Archive for the ‘ethics’ Category

Research Misconduct Identified by the US Food and Drug Administration: Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature

February 13, 2015 Comments off

Research Misconduct Identified by the US Food and Drug Administration: Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature
Source: JAMA Internal Medicine

Every year, the US Food and Drug Administration (FDA) inspects several hundred clinical sites performing biomedical research on human participants and occasionally finds evidence of substantial departures from good clinical practice and research misconduct. However, the FDA has no systematic method of communicating these findings to the scientific community, leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature.

To identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature.

Design and Setting
Cross-sectional analysis of publicly available documents, dated from January 1, 1998, to September 30, 2013, describing FDA inspections of clinical trial sites in which significant evidence of objectionable conditions or practices was found.

Main Outcomes and Measures
For each inspection document that could be linked to a specific published clinical trial, the main measure was a yes/no determination of whether there was mention in the peer-reviewed literature of problems the FDA had identified.

Fifty-seven published clinical trials were identified for which an FDA inspection of a trial site had found significant evidence of 1 or more of the following problems: falsification or submission of false information, 22 trials (39%); problems with adverse events reporting, 14 trials (25%); protocol violations, 42 trials (74%); inadequate or inaccurate recordkeeping, 35 trials (61%); failure to protect the safety of patients and/or issues with oversight or informed consent, 30 trials (53%); and violations not otherwise categorized, 20 trials (35%). Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection. No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published.

Conclusions and Relevance
When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct.

Most-Expensive Congressional Trips

February 10, 2015 Comments off

Most-Expensive Congressional Trips
Source: Legistorm

The congressional trips in our database were funded by private organizations. By searching our data you can learn details of each trip taken by a member of Congress or their staff, and who paid for the travel.

TIGTA – Additional Consideration of Prior Conduct and Performance Issues Is Needed When Hiring Former Employees

February 6, 2015 Comments off

Additional Consideration of Prior Conduct and Performance Issues Is Needed When Hiring Former Employees (PDF)
Source: Treasury Inspector General for Tax Administration
From press release:

The Internal Revenue Service (IRS) rehired hundreds of former employees with prior substantiated conduct or performance issues, according to a new report publicly released today by the Treasury Inspector General for Tax Administration (TIGTA).

Most rehired employees do not have performance or conduct issues associated with prior IRS employment. However, TIGTA identified hundreds of former employees with prior substantiated conduct or performance issues ranging from tax issues, unauthorized access to taxpayer information, leave abuse, falsification of official forms, unacceptable performance, misuse of IRS property, and off-duty misconduct.

Using Drugs to Discriminate — Adverse Selection in the Insurance Marketplace

February 4, 2015 Comments off

Using Drugs to Discriminate — Adverse Selection in the Insurance Marketplace
Source: New England Journal of Medicine

Eliminating discrimination on the basis of preexisting conditions is one of the central features of the Affordable Care Act (ACA). Before the legislation was passed, insurers in the nongroup market regularly charged high premiums to people with chronic conditions or denied them coverage entirely. To address these problems, the ACA instituted age-adjusted community rating for premiums and mandated that plans insure all comers. In combination with premium subsidies and the Medicaid expansion, these policies have resulted in insurance coverage for an estimated 10 million previously uninsured people in 2014.

There is evidence, however, that insurers are resorting to other tactics to dissuade high-cost patients from enrolling. A formal complaint submitted to the Department of Health and Human Services (HHS) in May 2014 contended that Florida insurers offering plans through the new federal marketplace (exchange) had structured their drug formularies to discourage people with human immunodeficiency virus (HIV) infection from selecting their plans. These insurers categorized all HIV drugs, including generics, in the tier with the highest cost sharing.

Insurers have historically used tiered formularies to encourage enrollees to select generic or preferred brand-name drugs instead of higher-cost alternatives. But if plans place all HIV drugs in the highest cost-sharing tier, enrollees with HIV will incur high costs regardless of which drugs they take. This effect suggests that the goal of this approach — which we call “adverse tiering” — is not to influence enrollees’ drug utilization but rather to deter certain people from enrolling in the first place.

China — Labor Rights Violations Continue in the Toy Industry

January 30, 2015 Comments off

Labor Rights Violations Continue in the Toy Industry
Source: China Labor Watch

China Labor Watch (CLW) today published a 66-page investigative report on continued labor rights violations in the toy industry. The four-factory investigation includes plants that manufacture for Mattel and Fisher-Price, Disney, Hasbro, Crayola, and other major international toy brand companies. During the investigation, the factories were making toys like Barbie, Mickey Mouse, Transformers’ Optimus Prime, and Thomas the Tank Engine.

The investigation, carried out from June to November 2014, targeted labor conditions in four facilities in Guangdong, China: Mattel Electronics Dongguan (MED), Zhongshan Coronet Toys (Coronet), Dongguan Chang’an Mattel Toys 2nd Factory (MCA), and Dongguan Lung Cheong Toys (Lung Cheong).

Collecting data through undercover probes and off-site worker interviews, the investigation exposes a set of 20 legal and ethical labor violations that include hiring discrimination, detaining workers’ personal IDs, lack of physical exams despite hazardous working conditions, workers required to sign training forms despite little or no safety training, a lack of protective equipment, ill-maintained production machinery, fire safety concerns, incomplete or nonexistent labor contracts, overtime hours of up to 120 hours per month, unpaid wages, underpaid social insurance, frequent rotation between day and night shifts, poor living conditions, environmental pollution, illegal resignation procedures, abusive management, audit fraud, and a lack of effective grievance channels and union representation.

See also: Working Conditions and Factory Auditing in the Chinese Toy Industry (Congressional-Executive Commission on China)
Hat tip: IWS Documented News Service

Medical Marijuana: A Primer on Ethics, Evidence, and Politics

January 22, 2015 Comments off

Medical Marijuana: A Primer on Ethics, Evidence, and Politics (PDF)
Source: The Journal for Nurse Practitioners – JN

Controversy in the United States about the decriminalization of cannabis to allow health care providers to recommend it for therapeutic use (medical marijuana) has been based on varying policies and beliefs about cannabis rather than on scientific evidence. Issues include the duty to provide care, conflicting reports of the therapeutic advantages and risks of cannabis, inconsistent laws, and even the struggle to remove barriers to the scope of practice for advanced practice registered nurses. This article reviews the ethics, evidence, and politics of this complex debate.

Final Report of the Rendition, Detention, and Interrogation Network Agency Accountability Board (Central Intelligence Agency)

January 16, 2015 Comments off

Final Report of the Rendition, Detention, and Interrogation Network Agency Accountability Board (Central Intelligence Agency) (PDF)
Source: Central Intelligence Agency

In what amounts to the fox announcing it did nothing wrong while guarding the hen house, the Central Intelligence Agency (CIA) has concluded its own people were not at fault for spying on a Senate investigation of the CIA’s torture program from last decade.

During a lengthy probe of the CIA’s controversial program, the Senate Intelligence Committee reviewed CIA files with the agency’s permission. However, in the course of the Senate committee’s work, several CIA officials searched the files being used by Senate staffers.

The controversy prompted the CIA’s top man, John Brennan, to organize a panel to determine whether his agency had acted improperly.

Brennan stacked the five-member panel with three senior CIA officers.


Get every new post delivered to your Inbox.

Join 1,015 other followers