Remove Diabetes Drug Avandia From Market

SATURDAY, Feb. 20 (HealthDay News) — The blockbuster type 2 diabetes drug Avandia raises users’ odds for heart attack and heart failure and should be removed from the market, according to confidential U.S. government reports.

The New York Times on Saturday reported on documents from the U.S. Food and Drug Administration that find that if people now taking Avandia (rosiglitazone) switched to a similar medication, Actos, about 500 heart attacks and 300 cases of heart failure would be eliminated each month. And in a report from the Institute for Safe Medication Practice, Avandia was linked to 304 deaths in the third quarter of 2009 alone, the highest for any prescribed drug in that time period, the Times reported.

In one of the FDA documents, dated October 2008, Drs. David Graham and Kate Gelperin — drug safety officials at the agency — agreed that “rosiglitazone should be removed from the market.”

The reports, obtained early by the Times, are yet another chapter in Avandia’s checkered history. The drug was once taken by millions worldwide, but that changed after a study released in early May of 2007 by the Cleveland Clinic suggested that Avandia carried cardiovascular risks. That study, which included more than 28,000 people, found that Avandia increased a user’s odds of heart attack by 43 percent compared to those not taking the medicine.

At the time, Dr. Bruce M. Psaty of the University of Washington — who also co-wrote an accompanying editorial in the New England Journal of Medicine — urged the FDA to restrict access to Avandia and cited both the agency and the drug’s maker, GlaxoSmithKline, for poor oversight.

“The primary problem here is that studies that were needed early on about the health benefits of this drug were never done,” Psaty told HealthDay. “As a result of the failure of the sponsor to do long-term clinical trials to show health benefits, as a result of the failure of the FDA to insist on it, we have data that are weak.”

Following on the Cleveland Clinic study, the FDA demanded “black box” warnings on labeling for both Avandia and Actos, warning of a potentially heightened risk for heart failure. However, other studies found no raised level of heart risk, and at the time the agency said it had not reached a definitive conclusion on the data.

In November of the same year, the FDA updated Avandia’s labeling to include a caution regarding heart attack risk. At the time, Dr. Janet Woodcock, acting director of the FDA’s Center for Drug Evaluation and Research, said that, “we are keeping Avandia on the market because we have concluded there isn’t enough evidence to indicate that the risk of heart attack is higher for Avandia than other type 2 diabetes treatments.”

The story got more complicated in 2008, as a number of studies emerged tying the use of Avandia to increased bone fracture risk.

Throughout 2009, more studies reiterating the drug’s heart risks also came to light, including one published in the BMJ suggesting that Avandia’s risk for heart failure seemed to outstrip those of its related rival, Actos.

By that point, “most clinicians [had] stopped using Avandia — some will use Actos instead or go to another class completely,” Dr. Carl J. Lavie, medical director of cardiac rehabilitation at the Ochsner Heart and Vascular Institute in New Orleans, told HealthDay at the time.

The emergence of the leaked documents on Saturday comes at a time when officials within the FDA seem to be at loggerheads over whether to ban Avandia or not, the Times reported. The newspaper said that some officials believe that safer alternatives exist, while others say the evidence on Avandia’s safety is conflicted and the drug should remain available as a treatment option.

Trying to sort things out, in December of 2009 Woodcock asked officials at the FDA to convene another advisory committee to determine whether Avandia should remain on the market, with a decision expected this summer.

In the meantime, a bipartisan Senate investigation — overseen by Sen. Max Baucus (D-Mont.) and Sen. Charles E. Grassley(R-Iowa) — has pored over 250,00 internal documents from GlaxoSmithKline. The investigation has placed much of the blame for the Avandia debacle on the company, contending that it neglected to warn patients for years of the drug’s dangers.

“G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” according to the Senate investigation report, which is slated for release Monday but was obtained early by the Times.

Speaking to the newspaper Friday night, agency commissioner Dr. Margaret Hamburg said that, “I await the recommendations of the advisory committee. Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved.”

In a statement released Saturday, GlaxoSmithKline said it “rejects the conclusions about the safety of Avandia (rosiglitazone)” as reported in that day’s Times story.

“Contrary to the assertions in the story, and consistent with the FDA-approved labeling, the scientific evidence simply does not establish that Avandia increases ischemic cardiovascular risk or causes myocardial ischemic events,” the company said. “In 2007, the FDA considered all the available scientific evidence on Avandia, including Dr. Graham’s assertions of elevated heart attack risk and demands that the product be withdrawn. Based on the scientific evidence and a recommendation by an independent advisory committee of experts convened by the FDA, the agency has ruled that Avandia remain available to patients for the treatment of Type 2 diabetes.”

In the wake of the controversy, GlaxoSmithKline had been directed by the FDA to conduct a trial comparing rates of heart attacks, strokes and heart-linked deaths among users of Avandia, Actos or a placebo. But according to internal documents accessed by the Times, Graham and Gelperin characterized the study, called TIDE, as “unethical and exploitive,” with patients being given Avandia despite the fact that it appears to come with greater risks and no added benefit over Actos.

One of the Graham/Gelperin reports — dated October 2008 — concludes that, “Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable.”

However, other FDA officials overruled those concerns and TIDE is still enrolling patients, with preliminary results expected by 2014. Responding to the criticism, GlaxoSmithKline noted Saturday that, “TIDE has been approved by an independent review board and appropriate safety boards that are responsible for assessing the safety of conducting the trial.”

The ongoing controversy has dampened patients’ and physicians’ enthusiasm for Avandia. According to the Times, while sales of the drug topped $3.2 billion in 2006, those numbers plummeted soon after the first studies suggesting risk emerged a year later.

Still, “hundreds of thousands” of people still take Avandia, the Times noted. GlaxoSmithKline’s patent on the drug expires in 2012.

By E.J. Mundell
HealthDay Reporter

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U.S. requires new warnings for asthma drugs

WASHINGTON (Reuters) – U.S. health officials on Thursday called for new warnings on certain asthma drugs to help reduce overall use of these medications, saying the medicines should not be used unless taken in combination with other inhaled drugs.

The Food and Drug Administration said its review of the drugs — long-acting beta-agonists (LABAs) that include GlaxoSmithKline PLC’s Symbicort — found they can increase the risk that asthma symptoms will worsen, and lead to hospitalizations and death.

The restrictions also affect two lesser-used medicines, Glaxo’s Serevent and Novartis AG’s Foradil.

Manufacturers must include warnings on the products that state the drugs should not be used alone in adults and children and should be taken along with inhaled corticosteroids, the FDA said. The warnings to patients and doctors also say the drugs should only be used long-term in patients who cannot control their asthma with other medications and should be used for the shortest time possible.

The companies must also conduct additional studies about the use of LABAs in combination with inhaled corticosteroids, the agency said.

(Reporting by Susan Heavey, editing by Matthew Lewis)

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First Oral Medications For MS Show Promise

Two new drugs — both oral, rather than injected — may soon be available to combat multiple sclerosis.

Three studies, all being published early online Jan. 20 in the New England Journal of Medicine, find that the new drugs — fingolimod and cladribine — reduce relapse rates in people with relapsing-remitting multiple sclerosis (MS). Both drugs work by altering the immune system response.

However, as is often the case with immune-suppressing medications, there are concerns about side effects, including an increased risk of serious infections and possibly, cancer.

“Oral drugs are what people with MS have been wishing for a long time. This is wonderful news for people with MS,” said Dr. John Richert, executive vice president of research and clinical programs for the National Multiple Sclerosis Society (NMSS). “The drugs appear to be quite effective, and at the moment, appear to have a reasonable risk-benefit ratio. However, it will be very important for people with MS and their physicians to remain vigilant and be on the lookout for side effects.”

All three studies were funded by the drug’s manufacturers — Novartis for fingolimod and Merck Serono for cladribine. Both manufacturers are currently pursuing U.S. Food and Drug Administration approval for their medications.

Multiple sclerosis is a chronic, potentially disabling illness that’s believed to be an autoimmune disorder. In MS, the body’s natural defense system mistakenly attacks the fatty substance that protects the nerves (myelin). About 400,000 Americans have multiple sclerosis, according to the NMSS.

The current treatments for MS are all injectable medications, which Richert said is sometimes a barrier for people to start early treatment. He said that treatments may be more successful if they’re started early in the course of the disease, so he’s hoping that having oral medications will help people start treatment sooner.

Two of the new studies focused on the oral medication called fingolimod. Both were phase 3 studies. One study included more than 1,000 people with relapsing-remitting MS. The study participants were randomly selected to receive a daily dose of 0.5 milligrams (mg), 1.25 mg or a placebo.

Annual relapse rates were less than 1 percent each year, but were 54 percent less for the lower dose of fingolimod and 60 percent for the higher dose. The study also found slower disease activity and progression.

In the second study on fingolimod, 1,153 people with relapsing-remitting MS were randomly assigned to receive a daily dose of 0.5 mg or 1.25 mg of fingolimod or a weekly dose of 30 micrograms of interferon beta-1a (Avonex) for one year. The annual relapse rate on either drug was less than 1 percent in this study as well. However, the people on fingolimod had up to a 52 percent lower relapse rate. This study found no significant differences in disease progression between the two treatments.

Both studies found that the lower dose of the drug was better tolerated. A small number of serious infections occurred, including two deaths from herpes infections in these studies. And, there appeared to be a higher incidence of cancer in people taking fingolimod.

Still, “the fact that fingolimod is given orally is a huge advantage,” said the lead author of the yearlong study, Dr. Jeffrey Cohen, director of experimental therapeutics at the Mellen MS Center at the Cleveland Clinic in Ohio. “It appears to be effective and is generally well-tolerated.”

The third study, also a phase 3 study, looked at the oral medication cladribine in comparison to placebo. In this study, more than 1,300 people with relapsing-remitting MS were randomly assigned to receive a cladribine dose of either 3.5 mg or 5.25 mg per kilogram of body weight or a placebo. During the second year of the study, those on cladribine were all given the lower dose.

As in the fingolimod studies, annual relapse rates were less than 1 percent. However, those on cladribine had relapse rates that were up to 58 percent lower. Disease activity and disability scores were also lower in the treatment groups.

Although the drug appeared to be generally well-tolerated, there were some serious side effects with cladribine as well, including serious herpes zoster infections. Herpes zoster is the virus that causes shingles, and there is a vaccine available for this virus. Whether getting the vaccine prior to treatment would lessen the risk of infection isn’t clear because it hasn’t been studied, said Richert. Cladribine was also associated with a potentially increased risk of cancer.

Another question that remains to be answered for both medications is whether or not they will increase the risk of a very serious brain infection known as progressive multifocal leukoencephalopathy (PML). It wasn’t discovered that the MS medication, natalizumab (Tysabri), caused a slight increase in the rate of these infections until the drug came to market. That’s because it’s such a rare side effect.

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Is the US swine flu epidemic over?

If the U.S. swine flu epidemic isn’t over, it certainly looks as if it’s on its last legs. While federal health officials are not ready to declare the threat has passed and the outbreak has run its course, they did report Friday that for the fourth week in a row, no states had widespread flu activity. U.S. cases have been declining since late October.

One U.S. expert said the epidemic has “one foot in the grave,” and there are many reasons to believe there won’t be another wave later in the year.

For one thing, the virus has shown no signs of mutating. The vaccine against it is effective. And roughly half the people in the U.S. probably have some immunity because they were infected with it or got vaccinated.

The World Health Organization is witnessing an international decline as well, and is discussing criteria for declaring the pandemic over. Britain this week shut down its swine flu hot line, which was set up to diagnose cases and give out Tamiflu.

“Clearly, the last four weeks have been one of the quietest January flu seasons I can remember in my career,” said Michael Osterholm, a prominent expert on global flu outbreaks with the University of Minnesota.

Since its emergence last April, swine flu has caused an estimated 15,200 deaths worldwide, mostly in the U.S. — a much lower number than initially feared. The positive outcome is primarily because the virus didn’t mutate into a deadlier form.

Even so, experts have praised the actions of the U.S. and Mexican governments and scientists who quickly developed an effective vaccine.

Criticizing the government for its intense response would be like chastising officials for building dikes in New Orleans to withstand a Category 5 hurricane and then seeing only a Category 3 come ashore, Osterholm said.

“The government did not overreact,” said University of Michigan flu expert Dr. Arnold Monto, echoing Osterholm’s point.

Whether it will stay quiet for the rest of the winter is hard to say, but some experts are beginning to lean that way.

“If it’s not dead, it’s weakening fast. It’s got one foot in the grave,” said Dr. William Schaffner, a flu authority at Vanderbilt University.

A poll released Friday by the Harvard School of Public Health found that 44 percent of Americans believe the outbreak is over.

The Centers for Disease Control and Prevention released numbers Friday showing most states continued to have only occasional flu activity last week. However, only three states had absolutely no reports, and a CDC official cautioned that swine flu is still around and is likely to keep infecting people for weeks or months to come.

“We don’t seem to be seeing the disappearance of this virus,” said the official, Dr. Anne Schuchat.

Whether there will be another wave of swine flu — as was seen in the spring last year and again in the early fall — is a much harder question, she added.

Her comments reflect a raging debate among scientists. One expert told The Associated Press he thinks a spike in H1N1 cases is likely by May, though perhaps a smaller one than last fall. Another said he did not expect another spike. A third predicted another wave, but not until next fall at the earliest. A fourth refused to even guess.

An estimated 70 million Americans have been vaccinated against swine flu through a government campaign that started in October. Counting those who have already been infected and others who were vaccinated, perhaps 40 percent of the public has some immunity to the virus.

However, that means at least half of Americans don’t have immunity, and there are many places that have not been hit hard by swine flu yet, some experts noted.

Also, this is a global disease that can move quickly through air travel, and much of the rest of the world is not vaccinated, Osterholm pointed out.

Experts give health officials generally good marks for their handling of the pandemic, even with months of delays in the production of swine flu vaccine.

About 60 percent of the 1,400 adults in the Harvard poll said U.S. public health officials did a good or excellent job in dealing with the pandemic. More than half said the government devoted the right amount of attention to the outbreak.

The telephone survey was done in late January and had a margin of error of plus or minus 3.2 percentage points.

___

Associated Press Medical Writer Maria Cheng contributed to this report from London.

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Medication Adherence Varies Between Races

Elderly black Americans use fewer medications than whites and are more likely to skip taking their meds, a new study finds.

It included 100 black and 100 white patients, aged 60 and older, who were interviewed at the start of the study, and again six months and one year later.

Overall, whites used more medications, had more chronic medical conditions and used more physicians. Whites were more likely than blacks to have adequate health literacy skills (58 percent vs. 29 percent) and less likely to be unable to afford medications (12 percent vs. 28 percent).

The most common problems for both whites and blacks were: medication non-adherence (42 percent vs. 68 percent), under treatment (83 percent vs. 87 percent), suboptimal drug use (59 percent vs. 66 percent), and suboptimal dosing (48 percent vs. 56 percent).

The findings support previous research showing that elderly black patients have higher rates of medication non-adherence than whites. But, overall, medication-related problems are prevalent and persist in both races, the researchers said.

“Strategies to better measure the quality of medication use in older adults are needed, and efforts to improve the quality of medication use in older adults must account for potential differences in both the number and types of problems affecting whites and blacks,” concluded Dr. Mary Roth and her colleagues at the University of North Carolina at Chapel Hill.

The study was published online Dec. 11 in the Journal of General Internal Medicine.

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How to Protect Yourself from Swine Flu

The new swine flu is scary, no doubt about it. But here’s the information you need to better understand the illness and the ways you can protect yourself and your family from infection.

Understanding the Swine Flu Virus

Human influenza, or the “flu,” is a viral infection that usually occurs seasonally and is transmitted between people. The viruses are categorized into two major types, A and B, and subtypes, named H and N. The current swine flu is a new type of influenza A virus, H1N1, which has not previously been seen. This strain is unusual in that it appears to be a cross between strains that infect swine, birds and human beings. While this new strain may yet present some surprises, we know a lot about how influenza is transmitted and how to slow or break that cycle.

The main way that influenza viruses are spread is person to person via the respiratory droplets of coughs and sneezes. The virus is transmitted when these infected droplets land on the mouth or nose of people nearby or when people touch respiratory droplets on another person or an object, and then they touch their mouth or nose or rub their eyes before washing their hands. Swine flu is not spread by eating pork or other food, and pigs pose little risk of viral transmission.

Protecting Yourself and Your Family from Infection

The bottom line of protecting yourself is to practice good hygiene and avoid coming into contact with the virus.

Keep your hands away from your face or wash them first. Stay away from crowds. Avoid contact with sick people if you can. If you can’t, wash your hands often with soap and water. Be sure to use a paper towel to turn off the faucet handles so as not to recontaminate your hands. The same paper towel precautionary measure applies to doorknobs. If you can’t wash your hands, use an alcohol-based hand sanitizer with at least 60 percent alcohol.

Cover your mouth when you cough and sneeze. Teach your family to do the same and to discard used tissues promptly. If no tissues are available, it is better to cough or sneeze into your sleeve than your hand. They should wash their hands immediately, before they contaminate other surfaces with infective secretions.

Keep ill family members away from others at home and stay at home unless medical care is needed. Masks are most effective when worn by infected people to prevent the spread of the virus, so if you are infected and you must go out, wear a mask to reduce the transmission of infected droplets to others. While masks are not effective against small viral particles that may be airborne, and airborne transmission may occur, large infective droplets are probably a major factor and the one that a mask can best protect against. Wear a mask if you are within six feet of an ill person. N-95 masks must fit tightly to work effectively. Don’t worry if you don’t have an N-95 or a fancy surgical mask. The key to prevention is to keep droplets away from your nose, mouth and eyes. You can use a cloth bandana or similar accessory to cover your nose and mouth. Change paper or cloth masks frequently. (In hospitals, N-95 masks are recommended because of higher exposure rates.)

Seek medical care promptly if you become ill with flu-like symptoms-fever, generalized aches, sore throat, cough, runny nose, vomiting, diarrhea and lethargy-especially if you are having trouble breathing. The antiviral medicines Tamiflu and Relenza are quite effective if taken within the first 48 hours of your symptoms’ appearance. If you are exposed to the new 2009H1N1 virus, you might also benefit from prophylactic antivirals to prevent infection, especially if you have underlying health problems. Check with your doctor.

Warning: Do not give aspirin (acetylsalicylic acid) to children or teenagers who have the flu; this can cause the serious and possibly fatal Reye’s syndrome. NSAIDS (nonsteroidal anti-inflamatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Naprosyn, Midol) and acetominophen (Tylenol) are safe to administer for their symptomatic relief.

Remember, staying away from crowds and using good hygiene can help you prevent the contraction of many flu illnesses and give you some measure of reassurance during this flu outbreak.

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U.S. panel to weigh safety of AstraZeneca’s Crestor

U.S. regulators see benefits to using an AstraZeneca Plc cholesterol drug in a vast new group of patients but will ask outside advisers to probe various safety issues, documents released on Friday said.

AstraZeneca wants permission to promote the Crestor drug, for preventing heart disease in people with normal cholesterol levels but other risk factors based on findings of a large study known as Jupiter.

A Food and Drug Administration reviewer, commenting on a higher number of diabetes cases reported with Crestor patients, said that, at the current time, the benefits seen in the Jupiter trial “outweigh the risk, but further clinical trials are needed to further define this benefit/risk ratio.”

The Jupiter trial “was relatively short in duration” and “therefore the long-term complications are unknown,” the reviewer said.

The reviewer also said the agency felt it was a “chance finding” that gastrointestinal-related deaths were higher in Crestor patients compared with a placebo.

The comments were included in documents the FDA released ahead of a meeting on Tuesday of a panel of outside advisers.

The advisory panel will be asked to comment on the diabetes and gastrointestinal findings before deciding whether to recommend approval for expanded use, according to a November 12 memo. The FDA also will seek input on a higher number of patients who reported a “confusional state” in the Crestor group, the memo said.

Barclays Capital analyst Brian Bourdot said he expects the advisory panel to support wider use of Crestor.

“Overall, the FDA review appears benign, with few safety concerns and little disagreement that Crestor shows a significant benefit” in the expanded group, Bourdot said in a note to clients.

The Jupiter study showed Crestor cut deaths, heart attacks and strokes in middle-aged people with healthy cholesterol, but elevated levels of C-reactive protein, which is associated with heart disease.

The FDA said it would ask the advisory panel to “keep in mind that an estimated 6 million middle-aged and older men and women in the United States” meet the criteria of people in the study.

AstraZeneca said in an analysis also released by the FDA that Crestor’s risks in the Jupiter study were “consistent with the known safety profile.” The company said potential side effects were outweighed by the benefits, including a 44 percent reduction in cardiovascular-related deaths, strokes, heart attacks and other problems.

An expanded label for Crestor would boost sales of the drug in the coming years, but industry analysts say the size of the opportunity is uncertain because of the looming arrival of generic versions of Pfizer Inc’s Lipitor in late 2011.

Gbola Amusa of UBS believes the Jupiter results could expand the overall statin market by 20 percent to 50 percent in volume terms, lifting AstraZeneca’s Crestor sales to some $8 billion in 2012 from $3.6 billion last year.

Others are more cautious, and the consensus forecast for 2012 is $6.75 billion, rising to $6.92 billion in 2013, according to Thomson Pharma.

AstraZeneca’s partner Shionogi & Co Ltd also sells Crestor in Japan and recorded $172 million in revenue from the drug in 2008.

The dramatic reduction in heart attack risk seen in Jupiter already has helped boost prescriptions for Crestor since details were unveiled in November last year.

The FDA will make the final decision on whether to allow AstraZeneca to promote Crestor more widely, but it usually follows panel recommendations.

Crestor is a key driver for AstraZeneca as other drugs go off patent, but its exclusivity through to 2016 is being challenged by generic manufacturers in a case due to go to trial in February 2010. AstraZeneca has requested a summary judgment ahead of the trial to eliminate the most significant issue in the case and is awaiting the judge’s decision.

AstraZeneca shares rose 0.9 percent to $45.77 in afternoon trading on the New York Stock Exchange.

(Reporting by Lisa Richwine and Ben Hirschler; editing by Gerald E. McCormick and Andre Grenon)

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Number of US diabetics to double in 25 years

The number of Americans with diabetes will nearly double over the next 25 years, rising from 23.7 million in 2009 to 44.1 million in 2034, according to a study by the University of Chicago.

In the same period, medical costs associated with treating the disease will triple from 113 billion dollars to 336 billion dollars, even without a rise in the incidence of obesity, according to the study published in the December issue of Diabetes Care.

“If we don’t change our diet and exercise habits or find new, more effective and less expensive ways to prevent and treat diabetes, we will find ourselves in a lot of trouble as a population,” said lead author Elbert Huang.

The study said its projections, despite being significantly higher than other recent estimates, may be too conservative because they assume the rate of diabetes and obesity, a risk factor for the disease, will remain stable.

In 1991, scientists projected that the number of Americans with diabetes would reach 11.6 million people in 2030, but some 20 years before that date the figure is already double that.

The study’s authors acknowledge that obesity rates have risen steadily in past years, but predict that they will level out over the next decade and then decline slightly from the current 30 percent level to around 27 percent in 2033.

The US health program Medicare, which provides health care for older Americans, spends some 45 billion dollars a year on diabetes treatment for 8.2 million people.

By 2034, the number of people with diabetes covered by the program is expected to rise to 14.6 million, according to the study, with associated costs rising to 171 billion dollars a year.

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CDC warns: Holiday could bring more swine flu

ATLANTA – Let us give thanks — and pass the Purell.

Your family might be sharing more than turkey and pumpkin pie this Thanksgiving. Swine flu may also be on the table — and at crowded airports and shopping malls.

Just as the pandemic seems to be waning around the country, some health officials are worried that holiday gatherings could lead to more infections. So the government has launched a new travel-health campaign.

“It’s important to remember the things that everybody can do to stay healthy,” said Dr. Beth Bell of the Centers for Disease Control and Prevention.

Thanksgiving is typically followed by at least a modest bump in early seasonal flu cases, according to reports from the past few years. But this, of course, is not a typical year. Swine flu is a new virus that accounts for nearly all flu cases right now.

Despite weeks of declining infections, health officials are staying vigilant. The federal government is putting up posters in airports, seaports and border crossings in time for Thanksgiving. The campaign also includes advertisements with slogans such as “Stop, Wash & Go.”

The CDC urges people to travel only if they are well, get vaccinated against swine and seasonal flu, wash their hands often, and cover coughs and sneezes with a tissue or sleeve.

Some 33 million Americans are expected to hit the nation’s highways over the Thanksgiving holiday, a slight increase from last year. About 2.3 million more will travel by airplane.

The elbow-to-elbow conditions expected on many flights may pose more of an infection threat than a runny-nosed tike at the other end of a Thanksgiving dinner table. One CDC official even suggested asking that a sick passenger be moved to another part of a plane.

But that’s not likely to happen on a crowded airliner or bus, and it isn’t much of a solution anyway, said a few people waiting at Atlanta’s downtown Greyhound station on Tuesday morning.

“That’s just putting it next to somebody else,” said Judd Nelson, 39, waiting to start a two-day bus trip to Phoenix.

Nelson had not been vaccinated against swine flu, and he did not have any hand sanitizer. He was resigned to his fate if someone with swine flu happens to be aboard his bus.

“The way I look at it is, if I get it, I’m going to get it no matter what,” he said.

Swine flu has sickened an estimated 22 million Americans, hospitalized about 98,000 and killed 4,000 since it was first identified last April. It is similar to seasonal flu but poses a much bigger threat to children and young adults.

Usually, seasonal flu is just getting going in late November, and holiday get-togethers allow illness to jump from small pockets to other parts of the country. Swine flu, in contrast, has been widespread for months.

“It’s not like we expect to see a bunch of infected people going to uninfected cities and towns,” said Andrew Pekosz, a flu expert at Johns Hopkins University.

The swine flu pandemic hit in two waves: first in the spring, then a larger wave that started in the late summer.

For the past three weeks, fewer states have been reporting widespread cases. School closings have dropped to the point that there were none on Monday — the first time that’s happened since late August — though there were six on Tuesday, according to the U.S. Department of Education.

But there are still plenty of ill people — as many as during the peak of many regular flu seasons, CDC officials say.

Indeed, disease trackers are quick to say that flu is unpredictable. A variety of things could happen, including a third wave or a mutation that could make the virus more deadly or less susceptible to medicines.

“We really don’t know what the trajectory is going to be,” said Bell, a CDC epidemiologist who has been a leader in the agency’s swine flu response.

Seasonal flu usually emerges at this time of year, but some experts think swine flu will muscle aside the seasonal viruses. That probably will not be known until next month, said Dr. Richard Whitley, an infectious diseases specialist at the University of Alabama at Birmingham.

At New York’s Pennsylvania Station, Katie Almroth was waiting to board a train Tuesday with her 11-month-old daughter Anna, who’s been vaccinated for seasonal flu but not for swine flu. They were headed to Harrisburg, Pa., to visit relatives for Thanksgiving.

The 33-year-old nurse from Jersey City, N.J., said she was not worried about traveling during the swine flu pandemic, but felt more comfortable on a train than an airplane with her daughter.

“I must admit I did bring little wipes along,” said Almroth, showing the antiseptic wipes she had tossed in her bag with small bottles of hand sanitizer.

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Weight May Not Drive Racial Disparities in Colon Cancer

MONDAY, Nov. 23 (HealthDay News) — Body weight and co-existing health problems don’t explain why black colon cancer patients have lower survival rates than whites, U.S. researchers say.

In an effort to determine why blacks have lower survival rates than whites for nearly all cancers, including colon cancers, investigators have explored a variety factors, such as differences in health care access, exposure to risk factors and tumor characteristics. However, the role these factors play in survival rate disparities remains unclear.

In the new study, researchers at the University of Alabama at Birmingham looked at how weight and comorbidity (the presence of other diseases in addition to colon cancer) affected colon cancer survival in 496 patients who had surgery for colon cancer between 1981 and 2002.

Black patients were 34 percent more likely than white patients to have died by 2008, according to the study published online Nov. 23 and in the Dec. 15 print issue of the journal Cancer.

Among patients with early-stage cancer, the risk of death from any cause was 2.2 times higher in those with a high level of comorbidity. Among patients with advanced cancer, being underweight was associated with an 87 percent increased risk of death. However, being overweight or obese reduced the risk of death by 42 percent among patients with stage IV colon cancer, the study authors noted.

These findings were the same regardless of race, which suggests that differences in weight or comorbidity don’t explain why black patients are more likely to die than white patients, the researchers concluded.

“Further efforts are needed to identify the basis for the survival difference by race for patients with colon cancer. A greater understanding of this complex issue may help eliminate the disparity,” research leader Upender Manne said in a news release from the journal’s publisher.

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