BBI

The European Commission's Scientific Committee on Medical Products and Medical Devices has recommended the establishment of harmonized regulations covering all elements in the blood transfusion chain throughout the European Union.

Currently all blood donations in Europe are tested for hepatitis B and C viruses and HIV, as well as ABO blood grouping and Rhesus (D) testing. For medicinal products derived from plasma or blood and prior to fractionation, there are specific requirements laid down by the EU Committee for Proprietary Medicinal Products (CPMP; London), including nucleic acid testing (NAT) for hepatitis C in manufacturing pools.

Syphilis screening is carried out in most European countries, while ALT (alanine amino transferase) and neopterin marker tests are used in some Northern European countries. In countries with significant immigrant population, malaria testing also is included in the standard panel, although the committee has expressed doubts as to the sensitivity and specificity of some test methods in use.

Universal blood filtration to remove leucocytes which can transmit bacteria and viruses is not yet recommended by the committee, although Germany plans to introduce this additional precautionary measure in the near future, according to Pall Corp. (East Hills, New York), market leader in blood filtration. In Germany, around one-quarter of its 4 million blood donations are filtered at present.

In the United States, the American Red Cross (Washington) has announced the goal of filtering all its blood by the end of this year. By last month, the Red Cross was filtering about 40% of its blood, but progress has slowed with last month's decision to suspend use of HemaSure's (Marlborough, Massachusetts) blood filtration system pending an investigation into adverse patient reactions.

Wider use of NAT screening for all donations and an increasing use of leukoreduction filtration techniques will inevitably increase the cost of blood to health services across Europe. Although blood donors in Europe are almost entirely volunteers who receive no payment, apart from a free meal or transportation, the cost of screening and testing blood donations is estimated to be around $50 for each donation. Around 16 million units are collected each year in Western Europe.

Worldwide, between 5% and 10% of HIV infections are transmitted through the transfusion of infected blood and blood products. WHO/UNAIDS estimates that 5.6 million new HIV infections occur each year. "Diagnostic tests for the HIV antibody became commercially available 15 years ago, but there still are many countries that cannot guarantee 100% testing of donated blood," said Jean Emmanuel, director of blood safety and clinical technology at the World Health Organization (WHO; Geneva, Switzerland). "Many countries still have no organized blood transfusion services and continue to rely on family or paid donors; on the other hand, in developed countries 98% of the blood supply comes from safe,voluntary, unpaid donors. All countries should have well-organized blood transfusion services that provide a safe and reliable supply of blood for all those involved," he said.

WHO estimates that each year unsafe transfusion and injection practices cause an estimated 8 million to 16 million hepatitis B virus infections, 2.3 million to 4.7 million hepatitis C virus infections and 80,000 to 160,000 HIV infections.

Modular urology systems

Both Siemens (Erlangen, Germany) and Philips Medical Systems (Best, the Netherlands) have developed modular systems for urology applications so that both diagnostic and therapeutic procedures can be carried out in the same suite.

The Uro Plus system from Siemens consists of a wide range of commercially available modules that can be configured for lithotripsy, prostate therapy, urological endoscopy, or relevant imaging procedures. Similarly, the Diagnost ME system from Philips also is fully modular, with base units including lithotripter, C-arm image intensifier and patient table. The Philips system is only available with ultrasound imaging, whereas Siemens can offer both ultrasound and X-ray. To improve selectivity and effectiveness in the lithotripsy mode, the Uro Plus system enables the patient table, C-arm and lithotripter to work together to provide reproducible constancy between the isocenter of the central X-ray beam and the focus of the shock wave system.

Urology departments tend to encounter a broad spectrum of pathology among patients. The potential flexibility of these two new systems means that they can be configured to meet a wide range of clinical requirements and their modular design helps to maximize system utilization.

Separately, Olympus Winter + Ibe (Hamburg, Germany) has launched an improved version of its OES 4000 percutaneous nephroscope for use in kidney stone lithotripsy as an alternative when extracorporeal shock-wave lithotripsy is contraindicated.

The new system, which is autoclavable, features reductions of the outer diameter of the continuous flow system to 24 Fr and of the single flow system to 19 Fr, considerably reducing dilation.

Lisa Laser Products (Katlenburg-Linden, Germany) has developed the Diolix medical diode laser for use in urology as well as the more usual dermatological sector. Within the urological field, the laser can be used in the presence of urethral stenosis, urethral flaps, and benign prostatic hyperplasia (BPH). The laser beam is delivered via flexible 600 micrometer core silica fibers.

In a separate statement, EDAP Technomed (Vaulx-en-Velin, France) reported FDA approval of its new 30-minute transurethral microwave therapy (TUMT) treatment protocol for use with EDAP's Prostatron system. The new protocol reduces the time to treat benign prostatic hyperplasia with the Prostatron from one hour to 30 minutes and already is available in Europe.

Multi-drug-resistant tuberculosis

The emergence of multi-drug resistant tuberculosis (MDR-TB), which is increasing substantially as a result of the HIV pandemic, usually refers to resistance to at least the two most effective TB drugs, rifampicin and isoniazid.

Increasingly, hospitals are being faced with the expense of inappropriate isolation of patients who present with risk factors for multi-drug resistance (e.g., previously infected with TB and known to be noncompliant with drug therapy) but who nevertheless subsequently turn out to have drug sensitive strains. The quicker the precise resistance profile can be established, the more rapidly inappropriate and costly isolation costs can be avoided.

In many countries, resistance to rifampicin is regarded as a good predictor of MDR-TB. Biotec Laboratories (Ipswich, England) has developed the FASTPlaque TB-RIF test to detect rifampicin-resistant strains in M. tuberculosis within 48 hours. The test, which relies on the phage infection principle, shows an overall accuracy of 97% as compared to the WHO Lowenstein-Jansen reference test methodology.

Becton Dickinson (Cockeysville, Maryland) has launched in Europe an improved version of its well-established BacTec MGIT 960 system which can now also carry out susceptibility testing for M. tuberculosis. The system provides a susceptibility and resistance profile for not only rifampicin but also other drugs commonly used in the treatment of TB, including streptomycin, isoniazid, and ethambutol. Pyarzinamide is planned to be added shortly.

Ultrasound-enhanced latex agglutination

A meningococcal test with results in less than 30 minutes instead of blood cultures taking several days – that is the claim of Electro-Medical Supplies (Wantage, England) using its Immunosonic test device.

This new system exposes a glass capillary tube situated in the axial high acoustic pressure region of a 4.5 MHz radial standing wave field to 60 seconds of ultrasound radiation. The tube, which contains equal volumes of patient serum and coated latex particle suspension, is taken out, a drop expelled and mixed on a microslide for microscopic examination. Agglutination indicates a positive result.

The sensitivity of the ultrasound-enhanced agglutination is considerably higher than classical latex agglutination methods, with a sensitivity level equivalent to PCR methodology.

Styling orthopedic shoes by laser

Conventional orthopedic shoes are not usually stylish, and wearing them can be an embarrassment, especially for the young. Until now, achieving a good fit has involved a large number of measurements and adjustments – tedious for the patient and difficult for the orthopedist.

Francois Venel of Cetiop (Limoges, France), together with four specialist footwear manufacturers – Gabilly in France, Buratto in Italy, BT in Germany and De Pretre in Belgium – has developed a foot digitizer, and a French company, Dilaco, will market it. Production is planned to start in 2001.

The new digitizer uses laser beams to create a 3-D model of the malformed or injured foot which is linked to an automated manufacturing unit. "Demand from the European markets is strong, both from orthopedists and shoe manufacturers," Venel said "It is clear that the market is waiting for this type of product." Although primarily designed for use by professional orthopedists, it could also be used by manufacturers of non-medical, custom-made shoes to ensure a perfect fit.

Orquest/Biopharm collaboration

Orquest (Mountain View, California) and Biopharm (Heidelberg, Germany) plan to pool their respective technologies to develop bioengineered matrices for the treatment of a variety of orthopedic conditions. Biopharm will contribute MP 52, a novel recombinant growth factor and a member of the bone morphogenic protein (BMP) family, while Orquest will contribute its unique proprietary materials and expertise in developing and assembling combinations of growth factors and matrices. Their first product, HealosMP52, is expected to enter clinical trials soon in the U.S. and Europe for spinal fusion applications. This project is in collaboration with Sulzer SpineTech (Minneapolis, Minnesota). Other development programs under way are in fracture, dental, and cartilage repair.

BMP products also are in development by a number of other companies and include BMP2 from Genetic Institute (Cambridge, Massachusetts) and OP-1 from Stryker Biotech (Allendale, New Jersey).

"Biotechnology products that combine growth factors with engineered matrices are opening up tremendous possibilities in orthopedics, especially in spine, cartilage and fracture repair," said James Poser, president and CEO of Orquest.

Separately, Sulzer Medica (Winterthur, Switzerland) has launched its first biological implant, the CMI collagen meniscus implant, in Europe. The product was jointly developed with ReGen Biologics (Redwood, California), in which Sulzer has a minority holding. The porous sponge-like structure of the CMI serves as a scaffold to support the ingrowth of cells and the formation of new meniscus tissue.

Edible vaccines on the way

Annick Mercenier and her team at Transgene (Strasbourg, France) have been investigating the possibility of using lactic acid bacteria (LAB) as candidates for oral vaccines and drug delivery vehicles. Their initial basic scientific research has confirmed that a number of LAB could be used as vaccine vectors. Since LAB can be taken orally, they are easy to administer. Also, since dietary LAB themselves have GRAS status (generally regarded as safe), they would be particularly useful when developing a vaccine for the young, the elderly, and those with compromised immune systems.

Mercenier, who has since moved to the Institut Pasteur de Lille (Lille, France), has now completed the three-year Labvac project with a group of nine academic partners and Innogenetics (Ghent, Belgium). In this project, several strains of engineered LAB have been produced and have shown good antibody responses with tetanus toxin and Aujeszky's disease virus in pigs.

Further research is planned on using a lactic acid vector against viral infantile diseases, and on using LAB as vehicles to deliver interleukins locally. "We have come a long way in five years. In the past, we spent a lot of time trying to interest vaccine development companies in our work. Now they seek us out," Mercenier said.

Separately, ProdiGene (College Station, Texas) has announced that its patented edible vaccine confers protection against transmissable gastrointestinal virus (Aujeszky's disease) in pigs. The vaccine is produced from maize genetically modified to express antigens of the virus. It is expected to be commercially available for pigs in two to three years. Demand in agribusiness is expected to be high, said Joe Jilka, vice president of product development at ProdiGene. The transgenic maize would be grown under rigorously controlled conditions and only used for the express purpose of vaccine production, he said.

World Online in Novartis deal

World Online (Rotterdam, the Netherlands), the pan-European Internet provider which was floated late in March on the Amsterdam exchange – valuing the company at $2.78 billion – has stepped up its rapid expansion in Europe through an alliance with Novartis (Basel, Switzerland). Under the deal, for which no financial details have been disclosed, World Online has agreed to build Europe's first health care portal. It will offer a range of information and health care products from prescription drugs to nutrition.

The Swiss Sandoz family owns 46% of World Online, and Intel owns another 8.7%. The deal will give World Online, with almost 2 million users in 15 countries, a head start as the first Internet company in Europe to team up with a pharmaceutical group.

Swiss ortho firms report strong sales

Synthes-Stratec (Chru, Switzerland) showed 18.2% growth to $141 million for the first quarter this year in North America. While European sales increased only 5.8% to $29 million, sales in the rest of the world grew dramatically by 36.4% to $10 million.

Sulzer Medica's total orthopedics and cardiovascular sales increased by 16% in the first quarter, with net income up 35%. Sulzer Medica predicts that sales and operating margins of its two core businesses will continue to improve throughout this year.

UK diabetes care gets poor report

Up to 50% of diabetics in the United Kingdom already have significant complications when diagnosed, according to a new report from the National Audit Office, an independent government inspection body.

Patterns of care differ around the country and many patients do not benefit from best practices, according to the report. The monitoring of glycemic control is particularly inconsistent, with HbAIc assay methodologies and reference ranges varying. Additionally, some areas do not use this system at all.

Diabetes currently accounts for about 9% of National Health Service hospital costs at $2.85 billion per year, with patient numbers projected to double over the next 10 years to around 2.8 million, according to the Audit Office report.

The report also cites research showing that good blood glucose control in diabetics can reduce kidney damage by one-third and that good blood pressure control also can reduce strokes by a third. Eye care and treatment for diabetics can reduce blindness by half, and foot care can reduce the incidence of diabetic ulcers complications by two-thirds.

The report regrets that little cost-effectiveness research on diabetes care has been published, but says that there is nevertheless sound evidence about what works.

Russian health care in crisis

Life expectancy in Russia fell to a low of 64.1 years in 1994, with a huge differential between that of women (71) and of men (57.4). While there have been modest improvements since then, the death rate still exceeds the birth rate, so Russia's population continues to fall.

The Russian medical sector proved highly effective in the post-World War II years in implementing mass programs of vaccination and immunization to tackle infectious diseases. But the techniques needed for handling lifestyle diseases like obesity, blood pressure, and lung cancer have proved too crude.

At the same time, the medical profession – like many others – has developed its own survival mechanisms. Behind the current theoretical constitutional right of free health care for all, cash payments have become widespread: for admission to hospitals, for drugs, for food and laundering, for nursing, and physician consultations alike. Add to this the substantial official expenditure on private health care and it is clear that the Russian system has been privatized – under the worst conditions possible.

French generics sales boosted

Efforts by French authorities to encourage the substitution of generics for branded medicines are beginning to pay off. A decree permitting pharmacists to propose the substitution of generics for drugs prescribed by physicians, which came into effect mid-1999, has shown increases in generic sales.

By the end of 1999, sales of generics in France rose to more than $10 million per month, compared to an average of $3 million in 1998. In 1999, generics sales totaled $82 million and are expected to grow to almost $300 million this year and $450 million in 2001.

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