The Three Rules Movement

We recently came across a website that is supporting a book by two Deloitte Consultants.  The book is The Three Rules by Micheal Raynor and Mumtaz Ahmed and here is a link to the site.  Here is another link to a radio interview on Bloomberg Radio. 

In short, it highlights for us the need to have companies focus on being better before cheaper. Our world today seems to be run by lawyers looking out more for risk mitigation, HR people who are looking for the exact specs on their job postings and finance personnel who are looking more at cost avoidance than revenue generation. Somewhere in all this advancement the last 4 years, industry and corporations focus less and less on the customer.  We believe this is very true in life science companies and to some degree we now see it in healthcare entities as they try to figure out how they are going to manage the US healthcare reform act.  

We are interested in your thoughts. Let us know what you think of the rules and the book.  

Six Enemies of Greatness (and Happiness) in Pharma

I was just browsing twitter and found a great article by Forbes contributor Jessica Hagy.  The article entitled "The Six Enemies of Greatness (and Happiness)" has real implications to life science and specifically large pharma companies.  Here are some of our thoughts.  

1. Availability
• Marketers typically take the path of least resistance.  They feel they need to push things fast and often miss future opportunities when the evidence right in front of them aligns 
2. Ignorance
• Life science marketers often have settled for what they can get done with their regulatory/legal colleagues. If we do not know how to make something great, we simply won't. It is easier to succumb to the legal challenges than take a longer term view and fight the key issue facing marketers.  The ability to create valuable medical content that patients and healthcare professionals want to read 
3. Committees
• Hagey's quote here says it all. "Nothing destroys a good idea faster than a mandatory consensus.  The lowest common denominator is never a high standard.
4. Comfort
• Many of us are all well paid and very comfortable in our lives.  People who are complacent are often not encouraged to pursue greatness. Only recently has the industry been feeling the need or desire to change.
5. Momentum
• If you have been doing something for more than 3-5 years and it is no longer providing you exciting results, you might want to change.  Marketers should begin to look at how the electronic communications are conveying important messages and value to customers.  
6. Passivity
• Do not accept something if you truly believe "this is a bad idea."  The challenge with many senior leaders is that they hear only the good news and do not accept contradictory views.

Finally, Hagey finished the article with a survey question to the reader.  What did they think was the biggest obstacle in achieving greatness?  The respondents suggested that comfort and passivity more than any other barrier prevent greatness.  

Lets see if we can not change this some.  

Why price increases will no longer work-a thought for the CEO's of life science companies.

So this article in FiercePharma on Friday (5/13) caught our eye.  What is the moment when reality and perception converge for the Pharma industry?  What will happen when the CEOs of all the top life science companies need to tell their boards there is no more room for growth.  We hope someone in these organizations is spending some time on this subject, because the time is now.


We have always suggested there is a new way to engage with customers.  Regardless of the marketplace conditions, we believe that treating a customer as you would like to be treated as a person is the best approach. But why has the industry through the years continued to see things differently, then when faced with the patent cliff the drug industry faces, we seem to be out of answers.


Our advice, start to manage the expectations of your boards that lower earnings and revenues are going to be a way of life.  Look to BRIC nations for your future growth and develop harvest strategies for Europe and the US.   Several are still looking to research and development for the answer, but we believe the best thing you can do is to ensure you keep the business you earn.


Ask your senior leadership team what they are doing to make sure refills, re-orders and customer complaints are managed more effectively than the constant focus on creating demand for your products/services.  We realize you have a big number to fill every year!  It seems we spend a lot of time (and money) doing some of the same things.  Medication adherence programs work!  Why not mandate that all your products and brands make them an integral part of their marketing plan. 

The HCC, Its Priorities, and Financial Disclosure

The headline on the Healthcare Channel article reads: Did Merck conceal funding to a vocal advocate of Gardasil?

If Merck tried to, it did a lousy job. Its financial connection to oncologist Maura Gillison, the woman who linked the human papillomavirus with a new type of tonsil cancer, is readily available on the Web. The earliest connection we found goes back to a Forbes story, written in 2009. If Merck tried to keep the connection out of the story, it failed.

There might be an earlier mention, but there’s no date on this disclosure: Dr. Gillison, who also has a PhD, apparently spoke at a webinar for the Association of Reproductive Health Professionals. She disclosed that she “receives unrestricted educational grants from Merck and Digene.” 

If you haven’t guessed already, this is yet another dust-up over financial disclosure. The Healthcare Channel apparently was all aflutter that Dr. Gillison hadn’t listed Merck as a funding source when she published an article in the New England Journal of Medicine in 2010. It notified NEJM; the journal investigated, and it decided that Dr. Gillison HAD NOT violated any of its disclosure rules because the financial arrangement had fallen into a “gray area.”

We don’t know why NEJM let Dr. Gillison slide; but we think this is an example where we need to be careful about the generalizations associated with industry and healthcare practitioners' relationships.

The Healthcare Channel wrote: “The Healthcare Channel has exclusively learned that Dr. Gillison was in fact receiving payments from Merck, going back to 2008 that benefited at the least her laboratory, while she was at Johns Hopkins.” Maybe if its writers had surfed the Web for 15 minutes, they would have found what we found.

This is what the Merck Web page says regarding the information it discloses:

"On March 29, 2011, Merck updated its report on payments to U.S.-based medical and scientific professionals who speak on behalf of Merck about our products and other health care issues. These reports include legacy Merck products prior to the November 2009 merger between Merck and Schering-Plough. The new report covers payments made to speakers for the full year 2010. The report provides data for 2,088 physicians and other health care professionals who, on average, participated in 5.9 programs each and earned an average of $1,659 per program…"

Dr. Gillison is not listed. The presumption: She didn’t speak for Merck during 2010.

We all know there is no uniformity among the current disclosure laws, or among the industry members who are disclosing on Web sites. We’ll all have to wait for 2013 for that to happen.

This is what the Forbes article said about Dr. Gillison and Merck: “Gillison spent three years trying to draw Merck's attention to HPV tonsil cancer. Finally, she is working with Merck to design a study to see if Gardasil can affect HPV infection in the throat. Merck admits studying the problem is ‘challenging’ but says the potential is big.”

Here is a physician who made the connection between HPV, oral sex and a new form of throat cancer. She did the right thing: She worked with industry to try and find a cure. She never hid her connection with industry.

That old expression about throwing the baby out with the bathwater keeps popping into our brains ....

Pharma Marketers: Smiling Through the Pain

Pharma marketers, it’s little wonder that you aren't happy people these days. The feds have yet again pushed off making decisions about how to regulate social media interaction; your DTC spend has dropped; the Sunshine Act will, indirectly, shift who your customer base is; and your end-users are spending lots of time checking out the goods on the Web before buying. Forgive us for reminding you that patients no longer just blindly take their doctor’s advice on a script.

Your mood is understandable. You need to account for every cent in your marketing budget. We get it.

But may we look at this from another angle? You may not have to recreate your wheel. You can take out a few spokes and replace them.

In other words: Have some fun while you’re miserable.

How? By learning about the game from others in the game. A Medical Marketing and Media article – an oldie but a goodie -- points out that while Pharma companies are learning from other industries’ marketing strategies, they haven’t yet caught on to the value of their own ROI experiences. The article suggests pharma needs “a clear optimization plan…. so that when results come in, everyone can deal with them as opposed to having an academic debate” about what mix works the best.

And then of course, there is keeping track of those Web searches –- not only the searches that patients make, but also those that physicians make. More than 70% of physicians search the Web for drug information, and 30% change the script or treatment course because of information they find on it, according to ThomsonHealthcare.

And more and more, those searches will lead pharma marketing pros to other social media sites like Facebook. For two years in a row, the word Facebook was the top search term on the Web, according to Experian Hitwise.

But waiting for the FDA to make a ruling before industry members are allowed to play the game will lead to many different challenges, not the least of which is disintermediation of their own products. When the FDA finally figures out how it wants industry to conduct itself in the social media world, marketers may not be able to create new spokes for that wheel. We suggest you do some scenario planning to get to those answers.

And hopefully, smile again.

The Pooled CME Model: A True Gift

Industry members, the American Gastroenterological Association (AGA) has handed you a gift, even though you might be insulted by its recent proposal that you adopt a centrally funded CME model. From our back-of-the-envelope calculations, we can’t figure out how pharma loses with this proposition, only gains from it—including some public credibility.

But first, for those who don’t know what happened recently: The AGA proposed at a recent meeting that its pharma supporters contribute to a general fund for its CME activities. AN AGA education committee would determine the curriculum. But, “If required … AGA would guarantee companies to produce one program in a therapeutic area of interest to the supporter,” according to the Medical Marketing and Media article.

Industry members who heard the proposal weren’t exactly in love with the idea.

But, if they thought about it, they could at least grow to like it. One well known study has shown that physicians aren’t exactly aware of when industry has paid for the CME courses they’re taking, although they seem to be aware of the drug ads in the journals.

If the former is true, and it’s true that industry expects to recoup $3.56 for every dollar it invests in CME, then what difference does it make what the money pays for? Pharma only wins here. It is helping educate physicians, and it can say to its critics, “See, we are supporting well done CME and not involved in influence-peddling.”

Industry shouldn’t fear the change here—pharma should fear that it’s passing up a great opportunity to deal with a meddlesome transparency issue.

Can the NIH Innovate Faster than Industry?

So it’s come to this: The federal government plans to entice industry with basic bench, and maybe even clinical trial results, to spur drug development.

Concerned that so few promising drugs are in the pipeline, that let alone meet FDA standards, the NIH is setting up a new research shop. Anticipating that penny-pinching Republican House members may give him a hard time about his idea, NIH chief Frank Collins is willing to “cannibalize other parts of the health institutes to bring more resources to the new center,” says the Times.

“There are some people that would say this is not the time to do something bold and ambitious because the budget is so tight,” he told the Times. “But we would be irresponsible not to take advantage of scientific opportunity, even if it means tightening in other places.”

For those who need a recount: The FDA approved 21 drugs in 2010, 25 in 2009, and 24 in 2008. No drugmaker, says Fiercebiotech, had more than one drug approved last year. The approval rules are getting tougher: We all saw what happened with the obesity drugs. Collins said in the Times article that industry’s “productivity has been declining for 15 years.”

It doesn’t look like many drugs will be approved this year: The Street said in January that 26 were in the queue and one’s already been rejected: Contrave, the obesity drug.

Industry is all tied up in what it considers a bad situation. While profits are increasing for some members, companies choose to focus on patent expirations, tough regulators – on both sides of the Atlantic – the new U.S. health care reform, and no doubt myriad other issues.

Fiercebiotech penned the apt phrase: A wave of impatience has crashed over the drug development and discovery business.

How did we get here? Another phrase is apt: The perfect storm.

Pharma’s past behavior forced overregulation, which added more costs to R and D. And since no one in discovery appears willing to give up its quest for innovation – read blockbuster – the costs of discovery continue to rise. So mergers and acquisitions make sense, which in our experience has drained talented R and D personnel.

So, academic researchers and advocacy groups may be the ones who drive new innovation, but it's doubtful they'll have enough funds to see any product through all the regulatory challenges. It appears to us no one is reconciling the priorities with the limited dollars available.

In our opinion: Drug research is too inefficient.

Industry critics continue to scream that pharma spends way too much on marketing and has no reason to cry poor mouth. This may be true: But the fact remains that collaboration in pharma is still a business, and pharma must answer to a board of directors, shareholders and its own future. As for the NIH, do we have evidence that research dependent on the federal government for basic bench research is the way out of this mess?

We believe both parties can find new ways to conduct research and conduct clinical trials. We just began working with a company that's ready to break down some of those challenges. We suggest this type of communication, knowledge management and performance measurement tool can help all parties involved in research. 

A comment from researcher Hugo Geerts posted on the Fiercebiotech article regarding the huge dependency on animal studies is another excellent point to consider.

His suggestion: Pharma should use more computer-based mechanistic disease modeling.

Pharma: It Must Invest in Improving Health Outcomes

If you're a businessperson and you see an opportunity, don't you take it? Especially if the opportunity is in a business that doesn't seem particularly interested in protecting its territory.

The territory we’re talking about: the quest for improving health outcomes. In a new Ernst and Young report, the authors say that non-traditional companies are investing in projects designed to improve health outcomes. To be sure, some of these partners are traditional, like Apple and Abbott Labs.

The non-traditional investments far outweigh those of Big Pharma. The non-traditionalists have spent $20 billion since 2006; Big Pharma’s figure was not given, but it wasn’t close to that, according to a Bloomberg story.

The authors say that Big Pharma has no choice but to invest in improving health outcomes, and for two reasons: the current health care system is not sustainable -- but new technologies can make it so. These technologies, the writers say, can drive behavioral change.

Examples of these projects include the insurer UnitedHealth Group, the YMCA, and Walgreens, which are working together in a diabetes management program. Others, according to Bloomberg, include GE, Telus Corp, a wireless carrier, and IBM.

One company, called PharmaTrust, based in Toronto, is creating a device called MedHome that dispenses the appropriate amount of medicines to patients in their homes. At the same time, it communicates with providers and caregivers about patients’ compliance, according to the report.

And Qualcomm, the mobile technology company, is hoping to increase compliance and health outcomes with its “connections:” an Internet-connected pill bottle cap designed to increase compliance and also lets patients refill prescriptions by pushing a button on the underside of the cap; and a “connected” blood glucose meter that tracks how often patients are testing themselves and reminds them when they are running low on supplies. They can even reorder from the device.

“Pharma is significantly behind the medical device industry in thinking about connectivity and using its power for productivity and business model innovation,” wrote one Qualcomm exec.

All we are suggesting is that innovation may quickly become the domain of others. What are the unintended consequences of this lack of pharma innovation? 

Investing in Health Outcomes: Does Pharma Get It?

A new Ernst and Young report on what it calls Pharma 3.0 – the industry’s migration from its sole focus on selling medicines to the inclusion of improved health outcomes – reminds us of the tale of the Big Three. Yes, we mean Detroit.

We’ll get to that analogy in a minute.

“In Pharma 3.0,” the authors write, “companies will succeed or fail based not on how many units of a drug they sell, but on how well their market offerings improve health outcomes.” Considering that this report included roundtable discussions and more from numerous Big Pharma execs, it’s safe to say it has lots of industry buy-in.

The report says that some pharma members are investing in such programs. By the authors’ count, 220 programs were launched between 2006 and 2010, with the lion’s share, 44%, coming last year. The authors say nearly all the top pharma houses “are active in the Pharma 3.0 space” with a few, such as Pfizer, Novartis and Roche “leading the charge” with more programs. (Pharma 1.0 is how business was conducted; Pharma 2.0 is considered Pharma’s pursuit of blockbuster drugs and is now coming to an end.)

The report doesn’t talk about how big the programs are, or how much money industry has spent.

But it does mention how much money other companies – non-traditional organizations like Apple and IBM – are spending: $20 billion.

And counting. The writers aren't pleased with industry's skimpiness.

“Pharma is still focused on investing in drug innovation,” says a Johnson and Johnson exec. “We’re not making the kinds of investments in Pharma 3.0 that many non-traditional entrants are making.”

And now for that Big Three connection.

For those of us old enough to remember, do you recall when Toyota and other foreign automakers seriously started selling their cars on American soil? The Big Three ignored their fuel efficiency, their smaller size, their better performance – until it was nearly too late.

The article authors make a similar connection.

“It is important, however, for pharma companies to recognize that they may have a limited window of opportunity. Today’s non-traditional entrants, though unfamiliar with the health care business, could prove to be quick learners, and the advantages that the pharma companies have because of their domain knowledge could shrink in a few years.”

Tomorrow: what those non-traditional entrants are doing.

Can Pharma See Wisdom in the Sell-Off?

The Street is pushing Big Pharma members to sell off their non-core assets. Why? To keep stockholders happy, of course. Even the media-deprived know that last year was not a stellar year for pharma, finance-wise or any other wise.

The Street people are arguing that some Big Pharma members are worth more dissected than they are whole. If Abbott Labs, for example, were torn asunder and its various pieces sold off, it would make a handsome profit, and its stock price could jump 30%, according to an analyst quoted in Barron’s.

Obviously, that money could be used for what’s needed: R and D.

FiercePharma brings up the point, and it’s a good one, that such dissection would run counter to what pharma members have been trying to do with all these mergers and acquisitions, and that is survive – a sophisticated way of hitting the mattresses, if you will.


Our two cents: We’re with the Street, but not for the same reason. We think it’s time for pharma members to get back to their roots, and that is Research and Development, 24/7. If discovery, trials, regulatory, and so on were the same as they were 30 years ago, it would be one thing, but they are all much tougher today. The amount of focus and concentration needed is exceptional.

Too many divisions cause too many distractions, too many worries.

Barron’s is right: Bigger is not always better. In fact, it can be a real burden.

Transparency and Health Advocacy Organizations

The release of the American Journal of Public Health study [here’s the abstract ] showing that the vast majority of health advocacy organizations (HAO) did not reveal that they had received grants from an industry member raised the predicable media ruckus. The industry member was Lilly, and only because Lilly was the first member to disclose its HAO contributions. The study year was 2007 – four years ago.

According to the study, only 25 percent of the 161 groups – mainly mental health organizations -- acknowledged receipt of the money on their Web sites, and 10 percent admitted that Lilly was a sponsor. The concern, of course, is that the Sunshine Law only requires that industry members make public its financial arrangements with physicians –- not with nurses, not with HAOs. You can find the groups here.

We’ve decided to present another side of the picture, one other press outlets didn’t mention, at least that we could find.

Thomas Sullivan, who writes the blog Policy and Medicine, says the study is essentially skewed: it was funded, he says, by organizations and individuals he considers industry critics – the Pew Charitable Trusts, George Soros, the Rudin Family Association – who want to present this data “in a negative light."

Industry, he says, already has adopted transparency via the Sunshine Law. Forcing HAOs to do the same is wasting money and time. What is needed is more collaboration between industry and HAOs “to focus their research and development budgets on diseases and new breakthroughs.”

“While transparency is important and it should certainly be feasible for HAOs to disclose their corporate grants, the information and data must not be used to discredit the organizations or programs… that help improve health care for patients,” he writes. “However, that is exactly what Rothman’s [AJPH] article attempts to do.” The study asserts that the HAOs’ lack of transparency is “disappointing because [the grantees] ‘pursued activities that promoted the sale of Lilly products.’ But this claim is overstated.”

He continues. “What is really disappointing is that the authors use their anti-industry bias to present the HAO programs as marketing endeavors, when in reality, these programs taught patients and physicians how to treat deadly and chronic diseases, create a strategy to end breast cancer, and to utilize the latest breakthrough in medical science."

As we’ve written time and again, all industry-initiated financial transactions should be made public. What we hope for, but doubt is happening, is that all parties involved here -- industry, its critics, and so on -- are mindful of the unintended consequences of these actions.

Patient Adherence: Money Can't Change Everything

Even if providers slash medication prices, some patients are not adherent. To wit: Patients’ decision not to get vaccinated during the current flu season.

It seems that some major retailers, like Rite Aid and Kroger, and smaller venues, like doctors’ offices, are awash in flu vaccine, and cutting vaccine prices to salvage their losses. The WSJ reports there aren’t enough takers for this year’s 163 million doses of flu vaccine.

Last year, there were 110 million doses manufactured, not enough to cover the demand for the potentially fatal H1N1 viral strain. Pharma ramped up production this year, hoping that the public’s demand would be the same as in the prior flu season, and because the CDC now says all people over six months old should get the shot.

During last year’s epidemic, in which 12,000 people died and millions were sickened in this country, you couldn’t turn to a media outlet without hearing about H1N1, the CDC, WHO, problems with the vaccines, and so on. If you’ll recall, there was even a huge stink involving the WHO and conflict of interest. This year, stories about the flu season have been perfunctory, found essentially on medical web sites.

But the general feeling about last year’s flu season was that the medical community, including pharma, cried wolf. One of the comments to the WSJ article was that “H1N1 was an overblown marketing effort for the most part.”  Said another: Of course it was overblown."  Comments such as these certainly help explain the public’s ambivalence to getting their flu vaccine – and to those in public health in trying to accurately forecast the reach of the flu.

This year's flu season is still early, January is just starting. It will be interesting to see what happens in the waning months of the winter. Imagine the public's outcry if the flu season gets really out of hand.

Which raises this point: Will industry and public health officials pay attention to how patients are reacting this year to getting their shots? We think that people choose not to  get vaccinated because there is no immediate value to them in doing so. We believe that focused efforts on adherence to medical evidence, providing reminders for vaccinations via text messages can help overcome the delicate balance of supply and demand for vaccines.

This is important public health work.  We believe those who are casting aspersions on the industry need to be educated to the real challenges industry faces in forecasting this often fatal disease.

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.

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. 

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.    

European Commission and Its Good Practice Recommendations

Et tu, EU? The European Commission has announced that it wants to see just how good a corporate neighbor pharma really is. The EC wants, says InPharm, “to examine corporate responsibility in the pharmaceutical industry with the aim of developing a series of good practice recommendations.”

What good corporate responsibility would entail seems to boil down to three areas, according to The Pharma Letter: ethics and transparency; access to drugs in Africa; and access to medicines in Europe. Further details, at least from scanning articles about this on the Web, are sketchy at best.

Are our European cousins piling on?

First, let’s define corporate responsibility. One definition says it’s “a voluntary approach that a business enterprise takes to meet or exceed stakeholder expectations by integrating social, ethical, and environmental concerns together with the usual measures of revenue, profit, and legal obligation. In another, it’s a “firm's sense of responsibility towards the community and environment ...

One says voluntary, the other says sense. Neither says obligatory. Are we suggesting that pharma should not be conscious of its moral and ethical obligations? Of course not. What we are suggesting -- and will continue to do so in this blog -- is that industry critics should be mindful of the unintended consequences of this constant drum-beat of criticism. (In the InPharm piece, the EC official does make note of pharma’s enormous economic contribution to the EU.)  As we have said again and again, let's focus on solving the problem!

Disruption of Research and Development of innovative medicines is serving no one!

Pharma Ethics: It’s Time for Constructive Ideas

The criticism of pharma continues. One of the latest salvos: “White Coat, Black Hat: Adventures on the Dark Side of Medicine,” by Carl Elliott, MD, professor at the Center for Bioethics at the University of Minnesota. In an interview with Pharmalot, Dr. Elliott spoke about industry ethics, and said that industry money has undermined trust. “The difficulty with the way things are done now is that you don’t know if you can believe what’s in the medical literature anymore,” he said.

His views on transparency: “I don’t think disclosure solves the problem. That seems to be the approach and I think it’s totally misguided. The more doctors who do it and the more widely known people know about it, the more widely it will be done and the practice will become normalized and nobody will feel any compunction about taking money from industry anymore.”

I think Dr. Elliott is right -- maybe time can correct some of these problems. Maybe some of the recently implemented regulations and the court proceedings will change poor behavior. 

But, friends, the criticism leveled at industry hasn’t been exactly constructive. What's needed are suggested solutions. We still do not have answers, we need operational leadership on where to go from here. We continue to suggest that we all move beyond the "industry/HCP relationship is dirty."  We suggest that you cannot highlight a problem unless you also offer a solution going forward.

Pharma: Is It Time To Answer the Critics?

It’s a question that’s begging to be asked: How can pharma get its groove back? Bad news, much of it self-inflicted, continues to besiege it. There’s the Pharmalot DOJ whistleblower’s story, which said that eight of the ten largest healthcare fraud cases involved drug makers. Says Pharmalot: “The scrutiny has been eating away at pharma’s reputation and gradually forcing changes in business practices. But attorneys say many more lawsuits are in the pipeline and the willingness of the federal government to pursue them - selectively - remains unabated.”

Then there is the ProPublica story. Reporters at ProPublica used industry-compiled databases containing the names of physicians and other thought leaders who have spoken on behalf of pharma and checked them out. What they found: Not all the thought leaders are worthy of the job. Some weren’t board certified. Others had “serious sanctions."

It sounds ugly. But if you do the math, it’s a small percentage: of 17,700 thought leaders checked out, 1.4% -- 250 — were found to be tainted in some way. (The story says more than 250, but doesn’t give a specific number.)

On the one hand: Some industry members interviewed by ProPublica reporters admitted that they didn’t do the background checks that they should have.

On the other: That 1.4% wasn’t in the story, but it doesn’t matter. The PR damage continues to be inflicted -- from within, and without.

In 1970, an American man or woman could expect to celebrate a 71st birthday. In 2003, that person could expect to live another 6 years or so. Pharmaceutical, Biotech & Medical Devices are a huge reason for those extra years. But few people – including pharma itself – seem to acknowledge that truth. Kinda of like some in Congress & the administration who do not take pride in the Healthcare Reform act. While Americans do not like this large entitlement program, in general we believe overall healthcare of the US population will be more improved.

Maybe it's time for pharma and others to speak up? Maybe. Being silent sure hasn’t helped the industry (or even the Democratic Congress for that matter).

Financial Disclosures and Journal Authors: Enough Rhetoric

When President Obama signed the healthcare reform act into law, part of the legislation package included the Physicians Payment Sunshine Act. We’re all familiar with it. Sometime soon, Industry will have to make public its financial transactions with industry consultants.

So, why are the media still acting like every undisclosed transaction – especially ones that are years old -- between physician and industry is like an unheard-of immoral outrage? Case in point: the 2007 study showing that 25 of 32 consultants to medical device companies didn’t reveal their connections in published journal articles. Those connections were worth millions, the Times says.

A constant critic of the industry-thought leader connection was quoted as saying that the study was “one more indication of the widespread corruption of the medical profession by industry money.”

It’s not clear from the article how many journals were involved in the study. The study apparently doesn’t name individual doctors or their articles. Two journal editors were quoted, each saying that yes, they must get stricter on disclosures. We’re not sure how these journals are funded, but if those sources are medical device companies, it won’t be easy biting the hand that feeds them.

We support transparency – our blog readers know this.

We do not support incomplete journalistic reporting – a check on even some of these journals in 2008, 2009, and 2010 would have rounded out the story. What were their disclosure records then? Did disclosure improve, stay the same, get worse? Is there a basis for comparison? If this record check did happen, it’s not mentioned in the Times article.

The article quotes the study’s author as saying he didn’t “know how often the journals required disclosures in 2008, but he said the lack of results showed ‘a broken system’ regardless of who was to blame.”

Physicians have battled over the question of financial disclosure for years – this NEJM editorial is from 1993.

Again, the unintended consequences of this constant, where-is-this-getting-us criticism: The effect on physician education! Physicians need to be educated in the latest research, newest drugs, newest medical devices. Industry use to be a trusted source of that information. Could we tone down the rhetoric, and begin a conversation?  We have to figure out solutions that improve healthcare overall and continue to recognize the value of medical innovation.

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