FDA Delays Decision on Morning-After Pill
There was still no word as the weekend began on whether the U.S. Food and Drug Administration would approve over-the-counter sales of levonorgestrel, the so-called "morning-after" birth control pill.
Barr Pharmaceuticals, the firm that markets the pill under the name Plan B, issued a news release saying the FDA had delayed its decision, which was expected Friday. Barr said it was still hopeful that the federal agency would approve the pill for non-prescription sales and that the delay came because FDA officials hadn't completed their review in time to meet the Jan. 21 deadline, the Associated Press quotes the company news release as saying.
The FDA rejected Barr's bid for OTC sales in May 2004, saying it didn't have enough evidence of the drug's safety among younger teenagers to allow unregulated use in that age group. Barr's new plan, submitted two months later, would restrict over-the-counter use to women 16 and older, and would still require a prescription for younger girls.
When it became apparent that the FDA would not meet its deadline, a federal lawsuit was filed in New York against the government, AP reports. The Center for Reproductive Rights filed suit against the FDA, saying that it didn't follow its own procedures or mandates, beginning when it first denied the application in May 2004.
Alzheimer's Drug Maker Announces Death Increase In Clinical Trials
U.S. government officials have been notified that two clinical trials involving a prescription drug that treats mild cases of Alzheimer's disease resulted in triple the number of deaths than those in the control group.
The New York Times reports that Johnson & Johnson, which developed Reminyl -- approved in 69 countries to treat mild-to-moderate cases of Alzheimer's disease -- notified the U.S. Food and Drug Administration Friday as well a regulators in Canada and Europe about the clinical trial results.
The trials were taking place in 16 countries using 2,000 people to determine whether Reminyl could also be used to treat people with mild cognitive impairment, a type of memory lapse that some believe could be a precursor to Alzheimer's, the newspaper reports. During the two year trial period, 15 patients taking Reminyl died, as opposed to five who were taking a placebo, according to the Times.
But a Johnson & Johnson spokeswoman, Carol Goodrich, told the newspaper that the investigators didn't believe there was a connection between the deaths and Reminyl. There could have been a number of reasons for the deaths, many of which were heart attacks or strokes, she maintained. Johnson & Johnson said the number of deaths was low for the elderly population participating in the trials.
Representatives of both the FDA and Health Canada -- that country's government health agency -- told the Times they were investigatig the results of the clinical trial! s.
Final Medicare Drug Benefit Provisions Unveiled
The U.S. Medicare program released final regulations Friday for establishing the long-awaited senior prescription drug benefit, to take effect in 2006.
Under the sweeping Medicare Modernization Act signed by President Bush in 2003, the new provisions begin the shift from the temporary drug discount cards now in use to broad-based drug coverage for all beneficiaries, according to a statement from Medicare's parent agency, the U.S. Department of Health and Human Services.
HHS says the new rules, affecting 41 million elderly and disabled Americans, include provisions to:
Give beneficiaries a choice of at least two drug plans that will cover a wide range of both brand names and generics.
Give relief to 9 million low-income beneficiaries by waiving any premiums and deductibles.
Ensure that people who qualify for participation in both Medicare and Medicaid are automatically enrolled in the drug plan if they fail to sign up by the December 2005 deadline.
Once the drug benefit takes effect, it's expected to save U.S. states an estimated $8 billion annually over the first five years, the statement said.
Anti-Bacterial Chemical Found in U.S. Waterways
An anti-microbial chemical used in hand soaps and other cleaning products appears to be present in about 60 percent of the 85 U.S. streams, rivers and other water resources investigated by researchers at Johns Hopkins University, according to a statement from the college's Bloomberg School of Public Health.
Triclocarban has been used for some 50 years, but rarely has been monitored for its effects on the environment, scientists led by Prof. Rolf U. Halden said. If the results were confirmed nationwide, it would mean triclocarban is the fifth most frequent contaminant among 96 pharmaceuticals, personal care products and organic wastewater contaminants evaluated, the school's statement said.
Triclocarban is often difficult to detect, noted Halden's team, which predicted the chemical's concentrations based on actual test results of similar contaminants found in the same cleaning products. The researchers said their results suggested that triclocarban contamination is "greatly underreported" nationwide.
Results of the study are published in the online edition of Environmental Science & Technology, a peer-reviewed journal of the American Chemical Society.
Jan. 24 is Most Depressing Day of Year: Psychologist
If a British psychologist's assessment is correct, next Monday will be the most depressing day of 2005 for many people.
Dr. Cliff Arnall, who specializes in seasonal disorders at the University of Cardiff in Wales, has devised a formula that accounts for such factors as weather, time since Christmas, monetary debt and motivational levels, reports MSNBC.
"Following the initial thrill of New Year's celebrations and changing over a new leaf, reality starts to sink in," Arnall told the network. "The realization coincides with the dark [winter] clouds rolling in and the obligation to pay off Christmas credit card bills."
Arnall devised the formula at the request of a British travel agency, which had asked him to estimate when people were most likely to seek respite from a long, harsh winter.
Japanese Government Ponders Iressa Ban
The Japanese government is considering banning the controversial lung cancer drug Iressa following a report that links the drug to 588 deaths in that country, more than four times the number of deaths previously believed to have been caused by the drug.
A spokesperson for Japan's Ministry of Health and Welfare told The Times of London that the report's findings raise the possibility that Iressa would be withdrawn from the Japanese market.
Along with the 588 deaths, the report concluded that 1,473 patients suffered serious side effects after taking Iressa. A full version of the report, compiled by a panel of scientists, is due in March.
The findings are part of an emergency investigation into the safety and efficacy of Iressa ordered last year after drug maker AstraZeneca said a clinical trial of Iressa showed the drug was no more effective than a placebo in prolonging the lives of lung cancer patients, The Times reported.
Japan accounts for more than 40 percent of total worldwide sale of Iressa.
Food Fact:
Asparagus tips.
Spear 25 on your fork to barely reach 100 calories? That's not all... This true dieter's delight is plentiful and inexpensive in spring. Asparagus is a great source of folic acid, and a good source of vitamins A and C. When buying asparagus, choose firm, bright green spears with tight tips. Wrap in plastic and store for up to 4 days in the refrigerator. If stems are thick, peel the outermost layer with a vegetable peeler. Steam or boil until just tender, about 3 minutes. Resist butter sauces or oil-rich vinaigrettes, which ruin the nutritional profile.
Fitness Tip of the day:
Be a road scholar.
It's easy to find out where you can work out on a business trip, if you know where to look online. Before you leave, go to a travel or city guide Web site for your destination and research the parks, community centers, tracks and fitness centers where you can get a little exercise. Nothing boosts your energy, creativity and effectiveness on the road like a workout. Bonus: Explore the local jogging paths, and you'll get a taste of city life you'll never find in a hotel or pitch meeting.
FAQ of the day:
How much red meat is too much?
If you choose to include red meat in your diet, you can greatly reduce your risk of chronic disease by limiting how much and how often you eat it. In population studies, individuals who say that they eat red meat "less than once a week" are generally at significantly lower risk of heart disease and cancer than people who eat red meat several times a week. A good goal: No more than once a month. You don't have to reach this goal overnight; work your way down to once a week, then once every two weeks, then once a month. Take it one day at a time; try fish, chicken, beans or soy tonight!
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