| 摘要 | Key Points
Introduction
America is singular among the nations in that its government does not control prescription medication prices, despite heavily regulating the pharmaceutical industry in many other respects. Drug prices, however, surface from time to time as a topic of political debate. The most recent instance centers largely on the high prices pharmaceutical manufacturers have been asking for a particular class of medications known as “specialty drugs.”
No exact definition for specialty drugs exists, but common usage applies the term to drugs that are expensive; address life-threatening diseases; may be complicated to produce, store, and administer; and often require elaborate patient monitoring. Although drugs and medical devices in general represent a small fraction (about 13 percent) of total health care expenditures, specialty drug prices temporarily accounted for the sharpest upticks (around 12 percent) in such spending.[1]
The increases reflect not only what companies have charged for new drugs upon regulatory approval and launch of sales, but also steady increases in the prices of some brand specialty drugs that have been on the market for some time.
Public and private insurers, pharmacies, health systems, and patients stuck with unexpectedly high drug bills have complained. Many physicians who prescribe specialty drugs have publicly stated that specialty drug pricing is “out of control” and “unsustainable” and that patients needing specialty drugs suffer financial hardship and may not comply with recommended treatments because of it.[2] A survey reported that consumers’ major health care concern is whether they can afford to pay for their drugs.[3] These concerns are prevalent items reported by the news media.
One exacerbation of the furor over drug prices erupted when a pharmaceutical company named Turing abruptly raised 56-fold the list price of pyrimethamine, an antibiotic used to treat infections in patients with compromised immune systems. Another involved Valeant Pharmaceuticals, a Canadian company, which markedly raised prices of two drugs made by pharmaceutical manufacturers it had acquired that treat heart conditions. Although none of these medicines qualify as a specialty drug—they are very old, no longer patented—the public outrage condemned the entire industry. Congressional hearings ensued, and many public figures including presidential candidates called for medication price controls across the board.[4]
Lending energy to criticism of drug pricing are notions that health care is a “right” and should not be treated as a commodity and that imposing high prices on potentially life-saving drugs is immoral.[5] These ideas fuel frequent resort to the “G-word” (greed) in criticisms of the pharmaceutical industry’s pricing practices.[6] Former Labor Secretary Robert Reich has compared the pharmaceutical industry to hedge funds, alleging that both are “rotten apples that are costing Americans a bundle.”[7]
Drug pricing discussions involve philosophical questions about society’s health priorities and resource allocations for which no easy answers exist. In this article, I propose that misrepresentation of the far less debatable technical aspects drug development has obscured these important fundamentals. The responsibility for this distortion lies with academics, the media, and litigators who have relentlessly demonized the pharmaceutical industry—pejoratively labeled as “Big Pharma”—over the past 30 years. They have succeeded in degrading its public reputation. I refer to this demonization as the “pharmaphobia” narrative.”[8]
I also explain that the debates have largely ignored a totally unique and very poorly appreciated feature of drug development: the enormous risks inherent in drug development due to the unpredictability of biology. I cannot think of any commercial activity in which the cost of taking a product to market bears so little economic relationship to its development, production, or assessments of present value. Because discerning investors with skin in the game assume that risk, the only way to sustain drug development is prices and sales that are high enough to provide them with sufficient returns.
This anomalous nature of drug development, I believe, explains why the American government’s hands-off approach has facilitated this country’s remarkable drug innovation accomplishments. It also predicts that imposition of drug price controls in the USA will compromise access to better future therapies, not just for Americans, but for patients’ worldwide because America is the world’s hub of drug innovation.
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