Psyllium husk intake and risk of type 2 diabetes: an evidence-based scientific and regulatory review of a qualified health claim conducted by the US Food and Drug Administration

2020 ◽  
Vol 78 (10) ◽  
pp. 787-797
Author(s):  
Crystal R Rivers ◽  
Mark A Kantor
Keyword(s):  
Type 2 Diabetes ◽  
Drug Administration ◽  
Scientific Evidence ◽  
Food And Drug Administration ◽  
Evidence Based ◽  
Health Claim ◽  
Regulatory Review ◽  
Psyllium Husk ◽  
The Us

Abstract The US Food and Drug Administration (FDA) received a petition from a company requesting that FDA issue an authorized health claim for the relationship between psyllium husk and a reduced risk of type 2 diabetes. After an initial assessment of the available scientific evidence, FDA determined that significant scientific agreement was lacking for this substance-disease relationship, whereupon the company agreed to have its petition reviewed as a qualified health claim. This article describes the process FDA used in conducting an evidence-based review of the science underpinning the proposed claim and addresses certain safety issues associated with psyllium husk that FDA considered in its review of the petition. Of the 6 studies from which scientific conclusions could be drawn, as identified through FDA’s review, psyllium husk significantly improved plasma glucose levels and insulin sensitivity in only 1 study. Therefore, FDA’s enforcement discretion letter for this qualified health claim stated: “Psyllium husk may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very little scientific evidence for this claim.”

scholarly journals Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus

Circulation ◽  
2019 ◽  
Vol 140 (25) ◽  
pp. 2108-2118 ◽  
Author(s):  
Javed Butler ◽  
Milton Packer ◽  
Stephen J. Greene ◽  
Mona Fiuzat ◽  
Stefan D. Anker ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Heart Failure ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
End Points ◽  
Sodium Glucose Cotransporter ◽  
The Us

Following regulatory guidance set forth in 2008 by the US Food and Drug Administration for new drugs for type 2 diabetes mellitus, many large randomized, controlled trials have been conducted with the primary goal of assessing the safety of antihyperglycemic medications on the primary end point of major adverse cardiovascular events, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Heart failure (HF) was not specifically mentioned in the US Food and Drug Administration guidance and therefore it was not a focus of these studies when planned. Several trials subsequently showed the impact of antihyperglycemic drugs on HF outcomes, which were not originally specified as the primary end point of the trials. The most impressive finding has been the substantial and consistent risk reduction in HF hospitalization seen across 4 trials of sodium glucose cotransporter 2 inhibitors. However, to date, these results have not led to regulatory approval of any of these drugs for a HF indication or a recommendation for use by US HF guidelines. It is therefore important to explore to what extent persuasive treatment effects on nonprimary end points can be used to support regulatory claims and guideline recommendations. This topic was discussed by researchers, clinicians, industry sponsors, regulators, and representatives from professional societies, who convened on the US Food and Drug Administration campus on March 6, 2019. This report summarizes these discussions and the key takeaway messages from this meeting.

Top-funded Companies Offering Digital Behavior Change Interventions for the Prevention and Management of Type-2 Diabetes: A Systematic Search on Venture Capital Databases and Content Analysis of Interventions (Preprint)

2021 ◽  
Author(s):  
Roman Keller ◽  
Sven Hartmann ◽  
Gisbert Wilhelm Teepe ◽  
Kim-Morgaine Lohse ◽  
Aishah Alattas ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Venture Capital ◽  
Diabetes Prevention ◽  
Scientific Evidence ◽  
Evidence Based ◽  
Level Of Evidence ◽  
Type 2 Diabetes Prevention ◽  
Behavior Change Interventions ◽  
Evidence Based Programs

BACKGROUND Advancements in technology offer new opportunities for the prevention and management of type 2 diabetes. Venture capital companies have been investing in digital diabetes companies that offer digital behavior change interventions (DBCIs). However, little is known about the scientific evidence underpinning such interventions or the degree to which those interventions leverage novel technology-driven automated developments such as conversational agents (CAs) or just-in-time adaptive intervention (JITAI) approaches. OBJECTIVE Our objectives were to identify the top-funded companies offering DBCIs for type 2 diabetes management and prevention, review the level of scientific evidence underpinning the DBCIs, identify which DBCIs are recognized as evidence-based programs by quality assurance authorities, and examine the degree to which these DBCIs include novel automated approaches such as CAs and JITAI mechanisms. METHODS A systematic search was conducted using two venture capital databases (Crunchbase Pro and Pitchbook) to identify the top-funded companies in type 2 diabetes prevention and management. Scientific publications relating to the identified DBCIs were identified via PubMed, Google Scholar, and the DBCI’s website and data regarding intervention effectiveness were extracted. The US CDC’s Diabetes Prevention Recognition Program (DPRP) was used to identify recognition status. The DBCIs’ publications, websites, and mobile applications were reviewed with regards to the intervention characteristics. RESULTS The 16 most-funded companies offering DBCIs for type 2 diabetes received a total funding of 2.4 billion USD as of June 15, 2021. Only four out of 50 identified publications associated with these DBCIs were fully powered randomized controlled trials (RCTs). One of those four RCTs showed a significant difference in HbA1c outcomes between the intervention and control group. However, all of the studies reported HbA1c improvements ranging from 0.2-1.9% over the course of 12 months. Six interventions were fully recognized by the DPRP to deliver evidence-based programs, and two interventions had a pending recognition status. Health professionals were included in the majority of DBCIs (81%, 13/16), whereas only 10% (1/10) of accessible apps involved a CA as part of the intervention delivery. Self-reports represented most of the data sources (62%, 74/119) that could be used to tailor JITAIs. CONCLUSIONS Our findings suggest that the level of funding received by companies offering DBCIs for type 2 diabetes prevention and management does not coincide with the level of evidence on the intervention effectiveness. There a is large variation in the level of evidence underpinning the different DBCIs and an overall need for more rigorous effectiveness trials and transparent reporting by quality assurance authorities. Currently, very few DBCIs use automated approaches such as CAs and JITAIs, limiting the scalability and reach of these solutions. Finally, more research is needed to establish the effectiveness of fully automated DBCIs in comparison to those offering human support.

How the US Food and Drug Administration evaluates the scientific evidence for health claims

2010 ◽  
Vol 68 (2) ◽  
pp. 114-121 ◽  
Author(s):  
Kathleen C Ellwood ◽  
Paula R Trumbo ◽  
Claudine J Kavanaugh
Keyword(s):  
Drug Administration ◽  
Scientific Evidence ◽  
Food And Drug Administration ◽  
Health Claims ◽  
The Us

Primer on Depression

Depression ◽  
2019 ◽  
pp. 197-217
Author(s):  
Naji C. Salloum ◽  
George I. Papakostas
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Mechanisms Of Action ◽  
Evidence Based ◽  
Augmentation Strategies ◽  
Investigational Drugs ◽  
The Us ◽  
Initial Medication

Several first-line antidepressant therapies are currently available for the treatment of major depressive disorder (MDD), but in most patients depression fail to remits after an initial medication trial. In this chapter, we explore the evidence for different augmentation strategies used to enhance the response from an initial antidepressant monotherapy. Atypical antipsychotics, several of which are now approved by the US Food and Drug Administration as adjunctive agents for the treatment of MDD, and lithium are among the most evidence-based augmentation pharmacotherapies. Other therapies, such as bupropion, mirtazapine, triiodothyronine, nutraceuticals, and psychotherapy, are also commonly used. Additionally, several investigational drugs, including ketamine, esketamine, and ALKS 5461, with novel mechanisms of action, show promise.

scholarly journals Clinical and Regulatory Considerations for Central Venous Catheters for Hemodialysis

2018 ◽  
Vol 13 (12) ◽  
pp. 1924-1932 ◽  
Author(s):  
Douglas M. Silverstein ◽  
Scott O. Trerotola ◽  
Timothy Clark ◽  
Garth James ◽  
Wing Ng ◽  
...  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Central Venous Catheters ◽  
Maintenance Hemodialysis ◽  
Central Venous ◽  
Regulatory Review ◽  
Design Considerations ◽  
The Us ◽  
Regulatory Challenges

Central venous catheters remain a vital option for access for patients receiving maintenance hemodialysis. There are many important and evolving clinical and regulatory considerations for all stakeholders for these devices. Innovation and transparent and comprehensive regulatory review of these devices is essential to stimulate innovation to help promote better outcomes for patients receiving maintenance hemodialysis. A workgroup that included representatives from academia, industry, and the US Food and Drug Administration was convened to identify the major design considerations and clinical and regulatory challenges of central venous catheters for hemodialysis. Our intent is to foster improved understanding of these devices and provide the foundation for strategies to foster innovation of these devices.

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