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The degree of trust that any industry’s consumers place in its most established authorities can have profound impacts on the nature and range of the products offered, the complexity of the transactions, and, ultimately, the prevailing business models that will determine the industry’s success or failure. Consider the recent global financial crisis. While many traditional financial institutions have survived this international recession, the faith that many personal investors once placed in the accepted “market authorities”—including investment house advisors and portfolio managers, many of whom encouraged consumer expectations of unfettered market growth—has been severely damaged. This erosion of trust has fueled increased regulatory scrutiny of the sector, skepticism among its core and peripheral constituencies, and a reevaluation within the industry itself of the kinds of products and services that will be most desirable to its consumers. A powerful analogy can be drawn between the worlds of finance and health.
Today’s patients distrust many aspects of the healthcare system—the regulators, the medical gatekeepers, the drug producers—and grow continually more resolved to take charge of their own treatments. The well-publicized examples of unsafe drugs and the rising cost of healthcare are key drivers of today’s movement toward “patient- centricity.” As out-of-pocket expenses increase—due to the dwindling levels of insurance coverage, rising co-pays and large numbers of people completely uninsured—patients insist on knowing more about potential treatment options, and demand that this information be supported by real-world evidence. At the same time, expanding knowledge resources, such as the Internet, provide consumers with the opportunity to proactively learn more about their own or their loved ones’ medical conditions, treatment options and to even interact with other patients around the world. Consequently, patients play a crucial role in today’s healthcare, and that trend appears poised to escalate and drive further changes in the industry.
“Patients would rather not be passive consumers of healthcare services,” says market analyst Richard K. Miller, president of Richard K. Miller & Associates and author of the annual Healthcare Business Market Research Handbook, now in its 14th edition. “Given the choice, they want to know about their health and medical condition, what healthcare services would cost, the efficacy of prescribed treatments and the clinical competence of their physicians and hospitals. Fortunately, such information is increasingly available to them, and the effects on the healthcare system can be highly beneficial.”
Individuals are becoming more informed, choosy consumers. Moreover, their charge to take over their own healthcare goes even deeper than traditional approaches to health. In some cases—more than imagined by many industry experts—patients already opt for lifestyle changes over prescription medicines when possible. In addition, consumers insist on evidence, such as examples of real-world outcomes from patients like themselves, before they will pay for a treatment or endure one that might not produce the desired outcome.
With patient-centricity and consumer disgruntlement both increasing, the biopharma and healthcare industries must ask themselves: what will it take to regain consumer trust and how will these trends affect our business?
In the Winter 2006 issue of the Hofstra Law Review, Maurice Hinchey, Democratic representative from New York, wrote: “The Vioxx crisis, the resulting investigations, and the ensuing lawsuits…strongly underscored a number of deficiencies within the FDA’s review and monitoring systems. Recent polls have shown that the agency has lost the public trust as well as the confidence of its employees.”
Most everyone in healthcare and biopharma knows about the Vioxx (rofecoxib) crisis to which Hinchey refers. This nonsteroidal anti-inflammatory blocks a form of the enzyme cyclooxygenase, known as COX -2. This enzyme plays a role in producing prostaglandins, which can lead to inflammation and pain. As a COX -2 inhibitor, Vioxx was approved as a treatment for pain from osteoarthritis, rheumatoid arthritis and migraines. Unfortunately, it also triggered safety concerns over its potential to increase heart attacks and strokes when used long-term at high dosage. Although the drug was a blockbuster, generating $2.5 billion in 2003, Merck withdrew Vioxx from the market in 2004.
For evidence of consumers’ deteriorating trust, Hinchey points to a 2006 Wall Street Journal Online/ Harris Interactive Health-Care Poll. A summary of this poll of 2,371 U.S. adults states that “the majority of U.S. adults think the U.S. Food and Drug Administration’s (FDA) most important function is to ensure the safety and efficacy of new prescription drugs.” It then adds that, “over the past two years, the public has become increasingly skeptical about the agency’s ability to meet that mission, with seven in 10 adults giving the FDA a negative rating.” Further, the report indicates that “large majorities across party lines say the FDA’s decisions are influenced by politics rather than medical science. All of this suggests the FDA is facing an uphill battle in the court of public opinion.”
This poll is merely one example of a growing trend of public discontent with the FDA. A similar study by the same group in 2004 found that 37 percent of those surveyed thought the FDA did only a fair or poor job of quickly bringing innovative medicines to the market. By 2006, that figure had climbed to 70 percent, quite a significant number considering the importance and authority of this federal agency. In addition, more than half of those polled—58 percent—thought that the FDA did only a fair or poor job of ensuring the safety and efficacy of new prescription drugs.
In large part, Representative Hinchey agrees, as he concluded his article with the somewhat grim assessment that, “unfortunately, the agency’s struggles with regulatory and statutory obstacles are keeping it from effectively executing its mandate.”
However, the FDA is just one of the health “authorities” in whom patients are losing trust. Various studies indicate that health providers make serious, sometimes deadly, mistakes with medications and other treatments. According to “Preventing Medication Errors: Quality Chasm Series,” a 2007 report from the Institute of Medicine of the National Academies, “The use of medications is ubiquitous. In any given week, more than four of five U.S. adults take at least one medication (prescription or over-the-counter [OTC] drug, vitamin/mineral, or herbal supplement), and almost a third take at least five different medications. Errors can occur with any of these products at any point in the medication-use process and in any care setting. The frequency of medication errors and preventable medication-related injuries represents a very serious cause for concern.” In the U.S. alone, states the report, medication errors injure 1.5 million people a year. And drug-related errors in U.S. hospitals incur costs of at least $3.5 billion a year.
Concerns about the FDA, along with countless stories of medical mishaps, provide a compelling and clear rationale for the growing public distrust of the pharmaceutical and healthcare industries. This distrust has colored many consumers’ expectations of their medicines and their perceptions of the patient’s status in the larger health enterprise. For instance, “The New Health Report”—a Quintiles-sponsored survey in 2010 of 144 executives in the biopharmaceutical industry, 129 managed care executives and 1,048 U.S. adults—found that 95 percent of patients, not so surprisingly, view the effectiveness of a treatment to be important. Moreover, safety and cost were ranked as important by 94 and 84 percent of the consumers, respectively. In terms of industry perception of patient influence, this survey also revealed that 60 percent of biopharmaceutical executives believe that in the past five years patients have been increasingly influential in determining which prescription drugs are available. Ironically, a whopping 70 percent of patients think that they’ve had virtually no influence on the availability of products. Instead, they indicated that they were taking matters into their own hands. For example, 45 percent of the patients reported they had made lifestyle changes in the past five years to avoid taking prescription drugs. By comparison, the biopharmaceutical executives polled thought this was true of only 6 percent of patients. These results reveal the ongoing disconnect between patients and biopharmaceutical companies.
The overall trends in patient empowerment, however, go beyond U.S. borders. “There’s rising demand,” says Sir Andrew Dillon, chief executive of the UK’s National Institute for Health and Clinical Excellence (NICE). “People expect more, and they know more—especially those living with a chronic illness. This puts added pressure on healthsystem providers.” At the same time, healthcare systems face reduced funding. “With very significantly tightened resources,” Dillon explains, “there is less money, in real terms, available for healthcare.” As a result, he says, healthcare systems “must reconcile that increasing demand with increasing cost.”
As an example of today’s trend toward individual empowerment in healthcare, consider the experience of Lisa Lindell, who has no medical training or specialized health knowledge. In 2003, she stood by the hospital bed of her severely ailing husband, Curtis, and had a nagging suspicion that something about his treatment was going terribly wrong. “At first, like most patients, I thought my job was to stay out of the way of the doctors,” recalls Lindell, an accountant for a construction company. “It soon became obvious that if I didn’t manage his care, he wasn’t going to get any.”
Curtis, 44, had been admitted to a Houston hospital for third-degree burns. For weeks, a revolving door of doctors and nurses pronounced him in stable condition. But as Lisa kept vigil by his bedside, she was watching Curtis deteriorate. Fearing for her husband’s life, Lindell decided to take matters into her own hands. With the help of her sister, a registered nurse, she began to ask questions, research his symptoms and seek out specialists.
During Curtis’s 108-day stay in the hospital, it was Lindell and her sister who pushed for surgery on his gallbladder, which unbeknownst to the doctors at the time, was critically infected. And it was the two women who called for an infectious disease specialist when Curtis’s lungs collapsed, and who pushed for the antibiotic, imipenem, that ultimately saved his life. “My husband wouldn’t be here today if not for my sister and me,” Lindell says. Her message to patients? “It’s critically important that you know as much as you can when it comes to your healthcare,” she says.
There are healthcare experts who wholeheartedly agree. “The person suffering from a disease should participate in developing a healthcare plan,” says Lucien Engelen, Health 2.0 ambassador at Radboud University Nijmegen Medical Center in the Netherlands. “In most cases, a patient only gets asked in the last stage, perhaps just to fine-tune a treatment plan.” He believes that planning should include the patient’s family, because they will help the patient fight the disease. “These are the experts—the patient and close family members—who know what it means to experience a specific disease in a particular instance,” Engelen says, “and they must face the challenge of balancing choices based on treatment efficacy and safety.”
A Culture Shift
Lindell is just one voice in a growing movement of more empowered patients challenging the age-old paradigm of Doctor Knows Best. “An empowered patient is someone who has figured out that healthcare is no longer best practiced in a paternalistic and beneficent way,” says Trisha Torrey, author of the blog Every Patient’s Advocate (www.everypatientsadvocate.com). “It means taking responsibility and collaborating with doctors to make the best decisions for you.” An empowered patient, she says, isn’t afraid to ask questions, seek second opinions, search for information online and—in some cases—question (without challenging) the doctor’s orders.
After decades of pushing by advocacy groups, the concept of a more consumer-based healthcare model has finally begun to take hold, even among healthcare providers. Although medical professionals many remain wary of the patient who arrives at an appointment with a list of questions and stack of Internet research, others are beginning to see the benefits of a more knowledgeable, engaged patient—not just for their own practice, but also for the healthcare system as a whole.
“Ideally, we’re working as a team—patient and doctor,” says Daniel Z. Sands, co-founder of the Society for Participatory Medicine. “We’re creating an environment where we’re sharing information [and] have better outcomes, lower costs and improved efficiency. To do so will require a culture shift, but it’s taking hold.”
However, to make Sands’s team concept a reality, patients must work hard to play their part. “Americans will not get their money’s worth for the $250 billion spent on prescription drugs in 2010,” says market analyst Miller. “The problem has little to do with the quality of the medications themselves, but rather how they are used, or not used.” In other words, patients must follow prescribed treatment regimens if they want effective and safe outcomes.
As Miller notes, “Study after study shows that only about half of people with chronic health conditions follow their physicians’ directions for care.” The so-called patient adherence depends on various factors, among them, the complexity of the drug regimen and the patient’s understanding of the reason for the medication.
Despite the array of challenges for patients to truly become empowered, the movement is spreading around the world. For example, “Euro Health Consumer Index 2009”—a survey of 33 European nations by the research group Health Consumer Powerhouse—ranked The Netherlands as having the most empowered patients in terms of patients’ rights, access to information, financial incentives and other indicators. Other top-ranked countries were Denmark, Iceland and Austria. The lowest-ranking ones? Bulgaria, Romania and Latvia—all regions where access to public healthcare remains a significant problem. Whereas government restrictions and lack of access to technology impede the empowered patient movement in developing countries, the biggest hurdle in the U.S., according to advocates, is a culture shift. “There are still a lot of people in healthcare who feel they should know everything, and that it’s better for a patient to just listen to the experts,” says Julia Hallisy, founder of the Empowered Patient Coalition. “But we are the best experts on our own bodies, and with cutting-edge information now at our fingertips, we need to start seeking it out and speaking up.”
Some advocates say the Internet is the best starting point: a virtual gold mine of medical information. “Patients can learn a lot online,” says Torrey. “It’s just important that any information you find online is verifiable.” Research shows that many patients already take advantage of such opportunities. More than 80 percent of U.S. adults say they turn to the Internet as one of their first sources for medical information, according to a recent survey by the Pew Internet & American Life Project.
Patients today are going beyond basic Web research to interactive sites where they can seek advice and, in many cases, chat about their physical and emotional symptoms. For example, CureTogether (www.curetogether.com), a destination for patients to share medical information, has active online communities for more than 350 health conditions, and Diabetic Connect (www.diabeticconnect.com) boasts more than 35,000 registered users.
“The Internet is changing what people know about medicine, creating much more of a symmetry between patients and providers,” says Susannah Fox, researcher at the Pew Internet & American Life Project. “When people have a medical question and need an answer, the Internet allows them, in realtime, to quickly answer it. But it also allows them to dive deeply into a topic and get industrial strength information, instead of consumer strength— sometimes through their peers.”
Although the Internet provides a range of healthcare information to people in any area, it comes with caveats. “Using the Internet provides good information and bad information,” says Judy Swindle, manager of social services and patient advocacy at OSF St. Joseph Medical Center in Bloomington, Ill. “On the good side, patients have more knowledge about possible healthcare options. On the bad side, patients don’t always verify online sources. Anyone can call himself or herself a doctor and put up a Web site.”
Nevertheless, Swindle and her colleagues use the Internet and social media to inform patients. “We have computer stations at the hospital, where patients can access information,” Swindle says. “Over the past year, we have Twittered several surgeries—everything from brain surgery to a birth. Our purpose in doing the live Tweets is to focus on patient education. This way, if there are individuals that need the particular surgery, they might have a little insight as to what to expect. Our followers are from the community as well as all over the country.”
Engelen believes in further expanding the online options. “Healthcare providers need to inform patients about medical options in new ways, such as through social media,” he says. Although some experts might not like this approach, “it will be thrust upon us,” Engelen asserts. “As patients gain access to more information, whatever the source, the classical medical approach of ‘experts know what’s best for the patient’ will no longer work. We are stepping into an era of shared decision making, when physicians and patients will choose the best therapy together.”
When asked if today’s patients already take a more active role in their health, Swindle says, “I think so. People know they need to make informed decisions, and patients now are more knowledgeable of the benefits and burdens of a particular treatment or surgery.” For example, she describes a patient in his 80s who had been very active until he needed heart surgery. “At first, he declined it,” she recalls. “Then, he did some research on his options and the likely outcomes, and he changed his mind.” The patient opted for the surgery. “He’s doing well and is active again,” says Swindle.
Despite the impact of the Internet on empowering patients, more can be done. “The Internet era already changes what patients expect,” says Engelen. “They want healthcare that is available 24/7. Patients expect access to healthcare information that includes choices and options. So far—in my homeland, the Netherlands, at least—healthcare does not offer that option.”
In addition to finding information on treatments, patients can use technology to keep track of their medical records. According to Lenore Janecek, founder of Save the Patient (www.savethepatient.org), an advocacy organization dedicated to empowering patients, “We need to have a concerted effort to educate people, and make them aware of the fact that it’s their right to have this information at their fingertips.” Save the Patient is currently working with a technology company to develop flash drives the size of a key chain, on which patients can carry and access their personal health records.
In the meantime, patients do not feel in control of their records. “From the perspective of average patients,” says Engelen, “their healthcare has been taken away. Their data are being kept from them, and choices are being made for them.”
To gain more control of those choices, some consumers evaluate healthcare providers (mostly at sites like www.rateMDs.com), so that other patients can make informed decisions in selecting physicians. For example, Angie’s List (www.angieslist.com), which requires users to pay to access doctor ratings, has posted patient ratings of more than 6,000 physicians.
Seeds for Change
In a healthcare system that has for so long encouraged patients to be passive, how can putting them at the center of decision making benefit the system as a whole? One advantage is better outcomes. The “National Healthcare Quality Report, 2009,” produced by the U.S. Department of Health and Human Services’ Agency for Healthcare Research and Quality, states that patient-centered approaches improve patients’ health status, lessen symptom burdens and “can reduce the chance of misdiagnosis due to poor communication.”
In some cases, providers already see the potential value of collaborating with patients on healthcare options. For instance, Miller points out, “Three dozen hospitals and clinics—including Fox Chase Cancer Center, Kaiser Permanente and the UCLA Medical Center, in conjunction with the Foundation for Informed Medical Decision Making—have recently launched clinical demonstration sites with the mission of amplifying the patient’s voice in healthcare decisions. The patients-as-partners model is sometimes referred to as Health 2.0.” Such shared decision making, Miller asserts, could save billions of dollars annually, because studies show that it leads patients to choose conservative and less costly treatment options more often. “For instance,” he continues, “when patients with herniated discs were shown a video explaining that similar outcomes could be expected whether they have surgery or not, rates of spinal surgery at Dartmouth-Hitchcock Medical Center dropped 30 percent.”
Time management is another consideration. As Hallisy, who is a dental practitioner, notes, “A patient who comes in prepared, engaged, aware of his or her symptoms and ready to ask questions makes for a much more timely and efficient office visit.”
“It’s true that the majority of my colleagues consider themselves in the old camp, where it’s up to us to give the orders,” says Charles Smith, a long-time family physician and founder, chairman and medical director of eDocAmerica, a Web-based provider of doctor-consumer consultations online. “My personal view is that the only way patients can obtain an optimum outcome is to take responsibility for their own healthcare. We’re the doctors, but it’s their health, their medication, their lifestyle.”
Some studies show how healthcare consumers already demand change. “Top 10 Health Industry Issues in 2010: Squeezing the Juice Out of Healthcare” from PricewaterhouseCoopers, states, “Patients want better access to care, and jams in the delivery system are prompting them to seek quicker and more convenient treatment outside physicians’ offices and hospitals.”
Such options are not merely on the horizon—they are here, and flourishing, today. In 2009, Merchant Medicine’s “Retail Clinics in the United States” report stated, “Retail health clinics have increased nearly 20-fold since 2005 and are beginning to expand the scope of their services to include management of chronic diseases such as asthma, osteoporosis and diabetes.”
Moreover, Kathryn Gohman, chief executive officer of the Patient Advocate Group in Dallas, Texas, points out, “current media coverage of healthcare issues has resulted in opening new doors. Involvement by large companies such as Wal-Mart, which plans to have 2,000 clinics in its stores in the future, will spur others to new ideas.”
Still, no simple strategy empowers all patients. No obvious steps can magically make every treatment safe and effective for every patient in all scenarios. No technology will prevent all medication errors. Nothing will ever make the Internet or any other means of electronic communication infallible. In fact, medical challenges sweep across every aspect of human health and the role of patients in it. Still, these very challenges set the bar for future healthcare. Although the bar for improved health sits high, life and death literally depend on getting over this obstacle, and it cannot be scaled alone. As Miller says, “In the end, better treatment depends on improved participation from providers and patients.”
Only such improved participation—engaging a wider range of participants, including pharmaceutical companies and regulators—can rebuild the public’s trust in the world’s overall health enterprise.
Molly Knight Raskin contributed to this article.
Patients and their advocates have an unprecedented amount of information sources available to them. The nature and degree of proactive engagement in treatment options among consumers can impact the regulatory, discovery and business aspects of health.
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