One of the things that drives me crazy is how the drug industry, instead of manufacturing useful medicines for existing diseases, manufactures diseases or epidemics and then the drugs to treat them. This is exactly backwards, but it is something that is happening more and more frequently.
One example is "pre-diabetes." Canadians are being bombarded with dire warnings about the skyrocketing number of people with diabetes – an "economic tsunami" according to the pharma-friendly Canadian Diabetes Association. The term pre-diabetes is not new — in the early postwar years many thought that women who gave birth to "large babies" were likely to develop Type 2 diabetes later in life, and they were described as being pre-diabetic (and, in line with sexist medical thinking, irresponsible as well). By the mid-1960s the association between pregnancy and pre-diabetes seems to have morphed into a diagnosis of gestational diabetes among pregnant women. But today, we're being told that pre-diabetes is an epidemic among people on the verge of developing the real thing and the main reason, according to the popular narrative, is obesity and, well, irresponsible sloth.
So let's parse out this picture. In Canada, the CDA says there are 2.7 million people with diabetes, including Type 1 (about 10% of the total), Type 2 or gestational diabetes. The numbers of people with diabetes is increasing in each category. But there are six million who are diagnosed as being "pre-diabetic" — a term that refers to those who are assumed to be at risk for Type 2. So the number of people who may get diabetes is actually higher than those who actually have it. Unfortunately, all of these different types, including the haves and the may-gets, are conflated into a single figure of nine million people.
How do they arrive at these scary numbers? One way is with a test that measures blood glucose levels. In 1997, the American Diabetes Association lowered the threshold that was used to arrive at a diagnosis of Type 2 diabetes from a fasting blood sugar level of 7.8 mmol/L to one of 7.0 mmol/L, a change that added another 1.9 million Americans to the list of people with this condition. Despite doubts about the evidence to support this move — not to mention warnings about the high cost as well as psychological and emotional impact of such an approach — the new standard was soon applied in Canada as well.
That same year the ADA introduced a new test to determine whether people had what was described as Impaired Fasting Glucose (IFG), a tool it said would help clinicians predict who would progress to Type 2 diabetes. In other words, to help doctors diagnose people with "pre-diabetes". The threshold was initially established at between 6.1 and 6.9 mmol/L, but by 2003, that level had dropped to 5.6 mmol/L. The change in the threshold increased the number of Americans diagnosed with IFG/pre-diabetes from 3.2% of the population to 9.7%.
Again voices of doubt were heard around the world. While the European Diabetes Epidemiology Group saw value in determining IFG levels, it looked at the evidence and rejected the higher threshold. Equally important, the Europeans preferred the more descriptive term "non-diabetic hyperglycaemia", and urged the diabetes community to avoid the use of the term "pre-diabetes" when describing those with an impaired fasting glucose. The EDEG pointed out that many people who meet the threshold for non-diabetic hyperglycaemia revert to normal glucose levels in subsequent testing. In addition, they said, "there is no fixed state of pre-diabetes" and warned of the emergence of a "pandemic" if the lower thresholds were used.
The controversy over the ADA thresholds went viral, leading to heightened scrutiny of the evidence used to support not only the glucose cut-offs, but of all the various tests used to diagnose Type 2 and "pre-" diabetes. By the end of the last decade, studies were pushing the use of a test called Hemoglobin A1c (HbA1c) to diagnose Type 2 diabetes and today, for better or worse, this is the standard used internationally, along with the "diagnostic cut-point" of 6.5%. In 2010, the ADA recommended that the HbA1c be applied to diagnose "pre-diabetes" as well, at a threshold of 5.7%.
As a diagnostic tool, the A1c test has its champions and its critics, including those who argue that the much higher costs associated with it increases the burden on the health care system. In addition, usefulness in certain populations is limited. The CDA's new pharma-sponsored guidelines will be published in March 2013, and it's likely that they, too, will embrace the HbA1c to diagnose pre-diabetes regardless of the fact that this is not a medical condition. So not only is this controversial diagnostic tool being used in spite of its limited utility, it is being used to diagnose a disease that, according to the EGED, doesn't exist. We are, after all, in epidemic mode!
The diagnosis of pre-diabetes is bad news for patients and their families, most of whom have no idea about all the drama in the background. But it's also bad news for society as a whole because of the enormous costs associated with treating millions of people who do not have a medical condition. But for the pharmaceutical and diagnostic industries, it's a great turn of events — and there's little doubt that Big Pharma has influenced the lower thresholds that have been put in place.
One of the companies that is hoping to benefit from a diagnosis of "pre-diabetes" is Sanofi, one of the largest pharmaceutical companies in the world. It has just unveiled a study that says insulin glargine (brand name Lantus) can delay full-blown Type 2 diabetes in those diagnosed with being on the verge of having the real thing. It's no coincidence, of course, that glargine is a Sanofi product and one of the most expensive insulins on the market.
The emergence of "pre-diabetes", according to one marketing firm, "should be viewed as an opportunity for pharmaceutical companies and manufacturers of blood glucose meters and nutriceutical products" who can educate physicians about new treatments for the pre-disease. And it's a big market — a much bigger market than the one made up of people who already have diabetes.
One of the most aggravating myths is that Type 2 is a "lifestyle" disease, brought on by sloth, laziness and poor eating habits. But the truth is that being poor is more likely to lead to diabetes than lifestyle choices — the poorest people are 4.14 times more likely to have Type 2 diabetes than those in the highest income category. And poverty isn't something that can be treated with a drug or a medical device.
Canada needs a strategy to reduce the chances that people will develop Type 2 diabetes. Key elements of such a strategy would be poverty reduction, including among the elderly, single women, Aboriginal people and people of colour; increased public funding for education; job security; and a more equitable distribution of wealth across the population.
* This article was originally posted June 27, 2012 on PharmaWatch Canada. Thanks to guest blogger Colleen Fuller for permission to repost here.