Television represents the largest direct-to-consumer (DTC) promotion expenditure for most pharma marketers. In the first quarter of 2010, 59 percent of pharmaceutical DTC spending was on television ads. 

 Photo credit: NBC (Cast of "Law & Order Special Victim's Unit") 

But brand managers who are relying solely on traditional ad placement methods rather than using newer, more sophisticated methodologies, may be missing opportunities to reach target patients as well as wasting spend.   

So what are these new methods? Digital capabilities that anonymously link what we tune in to watch on TV with the prescription behavior of consumers. The result? An ability to determine the most effective networks, programs, and times of day to reach patients of interest and to measure the impact of the campaigns.  In turn, it enables brand mangers to base the placement, measurement, and refinement of their strategies on empirical data, which can result in more efficient investments and greater accountability.  

A key objective of DTC advertising is to drive patients to visit their physician and request the prescription brand advertised. And when it works, it works: Take TV advertising for the osteoporosis market. At its peak in 2008, osteoporosis patients requested a specific drug from their physician during 20 percent of visits. And studies show that physicians tend to grant patient requests and issue the sought-after drug, unless there is a valid reason not to. In 2008, when Actonel was requested by patients, physicians issued it 98 percent of the time. 

Given the significant investment that goes into pre-market campaign planning, particularly creative and message testing, the same level of rigor needs to be applied to ensure the ad is effectively reaching the intended audience of patients. However, TV real estate continues to be purchased based on traditional parameters of audience age and gender demographics, at the right price. 

How exactly do these new methodologies work? Anonymous longitudinal patient data tracks, among other things, prescription activity over time. By reviewing what drugs patients have filled recently, they can be classified as being treated for conditions in different therapeutic markets. A combination of tuning and prescription behavior then enables an analysis of what patients in different healthcare markets are watching.  

In addition, evaluations can determine the influence an ad has had on patients who viewed it. Advertisers are then able to accurately gauge differences in the prescription behavior of patients exposed to an ad compared with nonviewers.   

An evaluation of a brand's recent ad schedule demonstrates how knowing what programs patients are actually watching could dramatically change the selection of programs made by an advertiser (figure 2).  In the six months ending March 2010, a popular depression drug was advertised most often on: 

3. "Law & Order: Special Victims Unit" (NBC) 

These shows most likely were chosen based on traditional age and gender criteria. However, a ranking of shows based on new insights gleaned from linked tuning and prescription data indicates that these were not the most optimal placements.  

And so while "Law & Order: Special Victims Unit" was the third-most-purchased show, it ranked No. 20 in reaching depression patients—meaning that 19 other shows would have been more efficient.  

The fifth-most-popular—and most expensive—advertising placement, "The Bachelor" on ABC, ranked poorly when analyzed in terms of patient healthcare behavior. It indicated that 36 other shows would have been more effective in reaching depression patients.  

Employing the new methodologies would have enabled marketers of this brand to either decrease spending and reach a better audience or continue with a similar investment but reach far more patients. Either scenario should result in a better return on investment. 

When patient-level data is being used, a true control group can be created that matches a group of patients who viewed the ad. Age, gender, past healthcare behavior, and other patient characteristics can be analyzed to help ensure that resulting differences in prescription behavior between the control and exposed groups can be attributed to the viewing of a campaign instead of outside factors. 

In addition, patient-level data is longitudinal and tracks patients over time. Therefore, a host of metrics about patient behavior pre- and post-exposure to the campaign can be analyzed. The objective of many ad campaigns is to draw new patients to the brand, either through acquisition of patients new to therapy or conversion of patients from other drugs in the category. Since the de-identified patients' past prescription activity is known, it's easy to discern the types of new patients acquired. 

Some campaigns are created to build brand loyalty and will include direct-response spots that encourage patients to join customer loyalty programs. The extent to which campaigns like these are effective at extending the length of therapy for patients can be measured by tracking viewers over time to determine how long they remain on therapy after being exposed to an ad campaign compared with those who didn't view the campaign.

 Senior VP, Pharmaceutical Sales at TRA, 

Articles

Pharm Exec Special Section (Features)

Brand managers choosing to advertise an anti-depressant on "Criminal Minds" may not be making the best choice. New methodologies reveal "Law & Order: Special Victims Unit" along with "The Bachelor" to be shows favored by depressives

Optimizing TV Advertising Placements & Results

As part of the effort to transform the nation's health care system, the Affordable Care Act (ACA) promotes greater transparency in pharmaceutical industry relationships with health professionals. The aim of a provision commonly known as the Sunshine Act is to reduce inappropriate prescribing, curb drug marketing, and lower health care spending overall through public disclosure of payments from drug and medical product manufacturers, to physicians and teaching hospitals. In the process, the program promises to alter industry business practices and marketing strategies and raise a host of thorny legal issues. 

Superficially, the Sunshine policy looks familiar. Companies have been tracking and reporting fees and gifts to healthcare professionals (HCPs) for several years to meet a range of state laws and other standards. The Pharmaceutical Research and Manufacturers of America (PhRMA) revised its marketing code in 2008 to address these issues by banning gifts to doctors and encouraging limits on fees. Furthermore, a number of pharma companies such as Eli Lilly, Merck, GlaxoSmithKline, and Pfizer are posting physician payments on their websites to comply with corporate integrity agreements negotiated to settle charges of illegal marketing activities.  

But the federal Sunshine Act expands disclosure requirements considerably and extends them to biotech and medical device manufacturers. These "applicable manufacturers" have to report a long list of "payments or other transfers of value" to "covered" recipients. Data submission includes recipient's name, address, medical specialty, amount received, date of payment, type of payment (cash, stock, in-kind products), and if the payment is related to a specific drug or product. Reporting applies to anything worth more than $10, or outlays that total up to $100 a year, and includes consulting fees, honoraria, payment for research, gifts, entertainment, travel, education, charitable contributions, royalties, licenses, grants, stipends to speakers, or anything else that the feds add to the list. Manufacturers and group purchasing organizations also have to report any "ownership or investment interest" held by a physician in that entity, a strategy designed to track whether investments in hospitals or drug companies spur doctors to purchase medical equipment or to prescribe particular medicines.  

Because small amounts can add up quickly, every dollar has to be captured in "aggregate spend" software systems and tracked over time. That means collecting massive amounts of information on sales force activities, marketing programs, and clinical research projects.  

The Department of Health and Human Services (HHS) is charged with implementing regulations by October 2011 to clarify which companies have to report what information about who. Everyone is looking for clearer definitions of "consulting fee," "honorarium," "teaching hospital," and how reporting applies to affiliated companies, product co-development partnerships, and third-party service firms.  

The process for submitting data to HHS and for the feds to make this information public remains murky. So far there's been little clarification from Washington, even though companies have to start collecting required data in 2012 in order to file their first reports in March 2013. That may seem like plenty of time to launch new systems, but the standard-setting process can take months, and no one at HHS seems to be in charge.  

Failure to comply with all the requirements "in a timely manner" carries fines that start at $1,000 for each reporting failure and jump to $1 million a year for firms that knowingly and deliberately disregard the new rules. Prosecutors and whistleblowers will have a sharp eye out for inadequate disclosure that can support anti-kickback cases and other charges. Because companies inevitably will file some spending information that turns out to be erroneous, False Claim Act cases will be "going through the roof," warned attorney Kirk Ogronsky of Arnold & Porter at the Center for Business Intelligence (CBI) aggregate spend forum in August. 

Reporting systems also will continue to track state disclosure policies, as federal pre-emption in the Sunshine Act is fairly weak. PhRMA backed federal Sunshine legislation as a way to replace diverse state laws with a national standard, but differing state requirements remain in effect, such as reporting of DTC advertising costs.  

Eight states, including Massachusetts, Vermont, Maine, Minnesota, and Washington, D.C., have enacted physician transparency policies with varying thresholds and timeframes for submitting information. The stated aim of these initiatives is to reduce health care spending, pointed out Vermont assistant attorney general Wendy Morgan at the CBI forum. Drug companies spend millions marketing to physicians, and this "affects the way doctors prescribe," said Illinois state representative Jack Franks. Vermont and several other states are moving from disclosure to outright bans on gifts to healthcare providers, as the HCPs more clearly aim to cut marketing expenditures. If you curb gifts, said Morgan, you eliminate "a huge chunk of money added to the cost of pharmaceuticals."  

Yet, pre-emption may have some impact. Morgan said that Vermont will adopt federal definitions and standards as much as possible to avoid redundancies. And Franks said he won't continue to pursue an Illinois disclosure law because a uniform federal policy is "better than a hodgepodge of legislation across the country." But Franks added that he'll be watching closely to see how federal reporting affects prescribing trends.  

While a number of states exempt fees paid to HCPs for conducting clinical trials, the federal law explicitly brings clinical research under the aggregate spend umbrella. Sunshine advocates believe that pharma companies may influence prescriber behavior by engaging physicians as clinical investigators, consultants, and advisors—in addition to their commercial encounters. 

But obtaining research-related data will be challenging. Pharma R&D and medical affairs staffs don't see themselves as part of marketing and are not accustomed to pulling investigator fees out of large research budgets. There's confusion over disclosure specifics, such as its application to interventional versus observational studies or to equipment supplied to a clinical site on a temporary basis. This is "unchartered territory," commented Wanda Toro, president of Bull's Eye Innovations, at the CBI forum.  

Another complication is that the federal legislation allows companies to delay public disclosure of fees related to clinical research until after product approval by FDA, or four years after the payments made, whichever comes first. Sponsors sought this provision as a way to retain some secrecy about investigational programs. But because companies still have to submit payment data every year, they must identify what falls into the clinical spend "bucket" to benefit from delayed disclosure.  

Just what HHS and others do with all the aggregate spend information remains to be seen. Beginning in September 2013, the government will start posting payment reports on a public database in a format that is searchable and easily aggregated and downloaded. HHS also will provide Congress with an annual report aggregated by reporting company, and each state will receive a summary of payments to its licensed practitioners. 

Public disclosure of physician payment data is expected to have a substantial effect on pharma-HCP relationships. Many doctors have become reluctant to make speeches on specific drugs or to consult on research projects. Investigators maintain that they have nothing to do with marketing and are unhappy about public disclosure of their research fees and the implication that such work compromises a physician's independence.  

Pharma companies may benefit in the long term from better information and tracking systems. But for now, they're overwhelmed by new tasks. They need to revise agreements with consultants and investigators to ensure they obtain all required information. Co-promotion and co-development projects need updates to clarify responsibilities for collecting and reporting required information. Reporting systems must provide HCPs who receive fees an opportunity to review and challenge payment reports. And internally, pharma companies have to decide which unit assembles the data, who verifies it, and who signs off on its accuracy.  

Improved tracking of payments will raise new issues. Corporate caps on annual compensation to an HCP for marketing activities, for example, may generate conflicts between the marketing department that wants to use a prominent clinician as a spokesman, and the research department planning to engage the same individual as an investigator. Reformers and regulators will be looking hard for any sign of fraud or conflicts of interest. 

's Washington correspondent. She can be reached at 

Columns

Health reform requires detailed tracking and full disclosure of fees to docs for marketing and research

Getting Ready for Sunshine

Outsourcing the management of clinical trials, manufacturing, and packaging, as well as (to a limited extent) data management and sales operations, is fairly commonplace in the world of pharma. However, companies are showing themselves to be even more adventurous in trying on for size the outsourcing of analytic functions. 

Ideally, outsourcing enables organizations to improve operational effectiveness and gain improved insights, freeing resources to focus on decision making (see Figure 1). The conventional wisdom is that these efficiencies can in turn put companies on the fast track to greater insight—an "aha!" moment, if you will—that can propel them toward greater commercial success. 

To date, knowledge-based outsourcing has been limited to a reliance on partners for incentive compensation, sales reporting, and some data management. While the amount of spending has been significant, it is concentrated on single processes and individual needs.  

Many companies in the industry are in an assessment phase to determine which activities and processes they should hold on to from a strategic standpoint versus those that might benefit from outsourcing. Advice and frameworks in the area abound, and making the wrong decision can be detrimental, especially as the industry moves from piecemeal initiatives to large-scale outsourcing efforts (see Figure 2). 

Figure 2: The Value Chain-Outsourcing Information-Intensive Processes 

At best, knowledge-based outsourcing can drive commercial excellence and cost efficiencies within and across commercial support functions by offering:  

More effective and adaptable decision support for sales, marketing, and managed markets operations; 

 Improved processes, stemming from wider exposure to methodologies that lead to the adoption of best practices in sales force effectiveness, sales and marketing analytics, multichannel marketing, and information management, for example; 

 Higher-quality data interpretation, owing to a broader perspective;  

 Greater staffing flexibility and access to critical expertise through peaks of demand (during launches, for instance) plus variability in cost structures as the need wanes. IT functions have benefited from utility computing—the notion that capacity is scalable and available on demand—and the same approach can work for knowledge-based activities;  

 Lower operational costs (tracked as being reduced by as much as 20 percent to 30 percent); 

 Global consistency and standardization; 

 Adherence to changing regulatory, privacy, and security requirements; and lastly 

 Freedom from the costs associated with training and retaining knowledge experts. 

Creating variable capacity via outsourcing can be complex when the functions under consideration are decentralized within the company. If a centralized operation is to be outsourced, typically fewer stakeholders are involved, and the process is less arduous. Successful transitions typically focus on: 

 Identifying cost reduction opportunities that don't compromise the integrity of existing programs; 

 Streamlining workflows and improving processes—within a specific country, across a region, or around the world; 

 Establishing analytical teams that are centralized, offshore/external, and scalable; 

 Enabling a common platform for research findings and recommendations; and 

 Focusing a smaller number of internal resources, each with unique talent or knowledge, on higher-value activities that leverage analytical output. 

However, if a company's processes or functions are decentralized, there is an even greater opportunity to drive speed to insight as analytical and information processes can be streamlined in a manner that eliminates commonly redundant activities through: 

 Improved data integration and management; 

 Best practice analytic approaches and methodologies; 

 Consistency in Key Performance Indicators (KPIs) and metrics to measure success; and 

 Leveraging a common knowledge repository.  

The migration towards outsourcing starts with an informed diagnostic assessment of the decision-making process and the supporting information processes. After one clearly defines the processes, a model can be developed to flexibly and effectively support the dynamic needs of the business. 

Outsourcing is not just about cost cutting via offshoring; it is about extending the organization's business edge while gaining resource efficiency and operational capacity. In doing so, companies may seek solutions for:  

 Commercial Operations–data integration, performance analytics and reporting, data management, incentive compensation, call planning, segmentation, customer relationship management (CRM), and sales administration; 

 Market Intelligence–analytics and reporting, brand insights, competitive intelligence, opportunity assessment, and forecasting; and 

 Managed Markets Analytics–contract management and administration, and government and market pricing, access, and rebate analysis/adjudication/reconciliation (see sidebar). 

One Key Application: Analytics in Managed Markets 

Such solutions span the commercial spectrum and drive companies toward efficiencies to be gained along an "analytics continuum" from retrospective analyses to future planning (see Figure 3). While the sales and marketing operations each require different types of data, at a high level they should follow similar processes, including integrating data and creating market definitions. Improving speed to insight is essential in order to better target customers and ensure better interactions with them. 

Figure 3: Spanning the Commercial Spectrum 

In its broadest sense, analytics covers both business intelligence and more sophisticated predictive modeling and scenario-based "guided analytics" (promotion response, segmentation, targeting). Such work helps a company focus on customer insights and track market trends to better gauge and predict the business impact of decisions. Both areas can be outsourced; however, the evolution toward guided analytics can evolve much faster than many believe because a greater competitive advantage can be gained by leveraging best practices, reducing information complexity, and applying more advanced analytic capabilities. Outsourcing-guided analytics involves working with a partner that has sufficient domain expertise to free in-house staff to perform analyses, interpret findings, and prepare recommendations—the higher-level work that they both want and need to be doing.  

Changing market dynamics and an evolving customer base have underscored the need to move beyond merely tracking, monitoring, and trending toward predictive modeling and forecasting. Increasingly, companies must do more than assess what happened and why; they must perform actionable analytics and make information-intensive processes more efficient. 

The two fundamental objectives of knowledge-based outsourcing are: 1) To introduce variable cost models to support fluctuating capacity requirements; and 2) To add strategic value and perspective to the organization. In less than ideal situations, these objectives compete with one another. However, when the partner understands the industry, the stakeholders, commercial functions, data sources, and the type of insight required to make business decisions, the two objectives can be met without conflict.  

The transition to outsourcing relationships will involve some level of disruption around the processes being streamlined. What may initially seem like loss of control can mask pathways to more intellectual leverage of internal resources. Another potential issue is the training required by partners who lack the necessary domain expertise (when, in some situations, those employees who would have been the ideal mentors are now gone). Underestimating the amount of oversight and project management required for the transition could lead to disappointing results.  

To effectively deliver value to the organization through knowledge-based outsourcing:  

Work with your internal stakeholders to create a strategic plan and associated roadmap, ensuring that what you envision will fit their needs.  

Determine which internal support structure and outsourcing approach will best serve the company depending on the diversity of its portfolio, the number and size of products in each therapy area, the stage of products in their lifecycle, and the company's growth prospects. (A "Vertical Brand Model" aligns resources to high-potential brands; a "Shared Services Model" pools the resources for users across commercial operations, business intelligence, and managed markets to tap into various services as needed. A hybrid approach combines features of each.)  

Engage partners that know the industry and can deliver value through domain expertise while also offering scalability and the means to drive larger cost savings.  

Features

Tracking, monitoring, and trend evaluation is not enough. Companies must now do more than assess what happened and why.

Knowledge-Based Outsourcing: Driving Deeper Insights

For many pharmaceutical sales forces, selling at the pharmacy level is something that is awkward and done infrequently at best. However, decision making that is exercised at pharmacies seems to be increasing along with a rapidly expanding generic market, more complex and authoritative managed care, and growing utilization of savings cards and free voucher programs. And while access to physicians seems to be declining nationally, there has never been a more significant time to capitalize on every opportunity to ensure the successful fulfillment of your products at the pharmacy level. 

There is a lack of familiarity that many sales reps experience at pharmacies, and this is largely due to the infrequency of these interactions. As a new rep, I quickly realized how uncomfortable these sales calls could be when I began to put local pharmacies into my route. A common scene that unfolded began with an annoyed cashier who would see my name tag, then roll their eyes at me and mumble, "Do you want to talk to the pharmacist?" And it often ended with a pharmacist dumping the savings cards or vouchers that I had just given him into an overcrowded drawer, never to be seen again. 

After a few of these interactions, I quickly realized that my territory needed a more focused and effective plan if I was going to make any difference at all in positioning my products so that patients have the greatest chance of actually filling the scrip that I had previously worked so hard for. Therefore, I developed a strategy to determine exactly how much business is either lost or gained at the pharmacy level and what can be done about it. The following list is comprised of 10 essentials that can be implemented into any pharmacy selling strategy and can mean the difference between a hard-earned scrip being filled or going to a competitor at the pharmacy level. 

Voucher cards go a long way if a rep takes the time to explain how easily they work.			

Understanding who the employees are, and their responsibilities, is essential. Typically, the pharmacist is not the only person who can help or hurt your business. The pharmacist is primarily responsible for patient consults as well as checking and rechecking prescriptions for accuracy and potential drug-to-drug interactions. The pharmacy technician is responsible for filling the actual prescription and may perform cashier duties as well. The cashier receives the scrip from the patient or doctor's office, applies any free vouchers or discount cards, and takes payment from the patient. 

After a few of the aforementioned interactions with pharmacies, it didn't take long for me to realize that, for the most part, they didn't really care about what I had to tell them. After all, I'm just some drug rep that wanders into their workplace infrequently and takes up the pharmacist's time. A great way for your selling team to show pharmacy employees that you care about their business is to get to know them. It's easy to be set apart as the only rep (or at least one of the very few) that takes time to do a product in-service in the pharmacy and provide lunch as a business courtesy (which is still permissible by current PhRMA guidelines). While product in-services may sometimes be underappreciated in doctors' offices, most pharmacies will jump at the chance to break their normal routine and learn about your products and programs over lunch. Being the only rep that knows the names of the pharmacy employees can make a big impact as well. This is a simple way to be more memorable and also to make it more likely that the pharmacy team will associate you with your product when they are filling it.  

Pharmacists and pharmacy technicians are experts at pharmacokinetics and pharmacodynamics, but making sure medicines are helping the patients get well or reach specific goals is the job of their doctor. Therefore, it's been my experience that pharmacy employees have been exposed to much less information about product efficacy than doctors have. Nearly every pharmacist I have shown trial data to has been surprised that there are any differences between my products and generics in the same class, and many other employees didn't realize that even though there are generics in the same class, there is no generic form of my products. Differentiating your product from the competition can give you the opportunity to explain why healthcare providers (HCPs) are prescribing your product instead of the others and how essential it is that the patient gets your product when prescribed. 

There is often a great disconnect between the organizations that produce savings cards/vouchers and the pharmacies that actually apply them. Take the time to inform pharmacists which patients qualify for vouchers and which do not. This provides clarity and confidence when employees are filling one of your products and makes them more likely to proactively offer savings to the patient. If there is a phone activation required, I always call the number and activate a card myself so that I can tell the pharmacy employees what to expect if they need to assist a patient who is having trouble navigating an automated phone system. 

If a pharmacy has never used one of my savings cards/vouchers, I will often ask them to pull up an imaginary patient at the register and do a mock fill to see how the card would be correctly applied. I apply this same principal to free product vouchers. Cashiers can also give you valuable information about the cash price of your products as well as the products of your competitors. 

The majority of pharmaceutical reps spend very little time, if any, calling on pharmacies; thus the reason these interactions are often awkward. Putting pharmacies right into a sales route will quickly give you a competitive edge in each pharmacy, because they will be familiar and comfortable with you since you are the rep they see the most. Consistent messaging will also ensure that they make a connection between you and your products when they are filling them. This can mean the difference between a discount card or free voucher being applied or not.  

Pharmacists and even pharmacy technicians can exercise a great deal of discretion when it comes to filling a prescription. In addition to having the authority to offer a generic version to the patient, they may also have to call a doctor's office and inform them that the prescribed product is not available (or too expensive) for the patient. There may be two or more options in the same class that are available to the patient, so ask for the business there. Once the appropriate relationships are in place, I always ask my pharmacy employees something such as, "If a patient cannot get product X, and my product is available to them, when you call the doctor's office will you inform them that my product is available to the patient?" The pharmacy or doctor's office may also be unwilling to complete a prior authorization for a competitor's product, so if your product does not require one, ask them to inform the doctor's office of this, too. 

Just like any of your other customers, it's important to know what matters to your pharmacies. For example, if their primary concern is keeping patients satisfied, then position your value cards/vouchers in a way that will ensure patients leave happy with the best medicines at the lowest possible price. If they are concerned with efficiency and going home on time, then re-enforce the great accessibility of your products without prior authorization. 

One of the best measures of the success of a comprehensive pharmacy sales program is direct feedback from the pharmacy employees themselves. A pharmacy tech can be a patient's hero by saving a patient several hundred dollars on a prescription. They will undoubtedly share these stories with you if you simply ask. Feedback may come from other sources as well. I have had physicians tell me that a pharmacist was boasting to them about the ease of one of my savings programs. Additionally, I've had other pharmaceutical reps tell me that they overheard a conversation in a pharmacy where one employee was educating another about the savings card for one of my products. 

Choose at least one person in each pharmacy that can be an advocate for you and your products. Typically, this will be the person with whom you have the best rapport. It's unlikely that every employee will understand—or even care about—your products and the various programs associated with them. Having at least one person who fully understands and can champion your products and programs in your absence will make a huge difference. This person will likely educate the rest of the employees if you ask them to. 

Pharmacies remain an underutilized resource for most pharmaceutical sales forces. Many veteran reps still find that interactions with pharmacists, pharmacy technicians, and cashiers seem unproductive and even awkward. Yet, in a market that is being bombarded by cheap generic options, pharmacies can exercise a great deal of authority in determining exactly what medication a patient receives and even how much they pay for it. Consider how your current sales approach could benefit from implementing a comprehensive pharmacy selling strategy that gives your team a competitive edge. 

 is a pharmaceutical sales specialist at AstraZeneca. He can be reached at 

An underutilized sales resource, pharmacies and their staffs can help lead to improved scrip fulfillment and increased business

Pharmacies are Our Friends

Swiss drug maker Roche has moved to master the hazard-prone digital communications space with a new set of internal guidelines on when, where, and how to apply social media tools to communicate with key stakeholders and the public. The initiative is a novelty for Big Pharma—Roche says it is the first in the industry to go public with a transparent standard for online behavior—and follows on the heels of written guidance issued by other corporate behemoths such as IBM, Wells Fargo, and Coca-Cola.  

The 14 Social Media Principles (see chart) piggyback on Roche's existing group code of conduct and communications policy. The guidance relies on simple "common sense" language, but carves new ground in making explicit the need to: 1) Differentiate between using social media in a personal versus professional context; 2) Build clarity in speaking about the company and on behalf of it, through third parties; and 3) Advocate for employees to serve as "scouts" in tapping networks to identify "sentiment and critical issues." 

The 14 principles consist of brief bullet points and are divided into two sections of seven principles each, covering personal and professional online activities.  

The document has been welcomed—if not widely celebrated—by the digital pharma community as a good example of corporate transparency and openness. Speaking on his STweM blog (

) on Aug. 17, the day the guidelines were released, Andrew Spong, Editorial Director, Nexus, at the PSL Group, called it "trust enabling," a "spur to ethical conduct," and heralding "a new era for healthcare communications."  

But for all their simplicity, clarity, and common sense, are the guidelines too general to be meaningful? The question is important as it also goes to the heart of how legal approaches to the regulation of online communications differ between the US and Europe. In the latter case, such information is subject to self-regulation, with the industry policing itself, while in the US companies must take a far more cautious stance because the FDA is the ultimate arbiter of what companies and their employees can or cannot say.  

Where Roche can be said to be breaking new ground—and where it is also laying itself open to criticism—is in its attempt to bring structure to the kind of ambivalent behavior that obscures the dividing line between personal and professional use of social media. Coming from a US legal perspective, Arnie Friede of 

, in an Aug. 17 post on the EyeOnFDA blog, noted the principles "suggest that employees can speak 'about Roche' in some kind of 'personal capacity' ... without providing clear ground rules about the permissible content of these communications." He adds that while the guidance document amounts to a "nice touch" from a PR/perception-of-transparency perspective, "absent clear rules about what things may be discussed ... the new standards may create more problems than they solve." 

Not surprisingly, Sabine Kostevc, Roche's head of Corporate Internet and Social Media, disagrees. She told 

 "Before this set of guidelines, we had a very elaborate document with do's and don't's as well as many references to some very detailed SOPs [standard operating procedures]. It is a key learning from that document that we needed a shorter and more basic first reference that was not too long to scare people away from reading it at all." 

Certainly, parts of the guidance are refreshingly straightforward, encouraging staff to disclose their affiliation with Roche when blogging or commenting on any related products or initiatives in a public forum. This seems responsible enough. Removing the shield of anonymity that can both define and cloud debates in online forums should, in theory, lead to more accountable and 'trustworthy' debating. Not least, as Spong comments, it should act as "a disincentive for the sort of 'Jekyll and Hyde' characters I am sure we have all met in our professional lives."  

But for some, the 'refreshingly straightforward' also yields a faint whiff of 'Big Brother'. "You are 'speaking' publicly and your contribution may stay searchable and retrievable for a long time to a broad audience," the guidelines say. "Anything that brings damage to our business or reputation will ultimately be your responsibility."  

Friede suggests that this leaves "too much liability associated with company employees. The principles need to be very clear on who has the authority and responsibility to speak about the company online." Even Spong admits that this responsibility is "empowering to the point that some of those on the payroll may consider it downright terrifying." 

Kostevc counters, "It is a fact of life that people will always discuss topics or issues around us—online and offline—and nobody is in a position to prevent this. We can only try to make sure that it happens in a responsible way where our employees are involved. 

The flexibility that the principles aim for is motivated by the fact that Roche is a global company and thus has to confront the challenges of implementing the guidelines in a specific country. The Roche document concedes as much in the 'professional' section of the principles when it says, "it is not realistic to have each response undergo full approval by communications, legal, and regulatory. Therefore, you should establish with your usual approval partners a common agreement on a bandwidth of topics and instances that may not require the normal process."  

Different countries will likely interpret this "bandwidth" differently. Could what is acceptable in one country raise serious concerns in another, rendering the operating procedures meaningless on a truly global scale? "On the contrary," says Kostevc. "As a highly decentralized organization, this is a standard approach for Roche spokespersons worldwide. They are trained professionals and handle issues independently in their fields, and would know when a certain topic exceeds their competence." 

Perhaps the most talked about point in the principles is the call for employees to act as scouts. "You are one of the most vital assets for monitoring the social media landscape," the document tells Roche staff. "If you come across positive or negative remarks about Roche or its products online that you believe are important, consider sharing them by forwarding them to your local communications department." The language is less strident here, and no one is under any illusion that this is an obligation. And if it gently secures the services of most of Roche's 80,000-strong workforce as global media scouts, tracking and monitoring what is being said about the company worldwide, so much the better for Roche.  

Nevertheless, the principles have to be sound in addressing the burden of compliance, especially on safety issues where the industry is uniquely vulnerable.  Hence the stern directive: "When you come across information where somebody mentions side-effects after having taken one of our drugs in a credible and identifiable way, you have to immediately forward such information to the global Drug Safety Team for further action." 

This language prompted the Social Media Healthcare blog to declare: "So, in an off-the-clock capacity, the employee is not only burdened with understanding global regulatory structures/impacts, but is now charged with flagging adverse reactions to the Roche Drug Safety Team? And what if they don't?" Friede commented, "I submit that Roche employees, who are encouraged by the company to speak 'about Roche' may be effectively acting as 'agents' of the company and that their communications may be ascribed to the company for regulatory, legal, and other purposes."  

, Kostevc casually played down any negative connotations to the call for employees to act as scouts. "There has not been general training on monitoring on being a 'scout', as this is not seen as a specific task for the social media user. We merely wanted to offer guidance on where to go if colleagues come across any issues. Apart from that, all employees are educated and required to report adverse event information that they encounter, [regardless of the] communication channel."  

Squabbles about wording and the concerns of those with a less charitable view of the guidelines notwithstanding, the consensus seems to be that Roche's document is a step forward for an industry still feeling its way around the social media minefield. Whatever the principles' long-term impact, it is inevitable that other Big Pharma companies will try to build on the document and follow the Roche lead. Companies that don't, Spong warns, "do not have a hope of reaching these heights unless they begin to participate more fully in the social media dialogue." Over time, these multiple responses may produce a consensus approach and prod the regulatory community to fall in line with clear standards that emulate the best practices that emerge. 

Will Roche's precedent push the regulatory community to create standards that will level the playing field for all contenders?

Roche Sets a New Social Media Standard

Generic drugs play a significant role in treatment decisions, helping to ensure access and reduce costs for millions of patients. Yet success is not guaranteed; the generics market presents specific business challenges requiring careful consideration. There remains a high demand for innovative medicines that address unmet needs and pinpoint challenging illnesses. The industry faces the imminent expiration of many patents, which has significant revenue implications for the whole system. Evolving legislation, including healthcare reform and the drive toward a biosimilar pathway, will impact the demand for generic drugs.  

In this complex but opportunity-laden environment, generics companies must carve out new business strategies in order to compete.  

The rapid emergence of the generic drug industry has been fueled by pressures on Big Pharma. Meanwhile, decreasing pipeline innovation, combined with consumer resistance to rising branded drug costs in developed nations, has created significant opportunity for generic drug companies. The recent economic downturn—and the continual demand for greater access to care and less expensive generic drugs—provides further opportunity for generic manufacturers to thrive. Today, 75 percent of all medicines prescribed in the US are filled as generics.  

The generics industry has not only grown in size, it has also changed in composition. Just a decade ago, the generics industry comprised a multitude of small companies. But with continued marketplace pressure on Big Pharma, major players began considering the generics space with fresh eyes; in the last two years alone, 11 major pharmaceutical companies created or acquired generics units, a magnitude equal to the total number of generics companies created by branded manufacturers between 1990 and 2008.  

Big Pharma's entrance into the generic market, along with the growth of independent generics firms, signals stiffer competition in coming years, with volume spread across more players. As Mike Chace-Ortiz, senior director of product strategy for Thomson Reuters, noted at the June 2010 Argyle Executive Forum for Leadership in Pharmaceuticals and Biotechnology, the generics market will grow only slightly or be flat in the coming year. If this is indeed the case, prospering in the competitive world of generic drugs will require business strategies to transform—to become, as it were, "less generic." 

While generics companies are not usually regarded as innovators, generic drugs require less capital investment than novel therapies. This opens the door for innovative development work in the so-called 'supergeneric' drug space—an area of new innovation leveraging existing competencies in both novel and generics models and specialty medicine channels. As opposed to commodity generics—which are bioequivalent clones of the original drug—supergenerics differ from the original product in formulation or method of delivery.  

While supergenerics represent one path to renewed success, some generics companies have opted to develop proprietary molecules in order to tap into the lucrative innovative market. Before the generic firm Pliva was acquired by Barr Pharmaceuticals, it was responsible for the discovery of the highly successful antibiotic azithromycin. In 2002, the drug, eventually marketed by Pfizer as Zithromax, was the most-prescribed brand name oral antibiotic in the US, and the second-highest-selling antibiotic in the world. 

Meanwhile, Teva has entered the marketplace with new chemical entities (NCEs). In addition to the more than 140 generics products it markets domestically, Teva is developing innovative drugs in the neurological and autoimmune therapeutic areas. Teva's major success has been Copaxone, which is now an important physician-prescribed treatment for multiple sclerosis (MS) in the US. 

Though seemingly counterintuitive, with Big Pharma's pipelines dwindling, generics companies are now poised to address therapeutic areas with unmet clinical needs. Many of these companies have honed knowledge around key health needs—specialty medical areas that are complex structurally or exist within complex regulatory environments—diagnostic medicine, growth hormone therapy, pain management, and oncology. 

Firms like Teva are doing just that. Using a so-called 'distributed model'—combining internal and external assets to solve medical problems in new and creative ways—these firms are expanding their focus to include new areas of pharmaceutical development, such as new formulations and biosimilar development. 

It starts by combining diagnostic and therapeutic assets, offering unique clinical opportunities to focus on medicine-delivery systems. In some cases, one company may utilize a technology from a second company to solve a medical need, which may be marketed by yet a third company that has the appropriate infrastructure to navigate complex regulations. 

A modified R&D process is the driving force behind the distributed model. A single NCE takes between 10 years and 15 years to develop from discovery to patient access on the open market, with an average cost of $800 million to $1 billion. In an economic environment that demands cost-cutting measures and reduced R&D spending, a distributed model maximizes 'incremental innovation,' allowing companies to innovate by reformulating and combining drugs with innovative delivery systems, rather than investing millions in a novel therapy that may or may not provide unique patient benefit. Further, the distributed model can make a huge difference in driving forward projects like drug development for neglected diseases, for which needs are great but funds are scarce. 

Focusing on areas such as pain and oncology, in which molecular targets are well understood, generics companies are providing patients with new diagnostic and treatment options. Successful approaches come in the form of new formulation utility, improved side-effect profiles, or achieving maximum therapeutic effect.  

The time when all generics companies focused exclusively on the development of commodity generics—easy to manufacture, oral versions of drugs with few barriers to market entry—has passed. Increasing competition, low margins, and fewer new molecules entering the market have shaped generics industry survivors into more efficient market players. 

If generics companies can balance both generics and NCE development—while deploying their channel and specialty medicine experience—they may be able to reap the benefits offered by both product types in the global healthcare environment. Governments are emphasizing cost containment and access to care, driving greater use of generics as alternatives to brand name drugs. Equally, if serious and chronic diseases are to be tackled effectively, there will be a continuing demand for innovative, disease-modifying drugs.  

Non-generic pharmaceutical companies, too, stand to gain from co-opting the distributed model and allowing it to flourish in cooperative competition with traditional R&D. Building on external research through collaborative strategies will allow companies to increase their innovation, productivity, and ultimately transform their business. In this era of tremendous scientific potential and fast-paced advances, adapting to future marketplace needs means fundamentally rethinking business models and demonstrating a willingness to implement major changes. 

Who will benefit if innovators and generic companies can adapt to this new business model? Ultimately, government payers, health providers, and patients will be the collective recipients of this best-practice adaptation. The call for change is in the air. All we need do is listen to societal demands. 

 is president of pharmaceuticals segment at Covidien plc. He can be reached at 

A leading industry player speaks out on what is fueling success in the sector

Taking a Less-Generic Route to Generics

 "A damp squib." That's how a leading figure in the European pharmaceutical industry described the European Commission's pharmaceutical sector inquiry this month, just over a year after it delivered its findings."But," he went on, "don't quote me on that." 

Which neatly sums up just how the sector inquiry has affected the European pharma industry. The high-profile, high-intensity, and high-rhetoric-infused investigation in the end led to very little action—but left plenty of people looking over their shoulders. It has had a ripple effect in other markets (South Africa, for example) in encouraging payers to consider competition restraints as a new tool for drug cost containment. 

When Commission officials started their investigation back in 2007, they made out that a revolution was on the way. Hopes—or fears—of a brave new world were raised by the promised exploration of how far Big Pharma was abusing patent law, colluding with generic rivals to stifle real competition, and neglecting real innovation. The reality is that not much has happened, and little has changed, except perhaps that things have become just a little bit more confused in the European pharma market. 

 A European Commission investigation into the abuse of patent law by Big Pharma cost plenty of money and even more time, yet still left patent holders with such little clarity about recource or settlements, that it felt like being blindfolded in a minefield. (GETTY IMAGES / STEVEN PUETZER)

It was the Commission that started the exercise—so let's start by looking at what it got out of it.  

The Commission got a lot of publicity when it released its final report, in July 2009. And most of it was complimentary, because the mass media uncritically swallowed the line pushed by Neelie Kroes, the competition commissioner who initiated the exercise. She claimed at the time that the inquiry was the biggest clean-out since the Augean Stables received a Herculean makeover, and she made a lot of noise about how it would not only put an end to murky deals to blunt generic access, but would also save everyone money and stimulate innovation. 

In concrete terms, all that the Commission has achieved so far is to initiate a range of investigations into a handful of companies—often commencing with a dramatic dawn raid, but mainly focusing on smaller firms, and with no outcome yet from any of them. No convictions, no fines. It is monitoring deals reached by patent holders with generic firms, and it calculates that there has been a decrease in what it calls "potentially problematic settlements," claiming credit for what it sees as increased awareness among companies of the risks of getting caught. But as to whether all this has led to the "measurable increase in innovation" that Kroes anticipated, the Commission has come up with absolutely no evidence at all—now even backtracking with the admission that increases in innovation are pretty hard to measure at all, and still harder to ascribe to any single cause. 

Within the industry, views are divided. Patent holders complain that it cost them a lot of time and money to respond to the Commission's questions during the inquiry (as well as a lot of bad press over suspected dirty deals). Worse, they lament that in spite of all the activity, there is still no more clarity now than there was before the inquiry about what is allowed and what is not in terms of patent settlements or recourse to patent protection. As a result, many of them say that they are simply out of pocket, and more confused. If they are more careful, it is that they are able to navigate precisely on the basis of unambiguous information: it is the consequence of being obliged to wander blindfolded across a minefield. 

A few firms directly in the firing line are having to spend still more time and money defending themselves. Lundbeck is being quizzed for questionable practices to defend Citalopram. Servier is under investigation not only for potentially dodgy deals to protect Perindopril, but also for allegedly supplying the Commission with misleading information during the inquiry. Sanofi-Aventis, Novartis/Sandoz, Teva, Ratiopharm, and a scattering of small generics firms have also come under scrutiny. The Commission doesn't say they are guilty—but doesn't say when it might pronounce them innocent, either. And the companies themselves are keeping their heads well down. 

The Commission's guns-blazing intervention has left every patent holder—even those who have emerged without so much as a flesh wound so far—with an uncomfortable sense of insecurity, since, as the Commission repeatedly makes clear, the whole thing could start up again any time. That explains in part the reluctance of even the most outspoken industry executives to go public on what they think about it all; to say too much might be to precipitate a new visitation. 

The generics industry claims that the Commission inquiry vindicated its own longstanding complaints about obstructionism from patent holders, and confirmed the existence of inefficiencies in the European patent system. This, in turn, says the European Generic Medicines Association, put pressure on the European Patent Organization to tighten up its controls. But there is still no evidence of faster generic market access—and generics companies continue to complain. 

For its part, the European Patent Organization (which is quite separate from the European Commission, and actually issues patents) self-righteously maintains that long before the Commission inquiry started, it was in any case reforming its procedures to limit the opportunities for patent holders to extend protection through filing dubious patent extension claims. Some additional controls will take effect this month, but the EPO resists the suggestion that its procedures have been seriously inadequate until now. Its officials privately murmur that the Commission didn't focus its inquiry very accurately—and consequently came up with only the most limited findings that didn't generate any real change. 

The Commission, meanwhile, is still trying to save its honor after more or less admitting that it was wrong in its initial suggestions that patent holders were the key villains in holding up generic launches. It finally had to acknowledge what patent holders argued throughout the inquiry—that the obstacles arising from regulation cannot be ignored in exploring barriers to generics getting onto the market—or indeed to innovation. As a small gesture of appeasement, the Commission is now reviewing its legislation on how national drug pricing systems function, in the hope that this could help cut through some of the red tape, for generics and even for new drugs. 

The inquiry was, of course, only one of many factors and forces influencing the European environment for pharmaceuticals—and for relations between patent holders and generic firms. In recent months, a final judgment has emerged from the European Court of Justice on a much older case, confirming that AstraZeneca misused regulatory procedures and made misleading representations to patent offices in a bid to protect Losec. There is a ceaseless series of national actions, in court or with national regulators, on the limits to patent protection. And big changes have taken place at the top level within the European Commission too. The abrasive Kroes has been replaced as competition commissioner by the more phlegmatic Joaquín Almunia—who feels less compulsion to pursue Big Pharma, especially since the focus of the Commission as a whole in the fiscal post-crisis world is on boosting recovery through innovation. Overall, therefore, even the most aggressive generics lobbies are not certain when or how more cases will be launched—and nor are the most optimistic patent holders confident that none will ensue. 

It is, as one industry executive wryly commented, a typical European result. Lots of talk, lots of time wasted, and not much to show for it. 

 anonymous columnist, a commentator so close to the action in Europe that his identity must remain secret.  

A report by the European Commission aimed at exploring patent exploitation by Big Pharma winds up generating more angst than answers

Euro Soul-Searching on Competition

The single most relevant management axiom for today's turbulent business environment is to prepare for the unexpected. To show the way forward, biopharma companies are placing big bets on scenario forecasting, market analytics, and other costly, metric-driven decision-planning tools. But our editorial investigations this month reveal that good intelligence on market changes can often be had for free, simply by leveraging the "I" powers of intuition and interaction. 

This depends in turn on the willingness of key C-suite decision makers to reach out to new people whose lack of familiarity with the daily grind of selling medicines is precisely what can yield those fresh perspectives. 

 cover feature this month marks the initiation of an effort on our part to expand the notion of industry "stakeholder." We begin with an interview with Nobel laureate Elie Wiesel, whose impact on health and science derives from a unique combination of moral presence, intellectual authority, and practical exposure to what is both sublime and bestial about the human condition.   

In the discussion, Wiesel underscores that no industry has as much potential to improve human life as biopharmaceuticals. It's an opportunity for public engagement that many CEOs have ignored by failing to capitalize on the legacy of history and memory to infuse a sense of public optimism about the future. In his role as convener of last month's 2010 Prix Galien awards ceremony for innovation in medicine, Wiesel points to just one of the nominated drugs—the anti-malarial Coartem—that has revolutionized treatment of malaria, especially in children, saving an estimated 650,000 lives since 2001. What a contrast this single figure makes against the blight that characterized his youth in a Nazi concentration camp—when global life expectancy, even for those privileged to enjoy freedom, was still well under age 60.  

Wiesel has a number of practical suggestions geared particularly to CEOs, noting the importance of communicating beyond the traditional one-page set of talking points. Says Wiesel, "A physician will tell you that without the capacity to stabilize brain patterns through dreams, stress will build and the body cannot survive. Why not make this connection to unleash the creativity of the research enterprise as well?" Yes, why not? With the industry's top offices occupied by a growing range of functional expertise, from marketers to manufacturers, lawyers, and, yes, even a few scientists, could the future hold a place for the philosopher too? At the very least, given the industry's eroding reputation, the ability to chart a clear course around life's more fundamental questions should be part of every CEO's skill set.  

 features this month provide a more prosaic amplification of the theme of acknowledging a larger community of stakeholders. Our profile on Roche's latest effort to create a better structure for its relationship with social media highlights the boundaries that risk and regulation can place on how companies reach out to the public. An interview with two observers of the payer base finds that evidence, data, and information is not sufficient to prevail in reimbursement negotiations. The human touch—intuiting what keeps the payer up at night—still counts.  

Finally, a column by a top executive of a leading generics firm shows how a precondition for success in that sector will be a capacity to think more about providing solutions through an external-facing, service-oriented approach—one that extends beyond the price point. And that requires knowing your customer—the stakeholder—as something more than a one-off commoditized transaction.    

Ultimately, what merges our content this month is the practical lesson of reaching forward to tap the human community—and the moral connection—that will preserve the "license to operate" in the biopharmaceuticals business: the business of life. 

From the Editor

Adam Smith's theory of the uncompromising market may set the tone for today's capitalism, but we forget that his first work,"The Theory of Moral Sentiments," made 'bettering the human condition' the basis from which all productive commerce flows.

Community: The Business of Life

The global health space continues to expand, and with it comes the gravitational pull from a new set of actors determined to play a role in shaping the destiny of one of its oldest but sputtering stars—the biopharmaceutical industry. In the following conversation, 

 launches a series of exchanges with these "non-traditional" stakeholders beginning with Elie Wiesel, the 1986 Nobel peace laureate and lead sponsor of the Prix Galien awards for innovation in medicine. His focus is on reinforcing ethical behavior in the industry, the importance of CEO leadership, and the moral obligation to change the way we think about the elderly, highlighted by the imperative to find new cures and treatments against the afflictions of age, as a way to avert generational conflict. 

As a noted author of more than 50 books, you have said that when words produce a dialogue among the disconnected, great deeds are possible. Your life is filled with examples of how a simple conversation can serve as a catalyst for action. How are you building on this premise to support cooperation in science, research, and the medical enterprise?

 The Wiesel Foundation for Humanity Marion and I established in 1987 serves as a forum for an ongoing series of exchanges with Nobel laureates in medicine, the healing sciences, and other disciplines. Shortly after our launch, the French President accepted our idea to convene a select group of these leaders in Paris at the Elysée Palace—eventually we attracted 79 laureates—to serve as a bridge between cultures and integrate perspectives on science and the humanities, with the aim of fostering international peace and conciliation. This conference took place in 1988 and at that time it was a very novel concept. 

Subsequently we organized a series of "Anatomy of Hate" conferences in New York, Oslo, Moscow, and Hiroshima. Most recently we held four annual conferences of laureates and senior government and international organization officials, hosted by the King of Jordan and held in the ancient city of Petra [in 2008]. We also created a Middle-East Science Fund with the King Abdullah II Foundation to sponsor joint scientific research in a range of disciplines—including medicine—and to promote exchanges among scientists and academic institutions in the region.  

You believe the scientific enterprise creates a larger social dynamic by forcing countries to focus more on common global interests. Must it also have a moral purpose?

 Because scientists converse in a universal language based on the search for verifiable truths, their work can transcend national boundaries and reduce distrust. Science is an engine of innovation and material well-being, a goal for all civilized and democratic societies. Although my laureate award is for peace, I owe a debt to scientists like the late fellow Nobelist Joshua Lederberg, who showed me how medicine can in fact be an enormous moral force for change. Everything we do in medical research today should have an "end point" linked to progress—not just against the clinical manifestations of death and disability, but against the dark barriers of the closed mind as well: fear, fanaticism, superstition, and ignorance.  

You are also a lead convener of the Prix Galien, a global movement to promote innovation in pharmaceuticals, vaccines, and medical devices.

 This annual awards program is managed directly by six Nobel laureates in the biosciences. What is distinctive about Prix Galien is the way the program demonstrates the diversity of the sources of pharmaceutical innovation—Prix Galien has active award programs in 12 countries and is now expanding to Asia and some emerging country markets.  

The potential of this organization is significant. Not only does Prix Galien serve as a vehicle for publicly recognizing the initiative of private enterprise in developing new cures and treatments, it also has a policy mission that is attractive to other stakeholders outside industry, especially the international community. One policy issue that certainly dominates the agenda today, where the effects of globalization and economic crisis are so apparent, is who shall pay for the next generation of treatments. More important, what are the terms of access to them, especially for the neglected populations of the world? The "convening expertise" offered through the Prix Galien, organized by Bruno Cohen, can help us answer that question.   

To what other ways would you attribute your influence in the field of science and medicine?

 Nobel laureates assume a moral obligation which allows us to try and persuade through dialogue, to sensitize people to ignorance, hate, and prejudice. When language fails, violence escalates.  

How do you—as an author, philosopher, and acute observer of the human condition—make the case for the role of the biopharmaceutical industry in society?

 The biopharmaceutical industry is a force for life, when so much of our world is consumed by illness and death and the activities and conditions that contribute to it. To see the array of novel and useful new medicines up for awards at the annual Prix Galien dinner on Sept. 28 should be a revelation—33 in all, each providing a new standard of care for conditions ranging from mass killers like diabetes and malaria to complex, select, and hard-to-treat diseases that attract less attention, such as autoimmune disorders. Tackling both is a moral imperative, if you approach disease from the basic biblical perspective that should guide all research: "Thou shalt not stand idly by."   

It is less well known how much the industry invests in studying medicines that may never be approved for patients. When this is discussed, the emphasis is always on the money. But what appeals to me is the way the industry provides dedicated scientists with a place to do ethical, honorable work. One CEO told me his company employs some 80 scientists to study the physiological origins of Alzheimer's disease. It is very basic research—a task entirely separate from the related commercial task of advancing a new drug to registration. There is an enormous secondary social benefit in making such a commitment, but I am not sure it is communicated. Clearly, industry provides a productive outlet for the efforts of some very motivated scientists. Without this outlet, medical progress would suffer.  

Looking forward, are there trends and developments that suggest an erosion in the capacity of innovation to sustain itself and maintain a high level of public support and investment?

 The basis for social progress in any field is inherently fragile. There is always a competing rationale—an excuse —for greed, intolerance, and blight. My own life experience is testament to that. Maintaining support for medical innovation requires fundamentally that it be considered as much more than a business process. If it were nothing more, I would not be engaged in the discussion nor would most other laureates. Hence it has to be linked to something much larger, and that is a moral imperative central to our human inheritance—rooted in our past, shaping our present, and driving the destiny of the next generation so that it will be in a better place tomorrow. Innovation always has to be presented in the context of a positive vision of the future.  

Is this not too much to expect from primarily private enterprises, whose mission is to make a profit? It appears grandiose.

 I don't think the emphasis on a larger moral mission is at odds with the operation of the market. President Clinton said it well in his remarks as a humanitarian award winner at last month's Prix Galien: "At no time have we asked you in private industry not to make money; just to make it in different ways." I hear many CEOs talk about the need for a new business model, so is his request not itself a way of encouraging more innovation?   

Are there other threats to the integrity of the scientific enterprise?

 Intolerance and declining support for education. The degradation of language, as evidenced by the failure of people to communicate through active listening; and the individualization of information against the interests of community. Fanaticism of all kinds.   

What do you see as the key obligation of the CEO in maintaining a high level of public support for the industry and its innovation mission?

Wiesel: Industry leaders must re-engage around a business profile that puts more emphasis on ethical performance. It should be the highest priority for the CEO because a culture of best practice begins at the top. Reputations of individual companies have suffered as a consequence of abuse of basic rules of engagement. It is also short-sighted to treat corruption and other ethical lapses as a regulatory, legal, or compliance matter. The implications are far larger in terms of public support and the overall "license to operate" that is critical for an industry whose biggest customer is often government.  

 The biopharmaceutical industry is a force for life, when so much of our world is consumed by illness and death and the activities and conditions that contribute to it 

Ethical behavior can be a bridge-builder in an era where Big Pharma needs to find new partners. Is it up to the challenge?

Pharmaceutical Executive-10-01-2010