Thursday, December 30, 2010

A reflective thought to close out 2010

"We seem to be a very adverse nation.  We are fast becoming the stupid giant of planet earth.   We're big, we're powerful, and we seem to be steadily growing less intelligent." * ---Leonard Pitts Jr., Miami Herald Pulitzer Prize Winner

(*From a public address on the decline of truth in journalism and the growing "stupidification of Americans" - phenomena he attributed to Americans' unquestioning allegiance to their political ideologies and fabrication of the truth.)

A business acquaintance, turned friend, included this quote on a note that he sent me, thanking me for being a valued business partner since we first met in 1999. You know the type: one of those people you just like doing business with.

His type -- reasonable, modest, accommodating, measured, understanding -- is quickly disappearing. His replacement -- one who would expect something in return for a small gift of appreciation. He possesses few, if any, of the aforementioned attributes.

And the crime of it is, his type is not confined to the business world. If we were only that lucky. We are, my friends, fast becoming a nation that is dividing itself and forcing people to choose sides. More of us need to start taking the 30,000 foot view, and looking at what we, as a species, are becoming. The ugliness of our politics, the mud fights in the press regarding KOL conflicts of interest, the lack of decorum in just walking down the street, need I go on?
Somewhere along the line we have lost the spirit to come together. Our government leaders and corporate executives are not willing to invest in people, but if not us, who or what else? The U.S. citizenry is -- always has been -- the backbone of our strength, power and wealth.

As we reflect on this past year, we at BioPharma Advisors want to thank all those who have made our company a success and continue to support our long-term goals. We wish nothing but the best for the new year!

Thursday, December 23, 2010

Merry Christmas and Happy New Year!

We hope you have enjoyed our step into the Social media.  We want to hear from you though!  Tell us what you are interested in, let us know what topics you would like to see in our future blog posts. Complete the survey if you like, we are going to strive to be more interactive in the future.

We all like to follow certain issues. Ours will continue to be Patient Adherence, Key Opinion Leader Development, Social Media and eMarketing in the coming year.  All very different spaces, but certainly the wave of the future given the cost constraints of life science marketing and the new regulations facing us today.
Best wishes to you and your family for a Merry Christmas and prosperous New Year!

Tuesday, December 21, 2010

KOLs, Background Checks, and Unintended Consequences

We look forward to the day when industry members will no longer have knee-jerk reactions to bad press – we just wish we had a reliable crystal ball to tell us when that will be.

Our bemusement stems from some members’ announcement that they now will conduct background checks on physicians – prior to their becoming consultants and speakers. This statement comes in the wake of ProPublica’s original story showing that some industry members hired physicians with tainted backgrounds. In the subsequent story, ProPublica only discusses the relatively serious infractions, like “prescribing unjustified or excessive medications and making serious medical errors.”

The industry members who made this announcement – AZ, Lilly, and Merck – did not provide lots of details on how these checks will be made, other than they plan to review state records. Nor did they discuss what kinds of infractions, if any, would be acceptable. One that comes to mind is failing to keep up with continuing medical education courses.

As we noted in a previous blog, the original ProPublica story found that of 17,700 thought leaders checked out, just 1.4%, or 250, were found to be tainted in some way. Of course, all industry members should have been looking at state and federal records from the get-go. This is something we encourage our clients to do as part of the normal contracting process.

A final thought: Will industry critics be happy with just a state and federal records check? Will they want something more intrusive? If so, we wonder if and how this will negatively impact the practice of medical research. We know this is the right thing to do, but what are the unintended consequences?  How will industry members change how they work with exceptionally influential KOLs?

Let us know what you think.

Saturday, December 18, 2010

Patient Bloggers and the "T" Word

What an opportunity for industry to regain the public’s trust – or at least some of it.

We’re talking about industry’s use of social media to promote and market product, an excellent way to bypass mainstream media and hone the message. Even though the FDA is expected this month to present guidelines on how pharma can market medicines on Twitter, Facebook, and the like, the agency really has no say on what individual patient bloggers may say about their relationships with industry members.

To quote Pharma Marketing Blog's John Mack: “FDA cannot enforce transparency -- it has no authority over patients who are free to do and say what they like without mentioning any relationship they may have with pharma companies.”

According to Pew Research, about 61% of adults turn to the web for health information, and no doubt some of those people read those blogs. But do those bloggers disclose their relationship with pharma members, if one exists? We think they should.That is why like Sally Church (@maverickNY) we are going to create a disclosure section of this blog and our web site. Trust can be re-built one brick at a time.

And that goes for industry as well: The pharma member who ensures that the blogger discloses the connection is that much closer to establishing company loyalty among the readership.

It’s the T word, folks.  But stay tuned, because the storm around content creation in the industry is the next chapter in this story.  

Thursday, December 16, 2010

The World Market: What's on the Horizon

We took part in a survey with McKinsey Quarterly. We thought the ensuing model put into context the current global thinking as the U.S. pharma market begins to change. This is primarily meant for you global strategy types, but we think you'll agree with us that Scenario #3 -- constrained markets with unbalanced domestic fundamentals --
is the leading indicator of where the global markets are headed.

What does this mean for our clients in the U.S.? It means they need to deal with the idea that we are no longer the top market in the world. As a result, business practices and attitudes should change accordingly. To further that notion, maybe things like patient adherence should be more of a focus for in-line commercial marketing teams in the U.S.

Let us know what you think.

Which of these scenarios is most likely to happen in the next 6 months?

Scenario 2:
Stable fundamentals underpin global economic outlook
·         Careful, effective removal of fiscal and monetary stimuli
·         Strong growth in emerging market economies
·         Modest corporate-sector growth in medium term (emerging markets, productivity, developed world)
·         De-leveraged consumers in developed countries remain weak in near term until income and job growth recover in medium term
·         Reduced potential for financial inflation

Scenario 1:
Robust global markets remain susceptible to shock
·         Fiscal and monetary stimulus-driven economies
·         Strong growth in emerging market economies
·         Strong corporate sector growth (very strong in productivity and developed world)
·         Stable U.S. consumer sector (job growth returns, slow de-leveraging, modest income growth)
·         High potential for financial inflation, resulting in rapid currency movements, commodity prices and stock/bond markets
·         Failure to re-balance debt ratios, energy policies, health care expenditures, and pension obligations

Scenario 4:
Troubled global markets overwhelm domestic fundamentals
·         New shocks derail emerging market economies, stalling growth
·         Market driven curtailment of fiscal and monetary stimuli in developed countries
·         Sustained weakness in global consumer sector
·         Public sector is neutral to negative impact
·         Corporate sector is neutral to negative impact
·         Potential for raid currency devaluation in developed countries

Scenario 3:
Constrained global markets perpetuate imbalances
·         Strong growing emerging market economies
·         Fiscal- and monetary- stimuli-driven economy, although with ballooning deficits; fundamental policies are not repaired
·         Stable corporate sector (emerging markets growth and productivity surge offset by stagnation in developed world)
·         Weak U.S. consumer sector (structural loss of jobs, continued de-leveraging, declining per capita consumption)
·         Slow devaluation of dollar relative to commodities and emerging market currencies and commodity based inflation (dollar/euro terms)

Monday, December 13, 2010

Industry and Social Media 101

In November, FedEx and Ketchum released this study that benchmarks the best practices of 60 leading companies who are leveraging social media to drive internal cultural, brand performance, and reputation management. "Companies are using social media to change the way they communicate with their employees and customers, indicating a convergence of external and internal communications." They have set up a website to discuss the survey.

Both organizations suggest in this survey that social media is disrupting the way the world communicates and companies must continue to evolve how they interact with people to remain relevant. In our view, this recognizes the lack of in-depth research regarding how social media impacts the way companies program, budget, and set up their marketing teams.

Ketchum used a standardized interview protocol to guide 30-minute conversations with chief communications officers or their social-media leads at 60 leading companies across most major industries. Interviews occurred between August and October of 2010.

Here are some insights derived from the study:
  1. If you’re not open to feedback, you’re not ready to play.
  2. Organizations should recognize the rise of citizen journalism and the need to engage bloggers to support brand development and reputation management.
  3. Participants conveyed significantly greater focus on external rather than internal social media applications, but expressed strong interest in building up internal capabilities—primarily via enhanced intranets—in 2011 and beyond.
  4. Organizations are trending towards more formal collaborative social media oversight models that are inclusive of diverse business units and functions.
  5. Most organizations do not have formal internal learning programs established to promote the development of social media expertise.
  6. Companies continue to see the value in partnering with third parties to develop and execute social media programming.
  7. Participants most frequently estimated spending between 5% and 15% of their overall communications budgets on social media programming in 2010.
  8. The pace and scope of change as new tools and technology emerge demands an unparalleled degree of organizational nimbleness.
  9. As digital and social tools become the go-to resources for everything from news and information to friendship and love, smart brands will continue to figure out better ways to add value to the online experience—internally and externally.
While these conclusions may not be news to pharma's social media veterans, they are still valuable: They can be used in discussions with senior management about social media trends and to leverage those difficult discussions on social media operations in their companies. For us, these study results demonstrate just how much more work the industry has to accomplish to even be a participant in this growing communications channel.  

But like other business issues, regulated content may inhibit the industry's ability to even participate in the leading edge of social media discussion.  We think it is time for industry to focus on insight #1, "If you're not open to feedback, you're not ready to play."

Our recommendations for anyone in industry in this space:  Use these 9 insights as your strategic building blocks for the next 3 to 5 years. 

Wednesday, December 8, 2010

CER: Learn How to Love It

Comparative effectiveness: It’s a concept that payers like, and like a lot. Case in point: Britain’s National Institute for Health and Clinical Excellence. NICE has rejected paying for drug after drug over the past year, claiming it couldn’t see paying high costs for brand drugs that don’t deliver much more than other medicines of lesser value. The latest rejection was Roche’s Avastin; another rejection was Novartis’ Afinitor.

For those industry members whose attention has been riveted on other business matters – and that’s understandable – it’s important to appreciate that comparative effectiveness isn’t going away. Tucked into the health care reform bill was $1.1 billion to study comparative effectiveness research.

According to the Annals of Internal Medicine, CER is “the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care." While the point is to "assist [stakeholders] to make informed decisions that will improve health care at both the individual and population levels," all this information affords interested parties "the opportunity to address hitherto unexplored topics in clinical decision making.” In other words, how to save money.

Now, industry members could argue, and rightly so, that clinical trials produce data that come from homogenous groups. In The Health Care Blog, Norton Hadler, MD, wrote, “The science that the FDA reviews does not speak to the effectiveness of the drug, but to its efficacy… CER asks whether an intervention works better than other interventions in practice where the patients and the doctors are heterogeneous.” His argument: Redesign trials so they are more efficient. Good point, but considering industry's current reluctance to embrace this topic and FDA's current focus on safety, that argument will likely not be a top priority anytime soon.

Our advice? Take a look at PharmExec’s article The Fruits of Comparative Effectiveness

It’s a thoughtful, well conceived piece on how industry members should approach comparative effectiveness. Quoting a Lilly exec, the article says, “The companies that survive and thrive in this new environment will be those that embrace comparative effectiveness research."

Fighting CER, friends, is not helping demonstrate the value of medicine.

Monday, December 6, 2010

The Midei Investigation: Get Your House in Order

Considering all the criticism against industry lately, this is not a good time for companies to be procrastinating about changing some of their business practices. Case in point: What an Abbott Labs division may be doing with Mark Midei, MD.  He is the cardiologist accused of implanting hundreds of more stents in patients than apparently were necessary.

When Dr. Midei was barred from his Baltimore-area hospital last year for allegedly performing the unnecessary surgeries, Abbott hired him as a consultant.

A Senate report -- investigating because of alleged Medicare fraud -- says that Abbott “showered” Dr. Midei with gifts and other handouts, and that he performed more stent surgeries than any other cardiologist in his area, suggesting that the two items are directly related. While we have discussed COI extensively in this blog, the Midei situation is yet another example of how industry needs to continually evaluate and update its contracts with Thought Leaders.

We think a big-name corporation is getting dragged into a situation it did not think was possible, but is becoming more the unintended consequential norm because of heightened scrutiny on the industry. Our advice to clients is get your house in order. Make sure your divisions and affiliates are reviewing their Thought Leader contracts.  Make sure you are taking the appropriate steps to improving your Sunshine Act compliance efforts.

If this is a challenge for you, let us help.


Friday, December 3, 2010

Are Tougher Rules the Real Reason Behind Fewer Gifts?

We have a slightly different read on that Archives of Internal Medicine study showing that fewer physicians are accepting gifts or money from industry. 

The study’s author seems to attribute the drop to the tougher rules that hospitals and medical schools have adopted over the past few years regarding such gifts. “The data clearly show that relationships have dropped dramatically,” Eric G. Campbell, director of research at the Mongan Institute for Health Policy, in Boston, told Bloomberg. No doubt, to a certain extent, he’s probably right. There were 1,891 doctors who took part in the survey.

But there could be more to it than just tougher rules.

Another article caught our eye. It seems that more doctors are getting out of traditional private practice. They’re entering the highly lucrative concierge business, or becoming hospitalists.  The reasons for entering either specialty are plentiful – and we believe a contributing factor is that physicians are not happy with the excessive scrutiny their profession and medical practices has come under.

Unintended consequences: We think there is a fundamental shift in medical practice back towards the hospital-based model.  Doctors now will be willing to live "under the protection afforded by hospitals." It is no longer prudent or profitable to practice medicine in the ambulatory setting. Care in these settings will be delivered by allied health professionals, who we think are very competent. 

But what does this mean for industry marketers?  Focus your development efforts, if your product, device or service, is a niche/specialty product, on the physicians.  If your product, device or service is ambulatory based, focus on the PAs and NPs.