An over-the-counter medication used to treat heartburn and acid reflux also appears to help decrease the debilitating effects of chronic heart failure, preliminary research shows. But more testing must be done before the drug is recommended for use by heart failure patients, doctors say.

According to the research, the same type of chemical reaction that allows stomach acid to cause heartburn and create ulcers also appears to damage and weaken diseased hearts. Blocking this process with the drug famotidine (Pepcid) may help to slow the progression of chronic heart failure (CHF).

The research, conducted by the National Cardiovascular Center in Suitra, Japan, appears in the Oct. 3, 2006 edition of the Journal of the American College of Cardiology. Lead researcher Masafumi Kitakaze, MD, PhD, said although the initial results look promising, more research is needed.

“We performed the present prospective study with only 50 CHF patients,” said Dr. Kitakaze, director of the Cardiovascular Division and vice president of the Research and Clinical Center at the National Cardiovascular Center. “Now we need to conduct a large-scale trial to confirm the present findings. The large-scale trial based on the results our present research may not help current heart failure patients because it takes time, but we hope it helps our children and grandchildren and others in the future.”

Gary Francis, MD, did not participate in the research, but is a cardiologist and heart failure expert at Ohio’s Cleveland Clinic. He, too, cautions that the benefits of famotidine for CHF patients remain unclear.

“At this point, we don’t know whether it would help,” said Dr. Francis, head of the Section of Clinical Cardiology at Cleveland Clinic. “In addition, there is an expense involved, and we’re not certain what the dose should be or what the safety would be of larger doses if they were necessary.

“I certainly would not recommend that patients go out and start taking Pepcid three times a day or anything like that,” he said.

Still, the research is important because it opens a new avenue of study in the ongoing effort to treat chronic heart failure, said Dr. Francis, who co-wrote an editorial that will be published in conjunction with Dr. Kitakaze’s research. Heart failure, which affects an estimated 23 million people worldwide, occurs when the heart is unable to pump as effectively as it should, resulting in shortness of breath, swelling in the legs and ankles, and other health issues.

For the current study, Dr. Kitakaze and his colleagues at Japan’s National Cardiovascular Center began with a unique hypothesis. Based on previous research, they speculated that blocking the effects of a specific chemical released by damaged heart cells would slow the development of heart failure. This chemical, one of several types of histamines produced by the body, also contributes to chronic heartburn and stomach ulcers. Famotidine is a histamine blocker, which prevents the chemical from binding to its receptor and causing problems.

To prove their theory, the researchers began by searching existing medical data for patients being treated for both chronic heart failure and gastroesophageal reflux disease (GERD). As suspected, the patients taking famotidine for their stomach problems seemed to have less-severe heart failure symptoms than patients using other types of stomach remedies. But could heart health really be linked to a stomach medication?

To find out, the researchers designed a prospective study in which 25 patients with both medical conditions were given famotidine and 25 patients were given an alternate heartburn medication called teprenone. (Instead of blocking histamine, this second medication works by causing the stomach to secret more mucous to coat and protect itself against excess acid.)

After 24 weeks, Dr. Kitakaze and his colleagues discovered that - as hypothesized - those patients receiving 30 mg doses of famotidine each day were displaying less-severe symptoms of chronic heart failure. All patients were examined by three independent cardiologists who were unaware of the treatment protocols to ensure unbiased results.

Dr. Kitakaze reports no disclosures with this research. Funding comes from the Japan Cardiovascular Research Foundation.

The European Commission on Friday approved Merck’s human papillomavirus vaccine Gardasil for sale and marketing in the European Union, London’s Guardian reports (Batty, Guardian, 9/22). FDA in July approved Gardasil for sale and marketing to girls and women ages nine to 26. According to Merck, the vaccine — which is given in three injections over six months and costs $360 — in clinical trials has been shown to be 100% effective in preventing HPV infection with strains 16 and 18, which together cause about 70% of cervical cancer cases, in women who do not already have the virus, and about 99% effective in preventing HPV strains 6 and 11, which together with strains 16 and 18 cause about 90% of genital wart cases. Gardasil also protects against vaginal and vulvar cancers, two other gynecological cancers that are linked to HPV, according to a study presented in June at a meeting of the American Society of Clinical Oncology in Atlanta (Kaiser Daily Women’s Health Policy Report, 9/22). Gardasil will be sold in the E.U. by Sanofi Pasteur, a joint company of Merck and Sanofi-Aventis. Sanofi Pasteur President Didier Hoch said the company will begin selling the drug in a European country by the end of next month (Reuters, 9/22). In the United Kingdom, the Joint Committee on Vaccination and Immunisation, an independent advisory committee for the U.K. Department of Health, will decide if the vaccine will be covered by the National Health System (Daily Mail, 9/22). A U.K. heath department spokesperson said the JCVI later this year will have meetings to review the vaccine’s safety, efficacy and benefits, adding, “No decisions will be taken until the main JVCI present their recommendations to ministers for consideration” (BBC News, 9/22).

Officials at the World Health Organization’s Asia-Pacific conference in Auckland, New Zealand, on Friday said a resolution calling for universal HIV/AIDS treatment access was withdrawn after U.S. delegates proposed amendments, including removing wording that supported the use of needle-exchange programs to curb the pandemic among injection drug users, the AP/International Herald Tribune reports. Health officials from across the region on Thursday called for universal access to treatment for all HIV-positive people who need it by 2010. U.S. officials, in addition to a dispute over the needle-exchange provision in the resolution, had differences with the resolution’s wording on high-risk groups — including IDUs, commercial sex workers and men who have sex with men — Richard Nesbit, WHO acting regional director, said. New Zealand Health Minister Pete Hodgson, chair of the meeting, said “[H]aving ascertained that no resolution would do no damage … I put it to the meeting that we would be better off to have no resolution than one that was perceived to be weakened.” Hodgson said the U.S. “position is that if they have needle exchanges, then people will use needles more and use intravenous drugs more,” adding, “I think it is demonstrably wrong. New Zealand has had needle swaps for 20 years. It has been an amazing success.” According to the AP/Herald Tribune, U.S. officials declined to comment (Mason, AP/International Herald Tribune, 9/21). U.S. foreign aid cannot be used to provide funding or services to programs that include needle exchanges. The U.N. Office on Drugs and Crime in 2005 at the 48th session of the Commission on Narcotic Drugs in Vienna, Austria, adopted the U.S. position opposing needle exchanges (Kaiser Daily HIV/AIDS Report, 6/29/05).

Staff members for House Republican leaders on Thursday submitted proposed changes to the fiscal year Homeland Security spending bill that would “weaken prescription drug reimportation provisions” lawmakers agreed to earlier in the day, CongressDaily reports (Cohn, CongressDaily, 9/22). On Thursday, House and Senate negotiators on a $33.7 billion FY 2007 Homeland Security appropriations bill reached a tentative agreement on prescription drug reimportation provisions that have delayed passage of the legislation for several days. Under the agreement, the final Homeland Security appropriations bill would include a provision under which U.S. residents could personally transport as much as a 90-day supply of prescription drugs from Canadian pharmacies. The provision would not allow U.S. residents to purchase prescription drugs from other nations through the Internet or by mail. The Senate in July voted 68-32 to approve an amendment to the Homeland Security appropriations bill sponsored by Sen. David Vitter (R-La.) that would prohibit seizures by U.S. Customs and Border Protection of prescription drugs purchased from Canadian pharmacies by U.S. residents. The House has approved two appropriations bills — Homeland Security and Agriculture — with provisions that would allow the purchase of prescription drugs from other nations. The provision included in the House Homeland Security appropriations bill would allow the purchase of prescription drugs from any nation (Kaiser Daily Health Policy Report, 9/22). The changes proposed Thursday would permit people in the U.S. to purchase drugs for personal use from other countries only with “documentation of intended use from a U.S.-licensed physician responsible for the individual’s treatment.” The proposed prohibitions also would apply to biological products, including infused drugs, such as dialysis solution; injected drugs; drugs that are inhaled during surgery; and drugs that are intended for topical use or in the eyes. Rep. Jo Anne Emerson (R-Mo.), who wrote the original proposed amendment allowing the overseas purchase of medications by mail or through the Internet, said the proposal is a “deal-breaker” that would serve to “basically gut the entire intent” of the previous compromise. A spokesperson for the House Appropriations Committee said, “We are working with the conferees to develop an acceptable compromise” (CongressDaily, 9/22).

Older patients need greater support, fewer interruptions and more sensitive care at mealtimes, according to research published in the October issue of the UK-based Journal of Clinical Nursing.

Researchers from the University of Adelaide, Australia, spent two weeks studying 48 hospital patients and 50 nurses during mealtimes on two medical wards.

They discovered that 58 per cent of the patients, who were aged 65 or over, had problems eating. Just under a third (31 per cent) left more than two-thirds of their meal and only 15 per cent had eaten it all.

More than half of the patients they studied (55 per cent) had problems opening food and about a third found it difficult to use cutlery (36 per cent) and add seasoning (32 per cent).

More than a fifth (23 per cent) were too far away from their food and 18 per cent said their eating position was uncomfortable or they had problems pouring drinks.

Although nurses were good at describing the food and encouraging patients to eat it, practical support was only given to a small percentage of patients. For example only six percent were made more comfortable or helped with cutlery.

Interruptions were also frequent. One in five patients (19 per cent) had a doctor’s visit during mealtimes and more than half (51 per cent) had mealtimes interrupted by other staff, mostly nurses (92 per cent).

Three patients were asked about their bowels while they were eating and four male patients had urine bottles place on the table beside meals.

“Recent research suggests that 40 per cent of older people are malnourished when they are admitted to hospital” says lead researcher Chenfan Xia, who was based at the University at the time of the study - with co-author Professor Helen McCutcheon - and now works in an aged care facility.

“The nutritional status of 60 per cent of all older patients will deteriorate further while they are in hospital, with those who were malnourished in the first place suffering worst. And insufficient food is regarded as a major cause of the problem.

“This is an important issue, especially with a growing elderly population, because poor nutrition and malnourishment is linked to poor health, slow recovery and longer hospital stays.

“However most of the research to date has been carried out in care homes, so little is known about the situation on hospital wards.”

The researchers make a number or recommendations:

–Nutrition should be given a higher priority in ward routines and staff training.

–Food intake needs to be monitored in the same way as urine output and drugs. The study found that monitoring was very patchy and often only covered fluid intake.

–Many patients were put off by large portion sizes and the researchers suggest that serving smaller portions at more regular intervals or providing nutritious drinks between meals are two possible solutions.

– Staff often took their meal breaks at the same time as the patients and these should be rescheduled to enable them to provide more help.

Interruptions such as doctors’ visits should be discouraged during mealtimes and staff should be more sensitive about discussing or highlighting issues such as toileting during meal times.

Lack of support for older patients during mealtimes was also highlighted by a recent Age Concern survey carried out in the UK. The charity found that nine out of ten nurses don’t always have time to help patients who need help with eating and has launched a campaign - Hungry to be Heard - to tackle the issue in UK hospitals.

China attracts interest all over the world. Finns are now exporting their health care expertise to China. A Chinese-Finnish collaboration, the Healthy China project is about the prevention of lifestyle diseases such as adult onset diabetes and cardiovascular diseases.

Lifestyle diseases have become more common in China with the westernisation of diet and increased prevalence of sit-down work.

“The idea behind the Healthy China project is to bring Finnish and Chinese expertise and technologies together,” says technology expert Jaani Heinonen, Chief Representative of Tekes Shanghai. The Finnish coordinators of the project are Tekes and Finpro, and the Chinese partners are Shanghai’s Huashan Hospital, Hudan University and key public authorities.

Healthy China has been underway for a year and a half. “So far we have mainly been assessing Chinese care models and searching for key actors for the project,” says Heinonen.

A future objective is to establish a Finnish-Chinese Centre at the Key Lab of Health Technology of Huashan Hospital. The Centre would be supported by a disease management programme providing an up-to-date overview of the patient’s status. Information technologies specialising in diagnosis, monitoring and risk management could then be incorporated into it - with the EBM Guidelines as a prime example. The Centre would offer a variety of services including foot examinations in diabetic patients, physiotherapy and advice related to physical activity and diet.

“Our ultimate aim is to find a comprehensive business model that enables us to expand the pilot project to other sectors,” says Heinonen. Project plans currently reach 2008, the year in which expansion is planned.

Chinese medicine and Finnish technology

“Finnish health care know-how and tools are unique even on a global scale,” says Heinonen. “There’s a lot of research, and organisations such as the National Public Health Institute and the Finnish Heart Association have done groundbreaking work in disease prevention and health promotion.”

Finland also has many businesses that have developed products related to issues such as health monitoring and disease prevention. Finns have also excelled in functional foods. Says Heinonen, “Integrating traditional Chinese medicine with Finnish technologies is a fascinating new area.”

About TEKES, THE FINNISH FUNDING AGENCY FOR TECHNOLOGY AND INNOVATION

Tekes, the National Technology Agency is the main financing organization for applied and industrial research and development (R&D) in Finland. The funds are awarded from state budget via the Ministry of Trade and Industry. The impact of Tekes activities is felt in Finland as increasing exports, a broader industrial base, more jobs and an improvement in the general welfare of society.

A time-compressed breast cancer treatment being used by the Hollings Cancer Center at the Medical University of South Carolina results in excellent cosmetic outcome for most women undergoing the treatment, said Anthony E. Dragun, M.D., who will be presenting his research findings Nov. 4 at the 48th Annual Scientific Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO) in Philadelphia, Pa.

MUSC began using the innovative therapy called MammoSite breast brachytherapy in 2002 and was one of the first hospitals in the nation to use the technique after its approval by the Food and Drug Administration.

As a result, MUSC has accumulated one of the largest databases of MammoSite patients with some of the longest follow-ups.

Dragun, chief resident in MUSC’s Department of Radiation Oncology, said that MammoSite is used to deliver radiation therapy following a lumpectomy for early-stage breast cancer. A major advantage of MammoSite is that it reduces the time frame for post-surgical radiation therapy from six weeks to just five days.

Surgeons place the MammoSite device in a separate procedure after a lumpectomy. Radiation oncologists then use the device to guide radiation only to that breast tissue, which is the highest risk for cancer recurrence, sparing the remaining breast tissue from further radiation.

The cosmetic issues that normally stem from traditional radiation therapy include painful redness and peeling of the breast skin. However, MammoSite virtually eliminates these complications. Dragun’s study shows that the majority of patients treated with MammoSite have an excellent cosmetic outcome. In his study, Dragun also found that complications resulting in fair to poor cosmetic outcomes have dropped significantly since the device was first introduced.

Dragun’s study, titled “Predictors of Cosmetic Outcome Following MammoSite Breast Brachytherapy,” was chosen from a record-breaking 1,640 abstracts submitted for review to be presented at the ASTRO meeting, which is the largest gathering of radiation oncology specialists in the world. ASTRO is the largest radiation oncology society in the world, with more than 8,500 members who specialize in treating patients with radiation therapy.

Biothera, the immune health company, announced today that it has successfully completed its second Phase I clinical trial for Imprime PGG(TM), its lead compound for activating the body’s own immune system to fight multiple types of cancer.

The randomized, double-blind, placebo-controlled clinical study in healthy volunteers indicates that Imprime PGG is safe and well tolerated over a wide dose range. The results of the study support the continued development of the drug candidate in multiple indications.

The dose-escalation study evaluated safety, pharmacokinetic and pharmacodynamic responses at three dose levels (1, 2 and 4 mg/kg) administered intravenously daily for seven continuous days. This study followed a previous Phase I study in which Imprime PGG administered in single doses was also shown to be safe and well tolerated in healthy volunteers. A total of 36 volunteers participated in the two Phase I studies.

“The consistent results of these studies confirm our expectations and demonstrate that Imprime PGG has a strong safety profile,” said Myra Patchen, Ph.D., Biothera executive vice president of pharmaceutical development. “We are looking forward to now quickly implementing our Phase II clinical program in cancer patients.”

Biothera’s Phase II clinical trial program is scheduled to begin in the fourth quarter of 2006.

“We are encouraged by these clinical findings and confident in the ability of Imprime PGG to work synergistically with monoclonal antibodies to treat numerous types of cancer,” said Daniel Conners, Biothera founder and chairman.

Preclinical research demonstrated that the combination of Imprime PGG and various anti-cancer monoclonal antibodies significantly improved on the effectiveness of antibodies alone as evidenced by reductions in tumor size and increases in survival in multiple types of cancer, including breast, lung and liver cancer.

Nigel Edwards, Director of Policy at the NHS Confederation which represents over 90 per cent of NHS organisations, said:

“The reduction in the number of beds in the NHS is not a new trend. Figures show that the number of beds has fallen by 40 per cent since 1959 because of developments in technology and changes in the way we treat patients not because deficits. High bed numbers do not necessarily mean better patient care. We should judge the NHS on how many people we make better and keep well.

“The Conservatives are quite right to point out that if we are going to continue to see this downward trend in the number of NHS beds, this must be done safely and with adequate provision of health services in the community. We agree that it is very important that bed occupancy rates are kept within the parameters of what is safe to reduce the likelihood of infection for those patients that have to stay in hospital.

”The NHS is doing more than ever before whilst the number of beds is reducing. What we need now is a well-informed debate which is based on evidence of what is best for patients.”

The NHS Confederation represents more than 90% of the organisations that make up the NHS. Its members include the majority of NHS acute trusts, ambulance trusts, foundation trusts, mental health trusts, primary care trusts, special health authorities and strategic health authorities in England; trusts and local health boards in Wales; and health and social service trusts and boards in Northern Ireland.

All types of intravascular devices (IVDs) pose a risk of bloodstream infection to exposed hospitalized adult patients, finds a study published in the September issue of Mayo Clinic Proceedings. What’s more, IVDs have become the leading cause of bloodstream infections in health care settings in the United States and worldwide. An IVD is described as any device that allows access to the bloodstream, but typically a catheter.

As many as 500,000 IVD-related bloodstream infections occur in the United States each year and lead to increased morbidity and prolonged hospital stays, from 10 to 20 days, costing $4,000 to $56,000 per episode. Catheter- or device-related bloodstream infections are widely considered the most preventable class of infections occurring in hospitals.

Authors of the IVD article in Mayo’s medical journal extracted data from 200 prospective studies to examine the risk of IVD-related bloodstream infections associated with each type of IVD. Lead author Dennis Maki, M.D., a researcher and infectious disease and critical care specialist at the University of Wisconsin Hospital and Clinics in Madison, says the findings offer “hard data” that IVDs pose a risk to all recipients.

“We thought this analysis might provide a unique opportunity to wave the flag and convince both health care workers and patients that all types of IVDs pose a risk,” Dr. Maki says. “Clinicians and quality assurance experts need to understand that these risks are significant and are often greater than they might think.”

The use of specialized IVDs for long-term or indefinite vascular access has dramatically increased in recent years in hospital and especially outpatient settings, but attention to reducing incidence of bloodstream infections has focused almost exclusively on patients with short-term central venous catheters in intensive care units, Dr. Maki says. In the last decade, virtually all progress in control of IVD-related bloodstream infections has been restricted to this relatively small fraction of hospitalized patients.

The same strategies need to be implemented on a far wider scale, argue the researchers, to make IVDs safer for all hospitalized patients, as well as outpatients who have IVDs.

Guidelines — such as those published by the Centers for Disease Control’s (CDC) Hospital Infection Control Practices Advisory Committee in 2002 — exist for prevention of IVD-related bloodstream infections and need to be adapted more widely by health care providers to ensure safer IVD use. Reduced bloodstream infections will follow, predicts Dr. Maki.

The article’s authors also urge wider use of novel IVD technologies designed to reduce IVD-related bloodstream infections. In an accompanying editorial, David Snydman, M.D., of Tufts-New England Medical Center, also cites advancing technology as a promising means for reducing IVD-related bloodstream infections.

“Technology holds far more promise for reducing risk than behavioral modification,” Dr. Maki says. “We believe that it holds the greatest promise. In our paper, we point up a number of IVD technologies that have been proven to be effective, but, as yet, inexplicably, aren’t widely used.”

Although consumers may be surprised to learn that all IVDs carry a risk of bloodstream infection, Dr. Maki advises them to become better informed, not alarmed. Vascular access is absolutely essential to today’s health care and in many cases is lifesaving, he says. But if an IVD insertion is scheduled, patients should feel comfortable asking their health care providers what measures will be taken to minimize their risk of bloodstream infection, Dr. Maki says.