Promotion of New Diabetes Products in the District of Columbia

Background: Growth in pharmaceutical expenditures for diabetes outpaced growth in diabetes prevalence. Prescribers accepting gifts and meals from pharmaceutical companies have been linked with higher prescription rates and costs[1]. Pharmaceutical marketing to these prescribers and patients often promotes newer, more expensive drugs, such as the GLP-1 analogues and SGL-2 inhibitors. These two drug classes are more expensive but no more effective than metformin,[2] the recommended first-line treatment for diabetes, and the oldest and cheapest available treatment. We investigated how cost of diabetes treatment was affected by marketing practices in the District of Columbia. Methods: The AccessRx program in DC requires pharmaceutical companies to report gifts given to healthcare providers, drug advertising expenses, and the salaries for staff engaged in promotional activities (“detailing expenses”). We combined data from AccessRx and the federal Open Payments system to estimate promotional payments. We used Medicaid drug utilization data to examine spending for diabetes treatment. Results: In 2014, DC Medicaid spent more than $17.1 million on pharmaceutical treatments for diabetes. We estimated that ten companies spent$3.8 million in detailing expenses to market diabetes drugs in 2014. SGLT-2 inhibitors and GLP-1 analogues had the highest estimated detailing expenses, each totaling more than $1.2 million. From 2014 to 2015, DC Medicaid spending for Victoza (liraglutide), a GLP-1 analogue, increased 51$183,873 to $362,230) and Invokana (canaglifozin), a SGLT-2 inhibitor, increased 213$8,933 to $27,958). Conclusions: Pharmaceutical promotion drives unnecessary use of newer, more expensive medications. The District of Columbia should provide education on rational prescribing for diabetes treatment (including diet and exercise). [1] Perlis RH, Perlis CS. Physician payments from industry are associated with greater Medicare Part D prescribing costs. PLoS One. 2016;11(5):e0155474. DeJong C, Aguilar T, Tseng CW, et al. Pharmaceutical industry-sponsored meals and physician prescribing patterns for Medicare beneficiaries. JAMA Intern Med. 2016;176(8):1114-10. [2] Prescrire International. Hypoglycaemic therapy in type 2 diabetics. Prescrire Int. 2015 Apr;24(159):103- 106. Prescrire International. Glucose-lowering treatment of type 2 diabetics. Prescrire Int. 2015 May;23(160):130-135

Treatment of Men for “Low Testosterone”: A Systematic Review

Testosterone products are recommended by some prescribers in response to a diagnosis or presumption of “low testosterone” (low-T) for cardiovascular health, sexual function, muscle weakness or wasting, mood and behavior, and cognition. We performed a systematic review of 156 eligible randomized controlled trials in which testosterone was compared to placebo for one or more of these conditions. We included studies in bibliographic databases between January 1, 1950 and April 9, 2016, and excluded studies involving bodybuilding, contraceptive effectiveness, or treatment of any condition in women or children. Studies with multiple relevant endpoints were included in all relevant tables. Testosterone supplementation did not show consistent benefit for cardiovascular risk, sexual function, mood and behavior, or cognition. Studies that examined clinical cardiovascular endpoints have not favored testosterone therapy over placebo. Testosterone is ineffective in treating erectile dysfunction and controlled trials did not show a consistent effect on libido. Testosterone supplementation consistently increased muscle strength but did not have beneficial effects on physical function. Most studies on mood-related endpoints found no beneficial effect of testosterone treatment on personality, psychological well-being, or mood. The prescription of testosterone supplementation for low-T for cardiovascular health, sexual function, physical function, mood, or cognitive function is without support from randomized clinical trials

Bioinformatik-Tools für die Systembiologie von Dysferlin-Mangel

The aim of this project was to build and apply tools for the analysis of muscle omics data, with a focus on Dysferlin deficiency. This protein is expressed mainly in skeletal and cardiac muscles, and its loss due to mutation (autosomal-recessive) of the DYSF gene, results in a progressive muscular dystrophy (Limb Girdle Muscular Dystrophy type 2B (LGMD2B), Miyoshi myopathy and distal myopathy with tibialis anterior onset (DMAT)). We have developed various tools and pipelines that can be applied towards a bioinformatics functional analysis of omics data in muscular dystrophies and neuromuscular disorders. These include: tests for enrichment of gene sets derived from previously published muscle microarray data and networking analysis of functional associations between altered transcripts/proteins. To accomplish this, we analyzed hundreds of published omics data from public repositories. The tools we developed are called CellWhere and MyoMiner. CellWhere is a user-friendly tool that combines protein-protein interactions and protein subcellular localizations on an interactive graphical display. It accepts a list of genes and generates a protein-protein interaction network graph organized into subcellular locations to mimic the structure of the cell. Localization annotations acquired from the manually curated public repositories, Gene Ontology and UniProt (Swissprot), are mapped to a smaller number of CellWhere localizations. Protein-protein interactions and their scores are acquired from the Mentha interactome server. CellWhere can be accessed freely at https://sys-myo.com/cellwhere MyoMiner is a muscle cell- and tissue-specific database that provides co-expression analyses in both normal and pathological tissues. Many gene co-expression databases already exist and are used broadly by researchers, but MyoMiner is the first muscle-specific tool of its kind. High-throughput microarray experiments measure mRNA levels for thousands of genes in a biological sample and most microarray studies are focused on differentially expressed genes. Another way of using microarray data is to exploit gene co-expression, which is widely used to study gene regulation and function, protein interactions and signaling pathways. These co-expression analyses will help muscle researchers to delineate muscle pathology specific protein interactions and pathways. Changes in co-expression between pathologic and healthy tissue may suggest new disease mechanisms and therapeutic targets. MyoMiner is a powerful muscle specific database for the discovery of genes that are associated in related functions based on their co-expression and is available at https://sys-myo.com/myominer. These tools will be used in the analysis and interpretation of transcriptomics data from dysferlinopathic muscle and other neuromuscular conditions and will be important to understand the molecular mechanisms underlying these pathologies

Average cost per claim and proportion of branded claims by gift value.

<p>Average cost per claim and proportion of branded claims by gift value.</p

Average number of claims per prescriber, claims per patient, cost per claim, and proportion of branded drugs.

<p>Medicare Prescribers by Gift Status.</p

Average cost of claims by specialty for gift and non-gift recipients.

<p>Average cost of claims by specialty for gift and non-gift recipients. ¶ Internal Medicine Specialties includes Cardiology, Endocrinology, Gastroenterology, Infectious Disease, Pulmonary Disease. ♯ Psychiatric Specialties includes Psychiatry, Psychiatry & Neurology, Neuropsychiatry, Geriatric Psychiatry. ⌃ Other Surgery includes Cardiac, Colorectal, Maxillofacial, Oral and Maxillofacial, Plastic and Reconstructive, Plastic, Neurological, Thoracic and Vascular Surgery. *Statistically Significant (p<0.05).</p

Included specialties and subspecialties.

<p>Included specialties and subspecialties.</p

Proportion of branded claims by specialty for gift and non-gift recipients.

<p>Proportion of branded claims by specialty by gift and non-gift recipients. ¶ Internal Medicine Specialties includes Cardiology, Endocrinology, Gastroenterology, Infectious Disease, Pulmonary Disease. ♯ Psychiatric Specialties includes Psychiatry, Psychiatry & Neurology, Neuropsychiatry, Geriatric Psychiatry. ⌃ Other Surgery includes Cardiac, Colorectal, Maxillofacial, Oral and Maxillofacial, Plastic and Reconstructive, Plastic, Neurological, Thoracic and Vascular Surgery. *Statistically Significant (p<0.05).</p

Average cost per claim and proportion of branded claims by gift value.

<p>Average cost per claim and proportion of branded claims by gift value.</p

Effects of Testosterone on Sexual Functioning.

<p>Effects of Testosterone on Sexual Functioning.</p