|Prescription For The Future: Drug-Delivery Product Embodies Development Trends|
Medical Device & Diagnostic Industry
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An MD&DI July 1999 Column
Drawing on the latest interdisciplinary research, a noted scientist prepares to produce a revolutionary controlled-release device. Will long lines at the drugstore be a thing of the past?
A major provision of the Administration's recently unveiled plan for Medicare reform is a proposal to offer prescription drug coverage to nearly 40 million elderly and disabled beneficiaries. President Clinton is confident that he can patch up Social Security and then find "enough funding left over" to help pay for the potions and pills.
Perhaps the President should check first with Robert Langer on the cost estimate. Because, if a project envisioned by MIT's celebrated Germeshausen Professor of Chemical and Biomedical Engineering actually materializes, the government could be on the hook not for 40 million prescriptions, but for 40 million drugstores!
In a keynote address delivered in San Francisco at the recent Biomaterials of the Future conference organized by Medical Data International (Santa Ana, CA), Langer discoursed on a range of current and near-term research developments in biomaterials, drug delivery, and tissue engineering. Prominent among these was what he called the "pharmacy on a chip." Together with colleagues in his laboratory, Langer designed a dime-sized, implantable drug-delivery device etched from a solid-state silicon microchip. The prototype chip incorporated 34 microreservoirs filled with saline; a commercialized version could house, say, 1000 reservoirs, each containing a dose of medication, hormone, or other chemical preprogrammed for release in concert or at different times over periods up to several months. The tiny wells are individually sealed with extremely thin anode membrane lids of gold, which can be made to dissolve upon application of an electrical pulse, releasing the dose.
While several aspects of this project are extraordinary, they are at the same time paradigmatic of wider trends in the device industry. The design brings together advanced work in a number of intensely active disciplines: microprocessor systems, biocompatible and biodegradable polymer technology, micromachining and microfabrication, biosensors, surface analysis. The incorporation of active agents in a biomaterial structure points up the increasing prevalence of various types of "combination" productsfrom other controlled-release matrices to encapsulated cell lines to bioactive coatings. And the ability of the chip to be externally programmed or reprogrammed depending on the condition or needs of the patient reflects evolving capabilities in interactive and remote power sources, control and monitoring mechanisms, and data gathering and transmission modalities.
The device is also remarkable for the scope of the problem it addresses and the potential ramifications should it or a similar product come to market. Langer stated that adverse drug effects from improperly used prescription medicationsby the feeble, the misinformed, the unluckyaccount for 15% of all hospital admissions and 100,000 deaths each year, at an annual cost estimated at $136 billion (greater than that incurred from heart disease!). For patients, ensuring drug compliance through an implantable pharmacopoeia could influence everything from subsequent treatment regimens to dependence on skilled caregivers to transportation requirements.
Langer and team have formed a company to explore commercial development of the pharmacy chip and other drug-delivery technologiesfor example, inhalation research investigating aerosol particle structure and size. This illustrates another prevalent trend: that many academics are going into business on the side. Perhaps the firm's first chip will be a startup business model: tinfoil lids and wells filled with caffeine and midnight oil.