Although more than 4 million mammograms are performed each year on patients suspected of having breast cancer in Germany, the quality of mammography has not always been satisfactory, too many young women have been unnecessarily screened and it has become necessary to weigh the benefits of the program against the burden on patients. Ulla Schmidt, federal health minister, made these points while inaugurating a breast-screening project in Bremen for women over 50.
"It is important that we respect European guidelines for quality control in mammography screening, and this is the reason we have introduced a number of regional screening programs," she said. In emphasizing that women from outside the selected regions also would benefit from the trials, she added, "health service organizations, including physicians' associations, Krankenkassen (sickness funds) and hospitals, are keen to review and to build on positive results." According to Schmidt, an early detection program will encourage regular self-examination. She also promised guidelines to encourage better treatment quality for breast cancer patients.
The state governments of Baden-Wurttemberg, Bavaria, Hesse and Schleswig-Holstein have submitted a petition to the German Bundesrat (upper house of parliament), which has issued a resolution calling on the federal government to take steps to improve breast-screening programs and to submit its proposals to the Bundesausschuss der Arzte und Krankenkassen, a federal committee that undertakes health technology assessments.
Incidence rates in all European Union countries for breast cancer are increasing, with a current average mortality rate of 68.8 per 1,000 population. Although incidence rates are somewhat lower than in the U.S., five-year survival rates of between 60% and 70% are somewhat worse. Mortality rates in Denmark, the Netherlands and the United Kingdom have started to decrease in recent years, possibly because of the national screening programs.
Orthopedic implants may be reclassified
National competent authorities in France, Germany and the United Kingdom are pushing hard for the reclassification of most orthopedic implants from Class IIb to Class III, a change that is being vociferously opposed by EUCOMED (Brussels, Belgium), Europe's medical device industry association.
The potential change, which would be implemented during the present five-year review of the EU Medical Devices Directive (MDD), was discussed at the last European Commission experts' working group meeting in July. The debate is expected to continue at the next scheduled working group meeting in October, when the commission's first draft of the revised MDD is likely to be presented.
The general opinion at the European Commission is that the competent authorities may win because of political pressures and the public's perception that tighter controls are necessary.
Following Sulzer Medica's (Winterthur, Switzerland) much-publicized recall of its Inter-Op hip shells, with an estimated 2,500 consequent revision surgeries and the company's tibial baseplate investigation (140 revisions to date), the French health care products safety agency, AFSSAPS (Paris), has announced the recall of hip implants from four manufacturers that incorporated zircone femoral heads produced by Saint-Gobain C ramiques Avanc es Demarquets (Clermont Ferrand, France). The four companies involved are DePuy (Warsaw, Indiana), Smith & Nephew France (Le Mans, France) Smith & Nephew Richards (Memphis, Tennessee) and Fournitures Hospitali res (Paris). The AFSSAPS instituted the recall after about 30 implant heads fractured in France, identified by the agency's database of adverse incidents.
Photodynamic therapy in Europe
Scotia Holdings (Stirling, Scotland) has been granted a delayed marketing approval by the European Medicines Evaluation Agency (EMEA) for its lead photodynamic therapy (PDT) agent, Foscan, for the treatment of head and neck cancer. Scotia called in Ernst & Young as administrators in January when the EMEA initially gave Foscan a negative opinion.
In the U.S., the FDA also had previously notified the company that it would need additional patient data on Foscan before regulatory filing could be considered. The decision now to approve the product in the European Union has come as a result of an appeal against the original EMEA opinion and a reevaluation of the clinical data by Scotia and Ernst & Young.
The administrators are now seeking licensees for Foscan both in the U.S. and Europe, an action that probably is too late to save Scotia, however.
Separately, PhotoCure (Oslo, Norway) has announced that it has received its first marketing authorization in Sweden for the use of its Metvix photodynamic therapy in the treatment of actinic keratosis and basal cell carcinoma.
New vaccine developments
Crucell (Leiden, the Netherlands) and Vaxin (Birmingham, Alabama) are to jointly develop new vaccines that can be administered in a noninvasive way. The combination of the two companies' technologies is intended to be the starting point for a new generation of vaccines, according to a Crucell spokesman. Crucell's PER.C6 cell line and related vaccination technology will be combined with Vaxin's skin delivery system for vaccines, called EasyVax. This delivery system makes possible the delivery of new antiviral vaccines that can be administered noninvasively to the skin surface using a patch.
Under the terms of the joint development agreement, Crucell and Vaxin will collaborate to develop two unidentified antiviral vaccines and will share costs and profits.
Solvay Pharmaceuticals (Brussels, Belgium) has obtained process approval in the Netherlands for a novel cell culture-based method for producing influenza vaccines. Until now, influenza vaccines have been produced on the allantoic membranes of chicken eggs, a slow and laborious process. The new Solvay process instead uses the mammalian MDCK (Madin Derby Canine Kidney) cell line, making possible more flexible, rapid and efficient vaccine production. The company says that pan-European registration of the new process already is under way and that it is considering partnering further technology development, scale up and the construction of a production unit. In the meantime, Solvay plans to continue producing its egg-based vaccine, Influvac.
A possible partner to Solvay could be Lonza (Zurich, Switzerland), which is investing heavily in fast-growing new biotech areas, such as mammalian cell fermentation capacity for vaccine and other therapeutic end uses. Sergio Marchionne, Lonza chief executive, said the company would continue to sell up to $600 million of non-core assets in order to refocus its activities as a specialist contract supplier to biotech and life science companies, which are outsourcing an increasing amount of their manufacturing needs.
The company has announced the sale of its small-energy division for $262 million and also is planning a third share buy-back this year for around $300 million. Over the past year, Lonza's shares have outperformed the sector and it is now one of Europe's most highly rated specialist chemical companies. First-half operating income rose 13% to $103 million and earnings per share were up 26% to $16.26.
New ideas for an old problem
Two alternatives to the existing procedure of ligation and stripping of the great saphenous vein (GSV) are showing excellent results in recent clinical trials to treat varicose veins.
The EndoVenous Laser Treatment (EVLT) uses 810-nm diode lasers from Diomed (Cambridge, England). The EVLT technique represents a new application, and has yielded positive results in clinical trials. The percutaneous endovenous laser treatment is performed as an outpatient procedure under local anesthesia and ultrasound guidance. Initial results are very encouraging, with success rates of around 95%. Laser energy is delivered to the inside of the vein via a fiber-optic laser fiber. The procedure is generally well tolerated by patients, who report little or no pain during the procedure, and who can return to normal activities almost immediately. Cosmetic results in particular are especially good, with no scarring.
Dr. Steven Zimmer, who carried out the UK clinical trials on 84 patients, said that preliminary results showed effective closure of incompetent GSV at nine months post-operatively. He concluded that this data indicates that EVLT of GSV incompetence appears to be a very safe procedure, with excellent short-term results and presenting significant advantages over existing techniques.
BTG (London) is speeding up development of Varisolve, its nonsurgical varicose vein treatment that shrinks the vein when injected. BTG has announced that Varisolve microfoam treatment has been proven safe and effective in two Phase I pilot studies at South Manchester University and Aberdeen Royal Infirmary in the UK. The overall success rate of the outpatient treatment was reported at 81%, comparable to the outcome from surgery. The FDA will permit BTG to proceed directly to Phase III clinical trials later this year without completing any Phase II studies, according to Rusi Kathoke, BTG's chief financial officer. The European launch of Varisolve is planned for 2005, the company said.
NICE's fall technology appraisal program
UK's National Institute for Clinical Excellence (NICE; London) has listed new medical device-based therapies that are to be reviewed this fall in its sixth appraisal program. These include insulin pump therapy for patients with Type 1 insulin-dependent diabetes, electroconvulsive therapy, thermal endometrial ablation for menorrhagia, tension-free vaginal tape for stress incontinence and a review of home-vs.-hospital dialysis for end-stage renal dialysis (ESRD) patients.
The fall program also plans the issue of new clinical guidelines covering chronic obstructive pulmonary disease, the diagnosis and treatment of lung cancer, and the identification, counseling and management of genetic risk in familial breast cancer.
Evans Vaccines in Readyject syringe deal
Evans Vaccines (Liverpool, England) has installed a state-of-the-art syringe filling line at its Speke facility near Liverpool. The line uses isolator technology to deliver up to 9,000 prefilled syringes per hour and production runs of up to 30 million units. The new type of prefillable syringes has been developed by B nder Glas (Dusseldorf, Germany) to allow for siliconization and heat sterilization immediately prior to filling.
After a somewhat checkered past in which Evans Vaccines has been owned by Glaxo (London) and Medeva (also London), it is now part of the PowderJect Pharmaceuticals Group (Oxford, England). An existing licensing deal between Weston Medical (Lewes, England) and Medeva to use Weston's Intraject needlefree injector technology with Evans' vaccines fell through when PowderJect acquired Evans, with plans to use its own needlefree technology.
Although Medeva has retained the rights to use Intraject technology for its flu vaccine in Europe, Weston has now secured a major licensing deal with Abbott Laboratories (Abbott Park, Illinois) to evaluate Intraject technology for potential use with up to 11 drugs in Abbott's pipeline. Abbott says that "potential annual peak sales for clinical candidates that may be appropriate are estimated to be in excess of $500 million." In comparison, Medeva's flu vaccine sales in Europe currently are worth $23 million to $25 million, but growing rapidly.
WHO plans new fight against flu
The World Health Organization (WHO; Geneva, Switzerland) is developing a Global Agenda on influenza – a kind of worldwide "hit list" of activities to reduce mortality and morbidity statistics from annual epidemics of influenza.
Far from being an innocuous cold-like infection, flu is a killer, causing around 20,000 deaths each year in the U.S. alone. During the 1918 pandemic, up to a quarter of the world's population is estimated to have been infected and as many as 40 million people may have died.
Explosive outbreaks of influenza – typically lasting six to eight weeks – occur every year. Experts predict that it is only a matter of time before a brand-new influenza strain emerges and sweeps across the world, causing another pandemic.
Iain Simpson of the communicable diseases program at WHO says that there is a particularly urgent need to tackle flu in developing countries, where it is often not perceived as a major public health problem. Included in the priority subject areas in the Global Agenda are the expansion of vaccine use, especially in developing countries, and the acceleration of the introduction of new flu vaccines and new methods of large scale immunization programs.
The virus which causes flu is highly contagious. One study of the most recent available evidence concluded that on average, one in 10 adults and one in three children contract influenza each year. While most healthy people fully recover from the illness, hospitalizations and deaths among the elderly and chronically ill are too high and place a strain on national health care systems.
More than 50 logistical experts from international organizations met in early August in Geneva to review logistics management systems for humanitarian assistance in emergency situations such as flu epidemics. The workshop, a joint initiative of WHO, the Pan American Health Organization (PAHO) and other groups, has agreed to use the experience and philosophy of SUMA, a basic tracking system developed by PAHO, to facilitate the exchange of logistical information between organizations.
Dr. Claude de Ville de Goyet, chief of PAHO's Emergency Preparedness and Disaster Relief Program, said that use of SUMA should be useful not only for United Nations agencies and humanitarian assistance organizations, but also for national authorities in disaster-prone countries. "From experience, we know that the availability of a logistics information system in a disaster situation helped countries like El Salvador and Honduras quite a lot in efficient management of international assistance. It also improved transparency and accountability for the management of donations, which is very important," he said.
Surgery or drug-based treatment?
Parkinson's disease affects around 120,000 people in Britain and around 1.5 million in the European Union. One in 100 over the age of 65 and one in 50 over the age of 80 are affected, although one in 20 of Parkinson's sufferers is less than 40 when diagnosed.
The Medical Research Council and the Parkinson's Disease Society in the UK will provide almost $2 million between them to start a long-term study comparing outcomes from surgery or drug treatments for Parkinson's disease. Around 500 patients will be studied at British hospitals, recruited over a four-year period with a nine-year follow-up.
Professor Adrian Williams of the Queen Elizabeth Hospital (Birmingham, England), leader of the project, said that past research publications have not produced sufficiently reliable clinical evidence of the long-term benefits of surgery.
Standard drug-based treatments currently in use tend to lose their effectiveness over time, whereas surgery can offer a one-time procedure with long-term quality of life benefits, according to Williams. He said the study also aims to assess the optimal operating technique, surgical site and timing.
There are potentially three surgical sites – the thalamus, globus pallidum or subthalmic nucleus – and two methodologies – radiofrequency lesioning or electrical stimulation, with the latter being preferred in the UK, Williams said. The stimulation procedure involves implanting an electrode at the appropriate site and connecting it to an external stimulation device, he noted.
Compass increases presence in U.S.
Compass (London), the world's largest contract catering group, has boosted its position in the U.S. health care market with the acquisition of Crothall Services (Wayne, Pennsylvania) for $170 million in cash.
Mike Bailey, CEO at Compass, said the addition of Crothall, which specializes in housekeeping, portering and laundry service, would help Compass win North American contracts where both facilities management and catering services are required. "Over the last three or four years, we have seen a number of requests for bundled services – that is, food services with other services such as housekeeping and portering – move from about 5% to 30%," he said.
The acquisition of Crothall follows the purchase of Morrison Management Specialists (Mobile, Alabama), the second-largest contract caterer in the U.S. health care market, for $563 million earlier this year.
Crothall, which provides services to more than 250 hospitals across the U.S. and Canada, was bought by its management from Morrison about 10 years ago, and it is expected to generate profits of $17.5 million on sales of $350 million in the current year.
Crothall will remain as a stand-alone division, according to Bailey, who added that the acquisition would be funded from the proceeds of Compass's hotel disposals.
BioTissue targets German skin graft market
BioTissue Technologies (Freiburg, Germany) has started a European multicenter study led by Professor Wolfgang Vanscheidt of the Wound Biology Clinic (H chenschwand, Germany) to develop more data concerning applications and use of its skin cell substitute, BioSeed-S. The data will be used to encourage and support reimbursement coverage of the product by health insurance organizations across Europe.
BioSeed-S, which already has European Union marketing authorization, is the subject of a globally exclusive marketing deal with Baxter International (Deerfield, Illinois).