It's no secret that the pharmaceutical industry has been going through big changes, with doubtless more on the horizon. Industry-wide layoffs, a looming election, and changing public perceptions are all having an impact. How will pharma companies staff their organizations? And what does this mean for the existing sales model? To answer these questions—and more—Pharmaceutical Executive teamed up with its sister publication, Pharmaceutical Representative, to convene a panel of experts. An edited transcript of that discussion follows.

): News of sales force downsizing has captured headlines, but how do these layoffs correlate to pharma's changing sales model?

David Snow (vice president, commercial operations, AstraZeneca):

 We largely make decisions on size and structure based on where we're going strategically with our portfolio. Everyone would like to be a primary care company, if the portfolio supported that. But most product portfolios are moving toward specialty. And if you have specialty products, then you probably don't need as many people in your sales force. 

Sandy Jennings (senior vice president of selling solutions and operations, inVentiv Health):

 Overall, we see that large and emerging pharmas are looking for a more flexible model, where they can quickly respond to FDA delays or generic hostile intrusion that is really challenging the patent expirations of some major brands. They need to create models where they can upsize and downsize without having to put out a press release to the financial community. Contract sales organizations can help them do that. 

It's difficult for pharma companies as they optimize their field force structure to determine how long that optimization will last. Ideally, you'd like to get two or three years out of the structure that you put into place. 

): Many companies are moving to the specialty model. How does the change manifest itself at the rep level?

Todd Lambert (national sales director, GI business unit, Shire):

 Big Pharma is looking at some of the ways smaller companies operate. 

Specialty companies hold reps to higher standards and see that as an opportunity to create some equity for the company. That means reps will have greater access and asking power down the road, and the company can keep their name out there and continue to feed their commercial business units with more products. 

Rick Rosenthal (associate principal, director of sales force effectiveness research, Health Strategies Group):

 In primary care and specialty offices, the way reps are effective ends up being very different. In a typical primary care office-based call, reps must understand what it takes to generate the intent to prescribe a drug and how to remove the roadblocks to that prescription.  

An effective specialty representative encompasses all of that, but they also become much more embedded in the delivery and the healthcare system around that condition. There's much more involvement in medical societies and patient advocacy groups—the rep becomes a real player in how that condition is treated in their territory. 

 Throughout the years, the rep/physician relationship—making sure that there was impact in the office—was such a key focal point. But today, doctors don't have a lot of time for small talk. They're looking for a more scientific approach and a more scientific message—and that's an important area for training. In some ways, it's almost like going back to where we started in the industry many years ago. 

Breitstein: All companies say reps should add value to the healthcare equation. Are these new approaches working? How can you tell?

 A relationship and ongoing conversation about the rep's products and services has to be present. With the constant realigning in the industry, it can be a challenge just to overcome that first hurdle. 

Then we can see if the physician is satisfied with the relationship and values the time he or she spends with the representative. When those elements are present, at least at a basic, measurable threshold level, you could say there's value. 

 In the past, we were trying to coordinate 10 or 12 different selling teams in primary care. Top-tier physicians could have as many as 175 reps across the industry calling on them. That's not being customer focused, I'd say. 

We started to do some research in 2004 around other options out there, and we tested several variables to understand what might work for us. However, I want to emphasize that the portfolio dictates a lot of what the structure of your sales force will be. 

In January, we altered our sales force structure to drive fewer faces. But we found the real benefit is that it clears up a lot of the complexity of trying to manage across 12 different teams—that difficult dance reps do to keep out of each other's way on a four-or six-week cycle. 

That's made the reps feel more accountable, because they have ownership over their practices in key physician relationships. And it helps us to be much more flexible in driving changes, and understanding what's going on, at the physician level. It's really been a good change for us—and other larger companies' experience has been consistent with that. Lilly and Merck have also been down that path. 

Herman: Accountability is not a new concept in pharmaceutical sales. But we're hearing more about it. Are companies using accountability in a new way?

Rick Keefer (chief operating officer, Publicis Selling Solutions Group):

 Accountability is what has generally appealed to high-performing reps in the specialty market. It's what attracts the high-performing rep to say, "Let me show you what I can do." 

Now, in the large primary care sales forces, pharma companies are trying to assign product accountability and responsibility to one rep, rather than a pod or a multitude of reps. It's changing the model. We're now seeing a different profile of rep that companies are beginning to hire because some reps don't like that accountability. It's hard to hide. 

Paul Stickler (senior director of sales, Ovation):

 I've seen that holding reps more accountable for their activity drives superior performance, and that performance is going to drive more value. It's a simple thing that really can make a big difference. 

Breitstein: How do you make reps accountable?

 Well, sales, right? Ultimately, sales is about driving prescriptions—it's the metric that analyzes your impact and ability to influence prescribing behavior. 

 I'd be careful about suggesting that it's only about the prescription. We care a lot about the quality of the call, and we recognize that it's a bigger world out there than just this rep/physician relationship and just driving a message and driving an Rx.   

Herman: Are companies redefining the profile for representatives? What are the skills reps must possess to be successful in the new sales model?

Scott Hull (manager of field sales technology, Abbott):

 We need to make reps smarter and better able to handle multiple products across disease states. But they need to have more than just product and disease knowledge. It's about knowing the payer mixes and the lifecycle of the product, which has relevance to how reps promote and bring value into doctors' offices. That takes a much higher level of business acumen on the part of the rep.  

 Based on a study on business acumen among sales reps and regional and district managers, I can tell you that pharma companies generally think of business acumen as a collection of facts reps can recite and knowledge they appear to have. 

But what differentiates them from their peers is not what they know, it's what they do with what they know. I would encourage each company to think more about getting people to translate knowledge in their head into the actions they can take. 

 The field sales force has to be more focused on solutions and on patient outcomes. That means that, from a brand standpoint, reps have to be able to convey solutions for the practice and for the patient long term. 

 Before we can prepare our reps, we have to define what the profile of that rep should be and the actual role they're playing in the practice. I see a lot of pharma companies using the tiered approach by having a sales representative, a customer-service rep, a medical-science liaison, a clinical-nurse educator, on-call nurses, and others approach the practice. And as we start to look at doctors' offices more around therapeutic area, we can plug and play those different roles so we can offer the doctor a full understanding of the disease state, therapeutic class, and the offerings to treat their patient population. 

Breitstein: Do pharma companies have the necessary training systems in place to ensure that reps have the skills they need?

 From a pure training perspective, Big Pharma does a pretty darn good job of investing in their people. Having been in specialty, I've looked at hiring Big Pharma people simply because of the rigor and discipline that they've had in their training. 

 But training is a temporary state of affairs. District managers are only with an individual rep one out of 40 or 50 days—if they're lucky.  

 It's important to understand how these managers are going to coach the reps. We have a population of first-line managers that don't have the experience around the scientific approach. Even when it comes to business acumen, depending on the pharmaceutical company you've worked for, you might have been exposed to only a very narrow scope of what a district manager might do. We need to make sure the district managers know how to be successful, because they are the number-one reason reps leave the job. 

 You also have to consider that the variability of reps across the United States can be quite large. Distance-learning platforms can help the industry in diagnosing individual rep needs, which is different than a one-size-fits-all three-day event.  

 We're also seeing the benefit of new gaming technology that puts very high science into a training format that reps can identify with. That's really starting to mushroom in terms of interest in the industry. 

Herman: Within the sales organization, where are companies finding the most success with new technology?

 We have only 51 representatives across the country, divided into two different sales forces and two different therapeutic areas. We've made a decision to go with the tablet PCs and electronic promotional material. 

Articles

Features

Industry insiders explain how pharma companies are reorganizing their salesforces in the wake of industry-wide layoffs

Salesforce Roundtable

The United Kingdom's National Institute for Health and Clinical Excellence, or NICE, has come under fire from a government committee that claims its evaluation process is too slow. It was also blasted for failing to include the wider benefits of treatments to society, such as the impact on caregivers, in its assessments. 

NICE was established in 1999, and its assessments and guidelines have been copied around the world. Yet this has been accompanied by criticism from industry and patient groups alike that its decisions are not always fair or transparent and that it slows down the availability of new medicines to patients. 

The House of Commons Health Committee last looked at NICE back in 2002, and many—but not all—of the recommendations it made have been implemented. At the top of the committee's list of recommendations this time was that drugs should be assessed at the time of licensing, as all too often doctors and Primary Care Trusts (PCTs, the local organizations responsible for budgets) await a NICE decision before they prescribe a newly approved treatment.  

However, the committee acknowledged that NICE does not always have all the information it needs to make an assessment and said that it should have access to all data submitted to the regulatory authorities. NICE should also work more closely with pharma to ensure it can get the information it needs.  

The committee also says that there is insufficient emphasis on disinvestment, with old treatments continuing to be used regardless of the availability of newer, more effective alternatives that might also be cheaper in the long run. And it reiterates a recommendation made in its 2002 report that has not been implemented: that the wider benefits to society of treatments should be taken into account. If a treatment keeps a patient healthier for longer, then he will be able to earn money and pay taxes for longer—and relatives who otherwise might have to give up their jobs to care for the patient would too.  

The Association of the British Pharmaceutical Industry (ABPI) does not believe the committee's recommendations would benefit patients. Claiming that the report contains the first formal admission that medicines are rationed in the United Kingdom, ABPI believes that its recommendations would have no impact on patients' access to modern medicines. "British patients already have worse access to new medicines than others in Europe," says ABPI director general Richard Barker. "Faster, 'quick and dirty' assessments of medicines against tougher cost-effectiveness hurdles will make this problem worse. What we need most is an innovative National Health Service, not one more determined to ration care before we even know how patients will benefit from it." 

In response to the suggestion that NICE should look at all drugs, chief executive Andrew Dillon says that it currently looks at 30 to 40 percent of all the new treatments launched in the United Kingdom. However, he is not convinced of the value of appraising everything. "We look at the most challenging, interesting, innovative, controversial, expensive things that come in," he says. "Many of the new drugs that are introduced are license extensions, and...NHS can pretty much make its own judgment on many of them. That said, if NHS particularly wanted us to do something, we'd be happy to—and we'd probably find that the rate of appeals would reduce, as we'd be doing fairly uncontroversial things." 

The committee's chairman, Kevin Barron, said the government should not interfere with NICE's work. "It is essential that NICE is left to do its job without ministerial interference," he said. "At the same time, it must have the support of ministers when it makes a difficult decision." 

NICE will never be able to make everyone happy. Patient organizations and pharma companies both think that NICE's cost-effectiveness thresholds are often set too low, whereas PCTs frequently struggle to implement its recommendations, citing a lack of resources, and think the thresholds should be made lower still. The report concludes that implementation of NICE guidance should be improved and, if necessary, some elements of the clinical guidelines made compulsory. "The fact that some PCTs apparently find NICE recommendations unaffordable is more a reflection of poor forward planning for innovations in the NHS than it is of the value they deliver," concludes ABPI's Barker. 

's global correspondent. She can be reached at 

Global Report

UK agency takes the heat for slow evaluations and failing to consider societal benefits of new drugs

Fire and NICE

Even though federal legislators approved a significant expansion of prescription-drug regulation last fall, there has been no let-up in accusations against and investigations of the pharmaceutical industry—or criticism of the Food and Drug Administration. An article in the 

 (Jan. 17, 2008) reignited concerns about the loss of valuable information from clinical studies on antidepressants that were never published—the "wastebasket effect." Even FDA action halting marketing of cold medicines to young children generated questions about the value of other pediatric treatments. 

The latest big eruption involves the combo anticholesterol drug Vytorin (ezetimibe/simvastatin). Comarketers Merck and Schering-Plough ran into a buzz saw when they released less-than-stellar efficacy results after what seemed an unreasonable delay. Heavy DTC marketing for the drug was pulled in an attempt to quell the storm, as trial lawyers filed suits charging consumer fraud from Vytorin claims of being more effective than low-cost generics. Congressional critics even raised questions about whether FDA should rely on cholesterol levels as a biomarker for preventing heart disease.  

And the Ketek (telithromycin) controversy, like the battery-powered bunny, just keeps going and going. The House Energy and Commerce Committee subpoenaed testimony from FDA criminal investigators on what they knew about research fraud related to testing the Sanofi-Aventis antibiotic—and when they and the company knew it. The legislators are demanding volumes of FDA documents to see if Commissioner Andrew von Eschenbach presented misinformation in testimony last year on Ketek safety concerns.  

Von Eschenbach is spending a lot of time on Capitol Hill addressing these issues and charges that FDA's paltry resources have made it ineffective and unable to protect public health. Members of the E&C Oversight subcommittee drilled von Eschenbach in January on how he was (or was not) responding to charges by the agency's Science Board that FDA is vastly underfunded and in danger of breaking down. The commissioner would not estimate the cost of remedying these problems, so Rep. Henry Waxman (D-CA) and Sen. Edward Kennedy (D-MA) asked the Government Accountability Office (GAO) to examine FDA's staffing, IT, and resource needs. In addition, E&C leaders asked Gail Cassell of Eli Lilly, who chaired the Science Board subcommittee, to have her panel determine whether the administration's 2009 FDA budget plan will address the funding problems raised in the Board's report. 

It's unlikely that Cassell's group will have much praise for the FDA budget proposal. Attorney Peter Barton Hutt, who calculated FDA's funding shortfall for the Science panel, told the House panel that FDA needs to double its appropriations over the next two years and to increase staff by 50 percent.  

Although FDA got nearly a 6 percent increase in 2009 funding to $2.4 billion, most of the gain is from rising user fees that support select programs. FDA appropriations are only $1.8 billion—way below the $2.1 billion level sought by the Alliance for a Stronger FDA. The administration's budget, said former FDA official and Alliance spokesman Bill Hubbard, provides "barely half of what FDA needs just to keep pace with inflation."  

Moreover, the $628 million in user fees includes $16 million from generics makers, which that industry opposes without a number of regulatory reforms. It also includes $6 million in fees to support pre-review of DTC TV ads, a program FDA wants to revive after Congress refused to appropriate it for this year. While critics fulminate about FDA's increased reliance on industry payments, the user fees keep going up to fill in the gaps created by funding shortfalls.  

Even though FDA's budget is a tiny drop in the federal-spending bucket, it will be tough for Congress to expand it very much. The administration's $3 trillion 2009 budget attempts to keep its deficit below the $400 billion mark by curbing Medicare and Medicaid spending and freezing outlays for most discretionary programs. The National Institutes of Health is basically flat-lined, and there's a hefty cut proposed for the Centers for Disease Control and Prevention and others.  

Congressional leaders say this last Bush budget is even more dead on arrival than previous versions. Democrats blasted defense increases, tax cuts for the wealthy, and the proposals to reduce healthcare and other services for the elderly and poor. No one expects big cuts in Medicare during an election year, so there will be a desperate scramble for any available funds to shore up federal government programs one more year.  

FDA's larger problem is that many influential members of Congress either don't trust the agency to monitor the industry appropriately or have found it politically expedient to keep sounding alarms about inadequate oversight of food and drug safety, research, marketing, and pricing. House appropriators killed the DTC-advertising user fee largely because they don't believe that FDA regulates drug advertising forcefully enough. And they nixed the Reagan-Udall Foundation because of fears it will permit pharma to exert more influence on agency research programs. There are continual complaints about conflicts-of-interest among advisory committee members, which further taints agency advisors.  

Congressional leaders also are unhappy with the Bush administration's continued support for federal preemption of state laws involving drug labeling and regulation. While federal preemption makes sense to anyone marketing a regulated product on a national basis or conducting clinical trials at multiple sites, challenges to state laws, in the current political climate, appear to undermine consumer protections at the local level. And they block lawsuits against the industry. 

Key Democrats in the House and Senate are calling for legislation in response to the recent Supreme Court decision (

) that supports FDA preemption of state medical-product regulation. Although the Justices ruled 8 to 1 that FDA-approved medical devices are protected from personal injury suits at the state level, Democrats insist that such blanket protection was not the intent of Congress. The high court is slated to rule later this year on whether preemption applies similarly to injuries related to drugs, which is less clear under the current statute.  

Federal preemption was a controversial issue in crafting the FDA Amendments Act last year. The issue recently reared up over an FDA proposal to clarify when manufacturers can file changes-being-effected (CBE) supplements to quickly make labeling changes involving new drug-safety information. House and Senate leaders objected that the proposed rule actually would give pharmaceutical companies a rationale for hiding drug safety information and would shield marketers of unsafe products from legal action.  

Meanwhile, states are enacting laws that aim to curb pharmaceutical-marketing activities. The rationale is that reduced spending on drug detailing and advertising will lead to lower drug prices, a fairly tenuous link. California and Vermont want to restrict the ability of drug marketers to access physician-prescribing information. A Maine law undermines detailing.  

Some of these restrictive policies have been challenged as violating free speech rights. But the proliferation of marketing curbs by state governments, academic centers, and hospitals, as well as continued proposals from Congress, is prompting industry to weigh the need for stronger self-regulation of marketing and advertising activities. PhRMA (Pharmaceutical Research and Manufacturers of America) established a voluntary DTC code of conduct two years ago, but it's fairly toothless. The code encourages FDA review of planned ads and discourages airing suggestive ads during early prime time.  

But there's not much uptake on the suggestion to delay DTC advertising of newly approved drugs, and there's no enforcement mechanism or disclosure of consumer complaints. With Democrats on Capitol Hill and on the campaign trail promising to cut drug costs through tougher price negotiations, drug importing, and curbs on marketing, any pharma misstep is sure to make headlines and draw accusations of public harm and fraud. 

's Washington correspondent. She can be reached at 

Washington Report

Congress is firing plenty of ammunition at pharma companies-and the regulators

Open Season on FDA

When I was a kid, one of the high points of the Sunday funnies was Al Capp's 

a unique brew of social satire, old-fashioned hick humor, and PG-level cheesecake drawing, set in the backwoods hamlet of Dogpatch, USA. A recurrent character in the strip was a mournful little guy named Joe Btfsplk. Joe was a jinx. Whenever he arrived, trailing his own personal rain cloud, disaster was sure to follow. 

These days, the pharma industry seems to be trailing its own cloud, and it's playing Btfsplk for almost everyone it's associated with. Doctors are under fire for allegedly selling their souls  

for pharma-bought lunches and tchotchkes. Medical journals, in several embarrassing instances, have been forced to denounce articles that have passed their own peer-review systems, because of a supposed pervasive pharma influence. Medical education providers seem close to being told that their business is simply untenable—that no education paid for by pharma could possibly be objective, no matter how elaborate the firewalls and protections. 

And then there's FDA. You remember FDA—it's that quivering lump of submissiveness in your hip pocket that takes your money, does your bidding, and tries to injure as many Americans as possible in a given year...or so they say. 

At a time when you need friends, collaborators, objective judges, and regulators with the muscle to make their decisions stick, virtually all the institutions that you rely on are under the pharma jinx. Sure, everyone (except perhaps the 

 Chuck Grassley, and Steve Nissen) knows you're not the world's sole cause of failure, confusion, and faulty data. But let's face it: Every time you show up at the picnic, clouds start to gather. 

For pharma to function, it needs a whole network of individuals and institutions whose words and actions command trust. Without them—FDA, the journals, individual prescribers, and others—the only alternative is the sort of regulation by mass tort that we've been sliding into in recent years.  

The current call for transparency will help, I suppose. But recent events suggest that the industry needs to go further, toward a culture of setting and maintaining the standards of drug safety and efficacy on its own, as if there was no one to vouch for a drug or a company but the company itself. 

I'm sure that many in the industry would claim to be operating that way already. But I'm not so sure. Think of the recent brouhaha over Chinese-manufactured heparin. Should FDA have inspected the plant where the suspect product was manufactured? Of course. But should Baxter have relied on FDA as its defense against defective product? Absolutely not. Should FDA have caught the recently revealed errors in Paxil's safety data? (You can read about it at the Pharm Exec Blog, at 

.) Yes. But we all know how thin FDA is stretched. By submitting faulty data, GSK set FDA up to fail. And that hurts the whole industry.  

At the hearings over Avandia, numerous members of the FDA Advisory Committee complained that the data did not tell them what they needed to know. Their decision, to an outsider, looks more like a guess than an assessment. Can GSK really afford that? Can any of us? 

The idea of FDA as a hurdle to be crossed is deep-seated. It's going to take a lot to change to a mode of action that protects this vital resource. But come on, pharma is an industry of miracle workers. Surely it knows enough to come in out of the rain. 

From the Editor

For pharma to function, it needs a whole network that commands trust. The only alternative is the sort of regulation by mass tort that we've been sliding into in recent years

Come in Out of the Rain

Ask anyone in pharma if the media's scrutiny of the industry is lessening, and he would most likely answer with a vehement "no." But new research shows that it is—ever so slightly—even as major issues such as drug safety dominate the headlines.  

You might ask yourself, How is that possible? Here's how: First off, there's less media coverage. Compared with 2006, the number of articles written about the pharmaceutical industry in 2007 has been halved. At the same time, many publications have softened their stance, as witnessed through a near doubling of the percentage of articles that positively report on the industry and its positions. 

But let's not get ahead of ourselves too quickly: Bad news about the industry continues to command much of the news flow, and keeping an eye on just how the media report on pharma—and how that coverage compares with previous years—remains essential knowledge for executives. 

To help the industry keep up, the Arrupe Center for Business Ethics at Saint Joseph's University conducts an Annual Press Audit to identify the issues that attract media attention. This audit, now in its fourth year, uncovered some important findings:  

 Media coverage of the industry has dropped 46 percent, with fewer articles in every major newspaper. 

Coverage was still more negative than positive, but less so than in the past.  

Drug safety continues to be the hot-button issue and was included in half of all media coverage. 

Media focus on FDA and regulatory issues continues to intensify, with the number of articles jumping from obscurity in 2005 to number two on the list of most-frequently-covered issues in 2007. 

This press audit analyzed content from the top-five US newspapers as defined by circulation: 

. The audit shed light on the following questions:  

What ethical and legal controversies face the pharmaceutical industry—and what kinds of coverage do they attract? 

Does the media support or oppose positions taken by pharma? 

How often is the industry's perspective included? 

Which pharmaceutical companies and brands are identified and discussed?  

To be included in the audit and our EthicsTrak database, an article had to be published between October 1, 2006, and September 30, 2007. It also had to (a) focus on an ethical or legal issue facing pharma and (b) appear either as a front-page story or on the editorial page—an indication of major news and public sentiment. We focused on daily newspapers rather than the broadcast media or weekly magazines for a number of reasons. Dailies can cover a broader range of issues and in more depth than the sound bites reported on radio and TV. Business and news magazines are also constrained by their weekly and monthly format. Further, newspapers provide editorial coverage that takes a specific and unambiguous position—pro or con—toward industry issues.  

For each article, we examined four elements: 

 We categorized the issues (as defined by PhRMA) that were discussed in each article. Many articles covered two or more issues and were included in relevant sections. 

 We categorized the headlines as positive, negative, or neutral toward pharma. For example, "Is Your Doctor Tied to Drugmakers?" (

, June 2, 2007) was classified as a negative headline, while "Yes, New Drugs Saves Lives," (

 We also analyzed each complete article to determine whether it took a positive, negative, or neutral position toward the industry. For example, any article that called for restrictions or a prohibition on DTC advertising—a position that the industry opposes—was deemed negative. In contrast, an article that claimed that DTC advertising resulted in more informed patients was designated as positive. 

 Despite the dominant position taken by the article, we also looked to see if it included the opposing viewpoint. When an explicit statement with an opposing view was included—even if it didn't receive equal coverage—we concluded that the article covered both sides. When the opposing view was not presented, the article was labeled as one-sided. 

There was a drastic drop in news ink on the industry in 2007, compared with the previous year. (See "Pharma Steps Out of the Spotlight," .) In 2007, 147 articles reported or editorialized on issues facing pharma. That compares with the 271 and 270 articles that ran in 2005 and 2006, respectively. (However, there was more coverage of the industry in 2007 than in 2004, when this audit began.) Since media coverage tends to be negative, the drop off in terms of number of articles is perhaps good news for the industry.  

Coverage of pharma decreased across the board in the five major newspapers. (See "Clipping Service," .) The 

 had the largest drop, running 60 percent fewer stories in 2007 than it had in 2006. While the number of front-page pharma stories was down, there was an even bigger change inside the West Coast paper: The number of editorials dropped from 36 in 2006 to 8 in 2007. The 

 also saw a significant drop in editorials: It ran 64 articles on pharma issues in 2006 and only 22 in 2007.  

For the articles that did run, what did they cover? Here's what the audit of the four factors revealed: 

 The issue of drug safety leapt into full public view in 2005, in the aftermath of the Vioxx recall. Since then, it remains the top-reported issue affecting the industry and has become increasingly prominent in the nation's conciousness. Indeed, while the number of articles on this topic had only a marginal uptick, from 73 in 2006 to 76 in 2007, the proportion of stories on drug safety leapfrogged from 27 percent of all articles in 2006 to more than half (52 percent) in 2007.  

 It's hardly a surprise that drug prices continue to be a sensitive issue. However, what is surprising is that, in terms of coverage, it was a distant second to drug safety, with only 37 mentions. While out-of-pocket drug prices continue to be an issue for the patient/consumer, that concern is trumped by drug safety. 

 The topic of FDA and regulatory affairs had the most remarkable change, catapulting from the middle of the pack last year to tie for second place (from 15 articles in 2006 to 37 in 2007). Some of these articles discussed the FDA Revitalization Act that "would give the Food and Drug Administration new power to police drug safety, order changes in drug labels, regulate advertising, and restrict the use and distribution of medicines found to pose serious risks to consumers" (

 Another significant change was the re-emergence of articles on research and development, jumping back up to seventh on the list from its rank of 12th last year. This is generally good news for the industry, as these articles tended to present and expand the discussion around the costs and risks of drug research as well as the promise of new drug development. In the study period, there were 16 articles that focused on R&D, nine of which were positive about pharma.  

 Data disclosure, clinical study design, and marketing and sales incentives used in the industry continued to attract attention, ranking four through six on the list. In particular, while there is indication that pharma is managing the sales and marketing issue more effectively through implementation of PhRMA Guidelines (dropped from No. 4 in 2006 to No. 6 in 2007), it is still a source of negative media coverage with 17 mentions this year.  

 Also attracting attention in 2007 is bioterrorism, previously included in the "Other" category. But with 15 articles in 2007, up from 12 in 2006, it is prominent enough to count as a stand-alone issue. Meanwhile, articles on generic drugs and importation/reimportation have faded in prominence since the beginning of the study. 

Certainly, it's no secret that the media coverage of the industry tends to be negative. But what's important to watch is a growing polarization of the reporting. (See "More Good News for Pharma," .) In 2007, there were fewer neutral articles and more negative articles—but there was an increase in the number of positive articles for pharma too.  

To determine the position of the article, we analyzed headlines and the full-text body copy. Here's what we found:  

 In 2007, headlines were mostly negative (52.4 percent), inching up from 51.9 percent of articles holding anti-pharma positions in 2006 and 42.9 percent in 2005. Since headlines can be influential in shaping public perceptions and are often all consumers read or remember from their morning newspaper, these results again represent a challenge to the industry. 

Positive articles double Reversing a trend, 2007 saw an increase in the number of positive articles and editorials for pharma. In fact, the proportion of positive articles almost doubled, from 15.6 percent to 29.3 percent of all articles. This could be due to more balanced reporting. 

 Regardless of whether articles took a primarily positive or negative tone toward the industry, we analyzed whether both sides of the disputed issue are at least acknowledged. Last year, 70.7 percent of articles mentioned both sides, up significantly from 58.5 percent of the articles in 2006. This can stem from a variety of factors on the part of the media or the industry. For example, perhaps industry execs are finally starting to weigh in on the issues of the day. 

This year, we introduced a new analysis into the audit: We tracked pharma companies and drug brands mentioned in newspaper articles. This analysis provided an excellent crosscheck between our findings about the issues and the companies and products responsible for generating media attention related to those issues.  

In the study period, the top-five newspapers mentioned 47 pharma companies. However, reporters focused most attention on 13 firms, which were mentioned five or more times. Leading the pack was Merck, which had 25 mentions on these papers' front and editorial pages. Following closely were GlaxoSmithKline, with 24 mentions, and Eli Lilly, with 16. Not surprisingly, the companies most often mentioned were linked to products most often cited in the news.  

When it comes to Merck, much of the newspaper coverage continues to be driven by the legal battles concerning Vioxx (rofecoxib) and its association with increased risk of cardiovascular events. Other coverage that mentioned Merck surrounded the FDA approval of Gardasil, its vaccine that guards against cervical cancer and genital warts caused by human papillomavirus (HPV). State proposals that would mandate HPV vaccinations of young girls was the focus of many of these pieces. For example, the 

 reported that Virginia Governor Timothy M. Kaine would sign a bill that required shots for all sixth-grade girls unless their parents object to the inoculation (March 9, 2007). 

Safety issues and news of adverse events drove other coverage of companies and brands. GlaxoSmithKline, for example, had 24 mentions, stemming mostly from the risk of heart problems associated with its diabetes blockbuster Avandia (rosiglitazone)—and Avandia-combination drugs Avandamet (rosiglitazone maleate/metformin) and Avandaryl (rosiglitazone maleate/glimepiride).  

Eli Lilly came in a distant third, with 16 mentions. Eleven of these articles stemmed from its antipsychotic medicine Zyprexa (olanzapine), for the treatment of schizophrenia and bipolar disorder. Coverage was driven by the link between Zyprexa and drug-induced diabetes experienced by thousands of patients taking the medication.  

Due in part to remnants from Vioxx, Avandia, and Zyprexa, drug safety is once again the number-one issue attracting media attention. If drug safety is viewed more broadly—the way clinical studies are designed, the way data are reported, and how those data are reviewed by FDA—the focus on drug safety is even more pronounced (FDA would rank as the subject of 37 articles; data disclosure, 22; clinical study design, 21). Combined with the 76 times drug safety was identified as an issue, the mentions serve to reaffirm the importance of the drug safety issue in the eyes of the media—and the public.  

Even a comprehensive, well-designed study cannot anticipate all possible negative coverage. In order to address this, pharma needs to manage the things it can control—particularly clinical study design and data disclosure. This becomes even more evident when one considers the cases of Vytorin (ezetimbe/simvastatin) and Trasylol (aprontinin). 

Pharma gets less ink as news reporters shift their sights to other topics? That's a good thing--Isn't it?

4th Annual Press Audit: Coverage Uncovered!

A new study comparing the prevalence of different diseases in the United States and Europe has not received the media coverage it deserves. The paper by Kenneth Thorpe, David Howard, and Katya Galactionova, published online by 

 (October 2, 2007), concluded that "disease prevalence rates...for 10 of the most costly conditions...for the noninstitutionalized population age 50 and older...are much higher in the United States than in these [10] European countries." 

Sick Americans by the Numbers: Eight of 10 common diseases are more prevalent in noninstitutionalized Americans age 50 and up than among those in Austria, Denmark, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, and Switzerland 

This conclusion was based on Organization for Economic Co-operation and Development data (see chart, 

). These findings are consistent with another piece of research published in 

Journal of the American Medical Association

 (May 3, 2006) by James Banks, Michael Marmot, Zoe Oldfield, and James Smith that compared both self-reported illnesses and biological markers of disease among non-Hispanic whites age 55 to 64 in England and the United States. They concluded that "based on self-reported illnesses and 

 [my italics] of disease, US residents are much less healthy than their English counterparts and these differences exist at all points of the SES (socioeconomic status) distribution."  

These dramatic findings trigger the obvious question: Why are the numbers so much higher here? One attractive hypothesis is that Americans are merely more likely to be diagnosed with diseases because of the more aggressive testing in this country.  

However, this hypothesis could at best explain only part of the difference. The use of biological markers in the US/England study confirmed that these differences are real, not just based on different patterns of diagnosis. Furthermore, the fact that the United States has fallen in international rankings of life expectancy from No. 11 to No. 42 over 20 years strongly suggests that Americans really are less healthy than people in most other affluent countries. 

Other factors mentioned by the authors are differences in obesity, lifestyles, health insurance, childhood experiences, and income inequality.  

My favorite hypothesis—based on the work of Michael Marmot and others, but barely hinted at in these papers—is stress. Having lived and worked on both sides of the Atlantic, it would not surprise me if Americans were substantially more stressed than Europeans. Americans work longer hours, have fewer vacation days, have a weaker safety net, and have greater income inequality than Europeans. There is growing evidence that stress can weaken the immune system and increase the likelihood of many diseases.  

It will probably take years to understand this issue. Meanwhile, both teams of researchers conclude that we need—guess what?—to do more research. 

 is chairman of the Harris Poll, Harris Interactive. He can be reached at 

Column

Americans take top spots in disease prevalence

Are We Less Healthy Than Europeans?

The SafeRx Act, legislation that requires licensure of pharmaceutical sales representatives in Washington, DC, is the latest in what looks to be a long line of efforts to regulate interactions between industry sales reps and physicians. Legislators in Maine, New Hampshire, and Vermont also are eyeing the relationship, proposing legislation that would further restrict pharmaceutical sales-and-marketing activities. 

This movement is increasingly organized and has what appears to be a growing number of supporters. No Free Lunch, a not-for-profit organization of healthcare providers, recently made headlines by urging medical students to resist the free pizza offered by drug companies. A health system in Duluth, MN, reported ridding its offices of 20 shopping carts of promotional items from pharmaceutical representatives and shipping them off to Africa. The Massachusetts Prescription Reform Coalition—a newly formed alliance that includes the AARP, the American Heart and Stroke Associations, as well as insurers such as BlueCross BlueShield of Massachusetts and Neighborhood Health Plan—announced its intention to work to eliminate the "inappropriate marketing practices" it says are driving up the cost of healthcare. The Prescription Project, an effort funded by the Pew Charitable Trust, has similar goals. 

Some groups advocate eliminating the pharmaceutical sales call altogether, and stories abound of healthcare systems that have banned or severely restricted sales representative visits to physicians—not to mention individual physicians who have decided they will no longer see reps in their offices or clinics. These and other efforts create the impression that more and more of today's practicing physicians and other providers see no value in any aspect of the pharmaceutical industry's marketing efforts and want nothing to do with sales representatives. But is that perception accurate? Do physicians really want to do away with the sales call by pharmaceutical representatives?  

To find out, CMR Institute decided to go to the source—physicians and industry representatives—and ask them about their experiences. What we found is that most physicians we surveyed do value sales representatives—if they are well informed, have something new to say, and have a well-rounded body of knowledge that goes beyond the specific attributes of the products they sell. Based on our preliminary research, CMR concluded that more education, not regulation, is the key to improving perceptions of the pharmaceutical industry and, most importantly, adding value to the quality of patient care. 

CMR Institute conducted a series of focus groups with primary care physicians and specialists across the country, as well as a quantitative online survey, in which doctors were asked what qualities were most important in a sales representative. When asked, fewer than 10 percent said they do not see sales representatives.  

Our research suggests that physicians do value pharmaceutical representatives whose knowledge goes well beyond familiarity with a particular product. Yet, bringing representatives to a knowledge level where they are confidently conversant in all these areas requires a real commitment from pharmaceutical companies and their sales teams. 

A standard already exists in Europe: Sales representatives have to meet strict corporate-responsibility standards set forth by the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA—the voice of 2,100 research-based European pharmaceutical companies—is committed to patient care and quality-of-life issues, with strong emphasis on research and development of new medicines. Its Codes of Practice, which all representatives must follow, regulate marketing tactics and require sales representatives to have "adequate training and sufficient scientific knowledge."  

To deal with the current onslaught of criticism against the industry in the United States, it is time to think about proactive steps to mitigate criticism and convince outsiders and providers that there is real value in the information exchange between clinicians and representatives. Industry leaders need to work with those in education and medicine—and also with critics—to quickly develop a voluntary educational standard. This will ensure that industry sales representatives who call on physicians to communicate information about their companies' products are ethical, well educated, and knowledgeable—exactly what our research shows physicians want. The industry should be proactive and lead through voluntary self-regulation and education rather than be legislated at the local, state, or federal level. A voluntary industry-wide learning standard would improve physician and sales representative interactions and demonstrate the value that quality education can lend to quality healthcare.  

With the increasing regulation of the industry, legislative requirements could quickly become a bureaucratic nightmare, creating an environment in which each pharmaceutical company would need to make certain that its sales representatives adhere to the myriad standards and guidelines in different states or even municipalities. How would these regulations advance patient care? 

We're at a critical juncture in the way the pharma industry sells and markets its products. We must act now and with a very real sense of urgency. We must find ways to demonstrate to the public and to providers the valuable role that the industry and its R&D activities play in improving the health and longevity of our nation's citizens. By increasing education and setting voluntary industry-wide standards, the industry can show its commitment to professionalism while ensuring that sales reps go beyond marketing to enhance the quality of patient care.  

 is president of the CMR Institute. He can be reached at 

New research points to the power of a highly educated sales force, supporting the case for a voluntary educational standard

Education Trumps Regulation

All truly great advertising is memorable—that's a given. It can also be smart, daring, beautiful, arresting, provocative, or all of the above. However, too often in pharma, ads play it safe, and in the process, miss the opportunity to communicate or inspire action.

There is a lot of excellent work out there. And for our fourth annual Ad Stars, the Pharm Exec staff looked through a year's worth of ads to find it. We were searching for ads that made us stop and think, provided real education, reflected the needs of patients, educated in a material way, and were a good use of the medium. We were open-minded: We value creativity, effectiveness, emotional connection, branding, patient and physician insight—and you'll find ads that reflect each of these components in the following pages.

Of course, it's not just the ads that need to be celebrated, but rather the people behind the ads—the smart and innovative agency folk, the strong clients who allowed the creative teams to take risks, or simply the execs who executed according to a well-developed plan. They are our Ad Stars.

Concentric Pharma Advertising for Bayer's Betaseron

Digitas Health for AstraZeneca's Arimidex

Euro RSCG Life Metamax NY for Biogen Idec and Elan's Tysabri

Harrison and Star for Roche and Genentech's Avastin

Heartbeat Digital for Organon and Schering-Plough's NuvaRing

Juice Pharma Advertising for Merck's Gardasil

MicroMass Communications for Shire's Fosrenol

Regan Campbell Ward-McCann for ProEthic's Lipofen

Pharm Exec shines the spotlight on the creative innovators behind the best pharmaceutical ads of 2007

Ad Stars 2008

Eighty percent of clinical trials are delayed. If that number doesn't scare you, it should. After all, if pharma can't roll out its research studies, then it can't produce tomorrow's drugs. 

Kathleen Drennan, Iris Global Clinical Trial Solutions			

Clinical trials often derail because of the failure to recruit qualified patients. Kathleen Drennan, head of Iris Global Clinical Trial Solutions, which specializes in patient recruitment, knows this well. "These 'rescue trials' come to us when companies have spent their budget, tried everything they could, and still, they can't fulfill patient enrollment," she says. 

Instead, companies should quit wasting their time and get strategic when it comes to mapping out their study strategy. Here, Drennan sits down with 

There are better drugs already on the market and fewer drug-naïve patients. But does that explain the massive delays in filling the industry's clinical trials?  

One of the more overlooked problems is that companies still rely on the individual investigators to recruit and educate patients 

 conduct the trial. In the old days, doctors could draw on patients in their practice. But today there are fewer big practices, so they have to go outside their offices to find patients. For instance, one investigator could run 10 studies for atrial fibrillation in cardiovascular disease. He's not going to have all those patients in his own practice, so he has to recruit—which means working with the media and doing grassroots efforts in the community. And guess what? The majority of docs don't do such a hot job. That's why studies are delayed.  

Of course, compounding the problem is the distrust of pharma. Patients confuse a lot of the issues, and largely because of drug prices, anything pharma companies sponsor they tend to be more distrustful of. 

Pharma hasn't really taken the gauntlet when it comes to clinical trials. Most people still think of it as testing on guinea pigs. Although patients can get information in newspapers or direct mail or on the Internet, they really get their information when something terrible happens and it hits the mass media. The industry doesn't do any type of major education initiative, so that's all patients know. 

First, they must put something into clinical trials that's been left out—strategy.   

Pharma companies must quit wasting money and get strategic when mapping out their clinical study strategies

Pharmaceutical Executive-03-01-2008

Salesforce Roundtable

Fire and NICE

Open Season on FDA

Come in Out of the Rain

4th Annual Press Audit: Coverage Uncovered!

Are We Less Healthy Than Europeans?

Education Trumps Regulation

Ad Stars 2008

Study Rescue

Earning the Public Trust—and Keeping It

In Praise of Independence: Q&A with Roche's Dan Zabrowski

The New Name of the Game: Adherence

Watch that Reputation

e-Pedigree to the Next Degree