A CDU

The UK Department of Health late last month named Cardiac Science (Irvine, California) as its sole provider of automated external defibrillators (AEDs). It plans to purchase about $3 million AEDs in a contract the company said represents the largest government purchase of such devices in history. The purchase of Cardiac Science's Powerheart G3 AEDs and associated accessories will be for distribution under the UK's National Defibrillator Program, described as "the world's largest government-sponsored public access defibrillation program."

Cardiac Science said it was awarded the sole-source contract after procurement process that included "rigorous due diligence and a detailed review of all AED products available in the market." The company said this phase of the National Defibrillator Program is focused on providing more than 2,000 AEDs to ambulance services throughout England in order to "significantly grow the number of first responders outfitted with AEDs within their respective local areas, as well as deployments in public places."

Chairman and CEO Raymond Cohen said, "Being selected as the sole-source provider of AEDs for a national program of this magnitude is not only testament to the quality and reliability of our AED technology, but underscores that fact that [we] can compete aggressively with larger players in the field and win." He said the order, which represents the single largest purchase of AEDs in the company's history, is expected to be delivered in the fourth quarter.

"The National Defibrillator Program is a great example of how governments can take the lead in establishing successful public-access defibrillator programs," Cohen said. "While England is the first European country to implement a nationwide AED program, we fully expect other countries to follow their lead." He said that when that occurs, his company will have established itself as the front-runner in the market "and will be well-positioned to compete."

The British government launched the National Defibrillator Program in mid-1999, based on a study detailing the life-saving potential of installing AEDs in busy public places such as railway stations, airports, bus stations and ferry ports. According to Cardiac Science, about 680 AEDs have been installed in 109 sites to date and more than 5,000 people have received training in basic life support and AED skills. Department of Health figures show that since the initiation of the national program, 23 heart attack patients have been saved after receiving emergency AED treatment by trained personnel at public sites. The department said 12,000 people suffer a cardiac arrest in a public place each year, adding that the introduction of automated external defibrillators would increase the chances of survival for many of those who suffer such attacks.

THINCS thinks cholesterol guidelines stink

The International Network of Cholesterol Skeptics (THINCS; Lund, Sweden), a non-profit organization of physicians, scientists and researchers, said recently revised cholesterol-lowering guidelines constitute a "major risk" to public health. Noting that the new guidelines will result in millions more people being placed on statins, THINCS said that its members are "deeply disturbed by the ever-increasing pressure to lower blood cholesterol levels, and the underlying commercial interests that have distorted scientific research in this area." The organization warned that statins "have been excessively 'hyped' by the pharmaceutical industry and medical opinion leaders who have, unfortunately, become little more than paid advertorials."

Uffe Ravnskov, MD, PhD, THINCS chairman, said, "These drugs have been shown to produce an alarming array of side effects," adding, "the public and medical profession do not realize that statins only benefit a small and select portion of the population." Ravnskov said that in the elderly, in women of all ages and in men without heart disease, cholesterol-lowering measures "have not prevented a single death in any trial."

Even in the highest male risk groups for heart disease, THINCS said in a press statement, "statin treatment resulted in [only] 0.5% fewer deaths per year, and this small benefit was found in the most positive of all trials. Other major statin trials, e.g., ALLHAT, showed no benefit at all, a fact that has been effectively buried." Acknowledging that even a small effect "would of course be worthwhile, provided that the treatment was free from side effects," THINCS said data its members had gathered show that statin drugs cause cancer both in animals and in human beings. It cited other side effects, including liver damage, nerve damage, cognitive decline and memory loss.

The best-known side effect, according to the organization, is muscle damage. "In severe cases," the organization said in its statement, "this causes kidney failure which has claimed the lives of several hundred people thus far, and resulted in one of the worst offending statins (cerivastatin) being withdrawn from the market." THINCS warned that all of these side effects have been seen at "relatively low doses," and that new recommendations are to use increasingly high doses, which the organization said would result in "even more complications of treatment, up to and including death."

Optimistic despite setback

Proteome Sciences (Cobham, UK) last month explained why partner Biosite (San Diego) declined to use the UK firm's biomarkers in its first stroke diagnostic device and gave an optimistic assessment of prospects for commercializing its proteomics markers before existing cash reserves are exhausted in mid-2005. Biosite's decision prompted shares in Proteome to fall from 1.09 to 62.25 pence on July 30. They fell further the following week to close at 58.5 pence.

CEO Christopher Pearce said the market's reaction to the news was overdone. "Should we have announced it? Yes. But it is a storm in a teacup. It may be that our markers will find their way onto [Biosite's] first [stroke diagnostic] panel. They will certainly be on subsequent ones." Pearce added that Proteome has budgeted for a nominal financial contribution from its deal with Biosite. "They are a development partner. They have invested millions of dollars in making antibodies to our markers."

Biosite has been evaluating Proteome's stroke markers for about 18 months, and short-listed a number of them for its first point-of-care panel. Proteome says those markers are highly sensitive and specific for stroke and ischemic attack at very early time points in the disease process. However, as a point-of-care test, Biosite's diagnostic uses whole blood, and it transpired that Proteome's markers were affected by hemolysis, in which blood cells burst open during sample collection and handling. The issue of hemolysis is well understood in the diagnostics industry, and in central laboratory high-throughput diagnosis (90% of the market), serum or plasma is used instead of whole blood to avoid the problem.

"In no shape or form does Biosite's decision affect the value of our stroke markers because if we don't get them into point of care, we will get them into high-throughput diagnostics, which we have always viewed as being the important area for us," Pearce said. Biosite is continuing to evaluate other Proteome biomarkers that are not affected by hemolysis.

4 billion in UK hospital projects

A 4 billion program that involves the development of 15 new hospitals in the UK was given the go-ahead by Health Secretary John Reid in late July. The new hospital developments will be funded largely through the Private Finance Initiative (PFI) and include plans for a new cardiac research institute and upgraded cardiac wing for Great Ormond Street Hospital and new buildings for what Reid termed Papworth Hospital's "world-class cardiothoracic services." Local health organizations now will be responsible for advancing the programs to the next stages of development.

Reid said the 15 projects will bring investment in new National Health Service (NHS) hospitals to more than 16 billion since 1997. He said the NHS is "well on course to meet the NHS Plan target of 100 new hospital schemes open to patients by 2010," with more than 40 already built and operational. "The NHS is in the middle of the biggest hospital building program in its history," he said. "After years of under-investment, the infrastructure of the NHS is at last being modernized and made fit for the 21st century." Reid added: "I look forward to seeing further progress on these ... and all of the other hospital building projects that are under way, and particularly to seeing the benefits they will bring to their local communities."

U.S. CRO collaborates with Dutch firm

Alquest (Minneapolis), a contract research organization (CRO) specializing in medical devices, combination products and biologics, has entered into a collaborative partnership with MediTech Strategic Consultants (Vaals, the Netherlands). The latter firm is a medical device CRO serving European markets through offices in the Netherlands, Paris and Dublin, with associates in Germany, Italy and the UK.

"The Alquest-MediTech partnership, coupled with our new California office [just opened in Los Altos, California], provides clients a one-stop national and international resource to execute clinical trials," said Linda Alexander, president of Alquest. She added, "The combination of each partner's extensive therapeutic and market knowledge will expedite product introductions for American clients expanding into Europe and for European firms entering the U.S."

Privately held Alquest provides clinical, regulatory and compliance services, coupled with reimbursement and business development consulting to form a platform of integrated and stand-alone services. MediTech's services include regulatory, clinical consulting, authorized representative and reimbursement support.

Guidance on mobile phones in hospitals

Updated guidance on the use of mobile phones has been issued to hospitals by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA). The agency said the advice takes into account developments in mobile technology and the growing communication needs of patients, visitors and hospital staff. The advice recommends that hospitals introduce measures to balance the risks of mobile phones interfering with critical devices and the desire for better communication in hospitals.

Professor Kent Woods, MHRA chief executive, said, "There is no reason why mobile technology can't be used in designated areas of hospitals where there is little or no risk of interference with critical medical equipment."

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