WASHINGTON – Women's groups cheered the government's decision to allow 17-year-olds to buy the "morning-after" emergency contraceptive without a doctor's prescription, but conservatives denounced it as a blow to parental supervision of teens.
The Food and Drug Administration said Wednesday it would accept, not appeal, a federal judge's order that lifts Bush administration restrictions limiting over-the-counter sales of "Plan B" to women 18 and older. U.S. District Judge Edward Korman ruled last month in a lawsuit filed in New York that President George W. Bush's appointees let politics, not science, drive their decision to restrict over-the-counter access.
Women's groups said the FDA's action was long overdue, since the agency's own medical reviewers had initially recommended that the contraceptive be made available without any age restrictions.
Korman ordered the FDA to let 17-year-olds get the birth control pills. He also directed the agency to evaluate clinical data to determine whether all age restrictions should be lifted.
The FDA's latest action does not mean that Plan B will be immediately available to 17-year-olds. The manufacturer must first submit a request.
"It's a good indication that the agency will move expeditiously to ensure its policy on Plan B is based solely on science," said Nancy Northup, president of the Center for Reproductive Rights, which filed the lawsuit.
Conservatives said politics drove the decision.
"Parents should be furious at the FDA's complete disregard of parental rights and the safety of minors," said Wendy Wright, president of Concerned Women for America.
Plan B is emergency contraception that contains a high dose of birth control drugs and will not interfere with an established pregnancy. It works by preventing ovulation or fertilization. In medical terms, pregnancy begins when a fertilized egg attaches itself to the wall of the uterus.
If taken within 72 hours of unprotected sex, it can reduce a woman's chances of pregnancy by as much as 89 percent.
Critics of the contraceptive say Plan B is the equivalent of an abortion pill because it can prevent a fertilized egg from attaching to the uterus. Recent research suggests that's possible but not likely.
The battle over access to Plan B has dragged on for the better part of a decade, through the terms of three FDA commissioners. Among many in the medical community, it came to symbolize the decline of science at the agency because top FDA managers refused to go along with the recommendations of scientific staff and outside advisers that the drug be made available with no age restrictions.
"The FDA got caught up in a saga, it got caught up in a drama," said Susan Wood, who served as the agency's top women's health official and resigned in 2005 over delays in issuing a decision. "This issue served as a clear example of the agency being taken off track, and it highlighted the problems FDA was facing in many other areas."
The treatment consists of two pills and sells for $35 to $60. Women must ask for Plan B at the pharmacy counter and show identification with their date of birth. The drug is made by a subsidiary of Teva Pharmaceutical Industries, an Israeli company. It does not prevent sexually transmitted infections, such as HIV/AIDS.
Supporters of broader access argued that Plan B is safe and effective in preventing unwanted pregnancy and could help reduce the number of abortions.
Opponents, including prominent conservatives, counter that it would encourage promiscuity and might even become a tool for criminals running prostitution rings, as well as for sexual predators.
Early in the Bush administration, more than 60 organizations petitioned the FDA to allow sales without a prescription. But according to court documents, the issue quickly became politicized.
In 2003, a panel of outside advisers voted 23-4 to recommend over-the-counter sales without age restrictions. But top FDA officials told their subordinates that no approval could be issued at the time, and the decision would be made at a higher level. That's considered highly unusual, since the FDA usually has the last word on drug decisions.
In his ruling, Korman said that FDA staffers were told the White House had been involved in the decision on Plan B. The government said in court papers that politics played no role.
In 2005, the Center for Reproductive Rights and other organizations sued in federal court to force an FDA decision.
The following year, the FDA allowed Plan B to be sold without a prescription to adults. But the controversy raged on over access for teens.
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AP Medical Writer Lauran Neergaard contributed to this report.
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On the Net:
FDA's Plan B page: http://tinyurl.com/ch3ys6
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Kamis, 23 April 2009
FDA to allow Plan B birth control for 17-year-olds
NYC takes lead in setting next food target — salt
NEW YORK – First, it was a ban on artery-clogging trans fats. Then calories were posted on menus. Now the New York City health department is taking on salt. City officials are meeting with food makers and restaurants to discuss reducing the amount of salt in common foods such as soup, pasta sauce, salad dressing and bread.
About three-quarters of the salt Americans eat comes from prepared and processed food, not from the salt shaker. That's why New York officials want the food industry to help cut back.
"It's very hard for an individual to do this on their own," said Dr. Lynn Silver, an assistant commissioner in the health department.
The department has shown its clout with bans on artificial trans fats and rules forcing chain restaurants to post calorie counts. To comply, fast food chains changed their recipes nationwide, and other cities and states have enacted similar policies.
Some manufacturers said getting rid of trans fats took work, and reducing salt has its own difficulties.
Unlike sugar, there's no substitute for salt. Cream soups — like that casserole favorite cream of mushroom — are the biggest challenge, said George Dowdie, head of research and development for Campbell Soup Co. The soup maker, which has been cutting salt for years, is in the talks with New York.
By fall, Campbell Soup plans to have more than 90 lower-sodium soups available. That includes its first soup, tomato, which will have almost a third less salt.
The industry hopes salt reduction remains voluntary.
"Literally freight cars full of salt have been removed from these products gradually over time," said Robert Earl, vice president of science policy, nutrition and health for the Grocery Manufacturers Association. "It has to be done carefully — gradually and incremental over time."
Herbert Smith Jr. never paid much attention to how much salt was in food until he developed high blood pressure. His doctor at a Harlem health center put him on medication and told him to exercise and watch his diet.
The 54-year-old church receptionist said he was alarmed to see how much salt was in the instant soup packages that he liked. He wants the food industry to cut down.
"For those who want to use salt, they can add it themselves," he said.
Too much salt raises blood pressure, and high blood pressure raises the risk of heart disease. A recent analysis showed that for every gram of salt cut, as many as 250,000 cases of heart disease and 200,000 deaths could be prevented over a decade.
"Very, very small changes in diet could have dramatic effects," said Dr. Kirsten Bibbins-Domingo, a researcher with the University of California, San Francisco.
For its salt initiative, New York has recruited public health agencies and medical groups across the country. The campaign — with a goal of cutting salt intake by at least 20 percent in five years — is modeled on a plan carried out in Britain. That effort set voluntary salt reduction targets for 85 categories of processed foods.
"Companies have been very innovative," said Corinne Vaughan, of Britain's Food Standards Agency. "And they have been very good at making what are quite huge reductions in salt levels."
Salt in pasta sauces has been cut by nearly a third, and soups by about one-quarter, she said. Some foods have been more challenging, she said, citing bacon, cheeses and packaged bread. With less salt, the dough is sticky and harder to process, she said. Salt is used mostly for flavoring but can also help preserve some foods and gives others texture.
Some British companies have also put "traffic light" labels on package fronts — green for low-salt, for example — so shoppers can "make a choice at a glance," Vaughan said.
Everyone needs some salt — or sodium chloride — for good health. The daily recommended amount for Americans is about a teaspoon, or 2,300 milligrams of sodium. But many people consume twice that amount. A Big Mac alone has 1,040 milligrams.
A recent government report showed that seven out of 10 adults should be eating even less than the recommended amount — about 1,500 milligrams. That includes anyone with high blood pressure, everyone over 40, and African-Americans, who are at greater risk than whites for high blood pressure.
The prospect of government intervention bothers some, and some critics note that not everyone is sensitive to salt. A few others contend there is not enough scientific evidence that reducing salt really drives down heart problems or deaths.
But many in the medical and public health field are firmly behind the idea.
"When you've got groups ... all saying we need to reduce salt, the evidence is exceedingly strong, you don't do more trials," said Dr. Stephen Havas, an adjunct professor at Northwestern University's medical school and a former American Medical Association vice president.
In the meantime, the Food and Drug Administration is considering a request that the government regulate salt content. An Institute of Medicine committee is also looking at ways to reduce salt consumption. The FDA says it is waiting for that committee report, due next year, before deciding the regulation issue.
Bibbins-Domingo, the University of California researcher, and her colleagues say their findings support efforts to lower salt levels, either voluntarily or through regulation.
She said her patients with high blood pressure struggle to cut down on salt. They give up potato chips, french fries and salty nuts, but end up eating processed foods like soups and pasta that can also have a lot of salt, she said.
"I realized how hard it is for patients who want to make those changes," she said.
New York resident Kristle Thompkins, 37, has been trying to make those changes herself.
She started reading labels and limiting salt a few years ago because of her high blood pressure. Now she's adjusted to eating less salt — although she still misses potato chips.
The macaroni and cheese she made for an Easter gathering now tastes "too salty."
"My salt tolerance has lowered," Thompkins said.
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On the Net:
New York City Department of Health: http://www.nyc.gov/health
British salt program: http://www.salt.gov.uk/
Swine flu cases in Calif. worry health officials
ATLANTA – Health officials alerted doctors Tuesday to a unique type of swine flu diagnosed in two California children, but it's unclear whether many people will be susceptible to the infection. The children were diagnosed last week. One was a 10-year-old boy in San Diego County, and the other a 9-year-old girl in neighboring Imperial County. Both recovered.
U.S. Centers for Disease Control and Prevention officials said there's no reason for the public to take unusual measures against it.
"CDC is concerned, but that's our job," said CDC spokesman Tom Skinner.
Health officials have long feared the emergence of a deadly form of flu. They have not noted a spike in flu cases or a rash of severe illnesses. But they are continuing to investigate the genetics of the virus and track down and test people who may have been in contact with the children.
Both children became sick in late March and experienced fever and cough. The boy also vomited.
The two had not been in contact with each other, CDC officials said.
The boy's mother and brother also had a flu-like illness recently, as did a brother and a cousin of the girl. None of those relatives were tested for flu at the time of their illness.
The San Diego County boy and his 8-year-old brother flew from California to Dallas in early April and are currently with relatives in Texas. Health officials also are trying to contact the plane's flight crew and two children who sat near the boys, CDC officials said.
In the past, CDC received reports of approximately one human swine influenza virus infection every one or two years. But more than a dozen cases of human infection with swine influenza have been reported since late 2005.
Most cases occur in people who were exposed to pigs. Neither child had touched a pig, according to their families, although the girl had been at an Imperial County agricultural fair four weeks before she got sick.
The jump in cases in the past few years could be because of technological improvements and expansion of public health laboratories, which have improved testing capacity. But genetic mutations could also play a role.
The new flu contains a unique combination of gene segments that have not been seen in swine or human flu viruses before, CDC officials said.
The same virus has not been detected in any California pigs. "But we don't test every pig for influenza, so we don't know all the strains that are circulating," said Dr. Gil Chavez, California's state epidemiologist.
Early tests indicate this type of flu is resistant to amantadine and rimantadine, two common antiviral medications. It is not unique in that respect — a more common virus that's been infecting people this flu season also is resistant to those drugs.
Health officials think the current seasonal flu vaccine may not protect against it.
Swine flu is an infamous disease in public health circles. In 1976, health officials were frightened by unusual cases of swine flu in soldiers at Fort Dix, N.J. The virus appeared to be similar to a deadly flu that killed millions around the world in 1918 and 1919.
Federal officials vaccinated 40 million Americans during a national campaign. The pandemic never materialized, but thousands who got the shots filed injury claims, saying they suffered a paralyzing condition and other side effects from the vaccinations.
The government is more sophisticated now in how it diagnoses and tracks diseases, said Dr. Lyn Finelli, a CDC epidemiologist.
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NY pharmacies agree to translate drug instructions
ALBANY, N.Y. – Many non-English speakers will soon be able to read prescription drug instructions in their primary language.
Five companies announced Tuesday that pharmacies at more than 700 stores statewide will translate the information.
The companies are Target, Wal-Mart, Costco, Duane Reade (dwayn REED') and A&P.
The companies agreed with New York Attorney General Andrew Cuomo to counsel and provide written translations in Spanish, Chinese, Italian, Russian and French.
(This version CORRECTS that agreement covers stores statewide, not nationwide.)
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More people live with paralysis than doctors knew
WASHINGTON – Roughly one in 50 Americans has some degree of paralysis, and five times more people than doctors thought are living with a spinal-cord injury — nearly 1.3 million — says a startling study released Tuesday.
It's a largely hidden population that neither the government nor medical organizations had ever attempted to fully count, and the findings promise to help health authorities understand the scope of need.
"Paralysis is not rare," said Dr. Edwin Trevathan, disabilities chief at the U.S. Centers for Disease Control and Prevention, which helped design the study. "These data demand that we recommit ... to help this population."
"Those are startling, startling numbers," said Rep. Jim Langevin, D-R.I., who has a spinal-cord injury himself and urged more investment in not just medical research but transportation, job opportunities and other day-to-day needs of the paralyzed.
The report found that overall, almost 5.6 million people have some degree of paralysis due to a variety of neurologic problems. Stroke and spinal-cord injury are the leading causes, but they also include multiple sclerosis, brain injuries, birth defects, surgical complications and a list of other ailments.
That's about 30 percent higher than previous estimates. But for spinal-cord injury alone, previous estimates were woeful — suggesting just a quarter million people were living with the trauma, a count that mostly included people like the late actor Christopher Reeve, who wound up at specialty treatment centers.
How could so many people have been missed? Partly, people are living much longer with paralysis, said CDC's Trevathan.
And they're now starting to face the added complications of aging on top of a disability.
"There's no road map for somebody like me," said Alan T. Brown of Hollywood, Fla., who broke his neck 21 years ago, just before his 21st birthday.
From a youth spent in wheelchair marathons, he's entering middle age suddenly needing more care, like an electric wheelchair instead of a manual. He's getting more infections, 17 urinary-tract infections last year alone. That's on top of the extra hurdles to arrange routine care, like a colonoscopy.
"This is finally going to open up people's lives to see what we live with," he said Tuesday.
For the new study, funded by the Christopher & Dana Reeve Foundation, University of New Mexico researchers designed a survey of 33,000 U.S. households to measure the full gamut of paralysis — how many people either cannot move or have difficulty moving an extremity.
The study paints a sobering picture of the cycle of paralysis and poverty. Sixty percent of people with paralysis have annual household incomes of less than $25,000. Worse, about a quarter report household incomes below $10,000, compared with 7 percent of the U.S. population, the study found.
Patients often lose their jobs, and caregiving needs can cost a spouse a job, too, ending employer-provided insurance. Treatment, including the physical therapy that can improve independence and sometimes movement, is costly. There are income limits to qualify for Medicaid, and cash-strapped states are limiting coverage.
The Reeve foundation plans to use the findings to push for health policy changes, including ending a federal requirement that disabled workers wait 24 months before getting health care through Medicare. Also on its target list: insurance policies that forbid $400 air cushions for wheelchairs until someone's already suffered a pressure-caused skin ulcer that can require a $75,000 hospital stay.
Florida's Brown knows he's lucky, able to pursue a lucrative public relations career and be a mentor to other spinal-cord patients despite being mostly paralyzed from the chest down. Before his injury, he had a private insurance policy that lasted until recently. Now, he said, he's paying tens of thousands of dollars yearly out-of-pocket, and worries about how his wife and two young sons will cope if he ever has to quit working.
"I thought I was bigger than the chair. I finally realized the chair is bigger than me," Brown said.
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On the Net:
Christopher & Dana Reeve Foundation: http://www.christopherreeve.org/
..read more...
