A few months ago came some alarming health news. “Diabetes nation? Half of Americans have diabetes or pre-diabetes,” a Los Angeles Times headline said.
WebMD weighed in with “Diabetes a Concern for Half of Americans.” NBC News announced, “Half of Americans Have Diabetes or High Blood Sugar.”
What was missing from these stories was the fact that the definition of who has the disease has been expanding, and a new disease called pre-diabetes has arisen from the changing definitions. That means, of course, that more people will get costly drugs when they might not need them and put themselves at risk from complications arising from blood sugar that is controlled too tightly.
Evidence is coming in that shows blood sugar levels can become dangerously low especially for older people, according to a study reported in 2014 in JAMA Internal Medicine. That study noted other research that showed drugs that lower blood glucose have been implicated in 25 percent of emergency hospitalizations for older people.
The lowering of the threshold shows how politics and money influence guidelines for many conditions.
Although diabetes medicines are necessary for people who truly have the disease, “not everyone accepts the claim that half of all Americans have either diabetes or pre-diabetes, primarily because not everyone accepts the rigid boundaries and the lower boundaries that now start labeling you as pre-diabetic if your hemoglobin A1C test comes back at 5.7 percent or higher,” Gary Schwitzer wrote in Health News Review.
One of those who doesn’t is Nilay Shah, Ph.D, a researcher at the Knowledge and Evaluation Research Unit at the Mayo Clinic, who told me the focus has been to get blood sugar numbers lower, but “getting it too low may not have potential benefits for patients.”
The American Diabetes Association considers people with A1C levels of 6.5 percent and higher to be diabetic; those with levels lower than 5.7 percent are normal, and everyone else is pre-diabetic.
These definitions have shifted over the years to include more patients, and as doctors label them diabetic or pre-diabetic, sales of drugs to treat these conditions have risen. The Milwaukee Journal Sentinel pointed out that before 1997 when the American Diabetes Association lowered the threshold for who qualifies as diabetic, 9.7 percent of American adults were considered diabetic. By 2014, 11 percent of adults were now diabetic.
In 2003 the threshold was lowered again, and in 2008 professional organizations like the American Association of Clinical Endocrinologists said that drugs could be used to treat pre-diabetes “with careful judgment.” The next year the sales of diabetes drugs reached $15 billion.
In 2010 when the American Diabetes Association said the A1C test could be used to diagnose pre-diabetes, nearly 22 percent of the adult population was considered pre-diabetic. In 2013 the professional groups issued another statement saying that pre-diabetics can be treated with drugs if diet and exercise don’t work. That year sales of diabetes drugs hit $23 billion.
Setting guidelines is hardly straightforward. In fact, the process is fraught with politics, Shah said. “There are a lot of different incentives people have that make it tough to figure out what the right numbers are.” Many members of the guidelines committees have strong ties to the pharmaceutical industry. Most of the time, but not always, those ties are disclosed in reports and published papers, and a patient can see that a drug company may have funded a committee members’ research.
Do those connections make it more likely members will vote to expand the market for a company that’s been generous to them? Do they make it easier to overlook evidence of harm caused by a particular drug?
Those new definitions of who has diabetes raise questions for millions of Americans with A1C levels in the pre-diabetes range. Should they take these drugs, change their diet, or exercise more?
“It’s increasingly acknowledged that setting the targets for lowering blood sugar should be done with doctors and patients based on what they believe is important and the benefit they are likely to derive,” Shah says.
The Mayo Clinic offers decision tools for patients to help them weigh risks and benefits of particular drugs. The Shared Decision Making National Resource Center http://shareddecisions.mayoclinic.org/ offers guides and information that should be helpful as patients work their way through the confusing, often misleading, and sometimes-scary claims about diabetes medications.
What are your experiences with diabetes medicines? Write to Trudy at trudy.lieberman@gmail.com
