May 2009 Archives

Last week we wrote about the challenges of communicating about our products through new media channels.  Two items from this week's news are illustrative of some of the unique issues with which we must contend when writing about our business.

An NPR story on the rise of pertussis cites doctors' anecdotal reports on "an increase in the number of parents refusing to vaccinate their children against childhood diseases."  As a manufacturer of vaccines we have an obvious business interest in pediatric vaccines that we believe aligns with public health interests.  The NPR story fairly addresses a significant public health issue so we'd like to highlight it on our blog.  But not so fast... we must first ask ourselves whether doing so could be seen as promoting our products.  If it is viewed that way, then we have an obligation to include additional information about the product in question. 

So, it isn't straightforward when a vaccines manufacturer communicates about vaccines.  There are times when even our disease-oriented communications might be interpreted as promoting our products, thereby requiring that additional information be included along with the mention of our products (approved indication statement, safety information, submission to FDA etc).  Many factors, including a pharmaceutical company's position in a particular market (ie, if they are the largest or only manufacturer of a product for the disease under discussion) and the product's approved indication can inadvertently raise the perception that the communication is promotional.

When it comes to Twitter, there isn't much collective experience or precedent for any of us.  So it isn't surprising that as one blog pointed out, Pharma hasn't nailed it yet.  However, in our view, the FDA's recent communications on sponsored links raises questions about how Twitter can be used to communicate about prescription drug products.  For example, FDA has made clear that the short 100 or so character ad copy used in sponsored links cannot be used for anything deemed to represent what the product is used for, without also including the safety information about the product in the sponsored link - a difficult challenge in such limited space. Including a direct link to the product's website where all the important information about the product is spelled out is not sufficient.

So before making claims that "Pharma doesn't know how to do this," we ask that you take into consideration that there may be much larger issues at stake governing the way we communicate.

I grew up in the '70s and '80s, and I don't recall any of my friends having food allergies, although I do remember my friend Dan telling me that he was "lactose intolerant" which sounded incredibly dangerous and exotic at the time. I also don't recall many of them being overweight or obese.  Our most common ailments seemed to be broken arms and scraped knees.  

That's because obesity was not nearly as common as it is today. According to the CDC website, the prevalence of obesity for children aged 2-5 years is 12.4%; for those aged 6-11 years, it is 17.0%; and for those aged 12-19 years, the prevalence is 17.6%.  Compared to survey data collected from 1976-1980, the prevalence rates for these age groups was between 5.0-6.5%. 

These children and adolescents not only face current health issues.  They are at risk for chronic conditions such as cardiovascular disease, high blood pressure, high cholesterol, and Type 2 diabetes--and are more likely to become obese as adults.  Since chronic conditions are the main driver of healthcare spending in the US--more than half of us have at least one chronic disease, and 75% of our healthcare dollars are spent treating chronic diseases (many of which are preventable and manageable), getting childhood obesity under control is a must-win for our health and our healthcare system.

Weight is a personal topic for many, and sometimes I fear "obesity coverage fatigue" with so many studies and stories, often conflicting, that talk about about the impact of obesity on our health.  It takes real motivation on the part of the overweight or obese individual to work toward a healthy weight, especially when the individual is a child.  (That's why GSK teamed up with the Washington Redskins last month to donate a "Youth Fitness Zone" to the Boys & Girls Clubs of Greater Washington, DC.  The program encourages nutrition, fitness and wellness to combat obesity in children ages 8-14.)

But now there might be another reason to ensure that each child maintains a healthy weight.  A new study of 4,000 children aged 2-19, published in the Journal of Allergy and Clinical Immunology found a significant association of overweight and obesity with allergic reactions to eggs, milk, peanuts, and other common allergens.  

Of course, their could be many reasons for these associations, but I think it certainly warrants investigation.  Since food allergies put restrictions on the diets of the children involved, it makes the task of obtaining--and maintaining--a healthy weight that much more difficult.  But what is clear is that childhood obesity is an issue that must be addressed now if we are to improve our national health in the future.

We're happy to report that reception to our blog has been largely positive, with an expected spot of skepticism here and there. Thanks to several of our fellow health care bloggers for covering our introduction, and one for posting a comment.

A number of you have raised some fair issues worth addressing:  

Why do we have content going back to January?

We just publicly unveiled the blog this week.  We've been piloting the blog since January with a small advisory group of folks inside and outside GSK.  Since we're new at this, the goal was to work through internal process issues and also ensure we had a product that was easy to use and worth reading.  In the interest of transparency, we decided to make the archives available to everyone. 

Who is this mysterious Michael M/Michael F?

Mike Huckman of CNBC and Ed Silverman of Health Journalist Blog both questioned our use of last-name initials (ie, "Michael M." and "Michael F." etc), suggesting it might contradict our stated goal of openness.  This is a tricky issue.

Due to legitimate privacy and security concerns, our corporate policies generally recommend limiting the amount of personal information we provide externally.  One of us has already been quoted in the press about this blog so we're certainly not hiding anything; but the larger point is that this blog is not about any of us individually; it is about the company as a whole.  Adhering to this policy actually allows us to bring wider perspectives from within the company.  We've also included posts from Ken, Sarah, Janie, and Gaile, and we intend to include more in the future--maybe even from outside of GSK.

(And just to clarify, there are indeed two Michaels involved in this blog.)

Why should we believe you?

It didn't take long to receive our first nastygram. Unfortunately, the bulk of the message was both inflammatory and off-topic, and therefore didn't meet the standards outlined in our Comments Policy, so we won't post it.  But its general thesis was to point out the difference between the industry's reputation and our stated goal of doing the right thing.  The comment alleged that the company's motive is "greed, pure and simple."

Now, we're not afraid to take this kind of criticism head-on.  Part of the reason we started this blog was to engage in the debate and try to correct the record.

Do we make mistakes?  Yes. But whether you choose to believe it or not, GSK employees are in the main idealistic and staunchly ethical and motivated by our special mission. This is a great and unique industry--having a chance to improve peoples' health, and therefore their lives, is energizing and rewarding.  And we're fortunate to now have another way of sharing that perspective.

Newsweek.com has a profile on Tom Frieden, head of New York City's Department of Health and President Obama's pick to lead the CDC.  In it, there is a quote from Dr. Frieden illustrating that he gets what's ailing us--and our healthcare system:

"Today we don't have a health-care system, but a disease-care system," Frieden says. It's a system that will pay $100,000 to treat a heart attack, but not pennies to prevent one. As Bloomberg says, "I'm not a psychiatrist, but I think I know the clinical term that describes this: it's nuts."

I couldn't agree more.  Now let's get that prevention message embedded in our healthcare system--and our culture.  In fact, if I were to head that organization, I would insist that we start using the full name/acronym: Centers for Disease Control and Prevention (CDCP).

Forbes.com recently published an interesting article on the role of patents in drug development.  The article lays out the arguments for and against longer patent protection for medications, alleging that studies looking at efficacy, safety and new innovative uses are increasingly difficult to conduct because of the constantly ticking patent clock.

It's often mentioned, but frequently goes unrecognized, that only one of every 10,000 potential medicines investigated by America's research-based pharmaceutical companies makes it through the research and development pipeline and is approved for patient use by the FDA.  Winning approval, on average, takes 15 years of research and development and costs over $800 million dollars.  With drug development taking longer and costing more than ever, industry is left with less time to recoup its investment in R&D.  This begins a cycle that has the potential to negatively impact investment into novel healthcare innovations. 

There is no doubt that patent protection is of critical concern for an innovative industry.  In fact, without the necessary protection, decreased innovation will adversely affect treatment advances.  Think about it...if we can't afford to invest in novel medicines, then, eventually, we'll be living in a healthcare time capsule, with fewer new medicines--yet evolution will continue, delivering new diseases and viruses but no way for us to treat them. Further, as we all know, we have yet to find medicines to successfully treat all cancers and diseases like Alzheimer's, so expensive research is still critical.

It is in the public interest to ensure that scientists continue to bring more lifesaving drugs to market. To do this, pharmaceutical and biotech companies need the income stream afforded by patents on their existing products. It is therefore in the public interest that drug patents are respected and that we prevent a premature loss of patent rights which would decrease research on lifesaving drugs.

Just last month, the Senate Judiciary Committee passed a new version of a patent reform bill.   GSK is pleased to be able to support the legislation, which improves the efficiency and effectiveness of our patent system. 

Most importantly, the bill allows the patent system to continue to encourage innovation and the investment of billions of dollars in research toward life-improving and life-saving medicines for patients. 

Now that's something we can all get behind.

Ah, graduation season.  A time for reflecting on years spent in study and looking forward to a bright and sunny future.  A little Robert Frost from the right speaker can make all the difference.  At least that's what we're meant to believe. 

But this year is tough for the current batch of college grads, as the troubled economy promises not a necessarily rosy sprint from the classroom to the dream job--especially if you thought that dream job was on Wall Street.  The New York Times blog, DealBook, posted a piece yesterday chronicling the challenges facing the Class of 2009, many of whom were banking on a Wall Street job offer.

For many the siren call of Wall Street was hard to resist in recent years, and college students planned their courses of study appropriately.  But I wonder if this current economy will encourage those entering universities in the fall to take a road that has been less travelled of late.  Instead of Wall Street, perhaps the sciences will beckon this year's crop of bright young minds.  There's no shortage of need, what with cancer, Alzheimer's Disease, and many other chronic conditions in desperate need of innovative research.

It might just make all the difference.

We all know the world of communications is experiencing a tectonic shift.  The way people seek and receive information is evolving before our eyes.

For organizations with important messages to share about their products, services, or mission, this changing landscape offers immense possibilities, as well as significant challenges.  But for GSK and other pharmaceutical companies, there is another layer of complexity.

Given the unique nature of our business--making and delivering medicines--pharmaceutical companies, like GSK, face some particularly unique regulatory parameters governing our communications. 

Yet, there is no question that patients, physicians, media, investors, payers, policymakers, and others are increasingly turning on-line to social media resources for information about healthcare issues and products.  So we feel obliged to these stakeholders, as well as our shareholders, to productively and appropriately engage in this new space.

Ergo, this blog.

But More Than Medicine is expressly uninterested in promoting GSK brands.  As stated in our credo, our intent is to express a point of view and create a dialogue on health and healthcare issues you can't find anywhere else--not to serve as another product marketing vehicle.

Still, there will be times when you might expect us to address product-related issues or news that clearly relates to the purpose of this blog and, by extension, our company's reputation.  We will endeavor to do so responsibly and ethically, and within the existing legal and regulatory boundaries.    

The myriad of considerations around posts that are related to a GSK product demonstrate the communication challenges we have with our participation in the ever-expanding social media milieu.  Despite recent FDA communications on sponsored links, as this NY Times article indicates, it is still unclear how, and in some cases, if pharma can appropriately utilize blogs, wikis, and applications like YouTube and Facebook to provide information about our products.

We need a candid, constructive dialogue about how the internet and social media can be used most appropriately to communicate about healthcare issues, including treatment options.  We look forward to being a part of it. 

The latest unemployment numbers were announced by the US Department of Labor yesterday, and were higher than expected.  It was also announced yesterday that there will be many auto dealers closing as a part of the industry-wide restructuring.

While this is an extremely tough time for many, it seems like a good time to remind people about GSK's Patient Assistance Programs, which have been in place since December 2000.

Since about half of Americans have at least one chronic disease--many of which can be managed but often require medication--we're concerned about the health of those who have lost their jobs and health insurance.  We're proud to be able to offer free medicines to those who have lost their jobs and meet the income eligibility guidelines. GSK's patient assistance programs do not limit help based on when a person lost his or her job or how long he or she has been taking GSK medicines.

GSK gives away medicines valued at more than $1 million each day to those who need help. We encourage those who have lost their jobs, lack health insurance or who are facing economic hardship to visit our website (www.gskforyou.com) to get more information and see if one of our programs can help them maintain or gain access to the medicines they need.

This is indeed a time of great stress and hardship for many Americans, and we want to do all that we can to support good health through improved access to medicines. 

President Obama held a roundtable discussion at the White House on Tuesday with the CEOs of several employers that have found innovative ways to lower health care costs and improve the health of employees.

There are a number of employers out there that have recognized that the driver of healthcare costs in this country is the epidemic of chronic diseases--diabetes, asthma, heart disease--and that many of these diseases can be prevented or better managed, which may result in lower spending on healthcare in the long run.  So these employers--companies like Pitney Bowes and GSK, and cities like Asheville, New Orleans, and the participants of the Diabetes Ten City Challenge, and the CEO Roundtable on Cancer--have instituted what has come to be known as value-based benefit design/health management. 

The goal is to make it easier for employees to take an active part in managing their health by implementing work-based programs to encourage and support them to make behavioral changes to prevent obesity, control diabetes, exercise, etc. The work-based initiatives range from on-site gyms and healthy cafeteria options to eliminating copays for medicines that treat chronic diseases.

In a fact sheet release by the White House, the Administration noted that "...employers are discovering that improving quality of care can reduce health care costs. Small actions in the workplace can generate large benefits."

"The President hopes that by encouraging more employers to adopt similar programs, we can improve the productivity of our workforce, delay or avoid many of the complications of chronic diseases, and slow medical cost growth," the statement said.

These companies have been investing in prevention and disease management programs, and many are seeing savings.  I think I'll send the President the link to GSK's Center for Value-Based Health Management.

We know that stress is really bad for us, especially for our cardiovascular health.  It can also suppress the immune system, speed the aging process, and interrupt sleep.  Stress is associated with a number of chronic diseases, so many people practice yoga and exercise as a way to prevent and manage stress.

Now we can add music to our arsenal of anti-stress tools. 

A new study out of Stanford University found that elderly patients who were diagnosed with depression gained self-esteem and saw an improvement in their mood when they were visited by a music therapist. 

The trick, though, seems to lie in variety.  So set that MP3 player to shuffle, folks. 

Now I am not suggesting that the the latest single from Lady Gaga is going to smooth those stress lines, or that Nina Simone's greatest hits double album will take all of your worries away.  But there are tools that each of us can employ to help manage our health--while continuing to see the doctor and follow his or her advice.   

Today, President Obama announced that he has secured the commitment of key industry groups--including the American Medical Association, America's Health Insurance Plans, the American Hospital Association, the Advanced Medical Technology Association, the Service Employees International Union, and the Pharmaceutical Research and Manufacturers of America (of which GSK is a member)--to do their part to rein in the growth of healthcare costs.

In a joint letter to the President, the groups pledged to offer concrete initiatives aimed at transforming our healthcare system:  

We are determined to work together to provide quality, affordable coverage and access for every American.  It is critical, however, that health reform also enhance quality, improve the overall health of the population, and reduce cost growth. We believe that the proper approach to achieve and sustain reduced cost growth is one that will: improve the population's health; continuously improve quality; encourage the advancement of medical treatments, approaches, and science; streamline administration; and encourage efficient care delivery based on evidence and best practice.

What struck me this morning as I heard the news that all of these groups would be joining the President at the White House today, was that even just a few years ago this meeting might never have happened.  But today, these groups--and the President(!)--together talked about their commitment to improving outcomes while managing overall spending, and the importance of preventive efforts, better management of chronic diseases, and continued medical advancement. 

Reforming our broken healthcare system is a huge undertaking, and it will require a collaborative effort from everyone involved--private sector, public sector, academia.  As the President said "It's the kind of broad coalition--everybody with a seat at the table--that I talked about during the campaign, that is required to achieve meaningful healthcare reform, and that is the kind of coalition to which I am committed."

With the aging of the Baby Boom generation, and retirement planning in full swing for many, Alzheimer's Disease is often in the news. 

There is no cure for Alzheimer's Disease, but there is hope.  And to provide a rather personal look at the personal impact of the disease on patients, caregivers, and loved ones, as well as an update on the hope in science, HBO is airing "The Alzheimer's Project" starting May 10.

"The Alzheimer's research community welcomed the opportunity to collaborate with HBO, seeking to raise new awareness and understanding of this devastating disease," says Richard J. Hodes, M.D., director of the National Institute on Aging, the component of the National Institutes of Health leading the federal Alzheimer's disease research program. "There is a compelling story to tell of scientific discovery, of research advances and challenges, and of the human faces behind the disease."

This disease could end up touching many of us--whether personally or through someone we know--in the near future.  I urge you to watch it.

(PET scan of a human brain with Alzheimer's disease courtesy of Wikipedia.)

This week, GSK has been in continuous discussions with the World Health Organization, the US Centers for Disease Control and Prevention, the US Department of Health and Human Services, and the European Centre for Disease Prevention and Control to gain a better understanding of the new influenza A (H1N1) strain. (Remember--we're not calling it swine flu anymore.) 

We're sharing resources and data with these authorities to help them develop estimates for manufacturing capability, timing of possible production, and use of adjuvant technology in production of a potential pandemic vaccine.  (Adjuvants are the parts of a vaccine that help the body respond more effectively to it.  Sort of like adding a shot of espresso to your iced coffee.)

GSK has an active pandemic influenza vaccine R&D program which includes development of pre-pandemic and pandemic vaccines and use of novel technology, such as adjuvants systems.   

GSK stands ready to begin manufacture of a potential vaccine against the new influenza A (H1N1) strain virus once the WHO and other public health authorities make recommendations for composition of the vaccine. 

In the meantime...sneeze into the crook of your arm and wash your hands often, folks!

(Images courtesy of CDC's Public Health image Library.)