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Serious Side Effects
PREFACE: As medicine continues going "high-tech," plenty of "low-tech" conversations still go on. One of them: How should health care professionals and the pharmaceutical industry relate to one another? It was exactly seven years ago, in the March/April 2002 issue of this journal, that the subject was tackled by four Narrative Matters authors with differing viewpoints. In the years since, some aspects discussed then remain the same; others changed or are changing. Several academic medical centers have created guidelines to insert firewalls between the medical profession and the drug industry. But as Jonathan Han writes, in his physician practice, the new guidelines produced unintended consequences for needy patients—and a new dilemma for their doctors. Next, recent medical school graduate Melinda Morton details her attempts—still fresh in her mind—to turn down free "drug lunches" during her student clinical experience. Adding to the current mix is a 2008 task force report on the subject from the Association of American Medical Colleges and a revised voluntary marketing code issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) to reinforce "responsible interactions" that went into effect earlier this year.
ON A SUNNY FALL MORNING Mr. Waite limped into my office carrying a newspaper. Grinning, he pointed to a front-page article and announced, "You’re famous now!" As a family physician practicing in a hardscrabble steel-mill town, I accepted his greeting and assessment with trepidation. It was September 2007, and I hadn’t seen Mr. Waite in more than a year. Although he still had the strong handshake and calloused hands that had built a successful construction business, he was now a frail sixty-two-year-old. A few months before his last visit, I’d diagnosed him with prostate cancer, and he’d started radiation and hormone therapy, tolerating numerous side effects with stoic acceptance. Then his health insurance premiums rose to unaffordable heights—and, three months into his cancer treatment, he’d lost his insurance coverage. Unable to afford care on his own, he’d stopped being treated. In the fifteen months since I’d last seen him, he’d developed serious urinary tract problems. Despite his progressive illness and pain, Mr. Waite had worked as much as he could to support his family. It was an all-too-familiar pattern—many patients in similar painful physical and financial straits proudly refuse public assistance. As his untreated prostate cancer grew, his urinary problems worsened. Mr. Waite became unable to work, his business failed, and his family was now experiencing serious financial hardship. Finally accepting that he was incapacitated, Mr. Waite applied for and started receiving Social Security disability benefits that allowed him to reestablish care at our practice. His state-funded health insurance didn’t, however, cover the cost of his many prescription drugs.
WE SAT IN THE EXAM ROOM RECONNECTING and discussing the interview I’d given our local newspaper. Winded just walking into the exam room, Mr. Waite managed to maintain his grace and good humor as he needled me about my new-found notoriety. Because I care for a medically underserved community, I’d been asked to comment on a major policy about to be put in place in our practice in the coming months. In general, the new policy was excellent. But there was a potential problem: I believed that the new policy would negatively affect many of our patients without prescription drug coverage—patients like Mr. Waite. The debate about the policy began when the large academic medical center (AMC) health system that owns our practice followed the lead of other prominent AMCs and announced a new conflict-of-interest policy. It restricted our doctors’ contact with pharmaceutical companies—including forbidding us from accepting free drug samples. Our new "industry guidelines" for dealing with the pharmaceutical and technology industries were developed from a 2006 proposal by Troyen Brennan and colleagues in the Journal of the American Medical Association, earlier policies in our health system, and policies created by the Association of American Medical Colleges (AAMC). They were intended to curtail the influence of the pharmaceutical industry over physicians’ prescribing practices. (Considering that in 2006 the industry generated $272 billion in sales, constituting 10 percent of the nation’s annual health care costs, that’s a lot of potential influence.) Another concern behind the industry guidelines was the eroding public trust in doctors who were persuaded to prescribe expensive brand-name drugs. Some of these drugs are no better than existing generic counterparts, yet doctors prescribe them at the urging of drug company representatives who’ve plied them with brand-embossed pens, catered lunches, upscale restaurant dinners, and other enticements. In the newspaper I expressed my concern with our new policy, that when our health system put its industry guidelines into effect, it would have "serious unintended consequences" for our uninsured and underinsured patients who depend on free drug samples from their doctors. They’re not the only ones in need. Today more than forty-seven million people in the United States don’t have health insurance or prescription drug coverage. In 2007, an additional twenty-five million people had health insurance but were underinsured and often experienced significant financial stress. Insufficient access to needed medications and medical care is a major preventable cause of illness and death in this country. Because Mr. Waite relied on free drug samples from our office before—and was hoping to do so again—he was understandably concerned about the financial and medical consequences of losing his no-cost medications under our new policy—and pleased by my public comment. In addition to prostate cancer, Mr. Waite had diabetes, chronic lung disease, and high blood pressure. The cost of his twelve-drug regimen (which included costly insulin and inhaled steroids) exceeded $900 a month, and many of his medications weren’t available in the popular $4 generic prescriptions sold at some pharmacies. The brand-name drug samples we’d given him in the past had helped him manage his medical problems, and they’d lowered his prescription costs enough to allow him to pay his utility bills.
I WAS AS FRUSTRATED AS MR. WAITE BY THE LIMITED medical care and medications available to the uninsured and underinsured. At the same time, as a society, to provide sustained health care for all, we need effective cost control, and evidence-based prescribing practices are an essential part of achieving that. Many doctors don’t use—and discourage the use of—free drug samples because they contribute extraordinary costs to U.S. health care. In 2005 alone, the pharmaceutical industry spent $18.4 billion on drug samples. Whether the costs of drug samples and the industry’s other promotional activities (such as direct-to-consumer advertising) contribute directly to rising retail drug prices is a matter of debate; many think there is, indeed, a direct relationship. Pharmaceutical companies intend for drug samples to be marketing tools. Doctors know this, nonetheless believing that they prescribe medications on the basis of scientific evidence. But the drug companies have it figured out: multiple studies demonstrate that pharmaceutical company marketing strategies—including providing drug samples—do influence physicians’ prescribing behavior. Uninsured patients who are struggling financially also influence prescribing physicians. Although most drug samples are distributed to patients who have insurance, a study by Sarah Cutrona and colleagues in the February 2008 American Journal of Public Health found that when uninsured patients received care in an office setting, they were more likely than insured patients to receive drug samples. From years of caring for patients like Mr. Waite, I’ve learned to compromise. Cobbling together treatment plans requires resourcefulness, accepting the uncertainties of undertreating versus not treating, and learning to respect patients who must give their health low priority. Despite my concerns about influence and the cost to society, I use drug samples to improve the chances that my patients will take their medications; it’s a compromise that I weight toward the interests of the patients sitting in front of me. Many doctors feel this tension and worry.
MY PRACTICE IS PART OF A FAMILY MEDICINE residency program in which I and others in the practice are faculty members. In August 2002 our faculty group took on the issue of how to deal with the needs of "medically indigent patients" (which is how someone like Mr. Waite is often described). Led by an experienced pharmacist, we set out to develop a plan to get medications for this group of patients in our residency program health center. Our goal was to provide both patient-centered services and responsible messages about conflicts of interest to our residents and medical students. We put in place what we called a hybrid drug distribution model, providing needy patients with medications that mix generic drugs and carefully selected brand-name drug samples. The hospital that our practice is part of supported the endeavor, and on an ongoing basis provided us with a limited number of generic drugs at no cost (as part of its nonprofit activities), which we gave without charge to patients who met income guidelines established by the health system. Over time, we also were able to expand the number of generic drugs available because of the hospital-negotiated pricing; otherwise, the retail price of the generic drugs would have been five to fifty times higher. (Put another way, for a generic the hospital bought at the negotiated rate of $1, a patient would have been billed between $5 and $50 for the same generic or brand-name drug at a pharmacy.) The drug cost to our hospital in a given year: less than $1 for each patient visit (17 percent of the patients in our health center were uninsured). Because the types of hospital-subsidized generic drugs available to us were generous but not comprehensive, we decided to accept drug samples from drug company reps—who were eager to make them available. We believed it was necessary—but we also recognized the "slippery slope" aspect of our decision. That’s why our residency program simultaneously established a pharmacy and therapeutics committee made up of pharmacists, physicians, and nurses, which met regularly to determine the drug samples to accept and the procedures to follow. We used a computerized tracking system to inventory all of the drug samples we received; this allowed us to monitor physicians’ prescribing patterns and contact patients if there was a drug recall. We also had to comply with the Prescription Drug Marketing Act of 1987, which explicitly forbids pharmaceutical manufacturers from using drug samples to provide chronic disease maintenance for the medically indigent. So, whenever possible, and despite an often onerous application process and several-week response time, we tried to enroll our patients in manufacturer-specific patient assistance programs (PAPs) designed for patients with little or no insurance. The time it took to support this hybrid medication distribution program was substantial. In a family medicine practice such as ours, where a sizable amount of patient care goes unreimbursed, the additional time spent procuring and distributing medications to needy patients might have been used to improve our bottom line. We decided that the medication distribution program was equally important. In 2006 alone, our practice prescribed more than 1,800 drug samples to 330 patients. Then, in May 2007, the systemwide conflict-of-interest policy was announced. Under the new guidelines, we would have to eliminate our successful hybrid drug program—no more free drug samples would be allowed—and the result would be devastating for many of our patients. "There will definitely be some serious problems if they take these samples away," Mr. Waite declared, pointing to the newspaper article. I nodded in agreement. The issues of inappropriate pharmaceutical company influence, excessive drug costs, and the needs of uninsured and underinsured patients all came together terribly.
NOW WE CAN LOOK DOWN THE ROAD AT WHAT lay in store for Mr. Waite. In a couple of minutes, my exam would reveal an enlarged, hard prostate, meaning that his cancer had progressed. In a few weeks, he would undergo surgery to relieve his urinary obstruction, then resume the hormone therapies he’d stopped when his insurance lapsed. In the next nine months he would be hospitalized several times with complications related to his cancer. It’s now March 2009, thirteen months since the conflict-of-interest policy went into effect here. Free "drug lunches" and brand-embossed pens have largely disappeared from our health system’s many hospitals and practices. Mr. Waite continues to have state-funded health insurance that covers his numerous hospitalizations. Because he lacks prescription drug coverage, however, and now needs even more medications (some of which are very expensive), he still struggles to pay for them. But now he also has help. In November 2007, there was a significant amendment to our health system’s conflict-of-interest policy that allows us to provide Mr. Waite and others with generic drugs and brand-name drug samples, lightening their financial load and improving their odds for treatment. Here’s how it happened: Shortly after the health system’s May 2007 announcement that it planned to put in place the new conflict-of-interest policy, many physicians let it be known that they didn’t want to eliminate our hybrid drug distribution program to medically indigent patients. My comments in the newspaper about the "serious unintended consequences" of ending the program foreshadowed a spirited and sometimes contentious debate between supporters of distributing drug samples and ardent advocates of the conflict-of-interest policy who were comfortable banning them completely. In response, our health system created a subcommittee made up of pharmacists, physicians (including me), and administrators. Our charge was to determine whether brand-name drug samples could be responsibly prescribed from physicians’ offices. Our carefully considered answer: "Yes." We went on to establish a centralized drug sample distribution program for the health system, an approach that was similar to what was later recommended in a June 2008 task force report from the AAMC titled "Industry Funding of Medical Education." (The chair of our subcommittee also served on the AAMC task force.) Our program greatly limits the access that drug reps have to our physicians, and it prohibits our physicians from receiving drug company marketing paraphernalia and other blandishments. Giving our patients free drug samples is still permitted—as long as specific documenting and education requirements are met. Members of our committee realized that we were making a compromise in accepting drug companies’ marketing practice of providing free drug samples. We felt compelled to do it, though. For vulnerable patients like Mr. Waite, drug samples were a medically necessary "work-around" (in his case, even though his prescriptions costs continue to strain his finances, we have reduced them dramatically). We feel fortunate—for the time being, anyway—to be able to continue prescribing drug samples to our needy patients, although we also have deep underlying concerns about how this nation should be providing health care for the underserved. The bottom line: Our hybrid drug sample program is a local, temporizing measure. It assists only a tiny fraction of our uninsured and underinsured patients who need medications—and we know it. It’s a work-around for us, too, putting us in the awkward position of being health care procurers in addition to our roles as health care providers. What we came up with is only a short-term solution, one that enables and incentivizes a profoundly broken health care system to remain unchanged. Ultimately, a safety net woven from a patchwork of work-arounds of this sort isn’t financially or physically sustainable—and there already isn’t enough time for the majority of physicians to support efforts like ours. Nor should they have to. Am I angry that we had to cobble together this type of dysfunctional status quo program to ensure that our patients receive what they need? Absolutely. It’s a morally suspect compromise. It’s also untenable for doctors and other health care providers to be put in a position where you’re damned if you do—and patients die if you don’t. We in the United States haven’t yet addressed the fundamental question of whether health care is a human right, nor have we yet solved how to reverse disparities and improve quality of care for all patients. The way it works now, allocating limited medical resources is often determined by who is "deserving" versus who is "undeserving"—a malignant form of neglect. In the health center where I work, we care for the "worried well" and the critically ill, the morbidly obese and the recalcitrant bulimic, the deeply depressed and the recovering alcoholic, the excon and the college provost. Taken as a whole, these patients represent every permutation of wealth and insurance status (including the complete lack of it). Compassionate, patient-centered medicine calls for physicians to respond empathically and care for every patient, validating each individual as unconditionally "deserving" of care. Is it possible for us to recapture the altruistic spirit expressed in our medical school admission essays and to embrace the idealism of Hippocrates and Maimonides, whose oaths and prayers we recite at medical school commencement ceremonies? To my mind, AMCs must take the lead in advocating not only for greater accountability in conflicts of interest, but also for equal access to high-quality medical care for all. I believe that the example set by the academic community can, indeed, promote change. Whether our health system’s industry guidelines work remains to be seen. But since they (or variations on them) were adopted by prominent academic health centers, the Pharmaceutical Research and Manufacturers of America (PhRMA) has created a voluntary revised marketing code, Code on Interactions with Healthcare Professionals, that went into effect in January 2009. It prohibits a number of previously sanctioned drug company marketing practices.
DURING A RECENT VISIT, MR. WAITE AND I talked about his ongoing efforts—and frustrations—in trying to make ends meet. Despite the medications we provide though our hybrid drug program, he was once again beginning to sacrifice some expensive medications he still had to buy as his cancer progressed and his family’s utility bills rose even higher. Would we be having this conversation, I wondered, if three years earlier he’d been able to keep his health insurance and continue treatment for his prostate cancer? And would he now need all of these expensive new medications for his worsened problems, some of which aren’t available either as samples or as generics? Soon we returned to our conversation of eighteen months ago, when we’d shared a laugh about my outspoken comments in the local paper. Mr. Waite thanked me again for speaking up for uninsured and underinsured patients like him. I know my small effort might not improve access to health care for folks like Mr. Waite. The conflict-of-interest issues involved are deep and longstanding. As Jerome Kassirer, former editor of the New England Journal of Medicine, wrote in 1995, "Market-driven health care creates conflicts that threaten medical professionalism." Millions of patients and health care professionals still worry about that. "Did you get in trouble for making those remarks in the paper?" Mr. Waite asked, winking. "Just a little," I said. But I knew it was something I had to say.
Jonathan Han (hanjk{at}upmc.edu) is medical director of the University of Pittsburgh Medical Center (UPMC) New Kensington (Pennsylvania) Family Health Center, and a faculty member of the UPMC St. Margaret Family Practice Residency Program. At the patient’s request, his name and certain identifying details have been changed. The author appreciates editorial assistance and support from Audrey Young, Royal Rhodes, and Marilyn Fitzgerald.
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A Frustrating Compromise
An Earlier Solution
