Health Highlights: July 24, 2006
Sunscreen That Blocks UVA Radiation Okayed for U.S. FDA Approves First Treatment for Hunter Syndrome Guidelines Issued for Justice System's Handling of Drug Addicts Breakthrough Cancer Drug Gleevec May Hurt Heart: Study FDA to Tighten Rules for Drug Advisory Panelists Sharon's Condition Deteriorates, Medical Experts Say
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Sunscreen That Blocks UVA Radiation Okayed for U.S.
Anthelios SX, a sunscreen that's reportedly better at blocking ultraviolet A (UVA) radiation than other sunscreens currently sold in the United States, has been approved by the U.S. Food and Drug Administration.
The product, made by the French cosmetics company L'Oreal SA, contains an ingredient called ecamsule, and has a sun protection factor (SPF) of 15, the Associated Press reported.
Ecamsule is more effective against UVA radiation than ingredients (which block mainly ultraviolet B radiation) contained in sunscreens currently sold in the United States. Ecamsule has been an ingredient in L'Oreal's sunscreens sold in Europe and Canada since 1993.
The FDA noted that UVA is a deeper penetrating radiation than UVB. There's a suspected link between UVA and long-term effects such as wrinkles, basal and squamous cell cancers and melanoma, the AP reported.
FDA Approves First Treatment for Hunter Syndrome
A drug called Elaprase (idursulfase) on Monday became the first treatment for Hunter syndrome to be approved by the U.S. Food and Drug Administration. Hunter syndrome is a rare, inherited disease that can cause premature death.
The condition is caused by a defect in the body's ability to produce a chemical required to break down complex sugars. It can cause growth delay, joint stiffness, respiratory and cardiac problems, liver and spleen enlargement, neurological defects, and death.
The FDA designated Elaprase an orphan product, which are generally developed to treat rare diseases or conditions that affect fewer than 200,000 people in the United States. Hunter syndrome is diagnosed in about one out of 65,000 to 132,000 births.
The FDA approval was based on a study of 96 Hunter syndrome patients. It found that patients treated with Elaprase showed an improved ability to walk. Side effects included potentially fatal hypersensitivity reactions including respiratory distress, drop in blood pressure, and seizure.
Under the Orphan Drug Act, a company has exclusive seven-year marketing rights for its product. Elaprase is made by Shire Human Genetic Therapies, Inc. of Cambridge, Mass. The company plans to have the drug available within 30 days, and treatment is expected to cost about $300,000 per patient per year, the Associated Press reported.
Guidelines Issued for Justice System's Handling of Drug Addicts
Research-based guidelines on how the U.S. criminal justice system should deal with drug addicts were released Monday by the National Institute on Drug Abuse (NIDA).
The 13 guidelines are based on the understanding that drug addiction is a brain disease that affects behavior, the Associated Press reported. The guidelines state that drug addiction requires carefully monitored and personalized treatment and that offenders may need access to addiction medications, such as methadone, after their release.
Offenders should be pressured into treatment as a condition of probation and they should have to undergo urine testing during treatment to detect and prevent relapses, the guidelines recommended.
Dr. Nora Volkow, director of the NIDA, noted that every $1 spent on drug treatment programs saves an estimated $4 in crime costs. Drug crimes cost the United States. an estimated $107 billion a year, the AP reported.
Breakthrough Cancer Drug Gleevec May Hurt Heart: Study
Gleevec, the cancer wonder drug, may be toxic to the heart and lead to heart failure in patients, researchers reported Sunday in an analysis of the drug.
The findings, published online in the journal Nature Medicine, detail how Gleevec inadvertently targets a protein maintaining cells that contract the heart muscle and help to force blood through the body. The implications of the study call into question a whole class of new cancer drugs that work in a similar way, the Philadelphia Inquirer reported.
The study followed up on 10 patients who developed severe heart failure after taking Gleevec. Those cases were first reported in 2004 by the University of Texas M.D. Anderson Cancer Center in Houston.
Scientists, however, do not know why Gleevec caused the heart to fail. "This finding is a big surprise," Thomas L. Force, a cardiologist researcher who led a Thomas Jefferson University team and conducted the study with Jean-Bernard Durand of the Texas cancer center, told the Inquirer. Gleevec is the first of a new class of cancer drugs designed to focus on a single cancer protein and avoid many side effects of previous cancer drugs.
Novartis, which makes Gleevec, called the side effect rare, and said that patients who show symptoms are easily treated with standard medications. The company said it had already reported the 10 cases of heart failure to health officials and that the side effect is now included on the drug's warning label, the Inquirer reported.
FDA to Tighten Rules for Drug Advisory Panelists
The U.S. Food and Drug Administration said Monday it plans to tighten guidelines for outside scientists and doctors who serve on agency advisory panels that make recommendations on drugs and medical devices going to market.
The new guidelines are expected to specify when panelists should be disqualified because of conflicts of interest and to make public panelists' financial disclosures, Bloomberg News reported Monday.
Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, told Bloomberg the new restrictions are designed to "make sure that the current system is rigorous, consistent and transparent."
Congress and public advocacy groups have in the past criticized the FDA for appointing doctors and scientists who have financial or other relationships with the companies whose products they are asked to consider. The House has already approved legislation that seeks to prevent the FDA from allowing those with conflicts to serve on advisory panels, Bloomberg reported.
Sharon's Condition Deteriorates, Medical Experts Say
Former Israeli Prime Minister Ariel Sharon's kidneys are failing and changes have been detected in his brain, medical experts said Monday.
Sharon, 78, has been in a coma at The Sheba Medical Center near Tel Aviv since suffering a severe stroke in January. A hospital spokeswoman refused to say whether his life was threatened by his deteriorating condition, the Associated Press reported.
But Dr. John Martin, a cardiovascular expert at London's University College, told the AP that the kidney failure and changes in the brain membrane that Sharon suffered in the past two days indicate that the former leader's life was in danger. His comments were echoed by other physicians quoted in Israeli media.
Kidney dialysis and drugs to treat what appears to be cerebral edema could lead to an improvement in Sharon's condition within hours, Martin said.
Sharon had a small stroke in December and was put on blood thinners before suffering a severe brain hemorrhage in January. The Israeli leader underwent several brain surgeries to stop the bleeding, and many independent experts doubted he would ever recover, the AP reported.