by Dr. G. Pepper | Jan 18, 2010 | diabetes, diet and weight loss, general health & nutrition, health
New Diabetes Treatment Guidelines Lack Credibility:
Recently the American Academy of Clinical Endocrinologists issued new treatment guidelines for treating Type 2 Diabetes. Complex medical guidelines are often referred to as a treatment algorithm. One of the stated goals of the AACE algorithm is to focus primarily on the theoretical ability of the diabetic medications to control blood sugar while ignoring the cost of the medication. The rationale to this approach is that controlling blood sugar with more expensive drugs will cost less in the long run since patients will be healthier and have less complications due better control of the blood sugar. On the surface this philosophy seems sound but digging beneath the surface reveals dangerous flaws in this thinking.
1. The first assumption, that newer medications for diabetes are better than older drugs is unsubstantiated. In fact there is ample evidence that newer diabetic drugs are no better than the older drugs for controlling blood sugar. The latest study finding no benefit of the newer diabetes medications is the FIELD study conducted outside of the U.S. This study showed that 5 years of treatment with the older diabetic drugs (sulfonylureas, metformin and insulin) resulted in adequate and prolonged control of blood sugar. In 2007 researchers from Johns Hopkins Bloomberg School of Public Health summarized the results of major studies using older and newer anti-diabetic medications and found no significant benefit of the newer medications.
2. The next assumption, that cost is not a key factor in treatment success contradicts most clinicians’ experience in diabetes care. It is clear to me, that patients are far less likely to comply with using expensive drugs than medications they can more easily afford. Looking at the numbers reveals the vast cost differences between the older (generic) versus the newer (brand) medications. Using figures provided by a local pharmacy I found that the retail cost of a typical two drug therapy for diabetes using older drugs is $59 per month. The retail cost of using two of the new drugs for a month ranges from $481 to $570. In more severe diabetes three drugs per day may be needed. The low cost alternative amounts to $185 per month while the high end alternative with new drugs is $610 per month. Looking at the cost of using insulin shows a similar vast cost difference between the older and newer drugs. Older forms of insulin may cost $100 for a month’s supply while a similar course of therapy with the newer insulin preparations will cost almost $250 per month. How many people will be willing and able to afford the new versus the old drugs, particularly knowing that there may be no health benefit to the more expensive drug combination?
The end result of not being able to afford these prices is non-compliance with medications and the result of non-compliance is higher costs passed on to the medical system. The Medco study from 2005 showed that the least compliant patients were more than twice as likely to be hospitalized compared to the most compliant, and that the yearly cost of caring for non-compliant patients is double that of compliant patients.
3. My next point is possibly the most contentious. The AACE guidelines were produced by a committee of physicians chaired by two distinguished endocrinologists, Dr. Paul Jellinger and Dr. Helena Rodbard. Both doctors are highly respected and accomplished. They are also both highly compensated consultants to the pharmaceutical companies which market the newest generation of diabetes medications. In the disclaimer attached to the committee’s recommendations, both Dr. Jellinger and Dr. Rodbard admit to consulting arrangements with virtually every one of the pharmaceutical companies whose interests are effected by their committee’s findings. I too am a consultant to many of these same companies (at least, until now), but I am not responsible for developing national guidelines for diabetes care. In my opinion the close association of both committee chairmen to the pharmaceutical companies detracts heavily from the credibility of their recommendations. The need for credibility is even more important when the AACE committee advises physicians to avoid using sulfonylureas, the only class of drugs not marketed by any of the big pharma companies. and which also happens to be the cheapest drug class, the drugs with the longest history of use, and the class of drugs many regard as the most effective at lowering blood sugar levels. The sulfonylurea class of drugs is so effective at lowering blood sugar, in fact, they are used as the gold standard by which the effectiveness of all new diabetic medications are compared.
4. In contrast with the AACE, the American Diabetes Association (ADA) has issued more conservative guidelines for diabetic therapy, preserving the role of the older generic drugs. My recommendation is that AACE go back to their committee and reconsider the way they have produced their algorithm. Appointing new leadership whose credentials do not lend themselves so readily to skepticism, would be an important first step in that process.
Gary Pepper, M.D.
Editor-in-Chief, Metabolism.com
by Gary Pepper M.D. | Jun 7, 2007 | diabetes
Today’s NY Times carries a front page article about the dangers of Actos and Avandia, two popular diabetes medications. The reason behind the news story is that the FDA has finally required the two companies that make these diabetes drugs to carry a “black box” warning (the strongest labeling warning that can be applied) about the potential for congestive heart failure (overload of fluid in the heart and lungs) in diabetics using these drugs. Is this warning really news? Not to doctors.
I have been to numerous seminars on the use of these two diabetes drugs and have been paid by the companies that manufacture these drugs to educate other health care professionals about the use and hazards of these drugs. Both companies gave all representatives and speakers the strictest instructions regarding their obligation to carefully mention the potential for fluid overload and congestive heart failure associated with the use of these drugs. I know that my colleagues, particularly the cardiologists (heart doctors) and endocrinologists (diabetes doctors), have been acutely aware of this information for years.
Did you know that the type of drugs known as sulfonylureas that have been used to treat diabetes since the 1960’s and remain popular today carry a “black box” warning since the 1970’s about the potential for causing heart disease? This class of drug include Diabinese, Orinase, DiaBeta, Micronase, glyburide, and glipizide. Why are these drugs still in widespread use, and where are the stories notifying the public about this? What’s the big deal about the black box warning on Actos and Avandia?
I think I smell some politics going on. The Commissioner of the FDA, Dr. von Eschenback, was appointed by President Bush in 2005. The harshest critics of the FDA on this issue are the Democrats on the House Panel. Coming out of the woodwork are various “injured” parties who were criticised by company representatives for speaking out against these drugs in 1999. These stories warrant a separate column in The Times today.
Are there real risks to taking Actos and Avandia in the treatment of diabetes. Of course there are, just as there is a real risk of treating diabetes with just about any drug. It is up to the medical profession to remain vigilant and educated about these risks and to balance them with the benefits. Inflammatory front page news stories which create an atmosphere of mistrust and hysteria may serve only narrow political purposes.
This blogged comment at metabolism.com is not intended to convey medical advice. Diabetics are encouraged to contact their own healthcare professional about advice about what to do at this time. Most authorities encourage the public not to panic and to wait instructions from their physician before altering their medical treatment.
