Did FDA Committee Make the Right Decision?

This will be hotly debated for the next several months. Many people are sure to be asking why now? What safeguards will be taken to prevent the problems that originally caused the limits to be put into effect? Even the original results when recomputed remained almost identical. Until the dust settles on the Food and Drug Administrations actions, we will only have a discussion as to the questionable value of Avandia.

I know several doctors that will start using it again; however, I doubt many patients will accept using Avandia. In my blog recently, I complained about the pill popper generations. I must expand this to doctors as most primary care physicians would rather prescribe pills than insulin. I am aware of many people with type 2 diabetes that are able to manage their diabetes on oral medications and many that are able to manage their type 2 diabetes without medications. Yet many patients need to stack one oral medication on top of another oral medication and still are not managing their diabetes.

Because many doctors are rightfully fearful of hypoglycemia, they will let diabetes do damage and become progressive before they will prescribe insulin. This is the shame of our medical teaching. Yet, not many can become diabetes doctors like Dr. Richard K. Bernstein.

The final decision now awaits the FDA. The FDA has no regulatory deadline by which to make a decision, and it's unclear when the agency will make a ruling, an FDA spokeswoman said. The FDA isn't obligated to follow the advice of its advisory committees, but usually does. Hopefully this time they will leave things alone.

So the wait begins.

Question – Is Avandia Safe?

This is an interesting conundrum for the FDA. Or at least it will be if they lift the restrictions on Avandia. Avandia is in the class of oral diabetes drugs Thiazolidinedione.  Avandia and Actos are the only two drugs in this class. Avandia is the product of GlaxoSmithKline (GSK) and Actos is manufactured by Takeda Pharmaceuticals. Avandia is known for causing heart problems and Actos has a raised incidence of bladder cancer. If restrictions are lifted on Avandia, will we find out that it too will raise the incidence of bladder cancer?

Although the big guns on both sides of the argument are not being quiet, I can well imagine that if the FDA lifts the ban on Avandia, the FDA will have to weather the storm of being accused of being too chummy with Big Pharma. Even I would be remiss in not considering this charge. All too often, I feel that when there are questionable trials and data, FDA approves a drug when it should require additional studies.

While it is true that most drugs have side effects of some type, in the last decades, too many drugs have made it to market and later had to be removed because of either something that was kept from the FDA, or something overlooked by the FDA. I will pull no favoritism because I feel that Big Pharma is laughing up its sleeve and saying to the FDA, "heads, I win, tails, you lose." Then on the other side, we have the patients screaming at the FDA for its slowness of approval for drugs they feel would help their disease.

If those of us with diabetes did not have insulin available, then I could possibly understand the need for oral medications with dangerous side effects. I am not in favor of this because too many in my generation and the next generation are pill poppers and if they have an illness or in this case a chronic disease, all they want is a pill to pop in their mouth and go on with life. Is it any wonder that diabetes becomes progressive for many people? They won't learn how to manage diabetes and many won't learn because they have that pill to take.

For those that have not followed the Avandia debate, this is where it started for me and now that the two-day session is in progress (June 5 and June 6), it will be interesting to read about the outcome. The second article is here by Dr. Matthew Mintz. The latest article is from the digital side of the New York Times and you may read it here.

Now, this evening (June 5) there are two more articles that could make an excellent read.  Before reading this blog by Dr. Mintz, but sure to read the one above.  The second is an article in Forbes dot com.