Jones Public Affairs blogs

Industry and Government Deepen Relationship to Drive Drug Delivery Solutions

tracy — Mon, 07 May 2012 18:30:44 +0000

Who says you can't teach old dogs new tricks?

Last Friday Washington Post journalist David Brown reported how pharmaceutical companies, including Pfizer Inc., Eli Lilly & Co. and AstraZeneca PLC are providing clinical data to the National Institute of Health’s National Center for Advancing Translational Science on shelved drugs. The goal is to re-evaluate formulations previously found to be safe, but not effective for treating specified conditions and have NIH-funded researchers study findings to test effectiveness in treating other conditions.

The collaboration represents pharmaceutical companies’ efforts towards repurposing resources and past work done for positive gain. It also demonstrates the progression of a closer relationship between industry and government.

When one thinks about the current economic climate this relationship isn’t too surprising.

As discussed by Matthew Herper in a thought-provoking article in Forbes, the average drug developed by a major pharmaceutical company costs at least $4 billion and can be as much as $11 billion. Concurrently, more drug makers have been forced to downsize staff due to poor productivity.

From a drug delivery perspective, the shared commitment to innovation has the opportunity to foster a significant uptick in the amount of discoveries and potential medicines. From a marketing perspective, it will be interesting to see how the successful collaborations parlay into educational efforts and overall evolve the current regulatory landscape.

New Legislation Calls for Increased Transparency, Accountability from the FDA

carrie — Fri, 27 Apr 2012 20:55:05 +0000

U.S. senators Richard Burr (R, NC) and Tom Coburn (R, OK) recently partnered to introduce a new bill designed to improve FDA regulation of drugs and medical devices. The Promoting Accountability, Transparency, Innovation, Efficiency and Timeliness at FDA (PATIENTS’ FDA) Act, would hold the FDA more accountable for its actions, calling for improvements in planning and management processes to forward regulatory science and requiring transparent reporting of annual progress against its own priorities and deadlines.

What this proposal will mean for the future of drug and medical device regulation by the FDA is uncertain. It is clear, however, that a growing number of people feel the FDA requires congressional oversight in order to meet performance standards and fulfill its mission in safeguarding public health. Paul Howard of Medical Progress Today suggests the 55 page bill can be summarized in one sentence: “What gets measured gets done.”

If approved, the bill would require the FDA to publish detailed summaries of its review process, allowing manufacturers to learn from the mistakes of preceding device applications and to build upon existing approvals.

While the PATIENTS’ FDA act may not change the FDA’s tendency to slow innovation, if approved it will serve to organize the FDA’s management practices (something the GAO called for last month) and make public its review rationale and processes, hopefully speeding the approval of innovative science to better care for patients in need.

Announcement of the plan coincides with the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA), set to expire later in 2012.

Three Tips for Improving Communication to Women

tracy — Mon, 23 Apr 2012 19:53:43 +0000

This year’s emerging “War on Women” – detailed by Bloomberg View columnist Margaret Carlson, has increasingly dominated headlines in recent months. Stories have shifted from insurance coverage of birth control to the role of working mothers. What is troublesome, however, are how some serious health issues affecting women have been overshadowed, due to lack of political backing.

For example, the U.S. Preventive Services Task Force recently recommended that women have less frequent cervical cancer screening to avoid over treatment. What was lost in the discussion were the important messages coinciding with this issue and implications of the policy.

JPA provides three tips to improve the messages to women:

Don’t dismiss the science. Too often health conversations are being driven by rhetoric rather than scientists. For example, The National Cancer Institute estimates that more than 12,000 new cases of cervical cancer will be diagnosed in the United States.Yet vaccines, such as Gardasil are available, safe and effective for eradicating cervical cancer.
- Ensuring science is included in health conversations and having trustworthy researchers brings credibility and balance to an issue. It is also important to engage in, and not always step away from what could be seen as controversial, to educate the public about a disease’s implications.
Be nimble with your messages. After a story is covered by the press, it is important that marketers both understand the messages being delivered to women and address the issues head-on.
- For example, shortly after the cancer screening changes announcement, Tara Parker-Pope at The New York Times wrote how women felt the annual gynecologist appointment had lost relevance. This is an important finding from an influential reporter – and messages should ensure this new issue is being addressed.
Keep it simple. Last week Dr. Oz contributed a great article for TIME that discussed why the new task force guidelines are anxiety-provoking but shouldn’t be. He boiled it down to the fact that changes in women’s health recommendations are based on the evolution of better drugs and imaging, as well as our increased understanding of holistic healing.
- His article is a good reminder that when preparing for an interview, make sure your content is relevant, easy to remember and simple to digest.

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Want to read more about women’s health issues? Follow @jpawomenshealth

FDA Works to Speed Drug Approval and Access

valerie — Mon, 19 Mar 2012 20:44:59 +0000

Recently, the U.S. Food and Drug Administration (FDA) announced it is exploring new ways to improve patient access to important medicines and ensure these drugs are brought to market more quickly. This new effort by the FDA comes amid growing complaints over the last few years among drug companies, patient advocacy groups and lawmakers that the FDA approval requirements are far too prescriptive compared to other countries around the world. As reported in CQ Roll Call, FDA officials outlined several areas it will consider changing in order to improve drug development and access, including:

Allowing more prescription drugs to be available over-the-counter for conditions like diabetes
Determining new benchmarks for drug approvals other than the traditional overall patient survival, such as whether a drug shrinks tumor size
Expanding the agency’s “accelerated approval” system
Reviewing off-label restrictions and developing designations for certain drugs that can be tested on fewer patients and available to more patients with specific life-threatening diseases

At a briefing with reporters FDA Commissioner Margaret Hamburg said, “The world is changing and we have to change to with it. We’re not talking about abandoning standards for safety and efficacy; we’re talking about leveraging opportunities in science so we can do a more effective job as regulators and also improve the drug development process.”

Despite this well publicized announcement, the FDA has not made any promises to actually pursue any of these newly proposed guidelines, stating these ideas are still in the very early stages of evaluation. The FDA has scheduled a public hearing to further discuss these new ideas on March 22 and 23, 2012 from 9 a.m. to 4 p.m. at FDA’s White Oak Campus in Silver Spring, Maryland.

Ingredients of Viral Success

ken — Fri, 16 Mar 2012 16:25:57 +0000

This week clients have most likely been asking their PR consultants the same question: can we do a video like KONY 2012 to get our message out to millions?

Today, J. David Goodman at The New York Times did a great job breaking down some of the reasons the video has been a success:

1) Rapid spread among those age 25 and younger

Viral campaigns have two targets – the people you are trying to reach (political targets, donors, etc.) and the accelerators, people who help spread the message.

2) Celebrity engagement

While celebrities may not always be credible for delivery of serious messages, when they talk, people listen.

3) Willingness to engage, even when conversation is critical

Controversy drives conversations (heard about birth control lately?), but conversations end when only one side talks.

4) An involved audience

Invisible Children has been working with high school and college students for years. The traditional organizing provided a base to mobilize.

5) A tangible connection

“Those kids are just like me” – the topic connected with the audience (it was not just the quality of the video production).

Interestingly, the story left out one of the most important factors – the role of traditional media in promoting social media.

While YouTube is one of the top cited sources in social media, top traditional news sites are cited and linked when conducting searches. While this video began becoming popular in social media on March 5^th, by March 7^th traditional media outlets, like The Los Angeles Times, Washington Times and ABC News picked it up and expanded its reach even further.

New International Guidance Defines Ethical Interactions with Patient Advocates

jen — Mon, 05 Mar 2012 22:55:06 +0000

Late last week (March 1), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) issued an updated Code of Practice, extending its guidance to include all interactions with healthcare professional groups, medical institutions and patient organizations.

The code now incorporates specific guidance on engaging with patient advocacy organizations, a key area of interest for JPA clients, which is outlined in brief below.

Key Highlights – Article 11 – “Interactions with Patient Organizations”:

11.1 – Scope: All interactions with patient organizations must be ethical, and the independence of the patient organization must be respected.

11.2 – Declaration of Involvement: Companies must ensure that the nature of their involvement with patients organizations is clear from the outset, and no company may require that it be the sole funder of a specific patient organization program, activity or initiative.

It is permissible, however, for a company to be the sole funder of a patient organization program if the organization makes the decision to only accept funding from one company.

11.3 – Written Documentation: When a company provides financial support or in-kind contributions to patient organizations, it must execute written documentation outlining the nature of support, including the purpose of any activity and its funding.

11.4 – Events: Companies may provide financial support for patient organization meetings if the primary purpose of the meeting is professional, educational and scientific in nature, or if the meeting otherwise supports the organization’s mission.

Venue and location must be appropriate and conducive to communication.
Meals and refreshments provided must be “modest as judged by local standards.”

At JPA, we are working to ensure this new guidance is kept under close consideration as our Industry clients engage with patient advocacy organizations, in addition to regional and local standards previously established by other organizations and regulatory agencies. IFPMA members must implement these standards by September 1, 2012 to ensure compliance.

Honoring Equal-Rights Advocates by Undertaking Health Disparities

tracy — Tue, 28 Feb 2012 23:22:30 +0000

Every February, in honor of Black History Month, we are blanketed with stories of heroism and reminded of the arduous times Americans have gone through to make positive changes for the future.

Though celebrations have been held nationwide to commemorate our nation’s milestones, simultaneous government budget cuts to critical cancer screenings threaten to impact the health and lives of African Americans and other minorities.

As reported in a great Huffington Post article authored by business reporter Janelle Ross, Blacks and Latinas made up less than 30 percent of the nation’s 2011 population. These groups also made up almost half of the country’s uninsured population.

It is imperative that healthcare communicators effectively publicize methods for closing healthcare gaps for minorities. Even more importantly is ensuring messages reach the intended audience(s).

Below are examples of methods to do this for today’s societal leaders and healthcare crusaders.

Empower the Audience
Similarly stated by the inspiring Phill Wilson, president and CEO of the Black AIDS Institute and one of my favorite physicians, Dr. Hilda Hutcherson, it is essential that support systems be infused into healthcare campaigns.

It is not enough to say a message and state where individuals can get more information. It is about providing tools that empower. I’m proud that a client of mine, the Cancer Support Community, is doing this through a new program focusing on improving physician-patient communications.

Pursue Partnerships that Overcome Cultural Barriers
Look at social science studies and conduct your own research to identify groups that can disseminate health information into the “right hands.”

When doing local outreach, think creatively. It may not be a disease-focused organization, but instead, a nontraditional partner, like a hair salon that can get the information to your audience (check out this cool case study). On a national level, interview some advocate organizations to identify education gaps and brainstorm how these can be filled.

Deliver the Data that Resonates
Assemble quantitative and qualitative data that has enough of the population at hand (don’t have a survey that only includes 30 minority participants and try to use it) and addresses the problem to help state your objective.

Here’s an example: According to the Centers for Disease Control and Prevention, a patient’s self-assessment of health is a reliable indicator of health and well-being. When asked about health status, minorities are MORE likely than whites to characterize their health status as fair. (Issue to be addressed – education about what healthy means).

One Size Does NOT Fit All

valerie — Fri, 24 Feb 2012 16:03:31 +0000

Picture this - your company just implemented an enormously successful breast cancer awareness program in the United States. Your leadership team is so thrilled they’ve asked you to replicate the program in Japan. You translate the program materials; send the program resources to a colleague across the globe and wait for news of another successful program. Not so fast.

In any patient communications effort, it is critically important to tailor your program or initiative to the people you are trying to reach. We continue to see the advocacy landscape ever-changing from country to country and across various disease states. You should never underestimate the power of knowing your audience. Here are a few things to keep in mind as you work to reach patients around the world:

Don’t Get Lost in Translation
Translation is more than swapping words in one language for another. It’s easy for the true meaning of taglines, program titles or other materials to get lost in translation. When translating program materials, make sure you work with someone who is fluent in the language so that you are accurately communicating about your effort.

Understand Cultural Nuances
Every country has its own social norms, business protocols and etiquette. If you truly want to make an impact, it is important to recognize the cultural nuances of different countries. The breast cancer awareness campaign you implemented in the U.S. is likely to resonate very differently with the audience you are trying to reach in Japan. Understanding the customs of your audience is critical to implementing a successful program.

Know the Rules of Engagement
Keep in mind that there are numerous laws and guidelines that vary from country to country, which impact the engagement and information exchange between Industry, advocacy groups and the patient community. Be sure you fully understand all of the regional nuances before engaging with the advocacy community.

Find a Happy Medium
Different cultures use different modes of communications. While it might make sense to communicate with an audience in one market with social media and digital applications, you may make a bigger impact in another market communicating through key opinion leaders, doctors or nurses. Be cognizant of finding the right communications medium to reach your target audience.

The key takeaway to remember is that one size does not fit all when implementing advocacy programs around the world. Yet with a thoughtful, strategic and tailored approach, your organization can reach audiences around the globe in a very meaningful way.

Meet Your Match

ken — Mon, 13 Feb 2012 22:51:00 +0000

Whether looking for a life partner or an organization to partner with to reach key audiences, data is playing an increasing role.

So, can data help you find your match?

Yesterday’s New York Times Week in Review started with praise of leveraging data (News Analysis: The Age of Big Data) which focused on how insights are being derived from the mass volume of data we are each leaving behind.

The same Week in Review ended with a scientific critique of the use of data and algorithms in online dating (The Dubious Science of Online Dating) which looked at the challenges of analyzing data that people provide as part of a service.

Clearly, leveraging “big data” to measure actual behavior provides more insight then asking people what their behavior would be.

In the healthcare PR world, there is a significant amount of public data showing the relationship between thought leaders and the sources they pay attention to (i.e. - media outlets, advocate organizations, academics, and bloggers). When you analyze thousands of blogs and compare the linking patterns and mentions of thought-leaders, a clearer picture emerges.

For example, if you are trying to reach medical providers on a treatment issue, JPA’s recent research points to some specific bloggers. If however you are trying to reach the providers that are more focused on public policy you might be better matched with a couple of the patient advocacy groups or trade press. There are also “unusual” suspects that emerge – for example why liberal bloggers are disproportionately speaking about cervical cancer.

While analyzing data provides a good starting point to find the right pool of people (or matches), in the end, it’s always real relationships that are built through personal connections that are the most powerful and predictable.

A Six-Time NBA MVP Explains Why the Winning Formula Must Include PR

dana — Thu, 02 Feb 2012 14:24:52 +0000

My work in healthcare public relations has influenced how I read news—I’m always analyzing media trends, guessing which stories were placed by PR people and reading articles looking for pre-determined key messages. My passion for analyzing news and the media often overlaps with my hunger for following Boston’s professional sports teams. I start to analyze the interview styles of players, coaches and “league sources.”

Sports have always had a strong influence in my life. Playing basketball late into summer nights with my older brother instilled grit in me (I lost our one-on-one battles 90 percent of the time). Being captain of my college soccer team during a painful losing season taught me how to motivate a team under challenging circumstances. And early in my career, a mentor noted how the lessons you learn playing sports are frequently translatable to business. The advice has helped frame the way I think about many business situations.

So it was with great interest when Harvard Business Review profiled Kareem Abdul-Jabbar for their “Life’s Work” column in the January-February 2012 issue and linked my two areas of interests. Kareem discusses the major career challenge he faced—not securing a head coaching job after retiring as a player—and pinpoints one main reason for not reaching this goal.

As a player, he was 100 percent focused on being at the top of his game; talking to the media and being accessible to fans were not relevant to winning. As the article notes, Kareem developed a reputation for “being focused but not very personable.”

He didn’t fully understand the power of public relations earlier in his career. He speaks the words of a PR person’s dreams: “I had no one to explain the value of public relations to me.”

And then the words of a reporter’s dreams: “A lot of the people in the media are good people, and by being more accessible, you get to find that out.”

Anyone who works in PR can tell you that one of the most rewarding aspects of the job is working directly with senior leaders at high-performing companies and non-profits. We get an up-close view of how executives lead their teams and handle challenges, often under the most celebrated or challenging circumstances, when everyone is watching and the media is asking good, hard questions. And while it’s cliché to say every leader wants to win and the majority are very competitive, it’s a thread that runs through the most successful executives.

But not every leader understands that while winning is the number one priority, public relations is often a close runner-up. Having a strong working relationship with the media can have a profound, positive impact on companies, non-profits and sports figures. It’s a message that is beginning to gain momentum: according to a recent PRSA study, 97 percent of executives surveyed indicated it was important for CEOs to have a well-developed understanding of the role of corporate reputation management.

My dream is that Patriot Head Coach Bill Belichick, the NFL’s renowned curmudgeon who makes headlines for actually smiling, is reading this as he prepares to lead his team on the world’s biggest stage.

Bill, consider some advice from Kareem: winning is the most important thing, but it wouldn’t hurt to have an appreciation for the power of public relations.