Pharmaceutical News and Articles: September 2007

September 22, 2007

Leptin, Central Nervous System Involved in Bone Gain, Bone Loss

September 21, 2007 (Honolulu) — The discovery of a pathway in the brain that triggers osteoblast activity and the formation of bone opens the door to a new way to combat osteoporosis.

The neuromedin U pathway was described here at the American Society for Bone and Mineral Research (ASBMR) 29th Annual Meeting this week by Japanese researchers, whose work earned top honors at the meeting.

"Work by this group and other scientists has revealed a surprising finding — that bone cell activity is regulated in part by hormones and factors that are involved in the control of brain and fat metabolism," ASBMR president Steven R. Goldring, MD, professor of medicine at Harvard Medical School in Boston, Massachusetts, told Medscape.

The work was presented by Shingo Sato, MD, from the Department of Orthopedic Surgery at Tokyo Medical and Dental University in Tokyo, Japan.

"Dr. Sato and colleagues have identified neuromedin U, a central nervous system–derived molecule that helps control appetite and fat metabolism, as a potentially important regulator of bone formation," Dr. Goldring explains.

Neuromedin U–deficient mice showed a 30% higher level of bone formation and bone mass over wild-type mice, Dr. Sato's team showed.

Leptin infusions decreased osteoblast activity in wild-type mice but significantly increased bone formation in neuromedin U-deficient mice. "However, and surprisingly, intracerebral leptin infusion paradoxically increased bone formation and osteoblast number in neuromedin U-deficient mice," Dr. Sato reported.

Earlier studies showed that the beta-blocker isoproterenol inhibits bone formation in wild type-mice. In neuromedin U-deficient mice, isoproterenol had no effect on osteoblast activity.

This discovery opens the door for a way to regulate bone formation through the leptin pathway, Dr. Sato said.

Dr. Sato's work "provides insights into the role of the nervous system in controlling bone remodeling and offers potential unique and novel approaches for preventing bone loss and treating osteoporosis," Dr. Goldring declared.

"The mission of the ASBMR, the world's largest bone research society, is the translation of the highest-quality and most recent and innovative scientific discoveries into improving the care of individuals with skeletal disorders," Dr. Goldring said as he explained why the society awarded Dr. Sato and colleagues the 2007 ASBMR Most Outstanding Abstract Award.

"Understanding the mechanisms that lead to osteoporosis is a major focus of bone research. Osteoporosis is the most common bone disease, affecting tens of millions of individuals and frequently leading to marked disability and impaired quality of life," Dr. Goldring asserted.

Neither Dr. Sato nor Dr. Goldring report any relevant financial relationships.

American Society for Bone and Mineral Research 29th Annual Meeting: Abstract 1061. Presented September 17, 2007.

New FDA Orphan Drugs: IPI-504, Pafuramidine, Preos

September 21, 2007 — The US Food and Drug Administration (FDA) has granted orphan drug designation for IPI-504 for the treatment of gastrointestinal stromal tumors, pafuramidine for the treatment of African sleeping sickness, and PREOS for the treatment of hypoparathyroidism.

Orphan Drug IPI-504 for Gastrointestinal Stromal Tumors

On August 31, the FDA granted orphan drug designation to IPI-504 (Infinity Pharmaceuticals, Inc, and MedImmune) for the treatment of gastrointestinal stromal tumors (GISTs).

A GIST is a rare tumor that is thought to develop in the interstitial cells of Cajal (ICCs) in the wall of the gastrointestinal tract, usually in the stomach or small intestine, and can be either malignant or benign. Malignancy in the majority of cases occurs when specific mutations in the cellular signaling enzymes, KIT or PDGFRA, cause the growth and survival of the signal cell to become permanently active. Both KIT and PDGFRA are client proteins of HSP90, a molecular chaperone that responds to cell stress caused by heat.

IPI-504 is a small-molecule drug that is administered by intravenous infusion. Preclinical studies have shown IPI-504 to selectively inhibit HSP90 as well as to have broad potential to treat certain cancers when used as monotherapy or in combination with other drugs.

Orphan Drug Pafuramidine for African Sleeping Sickness

On August 31, the FDA granted orphan drug designation to pafuramidine (Immtech Pharmaceuticals, Inc) for the treatment of human African trypanosomiasis (African sleeping sickness), a parasitic infection that is transmitted to humans by tsetse fly bite.

African sleeping sickness is found in sub-Saharan Africa, with an estimated 50,000 to 70,000 people currently infected. The parasites, which multiply in subcutaneous tissues, blood, and lymph, eventually cross the blood–brain barrier to infect the central nervous system and cause systems such as confusion, sensory disturbances, poor coordination, and disturbance of the sleep cycle. The disease is fatal in patients who do not receive treatment.

Pafurmidine is the first orally administered drug for African sleeping sickness and has a favorable toxicity profile, though it is effective only during the first stage of disease — a phase that may extend over a period of years without symptoms.

Orphan Drug Recombinant Parathyroid Hormone (Preos) for Hypoparathyroidism

On September 19, NPS Pharmaceuticals, Inc, announced FDA designation of parathyroid hormone (rDNA origin) for injection (Preos) as an orphan drug for the treatment of hypoparathyroidism, a rare deficiency of parathyroid hormone.

Hypoparathyroidism can be inherited or caused by injury to the parathyroid gland and is estimated to afflict 65,000 Americans. The parathyroid hormone deficiency compromises the proper absorption of calcium, which can lead to symptoms such as tetany, hair loss, dry skin, or malformed nails; unusual sensations around the mouth and fingers; and candidiasis. Left untreated, the condition may lead to complications, including breathing problems, cataracts, and muscle, ligament, and nervous system disorders.

Recombinant human parathyroid hormone has been approved in Europe under the brand name Preotact. There is currently no FDA-approved treatment for hypoparathyroidism.

Moderate Wine Consumption Improves Fasting Plasma Glucose Levels in Diabetics

September 21, 2007 (Amsterdam, the Netherlands) - A randomized trial conducted in diabetic teetotalers suggests that a glass of wine with dinner may improve glucose control, particularly in those with higher HbA1_c levels to begin with. The study, while small, adds to anecdotal evidence and meta-analyses that suggest wine, whose cardiovascular benefits have been widely touted, may hold specific benefits for diabetics.

Dr Iris Shai (Ben Gurion University, Beer-Sheva, Israel) presented the results of the study here at the European Association for the Study of Diabetes 2007 Meeting.

Shai noted that the proportion of alcohol abstainers is relatively high in Israel, where the study was conducted; however, the potential health benefits of moderate alcohol consumption persuaded 109 adults between the ages of 40 and 75 to participate. Indeed, dropouts during the three-month trial were higher among those randomized to the nonalcoholic diet malt beer than among those randomized to their choice of red or white wine, with many of the dropouts citing their disappointment over not being assigned to the alcohol group.

At the end of three months, 91 subjects remained in the study; those in the alcohol-intervention group experienced a statistically significant drop in fasting plasma glucose, from a mean of 139.6 mg/dL to 118 mg/dL. By contrast, subjects in the nonalcoholic-beer group experienced no real change in fasting plasma glucose.

Of note, alcohol consumption did not appear to affect two-hour postprandial glucose levels. Shai pointed out that ethanol metabolism is believed to inhibit gluconeogenesis, which could increase the risk of hypoglycemia. "Because of this, patients were guided to drink their beverage during dinner, which was a carbohydrate-based meal. But this process largely controls fasting, rather than postmeal, glycemia," she said, which might help explain the lack of an effect on two-hour postprandial glucose.

Better glucose, better sleep

Changes in fasting plasma glucose levels were particularly marked among patients who had higher baseline HbA1_c levels, Shai noted. Waist circumference and LDL levels were also reduced from baseline over the three-month period in the alcohol-intervention group, but no changes from baseline were seen in HDL levels. While "surprising," Shai suggested that the lack of effect on HDL might be due to the relatively short duration of the trial.

Prompting giggles in the audience, Shai said that despite a range of other parameters queried or measured in the trial, the only other significant difference between the two study groups was an improved ability to fall asleep, reported in the alcohol-intervention arm of the study.

Three months after the termination of the trial, 61% of the study subjects told investigators that they believed alcohol was likely beneficial and 49% were continuing to drink alcohol in moderation.

The complete contents of Heartwire, a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.

In-House Pioglitazone Studies Support Safety, Efficacy, Yet Epidemic Rages on

September 21, 2007 (Amsterdam, the Netherlands) - Pioglitazone (Actos) manufacturer Takeda is trumpeting the results of two in-house studies presented here at the European Association for the Study of Diabetes (EASD) 2007 Meeting, with plump press packages and a media event. But the studies themselves, both poster presentations at the meeting--should not be "overinterpreted," one outside expert told heartwire.

The first study, by Teresa McCall and colleagues--with McCall and two of five coauthors being Takeda employees--found that the starting dose of 30-mg pioglitazone in the Takeda-sponsored GLAI study was better than the starting dose of 4-mg rosiglitazone (Avandia, GlaxoSmithKline) in terms of controlling glucose levels and improving lipid profiles during the three-month run-in phase of the trial.

The second study, by Dr Yaping Xu (Takeda Pharmaceuticals) and colleagues, was a retrospective analysis of the US healthcare plan database i3 Innovus. Xu et al report that risk of stroke and MI were reduced in subjects taking pioglitazone as compared with patients taking other, nonthiazolidinedione diabetes drugs.

Taken together, the findings "reinforce the consistency of pioglitazone data and underscore that Actos has different effects from the other thiazolidinedione, rosiglitazone, due to differences in molecular structure," a Takeda press release proclaims.

But commenting on the results to heartwire, Dr Giatgen A Spinas (Universitatsspital, Zurich, Switzerland) expressed misgivings about even discussing the results, saying they did not constitute "new" news and that studies of this nature cannot be used to inform the choice of drug in diabetes care.

Lipid, glucose effects of starting doses: pioglitazone vs rosiglitazone

McCall et al's analysis included 369 diabetic patients with dyslipidemia randomized to pioglitazone and 366 randomized to rosiglitazone. While the primary end point of the GLAI trial was change in triglycerides at six months, the present analysis looked only at three-month outcomes, during which time patients had not yet been uptitrated to the full dose. At this point, pioglitazone produced significantly better effects on triglycerides, HDL, non-HDL-cholesterol, and HbA1_c levels than did rosiglitazone, the authors report, suggesting that "initial treatment" with the pioglitazone starting dose is more effective than the rosiglitazone starting dose.

Spinas, however, dismissed the analysis as data mining, emphasizing that the 4-mg dose of rosiglitazone was "not a good dose," since it is already well accepted that a 4-mg starting dose is not an effective dose. Most patients need to be uptitrated to the 8-mg dose to get the benefit of rosiglitazone, he said.

"You should compare pioglitazone 30 mg with rosiglitazone 8 mg, to be fair," he said. Of note, results for the second half of the GLAI trial, looking at the maintenance doses over an additional three months, were not included in the EASD poster. Looking only at the starting doses, "this is was what you would expect; this is not new," Spinas commented. "If you really use comparable doses of pioglitazone and rosiglitazone, the effect on glucose lowering is similar and the effect on lipids is more favorable for pioglitazone, but this is not new information. We knew already about the more favorable lipid effects from the GLAI trial."

Stroke, MI: Pioglitazone vs nonthiazolidinedione drugs

Xu et al's study looked only at patients taking pioglitazone or a nonthiazolidinedione drug, using pharmacy and medical claims in the i3 Innovus database. Among the more than 11 000 patients taking pioglitazone, the relative risks of stroke and MI were lower than that of the >55 000 patients taking other diabetes drugs, even after adjustment for age, gender, hypertension, hyperlipidemia, heart failure, edema, use of concurrent antidiabetic drugs, antiplatelet drugs, and lipid-lowering drugs.

We conclude that, in a clinical-practice setting, in patients with type 2 diabetes mellitus, therapies that include pioglitazone are associated with significant reductions in the risk for stroke or MI compared with nonthiazolidinedione therapies," the authors conclude.

But again, Spinas emphasized that Xu et al's results must be firmly kept in perspective. "This is just a retrospective look at data; it may give some hints but is not proof," he said. "This can only give some hints that maybe, maybe one drug is better. But really, one should not use retrospective studies to say this. This needs to be done in a setting where patients are enrolled in a randomized, controlled, prospective study designed for this purpose."

Prevention the best medicine

That said, Spinas echoed the prediction made by others in recent months that a large, randomized study comparing pioglitazone and rosiglitazone is unlikely. "To compare the two in terms of these kinds of cardiovascular end points, stroke and MI, would take years," he said. "And in a couple of years, these drugs will not seem as fancy as they do now."

Spinas also emphasized that all the current hullabaloo over the cardiovascular safety of the thiazolidinedione class of drugs flies in the face of the fact that, particularly for rosiglitazone, red flags were raised when the agents were first approved. "We knew from the outset that there might be problems with cardiovascular disease with these drugs. This was stated from the beginning, and doctors who knew about it were probably careful about this. So this is not such a big surprise."

He believes that all of the attention being paid to the glitazone drugs and to other up-and-coming agents is diverting attention from the main problem at hand: diabetes prevention. Indeed, for all the fuss in the media and even in the cardiology community over the rosiglitazone-pioglitazone controversy, these drugs took up minimal turf in the EASD program, a nod, perhaps, to the larger task at hand.

"Diabetes is increasing, so it's going to be a market for a long time, and companies are always watching out for possible indications," Spinas observed. "But I still think the best treatment for diabetes is prevention, and we should not be treating healthy people with harmful drugs. People like to take drugs and carry on with their unhealthy lifestyles, but this should not prevent governments and society from putting the emphasis on prevention very early. There are so many drugs on the market for diabetes, but the epidemic is still increasing, and the drugs aren't helping with that."

The complete contents of Heartwire, a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.

Bayer, Genzyme Get OK for Wider Leukemia Drug Use

FRANKFURT (Reuters) Sept 20 - The U.S. Food and Drug Administration (FDA) has approved the use of leukemia drug Campath to newly diagnosed patients, Bayer and Genzyme Corp said on Thursday.

The product is currently approved to treat B-cell chronic lymphocytic leukemia, or B-CLL, in patients who have failed two types of treatment.

"Campath is clearly an important single agent for the first-line treatment of CLL," said Peter Hillmen, lead investigator of the pivotal study comparing Campath against chlorambucil.

Gunnar Riemann, a board member of Bayer Schering Pharma, said the ability to use Campath earlier for patients would make an important difference in battling leukemia.

"It may help patients by offering a potentially more effective treatment approach that can extend progression-free survival," Riemann said.

According to the Leukemia and Lymphoma Society, about 15,000 new cases of B-CLL are diagnosed in the United States each year. It is the largest subset of chronic lymphocytic leukemia, the most common form of adult leukemia in the western world.

Campath is known outside the United States as MabCampath and is marketed by Germany's Bayer Schering Pharma AG. It is marketed in the United States by Bayer AG's U.S. affiliate, Bayer HealthCare Pharmaceuticals.

Genzyme makes the drug and Bayer markets it under a licensing agreement with Genzyme.

FDA Proposes CFCs Phase-Out in Epinephrine Inhalers

WASHINGTON (Reuters) Sept 20 - U.S. health officials Thursday proposed phasing out the use of chlorofluorocarbons (CFCs) in metered-dose asthma inhalers that contain epinephrine.

The Food and Drug Administration said it had tentatively concluded that there were no substantial technical barriers to making epinephrine inhalers that did not release CFCs, which are used as propellants but deplete the Earth's ozone layer.

Under the FDA proposal, epinephrine metered-dose inhalers that contain CFCs would be removed from the market by the end of 2010. The agency said it would accept comments on the plan for 60 days and hold a public meeting.

Epinephrine metered-dose inhalers, which are sold over the counter, are used for temporary relief of occasional symptoms of mild asthma. If companies do not develop CFC-free versions, patients would need to obtain a prescription-only alternative treatment, the FDA said.

The United States has generally banned CFCs in consumer products such as hair spray since 1978, but their use has been permitted in medical products when the FDA deems it essential.

Roche Says Viracept Licence in Europe Re-Instated

ZURICH (Reuters) Sept 20 - Swiss drugmakerRoche Holding AG said on Thursday a European medical committee had recommended the reinstatement of its HIV drug Viracept's marketing authorisation.

The positive recommendation from the European Medicines Agency's Committee for Human Medicinal Products (CHMP) will now go to the European Commission for a final decision, Roche said in a statement.

Roche said in June the licence was being temporarily suspended pending a review by authorities.

The European Commission then suspended Viracept's licence due to the contamination of certain lots with ethyl mesilate.

"Roche fully intends to re-supply Viracept (nelfinavir) once the suspension is lifted," the company said. "However, it may take a few months for Viracept to be available again to prescribers and patients."

EU Agency Backs Bayer's Nexavar for Liver Cancer

LONDON (Reuters) Sept 21 - The European Medicines Agency has recommended approval of Bayer and Onyx Pharmaceuticals' oral medication Nexavar (sorafenib) as a treatment for liver cancer, the agency said on Friday.

The drug is already approved in Europe and the United States for kidney cancer.

It became the first medication to extend the life of patients with advanced liver cancer in a large study -- adding about 3 months to survival compared with a placebo -- according to trial results released in June.

Recommendations for marketing approval by the European agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

Nexavar is also being tested against several other types of cancer, including non-small cell lung cancer and breast cancer.

The drug is being reviewed as a treatment for liver cancer in the United States.

EU Agency Backs Tasigna for CML and Galvus Combo for Diabetes

LONDON (Reuters) Sept 21 - Novartis AG's experimental leukaemia drug Tasigna -- a follow-up to Glivec/Gleevec -- has been recommended for approval in Europe for patients who no longer respond to Glivec.

Tasigna works in about half of those patients who develop resistance to Glivec, the market-leading drug for the most common type of chronic myeloid leukaemia, or CML.

Bristol-Myers Squibb's rival product, Sprycel, is designed to treat the same group of patients.

The European Medicines Agency also said on Friday it had backed a new product, called Eucreas, combining the Swiss group's Galvus (vildagliptin) with metformin as a treatment for diabetes. Eucreas will be the first single-tablet combination of a DPP-4 inhibitor drug and metformin in Europe.

Galvus itself won a positive recommendation in Europe in July and may be formally approved by European authorities later this month or in October.

Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

Galvus's path to market in the key U.S. market has been delayed by worries over skin toxicity.

Merck Halts Study of "Ineffective" HIV Vaccine

NEW YORK (Reuters) Sept 21 - Merck & Co has halted testing of its experimental HIV vaccine -- long considered one of the most promising vaccines in development -- after a monitoring board found it was ineffective, the company said on Friday.

The failed tests represent a major setback in the global effort to stem HIV infections. Merck had expressed great optimism for the vaccine, which it has been testing for a decade.

The independent Data Safety Monitoring Board, after reviewing interim results of the study of the vaccine, recommended discontinuing vaccinations of volunteers as the trial was headed for failure, Merck said.

"No one really knows when and if we will ever have an effective HIV vaccine because the virus is such a great challenge," Mark Feinberg, vice president of medical affairs at Merck's vaccine unit, said in an interview.

The vaccine consisted of a common cold virus expressing three HIV proteins.

Asked if Merck would attempt to develop other HIV vaccines in the wake of the failed trial, Keith Gottesdiener, another senior Merck research executive, said, "At this point, we can't give an answer; we're just starting to look at this data and all its implications."

The New Jersey-based company, which was developing the product in partnership with the federally funded HIV Vaccine Trials Network, said two other early-stage trials of the vaccine had also been discontinued.

Study investigators have been instructed to discontinue vaccinating volunteers and to monitor them, Merck said.

Merck's discontinued international trial, called STEP, involved 3,000 HIV-negative volunteers from diverse backgrounds, between the ages of 18 and 45, at high risk of HIV infection.

An interim efficacy analysis, involving about 1,500 volunteers expected to have the best response to the vaccine, showed it was ineffective.

One-Third of U.S. Lacked Health Insurance: Survey

WASHINGTON (Reuters) Sept 21 - More than one-third of the U.S. population under the age of 65 went without health insurance for all or part of the last two years, a consumer group said on Thursday.

The nonprofit Families USA group used data from last month's U.S. Census Bureau report that found 47 million Americans went without health insurance for all of 2006.

Families USA broke down that figure and calculated that 89.6 million people under age 65 -- 34.7 percent -- went without health insurance at some point during 2006-2007. It used a projection for the remaining months of this year.

After age 65, Americans become eligible for Medicare, the state-federal health insurance plan for the elderly.

"The huge number of people without health coverage over the past two years helps to explain why health care has become the top domestic issue in the 2008 presidential campaign," Ron Pollack, executive director of Families USA, said in a statement.

"The expansion of health coverage in America is no longer simply a matter of altruism about other people but a matter of intense self-interest."

In the United states, an employer generally supplies health insurance. But rising costs mean fewer employers are offering this benefit.

Budget crunches mean states have tightened eligibility for programs such as Medicaid, the public insurance plan for the poor and disabled, and for programs covering children.

Surveys also suggest that many of those going without insurance are middle-class and employed.

The Families USA report found that nearly two-thirds of people who lacked coverage at some point went uninsured for six months or more, and half went uninsured for nine months or more.

Texas had the most people without insurance -- 45.7 percent of the non-elderly population.

The report found that more than 79 percent of those without insurance were in families in which at least one person had a job, 70.6 percent were themselves employed full-time, and 8.7 percent were employed part-time.

"The number of uninsured has reached crisis proportions that must be addressed by the President and Congress to ensure that health coverage is available and affordable for all," Pollack said.

Health insurance is a major topic of the 2008 presidential election campaign, with virtually every candidate offering a plan. Various nonprofits, big employers, unions and other groups are also proposing plans to cover more people.

September 19, 2007

Researchers examine 'purging disorder'

DES MOINES, Iowa - An Iowa researcher is studying a little-known eating disorder that some doctors may miss: purging disorder. Though similar to women with bulimia, patients who fit this description don't binge-eat. Yet they feel compelled to purge, usually by vomiting, even after eating only a small or normal amount of food, said Pamela Keel, the University of Iowa researcher who led a study on the subject.

Keel, a psychology professor, and colleagues from Iowa and the Harvard Medical School describe their research in this month's issue of Archives of General Psychiatry.
"Purging disorder is new in the sense that it has not been officially recognized as a unique condition in the classification of eating disorders. But it's not a new problem," Keel said. "Women were struggling with purging disorder long before we began studying it."
If further study supports that it is a distinct disorder, Keel said the American Psychiatric Association could revise its criteria for diagnosing eating disorders. That's important because doctors could then better screen these patients and identify treatments for them. Otherwise, they might be missed because they are normal weight and don't report binge-eating, she said.
"The bottom line is there are women out there right now who have this condition, and very little is being done to figure out why they have this problem or how to help them with it," Keel said.
The study focused on women because they are about 10 times more likely than men to suffer from bulimia, in which people compulsively overeat and then force themselves to vomit, fast, take laxatives or exercise excessively to burn calories.
The dangers of purging disorder are similar to those of bulimia: psychological problems, dehydration, electrolyte imbalances that can affect the heart and kidneys, and potential dental problems because of self-induced vomiting.
Keel's research, conducted from 2001-05, was funded by the National Institute of Mental Health. The study looked at 90 women: 20 women had symptoms of purging disorder, 37 had bulimia and purged after binge-eating, and 33 had no eating disorders. Each woman was interviewed about her eating habits, drank a liquid meal and had blood drawn before and after the meal.
Keel said there were significant differences in the groups when it came to satiety, or feeling full.
In response to the liquid meal, women with purging disorder and those who had no eating disorder had similar levels of a chemical called cholecystokinin. It is released from the upper tract of the small intestine and appears to signal people to stop eating.
"That makes sense, because in terms of eating patterns, women with purging disorder are not actually eating more" than the women who had no eating disorder, Keel said. The bulimic women had lower levels of the chemical.
The women with purging disorder said they felt much more full after the test meal, and they reported more stomach discomfort than the bulimic women and the women with no eating disorders.
"It kind of begins to provide a clue for why these women may feel a need to purge after eating an amount of food that most people would be fine with. They are actually responding to it differently," Keel said.
The women with purging disorder and the bulimics shared emotional and psychological characteristics, including body image problems, anxiety and depression. Both groups also had strict rules about what they could eat and when, Keel said.
Keel "has helped put purging disorder on the map" as something that should be studied, said Dr. Tim Walsh, professor of psychiatry at Columbia University Medical Center.
Many people with eating disorders don't meet all of the criteria for anorexia or bulimia, "so it suggests that we need additional descriptions to help patients," he said. Walsh heads a work group with the American Psychiatric Association that is charged with revising criteria for diagnosing such disorders.
Leslie Sim, a psychology professor and consultant with the Mayo Clinic's eating disorders program, called Keel a "great researcher" in the field and said her findings were new and interesting.
Sim said current criteria "are kind of limiting for diagnosis and treatment and also for reimbursement by insurance companies."
Keel is recruiting subjects for another study, which she said will look more closely into factors that give rise to the unique response to eating by women who have purging disorder.
___
On the Net:
University of Iowa: http://www.uiowa.edu/
Mayo Clinic: http://www.mayoclinic.com/

Exercise on par with drugs for aiding depression

NEW YORK (Reuters Health) - Regular exercise may work as well as medication in improving symptoms of major depression, researchers have found.

Reuters Photo: A jogger runs past a work titled 'red box bush' by Australian artist Zoe Amor...

In a study of 202 depressed adults, investigators found that those who went through group-based exercise therapy did as well as those treated with an antidepressant drug. A third group that performed home-based exercise also improved, though to a lesser degree.
Importantly, the researchers found, all three groups did better than a fourth group given a placebo -- an inactive pill identical to the antidepressant.
While past studies have suggested that exercise can ease depression symptoms, a criticism has been that the research failed to compare exercise with a placebo. This leaves a question as to whether the therapy, per se, was responsible for the benefit.
The new findings bolster evidence that exercise does have a real effect on depression, according to the researchers.
Doctors may not start widely prescribing exercise as a depression treatment just yet. But for patients who are motivated to try exercise, it could be a reasonable option, the study authors say.
"If exercise were a drug, I'm not sure that it would receive FDA approval at this time," noted study author Dr. James A. Blumenthal, a professor of medical psychology at Duke University Medical Center in Durham, North Carolina.
"But," he told Reuters Health, "there is certainly growing evidence that exercise may be a viable alternative to medication, at least among those patients who are receptive to exercise as a potential treatment for their depression."
The study, published in the journal Psychosomatic Medicine, included 202 men and women age 40 and older who were diagnosed with major depression. They were randomly assigned to one of four groups: one that worked out in a supervised, group setting three times per week; one that exercised at home; one that took the antidepressant sertraline (Zoloft); and one that took placebo pills.
After 16 weeks, the patients completed standard measures of depression symptoms.
By the end of the study, Blumenthal's team found, 47 percent of patients on the antidepressant no longer met the criteria for major depression. The same was true of 45 percent of those in the supervised exercise group.
In the home-based exercise group, 40 percent had their symptoms go into remission. That compared with 31 percent of the placebo group.
There are several theories on why exercise might improve depression. For example, physical activity seems to affect some key nervous system chemicals -- norepinephrine and serotonin -- that are targets of antidepressant drugs, as well as brain neurotrophins, which help protect nerve cells from injury and transmit signals in brain regions related to mood.
Exercise may also boost people's feelings of self-efficacy and promote positive thinking. Some experts speculate that group exercise, with its social aspect, may have added benefits.
Though the home exercise group in this study did better than the placebo group, it's not clear whether it's as good as supervised classes, according to Blumenthal. "Home exercise may be more convenient," he noted, "but patients not push themselves as hard on their own."
He added that supervised exercise may also be safer for some people, such as those with heart disease.
SOURCE: Psychosomatic Medicine, September 2007.

County resident with WNV advises caution

For the Sun-News

When George, a 73-year-old resident of Doña Ana County, began to feel sick in late August, he attributed his slight fever and lower energy to allergies. When his fever rose to more than 104 degrees, he knew it was more severe than an allergic reaction.
Within days after visiting his doctor, George was diagnosed with West Nile virus, which led to viral meningitis. For seven days, he was hospitalized in Texas, often experiencing severe shakes and a fever so extreme doctors used a combination of IV fluids, antibiotics and ice packs on both sides of his ribs to keep him cool. George wants to maintain his anonymity by not releasing his last name, but does want to share his experience so others will take the disease more seriously.
"I was not doing anything to protect myself because normally I don't get bitten by mosquitoes at all," George said. "The one that did bite me had West Nile and now I'm lucky to be alive. I take those precautions very seriously now and I would advise everyone else in the county to follow them closely."

Paul Ettestad, state public health veterinarian for the New Mexico Department of Health, said Doña Ana County is having a high incidence of West Nile virus activity in mosquito pools that are being tested. In August, 20 out of 26 mosquito pools from Doña Ana County tested positive. Every pool from Las Cruces was positive and seven out of eight pools tested in Mesilla were positive.

"With this high number of positive mosquitoes, people need to avoid getting bit by even one mosquito," Ettestad said.
Of the 27 human cases of West Nile Virus, Doña Ana County has had eight, the most in the state. One of the two fatalities was in Doña Ana County.
The Department of Health recommends the following steps to reduce the risk of infection from West Nile virus:

Wear long-sleeved shirts, long pants and socks whenever you are outdoors.
Products containing DEET or Picaridin can provide longer-lasting protection. Use insect repellent products with no more than 35 percent DEET for adults and follow the directions on the label for children from ages 2 to 12. Natural products containing soybean oil or lemon eucalyptus oil have also been shown to be effective but need to be applied more often.
Keep windows and doors closed if not screened. If you leave your doors or windows open, make sure they have screens that fit tightly and have no holes.
Do not allow water to stagnate in old tires, flowerpots, trash containers, swimming pools, birdbaths, pet bowls, etc.
Horse owners should contact their veterinarian to have their horses vaccinated against West Nile virus.

Insect repellents should never be used on pets, according to the National Animal Poison Control Center, which is part of the University of Illinois College of Veterinary Medicine. Dogs and cats tend to lick themselves and can ingest toxins, which could harm them significantly more than the West Nile virus. So far both dogs and cats have been fairly resistant to the virus.
The other West Nile virus death was in McKinley County. The other 27 human cases are from: San Juan County (5), Bernalillo County (4), Chaves County (3), Grant County (1), Sierra County (1), Roosevelt County (1), Curry County (1), Socorro County (1) Rio Arriba County (1), and McKinley County (1). There has also been West Nile in horses and mosquitoes throughout the state.

West Nile virus can cause an illness with flu-like symptoms such as fever, nausea, headache and muscle aches, and it can also cause more severe illnesses such as meningitis and encephalitis. People older than 50 are at the highest risk for serious complications from West Nile Virus.
Chris J. Minnick works for the New Mexico Department of Health and writes a weekly column for Healthy Living. He can be reached at christopher.minnick@state.nm.us.

FDA Set to Get Broad New Powers

Congress is on the verge of sending President Bush the largest expansion of Food and Drug Administration regulatory powers in a decade, seeking to bolster the monitoring of prescription drugs and medical devices.
Democratic and Republican members of the House Energy and Commerce Committee lauded a compromise reached Wednesday after weeks of negotiations.
“This legislation strikes the proper balance between new drug-safety measures and ensuring consumers have access to innovative prescription pharmaceuticals in a timely manner,” said Energy and Commerce Chairman John D. Dingell, D-Mich., the bill’s primary House author.
The bill marks a success for the Democratic majority. It also would expand labeling, tighten the regulation of drug advertising and give consumers access to information on clinical trials of drugs and medical devices.
The House passed the legislation (HR 3580) by 405-7 under suspension of the rules Wednesday, setting up final action by the Senate to clear the compromise bill. No amendments were permitted under the House’s fast-track procedure, which required a two-thirds majority.
Senate Majority Leader Harry Reid, D-Nev., was checking with senators to determine whether he could clear the legislation on a voice vote this week, Reid’s spokesman said Wednesday evening.
User fees paid by pharmaceutical manufacturers and medical device makers finance FDA reviews of applications to market new products. Unless those fees are reauthorized by Sept. 30, the agency would have to lay off some 2,000 employees. Lawmakers had vowed to complete work on the reauthorization by Sept. 21.
Frank Pallone Jr., D-N.J., chairman of Energy and Commerce’s Health Subcommittee, acknowledged that the bill was not everything the Senate wanted, but he still expected the chamber to clear it.
“I’m not going to say they signed off on it,” Pallone said. But he added, “I’m expecting them to take it up the way it is.”
However, Reid’s attempt to clear the measure by voice vote Wednesday night was blocked by several Republicans who wanted more time to study the 422-page bill, according to a GOP aide.
“It seems a number of senators are objecting because they’re upset that leadership is trying to secretly ram through a Pelosi bill over 400 pages long that no one has even read,” said the aide, referring to House Speaker Nancy Pelosi, D-Calif.
Even the bill’s strongest advocates in the Senate were not entirely happy. “This is not a perfect bill, and compromises were made to assure its passage,” said Edward M. Kennedy, D-Mass. He added: “But after so many recent instances in which Americans have been harmed by unsafe prescription drugs and contaminated food, America cannot afford inaction on this important measure.”
The cornerstone of the package is a reauthorization of the FDA’s drug-approval program, funded by nearly $400 million in drug and device company user fees that finance FDA reviews of applications to market new products.
House and Senate negotiators wrote the legislation from bills (HR 2900, S 1082) the chambers passed earlier in the summer. The drug-safety provisions in the original House bill were considered more far-reaching than those in the Senate measure. The new bill was built on several compromises between the House and Senate versions.
Many of the bill’s drug-safety regulations grew out of problems discovered in widely prescribed drugs that had been approved by the FDA and were marketed to millions of Americans.
One such case involved the arthritis drug Vioxx, which was shown to increase cardiovascular risk and is the subject of hundreds of lawsuits throughout the country.

Major Provisions

Under the compromise, drug companies would pay a new user fee totalling some $225 million over five years that would fund FDA drug-safety activities. The agency could force drug manufacturers to conduct follow-up safety studies after a drug has been approved. The agency would also have the authority to require changes to drug labelling and levy fines for non-compliance.
Direct-to-consumer ads, such as the ubiquitous television commercials for certain drugs, would be more strictly regulated by the FDA. The agency would be able to review drug ads and fine companies for false or misleading ads, but it would not be able to ban them, even temporarily.
The bill discards the idea of a specific limit on the number of waivers allowed for FDA advisory panel members with financial conflicts of interest. Advisory panels, made up of academic researchers and other experts, offer influential guidance to the agency on whether a new drug appears to be both safe and effective enough to warrant approval. Instead, using 2007 as a baseline, the measure would reduce by 25 percent the allowable number of conflicts of interest, which can arise if a panel member has conducted research with grants from a drug company whose product is under review.
House Democrats originally pushed for a limit of one waiver per panel. The Senate bill would have largely preserved current law, which does not put a limit on waivers.
House Democrats also won inclusion of a provision sought by Henry A. Waxman, D-Calif., that would create a public, searchable database of clinical trials for drugs and medical devices. It would include information on safety risks and would be administered by the National Institutes of Health.
Drugmakers that conduct studies on new pediatric uses of drugs would be granted six months of market exclusivity. In the Senate version, so-called blockbuster drugs would have been given only three months of exclusivity.
The final version did not please all Democrats.
“I want to express my deep disappointment that today we’re walking away from our opportunity to adjust the windfall profits that drug companies receive from conducting pediatric studies,” Waxman said.
He said the large profits that drugmakers reap far outweighed the expense of conducting new studies.
First posted Sept. 19, 2007 4:46 p.m.Source: CQ Today

CDC Touts Ample Supply of Flu Vaccine

WASHINGTON (AP) — Come one, come all: After years of shortages and confusion, this fall promises plenty of flu vaccine to go around — up to 132 million doses, more than the nation has ever produced.
The ample supplies have the government urging vaccinations not just for people at highest risk of dying from influenza, but for anyone who wants to avoid a week of aching misery.
"Flu is a formidable foe," Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention, said Wednesday. "It is not an illness we should be complacent about."
But new CDC data show only a fraction of people who need flu shots the most get them, including just one in five babies and toddlers. And there's wide geographic variation, with Rhode Island reporting the most high-risk adults vaccinated and Nevada the fewest.
Shots aren't the only option. Wednesday, the government ruled that it's safe for younger kids than ever before to try a nasal-spray vaccine called FluMist. Once only an option for people ages 5 to 49, FluMist now can be used by children as young as 2.
Flu usually peaks in February, so a winter vaccination isn't too late. Still, Gerberding advised seeking vaccine early in case flu begins striking before the usual November.
Indeed, there already are reports of sick schoolchildren in Hawaii, although the geographic distance makes it impossible to predict if that signals an unusually early flu season for the rest of the country.
Perhaps of more concern, CDC is closely monitoring whether a new strain that emerged near the end of Australia's flu season will cause illness here — a strain that this year's vaccine doesn't specifically target.
Each year's vaccine contains protection against three influenza strains — two Type A strains, an H1N1 and an H3N2 version, plus a milder Type B — that experts predict will cause the most illness. The vaccine isn't always a perfect match, and this year's contains a different H3N2 version than the newly emerging one, nicknamed H3N2/Brisbane-like.
Get vaccinated anyway, Gerberding stressed. The other two strains in the vaccine are causing illness around the world, and even if the newer one travels here, too, the vaccine should provide some cross-protection.
Every year, flu infects up to 20 percent of the population, causes the hospitalization of 200,000 people and kills 36,000.
Who's at highest risk? Anyone over 50 or under 5; people of any age who have asthma, heart disease, weakened immune systems or other chronic illnesses; and pregnant women.
Vaccine also is particularly recommended for relatives and caregivers of those people, and health care workers — people who may be robust enough to recover themselves, but could infect the more vulnerable before they realize they're ill.
"The day before you become sick, you're already excreting the virus," warned Dr. William Schaffner of Vanderbilt University, vice president of the National Foundation for Infectious Diseases.
That equals 218 million people who should be vaccinated each year. Nowhere near that many seek vaccine. Last year, about 18 million of the nearly 121 million doses produced weren't used and had to be thrown away.
But the CDC's new estimates of how many high-risk patients get vaccinated, gleaned from public-health surveys, shed new light on the most troubling gaps.
People 65 and older are most likely to get vaccinated, 69 percent during the 2005-2006 flu season, the latest count available.
But that's still well under the national goal of vaccinating 90 percent of seniors — even though Medicare provides them flu shots for free.
Just over a third of 50- to 64-year-olds are getting vaccinated, and just 30 percent of high-risk younger adults, CDC found.
Flu vaccine is a little more complicated for young children, because they need two doses a month apart the very first year they're inoculated. Just 21 percent of youngsters ages 6 months to 2 years were fully vaccinated, and just over one in 10 who needed two doses got both, CDC reported.
If a young child missed that necessary second dose last year, health officials are recommending that he or she make it up this year with two shots.
On the Net:CDC: http://www.cdc.gov/flu
National Foundation for Infectious Diseases: http://www.nfid.org

September 18, 2007

Fracture care overhaul demanded

The care of people who suffer fractures needs overhauling with the introduction of national screening, experts say.
Doctors said everyone over 50 in the UK who has a fracture after a minor fall should have their bone density tested to see if they have osteoporosis.

The British Orthopaedic Association and the British Geriatrics Society said such a measure would help prevent future fractures, saving the NHS money.
The government said it was investing more in fracture care.
Half of women and a fifth of men have fractures after the age of 50, but the two groups said services were still a lottery.
They said just a third of patients over the age of 65 have DXA scans, a test which measures bone density.

Hip fractures are the most serious and complex ones to treat, costing the NHS and social service £20,000 per patient on average.
Some 75,000 people in the UK suffer hip fractures each year - and these are set to double by 2050 with the ageing population, doctors said.
But evidence shows many of these people will have already had other fractures, normally wrists or knees.
The two groups said if patients were regularly tested for osteoporosis their risk of future fractures could be halved with drug treatments.
Professor David Marsh, of the British Orthopaedic Association, said: "The vast majority of people are not being assessed and that is not fair on patients or efficient for the health service.
"We know the drugs which are available can help reduce the risk of future fractures, so we should be using them."
The groups have also called for faster access to surgery following fractures and better auditing of cases and treatments through a national database so performance can be monitored more closely.

'Extra investment'

Pamela Holmes, of Help the Aged, agreed with the call for change.
"When an older person breaks a bone and is admitted to hospital for treatment, it makes absolute sense that they should be tested for osteoporosis.
"It's quite extraordinary that it doesn't already happen."
But Professor Ian Philp, the government's older people's tsar, said steps had already been made to improve care.
"Thanks to recent extra investment in falls and bone health services, we have seen better access to screening for those at risk and faster treatment."
And he added auditing of care had taken place last year and was due to be repeated to keep track of progress and identify where more investment was needed.
And on screening those over 50, he said it would be up to the clinical judgement of doctors.
It comes as research in the New England Journal of Medicine found that a once-a-year drug, Aclasta, cuts the number of deaths among patients with fractures caused by osteoporosis.
Previous studies have also said it reduces the risk of bone fractures.
The drug is expected to receive its licence for use in the UK before the end of the year.

Surgery Without Scars? "Natural Orifice" Surgery Called "Next Greatest Surgical Evolution"

"Natural orifice transluminal endoscopic surgery" eliminates big incisions -- and surgical scars -- and speeds recovery after surgery. (CBS)

(WebMD) French doctors who report removing a woman's gallbladder through her vagina say such "no-scar surgery" may be the wave of the future.
At least two U.S. women -- one at New York Presbyterian Hospital and another at the University of California San Diego Medical Center -- have undergone similar surgeries.
Doctors who advocate the technique call it "natural orifice transluminal endoscopic surgery" or NOTES. "Natural orifice" here means the vagina, the anus, or the mouth. "Transluminal" means surgeons insert surgical tools (endoscopic tools) through the body's natural openings. And the "surgery" part means doctors still have to cut through to the inside of the body and to operate on diseased organs.
The idea is to eliminate big incisions -- and surgical scars -- and to speed recovery after surgery.
Jacques Marescaux, M.D., and colleagues at Louis Pasteur University in Strasbourg, France, appear to have been the first to perform NOTES surgery without backup from the laparoscopic instruments used for conventional minimally invasive surgery.
"With its invisible mending and tremendous potential for improving patient care and well-being, NOTES might represent the next greatest surgical evolution," Marescaux and colleagues suggest.
The surgeons report details of the operation in the September issue of Archives of Surgery.
Fast Recovery After Natural Orifice Surgery
Marescaux and colleagues performed the NOTES gallbladder removal on a 30-year-old woman with gallstones. The surgeons used endoscopic tools inserted through the woman's vagina during general anesthesia.
To reach the gallbladder, the surgeons made a small incision at the rear of the woman's vagina. The only external incision was a tiny cut in the woman's abdomen to insert a needle scope (the cut was also used to inflate the abdominal cavity with gas and to aid in removal of the gallbladder).
The gallbladder was removed through the vagina.
On the evening after surgery, the woman felt well enough to go home.
Because she was their first NOTES patient, her doctors kept her overnight and she left the hospital the next morning. Ten days later, the woman had resumed full activity with no discomfort, discharge, or bleeding.
Doctors developing the NOTES technique say similar operations could be done by mouth. However, this would mean making a cut in the stomach or gut to get to internal organs. Research continues on the best way to make sure these cuts can be closed without risk of leakage.
A group of surgeons has formed the Natural Orifice Surgery Consortium for Assessment and Research -- NOSCAR -- to promote NOTES research and responsible use of the technique. The group hopes to develop better techniques and better medical tools for NOTES surgeries.
NOTES Vs. Laparoscopy
The NOSCAR group obviously is promoting the "no scar" aspect of NOTES. But current minimally invasive laparoscopic surgical techniques already leave no lasting scar, says John G. Hunter, M.D., professor and chairman of surgery at Oregon Health & Science University in Portland.
"Having had laparoscopic surgery myself, and as a laparoscopic surgeon, I can tell you there are no scars within six months to a year of the operation," Hunter tells WebMD. "To suggest laparoscopy is scarring and NOTES isn't is not accurate."
Hunter also questions whether recovery time is truly longer with minimally invasive surgery than for NOTES.
Hunter's editorial comments accompany the Marescaux report in the Archives of Surgery.
"The benefits of NOTES are not earthshaking and the risks are real," he writes. "Marescaux and colleagues. You have (again) put man on the moon. Now we need to figure out if there is any reason to populate this new plane."
Hunter is all too aware of how this makes him sound. As a young surgeon advocating minimally invasive surgery, he remembers being told by older surgeons that he was wasting his time.
"They said laparoscopy would never fly -- and they were completely wrong," he remembers.
While Hunter doesn't think that NOTES will end up being the best way to perform gallbladder operations, he does see ways the technique could, in the future, improve a number of surgical procedures.
"There is a lot of great opportunity here," he says. "I don't see NOTES as revolutionary. It might be incrementally better for some things. It is evolution rather than revolution at this point."

Studies: TB Can Be Treated in Few Months

CHICAGO (AP) — New research gives hope for successfully treating tuberculosis in a few months rather than the six months or more currently needed to beat the contagious lung disease, doctors reported Tuesday.
Adding the antibiotic moxifloxacin to the usual TB drugs shortened the time to cure to an estimated four months in a study in Brazil, Johns Hopkins University scientists reported at an American Society for Microbiology conference in Chicago.
A second study by Hopkins researchers cured mice of TB in 10 weeks instead of the usual six months with moxifloxacin plus the TB drug rifapentine at higher doses.
"It sounds fantastic," said Dr. Melvin Spigelman, research and development director for the nonprofit Global Alliance for TB Drug Development in New York. "The science is there" and just needs to be verified in larger studies, he said.
The group will launch a 2,400-patient study later this year.
Also on Tuesday, the Seattle-based Bill & Melinda Gates Foundation announced its largest grants ever to fight TB — $280 million for research on vaccines, diagnostics and drugs.
"If everything goes well, it should be feasible to shorten treatment time," possibly even to ultra-short regimens of two weeks to a month, said Ken Duncan, the foundation's program director.
More than 8 million people worldwide develop TB each year, and nearly 2 million die of it. The disease is mostly a problem in poor countries, but the recent case of Andrew Speaker, an Atlanta attorney who created an international health scare by traveling while he had a multidrug-resistant strain of TB, shows the danger in the United States as well.
Recently, a Mexican teenager was jailed in Georgia and threatened with deportation after refusing to take his recommended nine months of TB treatment.
On Tuesday, a man with a multiple drug-resistant form who had been detained after walking in public without a mask was returned to Arizona after doctors treating him in Colorado said he was no longer infectious.
Treatment now consists of three or four antibiotics taken daily for six months or more. But half of patients do not take all their pills, allowing resistant bacteria to grow and spread, said Dr. Jacques Grosset, the Hopkins researcher who led the study of several hundred mice.
The Brazil study involved about 170 men and women in Rio de Janeiro who had active TB. All were given three standard anti-TB drugs plus either moxifloxacin or an older drug, ethambutol.
After two months, 85 percent of those on moxifloxacin tested negative for the infection compared to 68 percent on ethambutol. The treatment advantage showed up in as little as two weeks.
"Based on what we know, if you get that big a difference at two months, you should be able to shorten the duration of treatment ... down to four," said Dr. Richard Chaisson, director of TB research at Hopkins.
In a third study of about 400 TB patients throughout Africa, 60 percent who received moxifloxacin plus three other drugs tested negative for TB at two months versus 55 percent given isoniazid and the other medications.
The federal government paid for the studies, and Bayer Healthcare AG donated moxifloxacin, which it sells as Avelox in the United States for short-term use against pneumonia and other respiratory illnesses. The pill costs $10 a day, but researchers said Bayer has promised to make it available in poor countries for less if it is approved to treat TB.
On the Net:
Microbiology conference: http://www.icaac.org
Gates foundation: http://www.gatesfoundation.org

Hand Washing Frequency Dips in U.S

Only 77% Lather Up in Public Restrooms, a 6% Decline From 2005.

Sept. 17, 2007 (Chicago) -- Are we becoming a nation of dirty liars?
Researchers who discretely observed men and women in public restrooms found that only 77% washed their hands with soap and water -- a 6% decline from 2005.
But not many people are admitting to slipping up: In a separate telephone survey, 92% of Americans claimed they always lather up in public restrooms.
The findings were reported at a meeting of the American Society for Microbiology (ASM).Men Blamed for Slipup
The blame lies squarely with the men, says Brian Sansoni, a spokesman at the Soap and Detergent Association, which cosponsored the survey with the ASM.
The percentage of men observed washing their hands fell from 75% in 2005 to 66% in 2007. In contrast, hygiene habits basically stalled among women: 90% washed up in 2005, compared with 88% in 2007.
Why Americans are more complacent than in the past “is the million dollar question,” Sansoni tells WebMD. “But Americans, especially guys, need to step up to the sink.”
(Do you always wash your hands before leaving the restroom? Why or why not? Fess up on WebMD's Health Café message board.) Chicago: The Cleanest City
For the observational study, the researchers monitored the hand washing habits of 6,076 adults at six public bathrooms in four major cities from Aug. 17 to Aug. 25 of this year. The sites were the same as in the 2005 survey: Atlanta's Turner Field, Chicago's Museum of Science and Industry and the Shedd Aquarium, New York's Penn and Grand Central train stations, and San Francisco's Ferry Terminal Farmers Market.
Among the findings:

Chicagoans appeared to have the best hand hygiene: 81% of men and women lathered up. New York followed, with 79% washing up, followed by Atlanta (75%) and San Francisco (73%).
Male sports fans have some of the dirtiest hands: Only 57% were observed washing their hands at Turner Field in Atlanta, the lowest figure at any locales.
On the other hand, women hit a home run at the home of the Braves: 95% were observed cleaning their hands -- the highest figure at any locale.

Telephone Survey Paints a Different Picture
For the telephone survey, 1,001 men and women were asked about their hand washing habits both in public restrooms and at home.
Among those findings:

86% said they always wash up after using the bathroom at home. In 2005, that figure stood at 83%.
Nearly 3/4 (73%) said they always wash their hands after changing a diaper -- the same as two years ago. Seventy-eight percent say they always wash before handling or eating food, compared with 77% in 2005.
Only 1/3 (34%) of respondents said they always wash their hands after coughing or sneezing, a slight improvement from the 32% in 2005.

Hand Sanitizers Can Also Kill Germs
“Hand washing is the single most important thing we can all do to keep from spreading bugs,” says Judy A. Daly, PhD, an ASM spokeswoman and director of the microbiology laboratories at the Primary Children’s Medical Center in Salt Lake City.
“It can work miracles at preventing colds, the flu, and other infectious diseases,” she tells WebMD.
For the new study, the researchers made sure that public bathrooms were well stocked with soap, running water, and towels.
So what do you do if the next restroom you hit doesn’t meet these standards? Reach for the hand sanitizer or hand wipes, Daly advises.

Gates Foundation hands out $280 million to fight tuberculosis

By TOM PAULSONP-I REPORTER
The war against tuberculosis, a disease that continues to spread worldwide and increased 16 percent in the Seattle area in the past year, is being fought with medical weaponry about a century old.
So, the Bill & Melinda Gates Foundation on Tuesday announced $280 million in grants to develop better TB vaccines, drugs and diagnostics to fight a disease that infects one of every three people on the planet and is becoming increasingly resistant to drugs.
"The TB vaccine is 80 years old and rarely effective after childhood," said Dr. Tachi Yamada, director of global health for the Gates Foundation.
Standard TB drug regimens are similarly archaic, cumbersome to use, and increasingly ineffective, he said.
Meanwhile, the disease is killing 2 million people a year.
The Seattle philanthropy, which has made global health its primary mission, awarded 11 grants to nearly a dozen organizations -- including $7.4 million to Seattle Biomedical Research Institute to explore one of the most fundamental mysteries of TB.
"Nobody knows why it usually takes six months or so to treat tuberculosis," said Dr. David Sherman, a TB researcher at Seattle Biomedical with a joint appointment at the University of Washington.
Today's drug treatments require keeping TB-infected people on antibiotic drugs for many months, Sherman said. Often, patients stop taking the drugs too early, so the treatment often fails. The disease rebounds and this sometimes leads to drug-resistant strains of TB. Sherman said the Gates grant would support his lab digging deeper into the basic biology of these bacteria in the hope that this may lead to simpler, faster and more effective drugs.
"We hope to translate promising ideas into tools that can save millions of lives," Yamada said.
The bulk of the Gates grants -- $200 million -- will go to an organization working on developing new TB vaccines, Yamada said.
"A preventive vaccine is absolutely necessary," said Dr. Jerald Sadoff, president and chief executive officer of Aeras Global TB Vaccine Foundation.
The non-profit organization, based in Rockville, Md., has been working on new TB vaccines since 1997. Sadoff said the Gates grant would allow them to bring six experimental vaccines into early stage clinical testing.
Another $62 million from the Gates Foundation announcement Tuesday goes to research and development aimed at finding better TB tests or diagnostics. A Geneva-based organization, the Foundation for Innovative New Diagnostics, will spearhead that effort.
Yamada said this package of grants represents the philanthropy's single largest package of grants for TB research. The remaining $18 million for drug discovery, he said, is smaller because these grants represent initial investments in fundamental science.
Besides the $7.4 million to Seattle Biomedical, the Gates Foundation awarded eight other "drug discovery" grants to Johns Hopkins University, Colorado State University, Weill Cornell Medical College, Ordway Research Institute, Northeastern University and Ecole Polytechnique Federale de Lausanne in Switzerland.
"I've never been so optimistic as I am now that we are going to finally make progress against this disease," Sherman said.
About one in seven of the new TB cases reported in the Seattle area last year were resistant to at least one drug, according to officials with Public Health -- Seattle & King County. Many people who are infected with TB don't know it and won't show symptoms for many years, health officials say.
P-I reporter Tom Paulson can be reached at 206-448-8318 or tompaulson@seattlepi.com.

Merck Sued for Medicaid Fraud

NEW YORK (AP) — The state and city sued Merck & Co. Inc. on Monday, accusing the drugmaker of defrauding Medicaid and other government insurance programs by hiding the risks of heart problems associated with its pain medication Vioxx.
The lawsuit, filed in Manhattan's state Supreme Court, said the state's Medicaid and Elderly Pharmaceutical Insurance Coverage programs have paid more than $100 million for Vioxx prescriptions since the drug went on sale in 1999.
For its residents receiving Medicaid assistance, New York City paid a substantial share of those costs.
The lawsuit says tens of millions of dollars were paid for prescriptions for patients with preexisting heart conditions. Those funds would not have been spent had the risks associated with Vioxx been known, court papers say.
The filing was announced by New York state Attorney General Andrew M. Cuomo and New York City Mayor Michael Bloomberg.
Merck, based in Whitehouse Station, N.J., removed Vioxx from the market in Sept. 30, 2004 because it doubled risk of heart attack and stroke.
Before stopping Vioxx sales, court papers say, Merck "undertook a concerted and tenacious campaign of false and fraudulent statements to minimize the import and seriousness" of the possible association between Vioxx and heart problems.
This "disinformation campaign" continued until a month before Merck ceased sales of the drug, causing New York doctors to continue writing prescriptions for Vioxx that they otherwise would not have written, according to the lawsuit.
Merck spokesman Kent Jarrell said the company researched and monitored the drug while it was on the market and voluntarily withdrew it when problems were suspected.
"We are confident that our behavior has been responsible," Jarrell said, adding that similar lawsuits seeking reimbursement for insurance costs have been filed in "a handful" of other states.
The lawsuit asks that Merck be ordered to pay New York City and the state three times their damages, to be determined at trial. It also asks that Merck be required to pay the state a civil penalty of $12,000 for each false claim, and $15,000 to the city for each such violation. The number of false claims would be determined at trial.
Merck, based in Whitehouse Station, N.J., faces almost 27,000 lawsuits from people claiming Vioxx caused heart attacks and strokes, but more than 1,170 cases have been dismissed. Of cases that have reached verdicts, Merck has won nine and lost five; a new trial was ordered in another case.
Merck shares fell 13 cents to $49.41 Monday.

Low dose bird flu shot promises pandemic protection

18/09/2007 - A new H5N1 pandemic flu vaccine developed by Sanofi Pasteur could make all the difference in pandemic stockpiling, the new super low dose shot stimulating high immune response in trial subjects.
Sanofi Pasteur''s formulation, which could have less than one tenth of the antigen content found in traditional seasonal flu vaccines, could have prove a real help in terms of dose-sparing and stockpiling strategies in the face of a pandemic threat.
The company used a proprietary novel adjuvant to enhance the immune response to its investigational H5N1 pandemic flu vaccine, which significantly reduced the amount of antigen required in each dose while still stimulating a good response in patients.
Vaccine containing only 1.9ug of antigen stimulated a "high level" of seroprotective immune response in over 70 per cent of the adults on the trial, with a higher dose of 3.75ug generating a high immune response in over 80 per cent of trial subjects.
This is particularly noteworthy when one considers the fact that traditional seasonal flu vaccines (which admittedly comprise three virus strains) contain nearer 45ug of antigen.
Sanofi has used its proprietary emulsion-based adjuvant to boost the immune response of patients treated with the vaccine, which has allowed the vast reduction in antigen content in each dose of vaccine.
The adjuvant was developed by Sanofi in-house specifically for the pandemic and pre-pandemic setting, according to a spokesperson for the company. Although it could feasibly be applied to other vaccine products, the priority for now is to develop a vaccine for pandemic stockpiling, in-PharmaTechnologist.com was told.
Subjects in the vaccine trial received two doses of vaccine, with four levels of antigen dose tested in all. As well as the enhanced immune response, Sanofi also reported that preliminary data showed good cross-reactivity to a more recently circulating H5N1 strain, with assessment of this feature of the vaccine currently ongoing.
Sanofi Pasteur is the current global leader in vaccine manufacturing capacity, in 2006 producing 170 million doses of seasonal flu vaccine - over 40 per cent of global capacity.
However, with the vastly reduced antigen content of the adjuvanted H5N1 vaccine, Sanofi believes that it has the potential to provide "billions" of doses of vaccine from its manufacturing sites in Pennsylvania in the US and Val de Reuil in France where the vaccine will be manufactured.
Sanofi is hailing the investigational vaccine as "a significant achievement for public health and a breakthrough in research and development of pre-pandemic and pandemic vaccines," and is keen to move on with development following the successful trial results.
"Having now demonstrated the potency of the adjuvant, we take that as the green light to continue development of the vaccine," a spokesperson for the company said.
The results announced today followed completion of Phase Ib trials, with clinical trials in the US planned for early next year, along with an expanded EU trial.
As to when the vaccine might eventually make it to market, Sanofi is reluctant to pin down a solid time frame.
"Obviously the objective is to develop the vaccine as quickly as possible," a spokesperson for the company said.
"But we should use the time while we are not in a pandemic situation to fully develop the vaccine. Plans could always be accelerated according to government requirements."

E. Coli Fears Spark Bagged Salad Recall

SAN FRANCISCO (AP) — A package of Dole salad mix that tested positive for E. coli has triggered a recall in at least nine states, prompting new produce fears almost exactly a year after a nationwide spinach scare.
The tainted bag of Dole's Hearts Delight salad mix was sold at a store in Canada, officials said. Neither Canadian health officials nor Dole Food Co. have received reports of anyone getting sick from the product.
The voluntary recall, issued Monday, affects all packages of Hearts Delight sold in the United States and Canada with a "best if used by" date of September 19, 2007, and a production code of "A24924A" or "A24924B," the company said.
Last year, an E. coli outbreak traced to bagged baby spinach sold under the Dole brand was blamed for the deaths of three people and for sickening hundreds more across the U.S. Authorities eventually identified a central California cattle ranch next to spinach fields belonging to one of Dole's suppliers as being the source of the bacteria.
A recent Associated Press investigation found that government regulators never acted on calls for stepped-up inspections of leafy greens after that outbreak, and regulations governing farms in the fertile central California region known as the nation's "Salad Bowl" remain much as they were.
The latest recall affects packages sold in Ontario, Quebec and the Maritime Provinces in Canada and in Illinois, Indiana, Maine, Michigan, Mississippi, New York, Ohio, Pennsylvania and Tennessee starting around Sept. 8, said Marty Ordman, a Dole spokesman.
Eighty-eight cases — or 528 bags — were distributed in Canada, and 755 cases containing 4,530 bags were distributed in the U.S., he said. FDA spokesman Michael Herndon said the agency was talking with Westlake Village, Calif.-based Dole about the situation.
The romaine, green leaf and butter lettuce hearts that went into the blend were grown in California, Colorado and Ohio, then processed at Dole's plant in Springfield, Ohio, on Sept. 6, according to Ordman.
An inspector from the Ohio agriculture department was at the plant Monday and Tuesday, said agency spokeswoman Cindy Brown. Tests performed on lettuce at the plant by Dole and the FDA came back negative for E. coli, she said.
The Canadian Food Inspection Agency said it would be looking to find out at what point the salad blend became contaminated and to see if any other products are affected, spokesman Garfield Balsom said. "We'll go back and find the origins and determine where the product was produced and packaged," Balsom said.
Dole contacted the FDA on Sunday night, as soon as the company got word of the contaminated bag of salad in Canada, said Ordman. "They have been to our plant and they will visit the growers," he said.
The salad mix subject to the recall may have been available in the U.S. in states other than the nine already identified by Dole because in some areas the product was distributed by a wholesaler with clients in overlapping markets, Ordman said.
Food contaminated with this strain of E. coli may not look or smell spoiled but health officials say the bacteria can cause life-threatening illnesses.
Symptoms include severe abdominal pain and bloody diarrhea; some people can have seizures or strokes and some may need blood transfusions and kidney dialysis, while others may live with permanent kidney damage.
Associated Press writers Rob Gillies in Toronto and Andrew Bridges in Washington contributed to this report.
On the Net: Recall: http://tinyurl.com/2naakt

Dole Lettuce Recalled in U.S., Canada

SAN FRANCISCO (AP) — A division of Dole Food Co. issued an international recall of bagged salad Monday after a sample taken from a store in Canada tested positive for E. coli, the company said.

There have been no reports of illness, company officials said.

The voluntary recall affects all packages of Dole's Hearts Delight salad mix sold in the United States and Canada with a "best if used by" date of September 19, 2007, and a production code of "A24924A" or "A24924B," Dole said.

The product was sold in Ontario, Quebec and the Maritime Provinces in Canada and in Illinois, Indiana, Maine, Michigan, Mississippi, New York, Ohio, Pennsylvania,and Tennessee starting around Sept. 8, said Marty Ordman, a Dole spokesman. The product may have been available in other U.S. states wholesalers distributed to, Ordman said.

The romaine, green leaf and butter lettuce hearts that went into the blend were grown in California, Colorado and Ohio, then processed at Dole's plant in Springfield, Ohio on Sept. 6, according to Ordman.

Eighty-eight cases — or 528 bags — were distributed in Canada and 755 cases containing 4,530 bags in the U.S., he said.

The company's move came a day after the Canadian Food Inspection Agency warned consumers not to eat Hearts Delight.

"Our overriding concern is for consumer safety," Eric Schwartz, president of the Dole Fresh Vegetable division said in a statement. He said the company was working with U.S. and Canadian health agencies, as well as those in various states.

The Food and Drug Administration was talking with Westlake Village, Calif.-based Dole about the situation, agency spokesman Michael Herndon said.

The Canadian agency said it would be looking to find out at what point the salad blend, which is imported into Canada, became contaminated and to see if any other products are affected, spokesman Garfield Balsom said.

Last year, an E. coli outbreak traced to bagged baby spinach was blamed for the deaths of three people and for sickening hundreds more across the U.S.

State and federal authorities ultimately identified a central California cattle ranch next to spinach fields belonging to one of Dole's suppliers as being the source of the bacteria.

Food contaminated with this strain of E. coli may not look or smell spoiled but health officials say the bacteria can cause life-threatening illnesses.

Symptoms include severe abdominal pain and bloody diarrhea; some people can have seizures or strokes and some may need blood transfusions and kidney dialysis, while others may live with permanent kidney damage.

2 diagnosed with West Nile virus

A 53-year-old Arlington man and a 48-year-old Worcester woman have been diagnosed with West Nile virus, the first known cases of the mosquito-borne illness contracted in Massachusetts this year, health authorities said today.

Both the man and the woman became sick in August, and both are now at home recovering, said Donna Rheaume, a spokeswoman for the state Department of Public Health.

Three other people were diagnosed earlier in the summer with West Nile while in Massachusetts, but in two cases, the patients were visitors who had been infected in their home state. The third case involved a Boston man exposed to the virus while outside of Massachusetts.

So far this year, nearly 1,400 cases of West Nile have been documented in the United States, with most reported from states west of the Mississippi River.

In the most severe cases, West Nile virus can cause a high fever, headache, neck stiffness, stupor, coma, tremors, convulsions, muscle weakness, and paralysis. The US Centers for Disease Control and Prevention estimates that one of every 150 people infected with West Nile develops severe symptoms.

To avoid contact with infected mosquitoes, the Massachusetts Department of Public Health recommends limiting outdoor activities from dusk to dawn, peak biting times for mosquitoes. Otherwise, wear as much clothing as comfortable and apply insect repellent such as DEET, permethrin, picaridin, or oil of lemon eucalyptus.

DEET should not be used on infants under the age of 2 months and should be used in concentrations of 30 percent or less on older children. Oil of lemon eucalyptus should not be used on children under 3 years old.

West Nile case confirmed

Fulton County’s first case of West Nile virus (WNV) was confirmed in a 56 year-old Atlanta man who was treated and released from an area hospital. The infection marks the 12th in Georgia during 2007, with Fulton County Department of Health and Wellness urging residents to take precautions when outside and to clean areas of standing water.

“We are in the season for increased mosquito activity,” says Dr. Steven Katkowsky, director of the Fulton County Department of Health and Wellness. “The weather has contributed to growth in the mosquito population which unfortunately adds to our increased risk to mosquito bites.”

Symptoms of WNV include headache, fever, neck discomfort, muscle and joint aches, swollen lymph nodes and a rash. WNV can cause encephalitis (inflammation of the brain) or meningitis (inflammation of the spinal cord and lining of the brain). People with compromised immune systems or other underlying conditions are at greater risk for complications from the disease.

“During this time of year, transmission of this potentially serious illness from mosquitoes to humans is at its peak. West Nile Virus is serious but preventable if we take action to reduce our exposure to mosquito bites,” Katkowsky said.

Katkowsky recommended that residents reduce their chances for exposure by eliminating sources of standing water needed for mosquitoes to breed, noting that breeding can occur in any puddle or area of standing water that is present for more than four days. Breeding can occur in sources such as old tires, flower pots, bottles, jars, clogged gutters, wading pools, outdoor toys, or leaky pipes and faucets.

Health and Wellness also recommended using Mosquito Dunks, a larvicide used to kill mosquito larvae, to control mosquitoes in areas with standing water and in containers that cannot be dumped.

Mosquitoes that carry the West Nile Virus bite during the evening, night and early morning. Residents should take precautions to protect family members during these periods. Katkowsky recommended wearing long-sleeve shirts, long pants and socks when outdoor, especially at dawn and dusk. Residents may purchase an insect repellent containing the active ingredient N, N-diethyl-m-toluamide (DEET), spraying the outer surface of clothing and exposed skin and being sure to follow the instructions on the label

There have been more than 900 confirmed cases of West Nile virus in humans in 32 states so far in 2007, with 12 of those in Georgia, according to federal Centers for Disease Control and Prevention (CDC). Of the cases nationwide, 26 resulted in death. Most of the human cases have occurred in the western United States. Other cases in Georgia included two in DeKalb County, one in Gwinnett County, one in Cherokee County, one in Cobb County,one in Johnson County, three in Muscogee County, one in Columbia County and one case in Tift County, according to U.S. Geologic Survey. All cases occurred since the first week of July.

West Nile virus did not pose a serious threat to humans until the mid-1990s, when deadly outbreaks sprang up in Romania, Russia, Israel and, eventually, the United States. Researchers at University of California (Davis) are studying the possibility that new strains of WNV contain a mutation in a gene involved in viral replication, thus enhancing the efficiency of infection, according to New Scientist.

For more information on West Nile Virus and prevention methods, call the Mosquito Hotline: 404-730-5296 or contact the Fulton County Department of Health and Wellness, Division of Environmental Health at (404) 730-1301.

West Nile Virus still a threat, two more Bay State cases

Two more Massachusetts residents have been infected with mosquitoes carrying the deadly West Nile Virus, and public health officials are warning that the risk of contracting the disease is still high.

A 53-year-old man from Arlington and a 48-year-old woman from Worcester became ill in August with West Nile Virus, the Department of Public Health announced today.

Three others in Massachusetts have been infected with West Nile Virus-carrying mosquitoes, although DPH officials believe they all contracted the virus while out of state.

The Arlington man and Worcester woman are the first cases where the infection likely occurred in Massachusetts, DPH said today.

Even though it may feel like fall, September is still a “key time period” for human cases of West Nile Virus and eastern equine encephalitis, another dangerous mosquito-borne illness, said Al DeMaria, director of Communicable Disease Control at DPH.

“With the recent rains and warm weather scheduled for later this week, we’re likely to see continued mosquito activity for several more weeks,” he said.

People age 50 and older are at higher risk for severe disease from West Nile Virus.

There have been 1,395 cases of West Nile virus infections in humans this year in the United States, according to the Centers for Disease Control and Prevention, including eight in New England.

DPH has found West Nile in 36 birds and 52 mosquito samples. EEE has been found in 24 mosquito samples this year.

DPH officials urged residents to take precautions to avoid getting bit.

“People have an important role to play in protecting themselves and their loved ones. We hope that individuals will respond with a heightened awareness of the danger and greater use of personal protection to avoid mosquito bites,” Mary Gilchrist, director of the State Laboratory Institute said in a statement.

Dole salad recalled after E. coli warning in U.S., Canada

A division of Dole Food Company issued Monday a recall of bagged lettuce salad sold in the United States and Canada. (Xinhua Photo)
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BEIJING, Sept. 18 (Xinhuanet) -- A division of Dole Food Company issued Monday a recall of bagged lettuce salad sold in the United States and Canada after a sample in a Canadian store was tested positive for E. coli.

The recall came after Canadian Food Inspection Agency issued an official public warning about Dole brand Hearts Delight lettuce salad on Monday morning.

The affected product was sold in 227-gram packages. Eighty-eight cases had been sold in Canada and 755 in the United States starting the weekend before last, a Dole spokeman said.

Dole Fresh Vegetables division said there were still no reports of illness, but it would be "better safe than sorry" since the bacteria can cause life-threatening illnesses.

"Our overriding concern is for consumer safety," Eric Schwartz, its president added in a statement.

The Canadian agency is working to find out at what point the ready-to-eat blend of romaine, green leaf and butter lettuce hearts became contaminated and to see if any other products are affected.

Surgeons Remove Patient's Gall Bladder Through Vagina

Science Daily — Surgeons at the University of California, San Diego Medical Center have performed the first clinical trial surgery in the Southwest to evaluate the safety and effectiveness of performing abdominal procedures through the body’s natural openings, virtually eliminating scarring.

The UCSD Medical Center procedure involved removing the gallbladder through the patient’s vagina without traditional incisions through the skin. Only one small incision through the naval was required to help guide the surgeon. This procedure received approval for a limited number of patients by UC San Diego’s Institutional Review Board (IRB) which oversees clinical research.

The procedure, called Natural Orifice Translumenal Endoscopic Surgery (NOTES), involves passing surgical instruments, and a tiny camera, through a natural orifice, such as the mouth or the vagina, to the desired organ. By avoiding major incisions through the skin, muscle, and nerves of the abdomen, patients may experience a quicker recovery with less pain and scarring while reducing the risk of post operative hernias.

Santiago Horgan, M.D., a leader in minimally invasive and robotic surgery, and Mark A. Talamini, M.D., professor and chair of the Department of Surgery at UC San Diego Medical Center performed California’s first NOTES surgery on a 42-year old San Diego resident. Her gallbladder was removed through the vagina during a 1.5 hour procedure. UC San Diego Medical Center is the third U.S.-based hospital to perform NOTES.

“We are testing a whole new approach to minimally invasive surgery,” said Horgan, director of minimally invasive surgery at UCSD Medical Center. “Yesterday’s procedure went exceptionally well and we look forward to studying and comparing all the study results to determine if this surgery is a desirable option for patients.”

A total of four patients will be recruited for the UC San Diego NOTES clinical trial. One more female patient will have her gallbladder removed through the vagina and two patients will have the organ extraction performed through the mouth. If the IRB determines that the procedures are safe, approval will be granted to enroll more patients.

“This emerging technique marks a pivotal time in the world of surgery and patient care,” said Talamini. “With this approach, we are hoping to take minimally invasive surgery one step further in terms of reducing pain, scarring, and recovery time.”

Horgan used FDA-approved RealHand High Dexterity (HD) instruments developed by Novare Surgical Systems, and a flexible endoscope, developed by Olympus to perform the NOTES procedure.

“By testing this novel approach, we may develop a technique that amplifies the trend of moving away from open cavity surgeries that involve major incisions and long hospitalizations to more minimally invasive outpatient procedures,” said Talamini. “We are refining techniques that will allow patients to return to their home, family and work more quickly.”

Note: This story has been adapted from a news release issued by University of California, San Diego Health Sciences.

Novartis Drug Curbs Repeat Hip Fractures

A variation of a drug commonly given to cancer patients with bone damage appears to be an effective tool for preventing repeat hip fractures in elderly patients, according to a study in the New England Journal of Medicine.

The study results, which were to be presented yesterday in Hawaii, have potentially big implications because hip fractures are a common and debilitating injury for older people. Most of the 300,000 hip fractures each year in the U.S. are related to osteoporosis in older people, as well as falls, according to an editorial accompanying the study. Older people who fracture their hips are more likely to have second fractures, and repeat fractures are associated with increased risk of death.

The study found that elderly patients who fractured their hips and then received once-a-year infusions of Reclast, an osteoporosis drug, were less likely to suffer second fractures than those who received a placebo. The Reclast group also lived longer. The rate of new fractures in the Reclast group was 8.6%, compared with 13.9% in the placebo group. The risk of death was reduced by 28% in the Reclast group, where 101 people died, compared with 141 in the placebo group. The study tracked 2,127 patients for nearly two years. The average age of the study participants was 74.

The drug's maker, Novartis AG, which is based in Switzerland, says it plans to ask the U.S. Food and Drug Administration and regulatory agencies in other countries to expand the drug's label for its use in preventing repeat hip fractures.

In the accompanying editorial, pharmacists from the National Institutes of Health and the University of Maryland called the study results "powerful and compelling" and the reduction in fractures and deaths "striking." The study, they added, clearly establishes the need for hip-fracture patients to get treated with Reclast or another drug in that class.

Reclast is a bisphosphonate, a class of drug that includes Fosamax, which is made by Merck & Co. Reclast's active ingredient is zoledronic acid, which is the same active ingredient in Zometa, another drug from Novartis with sales of $1.3 billion last year. Zometa is given to cancer patients with bone damage. Zoledronic acid works by increasing bone mass.

Reclast was approved by the FDA this year to treat osteoporosis in women after menopause and Paget's disease, a bone disorder. The study results should provide a boost to Reclast sales, says Joseph Tooley, an analyst with A.G. Edwards in St. Louis. He said the drug should garner sales of close to $1 billion annually by 2011.

A potential area of concern will be the heavy influence of Novartis, which funded the study, helped design it and performed the data analysis. Many of the academic investigators in the study had consulting arrangements with Novartis or received research grants from the company.

Lead author Kenneth Lyles of Duke University said the analysis was independently confirmed.

Write to David Armstrong at david.armstrong@wsj.com

September 22, 2007

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