Allergan CEO David Pyott

Allergan CEO David Pyott is bullish on Botox’s potential as a salve for chronic migraine. He’s also betting on a next-gen dihydroergotamine (DHE) – Levadex – from MAP Pharmaceuticals.

It’s hard to know whether migraine sufferers will get behind Botox as a treatment; migraine patients are notoriously allergic to doctor visits, and many go undiagnosed. But for the worst kinds of migraines, particularly those that don’t respond to triptans or currently marketed DHEs, patients will probably be willing to try just about anything. Allergan CEO David Pyott, and MAP Pharmaceuticals CEO Tim Nelson, see headroom for growth in the category.

In 2009, the migraine market slipped into a steady decline after Imitrex, the go-to member of the triptan class, lost its patent (and blockbuster sales). Many of Imitrex’s classmates – Maxalt, Amerge, Zomig, and others – will face generic competition this year, if they aren’t facing it already. That makes Botox for migraine a difficult sell – it’s for chronic migraine, firstly, and it costs exponentially more than generic Imitrex – but during a 4Q earnings call yesterday Pyott said the migraine indication is performing “better than planned.” Around 4,600 physicians have been trained to give the injection, to date, said Pyott. “The vast majority of neurologists will inject for as long as three injection cycles,” even if they’re skeptical about the drug’s efficacy for migraine,” he Pyott. He’s hoping they’ll be convinced after that.

Branded print ads for Botox migraine will launch in women’s magazines this month, and an unbranded disease awareness campaign on television “has worked – the click-through on the website is positive,” said Pyott, adding that Allergan’s internal consumer surveys have shown “a high level of satisfaction” among patients.

After an upfront payment of $60 million last February, MAP Pharmaceuticals scored a $20 million milestone payment last August, when it filed Levadex with FDA. The company could receive up to $97 million more from Allergan if all goes well with the regulatory process; the PDUFA date on Levadex is March 26. Levadex, like Valeant Pharmaceuticals’ Migranal, is a DHE, but Migranal is a nasal spray, while Levadex is inhaled. The benefit with inhalation means that the drug sidesteps first pass metabolism en route to the brain – it avoids the GI tract, and potential dilution. At JP Morgan’s 30^th Annual Healthcare Conference in January, MAP CEO Tim Nelson said that Levadex “works faster, and has fewer side effects, than the triptans.” He added that 29 million scripts for migraine were written in 2008, and close to half of them were written off-label. After triptan, “41 percent of the scripts were for opioids, and 28 percent were anti-depressants,” said Nelson. MAP will hire 50 specialty sales reps if Levadex gets the FDA go-ahead, and will expand the drug into pediatrics and other neurological conditions later on, he said.

Levadex won’t compete directly with Botox for migraine; the former is for acute migraine, the latter for chronic migraine. Nelson said Allergan’s expertise in managed care, reimbursement and experience with FDA, makes it a good partner for Levadex. MAP is also looking for “a partner in Asia, and in ex-US in general,” said Nelson.

At $40 to $80, with a ceiling at $100 per dose, though, Levadex may be as tough a sell as Botox. But then again, migraine sufferers only want one thing when the pain sets in: for it to be gone.

Energy. An active lifestyle. Mental and emotional stability. Absence of disease. Nutrition. These are some of the words and phrases that the public used to define “health” in the 2011 Edelman Health Barometer, released in October.

“What does it mean to be healthy?” Edelman posed this open-ended question to 15,000 respondents in 12 countries and captured, verbatim, the public response. “The public is redefining ‘healthy’ as ‘How I act, what action I can take, and what actions I do take,’ rather than just ‘how I am,’” explains Nancy Mensch Turett, global chair, Health, at Edelman. And increasingly, the barometer found, this less frequently means people’s perceptions of the environment and their dealings with the healthcare system, and more often their own lifestyle and nutrition choices. “And when we asked people who influences their health—their lifestyle and nutrition—the most, second only to themselves were family and friends.”

The implications of such a statement are far-reaching. It means that regardless what standards of health or beauty we see in Hollywood, which hot new fitness personality bombards us with ads, or even how many times our doctor tells us we should really drop a few pounds, what’s really going to influence our behavior and help spread the habits that make good health communicable is each other.

“We believe there is no such thing as a non-communicable disease,” says Turett. “All diseases are communicable, whether through viruses, bacteria, behavior, or a combination of these things. A key to the future well-being of the healthcare industry, but even more importantly to society, is to understand the communicable nature of all health.” For example, the barometer found that 31 percent of respondents will spend less time with a friend because of the friend’s unhealthy behavior. Additionally, according to study results, the idea of influencing one’s peers and driving communicable good health is a bigger motivator for maintaining one’s own healthy habits than personal gain—41 percent of respondents listed “realizing that the long-term health benefit of another person would improve” as their primary trigger of action in personal health advocacy. Another 28 percent listed their primary trigger as “making a personal commitment to help others.”

Turett compares being healthy to being “green” in that, like environmental consciousness, “the sustainability of our species depends on it.” Health is “the most personal of public issues and the most public of personal issues,” she says, and so “people are very attuned to brands’ and companies’ engagement in health. And from the standpoint of the pharmaceutical industry and the healthcare industry more broadly, this means that because your business is actually a social issue—one that people feel so personally and strongly about, and is such a big public issue from an economic and societal viewpoint—people in the business of health need to attend to the social as well as the business impact of their actions.”

Much like the “green” movement, the public in fact expects government, corporations, and healthcare stakeholders to be a positive influence. And despite the bad rep we sometimes believe pharma has earned for focusing only on the bottom line, the truth is, pharma is in fact a trusted authority whose input the public values—and expects—when it comes to health issues. “In our first study we saw that the public craves engagement from the brands and companies that are involved in health,” she confirms. “The public feels that being active in health is actually an imperative for businesses across the board. People are basically saying, if you want to be relevant to me and really make a difference in my health, you need to support lifestyle and nutrition. You can’t just come to me through other channels like the healthcare system.”

This year’s health barometer confirmed those findings, showing that all businesses are expected to engage with their employees and the public as a whole on health issues, through avenues such as education communications, public policy, philanthropy, partnerships, and innovation centered on spreading and encouraging healthy behaviors.

When you consider the heavy influence of peers on health today, the digital world can no longer be overlooked. Online health communities of peers—groups of patients with the same diseases and health conditions commiserating and collaborating together—are undoubtedly part of the peer influence in today’s “health 2.0” environment. And those in this multimedia space also agree that pharma has a rightful place at the table when it comes to making good health communicable. “Patients in these online communities are not cynical of pharma for the most part. I think this almost conventional wisdom that patients are skeptical or cynical of pharma companies—I don’t see that,” says Brian Loew, CEO of Inspire, which partners with nonprofit organizations to create and host online support communities for patients and caregivers in specific therapeutic areas. “You don’t see patients looking for bad guys and conspiracy theorists. You see patients who are saying, ‘I’m really grateful that I have these treatments. I’m trying to fine-tune it, I’m trying to find out what the best treatment is,’ but they’re incredibly appreciative of the therapeutic drugs that they are taking. And they overwhelmingly don’t have animosity towards the companies. I’d love it if we could debunk some of that, because I think people feel good about pharma companies.”

Catie Coman, director of communications at the National Psoriasis Foundation (NPF)—which has partnered with Inspire for a patient online community called TalkPsoriasis—agrees. “Patients look to the pharma companies and their websites for authoritative information. So, if I want to learn everything possible about what’s on the label for a psoriasis treatment, for example, I go to the manufacturer’s website. I think they look to pharma information as valuable reference material, at least based on what we see.”

Indeed, in a new study—ePharma Consumer 2011—released by pharmaceutical and healthcare market research company Manhattan Research, 42 percent of online consumers agree that pharmaceutical companies should be involved in online health communities for consumers. The study, of 6,643 U.S. residents ages 18 and over, also found that 39 percent of online U.S. adults visit pharma prescription drug websites, and 35 percent visit pharma corporate websites. Clearly, the messages pharma chooses to send matter, and in fact consumers are looking for more, not less, input from pharma. “We asked online consumers about their use of and interest in various types of online information and tools from pharma companies. The results revealed that there is considerable unmet demand for disease management support (online tools or information to help manage a condition) and consult preparation (guide or tools to help prepare for a discussion with a doctor),” Manhattan Research told Pharm Exec.

“Pharmaceutical marketers and communicators who are looking to really create communities of health, and to support not only the healing but also the prevention of unnecessary progression of disease, really should be looking at the social unit and not just the individual,” says Turett.

In 2011, the patient’s clout as a stakeholder was firmly established, as reflected in several industry conferences. What’s next for the patient in 2012?

In 2011, many healthcare organizations came around to the idea that patients should be included in discussions that had customarily taken place about them, but without their direct participation. This shift was evident at several healthcare conferences last year, and bodes well for 2012 as a year when further overtures – and partnerships – will be formed with and between patients.

Health2.0

The Health2.0 conference in San Francisco brought a deluge of innovation and shiny, new healthcare applications. Data plus IT and innovation represent the future of healthcare, and individual patients are a critical component of this equation (not just their data). This was a key theme of the Health2.0 conference. “Patient stories” have often been highlighted at conferences, and used as bookends to infuse a dose of reality to educational sessions.  What impressed me about the Health2.0 conference was the inclusion of patients and caregivers in the conversations, allowing for bi-directional exchange. Patients2.0, an offshoot of Health2.0, is a movement that aims to revolutionize healthcare delivery around the patients. The goal is to leverage the Health2.0 phenomenon and develop a hub for patients to exchange experiences through peer-to-peer networks, to obtain information, and most importantly, to have a collective voice in healthcare decision-making. By sharing stories, co-creating health data, and aggregating issues across the healthcare spectrum, the voices of Patients2.0 are empowered to be part of the larger conversation, and to exert influence on the health system by shaping future policy. Patients are the new healthcare disruption that can help transform the landscape, and using forums such as Health2.0 to involve them every step of the way is truly ahead of the curve.

Epatient Connections

The key theme at the Epatient Connections, held in Philadelphia, was that “Healthcare is Social.” Physician, medical and patient communities are forming connections through various social media channels, but there are a still a few less progressive entities a step behind as they figure out how to navigate uncharted regulatory waters. As connections are made, patients are becoming further engaged in their care as they learn from what others are doing. The key is to take those connections one-step further and bridge the various pockets of connection. There needs to be further inter-connectivity between patient voices, scientific publications, medical results and records, and medical education geared towards healthcare professionals, and these need to set the stage for a longitudinal data set. Patient engagement tools that were showcased included everything from health management tools to game-ification that integrated feedback mechanisms and incentives to an Internet enabled robotic telepresence, allowing immobile patients to interact with their healthcare community.

SXSH Unconference

The SXSH Unconference also took place in Philadelphia (Sharing, Exchanging, Social Health). Todd Park, CTO, US Department of Health & Human Services opened up the conference with an introduction to the Data Liberation initiative: New Incentives+ Information Liberation= Rocket Fuel for Innovation. Medicare, Medicaid, and the Veteran’s Administration represent the largest repository of public health data in the world. Patient data liquidity and information about the public health, stripped of personal identification, is being made available so that innovators can use it to create health-maximizing options.

2012

2011 was a year where a foundation for the “patient voice” was established as a critical component of the healthcare system. 2012 will be an even more important year, as healthcare organizations empower more patients by personalizing communications for individual patients. Patients are often overwhelmed with the amount of information they must retain to successfully manage their health. How will healthcare organizations come together to simplify navigation of the healthcare system? How will different healthcare systems, records and applications that serve different purposes connect with one another to prevent redundancy? How will patient stories be further synthesized and culminated into “patient issues” that a roundtable of healthcare sectors can further troubleshoot at future conferences? If 2011 was the year of dipping toes in the waters of “patient engagement” …2012 should be the year of swimming alongside others towards a unified goal—a year of patient engagement through an open network of inter-connectivity.

Sarah Krüg is CEO/executive director of CANCER101, a patient outreach and advocacy organization. She is also president-elect of The Society for Participatory Medicine.

In response to off-label inquiries about a drug, biopharma companies can use the kind of boilerplate they’ve been inserting on social media sites for years – thanks for your comment, here’s our contact information, call us for more information – but they cannot address the question publicly, where it appears, a privilege many hoped would be included in FDA’s long-promised and long-awaited social media guidelines. Companies must also include a “mechanism for providing readily accessible current FDA-required labeling,” but cannot include a link to anything that could be construed as promotional, like a “product website, product promotional materials, firm websites, or third-party websites.” Guidance on responding to unsolicited requests for off-label information was published in the Federal Register a few days before the end of 2011.

Responding to an unsolicited off-label question/comment is only appropriate when a specific brand is named, and if the question is “broad in nature,” drug companies should “appropriately narrow the question.” FDA recognizes the fact that companies are “capable of responding to requests about their own products in a truthful, non-misleading, and accurate manner,” and that companies probably know more about their own products than other self-appointed responders:

It can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are made in public forums, especially since other responders may not provide or have access to the most accurate and up-to-date medical product information.

Unlike other forum responders, who can comment publicly in response to any question, manufacturers must wait for the original commenter to respond to the boilerplate message with contact information, before providing “any substantive communication about off-label uses for the product, in response to the original unsolicited off-label question,” and that communication must occur “solely between the firm and the individual who made the request…the firm should not make its detailed response with off-label information publicly available within the same forum.”

FDA’s guidance on industries’ social media interaction with patients, at least with respect to off-label inquiries, seems to be: Don’t participate publicly. According to the guidance document, this sentiment reflects a concern that publicly posted off-label information – in response to an unsolicited query – would be available for an indefinite period of time, and would also reach the eyes of readers who have not requested such information. Even if the drug information is accurate when it’s posted, it may not be accurate next month. For viewers who didn’t ask about an off-label use, but are still party to a public response, the information itself, regardless of its scientific merit, “may promote a product for a use or condition for which FDA has not approved or cleared.”

Those companies that would like to respond to an individual with a question, assuming that person has called or emailed the company in response to the provision of contact information – contact info that leads to a firm’s medical or scientific department, not a marketing department, the guidance clearly states – should include the following materials, according to the document:

• FDA—required drug label
• A prominent statement saying the product has not been FDA approved
• A prominent statement disclosing approved indications, if any
• A prominent statement of all important safety info, including box warnings, if any
• A complete list of references for all of the information disseminated in the response (firms should use peer-reviewed articles whenever possible)

Companies should also maintain the following records about off-label responses:

• The nature of the request for information, including the name, address and affiliation of the requestor
• Records regarding the information provided to the requestor
• Any follow-up inquires or questions from the requestor

The guidance is open for comment for 90 days. Here’s the Federal Register entry.

Pharmaceutical manufacturing in the US is in rapid decline. Higher regulatory standards for efficacy and safety, among other reasons, have led to a significant level of difficulty in replacing “blockbusters” developed in the 1980s and 1990s that are now coming off patent. The rapid growth in biological understanding remains a source for current and future drugs, but has also raised the bar on selectivity and toxicology expectations. Industry is also grappling with issues of quality and compliance in manufacturing. There are also fundamental reasons why pharmaceutical manufacturing has lagged behind other high-tech industries. Every product is a different molecule, with different characteristics, method of manufacture, analytical methodology, stability characteristics, and so forth. Most pharmaceutical products involve powder processing, which is—at best—a partially understood field. As a result, for every product, the entire product-development process is developed from scratch.

In contrast, other large-scale manufacturing industries such as petrochemicals, automobile, and microelectronics, deal with a much smaller number of materials and use processes that are better understood. The products and manufacturing methods evolve and improve with time because one can build on what was done before.

New divisions of players
Industry faces a pressing conundrum: how to manage the quality and compliance of pharmaceutical manufacturing, which has lagged behind other industries even in the best of times, during a period of cost-cutting and fragmentation, with a myriad of manufacturers of various degrees of sophistication in a variety of countries and cultures. At the same time, our country seeks to increase manufacturing as a percentage of the US economy as a means of remaining competitive as a nation. We propose here that these two imperatives are related and can be managed in an integrated fashion.

It is useful to separate pharmaceutical manufacturing, both primary and secondary, into two groups: those operations that have become conventional and essentially commoditized, which are now being executed around the globe, and which are unlikely to return to the US; and those operations which relate to novel, “smart” products and processes that are knowledge-intensive, have IP protections, and are less sensitive to labor costs.

In the case of the first group, commoditized manufacturing, quality and regulatory compliance remain crucial. Indeed, quality compliance has become more challenging in the outsourced-manufacturing environment because it now must be managed across many more intercompany barriers. Fortunately, a solution has been demonstrated in the chemical industry. The answer is to make manufacturing technology mature, transparent, and portable. The operations involved must be categorized and described in detail, making it possible to harmonize methods, approaches, operations, control algorithms, and quality tests, such that the operations can be understood fundamentally, modeled mathematically, and then executed under predictive-model controls as is done by other high-tech industries.
The later group of “smart” products and processes involve targeted drugs and delivery systems, personalized medicine, medicines prepared locally on demand, complex hybrid biologics, sensors, and new diagnostics. These technologies are enormously promising, but they require long-term fundamental research to create new products, new manufacturing methods, and new technologies.

A plan forward

Given this environment, re-energizing pharmaceutical manufacturing in the US is likely to take place only if a coherent plan is implemented. Such a plan must address four crucial elements: strong long-term technology development, a nurturing ecosystem where collaborations among innovation players are facilitated while transactional costs between them are minimized, science-based compliance with high quality standards, and a concerted effort to create and maintain a highly skilled labor pool capable of supplying the needs of industry, government, and academia. Thus, we propose a strategy involving the following components:
1. Create a long-term, strategically driven research center, bringing industry, academia, and government together.

2. Develop a well-funded, agile innovation ecosystem where technology customers (i.e., finished goods commercialization companies) and technology suppliers (e.g., NME suppliers, equipment and instrumentation companies, CROs, CMOs, commercial integrators, and universities) can work together effectively, with access to funding, and with minimal transactional overhead.

3. Establish a regulatory science center that can provide scientific support to the FDA and to ensure that regulations are updated, transparent, and promote higher quality standards while decreasing regulatory risk.

4. Enable training and educational programs that ensure a supply of properly skilled labor for all of the noted parties. To rejuvenate pharmaceutical product and process development and manufacturing in the US, an entire generation of pharmaceutical scientists (and their management) must be educated, or in some cases, re-educated on modern product and process engineering methodologies.

This approach is entirely feasible. One of the few silver linings of the recent massive restructuring in US-based branded pharma is that there is a ready supply of available scientists eagerly awaiting the opportunity to upgrade their technical skills. It is hard to conceive a better use of educational resources than to devote them to this purpose.

A plan such as the one proposed here will not happen spontaneously. It will take time and effort. It will take leadership and aggressive advocacy. However, if we consider the alternative, which is to let yet another great American industry leave our shores, the path forward appears self-evident.

To advance these goals, the authors plan to organize a Summit Meeting at Rutgers University in Spring 2012 to gather input from all sectors and to develop concrete plans. We call all leaders in the pharmaceutical industry, government, and academia to join us in an effort to bring these ideas to Washington.

For the full version of this article, click here.

About the authors
Fernando Muzzio, PhD, is director of NSF Engineering Research Center at Rutgers University. Mauricio Futran, PhD, is professor and chair of the Department of Chemical and Biochemical Engineering at Rutgers University (mauricio.futran@rutgers.edu)

Consider this: In 2011, IMS projects US Rx market growth to be 2.7 percent. The top 10 pharma companies account for 50 percent of the entire market’s revenue, but will deliver only 10 percent of the growth. In fact, the growth rate of the top 10 is estimated at 0.9 percent.

And it’s even worse than that: Take out the non-organic growth, i.e., the ‘growth’ padded on purely by gobbling up acquisitions, and growth among the top 10 companies is, in fact, negative.

So Pfizer, Merck, GSK … the largest companies keep getting fatter. And slower. And more dysfunctional. And people inside these companies know this. But very few are willing to say it out loud.

If the industry is going to prosper, C-suiters need to do two things: liposuction down their companies to their essential, vital cores; and change the reward system to truly—finally!—value innovation inside and beyond the labs.

There are only a few things a pharma company needs to be good at: 1) developing products and services of true, differentiating value for patients, doctors, and payers; and 2) figuring out how to market and service those products and services powerfully, ethically and efficiently. That’s it.

The ability to deal with information with great speed and agility (what I call ‘knowlagility’) is a critical source of competitive advantage in myriad ways: it provides deep customer insights, it enables more efficient delivery of high value across the healthcare delivery continuum, and, critically, it empowers companies to make credible arguments about the true economic impact of their therapies to the healthcare system.

Yet little of this capability—which is extraordinary in its importance now, and even more extraordinary in the rate its importance will increase—has been built into pharma IT as it is currently configured. The layers in a super-pharma organization actually cover the company in folds of bloat, threatening the vital organs.

Let the Sucking Begin

That’s why it’s essential to cut out any non-essential IT process. Stop obsessing about the trivial—that means please stop talking about social media! Instead implement programs that deliver the ability to see farther and move faster.

The idea is to get smaller, yes. Spin off those divisions that aren’t crucial, sure. But more than that, cleave the processes that are more about ‘control’ than value.

A ridiculous example: We have clients who can’t run basic software or access popular websites. Why? Either because IT plays the ’security’ card and so access to—and insight about—much of the world gets cut off. Or else Finance cries ‘efficiency’ and suggests that if only we could get people off Facebook, then we’d be more profitable.

If you are a CEO and hear these things from your managers, you can do more for your profitability by firing them.

In the Speed of Change era, IT has one of the most important jobs in the entire organization. But it’s not about control; it’s about the discovery and release of value. Sure, you have to do the basics of control: secure your (cloud-based, I hope) networks and endure the Sarbanes-Oxley torture, etc. Just understand that this is a distraction from the real work.

The real work then is in applying knowlagility to unlock potential; by uncovering patterns in the data about your customers, and patterns in the data about potential products and services. In a post-blockbuster world, the winners will be those companies (of whatever size) that are better at identifying the highest-value opportunities and delivering them to customers with greatest possible speed and satisfaction.

Smaller companies, or large companies with ‘federated’ structures (e.g. Johnson & Johnson), stand a better chance of combining the advantages of size and agility. But whatever the size or structure, the organizing principle remains the same: In a Speed of Change world, victory belongs to the swift.

For the full version of this article, click here.

Bill Drummy is the CEO of Heartbeat Ideas. He can be reached at billd@heartbeatideas.com

Amidst yellow sandstone arches and California Mission Revival architecture, The Medicine 2.0 +Stanford Summit (otherwise known as the Fourth World Congress on Social Media and Web 2.0 in Health Medicine) set out on a three day journey to challenge its diverse audience to break down silos and expand beyond traditional boundaries. From a focus on research findings and scientific data to dialogue around the future of science, medicine and emerging technology, innovators and thought leaders congregated from around the globe at the state-of the-art Stanford venue, Li Ka Shing Center for Learning & Knowledge. Through the congress, Stanford extended an invitation for open scientific inquiries into the pursuit of teaching, learning, and research, in alignment with its motto. ¹

The energy in the room was contagious starting with the unique conference badges that featured personal QR codes (eliminating the need for business cards), lively twitter feed and building of a #med2 community (over 5,000 tweets!), to the theatrical presentations that conveyed unconventional solutions to healthcare issues. From theory to practice–patients, healthcare professionals, academics and executives discussed and debated concepts such as participatory medicine, patient self management, behavioral change, decision making, the quantified self, communities of practice, social networking, gamification, personalized healthcare, and innovation in medical education. There were so many interesting points made at Med2.0, but I’ve captured a few highlights below:

Abraham Verghese, MD eloquently walked us through the bedside ritual of examining the patient as a critical but threatened skill that is the foundation to the patient-physician relationship. He explained the potential of displacing the patient during the digital age and reliance on technology during the clinical encounter —with more emphasis placed on patient data, rather than the person being treated.

Jennifer Aaker, PhD delivered a brilliant keynote that demonstrated the impact of social media saving lives through storytelling, collaboration, and enabling the wider community to quickly act. The story began with 2 Indian men with AML in search of bone marrow matches and ended with 20,000 South Asians registering as a result of a powerful awareness and social media campaign. Attendees had the opportunity to have their cheeks swabbed and sign up for the Be The Match Registry during the break in the corridors.

The eclectic BJ Fogg, PhD shared his behavior change model which shows that three elements must converge at the same moment for a behavior to occur: B = MAT (Behavior = Motivation x Ability x Trigger).

Susannah Fox gave the closing keynote on the impact of “peer to peer healthcare” where patients are seeking and sharing health advice online. Roadblocks included pockets of offline patients, patients not motivated to engage in their healthcare, silo tools/communities, and lack of awareness of resources. Opportunities included leveraging the power of online caregivers, engagement prompted by life changing diagnoses/events, rise of mobile adoption, and emerging focus of technology that bridges silos and allows data flow. The beacons of change in these efforts include patient, clinician, and technology leaders.

There was a major focus on patient self management platforms in chronic diseases, the Quantified Self and use of digital devices to collect real-time quantifiable patient data, decision support tools to make informed choices, and gaming to change behavior by rewarding patients for meeting health related goals. With all the data being collected, the question is how do you give back the data to patients, synthesize, and set context in a way they can understand?

The use of technology as a catalyst in healthcare improvement was prevalent.  From the use of social media and mobile health tools by physicians to communicate and improve clinical workflow to the use of virtual community platforms by patients to share experiences, understand options and obtain social support–It was clear that patients and healthcare professionals are embracing the impact of technology—although not necessarily at the same pace. Patient online usage to share and obtain healthcare information is on the rise; however a research abstract (764) demonstrating physician attitudes towards social media for their own professional education and knowledge sharing showed that usage and intent to use is fairly low. Plagued with social media privacy concerns and associated risks, traditional modes of learning, and lack of clear guidance and policies—physician usage is growing at a snail’s pace in comparison.

There was a spotlight on the e-patients, of which 23 received scholarships to attend the conference. Each had a compelling story to tell regarding their personal but at times unfavorable experiences with the healthcare system and how they made informed medical decisions by becoming more empowered and engaged in their healthcare. These real life interactions crystallized key themes conveyed throughout the conference.

Larry Chu, MD was the skilled conductor of this colorful performance, which set the bar high for future Med2.0 conferences. We were each given the opportunity to challenge both established and new orthodoxies in healthcare, infuse innovation and creativity into potential solutions, and explore collaborations among the diverse Med2.0 community to make things happen!

Planning for the 2012 Med2.0 Congress is underway to be held September 15-16^th at Harvard Medical School. Stanford will also debut MedicineX in 2012 focused on the intersection of emerging technology and the future of medicine.

¹ Die Luft der Freiheit Weht-unofficial Stanford Motto, Ulrich von hutten, 16^th century

Sarah Krüg is executive director at Cancer101, a patient organization. She was previously Global Education Director in the Medical Education Group at Pfizer

Last week, the MMRF launched a 1,000-patient trial with newly diagnosed multiple myeloma patients, to study the relationship between a patient’s genetic profile and treatment outcome. The study, part of the MMRF’s “Personalized Medicine Initiative,” will track patients from initial diagnosis through the course of their treatment, over a minimum of five years. The study will “conduct sequential tissue sampling to identify how a patient’s molecular profile may affect his or her clinical progression and individual response to treatment.”

To what end? If pharmaceutical companies are reticent to integrate genomic data into the clinic, for the reasons above as well as regulatory issues around data validation and patient privacy, who will? Physicians will, according to Richard Resnick, CEO, GenomeQuest, and a former manager of bioinformatics software at Wyeth-Ayerst. “Physicians could potentially disrupt the value chain in pharmaceuticals, if [drug companies] don’t listen,” said Resnick, during a panel discussion yesterday at a Cambridge Healthtech Institute conference on next generation genome sequencing.

Brad Smith, VP, translational medicine at Quintiles, acknowledged that some Big Pharma companies are recognizing the importance of patient biomarkers in the early stages of drug discovery, but they aren’t making it a priority. “In our partnerships with pharma, biomarkers and lab tests are usually pretty far down at the bottom of the list,” said Smith during the panel discussion. “Suggesting a new endpoint adds risk to the trial protocol.”

What the pharmaceutical industry really needs to overcome cost concerns is a clear success story, said Iya Khalil, SVP and co-founder of GNS Healthcare, during the panel discussion. Despite the approvals last month of Roche/Daiichi-Sankyo’s Zelboraf (for melanoma) and Pfizer’s Xalkori (for lung cancer) – and their respective companion diagnostics – Khalil said the industry still needs a clear, end-to-end success story for expediting drug approval by using data collection, genomic sequencing and microRNA transcription, phenome measures including physiological outcomes, and finally, predictive analytical software. Khalil said the approval of Xalkori, originally a drug targeting the c-MET gene to prevent a certain type of protein expression in cancer cells, hinged on a serendipitous discovery of ALK inhibition. “Pfizer got lucky, good for them, but we know there’s a more rational way to do [discovery] that can work, there’s no reason why…you can’t profile these patients and study these things,” said Khalil. “The question is who is going to take the chance on that pilot that actually shows that this will work.”

At the conclusion of the “Genomics in Clinical Trials: Has the Time Come?” panel, Resnick was asked how many years it would take to have a full genome sequencing done for 50% of the US population. His estimate was 15 to 20 years.

Consumers and healthcare practitioners have come to rely on digital platforms for medical advice, but as Google trumps nurses, pharmacists, and friends and family as the second most frequently named influencer of health decisions,* pharmaceutical companies are disproportionately silent in the digital space.

Many fear the wrath of ambiguous regulatory policies, but brands without a digital presence stand to lose their grip on the audiences that matter most.  Although 89 percent of internet users have looked for health information online, pharmaceutical marketers have largely ignored the digital habits of consumers and healthcare practitioners.

To quantify this discrepancy, L2 Think Tank founder Scott Galloway, has devised an annual Digital IQ Index for pharmaceutical brands. As the first study of its kind, the index ranks the digital acumen of dozens of pharmaceutical brands across site, social, search, and digital.

“The industry as a whole disappoints,” Galloway says, “as most brands offer obsolete technology, anemic content and scant social media programs.”  According to statistics from the first and second annual studies,** only 19 percent of pharmaceutical brands maintain a presence on at least one social media platform and less than one quarter of brands advertise on highly trafficked physician portal sites like Medscape, MDLinx, and The New England Journal of Medicine.

In response to the quality gap, users have voted with their browsers. Brands categorized as genius in the consumer study saw an average one year traffic growth of 175 percent while 40 percent of brands in the Digital IQ Index saw a decrease in website traffic.***

Although many brands are starting to catch onto direct-to-consumer marketing tactics, strategy for reaching healthcare practitioners online still eludes most pharmaceutical marketers.  31 percent of brands in the direct-to-consumer study earned Challenged or Feeble Digital IQs, but more than 60 percent of brands’ HCP efforts led to Challenged or Feeble status.****

Most brands are not purchasing HCP-targeted search terms, deploying email marketing programs, or investing in mobile or display advertising on physican portal sites.  This represents significant low-hanging fruit in the industry, but also huge potential losses amongst some of the industries most coveted influencers.

Fear of regulators may leave most brands silent and stifled, but the cost of not participating in the digital revolution will only increase over time.  Facebook ads alone have experienced a 45 percent year over year growth***** and the investment required to capture the attention of healthcare practitioners and consumers stands to rise.

As the digital revolution takes hold, pharmaceutical companies must find a way to follow in the footsteps of Genius brands like Pfizer, AstraZeneca for direct to consumer digital marketing, and Johnson & Johnson’s Concerta in their efforts to reach healthcare practitioners online.

For more information and tangible flashes of genius in the industry, download the Digital IQ Indices from l2thinktank.com/research/reports.

Lauren Procter

*         Capastrat & Public Policy Polling, April 2010
**       L2 Digital IQ Index: Pharma 2010, L2 Digital IQ Index: Pharma 2011
***     L2 Digital IQ Index: Pharma 2010
****   L2 Digital IQ Index: Pharma 2011
***** “Facebook Ad Prices Soar More Than 74 Percent”, Financial Times, July 2011Pharma

Abram’s comments, made during a panel this morning at the Drug Information Association’s (DIA) annual meeting in Chicago, prompted audience members to probe Abrams, and his CBER colleague Lisa Stockbridge, branch chief of the Advertising and Promotional Labeling Branch, about specific policies governing online promotion. One audience member wondered whether unbranded, educational campaigns online could link to branded sites, or if that kind of activity would generate an enforcement letter. Abrams responded that his own question, in that instance, would be, “Why are you linking to a brand site?” if a campaign is designed specifically to educate about a disease, as opposed to a branded campaign designed to sell a product. When pressed, he said an educational or awareness campaign – which isn’t required to present risk information, since no drug is being promoted – linking to a brand site would “have to be considered on a case by case basis.” Industry has been browbeating DDMAC about issuing social media guidelines for years.

On FDA’s Bad Ad program, one audience member asked what sort of proof would be required to verify improper promotion by a sales rep, given that a discussion between a rep and a physician would likely be verbal and unrecorded. Abrams said that an extensive review of the complaint would happen before moving forward, and then a signed affidavit from the physician, testifying to what was said during a sales meeting, would most likely be required. John Kamp, executive director at the Coalition for Healthcare Communications, and moderator of the panel, wondered aloud about whether a sales rep making hundreds of calls a week would be able to recall exactly what was said during a specific detail. “Couldn’t a sales rep say, ‘I don’t remember what I said, but my training and common response in this situation would be X.’ Would that kind of [defense] fly?” asked Kamp. Abrams didn’t answer the question directly, but insisted that DDMAC was diligent in investigating complaints, and the circumstances surrounding a potentially illicit conversation.

Abrams also discussed a proposed update to Section 502(n) of the Federal Food Drug and Cosmetic Act (FDCA) dealing with “clear, conspicuous, and neutral” major statements, or legally-mandated statements on major risks associated with a given drug. The update was announced in March of last year, and deals with DTC advertising, specifically television and radio, said Abrams. One of the four proposals put forward by DDMAC would require that an “advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of a major statement.” Anyone who has seen a drug ad on television will recognize the target of this proposal; the last seconds of a DTC ad are typically used for a voiceover announcing a drug’s “major” risks, while simultaneously providing unrelated images associated with the actors or visual narrative of the commercial.

DDMAC is in the process of being elevated from a division to an office, a process that is “slow even by government standards,” joked Abrams. The new office will be separated into two divisions, healthcare professional and consumer, he said.