FDA Investigating Anti-Smoking Drug
The U.S. Food and Drug Administration is probing whether the smoking cessation drug Chantix (varenicline) raises users' risk for suicidal thoughts and "aggressive and erratic behavior," according to a statement released by the agency Tuesday.
First approved in May 2006 to help smokers kick the habit, Chantix made headlines in September after the violent death of Dallas musician Carter Albrecht. According to the Associated Press, Albrecht was shot in the head by his girlfriend's neighbor after he became enraged and attempted to kick down the man's door. Family members believe Chantix may have played a role in Albrecht's emotional state.
An autopsy report showed Albrecht's blood alcohol limit was triple the legal limit at the time of the incident, the AP added.
FDA says it is aware of the Albrecht case, as well as various anectdotal reports of increased suicidal behavior and ideation while taking Chantix, reported in the media and on Internet sites. The agency has asked the drug's maker, Pfizer Inc., for information on "additional cases that might be similar."
"The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness," the agency said.
The FDA said it is currently reviewing information supplied by Pfizer, and is checking on information suggesting that Chantix can make users drowsy. In the meantime, patients are encouraged to "contact their doctors if they experience behavior or mood changes," the agency said, and to be cautious when driving or using machinery while taking Chantix.
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Global HIV/AIDS Cases Decline
The number of global HIV/AIDS cases decreased from 39.5 million in 2006 to 33.2 million this year, according to a report to be released Wednesday by the World Health Organization and the United Nations AIDS agency.
However, previous estimates may have been too high and this year's lower numbers may be due to new methodology, the Associated Press reported. Previous estimates of HIV/AIDS in the general population were largely based on the numbers of infected pregnant women at clinics and rates in specific high-risk groups, such as drug users.
Officials said that approach produced flawed numbers, and the new figures factor in more kinds of data, such as national household surveys.
Even if this year's decline is mostly the result of changes methodology, U.N. officials said the new figures still show slowing momentum in the AIDS pandemic, the AP reported.
"For the first time, we are seeing a decline in global AIDS deaths," said Dr. Kevin De Cock, director of the WHO's AIDS department.
The Los Angeles-based AIDS Healthcare Foundation questioned whether the new estimate is any more accurate than previous numbers, and called for greater transparency among international agencies that monitor and track HIV/AIDS.
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Too Few U.S.-Trained Primary Care Doctors: Study
Only 31 percent of primary care doctors in the United States are homegrown, reports a study in the journal Annals of Family Medicine. That's because more and more U.S.-trained medical students are becoming specialists so that they can work fewer hours and make more money, ABC News reported.
As a result, the U.S. is increasingly dependent on foreign medical school graduates to fill the primary care role. This situation highlights the need for fundamental reforms in the primary care field, according to experts.
"The dependence on recruiting international medical graduates is symptomatic of the sad state of primary care in the U.S.," Dr. Allan Goroll, professor of medicine at Harvard Medical School in Boston, told ABC News.
Low pay, inadequate funding, and poor organization are among the reasons why U.S. medical graduates shun primary care, he said.
The study authors noted that this situation also affects other nations, because the U.S. recruits top medical school graduates from poor and underdeveloped countries with severe doctor shortages, ABC News reported.
"What is most significant about this study is not only the fact that we import physicians, but that we preferentially import them from poor countries, to buttress our own primary care physician supply," said study lead author Dr. Barbara Starfield, a professor of health policy and management at the Johns Hopkins School of Public Health in Baltimore, Md.
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Gene Therapy for Parkinson' s Disease Shows Promise
An experimental form of gene therapy shows promise in treating Parkinson's disease, according to a U.S. study published in the journal Proceedings of National Academy of Sciences.
The University of New York-led team used a virus that was genetically modified to carry a human gene that makes a chemical called GABA, which calms over-activity in an important part of the pathway that controls movement, BBC News reported.
Symptom assessment and positron emission tomography (PET) brain scans on the 12 patients who received this therapy showed significant improvements that were still present up to one year after treatment. Patients who received the highest doses of the gene therapy had the longest-lasting effect.
While this form of gene therapy shows promise, the research is still in the early stages, BBC News reported.
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U.S. Hysterectomy Rates Remain High
Although there are less expensive alternatives, the number of hysterectomies performed in the United States has remained at about 600,000 per year over the past 25 years, says a report released Monday by the not-for-profit National Women's Health Resource Center (NWHRC).
About one in every three women will have a pelvic disorder by age 60. Based on current trends, about 25 percent of women in the United States will have had a hysterectomy by age 60, and most will be treated with the open total abdominal procedure, said the report, presented at the Global Congress of Minimally Invasive Gynecology in Washington, D.C.
"Many women are still being treated for fibroids and menorrhagia (heavy menstrual bleeding) with hysterectomy, particularly the most invasive total abdominal hysterectomy (TAH), even though it comes with a long and painful recovery," Elizabeth Battaglino Cahill, NWHRC executive vice president, said in a prepared statement.
"While there are some cases where TAH is appropriate, women need to understand that there are less invasive options to hysterectomy that can get them back to their daily lives quicker and are actually more cost effective," she said.
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Three E.U. Countries Halt Sales of Prexige
Austria, Germany and the United Kingdom have halted sales of the anti-inflammatory painkiller Prexige due to concerns that it may cause liver damage, Agence France-Presse reported.
Earlier this year, Australia and Canada suspended sales of the Novartis drug, which hasn't been approved by U.S. Food and Drug Administration.
"Patients taking Prexige in the U.K., Germany and Austria should consult their healthcare provider," said a statement released by Novartis. The drug maker also noted that other European Union countries "may decide to independently suspend the marketing authorization or sale of Prexige ahead of a decision," by the E.U.'s medical regulator expected in December, AFP reported.
According to Novartis, "available data suggest that Prexige 100 mg once-daily for osteoarthritis is not associated with increased hepatic [liver] risk" compared to other painkillers.
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