Should the FDA Require Cardiovascular Studies for Diabetes Medications?
The FDA is considering the possibility that required cardiovascular studies should be added to the approval process for diabetes drugs. There does seem to be a correlation between cardiovascular risks and diabetes medications. The meta-study on Avandia showed a possible risk of serious cardiovascular events, even though it was ultimately found to be inconclusive. The portion of the ACCORD study which was testing the benefits of tight control of diabetes was halted due to increased cardiac related deaths.
Diabetes is a double-edged sword. When blood sugar is uncontrolled, all kinds of complications can arise, including cardiovascular complications, such as heart disease, and risk of strokes. But it also seems that some medications and therapies might also increase the risk.
The FDA says that, "conclusive evidence of a reduced risk of macrovascular complications in type 2 diabetes has not yet been established for any of the currently available antidiabetic medications, including insulin."
On the other hand, there might be enough evidence to warrant studying the cardiovascular safety of diabetes drugs.
The FDA at a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee meeting, July 1-2, 2008, stated, "Type 2 diabetes affects millions of people in the United States, causing considerable morbidity and mortality. Cardiovascular disease accounts for most deaths among people with diabetes. Therefore, the question of cardiovascular assessment of drugs and biologics developed for the treatment of type 2 diabetes is of high public health importance."
Do you think that cardiovascular studies should be done on diabetes drugs before they are approved? Should diabetes drugs that are already on the market also be studied? Does the cost of conducting studies of this magnitude outweigh the benefits? Post your comments at the bottom of this article or email me, your diabetes guide, at diabetes.guide@about.com.
Comments
There is no easy answer to this question. Both diabetes and cardiovascular (CV) disease have risks associated with them and when co-morbid, the risks are supra-additive. Sorting out whether diabetes drugs exacerbate risk when both conditions so commonly co-exist is complex. When a person is diabetic in the absence of CV disease, the CV consequences of diabetic drugs may be easier to assess, however. Looking back at experience with new drugs in general, it is common for adverse effects to emerge only after an abundance of data accumulates from clinical use after approval is granted. The costs of accumulating this volume of data as part of the pre-approval clinical trial phase will be a major disincentive to drug companies to begin drug development and would add enormously to the cost of the drug when it hits the market. If such exhaustive testing does expose apparent risk leading to the abandonment of a proposed drug, how will the enormous cost be recovered? Will these costs add to the costs of other drugs making it to market? Look at rosiglitazone. After-market experience generated concern over associated CV risk and quite a controversy developed with alarm in many quarters. As the dust has settled, data suggesting a link has been judged ‘inconclusive’. More recently, an association between use of rosiglitazone and increased risk of fractures in some populations has emerged. How far should testing for all possible consequences be carried? Pre-approval drug evaluation carried to extremes will soon cause the stream of new agents to dry up as costs soar. We cannot afford to have this happen. As someone with a 19-year history of CV disease and only a 3-year history of Type 2 diabetes, I say keep new drugs coming and let’s not get carried away with testing so obsessive that drug development grinds to a crawl.
I beleive that these drugs should be tested thorouhly before they hit the market.Also the ones like “AVANDIA” should be pulled from the market.It is the drug companies and the doctors to explain how dangerest this drug can be. What would you say if the doctor tell you to take this medicine to help your diabete but fail to tell that it may end up killing you slowly?
I was had taken AVANDAMENT & AVANDIA for almost 3 years. I am already blind one eye do to an accident I was 10 yrs. old and my doctor was aware of this. She put me on this medications that had side effects of blurry vision,swelling of the legs and ankles,severe shortness of breath,fluid in the lungs, rapid weight gain and possible liver damage. Now I had 6 of these symptoms and now feel depressed because I can do the thing I used to.On March 21,2007 went to the emergency room and was told that I had congestive heart failure and on Oct.18,2007 I had to have a difibrilator implanted. I just had a visit with my cardiologist and he & the device reps. said that my heart rythm had to be corrected on Nov. 27,2007 and it was lucky I had the device. That was one year from my brother’s death.
So yes I beleive this drugs should be tested or at least fully explained and give the patient time if possible to review.
I was blessed to have insurance otherwise I would not be here to give my opinion.Who knows how much time I have because of the above mentioned side effects.
It is my hope that my story and opinion helps someone.
No doubt the issue is a complicated one as can be Diabetes. However, as an RN and a person who has had Type 1 DM for almost 40 years- my suggestion: Do whatever you can to avoid taking any drugs manufactured in this country. I know that sounds very drastic- you may have to eventually take something but, consider the alternative approaches available to assist you. Westerm medicine has severe limitations. Here’s another story for this column: My mother was placed on three drugs for her Type 2 Diabetes at the age of 75 when she developed it. And was sent home to sort it out herself. Appalling to me- and of course she was dropping very low all of the time. And intuitively she knew it was too much. She and I titrated her doses and I even suggested she talk with her MD about removing one entirely- He agreed. I also asked her to tell him to take her off of the ‘cholesterol lowering drug,” Lipitor. This drug causes limb pain and an increase in arthritis symptoms and she was having both. (Plus her cholesterol levels were barely above normal- total overkill). You cannot tell me that during drug trials the issue of limb pain and aching joints did not arise. Out of 4 older women that I know who were on Lipitor- 2 had to discontinue it for this reason. That is 50% folks. And, “drug testing” having worked in Research- does not always mean “honest results drug testing,” as we have witnessed over the years. I do not think there is a problem with more drugs coming down the pike, that will never stop happening. I do think there is a major problem with honest results and overuse of artificial, lab developed medicine in this culture. So- yes more testing- the pharmaceutical companies that are making millions each year will not suffer for it. So my friends- do not think when you develop Type 2 that drugs are your first option- they are not. Get some help with your food habits- try alternatives to medicines- and move that body! Every little bit counts, believe me. I am sorry to hear about all of the trials that the second gentleman suffered.