Every day, pharma brand managers, e-marketers, and executives are bombarded by industry leaders insisting that they jump on the Web 2.0 express. While the message is clear, no one quite knows where to get a ticket. As a result, resistance is high (to put it mildly). One pharma rep said that if she puts the words "Web 2.0" in a meeting invitation, nobody will show up. So what's it going to take for pharma to get on board Web 2.0 and depart from the "selling and telling" approach?  

Perhaps the way forward is for pharma to look back. In 1999, Rick Levine, Christopher Locke, Doc Searls, and David Weinberger authored 

, a series of 95 theses offered as a primer on Internet marketing. "Through the Internet," reads the manifesto, "People are discovering and inventing ways to share relevant knowledge with blinding speed. As a direct result, markets are getting smarter—and getting smarter faster than most companies." 

The Internet has forever changed the nature of business communication and marketing. Though 

's 95 theses were drafted almost 10 years ago, they still ring true. Here are a few that are particularly relevant for pharma. 

Every day, millions of patients are participating in online conversations. Unfortunately, much of it is misinformed. One recent blog post from a bipolar patient blamed a leading treatment for "ruining [his] life." However, the impact of his bottle-per-day gin habit seemed lost on the many respondents who claimed they would immediately stop taking their medication for fear of similar side effects.  

Thesis 2: Markets consist of human beings, not demographic sectors

 The industry does an impressive amount of research on its target patient populations (including gender, age, income and education levels, nationality) but doesn't know what it feels like to have the conditions they're targeting. For instance, does the maker of a fibromyalgia treatment know many sufferers complain that their clothes hurt? They would if they read the comments posted on many of the leading health forums. If a factor like that was used in a marketing campaign, the audience might think, "Wow, they get it."  

Thesis 17: Companies are kidding themselves if they assume online markets are the same markets that used to watch their ads on television

 An online audience is looking for specific answers; they're not satisfied by smiling faces and a smooth voice-over. They don't want to read a highly edited patient story. They would, however, like to communicate with someone who has used the product 

Thesis 29: Elvis said it best: "We can't go on together with suspicious minds" 

The public doesn't trust pharma, and the industry doesn't trust the public. Yes, there is the adverse event issue, but that's not the whole picture. Pharmas want to control the conversation about their brands.  The trust issue has many origins, from misconceptions about product recalls to lack of understanding about profits and regulation. The best way to close the gap is open, unbranded communication. 

The first step is partnering with a Web provider, nonprofit, or similar organization that has a trusted following. Explore appropriate ways to address the dialogue in message boards. One solution might be to support the identification of a clinician who could participate in forums and message boards. The candidate would need to be independent—not a pharma KOL—and highly qualified to answer questions, and, when necessary, set the record straight. The dialogue cannot be controlled or reviewed by pharma, the expert has to win the trust of the audience, and ensure they've got the facts.   

Pharmas can take advantage of the fact that Web providers have no requirement to report adverse events. They can develop a program that harvests the best conversations about a condition. The focus doesn't have to be on treatment; pharmas can focus on the experience of having the condition and how sufferers have overcome obstacles Those comments could be woven into a larger program sponsored by the company.   

The program will resonate with the target audience and have a much higher chance of succeeding. The health consumer will recognize his/her own words, will embrace the program, and will want to interact and contribute. And there's no better way to capture a new customer. 

 is senior vice president, general manager, Everyday Health for Waterfront Media. She can be reached at 

Articles

Columns

Bring customers back into the conversation

All Aboard!

"Don't Just Stand There, Do Something," has long been an axiom of American business, especially within the vitally active sales functions. Pharmaceutical companies have too much riding on the success of their sales efforts to become victims of the inactivity trap. A growing number of companies are looking beyond the performance charts to the underlying drivers of performance and then building an action plan based on disciplined analysis. 

After all, what sales executive inside or outside pharmaceuticals hasn't puzzled over sales performance charts trying to divine a formula for raising revenue yield per sales rep? When it comes to raising overall performance, several stock answers come to mind: providing general sales training, having in place a robust on-boarding process, mentoring new hires, providing necessary resources, and so on. But how well do these techniques really work? 

The chart below depicts the performance of the 100-person North American sales force of a global pharmaceutical company with yearly revenue just over $377 million. Sales reps in the top quartile posted average sales of over $5.5 million annually, compared to slightly over $2 million for the bottom-quartile performers. That's a fairly wide range. What accounts for such a variance in performance? What distinguishes the stars from the underachievers?  

Looking at the performance curve raises several other questions. For one: How can a company increase the performance of every one of its sales reps? We know that a rising tide raises all boats. What "rising-tide" actions can be taken to raise performance across the board and within each of these quartiles? 

In 20 years of research on driving up individual and company performance, Metrus Group has developed seven less obvious, more cost-effective recommendations for putting a company's sales force on that upward trajectory. 

1. Set a Sales Strategy and Stick with It

If you examine what passes for sales strategy at most companies, you'll find that in many cases it's nothing more than a collection of time-and-territory management tactics. That's a big problem, because the last thing you want for a sales force headed in the wrong direction is for it to get there more efficiently.   

Sales strategy begins with identifying the market, segmenting it, and deciding which segments are high priority. It includes deciding which products/services you will (and will not) offer each segment. It also requires identification and planning to develop the core competencies required to implement the strategy. 

 Sales strategies typically fail because they don't zone off what sales reps should not target. When William Crouse became CEO of Ortho Diagnostics Systems in the early 1990s, one of his biggest challenges was "deciding what we would not do and then sticking to it." He found that it was easy for sales reps to justify calling on a 200-bed hospital in the neighborhood, while avoiding the more difficult call on a 500-bed hospital that had been targeted. Crouse observes, "It's hard for salespeople to give up easy victories, even when they know those are not part of the sales strategy."  

Difficult as it may be, setting a sales strategy, communicating it fully, and requiring reps to stick to it constitutes the bedrock for successful sales operations.  

Before setting sales strategy in stone, healthcare companies should head for the marketplace to test their customers' assumptions. Market research is a must, yet while many healthcare organizations conduct market research, they often fail to focus on customers' perceptions of the sales relationship. One East Coast physician expressed his frustration thus: "I don't understand why sales reps cannot get my concerns back to their marketing or management leaders." 

One of the richest sources of information about customers' needs is sales reps, who, after all, are more likely to get up close with customers than are those who occupy the executive suite. In focus groups conducted for major pharmaceutical companies, Metrus has heard many comments such as this one from a Los Angeles sales rep: "I just listen to what they try to push down on us from above, and then I do everything I can to ignore it and deliver what the customer wants. I have the top sales numbers in my region."   

However, Michael Burgett, former US vice president of operations for QIAGEN Sciences and former vice president and general manager of Ortho's Blood Bank business unit, cautions that overpromising or misinterpreting data can lead to disaster. "Ask yourself if your sales force is aligned with your customers and therefore committing your organization to the most important deliverables," he recommends   

One caveat: When looking at data, ask whether or not reps' comments "mirror" those of customers. Members of the sales force are representatives of the brand—they influence service perceptions and play a major role in building relationships. One of the first tests of whether a sales strategy will be successful is how well aligned sales reps are with customers' needs.   

Attempting to raise the performance of your entire sales force is an admirable but costly goal. Unless you're blessed with deep pockets, it's wiser to focus on managing and leveraging the current performance curve for greater sales growth. In every sales group, individual performance varies. Some of the reasons are obvious, as when performance varies by different products or territories, across different demographic groups, or in reps with shorter tenure or less experience. Some less obvious drivers of sales performance are related to "People Equity."   

Research has demonstrated, over and over again, that star performers have a high degree of People Equity. That is, they possess three key performance drivers:  

They are in Alignment with the overall sales strategy. 

They possess the Capabilities—the knowledge, skills, information, and resources—that customers need and expect. 

They have a high degree of Engagement with their job, their function, and the company as a whole. 

Strategic alignment is crucial in optimizing performance. Misalignment leads to higher costs and customer dissatisfaction. For example, one Metrus study found that by aligning company and sales strategy with sales reps' skills, process, and speed of execution, customer defections were cut in half and productivity increased dramatically. Being aligned freed up 25 percent of reps' time, allowing them to call on more target customers, use customer time more wisely, and conduct more effective follow-up calls.   

Capabilities include not only the ability to close a sale, but the ability to access information and resources when the customer wants them. Pharmaceutical reps who possess good sales skills but lack the information that doctors want will fail at the moment of truth. Capabilities must all come together at the right time. 

Henry Cohen, senior vice president of human resources for Orasure Technologies and former executive with Johnson & Johnson, looks for sales reps who have "a need to work and win, in addition to their strong capabilities." This is engagement—the vital energy that salespeople bring to the equation. Engaged employees are not quietly satisfied with their job; they think and act like ambassadors for the organizations they work for, expressing their enthusiasm to colleagues, customers, and anyone else who will listen.  

A gap in alignment usually means "working hard" instead of "working smart." One VP of sales for an Asia-headquartered pharma says, "We always find time to redo things that haven't been done right the first time, but it's costly." At a time when many pharmaceuticals have restructured and made their sales forces leaner, the alignment dimension is absolutely critical. 

Gaps in capabilities usually lead to market damage. Customers may detect these gaps, and such customers become low-hanging fruit for competitors. The degree to which sales reps are—or are not—informed and skilled has a profound effect because they represent the organization on multiple fronts: product knowledge, service, problem-solving, and information assistance. 

Gaps in engagement can lead to lower productivity and higher levels of employee and customer turnover. According to Henry Cohen, "Sales managers must be monitors of engagement—they need to monitor disconnects, eliminate the underlying causes, and take action."  

Each of these performance drivers can propel or inhibit important business outcomes. By pinpointing the gaps in each sales dimension, it's possible to focus resources in that area: it is usually best to target the area in which scores are lowest as a starting point for improvement.   

The key to eliminating problems is identifying the root cause(s) of low alignment, capabilities, or engagement. For example, frequent causes of low alignment are fuzzy goals, poor understanding of company or functional strategy, poor or no feedback on performance, lack of coaching, and misaligned values or rewards. In the area of capabilities, gaps are more often due to selection or training issues. And when it comes to engagement, a rep's immediate manager often causes him or her to disengage by failing to communicate, show respect and trust, or recognize the rep's accomplishments.    

Linkage analysis, which statistically connects results with drivers, enables us to understand whether it's more important to improve coaching or training, rewards or recognition, communication of product priorities or communication with customers in order to bridge the gap in one of the ACE areas. For example, using linkage analysis, a key sales organization within GlaxoSmithKline found that three employee drivers were the largest contributors to growing market share: the immediate sales manager, employee engagement, and sales skills or capabilities. In terms of the sales managers, three activities proved to be major differentiators of high versus low market share within the geographies they operated: conveying company direction, helping reps build the right skills, and willingness to listen to reps (a key correlate of engagement). When the importance of the sales manager driver was recognized, manager training in the identified areas was actually increased despite major cuts in several other programs. 

At a recent speech, when audience members asked Richard Romer, former executive vice president of Sales for CIT Group, about the insights from his stellar career, he lamented the time he had wasted on poor performers. "They draw way too much of your time away from your top performers," explained Romer.  

Smart executives know the importance of weeding out underperformers. In any sales force, there are likely to be sales growth opportunities in which the top quartile can grow revenue by 20 percent, while the lowest quartile will probably only be able to grow it by 5 percent, even after considerable exertion. As William Crouse, managing director of HealthCare Ventures, LLC and former leader of major healthcare businesses for Johnson & Johnson observes, "It has always been my philosophy to pare away the bottom quartile. If they are still around, management is not doing its job."   

But getting rid of poor performers is just half of the equation. The real challenge is keeping your best people. One of the biggest killers of overall sales performance is the loss of top-quartile performers. The impact of such turnover can be demonstrated by taking another look at the 100-person sales organization profiled in Figure 1. If that organization lost one-fifth, or 20, of its reps annually, the company would probably lose more top performers than poor performers (since the latter generally have fewer options, and as a result stay put). If that company lost just five reps in each of the top two performance quartiles, that would put approximately $47 million in revenue at risk. 

Average Annual Sales Performance per Pharmaceutical Rep 

Why do top performers depart? One of the major weaknesses Metrus Group uncovered in research on sales force turnover is a lack of objective data on the causes of top performer departures. However, Allen Weisberg, former chief learning officer for Johnson & Johnson and vice president at Ethicon, has a theory: "One of the biggest factors is that many of the reps didn't know they were doing well. No one had bothered to tell them."  

Organizations that are serious about preventing such losses employ a disciplined approach to identifying root causes. For starters, they do not trust the data from exit interviews. Most departing employees play it safe during exit interviews—better not to burn a bridge or risk a bad reference. Rarely do they cite bad supervisors, skill gaps, stress, product problems, or lack of recognition. Not surprisingly, 50 percent of the data from exit interviews turns out to be invalid.  

To probe the real reasons for departure, it's often better to wait until former employees have settled into new jobs, and have an objective third party interview them. They're more likely to express greater candor and sharper insights. The interviewer may also discover that what the employee got was less than was promised. Many good reps have revealed that while the pay or benefits are better in the new job, they lost something else of importance—such as great technical support, a values-driven  culture, or access to training. This is critical information that allows employers to place special emphasis on factors that may be undervalued and underpromoted, but are core strengths of a company. 

Smart organizations don't wait until their high performers are weighing a better deal. They take a proactive approach to retaining talent, identifying their best and assessing the risk of losing them. The most effective tool to carry out this proactive analysis is a "Sales-Force Productivity and Retention Survey," coupled with in-depth interviews or focus groups. These instruments allow management to identify the factors that are driving sale reps away, as well as the ones that cause them to stay with the organization. 

When coupled with the findings from former employees and analyzed by performance levels, this process can identify retention (and productivity) risk factors. Finally, by pairing this data with a cost-benefit analysis, it is possible to make decisions on where and how to invest in staff.  

After conducting such an analysis, one global pharmaceutical company discovered that neither of these factors had a significant impact on its staff; rather, departures were being fueled by a regional leadership problem, a product-breadth issue, and a training gap.  

By integrating hiring and training costs, productivity, and customer impact into a cost model, the company averted a $2.3 million revenue loss. Approximately $250,000 was invested in fixes to training and product-knowledge issues, increasing the likelihood that both current employees and future hires would remain on board. 

One of the practices seen among leaders in the healthcare arena is tracking their former stars' careers and, in many cases, enticing them to come back to the company. It may take some pride-swallowing, but smart sales executives recognize that reps often learn by doing—including doing something for someone else.  

With little to lose and lots to gain, it may prove worthwhile to initiate a conversation. Former employees sometimes confess that they've found the grass not greener across the street, and may miss aspects of their former job. By opening that door, a company can reclaim reps who are already trained and knowledgeable, and who can contribute from day one. 

Features

Seven steps you never knew that could fix the sales force

Do Something!

Presently, the only real postmarket surveillance in the pharmaceutical industry comes from passive, generally unreliable adverse event reports by doctors and pharmacists. But now Congress has instructed FDA to establish an active postmarket safety surveillance and analysis system. The new Sentinel System, part of the FDA Amendments Act (FDAAA), will expand FDA initiatives to access health information databases on an estimated 25 million patients by 2010, and 100 million by 2012. This more extensive monitoring system will detect drug safety signals much faster, and provide a broader picture of drug utilization and related safety problems. 

While FDA and industry are busy rolling out implementation plans and launching pilots for more effective postmarket surveillance, the initiative raises a larger issue:  How will improved understanding of drugs' effects in real world settings influence drug discovery and FDA approval of new products? The agency has been blasted in recent years for approving drugs that later prove to have safety problems. And even where FDA is not consciously more risk-averse, sponsors have been dropping development programs, and fewer new drugs are coming to market. A number of high-profile products marketed in Europe have not made it through the FDA review system, and additional postmarket monitoring requirements are generating considerable uncertainty in pharma R&D departments. In addition, marketers fear that earlier and broader postmarket data assessment will yield false negatives that set off alarms on every new drug. 

A more proactive, more efficient postmarket surveillance system will give regulators more confidence that safety problems can be identified quickly and correctly after a drug goes to market. As a result, FDA may be more willing to approve applications for innovative products despite risks. Agency officials are optimistic about the potential benefits of the Sentinel System, and believe that the program may even reduce the scope of late-stage clinical trials and Phase IV studies. Expanded postmarket assessment could dispel safety concerns about a new drug or vaccine raised in pre-licensure studies, observes Jesse Goodman, director of the Center for Biologics Evaluation and Research (CBER). "The data can cut both ways," says Goodman. 

At a Brookings Institution forum in June, former FDA commissioner and Medicare chief Mark McClellan (now with Brookings) predicted "a new era for determining how drugs should be used on the market." FDA commissioner Andrew von Eschenbach agreed that sophisticated information-gathering technologies will support new discovery platforms. Johnson & Johnson corporate vice president Garry Neil anticipates "a true revolution in healthcare," as clinical information supports the discovery of safer, more effective, less costly medical products.  

McClellan further explained at the June annual meeting of the Drug Information Association (DIA) that an active postmarket surveillance system reflects a move away from distinct pre- and postmarket regulatory processes and toward a life-cycle approach to drug development and regulation. However, he also noted that rising FDA concerns about drug safety are "not just a pendulum swing," but reflect higher expectations about long term safety.  

To achieve this regulatory revolution, FDA published a five-year drug safety plan and a formal Sentinel Initiative proposal spelling out the multiple goals and deadlines for establishing an active surveillance system. The initiative requires standards and methods for more effective analysis of health information, and better strategies for communicating new safety information to providers and patients. One important project is to improve FDA's existing adverse event reporting program [see sidebar: "Modernizing AERS"]. 

Agency officials, however, are not looking to build a giant federal health database based on an expanded AERS system. Instead, FDA will expand postmarket surveillance by accessing more data—on drug use, patient outcomes, and specific safety issues—held by private health plans, database operators, government agencies, and manufacturers. By utilizing this distributed network, all personal medical data will remain behind firewalls, reducing concerns about patient privacy and data security.  

FDA has been laying the foundation for the Sentinel System for years through contracts and partnerships with healthcare "data owners" that permit queries to electronic health records and claims databases on specific drug safety issues. For example, the agency contracts with UnitedHealth Group's Ingenix, Vanderbilt University, the Kaiser Foundation Research Institute, and Harvard Pilgrim Health Care to access pharmacoepidemiologic information that can test hypotheses arising from AE reports. CBER works with the Centers for Disease Control and Prevention (CDC), the Veterans Health Administration (VHA), the Centers for Medicare and Medicaid Services (CMS), and large healthcare plans to monitor use of influenza vaccine and related outcomes. Several projects with the Agency for Healthcare Research and Quality (AHRQ) are currently assessing the use of distributed networks for comparative effectiveness and safety studies.  

A new CMS policy gives FDA access to millions of pharmacy claims submitted by Medicare Part D drug plans [see "Leading Indicators/News," July 2008]. With additional funds to support postmarket surveillance, FDA plans to expand access to CMS, VHA, and health plan databases, further expanding its ability to detect and assess adverse events related to marketed drugs.  

FDA and its partners are beginning to map strategies for how this network will operate. A charter will define which entities can join the partnership, what data sources will be used, what queries can be run on the system, who can pose queries, how specific evaluations will be paid for, how results will be communicated, and how privacy protection will be ensured. Most likely, a nonprofit network "convener" will channel queries to the partnership and oversee distribution of results.  

Network partners will also research best practices and standards for postmarket assessment, most likely under the direction of a scientific advisory board. New models for data aggregation are needed to permit FDA to trace back to individual cases when necessary, and improved statistical methods will help sort out causality and distinguish meaningful signals in large information databases.  

Many of these issues will be explored by an active surveillance pilot program sponsored by the Pharmaceutical Research and Manufacturers of America (PhRMA). After more than a year in development, the project is being launched as a public–private partnership involving PhRMA, FDA, and the Foundation for NIH. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), will chair this test program for organizing and operating a drug safety query system using a distributed information network.  

In the future, it may be possible to monitor medical product safety through a national health information network that connects clinicians, consumers, and providers across the healthcare system in real time. FDA would have access to such data for public health purposes, but would have to ensure that information exchanges are secure and confidential. FDAAA specifically instructs FDA to examine privacy issues, and for the Government Accountability Office to report on the agency's progress. 

A linked system would give a broader picture of health problems and better track patients that change providers. But it would also require a higher degree of consistency and transparency, Woodcock explained at the Brookings forum. "This could be something for the future," she said. "We would not do this to start, but don't want to rule it out." 

Effective communication about safety signals from interim results will be a challenge, as will efforts to provide adequate and sustained financial support. These are issues that FDA and its Sentinel partners will address, as well as concerns about scientific accuracy and data reliability, said von Eschenbach. FDA is not implementing the Sentinel System "solely because Congress told us to, but because it's the right thing to do. FDA must and will do this," von Eschenbach said. 

's Washington correspondent. She can be reached at 

Washington Report

FDA's new sentinel system shows the pendulum swing toward safety won't swing back anytime soon

Can Sentinel Save Drug Development?

The amount of "unstructured information"—data not easily read by a computer—that pharmaceutical companies produce staggers the mind. This information typically appears in the form of research reports, sales records, emails, patent documentation, and clinical studies. Though critical information lies within this unstructured mass, locating the data in an online search is often extremely difficult. 

Unstructured content has no conceptual definition. In structured data, a word is simply a word—like a spreadsheet in which every piece of information is in a defined format, and stored electronically. But according to a 2003 Merrill Lynch report, structured data accounts for only 15 percent of all potentially usable business information. The rest is hard-to-access, unstructured data. 

The opportunities and challenges presented by this efflorescence of information, misinformation, and disinformation are unprecedented. Making unstructured data searchable and retrievable is essential to performing all kinds of pharma functions, from understanding trends to quelling rumors to researching drug development. The trick is turning all that noise into meaningful signals. One way to do this is with semantic intelligence. 

A search engine is a retrieval system designed to help find information stored in a computer. Since the birth of the Internet, there have been various search engine incarnations, but none is as successful and popular as Google. Google crawls the Web, stores a local cache of the pages it finds, and builds a lexicon of common words, then builds a list of pages containing each word. A query for a given word returns that list, sorted by page rank.  

The problem with Google and its search clones is that the intelligence behind the search does not fully recognize language in its natural form—the clichés, synonyms, homonyms, brand names, and so on. For example, when searching for the phrase "soft tissues," a Google search cannot decipher whether you are looking for information about a group of cells or a handful of Kleenex. Instead, you get results about both.  

Semantic intelligence extracts valuable information from texts by identifying people, places, things, time, money, and many other key signifiers.  (Why "semantic"? Because  the method derives from the science of assigning meaning to every word in a document rather than simply treating a word, as Google does, as a token.) But more than that, semantic intelligence finds events of interest, how objects are connected to one another, and the tone or sentiment expressed by an author. The end result is more precise search results.  

Searches based on semantic intelligence can draw direct relationships between terms because it understands both the user's query and the Web text. How? By using cognitive algorithms similar to the way the human brain thinks. It knows magazines are also called publications, that people work for a company, that price is related to cost, and so on. By bringing together linguistics and IT, semantic intelligence offers a highly sophisticated solution for searching, collecting, and organizing unstructured data.  

For example, if a user searches for the word "aspirin," semantic intelligence automatically extends the search to words for related concepts or synonyms such as "analgesic," "anodyne," and "painkiller." In addition, if your search uses a keyword that has multiple meanings, such as "formula," semantic intelligence retrieves only the documents that use the word in the desired context. A tool that allows users to select the intended use of a word by right-clicking will let them discard search results that do not apply.  

Semantic intelligence connects objects (words) by locating events of interest to the end user and storing these in a relational database. Once in the database, different models can be built into queries and visualizations that represent the connections. For example, a user can semantically process thousands of Big Pharma patents, tuning the search to look for examples of how each company uses oxygenation or pH levels as a method to fight cancer, and retrieve it in an X by Y chart to show how each company has chosen to concentrate on one method over the other. This insight is hard to glean from reading alone; there's simply too much data to process. 

By decreasing the volume of document iteration, semantic intelligence makes information gathering faster and more efficient, saving time and money at the front end of R&D. For example, it can: 

» Ease access to new information in scientific studies

 There's a hierarchy among words, and semantics can make precise use of this hierarchy. For example, one study may refer to the antibacterial methenamine, while another mentions a different antibacterial, nitrofurtoin; neither study mentions the other, and a researcher is unaware that both are used for urinary tract infections. Semantic intelligence can make this connection because it tracks the hierarchy of both.   

» Accelerate the earliest phase of drug development by recognizing new chemical formulas

 All candidate compounds start with a literature review to match them with indications. Often there are more degrees of freedom, or steps that make a connection, between compounds and indications than can be discovered by researchers. Semantic intelligence can capture all of this knowledge. 

» Help protect the intellectual property of a patented drug

 Many patents are a fog of claims and descriptions. Semantic intelligence can draw out the overlap between two patents no matter how densely they are written.  

It's common knowledge that health is one of the most frequently searched categories online. A recent report from iCrossing on how Americans search for health questions found that in the last year, patients turned first to the Internet 59 percent of the time. Knowing what consumers are asking and saying about drugs, disease, symptoms, side effects, and other issues can help inform new approaches to medical and marketing communications.  

A central concern is, of course, the opinions and other expressions circulated about the company and its drugs through so-called consumer-generated media (CGM): Internet forums, blogs, wikis, social networks, and Twitter (see "Today's New Words!"). Pharma faces unique hurdles with CGM in the following areas: 

 Consumer-to-consumer communication can promote inaccurate perceptions of the use of drugs. Semantic intelligence can be used to find misinformation about issues such as dosing, side effects, and "natural" alternatives. Pinpointed "back-messaging" (targeting responses to negative comments) can then help correct the misinformation. 

 CGM can make it appear as if a drugmaker is promoting a product for unapproved uses—and committing fraud. Finding, tracking, and recording the source using semantic intelligence is a form of legal protection.  

A drugmaker is responsible for informing FDA of all reports, including Web-based, of a drug's side effects and interactions with other drugs. Semantic intelligence can understand unstructured content, and uncover data in the far corners of the Web; companies can report blog comments and online discussions about side effects and other issues.  

Whether in the executive suite, the laboratory, or the field, employees at pharmaceutical companies are simultaneously drowning in information and starved for knowledge. Finding new ways to negotiate the proliferating universe of unstructured data can help focus even drug giants on their most important goal: developing new drugs to target challenging diseases. 

is the CEO of Expert System USA, a semantic technologies company. He can be reached at 

Technology

Here's how to search for meaning through unstructured data.

Search for: Meaning

For now, the future seems to recede ever further in the media onslaught of the endless presidential campaign. But come November 5, when life as we once knew it resumes, the drug industry will have not only a new administration to do business with but a bunch of new opportunities/challenges to add to its to-do list. Some of them are familiar, such as the "how" and the "how much" of outsourcing, while other issues are still emerging or barely even noticeable. Each year, IMS Health, the healthcare information and consulting king, surveys the pharma landscape for developments likely to drive trends or have major future impact. Here are eight strong harbingers to watch—and watch out for—when planning for '09. 

For years, oceanographers have relied on the release and recovery of "drift bottles" to model ocean currents and surface drifting. Serendipity has, however, provided them with an additional measurement in the form of 29,000 plastic ducks created in China and lost in the Pacific Ocean 15 years ago. In July 2007, British newspapers warned that a flotilla of 10,000 of these lovable bath toys would begin washing up along Britain's shores. The ducks' remarkable odyssey could be followed by another Chinese product "invasion" that may not be as innocuous. 

In July, FDA approved the first Abbreviated New Drug Application (ANDA) for a product fully manufactured in China: nevirapine (known by the brand name Viramune, an HIV med made by Boehringer Ingelheim) from Zhejiang Huahai Pharmaceutical. Coincidentally, in July the US government set up the Interagency Working Group on Import Safety.  

The importation of a finished pharmaceutical product is almost certainly the beginning of a sustained Chinese assault on the US and other strategic markets. Industry experts forecast that regulators will approve ANDAs for no fewer than 10 Chinese pharmaceutical companies, and the drugs have a good chance of passing FDA reviews. In order to ensure their success, the Chinese manufacturers are likely to undercut all others on price. 

Chinese policy will drive generic prices down further—with far-reaching consequences for both R&D players and international generics. R&D is increasingly looking to emerging markets for top-line growth, while generics are seeking top-line growth and profit stabilization. 

China's success would also accelerate the transition of the Indian multinational business model to embrace a balanced profile, including serving as third party preferred manufacturers for patent-protected brands, partnering with the global players in drug development, and expanding R&D. The Chinese makers of finished doses that will generate the most generics profits in the US will likely be those that integrate back into the supply chain via Active Pharmaceutical Ingredients (APIs). While Indian suppliers accept that large numbers of APIs will be supplied from China, they maintain that it is more efficient to convert APIs into finished products in India than in China.  

How this unfolds may come down to reputation. India is developing an image of excellence in pharmaceutical provision. China has a long way to go to eliminate or minimize risk. The speed and the success they achieve will determine China's importance in the manufacture of pharmaceuticals. 

Top Pharmas Withdraw from Manufacturing in a Big Way

Imagine a world where a basic activity—sleeping—becomes outsourced. That's the premise of the short story "Tough Girls Don't Dream" by Jeanette Winterson. In this world, people are too busy to sleep, though dreaming is acknowledged as beneficial. Thus, civil servants are paid to sleep so that others can enjoy their dreams. There was a time when the thought of major pharmas outsourcing a sizeable portion of their manufacturing was nearly as improbable. But times change. 

In 2007, three of the top ten pharmas announced plans to outsource manufacturing on an unheard-of scale. AstraZeneca is  expanding purchase of semi-manufactured medicines and external manufacturing of APIs over the next five to 10 years. Bristol-Myers Squibb reported that it will use third parties as backup manufacturers, closing more than half of its 27 manufacturing facilities by 2010. GlaxoSmithKline plans to save approximately $1 billion through 2010 with a program likely to include outsourcing. Pfizer, which already outsources 15 percent of its manufacturing to Asia, aims to double that, saving some $2 billion a year. 

These decisions give rise to three new tenets in pharma. The first is that there's no requirement that R&D be linked to manufacturing; the second is that intellectual property is no longer a key factor  in determining business partnerships; and the third is that the technology and skills required to produce branded pharmaceuticals can be found in emerging markets.  

In an age of generics, there's ample incentive to outsource production of low-margin goods to lower-cost manufacturers. Outsourcing could also be a way to improve time to market—a manufacturer that can shorten development time by 19 percent can save $100 million. When companies do not need to adjust their own workforce and operational capacity to fluctuating demand, they can concentrate on innovation and brand building. 

Of course, relying on partners can be challenging. There's uneasiness, especially in the US, over the quality and safety of pharmaceuticals sourced in emerging markets. As manufacturing processes become more complex, drugmakers will be required to provide impeccable sources and guarantees. Legal liability will be the subject of increased scrutiny in an increasingly risk-averse environment.  

The second issue is that contract manufacturers can turn the tables completely. A contract manufacturer for a major pharma could tout its quality and the credibility gained from the outsourcer to eventually put its own brand on packages. And the specter of challenges to intellectual property rights refuses to go away, despite recent progress in countries such as India.  

The third issue concerns local market access. Multinational companies have been hindered in their attempts to invest in emerging markets where pharmaceutical consumption is predominantly generics. Since growth is coming increasingly from these markets, it's not surprising that major drugmakers are looking for new avenues to build businesses. Strong partnerships could provide the basis for closer commercial arrangements.  

Lastly, there are growing political and economic concerns. For example, the research-based pharmaceutical industry remains one of the best-performing high-technology sectors in Europe. So if the move to outsource pharmaceutical manufacturing takes hold, political intervention may follow. Concern over jobs and trade imbalances may help to renew a dialogue between governments and Big Pharma on a more favorable basis than in recent years.   

Big wave surfers must be able to predict how a wave will break. In order to stay ahead of the whitewater, they study wave dynamics and consult sophisticated surf forecasts based on data from ocean buoys and space satellites. This meticulous preparation is often what separates thrill from peril. Pharmas that are ready to ride the wave created by Health Technology Assessments (HTAs) must learn to predict how assessors will behave. They must understand what proof points assessors will require and use the science at their disposal to avoid "wiping out" when seeking the HTA's stamp of approval.  

In December 2007, Novartis announced a deal with the National Institute for Health and Clinical Excellence (NICE) in the UK whereby the two organizations will be partners in the design of a Phase III clinical trial. NICE will provide advice on evidence requirements in the areas of clinical effectiveness and cost effectiveness prior to Phase III clinical development. 

NICE has become pivotal to the success of newly launched products on the strength of its guidance on cost effectiveness. Novartis hopes to provide NICE with the evidence necessary for an endorsement, and presumably to speed NICE's decision-making, which normally takes two years following marketing approval.  

Impartial observers have asserted for years that relationships between stakeholders in the healthcare sector are inefficient and confrontational. In August 2006, a submission to the UK's 

 by the American Pharmaceutical Group (APG)—which represents the top ten US-owned pharmas that invest in the UK—recommended that "an earlier dialogue between NICE and clinical researchers could better direct research to ensure a satisfactory and speedy NICE appraisal." Novartis has taken the lead by starting dialogue at the clinical research stage. 

Incremental successes in drug development have driven demand over the past 50 years, especially in chronic illnesses, and have generated a cost base that requires payers to carefully manage financial resources. With HTAs becoming more important in drug marketing, pharmas can no longer overvalue the scientific contribution of their innovations or ignore the influence of HTAs. The Novartis initiative may signal the end of Big Pharma's isolationism. 

Experiments such as Novartis' may lead to a consensus on targets for R&D. According to the APG's 

 submission, clinical trials are costing manufacturers in the neighborhood of $500 million; therefore, anything that can direct research in the most promising directions is bound to win support.  

US Research Agency Backs Head-to-Head Trial

Dramatic turning points in history have often begun with a single shot—like the musket shot that began the American Revolutionary War or the assassination of Austria's Archduke Franz Ferdinand, which plunged Europe and its allies into World War I. A large, head-to-head trial sponsored by the US National Eye Institute (NEI) on two marketed products should be seen by manufacturers as such a shot. It signals a new level of activism on the part of other stakeholders, who will fund their own trials when pharmas are unwilling to do so. 

NEI, part of the National Institutes of Health (NIH), is pouring about $16 million into a trial that will compare the safety and efficacy of two on-market therapies for wet age-related macular degeneration (AMD): intravitreal injections of the anticancer drug bevacizumab (Avastin) vs. ranibizumab (Lucentis). Both products are anti-VEGF agents, and both have been used to treat wet AMD. But Lucentis is specially formulated for use in the eye and has conducted specific, high-quality AMD clinical trials. By contrast, use of Avastin in AMD has been off-label. 

This type of clinical trial is normally the purview of the drugmakers. In this case, the originator of both agents, Genentech, will have nothing to do with the trial. The NEI, spurred to action by a Medicare advisory panel, is stepping forward because of the disparity in cost between the two drugs: Lucentis costs around $2,000 per injection, whereas Avastin, when used for this indication, costs only $40 to $75 per dose. With a typical course of eight to 12 injections, the cost of Lucentis would amount to around $24,000, compared to approximately $900 for Avastin.  

If the trial, which ends in 2010, finds that Avastin is as effective and as safe as Lucentis, US sales could largely disappear. And there would undoubtedly be a spillover effect in other countries. Avastin sales could benefit, but substantial value would be lost to Genentech forever. 

This will also affect the relations that the entire industry has with policy-makers and payers. The NEI-sponsored trial signals a new level of activism in the US by the single-largest payer body: the Centers for Medicare and Medicaid Services (CMS). The US will no longer categorically accept drugmakers' pricing of biologics.  

The industry is a-changing. Here are eight seminal events that describe how.

Harbingers of Change

This year the Supreme Court has given itself three opportunities to rule on the question of whether FDA decisions trump the ability of consumers to sue pharma companies in state courts. The score so far: one minor loss for pharma and one pretty big win for medical devices, with a big case yet to come. 

But don't count on any relief, even if the Court comes down resoundingly on the industry's side later this year when it hears Wyeth v. Levine. Henry Waxman doesn't believe in preemption, as it's called. "The Supreme Court's decision strips consumers of the rights they've had for decades," Waxman told 

reporters after the court ruled in Riegel v. Medtronic, the device case. He followed up by introducing a bill in Congress to eliminate preemption for devices, and it's a good bet he'll do something similar if the Court rules for Wyeth in Wyeth v. Levine. 

When you think of it, it's kind of an odd idea that pharma companies should be liable for injuries caused by products that are properly manufactured, correctly labeled, and FDA approved. Waxman is right, the idea goes back decades—to 1955 and the  "Cutter Incident," when a batch of polio vaccine manufactured by Cutter Laboratory proved to contain live virus, infecting 70,000, paralyzing 2,000, and killing 10.  

At trial, Cutter argued that using current science it was unable to anticipate or even test for the problem that tainted the vaccine. The jury agreed, in a handwritten pencil note that accompanied their verdict finding for the plaintiff, according to Paul Offit, a medical professor who described the case in his 2005 book The Cutter Incident.  

If the company did nothing wrong, why make it pay? According to Offit, the theory was laid out in an article in the Yale Law Review, published just months after the vaccine disaster. The article suggested that drug companies should pay, not because they deserved to pay, but because they could most efficiently distribute the cost of compensation back to the group of people who had benefited by the product—the patients who'd taken it. 

That's not such a bad theory. The only problem is that it doesn't work in practice. The authors of the law review article envisioned an orderly process of compensating victims. What we have instead is a lottery, with juries basing their decisions on God-knows-what, a few folks who hit the jackpot, a lot of who come away undercompensated, and lawyers siphoning a significant share of the money. 

Maybe it's time to get drug cases out of the courts entirely. There's a good model in the Vaccine Injury Compensation Program, a federal program launched in 1988 to lure manufacturers back into the vaccine arena, which had been ravaged by lawsuits. The program is not perfect: Critics say it is still more adversarial than it needs to be, and it is unpopular for relying on science when juries probably wouldn't—especially in regard to vaccines and autism. But it's relatively efficient, and it compensates victims without demonizing the industry. 

We know patients will continue to be harmed by drugs, no matter how careful FDA and the industry are. That's not something anyone in the industry likes; but it's the reality for the indefinite future. As a society, we've agreed to live with that reality. Call me naive, but I think it's time for a system of victim compensation that acknowledges that choice. 

From the Editor

FDA preemption is a hot issue for pharma, and it's likely to get hotter. But it's the wrong issue.

Cutter's Way

For more than half a century, drug prices in the United Kingdom have been set by the Pharmaceutical Price Regulation Scheme (PPRS), a "cost plus" profit control plan developed in 1956 to ensure that the National Health Service (NHS) has access to "quality branded medicines at reasonable prices, and promotes a healthy, competitive pharmaceutical industry." Over the years, this complex system has evolved to the point that pharma companies are now free to set the price for their product, as long as profits do not exceed a predetermined level. 

The PPRS is usually renegotiated every five years, with the current deal set in January 2005. But last August, the UK Department of Health sent shock waves through the pharma industry when it announced that it would scrap the current agreement and begin renegotiation a couple of years early.    

Now it appears that the Association of the British Pharmaceutical Industry (ABPI) and the British government have come up with a solution that isn't as bad as the industry had feared. The government's aim is for the new system to be up and running in January 2009. The meat of the proposal is a cost savings of 5 percent on drugs the NHS buys, with an additional 2 percent cut to kick in if the increase in total cost exceeds 6.7 percent either this year or next year. This extra reduction would take effect in 2010 or 2011.  

The 5 percent cut will comprise a 2 percent across-the-board reduction in price of all branded medicines, combined with a system to lower the prices of off-patent meds where there is generic competition. Additional variable price cuts will bring the overall figure up to 5 percent. Companies with sales of less than £25 million will be exempt from the price cuts on their first £5 million of sales.  

While the new PPRS may seem gloomy, there is a silver lining for industry—a government promise to support innovation in return for the cuts. For years, pharma companies have been complaining that the adoption of innovative medicines is extremely slow in Britain. Even after a drug is approved by regulators, pharmas have to clamber over cost-effectiveness hurdles set in place by the National Institute for Health and Clinical Excellence (NICE). This leads to the phenomenon called "NICE blight," where Primary Care Trusts (the local groups responsible for health budgets) refuse to sanction the use of licensed drugs until NICE rules—NICE rulings can take months or years.  

The current lack of support for new medicines flies in the face of the government's stated commitment to promote innovation, and to do so by purchasing. Several new proposals aim to remedy this. One idea is to set up a single horizon-scanning process to keep an eye on developmental drugs, with the formal involvement of industry. This should allow for better forward planning to prevent the launch of important but costly drugs coming as a huge financial shock. Another plan is to pilot prescribing-incentive schemes, which would encourage PCTs to prescribe new meds.  

In addition, new metrics will be introduced to track the adoption of NICE-approved medicines, comparative to international figures. Patient groups can then "name and shame" PCTs that aren't playing by the NICE rules. 

The ABPI described the government's proposals as a "significant deal" that provides an excellent platform to improve access to innovative medicines. "The [newly outlined] PPRS will not only offer benefits to the NHS and to the industry, but most of all to patients, with a raft of measures designed to eliminate delays in providing the most modern medicines," said ABPI president Chris Brinsmead, chairman of AstraZeneca UK.  

The government is happy with the progress, too. "I am delighted [we] have been able to make such encouraging progress," says Secretary of State for Health Alan Johnson. "We have a duty to ensure that patients continue to benefit from innovative products at a reasonable price, and the taxpayer gets value for money. We also recognize the industry's important contribution to the economy, developing new medicines, and to the UK's research capacity." 

's global correspondent. She can be reached at 

Global Report

Britain's new approach to drug pricing isn't as bad as the industry feared.

Jumping the Gun

It's Midsummer, And across the country pharma sales managers are participating in what's become an annual ritual. "What's happening to sales?" the rep's boss asks. "Sales are off," the manager replies. "Consumers are hitting the doughnut hole (or gap). My reps tell me that patients are dropping off therapy because now they have to pay full price." Or: "We need a new patient assistance program to fill in the gap."  

The "Doughnut Hole"—the coverage gap built into the Medicare Part D benefit design—was originally intended as a means of shifting the cost of this new program back onto consumers, and limiting the budget impact of a prescription benefit for the federal government. But it has also created significant uncertainty for pharmaceutical companies, which need to know how this shift to a defined contribution toward annual drug spending ($2,400 in 2007) will affect sales. In addition, it has created virtually unanswerable excuses for sales reps and managers.t does the doughtnut hol reallyUntil now, it has been difficult to verify these claims. The impact of the coverage gap on patient behavior has largely been a mystery. 

The question is: What does the doughnut hole really do to drug sales?  

Until recently, it's been impossible to tell. But over the last year, Amundsen Group has worked with healthcare data provider Verispan to demystify the impact of the coverage gap on Part D patient behavior. Specifically, Amundsen used Verispan's anonymous longitudinal patient data (ALPD) to create a representative sample of more than 3 million Medicare Part D beneficiaries who might have had exposure to a gap in branded or generics coverage, tracking their behavior as their share of prescription costs changed from a standard Part D copay or coinsurance to paying full price. For the 2006 and 2007 benefit years, this extensive sample was used to help a number of clients answer pressing questions such as: How many of my patients reach the coverage gap? How do they behave when they reach it? Do they stop taking my brand or shift to a generic? If they reduce their adherence at the end of the year, do they come back when their cumulative drug spend resets in January? 

1) It is possible, although very difficult, to measure the impact of a coverage gap on specific therapeutic classes and brands

 When you do so, it is quickly apparent that far fewer prescriptions require patients to pay the full price than most manufacturers expect, thanks to employer supplemental coverage, state and manufacturers' patient assistance programs, other third party coverage, and the Low Income Subsidy (LIS) program. (LIS patients use about half of the drugs prescribed under Part D and pay almost nothing.) 

2) The industry has been asking the wrong question 

"What happens when my patient crosses the coverage gap threshold?" is not the only relevant question. Rather, how does the existence of a gap in branded or generics coverage affect overall patient adherence in Part D? It turns out that the largest impact of the coverage gap is often found among patients who 

 the coverage gap by stretching their prescriptions or dropping some medications—thus never reaching the threshold. 

3) The impact of the coverage gap will be very different by therapeutic class and brand

 It depends on whether or not a widely accepted generic or an OTC alternative is available. 

 By tracking patients longitudinally, and ensuring that we have captured all of their prescriptions, Amundsen has been able to mimic the Part D insurers' calculation of cumulative drug spend and out-of-pocket cost sharing for a given patient, thereby having a reasonable estimate of when they should have reached the $2,400 limit in 2007 ($2,250 in 2006). 

From the 3 million patients in the Verispan/Amundsen coverage gap database, it was estimated that approximately 72 percent of nonsubsidy patients and 83 percent of total enrollees do not have a coverage gap, or do not reach the cumulative drug spend that would put them in the gap. LIS patients, who had very distinctive branded copays of $3.10 and $5.35 in 2007, and who have no exposure to the coverage gap, account for about 38 percent of enrollees and frequently are a higher proportion of the prescriptions in any given class.  

Of the remaining 18 percent of patients who actually reach the $2,400 threshold, about half are actually paying full price for all their drugs. The remaining half have either full coverage or some gap coverage. Plans with some gap coverage may be "generics only," or have identified a number of branded drugs that are apparently exempted. The number having full coverage in the gap remains a bit of a surprise, and the explanation for its importance varies by therapeutic class and Part D region.  

These percentages will be very different for any cohort of patients who might be taking a particular class of drugs. Take branded proton pump inhibitors (PPIs) as an example. Because branded PPIs have relatively high negotiated prices, and because PPI patients in Part D have many comorbid conditions, a higher percentage of PPI patients reached the coverage gap in 2007—29 percent, compared with 18 percent in the group as a whole. Of the nonsubsidy PPI patients who reach the threshold, more than one-third will have coverage for virtually all of their medications. Another group will have some gap coverage for generics only, or for some branded products. 

To measure how much impact the coverage gap has had on each of the cohorts that experience exposure to the coverage gap, Amundsen used a standard methodology that benchmarks the persistence, compliance, adherence, and generics substitution of each exposed cohort against a group that should not be affected—those who have full coverage in the gap. For example, we would expect to see a reduction in the share of branded PPIs as plans and consumers put more emphasis on generic omeprazole. Both the LIS cohort and those PPI patients with full coverage increased their utilization of generics by about 5 market share points over the 12 months of 2007. Those in the exposed cohorts, on the other hand—those with no gap coverage, some branded coverage, or generics coverage—shift 10 to 15 market share points to generics over the same time period. 

What pharmaceutical executives really want to know is how many days of therapy they might be losing from Part D patients as a result of this feature of the benefit design. In seeking this information, most marketing and sales people in the industry have focused their attention solely on those who may have exceeded the coverage threshold for a given year.  

But to truly understand the impact of the coverage gap, you have to consider other groups as well—particularly those who don't reach the $2,400 limit, LIS patients who have no gap in coverage, and the sickest Part D patients who have spent $3,850 out of pocket and thus qualify for catastrophic coverage with lower copays. For each patient cohort you want to know: 

 Number of patients, average number of prescriptions per year 

 Percentage of days of therapy lost after reaching the coverage gap? 

In analysis of several therapeutic classes, the group that shows the most change has often been the cohort that never reaches the coverage gap. For most therapeutic classes, this is the largest cohort. They cut back refills the most, reducing their days of therapy. And they start to change their behavior earlier in the calendar year. The "avoidance cohort," as it is called, typically start out taking many different drugs each month, and the majority of these patients spend more than $200 a month in the first half of the year. By mid-year, however, these patients change their behavior significantly. They drop therapy or switch to an OTC alternative (which can't be tracked in retail Rx data). They reduce their compliance and stretch out their prescriptions. They are also more likely to switch to a generic if it is available in the classes of drugs they are using.  

Patients who reached the $2,400 threshold in 2007 got there for a reason. They were compliant with their medications, and filled enough prescriptions to get into the gap early in the year. In terms of days of therapy lost, however, they can be less important than the avoidance cohort. For one thing, there are far fewer of them. And on average, they reduce usage less and are affected for the shortest periods of time. 

Patients who started the year on a branded PPI product, but didn't spend enough on all prescriptions to reach the coverage limit, were just as likely to drop off therapy as were patients who reached the coverage gap and faced full prices. Patients with coverage in the gap—from their LIS status or some other coverage—were far more likely to be persistent. 

When you calculate—How many? How much impact? How long?—for each of these cohorts, you can determine the overall impact of the gap in coverage on the nonsubsidy patients in a therapeutic class. In the PPI class, for example, about 2 percent of days of branded therapy were lost among nonsubsidy Part D patients as a result of the coverage gap.  

Although this analysis has been conducted for a wide range of therapeutic classes and products, we have been unable to predict, a priori, which patients will be most impacted by the coverage gap. However, the coverage gap can be less of an issue in classes in which LIS enrollees account for a disproportionately high percentage of the Part D prescriptions. For example, LIS patients may account for more than 75 percent of prescriptions filled for atypical antipsychotics, such as Zyprexa (olanzapine). Conversely, the presence of a widely accepted generics alternative, such as omeprazole or simvastatin, is a good predictor of a class that will be impacted more significantly. Other factors that may influence the importance of the coverage gap include the existence of manufacturers' patient assistance programs, the legacy effects of state patient assistance programs that might have granted preferred status to a particular product, and the availability of OTC alternatives that would be acceptable to the consumer—such as allergy products.  

Will patients who hit the coverage gap in 2007 come back to the brand when their cumulative drug spend resets to $0? Will patients who were exposed to the coverage gap last year learn how to manage around it and get smarter every year? Will manufacturers find ways to respond to the coverage gap in a cost-effective way? 

Like our clients, we want to lift another veil from the coverage gap mystery, and will do so as 2008 data become available.

 are  directors of the Amundsen Group. They can be reached at 

 is senior director of managed care product management for Verispan. He can be reached at 

An answer to your question: What does the Part D coverage gap do to drug sales?

Inside the Doughnut Hole

The British geneticist J.B.S. Haldane, so the story goes, was once asked what he had been able to deduce about God from studying nature. "An inordinate fondness for beetles," Haldane replied. 

It wasn't the answer his interlocutor wanted, I suppose, but it's elegant as well as funny. With an estimated five to eight million species, accounting for a quarter of all known life forms, beetles have to count for something when you're assessing the Creator. 

Take the same sort of logic and apply it to another question: What can we say about modern medicine? The answer, of course, is that it's brilliant at curing the ailments of mice. 

 is where the action is. Browse through just the most recent reports, and you'll discover that scientists have cured mice of a whole array of diseases that still plague humankind. 

There's a cure for everything, as long as the patient is a mouse

Pharmaceutical Executive-08-01-2008