Health Highlights: Dec. 24, 2005
New Rheumatoid Arthritis Drug Approved, Maker Says 9 Families Sue UC Liver Transplant Program Stem Cell Research Faked: Report Barley Products May Claim to Lower Heart Risks: FDA FDA OKs Tamiflu for Children 1 to 12
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
New Rheumatoid Arthritis Drug Approved, Maker Says
A drug that fights painful rheumatoid arthritis by limiting a signal in a person's immune system has received government approval, its manufacturer has announced.
Bristol-Myers Squibb says the medication with the generic name of abatacept (marketed as Orencia) received U.S. Food and Drug Administration approval Dec. 23.
In clinical trials published in the Sept. 15, 2005 issue of the New England Journal of Medicine abatacept more than doubled the odds that someone with difficult-to-treat rheumatoid arthritis had at least a 20 percent improvement in symptoms.
"Rheumatoid arthritis patients should be optimistic because there's now another option that works well, even where other drugs haven't," Dr. Mark Genovese, an associate professor of medicine and the associate division chief in immunology and rheumatology at Stanford University, told HealthDay. Genovese is the lead author of the study and also a paid consultant for Bristol-Myers Squibb.
More than 2 million Americans have rheumatoid arthritis, according to the Arthritis Foundation. As the disease progresses, loss of movement and function in the affected joints can occur.
Current treatment options include over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs) and other pain relievers; oral steroids; anti-rheumatic drugs, such as methotrexate; and biologic response modifiers, such as etanercept and infliximab, according to the Arthritis Foundation.
According to Genovese, abatacept works by blocking a signal that fully activates the immune system's T-cells. Because the drug modifies the response of the immune system, the risk of infection is potentially increased.
9 Families Sue UC Liver Transplant Program
The families of nine people who died while waiting for new organs from the University of California at Irvine liver transplant program have filed a wrongful death lawsuit against the school.
The suit was filed Friday against the University of California, Irvine, (UCI) Medical Center, as well as some of its doctors, the former chief of the transplant program, and the University of California regents, the Associated Press reported.
The school shut the program last month in the wake of a federal government report's findings that the program had a one-year survival rate of 68 percent - 70 percent between July 2001 and June 2004. The minimum federal requirement is 77 percent, the AP said. In addition, more than 30 patients died awaiting transplants over the past two years, according to federal data cited by the wire service.
The federal report was filed by the Centers for Medicare and Medicaid Services on Nov. 10, according to the AP, which also reported that the hospital allegedly performed "far fewer than the 12 transplants per year required by the government for federal reimbursement."
Attorney Larry Eisenberg, who filed Friday's lawsuit in Orange County Court, alleged that the UCI program continued to accept patients even though its officials knew they didn't have the capability to perform transplants, the AP reported. Eisenberg also alleged that the program at one time did not have a liver transplant surgeon on staff, the wire service said.
The lawsuit seeks unspecified general and wrongful death damages.
Stem Cell Research Faked: Report
South Korean stem cell researcher Hwang Woo Suk faked at least nine of the 11 stem cell lines he claimed to have created, a Seoul National University expert panel said Friday when it announced findings from its investigation into the controversy.
In response to the panel's report, Hwang resigned his post at the university's College of Veterinary Medicine.
"I sincerely apologize to the people for creating a shock and disappointment," Hwang told reporters as he left his university office.
In a study published in the journal Science in May, Hwang said he used cloned human embryos to create 11 stem cell lines matched to specific patients. Recently, Hwang has been plagued by accusations that his research had been faked.
In its report, the university's panel concluded that "the laboratory data for 11 stem cell lines that were reported in the 2005 paper were all data made using two stem cell lines in total."
DNA tests are currently being conducted to determine if the two remaining stem cell lines were actually successfully cloned from a patient, the Associated Press reported.
The panel said that Hwang faked DNA results purporting to show a match by splitting cells from one patient into two test tubes for the analysis, rather than actually matching cloned cells to a patient's original cells.
"Based on these facts, the data in the 2005 Science paper cannot be some error from a simple mistake, but cannot be but seen as a deliberate fabrication to make it look like 11 stem cell lines using results from just two," the panel noted.
The panel also said it would now investigate Hwang's other landmark papers, which included another Science article in 2004 on the world's first cloned human embryos, and an August 2005 paper in the journal Nature on the first cloned dog.
Barley Products May Claim to Lower Heart Risks: FDA
Whole barley and barley-containing products can now carry labels that claim they reduce the risk of coronary heart disease (CHD), the U.S. Food and Drug Administration said Friday.
Food manufacturers can make this claim immediately on products that provide at least 0.75 grams of soluble fiber per serving of the food. Consumers can expect to see the health claim on whole barley and dry milled barley products such as flakes, grits, flour and meal.
The claim may look something like this: Soluble fiber from foods such as (barley), as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of (barely) supplies (x) grams of the soluble fiber for necessary per day to have this effect.
CHD causes almost 500,000 deaths each year in the United States. CHD risk factors include high total cholesterol levels and high levels of low density lipoprotein (LDL) cholesterol. Research indicates that consuming barley can lower serum cholesterol.
The diet choices that people make can have a major impact on their health, and these kinds of food health claims can help consumers make wise choices, noted Dr. Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, in a prepared statement.
FDA OKs Tamiflu for Children 1 to 12
The use of Tamiflu for prevention of seasonal flu in children ages 1 to 12 who've had close contact with an infected person has been approved by the U.S. Food and Drug Administration.
This is the first approval given to a drug for prevention of both influenza A and B in pediatric patients. Tamiflu, an oral anti-viral drug, is already approved in the United States for treatment of adults and children 13 years and older and in children younger than 1.
In granting this latest approval, the FDA looked at the results of a study of the spread of flu in households, which involved more than 1,100 people, including 222 children ages 1 to 12.