FDA approves gene-targeting lung cancer drug (AP)

WASHINGTON � The Food and Drug Administration has approved a new Pfizer drug for a subset of lung cancer patients with a particular genetic mutation.

The twice-a-day pill, called Xalkori, is part of a new wave of personalized medications that fight disease by targeting specific genes found in certain patients. Last week, the FDA approved another drug that uses similar gene targeting technology to treat two rare forms of lymph node cancer.

Xalkori is approved to treat a small subset of non-small cell lung cancer patients, less than 7 percent, who have an abnormal gene that stimulates cancer cells and causes tumor growth. It works by blocking proteins produced by the gene.

"It's another example of how we're using molecular medicine to subtype lung cancer into more specific and treatable diseases," said Dr. Roy Herbst, a lung cancer expert who is chief of medical oncology at Yale University.

Including previously approved targeted therapies, "we have specific therapies now that we can offer for about 18 percent of lung cancer patients that are far superior to chemotherapy and that in many cases can cause their tumors to melt away with few side effects," Herbst said.

The FDA said it also approved a genetic test to screen for the mutation, known as an abnormal anaplastic lymphoma kinase gene. The test is made by Abbott Laboratories.

About 187,000, or 85 percent, of the 220,000 lung cancer cases diagnosed each year are non-small cell lung cancer. Roughly three-fourths of patients aren't diagnosed until tumors have spread, and only 6 percent of those patients live five years.

"It's pretty exciting," said Dr. David Carbone, a lung cancer specialist at Vanderbilt University, one of the sites that tested the drug. Only a small share of lung cancer patients have the gene mutation this drug targets, "but for those people it makes a huge difference," he said.

Analysts predict Xalkori could be a blockbuster product for Pfizer, eventually reaping more than $2 billion in annual sales by 2021.

The FDA approved the drug under its accelerated approval program, which speeds up the clearance of therapies that show promising early results.

Pfizer released follow-up data on the drug in June, reporting that 88 percent of patients in one study saw their tumors shrink at least somewhat after one year on Xalkori. In a second study, 54 percent of patients had their tumors shrink by about a third or more and 83 percent had tumors shrink somewhat. Most patients had only mild side effects, but two of the nine patient deaths during that study were considered treatment-related.

The most common side effects of the drug include vision disorders, nausea, diarrhea and inflammation.

The FDA's accelerated approval program has come under criticism in the last year after follow-up studies showed the best-selling cancer drug Avastin did not extend the lives of patients with breast cancer. The FDA granted the drug accelerated approval because a single study suggesting it slowed tumor growth. The FDA is now in the process of trying to remove the drug's indication, though the drug maker, Roche, has appealed the decision.

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AP Medical Writer Marilyn Marchione contributed reporting from Milwaukee.

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Report: Vaccines generally safe, some side effects (AP)

WASHINGTON � Vaccines can cause certain side effects but serious ones appear very rare � and there's no link with autism and Type 1 diabetes, the Institute of Medicine says in the first comprehensive safety review in 17 years.

The report released Thursday isn't aimed at nervous parents. And the side effects it lists as proven are some that doctors long have known about, such as fever-caused seizures and occasional brain inflammation.

Instead, the review comes at the request of the government's Vaccine Injury Compensation Program, which as the name implies, pays damages to people who are injured by vaccines. Federal law requires this type of independent review as officials update side effects on that list to be sure they agree with the latest science.

"Vaccines are important tools in preventing serious infectious disease across the lifespan, from infancy through adulthood. All health care interventions, however, carry the possibility of risk and vaccines are no exception," said pediatrician and bioethicist Dr. Ellen Wright Clayton of Vanderbilt University, who chaired the institute panel.

Still, the report stresses that vaccines generally are safe, and it may help doctors address worries from a small but vocal anti-vaccine movement. Some vaccine-preventable diseases, including measles, are on the rise.

"I am hopeful that it will allay some people's concerns," Clayton said.

The review echoed numerous other scientific reports that dismiss an autism link.

But it found convincing evidence of 14 side effects:

_Fever-triggered seizures, which seldom cause long-term consequences, from the measles-mumps-rubella, or MMR, vaccine.

_MMR also can cause a rare form of brain inflammation in some people with immune problems.

_The varicella vaccine against chickenpox sometimes triggers that viral infection, resulting in widespread chickenpox or a painful relative called shingles. It also occasionally can lead to pneumonia, hepatitis or meningitis.

_Six vaccines � MMR and the chickenpox, hepatitis B, meningococcal and tetanus-containing vaccines � can cause severe allergic reactions known as anaphylaxis.

_Vaccines in general sometimes trigger fainting or a type of shoulder inflammation.

There's suggestive evidence but not proof of a few other side effects, including anaphylaxis from the human papillomavirus, or HPV, vaccine and short-term joint pain in some women and children from the MMR vaccine.

On the other hand, the report cleared flu shots of blame for two long-suspected side effects: Bell's palsy and worsening of asthma.

That doesn't mean there aren't other side effects � the review couldn't find enough evidence to decide about more than 100 other possibilities. Some vaccines are just too new to link to something really rare. Another example: Flu shots have long come with a caution about rare, paralyzing Guillain-Barre syndrome, but Clayton said research hasn't settled if that's a coincidence since the disorder is more common during the winter.

The Health Resources and Services Administration, which runs the vaccine compensation program, is reviewing the report but said it's too early to predict if it will prompt changes to the injury list.

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Specialized mosquitoes may fight tropical disease (AP)

NEW YORK � Scientists have made a promising advance for controlling dengue fever, a tropical disease spread by mosquito bites. They've rapidly replaced mosquitoes in the wild with skeeters that don't spread the dengue virus.

More than 50 million people a year get the dengue virus from being bitten by infected mosquitoes in tropical and subtropical areas, including Southeast Asia. It can cause debilitating high fever, severe headaches, and pain in the muscles and joints, and lead to a potentially fatal complication. There's no vaccine or specific treatment.

Some scientists have been trying to fight dengue by limiting mosquito populations. That was the goal in releasing genetically modified mosquitoes last year at sites in Malaysia and the Cayman Islands.

Australian scientists took a different tack, they report in Thursday's issue of the journal Nature.

First, they showed that Aedes aegypti mosquitoes, the chief carriers of the dengue virus, resist spreading that virus if they are infected with a particular kind of bacteria. Then they tested whether these resistant mosquitoes could displace their ordinary cousins in the wild, thus reducing the number of dengue-spreading mosquitoes.

The resistant mosquitoes have an advantage in reproduction. Resistant females can mate with either resistant or ordinary mosquitoes, and all their offspring will be resistant. But when ordinary females mate with a resistant male, none of the offspring survive.

For the experiment, scientists released more than 140,000 resistant mosquitoes over 10 weeks in each of two isolated communities near Cairns in northeastern Australia, starting last January. By mid-April, monitoring found that resistant mosquitoes made up 90 percent to 100 percent of the wild population.

The result is a "groundbreaking first step," Jason Rasgon of the Johns Hopkins Bloomberg School of Public Health in Baltimore wrote in a commentary accompanying the paper. Rasgon, who did not participate in the study, said the next hurdle is to test the idea in areas where dengue is spread constantly, rather than sporadically as in Australia. Researchers will also have to show it works against varied strains of the dengue virus, he said.

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Online:

Journal: www.nature.com/nature

Disease information: http://bit.ly/r0i8Lq

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FDA warns of heart risks with high doses of Celexa (AP)

WASHINGTON � Federal health regulators are warning doctors not to prescribe high doses of the antidepressant Celexa, because of the risk of fatal heart complications.

The Food and Drug Administration said in an online posting that the drug can interfere with the heart's electrical activity at doses above 40 milligrams.

The label for Celexa previously stated that some patients should receive 60 milligrams, but the FDA has eliminated that language. "Studies did not show a benefit in treatment of depression at doses higher than 40 mg per day," the FDA states.

The new label will emphasize that Celexa should not be used in patients with congestive heart failure and other conditions that affect the heart's pumping action.

Drugmaker Forest Laboratories sells Celexa in doses of 10, 20 and 40 milligrams

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APNewsBreak: Global Fund lifts China grant freeze (AP)

BEIJING � A high-profile global health fund that has come under pressure to clean up corruption has ended its dispute with China and will resume hundreds of millions of dollars in funding for programs to fight AIDS and other diseases, thereby removing a source of embarrassment for Beijing.

The Global Fund to Fight AIDS, Tuberculosis and Malaria froze disbursements of its AIDS grant to China in November and then all other grants in May over suspected misuse of the money and the government's reluctance to involve community groups. The move was seen as a rebuke to the authoritarian government over its customary suspicion of independent groups.

The Geneva-based Global Fund said Tuesday it is lifting the freeze on funding to China to ensure AIDS work in the country continues while it works with government officials, representatives from United Nations' agencies and private groups to resolve the dispute.

"During these discussions, the parties agreed to resume funding flows to ensure that the Chinese AIDS program would not be impeded by the ongoing efforts to strengthen fiduciary controls and to ensure sufficient civil society engagement in The Global Fund-supported programs," Global Fund spokesman Jon Liden emailed in response to an Associated Press query.

"China and The Global Fund will continue to work closely together to tighten fiduciary controls and ensure that programs are as effective as possible in combatting the three diseases," Liden said. He said the lifting was effective immediately.

The Global Fund froze payments of a $283 million AIDS grant in November after finding that Chinese government agencies had breached an agreement by channeling too small a share of the funds to grass-roots groups. Then in May, it stopped payments of all other grants in China after concerns about how the money was being used by the thousands of counties that receive grant payments.

Earlier this year, the $22 billion Global Fund faced a backlash among major donors over reports of corruption. It has said it will make public more detailed information about money it has lost to fraud and mismanagement.

Resolving the China dispute could mean China will continue to receive payments of $300 million in funding over the next several years for programs to prevent and treat HIV and AIDS in prostitutes, injecting drug users and others and for malaria and tuberculosis � unless the recent talks resulted in a reduction of the funding.

Beijing already funds the majority of its efforts to fight AIDS, TB and malaria, the fund added in its statement.

The dispute comes amid a larger debate among international aid donors and groups about whether China should continue to receive foreign aid, considering its relative prosperity resulting from decades of high economic growth. Critics point to the government's ability to fund a manned space program and extravaganzas like the 2008 Beijing Olympics, while proponents say China still has hundreds of millions of poor and needs international know-how.

Critics have said that by competing with poorer developing countries for Global Fund grants, China is effectively robbing the poor. Since 2003, the Global Fund has disbursed $570 million in grants to China.

The Global Fund did not provide details about what the Chinese government has done to meet the demands of the fund before the decision to lift the freeze was made.

But in the months since the freeze, China's Health Ministry has issued statements acknowledging the contributions of China's independent health groups. Health Minister Chen Zhu attended a meeting with community AIDS groups in late June in the southwestern city of Kunming and pledged that his ministry would try to help facilitate the work of private groups.

The government has also agreed to allocate 25 percent of the Global Fund budget to community organizations, and to set up a separate entity to manage all funding that is allocated to civil society groups, according to a public tender notice issued late last month by the Chinese Center for Disease Control and Prevention, or China CDC, the Global Fund's main recipient in China.

The China CDC's moves were welcomed by the leader of a network of more than 130 groups working to help people with HIV across in China.

"To community groups, this is a really good thing, because it has pushed the government to change its attitude toward us," said Wang Long, who heads the China National Network of AIDS Community-Based Organizations. "It has made the government value the contribution of civil society groups."

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Follow Gillian Wong on Twitter at http://twitter.com/gillianwong

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Hospitals are giving faster heart care, study says (AP)

In a spectacular turnabout, hospitals are treating almost all major heart attack patients within the recommended 90 minutes of arrival, a new study finds. Just five years ago, less than half of them got their clogged arteries opened that fast.

The time it took to treat such patients plunged from a median of 96 minutes in 2005 to only 64 minutes last year, researchers found.

Some hospitals are moving at warp speed: Linda Tisch was treated in a mere 16 minutes after she was stricken while visiting relatives near Yale-New Haven Hospital in Connecticut this month. Emergency responders called ahead to mobilize a team of heart specialists.

Once she arrived, "they had a brief conversation and I went straight into the OR. My family was absolutely flabbergasted," said Tisch, 58, who went home to Westerly, R.I., two days later.

Tisch wasn't a fluke. The hospital took 26 minutes on another case on Thursday.

"Americans who have heart attacks can now be confident that they're going to be treated rapidly in virtually every hospital of the country," said Yale cardiologist Dr. Harlan Krumholz. He led the study, published online Monday by an American Heart Association journal, Circulation.

What is remarkable about this improvement, Krumholz said, is that it occurred without money incentives or threat of punishment. Instead, the government and a host of private groups led research on how to shorten treatment times and started campaigns to persuade hospitals that this was the right thing to do.

"It's amazing and it's very gratifying. I'm surprised that we were able to achieve that type of dramatic improvement" so quickly, said Dr. John Brush, a cardiologist at Eastern Virginia Medical School in Norfolk, Va., who helped the American College of Cardiology design its campaign, which involved more than 1,000 hospitals.

Heart attacks are caused by clogged arteries that prevent enough oxygen and blood from reaching the heart. Each year, about 250,000 people in the United States and more than 3 million worldwide suffer a major one, where a main artery is completely blocked.

The best remedy is angioplasty, in which doctors push a tube through an artery to the clog, inflate a tiny balloon to flatten it, and place a mesh prop called a stent to keep the artery open.

The period from hospital arrival to angioplasty is called "door-to-balloon" time, and guidelines say this should be 90 minutes or less. Any delay means more heart damage, and the risk of dying goes up 42 percent if care is delayed even half an hour.

Not all hospitals have the capability to do angioplasty around the clock, so part of the effort to speed care involved setting rules for who has to be consulted before deciding to do the procedure.

The study involved more than 300,000 patients who had an emergency angioplasty at hospitals that get Medicare reimbursements. The researchers looked at records from 2005, just before campaigns to shorten treatment times were launched, through September 2010.

Only 44 percent were treated in the recommended time in 2005, but by last year it was 91 percent.

The National Heart, Lung and Blood Institute and the Centers for Medicare and Medicaid Services paid for the study.

"It's not an exaggeration to say that care of heart attacks in the United States has been transformed by this improvement," said Dr. Christopher Granger, a Duke University Medical Center cardiologist who led a Heart Association program to improve care.

"We've made very important progress but there still is a lot of unfinished work in improving heart attack care," such as what happens before people get to a hospital where angioplasty is done, he said.

Patients also need to do their part, by knowing the warning signs of a heart attack:

� Discomfort in the center of the chest lasting more than a few minutes, or that goes away and comes back. It can feel like pressure, squeezing, fullness or pain.

� Pain or discomfort in one or both arms, the back, neck, jaw or stomach.

� Shortness of breath, which might include breaking out in a cold sweat, or feelings of nausea or lightheadedness.

What to do is simple, doctors say: Call 911.

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Online:

How hospitals rate: http://www.hospitalcompare.hhs.gov/ Heart association: http://www.americanheart.org/ College of Cardiology: http://www%h%href_on(http://www.acc.org/%)ref_off(%).acc.org/ __%href_on(http://www.acc.org/%)_

Marilynn March%href_off(%)ione can be followed at http://twitter.com/MMarchioneAP

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