A custom collaboration with: Quintiles
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.”
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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