Despite representing only 4% of the world’s population, the United States accounted for almost 35% ($326 billion) of the global market for pharmaceutical drugs in 2012. Not surprisingly, the pharmaceutical industry’s business practices, considerable marketing budgets, and substantial profits are hotly debated as part of virtually every health policy discussion. But before addressing the possibility of transcendent evil in that industry, we should pose a more mundane yet critical question: Is our enormous investment in pharmaceutical drugs paying off?
Given the variability of drug prices and the lack of reliable, publicly available prescription data, the collective impact individual therapeutic classes have on their respective target diseases is difficult to determine with certainty. But by comparing prescription data from IMS Health with mortality data from the CDC for two separate years (2008 and 2011), one can gain at least some insight on the issue. And the tale that emerges from this rudimentary exercise is a cautionary one for both patients and physicians.
First, consider the impact of pharmaceuticals on diabetes, our 7th leading cause of mortality. In 2008, it was responsible for 2.9% (70,553) of all deaths. We spent $13.6 billion on the disease that year, writing 166 million prescriptions for things like injectable and oral hypoglycemics. By 2011, our spending on those drugs had increased by over 50% to $20.5 billion (173 million prescriptions), yet diabetes remained the 7th leading cause of death, again accounting for 2.9% (73,282) of all deaths.
Next, let’s look at cancer, the 2nd leading cause of death in this country. In 2008, it accounted for 23% (565,469) of all deaths, and we spent $19.7 billion on pharmacological interventions to combat malignancies. In 2011, however, cancer again caused 23% (575,313) of all deaths, despite spending $24 billion (an additional $4.3 billion) on pharmaceutical drugs.
Finally, let’s consider suicide (no pun intended), the 10th leading cause of death. In 2008, intentional self-harm was responsible for 1.5% (36,035) of all deaths. We spent $26 billion that year on mental health drugs including SSRIs, antipsychotics, and anxiolytics. Three years later, suicide again accounted for 1.5% (38,285) of all deaths, despite an additional $3.7 billion investment in those pharmaceuticals.
Admittedly, this type of aggregate analysis fails to establish causation, or even correlation, and ignores the performance and prices of individual drugs, the impact drugs have on outcomes other than death (e.g. quality of life), and the role these drugs play in a particular patient’s health. It also fails to control for many other variables that significantly affect outcomes, and the three-year span may be too short a time frame for any investment to “pay off.”
Despite their limited statistical significance, however, the data are quite intellectually significant. They help us understand that pharmaceuticals don’t cure all, that over-reliance on prescription drugs is quite possibly not only costly but also stunningly ineffective. They help us see that many of the clinical trials touted as “evidence” of a drug’s efficacy are poor indicators of the drug’s impact in real-world situations. Even with cardiovascular disease, where pharmaceutical drugs may have slightly improved aggregate mortality, the costs associated with exceedingly modest gains should give us pause.
Intuitively, spending billions of dollars on drugs that produce little or no improvement in mortality should generate considerable cognitive dissonance. Yet our country, more than any other, continues to exhibit an unquenchable thirst for drugs that produce lackluster results. The aspect of the pharmaceutical industry’s business model worthy of scrutiny, then, is not how often sales reps buy lunch for physicians (the Internet, social media, and DTC advertising have rendered patients a much more powerful influence on prescribing habits than industry lunches). Instead, value delivery should be our focus — how well the industry’s drugs perform in the real world relative to their cost, their ability to improve outcomes or quality of life.
Now, back to the original question: Is Big Pharma evil? Pharmaceutical companies are businesses, entities with a fiduciary responsibility to deliver the highest possible return for shareholders. That certainly doesn’t mean one should tolerate illegal or unethical business practices, but that industry does not exist in a vacuum. Given the medical profession’s inextricably interdependent relationship with the industry and the relative infrequency of blatant crime therein, it is disingenuous and counterproductive to label the entire industry “evil.” Pharmaceutical companies employ millions of Americans and deliver many drugs that work, drugs that actually do improve the lives of patients.
Expecting legislation alone to curb our country’s appetite for pharmaceutical drugs is unrealistic. Spending on pharmaceuticals has increased despite FDA marketing restrictions, and the costly trend began well before the industry was allowed to market directly to consumers. While instituting price controls or allowing the importation of drugs from other markets may control costs initially, it will do nothing to slow the increasing rate at which ineffective drugs are being consumed. The only way to drive real change is to align the interests of all stakeholders. And, as much as it pains me to add to an already full plate, physicians are the only ones capable of achieving this. But they need help.
Physicians have a fiduciary responsibility to patients, an obligation to advocate for them. And each prescription a physician writes delivers a powerful message to the market: “We want more of this; this is what our patients need.” Collectively, then, the threshold for prescribing a drug needs to be significantly higher than it currently is. Specifically, if a new drug does not offer a substantial health benefit over behavior modification or existing therapy, that drug should not be prescribed. If physicians simply stop prescribing medications with marginal or no benefit, the pharmaceutical industry will be forced to develop more efficacious drugs or face decreasing profits. We can blame Big Pharma all we want, but the truth is without physicians there is no market.
It’s also critical, however, that patients become increasingly aware of the limited benefits of, and significant risks associated with, most pharmaceutical drugs. As difficult as it is to do, they must accept that diet, exercise, and many other health behaviors, along with socioeconomic phenomena, are what truly determine health status and susceptibility to disease. Advances in molecular biology have elucidated the genetic basis of some diseases, but, for many of the most common illnesses, the aforementioned facts are indisputably true. So viewing office visits that don’t yield a prescription as failures is counterproductive, particularly if sustained, improved health is the goal.
Patients must understand that the number of diseases pharmaceutical drugs can actually “cure” is still exceedingly small. No pill can reverse all of the effects of unhealthy lifestyles or harsh socioeconomic realities. Despite what television ads often seem to imply, oral hypoglycemics don’t effectively emulate the effects of exercise, SSRI’s alone are no match for unemployment or child abuse, and chemotherapy can’t reverse the effects of smoking. And sadly, spending billions at the end of life often does nothing more than alleviate guilt, guilt that stems from the mistaken belief that drugs can effectively reverse death, that all death is unnatural. Regulation alone won’t change these misconceptions.
Marginally outperforming a placebo should by no means be sufficient motivation for physicians to prescribe a new drug, regardless of its price. And patients need help performing truly informed, realistic risk-benefit analyses for any proposed therapy. Moreover, when professional organizations release “evidence-based guidelines” that, in effect, lead millions of Americans to take prescription drugs offering little or no true health benefit, they only make matters worse. Until the prescription pad becomes more of a last resort and less of a foregone conclusion at every office visit, we’ll all continue to die expensive, “chemically modified,” but still unavoidable, deaths.