Drug Company Tries to Change Diabetes Testing Guidelines

Health Letter, September 2014

By Elizabeth Barbehenn, Ph.D.

If you have ever wondered how your doctor decides to test you for certain diseases, you might be interested in the recent activities of the pharmaceutical company Novo Nordisk, which markets numerous drugs for treating diabetes. The company is currently attempting to influence the rewriting of the guidelines for testing for Type 2 diabetes. Novo Nordisk is pushing for guidelines that would encourage more people to be screened for diabetes, which would lead, eventually, to more people taking the company’s diabetes medications, thus improving the company’s profits.

USPSTF recommendations for Type 2 diabetes screening

The body that sets guidelines for preventive health care services, the U.S. Preventive Services Task Force (USPSTF), is “an independent, volunteer panel of national experts in prevention and evidence-based medicine.”[1] The task force reviews the medical literature and publishes prevention-oriented guidelines on topics such as when to screen people for certain diseases, such as cancer and heart disease, and when to use medicines or other interventions to prevent disease, such as taking aspirin to prevent a heart attack. The aim of the USPSTF is to provide health care providers and patients with the best information available for making health care decisions.

The current USPSTF guidelines for screening adults for Type 2 diabetes were published in 2008 and are now being reviewed for possible updating. The USPSTF currently recommends screening adults who display symptoms of diabetes, such as excessive amounts of urine, excessive thirst and increased appetite.[2] In adults with no symptoms, it recommends screening only those with treated or untreated blood pressure greater than 135/80.[3],[4] For asymptomatic adults with blood pressures of 135/80 or lower, the USPSTF concluded that the current evidence is insufficient to recommend screening for Type 2 diabetes.

In recommending that diabetes screening be limited, the USPSTF felt it was important to avoid screening that could result in a large part of the U.S. population being labeled as “abnormal,” which could induce anxiety in those with prediabetes, a condition in which the blood sugar level is higher than normal but not high enough to be classified as diabetes. The panel made an exception to consider screening for those who have normal blood pressure but a high 10-year risk of developing coronary heart disease.[5]

With the USPSTF currently reviewing the screening guidelines for diabetes, Novo Nordisk (along with a number of other groups interested in diabetes) is attempting to influence the task force to broaden the population that would be screened. Like any for-profit company, Novo Nordisk is primarily interested in maximizing profits, and guidelines that recommend screening for a wider population would lead to more potential customers for its numerous diabetes products. The company has applied a number of tactics to publicly pressure the USPSTF.

Founding coalitions

Novo Nordisk has been involved in organizing coalitions such as the Diabetes Advocacy Alliance (DAA)[6] and the Medicare Diabetes Screening Project.[7] These groups bring the combined pressure of multiple like-minded organizations to bear in publicizing their positions and influencing the task force. For example, in January 2013, the DAA wrote a 13-page letter to the USPSTF emphasizing the large number of people estimated to have either diabetes or prediabetes: “We urge USPSTF … to expand its current screening recommendation, such that more people with undiagnosed diabetes can be identified.”[8] The letter was signed by Novo Nordisk and the American Diabetes Association (ADA), along with 12 other organizations.

Publishing articles

Novo Nordisk commissioned an article that supported its position in the public health journal Population Health Metrics.[9] The article stated that “millions more American adults with undiagnosed diabetes and prediabetes could be identified” using its preferred guidelines rather than the current USPSTF guidelines.

In addition to articles in journals, Novo Nordisk also has created its own online publication to advocate its position to increase screening: The Novo Nordisk Bluesheet is published online quarterly and discusses topics relating to diabetes and other chronic diseases. The summer 2013 issue quotes a director of the ADA saying that, in reference to revisions to the USPSTF screening guidelines, “The DAA [Diabetes Advocacy Alliance] plans to provide information and comments at every step of the way. We believe there is now evidence to support a broader screening guideline than the current USPSTF recommendation, which we believe is too restrictive to achieve public health goals in diabetes prevention and detection.”[10]

Sponsoring websites to influence the public

Novo Nordisk also tries to increase public pressure on the task force by creating websites designed to persuade people that they might be at risk for Type 2 diabetes. Ask.Screen.Know (askscreenknow.com)[11] purports to be “a national program dedicated to increasing awareness of the benefits of early diabetes screening and detection … to reach the estimated 79 million Americans who are living with prediabetes.” Sites like this claim to be focused on public health, but language on the sites makes it clear that they are sponsored by the drug industry and are geared toward promoting the interests of that industry. Screenfordiabetes.org, another website advocating wider screening, notes that it is “made possible by support from Novo Nordisk.”[12]

The story is still unfolding

Although it may seem like no harm can come from screening more people for diabetes, the USPSTF’s current guidelines make clear that widening screening could expose people to needless anxiety and that labeling a large proportion of the adult U.S. population as abnormal could have unknown long-term effects. Public Citizen’s Health Research Group recently opposed overly wide screening for cardiovascular diseases in our letters to hospitals that had partnered with HealthFair, a company that engages in direct-to-consumer, fearmongering promotion of such screening.[13] We have similar concerns regarding efforts to expand screening for Type 2 diabetes: Screening too wide a population for diabetes may end up doing more harm than good.

We will have to wait and see whether Novo Nordisk and its partners are successful in their efforts to influence the USPSTF to change the guidelines for diabetes screening in a way that benefits the company. In the past, the task force has resisted such industry influence and preserved the independence of its recommendations. Once the new guidelines are issued, we will be able to determine if the USPSTF has again succeeded in this regard.


References

[1] U.S. Preventive Services Task Force. http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/diabetes-mellitus-type-2-in-adults-screening Accessed August 19, 2014.

[2] U.S. Preventive Services Task Force. Screening for Type 2 Diabetes Mellitus in Adults. June 2008. http://www.uspreventiveservicestaskforce.org/uspstf08/type2/type2rs.htm. Accessed July 1, 2014.

[3] Ibid. Accessed July 14, 2014.

[4] U.S. Preventive Services Task Force. Grade Definitions After May 2007. http://www.uspreventiveservicestaskforce.org/uspstf/gradespost.htm#brec. Accessed July 14, 2014.

[5] Framingham Heart Study. Cardiovascular Disease (10-year risk). http://www.framinghamheartstudy.org/risk-functions/cardiovascular-disease/10-year-risk.php#. Accessed July 1, 2014.

[6] Novo Nordisk. The Diabetes Advocacy Alliance (DAA). http://www.novonordisk-us.com/documents/article_page/document/cd_daa.asp. Accessed July 24, 2014.

[7] Medicare Diabetes Screening Project. http://www.screenfordiabetes.org. Accessed July 24, 2014.

[8] American Diabetes Association, et al. Letter to Agency for Healthcare Research & Quality. Jan. 29, 2013. https://www.aace.com/files/views/ahrquspstf-screening.pdf. Accessed Aug. 7, 2014.

[9] Diabetes Advocacy Alliance. In the News. http://www.diabetesadvocacyalliance.org/html/media_latest_news.html. Accessed July 24, 2014.

[10] Novo Nordisk. Diabetes Advocacy Alliance works to improve the lives of people with diabetes and prediabetes. Novo Nordisk Bluesheet. July 2013. http://press.novonordisk-us.com/bluesheet-issue14/. Accessed July 24, 2014.

[11] Novo Nordisk. About A.S.K. http://www.novonordisk-us.com/documents/article_page/document/cd_askscreenknow.asp. Accessed July 24, 2014.

[12] Screen for Diabetes. High Blood Pressure & Diabetes: What You Need to Know. http://www.screenfordiabetes.org/wp-content/uploads/2010/10/NCOA_MSDP_Hypertension.pdf. Accessed July 24, 2014.

[13] Public Citizen Press Release. https://www.citizen.org/pressroom/pressroomredirect.cfm?ID=4220. Accessed August 19, 2014.