Mexico plans shutdown as World flu alert raised

MEXICO CITY – Mexico readied a "temporarily closed" sign — taking the drastic step of ordering a suspension of nonessential federal government and private business activity as it tried to squelch a swine flu epidemic. The World Health Organization ratcheted up an alert and warned that "all of humanity" is threatened.

The dire warning showed that world health officials are very worried about the potential for massive numbers of deaths worldwide from the mutated virus, even though the epidemic so far has claimed only a confirmed eight lives in Mexico and one in the United States. Roughly 170 deaths are suspected of having been caused by the virus in Mexico.

The Phase 5 alert, indicating a pandemic could be imminent as the virus spread further in Europe, prompted Mexico to announce the partial May 1-5 shutdown, Mexican Health Secretary Jose Cordova said late Wednesday.

In Washington, President Barack Obama promised "great vigilance" in confronting the outbreak which has sickened nearly 100 people in 11 states and forced schools to close. A Mexican toddler who visited Texas with his family died Monday night in Houston, becoming the first fatality in the U.S., and 39 Marines were confined to their base in California after one came down with the disease.

The virus, a mix of pig, bird and human genes to which people have limited natural immunity, has also spread to Canada, New Zealand, Britain, Germany, Spain, Israel and Austria.

"It really is all of humanity that is under threat during a pandemic," WHO Director General Margaret Chan said in Geneva. "We do not have all the answers right now, but we will get them."

In a televised address, Mexican President Felipe Calderon praised "the heroic work" of doctors and nurses and asked his countrymen to literally stay in their homes between May 1 and May 5, saying "there is no safer place to protect yourself against catching swine flu, than in your house."

"In recent days, Mexico has faced one of the most serious problems in recent years," Calderon said Wednesday night. He brushed aside criticisms that his government's response was slow, stressing several times that authorities had reacted "immediately."

School in Mexico has already been canceled until May 6. During the shutdown, essential services like transport, supermarkets, trash collection and hospitals will remain open.

Calderon said authorities would use the partial shutdown to weigh whether to extend the emergency measures, or "if it is possible to phase out some" restrictions.

The outbreak appeared to already be stabilizing in Mexico, the epicenter. Confirmed swine flu cases doubled Wednesday to 99, but new deaths finally seemed to be leveling off after an aggressive public health campaign was launched when the epidemic was declared April 23. Although 17 new suspected deaths were reported, only one additional confirmed death was announced Wednesday night, for a total of eight countrywide. The virus is believed to have sickened as many as 2,955 people across the country, though hospital records suggest the outbreak may have peaked here last week.

The WHO said the global threat is nevertheless serious enough to ramp up efforts to produce a vaccine against the virus. It declared a Phase 5 outbreak — the second-highest on its threat scale — for the first time ever, indicating a pandemic could be imminent.

In the U.S., eight states closed schools Wednesday, affecting 53,000 students in Texas alone.

Obama said his administration has made sure that needed medical supplies are on hand and he praised the Bush administration for stockpiling 50 million doses of antiviral medications.

"The key now is to just make sure we are maintaining great vigilance, that everybody responds appropriately when cases do come up. And individual families start taking very sensible precautions that can make a huge difference," he said.

Ecuador joined Cuba and Argentina in banning travel to or from Mexico and Peru banned flights from Mexico. The Panama Canal Authority ordered pilots and other employees who board ships passing through the waterway to use surgical masks and gloves. An average of 36 ships per day use the canal, most from the United States, China, Chile and Japan.

In France, President Nicolas Sarkozy met with Cabinet ministers to discuss swine flu, and the health minister said France would ask the European Union to suspend flights to Mexico.

The U.S., the European Union and other countries have discouraged nonessential travel to Mexico. Some countries have urged their citizens to avoid the United States and Canada as well. Health officials said such bans would do little to stop the virus.

Medical detectives have not pinpointed where the outbreak began. Scientists believe that somewhere in the world, months or even a year ago, a pig virus jumped to a human and mutated, and has been spreading between humans ever since.

China has gone on a rhetorical offensive to squash any suggestion it's the source of the swine flu after some Mexican officials were quoted in media reports in the past week saying the virus came from Asia and the governor of Mexico's Veracruz state was quoted as saying the virus specifically came from China.

One of the deaths in Mexico directly attributed to swine flu was that of a Bangladeshi immigrant, said Mexico's chief epidemiologist Miguel Angel Lezana.

Lezana said the unnamed Bangladeshi had lived in Mexico for six months and was recently visited by a brother who arrived from Bangladesh or Pakistan and was reportedly ill. The brother has left Mexico and his whereabouts are unknown, Lezana said. He suggested the brother could have brought the virus from Pakistan or Bangladesh.

By March 9, the first symptoms were showing up in the Mexican state of Veracruz, where pig farming is a key industry in mountain hamlets and where small clinics provide the only health care.

The earliest confirmed case was there: a 5-year-old boy who was one of hundreds of people in the town of La Gloria whose flu symptoms left them struggling to breathe.

Days later, a door-to-door tax inspector was hospitalized with acute respiratory problems in the neighboring state of Oaxaca, infecting 16 hospital workers before she became Mexico's first confirmed death.

Neighbors of the inspector, Maria Adela Gutierrez, said Wednesday that she fell ill after pairing up with a temporary worker from Veracruz who seemed to have a very bad cold. Other people from La Gloria kept going to jobs in Mexico City despite their illnesses, and could have infected people in the capital.

Cordova, the Mexican health secretary, said getting proper treatment within 48 hours of falling ill "is fundamental for getting the best results" and suggested the virus can be beaten if caught quickly and treated properly. But it was neither caught quickly nor treated properly in the early days in Mexico, which lacked the capacity to identify the virus, and whose health care system has become the target of widespread anger and distrust.

In case after case, patients have complained of being misdiagnosed, turned away by doctors and denied access to drugs. Monica Gonzalez said her husband, Alejandro, already had a bad cough when he returned to Mexico City from Veracruz two weeks ago and soon developed a fever and swollen tonsils.

As the 32-year-old truck driver's symptoms worsened, she took him to a series of doctors and finally a large hospital. By then, he had a temperature of 102 and could barely stand.

"They sent him away because they said it was just tonsillitis," she said. "That hospital is garbage."

Gonzalez finally took her husband to Mexico City's main respiratory hospital, "dying in the taxi." Doctors diagnosed pneumonia, but it may be too late: He has suffered a collapsed lung and is unconscious. Doctors doubt he will survive.

Swine flu has symptoms nearly identical to regular flu — fever, cough and sore throat — and spreads like regular flu, through tiny particles in the air, when people cough or sneeze. People with flu symptoms are advised to stay at home, wash their hands and cover their sneezes.

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AP writers Frank Jordans in Geneva, Tom Raum and Lauran Neergaard in Washington, Olga Rodriguez in Oaxaca, Mexico, Paul Haven and E. Eduardo Castillo in Mexico City, and Mike Stobbe in Atlanta contributed to this report.

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World takes drastic steps to contain swine flu

From Egypt's order that all 300,000 pigs in the country be slaughtered to travel bans and putting the kibosh on kissing, the world is taking drastic — and some say debatable — measures to combat swine flu.

Egypt ordered the pig slaughter even though there hasn't been a single case of swine flu there and no evidence that pigs have spread the disease. Britain, with only five cases, is trying to buy 32 million masks. And in the United States, President Barack Obama said more of the country's 132,000 schools may have to be shuttered.

At airports from Japan to South Korea to Greece and Turkey, thermal cameras were trained on airline passengers to see if any were feverish. And Lebanon discouraged traditional Arab peck-on-the-cheek greetings, even though no one has come down with the virus there.

All this and more, even though world health experts say many of these measures may not stop the disease from spreading. On Wednesday, the World Health Organization raised its pandemic alert to the second-highest level, meaning it believes a global outbreak of the disease is imminent.

"Scientifically speaking, the main thing is that every virus behaves differently," said Joerg Hacker, president of the Robert Koch Institute, Germany's top public health authority. "At the moment, the main issue is to get to know this virus, how it works."

In Germany, where officials confirmed three cases, Lufthansa announced that starting Thursday it will put a doctor aboard all flights to Mexico, the epicenter of the outbreak.

Experts said that makes sense: The doctors will be able to field questions from uneasy passengers and tend to anyone who might fall ill.

The World Health Organization said total bans on travel to Mexico — such as one imposed by Argentina, which hasn't had any confirmed cases — were questionable because the virus is already fairly widespread.

Roselyne Bachelot, France's health minister, said she would ask the European Union to suspend all flights to Mexico at a meeting Thursday in Luxembourg.

Travel bans were effective during the 2003 outbreak of SARS in Asia, because that illness can be transmitted only by people who already show symptoms. With flu, by contrast, the incubation period ranges from 24 hours to four days, meaning people often are infectious before they have symptoms.

Health officials don't know enough about swine flu right now to say what the precise incubation period is, but if it's similar to other flu, people are likely able to spread it before they're sick.

"WHO does not recommend closing of borders and does not recommend restrictions of travel," said Dr. Keiji Fukuda, the Geneva-based organization's flu chief. "From an international perspective, closing borders or restricting travel would have very little effect, if any effect at all, at stopping the movement of this virus."

Nor will killing pigs, as Egypt began doing Wednesday, infuriating pig farmers who blocked streets and stoned Health Ministry workers' vehicles in protest. While pigs are banned entirely in some Muslim countries because of religious dietary restrictions, they are raised in Egypt for consumption by the country's Christian minority.

Unlike bird flu, where the H5N1 strain that spread to humans was widespread in bird populations and officials worried about people's exposure to infected birds, WHO says there is no similar concern about pigs — and no evidence that people have contracted swine flu by eating pork or handling pigs.

"There is no association that we've found between pigs and the disease in humans," WHO spokesman Dick Thompson said.

But that hasn't stopped governments from banning pig products. Macedonia ordered a halt to all live pig imports and on Tuesday, Mexico City closed down all its popular streetside taco stands for at least a week.

Dr. Nikki Shindo, a WHO flu expert, said the agency will consider requests to stop calling the disease swine flu, since the virus is not food-borne and has nothing to do with eating pork.

U.S. Agriculture Secretary Tom Vilsack and others have suggested a new name, arguing that swine flu implies a problem with pork products. China, Russia and Ukraine are among countries that have banned pork imports from Mexico and parts of the United States affected by swine flu.

But some anti-flu measures have merit, such as Obama's admonition Wednesday that more American schools might have to be closed temporarily if swine flu cases spread. Already tens of thousands of students in Texas, New York, California, Chicago and elsewhere are out of school.

The WHO said closing schools and public places, along with banning or restricting mass gatherings, can be a way to contain the spread of disease. Epidemiologists call it "social distancing," and the idea is simple: If you keep people who have the virus away from others, you can stop the chain of transmission.

"That's a technique we would be recommending in a pandemic," said WHO's Thompson. "We would recommend it to nations as a useful technique to be applied given the special circumstances of each nation."

Officials in Hong Kong, which has no confirmed cases, said workers were scrubbing public toilets every two hours in an effort to improve hygiene.

"Not only will we be stepping up our usual efforts, but also we will make special efforts to make sure that our back alleys, public housing estates, recreation and transportation facilities are thoroughly cleansed and disinfected," said Gabriel Leung, undersecretary for the Food and Health Bureau.

Experts, however, said it's debatable how much good disinfecting public places will do. It probably helps cut down on bacteria and kill viruses lurking on surfaces, but it's unclear whether it would stop person-to-person transmission.

Ditto the advice to stop kissing on the cheek, which was among the earliest measures — along with refraining from handshakes — to be recommended by authorities in Mexico.

WHO's Thompson was noncommittal on the "don't kiss" advice, saying only: "There are different national circumstances that health officials are going to know far better than we will. It's up to them to make that call."

But at a news conference announcing the elevated pandemic level, WHO chief Margaret Chan went further, suggesting it was time to rethink the traditional three kisses on the cheek popular in Switzerland and elsewhere in Europe. "Perhaps instead of having the traditional three hugs to say hello and welcome your friends, maybe you don't do that anymore," she said. "Don't hold each other and hug their face three times."

The flu virus is airborne and spread through tiny particles — mostly through sneezing and coughing. That helps explain why governments worldwide have been distributing millions of face masks, even though the U.S. Centers for Disease Control and other agencies have questioned their effectiveness.

Some doctors warn masks might even be harmful, causing people to take risks — like venturing into crowds or neglecting to wash hands — in the mistaken belief the mask protects them. More expensive high filtration masks like those used by health professionals can filter out fine particles carried in the air, but even these must be used properly to give real protection.

Other measures, such as installing thermal cameras at airports to screen passengers from infected countries, are simply inconclusive. Scanners were set up across Asia during the SARS outbreak, but officials aren't sure they caught any cases. WHO says the usefulness of such devices is debatable.

Amid the flurry of measures being taken, fear mingled with a sense of fatalism.

"You can't protect yourself — not in the way that people are traveling nowadays," said Karin Henriksson, 56, of Stockholm.

"Then you would have to put the entire population in quarantine. And you can't do that, can you?"

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Kole reported from Vienna; Cheng, an AP Medical Writer, from London.

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Scientists struggle to understand swine flu virus

ATLANTA – Mexico's health secretary may have thought he was allaying fears about swine flu when he suggested that the nation's swine flu death rate was 6 or 7 percent. In reality, that would mean a monstrous killer virus — and no experts are close to saying that. The secretary's comment reflects how much remains unknown about the new flu virus — most notably how lethal it is and why it seems so much deadlier in Mexico than anywhere else.

American health officials believe they are getting closer to answering those questions, or, at least, to ruling out wrong-headed theories.

"We've begun to knock off hypotheses," said Dr. Scott F. Dowell, director of global disease detection with the U.S. Centers for Disease Control and Prevention.

Among the factors disease detectives have discounted are Mexico's air pollution, secondary infections and poor health care. But they still do not know why so many Mexicans have died, although it could be because many more people actually have had the virus than health officials realize.

In Mexico, the virus is suspected of killing more than 150 people and sickening more than 2,400. Recent information suggests swine flu-related hospital admissions and deaths may have peaked and are declining, but no other country has shown any numbers close to those seen in Mexico.

The only other country to report a swine flu death is the United States, and that involved a toddler from Mexico who was visiting Texas with his family.

The leading theory remains that the virus itself is not significantly different in Mexico, but that the outbreak has for some reason just hit harder there, infecting more people overall. The more people who are infected, the more likely there will be severe cases and even deaths.

When the Mexican health secretary spoke this week about a 6 or 7 percent death rate, his figures were based on the number of deaths divided by the number of suspected infections. But authorities cannot be certain how many people have been infected, especially those who suffered only mild symptoms.

Mexican authorities have not tried to count mild cases, focusing instead on the severely ill and the dead. So the death rate may be much lower than 6 or 7 percent — and probably is, according to some experts.

A 6 to 7 percent death rate would make the Mexican swine flu nearly three times deadlier than the worst flu pandemic in the last 100 years — the 1918 Spanish flu, which killed an estimated 20 million to 50 million people worldwide.

That seems unbelievably high for this new virus, said Richard Webby, a flu researcher at St. Jude Children's Research Hospital in Memphis.

Webby and others do not believe the swine flu in Mexico is different from what's been seen in U.S. patients. The virus samples in both countries match.

The CDC sent four epidemiologists and one lab scientist to Mexico over the weekend to investigate the disease there, and the agency expects to send a half-dozen more people this week, said Dowell, of the CDC.

Among the hypotheses being ruled out as explanations for Mexico's higher death rate:

• A second infection complicating the flu cases. A common danger in flu is that the patient is co-infected with pneumonia or other bacteria, which can lead to death. But lab tests of 33 Mexican patients, including seven who died, did not find that problem.

• Low-quality health care. CDC investigators have not seen any obvious problem. They have found capable doctors and well-equipped, high-quality hospitals, Dowell said.

• A medicine is compounding the problem. Investigators have looked into whether patients who got sick had taken some over-the-counter medicine or folk remedy that actually made things worse.

Such a problem has sometimes occurs in children recovering from flu who are given aspirin — a severe illness called Reye's syndrome, which causes vomiting, lethargy and even seizures. But there's no evidence of something like that in Mexico, Dowell said.

• Altitude or air pollution: Mexico City's altitude and its infamous air pollution have raised speculation that those factors may have made people more susceptible to the virus. But severe cases are being reported over much of Mexico, including coastal communities and places with cleaner air, making that theory unlikely.

The CDC has also been investigating when the swine flu first hit Mexico.

Some have wondered whether it's possible people have been getting sick with the virus for months, but the illness went undetected because special swine flu tests were not used to diagnose patients.

But CDC officials say no, the flu probably did not hit Mexico until March at the earliest. An analysis of hundreds of samples from Mexico that were collected from January to March never turned up the swine flu virus, Dowell said.

There's also the question of where it started — a standard inquiry of public health investigations since at least the mid-19th century.

One of the heroes of public health history is John Snow, a London physician who helped end an 1854 cholera outbreak by determining that cases were clustered around a water pump and that the disease was spread through water. The pump handle was removed, and the cholera deaths subsided.

But flu is different because it's spread by human-to-human contact. Scientists know it's more difficult to pin down the origin of a novel strain of influenza to a specific country, let alone a village or pig farm.

Knowledge of the origin is also less useful than in a cholera outbreak.

"Flu, unlike cholera, spreads around the world in a matter of weeks. You can't remove the pump handle" to stop the epidemic, said Dr. Andrew Pavia, a University of Utah pediatrics professor who leads the Infectious Diseases Society of America's pandemic flu task force.

A current theory is that the outbreak started in the town of La Gloria on the eastern coast of Mexico, because a 5-year-old boy was the first known case. He first suffered flu-like symptoms in late March. However, Mexican health officials have downplayed claims the outbreak started in La Gloria, because mucous samples of other patients from there found nothing.

Dowell said the place of origin is a secondary concern at the moment.

"That probably will be useful in the long term. But for the present, our team in the field is focused on things that will make the most difference for mitigation" of the outbreak, he said.

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Associated Press Writer Olga R. Rodriguez in Mexico contributed to this report.

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Little boy, far from home, 1st US swine flu death

HOUSTON – He was not yet 2, far from home and dying. The first victim of swine flu in the U.S. was a Mexican toddler who struggled to survive for weeks in Texas hospitals — long before it was known doctors were dealing with an international outbreak.

Now the hunt is on to find anyone who came into contact with the little boy while he visited relatives in the border city of Brownsville from his home in Mexico City.

The state's health director, Dr. David Lakey, at an Austin news conference, called it "highly likely" that the boy contracted the disease in Mexico before his trip to the U.S.

Officials in Brownsville are trying to trace his family's trip to find out how long they were in the area, who they visited and how many people were in the group, said Cameron County Judge Carlos Cascos.

The boy, who was 23 months old, had "underlying health issues" before he flew to Matamoros, Mexico, on April 4 and crossed into Brownsville to visit relatives, state health officials said.

He developed flu symptoms four days later and was taken to a Brownsville hospital April 13 and transferred the following day to Texas Children's Hospital in Houston, where he died Monday night.

The U.S. Centers for Disease Control and Prevention on Wednesday confirmed that he had been infected with the swine flu virus. The cause of the death was pneumonia caused by the virus, Cascos said.

Health officials insisted the boy posed no contagion threat to Houston. He had no contact with other patients at Texas Children's Hospital and none of the staff was exposed, said Dr. Jeffrey Starke, the hospital's director of infectious disease.

This case "shouldn't trigger any undue alarm in the community," Starke told a news conference. "The child did not acquire the virus in Houston, Texas."

Dr. Brian Smith, regional director of the Texas Department of State Health Services, said antiviral treatments were given to family members who had close contact with the child and none had contracted swine flu. He said that with the virus' short incubation period, health officials would have begun seeing secondary cases among the child's close contacts by now, but none has appeared.

Although the boy wasn't initially identified as a swine flu case, Starke said concern grew over the last several days as news of the virus intensified.

Officials refused to release any further information about the boy or his family, including his name or any details on his other health issues, citing privacy laws.

Starke said the child was "critically ill the entire time the child was under our care," and that he was transferred to Houston because the hospital in Brownsville, an impoverished border city of 140,000, couldn't provide the kind of care he needed.

Swine flu is suspected of killing more than 150 people and sickening over 2,600 in Mexico, Canada, New Zealand, Britain, Germany, Spain, Israel and Austria.

The virus has spread to 11 U.S. states from coast to coast. Total American cases surged to nearly 100, including a Marine at the Twentynine Palms base in southern California.

According to the CDC, more than 20,000 children younger than age 5 are hospitalized every year because of seasonal flu. In the 2007-08 flu season, the CDC received reports that 86 children nationwide died from flu complications.

Authorities have confirmed at least 93 swine flu cases in the United States. They've identified 16 cases in Texas, 51 in New York, 14 in California, three in Maine; two in Kansas, two in Massachusetts, and one each in Indiana, Ohio, Arizona and Nevada. The CDC also said Michigan had two, but state officials maintained only one was confirmed.

Texas Gov. Rick Perry announced a disaster declaration Wednesday for the entire state. The declaration will allow officials to begin emergency protective measures and seek reimbursement from the federal government.

Texas officials also are postponing all public high school athletic competition until May 11. Schools serving more than 130,000 kids across Texas were closed.

As for future action, Perry said closing the border with Mexico is an option, but he doesn't want to play a "what-if game."

"There's no need to panic," Perry said. "I urge our citizens to act responsibly in the course of this situation. Heed the advice of local and state health officials."

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On the Net:

CDC: http://www.cdc.gov/swineflu

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Attorney in 2007 tuberculosis scare sues CDC

ATLANTA – An Atlanta attorney at the center of an international health scare when he flew to Europe for his wedding even though he was infected with a drug-resistant form of tuberculosis is suing federal health officials, claiming they invaded his privacy.

Andrew Speaker said Wednesday that federal officials knew he was infected with the sometimes deadly lung disease before he left in 2007 and advised him to begin treatment when he returned. Once he was overseas, however, doctors urged him to return because they thought he had a more severe form of the disease. Later tests revealed he had contracted a less dangerous strain.

In the lawsuit, Speaker said Centers for Disease Control and Prevention officials gave him the go-ahead to leave and then pinned the blame on him.

"The whole point of the lawsuit describes how the CDC knew I had TB before I left," he said in a telephone interview. "All the sudden, I get over there and they hold this big press conference."

The lawsuit filed in federal court in Atlanta on Tuesday claims the CDC damaged Speaker's reputation and made him the target of death threats. It also says he and his new bride split up because of the stress and seeks unspecified damages and court fees.

It accuses the CDC of "unlawfully and unnecessarily" revealing Speaker's private medical history and other sensitive information during an extensive media blitz in May 2007.

CDC spokesman Tom Skinner declined to comment.

"We are not in a position to have anything to say about pending litigation," he said.

Speaker, a plaintiff's attorney, was in Europe for his wedding and honeymoon when he learned tests showed he had an extremely drug-resistant strain of tuberculosis known as XDR-TB. He'd been advised not to fly to Europe in the first place, but at that point he'd been diagnosed with a less severe strain.

Despite warnings from health officials not to board another international flight, Speaker flew to Montreal and drove over the American border.

He subsequently became the first American quarantined by the federal government since 1963, and was treated in a Denver hospital. Health officials there learned that Speaker was infected with a less severe strain of the disease.

The lawsuit also seeks records of his test results that he said the CDC has failed to turn over despite repeated requests using the Freedom of Information Act. The complaint, he said, aims to set the record straight.

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FDA to allow Plan B birth control for 17-year-olds

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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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.

___

On the Net:

New York City Department of Health: http://www.nyc.gov/health

British salt program: http://www.salt.gov.uk/

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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.

___

On the Net:

Christopher & Dana Reeve Foundation: http://www.christopherreeve.org/

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When unhealthy foods hijack overeaters' brains

WASHINGTON – Food hijacked Dr. David Kessler's brain. Not apples or carrots. The scientist who once led the government's attack on addictive cigarettes can't wander through part of San Francisco without craving a local shop's chocolate-covered pretzels. Stop at one cookie? Rarely.

It's not an addiction but it's similar, and he's far from alone. Kessler's research suggests millions share what he calls "conditioned hypereating" — a willpower-sapping drive to eat high-fat, high-sugar foods even when they're not hungry.

In a book being published next week, the former Food and Drug Administration chief brings to consumers the disturbing conclusion of numerous brain studies: Some people really do have a harder time resisting bad foods. It's a new way of looking at the obesity epidemic that could help spur fledgling movements to reveal calories on restaurant menus or rein in portion sizes.

"The food industry has figured out what works. They know what drives people to keep on eating," Kessler tells The Associated Press. "It's the next great public health campaign, of changing how we view food, and the food industry has to be part of it."

He calls the culprits foods "layered and loaded" with combinations of fat, sugar and salt — and often so processed that you don't even have to chew much.

Overeaters must take responsibility, too, and basically retrain their brains to resist the lure, he cautions.

"I have suits in every size," Kessler writes in "The End of Overeating." But, "once you know what's driving your behavior, you can put steps into place" to change it.

At issue is how the brain becomes primed by different stimuli. Neuroscientists increasingly report that fat-and-sugar combinations in particular light up the brain's dopamine pathway — its pleasure-sensing spot — the same pathway that conditions people to alcohol or drugs.

Where did you experience the yum factor? That's the cue, sparking the brain to say, "I want that again!" as you drive by a restaurant or plop before the TV.

"You're not even aware you've learned this," says Dr. Nora Volkow, chief of the National Institute on Drug Abuse and a dopamine authority who has long studied similarities between drug addiction and obesity.

Volkow is a confessed chocoholic who salivates just walking past her laboratory's vending machine. "You have to fight it and fight it," she said.

Conditioning isn't always to blame. Numerous factors, including physical activity, metabolism and hormones, play a role in obesity.

And the food industry points out that increasingly stores and restaurants are giving consumers healthier choices, from allowing substitutions of fruit for french fries to selling packaged foods with less fat and salt.

But Kessler, now at the University of California, San Francisco, gathered colleagues to help build on that science and learn why some people have such a hard time choosing healthier:

_First, the team found that even well-fed rats will work increasingly hard for sips of a vanilla milkshake with the right fat-sugar combo but that adding sugar steadily increases consumption. Many low-fat foods substitute sugar for the removed fat, doing nothing to help dieters eat less, Kessler and University of Washington researchers concluded.

_Then Kessler culled data from a major study on food habits and health. Conditioned hypereaters reported feeling loss of control over food, a lack of satiety, and were preoccupied by food. Some 42 percent of them were obese compared to 18 percent without those behaviors, says Kessler, who estimates that up to 70 million people have some degree of conditioned hypereating.

_Finally, Yale University neuroscientist Dana Small had hypereaters smell chocolate and taste a chocolate milkshake inside a brain-scanning MRI machine. Rather than getting used to the aroma, as is normal, hypereaters found the smell more tantalizing with time. And drinking the milkshake didn't satisfy. The reward-anticipating region of their brains stayed switched on, so that another brain area couldn't say, "Enough!"

People who aren't overweight can be conditioned hypereaters, too, Kessler found — so it's possible to control.

Take Volkow, the chocolate-loving neuroscientist. She's lean, and a self-described compulsive exerciser. Physical activity targets the dopamine pathway, too, a healthy distraction.

Smoking didn't start to drop until society's view of it as glamorous and sexy started changing, to view the habit as deadly, Kessler notes.

Unhealthy food has changed in the other direction. Foods high in fat, sugar and salt tend to be cheap; they're widely sold; and advertising links them to good friends and good times, even as social norms changed to make snacking anytime, anywhere acceptable.

Retrain the brain to think, "I'll hate myself if I eat that," Kessler advises. Lay down new neural reward circuits by substituting something else you enjoy, like a bike ride or a healthier food.

Make rules to resist temptation: "I'm going to the mall but bypassing the food court."

And avoid cues for bad eating whenever possible. Always go for the nachos at your friends' weekend gathering spot? Start fresh at another restaurant.

"I've learned to eat things I like but things I can control," Kessler says. But he knows the old circuitry dies hard: "You stress me enough and I'll go pick up that bagel."

___

EDITOR's NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

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Study paints picture of collegiate mental health

STATE COLLEGE, Pa. – Ever since campus counseling centers were established in the 1940s, college officials have known that the prevalence and severity of students' mental health problems were rising. They just didn't know by how much.

A pilot study released Monday by the Center for the Study of Collegiate Mental Health, at Penn State University, hopes to fill that void. Organizers call it a first-of-its kind effort by college counseling centers designed to get an up-to-date picture of mental health trends affecting higher education.

Most schools collect data of counseling center clients on their own. Until now, though, there have been no national data to help study perceived trends, organizers said.

"Mental health affects every aspect of a college student's functioning," said Ben Locke, executive director of the center. "The earlier you intervene in mental health issues, the more likely you are to be successful in treating it."

The numbers will further help colleges and universities equip themselves to support students, Locke said.

The Association for University and College Counseling Center Directors does a separate annual survey of its members. That survey estimated that about 1 in 10 college students seek treatment from campus counseling centers.

But the Penn State study is the first to get data from the counseling center clients themselves, Locke said.

"This is actual data from the counseling centers: the clients who are coming in, what they're saying," said Robert Rando, the director of counseling and wellness services at Wright State University in Dayton, Ohio. "It's accurate in that way, and no one has done that."

There is concern about the increased severity of mental health problems counseling centers are seeing among student clients, in part because of the increased use of medications such as Prozac by high school students, Rando said.

The collaboration began four years ago, but data collection began only in fall 2008.

The effort had been in the works before the high-profile campus shootings at Virginia Tech in 2007 and Northern Illinois University last year.

The killing of 33 people, including the gunman, at Virginia Tech and five people at Northern Illinois put a spotlight on campus counseling services and risk reduction, said Dennis Heitzmann, director of counseling and psychological services at Penn State.

"What this effort will do will keep our work in the forefront, identify the importance of our function before the administration, parents and students themselves," Heitzmann said.

More than 130 schools nationwide are registered with the center. Of them, 66 participated in the initial study, with responses from more than 28,000 students who received mental health services in fall 2008.

Each counseling center asked clients to answer standardized questions, with the data pooled nationally. All data were anonymous.

Among the study's findings:

• One percent of students who answered a question about binge drinking reported going on a binge 10 or more times in the previous two weeks. Nearly half of those respondents said they had seriously considered suicide in the past.

• The vast majority (93 percent) of students who responded to a question about campus violence had little to no fear of losing control and acting violently.

• The 7 percent considered to have strong fears were most likely to be male and said they had previously harmed another person. They also tended to have experienced a cluster of other symptoms, such as a fear of having a panic attack or suicidal thoughts.

The results "don't translate into a guaranteed assessment or reliable profile at any point, but they offer a starting point in assessing risk in counseling center clients," Locke said.

The center has received $45,000 in funding over the past five years, Locke said. The Jed Foundation, a nonprofit that describes itself as trying to reduce suicides and emotional distress among college students, is listed as a past contributor.

The center also requires members to pay a $150 annual fee. In addition, researchers have received about $100,000 in in-kind funding from Titanium Software.

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AP IMPACT: Tons of released drugs taint US water

U.S. manufacturers, including major drugmakers, have legally released at least 271 million pounds of pharmaceuticals into waterways that often provide drinking water — contamination the federal government has consistently overlooked, according to an Associated Press investigation.

Hundreds of active pharmaceutical ingredients are used in a variety of manufacturing, including drugmaking: For example, lithium is used to make ceramics and treat bipolar disorder; nitroglycerin is a heart drug and also used in explosives; copper shows up in everything from pipes to contraceptives.

Federal and industry officials say they don't know the extent to which pharmaceuticals are released by U.S. manufacturers because no one tracks them — as drugs. But a close analysis of 20 years of federal records found that, in fact, the government unintentionally keeps data on a few, allowing a glimpse of the pharmaceuticals coming from factories.

As part of its ongoing PharmaWater investigation about trace concentrations of pharmaceuticals in drinking water, AP identified 22 compounds that show up on two lists: the EPA monitors them as industrial chemicals that are released into rivers, lakes and other bodies of water under federal pollution laws, while the Food and Drug Administration classifies them as active pharmaceutical ingredients.

The data don't show precisely how much of the 271 million pounds comes from drugmakers versus other manufacturers; also, the figure is a massive undercount because of the limited federal government tracking.

To date, drugmakers have dismissed the suggestion that their manufacturing contributes significantly to what's being found in water. Federal drug and water regulators agree.

But some researchers say the lack of required testing amounts to a 'don't ask, don't tell' policy about whether drugmakers are contributing to water pollution.

"It doesn't pass the straight-face test to say pharmaceutical manufacturers are not emitting any of the compounds they're creating," said Kyla Bennett, who spent 10 years as an EPA enforcement officer before becoming an ecologist and environmental attorney.

Pilot studies in the U.S. and abroad are now confirming those doubts.

Last year, the AP reported that trace amounts of a wide range of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been found in American drinking water supplies. Including recent findings in Dallas, Cleveland and Maryland's Prince George's and Montgomery counties, pharmaceuticals have been detected in the drinking water of at least 51 million Americans.

Most cities and water providers still do not test. Some scientists say that wherever researchers look, they will find pharma-tainted water.

Consumers are considered the biggest contributors to the contamination. We consume drugs, then excrete what our bodies don't absorb. Other times, we flush unused drugs down toilets. The AP also found that an estimated 250 million pounds of pharmaceuticals and contaminated packaging are thrown away each year by hospitals and long-term care facilities.

Researchers have found that even extremely diluted concentrations of drugs harm fish, frogs and other aquatic species. Also, researchers report that human cells fail to grow normally in the laboratory when exposed to trace concentrations of certain drugs. Some scientists say they are increasingly concerned that the consumption of combinations of many drugs, even in small amounts, could harm humans over decades.

Utilities say the water is safe. Scientists, doctors and the EPA say there are no confirmed human risks associated with consuming minute concentrations of drugs. But those experts also agree that dangers cannot be ruled out, especially given the emerging research.

___

Two common industrial chemicals that are also pharmaceuticals — the antiseptics phenol and hydrogen peroxide — account for 92 percent of the 271 million pounds identified as coming from drugmakers and other manufacturers. Both can be toxic and both are considered to be ubiquitous in the environment.

However, the list of 22 includes other troubling releases of chemicals that can be used to make drugs and other products: 8 million pounds of the skin bleaching cream hydroquinone, 3 million pounds of nicotine compounds that can be used in quit-smoking patches, 10,000 pounds of the antibiotic tetracycline hydrochloride. Others include treatments for head lice and worms.

Residues are often released into the environment when manufacturing equipment is cleaned.

A small fraction of pharmaceuticals also leach out of landfills where they are dumped. Pharmaceuticals released onto land include the chemo agent fluorouracil, the epilepsy medicine phenytoin and the sedative pentobarbital sodium. The overall amount may be considerable, given the volume of what has been buried — 572 million pounds of the 22 monitored drugs since 1988.

In one case, government data shows that in Columbus, Ohio, pharmaceutical maker Boehringer Ingelheim Roxane Inc. discharged an estimated 2,285 pounds of lithium carbonate — which is considered slightly toxic to aquatic invertebrates and freshwater fish — to a local wastewater treatment plant between 1995 and 2006. Company spokeswoman Marybeth C. McGuire said the pharmaceutical plant, which uses lithium to make drugs for bipolar disorder, has violated no laws or regulations. McGuire said all the lithium discharged, an annual average of 190 pounds, was lost when residues stuck to mixing equipment were washed down the drain.

___

Pharmaceutical company officials point out that active ingredients represent profits, so there's a huge incentive not to let any escape. They also say extremely strict manufacturing regulations — albeit aimed at other chemicals — help prevent leakage, and that whatever traces may get away are handled by onsite wastewater treatment.

"Manufacturers have to be in compliance with all relevant environmental laws," said Alan Goldhammer, a scientist and vice president at the industry trade group Pharmaceutical Research and Manufacturers of America.

Goldhammer conceded some drug residues could be released in wastewater, but stressed "it would not cause any environmental issues because it was not a toxic substance at the level that it was being released at."

Several big drugmakers were asked this simple question: Have you tested wastewater from your plants to find out whether any active pharmaceuticals are escaping, and if so what have you found?

No drugmaker answered directly.

"Based on research that we have reviewed from the past 20 years, pharmaceutical manufacturing facilities are not a significant source of pharmaceuticals that contribute to environmental risk," GlaxoSmithKline said in a statement.

AstraZeneca spokeswoman Kate Klemas said the company's manufacturing processes "are designed to avoid, or otherwise minimize the loss of product to the environment" and thus "ensure that any residual losses of pharmaceuticals to the environment that do occur are at levels that would be unlikely to pose a threat to human health or the environment."

One major manufacturer, Pfizer Inc., acknowledged that it tested some of its wastewater — but outside the United States.

The company's director of hazard communication and environmental toxicology, Frank Mastrocco, said Pfizer has sampled effluent from some of its foreign drug factories. Without disclosing details, he said the results left Pfizer "confident that the current controls and processes in place at these facilities are adequately protective of human health and the environment."

It's not just the industry that isn't testing.

FDA spokesman Christopher Kelly noted that his agency is not responsible for what comes out on the waste end of drug factories. At the EPA, acting assistant administrator for water Mike Shapiro — whose agency's Web site says pharmaceutical releases from manufacturing are "well defined and controlled" — did not mention factories as a source of pharmaceutical pollution when asked by the AP how drugs get into drinking water.

"Pharmaceuticals get into water in many ways," he said in a written statement. "It's commonly believed the majority come from human and animal excretion. A portion also comes from flushing unused drugs down the toilet or drain; a practice EPA generally discourages."

His position echoes that of a line of federal drug and water regulators as well as drugmakers, who concluded in the 1990s — before highly sensitive tests now used had been developed — that manufacturing is not a meaningful source of pharmaceuticals in the environment.

Pharmaceutical makers typically are excused from having to submit an environmental review for new products, and the FDA has never rejected a drug application based on potential environmental impact. Also at play are pressures not to delay potentially lifesaving drugs. What's more, because the EPA hasn't concluded at what level, if any, pharmaceuticals are bad for the environment or harmful to people, drugmakers almost never have to report the release of pharmaceuticals they produce.

"The government could get a national snapshot of the water if they chose to," said Jennifer Sass, a senior scientist for the Natural Resources Defense Council, "and it seems logical that we would want to find out what's coming out of these plants."

Ajit Ghorpade, an environmental engineer who worked for several major pharmaceutical companies before his current job helping run a wastewater treatment plant, said drugmakers have no impetus to take measurements that the government doesn't require.

"Obviously nobody wants to spend the time or their dime to prove this," he said. "It's like asking me why I don't drive a hybrid car? Why should I? It's not required."

___

After contacting the nation's leading drugmakers and filing public records requests, the AP found two federal agencies that have tested.

Both the EPA and the U.S. Geological Survey have studies under way comparing sewage at treatment plants that receive wastewater from drugmaking factories against sewage at treatment plants that do not.

Preliminary USGS results, slated for publication later this year, show that treated wastewater from sewage plants serving drug factories had significantly more medicine residues. Data from the EPA study show a disproportionate concentration in wastewater of an antibiotic that a major Michigan factory was producing at the time the samples were taken.

Meanwhile, other researchers recorded concentrations of codeine in the southern reaches of the Delaware River that were at least 10 times higher than the rest of the river.

The scientists from the Delaware River Basin Commission won't have to look far when they try to track down potential sources later this year. One mile from the sampling site, just off shore of Pennsville, N.J., there's a pipe that spits out treated wastewater from a municipal plant. The plant accepts sewage from a pharmaceutical factory owned by Siegfried Ltd. The factory makes codeine.

"We have implemented programs to not only reduce the volume of waste materials generated but to minimize the amount of pharmaceutical ingredients in the water," said Siegfried spokeswoman Rita van Eck.

Another codeine plant, run by Johnson & Johnson subsidiary Noramco Inc., is about seven miles away. A Noramco spokesman acknowledged that the Wilmington, Del., factory had voluntarily tested its wastewater and found codeine in trace concentrations thousands of times greater than what was found in the Delaware River. "The amounts of codeine we measured in the wastewater, prior to releasing it to the City of Wilmington, are not considered to be hazardous to the environment," said a company spokesman.

In another instance, equipment-cleaning water sent down the drain of an Upsher-Smith Laboratories, Inc. factory in Denver consistently contains traces of warfarin, a blood thinner, according to results obtained under a public records act request. Officials at the company and the Denver Metro Wastewater Reclamation District said they believe the concentrations are safe.

Warfarin, which also is a common rat poison and pesticide, is so effective at inhibiting growth of aquatic plants and animals it's actually deliberately introduced to clean plants and tiny aquatic animals from ballast water of ships.

"With regard to wastewater management we are subject to a variety of federal, state and local regulation and oversight," said Joel Green, Upsher-Smith's vice president and general counsel. "And we work hard to maintain systems to promote compliance."

Baylor University professor Bryan Brooks, who has published more than a dozen studies related to pharmaceuticals in the environment, said assurances that drugmakers run clean shops are not enough.

"I have no reason to believe them or not believe them," he said. "We don't have peer-reviewed studies to support or not support their claims."

___

Associated Press Writer Don Mitchell in Denver contributed to this report.

___

The AP National Investigative Team can be reached at investigate (at) ap.org

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Studies find factories release pharmaceuticals

Federal scientists testing for pharmaceuticals in water have been finding significantly more medicine residues in sewage downstream from public treatment facilities that handle waste from drugmakers.

Early results from two pivotal federal studies compare wastewater at treatment plants that handle sewage from drugmakers with those that do not. The studies cover just a small fraction of the 1,886 pharmaceutical manufacturing facilities counted in a 2006 U.S. Census report.

In one study, samples taken at two treatment plants down the sewer line from drugmaking factories contained a range of pharmaceuticals — among them opiates, a barbiturate and a tranquilizer at "much higher detection frequencies and concentrations" than samples taken at other plants, according to preliminary research by the U.S. Geological Survey.

One drug, the muscle relaxant metaxalone, was measured in treated sewage at concentrations hundreds of times higher than the level at which federal regulators can order a review of a drug's environmental impact.

Based on secrecy agreements with the researchers, the treatment plants were not identified.

USGS researcher Herb Buxton, who co-chairs a White House task force on pharmaceuticals in the environment, said it's important that federal scientists test the pharmaceutical industry's claims that their wastewater is not a meaningful source of pharmaceuticals in water.

"It's critical that those types of assumptions are confirmed through real testing," said Buxton.

In another study, Environmental Protection Agency researchers tested sewage at a municipal wastewater treatment plant in Kalamazoo, Mich., that serves a major Pfizer Inc. factory. Bruce Merchant, Kalamazoo's public services director, provided data that showed unusually high concentrations of the antibiotic lincomycin entering the plant, a drug the factory was producing around the time samples were collected.

"There's some product going down the drain," said Merchant.

While nearly all the lincomycin was removed during wastewater treatment, some did survive. According to a separate 2008 study, lincomycin combined in minute concentrations with several other drugs that also have been detected in surface water made human cancer and kidney cells and fish liver cells proliferate.

Biologist Francesco Pomati, at the University of New South Wales in Sydney, Australia, was so concerned with the findings that he and his colleagues warned that chronic exposure to the combination of drugs via drinking water could be "a potential hazard for particular human conditions, such as pregnancy or infancy."

In earlier experiments, lincomycin acted as a mutagen, changing genetic information in bacteria, algae, microscopic aquatic animals and fish.

Pfizer spokesman Rick Chambers said that while the company does not test wastewater from the facility for the drugs made on site, "compliance with all environmental, health and safety laws is imperative to our business operations worldwide."

The two domestic studies follow a burst of recent research in Asia and Europe that has started to link factories to the presence in water of drugs including the antibiotic sulfamethoxazole, the pain reliever diclofenac and the anticonvulsant carbamazepine, as well as an antihistamine, female sex hormones and aspirin.

Researchers in India, where multinational companies have increasingly turned for the manufacture of raw pharmaceutical ingredients, found that 100 pounds a day of the antibiotic ciprofloxacin enters a river from a wastewater treatment plant that processes sewage from dozens of pharmaceutical makers.

In Switzerland, a study sponsored by drugmaking giant Roche documented that 0.2 percent of active pharmaceutical ingredients escape during its own processing. That kind of loss rate doesn't sound like a lot until it's projected out over the entire annual production of drugs worldwide. Studies in Taiwan and China also suggest drugmaking plants discharge product.

All of which raises questions about U.S. manufacturing.

"Is it as bad in the U.S. as it is in India? Probably not. But it does make me think we should test," said Kyla Bennett, a former EPA enforcement officer who is now an ecologist and environmental attorney.

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Diabetes? Some beat it, but are they cured?

JoAnne Zoller Wagner's diagnosis as prediabetic wasn't enough to compel her to change her habits and lose 30 pounds. Not even with the knowledge her sister had died because of diabetes.

"I didn't have that sense of urgency," said the Pasadena, Md., woman.

But nine months later, doctors told Wagner her condition had worsened. She, too, now had Type 2 diabetes.

That scared her into action.

Now, two years later, the 55-year-old woman has slimmed down. She exercises regularly and her blood sugar levels are back in the healthy, normal range. Thanks to her success, she was able to avoid diabetes medication.

Diabetics like Wagner who manage to turn things around, getting their blood sugar under control — either escaping the need for drugs or improving enough to quit taking them — are drawing keen interest from the medical community.

This summer an American Diabetes Association task force will focus on this group of patients and whether they can be considered "cured." Among the points of interest:

_What blood sugar range qualifies as a cure and how long would it have to be maintained?

_How might blood pressure and cholesterol, both linked to diabetes, figure into the equation?

_And what if a "cured" diabetic's blood sugar soars again?

"For right now, we're not saying they're cured, but the bottom line is ... good glucose control, less infections," said Sue McLaughlin, president of health care and education for the American Diabetes Association. The organization has no estimate of how many people fall into that category.

Being overweight is the leading risk for Type 2 diabetes. Genetics also plays a role, and blacks, Hispanics and American Indians are at greater risk than whites.

Nearly 57 million Americans are prediabetic. Another 18 million have been diagnosed with diabetes, while the diabetes association estimates almost 6 million more Americans have diabetes and don't know it. About 90 to 95 percent of diabetics have Type 2, the kind linked to obesity.

The future is potentially even gloomier, with one study estimating that one of every three children born in the U.S. in 2000 will eventually develop diabetes.

But the news isn't all bad. Thirty minutes of daily exercise and a 5 to 10 percent loss in body weight can lower the odds of diabetes by nearly 60 percent and is more effective than medicine in delaying its onset, according to a diabetes prevention study.

Still, such lifestyle changes are often difficult.

"It sounds like such a nonmedical recommendation, and yet it's the thing people say is the toughest to implement," said McLaughlin, the diabetes association official.

For Wagner, it meant changing not just her diet, but her lifestyle. A teacher, she now cooks most of her meals at home and avoids the sweets in the school lounge. She also tries not to stay late at work, using the extra time to exercise and make healthy meals.

Alice Stern describes a similar journey back to health since her diabetes diagnosis in 2007. The 50-year-old Boston woman was able to avoid diabetes drugs through diet and exercise, managing to trim 40 pounds off her 5-foot-2 frame.

"It is about willpower. That's how you make the changes," said Stern.

Even diabetics who have resorted to weight loss surgery have seen their blood sugar levels return to normal.

Lucy Cain, 61, of Dallas tried to control her diabetes through diet and exercise after she was diagnosed in 2004. But she found it difficult, and two years later had gastric bypass surgery. The 5-foot-7 Cain, who once weighed over 300 pounds, is down to about 185, still losing weight and is off diabetes medication.

Whatever the route, weight loss is key, doctors say.

"There is no special diet. You've got to eat fewer calories than your body burns," said Dr. Robert Rizza, a Mayo Clinic endocrinologist and former president of the American Diabetes Association.

Many doctors stop short of calling these successful patients cured.

Dr. Philipp Scherer, director of the diabetes research center at University of Texas Southwestern, describes diabetes as a one-way road. He said it can be stopped in its tracks with diet and exercise, but there's no turning back.

Dr. Kevin Niswender, an assistant professor in the department of medicine at Vanderbilt Medical Center, said "technically, you could call somebody cured," but that patient still needs to be followed closely.

Doctors caution that, for some diabetics, lowering blood sugar may be only temporary. Stress, weight gain and other factors can push it back to unhealthy levels.

"Blood sugars can come down to normal. Then the issue is how long does that last?" said Dr. Sue Kirkman, vice president of clinical affairs for the diabetes association. "Sometimes people start putting weight back on and their blood sugars come back up."

In other cases, patients are diagnosed so late that blood sugar levels can't be brought back to normal, even with weight loss, she said. As the disease progresses, even those who made diet and lifestyle changes might eventually have to go on medications.

That's one reason Wagner and some other diabetics who've managed their disease through diet and exercise are also reluctant to consider themselves "cured."

"American culture, our environment, is not conducive to having good health," said Wagner. She believes diabetes will always be lurking in the background, waiting for her to slip.

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On the Net:

American Diabetes Association: http://www.diabetes.org/

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Yikes, bedbugs! EPA looks to stop resurgence

ARLINGTON, Va. – "Don't let the bedbugs bite." Doesn't seem so bad in a cheerful bedtime rhyme, but it's becoming a really big problem now that the nasty critters are invading hospitals, college dorms and even swanky hotels. With the most effective pesticides banned, the government is trying to figure out how to respond to the biggest bedbug outbreak since World War II.

Bedbugs live in the crevices and folds of mattresses, sofas and sheets. Then, most often before dawn, they emerge to feed on human blood.

Faced with rising numbers of complaints to city information lines and increasingly frustrated landlords, hotel chains and housing authorities, the Environmental Protection Agency hosted its first-ever bedbug summit Tuesday.

Organized by one of the agency's advisory committees, the two-day conference drew about 300 participants to a hotel in Arlington, just across the Potomac River from Washington. An Internet site notes that the hotel in question has had no reports of bedbugs.

One of the problems with controlling the reddish-brown insects, according to researchers and the pest control industry, is that there are few chemicals on the market approved for use on mattresses and other household items that are effective at controlling bedbug infestations.

Unlike roaches and ants, bedbugs are blood feeders and can't be lured by bait. It's also difficult for pesticides to reach them in every crack and crevice they hide out in.

"It is a question of reaching them, finding them," said Harold Harlan, an entomologist who has been raising bedbugs for 36 years, feeding them with his own blood. He has the bites to prove it.

The EPA, out of concern for the environment and the effects on public health, has pulled many of the chemicals that were most effective in eradicating the bugs in the U.S. At the same time, the appleseed-sized critters have developed a pesticide resistance because those chemicals are still in use in other countries.

Increasing international travel has also helped them to hitchhike into the U.S.

"One of our roles would be to learn of new products or safer products. ... What we are concerned about is that if people take things into their own hands and start using pesticides on their mattresses that aren't really registered for that, that's a problem," said Lois Rossi, director of the registration division in the EPA's Office of Pesticide Programs.

The EPA is not alone in trying to deal with the problem. An aide to Rep. G.K. Butterfield, D-N.C., says the congressman plans to reintroduce legislation next week to expand grant programs to help public housing authorities cope with infestations.

The bill will be called the "Don't Let the Bedbugs Bite Act."

"It was clear something needed to be done," said Saul Hernandez, Butterfield's legislative assistant.

Bedbugs are not known to transmit any diseases. But their bites can cause infections and allergic reactions in some people. The insects release an anticoagulant to get blood flowing, and they also excrete a numbing agent so their bites don't often wake their victims.

Those often hardest hit are the urban poor, who cannot afford to throw out all their belongings or take other drastic measures. Extermination can cost between $400-$900.

So bedbug problems increase, said Dini Miller, an entomologist and bedbug expert at Virginia Tech, who until 2001 saw bedbugs only on microscope slides dating from the 1950s. Now she gets calls and e-mails several times a day from people at their wits' end.

"I can't tell you how many people have spent the night in their bathtubs because they are so freaked out by bedbugs," Miller said. "I get these people over the phone that have lost their marbles."

Because the registration of new pesticides takes so long, one thing the EPA could do is to approve some pesticides for emergency use, Miller said.

Another tactic would be to screen pesticides allowed for use by farmers to see if they are safe in household settings.

Representatives of the pest control industry will be pushing for federal funding for research into alternative solutions, such as heating, freezing or steaming the bugs out of bedrooms.

"We need to have better tools," said Greg Baumann, a senior scientist at the National Pest Management Association. "We need EPA to consider all the options for us."

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On the Net:

Harvard School of Public Health: http://www.hsph.harvard.edu/bedbugs/

University of Kentucky Insect Advice: http://www.ca.uky.edu/entomology/entfacts/ef636.asp

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Company says prostate cancer vaccine shows promise

An experimental treatment that takes an entirely new approach to fighting prostate cancer extended survival in a late-stage study, its maker announced Tuesday.

Seattle-based Dendreon Corp. said that its Provenge cancer vaccine improved overall survival when compared to a dummy treatment in a study of 512 men with advanced disease.

No survival details or information on side effects were given. Full results will be presented at an American Urological Association meeting later this month, and Dendreon said it would seek federal approval of the treatment later this year.

Provenge is not like traditional vaccines that prevent disease. It's a so-called therapeutic vaccine that treats cancer by training the immune system to fight tumors. If approved, Provenge would be the first such treatment on the market.

This is the second major study in which Provenge has shown a survival benefit, leading some scientists to hope not just for its approval but for a new approach to fighting cancer beyond the surgery, radiation, hormones and chemotherapy used now.

"This is an exciting result, demonstrating that harnessing a patient's own immune system can successfully attack prostate cancer," said Dr. Eric Small, cancer specialist at the University of California at San Francisco. "Now we have more confidence that the initial results we saw were real."

He enrolled some patients in the new study and led the earlier one, but has no financial ties to the company or the vaccine.

In the earlier study of 127 men, those treated with the vaccine lived an average of 4 1/2 months longer than those given dummy treatments. After three years, survival was 34 percent in the vaccine group and only 11 percent in the other.

Those results led advisers to the Food and Drug Administration to recommend Provenge's approval two years ago. But the FDA delayed action and asked for more data, because extending survival wasn't the main goal of that study — slowing progression of the cancer was, and the vaccine failed to do that.

The decision sparked protests from men's groups and cancer advocates because the vaccine did prolong survival, which they considered a more important result.

On Tuesday, results of the new study boosted Dendreon stock by $9.69, closing at $16.99, more than doubling in value as investors bet on improved chances of FDA approval and the potential for a lucrative market.

Provenge is a treatment that is customized for each patient. Doctors collect specialized cells from each patient's blood. Those cells help the immune system recognize cancer as a threat, much as it would germs that enter the body.

The cells are mixed with a protein found on most prostate cancer cells to help activate the immune system. The resulting "vaccine" is given back to the patient as three infusions two weeks apart.

So far, the vaccine has been tested on men with cancer that has spread beyond the prostate and is no longer responding to hormone treatments to curb its growth.

If Provenge proves safe and wins approval, "it would be an important breakthrough," said Dr. William Oh, a cancer specialist at Dana-Farber Cancer Center in Boston. Three years ago, he consulted for Dendreon on the vaccine but has had no financial ties to it since then.

"There are so few treatments available" for men whose prostate cancer has spread widely — a situation that affects 40,000 to 60,000 American men, he said.

Prostate cancer is the most common non-skin cancer in American men. An estimated 186,000 new cases and 28,660 deaths from it occurred last year.

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