A Medical Device Daily

People in low-resource countries who are ill with multidrug-resistant TB (MDR-TB) will get a faster diagnosis — in two days, not the standard two to three months — and appropriate treatment thanks to a new initiative spurred by the World Health Organization (WHO; Geneva, Switzerland), the Stop TB Partnership, UNITAID and the Foundation for Innovative New Diagnostics (FIND).

MDR-TB is a form of TB that responds poorly to standard treatment because of resistance to the first-line drugs isoniazid and rifampicin. It is estimated that only 2% of MDR-TB cases worldwide are being diagnosed and treated appropriately, mainly because of inadequate laboratory services. Its backers say the new initiative should increase that proportion at least seven-fold over the next four years, to 15% or more.

The new effort consists of two projects. The first, made possible through $26.1 million in funding from UNITAID, will introduce a molecular method to diagnose MDR-TB that until now was used exclusively in research settings. These rapid, new molecular tests, known as line probe assays, produce an answer in less than two days.

Under a second, complementary agreement with UNITAID for $33.7 million, the Stop TB Partnership's Global Drug Facility will boost the supply of drugs needed to treat MDR-TB in 54 countries, including those receiving the new diagnostic tests. This project also is expected to achieve price reductions of up to 20% for second-line anti-TB drugs by 2010.

"Through the $60 million support provided by UNITAID, these projects are expected to produce significant results in diagnosing and treating patients as well as reducing drug prices and the costs of diagnosis. These efforts illustrate the way in which innovative financing can be deployed for health and development," said Philippe Douste-Blazy, chairman of UNITAID's Executive Board.

British Prime Minister Gordon Brown, who helped launch the Stop TB Partnership's Global Plan to Stop TB in 2006 and whose government is a founding member of UNITAID, said, "I am delighted that this initiative will improve both the technology needed to diagnose TB quickly, and increase the availability of drugs to treat highly resistant TB. The UK is committed to stopping TB around the world, from our funding of TB prevention programs in poor countries to our support of cutting-edge research to develop new drugs."

In developing countries, most TB patients are tested for MDR-TB only after they fail to respond to standard treatments. Even then, it takes two months or more to confirm the diagnosis. Patients have to wait for the test results before they can receive life-saving second-line drugs. During this period, they can spread the multidrug-resistant disease to others. Often the patients die before results are known, especially if they are HIV-infected in addition to having MDR-TB.

The initiative comes shortly after WHO recommended line probe assays for rapid MDR-TB diagnosis worldwide. This policy change was driven by data from recent studies, including a large field trial — conducted by FIND together with South Africa's Medical Research Council and National Health Laboratory Services — which produced evidence for the reliability and feasibility of using line probe assays under routine conditions.

Over the next four years — as lab staff are trained, lab facilities enhanced and new equipment delivered — 16 countries will begin using rapid methods to diagnose MDR-TB, including the molecular tests.

Study backs KCI's V.A.C. wound therapy

Kinetic Concepts (San Antonio) said it has moved another step closer to introducing its V.A.C. Therapy wound care system in Japan with the completion of a two-phase clinical study designed to determine the clinical efficacy, safety and utility of the therapy for wound healing in that country.

KCI said the study was the first to evaluate negative pressure wound therapy for use in Japan and compared results from a multi-center prospective clinical trial to historical control data derived from a retrospective study of standard care treatment for acute wounds, including open traumatic and post-operative wounds.

Results showed a significant treatment difference in median time to wound closure of 15 days for V.A.C. Therapy vs. 41 days for the historical control. In addition, 50% granulation tissue formation, an indication of healing, was achieved in half of the patients on V.A.C. Therapy about one week after treatment initiation.

Linwood Staub, president-global V.A.C. Therapy for KCI, said, "We estimate that in Japan approximately 250,000 wounds annually are appropriate for V.A.C. Therapy, which provides a substantial market opportunity."

The data from the study, along with its submission for regulatory approval, have been submitted to the Pharmaceutical and Medical Devices Agency in Japan for review. n

Problems roiling exam-glove industry

Medline Industries (Mundelein, Illinois) said it has been notified by Hong Ray Enterprises (Shijiazhuang, China), the world's largest maker of vinyl exam gloves and a major manufacturer of nitrile gloves, that it will be unable to meet its normal agreements to customers.

"This disruption to supply will have a cost impact on the entire industry," said Tripp Amdur, president of Medline's glove division. "We are moving quickly to secure adequate supply for our customers through alternative factories, at ultimately a much higher cost."

In its letter to Medline and its other U.S. customers, Hong Ray cited a long list of events and government actions that have led to its inability to fulfill its contracts. These include a fire at a major raw material manufacturer, "dramatic changes" in government policy impacting labor, taxes and credit, and pollution-control measures associated with the Beijing Olympics.

According to Amdur, Hong Ray's situation is not unique. "All of our suppliers are facing enormous and unexpected obstacles in fulfilling their contract obligations," he said. "While Hong Ray is the first factory to formally declare 'force majeure,' other factories, including those that manufacture latex gloves, face similar circumstances. In Malaysia, for example, the government recently declared a change in pricing for natural gas, almost tripling the price overnight."