December 29, 2010

7 Major Advances Predicted for Health & Medicine in 2011

Dec 29, 2010 4:59 PM ET
By Lauren Cox, MyHealthNewsDaily Contributor

In terms of advancement in the fields of science and medicine, 2010 was a stellar year. German doctors appeared to have cured a man of HIV. Doctors watched a drug called PLX4032 melt away the tumors of melanoma patients who otherwise were out of treatment options. And scientists created the first "synthetic life."

What significant advances can we expect in 2011? Here are seven predictions, provided by experts in these fields who gave MyHealthNewsDaily the lowdown on what might promote our health next year.

Prediction 1: Results of a promising HIV vaccine will be announced.

An American man made international headlines this month when German doctors announced he had been cured of the virus that causes AIDS. The HIV-positive man had suffered from acute myeloid leukemia — a deadly blood cancer — so in 2007 the doctors performed a bone marrow transplant to treat the leukemia. They were lucky enough to find a bone marrow donor with a rare mutation, called Delta 32, that provides natural resistance to the human immunodeficiency virus.

Three years after the transplant, the man continued to show no signs of HIV.

But for all the media attention to this case, another scientific advance is likely to help more people battle HIV and AIDS in 2011.

In 2009, studies in Thailand showed a vaccine could reduce the risk of contracting HIV by about 30 percent. Dr. Susan Zolla-Pazner, an HIV researcher at the New York University Langone Medical Center in New York City, said it was the first sign of real success for an HIV vaccine, and a guide to future research.

"It was the first and only light in a very dark tunnel that suggested that we were beginning to get off of home plate in terms of making any progress," Zolla-Pazner said.

Reflecting on the case of the German achievement, Zolla-Pazner pointed out that only a tiny fraction of HIV patients would be able to find matching bone marrow from a naturally resistant donor, and even then, those patients would risk dying from the bone marrow transplant procedure.

"It shows that, in theory, with bone marrow transplants, you can cure [HIV], which is interesting. But certainly it is not anything that could be applied even on a small scale, let alone on a vast scale with millions of people," Zolla-Pazner said.

So instead of bone marrow transplants, Zolla-Pazner is setting her hopes on HIV vaccine advancements.

"If there's a clear answer about what that vaccine did to provide protection, it provides a foundation to build another vaccine," she said.

Zolla-Pazner said more results based on the experimental vaccine are expected to be announced in mid-2011.

Prediction 2: Many broken hearts will be fixed by freezing them.

The 2.2 million people in the United States afflicted with atrial fibrillation will see another tool in the fight against their condition in 2011: a device that freezes heart tissue.

A healthy heart contracts under a timed pattern of electrical signals, but people with atrial fibrillation have irregular electrical signals, causing the upper chambers of their heart to quiver instead of beat, according to the American Heart Association. Atrial fibrillation can lead to fatigue, shortness of breath, and even stroke.

This month the Food and Drug Administration approved the Arctic Front cardiac cryoablation catheter system device, which freezes sections of heart tissue instead of burning them with radio-frequency energy. Doctors can use the device to purposefully scar certain sections of the heart, blocking the irregular signals that create atrial fibrillation.

"This treatment model has shown to cure this disease in 70 percent of patients," said Dr. Moussa Mansour, who used the device in clinical trials at Massachusetts General Hospital in Boston.

"The old way [radio-frequency ablation] had a similar range of success, but we believe it is easier to do it in the new way," Mansour said. Now that the cryoablation technique has been approved, he added, more people will receive therapy.

Prediction 3: The lowered bar for lap-band surgery will have an impact on the decisions made by millions of obese Americans.

Surgery is one of the more controversial solutions to the nation's obesity problem, even though research shows stomach surgery for weight loss is sometimes the most effective treatment.

This coming year will open up the option of bariatric weight-loss surgery to millions more Americans. Until recently, only people with a body mass index (BMI) of at least 40, or those with BMIs of 35 and higher with another serious health problem related to their obesity, were candidates for lap-band surgery from Allergan, according to the FDA. In the lap-band procedure, a doctor places an inflatable silicon ring around the upper portion of the stomach and constricts it.

In late 2010, the FDA voted to change the eligibility criteria for the Allergan procedure. Now, most people with a BMI of 35 or higher, and patients with a BMI of 30 or higher who also have another serious medical condition, can undergo the operation.

"Only one in 50 people will keep 50 pounds off for one year using diet and exercise. It's just a profound waste of time for people who are obese," said Dr. George Fielding, an advocate of the surgery who works in the Division of Bariatric Surgery at NYU Langone Medical Center.

"Surgery does work, it's just so well established," he said. "All around the world, no matter what method you use, you can see results."

Fielding noted that if a person with diabetes and a BMI of 30 loses 50 pounds and keeps it off, he has an 80 percent chance of coming off their diabetes medications. "There are millions of people, literally, with the BMI of 30 and 35 who have diabetes," he said.

But physicians who specialize in weight loss warn about the dangers of opening a patient’s body when there are other options.

"The issue with surgery, any kind of surgery — banding, bypass, etc. — is they work, by far, better than anything else. The problem is that they are surgery, so they're invasive, " said Dr. Lee Kaplan, director of the Massachusetts General Hospital's Weight Center. "They have risks associated with them. "

Kaplan said only 2 percent of patients who meet the criteria for weight-loss surgery actually undergo the procedure, in part because of the risks. Because of this, he doesn't think dropping the criteria by 5 BMI points will drastically change the odds of an obese person submitting to the procedure.

Kaplan acknowledged that research on people who’ve had weight-loss surgery has contributed to the understanding of exactly how the body can lose weight — or keep it on.

"We're learning an enormous amount from surgery, even though surgery itself is used infrequently," Kaplan said. Doctors used to think weight-loss surgery worked by making the stomach smaller, but they have found evidence that the surgery actually changes physiological mechanisms in the body that eventually determine whether or not a person gains weight, he said.

Prediction 4: School lunches will get a makeover that will lower obesity in the next generation.

More than about any surgery, obesity experts are excited about the Healthy, Hunger-Free Kids Act, which takes effect in 2011.

The new legislation raises the federal reimbursement rate for school lunches by 6 cents per meal, according to the American Academy of Pediatrics. The bill will allot an additional $4.5 billion toward school lunch programs over 10 years, and it has tasked the U.S. Department of Agriculture with creating nutrition standards for food sold through vending machines in schools.

"If you can tell a kid at age 5 or 6, ‘Look, this food is really yummy — it just doesn't come from McDonald's, it's just fresh food,' then you've got a chance," Fielding said. "Once a kid is fat and 10 or 12 years old, it doesn't matter how much you're going to tell them, it's hot air."

"You can make the next generation have a chance by teaching them about healthy food," he said.

Kaplan called the legislation "terrific. "

"When the [school lunch] program was developed 50 years ago, the focus was not on obesity, it was on malnutrition," Kaplan said. "Now … we see obesity is an even bigger problem than malnutrition."

Prediction 5: Restaurant menus that list calories will help us cut our daily total.

This year the nation will follow New York City in requiring restaurant chains to post calorie counts next to standard menu items. The mandate comes as part of the Patient Protection and Affordable Care Act, and requires chains with 20 or more locations to list calories by spring 2011.

Physicians who specialize in weight loss say the move will help some who don't realize their latte has 300 calories, or that their favorite dish might pack more than 1,000 calories. But the doctors aren’t predicting whether it will make a dent in the nation's obesity rate.

"I don't think people care. If they did, they wouldn't be going to these stores, because they all know what they are," Fielding said.

The mandate also requires the listing of calories in vending machines and "similar retail food establishments," according to the FDA.

"I think it might help," Kaplan said. But realistically, the effect "is going to be quite modest."

However, Kaplan added, "I think the risk of doing this is essentially zero, and the benefit is undetermined. But with so little risk, I think we ought to do it."

Prediction 6: Genomics will find medicines that work for you.

Sequencing an entire human genome cost about $3 billion a decade ago. Last year it cost around $10,000, according to Dr. Eric Topol, director of the Scripps Translational Science Institute in La Jolla, Calif.

Topol said he expects to see the price drop again in 2011, to about $4,000. And with lower financial barriers, he said, more medical advances from genomic research will come in the next year.

"This field is exploding," he said.

For example, Topol said, last year pharmacy benefit managers Medco and CVC/Caremark started examining the genes of patients on the widely used heart drug Plavix. The researchers identified two genes — called PON1 and CYP2C19 — that can determine how a person would respond to Plavix.

"These two genes explain why this drug, which is the second biggest drug in the world, is so inconsistent," Topol said. "Two-thirds of patients on Plavix do well, but the others either don't see the drugs’ effects and/or suffer from side effects."

Genotyping has already found mutations that would determine a person's response to malaria drugs, blood thinners, and breast cancer therapy, Topol said.

For the hepatitis C drug interferon, Topol said, researchers have identified genes that could save about half of all hepatitis C patients from side effects.

"Fifty percent of people don't respond [to interferon], and that drug costs $50,000 and it makes you sick," Topol said. "That is a really striking example.”

Genetic analysis “saves lots of money; it saves patients from being sick for years with a drug that doesn't help them."

Prediction 7: Genomics will help us understand cancer.

Topol predicted the low cost of genome sequencing will also bring good news in cancer research next year, "because the sequencing is becoming so much cheaper and fast, and because bioinformatics is getting more advanced," he said.

With faster technology, Topol said it's become increasingly feasible for cancer researchers to compare a person's genome — the "germ line" genome the patient was born with — with the mutated genome of his or her cancerous tumors, to find the genes that are driving the cancer. In other words, they’ll find the genes that are making cancerous cells act cancerous.

Topol said such research has already benefited melanoma patients taking the powerful drug PLX4032. Genomic research has showed melanoma patients with tumors that have what's known as a BRAF mutation will benefit from the drug, while patients whose tumors don't have that mutation will likely get worse with the drug.

Topol said similar research is "just going to get better" in 2011.


Dynavax Phase 1B safety and immunogenicity study shows tolerance and safety of doses of DV-601

EquityBites - Dec. 24, 2010

Clinical-stage biopharmaceutical company Dynavax Technologies Corporation (Nasdaq:DVAX) on Thursday reported safety and immunogenicity data from its Phase 1b clinical trial of DV-601, its proprietary hepatitis B therapeutic vaccine.

The dose escalation study assessed safety and the immunologic and virologic responses in 14 subjects with chronic hepatitis B infection.

The company said that the Phase 1b data showed that all doses were generally safe and well tolerated. Also, individual immunologic and virologic responses were observed across cohorts at all dose levels.

No conclusions regarding the potential clinical impact of the therapy could be reached in this small study.

The company's candidate vaccine, DV-601, is designed to induce an immune response against HBV-infected cells and if proven to be safe and effective, may offer an alternative therapeutic option for patients chronically infected with HBV.