The FDA said Chantix and Zyban will carry the warnings to alert consumers to the risks of depression and suicidal thoughts when using the drugs.

The drugs also have been reported to cause changes in behavior, hostility and agitation in users, whether users had a history of psychiatric illness or not. In many cases, side effects started shortly after use began and ended when the medication was stopped. The FDA does not know what is causing the changes and said people taking these products should be monitored by their doctor.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Smoking is the leading cause of preventable disease, disability and death in the United States, and we know these products are effective aids in helping people quit.”

The agency also is requiring Pfizer Inc., which makes Chantix, and GlaxoSmithKline, maker of Zyban, to conduct a study looking at how often these serious symptoms occur.

Pfizer says it updated its label in 2007 to include information of neuropsychiatric symptoms and has revised the label again to reflect Wednesday’s warning.

“The labeling update underscores the important role of health care providers in treating smokers attempting to quit and provides specific information about Chantix and instructions that physicians and patients should follow closely,” said Dr. Briggs W. Morrison, senior vice president of the primary care development group at Pfizer. “Quitting smoking is one of the best things people can do for their health, but the quitting process is both difficult and complex.”

The FDA says that since Chantix was approved in 2006, the agency has had reports of 98 suicides and 188 attempted suicides. Zyban has had reports of 14 suicides and 17 attempts.

Zyban contains the same active ingredient as the antidepressant Wellbutrin and already carried a box warning about the increased risk of suicidal thinking and behavior.

Neither Chantix nor Zyban contains nicotine, and the FDA said some symptoms could be the result of nicotine withdrawal. Still, the agency said, people using these drugs experienced some of these symptoms while they were still smoking.

In a review of side effects in patients using the nicotine patch, the agency said it didn’t find a clear link between those products and suicidal events.

Two anti-smoking drugs to carry mental-health warnings

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“Bao” began his journey at St. Louis, Missouri, took a connecting flight at St. Paul, Minnesota, for Tokyo, Japan on May 7th, according to Xinhua state-run news agency.

On May 8, according to the Health Ministry, he flew from Tokyo on flight NW029 and arrived at Beijing Capital International airport on May 9 at 1:30 a.m. At the time of his arrival in Beijing, he had no symptoms and had a body temperature of 37 degrees Celsius (98.6 degrees Fahrenheit).

Soon after, he took a flight onwards to Chengdu and felt feverish, with throat pain, coughing, and a stuffy and slightly running nose and was confirmed with human swine flu on Monday, the Health Ministry said.

The patient is in isolation and is being treated at the Chengdu Infectious Diseases Hospital where he’s listed as having recovered with a normal body temperature, the Health Ministry said.

Most of the passengers aboard the same Beijing-Chengdu flight have been tracked down in 21 different provinces and sent to medical observation, according to the Health Ministry.

The case comes more than a week after a 25-year-old Mexican man with the H1N1 virus arrived in Hong Kong from Mexico via Shanghai, leading to the weeklong quarantine of more than 340 people in the Chinese special administrative region.

There have been 4,657 confirmed human cases of H1N1 in the world as of Sunday.

China confirms mainland swine flu case

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The outbreak of the new virus transmitted from human to human that has killed up to 60 people and infected hundreds in Mexico and infected eight in the United States is a “serious situation” with a “pandemic potential”, the head of the World Health Organization said Saturday.

In Mexico City, where 13 of 20 confirmed deaths occurred, officials said no deaths from swine flu had been registered on Friday, but reassurances came amid the severest public health measures seen here since a 1985 earthquake.

Meanwhile in the United States, where eight non-fatal infections occurred in Texas and California, reports said that 75 students in New York being treated for flu-like symtoms had recently traveled to Mexico, but no swine flu case was confirmed.

“A new virus is responsible” for the cases reported in Mexico and the United States, WHO Director General Margaret Chan said in a telephone press conference Saturday.

How the situation will evolve is “unpredictable,” she said, urging other countries to “increase vigilance”.

“This virus has clearly a pandemic potential,” Chan added.

Mexican Health Minister Jose Angel Cordova confirmed 20 deaths from swine flu late Friday and said authorities were probing another 48 who had died with similar symptoms.

Health officials have been investigating more than 1,000 possible swine flu infections.

Apart from the capital, four other deaths were in central San Luis Potosi, two in Baja California, in northwest Mexico, and one in Oaxaca, in the southeast.

But Cordova added that it was “an epidemic, not a pandemic.”

Mexican President Felipe Calderon said that the government would decree necessary emergency or preventative measures.

Authorities on Friday launched a huge campaign to prevent the spread of the virus, urging people to avoid contact in public.

In Mexico City, schools closed for up to a week, according to the health minister, and numerous public venues, including museums and sports stadia were closed to the public.

Mexico City Mayor Marcelo Ebrard said late Friday that 553 sporting and cultural events had been canceled for at least 10 days to avoid large public gatherings.

The capital did not register any deaths on Friday, Armando Ahued, the local health minister said Saturday.

“The good news is that sick people are reacting adequately to the medication,” Ahued said, without giving further details.

Mexico City authorities initially announced a mass vaccination campaign using regular human flu vaccines, but later admitted that the WHO had advised them that it was better to use antiviral medicines, and said they had more than one million doses of suitable drugs.

The CDC website states that there is no vaccine to specifically protect humans from swine flu, only to protect pigs.

The US Centers for Disease Control and Prevention (CDC) said tests show some of the Mexican victims died from the same new strain of swine flu that affected eight people in Texas and California, who later recovered.

The WHO, which was to send a team of experts to Mexico, said Friday that most Mexican cases had occurred in otherwise health young adults.

“Because there are human cases associated with an animal influenza virus, and because of the geographical spread of multiple community outbreaks, plus the somewhat unusual age groups affected, these events are of high concern,” the Swiss-based body said in a statement.

Seven other countries on the continent on Friday adopted preventative measures to try to avoid the spread of the virus to their territory.

In Mexico City, medical teams were on stand-by at the international airport, and all passengers had to fill out a health questionnaire.

Human outbreaks of H1N1 swine influenza virus were recorded in the United States in 1976 and 1988, when two deaths were recorded, and in 1986. In 1988 a pregnant woman died after contact with sick pigs, according to the WHO.

In recent years, the global focus for a pandemic has shifted to the H5N1 bird flu virus, which has spread from poultry to humans and killed 257 of the 421 people infected by the virus since 2003.

If a pig is simultaneously infected with a human and an avian influenza virus, it can serve as a “mixing vessel” for the two viruses that could combine to create a new, more virulent strain.

Mexico seeks to reassure over deadly swine flu

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Researchers at the University of Rochester Medical Center in New York gave teriparatide (Forteo) to 145 people who had bone fractures that had not healed, many for six months or more. They found that 93 percent of them showed significant healing and pain control after eight to 12 weeks.

Teriparatide speeds the healing of fractures by changing the behavior and number of cartilage and bone stem cells involved in the healing process, the researchers found.

“The decreased healing time is significant, especially when fractures are in hard-to-heal areas like the pelvis and the spine, where you can’t easily immobilize the bone — and stop the pain,” Dr. Susan V. Bukata, medical director of the university’s Center for Bone Health, said in a news release from the center.

“Typically, a pelvic fracture will take months to heal, and people are in extreme pain for the first eight to 12 weeks,” she said. “This time was more than cut in half. We saw complete pain relief, callus formation and stability of the fracture in people who had fractures that up to that point had not healed.”

Based on the findings, the news release said, the U.S. National Institutes of Health has funded a clinical trial of the drug’s use on fractures. The study will include men and post-menopausal women older than 50 who have what’s called a low-energy pelvic fracture and who are admitted to the emergency department of Strong Memorial Hospital in Rochester.

Participants in the study will be given either teriparatide or a placebo and will be followed for 16 weeks to measure fracture healing in a number of ways, including pain levels, microscopic bone growth determined through CT scans and functional testing of bone strength.

Teriparatide was approved by the U.S. Food and Drug Administration in 2002 as a treatment for osteoporosis.

If clinical trials prove that the drug speeds bone healing, it could prove especially important for older adults, who suffer the majority of broken bones that heal slowly.

“In many people, as they get older, their skeleton loses the ability to heal fractures and repair itself,” J. Edward Puzas, head of orthopedic bone research at the medical center and the lead investigator for the clinical trial, said in the news release. “With careful application of teriparatide, we believe we’ve found a way to turn back the clock on fracture healing through a simple, in-body stem cell therapy.”

Bracing and immobilization cannot be used for the approximately 60,000 Americans who suffer a pelvic fracture each year.

“It takes three to four months for a typical pelvis fracture to heal,” Bukata said. “But, during those three months, patients can be in excruciating pain, because there are no medical devices or other treatments that can provide relief to the patient.”

“Imagine if we can give patients a way to cut the time of their pain and immobility in half?” she said.

Speeding the healing time for pelvic fractures could also reduce the risk of death and medical costs.

Pelvic fractures carry the same risk of death as hip fractures. About “one-quarter of all older women with pelvic fractures will die from complications,” Bukata said. “And during that year of recovery, a patient typically puts a greater strain on our health-care system, not to mention their pain and suffering.”

Slow-Healing Bones May Get Boost From Drug

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Setton Pistachio of Terra Bella, Calif., said it was recalling all lots of roasted in-shell pistachios, roasted shelled pistachios and raw shelled pistachios that were produced from nuts harvested in 2008.

Last week, the company recalled a small portion of that harvest — about 2 million pounds — on the theory that it may have been contaminated by a sanitation mistake that affected just one or two production lines.

But after the Food and Drug Administration and the California Department of Public Health took hundreds of samples from the plant and its products for laboratory analysis, Setton Pistachio announced last night that it was pulling more pistachio nuts from the market. Government investigators found salmonella in critical areas of the facility but did not provide details yesterday.

Because Setton supplies about 35 wholesalers and food manufacturers that repackage the nuts for retail sale or use them as ingredients in other products, federal officials said it could take weeks before a comprehensive list of affected products is available. The FDA has begun compiling a searchable database of recalled consumer products, which can be found at http://www.fda.gov. It already includes some well-known labels such as Frito-Lay, Planters, Kirkland and the 365 brand sold by Whole Foods Market.

Consumers should not eat pistachios or foods containing the nuts unless they can determine that the nuts are not part of the recall, FDA officials said. And wholesalers, retailers and restaurants should not sell products containing pistachios unless they know the source, federal officials said.

The recall is voluntary; the FDA does not have legal authority to mandate that a manufacturer recall its product. Setton Pistachio distributes its products nationwide and to 14 other countries.

The FDA is also investigating a sister plant, Setton International Foods, which is based in Commack, N.Y., on Long Island. That company, which makes chocolate- and yogurt-covered nuts, failed its March 9 inspection by New York state officials, who found cockroaches and rodent droppings in the facility.

No illnesses have been linked to the nuts from Setton. Two people have complained to the FDA that they got sick after eating pistachios, but health officials have not made any definitive connection to the nuts in question. Salmonella can cause diarrhea, fever and cramping. The infection can be fatal to children, the elderly and people with weakened immune systems.

The FDA learned about problems at Setton Pistachio on March 23 when it was notified by Kraft Foods that its internal testing found four strains of salmonella in a trail mix made with Setton’s pistachios. Yesterday, a spokeswoman for the food giant said that it had actually detected salmonella in its trail mix as early as December 2007, but that it took 15 months to link it to the pistachios.

Kraft spokeswoman Susan Davidson said Georgia Nut, which makes the trail mix under a contract with Kraft, found salmonella in samples on four occasions between December 2007 and last month. In each case, Kraft destroyed the suspect product and Georgia Nut tested its equipment and raw ingredients to try to identify the source of the contamination, Davidson said.

Kraft did not notify the FDA about the earlier test results because none of the affected products entered the food supply, she said.

“We believed there was no public health risk,” she said, adding that Georgia Nut conducted hundreds of tests of its equipment, facility and raw ingredients. Only in March did officials at Georgia Nut and Kraft realize that pistachios were the single common ingredient among the batches of trail mix that had tested positive for salmonella, she said.

Under state and federal law, neither Kraft nor Georgia Nut are required to notify regulators about internal tests that show a food contaminated with bacteria.

Meanwhile, the pistachio industry took the unusual step yesterday of launching a Web site (http://www.pistachiorecall.org) that lists products not affected by the recall. The industry is hoping to reassure consumers and prevent the sharp drop in sales that devastated the peanut industry earlier this year after a nationwide outbreak of salmonella illness was traced to a Georgia peanut firm, said Richard Matoian of the Western Pistachio Association, which represents more than 400 pistachio growers in California, Arizona and New Mexico.

Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, a Washington-based health advocacy group, said the industry Web site is a great idea. “In these really large ingredient recalls, consumers really need to know which products are not affected,” she said.

Pistachio Firm Expands Recall Over Salmonella

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The northeastern corner of Ontario — a vast area extending from just northeast of Wawa to Hudson Bay — has 51 hospitals and one permanent radiologist.

That’s why Northern Radiology (NORrad) was created seven years ago to allow nine of those hospitals to share digital diagnostic images such as X-rays and ultrasounds. Before NORrad, emergency-room physicians in remote communities with only limited diagnostic capabilities often had to ship patients out to larger centres.

Now 17 hospitals are tied in to NORrad, allowing a radiologist in Timmins and visiting specialists — known as locums — to read medical images remotely, which has greatly reduced the number of patients being transferred, says Guy Guindon, manager of NORrad’s medical imaging and cardiopulmonary department.

Especially in remote communities, that’s one big reason Canadian hospitals need to share medical images — something many still can’t do.

Picture archiving and communications systems (PACS) replace film with digital images, which must happen before hospitals can share them electronically.

The shift to PACS is nearly complete, says Mark Nenadovic, group director of programs for Canada Health Infoway, the federally funded non-profit organization promoting electronic health records across the country. But most are still limited to a single hospital or multi-site health-care organization.

Projects like NORrad have started breaking down those barriers across Canada.
Easier access to images

Another reason to share images is that patients don’t always visit the same hospital. If a Sydney, N.S., resident goes to Halifax to see a specialist, that specialist can look at any medical images taken of that patient in Sydney, says Sandra Cascadden, chief information and health transformation officer for the Nova Scotia Department of Health.

Images taken anywhere in the province are available because Nova Scotia is one of three provinces — the other two are neighbouring Prince Edward Island and Newfoundland — that have fully adopted diagnostic image sharing.

Alberta is well along with a similar system. More than 90 per cent of that province’s diagnostic images are digital, and all hospitals can share images within their health districts, according to Dan Sheplawy, executive director of Alberta Health and Wellness’s information systems delivery branch.

By the end of 2010, image-sharing will be possible between Alberta’s health districts.

British Columbia has image sharing in its Fraser and Interior health authorities and is working to extend it through the province.

The other provinces and territories are in various stages of implementation, Nenadovic says. Ontario and Quebec, the largest provinces with the most hospitals, each have some regional image-sharing projects but will not have provincewide sharing for at least a year.

Digital networks help to bridge staffing gaps at Canadian hospitals

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The figures mean that on average, a new cancer patient was being diagnosed in the country every 7 minutes, 10 seconds in 2006, up slightly from the average of 7 minutes, 38 seconds in 2005, when 68,907 new cases were recorded, according to Chao Kun-yu, deputy chief of the DOH’s Bureau of Health Promotion.

The report showed that for the first time, colorectal cancer replaced liver cancer as the most common type among new cases recorded in a single year.

Compared with 2005, the number of new colorectal cancer cases rose by 644 to 10,248 in 2006, and liver cancer or intrahepatic bile duct cancer was found among 10,092 people – a jump of 176 cases.

Chao attributed the increased prevalence of colorectal cancer among Taiwanese to increasingly unhealthy dietary habits, such as high consumption of red meat and fat and low fiber intake.

Although people between ages 50 and 69 are advised to have fecal occult blood tests every two years to help early diagnosis of colorectal cancer, DOH statistics indicate that only 11 percent of that age group received the tests in 2008 or 2007, he said.

The third highest number of new cases in 2006 were cancers of the lung, trachea or bronchus, totalling 8,748, followed by breast cancer among women, 6,895 cases; and cancer of the mouth, oropharynx or hypopharynx, 5,352 cases, according to the report.

Rounding out the list of top 10 most common types of cancer in 2006 were stomach cancer, with 3,794 new cases; prostate cancer, with 3,073 new cases; skin cancer, with 2,457 new cases; cervical cancer, with 1,828 new cases; and uterine cancer, with 1,159 new cases.

In terms of age-adjusted incidence rate, an average 50 per 100,000 women were diagnosed with breast cancer in 2006; 37.44 per 100,000 people were diagnosed with cancer of the liver or intrahepatic bile duct cancer; and 37.35 per 100,000 people were found to have colorectal cancer.

The report revealed that in Taiwan, the risk of cancer among men was 1.4 times higher than among women.

Because of an almost exclusively male habit of chewing betel nuts, the age-adjusted incidence rates of esophageal cancer and oral cancer among men were 15.6 times to 10.4 times higher than among women in 2006, the report stated.

However, women were found to develop cancer at an earlier age than men, with the median age at diagnosis being 59 among women and 65 among men.

Colorectal cancer most common:

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Air pollution from car fumes is the likely culprit, suggest Annette Peters, PhD, and colleagues at the Institute of Epidemiology, Helmholtz Center, Munich, Germany.

In a previous study, Peters and colleagues found that a sizeable proportion of heart attacks — about 8% — could be attributed to being in traffic.

To follow up, the researchers interviewed 1,454 people who survived heart attacks. In the hour before their heart attack, many of the survivors had been in heavy traffic.

Analysis of the data showed that these heart-attack-vulnerable people were 3.2 times more likely to suffer a heart attack if they’d been in heavy traffic in the previous hour.

“One potential factor could be the exhaust and air pollution coming from other cars,” Peters says in a news release. “But we can’t exclude the synergy between stress and air pollution that could tip the balance.”

Making it less likely that stress was involved was the fact that patients didn’t have to be driving; the risk was the same whether they were driving or taking the bus.

Traffic appeared to be five times more dangerous to women than to men in the study, although the relatively small number of women in the study (325) may have made this calculation less accurate.

To nail down the true culprit, Peters and colleagues are working with University of Rochester researchers to determine exactly what it is about traffic that raises heart attack risk.

In that study, 120 healthy volunteers are driving to work and running errands wearing heart monitors, while other instruments measure their exposure to air pollution and to noise. The data and findings from this trial are not yet available.

Traffic Triples Heart Attack Risk

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An independent committee monitoring the study recommended halting it after concluding that patients on Sutent stayed free of disease progression for longer than those on placebo plus best supportive care.

The patients in the study had advanced pancreatic islet cell tumors, a rare cancer with limited treatment options, according to Pfizer.

Sutent is currently approved for treating both advanced renal cell carcinoma and gastrointestinal stromal tumors.

Pfizer Cancer Drug Shows Benefits, Shares Rise

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The technique, which leaves healthy cells unaffected, could potentially offer hope to people with hard-to-treat cancers where surgery is not possible.

Although it has only been tested in mice so far, the researchers hope for human trials in two years.

The UK study is published online by the journal Cancer Research.

The genes were wrapped up in microscopic nano-particles which were taken up by cancer cells, but not their healthy neighbours.

Once inside, the genes stimulated production of a protein which destroys the cancer.

The researchers say the technology could potentially be particularly relevant for people with cancers that are inoperable because they are close to vital organs.

They hope it will eventually also be used to treat cancer that has spread.

‘Exciting step’

Lead researcher Dr Andreas Schatzlein, from the School of Pharmacy in London, said: “Gene therapy has a great potential to create safe and effective cancer treatments but getting the genes into cancer cells remains one of the big challenges in this area.

“This is the first time that nanoparticles have been shown to target tumours in such a selective way, and this is an exciting step forward in the field.

“Once inside the cell, the gene enclosed in the particle recognises the cancerous environment and switches on. The result is toxic, but only to the offending cells, leaving healthy tissue unaffected.

“We hope this therapy will be used to treat cancer patients in clinical trials in a couple of years.”

Traditional chemotherapy indiscriminately kills cells in the affected area of the body, which can cause side effects like fatigue, hair loss or nausea.

It is hoped that gene therapy will have fewer associated side effects by targeting cancer cells.

Dr Lesley Walker, of the charity Cancer Research UK, said: “These results are encouraging, and we look forward to seeing if this method can be used to treat cancer in people.

“Gene therapy is an exciting area of research, but targeting genetic changes to cancer cells has been a major challenge.

“This is the first time a solution has been proposed, so it’s exciting news.”

Nano-treatment to torpedo cancer

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