To Your Health: NLM update Transcript

Reassessing research: 10/13/2015

Greetings from the National Library of Medicine and MedlinePlus.gov

Regards to all our listeners!

I'm Rob Logan, Ph.D., senior staff, U.S. National Library of Medicine (NLM).

Here is what's new this week in To Your Health, a consumer health oriented podcast from NLM, that helps you use MedlinePlus to follow up on weekly topics.

A reassessment of a medication intended to treat teen depression is the first example of a new effort by BMJ to reevaluate selected prior research findings to improve their overall accuracy, reproducibility, and transparency.

A commentary by Fiona Godlee M.D., BMJ's editor, notes the journal's re-evaluation finds no clinical advantage to prescribe paroxetine to teens compared to a placebo. The findings from the clinical trials originally published 14 years ago by another journal, suggested the medication was clinically efficacious for teenagers. MedlinePlus.gov's drugs and supplements page explains paroxetine is approved for clinical treatment for an array of patients — but not for persons 18 and younger in the U.S. Incidentally, the drug sometimes is known as paxil.

Godlee writes (and we quote): 'The restorative authors set to work accessing and analysing the clinical study report and patient level data...They also uncovered "serious, several, and suicide related adverse events" that had been overlooked or hidden' (end of quote).

Godlee explains BMJ's editors learned (and we quote): 'that the (original) paper was drafted not by any of the 22 listed authors but by a writer paid by the manufacturer. But most alarmingly, reports emerged of serious adverse effects of paroxetine in adolescents...' (end of quote).

In a further discussion of BMJ's rationale to conduct a reanalysis, Godlee writes (and we quote): 'Efforts to get the (original) authors, the journal that published the trial, the professional society that publishes the journal, and the authors' institutions to act or even respond to criticism have failed' (end of quote)

An accompanying article on research conduct by BMJ's associate editor, goes further and notes the teen-depression drug's 14 year odyssey is a case study of multi-level medical institutional irresponsibility.

Godlee explains paxil's reassessment is the first of future reviews of other, previously published randomized trials, which are intended to illuminate invisible and abandoned clinical trial information as well as foster open access to trial findings. In a news story article about BMJ's initiative, the New York Times writes the effort represents (and we quote): 'a clear break from scientific custom and reflects a new era in scientific publishing... opening the way for journals to post multiple interpretations of the same experiment' (end of quote).

Moreover, Godlee writes the current reassessment shows (and we quote): 'how much our current systems are failing patients and the public' (end of quote).

Meanwhile, MedlinePlus.gov's drugs and supplements section explains paroxetine/paxil is used to treat depression, panic disorder, social anxiety disorder, obsessive-compulsive disorder, and posttraumatic stress disorder.

MedlinePlus.gov's drugs and supplements section reports paxil also is sometimes used to treat hot flashes and some premenstrual disorders. MedlinePlus.gov's drugs and supplements section explains paxil additionally is used to treat chronic headaches, a tingling in the hands and feet caused by diabetes, and some male sexual problems.

MedlinePlus.gov's drugs and supplements section adds information about how paxil should be used and provides a list of more than 30 side effects, such as: dizziness, confusion, nausea, sore teeth and gums, and constipation.

MedlinePlus.gov's drugs and supplements section provides a list of user special precautions as well as an inventory of symptoms associated with overdoses.

To find MedlinePlus.gov's drugs and supplements information, just click on the drugs and supplements link near the top of MedlinePlus.gov's home page. An alphabetical list of drugs and supplements is provided with a common structure that answers basic questions including: how should medicines be used, what special precautions to follow, dietary instructions, side effects, storing and disposing of medications, and what to do in case of an emergency or overdose.

Overall, the paxil reassessment seems to be a pioneering effort to selectively reevaluate or validate some clinical research. It will be interesting to see if other journals join this effort and whether their aggregate initiatives someday will improve the reproducibility, credibility, and transparency of clinical research.

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