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From our perspective in 2005, we have much to be proud of in the world of diabetes, obesity, and cardiovascular treatment. Yet despite our considerable progress in developing new therapies, we are not doing enough to make sure all patients benefit.
Let's first look at our achievements. Numerous tools to effectively treat diabetes are widely available, including various insulins and their analogs, insulin secretagogues, and insulin sensitizers. For more than 2 decades, home blood glucose monitoring and glycated hemoglobin (A1C) tests have been used to help monitor glycemia. One of the most significant contributions has come from the greater use of certified diabetes educators.
It has been 23 years since the Multiple Risk Factor Intervention Trial (MRFIT) showed that reducing cholesterol with dietary intervention, improving blood pressure, and stopping cigarette smoking could reduce cardiovascular mortality. It's been 18 years since the introduction of the first statin, which subsequently has been shown to be one of the most powerful agents to treat and prevent coronary artery disease (CAD). Numerous other agents, such as aspirin, beta-blockers, and ACE inhibitors also have been shown to have important beneficial effects on CAD.
The explosion of obesity and the appearance of metabolic syndrome have led to the development of bariatric surgery, evidence-based nutritional therapy, and physical-activity and lifestyle-change programs. Sibutramine (Meridia, Abbott), orlistat (Xenical, Roche), and other drugs offer still more weight-loss therapy options.
The future looks even brighter, as demonstrated in reports from the 65th Scientific Sessions of the American Diabetes Association. Rimonabant (Acomplia, Sanofi Aventis), the first cannibinoid receptor antagonist, awaits approval from the Food and Drug Administration (FDA) for treating obesity ("Rimonabant a Triple Threat to Diabetes," see page 6). Dual (alpha and gamma) peroxisome proliferator-activated receptor (PPAR) agonists are in development to treat diabetes ("PPAR Benefits Beyond Glucose Control," see page 14), and several companies hope to introduce continuous blood glucose testing next year. Interestingly, this is a very incomplete list!
COST CONCERNS
But I am skeptical that even all of these remarkable advances will improve the health of the 18 million-plus Americans with diagnosed or undiagnosed diabetes and the millions more who are overweight and facing heart problems.
Chief among my concerns is the high cost of these new drugs, devices, and services. A recent study in Health Affairs concludes that the high costs of health care in the U.S. are a result of the high costs of prescription drugs, hospital stays, doctors' visits, and diagnostic tests.1 Per capita spending in the U.S. in 2002 was 140% higher than the median for 29 other countries surveyed, the report concludes, but investigators found no evidence that the U.S. spends more because its residents have access to more services.
As an example, let's look at the recently approved diabetes drug exenatide (Byetta, Amylin/Lilly) (DOC News, July 2005). Exenatide costs about $8 per day if purchased at a local pharmacy. That adds up to $240 per month, or $2,880 per year. Compare that with generic met-formin or generic glyburide: 1 g of metformin taken twice daily costs $1.87 per day, and 5 mg glyburide taken twice daily costs $0.80 per day.2
If I am a managed-care director concerned about cutting drug costs, which one of these three drugs would I not include in my formulary, based on A1C as the main outcome? Apart from drugs routinely used outside of primary care, exenatide will break our current standards for moderate diabetes drug costs. Indeed, it will cost approximately $100 more per month than a high-dose thiazolidinedione.
This "concierge agent" appears to have been developed for people with good insurance, not those from the typical lower socioeconomic population with type 2 diabetes, such as Medicare or Medicaid patients, those who obtain their drugs at Veterans Affairs hospitals, the uninsured, the underinsured, or those with restrictive formulary status.
There is another downstream effect from these costly drugs: Residents and fellows are not always able to use these agents in their training. At a recent Endocrine Fellows Foundation meeting, I was surprised to see that 20–25% of endocrinology fellows have no patient experience with insulin analogs because these drugs are restricted from the formularies of the hospitals where they train.
ACCESS AND SYSTEM FACTORS
Until our systems for using new therapies improve, simply adding a pill or shot will have little effect. None of the new technology accounts for the time required to educate patients about how to use these medications and devices—time most of us don't have. Indeed, a recent study found the average family practice physician will spend only 20 minutes with each patient each year.3 As is often the case in medicine, these realities contribute to the poignant separation of the "haves" and "have-nots."
There always will be a small minority of patients who receive their care in multidisciplinary diabetes clinics. I am not aware of any well-known clinics that are profitable from patient care. Yet these are the venues where many of the new tools will be used, perhaps very successfully.
Similarly, though it can be argued our treatments of obesity are primitive considering our understanding of the regulation of appetite, only a few people can afford bariatric surgery when insurance doesn't pay for it. Statins may have revolutionized treatment for elevated LDL cholesterol in the past decade, but a recent study concludes that recommended statin therapy is not prescribed during many ambulatory visits of moderate- to high-risk patients.4
Meanwhile, according to the American Heart Association, hypertension strikes twice as many blacks as whites. Searching for causes, medical researchers look at environmental factors like racism, stress, and diet, but more systematic factors could be at play.
Unfortunately, we've witnessed this severance of time, economics, education, and utilization over and over again. While the new studies are exciting, economic realities and the quest for profits continue to rule. The cost of new tools will further divide our patients into those who can afford to take advantage of these medical advances and those who cannot.
I am not advocating that each new tool be used indiscriminately, but I do
hope more people coping with diabetes, obesity, and cardiovascular disease
will have better access to all of the treatments that may help them live
better, healthier lives. High costs, system failures, lack of time— all
add up to a much bigger problem than can be solved if all we do is make
individual decisions about which drugs or devices to prescribe for each
patient. It is up to us to also address the more global issues and to assure
equitable medical care is provided to all of our patients. 
Footnotes
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References
2. www.drugstore.com, accessed July 11, 2005.
3. Ostbye T, Yarnail KSH, Krause KM, et al.: Is there time for
management of patients with chronic diseases in primary care? Ann
Fam Med 3:209–214, 2005.
4. Ma J, Sehgal NL, Ayanian JZ, et al.: National trends in statin use by coronary heart disease risk category. PLoS Med 2: e123. Epub 2005. May 31, 2005.[Medline]
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