|
|
|
|
|
|
|
As health care reform is debated in Congress, the fact remains that health care costs are 14% of GNP and 55 million Americans are uninsured or under-insured. Pharmaceuticals represent only 7% of the health care costs but still, as the Health Security Report on American People [1] indicates, prescription drugs constitute the largest cost of daily living for 45% of the people over 65. |
|
|
|
|
|
|
|
|
It is unimaginable that price controls, price negotiation of new drugs, or other government restrictions will be imposed on pharmaceuticals. Such restrictions would stifle high risk research, which is necessary to discover the new pharmaceuticals to treat the diseases of our age: AIDS, Alzheimers, drug resistant infections, and others. |
|
|
|
|
|
|
|
|
However, the attitude toward health care in the United States will never be the same. The passage of the Waxman-Hatch Act, allowing generic drugs to be marketed upon patent expiry and the emergence of large buying groups, HMOs and other organized buyers of health care services, shifted the price control from the pharmaceutical company to the person paying the bill. Mergers, acquisitions, strategic alliances, layoffs, and voluntary price controls were the result. |
|
|
|
|
|
|
|
|
We believe that in the above mentioned environment of uncertainty and cost control, the development of novel drug delivery systems will flourish. Over 250 million dollars are required to bring a new drug to the market, but marketing approval of a novel drug delivery system can be secured for as little as ten million dollars. As the pharmaceutical companies adjust their strategies to one of disease management, novel drug delivery offers us the capability of developing a series of niche and line extensions to enhance the product line offered around the disease focus. |
|
|
|
|
|
|
|
|
In addition to cost containment, novel drug delivery systems can impart important advantages such as extending the duration of drug activity, which allows greater patient compliance owing to elimination of multiple dosing schedules; reducing side effects due to optimization of the blood concentration-time profiles; addressing chronobiological issues by temporal optimization of dosing and by using feedback control self-regulatory polymers and other systems; and being the carriers of proteins and peptides and the vehicles for drug targeting. |
|
|
|
|
|
|
|
|
The practical importance of compliance is obvious. If the patient does not comply, the therapeutic goal is not achieved and the cost of drugs prescribed but not taken becomes enormous. In the last few years, adherence to medication has been studied for hypertensives [2], antiasthmatics [3], allergics [4], diabetics [5], cancer [6], and ulcer patients [7], and the elderly [8]. In all cases |
|
|
|
|
|