FDA Panel Backs New Leukemia Drug
A U.S. Food and Drug Administration advisory panel on Friday recommended approval of a new drug that treats certain leukemias when other treatments have failed, the Associated Press reported.
The drug, known as Sprycel, would be used to treat chronic myeloid leukemia (CML) in patients who have developed a resistance or intolerance to Gleevec. CML represents 14 percent of all adult leukemias, according to the FDA.
Bristol-Myers Squibb, which makes Sprycel, also got the panel's blessing to use the drug to treat Philadelphia chromosome-positive acute lymphoblastic leukemia, the AP reported.
The FDA is expected to decide whether to approve Sprycel by June 28; the advisory panel met in Atlanta to coincide with the American Society of Clinical Oncology (ASCO) annual meeting, which is being held in that same city.
Vets May Have Been Exposed to Virus
Improperly sterilized equipment might have exposed more than 22,000 veterans who underwent prostate biopsies to deadly viruses, federal officials have warned.
The Associated Press reported Saturday that U.S. Department of Veterans Affairs officials said it was unlikely someone could get infected, and no patient is known to have fallen ill yet.
Regardless, the agency is offering free blood tests as a precaution. Maine officials were the first to question whether the cleaning procedure for prostate biopsy equipment was sufficient, VA spokesman Jim Benson told the wire service. The equipment contains a probe that could hold traces of fluids that might harbor the viruses that cause AIDS or hepatitis.
Since April, the VA has alerted 21 medical centers in 18 states, including Puerto Rico, about the possibility of contamination. About 7,000 veterans have contacted the federal agency, and 2,000 have been tested.
"It's too soon to have any information on their test results because each of the potential diseases we might be worried about require not only initial tests but confirmatory tests as well," Benson told the AP. "Right now, our first priority is getting information out to every veteran."
Experts Question High Cost of Cancer Care
Cancer treatments are the most expensive medical therapies in the United States, and a panel of experts said Friday it is time to rethink the cost of drugs that only add a few months to a patient's life.
Convening at the American Society of Clinical Oncology annual meeting in Atlanta this weekend, the six doctors on the panel noted that physicians and ethicists alike are struggling with the dilemma, according to Newsday. The cancer treatment industry is a $210 billion annual enterprise, the paper reported.
A steady stream of highly priced drugs has been pumped out by the pharmaceutical industry in recent years, and these medications tend to cost insurers and patients $2,000 to $5,000 a month, the panel said. However, these treatments have captured both headlines and the attention of patients desperate for a few more months of life.
"Everybody is affected," said Dr. Neal Meropol, of the Fox Chase Cancer Center in Philadelphia. ""The doctors, patients, insurers, entire economies."
Scios to Conduct Safety Review of Heart Drug Natrecor
Scios Inc., a division of Johnson & Johnson, said Thursday that it would spend more than $100 million to conduct a safety study of its controversial heart-failure drug, Natrecor.
The trial seeks to address safety issues concerning the drug since last year. Other studies had suggested that Natrecor, an intravenous drug approved in 2001 that was designed to treat breathing problems that can accompany heart failure, could lead to increased risk of kidney problems and a higher risk of mortality within the first month of treatment, the Associated Press reported.
Patient enrollment is expected to begin early next year and involve 7,000 people in the United States, Canada and Europe, according to Scios. The company has yet to select the lead researchers, and said it doesn't know how long the trial will take to complete, AP reported.
Clot-Busting Drug Helps Revive Cardiac-Arrest Patients
Emergency room doctors were able to double the number of patients who could be revived from cardiac arrest after using a "clot buster" drug normally reserved for treating patients during a heart attack, according to a study in the June issue of Resuscitation.
The pilot study involved patients with cardiac arrest who didn't respond to standard therapy. Of 50 patients who received the clot-buster tenecteplase, known medically as a fibrinolytic agent therapy, 26 percent were revived, compared to 12 percent of patients who got standard therapy alone. However, not all patients who were revived lived long enough to be discharged from the hospital, according to the study.
Sudden loss of heart function occurs in more than 260,000 people a year nationwide and at least 93 percent of them die, according to the report. Standard treatment for cardiac arrest is Advanced Cardiac Life Support (ACLS) measures, which include cardiopulmonary resuscitation (CPR), drugs such as adrenaline, and defibrillation, an electric shock to the heart.
"Clot-busting agents show promise as a new therapy for this abrupt and catastrophic loss of heart function," said study author Dr. William P. Bozeman, an emergency medicine specialist at Wake Forest University Baptist Medical Center in Winston-Salem, N.C. "We are in dire need of additional treatment options for sudden cardiac arrest, because there is only a 5 percent to 7 percent survival rate using interventions we now have."
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