Eye on FDA

World AIDS Day - Past, Present and Future

It is hard for me to believe that it is nearly 30 years ago that the AIDS epidemic first surfaced in what were considered the "epicenters" at the time in the U.S. - New York, Los Angeles and San Francisco. I graduated law school in 1981 and at about the same time, people started getting sick. One of my law professors died a few months after I graduated of a disease that still had an indeterminate name.  

The following year, one of my friends invited me to a meeting of a bunch of lawyers who were getting together to help people who had this new disease - many of them were being thrown out of jobs, houses, hospitals and just about every other place you could be thrown out of.  Almost all of them were dying within a few months of being diagnosed with an opportunistic infection that, up until then, no one had ever heard of - so wills were in high demand.  And there were insurance problems.

In 1985, the legal program had become more formalized and I became the Director of Legal Services at the Gay Men's Health Crisis, which provided a range of services for people with AIDS.  I started as the only lawyer on the staff and had a fleet of volunteers to help do the work ultimately for over 3000 clients.  I was one of 18 employees when I started work there and today, only a few of us are left alive.  

It is difficult to characterize the darkness of those days.  One discovered one's infection at the same time one discovered their diagnosis with AIDS, not usually by virtue of having taken a test. Mortality was broad and deep and swift.  Discrimination was harsh.  Families often fell apart.   And people tried all sorts of homemade remedies involving tea and mushrooms and cucumbers and I can't remember what else - remedies that came from all over the world - in a hopeless attempt to escape.  

A long time passed before there were any effective treatments and many, many good souls were lost along the way, some of whom are daily in my memory and thoughts.

In 1996, there was finally progress when treatments made it to the infected that actually could make a difference.  And I recall the day so well, when I remember the world changed.  It was in Vancouver at the XI International AIDS Conference.  I have said before and will say again how amazing it was to stand in the audience during a presentation by Dr. David Ho and to hear him utter the phrase "eradication of the virus" - a concept that many of us who had been working in AIDS had not dared to even think possible anymore.  For me, that is the moment when the world became a different place entirely.  

Of course, the virus has not been eradicated and is with us still today.  The epidemic became a pandemic and spread wide and deep.  But today, many children are born without the virus to mothers who have the virus, and many people are living who otherwise would not be, but for the treatments that were developed and distributed, thanks in large part to a global dedication to save lives by providing access.  

The pain of those first years of the AIDS pandemic without treatment are haunting.  The success that has been realized with the widespread access for the infected to treatment must continue and must be sustained.  Sustainable access has been called into doubt.  But it should not be.  Because while the lack of treatment in the 1980s was one kind of hell, but lack of treatment in a time when treatments in fact exist, is another kind of hell altogether.  All nations need to step up to the global challenge of HIV and enhance access for the future.  

Another Potential for Semantic Search - The Google Wheel

The week before Thanksgiving, I wrote a post about a great new example of evolving semantic search citing an example provided by LinkTV at their newly launched ViewChange.org site.  The point is worth raising because the semantic web may be the next generation of search and if so, there are plenty of things for everyone in health care to think about with respect to how it might more specifically guide patients, caregivers and physicians seeking both information and community on the Internet.

Today I want to point out another potential tool that is in its infancy in this regard, but has the potential to develop into another type of powerful search tool that provides more context to search than occurs today with a simple search.  It came to my attention when I attended the Google Think Health 2010 in New York at the end of September.  

It is called the Google Wonder Wheel.  Wonder Wheel is available when you perform a simple search on Google and you get your page of results.  To the left you will see a bolded heading called "All Results" and under that heading you will see "Wonder Wheel".  If you click on Wonder Wheel, you will see your search put up on the screen with several offshoots that allow you to explore specific topical areas related to your search.  Here is one I did using the search term "diabetes"  - 

What you see is that in the center, you have the Wheel with its many options for you to consider.  To the right, you have some more resources related to diabetes as might show up in your regular simple search to which you are already accustomed.  Here is the Wheel close up:

Here on this search, one sees different types of diabetes as spokes, along with information on diet. The Wonder Wheel presents some interesting possibilities and questions.  How are the topical areas for the spokes chosen?  Can they be optimized in any way?  How does a wheel provide a balance of choices with a search term as broad as diabetes between treatment and prevention and resources and advice?  And, of course, are there any regulatory aspects to be considered here and what are they?

Healthcare is one of the main reasons people use the Internet and search, yet the medical products industry is ironically far behind other sectors in anticipating new developments and responding to them, due in no small part to the lack of regulatory clarity in this space.  However, advancements aren't waiting.  It is possible that semantic search may one day assume a more prominent role and it is a good idea to explore now, rather than catch up later, how the health care industry might utilize this new tool.  

Happy Thanksgiving!

I'm taking the rest of the week off.  

But I wanted to take a moment to say thanks to all of you who are subscribers and frequent readers of the blog.  I am quite surprised by the number of subscribers and by all the people who visit each day and I'm much obliged for your interest and encouragement.

I wish you all a very Happy Thanksgiving, and for the 20% of readers who are outside the U.S., just have a good week and be well.  In intend to put on a few pounds.... 

Best,

Mark

 

FDA MedWatch Opens Twitter Feed - Can Pharma Re-Tweet?

I got a heads up from a good fellow on Twitter this week that the FDA had begun a new twitter feed from MedWatch called, of course, @FDAMedWatch.  MedWatch is a service set up by the FDA to alert the public to safety information about products over which it has jurisdiction, including drugs, devices and biologics, about safety issues or adverse events.  This makes a total of 8 twitter feeds from the FDA, all of which are contained on the Eye on FDA listing of FDA feeds.

That is a smart move on the part of FDA, and probably late in coming.  Having a twitter feed is one of the fastest ways to spread news - it is free, it is easy and it is highly targeted to reach people who care about what you have to say .  You not only reach your friends, but your friends' friends.  It is what I call the Twitter Echo Chamber.

Back in March 2009, when I interviewed the FDA via a podcast about their position on regulating social media, it was the first time the agency had said anything about the topic.  At the time I only had about 750 twitter followers (today, thanks to my 3678 followers!).  I sent out a tweet that let people know about the podcast and asked my followers to re- tweet the message.  If my memory serves me correctly, about 46 of them did within a few hours.  I actually went and tallied the number of followers that each of them had and added them up.  It numbered nearly 10,000 people.   These, of course, weren't any people, they were mostly people probably pre-disposed to being interested in the information, because they were following people who were following me.  That is the beauty of social media.  You don't have to advertise to the 5,000,000 to get to the 10,000 who you need to hear your message, you just get directly to the people who matter to you.  Today, the second generation of followers of my followers numbers extraordinarily high, as probably do your's.  

For that reason, a  number of pharma companies have also started Twitter feeds, as documented by Jonathan Richman's social media and pharma Wiki at Dose of Digital.  In fact, a lot of pharma companies have embraced Twitter on multiple levels, including for the recruitment of new staff. And it stands to reason that a number of people who follow them on Twitter are people who use their products.

Let's make up a hypothetical here.  Let's say drug XYZ made by MonCom (Monster Company) is approved by FDA for the treatment of a cardiovascular ailment, but also has an indication for treatment of Type 2 diabetes.  Let's also say MonCom is on Twitter and their feed is followed by both heart groups and patients, and Type 2 diabetics and their patient organizations.

What would happen if FDA's MedWatch twitter feed issued an adverse event report that was particular to one indication for drug XYZ - the one for Type 2 diabetics.  So something like "Adverse event associated with XYZ drug for Type 2 diabetics".  Could MonCom re-tweet the FDA's MedWatch Tweet?

Hmmm.  What would MonCom's Regulatory folks say about that?  The company would be re-tweeting a tweet that carries the name of the drug and the indication without the additional information about risk.  Would a company risk a Notice of Violation letter by re-tweeting the FDA tweet about an adverse event associated with their own medical product?  They would be performing a public health service but possibly incurring a technical violation.   And DDMAC  is all about the technical violation.  Yet if they don't re-tweet the FDA MedWatch tweet, then it is possible that a number of their Type 2 diabetic patients might not see the adverse event report.  

To tweet or not to tweet?  I leave it up to you.  But it is just one more indication of the type of predicament that is created when the agency that regulates communications in a rapidly changing environment does not keep up with the times.  And speaking of keeping up, isn't it almost past time for the first installment of the guidance from FDA on the regulation of the Internet and social media?  DDMAC has long promised it this year, though has also said that it could not be guaranteed.  We are waiting to see if MonCom should hit the SEND button and send out the FDA MedWatch alert....

LinkTV Launches New Semantic Search Tool in Global Development - Pharma Should Take Notes....

(By way of disclosure, with this post I am doing something unprecedented by writing about a project and subject involves a client (LinkTV) with whom I have worked and a project in which I had a very tangential hand.  I have chosen to do so because I think that the implications of the technical development of a resource such as this has potential implications on a much broader scale than this project.)

There are two stories here.  

The first is about global development and global public health and a new Web -based resource that is being launched today by Link TV called ViewChange.org.  It is a collection of highly searchable video content that follows progress being made in reaching the United Nations Millennium Development Goals.  If you are interested in global development and international public health issues, it is a treasure trove.

But there is another story - one that I think is riveting for those seeking to provide a complex range of information to a target audience.  This story is about the technical structure for housing video and a search element that sets it apart in terms of what is provided to the user.  That is because the search tool used on ViewChange.org employs semantic properties that takes search to entirely new levels.  And those in healthcare should pay attention, because this combines aspects of what many in pharma are trying to do with patients right now.  The only problem is that to do so, industry is using multiple platforms such as Twitter, Facebook and YouTube to reach the patient with information and support.  With semantic search, much more is possible.  

What do I mean by the semantic properties of search?  I mean that when you search for material on this site, it provides you with much more additional context than you would get in an ordinary search.  On this site, you search for video.  But what you get is much more.

That is because as you search for video on this site, what you will get in your search result is not only video that is tied to the subject matter of your search, but you will also get references to other videos on the Web that might be of interest to you as a result of the subject of your search.  The site reaches outside of itself.  In addition, you will get news articles about the topic for which you searched.   In other words, the user now has video, news, prompts where to "take action" and references to other video.  

Here is a quick walk-through of the way it works.  This is the landing page for ViewChange.org.  Notice that the wheel of video topics includes one that says Health.  I'm going to click on it....  

The next page takes me to videos that are solely about health and in parentheses you can see the number of videos available in each category.  You can see in the red circle that I've drawn here, that you can narrow your search in healthcare down, by either disease topic or even geography.  

I've narrowed my search by disease, having chosen the topic of HIV and as a result, there are several different types of HIV topical videos ranging from a talk by Melinda Gates to videos that focus on specific projects.  I'm going to choose a video called "Fighting HIV".... 

What I get as a result is not just the video, but a host of other resources.  Note that in the first red circle, there are tabs that will take me to (1) watch other videos on ViewChange.org about HIV; (2) to see about HIV in the news; and (3) to connect with organizations that are doing something about fighting HIV in the developing world.  In the second red circle, you will find referrals to videos out on the Web that also have to do with fighting HIV.  

Compare that with a search on YouTube, and you get why this is exciting.  But it isn't just about video.  Right now, some pharma companies have embraced social media to develop relationships with patients and consumers by providing resources for them through a number of platforms.  For example, J&J which has been a forerunner and pace setter in the field of social media and pharma communications, has a huge video library set up on their site spanning a number of topics.  At the same time, they have Facebook affinity pages set up for specific conditions and diseases where there is a provision of resources, and the company runs a blog.  Other pharmas have some interesting YouTube channels while others have some that barely hang on.

To me, the future looks more like ViewChange.org - a more comprehensive one-stop shop that puts context to my search for healthcare information.  For example, let's say I am a newly diagnosed patient with a condition - prostate cancer.  I go to a site that was perhaps sponsored by a pharma company where I can find not only videos about prostate cancer, but links to the latest abstracts from medical conferences, links to support organizations, links to advocacy organizations, special treatment centers all organized under headings that I can pick, chose and customize.  All of that is included in my search, along with a window that allows me to see real time search results appearing on my search topic - the latest being said on Twitter, Facebook and on blogs.  That, in my mind, is the next generation of patient support search and a site like ViewChange.org both sets a new bar for the provision of Web based resources and lays out a whole new paradigm.  That is the face of semantic search in healthcare.  

The ViewChange.org site was funded by the Bill & Melinda Gates Foundation.