Thursday, March 22, 2012

EASL-Decision to amend the abstract availability and embargo policy


The European Association for the Study of the Liver-EASL held in Barcelona will begin on April 18th. The meeting has become an important window into clinical research for the now savvy HCV patient, who each year looks forward to the conference.

This year the meeting has caused a bit of controversy (read more here and here), from the delay of abstracts posted on the EASL's website, to early availability of research abstracts to selective journalists. One such journalist Adam Feuerstein wrote about the unfair policy and for the most part was behind the policy change, he writes for investors at TheStreet.

The controversy over the policy, in particular those journalists who write for investors may not be a concern to patients, but it should. Information from the meeting presented to investors is easy to comprehend which becomes an asset to everyone.  Exciting research on the new experimental hepatitis C drugs presented at the EASL is useless to the HCV patient until it can be understood and applied to future decisions on possible therapy strategies. Those days of patients idly sitting by waiting for a physician to lead them through a course of treatment are long gone. Today, people living with this disease have become their own advocate, with the help of accessible HCV information online and coverage on clinical research presented at these conferences.

The information presented at the EASL is only viable to the HCV community when an author converts the data into information that can be digested by the average patient. We unfortunately lack a pool of authors available to us which break down conference information. The online resources consist of a few sites which are not all encompassing hepatitis C sites, they are Medpage and Medscape.

Thankfully, we still have a handful of comprehensive hepatitis C websites, with incredible authors, including HIV and hepatitis which offer readers a break down of meeting data. We also have CCO, and  NATAP where commentary or full studies are available to view. Coverage and updates can be found in a monthly newsletter from  HCV Advocate, with easy to read snapshots of the meeting. The downside is waiting for these invaluable sites to publish updates. As the anticipation builds we find coverage elsewhere. I personally read everything written by Adam Feuerstein, right along with the sites investors.

Today at TheStreet the author reports on the policy change (or his policy change) in an article titled  "EASL Backs Down, And Will Publicly Disclose Key Hep C Data"

He writes;

In a total reverse of its previous policy, EASL said Thursday that research abstracts for its International Liver Congress, taking place April 18-22 in Barcelona, would be made publicly available online on April 4. Clinical data in the abstracts will not be under embargo, meaning journalists will be allowed to report on them.

"EASL is making these changes in light of recent criticism of its proposed policy, which suggests 'selective distribution' of officially accepted clinical data in advance of the Congress would make our proposed embargo policy untenable," EASL said in a statement issued Thursday.

So there you have it, in my opinion, a little change by the EASL, all because of one journalist.

Please do read Mr. Feurstien's future and recent EASL articles here. 

Additional information on the policy change is available at Embargo Watch

EASL Press Release

Online posting of abstracts delayed due to review of abstract policy

International Liver Congress™ 2012: EASL Updated Embargo Policy: Abstract Release Suspended Until Wednesday 04 April 2012

In response to concerns raised with EASL's abstract availability and embargo policy for the International Liver Congress™ 2012, EASL has taken the decision to review both policies and will delay making the abstracts available online until two weeks in advance of the opening of the Congress - Wednesday, 04 April 2012.

EASL is making these changes in light of recent criticism of its proposed policy, which suggests that "selective distribution" of officially accepted clinical data in advance of the Congress would make our proposed embargo policy untenable.

EASL accepts that we must address this issue, and we acknowledge the efforts of several individuals to draw this to our attention.

To preserve the integrity of The International Liver Congress™ 2012 for our members and industry sponsors, the EASL Secretary General has made the decision to review and amend the abstract availability and embargo policy.

As such, abstracts will be made publicly available on the congress website two weeks in advance of the congress and will not be under embargo. Abstracts selected to be highlighted during official EASL Press Office activities or in official EASL Press Office materials will be made publicly available on the congress website at 1800 (CET) on the day of their presentation, and are under embargo until the date and time of their presentation.

Authors of abstracts selected to be highlighted during official EASL Press Office activities or in official EASL Press Office materials will be informed of their selection this week.

*UPDATED International Liver Congress TM 2012 EMBARGO POLICY  
Source - EASL

International Liver Congress™ 2012 abstracts will be made publicly available on the congress website two weeks in advance of the congress - Wednesday, 04 April 2012. Abstracts posted online on Wednesday, 04 April 2012 are NOT under embargo.

Abstracts selected to be highlighted during official EASL Press Office activities or in official EASL Press Office materials will be made publicly available on the congress website at 1800 (CET) on the day of their presentation at the congress. Abstracts selected to be highlighted during official EASL Press Office activities or in official EASL Press Office materials are under embargo until the date and time of their presentation at the congress.

On Wednesday, 04 April 2012 industry may issue a press release announcing that their abstract has been selected for inclusion in official EASL Press Office activities or in official EASL Press Office materials (abstract title only). Industry must not issue press releases ‑ even under embargo ‑ covering the data contained in abstracts selected to be highlighted during official EASL Press Office activities or in official EASL Press Office materials until the individual embargo for each data set lifts.

Media must not issue coverage of the data contained in abstracts selected to be highlighted during official EASL Press Office activities or in official EASL Press Office materials until the individual embargo for each data set lifts.

Journalists, industry, investigators and/or study sponsors must abide by the embargo times set by EASL.

Violation of the embargo will be taken seriously. Individuals and/or sponsors who violate EASL's embargo policies may face sanctions relating to current and future abstract submissions, presentations and visibility at EASL Congresses. The EASL Governing Board is at liberty to ban attendance and/or retract data.

Copyright for abstracts (both oral and poster) on the website and as made available during The International Liver Congress™ 2012 resides with the respective authors. No reproduction, re-use or transcription for any commercial purpose or use of the content is permitted without the written permission of the authors. Permission for re-use must be obtained directly from the author.

The bottom line? Journalists will begin coverage thanks to Mr. Feurstien on April 4th. 

*The data presented at the EASL should be considered preliminary until it has been reviewed and published in a peer-reviewed publication.

When studies are completed, the results are often presented informally at meetings arranged by a sponsor, or manufacturer, of a drug. In addition, preliminary study conclusions and some of the data may be presented at medical meetings and published as an abstract (a very brief synopsis of the study). The most comprehensive information comes from research articles published in medical journals after peer-review. Peer-review means that the paper is reviewed by two or three independent physicians or investigators with no relationship to the study authors or sponsors. In addition, the editor and associate editors of the journal also carefully review the research study methods and conclusions. These peer-reviewed studies, when published in a prestigious journal, carry great weight. The FDA also reviews every piece of the original data from the clinical trial in detail before approving a new drug for use. Every single patient record is scrutinized to confirm the accuracy of the data and the statistical analysis.
 Source-Continue Reading At HCV Advocate


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