Mike Faden

The fast-changing nature of the Internet continually opens new opportunities for communicating with consumers and physicians. It also brings new regulatory challenges, as the FDA struggles to keep up—and pharmaceutical companies try to take advantage of technology without falling foul of the rules. 

Currently, the spotlight is on two technology areas: paid search; and the rapidly growing technologies collectively known as social media, including, most prominently, Facebook and Twitter. 

Within the Internet realm, the two could hardly be more different: paid search is an extremely established advertising technique used throughout the pharmaceutical industry, while social media represent uncharted territory in which the primary concern is how to participate in sites that could include user-generated content containing adverse event reports (AERs), negative comments about brands, and discussions of off-label uses.

	Both areas were extensively covered—with a huge amount of comment and discussion&mdash;in FDA hearings last November. The hearings were designed to gather input on five issues related to promotion via the Internet and social media: fair balance on the internet; industry responsibility for content posted on social media and other websites; posting corrective information; the use of links; and adverse event reporting. 

Following the hearings, FDA’s DDMAC is currently working on updated guidance expected to cover at least some of these issues, and widely anticipated in draft form this year—though FDA won’t confirm the date. The guidance is expected to be technology-independent, to ensure it doesn’t quickly become worthless. “Given how fast the technology is evolving, DDMAC does not want to issue guidance that may become quickly outdated,” an FDA spokesperson says. “DDMAC continues to plan its focus for guidance in this area on concepts that have long-term applicability … rather than on a particular venue or tool.” It is possible that DDMAC may develop multiple draft guidance documents related to Internet and social media promotion of FDA-regulated medical products, she says. 

The DDMAC guidance won’t cover AER reporting based on information generated on Internet and social media sites, an area of huge concern among pharmaceutical companies: The lead role in that area falls to CDER Office of Surveillance and Epidemiology. FDA says only that it is considering whether to issue future guidance in this area. 

To put all this in perspective, pharmaceutical promotional spending on the Internet still accounts for only a tiny fraction of the industry’s total promotional expenditure, according to data from The Nielsen Company (New York)—though it is growing fast. For example, in 2009 spending on online direct-to-consumer display ads surged by almost a third in 2009 to about $117M, but still represented less than 4% of the amount that pharmaceutical companies spent on TV DTC ads. 

	The story of paid search provides a curious illustration of FDA’s difficulty in regulating Internet-based promotion. In April 2009, the agency fired off warning letters to 14 pharmaceutical companies that were using the so-called—but non-existent&mdash;“one-click rule.” Using this approach, sponsored search results on the link took typically included both the drug’s brand name and its indication, along with a link. To view the risk information, users needed to click on the link, which led them to a brand site where the risk information was displayed. FDA‘s letters said that this approach violated the requirement for fair balance between risk and benefit information. 

Two proposals presented at the November FDA hearings offered modified one-click approaches that attempted to address the need for fair balance. Google proposed including brief drug-specific risk information along with the drug’s indication on the search results page, with separate links to additional product and risk information; PhRMA proposed a generic “all drugs have risks” statement on the results page, together with an “FDA-approved” symbol to indicate that it refers to approved products and information (see Fig. 2). 

The warning letters had a significant effect, but perhaps not the one that was intended. Initially, the industry’s use of paid search dropped sharply. However, companies quickly adopted two new approaches to staying compliant. In one, the drug’s name isn’t mentioned in the sponsored search link: The link appears to be an unbranded disease state site, but this is merely a “vanity URL” that redirects to the brand website. The other approach mentions the drug’s name but not the indication. 

Experts say the new approaches have two disadvantages: they are less effective for industry, and more misleading for consumers. At the hearing, Google presented data showing that users click on these links less frequently. ComScore (Reston, VA) VP John Mangano agrees that the use of vanity URLS has drawbacks. “It allows you to ultimately follow the rules as they are understood today,” he says. “That said, I’m not sure it is the clearest for the consumer, because they don’t know where they are going until they get there.” 

FDA appeared, at the hearing, to get the message, says John Kamp, executive director of the Coalition for Healthcare Communication. “I think that the agency understood some pretty compelling evidence that their enforcement wasn’t achieving what they wanted it to achieve. There were fewer patients learning about side effects after the warning letters than before—which is not what FDA intended.” 

After the initial drop off, the industry’s use of paid search has rebounded, says comScore’s Mangano, though in general pharmaceutical companies are not buying search terms as aggressively as before. For some brands, paid search is generating almost as much traffic to the brand website as before the warning letters, according to comScore data. 

	As the use of social media has exploded—according to Nielsen data, Facebook is now among the top three most-visited websites&mdash;so has its value as a method for exchanging healthcare information. For example, at health-information sites such as WebMD and HealthCentral, users engage in lively discussions of their experiences with regulated drugs, frequently discussing off-label uses and side effects. 

It’s the presence of this user-generated content that has caused pharmaceutical companies to be fearful of social media, and correspondingly slow to get involved. There are several concerns; the most frequently cited is the fear of being held responsible for unearthing and reporting AERs mentioned on social-media sites. 

The industry’s activity now appears to be increasing rapidly. Jonathan Richman, director of strategic planning for ad agency Bridge Worldwide (Cincinnati), maintains a list of pharma and health-related social media activities at the Doseofdigital.com website. He says the number of social media sites listed has grown at least five-fold over the past year, with most of the growth taking place in the last six to nine months. The list spans everything from pharma-owned unbranded disease-management websites and blogs to industry-contributed content on Facebook, YouTube, and Twitter. 

The growth is a little misleading, because pharmaceutical companies are in general still carefully restricting their efforts to efforts where they are less likely to encounter regulatory issues. Typical examples are unbranded disease-management information sites operated either as standalone websites or on Facebook, YouTube or other major social-media sites. “Because they are unbranded, they don’t need to worry as much about adverse event reporting and fair balance,” says Melissa Wells, who heads the healthcare group at Nielsen Online. 

Often, the ability to provide user-generated comments is disabled, so the sites are “really not true social media,” she adds. Where comments are allowed, the sites almost invariably screen or “pre-moderate” them to filter out potential problems. An example of the possible problems—and pharmaceutical companies’ reaction&mdash;occurred on Sanofi-Aventis’ Voices Facebook page, which accepted comments until a reader repeatedly complained of side effects, after which the ability to comment was removed and a disclaimer added. 

Meanwhile, pharmaceutical companies have generally avoided directly taking part in social media conversations that they don’t control. For example, as noted by FDA in its announcement of last year’s hearings, pharmaceutical companies have avoided posting corrective information, because of fears that they could be held responsible for all the content on the sites. As a result, while social-media discussions may include inaccurate information about drug uses and side-effects posted by just about anyone, the manufacturers are not able to respond with accurate approved content. 

The effect of this was highlighted by WEGO Health (Boston), a patient community site that, for the FDA hearings, surveyed the “patient activists” that run its discussion groups. “They were saying that pharmaceutical companies are largely absent, and that it’s a glaring hole,” says WEGO CEO Jack Barrette, “As a result of their absence, due to antiquated regulations, we’re not getting good information. But by no means are we saying let’s lift the regulations—pharmaceutical companies need to watch for misinformation and correct it, and they need to follow regulations for adverse event reporting very closely.” 

At some sites, pharmaceutical manufacturers also have held back from placing ads within discussions, where they could appear next to adverse events or off-label discussions, even though the companies advertise elsewhere on the site. “In actual discussions—where people are talking to each other or answering each other’s questions&mdash;by and large, there is no branded pharma advertising,” says Jeremy Shane, HealthCentral president and chief operating officer. “All publishers are looking for clarity from the FDA.” 

However, Barrette says that a lack of advertising is largely due to other concerns. “There’s no question that pharmaceutical companies are very concerned with user-generated content—but that’s mostly because of the concern of negative adjacency&mdash;it’s mostly more of a brand issue than a regulatory issue. I see that going away very quickly&mdash;many large companies are beginning to change their position.” 

	Still, if the most-cited social media concern is adverse-event reporting, and one key aspect of this is how much of the Internet a pharma company is supposed to be monitoring to detect these events. “What is your responsibility to monitor all these conversations whether you are advertising or not? That is by no means clear, I believe, in the minds of pharmaceutical companies or regulators,” Barrette says. 

Existing draft guidance states that companies should review Internet sites that they sponsor; they are not responsible for reviewing sites they don’t sponsor. One concern is what constitutes sponsorship; one specific proposal presented by HealthCentral’s CEO Chris Schroeder suggested that merely advertising on a page should not, in itself, constitute sponsorship; and that the definition of sponsorship should be limited to specific circumstances, such as those in which a pharmaceutical company owns or has editorial control or influence over the content of the web page. 

If pharmaceutical companies are ultimately determined to responsible for monitoring vast areas of the Internet for adverse events, how much work would it take? One often-cited analysis, by Richman and former Nielsen analyst Melissa Davies, concluded that only 1 in 500 posts contain enough information to meet all four criteria required for a reportable event: an identifiable patient, an identifiable reporter, a specific drug or biologic involved in the event, and an adverse event. Even across nearly 1,400 health-related web sources tracked by Nielsen, this would result in only about 166 AEs per day for the entire pharmaceutical industry. However, notes Nielsen’s Wells, some companies use a more conservative approach when assessing whether an AE should be reported — they may require fewer than four criteria, which could greatly increase the number of reports. 

Amid the current confusion over social media, some see at least of glimmer of hope that—if clear guidance emerges that facilitates two-way communication with consumers&mdash;social media could present a way for the pharmaceutical industry to rebuild the public’s trust in the industry. “So much of the industry’s reputation is based on the inability to communicate because of regulations,” says Barrette. “I believe transparently communicating through social media is the pharmaceutical industry’s last best hope to rebuild its reputation with consumers.” 

Indeed, the pharmaceutical industry took a positive step in its approach to last year’s hearing, says Richard Minoff, managing partner of 1 Global Partners (King of Prussia, PA), an industry consulting firm. “It seems logical that the FDA, and pharma naysayers, would be pleased with the responsibility industry has shown by asking for a clear set of rules and regulations designed to ensure appropriateness,” he says. “This should not be an adversarial situation, but rather a unique collaborative opportunity. Is this really possible? Based on history, I’d say no.” PC 

Articles

Healthcare discussions are booming on the Internet. How will FDA allow pharma to participate?

Pharma, FDA Wrestle with Social Media Tools

	One is the big-pharma consolidation that is causing some reshuffling of the animal-health industry. Merck, to fend off anti-trust concerns over its purchase of Schering-Plough, agreed to sell its half of animal-health company Merial to co-owner Sanofi-Aventis. In addition, Pfizer, whose animal-health unit is the industry’s largest, is acquiring Wyeth, which includes the Fort Dodge Animal Health unit, and may need to shed some animal-health products to gain regulatory clearance. “The big players are still consumed by this,” says Jill Sackman, senior consultant at Numerof & Associates, Inc. (St Louis).

In late September, to win FTC approval, Pfizer and Wyeth agreed to sell about half of the Fort Dodge business, and part of Pfizer’s animal-health business, to Boehringer Ingelheim. Terms were not disclosed. 

The other, more enduring trend is the increased willingness by consumers to spend more on their pets—the so-called “companion animal” sector&mdash;which is making this area of animal health look at least somewhat recession-proof. “Pets used to sleep in the back yard&mdash;now they sleep in your bed at night,” says John Ryan, VP of marketing at veterinary products distributor MWI Veterinary Supply in Meridian, ID. “People might not be going on expensive vacations, but pets are regarded as members of family, and not something they see as discretionary spending.” 

As a result, pharmaceutical sales for pets have remained relatively strong. Long term, the worldwide market for pharmaceuticals for food or “production” animals such as cattle and pigs — traditionally the core of the animal-health market&mdash;is expected to remain strong too, but currently US farmers are being badly hit by the recession and other factors. As a result, US sales to this sector are suffering, says Ron Brakke, of animal-health management consulting firm Brakke Consulting, Inc. in Dallas, TX. “The fastest growing part of the industry is companion animal. Things have slowed a bit&mdash;but in general we still expect growth in companion animal this year. In food animal, we don’t.” 

The cycle driving increased companion-animal sales goes something like this. Pets are living longer because owners take better care of them, and as a result develop more age-related conditions ranging from cancer to arthritis, says David Lummis, author of the recent 

 report, “The US Market for Pet Medications.” As pets live longer, owners develop an even stronger emotional attachment and become even more likely to spend money on medications that further prolong or enhance the pet’s life rather than euthanizing the animal. 

As a result, the market, traditionally dominated by the production animal sector, has shifted steadily towards pets. According to the International Federation for Animal Health (IFAH) Worldwide, companion animals accounted for about 41% of the industry’s revenues in 2008; the share in the US, which is leading the pet-meds trend, is generally estimated to be higher. Lummis thinks US retail sales of pet medications grew 11% to about $5 billion in 2007, and that more than half of US pet market revenues are directly healthcare-related. 

One aspect of this growth is the continuing “humanization” of the pet pharmaceuticals market. Though the biggest-selling products are still anti-flea treatments such as Merial’s Frontline—the first animal health blockbuster with more than $1 billion in sales&mdash;and Bayer Animal Health’s Advantage, pharmaceutical companies are intensively developing products for many therapeutic categories that are familiar from the human side. 

“We are looking to areas where there is a medical need, and people are willing to help their animals and pay for treatment—and when you talk about cancer, that can be pretty significant,” says Ernst Heinen, VP of research and development at Bayer Animal Health in Kansas City, MO. 

Because the global animal-health market is tiny, compared with the human pharmaceuticals market, it’s tough for the animal-health units of pharmaceutical companies to fund the research of new drugs from scratch; instead, they often seek to take advantage of work already undertaken by their parent company for the human pharmaceutical market. “It is very rarely that can animal health do afford the expensive exercise of finding and developing molecules,” Heinen says. “We look for molecules from the human side; we are looking for closely related molecules—mostly not identical, but where we have a good base dataset.” Heinen declined to elaborate on specific plans, but noted that that veterinary medicine now includes many of the specialist areas that exist in human medicine, focusing on age-related problems such as cardiovascular disease, diabetes, and other metabolic disorders as well as cancer. 

	The industry is also focusing on new formulations more acceptable to animals, such as flavored and chewable tablets, he says. Other areas seen as promising within the industry include so-called “lifestyle” drugs, including anti-obesity products: “I think the whole industry is working on it, but there has been no breakthrough so far,” Heinen says. It’s a difficult problem, he says: “You need to have very safe drug that does the job—and normally people also need to change behavior, how they feed the animals.” 

Cancer drugs represent one of the newest categories to emerge. This year, Pfizer received FDA approval for Palladia, the first animal-specific targeted cancer therapy approved in the USA. Palladia is aimed at mast cell tumors, a common cancer in dogs, and is in the same class—tyrosine kinase inhibitors&mdash;as Pfizer’s human drug Sutent. Pricing hasn’t been set yet. 

Another company working in this area is AB Science, which plans to introduce its own tyrosine kinase inhibitor drug (masitinib) in the US; the product has already been approved in Europe. “We’ve been talking for over two decades about bringing this type of sophisticated high-powered therapy to veterinary medicine,” says Albert Ahn, president of US operations at AB Science in Short Hills, NJ. “We want to build a portfolio that will be available for vets as they treat cancers, and moving forward other diseases that have proven very difficult to treat or manage.” Examples of such conditions include the skin condition atopic dermatitis, he says. 

Other categories are already very well established; over the past decade millions of arthritic pets have been treated with a growing number of nonsteroidal anti-inflamatory drugs (NSAIDs) such as Pfizer’s Rimadyl, Novartis’ Deramaxx and Merial’s Previcox. “There’s an emphasis on palliative care, with a reliance on pain management, that one would not have imagined 10 to 20 years ago,” says analyst Lummis. 

Less clear is the success to date of lifestyle drugs, the best known of which is Pfizer’s Slentrol weight-management drug for dogs launched in 2007, for which Pfizer’s publicity efforts included a consumer-education website to raise awareness of canine obesity. It’s widely accepted that there are millions of overweight dogs in the country. Pfizer also has a product, Cerenia, designed to prevent motion sickness in dogs. Then there’s Eli Lilly’s Reconcile, which is fluoxetine (Prozac) packaged and sold for separation anxiety —a dog’s reaction when its owner leaves it alone in the house all day. 

Lifestyle drugs remain a somewhat controversial area. “Do we really need pharmaceuticals to help our pets lose weight or should we just be feeding them less, giving better-quality food, or more exercise?” Lummis says. “Personally, I wouldn’t expect to see those kinds of products flying off the shelves that quickly.” 

Consultant Brakke is more blunt about his perception of Slentrol and Reconcile: “I would say neither introduction has been very successful,” he said. “Pfizer spent a lot of money on Slentrol and missed their target dramatically for what they expected to sell.” 

Pfizer Animal Health spokesman Rick Goulart says one issue has been the uncomfortable discussion of obesity that the vet needs to have with the pet owner. “We’ve found typically there is a little bit of hesitancy on the part of the caregiver to embrace the notion that his or her dog is at an unhealthy weight ,” he says. Pfizer stresses that Slentrol is not designed to replace good diet or exercise. “What it does is to help the caregiver bring the dog down to a healthy weight by suppressing appetite, then they are able to move off the drug into a healthier diet and exercise program,” Goulart says. 

	Lifestyle drugs aside, the generally strong pet medications market is a far cry from the current challenges in the US production animal sector. Though growing worldwide demand for meat is expected to sustain market growth in the long term, the recession has hit US farmers hard, reducing demand for some meat products from both domestic consumers and other countries. Dairy producers have been also been hurt by historically low milk prices that have caused big reductions in dairy herds, and pig producers have faced a slump in sales. All of this has reduced demand in the US for pharmaceuticals, Brakke says. 

Another area of potential change is that of antibiotics supplied as continuous feed additives to enhance growth. The practice has already been banned in the EU, and there have been various proposals to ban US use too. Brakke says US use has already dropped dramatically over the past 10 years. As Bayer’s Heinen notes, products for farm animals must be acceptable to humans too: “It’s not only that you need a safe and efficacious product—it also needs to meet the hurdle of public opinion,” he says. 

One category that is generally well accepted by the public—and is growing rapidly for both farm animals and pets&mdash;is vaccines. According to the IFAH, worldwide sales of biologicals, a category that includes vaccines, grew faster than any other in 2008, surging more than 13% to reach $4.7 billion. In contrast, sales of feed additives grew just 2.6%. Recent introductions include the first canine influenza virus, from Intervet/Schering-Plough Animal Health. 

For the global farm-animal pharmaceuticals market, the long-term picture may be much more promising. Emerging markets are expected to drive much of the growth, just as with human pharmaceuticals. The IFAH expects global demand for animal protein to rise by 50% by 2020, as the world’s population grows, and more households in emerging economies reach middle-class status and consume more meat; those middle-class consumers are also likely to spend more on their pets. PC 

BOX: UNIVERSAL HEALTHCARE INSURANCE FOR PETS—NOT 

Pet industry hasn’t given up on establishing owner insurance

Only a tiny fraction of US pet owners take out insurance; in a recent owner survey from the American Pet Products Assn., only about 3% of dogs and 1% of cats were covered by insurance. 

However, there are signs of change. The market has long been dominated by Veterinary Pet Insurance, which Packaged Facts analyst David Lummis estimates still has more than 60% of the market. But half a dozen or more new companies have entered the market in recent years, and the market grew more than 20% in 2007 to reach $248 million, according to a report published by Packaged Facts last year. 

Each of these new companies is focusing on direct-to-consumer marketing, and for the first time pet insurance is being sold under nationally known pet care brands. For example, consumers can now buy PurinaCare, from the Nestle SA pet-food subsidiary; the ASPCA is offering insurance for cats and dogs, in a plan administered by the Hartville Group; and the American Kennel Club also offers a plan. 

A key factor driving the new interest is the rising cost of veterinary care, plus the fact that owners are more willing to buy that care for their pets. Most plans cover pharmaceuticals, so insurance could make it easier for owners to buy some of the more advanced drugs emerging into the market. These newer entrants tend to resemble scaled-down versions of human health-insurance plans, and to emphasize their simple structure, often applying the same 10-30% copay rates for all services up to an annual or lifetime limit. PC 

With sales of human pharmaceuticals languishing, several factors are focusing increased attention on animal health products, once a little-noticed industry niche market

Industry Mergers Reshuffle Animal-Health Leadership

	Like many other parts of the pharmaceutical sales process, sampling is under some duress these days. Access to physicians’ offices is being restricted at many locations; legislators are looking more closely at any exchange of value between the industry and physicians; and in academic circles, there is talk of the presumed impropriety of any type of sampling at all.

Nevertheless, sampling is generally considered one of the most effective methods for pharmaceutical marketing, and a key factor in reps’ access to doctors. Survey data from IMS Health estimated that sampling was worth around $16 billion at mid-decade (based on retail value of the samples), which would represent nearly half of the overall marketing budget for the industry. And while some physicians may be critical of the practice, it is undeniable that samples provide a way for both physicians and patients to gain experience in new drugs, and to accelerate the education of both parties in the newest treatment alternatives. 

The question, then, is what to do? For a number of years, marketing service providers to the pharma industry have provided voucher programs that can act as an alternative to direct sampling. Various forms of “tele-sampling” and online sampling have been offered. Initial industry reaction has been muted, but these alternatives are getting a new look as more physicians become comfortable with e-detailing and other online resources. 

Physicians’ use of the internet continues to expand, making e-sampling a natural extension of physicians’ online activities. Also, pharmaceutical companies have been overcoming their unease about accepting orders online—one factor that contributed to the initial slow adoption of e-sampling, which has been around for more than five years. 

“I think you’re seeing more uptake, especially among large pharmaceutical companies, because everyone’s looking at the most cost-effective way to distribute samples,” says Bill Buzzeo, VP and GM, compliance solutions at Cegedim Dendrite (South Bedminster, NJ). Even so, he says, e-sampling is just one more technique available alongside more traditional low-cost methods such as faxing or mailing sample requests. “This is just an additional option—to gain access to practitioners by another method.” 

Rick Keefer, president of Publicis Selling Solutions (Lawrenceville, NJ) can view sampling from both the traditional rep-driven perspective as well as the various e-alternatives. Publicis Selling is part of a larger group (Publicis Strategic Solutions) that includes a call-center-driven service company (Arista Marketing Associates) and a sample-delivery service (Pharmagistics). “In today’s environment, pharma companies have to do everything—live sampling, e-sampling, vouchers and other fulfillment systems,” he says. “One size doesn’t fit all situations.” He notes that restricted visiting by reps is not new&mdash;it has flared up at various times in the past&mdash;and the problems of reduced selling staffs and vacant territory coverage are now affecting sales campaigns. 

Publicis recently won a contract with a manufacturer to provide multi-product, “multichannel” physician access through its Arista unit. It will deploy live phone calls, live, Web-enabled video detailing (see Pharmaceutical Commerce, April, p. 17), e-mail, direct mail, fax-on-demand and sample and literature fulfillment. 

	Market data are hard to come by, but research by SDI Health (Plymouth Meeting, PA), as part of the company’s 2008 ePromotions study suggests many physicians are already using e-sampling to a limited extent—though reps still account for the bulk of samples distributed. In an online survey of 1050 physicians, SDI asked whether the doctors utilized cost-saving measures including sampling. SDI received 2031 responses, indicating that many of the physicians use multiple methods; online ordering of samples was mentioned 341 times, while requesting samples from reps was mentioned 887 times&mdash;more than twice as often. Of those physicians ordering samples online, 59% said they get less than 10% of their samples by that route, according to Elizabeth Bond, Product Manager- Promotion Solutions at SDI. 

The key attraction of e-sampling is cost. Including sample delivery, e-sampling usually is 1/6 to 1/10 of cost of a rep visit, says Cecil Kost, president and CEO of MedManage Systems Inc., the most established of the e-sampling suppliers. MedManage was acquired last year by Physicians Interactive, a company that operates a website offering a number of services to physicians. 

MedManage offers what Kost describes as a sample utility service. Pharmaceutical companies determine which physicians should receive samples of specific brands, and in what quantity. MedManage stores that information in its physician database and tracks the sample orders. Physicians access the service via portals such as Physicians’ Interactive and the Thomson Reuters Physicians Desk Reference website PDR.net ; they perceive the service as a virtual sample closet containing samples from multiple suppliers. 

After authenticating the physician’s identity, Medmanage passes the sample orders to warehouses that actually ship the samples. “Everything that we do presents to the prescriber a personalized sample closet based on a set of business rules determined by the pharmaceutical company,” says Kost. “It’s brand-specific, pharma-rule-driven—which is important because it ensures pharmaceutical companies utilize e-sampling in a way that is complementary to other marketing tactics and channels.” Kost claims that most of the top 15 pharma companies use the service for at least one brand. 

Ryan Luce, director of product management for Physicians Desk Reference, says PDR.net has seen the e-sampling service grow rapidly. “The number of physicians using this service has increased significantly over the past year and a half,” he says. “Some of this stems from our increased focus on the e-sampling service, but it also stems from general trends in physician behavior. Increasingly, physicians are turning to online tools to help them in their workflow. Additionally, pharmaceutical companies are finding it increasingly difficult to visit physicians in person.” 

There’s no single agreed definition of e-sampling, but most offerings have common elements. Physicians’ participation typically starts with an invitation to participate in an email or other communication from the pharmaceutical company. 

Physicians may order samples using a fully electronic process that requires the physician to enter an electronic signature—a combination of identifying information and password&mdash;for authentication. Systems providing this capability must be validated to show they meet the electronic signature requirements specified in Title 21 CFR Part 11, a process that can take several months. There Cegedim Dendrite’s Buzzeo says pharmaceutical companies were initially hesitant to use electronic signatures: “Some of the slow adoption has been based on the pharmaceutical companies, and I think it was around the uncertainty of using a true electronic signature to request a sample,” he says. 

Some suppliers also include in the definition of e-sampling various hybrid paper-electronic approaches that are easier to implement, such as allowing physicians to print vouchers on demand or mailing paper vouchers in response to online requests. An even more basic approach is to publish an online form that physicians print and fax. 

With all these methods, the order typically finds its way to a warehouse that, as with any sample-ordering system, must once again verify the physician is a legitimate prescriber before shipping the samples. 

The duty of validating electronic signatures has been looked on as a burdensome, problematic task by pharma marketers, according to several sources, but the trend is clearly in going in this direction. One significant shortcoming of paper-based techniques is that the paper itself becomes a problematic form of data storage; the same logic that is being applied to electronic medical records in the healthcare arena applies here. 

Some companies that offer warehousing and sample-management services—and already have systems in place to ship samples to reps, and to physicians using more traditional methods such as faxes to request samples&mdash;are directly implementing their own e-sampling systems. An example is Knipper & Co. (Lakewood, NJ). Michael Laferrera, SVP, sales and marketing, says the company’s e-sampling business has grown considerably since it because available about two years ago; the company now has just under 10 pharmaceutical companies using the system, most of them small to medium-sized. “Some of that [increase] is out of necessity,” he says. “There are a lot less sales reps than there were a year ago.” 

He says e-sampling, like other alternative sampling request methods, is used to cover territories temporarily left vacant when reps leave the company; and to cover territories that are too large, with doctors too far apart to justify rep visits. In addition, some customers use alternative methods for OTC products that are too weighty, in volume, for reps to lug around. 

E-sampling can also be used as a low-cost method for products that are nearer the end of their product lifecycle, says Kelly Gratz, president inVentiv Interactive Group. However, she says that pharmaceutical companies still want the flexibility to offer additional alternative methods, such as business reply cards. Inventiv offers a range of pharmaceutical services including warehousing and e-sampling. Though e-sampling is growing, “we don’t see a wholesale shift,” adds Steve Gornto, COO at another inVentiv company, PRS/Franklin Group. 

The growth is attributed partly to demand from doctors, who are conducting more and more of their interactions with pharma online. That’s driving a trend to combine e-sampling with other services such as e-detailing. SDI’s 2008 ePromotions study asked physicians which follow-up activities they were most likely to do after completing an e-promotional activity such as an e-detail; 54% said they were most likely to request samples. 

Aptilon, a software company in Montreal, is one company that has added e-sampling to its suite of e-detailing and other services. Mark Gleason, SVP, corporate development, says the company recently licensed its software to Triple i, a pharmaceutical

	services company that is part of MediMedia (Chatham, NJ). E-sampling can become part of an online physician-rep interaction, Gleason says. For example rep may perform an online video detailing session that includes opening up an online sample ordering form, which is subsequently faxed. 

Another example of this trend is Physician Interactive’s acquisition of MedManage. PI offers a portal with a growing range information and services aimed to provide physicians with more reasons to use the site—and keep using it over time. “What keeps me up at night is, ‘How do we keep physicians coming back.’” says Donato Tramuto, CEO and vice chairman of PI in Libertyville, IL. His goal is to continue to build out this “digital mall,” to include other online information and services that physicians traditionally received in other ways. “Whatever physicians receive in person, we are going to do through online channels.” 

In the final analysis, the communication channels to reach physicians are not dictated by what new technologies provide, but by what the “customer base”—physicians&mdash;want to tap into. “Physicians are getting their educational info in many ways: they will continue to see reps, they are getting more comfortable with the Internet,” says Publicis’ Keefer. “As an industry, we will have to meet our customer demands.” PC 

BOX:  TEACHING HOSPITALS CAST A CRITICAL EYE AT SAMPLING

Experimental program in Pittsburgh shows limited success

The clinical settings that are most uncomfortable with current sampling practices seem to be academic teaching hospitals. In April, Johns Hopkins adopted a policy that limits rep-physician interactions (banning gifts and food) and plans to ban free samples in 2010. In January, the University of Iowa instituted a ban on physicians dispensing free samples to patients (which would appear to make the samples unavailable to the physicians themselves). In February, a conflict-of-interest task force of the University of Wisconsin system recommended a ban on nearly all physician samples. A database at the Institute of Medicine (imapny.org) lists many types of conflict-of-interest policies; in June, 34 centers, nearly all of them teaching hospitals, listed restricted sampling, although the majority of these prohibitions were to prevent physicians or their families from making use of free samples. 

Another indication of the mood within parts of the medical community is an Institute of Medicine report issued early this year, which suggested that “free samples may contribute to inappropriate prescribing practices … and increased drug costs,” and recommended that medical centers should “limit use of drug samples to patients who lack financial access to medications.” 

However, one closely watched alternative approach, at the University of Pittsburgh Medical Center recognizes the value of samples—and uses e-sampling as a way to deliver them. Last year, the center adopted a policy that noted that while sampling has been shown to boost sales, it also “provides invaluable assistance to some patients to quickly begin a course of treatment or to determine which therapeutic option is most beneficial for that patient.” 

The center decided to continue to allow reps to visit physicians, by appointment only—but in an effort to focus these visits on education, did not allow them to hand out samples. Instead, it provided a new application, known as the eSample Center, based on the service from MedManage Systems. The application allows physicians to order available samples, vouchers, and coupons via a Web-based system accessible through UPMC’s intranet. The center made this system the exclusive mechanism for physicians to obtain samples as of April this year. 

According to a UPMC spokesperson, by early June—more than six months after the system began operating&mdash;131 physicians had registered to use the system, and only 46 had placed orders. That’s a fraction of the approximately 2,700 physicians employed at UPMC, although the spokesperson says at least half of those physicians were not providing samples even before the new policy took effect. PC 

While storm clouds gather over pharma sales activities, marketers look to e-sampling as a potential alternative

Interest Grows in Handling Physicians' Samples Electronically

	It is rapidly becoming a cliché that pharma sales forces must change their traditional practices. Sales forces are being reduced by the thousands; practitioners are putting more and more limits on face time with reps; the sales process is becoming more complex with formulary design and related managed-care issues, yet more constrained through new state laws and the PhRMA promotional code of ethics.

It would be nice to say that an evolving IT tool, closed-loop marketing, is riding to the rescue. But the results so far have been mixed. No one is rejecting CLM outright, but the sense among industry sources is that it will need to be applied more intelligently.

	By using PC-based technology to capture every interaction with a physician during a detail, CLM promises to let marketing groups analyze physician preferences and the most effective sales tactics, then use this information to deliver personalized content that closely matches physicians’ interests— “closing the loop” and ultimately boosting prescriptions. 

Most of the products marketed as CLM (also known as Closed Loop Promotion, or CLP) began—and often are still primarily used&mdash;as e-detailing software that typically runs on tablet PCs. The software displays and manages visual aids such as presentations, reprints, and even animations. As it does so, it captures the interactions between reps and physicians by recording which items are viewed and for how long. 

In theory, to start closing the loop, the software transfers the data from the tablet to a back-end system for analysis. Through integration with the company’s customer-relationship management system (CRM) and data sources such as records of prescribing behavior, the data captured during details can be correlated with other information to pick out trends. As a result, marketing groups can better understand what works for each physician or different groups of physicians, and adjust e-detailing content accordingly. The tablet-based software can manage large amounts of content that can be navigated in different ways; it may suggest the most effective content based on the information that has been built up about the physician. 

That’s the theory, but many feel that the practice has been a different story. Starting more than five years ago, a surge in pharma interest and vendor activity—Proscape Technologies is generally recognized as the pioneer&mdash;helped put tablets in the hands of thousands of reps, and generated many e-detailing and CLM pilots. Merck & Co. and AstraZeneca are among the companies named as Proscape customers that have widely deployed tablets to the sales force. 

However, often deployments never made the leap from e-detailing to CLM, or from pilot to production. One reason was that pharmaceutical companies simply did not analyze and act on the vast amounts of data generated from e-details. “My skepticism is that people have not effectively closed the loop,” says Dale Hagemeyer, a research VP at Gartner Inc. “I’m not aware of many companies that have collected data and usefully used it. I’m a believer, but somebody needs to go and close the loop.” Indeed, he says, in at least some cases, pharmaceutical firms purchased the software, used it simply as a “show-and-tell delivery platform, then said ‘I think I can do this myself rather than paying these companies a bunch of money.’” 

Simply converting paper-based materials to e-details “doesn’t fundamentally change the relationship with the physician. The value you get from it is not great,” says Matt Wallach, executive VP at Veeva (formerly, Verticals onDemand), a CRM software-as-a-service supplier. Because the industry did not effectively analyze the data generated from tablets, it was not able to analyze the ROI delivered by the technology, he says. “So basically what you had was a plague of pilots. They never got beyond pilot because they could not prove ROI, and they could not prove ROI because they did not use the data.” 

	Now, some say they believe this situation is changing—not least because the pharma industry itself recognizes that it needs to change. Implementing true CLM far more is challenging than simply providing tablets to the sales force, says Chris Colapietro, VP of strategy and marketing at HighPoint Solutions, an integrator in King of Prussia, PA that has worked on CLM projects for several pharmaceutical industry clients. “It’s more about change than technology,” he adds. He believes implementation involves at least seven key stakeholders: Sales, sales operations, marketing, market research and analysis, training, legal and regulatory, and information technology. “It’s like herding cats,” he says.

	Five years ago, there wasn’t much incentive to make that change, because the industry was doing just fine with the traditional reach-and-frequency sales model. Now, the picture is very different, as sales forces are slashed, more doctors refuse to see reps, and the industry’s image has slumped. These and other pressures could be the catalysts needed to drive change, Colapietro argues. 

There’s evidence that takeup is increasing, including data from TGaS Advisors, a benchmarking and advisory firm whose clients include 30 of the top 50 pharma companies. In a 2008 survey of 28 companies (Fig. 2), seven (25%) said they were engaged in full closed-loop promotion—more than double the percentage in 2007. An additional eight companies (29%) said they were doing digital detailing in 2008 — about the same percentage as in 2007. Another, smaller TGaS study last year found that three of 11 companies had implemented CLM, with a fourth company at the pilot stage; another six were evaluating the technology or specific vendors. 

One factor is that more vendors have entered the market and begun to gain traction with pharma companies. The most commonly mentioned are Skura Corp., whose software is being used for production sales force deployments by companies including Boehringer Ingelheim and a Johnson & Johnson unit; Exploria SPS, which has software in use at Wyeth and announced a contract with Pfizer this year; and Agnitio A/S from Denmark. Software giant Oracle, which now owns the Siebel customer-relationship management software used by many pharmaceutical companies, also announced e-detailing software last year. To date, though, the market is still small; Hagemeyer estimates that the combined CLM software revenues of the main suppliers currently total only about $25 million, with Proscape still the largest. 

The suppliers of CLM and e-detailing products claim several specific benefits from the technology. Derek Pollock, president, Proscape Life Sciences, says that pharmaceutical companies have found that e-detailing can save money by replacing paper sales aids; this “eliminates printing, costs associated with updates, and redundancy associated with multiple copies in multiple countries.” Proscape says that one customer is saving $8 million a year by doing this. 

However, others suggest that it is not so easy to eliminate paper and cut costs that way. TGaS Advisors describes this as a “myth,” saying that anecdotal feedback from customers who have widely deployed CLM is that they have not seen a material decrease in their expenses for printing, warehousing and distribution of print materials. Some reasons are that reps still like to have paper materials as a backup, and that some prescribers prefer to see materials in printed form or at least want a printed copy. 

Pollock says a second benefit is the ability to deliver different messages to different customers, based on profiles of those customers. And the third is to gain insight into what is actually happening during the physician interaction; using the tablet-based software as a “flight data recorder” instead of relying solely on reps to record information about each call in the CRM system. 

“One of challenges is making the data actionable,” Pollock admits. For example, aligning data from Proscape with records of prescribing data can be challenging. “It’s harder than you think, because globally there are multiple providers and different levels of detail available.” Pollock says Proscape is working to bring out a tool to make this analysis easier, particularly for smaller pharmaceutical companies. 

This ability to analyze and act on the data is, of course, at the heart of CLM. Skura is one company that emphasizes the analysis capabilities of its product and the resulting “predictive modeling,” a term that has become commonly used. “You take the results of what have captured from a tablet pc or a clickstream on a website and run it through advanced algorithms to determine what’s working and what’s not with specific customers,” says Jeff Wessinger, Skura’s president. Then, when the rep is going through an e-detail, Skura’s software “suggests the assets that will work best in priority order, based on everything we know about the physician and others like him.” 

Wessinger suggests that this automatically customized e-detailing is particularly relevant to the pharmaceutical industry. Reps may make 8-10 calls a day, leaving them little time to manually customize content for each physician. When visiting a clinic, they may not even know exactly who they will run into. 

Another of the more recently established suppliers is Exploria, which emphasizes its content management technology. “The number one thing about Exploria is the built-in rules, policies and permissions system,” says Richie Bavasso, Exploria SPS president. Regulatory groups like the controls that this system enforces, he says. “For example, the person building content only has permission to share with brand and legal, and cannot distribute it.” 

	Bavasso, like others, also notes that tablets are not the best tool for all selling situations. The widely cited 90-second average detail duration doesn’t give a rep much time to pull out a tablet and start displaying an e-detail. In fact, in situations such as a rushed hallway encounter with a physician, a tablet may be a deterrent rather than an asset. “We learned that doctors, if they see a rep with tablet, think the tablet is going to take a long time. They tend to run the other way. But for a scheduled 15 minute meeting, the tablet is fantastic — you can store so many assets and get to them so quickly,” Bavasso says. 

A new competitor is Oracle, which not surprisingly emphasizes the integration with Siebel software as a key selling point for its product, called Personalized Content Delivery (PCD). This means PCD is delivered as a module within the Siebel software; when reps synchronize CRM data on their tablet with data on the back-end CRM system, PCD can synchronize at the same time using the same infrastructure, says Rajan Krishnan, VP Product Strategy at Oracle. Data collected by the software also can be analyzed using the existing Siebel analytics platform, he adds. Oracle is piloting PCD with at least four pharmaceutical companies, he says. 

Despite the increased interest from vendors and the pharmaceutical industry, it remains hard to find consistent data showing positive ROI attributable to CLM technology. TGaS Advisors found that pharmaceutical companies believe the top three factors contributing to ROI will be to increased rep productivity, because it takes reps less time to record the call; Rx lift due to better message adherence; and Rx lift due to better responsiveness in the call. 

Proscape cites customer studies that have shown increased call duration and new prescriptions. However, others say that they have observed a variety of results, including some negative ones. One difficulty is isolating whether changes in prescribing are due to CLM or to other factors outside pharma control, such as reimbursement changes. Another is that it can take time—as much as a year&mdash;to accumulate enough e-detail information for analysis. 

TargetRx, a Horsham, PA consulting firm, recently performed an analysis of thousands of details by reps from multiple pharmaceutical companies, comparing the effectiveness of tablet-based and traditional details. Call effectiveness was not statistically significantly better when tablets were used, says TargetRx co-founder Mike Luby, although the data was beginning to trend that way, with some indication of increased call duration. He also said there was much greater variability in effectiveness among tablet-based details, suggesting less consistent execution due to the fact the technology is new and best practices are still being established. 

Luby also noted that current CLM products only measure a small part of the overall world of pharma-physician interactions. “They have done a nice job of branding CLM to their services,” he says. “The problem is that I don’t think this is CLM—it is missing the physician’s attitudinal response, and it’s only looking at a single tactic, a single channel.”

	Vendors are, however, broadening their products to monitor multiple channels. Increasingly, physicians are turning to the Internet for information. Suppliers are seeking to extend their products so the same content that’s digitized for use on a tablet can also be presented over the Web. The interaction with physicians can also be tracked, just as it can with a tablet-based e-detail. For example, the e-detail can be presented in a “co-browsing” session in which rep and physician work through the content online rather than in the doctor’s office, or a self-directed detail that the physician accesses on the pharma company’s website. 

Physician responses captured online could then be used to personalize content delivered by tablet PC on a subsequent visit, and vice versa. Skura’s Wessinger says he also sees the extension of this technology to social networking sites such as LinkedIn and Facebook; for a few dollars, a branded ad can be displayed on a consenting physician’s page; clicking on the ad would direct the physician to an e-detail on the pharma website. “I think social networking will play a big part in the next generation of CLM,” Wessinger says. 

To realize the potential benefits of CLM, though, pharmaceutical companies have to be up to the challenges of implementation. Sales and marketing groups will have to work closely together to collect and analyze data, something that often hasn’t happened, says Veeva’s Wallach. “The industry is in turmoil and cannot continue to do things the same way; sales and marketing have to get into the same room and make this work,” he says. If that happens, “I think we can start to see successful CLM deployment, and CLM could become an important part of the strategy for talking to doctors.” PC 

Among sales-force automation tools, closed-loop marketing is getting attention as a better way to sell