Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices

The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, which leave doctors and medical sleuths in the dark

Kaiser Health News senior correspondent Christina Jewett explains how she investigated a Food and Drug Administration database where medical device makers report malfunctions and patient injuries, skirting the public record. Because the cache of information is buried deep within the agency, it’s often hard for physicians, researchers and patient safety advocates to access the information.

What inspired ICIJ investigation into the medical device industry ?

Implant Files, video published by ICIJ, 8 March 2019

ICIJ year-long investigation into the medical device industry started with one reporter — Jet Schouten — and her very original use of a mandarin orange net.

ICIJfights corruption with the world’s best cross-border watchdog journalism by over 160 investigative reporters in 60+ countries. The home of Offshore Leaks.”

How to use the International Medical Device Database

Implant Files, video published by ICIJ, 27 February 2019

ICIJ show you how to navigate their public medical device database, now containing 90,000+ records from 18 countries. There you can find safety alerts and recalls for thousands of medical devices.

ICIJfights corruption with the world’s best cross-border watchdog journalism by over 160 investigative reporters in 60+ countries. The home of Offshore Leaks.”

Laura’s breast implant story

Implant Files, video published by ICIJ, 26 November 2018

“Thank you for watching! So thankful to have support. It is a journey I never thought I would have to take, but I hope that my voice is making a difference”.

Laura McCandliss, January 2019.

Read more about ICIJ implant files investigation.

ICIJfights corruption with the world’s best cross-border watchdog journalism by over 160 investigative reporters in 60+ countries. The home of Offshore Leaks.”

Meet the people who lived with defective devices

Implant Files, video published by ICIJ, 25 November 2018

ICIJ listened to hundreds of stories from patients with poorly-functioning medical devices. Here are just five of their testimonies.

Read more about ICIJ implant files investigation.

ICIJfights corruption with the world’s best cross-border watchdog journalism by over 160 investigative reporters in 60+ countries. The home of Offshore Leaks.”

Why join the Implant Files investigation ?

Implant Files, video published by ICIJ, 25 November 2018

Journalists explain why they decided to investigate medical device harm with ICIJ reporters.

Read more about ICIJ implant files investigation.

ICIJfights corruption with the world’s best cross-border watchdog journalism by over 160 investigative reporters in 60+ countries. The home of Offshore Leaks.”

A global investigation into medical device harm

Implant Files, video published by ICIJ, 24 November 2018

Patients around the world have become unwitting test subjects for new medical technology. Often following the trusted advice of their doctors, they have been injured, maimed and killed by poorly-tested implants.

Read more about the their implant files investigation.

ICIJfights corruption with the world’s best cross-border watchdog journalism by over 160 investigative reporters in 60+ countries. The home of Offshore Leaks”.

The Lancet Commission on pollution and health

How to control and mitigate the effects of pollution on public health

It is estimated that pollution is responsible for 16% of all deaths worldwide. In the most severely affected countries, pollution-related disease is responsible for more than 25% of deaths. It is important to note that pollution disproportionately kills the poor and the vulnerable.

Pollution is the world’s largest environmental cause of disease and premature death.

The Lancet Commission on pollution and health brought together leaders, researchers and practitioners from the fields of pollution management, environmental health and sustainable development to elucidate the full health and economic costs of air, water, chemical and soil pollution worldwide.

By analysing existing and emerging data, the Commission reveals that pollution makes a significant and underreported contribution to the global burden of disease, particularly in low- and middle-income countries.

The Commission also provides six recommendations to policymakers and other stakeholders looking for efficient, cost-effective and actionable approaches to pollution mitigation and prevention.

  1. Make pollution prevention a high priority nationally and internationally and integrate it into country and city planning processes.
  2. Mobilise, increase and focus the funding and international technical support dedicated to pollution control.
  3. Establish systems to monitor pollution and its effects on health.
  4. uild multi-sectoral partnerships for pollution control.
  5. Integrate pollution mitigation into planning processes for NCDs.
  6. Research pollution and pollution control.

COMPare: a prospective cohort study correcting and monitoring 58 misreported trials in real time

First empirical study of major academic journals’ willingness to publish a cohort of comparable and objective correction letters on misreported high-impact studies

Abstract

Background
Discrepancies between pre-specified and reported outcomes are an important source of bias in trials. Despite legislation, guidelines and public commitments on correct reporting from journals, outcome misreporting continues to be prevalent. We aimed to document the extent of misreporting, establish whether it was possible to publish correction letters on all misreported trials as they were published, and monitor responses from editors and trialists to understand why outcome misreporting persists despite public commitments to address it.

Methods
We identified five high-impact journals endorsing Consolidated Standards of Reporting Trials (CONSORT) (New England Journal of Medicine, The Lancet, Journal of the American Medical Association, British Medical Journal, and Annals of Internal Medicine) and assessed all trials over a six-week period to identify every correctly and incorrectly reported outcome, comparing published reports against published protocols or registry entries, using CONSORT as the gold standard. A correction letter describing all discrepancies was submitted to the journal for all misreported trials, and detailed coding sheets were shared publicly. The proportion of letters published and delay to publication were assessed over 12 months of follow-up. Correspondence received from journals and authors was documented and themes were extracted.

Results
Sixty-seven trials were assessed in total. Outcome reporting was poor overall and there was wide variation between journals on pre-specified primary outcomes (mean 76% correctly reported, journal range 25–96%), secondary outcomes (mean 55%, range 31–72%), and number of undeclared additional outcomes per trial (mean 5.4, range 2.9–8.3). Fifty-eight trials had discrepancies requiring a correction letter (87%, journal range 67–100%). Twenty-three letters were published (40%) with extensive variation between journals (range 0–100%). Where letters were published, there were delays (median 99 days, range 0–257 days). Twenty-nine studies had a pre-trial protocol publicly available (43%, range 0–86%). Qualitative analysis demonstrated extensive misunderstandings among journal editors about correct outcome reporting and CONSORT. Some journals did not engage positively when provided correspondence that identified misreporting; we identified possible breaches of ethics and publishing guidelines.

Conclusions
All five journals were listed as endorsing CONSORT, but all exhibited extensive breaches of this guidance, and most rejected correction letters documenting shortcomings. Readers are likely to be misled by this discrepancy. We discuss the advantages of prospective methodology research sharing all data openly and pro-actively in real time as feedback on critiqued studies. This is the first empirical study of major academic journals’ willingness to publish a cohort of comparable and objective correction letters on misreported high-impact studies. Suggested improvements include changes to correspondence processes at journals, alternatives for indexed post-publication peer review, changes to CONSORT’s mechanisms for enforcement, and novel strategies for research on methods and reporting.

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