Gene Therapy Shows Promise Against HIV

A new study is among the first to hint that gene therapy could become a weapon against the virus that causes AIDS.

However, any treatment remains far from being ready for use by patients, and would likely be expensive, experts said.

Still, the research is "a step in the direction of using gene therapy" to treat HIV patients, said Dr. Pablo Tebas, co-author of a new study and associate professor of medicine at the University of Pennsylvania.

Existing AIDS drugs allow many patients to live fairly normal lives despite being infected with HIV. But they can cause a variety of side effects, and some patients become immune to them over time.

"The next big challenge is going to be: Can you cure the infection or control it to a level that allows patients to not take these expensive and complex medications that can be toxic?" Tebas said.

One possible solution is to help the body fight off HIV without the use of drugs. That's where gene therapy comes in, Tebas said. "Can you make the patient resistant so they can control HIV on their own?"

In the new study, the Pennsylvania team tested a gene therapy approach in which scientists first remove immune cells from patients, tinker with their genes and then put them back into the bodies of the patients.

Eight HIV-infected people took part in the study. After the genetically modified cells were placed back into the patients, "we stopped HIV treatment and tried to see what happened," Tebas said.

The findings are scheduled to be reported this week at the Conference on Retroviruses and Opportunistic Infections in San Francisco.

The levels of HIV fell below the expected levels in seven of the eight patients, the team found. Signs of the virus disappeared altogether in one patient, although that happens sometimes -- it's not an indication that the disease is cured -- and the researchers aren't sure why it happened in this case.

"We need to understand why it happened and see if we can reproduce that in the general population," Tebas said.

It's still early in the development of the treatment: the current research is in phase 2 of the customary three phases of research that new medical treatments go through.

If gene therapy does become a treatment for HIV patients, it may be best for those who aren't doing well on existing antiretroviral drugs, said John Rossi, chairman of the molecular and cellular biology department at the Beckman Research Institute of City of Hope Medical Center near Los Angeles.

"There are thousands of people who are completely resistant to all the drugs that are out there, and this is one more option they could have," Rossi said.

But the cost of the treatment would probably be high, he added, perhaps reaching around $20,000. And it's not clear how long the treatment would last, he said, since the immune cells aren't permanent.

Genetic Mutation Linked to Prostate Cancer in Blacks

Researchers have identified a mutation in a small number of black American men with a family history of prostate cancer.

This germline mutation of the androgen receptor (AR) may prove to be a genetic biomarker for familial prostate cancer in the black American male population, according to the team at Louisiana State University in New Orleans.

Black American men have a higher incidence of prostate cancer than any other racial group. The small amount of research that's been done on the role that AR mutations play in prostate cancer has been limited to white men.

This study found a germline AR-A1675T substitution mutation in the DNA-binding domain in three black American men with a family history of early-onset prostate cancer. This mutation may contribute to prostate cancer by "altering the AR DNA-binding affinity and its response to androgens, non-androgenic steroids or anti-androgens," according to a news release about the study.

The study was published online this week in the Asian Journal of Andrology.

Further research is needed to learn more about the role this mutation plays in prostate cancer in black Americans, the researchers said.

More information

The U.S. Centers for Disease Control and Prevention has more about prostate cancer.

US scientists warn of fraud of stem cell 'banks'

Clinics that offer to "bank" stem cells from the umbilical cords of newborns for use later in life when illness strikes are fraudsters, a top US scientist said.

Clinics in many countries allow parents to deposit stem cells from their neonate's umbilical cord with a view to using the cells to cure major illnesses that could occur later in life.

In Thailand, for example, parents pay in the region of 3,600 dollars to make a deposit in a stem cell bank, thinking they are taking out a sort of health insurance for their child.

But Irving Weissman, director of the Institute of Stem Cell Biology and Regenerative Medicine at Stanford University in California, said the well-meaning parents were being fleeced by the stem cell bankers.

"Umbilical cords contain blood-forming stem cells at a level that would maintain the blood-forming capacity of a very young child," Weissman told reporters at the annual meeting of the American Association for the Advancement of Science (AAAS).

"They could also have derived mesenchymal cells -- fiberglass-like cells that have a very limited capacity to make scar, bone, fat -- but they don't make brain, they don't make blood, they don't make heart, they don't make skeletal muscle, despite what various people claim," he said.

Weissman said these "unproven stem cell therapeutic clinicians" tend to set up shop in countries with poor medical regulations, but AFP found websites for umbilical cord stem cell banks in European Union member states and in the United States.

"They do the therapies, then they let the patients go on their own, short of maybe 50-150,000 dollars for a therapy that has no chance -- taken away from a family that needs them when they have an incurable disease," Weissman said.

"It is wrong."

The International Stem Cell Society is due to issue a report in April about unproven stem cell therapies such as banking a baby's umbilical cord blood for future use.

Heart Stem Cells Move Closer to Human Treatments

Researchers are moving ahead -- although sometimes ploddingly -- toward the goal of using stem cell therapies to rescue people with cardiovascular disease, the leading killer of men and women in the United States.Although much of the gains thus far have been in basic science, stem cells do seem close to actually being able to help actual humans.

"We have seen consistent but modest effects of stem cells in improving heart function and reverse remodeling of heart," said Dr. Gordon Tomaselli, a spokesman for the American Heart Association and an associate professor of medicine at the Johns Hopkins University School of Medicine in Baltimore.

"I think there's great hope," added Dr. Darwin J. Prockop, director of the Texas A&M Health Science Center College of Medicine Institute for Regenerative Medicine at Scott & White in Temple.

Several studies presented last November at the annual scientific sessions of the American Heart Association in Orlando serve as examples.In one study, out of Germany, 35 patients who received bone-marrow stem cell transplantation during coronary artery bypass surgery achieved "excellent long-term safety and survival."

Ten patients who received similar transplantations after repair of mitral valves also fared well, with improvements in the heart's pumping capacity.

Slovenian investigators had similar success, with improvements seen in patients with advanced heart failure who received bone-marrow derived stem cells.There were also advances in gene therapy reported, with Singaporean researchers using nanotechnology to deliver genetically modified cells to help heal heart attack damage in rabbits.The stem cell promise hinges on the ability to produce unlimited supplies of human cardiac cells, experts say.

Kevin Eggan, chief scientific officer for the New York Stem Cell Foundation and associate professor of stem cell and regenerative biology at Harvard University, noted two breakthrough treatments that would require steady production of stem cells.One is a future "patch" made out of these cells to fix a damaged heart after a heart attack. Researchers also hope to fashion blood vessels out of stem cells for use in bypass surgery and other procedures.

"People are making very substantial progress in being able to make those various vascular cells you would need," Eggan said. "Transplanting those is something that will come from all of this."

More immediately, perhaps, is the use of stem cells to screen heart drugs, sort of like test-driving the drugs in preclinical trials, Eggan said.

"You can do this in a couple of different ways," Eggan said. Researchers could determine in a laboratory dish if a drug actually works on heart cells, he said. The other method would involve manufacturing heart cells for a variety of people to find out which cells the drugs work on.

"One of the tricky things about drug trials is they often don't work on all people equally well," Eggan explained. "You have to study a whole lot of people to be able to see any sort of effects. This would screen out people that the drug doesn't work on. It would enable personalized medicine."

One innovation that is close to market, Eggan said, is a method for identifying and eliminating toxic drugs before they go into clinical trials.A system is in the works that would involve testing drugs on heart muscle cells in a lab dish.

"This could save enormous time and money in clinical trials," Eggan said.

Gene therapy has not advanced as far, he added, but predicts that it will combine with stem cell therapies in the future.

"The one good thing that really has come out is that nobody has been harmed by [the stem cell] therapies," Prockop pointed out.

Survey Finds Many Men Complaining of Ill-Fitting Condoms

Poorly fitting condoms not only boost the risk of sexually transmitted diseases, they also reduce sexual pleasure during intercourse, a new study has found.

The findings are based on a survey of 436 men, aged 18 to 67, who responded to an Internet survey after being recruited through newspaper ads and a blog on a condom sales company Web site. The survey asked the men about how a condom fit the last time they used one while having sex with a female.

Nearly 45 percent said they'd used a condom that fit poorly the last time they had sex during the previous three months. These men were more than 2.5 times more likely to say their condom broke or slipped compared to those who said their condoms fit well. And they were five times more likely to say they experienced irritation to the penis.

The men whose condoms fit poorly were also about twice as likely to say that the condoms made it difficult for them, their partners or both to reach orgasm. Not surprisingly, this made intercourse less pleasurable, the study authors noted.

And the men with poor-fitting condoms were twice as likely to say they took off the condoms before they finished having sex, the survey found.

The findings "emphasize the point that men and their female sex partners may benefit from public health efforts designed to promote the improved fit of condoms," the researchers wrote.

The study, which surveyed men through the Web site of the Kinsey Institute for Research in Sex, Gender and Reproduction, is published online in February in the journal Sexually Transmitted Infections.

More information

The U.S. National Library of Medicine has more on condoms.

High-fat diets raise stroke risk in women

A moment on the lips, forever on the hips? A bad figure is hardly the worst of it. Eating a lot of fat, especially the kind that's in cookies and pastries, can significantly raise the risk of stroke for women over 50, a large new study finds. We already know that diets rich in fat, particularly artery-clogging trans fat, are bad for the heart and the waistline.The new study is the largest to look at stroke risk in women and across all types of fat. It showed a clear trend: Those who ate the most fat had a 44 percent higher risk of the most common type of stroke compared to those who ate the least.

"It's a tremendous increase that is potentially avoidable," said Dr. Emil Matarese, stroke chief at St. Mary Medical Center in Langhorne, Penn. "What's bad for the heart is bad for the brain."He reviewed but did not help conduct the research, which was presented Wednesday at an American Stroke Association conference. It involved 87,230 participants in the Women's Health Initiative, a federally funded study best known for revealing health risks from taking hormone pills for menopause symptoms.Before menopause, women traditionally have had less risk of stroke than similarly aged men, although this is changing as women increasingly battle obesity and other health problems.After menopause, the risk rises and the gender advantage disappears, said Dr. Ka He, a nutrition specialist and senior author of the study from the University of North Carolina, Chapel Hill.He and another researcher, Sirin Yaemsiri, wanted to see whether dietary fat affected the odds.

Participants in the study had filled out detailed surveys on their diets when they enrolled, at ages 50 to 79. Researchers put them into four groups based on how much fat they ate, and looked about seven years later to see how many had suffered a stroke caused by clogged blood vessels supplying the brain — the most common kind.

There were 288 strokes in the group of women who consumed the most fat each day (95 grams) versus 249 strokes in the group eating the least fat (25 grams), Yaemsiri told the conference.After taking into account other factors that affect stroke risk — weight, race, smoking, exercise and use of alcohol, aspirin or hormone pills — researchers concluded that women who ate the most fat had a 44 percent greater risk of stroke.They also found a 30 percent greater risk of stroke among women eating the most trans fat, which is common in stick margarine, fried foods, crackers and cookies.

"We need to look at the labels on the foods we buy," because many of these fats are hidden in baked goods and people are not aware of how much they're consuming, Matarese said. "This is a simple way that any woman, especially postmenopausal women, can improve their health. Simply avoiding fried foods is a big one."

On average, American women in their 50s and 60s eat 63 to 68 grams of fat a day, federal health statistics show. A little context: A 2-ounce Snickers bar contains 14 grams of fat; a 2-ounce bag of Crunchy Cheetos has 20 grams, as does a Haagen-Dazs ice cream bar.The American Heart Association recommends limiting fat to less than 25 to 35 percent of total calories, and trans fat to less than 1 percent. The healthiest fats come from nuts, seeds, fish and vegetable oils.

"We don't do a good enough job of emphasizing the importance of a good diet," said Dr. Lee Schwamm, a stroke specialist at Massachusetts General Hospital. Pediatricians in particular need to address the risk for chubby kids.If you don't change their patterns and problems in childhood, you're really looking at a lifetime of obesity," he said.

___

Health Tip: What's Gastroparesis?

Gastroparesis, commonly affecting people with diabetes, occurs when the vagus nerve is damaged and the stomach and intestines don't process food normally. As a result, the stomach takes too long to empty.

The American Diabetes Association says common symptoms of gastroparesis include:

• Heartburn.
• Feeling nauseous, or vomiting food that hasn't been digested.
• Feeling full very quickly.
• Losing weight.
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• Fluctuating blood glucose levels.
• Gastroesophageal reflux (heartburn).
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Interval training can cut exercise hours sharply

LONDON – People who complain they have no time to exercise may soon need another excuse. Some experts say intense exercise sessions could help people squeeze an entire week's workout into less than an hour. Those regimens — also called interval training — were originally developed for Olympic athletes and thought to be too strenuous for normal people.But in recent years, studies in older people and those with health problems suggest many more people might be able to handle it. If true, that could revolutionize how officials advise people to exercise — and save millions of people hours in the gym every week. It is also a smarter way to exercise, experts say.

"High-intensity interval training is twice as effective as normal exercise," said Jan Helgerud, an exercise expert at the Norwegian University of Science and Technology. "This is like finding a new pill that works twice as well ... we should immediately throw out the old way of exercising."

Studies on intense training have been published in sports medicine journals and have largely been based on young, healthy people. Experts say more studies are needed on how older and less fit populations handle this type of exercise before it can be recommended more widely.Intense interval training means working very hard for a few minutes, with rest periods between sets. Experts have mostly tested people running or biking, but other sports like rowing or swimming should also work.Helgerud recommends people try four sessions lasting four minutes each, with three minutes of recovery time in between. Unless you're an elite athlete, it shouldn't be an all-out effort."You should be a little out of breath, but you shouldn't have the obvious feeling of exhaustion," Helgerud said.

In Britain and the U.S., officials recommend that people get about 2 1/2 hours each week of moderate exercise. Those guidelines target a mostly sedentary population and are intended to help with weight control and heart health, not boosting fitness levels, increasing strength or endurance.Some experts have cautioned that ordinary people shouldn't substitute their regular exercise routine for intense training.

"There isn't enough evidence to say people should do one or the other," said Gary O'Donovan, a sports and exercise expert at the University of Exeter. "Any bout of exercise has the potential to improve your blood pressure or lower your cholesterol, and it doesn't necessarily have to be intense."

Still, O'Donovan said more intense exercise would probably produce better benefits.Helgerud says the time people spend in the gym could be slashed dramatically if they did interval training instead. He said officials have been too afraid of recommending intense training for fear it would be too much for some people.

"I'm much more afraid of people not exercising at all," he said. "Inactivity is what's killing us."

When compared to people on a normal exercise routine, like jogging, research has shown those doing interval training can double their endurance, improve their oxygen use and strength by more than 10 percent and their speed by at least 5 percent. Even studies in the elderly and in heart patients found they had better oxygen use and fitness after doing interval training.

Still, experts advise people to consult a doctor before starting any fitness program.

For Adamson Nicholls, a 36-year-old Londoner and martial arts enthusiast, interval training is a way to boost his endurance so he can outlast sparring opponents. "It's a shortcut to explosive fitness," he said, adding the training resulted in snappier and heavier punches.Using interval training, Nicholls got into top shape last year in about six weeks with weekly 45-minute sessions. He estimates the same level would have taken about three months via regular training.Experts say that's because intense bursts of activity are precisely what the body needs to build stronger muscles. Traditional workouts lasting an hour or more simply don't push the body enough.

"A lot of the (benefits) from exercise are due to a stress response," said Stephen Bailey, a sports sciences expert at the University of Exeter. "If you disturb your muscles, there's an imbalance created and your body will start signaling pathways that result in adjustments."

Bailey said intense bursts of exercise help the body to convert one type of muscle fiber into another type that uses oxygen more efficiently and is capable of exercising a lot longer. Even though interval training only takes a few minutes, its effects last for hours.

Chronic Back Pain Soothed by Cognitive Behavioral Therapy

People suffering from chronic lower back pain may find relief through cognitive behavioral therapy, a short-term treatment aimed at challenging and reframing negative beliefs.

Chronic lower back pain is one of the three most disabling conditions in the developed world, the British researchers report. And, it can be expensive to treat.

"Back pain is a physical health problem, not a psychological problem," said study co-author Zara Hansen, a physiotherapist and cognitive behavioral therapist at the University of Warwick in Coventry, England. "The intervention uses a psychological model to understand how we can manage back pain better, but it is not psychotherapy,"

In the study, cognitive behavioral therapy helped people change their thinking about their back pain and how they managed it, Hansen said.

"This is a relatively new approach to helping people manage long-term health conditions. People with persistent back pain are at risk of developing anxiety and depression, but this intervention did not aim to treat anxiety and depression," she said.

For the study, published in the Feb. 26 online edition of The Lancet, Hansen's team randomly assigned 701 patients with low back pain to therapy in addition to standard treatment or to standard treatment alone. The standard treatment included guidance on staying active and the best use of pain medication. The others got up to six sessions of group therapy. All participants had their back pain measured at the start of the study and one year later.

At one year, those who had CBT showed a 2.4 point improvement on one disability test and a 13.8 percent improvement on the other. Those who had no therapy saw a 1.1 point improvement on the one score and a 5.4 percent improvement on the other, the researchers found.

Cognitive behavioral therapy for health problems is based on a psychological model, Hansen said.

"The model explains that the way that we think about our health problems will determine how we behave or, put another way, how we manage them," Hansen said. "If we have unhelpful ways of thinking about back pain, we'll behave or manage it in unhelpful ways. A cognitive behavioral intervention targets the thoughts or behaviors directly."

"For example, if I have persistent back pain and I think that I should avoid anything that brings on pain in case I am damaging myself, then I will slowly become less and less active, less and less fit, and then the stiffness and weakness that comes with using my back less will make my back feel worse," Hansen said.

Therapy, offered individually or in a group setting, helps patients identify this vicious cycle. The aim is to understand that pain doesn't usually signify ongoing damage and that by gradually increasing activity they can relieve the stiffness and weakness, Hansen said. "The main aim of the intervention is to help people get back to doing enjoyable and/or rewarding activities that they may have stopped or avoided due to back pain," she said.

Back pain is increasingly common, said Dr. Laxmaiah Manchikanti, medical director of the Pain Management Center of Paducah, Ky. "However, it can be managed effectively for a significant proportion of patients in a primary-care setting with (therapy) when it is available."

Therapy costs about half of other treatments, such as acupuncture, the researchers noted. But as a treatment for back pain, it is not usually covered by health insurance in the United States.

Manchikanti noted that in Great Britain such therapy is available at a low-cost paid for by insurance. "Other countries than the U.S. should apply cognitive behavioral therapy prior to embarking on specialty referrals with other interventions or surgery," he said. "For the U.S., we should consider developing such systems."

Some other experts also think the therapy merits consideration for coverage. "The study supports the role of bio-behavioral therapy as a treatment option and notes that it does not expose patients to additional risk like many other treatment options do," said Brook Martin, a research scientist at the Comparative Effectiveness, Cost and Outcomes Research Center of the University of Washington.

"Despite some limitations, I would hope that this study will, at a minimum, raise providers' awareness to the potential role and cost-effectiveness that bio-behavioral therapy may play in clinical practice." he said.

Stroke study finds neck stents safe, effective

SAN ANTONIO – People at risk of a stroke because of narrowed neck arteries can be safely treated with a less drastic option than the surgery done now, the largest study ever done on these treatments concludes.

If Medicare agrees to cover it, hundreds of thousands of Americans a year might be able to have an artery-opening procedure and a stent instead of surgery to remove built-up plaque, doctors say. A stent is a wire-mesh tube that props the blood vessel open.

Stents have long been used to fix heart arteries but are approved for use in the neck only for people too sick for surgery. The new study, in people with less severe disease, suggests stents may find much wider use.

"The sea of people is gigantic" who could benefit, said Dr. Walter Koroshetz, deputy director of the National Institute of Neurological Disorders and Stroke, the study's main sponsor.

"We now have two safe and effective methods" to treat neck vessels, said Dr. Thomas Brott of the Mayo Clinic in Jacksonville, Fla. He led the study and gave results Friday at an American Stroke Association conference.

However, the treatments have different complications, and not all doctors are convinced stents are as safe. Three previous studies found they were not, including one published online Thursday by the British journal The Lancet.

The reason: Even though stents prevent strokes in the long run, the procedure itself can trigger a stroke if a bit of plaque travels to the brain.

The new study revealed a tradeoff: Strokes were a more frequent complication with stents, while heart attacks were more common after surgery.

Doctors say which option a patient chooses may depend on their general health, what risks they are willing to accept and how badly they want to avoid surgery.

Surveys show that people worry more about stroke than a heart attack, said Dr. Lee Schwamm, a top neurologist at Massachusetts General Hospital.

"They're terrified of surviving a stroke with major disability ... ending their years in a nursing home," he said.

In the study, "stroke was by far the more disabling complication," said Dr. Wesley Moore, a University of California at Los Angeles doctor who oversaw the surgery part of the study.

About 795,000 Americans each year suffer a stroke. Many are caused by a clot that forms in a narrowed neck artery and travels to the brain. Doctors can check for narrowed arteries by using a stethoscope to listen for abnormal sounds in neck arteries, and a painless ultrasound test can show blockages.

The top treatment has been surgery: with the patient under general anesthesia, the artery is cut open, the plaque removed, and the vessel sewn back together. Stents won approval as an alternative for certain patients in 2004; half a dozen companies make the devices now, although Abbott Laboratories stands to benefit most because its stents were in the study.

To place them, doctors put a tube in a blood vessel in the groin and push it to the narrowed artery. A parachute-like filter is placed to trap bits of plaque that dislodge and keep them from traveling to the brain. A balloon is inflated to flatten the clog, the stent is placed to hold the artery open, and the filter is removed. The patient is awake but sedated.

The study involved 2,502 patients in the United States and Canada. Half had recent symptoms such as a ministroke. The rest had no symptoms but significantly narrowed neck arteries. They were given either surgery or a stent made by Abbott Vascular, a division of North Chicago, Ill.-based Abbott Labs, which helped sponsor the trial.

A month later, about 4 percent of the stent group had suffered strokes versus 2 percent of those who had surgery. About 2 percent of the surgery group had heart attacks compared to 1 percent of those given stents.

There were nine deaths in the stent group versus four in the surgery group, but the difference in a study this size was so small that it could have occurred by chance alone, Brott said.

Age mattered.

"If you were younger than 70, you were slightly better off with a stent," while older patients fared better with surgery, Brott said.

There is no age limit for the surgery, said UCLA's Moore. "I've operated on people who are centenarians. If somebody lives to be 100 years old, they've got something going for them."

The study did not include a group of patients treated only with medicines to control stroke risk factors, such as high blood pressure and cholesterol. Without such a comparison group, it's impossible to know just how many strokes either treatment prevented.

Dr. Charles Simonton, chief medical officer of Abbott Vascular, said the results "are particularly impressive" because the study started a decade ago, when neck stents were still a new technology.

About 30,000 neck stents were used last year compared to 100,000 surgeries, but more people might be treated if a non-surgical option becomes available, Brott said.

Medicare pays $7,500 to $11,000 for surgery; stents cost around $12,000 because of the price of the devices, which range from $3,500 to nearly $5,000, said Dr. Charles Ross, vascular surgery chief at the University of Louisville.

If stents do win wider approval, patients should go to a place that offers both "so they can be given an unbiased opinion of how they would do with either procedure" or medicines alone, he said.