Commentary: Patents Pools and the AIDS Crisis
Essential Drugs and Health for All: Healthy Innovations from Bangladesh
Stripping Away Big Pharma’s Fig Leaf
Drug prices in the United States are out of control, and rising.
The reason is that the United States permits pharmaceuticals to be marketed by unregulated monopolies: Patent protection gives the drug companies monopoly control over their products. These companies face neither direct competition, nor price controls.
But what is the reason for the government grant of these patent monopolies (which often extend long beyond the official 20 years, thanks to a variety of Big Pharma "evergreening" tactics to block or delay the introduction of generic competition)?
Leaving aside the raw political power of the pharmaceutical industry and its allies, the policy rationale for patent monopolies is the cost of drug development. According to the drug companies, the cost of researching and developing a new drug is $800 million.
The myth of astronomical drug development costs is the fig leaf behind which Big Pharma and its paid associates (inside and outside of government) hide to escape criticism for price gouging. If this myth were peeled away, Big Pharma would stand exposed. And the prospect of a more rational system of drug development and pricing would rise dramatically.
This matter could be resolved, simply, if the drug companies were to open their books and reveal their actual investments in research and development (R&D). Instead, they implausibly claim that this information would give away trade secrets and must remain proprietary -- though when it suits their political agenda, they make all sorts of announcements about costs.
The industry claim of $800 million costs per drug relies on a study from an industry-funded research center at Tufts University in Boston. Tufts researchers supposedly had access to industry data to come up with their figure, but no one else is able to see the underlying data. So if you choose to believe in this number -- just like if you choose to believe in the tooth fairy, or Santa Claus -- it is simply a matter of faith.
There are several ways to get closer to the actual figures for the cost of drug development and company per drug expenditures on R&D.
The first option is to knock away the assumptions and built-in biases of the Tufts-industry study.
Approximately half of the Tufts-industry estimates are attributed to financing costs, known as the opportunity cost of capital. Money invested in drug R&D could have been invested in treasury bonds, say. While the bonds would start returning revenues right away, R&D returns are not realized for years, until a drug is discovered, developed, approved and put on the market. So in the Tufts-industry study, a "cost" of development is the forsworn income during the period of development.
This is all true, as far it goes, but it is not how people normally think about "cost." As James Love of the Consumer Project on Technology says, it is the equivalent of saying the cost of a car is not the sticker price, but the sticker price plus interest payments on a car loan.
Exacerbating the problem, the researchers may pick an unreasonably high interest rate. They may also set the period for drug development as too long -- in the Tufts-industry model, relatively small delays in getting the drug to market lead to big increases in the overall cost.
The Tufts-industry estimate is for the cost of new chemical entities for which the industry was wholly responsible -- that is, where there was no substantial public contribution to R&D.
It turns out, however, that the vast majority of new drugs Big Pharma brings to market do not involve new chemical compounds. A May 2002 study by the National Institute for Health Care Management (NIHCM) Foundation found that two-thirds of the prescription drugs approved by the Food and Drug Administration (FDA) between 1989 and 2000 were modified versions of existing medicines or identical to drugs already on the market (and only about 15 percent were both new and deemed by the FDA to provide significant improvement over existing medicines). Pharma denies it, but there is every reason to believe this less novel products are far cheaper to bring to market.
Then there's the not insignificant fact that the case of drugs brought to market without government support is the exception, not the norm. The federal government supports an enormous amount of research, and funds the earliest and riskiest portions of the R&D process: basic research and the earlier phases of clinical trials. This is true not only for the well-publicized cases of cancer and HIV/AIDS drugs, but also, according to a National Institutes of Health review, many of the top blockbuster drugs, treating ailments as diverse as hypertension and depression.
A second approach to the question of drug R&D costs is to look at actual, observable costs.
The $800 million Tufts-industry estimate represented more than a doubling -- in inflation-adjusted dollars -- of the previous study the Tufts group had completed a decade before. The Tufts-industry researchers said that increased costs in clinical trials accounted for much of this increase.
Looking at company filings with the IRS for tax credits on research for "orphan drugs" (drugs which treat small populations), however, the Consumer Project on Technology found that -- adjusted for risk -- drug companies report expenditures of only $7.9 million on clinical trials, less than 1 percent of the overall estimate.
Even if the costs for this category of drug are below average, as the industry claims -- even if they were, implausibly, a tenth of the average -- this would still suggest a much lower total development cost than the Tufts-industry estimate.
A third approach is to look at independent assessments of the cost of R&D. The Global Alliance for TB Drug Development has carefully examined the cost of bringing a new chemical entity to treat TB to market. It estimates the cost of discovering and developing a drug at between $115 million and $240 million. This includes both the costs of failure and the opportunity cost of capital.
A final cut on the issue is to look at the pharmaceutical industry's overall R&D expenditures -- the companies publish aggregate figures -- and compare them to the cost of new drugs brought to market.
Looking at industry investment in R&D during the period 1984 to 1990, and comparing this to new drugs placed on the market 10 years later (when the investment should bear fruit), Public Citizen calculated that companies spent $85.6 million per drug. (The figure is nearly double if R&D during the 1990s is compared to drugs put on the market during the same decade.) And these figures are almost certainly too high, because the industry numbers come from an unaudited trade association survey, and include substantial marketing costs in the R&D tallies.
Any honest examination of available evidence on the costs of drug development suggests the United States -- and most of the rest of the world, which thanks to the U.S./industry strong-arming tactics in international trade negotiations, now maintains or soon will adopt U.S.-style patent rules -- is massively overcompensating Big Pharma for its work in bringing drugs to market.
With the U.S. healthcare system bursting at the seams, seniors draining their bank accounts to buy drugs, and millions of people around the world going without medicines, the time has come for fundamental reform.
A minimum program would call for ending the industry's patent extension tricks, licensing drugs developed with public monies on a nonexclusive basis to permit price-reducing competition (or at least permitting competition where prices are excessive), and considering rollbacks to the 20-year patent term and the adoption of price controls.
But even these measures may be inadequate. Why couldn't the government simply take over the job of drug development, and then let private companies manufacture and distribute medicines in a competitive environment -- doing away with patent monopolies on drugs altogether?