yesterday Diabetic Investor spoke with a leading malpractice attorney who said that any physician who places new patients on Avandia is taking a major risk and those who leave their patients on Avandia are also at risk. As we have pointed out and this attorney confirmed, the fact that there are alternatives to Avandia puts any physician who sticks with the drug at even greater risk. While the FDA may clear Avandia in the long run, the legal risk to the physicians who prescribe the drug cannot be ignored.
Making matters even worse is the politicians have gotten involved and that can only mean one thing, someone must fall on their sword. It would be noble to think politicians really care about Avandia users but another sad reality is politicians are more interested in placing blame and making headlines then they are in actually doing something about the problem. This point was made abundantly clear as we have been down this road before with Vioxx. It would be naive to think that whatever decisions the FDA makes on Avandia it will be devoid of political pressure.
Glaxo is doing the best they can under the most difficult of circumstances. Diabetic Investor feels their pain and believes in the long run the company will be just fine. However, the future for Avandia is more problematic. The reality is the drug is already tainted and it will take Herculean effort to restore the public’s confidence even if the FDA clears the drug. The company has already acknowledged that the FDA would likely require a label change for Avandia and did not rule out the possibility of a “black-box” warning. The bottom line here is there are just too many issues, some real, some imagined with Avandia for the drug to survive.
David Kliff
Publisher
Diabetic Investor
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www.davesrunfordiabetes.blogspot.com
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