About Wayne Pines

Wayne Pines, president of regulatory services and healthcare at APCO Worldwide, provides strategic counsel to clients facing crises or media, legislative, regulatory or marketing problems.  He has worked on healthcare reform, litigation, tampering, product approvals, advertising issues, recalls, environmental problems and Congressional and Food and Drug Administration (FDA) hearings.  Before joining APCO in 1993, Pines was executive vice president of a large international public relations agency.  For the 10 years prior to that, Pines served at the FDA as chief of consumer education and information, chief of press relations and associate commissioner for public affairs.  He was the chief spokesman of FDA for seven years and also was the founding editor of FDA consumer magazine.  In 2004, Pines was named FDA’s Alumnus of the Year.  He recently published a book on crisis communications, "Communicating in a Healthcare Crisis"

Interview

The Pharmaceutical Industry

ES: The pharmaceutical industry appears to be in permanent crisis mode.  What are the factors that have contributed to this situation?

WP: The products made by the industry are essential to health, are never completely safe, are not effective all the time in all people, and are constantly being re-studied and re-evaluated using imperfect methodology. This is an intrinsic formula for permanent crisis.

The industry also is vulnerable because of its pricing policies and its marketing practices.  Many people expect healthcare products to be free or burden-less from a financial standpoint. Others object to companies marketing pharmaceuticals at all, or to some of the methods used by pharma companies. So, in a world of rising healthcare costs, pricing and marketing will be permanent issues for this industry.  Those are both issues that are highly visible and highly charged politically.    

ES: Overall, would you give pharma’s crisis communications activities a passing or failing grade?  What can the industry do to improve?

WP: It’s hard to rank the industry overall.  Some companies do a good job, others do not.  Certainly the performance of large pharmaceutical companies has been getting better, as senior management has recognized the importance of handling crises correctly from a communications standpoint.  So it’s not possible to give industry overall a passing or failing grade.

As the spokesman for big pharma, the Pharmaceutical Research and Manufacturers of America (PhRMA) has been doing a good job of organizing programs that pre-empt a lot of issues.  The Partnership for Prescription Assistance, for example, has been very effective in seeking to assure that all patients have access to needed medicines.

To improve, individual companies need to have their senior managements recognize the importance (1) of communicating properly, promptly and frankly during a crisis; (2) of telling the entire story, warts and all, themselves rather than letting others control the story; (3) of working with the government in communicating adverse new information about products or studies; and (4) of building relationships and credibility with the media and with potential allies during times of calm.  In short, companies need to invest in crisis communications constantly in order to communicate effectively during an actual crisis.            

ES: Although crises often occur unexpectedly, what can communications pros do to help their internal and external pharma clients succeed during one? 

WP: Crisis communications pros can, first of all, help companies build plans and infrastructures that will help companies deal with crises should they occur.  This building must take place constantly, not just be put into place when a crisis occurs.  The [development] of this infrastructure takes an investment that pays off during an actual crisis.  But many companies still do not see the value in having a usable and tested crisis communications plan in place.

During a crisis, a good crisis manager can bring perspective and experience to a situation.  What is needed are good communications and management skills; an ability to synthesize information quickly and be flexible when information changes; and a credibility within the organization that carries weight with all other members of the crisis team.  People not experienced in dealing with crises often fail the first time, and that’s why relying on experienced people is so important.  Plus, company management tends to get insular during a crisis. That’s the wrong way to think about it.   

ES: Are there any crisis situations pharma companies have no excuse not being prepared for?

WP: No. This is a mature industry.  Seldom do new issues arise.  There are many experienced crisis managers who have been through a lot and can bring their experiences to any situation.  We even have lived and learned from a national horror like 9/11.  So pharmaceutical companies need to anticipate all adverse events and have plans for them. There’s no excuse not to.

The FDA

ES: The FDA has clearly lost a lot of public trust since you served as associate commissioner for public affairs.  Why is this?

WP: Recent polls do show a decline in public trust for FDA.  That is truly unfortunate.  It is a great agency.

There are a number of reasons.  One is that the FDA does not have the budget support from Congress to be successful at everything it needs to do.  This needs to be fixed, and quickly.  For example, FDA has not had the resources to regulate food safety as comprehensively as it should, so spinach and Taco Bell scares occur, and make the public wonder whether the FDA is doing its job.

Second, the FDA has been so successful for a century that its success has been taken for granted by many, and therefore any failures in terms of food or drug safety are magnified.

Third, the product liability environment and the attendant publicity often make it appear that products have harmed more people than they have helped.  This reflects on the FDA.

Fourth, the news media today often report studies as definitive when they are not. How new studies are reported causes confusion in the public mind, because one study contradicts the next.  The FDA should help clarify some of that, but does not have the resources or the mandate to do so.  

Fifth, the proliferation of news media makes adverse news about the products regulated by the FDA more accessible, more quickly, but at the same time it is more difficult for the agency, and all others, to communicate.  It’s ironic that with all the new ways to communicate, in effect reaching people has become more challenging because people get information from so many different sources, and with MP3 players and DVDs, the public often tunes out entirely the traditional means of communications.

Sixth, FDA has lacked a strong visible voice for many years now, with the proliferation of short-term commissioners. 

Finally, pharmaceutical products today do more than they ever have, and therefore are more important to peoples’ lives, so when they fail, as they inevitably must in some cases, it’s news, and the public loses confidence in the FDA, which has always been there to protect them.

I can go on, but the reality is that it’s hard for any institution to maintain public trust, it’s especially hard for a government agency to do so, it’s even more challenging for anyone dealing with healthcare, and add to that that the FDA has been chronically underfunded, and it’s not hard to see why FDA’s credibility is not as strong as it once was.        

ES: Some have said that the FDA neither effectively prepares for nor reacts to the numerous crises it faces on a regular basis.  In your mind, is this assertion correct? 

WP: I think the people at FDA generally do well during crises, given that they have to deal with a crisis a day, do not have the needed resources, and often do not have conclusive scientific information.  The quality of how FDA has handled recent crises varies, depending on who’s handling it, but it’s unfair to be too critical of an agency that faces difficult circumstances.  I know. I managed FDA crises for seven years, during a time when the media was easier to deal with and FDA had a better resource allocation.

ES: Some FDA critics argue that the prescription drug user fee act (PDUFA) has compromised the agency’s independence.  How much does PDUFA contribute to public distrust of the FDA?

WP: I think in certain circles PDUFA poses a credibility issue, or at least is used as a mechanism for criticizing FDA on that basis, but anyone who really understands the FDA knows better.  PDUFA funding does not compromise FDA in any way, any more than the person behind the counter at the motor vehicle department is compromised because we all pay fees for that service.  For the general public, I do not believe PDUFA funding is an issue.

We do need to make FDA less reliant on PDUFA funds, not because of credibility or independence, but simply because PDUFA directs funds toward certain programs and in effect makes it more difficult to fund other programs. That’s a funding issue, not an independence issue.

ES: What are three things you would do to help the FDA develop a robust and proactive crisis communications plan?

WP: First, FDA needs a strong and visible spokesman who has credibility with the public.  At present too many people handle the public aspects of crises, so basically anonymous people are speaking for the government on these issues.

Second, FDA needs to upgrade and make more uniform its Website.  Increasingly people turn to the web for information, and FDA’s web site remains hard to navigate.

Third, FDA needs to explore other means of communicating, beyond the traditional ways it uses now.  FDA has said it will form an advisory committee on risk communications.  That’s a good first step.

And if I can add a fourth, FDA needs to make sure it has on staff people trained in communications. Often communications are controlled by people trained in the health professions or law, not in communications.    

Effective Crisis Communications 

ES: What are the major “dos” of handling a media crisis?

WP: There are so many ways to answer that question, so many ways to approach it.  In my recent book. Communicating in a Healthcare Crisis, I offered this as a starting list:

• Appoint a dedicated team to handle a crisis.
  
• Be candid and active with the media.
  
• Cooperate with the government.
  
• Use the right official as spokesman.
  
• Above all, do the right thing.

ES: How should healthcare companies/organizations deal with a crisis sparked on blog or other online source?

WP: There are almost an endless number of blogs, and they will proliferate further.  They can cause great damage with misinformation.  In general, since there is no regulation of blogs or other online information, and in my view there should not be, they pose real challenges for companies seeking to be responsible and especially for those whose communications are regulated by the government.

Pharma companies should approach blogs carefully.  From a regulatory standpoint, trying to respond to misinformation on blogs can be dangerous because blogs are not necessarily scientific and companies can be forced, if they respond, to deal with off-label information.  Any adverse reactions reported on a blog, arguably, needs to be reported to FDA, even when there’s no basis for the information. 

Bottom line is that blogs and other online sources need to be dealt with, but companies need to be careful they don’t escalate an issue or trigger an event that needs to be reported to the government. It’s a delicate judgment. 

ES: Please provide some final words of wisdom for communications pros seeking to hone their crisis communications skills.

WP: Many communications professionals claim to be crisis managers.  Everyone alive in 1982 takes credit for helping Johnson and Johnson manage the Tylenol crisis.  In fact, few communications professionals really have managed crises, and still fewer have been effective spokespeople during one.  So, my advice is: Be modest about your skills and experience.  Don’t delude your company or client, and especially yourself, into thinking you know what you’re doing.  Learn from others by reading or communicating with experienced people.  (I often see inexperienced people learning at their company’s or client’s expense.)  Admit when you need help, and seek it.

In managing crises, there’s no experience like real experience. I still learn from each one.

(back to the first page)