This is getting just a little ridiculous
“The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period January – March 2008 in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.” This statement comes for the FDA’s web site as they released a list of 20 approved drugs that MAY have a safety issue. Although there were no diabetes drugs on the list, the list speaks volumes about the direction the FDA is headed and once again demonstrates how the agency fails to understand the real world implications of their actions.
According to an article in today’s edition of the Wall Street Journal; “"It is very, very important that patients and their physicians understand the benefits and the risks of the drug. To speak about one without the other could have an impact on patient perception of their medications," said Tony Jewell, a spokesman forAstraZeneca PLC, whose psychiatric medication Seroquel made the list for the possible safety concern of overdose due to confusing sample-pack labeling.
Companies also cautioned that just because a drug is posted on the site doesn’t mean a causal relationship has been identified, and it is also risky if patients go off their medications without consulting a physician.”
This action by the FDA comes on the heels of their decision to warn physicians and patients about Byetta usage and pancreatitis. Even though the FDA considers this a “rare and uncommon” event they felt it necessary to warn the public. Understanding that the FDA holds the keys to the kingdom drug companies cannot publicly say the agency is overreaching here. Privately they must be shaking their heads and wondering what will the agency do next.
The facts are this, there is no such thing as an absolutely safe prescription medication. Over the past week Diabetic Investor has pointed out numerous examples of approved medications that unfortunately have adverse events associated with their usage. The same is true for medical devices as we pointed out in the last issue of Diabetic Investor. However, this fact somehow gets lost at the FDA as they apparently believe that no matter what the incidence rate or how infrequent an event may be it is their duty to warn the public. The FDA seems to have forgotten that their mission states they are supposed to use evidence based medicine. Worse the FDA fails to understand the concept of risk reward. Finally the FDA is living in fantasy land if they believe their actions do not carry lasting impact in the real world.
As sure as night follows day there will be patients who after seeing this list will stop taking the medication they need without consulting their physician. This is exactly what happened when the Avandia controversy came to light and what is happening now with patients who take Byetta.
Diabetes is a serious disease and when uncontrolled leads to severe complications. Diabetes is now the sixth leading cause of death. The cost of poorly controlled diabetes goes beyond dollar and cents. The fact is diabetes is both a serious healthcare and economic problem.
Someone needs to explain to Diabetic Investor how the FDA gets away with this. How can they take such action without following their mission? Why isn’t this agency which is funded with our tax dollars held accountable for their actions? To Diabetic Investor this action is classic government thinking of killing a house fly using a nuclear weapon. No question the fly will be dead but what about the nuclear fallout.
From our perspective the inmates are running the asylum. If things are left unchecked it won’t be long before the FDA issues a warning that insulin use can lead to severe hypoglycemia. Or that taking metformin can sometimes lead to serious gastrointestinal issues. Before you know it the agency will cripple the physician’s ability to effectively treat their patients.
Instead of moving into the future the FDA is headed back to the dark ages of medicine. Instead of fully investigating a possible adverse event and then go public with their findings; it’s a shot first ask questions latter policy. This is madness and for the good of the millions of patients with diabetes it must end.
Diabetes will not magically disappear. Patients and the physicians who treat them need more tools, not less to effectively treat diabetes. It’s time for the diabetes community to take a stand and be heard. The FDA is out of control and this is unacceptable when diabetes is growing at epidemic rates. This situation is beyond ridiculous. Once again it’s the patient who suffers most here. Someone needs to stand up to the FDA and tell them ENOUGH IS ENOUGH!!!!!