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Arthritis
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Definition of Arthritis
Arthritis is the inflammation of a joint, usually accompanied by pain, swelling, and stiffness, and resulting from infection, trauma, degenerative changes, metabolic disturbances, or other causes. It occurs in various forms, such as bacterial arthritis, osteoarthritis, or rheumatoid arthritis.
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FDA Advisory Panel Rejects Vioxx Successor
The proposed successor to the banished arthritis painkiller Vioxx was soundly rejected Thursday by an advisory committee to the U.S. Food and Drug Administration.
Expressing concern over the cardiac safety of the new prescription drug, Arcoxia, the panel of medical experts voted 20-1 to recommend against approval of it. The FDA does not have to follow the recommendations of its advisory committees, but it usually does.
"Just having a similar drug in the market is no reason to approve this drug or any other similar drug," Dr. Robert Meyer, director of the FDA's Office of Evaluation in its Center for Drug Evaluation and Research, said after the vote.
Meyer told a news conference that the panel wanted any new non-steroidal anti-inflammatory drugs, which include cox-2 painkillers like Vioxx and Arcoxia, to undergo head-to-head comparisons to similar drugs before applying for U.S. approval.
The action by the FDA's
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Debate Builds Over Drug Companies' Fees to FDA
Controversy continues to engulf renewal of the Prescription Drug User Fee Act (PDUFA), with the key issue being whether the law does enough to protect U.S. consumers from potentially harmful drugs.
The act was passed by Congress in 1992 to establish "user fees" that are paid by drug companies to the U.S. Food and Drug Administration to review and vote on new drug applications. In 2008, these user fees are expected to total $438 million and account for more than 42 percent of all the money the FDA receives for regulating drugs.
Now, several sides of the debate are expressed in a trio of opinions that will be published in the April 26 issue of The New England
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Clinical Trials Update: April 17, 2007
Asthma Osteoarthritis Rheumatoid Arthritis
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Sopranos Star Tackles Health Role
This spring's finale of The Sopranos will mark the end of Aida Turturro's star turn as big, bad sister of America's most famous TV mobster.
But the actress who garnered national acclaim for her riveting portrayal of the conniving "Janice Soprano" is taking center stage to play a perhaps more important role: diabetes spokeswoman.
In 2001, just one year after receiving an Emmy nomination for her work on the acclaimed television series, Turturro was diagnosed with type 2 diabetes.
Now, just one week after wrapping up her final shoot on the much-lauded HBO series, she has embarked on a nationwide tour of diabetes centers and hospital support groups to promote a proactive approach to living well with an illness that now strikes almost 21 million American children and adults.
"It's scary at first," said Turturro, recalling her initial diagnosis. "And it's really a very, very hard disease, because it never ends. So, it can feel overwhelming. Bu
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Genes Could Boost Arthritis Patients' Death Risk
Rheumatoid arthritis patients with certain genetic traits may be at increased risk of early death from heart disease or cancer, British researchers report.
The study, published in the May issue of the journal Arthritis & Rheumatism, tracked 767 people with rheumatoid arthritis for 18 years. Over that time, 186 of the study participants died. The two major causes of death were cardiovascular disease (28.2 percent) and cancer (24.7 percent).
Of those who died of heart disease or cancer, 29 (32.6 percent) had two genetic variants, called HLA-DRB1 SE. The researchers also found that rheumatoid arthritis patients with two of these variants generally died young than other rheumatoid arthritis patients.
This was especially evident among patients who died of ischemic heart disease --average age of 67.8 years for those with two SE variants. The researchers said they were also surprised to find that patients with the two SE gene types had no clinical
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U.S. Arthritis Numbers, Costs Soaring
As America's baby boomers move into late middle age, arthritis and other rheumatic conditions are taking up an ever larger chunk of health-care spending, a federal study warns.
The U.S. Centers for Disease Control and Prevention report, which spans the six years from 1997 to 2003, detected a 25 percent jump in the number of adult Americans with arthritis and other rheumatic conditions. Overall, more than 46 million people now suffer from arthritis, compared to 36.8 million in 1997.
That means more than one in every five adult Americans now has arthritis, the CDC says.
The total annual tab to care for these patients: almost $81 billion.
The $81 billion figure represents three percent of U.S. gross domestic product (GDP), "a startling figure," said Louise Murphy, an Atlanta epidemiologist who worked with the CDC on the report.
Something must be done to turn these figures around, experts say.
"An aging population isn't something that
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FDA Says No to Vioxx Successor
The U.S. Food and Drug Administration on Friday turned down Merck & Co.'s request to market Arcoxia, a successor to its banned arthritis drug Vioxx.
The decision came as little surprise, since an FDA advisory panel of medical experts had already voted 20-1 against the drug's approval on April 12.
Arcoxia (etoricoxib) is a cox-2 inhibitor, the same class of drugs that includes Vioxx, Bextra and Celebrex. Vioxx was withdrawn from the market in September 2004, after studies showed it doubled the risk for heart attack and stroke. Bextra was withdrawn for similar reasons early in 2005. Celebrex remains on drug store shelves, albeit with a strong warning label highlighting potential heart risk.
But "just having a similar drug in the market is no reason to approve this drug (Arcoxia) or any other similar drug," Dr. Robert Meyer, director of the FDA's Office of Evaluation in its Center for Drug Evaluation and Research, said after the advisory panel
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Green Tea May Ease Rheumatoid Arthritis
Green tea, already touted for its cardiovascular and anticancer benefits, may also help ease the inflammation and pain of rheumatoid arthritis, a new study suggests.
The study was conducted in the laboratory, and its findings are preliminary, stressed lead researcher Salah-uddin Ahmed, an investigator at the University of Michigan Health System, in Ann Arbor.
"It's too early" to fully recommend green tea to ease rheumatoid arthritis, he said, but the study "is a starting point."
Ahmed was scheduled to present the research Sunday at the Experimental Biology meeting, in Washington, D.C.
For the study, Ahmed isolated cells called synovial fibroblasts from the joints of patients with rheumatoid arthritis. These cells form a lining of tissue surrounding the capsule of the joints.
In patients with rheumatoid arthritis, this lining is inflamed, leading to long-term joint damage and chronic pain. About 2.1 million Americans have rheumatoid ar
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Medicaid Patients With Lupus Travel Farther to See Doctors
U.S. Medicaid patients with lupus travel farther to see specialists than patients with other kinds of health coverage, a new study reports.
Researchers at the University of California, San Francisco, conducted telephone interviews with 982 lupus patients and found that those covered by Medicaid had to travel longer distances to obtain lupus-related care from any health professional, especially rheumatologists.
The study also found that even though Medicaid patients were as likely as other patients to have seen a rheumatologist for a similar number of visits per year, the Medicaid patients reported more visits to general practitioners and to emergency rooms.
"These results suggest that Medicaid patients may face barriers on obtaining comprehensive medical services in proximity to their residences," the study authors wrote.
The study is published in the May issue of the journal Arthritis Care & Research.
Future studies may look at the
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Clinical Trials Update: May 4, 2007
Renal Cell Carcinoma Neoplasms Heart Disease
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Rituximab Reduced Disease Activity in MS Patients
The drug rituximab reduces disease activity in people with the relapsing-remitting form of multiple sclerosis (MS), according to two new studies.
Rituximab selectively targets and depletes a subset of immune cells called B-cells by targeting a specific protein on the cell surface. It's the first drug designed to target B-cells and may offer a new treatment for relapsing-remitting MS.
In one study, University of California, San Francisco, researchers gave two infusions of rituximab, delivered two weeks apart, to 69 patients, while 35 other patients received a placebo.
During the following six months, the patients who received rituximab had 90 percent fewer brain lesions and 58 percent fewer drug relapses than the patients who received the placebo (14.5 percent vs. 34.3 percent).
In the second study, researchers at McGill University in Montreal gave 26 patients two infusions of rituximab two weeks apart
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Health Highlights: May 9, 2007
U.S. Senate Votes to Overhaul FDA Report Cites U.S. Health-Care Disparities Scientists to Catalog 1.8 Million Known Species Doctors Paid Millions to Prescribe Anemia Drugs Chinese Company Linked to Cough Medicine Deaths Not Licensed Cracker Barrel Pulls Hamburgers After Woman Injured FDA Approves Respirators for Use in Flu Pandemic
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Proposal to Give FDA More Muscle Gets Mixed Reviews
A U.S. Senate bill that offers up the prospect of enhanced powers for the U.S. Food and Drug Administration in its dealings with the pharmaceutical industry is drawing both praise and criticism from health experts.
Some believe the bill, approved overwhelmingly in a 93-1 vote Wednesday, would help restore consumer confidence to a regulatory system that has been shaken in recent years by drug recalls and reports of serious health risks to consumers. But others say the proposed changes don't go far enough.
Under terms of the Senate bill, the FDA would be able to mandate changes in drug labels, remove from the market drugs considered dangerous to consumer health, and order more studies of drugs already on the market. The agency would also be required to establish a database of all clinical trials of drugs to make safety issues more transparent.
The Senate bill would also enable the FDA to fine companies up to $2 million if they do not comply w
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Clinical Trials Update: May 11, 2007
Depression Rheumatoid Arthritis Insomnia
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