Overdosed America (39 page)

The new body would also have the power to require that studies include people of similar age, gender, and medical condition to those to whom the results would be applied. Comparison with proven therapies (not just placebos)—including lower-cost treatments, generic drugs, and lifestyle interventions—would be required before a new drug could be considered the “best therapy.” The body would also have the authority to require that studies be continued long enough to determine the benefits and side effects of the various treatments and strictly forbid interrupting a study for “commercial reasons.”

The body would have the authority to require that clinical research measure the most important clinical outcomes, such as serious illnesses, overall mortality, and the quality of life—not merely intermediate end points such as bone mineral density, blood pressure, cholesterol level, and the amount of plaque in arteries.

Probably the single most important change that the fully empowered regulatory body could implement would be requiring transparency in medical research—making all research data available for external audit and public scrutiny. Nontransparency is now the norm for commercially sponsored medical research in much the same way that it had become the norm in accounting and business practices in companies such as Enron and Worldcom, and with much the same results—though the magnitude of the cost in dollars and health still remains a well-kept secret. Medical researchers must have access to all the results of their studies, perform their own analyses of the data, write up their own conclusions, and submit the report for publication to peer-reviewed medical journals. Research data must also be made available to peer reviewers for medical journals and to the new oversight body for independent evaluation.

How would these standards be enforced? Only studies that met these standards would be certified by the new body—thus establishing an effective performance threshold for validation of clinical research. This certification would become part of the peer-review process for medical journals—publication could be restricted to certified research or articles’ certification status could be clearly identified for readers. Certification would also be identified in all the scientific evidence presented to doctors in marketing material and continuing education. The public would be similarly informed about the certification status of research referred to in advertising and presented in the media. If drug companies threatened to withdraw advertising, the cost of public funding for the journals would be a pittance compared with the savings to the public that would result from basing medical care on unbiased scientific evidence.

Of course, the medical industry would do everything in its enormous power to prevent having to relinquish its control over medical knowledge. But what purpose is served by the current situation, in which the public’s interest in effective and efficient health care is subjugated to the commercial goals of the medical industry?

Would this oversight of the relevance and integrity of clinical research bring commercial funding to a halt? The drug and medical-device industries might use such a scare tactic to quash the growing public demand to rein in their excesses. Such a threat, if not simply posturing, would reveal industry’s need to bias research in order to make the undertaking worthwhile from a business perspective. If this were true, then all the more reason to return responsibility for producing medical knowledge back to the government, shielded from commercial distortion. Yes, it would be expensive in the short run to lose industry’s enormous financial contribution to medical research, but the net result would save Americans hundreds of billions of dollars each year as medical care became redirected away from commercial goals and back to the goal of producing the best health with the greatest efficiency.

In January 2004 the Institute of Medicine reported that
18,000 Americans die unnecessarily each year
as a result of not having health insurance. This death toll is six times greater than the one we experienced on September 11, 2001—and it’s happening every year. Have you ever wondered why the United States, the country with the highest per capita gross domestic product (except for tiny Luxembourg), is alone among industrialized nations in not providing health care coverage to all of its citizens? Our lack of universal coverage becomes even more puzzling when we realize that, according to an
ABCNews/
Washington Post
poll
conducted in the fall of 2003, four out of five Americans support universal health care and are willing to sacrifice their tax cuts to pay for it.

The key to understanding this paradox is that the medical industries maximize profits by providing the most care possible to those who pay full or almost full price. As long as the definitions of “quality of care” and the price structure of drugs, devices, and procedures are determined largely by commercial interests, universal health care will continue to appear unrealistic and in some vague way “un-American.” Yet the additional
cost of covering all Americans
is estimated to be $34–$60 billion annually—a trivial sum compared with the extra
$500 billion
spent each year on medical care “informed” by the findings of commercially biased science.

The prospect of extending health care coverage to the uninsured would jeopardize the medical industry’s excess profits and almost certainly trigger a demand for accountability: Americans of all political stripes would demand evidence of the real value that they (and the uninsured) were receiving for their tax dollars. Ideally, the independent federal oversight body I’ve described would determine the benefits to be included in universal coverage, based upon all of the scientific evidence (meaning that commercial sponsors of research would not be allowed to keep their data hidden). The cost of this care, according to the best evidence currently available, would be about one-third less than the current cost of commercial insurance or Medicare. The privileged profiteering of the drug, medical device, medical equipment, and hospital industry would be sharply curtailed.

However, the most serious threat posed to these industries under such a system would be the public realization that people covered by the universal health plan were receiving higher-quality care and better health outcomes than the people with regular insurance. When that happened, many Americans would demand similarly high value, low cost health insurance, effectively extending to all Americans coverage for medical services, drugs, tests, procedures, and therapies based upon certification by the independent federal body. All Americans would then be winners—the currently uninsured and the insured alike—as the quality of their health care improved and their costs declined as the result of objective standards of medical excellence replacing our current commercially based standards of care.

As the leaders of the Commonwealth Foundation wrote in
Health Affairs
at the end of 2003, “The inability of the health care industry to improve care sufficiently on its own and to increase the value that Americans receive for their dollars is an indication of private market failure.”

The failure of the market to serve Americans’ medical needs is certainly demonstrated by the combination of our poor health status compared with that of other industrialized countries, the low quality of our medical care (
barely half of the standards
for basic medical care are being met, according to a study done by the Rand Corporation and published in the NEJM in December 2003), and the singularly high cost of our medical care. But these are just symptoms of a more fundamental problem, which is not market failure, but market success. The medical industries have thrived as health care spending in the United States
increased more than fivefold
and the percentage of our GDP devoted to health care rose from 8.8 to 15.5 between 1980 and 2004.

How could the market have allowed the medical industries to thrive while serving Americans’ health needs so poorly and inefficiently? The problem is not with the market itself, but with the inadequate information and flawed incentives that currently shape our health care market. Drug companies earn higher profits when more people use expensive drugs, not when more people achieve better health. Doctors and hospitals are paid more for doing more, largely without regard for evidence of improved health outcomes (examples are the rapid increase in the number of MRI machines, excess capacity for neonatology and invasive cardiac procedures that lead to excess use, and the
approximately 12,000 deaths
that occur each year as the result of unnecessary surgery).
Health care providers that deliver high quality
, efficient care are financially penalized for not delivering a higher volume of more intensive services, beneficial or not (referred to as the “perverse incentive”).

Four fundamental changes are necessary to redirect American medicine toward what most agree is its rightful mission: to best improve the health of all Americans most efficiently.

First, accurate and transparent information is essential to support wise decision-making at all levels. Whether individuals are deciding about the best approach to their own health, or patient and doctor are deciding together about the best therapy, or purchasers of health care and government agencies are trying to improve the quality and control the costs of care, everyone needs much better information than is currently available. The federal board described earlier would go a long way toward making good information available to all.

Second, the mix of physicians needs to be rebalanced. The research of Dr. Barbara Starfield and her colleagues at Johns Hopkins, as well as the research of Dr. Elliott Fisher and his colleagues at Dartmouth, shows that, despite our faith in the latest high-tech medical care, the areas of the country that have higher concentrations of specialist physicians have both higher health care costs and worse health care outcomes; the areas that have more primary care physicians have lower health care costs and better health outcomes. However, because of the financial, lifestyle, and intellectual incentives that are brought so heavily to bear on medical students and practicing doctors, interest in careers in primary care is plummeting. The percentage of graduates of American medical schools entering family practice residencies declined by almost half between 1997 and 2004 (from 17.3 to 8.8 percent). What ought to be the basic unit of good health care, the primary care doctor-patient relationship, is at risk of soon becoming an endangered species.

Third, policy makers and payers should focus their attention on health care systems (groups of doctors, hospitals, and other medical services)—especially on figuring out how to reward them for providing the right care in the right amount, for achieving high levels of patient satisfaction, and, most important, for improving the health of the people they serve.

And, finally, the government cannot simply stand by as a paid-off sugar daddy to the medical (and especially the drug) industry. Well-functioning markets require active government oversight to make sure that the public’s interests are being served. The medical watchdogs need to be revived, and the industry money that has become a staple of their otherwise meager diet needs to be withdrawn and replaced with adequate, stable funding from noncommercial sources. The FDA and NIH should be independent of, instead of seamlessly interwoven with, the drug and medical device industries. Drug company lobbying can no longer be allowed to stand in the way of legislation that clearly serves the health interests of the American people, such as setting aside less than $0.02 per prescription in the Medicare prescription bill to determine the best drugs and therapies for seniors, or simply allowing the market to function so the government can negotiate the best price from drug makers to obtain the best value for American senior citizens.

Don’t forget the good news. You can take charge of many of your biggest health risks. The recommendations about a healthy lifestyle may at first seem too simplistic, but the research repeatedly shows that this is the best way to stay healthy. The challenge comes not in knowing what to do to optimize your health, but in integrating these simple recommendations into daily habits. Genuine change requires the exercise of real autonomy. This means a willingness to accept responsibility for maintaining your own health, with a realistic view of economic conditions and environmental factors, setting goals, honestly confronting resistance, and getting help when necessary to overcome that resistance. It also means a willingness to let go of old habits to make room for growth.

Though it may seem antiquated in our era of high-tech medicine, the foundation of good medical care is an ongoing relationship with a primary care physician with whom you feel comfortable (sometimes in conjunction with a nurse practitioner or physician’s assistant). The two essential components of such a relationship are that the patient trust the provider and have confidence in his or her competence, and that the provider have a sense of who the patient is and be willing and able to understand the patient’s concerns. Perhaps a third essential component is the patient’s being able to share his or her concerns about the commercial distortion of health care, and the ability for patient and doctor to decide together how to proceed in the context of this uncertainty.

How can you become a better health care consumer? The next time you hear about a medical “breakthrough,” try to determine who sponsored the study and whether the experts interviewed disclosed any financial ties to the products being discussed. Go a step further: see if the results are presented as relative risk (people who took the new drug were
x
percent less likely to develop a disease than the people who didn’t take the new drug) or as absolute risk reduction (taking the new drug protects
x
number of people out of 100 from developing the disease). The second approach provides much more information about the real benefit of the drug or therapy. Notice whether lifestyle and other interventions are discussed in addition to expensive drugs as a part of the solution. Most of all, immunize yourself from the drug companies efforts to convince you that you desperately need their advertised products. If you really needed the product, it is unlikely that the drug companies would be spending money on advertising. Remember, there aren’t many ads for insulin on TV.