The Danger Within Us

by Jeanne Lenzer

  These conflicts of interest led to millions (if not billions) of wasted taxpayer dollars—all in pursuit of a hugely expensive drug that was no more effective and caused more brain hemorrhages than an alternative drug.

  Yet Braunwald is unperturbed by the appearance of impropriety. In 2013, I asked him whether he was concerned about conflicts of interest when academic researchers partner with industry. He told me:

  This problem has been largely corrected by the development of rigorous disclosure rules, requiring academic investigators to list all of their financial ties to companies with whom they have a working relationship. Most academic institutions now have conflict-of-interest committees which evaluate their faculty’s relationships with industry. I think that the problems on the downside are not gone, but I would say it has been reduced by about—I would say by about 90–95 percent.359

  Braunwald went on to say that academics “have to partner with industry [because] they play a vital role.”339

  While Braunwald claimed that the problem of conflict of interest was 90–95 percent solved, the real-life human toll caused by financial conflicts has continued to mount—at Harvard and elsewhere. And Eugene Braunwald would continue in ensuing years to play a central role in the drama.

  * * *

  On December 13, 2006, four-year-old Rebecca Riley was found dead after her mother gave her an overdose of prescribed drugs for “bipolar disorder.” A public outcry followed Rebecca’s death, which raised tough questions about the ethics of diagnosing bipolar disorder in a toddler.360 There were calls for criminal charges against Rebecca’s psychiatrist, Kayoko Kifuji, but Kifuji defended herself, saying she was following the recommendations of Harvard psychiatrist Dr. Joseph Biederman, chief of the clinical and research programs in pediatric psychopharmacology and adult ADHD at Massachusetts General Hospital.

  Biederman had almost single-handedly changed pediatric psychiatry by insisting that bipolar disorder could be diagnosed in children as young as two years old, and his work was credited with a forty-fold increase in pediatric bipolar disorder diagnoses. His academic credentials at Harvard gave his recommendations credibility, and doctors and parents alike accepted his recommendations.

  An investigation by Senator Charles Grassley found that Biederman failed to disclose that he had received $1.6 million in research funding from fifteen drug companies between 2000 and 2006.361, 362 Two of the companies, Eli Lilly and Janssen Pharmaceuticals, manufacture two of the antipsychotic drugs he recommended for childhood bipolar disorder, together generating several billion dollars in revenue.363

  Public outrage over Biederman’s role in promoting the drugs led Harvard to form a commission to revise the university’s conflict-of-interest policy. Braunwald presided over the commission, and in 2010, after eighteen months of deliberation, he announced changes to the policy that were reported in the media as being “unusually stringent”—even though Harvard researchers could still accept vast sums of industry funding. Although doctors giving talks on behalf of drug companies were prohibited from accepting gifts with a value of $50 or greater, Harvard doctors could still take as much as $5,000 per day for “consulting” with industry under the new “stringent” rules.

  There’s no doubt that Eugene Braunwald has contributed enormously to scientific and medical knowledge. His stature as one of the leading medical researchers of our time is well deserved. Yet he also embodies some of the most troubling features of the medical-industrial complex. Above all, Braunwald’s career illustrates how greatly truth can suffer when the disinterested quest for scientific fact and human benefit becomes interwoven with the drive for profit. And when truth suffers, people suffer.

  Chapter Twelve

  What Is to Be Done?

  THE PROBLEMS I’VE DESCRIBED in this book are big and complicated. Fixing them will be a daunting challenge. But it’s not impossible. Many brilliant, determined individuals with deep knowledge of the issues are already hard at work on solving them.

  One of the leaders of this effort is Bernard Lown. At the age of ninety-five, Lown has a long list of achievements behind him. Along with two colleagues, he identified an abnormal heart rhythm known as the Lown-Ganong-Levine syndrome. As a young cardiologist and researcher at Harvard, he uncovered a critically important link between digitalis, a powerful heart drug, and low potassium, which could cause a deadly reaction.

  Lown has also been a lifelong activist. He founded or cofounded nearly half a dozen organizations over the course of his career, including Physicians for Social Responsibility, a national anti–nuclear weapons group, and International Physicians for the Prevention of Nuclear War, for which Lown and his cofounder, then Soviet cardiologist Evgeni Chazov, accepted the Nobel Peace Prize.

  But of his many accomplishments, Lown is perhaps best known for leading the effort to develop the modern cardiac defibrillator, which he and José Neuman invented in 1962. Lown had begun working on the device in response to the problem of “sudden cardiac death,” a leading cause of mortality in the developed world. Lown realized that, because sudden cardiac death is caused by an electrical failure of the heart and not necessarily by a heart too old or damaged to function, sudden-death patients could be brought back to life.

  Before 1962, heart surgeries were rare, and mortality was high. The defibrillator led to the creation of coronary care units where heart attack patients could be watched closely and resuscitated with the defibrillator. The invention also led to a dramatic increase in heart surgeries because doctors had a way to reliably restart hearts they’d paralyzed for surgery.

  But over time, Lown would grow increasingly alarmed by the explosive increase in risky and invasive surgeries and other procedures that his invention helped bring about. He strongly suspected that many of these procedures were unnecessary. In the 1970s, Lown proposed a randomized controlled trial to test treatment options for patients suffering from blockages in their coronary arteries. In the test, half the patients would undergo surgery and half would be managed medically. But cardiothoracic surgeons were outraged and declared that such a study would be “unethical.” For them, it was obvious that surgery was the only way to treat blocked arteries. Anything less, they assumed, would be malpractice.

  Unable to launch the sort of study he wanted, Lown decided instead to study patients who had already been told they needed surgery but who sought a second opinion from him. He published his results in the New England Journal of Medicine in 1981.364 Of 212 men studied for just shy of five years, eleven died (yielding an annual mortality of 1.4 percent), and only nine required bypass surgery. Lown concluded, “There is rarely a need to resort to cardiac surgery; medical management is highly successful and associated with a low mortality.” But his findings were ignored. No one believed them.

  Over time, bypass surgeries were replaced by a new treatment: doctors began to implant wire or mesh tubes called stents to prop open the tiny arteries that feed the heart. Each year, 700,000 Americans have coronary-artery stents implanted, according to a report in 2013 by Bloomberg News.

  As discussed in chapter 4, interventional cardiologists first assumed that these procedures were an improvement over open-heart surgery. But it was an assumption not based on any scientific studies, and Lown wasn’t convinced.

  He was proved right in 2012, when a meta-analysis of stent implants in 7,229 patients found no benefit in terms of a reduction in future heart attacks or death in patients who had stents placed electively (as opposed to during an evolving heart attack on an emergency basis).130 Another study confirmed the problem: in 144,737 patients who underwent percutaneous coronary interventions (PCIs), only half (50.4 percent) of the PCIs were found to be “appropriate.”365

  Unfortunately, few heart patients are aware of these sobering statistics. Lown told me about a talk he gave in 2013 to his fellow cardiologists. When he asked them to raise their hands if they told their patients that placing stents in a non-emergency situation would not reduce their chances of dying or of having a
nother heart attack. Lown says, “They just hung their heads. No one said a thing.”

  Lown has come to believe that the most important of all his accomplishments as a physician has been his commitment to educating scores of young cardiologists in the art of “doing as little as possible to patients and as much as possible for patients.” Lown recognized, long before most other physicians, that patients were being subjected to unnecessary treatments and tests—and deprived of the real care they often needed as much as or more than the technological wizardry of modern medicine. He has also come to believe that the problem of overtreatment could help unite people around a new healthcare reform movement by exposing the structural problems underlying a greed-fueled system that betrayed the public health in its drive for profits.

  Lown’s longtime colleague Vikas Saini, who trained with Lown and became president of the Lown Foundation in 2007, played a role in his decision to focus on overtreatment. After reading journalist Shannon Brownlee’s book Overtreated, Saini called Brownlee and asked her, “What are we going to do about this?” In a series of conversations, they agreed that many physicians and other healthcare professionals share concerns about the dysfunction of the healthcare system but lack a forum in which to discuss them or develop solutions.

  Lown and the nonprofit organization he founded would provide such a forum. In 2012, the Lown Foundation and the New America Foundation, a think tank where Brownlee was working, convened the first meeting ever held on the topic of overtreatment, or unnecessary care. The audience was filled with many luminaries in medicine as well as rank-and-file doctors from around the country and a number of patient activists. Audience members included doctors from Physicians for a National Health Program, the president of the Institute of Medicine, members of the Service Employees International Union, the National Physicians Alliance, women’s health groups, and patients’ rights organizations. I was there in my role as a medical journalist, sitting alongside Jerry Hoffman, the expert on medical illusions.

  As Bernard Lown took his place at the podium, he looked around the airy conference room, taking in each attendee in turn, then said slowly, “Ever since starting clinical practice sixty-two years ago, I have looked forward to this meeting.” It was a powerful statement. This lion of medicine was signaling that this moment, this effort to launch a sustained movement to transform healthcare, was the pinnacle of his life’s work. Lown had titled one of his books Never Whisper in the Presence of Wrong. On this day, Lown would roar.

  His opening statement must have resonated with many of the doctors, nurses, patients, and policy makers in the auditorium that day, who, though each had his or her own reasons for coming, shared a growing disillusionment with medicine, a sense of isolation, and a feeling of frustration with a massive bureaucracy that forces patients through a healthcare system as if they were mere widgets on an assembly line. During conference discussions, clinicians in the room expressed their yearning to connect with their patients and their frustration with the realities of modern healthcare, which force them to check off an increasing number of boxes on a computer, leaving less time to truly listen to their patients. They felt helpless individually to change the situations they face. But this moment, the moment Lown said he’d looked forward to for sixty-two years, was empowering. What one couldn’t do, many could.

  That moment would mark the birth of a new movement to fix the damage caused by our broken healthcare system. It is a movement that has the potential to radically transform the status quo but that will require profound changes in the culture of medicine and nursing and in society as a whole.

  Lown continued, “If more than half a century ago overtreatment was at a trickle pace, it is now at flood tide.” He quoted Jerry Hoffman, calling the simultaneous undertreatment of some individuals and overtreatment of others the “Siamese twins of profit-driven medicine.” He went on:

  High-sounding principles are used by advocates of market-driven medicine to polish its image and are merely incidental.…I believe that the market is not a solution. Indeed it is a major part of the problem. My objection to market-dominated healthcare is on deeper grounds than economic. In a democratic society healthcare must be a right, not a privilege. The underlying issues relate to essential moral principles. At the core…is a covenant of trust between health professionals and patients…[and] the expectation that the patient’s needs will be placed first, over and beyond personal interests of any third party.

  There is a moral absolute in medicine to help and never to wrong the patient. No such moral absolute can be found in the marketplace. Caveat emptor, let the buyer beware, is its underlying admonition. The warm and fuzzy rhetoric that “patients come first” is a transparent marketing ploy. For-profit healthcare is essentially an oxymoron.

  When Lown finished his speech to thunderous applause, Hoffman turned to me and said in a reverential tone, “He’s like Martin Luther King—and many of the people applauding him have no idea just how radical both of them are.”

  Bernard Lown and his followers aren’t the only ones striving to fix the problems created by the medical-industrial establishment. The Mario Negri Institute for Pharmacological Research, founded in 1961 in Italy, was conceived as a way to conduct medical research free of commercial distortions. Its 750 researchers and staff members are all salaried and receive no additional financial rewards for their discoveries. They do not hold patents for their inventions, instead turning over patent rights to manufacturers for one dollar. The institute has been proving for more than half a century that scientists will not only innovate but will also produce some of the most important research in the world without the incentives—or distortions—of profit.

  Donald Light, coauthor of Good Pharma, a book about the institute, notes that its research into drug treatments for cancer, heart disease, kidney diseases, and many rare ailments as well as its studies of environmental toxins, drug addiction, and epidemiology have won widespread respect. Its carefully constructed heart attack studies, published in the most prestigious medical journals, include one that was responsible for refuting the claim promoted by Braunwald and other industry advocates that the expensive new clot buster tPA was superior to streptokinase for the treatment of heart attacks.351, 366

  Free of commercial pressures, Mario Negri researchers can do what industry-sponsored researchers generally can’t or won’t do. In Light’s words, “They can research any active ingredient that might help with a disease whether it is patentable or not.” They can also conduct head-to-head trials of drugs to determine which is superior for a particular condition, including studies that compare older, cheaper drugs to newer, more costly offerings.

  Since institute researchers are insulated from market forces, they are also free to research environmental toxins without fear of retaliation from corporate sponsors. In the wake of a huge chemical explosion in Italy in 1976, cabbages, turnips, and cats were found to be dying of an unknown cause. Negri researchers were able to trace the problem to dioxin, a chemical then being produced by the pharmaceuticals company Roche that is related to Agent Orange. However, the institute does accept up to (but no more than) 10 percent of its budget from industry—with non-negotiable conditions usually not required by contract research organizations. According to the institute’s director, Silvio Garattini, these conditions require that the institute must be solely responsible for the planning and conduct of any study and that “ownership of the data and any decision made regarding their publication belongs to the researchers without any influence from the company.” These strict rules led one company to back out, unwilling to grant full independence to the institute.367

  During the first two decades of the twenty-first century, other groups of professionals and activists dedicated to reforming the healthcare system have emerged. By 2016, the “new civil rights movement for healthcare” that Lown envisioned was beginning to take shape. Many leaders of this new movement gathered that year in Chicago at the fourth annual conference of the Right Care Allia
nce, a project founded by the Lown Institute that welcomes all groups and individuals committed to healthcare reform, from labor unions to doctors’ groups to patient safety organizations.

  Some speakers focused on the ways medical overtreatment in the US tends to crowd out other forms of social spending. For example, Lauren Taylor, a PhD student at Harvard Business School and coauthor of The American Health Care Paradox, explained that for every dollar spent on healthcare, the US spends only ninety cents on social welfare programs such as those that offer job training, housing, and nutritional counseling. By contrast, other wealthy nations belonging to the Organisation for Economic Co-operation and Development (OECD) spend two dollars on social welfare for every dollar spent on medical care—and enjoy longer life expectancies and lower infant mortality rates than the US does.368

  Other speakers analyzed the social disparities in US healthcare and described programs that could help reduce them. Jeff Brenner, a family physician and executive director of the Camden Coalition of Healthcare Providers, in Camden, New Jersey, recounted his experiences working in a poor Puerto Rican and Dominican community beset by violence: “Primary care is utterly failing. We run from room to room to room in meaningless increments of meaningless fifteen-minute visits.” Brenner found that his patients, “swept in and out of a vortex of chaos,” were experiencing chronic stress that could lop twenty years off their lives. Under these circumstances, “right care” means changing living conditions. So Brenner and his group raised money to put people with highly complex medical problems into new apartments with a variety of social supports. Not only did their health improve, but costs also went down. (Brenner was profiled by writer and surgeon Atul Gawande in the 2011 New Yorker article “The Hot Spotters.”)369