Which Way on the Public Health Narrative on Zika?

Back in February in a post entitled “From HIV to Zika – The Role of Communications“, I listed several of the hallmark characteristics involving the communications environment and emerging pathogens, drawing not only on recent observations with respect to Ebola, Avian Flu and other public health threats, but from deep experience in HIV thirty years ago.

One of those hallmarks – the first actually – was that in an environment where more is unknown than known – conflicting information can thrive.

A singular focus of many in public health has been the staging of the 2016 Olympic games. We are 85 days away from the opening ceremony. And of course, Brazil has experienced an outbreak of Zika infection, the consequences of which have been shown over and over again in news reports.

This week the Harvard Public Health Review carried a special commentary – “Off the Podium – Why Public Health Concern for Global Spread of Zika Virus Means That Rio de Jeneiro’s 2016 Olympic Games Must Not Proceed“.  In it, listing five reasons as the basis for its conclusion, the article states -

“Simply put, Zika infection is more dangerous, and Brazil’s outbreak more extensive, than scientists reckoned a short time ago. Which leads to a bitter truth: the 2016 Olympic and Paralympic Games must be postponed, moved, or both as a precautionary concession.”

Also this week, The Lancet published an editorial “Zika Virus at the Games: Is it Safe?” Citing four specific reasons for its conclusions, the editorial concludes -

“…unless new data emerge before August, we can say that compared with the risks usually associated with travel, such as gastrointestinal infections (on which we have written previously), traffic accidents and falls, Zika virus represents a minimal threat to games visitors.”

Both articles articulate a convincing case and demonstrate the challenges that non-experts, as well as experts, are going to have in educating members of the public about the potential threat posed by Zika – in Brazil during the games and in the U.S. during the summer and beyond. Beyond the games, policy will have to be developed – both by federal, state and local governments and in the private sector – and that policy will be reliant on the opinions of public health experts. The fact is the task of policy-making may be vastly more complicated given there may not be absolute agreement in assessing the risks. A lack of clarity may make it harder to shape a public opinion which may be informed by mis-perceptions, misinformation and among some, a real skepticism about yet another public health threat.

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Weekly Roundup 4.29.16

Goodbye April. It was nice knowing you.

There were a lot of noteworthy developments this week and I would like to write about them all, but as usual, will pick only a few from the bunch.

  • FDA Issues Complete Response Letter for First Digital Medicine – In September 2015, two companies announced they were submitting an NDA for the first “digital medicine” – a combination product of an FDA approved medication with an embedded sensor. In this case, the medication was ABILITY, approved for the treatment of several mental health conditions and it was being combined with a sensor that would, among other things, measure adherence.  This week FDA issued a complete response letter regarding the application, according to the companies, indicating that the agency would like to see further data regarding the performance of the product under conditions in which it would be used.
  • Lawsuit Brought Regarding Advisory Committee Redacted CVs - Public Citizen announced this week that the organization had brought a lawsuit regarding redacted Curricula Vitae of FDA Advisory Committee members. As any regular reviewer of these CVs will know, information regarding specific details of an individual advisory committee member’s information is often redacted – some of it personal information, some of it associated with grants. Public Citizen makes the point that confidential information is not generally included on documents that are in fact meant to be shared.
  • First Commercial Zika Test Approved – There will be an increasing amount of news about Zika in the coming months. Ironically while this week there was the first U.S. death reported in the media attributed to infection with Zika occurring in Puerto Rico, there was also an announcement that the FDA had authorized the first commercial test for Zika for emergency use. Until now, testing was only available through the CDC and using specified labs but the new test will be made broadly available next week throughout the U.S.

That’s it for me this week. Have a good weekend everyone.

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What Pharma’s Are Doing on Periscope – Update on the Landscape

If you have Periscope on your phone, you may find yourself doing something and all of a sudden, hear a little whistle that is the sound cue to let you know that someone you follow has gone live. I set up an EyeonFDA Periscope handle quite a while ago, with the idea that it might be fun to interview people at conferences or even Advisory Committee meetings or to film the actual Advisory Committee vote. I haven’t used it yet, but I do have 178 followers!

Back in November I did a check in on how involved pharma was on Periscope (See Upscope! Pharma, Periscope and Some Regulatory Questions). I examined the top 25 companies by sales and found that 10 of them (40%) had developed a Periscope handle. Now instead of just doing a check, I have included them in the data base I started that tracks what pharma is doing in social media across several platforms, including Twitter, Facebook, YouTube, Google+, Pinterest and now Periscope. Here is what I found about pharma and Periscope use after going back to the top 25 companies.

  • There has not been a huge increase in the number of companies – I found 11 of the top 25 pharmas have created Periscope capacity – or 44 percent – not quite half;
  • Of those 11, 3 of the companies had multiple Periscope assets, including one that had 5, bringing the total of Pharma-related Periscope handles to 17
    • The company that had five is also a company that has multiple Twitter feeds, so it makes sense;
  • The number of followers ranged from a low of 1 to a high of 978;
  • And this one was a surprise, though it should not have been – it appeared that about half of the Periscope properties were from outside the U.S. – the reason that is not surprising is that of the 294 pharma Twitter feeds I follow, only 128 are U.S. based.
  • There was no finding of a Periscope handle for FDA, despite the many Twitter handles FDA has (you can see them all at work here).

So it does not appear that there has been explosive growth in the development of Periscope feeds, there is a continued dabbling by pharma. As for the regulatory issues raised in the November posting, no movement there.

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Weekly Roundup 4.22.16

A few weeks ago it was snow, now it is pollen – laden everywhere. Dogs, cars, outdoor seating, all covered in a fine yellow haze. Or is that me?

I have had such a busy week that the result has been no postings between the last Weekly Roundup and this one and for that I am sorry. Sometimes life just speeds up. Here are a few things I did note in passing however:

  • FDA Biosimilars Page – In the wake of the second approval of a biosimilar (covered a few weeks ago in EyeonFDA), the agency has been gearing up to educate stakeholders about the category. Currently on the landing page of the FDA website carousel is a link that takes you to a page entitled “Biosimilars: More Treatment Options Are on the Way“.  The page contains an overview of the most recent approval, a resource to sign up for updates, and also links to learning more about biosimilars. One of the links is to a page entitled “FDA 101: Regulating Biological Products“, including a delineation between CDER and CBER overview,  but no mention of the naming issue regarding biosimilars and it appears the page has not been updated for a long time. So more organization around education of biologics given a new potential era of biosimilars, but the material is some old/some new.
  • Agency Launches Smokeless Tobacco Campaign - FDA announced this week an expansion of a campaign called “The Real Cost” in 35 markets aimed at white, rural youth to carry warnings about the consequences of smokeless tobacco use, highlighting risks of gum disease, tooth loss and oral cancer. The campaign is integrating its approach including paid traditional media approaches as well as a social/digital effort. The campaign is part of a broader effort to educate at risk youth on tobacco use.

That’s it for me this busy week. I hope things slow down a bit. And by all means, have a good weekend.

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Weekly Roundup 4.15.16

It seems safe to say we are officially done with snow. Winter is finally at our backs. In the rear view mirror. Yes, we have shifted gears into that very, very short time of the spring – at least here in the Mid-Atlantic region – when you can wear a smart cotton sweater. Earlier it was too cold. In a few weeks it will be too hot. So this is the very narrow fashion window. It is a new day.

But it is the old week and we are at the end of it. This week we had a new approval in oncology, reports of a banner year in generic approvals, and an update to Zika news and new progress against an old killer.

  • FDA Approves CLL Treatment - The agency announced the approval of Venclexta (venetoclas) for use in the treatment of patients with chronic lympohcytiuc leukemia (CLL), one of the most common forms of leukemia in adults, who have a chromosomal abnormality called 17p deletion, ascertained through an approved companion diagnostic test, and who have been treated with at least one other prior therapy. The drug targets a protein that supports cancer cell growth and is overexpressed in many patients with CLL. Venclexta had breakthrough therapy, priority review, and accelerated approval as well as orphan drug status.
  • Banner Year for Generic Approvals – The good folks at the Regulatory Affairs Professionals Society (RAPS) reported this week that with over 700 approvals and tentative approvals, the ok for generic drugs hit an all-time high during 2015. As is well known, the more generics in a category that are on the market, there accordingly is a downward pressure on the price and as RAPS noted in their piece, generic drugs account for 88 percent of all prescriptions written on the U.S. This follows a year in which approvals for new drugs was also in full gear.
  • Zika Developments of Note - As regular readers may deduce, I believe that as we approach summer, the unfolding developments related to Zika are important to note and so from time to time here, newsworthy updates may be provided in the Weekly Roundup. This week, comments from CDC indicated that understanding of the impacts of Zika were unfolding and that more clearly demonstrated links between the virus and potential effects on those it infects, including the phrase that Zika was “scarier than initially thought”. More evidence appeared regarding the sexual transmission of Zika.
  • NIH Maps Gene for Pneumocystis – In the earliest days of the AIDS epidemic in the 1980s, there was no test for infection and one of the signs that gay men everywhere tried to self detect was whether or not they were experiencing a shortness of breath. That is because it was a symptom of one of the worst opportunistic infections brought on by a compromised immune system, pneumocystis pneumonia. As one of the more prevalent opportunistic infections, it killed thousands but culturing it in the lab to research it evaded science. This week NIH announced that it had sequenced the genome which, the agency said, could facilitate efforts to culture the organism, facilitating the pathway to screen for effective treatments.

That’s it for me this week folks. We are in store for a beautiful weekend and I hope wherever you are, your’s is as well, indoors and out.

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