Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘Health Journalism’

IFDA Logon the first part of his interview, Dr Jenkins shared with Biotech Strategy Blog the FDA perspective on what constitutes a breakthrough drug? Given he is one of the senior managers at the FDA and sits on the committee that decides whether to grant or deny a company’s breakthrough therapy request, his opinion counts.

In the second and final part of the interview, Dr Jenkins discusses the advantages and benefits of the Breakthrough Therapy designation, as well as some of the challenges the agency faces in administering it.

Receiving a breakthrough designation is no guarantee of FDA approval. Drisapersen (GSK/Prosena), a drug for the treatment of Duchenne muscular dystrophy failed a phase III trial in September, despite having received a breakthrough therapy designation in late June.

In this respect, the breakthrough therapy designation is no different from other expedited pathways such as accelerated approval, fast-track or priority review: you still have to generate clinical trial data from a registration trial that supports the initial promise shown.

What then, does the breakthrough therapy designation mean for cancer drug development? Subscribers can read below the second part of the interview with John Jenkins MD, Director, Office of New Drugs, Center for Drug Evaluation and Research at the FDA:

As many of you know, I previously wrote up on this blog the results from the Prostate Cancer Intervention versus Observation trial (PIVOT) that were presented during the plenary session at the recent American Urological Association (AUA) 2011 annual meeting.

Other science bloggers who were at the meeting also wrote about the presentation (see Scott Hensley’s excellent post on NPR’s health blog).

In fact anyone in the press room at AUA (I had a media pass as a science blogger) could have reviewed a copy of Dr Wilt’s presentation immediately afterwards and written about it.

However, what surprises me is that the data from this trial, which to many was the highlight of the AUA meeting and may be practice changing for urologists, has had relatively little or no pick-up by the mainstream news media.  The only reason I can think for this is due to the fact there is no abstract available, press release or other information for the media to use as reference.  Why is this?

As a scientist it makes no sense to me to present the results of a landmark study in the plenary session of a major scientific congress and not to share the data, especially when the data could have a major impact for men diagnosed with early prostate cancer and the practice of evidence based medicine.  Are urologists seriously supposed to rely on the notes they made from a rushed presentation or blog posts to guide them?

While it is common for abstracts to be delayed till the day of the presentation for groundbreaking or late-breaking research, there is no reason why an abstract with the main findings from the PIVOT trial should not have been released.

A cooperative study sponsored by government institutions such as the VA/NCI/AHRQ should be prepared to disseminate data, or else why present it at AUA?

Instead, the problem may be more due the fact that Dr Wilt, as Scott Hensley pointed out in his NPR blog post, has not submitted a manuscript of the data he presented at AUA for publication, so may be trying not to fall foul of the so-called “Ingelfinger rule” that medical journals insist upon.

This rule was named after the New England Journal of Medicine editor who established it.  In its simplicity, it states that data will not be accepted for publication if it has been published elsewhere.

However, with no disrespect to a full Professor of Medicine at a major medical school who has published numerous papers, it’s unfair to the scientific community to want to have your cake and eat it  i.e. have the glory of a plenary presentation without allowing the scientific community to use the data until you get round to writing a paper.  Clearly, it would have made more sense to have a manuscript in press before agreeing to present at the AUA plenary.

I am also troubled by the fact that what constitutes publication of the data does not include presentation at the plenary session of a major scientific congress.  If this isn’t publication, what is?  While technically a plenary presentation is not a peer-reviewed publication in the sense of having been through the rigors of a journal’s peer-review process (the value of which may not be as much as we believe), there is some implied peer review of scientific merit, or else why would it be given a plenary?

According to the Journal of the American Medical Association (JAMA) policy on dissemination of information, it’s OK to make a presentation at a scientific meeting, but not to disseminate further information to the media or the press.  I’m sorry but this makes no sense to me.  In other words it appears it’s OK for Dr Wilt to present the data, but not share it, but if you were at the meeting you can report it.  However, if you were not at the meeting, then you can’t obtain a copy of what was presented?

You can read the tangled logic of the JAMA policy below, and each journal is slightly different in how it views this:

Presentation of research findings during, or publication of an abstract for, an open scientific or clinical meeting does not preclude consideration of the study for publication in JAMA.

News media reports based on coverage that occurs during the usual course of presentation of a scientific or clinical paper does not preempt a manuscript from consideration for publication.

However, authors presenting papers at such meetings are advised to refrain from providing additional information beyond that covered during the course of their presentation and exchange with meeting attendees.

Yet, here we have the results of a major 12 year study which for the first time establishes evidence based medicine on the use of radical prostatectomy in early stage prostate cancer patients, and nobody wants to share the data with the public?

In the light of the presentation that was made at the AUA plenary and the lack of any further information while we wait for Dr Wilt to submit a manuscript through the peer-review process of a major journal, which can take several months, I think it’s important for this data to be shared.

Since media reports of data presented at meetings appear to not to forego the opportunity of publishing the results, at least according to the JAMA policy, I hope that we will see further news reports about Dr Wilt’s AUA plenary presentation.

The results from the PIVOT study are important to scientists, urologists and men talking to their doctor about prostate cancer.  This data may help them better judge whether they should undertake watchful waiting or undergo radical prostatectomy surgery.  The data slides and Dr Wilt’s conclusions speak for themselves, as you can see in my earlier post.  I look forward to reading the full scientific paper when it is eventually published.

Update May 23, 2011

A webcast with audio and slides of Dr Wilt’s plenary presentation of the PIVOT data is now available on the AUA website.

 

As readers may know, I recently attended the annual meeting of the Association of Health Care Journalists (AHCJ) in Philadelphia. I’m working my way through some posts from Health Journalism 2011 , and at the same taking the opportunity to experiment with new social media tools such as Storify.

So far I have written posts from AHCJ on Massachusetts health care reform and the drug development pipeline.  Tomorrow, I will be posting on nanotechnology and a presentation by Kacy Cullen, Ph.D from the Center for Brain Injury and Repair at the University of Pennsylvania – my highlight of the meeting!

On the last day of Health Journalism 2011 there was an engaging panel on social media and blogging moderated by Scott Hensley of National Public Radio (NPR).

I’m always looking for tips on what I could be doing better, so it was interesting to hear from experienced journalists on their approach to blogging and social media. I decided to use Storify to aggregate many of the live tweets, and in the process shares the tips from the session.

Storify is an interesting new tool in beta stage of development that allows you to capture social media and incorporate into a story and then embed it in a blog post.  Given that Twitter posts are not kept after several days, it’s a useful way to capture Tweets that may otherwise be lost. It also allows you to bring social media together from a number of sources e.g. Facebook, YouTube.

However, there’s room for improvement given the lack of a search feature on the Storify site and to me it seems hard to find stories that others have done, unless you have a link to them. Improved search will be key to success.

I’m also not sure to what extent any content posted on Storify makes it into search engines, or is crawled by bots.  Again, if your content cannot be found, then it’s social media utility is lowered.  However, it’s always good to try new tools and you can read what I put together on Storify from the Health Journalism 2011 session on blogging and social media below:


 

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