New Diabetes Treatment Guidelines Flawed


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

Share this post

  • Flo

    Deja Vu. It appears as though the AACE had such sucess taking money from the makers of Synthroid and then making that class of drug (synthetic T4) the only acceptable therapy for hypothyroidism, the AACE will do the same for diabetes patients. Soon the drug manufacturer that pays the AACE the most will become the standard treatment for diabetes and later they will refuse to prescribe the older, cheaper sulfonylurea class of drugs. If a patient responds to the sulfonylurea best, to bad for the patient. The patient will be told that can’t happen and offered prozac instead further increasing the profit of drug companies. I can’t feel bad there is a shortage of endocrinologists. In general, they are one so called specialty that should go away due to the contempt they have for the patients they are supposed to help,

  • Pingback: Tweets that mention New Diabetes Treatment Guidelines Flawed -- Topsy.com()

  • Pingback: New Diabetes Treatment Guidelines Flawed | Health News()

  • Tony Kingkade

    This is from my real-world, day to day practice in retail pharmacy where I interact with literally thousands of diabetics a year and my experience in helping manage their drug therapies, drug costs and therapy compliance:

    Dr. Pepper, first, let me address cost. You fail to mention that almost no diabetics pay full price for any of their prescription drugs, insulin and blood glucose test strips. They pay a co-pay as essentially all patients are on insurance of some sort that covers the vast majority of their drug and blood glucose testing costs. Due to the wide breadth of coverage of these products in these patients, the cost/compliance argument is not valid on an individual basis anymore. Cost is simply not a factor in compliance. That is not to diminish the impact on total health care spending, but as far as the patient is concerned a sulfonylurea may cost $5/month where a DPP-4 inihibitor may cost $10/month – not a big enough concern for the patient. And those that are so poor that it would be a factor are getting their meds for free on welfare.

    What is important from the patient’s perspective is freedom from side effects and convenience in dosing. So even though a sulfonylurea is cheaper, it may require multiple doses during the day making compliance a problem. Couple that with periodic low blood sugar excursions causing shakiness, hunger, lightheadedness and possible pelvic fractures from falling and you have just wiped out all cost benefits while inflicting great suffering on the patient. If you can achieve the same therapeutic result with a once a day dosed drug with no low blood glucose side effects, then patient compliance will be improved.

    For those that are interested, sulfonylureas where given less priority in the AACE/ACE treatment algorithm because use of these agents is associated with hypoglycemia, weight gain and limited duration of effectiveness after initiation of therapy and more drug-drug interactions than newer agents. They put them 3rd on the list of agents to be used (instead of 2nd) due to this.

    As for insulin, a once a day injection of a long acting basal insulin is much more convenient than multiple dosings of a cheaper, shorter acting insulin and improves patient compliance and lessens the incidence of hypoglycemic excursions.

    So if you want to improve compliance, use the products that result in the highest levels of compliance. Yes, they cost more – but not to the individual patient in the long run. They also carry lower incidences of side effects. Ever hear the phrase “First do no harm”?

    Before jumping to the conclusion that all enocrinologists who speak or consult with pharmaceutical companies automatically lose their credibility, be mindful that pharmaceutical companies want only the most highly regarded specialists as speakers and advisors because they are so renowned and credible. That’s why you see only the best and most credible physicians on their speaker lists. That’s who I would want to develop treatment guidelines, the best practicing speicialists, not the worst ones.

    These same “industry paid” endricrinologists also put metformin, a GENERIC drug, at the top of the list as the first drug of choice in their treatment concensus. Did you forget to mention that?

    And before all of you start screaming about total health care costs and big pharmaceutical company profits, let me just say that it’s the individuals who overate, got fat and obese, never exercised and now want all of us to take care of their health problems who are to blame for these costs. Type 2 diabetes can be largely avoided and even reversed with sound nutrition and exercise, but that’s just a little too politically incorrect to mention anymore in this land of “do anything you want and we’ll just take care of you”.

    At the very top of the AACE/ACE diabetes algorithm, before any drugs are listed, there are two words: LIFESTYLE MODIFICATION. Dr. Pepper, I’ll bet that virtually none of your diabetic patients have taken the proper steps to significantly change their lifestyles to improve their disease and reduce their need for drug therapy. I have rarely seen one that has done so. That’s why you and I continue to see an increasing number of new type 2 diabetic patients every year. So, just like the pharmaceutical companies, you and I also benefit financially from their poor lifestyle choices by providing us a constant stream of paying patients. Sad, but true.

  • Dr. G. Pepper

    Tony

    Thanks for your thoughtful reply. You have raised some important issues that I would like to address:

    1. Cost. You say that most diabetics have insurance that pays for the new drugs. I disagree. I’m sure you have heard about the enormous numbers of people in the U.S. who are uninsured or under insured. A study by U.S. Families in 2009 estimated that approximately 86.7 million people were uninsured at some point during the two-year period 2007-2008. This represented about 29% of the total US population or about one-in-three under 65 years of age. Every day in my practice I have to supply free medication (samples left by my kind pharma representatives) to patients who have lost their insurance or who never had it. In the Medicare population the higher cost of the new drugs depletes their meager drug allowances so that 2/3 through the year they are in the “donut hole” and are paying full price for their diabetes drugs. Consider that many diabetics are on 2 or 3 medications daily and these costs mount up to a staggering amount. Some people simply run out of medication resulting in great health risks. Higher cost of the new drugs cannot be discounted in the health care equation for these individuals.

    2. You mention that sulfonylureas are dangerous and lose their effectiveness sooner than newer drugs. I disagree. Any drug that has a potent effect can be considered “dangerous” if used improperly. Aspirin has been a main stay of medical care for decades but too much aspirin use can cause life threatening intestinal bleeding. Should we abandon aspirin for newer agents like Plavix which can costs $4 per pill? You say the generic sulfonylureas must be taken several times daily? What about glimiperide or glipizide xl? I use these tried and true medications for years once daily with great success. Remember also that by using a little common sense a physician can use tiny doses of generic sulfonylureas and still get great reduction in blood sugar levels while minimizing risks of hypoglycemia. By starting with tiny doses the physician can also extend the useful life of the sulfonylurea class by slowly increasing the dose over years as needed.

    3. I believe that physician leaders who are paid consultants to pharmaceutical companies are influenced by these relationships when producing treatment guidelines. Unfortunately, many of the best and brightest of the physician community have to rely on drug company funding to continue their careers in medical research/education. 30 years ago the government supported clinical medical research and education throughout the country but this support has all but disappeared except for a tiny fraction of the medical community. Only money from big pharma channeled into clinical research keeps many of our present medical leaders in their jobs. Do not minimize the impact this has had on medical education in this country. As a former researcher and teacher I can tell you that there are not many “upper eschalon” physicians who can bite the hand that feeds them.

    4. I definately agree that the epidemic of diabetes is a life style crisis. I also agree that I haven’t found the solution to this but I am still fighting the good fight, as I’m sure you are as well

    I could go on with this response but for now I think I have made my rebuttal.

    Regards,

    Gary Pepper, M.D.

  • Tony Kingkade

    I never used the word “dangerous” with respect to sulfonylureas. For those patients who can’t afford the brand name medications, please know that most pharmaceutical companies have patient assistant programs that will pay for most or all of the brand name medication (Merck, Lilly, Amylin, Sanofi Aventis etc). The donut hole thing is a great example of why we don’t want Congress to design our health care – and it will probably be eliminated in the future. The panel designed the algorithm by giving safety and efficacy a higher priority than cost as cost of medications is only a small part of the cost of care of diabetes (and its co-morbidities). I wonder if your opinion on the use of sulfonylureas would be different if they were still brand name drugs and cost the same as the newer classes of diabetes drugs (or if cost was not a factor for any of your patients).

  • Dr. G. Pepper

    Tony

    Thanks again for your comments.

    Although the pharma companies offer assistance programs you must be destitute to qualify for them. Many of the uninsured or under-insured people in my practice are the working poor,…people who are making a living but can’t or won’t spend a thousand dollars a month on health insurance that won’t pay for anything until you spend another 3 to 5 thousand dollars to meet the deductible.

    Sulfonylureas are more than just cheap diabetic drugs. They are the most effective oral agents for lowering blood sugar in type 2 diabetics aside from insulin. I agree that metformin is probably the first choice drug for type 2 since it is weight neutral but the intolerance rate in real life practice is very high. Also, metformin is contraindicated in renal insufficiency (even if only a very mild degree), congestive heart failure and liver disease. Any one of these can be found in a great percentage of diabetics limiting metformin use.

    As a pharmacist you know that the donut hole in Medicare coverage is a big problem for the elderly. The more expensive the drug the faster the Medicare drug allowance is used up. Each year by August my office is over-run with elderly people looking for samples of the expensive drugs or requesting I change them to cheaper generics. I, like you, hope that this problem is eliminated but for now the donut hole must be factored into any diabetic treatment algorithm in the U.S.

  • Janey

    As a diabetic, I happen to know, just by Personal Experience, that the lower one’s (mine) weight gets, the infininentially higher my sugar is getting. Also, I am a proponent of the Old protocol where insulin was made for Just a diabetic, not one for someone as a weightloss tool, and I am concerned, because anyone on insulin needs to have no natural insulin of their own because the shots take away the natural demad insulin( making it a designer nicotine type thing ) Also, why do I have permanent acid indigestion after NPH? A headache of an 8, and horrible pounding heart? I’ve totally completely cut out carbs and sugars, anything that says enriched or partially.

    Love,
    Janey

  • hi Dr. G. Pepper. I am Liza, a medical student from Indonesia. doctor, do you have AACE guidelines for treating Type 2 Diabetes in PDF format? would u like to send it to my email? I really need it for my study. this my email adress : rumput_liar008@yahoo.com

    thanks for your attention

    Regard
    Liza