Monday, June 13, 2005

Program Launched Kingdomwide for Screening NewbornsRaid Qusti, Arab News

RIYADH, 14 June 2005 — A nationwide program to detect problems in newborns was launched yesterday. Endorsed by the Prince Salman Center for Disability Research (PSCDR), the program is designed to detect disabilities within the first 72 hours of life.
The chairman of the center’s board of trustees, Prince Sultan ibn Salman, said that the program would include all newborns in the Kingdom according to an agreement with the Health Ministry and the King Faisal Specialist Hospital and Research Center (KFSHRC).
Prince Salman, governor of Riyadh and founder of PSCDR, formally inaugurated the program Sunday night at a function attended by Minister of Health Dr. Hamad Al-Manei and Minister of Social Affairs Abdul Mohsen Al-Akkas and Prince Sultan ibn Salman.
In his speech, Health Minister Al-Manie said that diseases of both metabolic and genetic origin were the cause of many unnecessary disabilities. “In case of metabolic and genetic diseases in newborns, early treatment can help prevent disability, especially if we take into account that most of the diseases are not apparent in the first days of life and that their symptoms appear later,” he said.
Prince Sultan said the program was a sign of the serious cooperation between the government and the private sectors. “Ninety percent of board members are either bankers or private businessmen. We even have foreign companies such as Exxon Mobil represented on the board; all of them support the PSCDR’s humanitarian efforts.”
The prince said that the aim of the program was to provide a future for Saudi Arabia as free as possible from genetic diseases. Between four and five hundred thousand infants are born in the Kingdom every year and before this program, only 10,000 of them were screened.
The PSCDR and the Ministry of Health plan to implement the program in phases.
In phase one, all new newborns in major government and private hospitals will be screened. In phase two, screening will be expanded to include all the regions in the Kingdom.
In the first year of implementation, screening will include 85,0000 newborns. The PSCDR will cooperate with maternity hospitals in different parts of the Kingdom. In the second year, the number of newborns screened will rise to 160,000 and in the third to 280,000. All newborns in the Kingdom will be screened in the fourth year.
According to the PSCDR, a blood sample taken from the infant’s ankle will be sent to the laboratory in the first 72 hours of life. If a problem is detected, the parents will be notified and the infant immediately given the necessary treatment.
Prince Sultan said that he hoped that special laboratories for this specific purpose would soon be established. When asked about the test results for infants in remote areas, he said, “The results will be sent by express mail to any location in the Kingdom within 48 to 72 hours.”
He went on to point out, “In many developed countries, these tests are compulsory for all citizens. The program is of great importance to our society and our country.”

New Insights Into Role Of Tumor Necrosis Factor On Sex Hormone Production In Rheumatoid Arthritis

A protein involved in multiple cell functions, tumor necrosis factor (TNF) is perhaps best known for provoking destructive inflammation. Recently, drugs blocking the action of TNF have shown promise in the early treatment of rheumatoid arthritis (RA).
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To expand the understanding of TNF's function in chronic inflammatory diseases, researchers at University Hospital Regensburg in Germany and the National Institute of Rheumatic Diseases in the Slovak Republic decided to take a closer look at this cytokine's impact on androgen production. Androgens are thought to play a critical anti-inflammatory role in rheumatic diseases, including various forms of arthritis and lupus, based on extensive clinical trials and animal models. For their study, the team investigated the role of TNF in the conversion of biologically inactive DHEAS--short for dehydroepiandrosterone sulfate--to biologically active DHEA, the steroid hormone parent of androgen, estrogen, and testosterone. Their findings, featured in the June 2005 issue of Arthritis & Rheumatism (http://www.interscience.wiley.com/journal/arthritis), shed new light on suppression of androgen by TNF in RA patients, as well as on the different nature of inflammation in RA from the most common inflammatory disease: osteoarthritis (OA).
To get a clear picture of how TNF affects hormone production and regulation, the research team analyzed samples of inflamed synovial tissue--obtained immediately after opening the knee joint capsules of 37 patients who underwent elective joint replacement surgery. 15 of the patients had a longstanding history of RA, with disease duration averaging 15 years. 22 of the patients were OA sufferers. Using tools for biochemical analysis, the team assessed the process of converting DHEAS to DHEA. The results revealed marked differences in the cellular activity of RA and OA patients.
On the evidence of both synovial cell and synovial fluid analysis, levels of DHEA from DHEAS were significantly lower among RA patients than OA patients. In addition, researchers found a negative correlation between converted DHEA and markers of inflammation among RA patients but not in patients with OA. They also found evidence that TNF inhibits the activity of steroid sulfatase, the key enzyme in DHEAS-to-DHEA conversion.
"This is the first study to demonstrate that the conversion of DHEAS to DHEA is decreased in patients with RA as compared with that in patients with OA," notes leading contributor Claudia Weidler. "In the present study, we were fortunate to demonstrate that TNF is also a strong inhibitor of the conversion of DHEAS to DHEA in synovial cells from patients with RA but absolutely not in patients with OA."
Providing the full picture of androgen deficiency in RA, this study affirms the need for further research into early anti-TNF antibody therapy in the treatment of this particular inflammatory disease.
###
Article: "Tumor Necrosis Factor Inhibits Conversion of Dehydroepiandrosterone (DHEAS) TO DHEA in Rheumatoid Arthritis Synovial Cells: A Prerequisite for Local Androgen Deficiency," Claudia Weidler, Sona Struharova, Martin Schmidt, Bernhard Ugele, Jürgen Schölmerich, and Rainer H. Straub, Arthritis & Rheumatism, June 2005; 52:6; pp. 1721-1729.

Scientists On the Warpath As Malaria Fights Back

Emergence of new mosquito species, coupled with the viruses' resistance to drugs, has researchers worried
The search for a lasting solution to the malaria menace has run into headwinds with the discovery of new malaria-causing mosquito species.
This is compounded by cost of treatment across Africa, which has become very expensive.
Things are not going to be easy, experts say, thanks to increased environmental pollution and a growing drug resistance, which threaten to undo the gains made in fighting its spread.
Prof Benson Estambale, the director of the Institute of Tropical and Infectious Diseases at the University of Nairobi (UNITID), said the number of malaria-causing species of mosquitoes resistant to current drugs in the market is on the rise across Africa.
Out of every 100 Kenyans, 40 are unlikely to respond to the available malaria treatment because they have developed resistance to the drugs.
Malaria, a parasitic disease found within the tropics, mostly warm climatic conditions that support its reproduction, has developed more dangerous strains and survival instincts, making its cure expensive and beyond the reach of many.
A new line of treatment based on an artemecin derivative and the coartem cocktails, which are now being recommended, is proving to be too expensive with the prices ranging from Sh400 to Sh600 a dose.
"How are people going to access these drugs?" posed Estambale. "Resistance to malaria drugs is a big problem. The resistance started with chloroquine in the Far East, spreading through Africa. The malaria parasite has enzymes which adopt to the drugs used to treat the infection."
Scientists are now vouching for the return of old malaria treatment methods to counter renewed drug resistance and the resurgence of the disease partly due to change of climate, which has created an enabling environment for their survival.
The parasite in the mosquito was discovered to degrade the active chemicals in the chloroquine, rendering the drug useless and forcing scientists to look for new methods and new combinations of drugs to manage the leading killer disease in developing countries.
Scientists say the high level of drug resistance is worrying given that most of the drugs developed to tackle the disease are rendered useless faster than scientists are able to develop a new combination. "The insurgence of malaria is due to the breakdown in the provision of health services," said Estambale.
Doctors working in Nairobi say the level of drug resistance has been fuelled by carelessness in drug use.
"It is a global trend because resistance to drugs has developed over the last 20 to 30 years," concurred Dr Ndwiga Njue Mwachandi, a Nairobi-based consultant paediatrician.
He explained: "Our first mode of treatment was the quinine, then we moved to chloroquine but resistance to these drugs developed very fast and we shifted to using a combination of drugs known as chamoquine, which is made up of fansidar and metakelfin, but these have also been knocked down by the resistant strains."
The complex nature of the mosquito parasite is seen in its very complex development and survival tactics, especially the malaria-causing type, the female anopheles mosquito. Scientists have counted up to 60 different types of mosquito species and innumerable sub-species in Africa.
"There are quite a number of mosquitoes, the most complex one is the anopheles Gambie; it has six sub-species and is the most efficient. It is strictly a human-biting species and usually bites people in the house," said Estambale.
He said the species has the potential to cause severe bleeding and can also spread deadly tropical diseases such as the dreaded Ebola and Marburg viruses, which killed 300 people in Angola.
"Mosquitoes cannot cause haemolysis - bleeding from all orifices after a major internal bleeding - but they can carry agents or diseases which cause haemorregic fevers," Estambale said in an interview at his Kenyatta National Hospital office.
"The malaria causing parasite became resistant to these due to the misuse of the drugs. People take a dose to suppress the germs, once the level goes down, they stop using it, this makes the mosquito parasite to develop resistance," Dr Mwachandi elaborated.
The high rate of drug resistance, a result of over-the-counter treatment methods that focus on suppressing the plasmodium, the germ that causes the killer disease, is to blame for the increasing drug resistance, he said.
"With time, you have an enemy and you need multiple doses to reduce its load but since the parasite has been used to being kept dizzy, even the new treatment mode finds it too resistant because the germ develops techniques to overcome the medicine," he said.
Medicines developed to attack the parasite are specifically modelled to fight a particular strain, which makes its elimination nearly impossible, the researchers say.
But Mwachandi explained the current combination of drugs mainly grouped under the name Coartem - a combination of lumefantiae and artemesisaia - as being very effective in fighting the parasite.
Relevant Links
East Africa Science and Biotechnology Malaria Sustainable Development Kenya Health and Medicine
"These drugs can interfere with the vital enzymes making it impossible for the parasite to survive. Some of these drugs, which combat malaria, prevent the organism from surviving," he reiterated.
The complex treatment process, which involves a combination of expensive drugs, scientists fear, may render the control of malaria impossible due to the high poverty levels across the country.

Diabetic Retinopathy Occurs in Pre-Diabetes

Diabetic retinopathy has been found in nearly 8 percent of pre-diabetic participants in the Diabetes Prevention Program (DPP), according to a report presented today at the American Diabetes Association's 65th Annual Scientific Sessions. Diabetic retinopathy, which can lead to vision loss, was also seen in 12 percent of participants with type 2 diabetes who developed diabetes during the DPP. No other long-term study has evaluated retinopathy in a population so carefully examined for the presence or development of type 2 diabetes.
i-Newswire, - “These findings reinforce the recommendation that patients with newly diagnosed type 2 diabetes should be screened for retinopathy,” said Emily Chew, M.D., of the National Eye Institute, part of the National Institutes of Health ( NIH ) under the U.S. Department of Health and Human Services, which funded the study. “We advise good control of blood glucose, blood pressure, and cholesterol as well as regular eye exams.” “Previous studies have not accurately defined when type 2 diabetes begins, so our understanding of the onset of diabetic eye disease has been limited. Now we know that diabetic retinopathy does occur in pre-diabetes. We’re also seeing it early in the course of diabetes — within an average of 3 years after diagnosis,” noted Richard Hamman, M.D., DrPH, professor and chair, Department of Preventive Medicine and Biometrics, University of Colorado School of Medicine, and vice chair of the DPP. “This adds to our understanding of the development of retinopathy and suggests that changes in the eye may be starting earlier and at lower glucose levels than we previously thought.” Pre-diabetes is a condition in which blood glucose levels are higher than normal but not high enough for a diagnosis of diabetes. The condition is sometimes called "impaired fasting glucose ( IFG )" or "impaired glucose tolerance ( IGT )," depending on the test used to diagnose it. People with pre-diabetes have an increased risk of developing type 2 diabetes, heart disease, and stroke. Diabetic retinopathy, which begins with changes in the small vessels in the back of the eye, often leads to loss of vision. Regular eye examinations to diagnose retinopathy are recommended for patients with diabetes because treatment with laser photocoagulation can often prevent blindness in more advanced cases. Diabetic retinopathy is still the most common cause of blindness in adults. ( For more information about diabetic retinopathy, see NEI’s Diabetic Retinopathy: What you should know http://www.nei.nih.gov/health/diabetic/retinopathy.asp ). “Certain retinopathy lesions are considered indicative of the presence of diabetes because they are the first retinal changes to develop in this disease,” explained Dr. Hamman. “Although the retinopathy seen in the DPP participants was at a very early stage and did not affect vision, eye changes typical for diabetes were found in 8 percent of our study population before they developed diabetes. These observations may lead diabetes experts to reconsider the diagnostic thresholds used to define diabetes, which are based on levels of blood glucose associated with the development of eye, nerve and kidney complications of diabetes.” DPP study chair David Nathan, M.D., of Massachusetts General Hospital, pointed out that the retinopathy results are based on a random sample of only 12 percent of DPP participants, all of whom had impaired glucose tolerance, a form of pre-diabetes, when the study began. “These initial findings confirm what other studies have suggested. The complications of diabetes may begin before diabetes is diagnosed, at least by the current-day standards,” he explained. “Ideally, an expanded study of the remaining 88 percent of DPP Outcome Study participants might enable us to define more appropriate diagnostic thresholds.” About 18.2 million Americans have diabetes, a group of serious diseases marked by high blood glucose levels that result from defects in the body's ability to produce and/or use insulin. Diabetes can lead to severely debilitating or fatal complications, such as heart disease, blindness, kidney disease, and amputations. It is the fifth leading cause of death by disease in the United States. Type 2 diabetes, which accounts for up to 95 percent of all diabetes cases, involves insulin resistance — the body’s inability to properly use its own insulin. It usually occurs in overweight adults, but it has increasingly been seen in obese children and teens in recent years. About 40 percent of U.S. adults ages 40 to 74 — 41 million people — have abnormal blood glucose levels without having diabetes. Many will develop type 2 diabetes in the next 10 years. ( In the DPP, about 10 percent of participants in the placebo group developed diabetes each year. ) Once a person has type 2 diabetes, the risk of heart and blood vessel disease is 2 to 4 times that of people without diabetes. Diabetes Prevention ProgramThe Diabetes Prevention Program was a major clinical trial in 3,234 people with impaired glucose tolerance. The study’s main results were announced in 2001 and reported in the Feb. 7, 2002 issue of the New England Journal of Medicine: Losing 5 to 7 percent of body weight through diet and a modest, consistent increase in physical activity ( e.g., walking 5 days a week 30 minutes a day ) lowered the incidence of type 2 diabetes by 58 percent. Treatment with metformin, an oral drug commonly used to treat diabetes, reduced the chances of developing diabetes by 31 percent. The DPP was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) and co-funded by other components of the NIH, the Centers for Disease Control and Prevention, and the Indian Health Service. The American Diabetes Association provided additional funding. Sources of corporate support included Bristol-Myers Squibb, Parke-Davis, Merck and Company, Merck Medco, Hoechst Marion Roussel, Sankyo, Lifescan, Lipha Pharmaceuticals, Slimfast, Nike, and Health-O-Meter. About 90 percent of DPP participants continue to be followed closely in the DPP Outcomes Study to examine the longer-term impact of the original treatment interventions. All participants are given access to quarterly lifestyle group sessions, while those in the original intensive lifestyle group have access to additional lifestyle activities to help them stay on track. The participants originally assigned to metformin therapy continue to have access to the drug. Retinopathy FindingsThree hundred two, or about 12 percent, of the DPP Outcome Study participants who had not developed diabetes during the study, and 588 of 876 participants who had developed diabetes, were selected to participate in the retinopathy study, funded by the NEI. To detect diabetic retinopathy, an evaluation of the fundus ( inner lining of the eye ) was performed with a special camera that provides a detailed look at the retina. Small changes in the vessels, called microaneurysms and hemorrhages, signal the development and degree of retinopathy severity. Participants with pre-diabetes and retinopathy typically had a small number of microaneurysms in the eye characteristic of early, mild retinopathy that is not yet linked to vision loss. Those who had developed diabetes in the previous 1 to 5 years had slightly more severe retinopathy. Higher average blood glucose levels and higher blood pressure were associated with the risk of developing retinopathy in the new-onset diabetic patients, similar to previous findings in people with longstanding diabetes who develop retinopathy. In its "Be Smart About Your Heart: Control the ABCs of Diabetes" campaign, the National Diabetes Education Program ( NDEP ) ( www.ndep.nih.gov/ ), jointly sponsored by the NIH, the Centers for Disease Control and Prevention, and 200 partner organizations including the American Diabetes Association ( ADA ), encourages people with diabetes to control their blood glucose as well as their blood pressure and cholesterol. By keeping all three as close to normal as possible, people with diabetes can live long, healthy lives. NDEP’s “Small Steps. Big Rewards. Prevent Type 2 Diabetes” campaign gives tips on lifestyle changes to prevent or delay type 2 diabetes. “Make the Link! Diabetes, Heart Disease and Stroke,” is a joint initiative of the American Diabetes Association ( www.diabetes.org/makethelink ) and the American College of Cardiology ( www.acc.org ), which works to increase awareness of the link between diabetes and heart disease and help educate physicians and people with diabetes about how to reduce those risks. The National Institutes of Health ( NIH ) — The Nation's Medical Research Agency — is comprised of 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary Federal agency for conducting and supporting basic, clinical, and translational medical research, and investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.CONTACT:Joan Chamberlain, NIDDK301-496-3583Rosemary Janiszewski, NEI301-496-5248

Chemokine Therapeutics receives U.S. Patent for novel cancer drug in clinical development

VANCOUVER, June 13 /PRNewswire-FirstCall/ -- Chemokine Therapeutics Corp. (the Company) (TSX: CTI), today announced that it has been granted U.S. Patent No. 6,875,738 relating to the use of its anti-cancer compound, CTCE-9908, in the treatment of cancer and inhibition of angiogenesis. CTCE-9908 is designed to block CXCR4, a receptor found on the surface of cancer cells. CTCE-9908 inhibits the growth and spread of certain common cancers, with the potential for use with existing therapies (chemotherapy, surgery, and radiation) to improve treatment outcomes. The patent entitled "Therapeutic Chemokine Receptor Antagonists", with a term lasting to August 2019, covers some of the methods by which CTCE-9908 treats cancer. It strengthens the Company’s growing proprietary position in peptide-based therapies which seek to address unmet medical needs in cancer, cardiovascular and infectious diseases.
VANCOUVER, June 13 /PRNewswire-FirstCall/ -- Chemokine Therapeutics Corp. (the Company) (TSX: CTI), today announced that it has been granted U.S. Patent No. 6,875,738 relating to the use of its anti-cancer compound, CTCE-9908, in the treatment of cancer and inhibition of angiogenesis. CTCE-9908 is designed to block CXCR4, a receptor found on the surface of cancer cells. CTCE-9908 inhibits the growth and spread of certain common cancers, with the potential for use with existing therapies (chemotherapy, surgery, and radiation) to improve treatment outcomes. The patent entitled "Therapeutic Chemokine Receptor Antagonists", with a term lasting to August 2019, covers some of the methods by which CTCE-9908 treats cancer. It strengthens the Company’s growing proprietary position in peptide-based therapies which seek to address unmet medical needs in cancer, cardiovascular and infectious diseases.
"With the issue of our most recent patent, we are expanding our proprietary position in peptide-based drug development, a burgeoning new pharmaceutical drug class with great potential to treat a number of diseases and disorders," said Dr. Hassan Salari, President and CEO of Chemokine Therapeutics. "I believe we are among the first companies to develop synthetic chemokines that have been shown to be functional in living systems and safe in our initial studies in humans."
What are chemokines?
Chemokines are a new class of cytokines, a group of small, soluble proteins, known as chemoattractant proteins, which signal biological responses that play a critical role in the immune system. Many of these biological signals are necessary for fighting infection, as well as tissue repair and regeneration. However, chemokines are also known to play an important role in cancer and autoimmune disorders which can paradoxically contribute to the survival and growth of abnormal cells that cause disease.
Key Patent Claim: Inhibition of blood vessel growth to tumors by novel blockade
CTCE-9908 represents an exciting new generation of drugs being developed that promise more targeted therapies to treat the underlying cancer while keeping healthy cells intact. The patent claims methods of treating cancer and inhibiting angiogenesis (blood vessel growth) by administration of an antagonist that blocks a chemokine receptor known as CXCR4. Leading cancer researchers have demonstrated that high CXCR4 expression in cancer cells is correlated to tumor progression, high metastasis rate and low survival rate. Blockage of CXCR4 reduces the growth of tumors by reducing blood vessel growth (anti-angiogenesis) which carries vital nutrients to a tumor. The Company has completed a Phase I, dose-escalation clinical trial using CTCE-9908 in the United Kingdom to assess its safety in healthy volunteers in which there were no serious adverse events noted in any subject during the study.
About Chemokine Therapeutics Corp. (TSX: CTI)
Chemokine Therapeutics is a publicly-traded biotechnology company developing drugs in the field of chemokines and cytokines, a family of small, soluble proteins, which regulate immune responses. The Company has five products with two lead product candidates in clinical trials; CTCE-0214, for immune system recovery, and CTCE-9908, to prevent the spread of cancer and its continued growth. For more information, please visit our website at http://www.chemokine.net/.

Tight Glucose Control Lowers CVD by About 50 Percent in Diabetes

A significantly lower risk of heart disease can now be added to the list of proven long-term benefits of tight glucose control in people with type 1 diabetes. Researchers announced this finding today at the annual scientific meeting of the American Diabetes Association after analyzing cardiovascular (CVD) events such as heart attack, stroke, and angina in patients who took part in the Diabetes Control and Complications Trial (DCCT) years ago."The longer we follow patients, the more we're impressed by the lasting benefits of tight glucose control," said Saul Genuth, M.D., of Case Western University. Dr. Genuth chairs the follow-up study of DCCT participants, called the Epidemiology of Diabetes Interventions and Complications (EDIC) study, which has been looking at the long-term effects of prior intensive versus conventional blood glucose control. "The earlier intensive therapy begins and the longer it is maintained, the better the chances of reducing the debilitating complications of diabetes."The DCCT was a multicenter study that compared intensive management of blood glucose to conventional control in 1,441 people with type 1 diabetes. Patients 13 to 39 years of age were enrolled in the trial between 1983 and 1989. Those randomly assigned to intensive treatment kept glucose levels as close to normal as possible with at least three insulin injections a day or an insulin pump, guided by frequent self-monitoring of blood glucose. Intensive treatment meant keeping hemoglobin A1c (HbA1c) levels as close as possible to the normal value of 6 percent or less. (The HbA1c blood test reflects a person's average blood sugar over the past 2 to 3 months.) Conventional treatment at the time consisted of one or two insulin injections a day with daily urine or blood glucose testing. In 1993, researchers announced the DCCT's main findings: intensive glucose control greatly reduces the eye, nerve, and kidney damage of type 1 diabetes. Tight control also lowers the risk of atherosclerosis, according to a study of DCCT participants published in 2003. But what's most remarkable about intensive control, the researchers say, is its long-lasting value. After 6½ years of the DCCT, HbA1c levels averaged 7 percent in the intensively treated group and 9 percent in the conventionally treated group. When the study ended, the conventionally treated group was encouraged to adopt intensive control and shown how to do it, and researchers began the long-term follow-up of participants. To the researchers' surprise, the benefits of the original 6 years of intensive control have persisted despite the fact that both groups' HbA1c values have leveled off at about 8 percent after a rise in blood glucose in the intensively treated group and a drop in blood glucose in those formerly on conventional treatment. In results announced today, among the 1,375 volunteers continuing to participate in the study, the intensively treated patients had less than half the number of CVD events than the conventionally treated group (46 compared to 98 events). Such events included heart attacks, stroke, angina, and coronary artery disease requiring angioplasty or coronary bypass surgery. Thirty-one intensively treated patients (4 percent) and 52 conventionally treated patients (7 percent) had at least one CVD event during the 17 years of follow-up. The average age of participants is 45 years; 53 percent are male. "The risk of heart disease is about 10 times higher in people with type 1 diabetes than in people without diabetes. It's now clear that high blood glucose levels contribute to the development of heart disease," said David Nathan, M.D., of Massachusetts General Hospital, who co-chaired the DCCT/EDIC research group and presented the results. "The good news is that intensively controlling glucose significantly reduces heart disease as well as damage to the eyes, nerves, and kidneys in people with type 1 diabetes. Tight control is difficult to achieve and maintain, but its advantages are huge." "The take-home message is that good glucose control should be started as early as possible to delay or prevent serious diabetes-related complications," said Alan D. Cherrington, PhD, president, American Diabetes Association. Is glucose control just as important for people with type 2 diabetes? "There is a strong and growing body of evidence that everyone with diabetes gains from strict blood glucose control," said Catherine Cowie, PhD, who oversees EDIC for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). DCCT and EDIC were funded by the NIDDK and other parts of the National Institutes of Health (NIH) under the Department of Health and Human Services. Genentech, Inc., also supported the studies through a Cooperative Research and Development Agreement with the NIDDK. The NIH also funds a great deal of research aimed at developing new approaches to help patients control diabetes, which is difficult for many people. About 18.2 million people in the United States have diabetes, the most common cause of blindness, kidney failure, and amputations in adults and a major cause of heart disease and stroke. At least 65 percent of people with diabetes will die from a heart attack or stroke, yet two out of every three people with diabetes are unaware of their increased risk. Type 1 diabetes accounts for up to 10 percent of diagnosed cases of diabetes in the United States (up to 1 million people). This form of diabetes usually strikes children and young adults, who need several insulin injections a day or an insulin pump to survive. Insulin, though critical for controlling blood glucose, is no cure. Most people with type 1 diabetes eventually develop one or more complications, including damage to the heart and blood vessels, eyes, nerves, and kidneys. In its "Be Smart About Your Heart: Control the ABCs of Diabetes" campaign, the National Diabetes Education Program (www.ndep.nih.gov/), jointly sponsored by the NIH, the Centers for Disease Control and Prevention, and 200 partner organizations including the American Diabetes Association (ADA), encourages people with diabetes to control their blood glucose as well as their blood pressure and cholesterol. By keeping all three as close to normal as possible, people with diabetes can live long, healthy lives."Make the Link! Diabetes, Heart Disease and Stroke," is a joint initiative of the American Diabetes Association (www.diabetes.org/makethelink) and the American College of Cardiology (www.acc.org), which works to increase awareness of the link between diabetes and heart disease and help educate physicians and people with diabetes about how to reduce those risks. The National Institutes of Health (NIH) — The Nation's Medical Research Agency — is comprised of 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary Federal agency for conducting and supporting basic, clinical, and translational medical research, and investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

HIV tests for all pregnant women

By Martin Johnston.- All pregnant women will be offered a blood test for HIV under a new scheme to be introduced first in Auckland and Waikato. The Health Ministry announced the policy yesterday, two hours after Health and Disability Commissioner Ron Paterson published a report critical of the existing, patchy screening of pregnant women for HIV, the virus that leads to Aids. He also criticised an unnamed midwife and hospital for not assessing the risk of HIV in a Thai immigrant when she was pregnant in 1999. She and her son were diagnosed with the disease in 2001, when the mother's ophthalmologist suggested an HIV test after reviewing an eye problem. Waikato Hospital infectious diseases physician Dr Graham Mills, who initiated the complaint to the commissioner for the boy's parents, said yesterday that the child, now aged 5, had to drink bad-tasting anti-HIV medicine three times daily, suffered developmental delay and was likely to die before he reached 20. Although HIV treatment had improved, children fared worse than adults because of the difficulties of sticking to the daily treatment regimen. Dr Mills strongly supported a national voluntary screening programme, which he said would be cost-effective and end the "Russian roulette" of not knowing which pregnant women had HIV. Three to five New Zealand-born babies are diagnosed with HIV each year, but experts say the actual number infected is probably higher. Last year, 157 people of all ages were diagnosed with HIV by antibody testing, up sharply from around 100 a year in the 1990s. The voluntary test, if a woman opts for it, will be run on a blood sample already routinely taken to check for hepatitis, syphilis and other conditions. Health Ministry spokesman Pat Tuohy said many developed countries, including Australia and Britain, already offered routine antenatal HIV screening. He expected the national programme would cost up to $2 million a year, including $11 a test for the nearly 60,000 births that took place every year. Auckland City Hospital physician Dr Lucille Wilkinson, who treats pregnant women with HIV, said caring for each child with HIV could cost millions over their lifetime. Children with HIV required high levels of specialist care in hospital and cocktails of drugs costing at least $20,000 a year. Dr Wilkinson welcomed the introduction of screening. "You can't tell from the outside whether someone has got HIV. [Screening] can prevent unnecessary disasters." The ministry introduced guidelines in 1997 that told health workers to offer an HIV test to those considered at risk of HIV - or where risk factors were unclear - including those who had had sex with people from Africa or Asia or other places at high risk for HIV/Aids.HIV and pregnancy * Babies born to a mother with untreated HIV have a 25 to 30 per cent chance of infection. * That falls to less than 1 per cent with treatment in newly diagnosed cases if drug therapy starts by about 27 weeks of pregnancy. * Children with HIV require high levels of specialist hospital care and cocktails of drugs costing at least $20,000 a year.

Growing peril from above... Rabies fear means bat contact is a threat

By BRODIE FENLON, TORONTO SUN
Summer is the season of the bat.
And as these beauty-challenged nocturnal mammals emerge from hibernation, so increases the risk of rabies.
Already this year, 10 bats have tested positive for rabies in Ontario, including one in York region and another in Peel.
A total of 287 Ontario bats were confirmed to have rabies from 2000-2004.
Before you panic, remember that human rabies from contact with bats is rare: There have been five Canadian cases since 1925, with the last causing the death of a 52-year-old B.C. man in 2003.

Before that, a 9-year-old Quebec boy died of rabies in late 2000 after he was exposed to an infected bat at his cottage.
ASSUME THE WORST
The number of rabid bats in southern Ontario is relatively small, but the consequences are so catastrophic that you have to assume any bat in human contact is rabid unless it's proven otherwise.
Between 1,000 and 1,500 Ontarians undergo rabies post-exposure vaccine treatment every year, with more than half of those cases due to contact with bats.
Six Toronto area residents have already been given the vaccine this year due to bats, and another 26 were treated last year.
The precautionary treatment, which involves five injections over a month, is often mandatory because the animal is set free or disappears before it can be tested for the fatal disease by public health officials.
"Rabies in bats is fairly rare. Less than 1% of bats have the disease," said Beverly Stevenson, information officer with the rabies research unit at Ontario's ministry of natural resources.
"But most of the human deaths caused by rabies in North America are a result of bat strains," she said.
Experts agree the prevalence of bat rabies has remained stable over the past decade. However, the number of confirmed cases has spiked dramatically over the last five years due to greater public awareness.
That's due in part to a recent change in policy at the U.S. Centers for Diseases Control and Prevention, which now recommends rabies treatment for anyone who awakens to find a bat in their room and the animal can't be tested. Same goes for children and invalids left alone with a bat.
DON'T ALWAYS LEAVE MARKS
"Bat bites hurt. They feel like sharp needle jabs. But they don't always leave visible marks on the skin," said Barbara French, science officer with Bat Conservation International, a non-profit agency based in Texas that works to protect bats and their habitats worldwide.
"You don't want to assume that someone wasn't bitten because you don't see a mark on their skin," she said.
High profile cases have also contributed to greater public reporting of suspicious bats. Earlier this year, a Wisconsin teen made international headlines for being the first person known to survive bat rabies without a vaccination.
Jeanna Giese was infected in September 2004 when a bat bit her hand at church. She did not seek medical attention until a month later, when rabies symptoms appeared, including fatigue, tingling and numbness in her hand.
Doctors gave her an experimental drug treatment and induced a coma to fight off the infection.
But the teen's case is an anomaly and the public should not be misled to believe that rabies can be treated after the fact, said George Matsumura, head of the rabies control program for Toronto Public Health.
"Rabies is fatal. That's why we deal with it as a high priority," he said. "If there's a bat in your home and you're able to catch it, don't discard it. Let us analyze it. Especially if you were sleeping and you awake with the bat in your home."
Heightened public awareness of bat rabies has meant a boom in business for AAA Wildlife Control, which offers bat removal and bat-proofing services to homeowners across the country.
"In the last two years, we've seen our bat work almost double," owner Brad Gates said.
"I think it's because bats are getting more media attention and the rabies situation is making people more concerned about having them live in their homes."
SQUEEZE THROUGH HOLES
Homeowners who want to keep bats out of attics should cover up any holes or loose vents, Stevenson said, noting bats can squeeze through a hole the size of a pinky finger or a pencil.
Unlike other animals in Ontario that carry rabies, such as the Arctic fox and raccoons, bats can't be vaccinated with baits.
So the province relies on public education to control the spread of the disease by these winged creatures, which are beneficial in many other ways -- especially for their voracious appetite for insects such as mosquitoes.
"Use common sense," Stevenson said. "If you see a bat flying around at night that looks like it's feeding on insects, odds are it's a healthy bat. If you encounter a bat that can't fly or is crawling around on the ground, then I'd be concerned about rabies, so don't handle it." Previous story: Duceppe stays in OttawaNext story: Hospital cleaners cry foul

Lawmakers are running out of time to pass insurance parity and stop discrimination against the mentally ill

Monday, June 13, 2005
S enate Bill 1, providing health insurance parity for mentally ill Oregonians, is caught in the deal-making of the last days of the Legislative Assembly. If this sausage-making is hard for the public to stomach, imagine how it looks to the exhausted families that have spent themselves into bankruptcy trying to get care for their mentally ill children.
If House Republicans get Senate Democrats to swap a capital gains tax cut for parity, Kathleen Ris could get to keep her son, rather than endure again the pain and humiliation of signing over his custody to the state, just to get him the health care that he needs.
Or, if House Speaker Karen Minnis gets the Senate to trade parity for her school funding plan, Sonja Tanner could get help the next time her son's mental illness flares, and he grabs a knife and vows to kill a boy having a birthday party across the street.
"It is nauseating," says Ris. "It just makes me sick. They think my son's health and his life are so trivial that this is just another bill to swap."
Senate Bill 1 would prohibit insurers from discriminating against people suffering from diseases of the brain. It is not just another bill; it is a long-overdue recognition of mental illness as a condition, not a stigma. It is a declaration that Oregon families should not have to lose everything, even custody of their children, to the hell of a mental illness.
Thirty-five other states already have some form of a law preventing insurers from putting more restrictions, such as spending caps and hospitalization limits, on mental illness than on other diseases. This compassionate, forward-thinking state should not be the last to eliminate discrimination against the mentally ill.
Opponents claim that insurance parity will drive up insurance premiums to businesses, and force many to drop health care insurance altogether. It is a fair concern, but it does not square with years of actual experience in other states. Study after study has demonstrated that providing equal coverage for mental illnesses results in less than a 1 percent increase in health premiums.
Every poll shows that Americans strongly believe in insurance parity. It is not a partisan issue -- not in neighboring Washington, which overwhelmingly approved parity this year, and not in the Oregon Senate, where SB1 passed 24-5.
Yet GOP leaders have locked Senate Bill 1 up in committee, and won't bring it to the floor for a vote. For House leaders, the parity bill is the ultimate trade bait -- because it is Senate President Peter Courtney's top priority.
These lawmakers cannot seem to see beyond their political calculations or the cold actuarial analysis that has prompted some business lobbies in Salem to fight the bill. They should talk to their own neighbors who are struggling with mental illness and suffering discrimination from insurers.
Ris and Tanner live near the east Multnomah County district that House Speaker Minnis represents. Ris' son is 14; Tanner's is 16. Both women tell heartbreaking stories of long battles to get mental health care for their boys.
Ris and her husband have remortgaged their home, wiped out their savings and spent nearly $100,000 on his care. For years their lives have been a blur of emergency rooms, psychiatric wards and fights with insurers.
Once when her son was hospitalized Ris got into a bitter argument trying to persuade her insurer to cover treatment in an inpatient day facility. "I was just trying to find a place for him when he got out the hospital, a place where he wouldn't kill himself, or me," she said.
Four hours later, she says, the hospital called and informed her it was discharging her son. The insurer had cut off payments to the hospital. The explanation: If Ris' son was well enough for day treatment, he must not need 24-hour hospital care. "I learned not to argue with them," she says.
Last year, Ris and her husband had little choice but to sign partial custody of their son over to the state, which would make him eligible for inpatient care. "It was so humiliating," she said. "It made us feel like we weren't capable, not good parents." They have since regained full custody of their boy, but she says they may again have to relinquish custody: "He's starting to slide."
Tanner has testified to the Legislature about the need for parity, but she didn't tell lawmakers everything. The single mom didn't tell them how her son "has threatened to kill so many children I can't even begin to name them." She didn't tell them about spending her last dollar on his care, how the gas company shut off service, sometimes for weeks, and she heated water in a microwave to wash dishes.
Tanner didn't tell them about all the years she kept her kitchen knives locked in a toolbox on the counter, or about how she found cash in an unsigned envelope in her mailbox on her birthday, and stood in her driveway crying.
Tanner's son is eligible for a total of 15 days of inpatient care. When the troubled boy burns through that treatment -- "it goes fast," his mom said -- he is out of care. He must go home.
Only about 15 days are left in this session. If this Legislature fails to stop the discrimination against the mentally ill, if all the cynical trade deals collapse, those who are responsible will have used up all their time in the Capitol. Their failure will follow them home.
This is the 12th in the Oregon's Forgotten Hospital series archived online at www.oregonlive.com/special/

Improved Diabetes Management Could Save $72 Billion in Next Decade According to New Data Presented at the American Diabetes Association Annual Meeting

U.S. economic analysis projects financial impact of improved diabetes management; related Swiss study demonstrates cost effectiveness of insulin pump therapy
Medtronic, Inc. (NYSE:MDT) today reported results of a health economic analysis that predicts the U.S. economy could save up to $72 billion in medical expenses and other costs if Americans with diabetes kept their blood sugar (glucose) levels in line with current treatment guidelines. Data from the Medtronic-supported study were presented at the 65th annual Scientific Sessions of the American Diabetes Association.
The predictive health economic analysis showed that lowering A1C to levels recommended by the American Diabetes Association (ADA) and the American Association of Clinical Endocrinology (AACE) in Americans with type 1 and type 2 diabetes would save between $35 and $50 billion in direct medical costs, such as hospitalizations, over a 10-year period. When indirect cost savings were included, the total savings would increase to between $50 and $72 billion. Indirect costs of diabetes include lost work time, premature mortality and disability.
An A1C test measures patients' blood sugar control over a three-month period and is a widely accepted indicator of how well diabetes is controlled. The ADA and AACE recommend that diabetes patients maintain A1C levels below 7 percent and 6.5 percent, respectively. Elevated A1C levels are associated with an increased risk of diabetes complications. Proper control of A1C levels is important because for every 1 percent reduction in A1C, diabetes complication rates drop by more than 25 percent, according to a study published in Diabetes 2001: Vital Stats. Serious complications of diabetes include coma, blindness, impotence, kidney failure, amputation and heart disease.
The U.S. healthcare savings data came from a predictive analysis that is part of the CORE (Center for Outcomes Research) Diabetes Model - a multi-national health economic model that projects costs and outcomes for diabetes patients based upon data from major clinical and epidemiological studies from published sources. The peer-reviewed CORE Diabetes Model, validated with 66 comparisons from published studies, estimated clinical outcomes and costs over 10 years by projecting the impact of reducing A1C levels to 7 percent and 6.5 percent in Americans with diabetes.
"Tighter control of A1C will make an enormous difference in the life of diabetes patients, reducing the risk of the severe, life-altering and sometimes fatal complications of the disease," said Michael E. Minshall, MPH, director of CORE-USA, LLC. "And, as dramatically demonstrated by this study, improving the blood sugar control of diabetes patients in the United States has the potential to save billions of dollars." CORE is a contract research company based in Switzerland and the United States that specializes in disease modeling, health economic analysis and medical writing.
The estimated annual direct and indirect healthcare cost of diabetes and its complications is currently more than $132 billion in the United States, according to a study published in 2003 by the American Diabetes Association (Diabetes Care, 2003; 26(3):917-932). More than 18 million Americans are estimated to have diabetes, with an approximately 5.2 million undiagnosed according to the Centers for Disease Control and Prevention. Diabetes is the sixth-leading cause of death in the United States. Type 1 diabetes accounts for about 10 percent of total diabetes cases, and type 2 diabetes for the remaining 90 percent. In type 1 diabetes, the pancreas does not produce insulin, which is needed to control blood glucose. In type 2 diabetes, the body is unable to make enough, or properly use, insulin.
Swiss Economic Study Also Presented at ADA
Another CORE Diabetes Model analysis based on Swiss data, also presented at the ADA meeting, demonstrated that insulin pump therapy extends life and is cost effective for treating type 1 diabetes compared to multiple daily injections (MDI) of insulin. The study projected that pump therapy would increase life expectancy by approximately 10 months (0.87 years on a discounted basis) compared to MDI (based on mean life expectancy). Moreover, the lifetime treatment costs of complications, such as vision loss, renal disease and vascular disease, were CHF 10,327 lower for pump therapy as compared to MDI (calculated in Swiss francs; approximately $8,400). The incremental cost effectiveness ratio (ICER) for pump therapy compared to MDI was CHF 22,444 (approximately $18,300) per life year saved, which falls within range of accepted values in many countries around the world. The ICER is a common methodology used to determine whether a new medical intervention provides economic value and is based on the incremental difference in costs and life expectancy between two treatment regimens.
How Pump Therapy Helps Improve A1C Control
Insulin pump therapy is the most advanced method for precise and adjustable insulin delivery, and has been proven to help patients lower their A1C levels. An insulin pump is a small pager-size device that delivers insulin around the clock, much like a healthy pancreas. Patients can also deliver insulin on demand at the touch of a few buttons. Unlike injection therapy, pump users can program their pump to deliver insulin at varying rates to meet their changing insulin needs throughout the day and overnight. Many patients experience improved quality of life with pump therapy, ridding themselves of multiple injections, strict meal schedules and rigid sleep patterns associated with injection therapy.
CORE Diabetes Model
The CORE Diabetes Model provides an insight into implementing diabetes treatment guidelines that would otherwise require 20 to 30 years in a clinical trial setting before results would be available. Computer-simulation models allow the projection of short-term data from clinical trials to evaluate clinical outcomes and costs over the long term, providing information that is often unavailable or otherwise difficult to collect. Patients with chronic diseases often need to be followed for a long period of time (more than 5 years) before the effectiveness of disease management strategies can be adequately evaluated. Modeling provides an early estimate of financial impact without having the added expense and burden of conducting an epidemiological or clinical study. Data from the Diabetes Control and Complications Trial were used to set the baseline typical A1C level for the theoretical type 1 diabetes cohort, and data from the National Center for Health Statistics were used to set the baseline typical A1C level for the type 2 diabetes cohort.
About Medtronic Diabetes
Medtronic Diabetes (www.minimed.com) is the world leader in pump therapy and continuous glucose monitoring. The company's products include external insulin pumps, related disposable products, and a continuous glucose monitoring system.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 30, 2004. Actual results may differ materially from anticipated results.
CONTACT:
Medtronic, Inc. Investor Relations: Rob Carson, 763-505-2705 or Public Relations: Deanne McLaughlin, 818-576-4325

Early HIV Testing Key for Success of African Treatment Programs, Expert Says at S Africa

Early HIV testing is an important factor for the successful implementation of HIV/AIDS treatment programs in African countries, Ernest Darkoh, former operations manager of Botswana's public antiretroviral drug program, said on Tuesday at the... 2nd South African AIDS Conference in Durban, South Africa, Reuters AlertNet reports (Quinn, Reuters AlertNet, 6/7). About 1,000 AIDS advocates and health professionals were expected to attend the three-day conference, which opened on Tuesday and aims to evaluate South Africa's HIV/AIDS treatment programs (Nullis, Associated Press, 6/7). Darkoh, who was the keynote speaker at the conference, said it is important for people to undergo early testing for HIV to avoid a "deluge of sick people hungry for treatment," according to Reuters AlertNet. Darkoh said that Botswana's decision in early 2004 to implement routine HIV testing for incoming patients at medical clinics made a "big difference in catching people before they are too sick to work and become a bigger burden on social services," according to Reuters AlertNet. "You are overwhelmed at first by the very sick, and they are very resource intensive, if you at least get them while they are still ambulatory, you have a chance," Darkoh said. Botswana has an HIV/AIDS prevalence of about 40% of the adult population, one of the highest in the world. Darkoh said that developing countries -- including South Africa -- could learn from Botswana's experience providing antiretroviral drugs, according to Reuters AlertNet. "The issues on the ground, at an operational level, are the same," Darkoh said, adding, "You have to wake up and say you are going to do it -- it may take 20 years, but you are going to do it" (Reuters AlertNet, 6/7).
South African Military The South African military is "fighting a war" against HIV/AIDS, which affects about 23% of the country's armed forces and is disrupting the country's ability to serve in peacekeeping missions abroad, South African Brig. Gen. Pieter Oelofse said on Tuesday at the conference, according to AFP/Yahoo! News. "From the military health perspective, we are fighting a war, a human war," Oelofse said, adding, "We are faced with a formidable enemy which is HIV and AIDS." U.N. guidelines discourage HIV-positive soldiers from serving in international peacekeeping missions, but Oelofse said that the military is a stretched and might need to depart from the guidelines if research shows that HIV-positive soldiers taking antiretrovirals can serve effectively, according to AFP/Yahoo! News (AFP/Yahoo! News [1], 6/7). A research project partly funded by the U.S. Department of Defense and NIH is examining which antiretroviral treatment regimens are most effective for treating HIV-positive soldiers, according to Reuters. South African Col. Xolani Currie, the project's leader, said that 2,779 military personnel and dependents have been screened for their eligibility to participate and that only those with the greatest need for the drugs have been accepted, according to Reuters (Quinn, Reuters, 6/7). Currie said treatment has raised the morale of those participating in the project, according to AFP/Yahoo! News. "We had members sitting hopelessly at the base with no hope," Currie said, adding, "Some of them are now running around in the mountains." However, Oelofse said that the program is still in its "early days," adding, "The data is being collected. It's a five-year project" (AFP/Yahoo! News [1], 6/7).
PEPFAR U.S. Ambassador to South Africa Jendayi Frazer on Tuesday at the conference said that the President's Emergency Plan for AIDS Relief over the past year has treated more than 25,000 HIV-positive people with antiretrovirals, trained more than 30,000 health professionals and provided services for more than 70,000 HIV-affected orphans or vulnerable children in South Africa, according to Xinhuanet. Frazer said that in the program's first year in South Africa, prevention programs have been implemented for labor unions, school children, uniformed services and resource-poor communities, according to Xinhuanet. President Bush and South African President Thabo Mbeki two years ago agreed to work together to implement PEPFAR in South Africa. "I am pleased to let you know that just last week, President Mbeki and President Bush met again and reconfirmed their commitment to the cooperative efforts our partners are engaged in to address HIV and AIDS in South Africa," Frazer said (Xinhuanet, 6/7).
Also Discuss Other Diseases, Health Minister Says South African Health Minister Manto Tshabalala-Msimang "caused an uproar" on Tuesday at the conference when she "questioned the necessity" of the meeting and also urged those present to discuss diseases other than HIV/AIDS, according to London's Guardian (Siegfried, Guardian, 6/8). "I hope you have come in such big numbers not just to focus on one ailment but to focus on all of them because many other people are dying of other diseases in this country," Tshabalala-Msimang said, adding, "Even though it is a conference on HIV and AIDS, you must not forget to talk about cancers, you must not forget to talk about diabetes, you must not forget to talk about other communicable diseases" (AFP/Yahoo! News [2], 6/7). The South African HIV/AIDS treatment advocacy group Treatment Action Campaign has called for Tshabalala-Msimang to resign because of her statements promoting natural HIV/AIDS treatments and her emphasis on the side effects of antiretrovirals, according to BBC News. TAC asked the minister to make an "unequivocal statement" endorsing antiretrovirals as the "most effective" treatment for HIV/AIDS, according to BBC News (Miles, BBC News, 6/7). "Reprinted with permission from kaisernetwork.org kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv.. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

New Remicade® Data Show Inhibition of Joint Destruction in Patients with Psoriatic Arthritis

New Phase III data show that treatment with REMICADE® (infliximab) resulted in significantly greater inhibition of structural damage compared to placebo in patients with psoriatic arthritis. Radiographic analyses showed treatment with REMICADE resulted in a mean change of -0.70 from baseline in structural damage as measured using the van der Heijde-Sharp (vdH-S) scoring method. With this method, higher scores indicate greater structural damage while lower scores indicate less structural damage. These 24-week data, presented this week at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology, also showed that REMICADE significantly reduced signs and symptoms of the joints and skin in these patients.
i-Newswire, - “The inhibition of joint destruction is critical in the management and treatment of psoriatic arthritis patients,” said Désirée van der Heijde, MD, PhD, Professor of Rheumatology, University of Maastricht in the Netherlands and one of the principal investigators in the trial. “While it is unclear exactly how to interpret negative score changes, the radiographic evidence clearly shows that more patients experienced no worsening of joint destruction in the REMICADE group compared with the placebo group.” In the Induction and Maintenance Psoriatic Arthritis Clinical Trial 2 ( IMPACT 2 ), REMICADE-treated patients had significantly less progression of structural damage compared to patients receiving placebo at week 24. Structural damage was measured using the van der Heijde-Sharp score, an X-ray measure of changes in joint destruction, including joint erosion and joint space narrowing. The mean ( ± standard deviation ) change from baseline in patients treated with REMICADE was a decrease of -0.70 ( ± 2.53 ) score, compared to an increase of 0.82 ( ± 2.62 ) score in the placebo group ( P < p =" 0.003" p =" 0.013"> 3 percent body surface area ( BSA ) psoriasis involvement at baseline, psoriasis activity was assessed using PASI at baseline and weeks 2, 6, 14 and 24. Through 24 weeks, a similar proportion of patients experienced adverse events ( AEs ) in each treatment group. No deaths, cases of tuberculosis or other opportunistic infections or serious infusion reactions were reported and serious infections were uncommon. Within 24 weeks of treatment, one placebo-treated patient was diagnosed with basal cell carcinoma. During the continued treatment with REMICADE beyond week 24, one REMICADE patient was diagnosed with Hodgkin lymphoma. Laboratory abnormalities were uncommon, with an elevation in liver function tests being the most common abnormality. There were more patients with serious AEs in the REMICADE group ( 8.7 percent ) than in the placebo group ( 6.2 percent ). See “Important Safety Information” below. About Psoriatic ArthritisPsoriatic arthritis involves joint pain and swelling that can lead to debilitation coupled with inflamed, scaly, red patches of psoriasis. Symptoms may include stiffness and tenderness of the joints and surrounding tissue, reduced range of motion, nail changes and redness and pain of the eye. Joints of the hands, wrists, knees, ankles, feet, lower back and neck are commonly affected. Approximately one million Americans have psoriatic arthritis, and the disease affects both men and women equally, most commonly between the ages of 30 and 50. According to the Arthritis Research Campaign, approximately 1 in 50 people have psoriasis in the United Kingdom and about 1 in 14 of these individuals will develop psoriatic arthritis. About REMICADE REMICADE is the global market leader among anti-tumor necrosis factor alpha ( TNF-alpha ) therapies and the only agent approved for the treatment of both rheumatoid arthritis ( RA ) and Crohn's disease ( CD ) in North America, the European Union ( EU ) and Japan. In the EU and in the U.S., REMICADE is approved for the treatment of active ankylosing spondylitis ( AS ) and psoriatic arthritis. In the EU, REMICADE is indicated for the treatment of severe, active CD in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. REMICADE also is indicated for the treatment of fistulizing, active CD in patients who have not responded despite a full and adequate course of therapy with conventional treatment ( including antibiotics, drainage and immunosuppressive therapy ). For RA patients in the EU, REMICADE, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in patients with active disease when the response to disease-modifying drugs, including methotrexate, has been inadequate, and in patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated. In the EU, REMICADE is also indicated for treatment of AS in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy. In addition, REMICADE, in combination with methotrexate, is approved for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease-modifying anti-rheumatic drugs. In the U.S., REMICADE, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately-to-severely active RA. REMICADE is the only biologic indicated for the treatment of patients with moderately-to-severely active CD who have had an inadequate response to conventional therapy. REMICADE is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD. In December 2004, REMICADE was approved for the treatment of active AS and in May 2005, REMICADE was approved for reducing signs and symptoms of active arthritis in patients with psoriatic arthritis in the U.S. REMICADE is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. In RA, CD, and psoriatic arthritis, REMICADE is a two-hour infusion administered every eight weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6. As a result, REMICADE patients may require as few as six treatments each year. In AS, REMICADE is a two-hour infusion ( 5 mg/kg ) administered every six weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6. The safety and efficacy of REMICADE have been well established in clinical trials over the past 12 years and through commercial experience with over a half a million patients treated worldwide. Important Safety Information Many people with heart failure should not take REMICADE; so prior to treatment you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure ( such as shortness of breath or swelling of your ankles or feet ). There are reports of serious infections, including tuberculosis ( TB ), sepsis and pneumonia. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for TB and perform a skin test. If you have latent ( inactive ) TB, your doctor should begin TB treatment before you start REMICADE. REMICADE can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, or the flu while taking REMICADE, tell your doctor right away. Also tell your doctor if you have lived in a region where histoplasmosis or coccidioidomycosis is common. There have been rare cases of serious liver injury in people taking REMICADE, some fatal. Contact your doctor immediately if you develop symptoms such as jaundice ( yellow skin and eyes ), dark brown urine, right-sided abdominal pain, fever, or severe fatigue. Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding, or paleness while taking REMICADE. Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, or visual disturbances while taking REMICADE. Reports of lymphoma ( a type of cancer ) in patients on REMICADE and other TNF blockers are rare but occur more often than in the general population. Tell your doctor if you have or have had cancer. Serious infusion reactions have been reported with REMICADE, including hives, difficulty breathing, and low blood pressure. Reactions have occurred during or after infusions. In clinical studies, some people experienced the following common side effects: respiratory infections ( that may include sinus infections and sore throat ), coughing, and stomach pain or mild reactions to infusion such as rash or itchy skin. Please read important information about REMICADE, including full US prescribing information, at http://www.remicade.com. For complete REMICADE EU prescribing information, call Schering-Plough Corporation at +1 908-298-7616. About Centocor Centocor is a leading biopharmaceutical company that creates, acquires and markets cost-effective therapies that yield long-term benefits for patients and the healthcare community. The company is dedicated to the research and development of treatments for a wide range of diseases including cancer, infectious diseases, cardiovascular and metabolic diseases and Immune-Mediated Inflammatory Disorders ( I.M.I.D. ), such as arthritis and inflammatory skin diseases. Centocor's products, developed primarily through monoclonal antibody technology, help physicians deliver innovative treatments to improve human health and restore patients' quality of life. Centocor is a wholly owned subsidiary of Johnson & Johnson, the worldwide manufacturer of healthcare products. Centocor discovered REMICADE and has exclusive marketing rights to the product in the United States. Schering-Plough Corporation has rights to market REMICADE in all countries outside of the United States, except in Japan, China ( including Hong Kong ), Taiwan and Indonesia, where Tanabe Seiyaku, Ltd. markets the product. About Schering-PloughSchering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is schering-plough.com. SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including the company's strategy and the market for drugs to treat rheumatoid arthritis. Forward-looking statements relate to expectations or forecasts of future events and use words such as "will" and "plans." Actual results may vary materially from the forward-looking statements, and there are no guarantees about the performance of Schering-Plough stock or Schering-Plough's business. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ from Schering-Plough's forward-looking statements. These factors include uncertainties of the regulatory approval and review process and difficulties in product development. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the company's first quarter 2005 10-Q and the 2004 annual report on Form 10-K. Michael ParksCentocor, Inc. Phone: 215-325-4010 Mobile: +1-215-983-8000http://www.centocor.comDenise FoySchering-PloughPhone: 908-298-7616Mobile: +1-908-720-6350schering-plough.com

Diabetic Retinopathy Occurs in Pre-Diabetes

Diabetic retinopathy has been found in nearly 8 percent of pre-diabetic participants in the Diabetes Prevention Program (DPP), according to a report presented today at the American Diabetes Association's 65th Annual Scientific Sessions. Diabetic retinopathy, which can lead to vision loss, was also seen in 12 percent of participants with type 2 diabetes who developed diabetes during the DPP. No other long-term study has evaluated retinopathy in a population so carefully examined for the presence or development of type 2 diabetes.
“These findings reinforce the recommendation that patients with newly diagnosed type 2 diabetes should be screened for retinopathy,” said Emily Chew, M.D., of the National Eye Institute, part of the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services, which funded the study. “We advise good control of blood glucose, blood pressure, and cholesterol as well as regular eye exams.”
“Previous studies have not accurately defined when type 2 diabetes begins, so our understanding of the onset of diabetic eye disease has been limited. Now we know that diabetic retinopathy does occur in pre-diabetes. We’re also seeing it early in the course of diabetes — within an average of 3 years after diagnosis,” noted Richard Hamman, M.D., DrPH, professor and chair, Department of Preventive Medicine and Biometrics, University of Colorado School of Medicine, and vice chair of the DPP. “This adds to our understanding of the development of retinopathy and suggests that changes in the eye may be starting earlier and at lower glucose levels than we previously thought.”
Pre-diabetes is a condition in which blood glucose levels are higher than normal but not high enough for a diagnosis of diabetes. The condition is sometimes called "impaired fasting glucose (IFG)" or "impaired glucose tolerance (IGT)," depending on the test used to diagnose it. People with pre-diabetes have an increased risk of developing type 2 diabetes, heart disease, and stroke.
Diabetic retinopathy, which begins with changes in the small vessels in the back of the eye, often leads to loss of vision. Regular eye examinations to diagnose retinopathy are recommended for patients with diabetes because treatment with laser photocoagulation can often prevent blindness in more advanced cases. Diabetic retinopathy is still the most common cause of blindness in adults. (For more information about diabetic retinopathy, see NEI’s Diabetic Retinopathy: What you should know http://www.nei.nih.gov/health/diabetic/retinopathy.asp).
“Certain retinopathy lesions are considered indicative of the presence of diabetes because they are the first retinal changes to develop in this disease,” explained Dr. Hamman. “Although the retinopathy seen in the DPP participants was at a very early stage and did not affect vision, eye changes typical for diabetes were found in 8 percent of our study population before they developed diabetes. These observations may lead diabetes experts to reconsider the diagnostic thresholds used to define diabetes, which are based on levels of blood glucose associated with the development of eye, nerve and kidney complications of diabetes.”
DPP study chair David Nathan, M.D., of Massachusetts General Hospital, pointed out that the retinopathy results are based on a random sample of only 12 percent of DPP participants, all of whom had impaired glucose tolerance, a form of pre-diabetes, when the study began. “These initial findings confirm what other studies have suggested. The complications of diabetes may begin before diabetes is diagnosed, at least by the current-day standards,” he explained. “Ideally, an expanded study of the remaining 88 percent of DPP Outcome Study participants might enable us to define more appropriate diagnostic thresholds.”
About 18.2 million Americans have diabetes, a group of serious diseases marked by high blood glucose levels that result from defects in the body's ability to produce and/or use insulin. Diabetes can lead to severely debilitating or fatal complications, such as heart disease, blindness, kidney disease, and amputations. It is the fifth leading cause of death by disease in the United States. Type 2 diabetes, which accounts for up to 95 percent of all diabetes cases, involves insulin resistance — the body’s inability to properly use its own insulin. It usually occurs in overweight adults, but it has increasingly been seen in obese children and teens in recent years.
About 40 percent of U.S. adults ages 40 to 74 — 41 million people — have abnormal blood glucose levels without having diabetes. Many will develop type 2 diabetes in the next 10 years. (In the DPP, about 10 percent of participants in the placebo group developed diabetes each year.) Once a person has type 2 diabetes, the risk of heart and blood vessel disease is 2 to 4 times that of people without diabetes.
Diabetes Prevention ProgramThe Diabetes Prevention Program was a major clinical trial in 3,234 people with impaired glucose tolerance. The study’s main results were announced in 2001 and reported in the Feb. 7, 2002 issue of the New England Journal of Medicine: Losing 5 to 7 percent of body weight through diet and a modest, consistent increase in physical activity (e.g., walking 5 days a week 30 minutes a day) lowered the incidence of type 2 diabetes by 58 percent. Treatment with metformin, an oral drug commonly used to treat diabetes, reduced the chances of developing diabetes by 31 percent.
The DPP was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and co-funded by other components of the NIH, the Centers for Disease Control and Prevention, and the Indian Health Service. The American Diabetes Association provided additional funding. Sources of corporate support included Bristol-Myers Squibb, Parke-Davis, Merck and Company, Merck Medco, Hoechst Marion Roussel, Sankyo, Lifescan, Lipha Pharmaceuticals, Slimfast, Nike, and Health-O-Meter.
About 90 percent of DPP participants continue to be followed closely in the DPP Outcomes Study to examine the longer-term impact of the original treatment interventions. All participants are given access to quarterly lifestyle group sessions, while those in the original intensive lifestyle group have access to additional lifestyle activities to help them stay on track. The participants originally assigned to metformin therapy continue to have access to the drug.
Retinopathy FindingsThree hundred two, or about 12 percent, of the DPP Outcome Study participants who had not developed diabetes during the study, and 588 of 876 participants who had developed diabetes, were selected to participate in the retinopathy study, funded by the NEI. To detect diabetic retinopathy, an evaluation of the fundus (inner lining of the eye) was performed with a special camera that provides a detailed look at the retina. Small changes in the vessels, called microaneurysms and hemorrhages, signal the development and degree of retinopathy severity.
Participants with pre-diabetes and retinopathy typically had a small number of microaneurysms in the eye characteristic of early, mild retinopathy that is not yet linked to vision loss. Those who had developed diabetes in the previous 1 to 5 years had slightly more severe retinopathy. Higher average blood glucose levels and higher blood pressure were associated with the risk of developing retinopathy in the new-onset diabetic patients, similar to previous findings in people with longstanding diabetes who develop retinopathy.
In its "Be Smart About Your Heart: Control the ABCs of Diabetes" campaign, the National Diabetes Education Program (NDEP) (www.ndep.nih.gov/), jointly sponsored by the NIH, the Centers for Disease Control and Prevention, and 200 partner organizations including the American Diabetes Association (ADA), encourages people with diabetes to control their blood glucose as well as their blood pressure and cholesterol. By keeping all three as close to normal as possible, people with diabetes can live long, healthy lives.
NDEP’s “Small Steps. Big Rewards. Prevent Type 2 Diabetes” campaign gives tips on lifestyle changes to prevent or delay type 2 diabetes.
“Make the Link! Diabetes, Heart Disease and Stroke,” is a joint initiative of the American Diabetes Association (www.diabetes.org/makethelink) and the American College of Cardiology (www.acc.org), which works to increase awareness of the link between diabetes and heart disease and help educate physicians and people with diabetes about how to reduce those risks.
The National Institutes of Health (NIH) — The Nation's Medical Research Agency — is comprised of 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary Federal agency for conducting and supporting basic, clinical, and translational medical research, and investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Lisofylline in Combination with Exendin-4 Reverses Diabetes in a Type 1 Model; LSF and GLP-1 Treatment Also Improved Islet Cell Viability and Normaliz

SAN DIEGO--(BUSINESS WIRE)--June 13, 2005--The combination of Lisofylline (LSF) and Exendin-4, a glucagon-like peptide-1 (GLP-1), reversed diabetes in a type 1 mouse model, according to results of a study presented at the American Diabetes Association (ADA) annual meeting. The same study also showed that the two drugs, when administered concomitantly, enhanced islet cell function and reduced islet cell death.
"The results of this study are very encouraging and demonstrate that it may be possible to regenerate beta cells with the combination of an immune modulator, such as LSF, and a GLP-1 agonist. These results are also consistent with previous findings that indicate Lisofylline has positive effects on insulin production and islet cell health," said Jerry L. Nadler, M.D., Chief of Endocrinology and Metabolism at the University of Virginia whose group presented the results at the ADA's Session on Beta-Cell Preservation. "If results of human studies with the LSF/Exendin-4 combination prove as successful, the treatment of type 1 diabetes and latent autoimmune diabetes of adults could be altered significantly."
LSF is a synthetic small molecule with novel anti-inflammatory properties that block autoimmune damage to insulin producing cells. GLP-1s, such as Exendin-4, stimulate pancreatic beta cell growth. However, the autoimmune process in people with type 1 diabetes rapidly destroys the beta cells, preventing GLP-1 action. The addition of an immune modulator such as LSF should provide a novel approach to restore beta cell function without the use of toxic immunosuppressive medications.
In the study, non-obese diabetic (NOD) mice, a well established model of type 1 diabetes, were treated for 28 days with the combination of LSF/Exendin-4. The treatment completely reversed diabetes as evidenced by restored glucose homeostasis. Additionally, there was evidence of new cell growth in the area of the islet cells in the mice given the combined therapy. NOD mice treated similarly with saline or Exendin-4 alone experienced no improvement in the diabetic condition. As part of the same study, isolated mouse pancreatic islets exposed to inflammatory cytokines and treated with the LSF/Exendin-4 combination experienced a 2.5 fold increase in metabolism and a 40% decrease in apoptosis (cell death) than controls.
"The blood sugar levels remained normal even after withdrawal of both drugs, suggesting that the combination of LSF and Exendin-4 led to beta cell regeneration," said Zandong Yang, M.D., Associate Professor of Medicine at the University of Virginia.
The study was conducted by Jeffrey Carter, B.S.; Meng Chen, M.D., Ph.D.; Kellie Smith, B.S.; Jerry L. Nadler, M.D.; and, Zandong Yang, M.D. of the University of Virginia and funded by local donor support.
Lisofylline has demonstrated that it can effectively prevent type 1 diabetes in preclinical models. LSF has shown to improve cellular mitochondrial function and to block interleukin 12 (IL-12) signaling and STAT-4 activation in target cells and tissues. IL-12 and STAT 4 activation are important pathways linked to inflammation and autoimmune damage to insulin producing cells. Therefore LSF, and the next generation of orally bioavailable immune modulators with a similar spectrum of action, offer the promise of providing a new therapeutic approach to prevent or reverse type 1 diabetes.
GLP-1 is a hormone that has generated significant attention in the diabetes community because it has multiple gluco-regulatory effects in the body. Several GLP-1 agonists are currently in clinical development for the treatment of diabetes and one product was recently approved as an adjunctive therapy to improve glycemic control in the treatment of type 2 diabetes.
Lisofylline and related compounds are being commercialized into therapies for diabetes and related complications by DiaKine Therapeutics, Inc. Dr. Nadler is the co-founder and current Chairman and Chief Science Officer of DiaKine Therapeutics.
According to the ADA, more than 18 million Americans have diabetes, a group of serious diseases characterized by high blood glucose levels that result from defects in the body's ability to produce and/or use insulin. Diabetes can lead to severely debilitating or fatal complications, such as heart disease, blindness, kidney disease and amputations. It is the fifth leading cause of death by disease in the U.S.
Contacts
For DiaKine TherapeuticsBill Wells, 404-281-7490

Data Presented at ADA Showed that Basal Insulin Therapy with Lantus(R) Achieved Target Glycemic Control in Poorly Controlled Type 2 Diabetes

Two Studies Show Insulin Glargine Control of HbA(1C) in Poorly Controlled
Type 2 Diabetes Patients, with Comparable Rates of Hypoglycemia
BRIDGEWATER, N.J., June 13 /PRNewswire-FirstCall/ -- Data presented today
at the 65th Session of the American Diabetes Association (ADA), San Diego,
demonstrated that people with type 2 diabetes achieved significantly better
glycemic control, and also achieved it earlier, when treated with the 24-hour
basal insulin analog Lantus(R) (insulin glargine [rDNA origin] injection,
sanofi-aventis) and their usual oral antidiabetes therapies* compared with
patients receiving oral therapy alone, with comparable rates of hypoglycemia.
Further data at the ADA show that Lantus(R) can be safely and effectively
initiated in both primary and secondary care, to achieve their target glycemic
control.
"These studies re-affirm that Lantus can help more people with type 2
diabetes reach their target blood sugar levels, and reach them earlier, so
that introducing insulin glargine earlier in these patients may be beneficial.
This data also highlights that Lantus can be titrated confidently and safely
in both a primary and secondary care settings with comparable rates of
hypoglycemia," commented Hertzel Gerstein and one of the investigators in the
INSIGHT study.
The INSIGHT (Implementing New Strategies with Insulin Glargine for
Hyperglycemia Therapy) study of 405 patients with type 2 diabetes for at least
6 months, demonstrated that earlier addition of insulin glargine to current
diabetes therapy effectively reduced HbA(1C) levels significantly more than
optimization of oral agents, and with comparable rates of hypoglycemia.
During the study, patients received either addition of once daily insulin
glargine (with no increase in oral antidiabetic therapy [OAD]), or were
optimized on OAD therapy with no insulin.
There were no differences in hypoglycemia noted between those receiving
Lantus and those receiving oral agents.
The American Diabetes Association recommends that people with diabetes
achieve an HbA(1C) <7% for optimal diabetes control, although more stringent
glycemic goals (i.e. a normal HbA(1C), <6%) may further reduce complications
at the cost of increased risk of hypoglycemia. Other organizations, namely the
European Diabetes Policy Group (EDPG) and the American Association of Clinical
Endocrinologists (AACE), recommend a lower target of under 6.5%.
In clinical practice, however, the majority of patients with type 2
diabetes do not routinely reach treatment targets. According to the National
Health and Nutrition Examination Survey (NHANES IV) 1999-2000, only 37% of
participants with previously diagnosed diabetes achieved the target HbA(1C)
goal of less than 7.0%, and 37.2% of participants were above the "take action"
HbA(1C) level of greater than 8.0%. These figures did not change significantly
from those reported in NHANES III, which encompassed the years 1988 to 1994.
Another study, presented at the ADA, focusing on a sub-analysis of the
AT.LANTUS trial in UK patients, further confirmed that Lantus(R) can be safely
and effectively initiated in both primary and secondary care. The data
highlighted that severe and nocturnal hypoglycemia rates are comparable
between primary and secondary care managed patients (p=NS).
The UK sub-analysis data are part of one of the largest prospective
treatment trials of diabetes management ever undertaken -- AT.LANTUS, (A Trial
comparing Lantus(R) Algorithms to achieve Normal blood glucose Targets in
patients with Uncontrolled blood Sugar) -- published in the June 2005 issue of
the ADA's Diabetes Care journal. The global study of nearly 5,000 people from
59 countries with type 2 diabetes, demonstrated that a simple patient-
administered titration algorithm with Lantus(R) significantly improves
glycemic control with a low risk of severe hypoglycemia.
"We know from large, landmark studies that a reduction on HbA(1C) levels
reduces the risk of a diabetic patient from developing both the micro and
macrovascular complications of diabetes. With over half of the patients with
type 2 diabetes failing to reach their glycemic targets, the inclusion of
Lantus the first and only once-daily, insulin analog which may be used in
combination with oral antidiabetes agents, provides an important approach to
achieving better glycemic control," commented Dr. Melanie Davies, Consultant
in Diabetes at the University Hospitals of Leicester.
* 83.2% of patients received their usual OAD whereas 16.8% were treated
only with lifestyle intervention
About LANTUS(R) (insulin glargine [rDNA origin] injection)
Lantus(R) is indicated for once-daily subcutaneous administration, at the
same time each day, for the treatment of adult and pediatric patients (6 years
and older) with type 1 diabetes mellitus or adult patients with type 2
diabetes mellitus who require basal (long-acting) insulin for the control of
hyperglycemia.
LANTUS(R) MUST NOT BE DILUTED OR MIXED WITH ANY OTHER INSULIN OR SOLUTION.
If mixed or diluted, the solution may become cloudy, and the onset of
action/time to peak effect may be altered in an unpredictable manner.
Lantus(R) is contraindicated in patients hypersensitive to insulin
glargine or the excipients.
Hypoglycemia is the most common adverse effect of insulin, including
Lantus(R). As with all insulins, the timing of hypoglycemia may differ among
various insulin formulations. Glucose monitoring is recommended for all
patients with diabetes. Any change of insulin type and/or regimen should be
made cautiously and only under medical supervision. Concomitant oral
antidiabetes treatment may need to be adjusted.
Other adverse events commonly associated with Lantus(R) include the
following: lipodystrophy, skin reactions (such as injection-site reaction,
pruritus, rash) and allergic reactions.
For full prescribing information, please visit http://www.lantus.com.
About sanofi-aventis
The sanofi-aventis Group is the world's third largest pharmaceutical
company, ranking number one in Europe. Backed by a world-class R&D
organization, sanofi-aventis is developing leading positions in seven major
therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases,
central nervous system, internal medicine, and vaccines. The sanofi-aventis
Group is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)
The sanofi-aventis Group conducts its business in the United States
through its subsidiaries Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc.
and Sanofi Pasteur Inc.
U.S. Contacts: Terri Pedone, +1-908-243-6578,
Terri.Pedone@sanofi-aventis.com
SOURCE sanofi-aventisWeb Site: http://www.sanofi-aventis.com http://www.lantus.comCompany News On Call: Company News On-Call: http://www.prnewswire.com/comp/232375.html

Genasense(R) plus Rituximab Reported Active in Patients with Relapsed Non-Hodgkin's Lymphoma

BERKELEY HEIGHTS, N.J., June 13 /PRNewswire-FirstCall/ -- Genta
Incorporated (Nasdaq: GNTA) today announced the presentation of clinical data
reporting the safety and activity of Genasense(R) (oblimersen sodium)
Injection, the Company's lead anticancer drug, in combination with rituximab
(Rituxan(R); Genentech IDEC). The trial was conducted in patients with
relapsed and refractory non-Hodgkin's lymphoma (NHL) by investigators from the
M.D. Anderson Cancer Center, Houston, TX, McMaster University, Hamilton,
Ontario, and the Fox Chase Cancer Center, Philadelphia, PA. The data were
presented by the trial's principal investigator, Dr. Barbara Pro, on Saturday
at the International Conference on Malignant Lymphoma in Lugano, Switzerland.
In this study, Genasense was administered daily for 7 days on weeks 1, 3
and 5, and rituximab was administered weekly for 6 weeks. Thirty-five
patients who had failed a median of 2 prior chemotherapy regimens with or
without rituximab were entered into this ongoing trial. To date, 6 patients
have achieved a complete response, one of whom was refractory to prior
rituximab therapy. Nine other patients have achieved a partial response for
an overall response rate of 42%. Patients with the specific subset of
follicular lymphoma showed a response rate of 56%. Twelve other patients have
had stable disease. Side effects of the combination appeared qualitatively
similar to that for rituximab alone, including but not limited to neutropenia,
fever, infection, anemia and fatigue.
Prior studies have shown preclinical synergy of Genasense with rituximab
in NHL (1,2). The concurrent treatment schedule employed in this clinical
study closely follows the optimized dosing regimen that was recently described
for the use of this combination (3). This study - the first to report
clinical activity of Genasense plus rituximab without the use of cytotoxic
chemotherapy - was supported in part by the National Cancer Institute. Recent
clinical studies have also demonstrated safety and activity when using
Genasense and rituximab in combination with chemotherapy, such as CHOP-R in
patients with mantle cell lymphoma (4). Ongoing work is also assessing the
use of Genasense in combination with rituximab plus fludarabine in patients
with chronic lymphocytic leukemia (CLL).
"The Genasense-rituximab combination trials are high priorities for the
Company in both NHL and CLL", commented Dr. Loretta M. Itri, President,
Pharmaceutical Development and Chief Medical Officer. "We anticipate that
future registration trials in both of these indications will incorporate the
use of rituximab. These early demonstrations of safety and activity are key
to the translation of promising preclinical work into patients, as well as for
building the combination regimens for new trials in these diseases."

About Genasense
Genasense works by inhibiting the production of Bcl-2, a protein made by
cancer cells that is thought to block chemotherapy-induced cell death. By
reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the
effectiveness of current anticancer treatments. Genasense is currently in
multiple, late-stage randomized and non-randomized clinical trials in multiple
indications including malignant melanoma, chronic lymphocytic leukemia (CLL),
acute myeloid leukemia and non-small cell lung cancer.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified
product portfolio that is focused on delivering innovative products for the
treatment of patients with cancer. The Company's research platform is anchored
by two major programs that center on oligonucleotides (RNA and DNA-based
medicines) and small molecules. Genasense(R) (oblimersen sodium) Injection,
the Company's lead compound from its oligonucleotide program is currently
undergoing late-stage, Phase 3 clinical testing. The leading drug in Genta's
small molecule program is Ganite(R) (gallium nitrate injection), which the
Company is exclusively marketing in the U.S. for treatment of patients with
cancer-related hypercalcemia that is resistant to hydration. For more
information about Genta, please visit our website at: http://www.genta.com/.
This press release contains forward-looking statements with respect to
business conducted by Genta Incorporated. By their nature, forward-looking
statements and forecasts involve risks and uncertainties because they relate
to events and depend on circumstances that will occur in the future. There are
a number of factors that could cause actual results and developments to differ
materially. For a discussion of those risks and uncertainties, please see the
Company's Annual Report/Form 10-K for 2004.
SOURCE Genta IncorporatedWeb Site: http://www.genta.com/