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GENETICS: POST-SURGERY MENTAL DECLINE LINKED TO GENES
Variants of two genes involved in the inflammatory system appear to protect patients from suffering a decline in mental function after heart surgery. Researchers at Duke University Medical Center said their findings, reported in the Journal of the American College of Cardiology, could help physicians identify patients at risk for mental decline after heart surgery. The findings also raise the possibility that these patients could be treated with drugs that are known to dampen the inflammatory response. Previously, the researchers found 42 percent of patients who underwent coronary artery bypass surgery had measurable cognitive decline after their procedure.

DIAGNOSTICS: GENETIC VARIANT RAISES RISK OF HEART ATTACK
A common genetic variant increases risk of heart attack, according to scientists at Reykjavík-based Decode Genetics and colleagues from the United States. The single-letter variant in the genome on a single chromosome was discovered through a genome-wide analysis in Iceland and replicated in three cohorts comprising more than 17,000 people of European descent from Philadelphia, Atlanta and Durham, North Carolina, as well as control subjects. Decode plans to bundle this discovery with other genetic variants it has linked to risk of heart attack into a DNA-based test for gauging inherited risk of heart attack.

OBESITY: PROTEIN COULD LEAD TO NEW OBESITY TREATMENTS
Researchers have found animals lacking a protein enriched in fat cells develop acute inflammation in deep pockets of fat. A study published in the journal Cell said the animals also showed symptoms of metabolic syndrome—including insulin resistance and fatty liver disease—even while on a regular diet. The researchers said finding ways to strengthen the STAMP2 protein or prevent its suppression could eventually un-link overeating and obesity and lead to new therapies to stem the rising tide of chronic metabolic disease.

OBESITY: PILL BURNS BODY FAT
Researchers have developed a so-called exercise pill that tells cells to burn fat. By giving the pill to mice, researchers at the Salk Institute were able to switch on the master regulator that controls the ability of cells to burn fat. During a presentation at the Experimental Biology annual meeting in Washington, D.C., researchers said even when the mice were inactive, flipping the chemical switch activated the same fat-burning process that occurs during exercise. It also made the mice resistant to weight gain on a high fat diet. Researchers hope this will lead to a new approach to treating metabolic syndrome, a cluster of obesity-related conditions including cardiovascular disease and diabetes.

DIABETES: DISEASE DAMAGES DNA IN SPERM
Sperm from men with diabetes have more DNA damage than sperm from men without the disease, according to new research published in Human Reproduction. It is believed to be the first research to show diabetes damages DNA and may affect fertility. The research, conducted by the Reproductive Medicine Research Group at Queen’s University, Belfast, Ireland, said if the increasing trend in the incidence of type I diabetes continues, diabetes will affect many more men before and during their reproductive years.

HEART DISEASE: TART CHERRIES OFFER HEALTH BENEFITS
Increasing the consumption of antioxidant-rich tart cherries could lower the risk of metabolic syndrome and cardiovascular disease, according to a study presented at the Experimental Biology annual meeting in Washington, D.C. The study from researchers at the University of Michigan Cardiovascular Center found that patients on cherry-enriched diets had lower blood cholesterol, triglycerides, insulin and fasting glucose. The cherries contain a compound known as anthocyanins, which gives them their deep red color and has been shown to have anti-inflammatory properties and other health benefits.

ARTHRITIS: GREEN TEA MAY TAME INFLAMMATION
A compound in green tea could provide relief to sufferers of rheumatoid arthritis, according to a study from researchers at the University of Michigan Health System. In a presentation at the ExpBiology annual conference in Washington, D.C., the researchers said green tea contains a potent anti-inflammatory compound known as EGCG. ECGC inhibited the production of several molecules in the immune system that contribute terimental o inflammation and joint damage from rheumatoid arthritis.

NEUROLOGY: STATINS REDUCE RISK OF STROKE, HEART ATTACK
Cholesterol-lowering statins have also been shown to reduce the risk of both heart attack and stroke, according to research presented at the American Academy of Neurology in Boston. The lead researcher said the findings show that reducing cholesterol can quickly have positive, long-term effects. The study was supported by Pfizer, which makes the statin Lipitor.

ALZHEIMER’S: NEW WAY TO PREVENT BRAIN DISEASE
Reducing levels of a protein produced by brain cells can prevent seizures and neurological deficits related to Alzheimer's disease, according to scientists at the Gladstone Institute of Neurological Disease. The findings, reported in the journal Science, show that when the protein tau is removed from mice that had been engineered to have Alzheimer’s, their memory is retained and they live a normal lifespan. Reducing tau levels also made mice more resistant to epileptic seizures. The study’s lead author said that though more work is needed to be done, this could lead to a major leap forward in the treatment and prevention of devastating neurological diseases.

MIGRAINES: HEADACHES LINKED TO BRAIN DAMAGE
Scientists have found evidence that migraines deprive the brain of oxygen like strokes do, altering it significantly. The research, conducted by neuroscientists at the University of Rochester Medical Center and published online in Nature Neuroscience, argues that it is critical for migraine sufferers to do everything they can to prevent their headaches because of the risk of brain damage. Normally, the focus of migraine treatment is to reduce the pain. Prevention will not only stop the pain, the researchers said, but also minimize potential damage.

OSTEOPOROSIS: DRUG EFFECTIVE EVEN AT ONCE A YEAR
A treatment for osteoporosis delivered once a year is as effective as current monthly or weekly regimens that aim to reduce the incidence of bone fractures, according to a new study led by researchers at the UCSF School of Medicine. The study, published in the New England Journal of Medicine, finds zoledronic acid, or Reclast, very effective in reducing the incidence of all types of fractures in women with postmenopausal osteoporosis. Reclast is an investigational drug developed by Novartis that is part of the same class of bisphophonate drugs now used either weekly or monthly to treat osteoporosis. The research was funded through grants from Novartis.

SUPERBUGS: MAGGOTS RID PATIENTS OF BACTERIUM
Researchers at the University of Manchester in the UK are ridding diabetic patients of the bacterium methycillin-resistant Staphyloccus aureus, or MRSA, by treating ulcerous foot wounds with maggots. The researchers found that they could cure patients in a mean period of three weeks, much faster than the 28 week typical for the conventional treatment. The researchers said the treatment could offer the first noninvasive and risk-free treatment that is safe and cost effective without toxic antibiotics for a growing problem. The study appeared in Diabetes Care.

DEALS: ASTRAZENECA LOOKS FOR MORE AFTER $15.6 B FOR MEDIMMUNE
A top executive of AstraZeneca told the Financial Times that the company would continue to look for in-licensing deals to strengthen its late-stage pipeline in the wake of its planned $15.6 billion acquisition of MedImmune. John Patterson, AstraZeneca’s executive director of development, told the Times that despite criticism that the MedImmune deal was too rich, it would pay for itself if even one or two good products result from it.

PANDEMICS: RAPID VIRUS DETECTION MADE POSSIBLE
Scientists have developed a way to capture and transport virus nanoparticles. This makes possible a device that could rapidly detect infectious biological agents. Chemical engineers from the University at Buffalo, New York, working with scientists from other institutions said the advance may pave the way for an on-the-spot virus detector, which would be helpful in military and public-health applications. The results, published in the journal Langmuir, comes amid concern over recently emerging viruses such as SARS, West Nile and avian flu.

MEDICAL DEVICES: JAPAN SLOW TO APPROVE NEW PRODUCTS
Japan's approval process for medical devices is the “slowest, least transparent, and most difficult regulatory system” in the world according to a report from the United States International Trade Commission. The report found that average time to win approval for a new medical device in Japan in 2004 was 1,083 days compared to 356 days in the United States. The delays appear to take a toll on the number of applications filed by U.S.-based medtech companies in Japan: these dropped to 8 in 2005 from 132 in 2003.

HEALTH ECONOMICS: UROLOGIC DISEASE COSTS $11 BILLION A YEAR
Bladder, prostate and other urinary-tract diseases cost Americans nearly $11 billion a year, according to a new report from the National Institutes of Health. Medicare foots the bill for nearly half that amount. The five most expensive urologic problems—accounting for $9.1 billion—are, in descending order, urinary tract infections, kidney stones, prostate and bladder cancers and benign prostate enlargement, according to the authors of the report “Urologic Diseases in America.”

INTELLECTUAL PROPERTY: PATENT RULING HURTS BIG PHARMA
A U.S. Supreme Court ruling will make its easier to challenge patents. In a unanimous ruling in KSR International Co. v. Teleflex Inc., the court said the federal appeals court used too rigid a formula in determining whether an invention meets the important standard of being “non-obvious.” The decision has implications for the pharmaceutical industry, which spends on average $1 billion and 10 years to bring a drug to market, by making it easier for competitors to challenge a company’s patents.

LEGISLATION: DRUG-IMPORTATION AMENDMENT THREATENS FDA BILL
President George Bush is threatening to veto legislation that would reauthorize user fees collected by the FDA if an amendment is attached to it that would open the door to drug importation. Senator Byron Dorgan (D-North Dakota) wants to allow people to import drugs from other countries where they cost less. Dorgan is willing to hold off on the amendment if congressional leadership will set a date to address his bill. The pharmaceutical industry and the Bush administration oppose re-importation of drugs. They argue that there are no guarantees to protect consumers against counterfeit products.

LEGISLATION: INDUSTRY WANTS 14 YEARS OF EXCLUSIVITY
The Biotechnology Industry Organization said any regulatory pathway for copycat versions of biologics should provide the original company with 14 years of exclusivity following its approval before the FDA can allow a follow-on product. The organization said companies need to have some certainty that they can protect their investment in the development of new therapies for a sufficient period of time in order to secure the investment necessary to develop products. The group said anything less could skew investment away from biologics research and development.

FDA: CRITICAL PATH CALLS FOR GENERIC INNOVATION
A number of unanswered scientific questions are impeding the development of generic versions of commonly used drugs, according to a new report from the FDA. The report, part of the agency’s Critical Path Initiative, says that while blood tests are sufficient to demonstrate bioequivalence for most generic drug candidates, they are generally not appropriate for certain drugs, including asthma inhalers, nasal sprays, and topical skin applications. As a result, few generic versions are available in these product categories, resulting in less competition and higher prices. The report calls for research on new bioequivalence methods tailor made for each challenging drug class.

RESEARCH: POLICE RAID GROUPS TARGETING BIOTECH FIRMS
Police in the UK, Belgium and the Netherlands raided suspected animal rights extremists. They questioned suspects about burglary, blackmail and other crimes against animal-research facilities including those operated by Huntingdon Life Sciences, a high-profile target of animal-rights extremism. The operation involved about 700 officers; 32 addresses in the three countries were raided according to a report from AFP. Police seized $200,000, cell phones and computers.

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