Avandia – The Patient Perspective

Avandia – The Patient Perspective

“This is frightening! I was on it for a bit over a year. Does anyone know if the negative effects diminish after one stops taking it?…..and doesn’t it make you wonder what they will discover down the road about Januvia?”

This statement comes from an Avandia patient and was posted on one of the message boards followed regularly by Diabetic Investor. It is also indicative of the many posts on messages boards and blogs. To Diabetic Investor it also points out the failure of our current system and the need for change.

Patients on Avandia are being advised to consult with their physician and not to stop taking their medication. Good advice, expect for one thing, the assumption is the physician is equipped to deal with the situation and has all the relevant facts to properly advise the patient. Avandia is used to treat type 2 diabetes, over 85% of the patients with diabetes are treated by a primary care physician. On average primary care providers spend less than 10 minutes in front of a patient, do not have a diabetes educator on staff and the information they have typically comes from pharmaceutical sales reps. These physicians do their best to keep up with all the latest research however there are only 24 hours in each day and when you have to warehouse patients there just isn’t enough time in the day to keep up with all that’s going on.

With each passing day more information is coming to light about Avandia and who knew what and when they knew it. Yesterday the Washington Post wrote an article which stated “The government’s own preliminary evaluation of the diabetes pill Avandia confirms the heart risks reported in a study earlier this week and suggests that as many as 60,000 to 100,000 heart attacks might be linked to its use since it came on the market eight years ago, a leading member of Congress said Thursday.” With statements like this it’s easy to understand why patients are losing confidence in the FDA. If they knew Avandia was linked to as many as 100,000 heart attacks why was no action taken?

The fact of the matter is all drugs have side effects however most patients believe if the drug is approved by the FDA it is safe to take. It is also true that physicians don’t have the time to properly educate patients on the various side effects of their medications. This is not to say physicians are being irresponsible it just points the realities of our health care system. A system designed to treat a problem rather than avoid one.

Patients taking Avandia need to know all relevant information so they can make an informed choice. They also need to feel confident that if they stop taking Avandia and switch to another drug that their new medication will not also cause problems down the line. Diabetes is a chronic life long disease for which there is no cure. While it is possible for a type 2 patient to use diet and exercise to control their diabetes and stop the need for medication, this is the exception not the norm. The fact is most patients will be on some form of medication for the remainder of their lives.

Knowing this perhaps it’s time for the FDA to reexamine who they approve medications for diabetes. Currently glycemic control is the benchmark on which drugs are evaluated, simply put does the medication lower a patients A1C, the gold standard for determining control. However with the many known complications associated with diabetes is glycemic control the proper benchmark? Should it be just one of many benchmarks? Frankly Diabetic Investor sees the FDA between the preverbal rock and hard place. Some balance needs to be brought to the system so that good drugs don’t take longer than necessary to get to market, while at the same time preventing drugs with adverse profiles from reaching the market.

In the meantime the Avandia situation makes clear the need for better patient education. Should a patient and their physician determine a switch is warranted the patient must fully understand the risk reward profile of the new medication. This only comes when both the physician and patient has all the facts.

Just a few short years ago when problems with Vioxx came to light we had a similar outcry for change. Congress investigated, scholars wrote articles and lawsuits were filed and what happened – nothing. Today millions of patients with diabetes are wondering if the drugs they are taking each day will do more harm then good. The American public is losing confidence in the FDA and the for all their investigations Congress appears more interested in headlines than taking corrective action. The system is broken and needs to be fixed. Part of the fix must include better education for both patients and their physicians. Based on past results Diabetic Investor is not optimistic that the government will lead the way which means the solution must come from the private sector. Is there anyone willing to accept the challenge?

David Kliff
847-634-4646 Fax
224-715-3761 Mobile