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The federal government’s push to control health costs through comparative effectiveness research could threaten strides in personalized medicine, in which medicines are tailored to an individual’s genetic makeup, the chief of the National Institutes of Health said on Monday.

“There is a potential collision here,” Dr. Francis Collins, director of the National Institutes of Health said at a forum sponsored by the American Association for the Advancement of Science.

Collins, a genetics pioneer tapped by President Barack Obama in July to head the NIH, said studies that lump together large groups of people to test the effectiveness of treatment A versus treatment B run the risk of overlooking clusters of people for whom a drug might have a dramatic effect.

“That’s going to get lost in the wash by considering everybody equivalent, which we know they are not,” said Collins, who helped lead the Human Genome Project that in 2003 produced a sequence of all the DNA in people.

“The antidote to that is pretty straightforward,” said Collins, saying that studies need to include genetic information that allows researchers to find such responses.

Backers of comparative effectiveness research, who include insurers and large employers, see the government-funded studies as a way to learn which treatments work best. But Collins said the studies should be well crafted.

“We need to be mindful of the goal of comparative effectiveness research and not lose all that we have gained in understanding how individuals differ and how that could be factored into better diagnostics and preventive strategies,” Collins told the meeting, which was broadcast on the Internet.

COST-CUTTING POTENTIAL

There is already evidence that personalized medicine can help reduce health costs, Collins said, pointing to Genomic Health’s Oncotype DX, a genetic test that can predict the recurrence of breast cancer.

“This test allows those individuals at low risk for recurrence to know they are at low risk and make a decision about whether to forgo chemotherapy, with all of its adverse consequences, based on that information,” Collins said.

He said the test costs $3,500, and most women who get tested and discover they are at low risk decide to forego chemotherapy, saving an average of $2,000 per patient in additional costs from chemotherapy treatment.

“In 2009, roughly 50,000 women are going through this process, predicting we will therefore save the healthcare system $100 million this year based on the availability of this kind of personalized medical test,” Collins said.

Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, told the meeting that many clinical trials are structured to determine if a drug is safe and effective in a large group of patients, but the drugs often leave out the why — why certain patients benefit while others do not.

The FDA increasingly is approving drugs with companion diagnostic tests using biomarkers — such as specific proteins or genes — that improve the odds that a new, high-cost biotechnology drug will work.

She said studies that look at the genetic profile of patients and its role in how drugs work could strengthen a drug’s application, lending more scientific certainty about why a new drug works.

“Perhaps then we could see more new drug applications in the pipeline that are more likely to succeed,” she said.

A diet high in a form of sugar found in sweetened soft drinks and junk food raises blood pressure among men, according to research likely to mean more bad news for beverage companies and restaurant chains.

One of two studies released on Wednesday provided the first evidence that fructose helps raise blood pressure. It also found that the drug allopurinol, used to treat gout, can alleviate the effect by reducing uric acid levels in the body.

The second study, which measured fructose intake in mice, suggested that people who consume junk foods and sweetened soft drinks at night could gain weight faster than those who don’t.

“These results suggest that excessive fructose intake may have a role in the worldwide epidemic of obesity and diabetes,” said Dr. Richard Johnson of the University of Colorado-Denver, who studied the link between blood pressure and men.

The findings provide the latest evidence of ties between sugar-rich diets and health problems that have prompted some experts to call for a tax on sugary soft drinks.

Fructose accounts for about half the sugar molecules in table sugar and in high-fructose corn syrup, the sweetener used in many packaged foods.

Johnson and colleagues at the Mateo Orfila Hospital in Spain studied 74 men given 200 grams of fructose per day on top of their regular diet. That amount is well above a daily intake of 50 grams to 70 grams of fructose consumed by most American adults.

Half the men were also given allopurinol.

After two weeks, the men who received only the fructose registered increases of six millimeters in systolic blood pressure — the top reading — and about three millimeters in diastolic or the bottom reading, the researchers told an American Heart Association meeting in Chicago.

REVERSIBLE EFFECT

Most of their blood pressure readings returned to normal levels after two months.

The men who did not get allopurinol also were twice as likely to develop metabolic syndrome, measured by risk factors such as too much abdominal fat, high blood pressure and poor cholesterol readings.

By contrast, those given allopurinol and fructose had significantly lower uric acid levels, and virtually no increase in systolic blood pressure or higher risk of metabolic syndrome.

For the second study, researchers in Ohio studied mice given fructose water to drink. Some had unrestricted access, while others received it during the day or at night.

“The first thing we noticed was that the mice on restricted access rushed to their drinking bottles to load up on the sweetened beverage, similar to teenagers who drink too many soft drinks,” said Mariana Morris of Wright State University in Dayton, Ohio.

The mice that drank fructose water during their regular daylight sleeping hours gained more weight and had higher stress hormone levels than the other mice.

“This model may be similar to the human condition of night time bingeing of fructose-laden foods and beverages,” Morris said.

The American Heart Association says women should eat no more than 100 calories of added processed sugar per day, or six teaspoons (25 grams), while most men should keep it to just 150 calories or nine teaspoons (37.5 grams). On average Americans consume 22 teaspoons (90 grams) or 355 calories of added sugar each day.

Sickle Cell Trait
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Did you know?
Sickle cell disease occurs more often in people from parts of the world where malaria is or was common. It is believed that people who carry the sickle cell trait are less likely to be infected with malaria.
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People who inherit one sickle cell gene and one normal gene have the sickle cell “trait.”
People with sickle cell trait usually do not have any of the symptoms of the disease. But, it is possible for a person with sickle cell trait to have complications of the disease under extreme conditions, such as:
High altitude (flying, mountain climbing, visiting cities with a high altitude)
Increased pressure (scuba diving)
Low oxygen (mountain climbing or exercising extremely hard, such as in military boot camp or when training for an athletic competition)
Dehydration (too little water in the body)

In addition, people with sickle cell trait can potentially pass the disease on to their children.

It’s important to know whether or not you have sickle cell trait. Sickle cell trait is diagnosed with a simple blood test. People at high risk for having sickle cell trait are those whose ancestors come from Africa, South or Central America, the Caribbean, Mediterranean countries, India, and Saudi Arabia.
The Cost of Sickle Cell Disease

Sickle cell disease is a major health concern. People with sickle cell disease can have lifelong disabilities. The average life expectancy is 42 years for men and 48 years for women.1 In addition, the cost to people with the disease and the health care system is high. For example, hospital stays due to complications of sickle cell disease cost an estimated at $475 million during the period 1989–1993.2
A Public Health Approach

Right now, there are no data systems to find out how many people have sickle cell disease in the United States. CDC, in partnership with the National Institutes of Health (NIH), is working to develop a pilot surveillance system to help learn more about how many people have the disease and how it affects them.

In addition, CDC is helping to educate people a bout this disease. We have a website with information about the disease and tip sheets on how to stay healthy, how to prevent infections, and when to see the doctor. We are also developing new materials to help people better understand certain drug therapies and to raise awareness among students, teachers, and others in the community.
Help Spread the Word

Every September—during National Sickle Cell Awareness Month—community organizations, families, and others join together to spread the word about sickle cell disease.

Sickle cell disease (SCD) is a common inherited blood disorder in the United States, affecting an estimated 70,000 to 100,000 Americans.

The Many Faces of Sickle Cell Disease

Sickle cell disease affects people of many racial and ethnic groups. In the United States, 1 in 500 African-American newborns has the disease. Other people affected include Hispanics, people of Mediterranean and Middle Eastern descent, and Asians. In addition, more than 2 million people carry the gene that allows them to potentially pass the disease on to their children.
About Sickle Cell Disease

In sickle cell disease, the red blood cells become hard and sticky and look like a C-shaped farm tool called a “sickle.” The sickle cells die early, which causes a constant shortage of red blood cells. Also, when these blood cells travel through small blood vessels, they get stuck and clog the blood flow. This results in repeated episodes of severe pain, organ damage, serious infections, or anemia.

People with sickle cell disease can live full lives and enjoy most of the activities that other people do. There are things that people with sickle cell disease can do to stay as healthy as possible. Here are some examples:
Get regular checkups. Regular health checkups with a primary care doctor can help prevent some serious problems.
Prevent infections. Common illnesses, like the flu, can quickly become dangerous for a child with sickle cell disease. The best defense is to take simple steps to help prevent infections. See tips to help avoid getting an infection.
Learn healthy habits. People with sickle cell disease should drink 8 to 10 glasses of water every day and eat healthy food. They also should try not to get too hot, too cold, or too tired.
Look for clinical studies. New clinical research studies are happening all the time to find better treatments, and hopefully a cure, for sickle cell disease. People who take part in these studies might have access to new medicines and treatment options.
Get support. Find a patient support group or other organization in your community that can provide information, assistance, and support.

If your immune system is weakened, you may want to rethink that daily shower.

New research suggests that ordinary showerheads are awash in germs, particularly a type that can cause lung disease in people whose immunity to illness is compromised.

The germs could be “blasted out of the showerhead and inhaled by the person showering,” said study co-author Leah M. Feazel, a researcher at the University of Colorado’s department of molecular, cellular and developmental biology.

But Feazel said showerheads shouldn’t pose a threat to most people. And while the new findings do raise questions, it’s not clear if showerheads are any more germ-friendly than other places around the house, such as faucets, counters and toilets, she said.

Feazel and her colleagues decided to look at showerheads because they seem like an ideal place for germs to grow.

The inside of a showerhead provides ideal conditions for microbial growth, Feazel said. “It is moist, warm, protected from disturbance, and frequently fed with nutrient resources in the tap water. Also, most people have noticed discoloration on their showerheads. This ’soap-scum’ is actually microbial growth.”

The researchers analyzed germs found in the film formed in 45 showerheads from nine U.S. cities. They found a variety of bacteria in showerheads, most of which don’t cause illness in people. But they also found germs called mycobacteria, which are common and can cause lung disease in people with compromised immune systems, Feazel said.

The levels of certain germs that could spell trouble were 100 times above what they were in water before it made its way to the showerhead, the researchers said.

The unique thing about showerheads is that the germs could be inhaled. People are unlikely to inhale other kinds of household germs that fit into the category known as biofilms, with the exception of those produced by humidifiers, according to the study.

The findings were published in this week’s online issue of the Proceedings of the National Academy of Sciences.

Feazel stressed that most people shouldn’t be concerned about showerheads.

“If a person is worried about the risk of lung infection from showering, they have several options,” she said. “Bathing, rather than showering, is probably best for those who are at risk. The size of the water droplets produced in bathing is too large to go deep into the lungs, whereas showering creates tiny particles that can go very deep and cause disease.”

An all-metal showerhead — not a plastic one with a metal coating — is another alternative, as is replacing a showerhead several times a year, Feazel said.

“Cleaning the inside of a showerhead is very difficult and may be only partially effective,” she explained.

George A. O’Toole, an associate professor in the department of microbiology and immunology at Dartmouth Medical School, noted that germs lurk everywhere.

“I imagine that if you looked at the kitchen sink, faucet and drain, the insinkerator, your dishwasher, the toilet, your washing machine and the hose in the yard, you might find similar pathogens,” he said.

In the case of showerheads, he said, “people with good immune systems really don’t need to worry about this. People with bad immune systems probably do, but they also need to worry about every encounter with microbes.”

People with weakened immune systems include those infected with HIV, cancer patients undergoing chemotherapy, and recent transplant recipients.

Language barriers may contribute to lower screening rates for colorectal cancer among Mexican-Americans, a San Diego State University study suggests.

A 2005 telephone survey of close to 17,000 older Californian residents found that two thirds of those of Mexican descent needed another person to help them talk with doctors — more than three times the rate of those non-Latinos surveyed.

This, the researchers said, could account for another finding: More than 40 percent of Mexican-Americans never received one of the two most common screening tests for colorectal cancer while the same was true of less than a quarter of non-Latino whites.

The study results appear in the summer issue of the journal Ethnicity & Disease.

While national statistics show that Latinos tend to be diagnosed with colorectal cancer during its later, advanced stages and thus have a lower survival rate than non-Latino whites, at least one doctor believes cultural issues may be at play as much as language barriers.

Luisa Borrell, an associate professor in the public health graduate program at Lehman College, City University of New York, notes that while a third of Californians may be Hispanic, the number of Hispanic doctors is still in the low single digits.

“The pipeline for Hispanics to increase the number of physicians is not ready to match the demand of the fast-growing Hispanic population now or in the near future,” Borrell, who was not involved in the study, said in a news release issued by Health Behavior News Service.

Borrell also noted language may be less of an issue in the future as California now has laws requiring translators be present in places where health care is offered.

Getting kids to sit down, focus and learn their schoolwork is an age-old problem. Today, parents face the added challenge of cell phones, portable music devices like iPods, and the many distractions of the World Wide Web. There are so many things that can pull your kids’ attention away from what needs to get done for school. How can you help them focus and succeed?

Scientists funded by NIH and other federal agencies are trying to find some answers by studying how kids learn, remember and think. They’ve discovered that children are more likely to become successful learners when their families actively support them. Reading with your kids, talking with their teachers, participating in school-related activities and helping them with homework all can give kids a tremendous advantage.

“There are many ways parents can help kids study,” says Dr. Janet Metcalfe, a psychologist at Columbia University. For instance, Metcalfe’s research shows that children in grades 3 and 5 are about as good as college students in recognizing what they know and don’t know—an ability called metacognition. But unlike college students, the younger kids often have trouble choosing the right things to study.

“College students usually won’t want to study the things they’ve already mastered, and they won’t study the things that are extremely difficult. They’ll pick things that are sort of in the middle,” says Metcalfe. “That’s the best way to learn.”

But grade-school kids, when given an option, often choose to study things they already know. “They say, ‘I want to study that. I know that. I like that.’ But that won’t help them learn,” says Metcalfe. “Instead they should study things that are just beyond what they already know. I call it the Goldilocks principle. They need to choose what’s not too easy and not too difficult, but just right.”

Parents can help by guiding younger kids to focus on concepts and homework that’s just beyond what they have already mastered. For instance, if you’re using flashcards and a child always gets the 2-times table correct, put those cards aside for a few days or weeks and focus on problem areas.

Flashcards can also help kids learn in another way. Research shows that most people remember better when they come up with answers themselves—as with flashcards or quizzes—than when they simply read or sit through a lecture. “It’s called the ‘generation effect.’ Children learn best when they generate answers for themselves,” says Metcalfe. “You may be tempted to give kids the answers, but be patient. Wait for them to come up with something on their own, even if it takes a while.” She adds that hints are OK if kids are really stuck.

If children have study sheets with both questions and answers, cover up the answers so they have to come up with solutions on their own. “Otherwise, they can fall into the illusion that they know the material when they really don’t,” Metcalfe says.

Another effective study technique involves waiting for a few days or weeks between study sessions. Relatively short review sessions that are spaced apart can significantly improve memory and test scores compared to a single, longer review session, many research teams have shown. “You’re much better off in the long run to study for about 20 minutes a day for several days than to spend an hour-and-a-half on the last day before the test,” says Metcalfe.

One recent study of more than 1,000 students showed that larger gaps between review sessions can lead to better recall of facts for longer periods of time. The research, funded by the U.S. Department of Education, found that the ideal spacing between initial learning and review depends on how long you want to remember the material. For example, if your test is in a week, it might be best to review the information the day after you first learned it. If the test is in a month, study a week after your first learning. Parents should encourage their students to study in smaller doses and not wait until the last minute.

Another way parents can help is to remove distractions during study time. Children may think they can learn and write papers while texting friends, listening to music, Twittering and playing video games. But the research says otherwise. “Many studies have shown that as you multitask, and the closer in time that you’re doing 2 or more tasks, the greater the number of errors you make, and you slow down,” says Dr. Jordan Grafman, a neuroscientist at NIH.

Some studies have shown that people can become better at multi-tasking the more they do it. But these improvements are limited to easy, superficial tasks done so often they become routine. “Any type of deep thinking—creative, inventive thinking—is not likely to come from multitasking,” says Grafman.

Grafman and his colleagues used MRI to pinpoint the brain regions important for multitasking. “These include the frontal lobes—one of the most evolved areas of the human brain,” Grafman says. “It’s also one of the last areas to mature in people—often not until they’re in their 20s.”

Grafman notes that many of the distracting devices and websites favored by students provide instant enjoyment, which can be hard for kids and even adults to ignore. The rapid-fire feedback they provide may ultimately stunt attention span and focused thinking.

“It’s important to have kids engage in activities where they are forced to turn off their devices and interact with each other, to actually have quiet time,” says Grafman. “Sit by a river or walk in the woods, but leave the devices at home. This pushes kids to learn how to think about things, and they become engaged. It may be difficult—especially with teenagers—but it’s worth the effort.”

Older patients, or those with a prior history of stroke, are most likely to get a benefit when using warfarin to treat atrial fibrillation, a common heart rhythm disorder, a new study finds.

Kaiser Permanente and Massachusetts General Hospital researchers also say the drug is especially beneficial for patients with multiple risk factors for stroke.

Atrial fibrillation, which occurs when the heart’s upper chambers quiver instead of contract, affects more than 2 million Americans. Because the disturbance promotes the formation of blood clots that can travel to the brain and block an artery, atrial fibrillation greatly increases the risk of stroke.

Researchers know that warfarin can prevent such strokes, but the treatment is difficult to control and often leads to hemorrhage. In fact, warfarin is associated with the most emergency admissions for drug-related adverse reactions, according to a Massachusetts General Hospital news release.

Balancing the benefits of warfarin against its severe risks is key to making the best therapeutic decisions for atrial fibrillation patients, study senior author Dr. Alan S. Go, director of the Comprehensive Clinical Research Unit at the Kaiser Permanente Division of Research, said in the news release.

The study appears in the Sept. 1 Annals of Internal Medicine.

Researchers followed almost 13,600 adults with atrial fibrillation treated within Kaiser Permanente of Northern California from 1996 to 2003.

The researchers analyzed rates of the most significant adverse events associated with warfarin therapy — ischemic stroke, the type produced by arterial blockage; and intracranial hemorrhage, bleeding within and around the brain.

For patients who did and didn’t take warfarin, the investigators balanced the reduction in ischemic stroke attributable to treatment against the increase in intracranial bleeding associated with the drug. Since intracranial hemorrhages usually have worse outcomes than ischemic strokes, bleeding events were given greater weight in the comparison.

While warfarin therapy benefited most atrial fibrillation patients, the balance of benefits over risks was greatest in those at highest risk of stroke — those with multiple risk factors, those with a history of stroke and the oldest patients. Benefits of treatment increased with age, with no clear value seen in patients younger than 65. However, a reduction of more than two strokes per 100 patients was seen in people 85 and older.

Racial disparities exist in many areas of health care, from heart disease treatment to rates of surviving cancer. And studies have suggested that white patients do better than African Americans following liver transplants. But race may not play a role in survival after liver transplants for hepatitis B infection, nor while waiting for one, according to a new study.

But an expert in the field who was not involved in the study cautions that the number of African-Americans included in the study — just 23, 17 of whom underwent transplantation — is too small to conclude that there are no racial disparities in survival on the “wait list” or after transplant.

Up to 2 million Americans are infected with the hepatitis B virus (HBV), and liver disease due to HBV infection accounts for up to 10 percent of liver transplants.

Several studies found that Asians who underwent transplantation for HBV infection fared worse than whites, but there is little information available on how African-Americans do after transplant for HBV, or on wait list outcomes for Asians or African-Americans, Dr. Natalie Bzowej of California Pacific Medical Center in San Francisco and her colleagues note.

To investigate, Bzowej and her team looked at 274 patients awaiting liver transplants for HBV infection at 15 different US centers, including 116 whites, 135 Asians, and 23 African-Americans. All had gone on the United Network of Organ Sharing wait list between 1996 and 2005.

The researchers found no racial disparities in the probability that a patient would receive a transplant, or survive on the wait list. Five years after the transplant, 94 percent of African-Americans were alive, compared to 85 percent of Asian Americans and 89 percent of whites, they report in the journal Liver Transplantation.

The only factor associated with survival after transplant was whether or not a patient had recurrence of liver cancer, and recurrence of the disease was the same in the three racial groups.

But within four years of undergoing transplant, 19 percent of white patients had a recurrence of HBV, compared to 7 percent of Asians and 6 percent of blacks. Whether or not a patient’s HBV returned after transplant didn’t influence their survival after the procedure.

In an editorial accompanying the study, Dr. Charles D. Howell of the University of Maryland School of Medicine in Baltimore points out that a study looking at liver transplantation for HBV between 1997 and 2001 found that while whites and Asians had similar survival rates, survival was less likely for African Americans.

The current study, he argues, included too few African-Americans for “dependable conclusions” to be drawn about whether African-Americans fare worse — or the same –after liver transplant for HBV compared to other ethnic groups.