Health Highlights: April 21, 2007
FDA Reaffirms Aspartame Not a CarcinogenDrug Maker: No Mortality Hike When Anemia Drug Was Used in Clinical Trial Surgeons Remove Woman's Gallbladder Vaginally Rabies Treatment Failed to Save 3 Children Increasing Hypertension Rates Could Cause Heart Disease Epidemic
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
FDA Reaffirms Aspartame Not A Carcinogen
After reviewing findings first presented in 2005 by an Italian-based research group, the U.S. Food and Drug Administration has concluded that there isn't enough evidence to conclude that the artificial sweetener aspartame causes cancer.
Aspartame, which is used in the sweetener Equal, among others and in a variety of soft drinks and other products, had already been found safe to use after a 2005 U.S. study of half a million participants.
But when the laboratory rat study conducted by the European Ramazzini Foundation (ERF) of Bologna, Italy said a few months later that there was evidence of increased tumor activity when aspartame was consumed, the FDA asked that the research be sent to it for review.
"... the data that were provided to FDA do not appear to support the aspartame-related findings reported by ERF," the FDA says in a statement on its Web site. "Based on our review, pathological changes were incidental and appeared spontaneously in the study animals, and none of the histopathological changes reported appear to be related to treatment with aspartame."
The FDA also said that repeated requests for additional information on the study from the ERF, including pathology slides, was never honored.
Drug Maker: No Mortality Hike When Anemia Drug Was Used in Clinical Trial
The pharmaceutical company Amgen says it has good news for patients and investors alike.
The New York Times reports that Amgen issued an overview Friday of a closely-watched clinical trial of its anemia drug Aranesp, saying that the medicine did not increase the death rate of lung cancer patients who were using it.
Earlier studies had indicated that Aranesp and other drugs in the same class might cause blood clots, worsen cancer or increase the risk of death if overused. In fact, the U.S. Congress had already entered into the discussion about the safety of these anemia drugs.
Last month, the House Committee on Energy and Commerce sent letters to drug makers Amgen (Epogen and Aranesp) and Johnson & Johnson (Procrit), asking them to clarify when they knew about the possible risks associated with the drugs and how they have promoted the drugs, the Times reported. The drugs are used by nearly a million Americans a year, mainly to treat anemia from kidney disease or cancer chemotherapy.
On March 9, the U.S. Food and Drug Administration and the drug makers agreed to put a "black box" warning (the most serious kind) on the labels of the anemia drugs to warn about the newly identified risks. An FDA advisory panel is scheduled to meet May 10 to discuss the safety of the drugs.
While the results from the lung cancer trial are encouraging, the Times reports that a number medical experts say more research is needed to ensure that these drugs are safe to use with other diseases as well.
Surgeons Remove Woman's Gallbladder Vaginally
In a procedure that required only minimal external incisions, surgeons used a flexible endoscope to remove a woman's gallbladder through her vagina. This new procedure, which is being used in an ongoing clinical trail, may help reduce pain, visible scarring and recovery time.
The NOTES (natural orifice translumenal endoscopic surgery) procedure was performed by doctors at New York-Presbyterian Hospital/Columbia University Medical Center. They inserted the endoscope through the woman's vaginal wall and into her body cavity. Using the endoscope, along with laparoscopic instruments inserted through the abdomen, the surgeons detached the gallbladder and removed it through the vagina.
"Advances in minimally invasive surgical techniques over the last 15 years have dramatically reduced the number of open abdominal surgeries necessary -- eliminating a great deal of the associated discomfort. This latest revolutionary advance -- abdominal surgery through a natural orifice -- represents the culmination of this progression," Dr. Marc Bessler, who led the surgery, said in a prepared statement.
"This technique allows us to make smaller and fewer skin incisions. And, in the future, some abdominal surgeries will be possible without any external incisions," said Bessler, director of laparoscopic surgery and director of the Center for Obesity Surgery at New York-Presbyterian/Columbia and assistant professor of surgery at Columbia University College of Physicians and Surgeons.
Bessler is scheduled to make a presentation on the procedure this Sunday at the annual meeting of the Society of American Gastrointestinal Endoscopic Surgeons in Las Vegas.
New York Presbyterian/Columbia is also using the NOTES technique for appendectomy, abdominal exploration and biopsy. In the future, NOTES may be performed through the mouth or rectum.
Rabies Treatment Failed to Save 3 Children
A combination of drugs used to save the life of a teen infected with rabies did not help three other infected youngsters, says an article published Friday in the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report.
In 2004, 15-year-old Jeanna Giese of Wisconsin was infected with rabies after she was bitten by a bat. She had not been vaccinated against the disease. Doctors in Milwaukee used drugs to induce a coma and then treated Giese with antiviral drugs, including ribavirin, ketamine and amantadine, the Associated Press reported.
She survived and the successful treatment was published in the New England Journal of Medicine.
However, the MMWR article said that the so-called Wisconsin protocol failed to save the lives of three U.S. children infected with rabies last year, the AP reported.
Reasons for the failure in those cases could include the strain of rabies virus, the drug dosing, and the time between infection and treatment, said Dr. Charles Rupprecht, co-author of the MMWR report and chief of the CDC's rabies program.
Increasing Hypertension Rates Could Cause Heart Disease Epidemic
Increasing rates of high blood pressure caused by modern lifestyles threaten to create a global epidemic of cardiovascular disease, warn international experts in a study unveiled at the European Parliament in Brussels.
Currently, about 25 percent of adults have high blood pressure and that figure could increase to 60 percent over the next 20 years if nothing is done to tackle the issue, such as encouraging people to adopt healthier, less-hectic lifestyles, BBC News reported.
Rates of hypertension are increasing most rapidly in emerging nations with westernized economies, such as China, India, Russia and Central European countries.
High blood pressure is a major risk factor for developing heart disease. Each year, high blood pressure contributes to an estimated 7.1 million deaths worldwide, the researchers noted.
They said that public policy efforts need to focus on earlier diagnosis of high blood pressure and addressing its underlying causes, BBC News reported.