DNA tests to determine warfarin dose

Sat, 13 Jan 2007 10:03:34 GMT
By LINDA A. JOHNSON, Associated Press Writer
TRENTON, N.J. - Personalized medicine, the tailored treatments that a few patients now get based on their own DNA, is finally headed for the masses: the many heart patients at risk of deadly blood clots.
At least 2 million Americans with an abnormal, clot-triggering heart rhythm take the pill warfarin, also sold as Coumadin.

Getting too little can lead to a stroke, and too much can cause life-threatening bleeding. To find the right dose for each patient, doctors use trial and error — and the errors lead to tens of thousands of hospitalizations and deaths every year.

Starting this month, about 1,000 patients who have a condition known as atrial fibrillation will take part in a project that will match their Coumadin dose to their specific genetic needs.

This genetic fingerprinting should single out the many people whose bodies break down warfarin faster or slower than normal, and their doctors can immediately adjust their dosage to prevent dangerous complications.

"Twenty to 30 percent of people are either very fast or very slow" to metabolize many drugs but don't know it, said Dr. Robert Epstein, chief medical officer at prescription benefit manager Medco Health Solutions of Franklin Lakes, N.J., which is collaborating in the effort with the Mayo Clinic, based in Rochester, Minn.

Meanwhile, the federal government and researchers at Harvard University and elsewhere have begun or are planning similar studies.

Epstein and other experts say the warfarin projects comprise the first broad use of personalized medicine, or targeted therapy, in which a person's genetic makeup is used to pick the best medicine or dose. This approach essentially adjusts for differences in body chemistry that explain why one pain reliever or allergy pill works great for you but not for your mom.

"It's a big deal," said Edward Abrahams of the Personalized Medicine Coalition, which includes industry, government and patient advocacy groups as well as insurers and research centers. "Warfarin is a very widely used drug, it's been around for 50 years and it has all these adverse events associated with it."

If the warfarin studies are successful, patients will start demanding personalized medicine, he predicted. Insurers will, too, if the Medco study proves it saves money and protects patients.

That's fairly likely, given Medco data showing that if patients have their warfarin dose changed more than once — meaning doctors didn't get it right the first two tries — their risk of being hospitalized for complications jumps from 20 percent to 31 percent.

Epstein said he's hit "a home run" with his pitch to get employers and insurance companies sponsoring the prescription plans to join the study.

"Everyone we've talked to unanimously was in," said Epstein, who expects the reduction in medical costs will be triple the test price of a few hundred dollars per patient.

He noted a couple dozen companies already are developing commercial tests for variations in the two genes crucial in warfarin dosing, the ones in the new studies. However, sales have been slow for the only government-approved testing device, Roche's Amplichip, which covers numerous gene variations.

A November 2006 report by the American Enterprise Institute-Brookings Joint Center predicts using genetic information to prescribe warfarin would save an estimated $1.1 billion in U.S. health care spending each year, while preventing about 17,000 strokes and 85,000 serious bleeding incidents.

Bleeding complications alone kill about 8,000 people a year and are the No. 2 reason for medication-related ER visits, said Dr. Elizabeth Nabel, director of the National Heart, Lung, and Blood Institute. Still, warfarin is far better at preventing clots than aspirin or drugs like Plavix, which only affect part of the clotting system, she said.

But patients on warfarin must have blood drawn and tested repeatedly to see if it clots too fast or too slow, initially every week or more often.

"Most hospitals have a warfarin clinic, where people come in for adjustments," she noted.
So along with the http://www.personalizedmedicinecoalition.org
Medco Health Solutions: http://www.medco.com
Atrial circulation information: http://www.americanheart.org/presenter.jhtml?identifier9

Ky. center seeks new heart treatments

Sat, 13 Jan 2007 01:08:04 GMT
By BRUCE SCHREINER, Associated Press Writer
LOUISVILLE, Ky. - Noted heart surgeon Laman Gray Jr. still wasn't settled into his office, but researchers were busy upstairs working on devices that someday might save people with failing hearts.
Gray's long-running dream of a research center focused on finding new treatments for congestive heart failure became a reality this week with the downtown opening of the nearly $28 million Cardiovascular Innovation Institute, which teams the University of Louisville and Jewish Hospital.

One goal is to shorten the gap between developing treatments and getting them to patients.

"We want to take the basic research and bring it to the clinical setting — to be able to treat people to make people better," said Gray, the institute's medical director.

Gray performed the first heart transplant in Kentucky in 1984 and is best known as a lead surgeon with a medical team that put the world's first totally implantable artificial heart in a human. The patient, Robert Tools, lived 151 days on the device. Gray and his team implanted AbioCor devices into seven patients at Jewish Hospital in surgeries this decade that drew worldwide attention.

Now Gray hopes the institute's teams of doctors, engineers and researchers can help develop the next generation of devices and therapies to combat heart disease.

The fight is a daunting one against a pervasive health threat.

Cardiovascular disease was an underlying cause in slightly more than one-third of all U.S. deaths in 2004, according to the most recent data from the American Heart Association.

Heart problems are especially prevalent in the South, where there were about twice as many angioplasties as in the Northeast, Midwest and West, the group said. Bypass surgery, open-heart surgeries and pacemaker implants had similar ratios, it said.

Just days after the Louisville institute opened, research teams already were settled into the laboratories and busy working.

In one lab, researchers worked on a heart-assist device for the tiniest of patients — infants suffering from congenital heart problems. Elsewhere, researchers toiled over a device that would reduce the heart's work load and provide more blood flow, and thus more oxygen, to the heart.

In another lab, researchers worked on a device with a dual function.

First, it would reduce the amount of work by the heart muscle, researcher Steven Koenig said.

"You make it easier for that heart to pump," said Koenig, a UofL associate professor of bioengineering and surgery. "Then once it's recovered cardiac function and healed itself, then we can transition it over to an exercise device where we can increase the work on the heart. So we exercise that heart to improve it."

Other work will focus on gene therapy and stem cell research. There will be work on developing other mechanical hearts. Another project will develop microscopic sensors that can be implanted to measure blood pressure and blood flow. The sensors could detect early signs of a heart attack.

Ronald Greenberg, the institute's executive director and senior vice president at Jewish Hospital & St. Mary's HealthCare, said the goal is to improve the quality and length of life for people suffering from cardiovascular disease.

"We think we've got several great opportunities to do that," he said.

A prominent heart surgeon in Texas called the institute a "wonderful addition" to the medical research network.
"They have the leadership and personnel to really make meaningful scientific contributions," said Dr. Bud Frazier, chief of cardiopulmonary transplantation for the Texas Heart Institute at St. Luke's Episcopal Hospital in Houston.
The collaboration between UofL and Jewish Hospital will help keep research projects on track, despite the many years it can take to get a device from the lab to a patient's bedside, Frazier said. The time-consuming process puts financial pressures on private research companies.
John T. Watson, a professor of bioengineering at the University of California, San Diego, said the center "can certainly become world class."
Watson, who as a scientific adviser helped recruit staff to the institute, said it will play an important role in developing devices that help damaged hearts recover, avoiding the need for transplants.
Once the five-story institute is fully operational, it will employ more than 100 people, Greenberg said.
Institute officials hope the center will accelerate the momentum of medical research by UofL. Since 1998, UofL's funding from the National Institutes of Health has grown more than 270 percent.
The institute is entering a growing segment of medical research. Cardiovascular devices are a nearly $13 billion global industry, growing at a rate of 12 percent a year.
So far, the institute is collaborating with a half-dozen research companies, some from Germany and Japan, Greenberg said. The institute has received millions of dollars in federal grants to pursue projects.
Greenberg said the goal is to make the institute financially self-sufficient in five years.
The institute's organizers hope it has a spinoff effect on the economy by spurring medical research firms to locate in the state's largest city.
Jewish Hospital put $15 million into developing the facility, while the state contributed $5.5 million, UofL provided $4.2 million and U.S. Sen. Mitch McConnell secured $6.2 million in federal funds. Kosair Charities provided a $5 million grant and the Gheens Foundation pitched in $1.5 million.
McConnell, the Senate's top Republican leader, said "we can look forward to a day when treatments for America's leading killer are developed right here in Louisville."

FDA investigates Texas embryo business

Sat, 13 Jan 2007 03:14:59 GMT
By ELIZABETH WHITE, Associated Press Writer
SAN ANTONIO - Federal officials are investigating a business that produces batches of ready-made embryos and lets prospective parents select one based on the donors' looks, ethnicity, education and other factors.
A consumer safety officer from the http://www.theabrahamcenteroflife.com

Carb and calorie intake low in young diabetics

Fri, 12 Jan 2007 22:54:31 GMT

NEW YORK - Young children with type 1 diabetes tend to have adequate dietary intake of most micronutrients, according to results of a study published in the Journal of the American Dietetic Association. However, carbohydrate and caloric intake may be too low, possibly because their diet plans are out of step with their age.
"Diet is an important component of the management of type 1 diabetes and may be central to achieving optimal health outcomes," Dr. Susana R. Patton, of the University of Michigan, Ann Arbor, and colleagues write. "The goal of conventional dietary management in type 1 diabetes is to consume a well-balanced, nutritionally adequate diet with insulin dose matched to carbohydrate intake to achieve blood as close to normal as possible."

In the current study, the researchers examined the diet and diet adherence of 33 young children with type 1 diabetes. Three-day diet diaries were used to measure the children's nutrient and caloric intake, and the team evaluated associations between dietary adherence and sugar control.

The children's daily intake of vitamin B-12 and calcium were below minimum Dietary Reference Intake levels, but other micronutrients were at or above minimum levels.

The children had better-than-predicted adherence to the number and timing of meals per day and the number of carbohydrate units consumed per meal. However, total daily carbohydrate intake was only 80 percent of recommended levels based on age and weight, and total daily caloric intake was only 78 percent of the recommended levels based on age.

"Because of rapid growth during the pre-school years, this finding suggests that young children with type 1 diabetes may need closer follow-up by registered dietitians to ensure that children's individualized diet plans are modified appropriately as they grow," Patton's team advises.

They add that further research is needed to evaluate these children's sugar control using several factors, including diet adherence, insulin treatment, activity levels, and their families' psychosocial functioning.

SOURCE: Journal of the American Dietetic Association, January 2007.

Prenatal infection may up leukemia risk in child

Fri, 12 Jan 2007 22:09:37 GMT
By Megan Rauscher
NEW YORK - A mother who contracts influenza, pneumonia, or a sexually transmitted disease around the time of pregnancy appears to be at increased risk of having a child that will develop leukemia, new research shows.
These observations "suggest that maternal infection might contribute to the develop of childhood leukemia, which has been postulated to have an infectious origin," Dr. Marilyn L. Kwan, from the Division of Research at Kaiser Permanente in Oakland, California told Reuters Health.

As reported in the American Journal of Epidemiology, Kwan and her colleagues studied 365 children diagnosed with childhood leukemia and 460 similar children without cancer. Data on maternal illnesses and drug use from before pregnancy through breastfeeding were obtained by interview with the mother.

The investigators found that a maternal history of influenza or pneumonia that occurred between 3 months before conception through the end of breastfeeding raised the risk of leukemia in the child as much as 89 percent.

A maternal history of sexually transmitted disease, such as herpes or chlamydia, had an even stronger effect on the risk of childhood leukemia, increasing the odds by more than sixfold.

By contrast, women who used iron supplements around the time of pregnancy had a decreased of having a child with leukemia.

"Overall, these results emphasize the importance of maintaining good health while pregnant, which has always been an overarching policy promoted by in order to have a smooth pregnancy and healthy baby," Kwan concluded.

SOURCE: American Journal of Epidemiology, January 1, 2007.

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