Seasonal variations in the occurrence of Vibrio vulnificus along the Dutch coast.

The seasonal variation in the occurrence of V. vulnificus in relation to water temperature and salinity was studied along the Dutch coast. In two consecutive years V. vulnificus strains could be isolated in August when the water temperature was highest. The indole-positive strains isolated from North Sea water samples were identical to most strains isolated from human disease and from the environment. However, strains isolated from four of five patients living in countries around the North Sea were different from the North Sea isolates in that they were indole-negative and have a lower NaCl tolerance.

Recombinant erythropoietin. Orphan product with a silver spoon.

The U.S. Food and Drug Administration's (FDA) approval to the orphan biological product recombinant erythropoietin (rEPO) in June 1989 resulted both in a breakthrough treatment for the chronic anemia of people who suffer from chronic renal failure and a powerful argument for change in the legislation that spawned its development: the Orphan Drug Act of 1983. At a cost of over $6,000 per patient per year, Congress could not understand how a product that no manufacturer wanted to produce was suddenly costing the federal government hundreds of millions of dollars each year. Congress attempted to change the act in 1990 to preclude a manufacturer from using its provisions to secure lucrative monopolies in certain drug markets. In early 1991, the FDA finally issued regulations to implement the act that addressed some of the very concerns that were caused by rEPO.

Medicare payment options for recombinant erythropoietin therapy.

We analyzed alternative payment approaches that Medicare could use to pay for recombinant human erythropoietin (rHuEPO) therapy. How Medicare pays for rHuEPO therapy will affect whether providers make prudent purchases of the biologic and prescribe it appropriately and whether companies offer the program low prices. Medicare's policies may also guide policies of other third parties. Selecting payment options for Medicare payment requires balancing desirable and undesirable implications, especially trade-offs between improving access to and quality of care for beneficiaries versus constraining costs to Medicare and its beneficiaries. The options for paying providers that contain financial incentives to constrain expenditures also contain incentives for providers to skimp on use, perhaps to the detriment of patients' quality of care. On the other hand, options that may reward additional use may lead to higher expenditures and threaten the quality of care from the direction of overuse. Medicare currently varies the level and method of payment for rHuEPO therapy according to the setting in which it is provided. Equity among beneficiaries and providers and incentives for efficient use of medical services would argue for paying the same amount for the same service, regardless of where it was provided. Whatever payment options are adopted, the Health Care Financing Administration (HCFA) will have to be able to exercise flexibility in monitoring and responding to changing market conditions. In this dynamic market, the number of manufacturers, medical indications for use approved by the Food and Drug Administration, and, eventually, Medicare's predominance are likely to evolve over time. The appropriate level and perhaps even the method of payment may well change with market conditions.(ABSTRACT TRUNCATED AT 250 WORDS)

Recombinant erythropoietin and Medicare payment.

The biologic recombinant human erythropoietin provides a recent case study of the great influence federal policies, especially Medicare payment, exert over the use and cost of medical technologies. By covering most dialysis patients, Medicare has been the predominant payer for recombinant erythropoietin, which corrects anemia associated with chronic renal disease. Medicare's leverage seems to have produced a low US price for the product. Paying a fixed rate per treatment with the biologic agent gave dialysis facilities a financial incentive to use low doses, but Medicare did not routinely monitor patients' responses. By August 1990, average and modal doses were low, and fewer than 45% of patients who had been treated for 6 months or more had ever attained the target hematocrit. Medicare should recognize the financial incentives of its payment policies and routinely evaluate the quality of care for beneficiaries.