Archive for June, 2010

Doctors Turning to Cardiac Catheterization Too Quickly

Thursday, June 24th, 2010

If you walk into an emergency room complaining of chest pains, the odds are high that you will end up having cardiac catheterization, where a thin wire is snaked into your heart to determine whether a blood vessel is totally or partially blocked.

But if you do have the invasive procedure, the odds are even higher — nearly two to one — that it will show no significant blockage, a new study finds.

“To me, what this says is that we need to re-evaluate how we work these patients up from start to finish,” said Dr. Manesh Patel, assistant professor of medicine at Duke University, and lead author of a report in the March 11 issue of the New England Journal of Medicine.

More than 10 million Americans each year experience chest pains that can lead to cardiac catheterization, Patel estimated.

He and his colleagues looked at data on nearly 400,000 people with no known heart disease who had cardiac catheterization at 663 U.S. hospitals between January 2004 and April 2008. Of those, just 37.6 percent had obstructed coronary arteries — slightly less than the 39.2 percent in whom no significant artery blockage was found.

Catheterization is called an invasive procedure because it requires that something be inserted into the body, which always carries a degree of risk. So doctors usually want to do a less risky noninvasive procedure, such as a stress test, to decide whether catheterization is advisable.

But while five of every six people in the study — 83.9 percent — did have a noninvasive test before catheterization, those tests did not have an enormous predictive value. Artery blockage was found in 41 percent of those who had noninvasive testing before catheterization and 35 percent of those who didn’t.

“We don’t know that this finding substantiated the kind of noninvasive test we should be using,” Patel said. “We don’t know what the patterns are, and we need more research.”

It’s not enough to simply say that cardiac catheterization is overused, he said. “What we want to do is use it more efficiently,” Patel said, “to determine the features that indicate catheterization is necessary.”

The study “points out a problem, but is not suggesting a solution,” he said. A national data bank on catheterization may provide information pointing toward a solution, as may some randomized trials that are now underway, Patel noted.

One of those trials, in which Patel is participating, is comparing the results of routine stress testing with computerized tomography angiography, which gives a three-dimensional view of the heart arteries, in 10,000 people.

The cardiac catheterization study results are not surprising, said Dr. Andrew Einstein, an assistant professor of clinical medicine at Columbia University Medical Center, whose specialty is cardiac imaging. An old rule of thumb is that one-third of cardiac catheterizations will show no artery blockage, he noted.

“This study does provide stronger data than we have ever had in the past,” Einstein said. “The important takeaway message is that better risk stratification is needed to inform decisions about catheterization. If we have a good strategy, people will not be referred as often for these invasive procedures.”

And cost is an inevitable issue in making those decisions, he added. “The cost of a diagnostic catheterization at our hospital is $2,600,” Einstein said.

SOURCES: Manesh Patel, M.D., assistant professor, medicine, Duke University, Durham, N.C.; Andrew Einstein, M.D., Ph.D., assistant professor, clinical medicine, Columbia University Medical Center, New York City; 2010, New England Journal of Medicine

Entire Family Genome Sequenced for First Time

Wednesday, June 16th, 2010

Children inherit fewer gene mutations from their parents than was previously thought, say U.S. researchers who are the first to sequence the entire genome of a family.

The analysis of the four family members — the parents, daughter and son — revealed that each parent passes about 30 mutations to their children. It had long been believed that each parent passes 75 gene mutations to their children.

“That’s the kind of power you get from looking at the whole genome. The mutation rate was less than half of what we’d thought,” Lynn B. Jorde, professor and chairwoman of the department of human genetics at the University of Utah School of Medicine, said in a news release from the school.

Most gene mutations passed from parents have no effect on children’s health. But it’s important to know the number of parent-to-child gene mutations.

“The mutation rate is our clock, and every time it ticks we have a new genetic variant. We need to know how fast the clock ticks,” Jorde said.

The actual rate of gene mutations each parent gives a child will vary depending on the age of the parents (particularly the father) when a child is conceived.

The study was led by the scientists at the Seattle-based Institute for Systems Biology and also included researchers from the University of Utah and the University of Washington.

The findings appear in the issue of Science Express.

Alzheimer’s ‘Epidemic’ Hitting Minorities Hardest

Wednesday, June 9th, 2010

Over 5 million Americans are living with Alzheimer’s disease, and blacks and Hispanics are at highest risk of developing the disease, a new report finds.

The report, 2010 Alzheimer’s Disease Facts and Figures, from the Alzheimer’s Association, finds that black Americans are about two times more likely to develop Alzheimer’s disease than whites, and Hispanics face about 1.5 times the risk.

“Alzheimer’s is continuing to be on the rise,” said Maria Carrillo, the association’s senior director of medical and scientific relations. “So many people are affected by it across the country, but we are rallying to highlight the disparities that exist in populations,” she said.

Much of the increase in Alzheimer’s is because of increasing high blood pressure and diabetes, which increase the odds of developing Alzheimer’s in all populations.

“African-Americans and Hispanics are particularly vulnerable, because the proportion of these two risk factors is higher even still,” Carrillo said. “We can actually do something about this increased risk with better management of the conditions.”

This year, 500,000 new cases of Alzheimer’s will be diagnosed, with a greater number of new cases expected in the years to come, the report found. By 2050, the report estimates that almost a million new cases of Alzheimer’s will be diagnosed annually.

In 2006, Alzheimer’s was the seventh leading cause of death in the United States and the fifth leading cause of death among those 65 and older.

From 2000 to 2006, death rates declined for most major diseases, including heart disease, breast cancer, prostate cancer, stroke and HIV/AIDS. However, deaths from Alzheimer’s rose more than 46 percent during that time period, according to the report.

Not only are there more cases of Alzheimer’s, but more families are shouldering the burden of the disease, Carrillo said. This is particularly true for minority families who may have less access to outside care.

“There are 5.3 million Americans with Alzheimer’s,” noted Robert J. Egge, vice president of public policy and advocacy. “And for each of those people there are many others whose lives are consumed with caring for those Alzheimer’s patients,” he said.

That totals some 11 million Americans, Egge said.

In 2009, these unpaid caregivers provided 12.5 billion hours of care “valued at $144 billion, more than the federal government spends on Medicare and Medicaid combined for people with Alzheimer’s and other dementias,” according to the report.

Part of the problem is that Alzheimer’s isn’t recognized until it is in a late stage, Egge said. “So there isn’t adequate care planning and other kind of support structures, especially in communities with socioeconomic disadvantages,” he said.

Another reason behind Alzheimer’s grim rise is that people are living longer — escaping illnesses such as heart disease and cancer that might have killed them before Alzheimer’s arose.

“We are managing many diseases that do allow us to live longer,” Carrillo said. “With age being the greatest risk factor, we are just skewing our population towards the Alzheimer’s arena.”

Another expert agreed.

“We have some pretty effective solutions for a lifetime of cardiovascular disease risk, but your bypass and stent may just give you time to dement,” said Greg M. Cole, a neuroscientist at the Greater Los Angeles VA Healthcare System and associate director of the Alzheimer’s Disease Research Center at UCLA David Geffen School of Medicine.

Often, it all adds up to many years of needed care. And since it often takes a long time to die from Alzheimer’s, “you may have lost touch with your loved ones for 10 years, sometimes even 20,” Carrillo said.

Research dollars remain key to turning the numbers around, she said. “We really need to focus on Alzheimer’s,” she said. “We need more of an investment in Alzheimer’s disease.”

The report found that payments for health and long-term care services for people with Alzheimer’s will total $172 billion this year.

In addition, Medicare costs for Alzheimer’s patients are almost three times higher than for other older people, and Medicaid costs are almost nine times higher, the report found.

Many people with Alzheimer’s also have one or more other medical conditions, such as diabetes or coronary heart disease, making their care even more expensive.

Yet far less is spent on Alzheimer’s research than on other diseases.

In fact, “for every $25,000 the government spends on care for people with Alzheimer’s and dementia, it spends only $100 for Alzheimer research,” the report said.

According to Cole, “this new report details how the long predicted ‘epidemic’ rise in Alzheimer’s disease and other dementia is already upon us.”

The report also sounds the alarm that the situation may get worse before it gets better.

“We hope to have better treatments, but cures are unlikely,” Cole said. “The only cost-effective answer we can realistically try to achieve is an effective prevention program,” he said.

SOURCES: Maria Carrillo, Ph.D., senior director, medical and scientific relations; Robert J. Egge, vice president, public policy and advocacy, both of the Alzheimer’s Association; Greg M. Cole, Ph.D., neuroscientist, Greater Los Angeles VA Healthcare System, and associate director, Alzheimer’s Disease Research Center, UCLA David Geffen School of Medicine, Los Angeles; Alzheimer’s Association report, 2010 Alzheimer’s Disease Facts and Figures

FDA rules out bisphosphonate, thigh fracture link

Wednesday, June 2nd, 2010

U.S. regulators said on Wednesday they have found no link between oral bisphosphonate osteoporosis medications such as Merck & Co Inc’s Fosamax and certain thigh bone fractures.

The U.S. Food and Drug Administration issued its statement following the publication of case reports of atypical subtrochanteric femur fractures - or fractures in the bone just below the hip joint - in women with osteoporosis using oral bisphosphonates.

Bisphosphonates are a class of drug aimed at preventing bone fractures and offsetting bone loss associated with menopause.

They include Fosamax, Roche Holding AG’s Boniva, Novartis AG’s Reclast and Procter and Gamble Co’s Actonel.

In June 2008, the FDA requested information from all bisphosphonate drug makers related to these type of fractures. The agency said a review of the data did not show an increased risk for women using the medications.

The FDA said that, although its review of the data did not show a clear connection between bisphosphonates and atypical subtrochanteric femur fractures, the agency is working closely with outside experts to gain more insight into the issue.

Bisphosphonates, which have been on the market for roughly a decade, have raised safety concerns in the past, including heart risks.

But in 2008, the FDA said the drugs showed no overall risk of heart problems. The agency’s review followed reports of serious atrial fibrillation, a type of abnormal heartbeat, in the New England Journal of Medicine.

In January, a Manhattan federal judge refused to dismiss a lawsuit alleging that Fosamax caused jaw damage to a woman during the nearly eight years she took the pill.

Merck faces a slew of lawsuits involving almost 900 cases by patients who say Fosamax caused osteonecrosis of the jaw, or death of jaw bone tissue.

The FDA recommended patients keep taking their medication unless told not to by their doctor. It also recommended that healthcare professionals be aware of a “possible risk” of atypical subtrochanteric femur fractures in patients taking oral bisphosphonates.