The unsteady state and inertia of chemical regulation under the US Toxic Substances Control Act.

After 40 years, the 1976 US Toxic Substances Control Act (TSCA) was revised under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Its original goals of protecting the public from hazardous chemicals were hindered by complex and cumbersome administrative burdens, data limitations, vulnerabilities in risk assessments, and recurring corporate lawsuits. As a result, countless chemicals were entered into commercial use without toxicological information. Few chemicals of the many identified as potential public health threats were regulated or banned. This paper explores the factors that have worked against a comprehensive and rational policy for regulating toxic chemicals and discusses whether the TSCA revisions offer greater public protection against existing and new chemicals.

Tripartite conflicts of interest and high stakes patent extensions in the DSM-5.

BACKGROUND: The revision process for and recent publication of the DSM-5 initiated debates about the widening of diagnostic boundaries. The pharmaceutical industry had a major financial stake in the outcome of these debates. This study examines the three-part relationship among DSM panel members, principal investigators (PIs) of clinical trials for new DSM-5 diagnoses, and drug companies. METHODS: Financial conflicts of interest (FCOI) of DSM panel members responsible for some new diagnoses in the DSM-5 and PIs of clinical trials for related drug treatments were identified. Trials were found by searching ClinicalTrials.gov. Patent and revenue information about these drugs was found using the US Food and Drug Administration's Orange Book and manufacturer Annual Reports. RESULTS: Thirteen trials met inclusion criteria (testing drugs for some new DSM disorders). Sixty-one percent of the DSM Task Force members and 27% of Work Group members reported FCOI to the trial drug manufacturers. In 5 of the 13 trials (38%), PIs reported ties other than research funding to the drug manufacturer. In 3 of the trials (23%), a PI had financial ties to the drug manufacturer and was also a DSM panel member who had decision-making authority over the revision process. CONCLUSIONS: These findings suggest that increased transparency (e.g., registration on ClinicalTrials.gov) and mandatory disclosure policies (e.g., the American Psychiatric Association's disclosure policy for DSM-5 panel members) alone may not be robust enough strategies to prevent the appearance of bias in both the DSM revision process as well as clinical decisions about appropriate interventions for DSM disorders.

Conflicts of interest and disclosure in the American Psychiatric Association's Clinical Practice Guidelines.

BACKGROUND: Clinical practice guidelines (CPG) are developed, endorsed, and disseminated through professional medical organizations such as the American Psychiatric Association (APA) as the standard of care for health care providers. Because of their influence, it is critical that CPG are based on objective data, unprejudiced by stakeholder groups, and that any financial associations between authors of CPG and the pharmaceutical industry are made transparent. The present study examined the degree and type of financial ties to the pharmaceutical industry held by authors of 3 major CPG. METHODS: By using multimodal screening techniques, we investigated the financial relationships to the pharmaceutical companies of 20 work group members who authored the guidelines for the treatment of schizophrenia, bipolar disorder, and major depressive disorder. RESULTS: Eighteen CPG authors (90%) had at least 1 financial tie to the pharmaceutical industry. All of the CPG authors who had industry relationships had financial relationships with companies whose products were specifically considered or included in the guideline they authored. The leading categories of financial interest held by CPG authors were research funding (77.7%), consultancies (72.2%), members of corporate boards (44.4%), and collaborators in industry-funded studies (44.4%). CONCLUSIONS: Ninety percent of the authors of 3 major CPG in psychiatry had financial ties to companies that manufacture drugs which were explicitly or implicitly identified in the guidelines as recommended therapies for the respective mental illnesses. None of the financial associations of the authors were disclosed in the CPG.

Breaking the germline barrier in a moral vacuum.

In November 2018 a Chinese scientist claimed to have used CRISPR/Cas 9 technology to genetically modify two human embryos that were then gestated in one adult woman through an IVF pregnancy and brought to term. The twin girls are allegedly the first babies born with their prenatal genomes edited. Using both English language and Chinese supporting documents, this paper discusses the background of this human experiment, the social context of Chinese science, and the alleged ethical transgressions of its principal scientist.

Roundup litigation discovery documents: implications for public health and journal ethics.

This paper reviews the court-released discovery documents obtained from litigation against Monsanto over its herbicide Roundup and through Freedom of Information Act requests (requests to regulatory agencies and public universities in the United States). We sought evidence of corporate malfeasance and undisclosed conflicts of interest with respect to issues of scientific integrity. The findings include evidence of ghostwriting, interference in journal publication, and undue influence of a federal regulatory agency.

When conflict-of-interest is a factor in scientific misconduct.

Under the guidelines adopted by the United States (U.S.) Office of Research Integrity (ORI), scientific misconduct is defined by one or more of three activities: fabrication of data, falsification of results, and plagiarism or the improper appropriation of other people's ideas or written work. This paper discusses whether three other breaches in scientific ethics, namely ghost writing, fabricating credentials, and failure to disclose conflicts of interest, rise to the level of scientific misconduct. After discussing the funding effect in science, the paper argues that, like ghost writing and fabricated credentials, conflicts of interest can bias the outcome of research. Thus, lack of transparency to reviewers, journals and readers for conflicts of interest should be considered a form of scientific misconduct.

Conflicts of interest among committee members in the National Academies' genetically engineered crop study.

The National Academies of Sciences, Engineering and Medicine (NASEM) publishes numerous reports each year that are received with high esteem by the scientific community and public policy makers. The NASEM has internal standards for selecting committee members that author its reports, mostly from academia, and vetting conflicts of interest. This study examines whether there were any financial conflicts of interest (COIs) among the twenty invited committee members who wrote the 2016 report on genetically engineered (GE) crops. Our results showed that six panel members had one or more reportable financial COIs, none of which were disclosed in the report. We also report on institutional COIs held by the NASEM related to the report. The difference between our findings and the NASEM reporting standards are discussed.

Conflict of Interest Policies and Industry Relationships of Guideline Development Group Members: A Cross-Sectional Study of Clinical Practice Guidelines for Depression.

Because of increased attention to the issue of trustworthiness of clinical practice guidelines, it may be that both transparency and management of industry associations of guideline development groups (GDGs) have improved. The purpose of the present study was to assess a) the disclosure requirements of GDGs in a cross-section of guidelines for major depression; and, b) the extent and type of conflicts of panel members. Treatment guidelines for major depression were identified and searched for conflict of interest policies and disclosure statements. Multi-modal screens for undeclared conflicts were also conducted. Fourteen guidelines with a total of 172 panel members were included in the analysis. Eleven of the 14 guidelines (78%) had a stated conflict of interest policy or disclosure statement, although the policies varied widely. Most (57%) of the guidelines were developed by panels that had members with industry financial ties to drug companies that manufacture antidepressant medication. However, only a minority of total panel members (18%) had such conflicts of interest. Drug company speakers bureau participation was the most common type of conflict. Although some progress has been made, organizations that develop guidelines should continue to work toward greater transparency and minimization of financial conflicts of interest.

Emergence of a scientific and commercial research and development infrastructure for human gene therapy.

A research and clinical subfield known as "human gene therapy" has grown rapidly since 1990, when the first human trials were approved in the United States. Using quantitative data, this paper describes and analyzes the research and commercial infrastructure, including academic centers, publications, intellectual property, and biotechnology firms, that has developed around the goal of discovering clinical applications for the modification and transport of DNA to somatic cells. Despite setbacks and few documented successes, the subfield of human gene therapy continues to serve as an influential clinical paradigm for the treatment of inherited and noninherited diseases.