No two patients are alike, but drug-makers may not consider how different a single patient’s perspective can be when viewed over time. A patient’s progress through disease management is a journey, and perceptions change over time. Changes in perceptions influence the meaning of “usability” and can have tremendous implications for how a drug delivery system supports the patient. To understand this concept better, consider two different points during the patient journey – a newly diagnosed patient and a patient further along with their condition – as examples of how different usage must influence the design of a drug’s delivery system.

The New Patient: Struggling to Adapt and Learn
Early on, patients who use delivery systems in their medical therapy struggle to cope with significant life disruptions. They often do not feel very well physically. Emotionally, they may be fluctuating between fear, anger and deep concern or depression. At the start of their disease management journey, these patients are asked to take on new responsibilities for their condition, learn new and sometimes difficult tasks, and become experts in managing parts of their disease, such as administering their own medication.

What does this mean for a drug company? Ease of use is a critical consideration; pharma should ensure that drug delivery requires as few steps as possible, guaranteeing that users can learn, remember and quickly master the process. Especially for the newly diagnosed, drug delivery devices need to provide clear, absolute confirmation that they were used properly, and that the medicine was successfully delivered. Any ambiguity heightens patient anxiety and will leave them questioning whether they received the proper dose. Such anxiety can lead to overdosing and create doubt that the device – and the drug – is trustworthy or effective, which quickly erodes adherence.

For a patient in an early stage, “ease of use” should translate to “ease of training.” With the rise of biologic therapies, patients rely on the support of healthcare practitioners and family to learn how to self-inject, for example, as they acclimate. Optimizing a drug for both self-administration and demonstration means manufacturers need to carefully consider how humans learn, and the differences between processing information by watching others, versus doing things ourselves. Failing to support these early stage requirements can lead patients to abandon therapies before they even have a chance to take hold.

Further Along: Staying Faithful
Later in the disease management journey, patients return to a more stable condition and reasonable quality of life. They have mastered their drug regimen and delivery system – but now the patient is more demanding of how the device supports quality of life. Reduced anxiety makes room for motivations based on convenience and the confidence that “I have this disease under control – at least for today.” As patients settle into this “new normal,” such attitudes can lead to skipped doses and lapses in adherence, often throttling the patient back to a state where the disease manifests itself more seriously.

At this point, the delivery system needs to not only continue to support efficiency with minimal steps, but also, and for different reasons, it must be designed based on convenience and lifestyle enhancement. Patient feedback must be considered differently and used to select a delivery design that encourages and incentivizes patients to remain adherent. For instance, compliance metrics, goal-oriented achievements or physiological measures might be tracked in order to encourage adherence, helping patients control their disease and improve their condition.

The Journey Determines Everything
Realizing that patients are on an ongoing journey is an important step in understanding the complexities behind how user-centered design can support adherence. Armed with this awareness, pharmaceutical companies are better enabled to select and develop safe, reliable and desirable drug delivery solutions.  These considerations can help to address the shifting nature of what usability means for any type of patient we may become, while traveling on our individual disease management journey.

Drug Usage by Demographic in 2011

Provisions in the Affordable Care Act (ACA) drove out-of-pocket costs down, while increasing drug spending among 19 to 25-year-olds in 2011, according to research published on Wednesday.

The decline observed in overall out-of-pocket spending last year was the “first on record,” and was “largely related to the introduction of the ‘donut-hole’ subsidy for Medicare Part D beneficiaries,” a highly-touted element of the ACA, according to the IMS Institute for Healthcare Informatics. While copays for commercial providers and Medicaid were flat (average commercial plan copays increased by $1.14, to $26.10 in 2011), seniors covered by Medicare Part D got the largest break, with average copays decreasing by $2.66 – from $25.97 in 2010, to $23.31 in 2011 – according to the report.

The dip in copay costs for seniors didn’t translate into an increase in volume for chronic or acute medications, however; in fact, patients 65-years and older reduced their drug usage by 3.1%. Prescription use among the same group declined in 2010 as well, by 2.7%, but the last two years represent an inflection from prior years, when “seniors’ usage of medicines grew on average at 4%,” the report found. College-aged patients (19-24 years old), on the other hand, were the only age group to increase their drug usage, by a modest 2%. That increase “coincides with the first full year of implementation of the provision of the ACA allowing under-26-year-olds to stay on their parents’ health insurance,” according to the report.

Michael Kleinrock, director of research development at the institute, said on a call with reporters that patients over 65 years old are foregoing the medications they use the most. Drug usage for hypertension, the most common disease among this population, decreased more than any other class of drugs. “This correlates strongly with the economy…seniors are on a fixed income, and costs [of living] are rising,” said Kleinrock on the call. Kleinrock called the development a “tipping point,” adding that seniors are resetting their expectations around how often, and under what circumstances, they will visit a doctor.

Per capita figures adjusted for currency changes showed a 0.5% growth in total drug spending in 2011 – to $320 billion. Other fun facts from the report include:

• New York state had far and away the largest growth in per capita retail prescription usage at 5.6%, bucking the national trend. Volume rates fell in 41 states.
• Visits to the ER increased by 7.4%, while doctor’s office visits decreased by 4.7%, from 2010 to 2011, a “possible result of continued high levels of uninsured patients associated with long-term unemployment,” according to the report.
• Copay card usage increased in 2011, but only by 1.4%. Still, patients used copay cards or vouchers for only 3.8% of dispensed brand prescriptions last year. The average copay card subsidy provided by drug manufacturers grew by 20%, from $19.34 in 2010, to $24.28 in 2011.
• Spending on new brand drugs – products approved in the last 24 months – was $12.2 billion, up from $8.5 billion in 2010.
• 34 new molecular entities (NMEs) launched in 2011, the most in “at least 10 years,” according to the report
• Key blockbusters that expired in 2011: Pfizer’s Lipitor, GSK’s Advair Diskus, Lilly’s Zyprexa, and J&J’s Levaquin and Concerta.
• Hydrocodone, an opioid for pain, was once again the most dispensed drug last year, at 136.7 million prescriptions.
• Among therapeutic classes, anti-depressants were dispensed most often, at 264 million prescriptions in 2011.

If the Supreme Court decides in favor of the Affordable Care Act, particularly the mandate to buy insurance, the spate of newly insured patients would likely curb the rise in emergency room admissions, and could also turn around the decrease in office visits, which are “the lowest-cost medical interventions,” according to the report.

Aligning humanistic objectives with business incentives is often the sine qua non of effective community activism. This year’s Rare Disease Day – hosted in the US by the National Organization for Rare Disorders (NORD) – attempts to do just that. Some 630 patient organizations, government agencies, research centers and corporations have signed up to be Rare Disease Day Partners this year, and both the NIH and the FDA are serving as venues for events on February 29 and March 1, respectively, under the banner of solidarity.

A symposium for patients and researchers at the NIH will “focus on things that are really new and cutting edge in rare disease research,” says David Eckstein, senior health scientist administrator at NIH’s Office of Rare Disease Research. Topics include the utilization of stem cells and next-generation gene sequencing, and what that will mean for rare disease research. “We’ll also be talking about new research paradigms,” says Eckstein. “People have always talked about ‘bench to bedside,’ but it’s really bench to bedside and back; there’s a lot of information that flows from what’s learned in the clinic, back to the laboratory.” Topics will be targeted to a lay audience, to encourage patients and their families to attend.

During an extended lunch period, NIH hopes attendees will visit table exhibits and posters, and to interact with researchers and pharmaceutical companies. “We’ve opened up the ability of all these patient groups to advertise their existence and make others aware of who they are and what they’re doing,” says Eckstein. For the NIH Rare Disease Day agenda, click here (events and presentations will be streamed live here).

FDA, for its part, is hosting a Patient Advocacy Day on March 1. Dr. Gayatri Rao, acting director for the Office of Orphan Products Development (OOPD) at FDA, emphasizes the importance of collaboration – and solidarity – across stakeholder groups, as a means to solve the challenges posed by rare diseases. “Patient Advocacy Day will bring together patients and the different centers and offices within FDA that regulate products for rare diseases…with the goals of engaging the patient community, increasing awareness about translating research into therapies, and providing education on the roles and responsibilities of the FDA in the development process,” says Rao. For the FDA agenda, click here.

Outside of Washington DC, a slew of research institutions, community centers, local government groups and pharmaceutical companies are hosting their own events, from wine-tastings, film screenings and a marshmallow roast, to marathons, concerts and a virtual “Handprints on the Hill” campaign, sponsored by NORD, that will encourage participants to sign a letter to President Obama and members of Congress that supports rare disease awareness. To bring attention to specific cases of rare disease, every signatory can personalize the letter. In Europe, where Rare Disease Day originated in 2008, the European Organization for Rare Diseases (EURORDIS) will host and facilitate numerous events across many countries.

Pharmaceutical companies like Genzyme, Lundbeck and Biomarin have planned special events around Rare Disease Day. Mary Dunkle, NORD’s VP of communications, points to Genzyme’s “mini-marathon” scheduled for February 29. “Genzyme has a team of employees who run the Boston Marathon every year, to raise money to donate to NORD on behalf of all rare disease patients,” says Dunkle. “This year, they’re doing a mini-marathon…they’re going to be running some very significant distances at four different Genzyme facilities, and each facility will host a small program.” NORD will be on hand to distribute literature, and to speak on the Rare Disease Day theme of solidarity.

The “Raise Your Hand to Fight Rare Diseases” campaign, happening for the third year in a row, asks interested parties to visit NORD’s website and “Raise Your Hand” by clicking on an icon. For every click, Lundbeck Worldwide, the underwriter of the campaign, will donate $1 (up to $10,000) to NORD’s general research fund. Last year’s $10,000 donation went toward a research grant for systemic sclerosis, a rare autoimmune disorder affecting an estimated 49,000 people in the U.S. Silvia Laura Bosello is leading the study on systemic sclerosis, which is aimed at improving the identification of abnormal B-cells and administering medications that are known to positively affect the production of B-cells. Siren Interactive, a marketing firm specializing in rare diseases, is asking a network of clients, colleagues and friends to visit crumblymorsels.com and build a cookie to share online. For every cookie shared through Facebook, Twitter, Linkedin or Google+, Siren will donate $1 (up to $1,000) to EURORDIS and NORD.

Increases in the number and activity level of patient organizations in recent years have helped to spotlight the business opportunities for pharmaceutical companies. “I spoke with PhRMA recently, and they said that there are now about 460 rare diseases being worked on by the collective membership of PhRMA, which is the biggest number they’d had, ever,” says Peter Saltonstall, NORD’s president. “More and more of the large companies who have never been in the rare disease space are now making a commitment.” Eckstein says pharma has become more interested in creating niche areas for business. Quite a few [pharmaceutical companies] are realizing that it can be profitable to get into the rare disease market,” says Eckstein. “We’re doing as much as we can to encourage that, and to encourage patient groups to work with pharma, to ensure that clinical trials are well-enrolled, so that trials can be done quickly, which saves everybody money and gets things through the FDA faster.”

The Rare Disease Day theme of solidarity this year speaks to the importance – and benefits – of collaboration between patients and pharma. “If you take all of those rare diseases and total up all of the populations, there are about 30 million Americans that are affected by rare diseases,” says Craig Kephart, president of Centric Health Resources, a direct-distribution company focused on specialty pharma and orphan diseases. “By joining together these 30 million Americans, they make up a large group of people that need to be heard. We need to address effective and meaningful ways of helping them lead better lives.”

Those issues (adverse events, off-label discussions, fair balance presentation, no meaningful FDA guidance) hardly need rehashing here, and despite the barriers, progress has been made on the digital front, as evidenced by – if nothing else – pharma’s willingness to invest in smaller-scale social media efforts not directly tied to product sales. In the digital sphere, ROI means “hitting the primary endpoint,” and that endpoint could be data collection, engagement with widgets or functionalities on a page or within an app, or the number of visitors (or likes) on a Facebook page. “The ROI of social media is that your business will still exist in five years,” a quote from Socialnomics author Erik Qualman that surfaced in one of the presentations, speaks to the accepted necessity – in some quarters – of social media participation and customer engagement.

“Advertising has already largely shifted to what people say about your brand,” as opposed to the magazine, television and radio ads that people consume, said Martin Husar, customer strategy and innovation at Sanofi Canada. In Canada, DTC isn’t allowed, but last October Sanofi tapped the Toronto-based agency MediResource for an interactive Facebook campaign around atrial fibrillation (A-fib). The business objective, said Husar, was to “own the primary venues for Canadian patients and caregivers to learn about AFib.” By his measure, the company’s Afib at Heart | La fibrillation auriculaire à coeur Facebook campaign has been a success – one need not “like” the page to access the content, and thousands have clicked on tabs like “Ask the Expert,” or “Don’t Skip a Beat,” a Simon-inspired memory game.

A Janssen Canada educational campaign around psoriasis goes a step further, offering a list of available treatments, and a dermatology locator that returns only those dermatologists who “agree that they will use biologics” – Janssen markets Stelara, an immunomodulating biologic – and who have voluntarily signed up to be listed on Janssen’s Living Well With Psoriasis website, according to Spilios Asimakopoulos, director of marketing technology, Janssen Pharmaceuticals Canada. The site also offers a psoriasis “severity calculator,” which is available online or as an app for download.

South of the Canadian border, others agree that the educational/disease awareness space is a good place for experimentation. John Patten, a sales rep for Facebook, told ePharma attendees that “Facebook makes sense in terms of initial support groups [for rare diseases], and locating others with the disease.” He also singled out Bayer’s Walk for Hemophilia and Sanofi Pasteur’s Voices of Meningitis as good examples of Facebook educational campaigns. “Pharma is more powerful in the unbranded, open wall pages” on Facebook, said Patten. Whitelisted brand pages, or pages with the comments function disabled, will be “de-prioritized in the news feed,” and they go against Facebook’s model, which Patten defined as “a distribution platform that promotes authentic sharing.” Perhaps as an added nudge to discourage whitelisted pages, Patten announced that by the end of February, “admins can drill down into individual commenters, and message them directly,” to help deal with “your drug turned my arm blue” adverse events comments.

A couple of hours before Patten’s presentation, however, a regulatory affairs director from a major pharmaceutical company was on a panel griping about the fact that while Facebook allows blocking of comments on the wall, “we can’t turn off sharing or commenting” on the actual brand image. Asked whether the company responds to such comments on the branded Facebook page, the panelist said no: “once you do that, where do you stop?”

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.

On November 17, FDA’s Risk Communication Advisory Committee (RCAC) will convene to discuss the best ways to take a drug’s complex clinical data, and present it to doctors and patients in an understandable way. The stated goal is to improve healthcare decision-making by clinicians, patients and consumers.

At issue is the implementation of a drug facts box or table, which would appear in a drug’s promotional labeling and print advertising. Research shows that a drug facts box, or a “table quantifying [health] outcomes with and without a drug,” as described by Dartmouth Medical School profs Lisa Schwartz and Steven Woloshin, could do a better job presenting the benefits and risks of a particular medicine, which facilitates a more informed decision about treatment. It would also dramatically change the way drugs are currently promoted, at least in print. (For a facts box mock-up, click here)

Woloshin says he has not looked into broadcast media applications for the facts box, but suggests that certain warnings, such as approval on the basis of a surrogate outcome, or the main efficacy finding for a drug, could be easily inserted into broadcast spots. For broadcast, “we imagine the primary goal would be to point people to a drug [facts] box, either in print or online…we have not tested these ideas, but hope to in the future,” says Woloshin.

On facts boxes in print, however, Woloshin and his colleagues have conducted extensive research, and have published a substantial body of literature. In fact, three years ago, FDA’s RCAC – then chaired by Baruch Fischhoff, of Carnegie Mellon University – gave the facts box a unanimous recommendation. Speaking to PharmExec about the facts box, Fischhoff calls it “a sound design, both analytically and empirically…it follows the theories of risk communication, it has demonstrated efficacy in its field trials, and is clearly much better than what we have out now.”

So what’s the hold-up on implementation, you may be wondering. Unsubstantiated suspicions abound, and a request for comment from HHS – which received a mandate via the Patient Protection and Affordable Care Act (Section 3507) to review the evidence for or against a quantitative summary of a drug’s risk and benefit, “such as a table or drug facts box,” and to make a judgment – went unanswered. A report filed to Congress by HHS in March requested at least three more years for additional research.

“It’s crazy that people – doctors, patients, tax-payers – don’t have ready access to summaries of [a drug’s efficacy and risks] in a way that we’ve shown can help them make better decisions,” says Woloshin. “FDA is supposed to be interested in transparency, getting information out to people in the most transparent form; that’s exactly what the facts boxes are meant to do.” Asked about possible reasons for foot-dragging at HHS, Woloshin says he’s “completely baffled by the delay,” an opinion he made known in the editorial pages of the New York Times last July. Fischhoff agrees: “Given the amount of work that’s gone into the fact box and the evidence that supports it, it’s hard for me to believe that [alternate design studies conducted by HHS/FDA] would justify a delay of a couple of years.”

RCAC is unlikely to make any bold decisions on Thursday; the discussion is primarily geared toward whether or not substantial gaps exist in the literature around a standardized risk/benefit format, and if data exist to shed light on how to select and present information for clinicians, patients and consumers. Interested parties can sit in on the RCAC meeting remotely, here.

In an exhaustive review of the literature on using quantitative summaries for the presentation of drug benefit and risk information – published on August 15^th – FDA admits that “numeric presentation of risk/benefit information appears to have had a positive impact on several outcomes relative to non-numeric presentation,” (non-numeric presentation means using words like “often” or “rare,” in place of numeric statistics). But the report insists that important gaps exist in the literature, such as “insufficiently investigated actual behaviors” versus theoretical behaviors, and a “focus only on risk information rather than on both risk and benefit information.” The report also cites differences in “a person’s numeracy or literacy levels” as a point against standardized, quantitative summaries.

Note: Apologies for the lack of a facts box quiz, alluded to in PharmExec‘s weekly newsletter. The quiz unfortunately died from editorial and technical complications. -BC

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

In an attempt to demystify that role, Medco CEO David Snow told attendees at the Cleveland Clinic’s Medical Innovation Summit last week that pharmacists are not in fact doling out health information to patients. “I’m not dissing retail [pharmacy], but…there’s a fiction that a pharmacist comes out and dialogues with you,” said Snow. “In reality, a high school student hands you a script from the shelf.”

In a follow-up dis to retail pharmacists, Snow added that Medco’s “robots” are “twenty-three times more accurate” than human pharmacists, in terms of errors in dispensing prescriptions. Physicians were also taken to task during Snow’s talk, titled “The Case for Smarter Medicine.” A large majority of the labels on drugs dispensed by Medco contain genetic information relevant to patient outcomes, and yet, “no one is doing the recommended testing or screening,” said Snow. “We call physicians who don’t prescribe correctly,” which is a more difficult telephone call to make than the one to non-adherent patients, he said.

Among chronic disease patients, 65% stop adhering to medication within 12 months, and poor management of chronic and complex disease leads to “$350 billon in excess healthcare costs annually,” said Snow, citing a statistic from a 2005 RAND Corporation study.

Responding to Snow’s comments, Chrissy Kopple, VP media relations for the National Association of Chain Drug Stores (NACDS), said in an email: “If there were any doubt about [Medco's] intent to impose mandatory mail order on more patients, depriving patients of their choice of pharmacies, then these comments should erase such doubt at this point.” Kopple wrote that “Americans trust their community pharmacists and find them highly accessible,” and cited three national surveys as evidence. For a view of the pharmacist contrary to Snow’s portrait, see the New Yorker’s recent profile of Dr. Don.

Medco and Express Scripts, the first and third largest pharmacy benefit managers (PBMS) in the country, respectively, are currently awaiting Federal Trade Commission (FTC) scrutiny on a proposed merger, which retail drug stores and pharmacists have sought to prevent. In testimony before the FTC, Dennis Wiesner, a pharmacist and member of the NACDS, said there is “only one stakeholder that would benefit [from the merger]: the new mega PBM.” Citing cases brought by “over 30 State Attorneys General,” Wiesner said PBMs have “accepted rebates from [drug] manufacturers in return for placing higher priced medications on prescription drug plans’ formularies,” among other things, and that an even larger mega PBM would “have even greater ability to dictate one-sided, unfavorable contract terms to pharmacies, health plans and employers, ultimately harming consumers.”

“Pharmacists help to ensure that patients understand their medications and take them as directed,” and they “collaborate with doctors and other local healthcare providers to assist in medication decisions,” said Wiesner in his FTC testimony. “Community pharmacies also provide critical, cost-effective services like immunizations, disease state management and monitoring, and health education and screening programs.”

In his own testimony before the FTC, David Snow argued that Medco depends on retail pharmacies, since “more than 85% of prescriptions filled for Medco customers are filled through our networks of more than 60,000 retail pharmacies…Medco is dependent on the continued existence of strong independent retail pharmacies.”

Asked whether DTC ads on television should be retired, Read answered unequivocally – “No” – and noted the difficulty of educating patients when “so many warnings are required that [a drug ad] scares more people than it helps.”

Robert Bazell, NBC’s chief science and health correspondent – and Read’s interlocutor during a lunch session at the Cleveland Clinic’s annual Medical Innovation Summit – picked up on Read’s comments about excessive warnings on televised drug ads, noting Pfizer’s 2007 Celebrex ad that lasted over two minutes, almost all of which was spent on the recitation of warnings (Celebrex, along with its fellow NSAIDs, picked up a black box warning in 2005).

Responding to the question of why Pfizer decided to go ahead with Celebrex DTC ads, post black box warning, Read said “the trials that gave rise to [black box] labeling in Celebrex, the data, if one patient had gone the other way, there would have been a different statistical result.”

Asked by Bazell about the issue of trust: “What is your perception of the public’s perception of Pfizer and the rest of the industry?” Read said Big Pharma’s reputation could use some improvement. “We’re above Congress and tobacco, and slightly below physicians and hospitals…there is blame on [industry’s] part for that.” Read said increasing transparency in clinical trials and other areas could ameliorate industry’s reputation. “We don’t sell a pill, we sell data. If you believe the data, there must be transparency,” he said.

Read emphasized the importance of incremental innovation to society, the need to protect industry’s intellectual property, and called for an explicit risk/benefit profile for drug development. He called the U.S. tax rate “uncompetitive,” citing tax rates in Europe “as low as 15%.” Industry “can’t work with one hand tied behind our back,” said Read. “Elites have lost faith in innovation as a social benefit…it’s a cost only conversation.”

The companies listed above – Abbott and GSK, on the one hand, and Danone and Nestlé, on the other – represent two distinctly different industries that are beginning to step on each other’s toes.  Consumer packaging goods (CPG) companies are skilled at developing and marketing consumer products, while pharma’s expertise is more science-oriented, in terms of product development and marketing requirements. Both industries have taken notice of a snowballing consumer interest in so-called nutraceuticals and functional foods, or products that don’t necessarily involve active pharmaceutical agents, but have marketable, science-based ingredients.

While Abbott, GSK, Sanofi and other pharmas have shown an interest in building a nutraceuticals or science-tempered nutritionals business around areas like heart disease, Alzheimer’s, diabetes and gastrointestinal disorders, others have shied away from the prospect of low margin consumer products, and the marketing efforts they require. Pfizer, for example, put Wyeth’s baby formula business up for sale in July; Nestlé and Danone are reportedly the leading bidders.

Given the pipeline gap, pharma can’t afford to cede the nutraceuticals market to CPGs like Nestlé, a company that is actively climbing over the fence into pharmaceuticals. Pharma companies are “gun shy” about aggressive consumer marketing, and less willing to take risks, says Leonard Fuld, CEO of Fuld & Company, a competitive intelligence firm, and host to the aforementioned war games. Pharma’s FDA regulatory funambulism is the source of its reticence, whereas CPGs are willing to risk obtrusiveness (and legal grey areas) in the attempt to dominate a market. You won’t see embedded video advertising for a pharma brand placed against pirated television shows hosted offshore, for example.

Fuld says the war game discussions also revealed that pharma companies are nervous about partnerships with CPGs, believing that brand identity or intellectual property could be usurped after handing over a product. While Nestlé in particular could “break the mold” – the company has walled off its high-science division, separating disciplines like genomics, biochemistry and human cell biology, from say, innovations in foam-boosted cappuccinos – Fuld says pharma companies need to make a public health case for nutraceuticals, since they don’t know how to educate consumers the CPG way: by creating and exploiting a broad, populist market need. CPGs like Nestlé and Danone are pushing into new, science-based products that don’t require a prescription. Fuld says pharma should be more willing to collaborate, and recognize the nutraceuticals and “designer foods” market for what it is: an opportunity for new revenue that bypasses a decade-long testing phase and an increasingly hostile payer environment.

Participants representing the four companies in the war game were culled from Dartmouth’s Tuck School, MIT Sloan, Northwestern’s Kellogg School, and the Yale School of Management. Actual company representatives observed and made comments.