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How Healthcare PR People Can Manage Clinical Trial Crises

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describe the imageAre you or your healthcare PR firm prepared to handle clinical trial-related crises?  Please review my 10-point primer published in the latest issue of Communique magazine to learn more. 

 

For a PDF of the article, click here.



Consolidation: How's it Working (or not) for Big Pharma?

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After the business challenges of 2009 and what remains a describe the imageprecarious economy this year, we at JFK Communications feel fortunate to be growing again in 2010. And it's starting to look like while the national unemployment numbers remain unacceptably high, the US economy is at last beginning to show signs of improvement.

To me, the US healthcare industry in general and the pharmaceutical, biotechnology and medical technology industries in particular have always been bright spots on the economic landscape, whether times were good or bad for the country overall. The past few years, however, have been a very different story as we all know.

On the jobs front, I was both surprised and disappointed to learn recently that for the first half of 2010, the US pharmaceutical industry has eliminated approximately 35,000 positions. This is on top of the nearly 60,000 pharma jobs that were eliminated during 2009.

Industry pundits will offer up many reasons for why these job cuts had to be made, not the least of which is the dire economic conditions. But the pharma bloodletting started well before the US economy tanked, and job eliminations in the pharmaceutical industry look set to continue in spite of improving economic conditions.

I think many of the industry's current woes are the direct result of the seemingly endless drive toward consolidation, attempts to create "economies of scale" and getting bigger because it seems that well, that's all big pharma can think to do right now to try to fix its problems.

Consider the following questions:

  1. Has the US pharmaceutical industry become a more dynamic, enjoyable and opportunity-rich place for people to work, or has it become less so as the result of increased consolidation?
  2. Is the world really better off without such great companies (and places to work) as Pharmacia, Lederle, Parke Davis, Warner Lambert, and Searle, to name just a few?
  3. Are more innovative drugs being brought to market in the US as the result of pharma industry consolidation and the existence of fewer, but larger pharmaceutical companies?
  4. Has industry consolidation improved the overall financial health of big pharma companies over the past 20 years?
  5. What about healthcare costs? Are patients paying any less for their drugs these days?

The culture of consolidation permeating the pharmaceutical industry has impacted every operational area, including how these companies purchase creative services such as advertising, public relations, market research, digital communications and graphic design. In many cases, smaller to mid-sized independent healthcare communications agencies have lost out to mega-sized communications conglomerates such as WPP Group, Omnicom, Publicis and Interpublic Group. These groups have all benefited by entering into "preferred provider" agreements with big pharma companies. I like to think of this trend as the "Walmart-ization" of healthcare communications.

Do marketing directors and brand managers at pharmaceutical companies with preferred agency networks enjoy being told which agencies they have to work with?

And last but not least, it makes me wonder: when has removing competition from the equation ever been good for business?

--David Avitabile

Good Direction or More Control?

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For better or worse, on November 12 & 13, 2009, the U.S. Food and Drug
Administration and its Division for Drug Marketing Advertising and Communications (DDMAC) will convene a hearing entitled “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.”  

Sorry, if you didn’t register by October 9, you will not be able to attend in person; however, all are welcome to participate.  Healthcare communicators, especially healthcare PR folks, should submit questions and comments to: “Electronic Comments,” identified with docket number FDA-2009-N-0441, at http://www.regulations.gov.  Everyone can watch and listen to this hearing for free by registering here.

The hearing will be just that.  Be prepared to listen to more than 80 (that’s right, eighty) 15-minute presentations by healthcare communication leaders from industry, academia, government, media and non-profits.  And, for one who has endured my fair share of FDA hearings, don’t expect any action, other than the obligatory, “We thank all of you for coming, for your time and thoughtful insights.”  “We will take all of your comments under advisement and will continue to compile outside comments and reconvene in 2010.”

We can expect that FDA and DDMAC will float a straw man document for comment in 2010.  And, perhaps after another hearing, they might finalize new regulations in 2010.  For those of us involved in healthcare communications, healthcare PR and medical communications, these new regs will help us reduce our risk of DDMAC violations.  However, it remains to be seen if these new regs will help or hinder industry communication to physicians, patients and caregivers. 

--John Kouten

Communicating with the Digital Health Consumer: Remain Teachable

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Do you want to lead? Remain teachable. This is especially true for healthcare communications and marketing professionals who want to engage the digital health consumer (in other words, all of us). 

Next week, we'll be participating in the e-Patient Connections Conference in Philadelphia, organized by my friend Kevin Kruse. If you want to see a Who's Who of leadership in digital healthcare communications and social media, check out the speaker line-up and the program for this event.

So here's a Healthcare PR Blog shout-out to Kevin Kruse and his team a Kru Research for putting this meeting together.

I'm sure we'll have a few things to blog about following this conference. We look forward to seeing our friends and colleagues at this event.

Stay tuned.

--David Avitabile

 

Will Media Report how Ted Kennedy’s Life was Extended through Improved Technology to Fight Brain Cancer? Probably Not

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Ok, I am backlogged on my reading, so what else is new?  If you are a healthcare public relations professional you are, by definition, behind on your reading!  If I can scan my newspapers, multiple news aggregators, and Twitter messages each day I’m ahead of the game.

 

However, I did take the opportunity to review PharmaceuticalExecutive’s Fifth Annual Press Audit.  While this appeared earlier this year, its findings are very relevant today, and will be valid until they field and report the 2010 press audit results. For those involved in healthcare communications and pharmaceutical and biotechnology public relations, these data are profound.

 

The PharmExec audit reveals that while articles covering pharma’s marketing, sales and other promotional practices have fallen, they have been replaced with articles about drug safety issues.  During 2008, Approximately 83% of articles focusing on pharmaceuticals and biotech were about drug safety concerns.  Negative articles about drug safety issues are at a five year high.  And, while overall media coverage of pharma is down, the majority of this coverage is negative, with only a small percentage considered positive (12%).

 

Considering these data, along with the ever increasing regulatory and political headwinds facing the pharma industry, we believe strongly that we need to restore confidence in the industry.  As leaders in healthcare PR and pharma marketing, we are proud of the work we do each day to raise awareness of new ground-breaking medicines and medical technologies.  We are passionate that pharma technology and R&D will contribute to cost savings in this era of healthcare reform and increased rationing. 

 

Many of our clients serve cancer patients and their families.  And, as we have witnessed today with the loss of Senator Ted Kennedy to cancer, the victory over this global scourge is still somewhere in the future. Senator Kennedy’s death is a terrible loss. However, we know that his life was extended months longer than it would have been just ten years ago because of the great strides we have made in the fight against brain cancer.

 

As healthcare communications professionals, I believe it is our responsibility to support a balanced portrayal of the pharmaceutical industry, and communicate with patients, legislators, the business community and the general public about its valuable contributions to extending and enhancing human life.

Town Hall Chaos, or Democracy at Work?

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As a healthcare communications professional, it has been very interesting to witness the continuous clashes over healthcare reform between concerned citizens and our nation’s political leaders taking place at Town Hall meetings throughout the country.

First of all, I think a bit of perspective is in order. The United States has a long and colorful history of vigorous debate, ideological clashes and differences of opinion. Just read about the presidential election of 1800 between John Adams and Thomas Jefferson. Or read about the Whiskey Rebellion of 1794, where President George Washington decided to declare martial law and send troops to Pennsylvania to put down a rebellion of farmers opposed to federal taxes on whiskey. The new taxes were introduced as a way to pay down the national deficit, which was a real concern following years of war with Britain and massive borrowing from France, Spain and Holland to finance the American Revolution.

The current debate over healthcare reform, and the scenes taking place at Town Hall meetings throughout the US, is tame by comparison to these early struggles. Viewed in historical context, one could even argue that the current national scene is an example of democracy at work.

However, as the debate continues, neither side is communicating effectively. Supporters of reform seem unable to define clear, effective key messages. Political leaders are falling into classic traps by allowing themselves to be provoked and driven off message, and few if any seem to be prepared to handle the hostility that they are facing. On the other side, hyperbole, misinformation and shrillness don’t seem to be working either. The work goes on in Washington, and displays of hysteria at Town Halls could have the undesirable effect of marginalizing opponents of healthcare reform at a time when different views should be heard and considered.

Most rational people agree that the current US healthcare system is badly in need of reform. There are legitimate concerns over what shape healthcare reform should take, how much it will cost, and how it will impact the lives of ordinary citizens. Whether we succeed or fail hinges upon how well we as a nation can define the critical issues, engage all the stakeholders in this debate, listen to differences of opinion and create a shared understanding of the way forward.

In other words, we need to communicate.

Tort Reform Anyone?

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Unless you missed it, on Friday, July 31, 2009, the Energy and Commerce Committee of the House of Representatives approved H.R. 3200 “America’s Affordable Health Choices Act.” This bill, which will require much more work, has successfully found more consensus than opposition.  It rests on a variety of reforms, most evident are underwriting practices of health insurers.

 

The devil is always in the details, so we can expect major debate over healthcare reform when legislators return from their August recess.  Based on current healthcare spending growth rates, most reasonable Americans understand that some form of healthcare reform will be required to stem the tide of rising healthcare costs. 

 

Healthcare communications professionals, the media and others who are following this debate are asking a number of critical questions. Will a new healthcare law reduce costs or raise costs?  How will such an extensive overhaul be funded? How will the insurance industry compete against a public healthcare insurance option?  Will healthcare reform harm the biomedical industry by hampering investment and innovation?  How will cost containment translate into rationing, and how will Americans react to government-mandated rationing?  Will the quality of physicians and care improve or deteriorate if there is a government-run system?

 

I have seen all of these questions raised by both sides, however, the major question I have not heard much about from either side (and perhaps I’m not listening hard enough) has to do with tort reform.  There just doesn’t seem to be much rhetoric or debate around allowing doctors to practice more preventive medicine and less defensive medicine. 

 

The point of healthcare reform is to reduce cost and improve access to quality healthcare for all Americans. An abundance of lawsuits against doctors, hospitals and insurance companies has had a massive impact on the rising cost of healthcare in this country. Yet the amount of media coverage on the issue of tort reform specifically as it relates to healthcare reform has been minimal at best.

 

A number of op eds have been published on the issue of healthcare reform, both for and against, and many of these have been pretty inflammatory depending upon the political stance of the writer. One of the very few op ed writers who has made a strong case for tort reform as part of healthcare reform is Charles Krauthammer in the Washington Post. Now let me be clear: I don’t necessarily agree with all of Krauthammer’s opinions on the issue of healthcare reform. However, he does raise the issue of tort reform, and the need for it, in order to reduce healthcare costs. On that issue, I believe he has a point.

 

There does need to be legal recourse for patients in legitimate cases of medical malpractice. However, for our leaders to focus on cutting out the waste and fraud in our current healthcare system while ignoring the very real need for tort reform as part of the overall healthcare reform package is disappointing.

 

Why haven’t we heard more about malpractice tort reform and capping malpractice awards?

 

Any healthcare reform will be a hollow victory without malpractice tort reform.

The Rhetoric of Healthcare Reform and Healthcare Communications

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Last week, National Public Radio’s show “On the Media” discussed the language being used in the healthcare debate. Frank Luntz, communications consultant for the Republican party, shared tips from “The Language of Healthcare 2009: 10 rules for Stopping the ‘Washington Takeover’ of Healthcare,” a 28-page memo instructing the GOP on the best language to sway public opinion.

Both sides of the debate are utilizing highly potent words: “government takeover,” “rationed medicine,” and “ticking time bomb.”  Now, with little chance of movement until after the recess, politicians and stakeholders on both sides of the aisle have the month of August to continue stoking the heat on the healthcare reform debate.

As public relations professionals, we understand the importance of using language to drive awareness, change perceptions and influence behavior.  Words – beyond their denotations – are the most basic of the tools we use.  

Many in life sciences community will rely on the thorough review process of legal, medical and regulatory representatives to tone down or strengthen language as appropriate.  However, with the knowledge that comes from being a healthcare public relations professional, I believe we have a duty to communicate with honesty in all writing, before it even gets to our clients’ desks. 

Words carry weight. Acknowledge your influence, and use them responsibly.

--Maureen Miller

Healthcare Public Relations and the Art of Storytelling

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A 13-year-old girl is taking a train ride to New York City with her dad. During the journey, they talk to each other about a lot of things, including the usual topics of school, friends, texting (of course), boys, and getting along with her two brothers. At one point in the conversation, the daughter tells her father that one of her favorite things is when her mom, dad and all the aunts and uncles get together and tell stories about when they were young. She goes on to say that for the next family gathering, she really wants to make a “talking stick” because sometimes the kids find it hard to listen when the adults interrupt one another.

That’s a true story, told to me this morning. When I heard it, I thought about how very human is the need to listen to stories, and how amazing it is that even in our high speed, 140 character limit, texting and Twitter-obsessed culture, the art of storytelling and our need to be engaged by good stories is alive and well. I defy you to show me anybody more immersed in our short attention span media and communication culture than a 13-year-old girl. And yet she’s expressing her joy at sitting and listening to her parents and relatives tell stories about when they were young.

At its very essence, marketing is storytelling. As we continue to evolve new ways to communicate, as we blog and Twitter and use LinkedIn and Facebook, let’s keep in mind that conversation between a 13-year-old daughter and her dad on the train to New York City, and let’s not lose sight of the fact that no matter what the medium, we all still want to hear a good story.

Clinical Trial Crises: Are You Prepared?

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Healthcare public relations professionals who have been in the business for even a short period of time have had to manage a number of issues and crises.  Unfortunately, during my career in healthcare PR and medical communications, I have had to manage numerous issues relating to clinical trials. 

 

JFK Communications and its seasoned staff of professionals have extensive experience with issues management and crisis communications.  This month we publish a 10-step strategic plan to prepare for, and manage, crises around clinical trials.  For our clients, clinical trials are one of the most critical aspects of their ability to successfully bring products to market. 

 

Any issues that delay the completion of clinical trials can reduce the value of any given developmental compound, diagnostic product or medical device.  These crises can also accrue damage to corporate reputations.  Unfortunately, in this very litigious environment, and with so many clinical trials underway, it is not an “if,” it is a “when” you will encounter crises situations in your clinical trials programs.

 

Are you ready for your next clinical trial crisis? 

 

To find out, please read our 10-step primer to managing clinical trial crises which appears in the July 2009 issue of Applied Clinical Trials magazine: http://tinyurl.com/n4gkrf

 

For a free consultation regarding potential risks to your clinical trials programs, please feel free to call John F. Kouten or David Avitabile at 609-514-5117.

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