Here are the latest clinical trials, courtesy of CenterWatch:
Rheumatoid Arthritis
The purpose of this six-month research study is to evaluate the safety and effectiveness of an investigational drug on people with rheumatoid arthritis. This investigational drug study is intended for those whose therapeutic options are limited as a result of failing anti-TNF medications (e.g. Enbrel, Humira or Remicade). Research site located in Lake Success, NY.
More Information
Please see http://www.centerwatch.com/patient/studies/cat132.html.
-----
Amenorrhea
If you are a female with abnormal menstrual bleeding, between the ages of 18 and 45, have not had a period for 90 days or more, or you have already been diagnosed with amenorrhea and taking hormones, you may be a candidate for this investigational study. Research site located in Pottstown, Penn.
More Information
Please see http://www.centerwatch.com/patient/studies/cat584.html.
-----
Venous Leg Ulcers
Participants are needed for a clinical research study involving an investigational medicine for leg ulcers. Eligible participants will receive study-related medical care. Research site located in Ann Arbor, Mich.
More Information
Please see http://www.centerwatch.com/patient/studies/cat314.html.
-----
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
New Orleans Sludge Still Contaminated With Bacteria, Oil
Initial tests conducted on sediments taken after floodwaters receded in New Orleans show high amounts of E. coli bacteria and oil runoff from fuel and chemical plants, the U.S. Environmental Protection Agency said Friday.
E. coli indicates there is fecal bacteria in the water and exposed sediment, and contact with both should be avoided, Marcus Peacock, the EPA's deputy administrator, told reporters Friday at a news conference, the agency's second this week. He said 18 sediment samples taken on Sept. 10 represented the start of "extensive" testing, the Bloomberg news service reported.
And flooded parts of New Orleans, which was 80 percent under water after Hurricane Katrina, include more than 60 chemical plants, oil refineries, and petroleum storage facilities, Bloomberg said.
The Coast Guard said Thursday that Hurricane Katrina may have spilled more than 7 million gallons of oil, about two-thirds of what was released in the Exxon Valdez accident in 1989, according to the Associated Press.
Contact with fuel oils can lead to skin and eye irritation, increased blood pressure, and headache, Bloomberg said.
Officials told Bloomberg that the full extent of the contamination probably won't be known until the city is completely pumped out, which they say could take until mid-October.
-----
Defibrillator Problems on the Rise: FDA Study
Malfunctions in implanted heart devices called defibrillators were increasing even before a huge recall this summer by Guidant Corp., according to a joint study released Friday by the U.S. Food and Drug Administration and Harvard University.
Defibrillators shock awkwardly beating hearts back into a normal rhythm. About 20 of every 1,000 devices malfunction, the researchers found. Those defects led to 31 deaths between 1990 and 2002, although that was a fraction of the more than 400,000 devices implanted during the span, the Associated Press reported.
Nonetheless, the study "points out the need for our agency to improve the way it regulates these products, and we're doing just that," Dr. Daniel Schultz, chief of the FDA's medical devices unit, told the AP.
The research was presented Friday at a daylong meeting of the Heart Rhythm Society in Washington, D.C., to discuss recent safety problems with defibrillators and other implanted cardiac devices, including pacemakers.
The study's leader, Dr. William Maisel of Harvard, found that from 1990 to 2002, 2.25 million pacemakers and 416,000 cardiac defibrillators were implanted in the United States. More than 17,000 of the devices had to be removed later due to malfunctions, the AP reported.
Equally troubling, 50 percent of the defibrillator malfunctions between 1990 and 2002 occurred within the last three years of that time period, the researchers said.
Guidant, and two other makers -- Medtronic and St. Jude Medical -- have recalled or issued warnings about more than 200,000 defibrillators since January, the wire service said. Guidant recently conceded that it waited three years before telling doctors and patients about an electrical defect in one of its models. The defect has been linked to two deaths, the AP reported.
-----
Aspirin at Night May Lower Blood Pressure
Not only may daily aspirin prevent a heart attack, it could also lower blood pressure -- especially if taken at night, researchers have found.
Scientists from Spain, writing in the Sept. 20 issue of the Journal of the American College of Cardiology, said they randomly divided patients with mild hypertension into three groups: those who took aspirin in the morning, those who took it before bed, and those who didn't take aspirin at all.
After three months, blood pressure rose slightly among those who took aspirin in the morning, but fell in the group that took it at night. The group that didn't take aspirin at all saw only a very slight decline in blood pressure that wasn't statistically significant, the researchers at the University of Vigo said.
The authors and other experts said the results would have to be confirmed in future studies.
"Given the widespread use of aspirin, the prevalence of hypertension, and the ease in altering the time of aspirin administration, these results should be widely disseminated," Dr. Joseph Messer, from Rush University Medical Center in Chicago, said in a prepared statement from the American College of Cardiology. Messer wasn't directly connected to the research, the statement said.
-----
Sara Lee Recalls Bread Products for Possible Contamination
Sara Lee Corp. is recalling certain lots of artisan breads, bagels, English muffins, garlic bread and pita bread produced at the company's Vernon, Calif., bakery. The products may contain bits of metal and plastic, according to a company news release posted by the U.S. Food and Drug Administration.
The products were sold in Arizona, California, Hawaii and Nevada. No complaints have been received from consumers, the company said.
Remaining inventories of these products have been removed from store shelves. Consumers may return any of the affected items to the store where purchased for a full refund.
For more information, contact Sara Lee toll free at 1-800-683-3466. A list of the recalled items can be found here.
-----
Lipitor, Celebrex Lead Price Increases, U.S. Reports
The cholesterol-lowering medicine Lipitor and the pain drug Celebrex had the most impact on a 25 percent overall increase in U.S. retail drug prices from 2000 to 2004, says a federal government report.
The Government Accountability Office report said that the price of a 30-day supply of 96 drugs used by older people increased by 24.5 percent from January 2000 to December 2004, the Kansas City Star reported.
The study found that 20 of the 96 drugs accounted for nearly two-thirds of that increase. Of those 20 drugs, 19 were name-brand drugs and one was a generic drug.
"The drug with the largest effect on the price index was Lipitor 10 mg, which accounted for 6.6 percent of the total increase," the report noted. Celebrex had the second greatest impact on drug prices. Both are made by Pfizer Inc.
The other drugs in the top five were: blood thinner Plavix, made by Sanofi-Aventis SA and Bristol-Myers Squibb Co.'; the ulcer drug Prevacid, made by Abbott Laboratories and Takeda Pharmaceutical Co. Ltd.; and Pfizer's Lipitor 20 mg.
The report's analysis was based on the usual price paid by uninsured patients at retail pharmacies, the average price that wholesalers paid to drug makers, and suggested manufacturer list prices for drug sales to pharmacies. The analysis did not factor in discounts given to insurance companies or government agencies, the Star reported.
Younger women with dense breast tissue, those under 50 and those who are premenopausal would benefit from having digital mammograms, the researchers said.
The findings, which will appear in the Oct. 27 issue of the New England Journal of Medicine, were released early to coincide with a presentation Friday at the fall meeting of the American College of Radiology Imaging Network in Arlington, Va.
"The kinds of cancer digital [mammography] found and film missed were important cancers -- the kind that kill women," said lead author Dr. Etta D. Pisano, a professor of radiology and biomedical engineering at the University of North Carolina School of Medicine. "We don't know for sure we saved their lives, but it was important to find those cancers."
In their study, Pisano and her colleagues in the Digital Mammographic Imaging Screening Trial collected data on 49,528 asymptomatic women screened for breast cancer. The women underwent both digital and film mammography. The researchers were able to evaluate data for 42,760 women.
"Overall, film and digital mammography were equally accurate," Pisano said. "But for women with dense breasts, women under age 50 and women who were pre- and perimenopausal, digital was significantly better."
Pisano believes that, particularly for these women, digital mammograms are the way to go. "For the 65 percent of women who had improved accuracy, they should get that kind of mammography," she said. "But for other women, there is no benefit of digital over film, and it's more expensive."
However, Pisano added that although digital mammography makes up only about 8 percent of the market today, it will eventually replace film mammography. "There is a trend toward digital, mainly for the other advantages that it offers," she added.
These advantages include the ease of storing and retrieving digital images, and making them part of a patient's electronic medical record.
"If you have dense breasts, if you are under 50, if you're pre- or perimenopausal, you should receive a digital mammogram," Pisano advised. "It is important that women get screened when they are supposed to be screened and not wait to get a digital -- if there is film available it's better than nothing."
One expert sees digital mammography as the future of breast cancer screening.
"Even without a clinical benefit, digital would replace film," said Dr. Rowan T. Chlebowski, a medical oncologist at Los Angeles BioMedical Research Institute. "With the current mandate for electronic medical records, you are going to have a hard time getting a film mammogram into an electronic medical record."
"Just the way we handle information, it's the future anyway," Chlebowski said. "But this study makes it more reasonable to go for the investment now, because you get an immediate clinical payoff."
Another expert stressed that women need to get screened for breast cancer, and not wait for digital screening if it is not available in their area.
"The finding that digital mammography is more accurate than film mammography in women under age 50 and women with medium and high breast density, which are somewhat overlapping categories, is an important finding that should lead to improvements in screening programs, if digital mammography is targeted to women who are likely to benefit the most," said Robert A. Smith, director of cancer screening for the American Cancer Society.
However, even though the availability of digital mammography is increasing, it is still limited, and it is unclear how soon or whether it will entirely replace film mammography, he added.
"The important thing is that women receive mammograms on a regular basis, regardless which technology they use," Smith said. "Younger women and women with denser breasts should not forego their regular mammogram if digital mammography is not available. While this study showed an advantage with digital imaging in these groups, it should be remembered that traditional film mammography also is effective."
More information
For more on mammography, visit the American Cancer Society.
