Report Follows Shady Arc of Diabetes Diagnostic Criteria and Drug Approval

If you were told that the American Diabetes Association (ADA) or the American Association of Clinical Endocrinologists (AACE) convened a panel of expert diabetes doctors in order to establish new definitions for things like pre-diabetes, or in order to update standard treatment guidelines for people with diabetes to reflect the very latest in advances, you would probably be encouraged.

Don't be.

A joint investigation by MedPage Today and the Milwaukee Journal Sentinel found that drug companies have been paying members of panels like these millions of dollars in speaking and consulting fees. These same companies have been frantically mixing up new concoctions to bring to market for the treatment of people with type 2 diabetes, and by lowering the threshold for what qualifies as diabetic or pre-diabetic these experts have been systematically creating a massive patient population to become consumers of these new and expensive drugs.

The result has been a massive $23 billion diabetes economy, and a betrayal of the trust patients put into physicians every day, in clinical settings all over the world.

The Payments

In order to determine which of these influential physicians were receiving payments by drug companies, MedPage Today and the Milwaukee Journal Sentinel used data provided by disclosures published by Eli Lilly, GlaxoSmithKlein and Merck, which only go as far back as 2009. The also used data provided by Medicare's Open Payments program, which only provides data covering the last five months of 2003.

Despite having a very narrow window to work from, investigators found that AACE panel members received $2.208 million in payments from drug companies, with the most coming from Merck—$735,367. Meanwhile, ADA panel members were paid $636,000 in the same time frame, with the most coming from Eli Lilly and Co—$312,754.

The Influential Panel Recommendations

When ADA or AACE panels like these meet, they discuss things like, should we re-evaluate the criteria used in order to determine whether a person can be diagnosed as having diabetes? You might think that such criteria would be set in stone, but in fact unlike diagnosing a broken bone, diagnosing diabetes presents a moving target—one that has been growing larger and easier to hit for many years.

The American Diabetes Association met in 1997 to discuss these criteria. Before the meeting, 21.6 million Americans had diabetes.

After the meeting, 25.5 million did.

All that was done was to lower the threshold that defined diabetes from a fasting blood glucose level of 140 mg/dl down to 125 mg/dl. That's an amazingly simple way to drum up business—create more sick people, not by making them sick but by redefining what it means to be healthy. When the meeting adjourned, 3.9 million unsuspecting Americans didn't suddenly go into diabetic shock; but perhaps some or many of them went to the doctor for a check-up and were shocked to learn that while last week they were OK, this week they have a chronic disease.

Six years later they did it again, only this time they lowered the threshold for diagnosing pre-diabetes, moving it from 110-125 mg/dl to 100-125 mg/dl. In 1997 they created almost four million new diabetics, but in 2003 they outdid themselves, creating 46.1 million new pre-diabetics who would be told that they are at high risk of developing type-2 diabetes. Remember this.

The New Drugs

Since 2004, the US FDA has approved 30 drugs for the treatment of people with type 2 diabetes. Most drugs take anywhere from 12-15 years to go from 'the bench to the bedside', so it's fair to assume that all of these drugs began their development somewhere around 1990 or after.

Of those 30 new drugs, how many of them are approved for pre-diabetes?

None. In fact there are no drugs approved to treat pre-diabetes. The reason for this is simple: Because there is not a shred of data supporting the use of these drugs in these patients. There is no proof that people with pre-diabetes who use these drugs will live longer or experience improved health outcomes. Patients who have taken the drugs do not demonstrate a reduced risk of developing the kinds of problems seen in people with diabetes, such as heart attacks, blindness, or amputations.

Despite the dearth of any evidence whatsoever, both the ADA and the AACE made recommendations in recent years saying that people with pre-diabetes could successfully be treated with drugs designed for people with diabetes.

Remember those 46.1 million Americans who, overnight, could be diagnosed with pre-diabetes? These experts were now telling Americans that they shouldn't let the fact that they do not have type 2 diabetes prevent them from taking drugs designed and approved for people with type 2 diabetes.

To make matters worse, the investigation uncovered the fact that since 2004, the newly approved FDA drugs for diabetes are considered the primary suspects in the deaths of 3,300 patients, and have sent another 20,000 to the hospital.*

The most egregious among these drugs are:

• Byetta (exenatide)
• Januvia (sitagliptin phosphate)
• Victoza (liraglutide)
• Janumet (sitagliptin + metformin)
• Levemir (insulin detemir)
• Onglyza (saxagliptin)

Read the full special report published by MedPage Today and the Milwaukee Journal Sentinel here: The Slippery Slope: A Bittersweet Diabetes Economy by John Fauber, Elbert Chu and Coulter Jones.

*You can find a full listing of adverse events from these drugs at MedPage Today's 5 Takeaways from the Diabetes Drugs Investigation.