Does menopause hormone therapy prevent Alzheimer's disease and dementia?

Nerattini M, Jett S, Andy C, Systematic review and meta-analysis of the effects of menopause hormone therapy on risk of Alzheimer's disease and dementia. Front Aging Neurosci. 2023;15:1260427.

Parkinson's Disease Psychosis and the Marketing of Pimavanserin.

In 2016, Nuplazid (pimavanserin) became the first FDA-approved treatment for Parkinson's Disease Psychosis (PDP). We explored the possibility that PDP was a term created to market Nuplazid. We examined trends in perceptions of psychosis in Parkinson's disease from the 1990s to 2020 through MEDLINE search term frequency, neurology textbooks, guidance from professional societies, Acadia annual reports, sponsored websites, and a sponsored meeting held by the National Institutes of Health (NIH).

Evergreened drugs or evergreened profits?

Background: Branded drugs contribute disproportionately to high prescription drug spending. Pharmaceutical companies utilize patent extension "evergreening" techniques that contribute to high drug costs.

Aims: This article describes various patent extension techniques and analyzes the tactic of combining generic drugs with branded drugs, using metformin combinations for diabetes treatment as a case study.

Making the Case for Accelerated Withdrawal of Aducanumab.

The controversial approval in June 2021 by the Food and Drug Administration (FDA) of aducanumab (marketed as Aduhelm), Biogen's monoclonal antibody for patients with Alzheimer's disease, raises significant concerns for the dementia field and drug approval process, considering its lack of adequate evidence for clinical efficacy, safety issues, and cost. On 15 December 2021, an international group of clinicians, basic science experts, psychological and social science researchers, lay people with lived experience of dementia, and advocates for public health met to discuss making a recommendation for whether aducanumab's approval should be withdrawn. Attendees considered arguments both in favor of and in opposition to withdrawal and voted unanimously to recommend that the FDA withdraw its approval for aducanumab and to support the Right Care Alliance's filing of a formal Citizen Petition to this effect.

Survey of opioid prescribing among dentists indicates need for more effective education regarding pain management.

Background: Dentists commonly prescribe opioids and are the highest prescribers of opioids to patients 18 years and younger. Little is known about dentists' beliefs regarding opioids and other analgesics.

Methods: The authors conducted a national survey of dentists about their opioid prescribing habits, perceptions regarding opioid effectiveness, beliefs about patient behaviors, and relationships with drug and equipment manufacturers.

Increase your Confidence in Opioid Prescribing: Marketing Messages in Continuing Medical Education Activities on ER/LA Opioids.

Background: Overprescription of opioids has fueled an epidemic of addiction and overdose deaths. The FDA required manufacturers of extended-release/long-acting (ER/LA) opioids to fund continuing medical education (CME) on opioids as part of a Risk Evaluation and Mitigation Strategy (REMS).

Objectives: We sought to determine whether industry-funded REMS on long-acting opioids were consistent with the FDA's goal to reduce serious, adverse outcomes resulting from inappropriate prescribing, misuse, and abuse.

A Ray of Sunshine: Transparency in Physician-Industry Relationships Is Not Enough.

Gifts from pharmaceutical and medical device companies to physicians in the United States have been reported since 2014, through the Physician Payments Sunshine Act. Although researchers have utilized these data to publish many studies on conflicts of interest (COIs) and prescribing behavior, there is no evidence that physician behavior regarding COI has changed, or that employers, meeting organizers, or medical journals are excluding physicians based on conflicts of interest. Disclosure is necessary but not sufficient to address the damage that industry relationships causes to medical knowledge and public health.

Changing Pharmaceutical Industry Interaction in US Family Medicine Residencies: A CERA Study.

Background: Pharmaceutical interaction in US residencies is common. This study explores the extent and type of learner interactions in US family medicine residencies with the pharmaceutical industry and compares interactions from 2008, 2013, and 2019.

Methods: We surveyed program directors of 628 family medicine residencies with 8 questions using the 2019 Council of Academic Family Medicine Educational Research Alliance Survey and compared the responses to 2008 and 2013 results.

Marketing Messages in Continuing Medical Education (CME) Modules on Binge-Eating Disorder (BED).

Background: In 2015, Vyvanse (lisdexamfetamine) became the first Food and Drug Administration (FDA)-approved treatment for binge-eating disorder (BED), a condition first recognized by the DSM-V in 2013. Because pharmaceutical companies use continuing medical education (CME) to help sell drugs, we explored possible bias in CME modules on BED.

Methods: We utilized a qualitative thematic analysis research approach to identify and classify patterns in CME activities focusing on BED.

Pharmaceutical Ethics and Grassroots Activism in the United States: A Social History Perspective.

Women's health activists laid the groundwork for passage of the law that created the U.S. Food and Drug Administration in 1906.

Influence of pharmaceutical marketing on Medicare prescriptions in the District of Columbia.

Importance: Gifts from pharmaceutical companies are believed to influence prescribing behavior, but few studies have addressed the association between industry gifts to physicians and drug costs, prescription volume, or preference for generic drugs. Even less research addresses the effect of gifts on the prescribing behavior of nurse practitioners (NPs), physician assistants (PAs), and podiatrists.

Objective: To analyze the association between gifts provided by pharmaceutical companies to individual prescribers in Washington DC and the number of prescriptions, cost of prescriptions, and proportion of branded prescriptions for each prescriber.

Testosterone and sexual function.

Purpose Of Review: Testosterone therapy has been advocated in the treatment of symptoms that may represent normal aging. We briefly review randomized clinical trials on the effects of testosterone therapy on sexual function.

Recent Findings: About half of clinical trials showed no benefit of testosterone therapy on any aspect of sexual function.

Pharmacist-industry relationships.

Objectives: The purpose of this study was to document, in their own words, beliefs and attitudes that American pharmacists have towards the pharmaceutical industry and pharmacists' interactions with industry.

Methods: An ethnographic-style qualitative study was conducted utilizing open-ended interviews with four hospital pharmacists, two independent pharmacists, two retail pharmacists and one administrative pharmacist in the Washington, DC, metropolitan area to elicit descriptions of and attitudes towards pharmacists' relationships with industry. Analysis of the qualitative material followed established ethnographic conventions of narrative thematic analysis.

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.

Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives.

Background: Industry payments to surgeons have received public attention, but little is known about the relationships between surgeons and medical device representatives. Medical device representatives ("device reps") have become an integral part of operating room personnel. The effect of their presence on patient care deserves discussion.

Direct-to-consumer Marketing to People with Hemophilia.

Adriane Fugh-Berman and colleagues describe how strategies similar to those used to market drugs to physicians are directed towards people with hemophilia.

Hypoactive sexual desire disorder: inventing a disease to sell low libido.

Condition branding is a marketing technique in which companies develop conditions concurrently with developing drugs; examples include gastro-oesophageal reflux disease, premenstrual dysphoric disorder, social anxiety disorder, erectile dysfunction and hypoactive sexual desire disorder. Although it is illegal for pharmaceutical companies to market drugs prior to regulatory approval, there are no restrictions on marketing diseases, and industry seeks to establish a disease state in the minds of clinicians years before an expected drug launch. Continuing medical education (CME) courses are an important part of promotion prior to drug approval and have become a key marketing tool for increasing clinician receptivity to new products.