Blog says pre-diabetes emphasis is “manufacturing diabetes”

The PharmaWatch Canada blog published an article, “Manufacturing Diabetes,” about the increasing focus on 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.

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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.”

Other concerns about the commercial interests behind diabetes treatment appeared in a series of articles published in the BMJ recently.

• Post-marketing studies of new insulins: sales or science?

• Post-marketing observational trials and catastrophic health expenditure

• Post-marketing observational studies: my experience in the drug industry.  Excerpt:

“…some of the studies I worked on were not designed to determine the overall risk:benefit balance of the drug in the general population. They were designed to support and disseminate a marketing message.

Whether it was to highlight a questionable advantage over a “me-too” competitor drug or to increase disease awareness among the medical community (particularly in so called invented diseases) and in turn increase product penetration in the market, the truth is that these studies had more marketing than science behind them.

Since marketing claims needed to be backed-up scientifically, we occasionally resorted to “playing” with the data that had originally failed to show the expected result. This was done by altering the statistical method until any statistical significance was found. Such a result might not have supported the marketing claim, but it was always worth giving it a go to see what results you could produce. And it was possible because the protocols of post-marketing studies were lax, and it was not a requirement to specify any statistical methodology in detail. On the other hand, the studies were hypothesis testing (such as cohort studies, case-control studies) rather than hypothesis generating (such as case reports or adverse events reports), so playing with the data felt uncomfortable.

Other practices to ensure the marketing message was clear in the final publication included omission of negative results, usually in secondary outcome measures that had not been specified in the protocol, or inflating the importance of secondary outcome measures if they were positive when the primary measure was not.”

(Photo credit:  AlishaV on Flickr)