A BBI

The infrastructure of the United Kingdom's National Health Service (NHS) is improving rapidly, Health Secretary John Reid said in a new report issued last month. The report, titled "A New Generation of Healthcare Facilities Modernizing the Fabric of the NHS," details how new hospitals, walk-in treatment centers, refurbished wards and state-of-the-art equipment have been delivered across the NHS landscape over the past six years.

Reid said, "We are regenerating the estate, which means staff and patients will be able to work and be treated in modern, purpose-built facilities, tailored to modern healthcare. Practically everywhere I visit in the NHS, I see evidence of building work in progress new wards, refurbished buildings and brand new facilities." He said that the NHS is making "huge progress" in those efforts, noting that compared to 1995, when half of the buildings occupied by the NHS were older than the service itself, today that figure stands at less than a quarter. "By 2010," said Reid, "40% of the estate will be less than 15 years old."

The report shows that:

120 million has been invested since 2001 to modernize or replace Nightingale wards for older people. More than 400 wards have benefited so far and by next April over 600 wards will have been updated or replaced.

329 million has been allocated to 30 schemes to replace unsuitable mental health accommodation.

More than 200 maternity units have been refurbished.

By 2004, up to 3,000 new general practitioner premises will be refurbished.

"When we asked the public how they wanted the NHS improved over the next 10 years," Reid said, "they said they wanted more staff, more up-to-date equipment and shorter waiting times." And, he added, "They wanted to see real improvements in the quality of the fabric of their local hospitals. This progress report shows where we are with our 10-year plan to make a difference to the fabric of NHS buildings."

The report shows that the NHS's equipment stock also is being expanded and updated. Already, cancer patients are benefiting from 44 new MRI scanners, 61 linear accelerators, 137 computed tomography scanners and more than 600 breast scanning devices. In the cardiovascular area, 81 new or replacement cardiac cath labs have been announced, and more are to follow.

In another announcement that ties into the improvements being made in infrastructure, Reid unveiled a plan that will see the establishment of 26 new surgical treatment centers capable of treating an additional 250,000 NHS patients a year. The new dedicated units will be located across England and will offer surgical and diagnosis facilities, particularly in specialties that have the longest waiting times for patients, including orthopedics and ophthalmology.

Around 2 billion will be spent over the coming five years, and the planned treatment centers will all be fully operational by 2005. Reid said the new services would be provided largely in brand-new buildings and in some cases in refurbished NHS hospitals. The plan also calls for implementation of two mobile ophthalmology surgery units that will travel to areas of most need.

The new treatment centers are a key part of the British government's effort to cut waiting times for patients. In making the announcement, Reid said, "Tens of thousands of NHS patients will have their operations quicker as a result of this initiative, free at the point of use. The new Treatment Centers are just one part of the reforms that are helping to increase capacity in the NHS at an unprecedented rate. But although the NHS is growing quickly, even more capacity is needed to ensure that patients wait no longer than six months by the end of 2005. That is why we are working with the independent sector to provide additional operations to cut waiting times for NHS patients."

The companies named as "preferred providers" under the plan include Netcare UK and Care UK Afrox, both from South Africa; Nations Healthcare and New York-Presbyterian Healthcare System from the U.S., and Mercury Health Ltd. and Birkdale Clinic of the UK. Those firms now will work with the NHS to finalize contracts, Reid said, with the aim of having some of the services up and running by early next year.

Under the Treatment Center Program, NHS staff will work side by side with international clinical and management teams. "This will allow the NHS to learn from innovative approaches from the independent sector while retaining the strengths of the NHS and protecting the high standards of care that have been developed in the best NHS hospitals," the Department of Health said in its announcement.

Antibiotic eyed for device coating

Researchers from the school of pharmacy at Queen's University Belfast (Belfast, Northern Ireland) reported at last month's British Pharmaceutical Conference in Harrogate, UK, on development of a new biodegradable polymer they say has potential application in reducing infection associated with the use of implanted medical devices.

One way of reducing risk of infection caused by bacteria adhering to implanted devices such as urinary stents and catheters is to coat the device with a biodegradable polymer coating, which causes bacteria adhering to the surface to be shed as the polymer degrades. The next step, as reported by the Queen's University researchers, is to incorporate an antibiotic into the coating to provide added protection. That in essence results in a two-pronged attack the release of antibiotic and the degradation of the substrate onto which the bacteria have adhered.

In order to test whether the addition of the antibiotic does not affect the mechanical properties of the coating, the Belfast experiments involved incorporation of the antibiotic rifampicin into films of polycaprolactone, a biodegradable polymer that has attracted attention as a coating material for implantable devices. The researchers said that the inclusion of rifampicin did not compromise the physicochemical properties of polycaprolactone, and thus, "this antimicrobial agent may be useful in the design of biodegradable coatings based on this polymer."

Professor David Jones of the Queen's University group said the challenge ahead "is to engineer the rate of degradation to equal the rate of bacterial adherence, thereby effectively cleaning the surface of the device."

A report from another Queen's University group at the pharmaceutical conference suggested that the practice of mixing antibiotics into the cement used to hold replacement hip joints in place might actually weaken the mechanical strength of the cement. Those researchers cited laboratory work in which they analyzed antibiotic release from bone cement polymers. The expectation was that any gentamicin the usual antibiotic used in such instances on the surface of the cement would be released, diffusing out in the presence of joint fluid. But the researchers said they were surprised to see that some gentamicin was also being released from inside the cement. They said it appeared that the antibiotic was causing cracks in the bone cement, providing more surfaces through which the drug could diffuse.

Dr. Ryan Morrow said that microscopic images "revealed a significant quantity of pores, voids and cracks in the surface of the cement, which were found to increase in approximate proportion to the amount of gentamicin loading. The formation of pores and cracks allows a low release of gentamicin from within their structure long after the initial burst of gentamicin from the surface of the cement." He added that such cracks "could aid further cracking and subsequent mechanical failure of the bone cement if placed under stress."

The Belfast team's theory is that the cracking occurs because the antibiotic is present as small particles dispersed in the cement polymer, so they are working on a new approach to instead incorporate the antibiotic as part of the polymer structure. Morrow noted the development of one such polymer, in which an antibiotic is attached by a chemical linkage that breaks to release the active antibiotic when it comes in contact with joint fluid. He said that since the antibiotic is part of the polymer structure, it should not affect the mechanical properties of the cement.

Medical products agency gets top official

The appointment of a chief executive for the UK's newly established Medicines and Healthcare Products Regulatory Agency (MHRA) was reported by the Department of Health in September. Kent Woods, professor of therapeutics at the University of Leicester (Leicester, UK) and director of the National Health Service's Health Technology Assessment Program, will take over as head of the agency Jan. 1.

The MHRA was established on this past April from a merger of the Medicines Control Agency and the Medical Devices Agency. Like its predecessors, the new organization is an executive agency of the Department of Health. The MHRA is responsible for the regulation and safety of medicines and healthcare products. Its primary objective is to protect public health by taking all possible steps to ensure that medicines, healthcare products and medical equipment are safe for those who use them.

Woods, who also is chairman of the Department of Health/Medical Research Council's Joint Project on Publicly Funded Trials of Medicinal Products, said, "It is a pleasure and a privilege to be joining the MHRA at this formative time in its development." He said the merging of the Medicines Control Agency and the Medical Devices Agency "brings a wealth of expertise to the evaluation of new therapeutic technologies. The agency is well placed to build on the international reputation of its predecessors. It will have a central role at the intersection of innovation, clinical practice and public health."

Predictive array trials planned

Agendia BV (Amsterdam, the Netherlands), a recently formed start-up, is planning three large-scale clinical trials of a genomics-based method for predicting the chance of primary breast cancers to recur and metastasize. If successful, the approach could alter the management of breast cancer by eliminating the need for adjuvant chemotherapy in many women. In Europe, more than 85% of women with breast cancer less than 55 years of age and who have no detectable tumor cells in local lymph nodes receive chemotherapy to lower the risk of recurrence. In the U.S., the figure is more than 95%. In either case, just 30% of patients actually need to undergo such therapy, said Laura van't Veer, Agendia's chief operating officer and head of clinical research. "Yet we are giving 95% or 85% [of patients] chemotherapy to reduce the risk of recurrence," she said.

Until now, it has not been possible to distinguish those patients at the primary tumor stage who will go on to have a poor prognosis from those who will experience a less-severe form of disease. Agendia's founders, based at the Netherlands Cancer Institute, collaborated with bioinformatics firm Rosetta Inpharmatics, now a wholly owned subsidiary of Merck (Whitehouse Station, New Jersey), on identifying 70 genes that have collective expression patterns that provide a predictive indicator of how breast cancer will progress. In two retrospective studies of archived tissue samples from breast cancer patients who underwent long-term follow-up, they defined genetic signatures that correlated with a "good prognosis" and a "bad prognosis."

The forthcoming prospective trials, which follow two small-sized initial studies, will involve about 13,000 patients in all. The Health Council of the Netherlands, based in the Hague, is funding one study involving 3,000 subjects, while the Avon Foundation (New York) is supporting a second, which will recruit 5,000 patients. "Both of them will start with a pilot phase in October," van't Veer said. A third study, which also will involve 5,000 subjects, will get under way next year, with support from the European Organization for the Research and Treatment of Cancer (Brussels, Belgium) and the Sixth Framework Program of the European Commission (also Brussels).

Agendia is planning to introduce its first commercial diagnostic services later this year. It is collaborating closely with Agilent Technologies (Palo Alto, California), in the development of its microarray-based platform.

dj Orthopedics forms French unit

U.S. orthopedic sports medicine products manufacturer dj Orthopedics (San Diego, California) has formed a wholly owned subsidiary in France to provide direct distribution of its product lines beginning this month. The new subsidiary replaces a third-party distributor and will have responsibility for the sales, marketing and distribution of dj Orthopedics products in France, the second-largest orthopedic sports medicine market in Europe.

Les Cross, president and CEO of dj Orthopedics, said, "With an orthopedics sports medicine market of approximately $90 million growing at nearly 7% annually, France is a compelling opportunity." He said dj Orthopedics has hired "several key local professionals, experienced in the French orthopedics rehabilitation market, to join our new subsidiary and help us launch and manage our direct business activities." Cross added, "We believe that the knowledge and experience of our new French team in local orthopedics selling strategies and customs, combined with our strong product offering, will facilitate a smooth transition for us in France and permit us to accelerate our revenue growth in this important market."

dj Orthopedics initiated its direct distribution strategy early last year, forming subsidiaries in Germany, the United Kingdom and Canada. Its international revenues increased 23% both in 2002 compared to 2001, and in the first six months of 2003 compared to the first half of 2002. "International operations continue to be one of the growth engines for the company, driven by our focused direct selling strategy in key international markets," Cross said.

dj Orthopedics is focused on products and services that rehabilitate soft tissue and bone, help protect against injury and treat osteoarthritis of the knee. It has a line of more than 600 products, including rigid knee braces, soft goods, specialty and other complementary orthopedic products.

Akzo to sell three businesses

Akzo Nobel (Arnheim, the Netherlands), whose product mix includes a substantial healthcare focus, said last month that it plans to sell three businesses from its Chemicals portfolio to create "more room to maneuver for the company." The businesses to be divested include Catalysts, Coating Resins and Phosphorus Chemicals.

Hans Wijers, chairman of the board of management, said, the divestment will allow the company to "create value by moving toward a more consistent portfolio of businesses." He added that the planned divestments 'involve three excellent and profitable businesses; collectively they represent close to EUR 1 billion in sales." Saying that the company is "not in a race against the clock to sell," Wijers noted that the priority is creating "maximum value for Akzo Nobel and its shareholders, not how fast we can do this."

Akzo Nobel serves customers worldwide with healthcare products, coatings and chemicals. Consolidated sales for 2002 totaled EUR 14 billion. The company has about 66,000 employees in more than 80 countries.

New UK unit for Pensa

Pensa (Ottawa, Ontario) has established a new UK subsidiary, Pensa Technology Solutions Ltd. (Birmingham, UK), aimed at better serving what the company terms "the increasing demand for regulatory compliance to the European life sciences marketplace." Pensa is a validation consulting firm that provides guidance and consulting services and productivity software to medical device, pharmaceutical and biotech companies.

Its consulting services include computer system validation, process and equipment validation, regulatory compliance training and workshops, regulatory risk assessment and remediation, and validation master plan development. In August, Pensa announced a partnership with Agile Software, creator of AgileMD; a product lifecycle management application designed specifically for medical device manufacturers. The Validation Manager is Pensa's software application for implementation enforcement and control of regulatory compliance across an entire enterprise.

Digital Pregnancy Test introduced

Unipath (Bedford, UK), a women's health consumer and professional diagnostic provider, has launched the world's first home digital pregnancy test. The company said the Clearblue Digital Pregnancy Test has been developed to eliminate uncertainty by displaying an unmistakable result in words "Pregnant" or "Not Pregnant" on a liquid crystal display. Such a presentation, the company said, "eliminates the need to interpret the result, which can be a cause of anxiety and uncertainty for many women."

Unipath described the new test as offering "the first significant change in pregnancy testing in over a decade," and said it has been proven in laboratory studies to be more than 99% accurate in detecting the hormone hCG.

Unipath is part of the Inverness Medical Innovations Group (Waltham, Massachusetts) and employs more than 500 people in the UK. Its products are sold in more than 80 countries worldwide.

Ophthalmic firm signs Italian distributor

Coronado Industries (Fountain Hills, Arizona) reported signing its first major European sales and distribution agreement with EuPharmed (Rome, Italy), which will distribute the company's proprietary pneumatic devices for the treatment of glaucoma throughout Italy.

The company said the agreement represents a "giant step" in its worldwide marketing efforts, noting that EuPharmed is focused on the Italian ophthalmologist servicing more than 5,000 of the 6,500 current ophthalmologists in that country with other products. The contract provides EuPharmed seven years of exclusive distribution rights in Italy.

Richard Smith, CEO of Coronado Industries, said that the agreement, together with the "strong revenue stream" that will accrue to the company, will provide opportunities to expand its operations quickly into other European and worldwide markets.

Genetic research ethics center opens

Cardiff University (Cardiff, Wales) has opened a new center for research into the personal, social and ethical consequences of genetic technologies.

CESAGen, the Centre for Economic and Social Aspects of Genomics, will bring together biomedical researchers, clinicians and social scientists to carry out cross-disciplinary studies in the field.

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