BBI

The Hôpital 2007 plan, first announced by the French Prime Minister Jean-Pierre Raffarin in early July, is taking form. Minister of Health Jean-Francois Mattéi has unveiled the main aims of the five-year plan, which is estimated to cost $6 billion.

Control of healthcare establishments in France, which until now has been centralized in Paris, is to be largely decentralized. Regional hospital agencies and hospital administration councils will have increased powers, with the main emphasis of the Hôpital 2007 plan being on investment in new buildings, medical equipment and information systems. A first installment of $300 million has been included in budgets for 2003.

According to Mattéi, this will allow the mobilization of up to $1 billion of investment using joint partnerships with the private sector. He said that modifications of existing laws would be made before the end of this year to allow commercial organizations to build hospitals in partnership with the state.

Purchasing regulations for medical equipment will be simplified for an initial 40 hospitals next year, Mattéi said, before changing all public hospitals over to the new simpler system in 2004, "We will simplify a number of regulations, in particular for purchasing, which produce simultaneously additional costs and confusion in the hospital administration," he said.

Agency to be 'powerhouse for improvement'

The plan to merge the UK's Medical Devices Agency (MDA) and Medicines Control Agency into a single entity next year will be a "powerhouse for improvement" in the regulation of healthcare technologies and therapies, in the view of Health Minister Philip Hunt. Speaking at the device agency's annual conference in late September, Hunt said the formation of the Medicines and Healthcare Products Regulatory Agency (MHRA) will represent "a model of common sense and proportionate regulation."

He said the new agency would be "all about patient safety." Assuring such safety "is not an optional extra," Hunt said in his talk. "People going into hospital or being treated at home ... believe that everything is there to make them well again and that healthcare products and medicines are safe and effective."

The British government announced in mid-September that the MHRA would make its bow next April. At the time of that announcement, Hunt said that a key reason for merging the two existing agencies into one is what he termed "the increasing convergence in the fields of pharmaceuticals and medical devices." He said that as technology develops, "there are likely to be growing numbers of products that cross the borderline between medicines and devices."

Gains in predicting development of diabetes

Attendees at this year's British Pharmaceutical Conference in Manchester, UK, were told that researchers are getting better at predicting which patients are likely to develop Type 1 diabetes, elevating hopes of preventing the disease. Professor Adrian Bone of the school of pharmacy and biomolecular sciences at the University of Brighton (Brighton, UK) said that two large trials in which family members of patients with Type 1 diabetes were screened showed that the screening process was "very accurate in predicting development of diabetes."

Bone called those findings "encouraging news," and said the accuracy of the screening process "will give confidence to researchers seeking to evaluate future potential intervention therapies."

He said the disappointing part of the two studies — one conducted in Europe, the other in the U.S. — was that drug treatments used in the trials with the aim of delaying or even preventing the onset of Type 1 diabetes had no effect on prevention of the disease. Diabetes "developed in exactly the same number of people in the drug and placebo groups over the five-year study periods," Bone said, adding the view that the most effective diabetes prevention drugs were not used in the studies because they involved healthy people "who were not known for certain to be at risk of diabetes."

But, he said, "now that we know we can accurately identify high-risk individauls ... potentially better drugs can be tested in the next studies."

Bone also reported on success achieved by a research group in Edmonton, Alberta, in carrying out islet cell transplants in more than 30 patients. Of those who received the transplants, 17 have been able to stop injecting insulin.

"These are better results than ever before," he said, noting that funding has been provided to at least four UK centers to follow the protocol established by the Canadian researchers and start islet cell transplant treatment of patients.

Noting that the major problem is the limited supply of islet cells for transplantation, Bone expressed optimism that the problem will be overcome by the use of islet cells from cloned pigs and from stem cell research. "Type 1 diabetes is so common that it must be a priority area for stem cell researchers," he said. "I'm certain that production of islet cells will be one of the first outputs from this new technology."

Global effort urged on sepsis

A global organization of intensive care professionals is attempting to focus greater attention on the need to reduce the number of deaths from sepsis, which it said is the 10th most common cause of death worldwide, estimated to take 1,400 lives every day. Up to 30% of those diagnosed with sepsis die within one month of such a diagnosis.

The Surviving Sepsis Campaign is an effort of the European Society of Intensive Care Medicine; its U.S. counterpart, the Society of Critical Care Medicine; and the International Sepsis Forum. During the European society's annual congress in Barcelona, Spain, members of those organizations endorsed the "Barcelona Declaration," an initiative pushing governments and healthcare providers to "recognize the growing burden of sepsis and to commit to providing adequate resources to combat it."

The group said sepsis develops particularly from infection associated with pneumonia, trauma, surgery, burns or conditions such as cancer and AIDS. It is characterized by "an overwhelming systemic response by the body to infection, which can rapidly lead to organ failure and ... death," the group said in a press release. In fact, it noted, "80% of patients who die from major injuries are actually killed by sepsis."

For healthcare providers, an action plan is aimed at improving the management of sepsis by:

• Facilitating early and accurate diagnosis through the adoption of a single, clear definition of sepsis.
• Ensuring appropriate and timely use of treatments and interventions through consistent clinical protocols.
• Recognizing universally acceptable referral guidelines throughout the world.
• Providing leadership, support and information to clinicians about sepsis management.
• Providing a framework for improving and accelerating access to post-ICU care and counseling for patients.

"We have the technology and resources today to treat most conditions and injuries, yet infection, which has been killing people since history began, still defeats us," said Professor Graham Ramsay, president of the European Society of Intensive Care Medicine. "Without greater government funding, education and awareness, [clinicians' efforts] can only have limited success."

Gastrointestinal disease survey begins

The United European Gastroenterology Federation (UEGF) last month launched the largest survey of gastrointestinal (GI) diseases to be undertaken in Europe. Professor Michael Keighley, chairman of the federation's public affairs committee, cited the "devastating impact that these diseases can have on patients." He said GI diseases represent a common cause of emergency admission to hospitals, are expensive to treat and "place a huge burden on healthcare systems."

Keighley said the organization wants patients, clinicians, healthcare providers and politicians to "recognize and understand the scale of the problem of GI diseases and the ... resources required to tackle them."

UEGF said the intention is to use the survey findings to "help raise awareness in European nation states and inform health policymakers and to highlight the need for an effective strategy to tackle GI diseases." It said it expects the emphasis to be on developing screening programs in areas such as colorectal cancer that focus on prevention and can cut the costs of hospital cancers.

Phase I results of the survey are expected to be announced and published early next year.

Intercept system nearing availability

The illuminator device for the Intercept Blood System being co-developed by Baxter International (Deerfield, Illinois) and Cerus (Concord, California) has received CE mark declaration, which the companies said is the final regulatory step before the pathogen-inactivation technology for blood platelets is made available in Europe.

The Intercept system is designed to reduce the risk of diseases being transmitted through blood transfusions by inactivating both known and potential emerging pathogens in blood components. The first approved application of the Intercept technology, which is based on Cerus' Helinx technology for controlling biological replication, is for blood platelets. Clinical trials also are under way for its use with plasma and red blood cells, which the companies said make the Intercept system the only pathogen-inactivation technology being developed for use with all primary blood components.

The system consists of the illuminator device and a processing set containing a light-activated, nucleic acid-targeting Helinx compound, which has the ability to permanently inactivate pathogens in the blood component. The companies said Intercept platelets may benefit hundreds of thousands of patients in Europe annually, including those undergoing chemotherapy, heart bypass surgery and other procedures that require platelet transfusions.

The system inactivates a broad spectrum of pathogens, including viruses, bacteria, parasites and potentially harmful donor white blood cells.

Greg Young, corporate vice president and president of Baxter's Fenwal division, said, "European regulatory approval for Intercept platelets represents ... the successful efforts of Baxter and Cerus, leveraging the technical expertise of both as well as Baxter's extensive experience in transfusion therapies, in developing a prospective approach to blood safety."

The Intercept system for platelets is required to undergo process validations in compliance with European blood bank good manufacturing practices requirements at the individual country level throughout Europe before it is available to patients. That process is under way in several countries, including Denmark, France, Germany, Sweden and the UK.

FreeStyle monitor launched in UK

TheraSense (Alameda, California) has launched its FreeStyle blood glucose monitoring system — which it touts as offering readings taken from the smallest blood sample — in the UK. The company's technology allows diabetics to take blood samples from the arm, thigh, base of the thumb or other locations, rather than traditional fingertip needlesticks, which are far more painful due to the presence of more nerve endings in the fingers than in the other locations from which FreeStyle samples can be drawn. Most users of the FreeStyle device choose to test their blood from the forearm or thigh. The FreeStyle unit requires only about a third of the blood needed by other meters to make accurate readings, and produces its readings within 15 seconds, which is as much a two-thirds less than the time required by other devices.

Simon O'Neill, head of care development at Diabetes UK (London), noted that blood glucose testing "can be painful and inconvenient for people with diabetes, who should be testing themselves regularly." He said the prospect of "being able to test with less pain and away from the sensitive fingertips is one which will be welcomed by many people."

A recent study of Type 2 diabetics by the UK Prospective Diabetes Study indicated that effective blood glucose control "could reduce the risk of diabetic eye disease by 25% and kidney damage by 33%," according to a TheraSense news release.

Computer-assisted surgery system

Philips Medical Systems (Best, the Netherlands), in a collaboration with the University of Hull and the Hull Royal Infirmary (both Hull, UK), has developed the Computer Assisted Orthopedic Surgical System (CAOSS), which is currently undergoing clinical trials due for completion in 3Q03.

The intraoperative imaging system and intelligent trajectory guide are aimed at improving the precision of orthopedic surgery, particularly with regard to optimal implant positioning. Protocols and software have been developed for a number of procedures including the implantation of dynamic compression hip screws, distal locking of intramedullary nails, the insertion of cannulated hip screws for fractured neck of femur.