#SaveJosh is What Patient Engagement Looks Like When Pharma Won't Engage

Failing to engage with the viral plea to provide compassionate use experimental medication to eight-year-old Josh Hardy was a maddening, self-destructive disaster for the pharmaceutical industry. When #SaveJosh trended top 5 on Twitter, the public wasn't just engaged with clinical research, they were really, really engaged and pharma was silent. Whether or not to give the child the experimental medication is an excruciating and gut-wrenching ethics muddle in itself. The topic of engagement is about the conversation. It is about the hundreds of meetings and millions of dollars trying to get the public engaged, but then being completely silent when they were. When people are in pain and need to hear from you, silence is contempt. Ignoring the public wasn't just pharma stabbing itself in the foot, it was pharma stabbing the customers in the heart.

On Monday, the typical news report* contained little information beyond the fact that the child's doctors wanted the drug, everyone wished it might save his life, and the finger pointing to Chimerix in Cary, NC. Even if a news outlet had wanted to provide more context, where were they going to obtain it on the viral news cycle?

Major media reported that Chimerix provided a link to this ethics document [PDF] from BIO. That's great if you are writing a term paper but completely irrelevant as a reply to viral breaking news. Chimerix is a 55-person company that does not have the resources to both engage in the business of responding to the core situation, as they were doing, and also respond to the public outcry.  The term paper was the best they could get their hands on.

BIO and PhRMA are large organizations formed in part to advance the voice of their members, but they have yet to find a voice that can respond to social media engagement. They may think they respond. Both organizations have large websites with lots of stuff. But is that stuff contextually available information for social sharing? Go to each website and see if you can find what they would like to see quoted in a blog post about compassionate use.

Remember, you are a blogger who has no background information on compassionate use, you are outraged about the #SaveJosh story (Facebook link, Twitter feed link- can be viewed without a Twitter account), and you are giving BIO and PhRMA the gift of a few minutes of your time and the opportunity to be heard as you write an impassioned plea to your readers. The organizations could have alert boxes reading "Background information related to current news trends" on their front pages, but they don't. Instead, the search bar on BIO doesn't even turn up the term paper. The search bar in PhRMA turns up a long list of irrelevant material.

That blogger who really wanted to provide his readers with background information and context? He couldn't get it from these organizations.  If the blogger searches for compassionate use on Google, top returns are from the FDA, Wikipedia and some patient and disease advocacy organizations which provide information on how the compassionate use process works but do not anticipate the level of engagement where the reader starts to ask ethical questions.

The workers of pharma development were the people who engaged on the human-to-human level, providing that context anonymously and often against company policies. Self-described pharma insider "Liz in Seattle" posted a long and thoughtful explanation of the ethical issues as a comment on the CNN version of the story. Her comment was appreciated with more than 4,000 likes, stayed as the top comment the entire day of the crisis and remains there today. She even came back several times to answer questions and provide even more engagement and context. On news report comment sections, blogs, chat boards and social media channels across the country, it was people like Liz in Seattle helping the public develop their understanding of this extremely painful story.

[What do you think? Should viral stories be engaged? When the viral story is about very small biotech, who should engage?  Let me know in the comments.]

The people of Chimerix have surely been through the wringer, but you can't tell that from their website. The website URL has been posted countless times in the last week, yet aside from press releases their website is unmoved and unchanged. The link to the BIO ethics article, reportedly provided to the media, isn't there for direct communication with the public. The email address for a compassionate use program that reportedly does not exist, which so outraged social media, is still there without any additional context provided.

Throughout the crisis, Chimerix chose to use neither their website nor their Twitter feed to communicate directly with a public that was communicating directly with them. They relied on the news media to tell their story even though thousands of people received the message to go to their website.  Outdated news media-based PR in 2014 becomes a Kafkaesque game of telephone: instead of addressing the people right in front of you, you whisper what you want to say to your PR rep, who in turn whispers it to authorized news media outlets, who then are way over there blaring something that may or may not have anything to do with the input you gave them.  But this whole time time public is sitting there staring at your website and your Twitter feed demanding an answer from you: Why not direct your response to them?

Would it have mattered if Chimerix had put an alert box on the front page of their website simply acknowledging the social media outcry at the height of the crisis? The company wasn't unmoved; I have no doubt that the CEO is not heartless. For a company without the resources to bring their website up-to-date and relying on old-fashioned PR methods, the smallest possible direct communication intervention, the alert box, would help communicate transparency, openness and humanity.

Meaningful response materials from BIO and PhRMA will help improve public engagement. Of course, that means accepted that the educational material is as useful to a small biotech trying to explain its decisions as it is to a small movement like #SaveJosh trying to shepherd its supporters through an educational process. Real engagement means the tools of communication serve everyone.

Posting material on social media at the right time so that communicators at all levels can find it contextually would help. This wasn't the first compassionate use crisis and it won't be the last. No one can claim that these industry organizations are unaware this material is needed. The problem is that pharma has been so focused on what kind of engagement we can get out of the public that we've dropped the ball on what kind of engagement we can give.

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*The typical news report has since been updated with more context without providing an audit trail to original versions. When making a call for transparency, I'm looking at you too major media.

Graphic background photo credit: Unknown Photographer, Dr. Lance Liotta Laboratory, AV-8803-3199 March 1988, US Government Public Domain

Version history: 17MAR2014 9:15AM Two grammatical errors updated.

How to protect the study blind with unblinded site staff and monitoring.

Study blinding is a complex topic administratively, scientifically, psychologically and philosophically.  The double-blind is the "gold standard" of clinical research, but often for reasons of persuasion and sales as much as for reasons of scientific exactitude. Meanwhile, the growing body of information and network effects available to both medical personnel and patients makes blinding more difficult than ever, and a growing variety of products, especially biologics, are more difficult to to successfully blind.

In 2009, I created a presentation for the SoCRA Annual Convention that year that was half philosophy and history overview and half administrative advice for how to protect blinding by segmenting off unblinded study staff and unblinded monitors and study management. Attached is a SoCRA Source article that I wrote after the 2009 presentation, and the current slide set from a more recent iteration of the presentation.

I think this presentation continues to be requested because dealing with complex blinding protections continues to be a footnote to clinical research administration.  The textbooks from my MSCR program did not mention it, and I know of no widely used clinical research management programs for sites or sponsors which included task support for unblinded study management.  Future blog posts will touch on why this might be.

The documents:

Article PDF: D'Rozario, MKD. (2011, February). Unblinded monitoring programs: Design and Education. SoCRA Source. 70-75

Unblinded Monitoring Programs from Mary D'Rozario (Select "Slideshare" to get the option to download the slides in Powerpoint format.)

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Post by Mary D'Rozario originally posted to the CRP Blog.

Blog Interview at BBK Worldwide

If you were at DIA 2012, BBK Worldwide was the company that took over with their awesome T-shirt give away. You can buy the t-shirts off their website for other events- "These HIPAAs don't lie" and others.  And I got paid absolutely nothing to tell you that. This is a company that knows how to mobilize excitement and interest, so I was thrilled when they invited me to do a blog interview about the challenges and successes of clinical research sites.  You can read the interview here.  And those t-shirts?  Here.

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Originally posted by Mary D'Rozario on the CRP Blog.

One Tiny Change Saves Time and Aggravation When Answering Queries

If I could help study coordinators absorb just one take-away from my MAGI West presentation on data management for sites it would be this:

Solve the query, THEN answer the query.

Did you know that a lot of automatic queries will simply disappear if you do this?  That's right, you won't ever have to answer them at all.

There are other good reasons to make this process update, starting with the fact that the study coordinator is the subject matter expert on their subjects.  The query is merely a red flag- it can cite unexpected data or inconsistent data, but it can't tell a study coordinator or investigator what the correct data are.  Only the subject source record and the judgment of the investigator can tell you this.

So solve the problem first, then respond to the query with a good explanation of what you did.  Solving the query before you answer the query will increase the likelihood you have given a full, complete and correct response to the query.  It will decrease the number of re-queries.  It will increase the quality of communication between the study coordinator and the data managers.

One way this works is by returning the focus from the communication in the query to the data on the page.  Query communication causes a lot of difficulties because study coordinators and data managers are coming from very different places, not just in terms of professional experience but often in terms of fundamental personality differences.  They see the world differently, so conflicts are inevitable when they try to partner to simplify a real-world interaction into a data listing.

It's impossible to beat this one improvement for return-on-investment (it's such a tiny change!), however there are additional process improvements which will improve the site's experience of data management.  Some of these improvements are about increasing data quality to start with, and others are about understanding some hidden rules in what data managers are looking for.

Here is the expanded Slideshare version of the MAGI West presentation (and all my Slideshare presentations are Creative Commons licensed for use in entirety and with attribution- so you can copy and use this presentation wherever you like):

Strategies for Dealing with the CRF from Mary D'Rozario

Is the patent cliff going to ruin my life?

This is the question a lot of clinical research professionals keep asking themselves. The bad news is clear: the most valuable set of drug patents in history will expire in 2013, major pharma will lose 90% of that revenue, and there are no new blockbuster drugs to fill in the gap. Meanwhile, clinical research is getting more complex and more expensive, and to top it all off the Affordable Care Act is anticipated to result in a short-term reduction of the remaining revenue of drugs under patent of around 10%.

So how about some good news:

• We are at least half-way through the patent cliff already.

• The long-term stock price may not be irrational. Because we are waiting for the sky to fall, it can seem like major pharma stock prices have not accounted for the patent cliff. But what if stock prices did account for it, just over the 20 year patent life instead of all at once? Go to Yahoo and run an all-history of the top four pharma and you will see the possibility.

• Pharmaceutical stocks have a comparatively low price-to-earnings ratio, making them attractive compared to other sectors.  This attractiveness is especially relevant in the case of an economic downturn sparking a flight to value.

• The largest pharmaceutical companies have enormous cash reserves- on the same scale as the total patent cliff.

• Pharmaceutical development remains an attractive bet. The investment pool and the people associated with it who already took their loss on pharma may not be back, but there is an endless line of people right after them. If you could take a flier on being a multi-billionaire, would you? So would a lot of other people.

It isn’t possible to predict the future, but as we try to assess the health of the industry we do well to remember that the “plus” column is not empty.