Opening statements

Jun/13/2007 02:05 Filed in: Pharma Business
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Well it take long for me to get some eMail on my last post. Thank you for responding and raising some great issues, but for a moment put yourself in a patients shoes. You are a Type 2 diabetic doing well on Avandia and really don't want to switch to another medication. As a patient what I would want to know is; what are the risks of a heart attack on Avandia, and what are my risks for a heart attack on Avandia? I would want to know the percentage of patients in ongoing clinical trials that had issues and if these issues were due to the medication or other risk factors including weight, family history of heart disease and high cholesterol. So the questions remain for GSK and the FDA to answer.



In any opening trial there are the opening statements. If I had completed law school and were a member of the BAR this what my opening statement would be:


There are millions of people here and abroad who suffer with Type II diabetes. Because of medical advances there are several medications available to treat this terrible disease and keep it in check. GSK has marketed a medication called Avandia and it has helped a lot of these patients treat their diabetes and many of them have done very well on this medication. But what you the jury have to decide is whether GSK manipulated or hid data that would have prevented the FDA from approving this drug? If they did minimize the risks of a heart attack in anyway then they should feel the full repercussion of the FDA, the justice department and patients who have been harmed. But as you have to look at the facts if they tell a different story, if in fact independent researchers find that the data submitted and subsequent analysis does not warrant a cause for alarm than GSK has the right to sue those who pointed the finger. For even if the data concludes that there is no greater risk for heart attack with Avandia than placebo or that risk is minimal and was communicated to HCP's and patients it makes no difference; the damage is done and Avandia will never regain it's former market share. So the key questions that need to be answered are as follows:


1. Did GSK manipulate data to get approval of Avandia?



2. Did GSK hide data to get approval of Avandia?



3. Finally, did GSK minimize the risks of heart attack with Avandia to patients and HCP's.


These are the questions that have to be answered not for the benefit of GSK but for the benefit of patients who are on the medication and want to know the risks associated with it. It's about patients but as this issue progresses it will be less about patients and more about litigation and GSK's stock price.

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