A number of speakers at the Right Care conference emphasized the need for a broad-based popular movement comparable to the civil rights movement of the 1960s to combat the complex economic and social problems affecting US healthcare. Urban planner and political scientist Phil Thompson recalled growing up “in a family and a network of churches very involved in the civil rights movement” and said that, for the healthcare reform movement to succeed, change must first take place among the people trying to make the change. “The real knowledge leaders are the people who live in the community…but we can’t build a movement if everyone shrinks when a doctor walks in a room.”
Eliseo Medina, an immigrant from Mexico who went to work after eighth grade picking grapes and worked with Cesar Chavez for eighteen years in the California farm workers movement, called healthcare an essential element of social justice that demands the same sort of mass action farm workers had to take. He said although Obamacare “is an achievement over what we had…it falls far short of what is needed. Far too many people still don’t have care.” He urged the audience to “discuss strategies and to plan for change,” adding that “the road will be long and hard, and it will seem you’ll never reach your destination. But if you persevere, there will be victories along the way.”
Shannon Brownlee and Vikas Saini, as cochairs of the Right Care Alliance, know that one of their jobs is to lay out a strategy for a better system—and a vision for what that system would be like both for patients and the people who work within it. They have a “grand strategy,” a term they’ve borrowed from foreign policy experts for a system that integrates healthcare with public health and a concerted national effort to improve health not only with proper medical care, but through social, agricultural, and jobs policies, a strategy, they hope, will serve as a road map for the Right Care Alliance’s campaigns.
It isn’t clear whether the Right Care Alliance will succeed—or even last. But it represents the kind of union among professional leaders, economic and technical experts, and social and political activists that will be necessary to effect systemic changes to the current system of market-driven medicine.
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One change that would go a long way toward simultaneously reducing undertreatment and overtreatment as well as reducing costs is the establishment of a single-payer health insurance program, sometimes dubbed Medicare for all, in the US. This is the kind of health coverage already routinely provided to citizens of most developed countries. In countries with national health plans, polls show that citizens are happier with their healthcare than their counterparts in the US are—and that their health outcomes and life spans surpass those of US citizens, with a far lower price tag.370, 371
In the US, patients complain that they are rushed through their doctor visits as if they were on an assembly line, a problem that arises in large part because the US system requires doctors to track and code every single diagnosis, lab test, and action for billing purposes. Time-motion studies show that US doctors spend more than two hours in administrative tasks for every one hour actually seeing patients and as many as one of every five hours doing purely billing-related tasks.372, 373 Doctors in England, Canada, and other well-off nations, freed of the burden of tracking every action for billing purposes, can spend less time doing administrative work and more time with their patients.
The French healthcare system provides every citizen with a card that looks much like a credit card and has his or her entire medical record embedded in it, including information from every healthcare provider who sees the patient. Because the patient carries the card with him or her, there are no delays or duplicate test orders because one doctor doesn’t have the record from another doctor. Tanya Blumstein, an American, describes the difference between the care she received in the US and the care she received in France as an expectant mother. She says care in the US was “hellish” because she had trouble getting insurance (pregnancy was considered a preexisting condition), and when she did get insurance, she had to work her way through expensive premiums, a high deductible, copays, coinsurance, and out-of-network costs. When she was pregnant in France, she could simply show up at a neighborhood health clinic at any time, with or without an appointment. When her baby was born and became sick with the flu, a doctor came to her home at 3:00 a.m. on a Sunday—all paid for by French public healthcare. During the first week after she gave birth, a nurse came to help with any needs she might have, a service provided to all new mothers in France.374
France has one of the lowest infant mortality rates in the world.
Consider, by contrast, the role that our current dysfunctional system of private health insurance has played in limiting access to care, through its extraordinary complexity and expense, and accommodating overtreatment. The latter point may seem counterintuitive, but by leaving everything to the marketplace rather than making rational allocations based on the needs of each community, the insurance industry has promoted the rise of the for-profit medical device industry that led to Dennis Fegan’s ordeal. Insurers paid for the VNS device, just as they paid for the treatment of thousands of patients who were hurt by the off-label use of spine implants, unnecessary stents, ASR XL hip implants, and many other flawed devices and procedures.
Contrary to public perception, commercial insurance not only fails to control medical costs in general, it often helps drive overtreatment. Competition among commercial insurers and cost-plus reimbursement schemes, in which insurers receive a percentage of any contracts to cover patient care means that insurers benefit from offering coverage of big-ticket items such as costly medical devices. Insurers pay for these items partly to compete with the offerings of other insurers and partly because the bigger the overall healthcare pie, the bigger their slice of it. In other words, a slice of a several thousand dollar contract covering employees for only minor care would reap little profit compared with a slice of a multi-billion dollar contract covering heart surgery (necessary or not) and organ transplants.
Commercial insurers create massive administrative waste, and they contribute to the preferential treatment of well-insured patients over others. David U. Himmelstein, professor of public health at the City University of New York and a visiting professor at Harvard Medical School, says that insurers have every incentive to “promise the world while delivering as little as possible.” So while insurers will cover big-ticket items such as coronary stents (because that’s where the money is), they will use every tool available to block or deny coverage on an individual basis after they’ve won a contract to provide insurance to an individual or a group of employees. Denial of coverage is achieved with a variety of small-print exclusions in policies that leave patients holding the bag.375, 376, 377
The American system of paying physicians for specific services provides an incentive for the use of medical devices, whether they are effective or not. Patients have been charged as much as $100,000 for VNS implants, including the price of the device itself, the surgeon’s fees, and hospital charges. And doctors have a regular, reliable income as patients return for scheduled checks of and adjustments to their VNS devices, each visit costing several hundred dollars. The allure of substantial financial gain inevitably tempts doctors to take the device company’s claims at face value rather than questioning them. Doctors paid with a salary would have no financial motive to perform needless surgeries or implant devices of questionable value. Conversely, a single-payer system eliminates the perverse financial incentives for insurers to reward doctors and their institutions for “saving” money by doing less for certain patients.
Medicare for all, or a single-payer system in which doctors are salaried, could ease or eliminate each of these problems. It would reduce overtreatment by removing financial rewards to doctors for doing more while tackling the problem of undertreatment by providing everyone with access to care.* And because everyone would be covered under the same plan, a single-payer system would eliminate preferential treatment of patients based on tiered insurance plans. And a
single-payer plan would still allow the availability of additional private insurance for individuals who choose to pay for add-on or “boutique” benefits.
Pundits and politicians often claim that Americans simply won’t accept single-payer universal healthcare. Yet polls from the Kaiser Family Foundation, Gallup, and others consistently show that a majority of the US population supports the idea of Medicare for all.378, 379 And, depending on the poll, roughly half or more of doctors also favor some form of a single-payer system, either along with the option for private insurance or without it.
The patent system, which provides enormous bonanzas for companies that develop and successfully market high-priced medical devices, is also ripe for reform. Patent protection for valuable inventions was developed to encourage and reward scientific creativity. But in recent years, the system has been so exploited that it is now obstructing rather than assisting innovation. Patents discourage open sharing of ideas, and because patents are awarded for trivial changes to preexisting items, monopoly extensions have become commonplace—with no benefit to the public. Dean Baker, an economist and codirector of the Center for Economic and Policy Research, in Washington, DC, estimates that getting rid of drug-company patent monopolies would save $270 billion annually in drug costs.
The goals of the system are further subverted by patent trolls—individuals or companies that amass patent rights with no intention of producing—or even the ability to produce—the product patented. Instead they file for patents with the sole intent of suing companies for infringement when they attempt to actually produce the items. This proves profitable for the patent trolls, because companies will often agree to a settlement rather than take on long and costly court battles. A study at Boston University found that patent trolls have drained the US of $500 billion since 1990.
Furthermore, industry often uses research developed on the public dime for private gain. Patents that are developed at taxpayer expense should belong to the public. Free-market advocates often oppose changes to the patent system on the grounds that new discoveries will grind to a halt unless profit incentives are maximized. But the experience of the Mario Negri Institute suggests otherwise. So does history. Scientists have always been driven to their discoveries by intense curiosity—not the promise of profits. Galileo, Einstein, Edward Jenner, Alexander Fleming, John Snow, Ignaz Semmelweis, and many others made seminal contributions to medicine and science without patents or the promise of profits. Sometimes they revealed their discoveries at great expense to themselves, including banishment and loss of livelihood (Semmelweis) and even the threat of death (Galileo).
Some great innovators even actively rejected the patent concept. George Washington Carver, the brilliant agricultural scientist, dismissed the idea that he should patent his hundreds of medical and scientific contributions, saying, “God gave them to me. How can I sell them to someone else?” Similarly, when Jonas Salk was asked in 1955 by newsman Edward R. Murrow who owned the patent on the polio vaccine, Salk replied, “Well, the people, I would say. There is no patent. Could you patent the sun?”
The assumption that only financial incentives can promote innovation ignores giants like Eugene Braunwald, who made his most significant contributions in his early years, while on salary, and Bernard Lown, who developed some of the most important scientific advances of the century while on salary. And it ignores the vast wasteland of patents that boost prices and protect extended monopoly rights on products based solely on minor tweaks that produce little or no public benefit.
Not only will scientists pursue innovative ideas without added financial incentives, but psychological and management studies also repeatedly show that financial incentives can actually inhibit creativity and innovation. In a series of studies sponsored by the Federal Reserve, economists at MIT, the University of Chicago, and Carnegie Mellon University found that financial incentives interfered with test subjects’ performance in solving cognitive problems.380 Their conclusion? Pay people enough money to take the issue of money off the table and allow them to focus on the creative task at hand.380
A third element of the healthcare system that is in desperate need of reform is the FDA. Yes, the agency continues to play a vital role in protecting the American public, ensuring that our food and many of our drugs are far safer than the food and drugs in some other countries. But as we’ve seen, in too many cases the FDA has abdicated its role as watchdog over industry to serve instead as an ally and partner with industry. The FDA claims that its partnerships with industry, through projects such as the joint writing and promotion of the 21st Century Cures Act, promotes innovation. But the FDA cannot be a partner and a watchdog at the same time. The roles must be distinct. To that end, leadership at the FDA must be returned to civil servants—and the practice of putting political appointees in leadership roles should end. In order for the hardworking and brilliant public servants at the FDA—people like the FDA Nine; David Graham, who first sounded the alarm about Vioxx; Andrew Mosholder, who reported on the dangers of antidepressant drugs for adolescents; and others—to do the job they believe in and want to do, agency leadership must be returned to civil servants, and Congress must prohibit political appointments to the agency.
Congress also needs to double the budget of the FDA, as recommended by the Project on Government Oversight, and roll back industry funding of the agency through channels such as the Prescription Drug User Fee Act and the Reagan-Udall Foundation.381
The 21st Century Cures Act needs to be drastically changed or abandoned. Lowering the levels of evidence necessary for industry to win FDA approval of its products will mean even worse outcomes for the public than those we are already seeing. The public may assume that deregulation means unburdening industry so it can be more “efficient,” but what does efficiency mean? The current administration promises to slash drug and device prices, but it appears that this will not be accomplished by putting caps on industry’s exorbitant profits. Instead manufacturers are relying on the president’s promise to slash regulations governing device and pharma companies “by 75 to 80 percent,” reducing prices by speeding approval times.382 But that approach doesn’t guarantee that any savings will be passed along to the public. Worse, by eliminating regulations intended to ensure scientific testing of devices, we can expect to see an increasing number of untested, unregulated devices pouring onto the market and into our bodies.
To prevent future disasters involving high-risk implanted devices, the FDA should insist that such devices be subjected to at least two randomized, controlled clinical trials that include medically managed control groups as well as sham-device groups whenever possible to control for the placebo effect.123 Patient-oriented clinical outcomes rather than surrogate end points must be tested, and the agency should seek out non-industry experts and methodologists as advisers.155, 383, 384
Needed reforms include the enactment of legislation to restore the right of patients to sue if they are harmed by devices, and Congress should be urged to pass the Sunshine in Litigation Act, which would ensure that important information uncovered during product liability suits isn’t held secret under confidentiality agreements. In many instances, drug companies settle cases with injured patients under a provision forbidding the patients’ attorneys from notifying the FDA that the drug or device caused harm.385–388
These urgently needed reforms have been and continue to be forcefully opposed by industry. Of course, this raises the even bigger problem of industry influence over members of Congress and other politicians, including the president. In the long run, it will not be possible to achieve the changes needed to fix our healthcare system without instituting campaign finance reform and thus eliminating the hold industry has over politicians.
As I’ve mentioned, another major problem with US healthcare is the lack of sound, independent scientific research. Too often what masquerades as science is not. And mere transparency is not enough: disclosure of the financial ties that connect researchers and regulators to big corp
orations cannot itself ensure unbiased research. We need to stop the flow of money from industry to public agencies like the FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health (NIH) and replace it with public funding.
Academia, which should be the real engine of independent research, has also been corrupted by lucrative partnerships with industry. We need to recall the reasons why universities came into existence in the first place. In his book Science in the Private Interest, Sheldon Krimsky writes that the concept of academic freedom, or “protected employment” of professors from external interests, “has its roots in the Middle Ages, when medieval scholars ‘sought to be autonomous and self-regulating to protect knowledge and truth from corrupt outside influences.’” Krimsky goes on to observe that “public-interest science requires people who are able and willing to speak out candidly and critically about toxic dangers, political injustice, pernicious ideolog[ies] that foment hatred, false idols, unsustainable paths of economic development, product liability, and environmental causes of disease.”320
To protect the lofty goal of encouraging rigorous inquiry without fear or favor, we must insist that our colleges and universities once again function as centers that seek truth, not profit. That means we need to demand that Congress repeal the Bayh-Dole Act and truly insulate our academic centers from industry pressures.
Furthermore, public health policy in the US needs to be modified to deemphasize paying for medical interventions designed to fix health problems and instead stress investment in social programs that can help prevent such problems in the first place. As part of this effort, we need to address the wealth gap, which is the single most powerful predictor of life span. While the most potent cancer drugs, costing between tens of thousands and hundreds of thousands of dollars per person per year in many instances, often add only months to a patient’s life span, being on the wrong side of the wealth gap lops up to twenty years off an individual’s life in the US.389–393
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