With a few keystrokes, national diabetes organizations declared millions of individuals in the United States as prediabetic by changing the criteria for the disease risk. At the same time, FDA approved 30 new diabetes drugs, allowing their introduction into the market with no rigorous proof that treatment with any of the new agents improved lives.
With a few keystrokes, national diabetes organizations declared millions of individuals in the United States as prediabetic by changing the criteria for the disease risk. At the same time, FDA approved 30 new diabetes drugs, allowing their introduction into the market with no rigorous proof that treatment with any of the new agents improved peoples’ lives.
These are but 2 of the key findings of a joint investigation undertaken by a team of journalists.1 The findings were published as part of a series developed to target FDA approvals as well as guideline initiatives and treatment decisions in cases in which the evidence is weak or completely lacking.
The joint reporting team from the Milwaukee Journal Sentinel and MedPage Today reviewed the 30 FDA-approved diabetes drugs in their investigation.2 All of the drugs were approved based on surrogate markers, in this case, the ability to lower blood sugar. For none of the drugs, however, approved from 2004 through 2013, is there rigorous proof that their use results in the reduction of clinical outcomes such as myocardial infarction, stroke, blindness, or amputations.
The US diabetes drug market is huge. In 2013, sales of diabetes drugs reached $23 billion according to data provided by IMS Health, a drug market research firm.
That sales volume is due in part to the increased number of US citizens who are diagnosed with the disease.
An aging population, more sedentary lifestyles, and increased rates of obesity all contribute to more diagnoses of type 2 diabetes. The condition can lead to cardiovascular disease, kidney failure, amputations, and other health problems.
Another factor also increased the diabetes population: lowering the bar for diagnosis.
In 1997, the American Diabetes Association (ADA) changed the definition of diabetes and consequently as many as 1.9 million more individuals were diagnosed with the disease. In 2003, an additional 25 million became “treatment eligible” when the association changed the standards for a condition known as prediabetes.
Physicians in the ADA and the American Association of Clinical Endocrinologists (AACE) panels that saw to the definition changes in diabetes and prediabetes had financial ties to drug companies, the investigation also found.1 Thirteen of 19 members of the AACE committee had received more than $2 million in speaking and consulting fees since 2009 from companies that make diabetes drugs. ADA panel members had received more than $600,000.
Today, persons with prediabetes are often treated with these new drugs despite the fact that the absolute lifetime risk for adverse clinical outcomes such as kidney failure and blindness in people with prediabetes remains very low, in the single-digit percentiles.
Importantly, many of the new drugs approved by FDA are associated with serious adverse events. For example, use of new, potent diabetes drugs has been linked to an estimated 100,000 emergency room visits each year by people with dangerously low blood sugar.1
Additionally, approximately 3,300 deaths and more than 20,000 hospitalizations have been linked to the new diabetes drugs since 2004, according to an analysis of FDA Adverse Events Reporting System (FAERS) data.3
It is interesting that these investigators are not the lone voices in raising questions about the way in which diabetes is diagnosed and treated. On January 12, 2015, a major medical journal published a review of more than 1200 diabetes patients aged 65 years or older.4 The lead author of that article raised concerns about safety in aggressively treating elderly diabetics, commenting that “The risks appear to outweigh the benefits.”
Using surrogate measures for approval is not exclusive to these diabetes drugs, nor are the potential issues. In October 2014, another investigation by the same team of journalists found that of 54 cancer drugs approved over the past decade, 40 (74%) were FDA approved based on surrogate measures, such as the shrinking of tumors, but not on proof that these drugs extended life.5 Further, seldom was there proof of improved quality of life.
Peggy Peck is vice president/editor-in-chief at MedPage Today.
1. Fauber J, Chu E, Jones C. The slippery slope: a bittersweet diabetes economy. MedPage Today. December 21, 2014. http://www.medpagetoday.com/Cardiology/Diabetes/49227. Accessed January 14, 2015.
2. Chu E, Jones C, Fauber J. 5 takeaways from the diabetes drug investigation. MedPage Today. December 22, 2014. http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/49196. Accessed January 14, 2015.
3. Chu E, Jones C, Fauber J. The slippery slope: adverse events and runaway diabetes train. MedPage Today. December 22, 2014. http://www.medpagetoday.com/Endocrinology/Diabetes/49221. Accessed January 14, 2015.
4. Lipska KJ, Ross JS, Miao Y, et al. Potential overtreatment of diabetes mellitus in older adults with tight glycemic control. JAMA Intern Med. Published online January 12, 2015. http://archinte.jamanetwork.com/article.aspx?articleid=2089233. Accessed January 14, 2015.
5. Fauber J, Chu E. The slippery slope: is a surrogate endpoint evidence of efficacy? MedPage Today. October 26, 2014.