October 13, 2006 | Volume 3, Issue 2
Powerful Medicines: The benefits, risks, and costs of prescription drugs; by Jerry Avorn
(Knopf Publishing Group, 2005)
When it comes to health care in the United States, we do a better job solving the hard problems than we do the easier ones, says Dr. Jerry Avorn. We’ve devised molecules that can mitigate the symptoms of cancer and schizophrenia, yet we’re struggling to figure out how to, for example, decide whether one drug works better than another, or make sure that patients actually take the medications they are prescribed (Avorn 2004, p. 359). Avorn tackles these “easier problems” in his book, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs. In it, he addresses the regulatory community’s shortcomings in accurately assessing risks of prescription drugs and the failure of the health care system to distribute care in a rational manner. But he also offers several practical, realistic solutions, a quality that distinguishes his work from much of policy analysis.
Studying the use of prescription drugs is an important undertaking for those who wish to understand problems with the U.S. health care system generally because, while the use of prescription drugs currently only constitutes 10 percent of all health care spending, it is rising faster than overall health care inflation (p. 217). And with the growing role the public sector will play in financing pharmaceuticals, through the Medicare prescription drug benefit, it will become more important to answer questions of how much money we’re spending on prescription drugs, which drugs we’re spending it on, and why.
Before a physician prescribes any drug, Avorn says, he must first decide that its clinical benefits outweigh its risk of side effects, and that these benefits (discounted by the risks) outweigh the costs of the drug in dollar terms. But a series of roadblocks prevents this idealized rational decision-making process from happening in reality. In weighing a drug’s benefit versus its risk of side effects, a physician is most often left to the mercy of the marketing information provided to them by pharmaceutical representatives. As an alternative, he can turn to the unwieldy Physicians’ Desk Reference, a volume that does a good job of listing every possible side effect of every drug on the market, but falls short of synthesizing information about the prevalence of side effects and relative merits of competing drugs within a given class (pp. 163–64, 363).
The situation is not helped by the Food and Drug Administration’s drug approval process, which is not designed to give a comprehensive assessment of a drug’s benefits and risks. To grant approval of a drug, the FDA requires that a drug company demonstrate through a clinical trial that its new product is safe and effective compared to a placebo. Because clinical trials necessarily involve a limited number of subjects, they cannot uncover every possible side effect that may occur once the drug is used by a large population. This would not be a problem if the FDA were equipped to monitor drugs after they entered the market; but it does not fulfill this function well, in part because the Office of Drug Safety lacks the mandate to require pharmaceutical companies to conduct postmarketing studies1.
When he argues that prescribing decisions should be subject to a cost-benefit analysis, Avorn does not advocate placing a dollar value on a human life or suggest that doctors should be in the business of rationing care. Instead, he argues that the overuse of expensive drugs when a cheaper alternative would provide the same clinical benefit is so rampant that a great deal of money can be saved without delving into these thornier issues. Avorn even goes so far as to claim that the inappropriate prescription of expensive medications constitutes the “single largest source of waste” in the American health care system – (a high claim, given the competition). He names antibiotics, calcium-channel blockers, and Cox-2 inhibitors as drugs that are over-prescribed, and cholesterol-lowering statins, ibuprofen, and aspirin as drugs that are underprescribed. Some classes of drugs, like anti-depressants, fall into both categories (p. 281–82). Citing a study he conducted with a colleague, Avorn posits that prescribing more thiazides and fewer calcium-channel blockers to treat high blood pressure could save the nation $1.2 billion a year for this condition alone, while actually improving outcomes for patients (p. 393).
When proposing solutions to these problems, Avorn does not confine himself to either the public or private sector. One initiative that Avorn himself has piloted, called “academic detailing” utilizes direct contact between physicians and prescription drug specialists without ties to pharmaceutical companies as a conduit of unbiased information designed to guide physicians’ prescribing decisions. Avorn also recommends that the FDA adopt more nuanced approval categories – in one of many instances of an insertions of humor, he suggests a few acronyms that could be used to describe the extent to which a new drug constitutes a “breakthrough”: Meaningful or Exceptional Advance in Therapy (MEAT) and Fundamentally Average Treatment (FAT) (p. 382).
One initiative that is addressing several of these problems is an initiative called the Drug Effectiveness Review Project, which is currently underway in fifteen states and at the Oregon Health and Science University. It is working to asses the benefits and risks of several widely used medications. They are focusing their research on drugs that treat common conditions where multiple brands are available2. Unfortunately, this project conspicuously omits any considerations of cost-effectiveness3.
The U.S. healthcare system would undoubtedly benefit from a large dose of the kind of evidence-based thinking Avorn proposes; however, it is difficult to imagine how this guiding principle could take hold in such a decentralized system with so many players and so many cross-competing incentives. Avorn addresses this problem to a certain extent when he acknowledges that the health insurance system needs “major surgery.” He does not advocate a single-payer model but believes that better-regulated, non-profit HMOs could do a better job of financing health care while keeping the interests of the patient in mind (pp. 412–13). Also, while it’s arguable whether reforms of the nature that Avorn proposes would save as much money as he claims, it’s clear that any change implemented to increase efficiency would have a one-time effect because they do not address the fact that healthcare costs will continue to rise as long as technological advances continue to occur in medicine4. Despite this caveat, Avorn’s book is worthwhile reading for anyone interested in a vision of a more rational U.S. health care system.
1 General Accountability Office, GAO-06–402: Improvement Needed in FDA‘s Postmarket Decision-Making and Oversight Process, Washington, DC: March 31, 2006. Accessed September 20, 2006 at http://www.gao.gov/cgi-bin/getrpt?GAO-06–402.
2 Oregon Health and Science University, “Drug Effectiveness Review Project” http://www.ohsu.edu/drugeffectiveness/ (accessed October 8, 2006).
3 Newman, Peter J, “Emerging Lessons from the Drug Effectiveness Review Project,” Health Affairs Web Exclusives 25, no. 4 (2006): 262–271.
4 Aaron, Henry J., William B. Schwartz and Melissa Cox, Can We Say No?: The Challenge of Rationing Health Care, Brookings Institution Press, 2005.