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 shareable 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.

Back in August, before there was any mainstream media coverage of the movement, Occupy Wall Street (OWS) cited Franklin Delano Roosevelt’s Economic Bill of Rights speech on one of its websites, which includes the “right to adequate medical care and the opportunity to achieve and enjoy good health.” To the pharmaceutical companies with headquarters in the tri-state area: why not send a few boxes of provisions to the demonstrators? Not prescription drugs, of course, but OTC products like Band-Aids, Neosporin and tampons (Johnson & Johnson), and Advil, Robitussin and ChapStick (Pfizer).

Pharmaceutical companies complain, rightly sometimes, that they aren’t duly recognized for the community service and philanthropic efforts they provide and support, outside of core business operations. Industry’s current reputation may be slightly “above Congress and tobacco,” as Pfizer CEO Ian Read recently put it, but that isn’t saying much. Pfizer headquarters is a subway ride away – without the need to change trains – from Zuccotti Park. Johnson & Johnson likes to talk about the clear social benefit its products have provided over the years, but here is a chance to bandage the cuts and scrapes of an active and visible community. It’s a PR play, but one that isn’t damaged by its transparency. Given J&J’s ongoing manufacturing difficulties, and Pfizer’s ongoing promotional missteps, both companies could use a reputational lift.

From an OWS perspective, companies like Pfizer and Johnson & Johnson represent a scientific vehicle fueled primarily by commercial interests, without seat belts or airbags; the humanistic objectives of most pharmaceutical scientists get left by the wayside. Executive compensation at top pharmas, in the context of plant closures in the U.S., is also a point of contention. Despite this perspective, a goodly portion of the demonstrators, not to mention their families and friends, have probably depended on medicines produced by one of these two companies, at one time or another. The question is, would OWS be willing to accept a gift of bandages, pain relievers, decongestants and other products from pharma, to aid in the struggle against the elements? My guess is that they would, and that they would be grateful. It wouldn’t hurt to ask. Perhaps the question can be put to the General Assembly, for a consensus vote.

Regardless of whether you believe access to adequate medical care is a right or a privilege, what would be lost by donating a few boxes of Dr. Scholl’s to OWS, Merck? The Congressional Budget Office’s October report on income growth (1979-2007) makes it more difficult for political pundits to continue saying they don’t understand what the OWS message is, or why these demonstrations are occurring (full CBO report here). Gifting medical supplies to protesters accomplishes PR goals, and it aids those demonstrators willing to stand and sleep outside for a cause they believe will help make America a stronger, more equitable place to live and work.

Pfizer, J&J, Merck and others, will you step up? Anyone own a subsidiary that makes hand warmers?

Pharmaceutical Executive served as a lead media partner for the 2011 Prix Galien awards, held September 27 at the Museum of Natural History in New York City. The annual gala awards dinner, which recognizes innovation in products and agents that improve the human condition, brings together stakeholders and top influencers in the industry, including professional and scientific groups, academia, patient associations, and more for a night of celebration.

This year, top winners were Janssen’s Stelara and Amgen’s Prolia and XGEVA for Best Biotechnology Product; and Pfizer’s Prevnar 13 for best medical agent. Additionally, Dr. Paul Farmer—medical anthropologist, physician, Kolokotrones University Professor at Harvard University, Chair of the Department of Global Health and Social Medicine at Harvard Medical School, and founding director of international non-profit organization Partners in Health—took home the Pro Bono Humanum award.

“Dr. Farmer is an exemplary model of how one person can be a catalyst between science, business, and government to serve as a beacon of hope to those in need. Dr. Farmer’s dedication to combating deadly diseases while fighting poverty and inequality in developing countries is inspirational,” said Nobel Peace Prize winner and Prix Galien USA 2011 Award selection committee member Professor Elie Wiesel in a statement.

As another year of innovation in the industry comes to a close and is honored by Prix Galien, Gerry Weissmann, chairman of the committee of the Prix Galien, reflects on all that’s been accomplished: “After two centuries of tough, sometimes controversial experimentation, we’ve replaced pre-FDA home remedies and snake oil with drugs that address the basic mechanisms of human disease,” he said during the ceremony. “This year, the score of candidates for the Prix Galien USA shows what happens when we bring basic science from the bench to the bedside in a bottle or pill that’s been approved by the FDA … Teddy Roosevelt would have been proud that the industry he helped save from snake oil has made a difference in human life.”

PE: How did patient advocacy groups first take on a role in shaping Expanded Access Programs (EAPs)?

DV: I was working at Burroughs Wellcome back in 1986. In fact, September 19 was the 25^th anniversary of the first AIDS drug, and I was there at Wellcome when we did that. It was the FDA’s recognition that people were dying, sometimes in only six months, of AIDS. And when we announced that we had a drug that could extend lives, FDA knew we had to figure out a way of getting the drug to people before it was approved, because those patients just didn’t have that much time to wait. So the whole idea of expanded access or early access actually began in large part with AZT. Burroughs Wellcome began working a lot with patients, particularly the AIDS activists who were so persistent and were pushing for FDA to do things quickly, and for companies to do things quicker and cheaper.

PE: What is the relationship today between patients groups and pharma when it comes to setting up these programs?

I think it’s wise for the companies to work with the activists to make sure that there is a proper expectation of what the drug may or may not be able to do, make sure that the company is aware of the needs of the patients, and make sure that the materials that are being developed for the EAP are developed with the activists groups—so that if anyone questions whether the materials were clear enough, the pharma company would be in a far better product liability position. Although generally I don’t think that there’s been a great product liability risk with these programs, if they’re done responsibly. We’ve all got to be careful, because of the distrust of the pharmaceutical industry, to make sure that we are transparent.

Another area where the patients groups have played a key role at times is when a pharma company has a life-saving drug and just can’t make enough of it. And sometimes getting patient groups involved, if they’re willing to be the people who help run the lottery, is a big help. They can explain to their membership—the good news is that we’ve got something here, but the bad news is that it can’t be ramped up fast enough to treat everybody.

PE: What stipulations govern which patients will gain access to these EAP medications?

EAPs are for serious or life-threatening diseases. Serious is defined as a disease that, without treatment, would result in a major, irreversible adverse event or condition that would lead to hospitalization or significant impairment of life.

Generally you’re going to start off asking, what were the original criteria for taking patients into the clinical trial? It may be, in the clinical trial—as so often happens—perhaps you’re excluding the sickest of the patients, because they’re so unlikely to make it that their deaths could destroy the drug for everybody, when you could possibly help people who are earlier in the disease state. Depending upon the toxicity of the drug itself, FDA often will allow you to treat a broader range of people in the EAP than were treated in the clinical study if it looks like it’s medically reasonable. And it is a standard that there is no other reasonable alternative for these patients.

PE: Is liability a concern for pharma when setting up EAPs?

DV: EAPs are still considered clinical studies. So anybody that wants to administer a drug through an EAP has to register as a clinical investigator. They get the full clinical investigator’s brochure of all the background and the information that is known to date on the drug. And the patients who enter have to sign an informed consent as a patient in a clinical study. So again it is very important to let patients know what legitimate expectations are, because the drug still is not approved. They’ve always had to have the informed consents and to make very clear that this drug is promising, but it has not been approved and things can still go wrong.

At Burroughs Wellcome I think we felt, to a degree, that with EAPs—particularly for life-threatening diseases or those that are causing severe handicaps—that people were just so grateful to get help, that there’s less of a liability risk in reality.

PE: What kinds of incentive does pharma have to participate in these EAPs?

I think it’s kind of a win-win, if you’re saving lives. And you’re also hopefully getting the drug out early, and getting the data back in a hopefully a little bit more controlled fashion. It also allows you to get a little bit more safety issues data. I’ve often said it might be an opportunity to add other kinds of patients in, in a sub-study. Potentially, if the EAP program goes well, you’re going to actually pull your whole adoption curve forward, you’re going to save some patients, and hopefully give them a free drug. And by the time the drug gets approved, the day it’s approved, you’re going to already have a certain number of patients on the drug.

PE: What work is still left to be done to leverage relationships between pharma and patient groups on these issues?

I think it’s making sure that we continue to build and maximize credibility together and that we recognize the minefields. We need to use the opportunities of transparency, of good clinical trial reporting, to make sure that we can hopefully reestablish the vanished credibility of the pharmaceutical industry with patient groups. We want to help remind people that there are companies out there that are trying. We win when we help patients. That is our goal. We’re not looking to sell drugs for indications that don’t work, because that hurts us in the long run.

David Vance will be part of a panel discussion moderated by William Looney on “The Challenges and Importance of Expanded Access Programs in the Context of the Current Industry Landscape” at the upcoming Center for Business Intelligence (CBI) conference: Expanded Access Programs—Develop Compliant Strategies to Manage Global Patient Access to Investigational Drugs, October 5-6 in Philadelphia. For more information about the conference and to register, visit www.cbinet.com/eaps

Pharm Exec’s sister conference organization, CBI, sponsored its 10th annual Patient Adherence Forum in April to highlight current trends in industry compliance and adherence programs — where companies reach out to help an increasingly skittish community of patients take their pills. A key feature of the conference is the grant of the Strategic Patient Adherence Awards (SPA) to recognize companies doing breakthrough work to promote the compliance agenda.

The competition aims to recognize successful programs that measurably increase patients’ compliance to their prescription medication regimen, devised and implemented by bio or pharmaceutical companies, pharmacies, health systems, payer groups, employers, agencies, or vendors.

To be eligible, a program must have been implemented prior to February 1, 2010, and campaigns must have been produced, printed, or aired and had response results tabulated between January 1, 2010 and December 30, 2010.

This year’s winners are:

• Best Branded Program: Lori-Jean Manness of Merck Canada, for the Merck/RxCanada Januvia program
• Scientific Pursuit of Excellence: Abhijit Gadkari of Merck US on behalf of Colleen McHorney
• Innovation – Suzanne Clough of WellDoc
• Best Employee Participation Program:  Laura Del Guerra of MAHCP’s Take Control Program
• Best Managed Care Program: Kelley Green of Kaiser Permanente

“I look for programs that use research, evidence, and science to drive design. I look for programs that operate at the patient level. Adherence is about people’s behavior and choices, which are terribly complex and not logical or rational. It’s personal. We quip that education alone does not improve adherence and that’s why. I also look for programs that are more subtle and affect behavior through the subconscious because that’s what drives our daily behavior,” says Steve Basiago, veteran judge and VP of trade relations at Walgreens.

“The biggest challenge is to address adherence as a long-term proposition. Chronic medications taken for a short period of time only add cost to the healthcare system without tangible benefit to health. Chronic medications when taken consistently over a longer time are more likely to provide health benefit and hopefully, reduce overall healthcare cost,” he continues.

“We often focus our attention on patients starting therapy because that’s a critical decision-making phase for them. But we still see significant discontinuation as time goes on. Instead of programs getting one extra prescription per year, how about getting an extra year of persistence?”

Finally, when asked what pharma can do to promote improved compliance, Basiago says, “My best advice is to get the funding of adherence out from under the brand marketing budget. Too often, brand marketers don’t understand adherence but are tasked with funding it as part of the brand strategy. They’re driven by and measured by new patient acquisition and not patient retention. They ration dollars and often under-fund adherence. The most successful companies have created an adherence leader, which helps with understanding. The really successful companies have funded adherence through Finance directly as an overall company priority.”

The emailed invitation to attend Allergan’s Facial Aesthetics Advisory Panel, which was reproduced, criticized, and circulated on the Association of Healthcare Journalists’ listserv, said the panel’s goal is to “engage in a discussion about current facial aesthetics, trends and innovations, perceived gaps in data, and any questions, concerns or misperceptions your readers may have about products and treatments.” Allergan makes Botox Cosmetic, Juvederm (a dermal filler) and Latisse, an eyelash enhancer.

Reporters agreeing to attend the two-hour event and sit on the panel stand to earn the equivalent of $125 an hour. “As a seasoned reporter in this space, we would greatly value your feedback, and we’d like to offer you a stipend of $250 for your attendance and insights,” the invitation states.

Elizabeth Fishman, associate dean for communications at Columbia University’s Graduate School of Journalism, said in an email that she had “never heard of reporters being offered ‘stipends’ for their ‘attendance and insights’ about a company or product that they cover.” Fishman added that in 10 years at CBS News, she was never offered financial compensation by a third party in exchange for editorial coverage. “To accept any such compensation would be breaking a fundamental CBS News standard, and I am quite sure, would break standards at other news organizations as well,” she said.

The Allergan stipend doesn’t obligate reporters to write about Allergan or its products, and while providing a stipend and free lunch to journalists, in exchange for their attendance at an event featuring discussions about products they potentially cover, is ethically dubious, it’s not illegal. However, companies hoping to gain the trust of patients and other stakeholders, or hoping to simply avoid negative reputational spillover, will want to avoid the kind of public relations exposure that casts them in the role of media briber. Blaming a third party for mistakes doesn’t amount to an abdication of responsibility.

According to a Q1 release, Allergan’s facial aesthetics portfolio, combined with its breast aesthetics products, accounted for 29% of the company’s $4.8 billion in revenues  for 2010. Botox, which is indicated for cosmetic and non-cosmetic uses including chronic migraine, upper limb spasticity, cervical dystonia and other indications, represented 30% of Allergan’s revenues in 2010, according to company data.

This year’s meeting — hosted by the Business School’s Lerner Center for the Study of Pharmaceutical Management — will take place on Thursday, April 21 at the Business School campus on One Washington Park in downtown Newark.  Focus will be on problems and prospects of the industry.  Highlights include a key note address by Sol Barer, Chairman of Celgene Corp., an emerging leader in biotech with a strong oncology and immune disordes franchise; and two expert discussion panels consisting of representation from payers [Blue Cross Blue Shield], think tanks [Rand Corporation], academia {Tufts University Center for the Study of Drug Development], media [Pharmaceutical Executive Magazine],  government [Rich Bagger, chief of staff for NJ Governor Chris Christie, as well as prominent industry leaders in R&D from Astra-Zeneca, BMS, J&J, and Pfizer.

Registration is free and is accessible through the following email address:
http://www.business.rutgers.edu/events/2011/04/21/annual-healthcare-symposium-problems-and-prospects-pharmaceutical-industry

I recently attended my first Healthcare Businesswomen’s Association (HBA) event—the 2010 HBA Leadership Conference, held October 27 – 29 in Philadelphia.

The Leadership Conference brought together women in all levels and all facets of the healthcare industry, from sales reps to CEOs, from Biotech to Big Pharma. I attended the conference for several reasons: to network and learn as a newbie to the pharma industry, to cover the seminars and speeches as a journalist, and to pick up some leadership and career development skills as a woman in the corporate world. I fulfilled all of these goals with the help of warm, welcoming volunteers and attendees who were eager to share their knowledge and their contacts with me.

The theme of this year’s conference was “Impact Delivered: Innovate, Orchestrate, Perform.” This theme was carried throughout the three days of workshops, seminars, networking events, and panels using the metaphor of an orchestra and a conductor to explain the relationship between a leader and his or her team members. The event that started the first full day of the conference was “The Music Paradigm,” presented by conductor Roger Nierenberg. This immersive, interactive experience had us, the attendees, sitting in the audience right alongside members of a symphony orchestra: the violinists and percussionists sitting alongside the physicians and CEOs and saleswomen of Big Pharma.

The conductor lead from the stage, and all of us got to see and here the fruits of the conductor and the orchestra working together all around us. In between beautiful moments of music, Nierenberg stopped to explain the trust, leadership, confidence, flexibility, creativity, selflessness, and honesty that comprises the relationship between the conductor and the orchestra, and between the individual musicians that make up this “team.” It was easy to infer how these skills and attitudes could be attributed to corporate teams, whether you’re talking about a major pharmaceutical manufacturing company, a small sales and marketing team, or the humble publication that aims to capture and convey the nuances of the industry (yours truly).

Every workshop, panel, and discussion after The Music Paradigm utilized this metaphor to teach the attendees something about being an effective leader/member of her corporate team or about using those skills to manage some aspect of her personal or professional life.

Three days surrounded by women who devote their lives and their careers to sharing their knowledge left me refreshed and hopeful—for my own professional endeavors, for the state of the industry, and for a future paved with understanding and collaboration. I remember calling my husband on the third day of the conference, trying to put into words why I was moved nearly to tears by the attitudes and aspirations of the women around me. We live in a world where, especially in today’s job market, most people are operating on a sheer “survival of the fittest” mentality when it comes to moving up in the corporate world, and where many jobs have become just another rat race to pay the bills. What an inspiration it was to wake up and share a breakfast table with a woman who has dedicated her life to curing cancer—and to spend three days with hundreds of women like this, who, together, can accomplish something so much bigger than any one of us ever could on our own.

Thanks to the HBA for being a practical, progressive venue to help all of us contribute to the greater good, and thanks to Pharm Exec’s Editor in Chief William Looney and Group Publisher Jay Berfas for introducing me to the inspirational side of the industry.