LONDON, Aug 25 (Reuters) - A sexually transmitted virus that causes cervical cancer is also to blame for half of all cases of cancer of the penis, Spanish researchers said on Tuesday.

The finding suggests already available human papillomavirus (HPV) vaccines for cervical cancer are also likely to be effective in the fight against penile cancer, doctors from the Catalan Institute of Oncology in Barcelona said.

Merck & Co's (MRK.N) Gardasil and GlaxoSmithKline's (GSK.L) Cervarix are both used widely to immunise girls against HPV infection, which can lead to cancer of the cervix.

Penile cancer is much rarer, accounting for less than 1 percent of adult male cancers in Europe and North America, although the incidence can be as high as 10 percent in parts of Africa and Asia. Worldwide, there are more than 26,000 new cases every year.

Dr. Silvia de Sanjose and colleagues reviewed cases of penile cancer reported in clinical studies between 1986 and 2008 and found 46.9 percent of tumours were associated with HPV.

Nearly all of these were linked to HPV strains 16 and 18, the two types that most commonly cause cervical cancer and which are targeted by Gardasil and Cervarix, they wrote in the Journal of Clinical Pathology.

Merck reported results of a clinical trial last November showing that Gardasil was effective in preventing lesions caused by the virus in men. [ID:nN13347832] (Reporting by Ben Hirschler; Editing by Victoria Main)

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) - U.S. officials should help drug companies speed up the supply of swine flu drugs and vaccines, making at least some shots available by mid-September, White House science advisers said on Monday.

Calling the H1N1 pandemic "a serious threat to our nation", they also urged the U.S. Food and Drug Administration to quickly decide on new, intravenous formulations of flu drugs, including current drugs such as Roche AG's Tamiflu and GlaxoSmithKline's Relenza but also BioCryst Pharmaceuticals' experimental drug peramivir.

The news sent BioCryst's shares soaring more than 25 percent to $12.60 as trading closed on Nasdaq.

The President's Council of Advisors on Science and Technology said the Department of Health and Human Services should tell manufacturers to begin to "fill and finish" H1N1 flu vaccines right away -- putting them into vials for shipment. "Such a decision would need to be taken almost immediately," the group said in a report.

Most experts believe people will need two doses of the vaccine, delivered at least two weeks apart, to develop full immunity to the new H1N1 flu.

Last week the U.S. Department of Health and Human Services said only 45 million doses of the new H1N1 vaccine would be on hand in mid-October, instead of 120 million previously forecast, with 20 million a week due after that.

HHS plans to eventually vaccinate at least 160 million people by December, with pregnant women, healthcare workers, children and young adults at the front of the line.

"We still think mid-October is a good target for a major production to roll off," HHS Secretary Kathleen Sebelius told reporters in Atlanta, where she was visiting the U.S. Centers for Disease Control and Prevention.

Five companies make swine flu vaccine for the U.S. market -- AstraZeneca's MedImmune unit, CSL Ltd, GlaxoSmithKline Plc, Novartis AG and Sanofi-Aventis SA.

The Council also recommended a quicker decision on intravenous versions of flu drugs. People who are seriously ill can only be given drugs intravenously.

NEW FLU DRUGS

Tamiflu, a pill known generically as oseltamivir, is made by Roche under license from Gilead Sciences Inc. Relenza, which is inhaled, is known generically as zanamivir and is made by Glaxo under license from Biota Inc.

Drugmakers are working on intravenous formulations of both and BioCryst is working to perfect peramivir, which is designed to be given intravenously.

The advisers said the CDC should strengthen guidelines on when these drugs should be given. Tamiflu and Relenza can treat and prevent all types of influenza A if given soon enough but the World Health Organization says they should be saved for use only by people who are at high risk of serious complications or death, such as pregnant women and asthma patients.

And the panel said the government should take advantage of the pandemic to improve flu surveillance.

Currently only a fraction of people with flu-like symptoms ever get a flu test and statistics on flu are extrapolated. [Theresa's note: People don't get flu tests because they are not sick enough to visit the doctor. Flu statistics are, indeed, extrapolated, and the "36,000 people die every year of seasonal flu viruses" statement has little to no basis in fact, which doesn't stop the government from shouting it at every available opportunity.] For instance, the CDC and WHO both have stopped counting actual H1N1 infections, saying only that more than a million people have likely been infected in the United States alone.

Pandemic H1N1 is circulating widely and experts expect it to worsen in the northern hemisphere's autumn as schools get under way. The council's report says the virus, although moderate, could infect 30 percent to 50 percent of the U.S. population this year, put 1.8 million into the hospital and kill anywhere between 30,000 and 90,000 people.

(Additional reporting by Matthew Bigg in Atlanta and Patricia Zengerle in Oak Bluffs, Massachusetts; Editing by Cynthia Osterman)

For decades, farmers, lawn care workers and professional green thumbs have relied on the popular weed killer atrazine to protect their crops, golf courses and manicured lawns.

But atrazine often washes into water supplies and has become among the most common contaminants in American reservoirs and other sources of drinking water.

Now, new research suggests that atrazine may be dangerous at lower concentrations than previously thought. Recent studies suggest that, even at concentrations meeting current federal standards, the chemical may be associated with birth defects, low birth weights and menstrual problems.

Laboratory experiments suggest that when animals are exposed to brief doses of atrazine before birth, they may become more vulnerable to cancer later.

An investigation by The New York Times has found that in some towns, atrazine concentrations in drinking water have spiked, sometimes for longer than a month. But the reports produced by local water systems for residents often fail to reflect those higher concentrations.

Officials at the Environmental Protection Agency say Americans are not exposed to unsafe levels of atrazine. They say that current regulations are adequate to protect human health, and that the doses of atrazine coming through people’s taps are safe — even when concentrations jump.

But some scientists and health advocates disagree. They argue that the recent studies offer enough concerns that the government should begin re-examining its regulations. They also say that local water systems — which have primary responsibility for the safety of drinking water — should be forced to monitor atrazine more frequently, in order to detect short-term increases and warn people when they occur.

The E.P.A. has not cautioned pregnant women about the potential risks of atrazine so that they can consider using inexpensive home filtration systems. And though the agency is aware of new research suggesting risks, it will not formally review those studies until next year at the earliest. Federal scientists who have worked on atrazine say the agency has largely shifted its focus to other compounds.

Interviews with local water officials indicate that many of them are unaware that atrazine concentrations have sometimes jumped sharply in their communities. But other officials are concerned. Forty-three water systems in six states — Illinois, Indiana, Iowa, Kansas, Mississippi and Ohio — recently sued atrazine’s manufacturers to force them to pay for removing the chemical from drinking water.

Representatives of the E.P.A. and Syngenta, the company that manufactures most of the atrazine sold, say that current federal standards are based on hundreds of studies showing Americans are safe. In a written statement, the E.P.A. said that it applied large safety buffers in regulating atrazine and continued to monitor emerging science.

“The exposure that the agency allows under its atrazine drinking water regulations is at least 300 to 1,000 times lower than the level where the agency saw health effects in the most sensitive animal species tested,” the statement said. New studies, while raising important issues, do not “suggest a revision to E.P.A.’s current regulatory approach, which has been built on the review and consideration of hundreds of studies, including animal toxicity and human epidemiological studies dealing with atrazine,” the agency said.

Syngenta said the lawsuits were baseless.

But the head of another government agency voiced apprehension. “I’m very concerned about the general population’s exposure to atrazine,” said Linda S. Birnbaum, director of the National Institute of Environmental Health Sciences, a division of the Department of Health and Human Services. “We don’t really know what these chemicals do to fetuses or prepubescent children.”

“At a minimum, pregnant women should have access to accurate information about what’s in their drinking water,” Dr. Birnbaum added.

Critiques of the E.P.A.

Atrazine is just one example of what critics say are regulatory weaknesses in the protections of America’s drinking water. Health and environmental advocates argue that the laws safeguarding drinking water and policing toxins are insufficient, and that the E.P.A. is often too slow in evaluating emerging risks, not cautious enough and too unwilling to warn the public when health concerns arise.

In January, a Government Accountability Office report said that the E.P.A.’s system for assessing toxic chemicals was broken, and that the agency often failed to gather adequate information on whether chemicals posed health risks.

Forty percent of the nation’s community water systems violated the Safe Drinking Water Act at least once last year, according to a Times analysis of E.P.A. data, and dozens of chemicals have been detected at unsafe levels in drinking water.

In interviews, some E.P.A. officials conceded that they were frustrated by the limitations they face in scrutinizing chemicals like atrazine. An estimated 33 million Americans have been exposed to atrazine through their taps, according to data from water systems nationwide.

“The public believes that the E.P.A. has carefully reviewed all the chemicals that are used and has the authority it needs to deal with risks, but that’s often not the case,” said Erik D. Olson, director of food and consumer product safety at the Pew Charitable Trusts, and a former lawyer at the E.P.A. and for the Senate Committee on the Environment and Public Works.

“The E.P.A. is working with weak laws, basic research at the agency is often seriously underfunded, and in some cases there’s institutional inertia against change,” he added. “That’s contributed to a sense that the agency is often slow to react to new science showing risks.”

Though the hazards posed by atrazine are far from clear, some scientists and health advocates argue that the chemical deserves special scrutiny because it is so widely used. The European Union, for instance, has banned atrazine as part of a precautionary policy that prohibits pesticides that easily contaminate groundwater. (European regulators did not evaluate the chemical’s health risks.)

Atrazine, which is sold under various brand names including AAtrex, is most commonly used on corn in farming states. But it can also be found on lawns, gardens, parks and golf courses. Sometimes, the only way to avoid atrazine during summer months, when concentrations tend to rise as cropland is sprayed, is by forgoing tap water and relying on bottled water or using a home filtration system.

E.P.A. officials note that anyone using atrazine must complete a short training course and is warned to wear long-sleeve shirts and pants, as well as chemical-resistant gloves and shoes, when spraying. The chemical cannot be applied near lakes, reservoirs or other bodies of water. And local water systems must produce an annual report detailing the highest concentrations of atrazine and other chemicals detected over the previous year.

Some high-ranking E.P.A. officials say there are concerns over atrazine, and that it, among other chemicals, is likely to be closely re-examined by the new E.P.A. administrator, Lisa P. Jackson.

“Atrazine is obviously very controversial and in widespread use, and it’s one of a number of substances that we’ll be taking a hard look at,” said Stephen A. Owens, who was recently confirmed as the E.P.A.’s assistant administrator for prevention, pesticides and toxic substances.

He went on: “I can’t say whether the outcome will be any different, but Administrator Jackson has made clear that we need to take a close look at decisions made in the previous administration, and be certain about the science behind those judgments.”

The New Science

Some of the current regulations governing atrazine in drinking water were established in the 1990s. Critics say that science has changed since then — but that the regulations have not.

Recent studies suggest that when adults and fetuses are exposed to even small doses of atrazine, like those allowed under law, they may suffer serious health effects. In particular, some scientists worry that atrazine may be safe during many periods of life but dangerous during brief windows of development, like when a fetus is growing and pregnant women are told to drink lots of water.

“There are short, critical times — like when a fetus’s brain is developing — when chemicals can have disastrous impacts, even in very small concentrations,” said Deborah A. Cory-Slechta, a professor at the University of Rochester in New York who has studied atrazine’s effects on the brain and serves on the E.P.A.’s science advisory board. “The way the E.P.A. tests chemicals can vastly underestimate risks.”

“There’s still a huge amount we don’t know about atrazine,” she added.

In recent years, five epidemiological studies published in peer-reviewed journals have found evidence suggesting that small amounts of atrazine in drinking water, including levels considered safe by federal standards, may be associated with birth defects — including skull and facial malformations and misshapen limbs — as well as low birth weights in newborns and premature births. Defects and premature births are leading causes of infant deaths.

Some of those studies suggest that as atrazine concentrations rise, the incidence of birth defects grows. One study — by researchers at Purdue University, published in the journal Environmental Health Perspectives — suggests that concentrations as small as 0.1 parts per billion may be associated with low birth weights.

The E.P.A. generally does not require water systems to notify residents unless the yearly average of atrazine in drinking water exceeds 3 parts per billion, and under a determination made earlier this decade, the agency considers one-day exposures of up to 297 parts per billion safe.

Another study suggests that concentrations of atrazine in drinking water below the E.P.A. thresholds may disrupt menstrual cycles.

Many of those studies examined large populations that are already exposed to atrazine and sought to exclude the effects of other contaminants and environmental or health factors. However, such epidemiological studies cannot prove that atrazine causes specific diseases. Definitive scientific proof would probably require unethical experiments, like exposing pregnant women to the chemical in controlled settings. Some research found that other pesticides may have also contributed to health problems.

Agency and Industry Rebuttal

In written statements, the E.P.A. and Syngenta argued there were problems with all of the studies suggesting health risks from low doses of atrazine.

Agency officials pointed out that epidemiological findings cannot fully differentiate between multiple influences, and that they only highlight associations, and do not demonstrate a cause-and-effect relationship, and that the “E.P.A. has required and extensively reviewed laboratory studies on atrazine and developmental effects.”

“Data from these studies,” the E.P.A. said, “do not suggest that birth defects, small-for-gestational-age, or effects on limb development would occur as a result of exposure to levels of atrazine found in the environment.” Officials added that the agency evaluates all studies as they appear and takes appropriate actions.

Syngenta said in a written statement that “the evidence is overwhelming that atrazine does not cause adverse health effects at levels to which people are normally exposed,” and that “studies have shown that atrazine does not cause birth defects and does not cause reproductive effects.”

But six researchers asked by The Times to review the epidemiological studies said the results were troubling. “These suggest real reasons for concern,” said Melissa Perry, an associate professor at the Harvard School of Public Health. “The results need to be replicated, but they suggest there are real questions for policy makers about what constitutes safe levels of atrazine.”

Concerns have also been raised by researchers at the E.P.A. itself. Since 2003, for instance, research published by agency scientists in journals like Toxicology and Applied Pharmacology has shown that when rats are exposed to brief doses of atrazine as fetuses, some experience delayed puberty and their mammary glands change in ways that could make them more vulnerable to cancer later in life.

“The morphological changes we see look similar to those caused by other compounds that make tissue more susceptible to carcinogens,” said Suzanne Fenton, an E.P.A. scientist who has written about atrazine. “This theory hasn’t been tested for atrazine. There’s still a lot that we don’t know.”

E.P.A. and Syngenta representatives said that experiments showing changes in rats used higher doses than found in drinking water and that those studies did not provide the scientific confidence required for regulation. Outside scientists, in interviews, said other research suggested that similar effects could be observed at lower doses.

Dr. Fenton says she is no longer working on atrazine. Other E.P.A. employees also said they had been encouraged to redirect their energies to other chemicals, because of insufficient resources and competing priorities.

E.P.A. officials said that other researchers were currently working on atrazine and that the agency intended to convene a panel by 2011 to evaluate epidemiological and other studies.

Below the Radar

The federal Safe Drinking Water Act was created, in part, with cities like Piqua, Ohio, in mind. A town of 20,500, it has its own water system, and thanks to federal right-to-know laws created to warn residents about chemicals in their drinking water, Piqua’s officials must test for atrazine and other substances and inform people of the highest concentrations detected.

But when spikes in atrazine occur in Piqua and elsewhere, residents often do not learn of them, a review of E.P.A. and state data shows.

Since local water systems test for atrazine as infrequently as once a year, the E.P.A. has required that the companies manufacturing the chemical, primarily Syngenta, monitor the drinking water of a sample of towns — as many as 154 communities — as often as once a week. The companies submit that data to federal officials. The E.P.A. says those tests indicate that few towns have violated Safe Drinking Water limits for atrazine.

However, a Times review of Syngenta’s data shows that some communities had large spikes of atrazine in their drinking water, sometimes for months at a time. But residents were not warned.

For instance, in April 2005, the drinking water in Piqua contained atrazine concentrations of 59.57 parts per billion. The residents of Piqua were also exposed to elevated concentrations of atrazine in 2004 and 2007. Data shows similar patterns in dozens of other cities, like Versailles, Ind., and Evansville, Ill.

But the people of Piqua never learned about those spikes from local water officials or the E.P.A. City officials test for atrazine only once a month in the spring, and the annual report sent to residents in 2005 said the highest level of atrazine detected was only 11.6 parts per billion — 80 percent lower than the peak measured by Syngenta. Residents were also not told when peaks had occurred or how long they lasted or whether there were multiple spikes.

Syngenta said the company regularly provided city officials with testing results. Piqua officials were largely unaware of or did not use those notifications.

“I didn’t know that we got any information about atrazine besides our own testing,” said Frederick E. Enderle, Piqua’s city manager since 2005. “I’m not even sure what we would do with it.”

Some residents are angry.

“This makes my blood boil,” said Jeff Lange, a Piqua resident and environmental activist. “I have friends and family drinking this water. How are pregnant women or sick people supposed to know when to avoid it?”

Drinking water experts say atrazine spikes most likely occur in many other towns that are not monitored by Syngenta. In those areas, there is essentially no way for residents or officials to monitor how high levels go.

E.P.A. officials said that under the Safe Drinking Water Act, the data collected by third parties, like Syngenta, did not fall under right-to-know provisions and that Piqua was required only to notify residents based on the city’s testing.

But residents, including Mr. Lange, said Syngenta’s findings should have at least prompted the city to test more frequently, or led the E.P.A. to tell the city to change its testing schedule.

E.P.A. officials also said they do not believe that atrazine spikes like those in Piqua are dangerous. “A one-time reading of 59 parts per billion in finished water does not pose a risk to human health,” the agency wrote.

However, studies like the one at Purdue suggest there are health risks at much smaller concentrations, and other studies suggest those risks rise as exposures grow.

Critics contend that atrazine is just one of the many chemicals the E.P.A. has not regulated with sufficient caution.

The Natural Resources Defense Council, an environmental advocacy group, is expected to release a report on Monday saying that weak E.P.A. regulation of atrazine poses risks to humans and the environment. Other organizations have made similar charges about a variety of chemicals, including fuel additives, dry cleaning and manufacturing solvents, and industrial waste dumped into water supplies.

“There’s pretty broad consensus that the laws regarding toxic substances need to be modernized and overhauled, and that the E.P.A. needs more resources,” said Mr. Olson of Pew, who added that the agency’s new leadership had begun addressing many issues.

“But in the meantime, people are getting exposed to dangerous chemicals,” Mr. Olson said. “And the E.P.A. isn’t responding swiftly enough.”

WASHINGTON - Drugmaker GlaxoSmithKline P.L.C. used a sophisticated ghostwriting program to promote its antidepressant Paxil, letting doctors take credit for medical-journal articles mainly written by company consultants, according to court documents obtained by the Associated Press.

Glaxo has major operations in the Philadelphia area.

An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.

The paper explains how the company can help physicians with everything from "developing a topic" to "submitting the manuscript for publication."

The document was uncovered by the Baum Hedlund P.C. law firm of Los Angeles, which is representing hundreds of former Paxil users in personal-injury and wrongful-death suits against Glaxo. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects.

A spokeswoman for London-based Glaxo said the published articles noted any assistance to the main authors.

"The program was not heavily used and was discontinued a number of years ago," said Mary Anne Rhyne.

According to the memo, which dates from April 2000, the program was designed to "strengthen the product positioning and overcome competitive issues."

At the time, Paxil was competing with antidepressant blockbusters from Eli Lilly & Co. (Prozac) and Pfizer Inc. (Zoloft). Paxil has since lost its patent protection and competes against cheaper generic versions. Sales of Paxil last year totaled $849 million.

Drugmakers frequently hire outside firms to draft a manuscript touting a company's drug, and then retain a physician to sign off as the author.

* Articles "sensational and misleading"

* Company seeks recovery of documents, compensation

* FDA cleared plant last week

* Mylan shares up 0.3 percent (Adds Post-Gazette comment, legal advocate comment)

By Lewis Krauskopf

NEW YORK, Aug 19 (Reuters) - Generic drugmaker Mylan Inc (MYL.O) has sued the Pittsburgh Post-Gazette newspaper over what it called "sensational and misleading" articles concerning quality controls at one of its main manufacturing plants.

The U.S. Food and Drug Administration cleared the West Virginia plant last week after an inspection prompted by the newspaper's reporting.

Mylan's share price fell sharply after the Post-Gazette's initial report that workers had overridden controls intended to ensure the safety and efficacy of prescription drugs.

"The Post-Gazette's article, and a series of articles that followed, are sensational and misleading articles based on improperly obtained and misconstrued confidential, proprietary and/or privileged internal documents," the world's No.3 generic drugmaker said in its suit.

"The articles mischaracterized facts relating to an internal Mylan procedure, creating the false appearance of significant quality and regulatory issues at Mylan's Morgantown, W.Va., plant," the company said in the suit, which it announced on Wednesday.

John Robinson Block, the Post-Gazette's publisher and editor-in-chief, said he had not seen the complaint so could not comment on it.

"But the Post-Gazette stands fully behind its reporting and its news gathering and will defend the suit vigorously," he said in a statement.

The newspaper is owned by privately held Block Communications Inc of Toledo, Ohio.

"TRADE SECRETS"

The civil suit, which was filed in the Circuit Court of Monongalia County, West Virginia, also names reporters Patricia Sabatini and Len Boselovic as defendants.

Messages left for Boselovic and Sabatini were not immediately returned. Sabatini's voicemail said she was out of the office this week.

The suit, which does not include claims of libel, claims misappropriation of trade secrets related to documents that Mylan contends were wrongfully obtained.

Mylan said the documents disclosed aspects of processes employed in production and quality assurance at the facility. It is seeking their return, as well as compensation.

Arguments in the case will likely center on how the newspaper got possession of the documents, said Lucy Dalglish, executive director of The Reporters Committee for Freedom of the Press, which provides legal assistance to journalists.

"What they're going to have to prove is that there was illegal behavior here, and the reporter was actively involved in obtaining the information," Dalglish said.

"And that's hard to do."

As libel has gotten harder to prove, Dalglish said, "companies in particular have gotten more aggressive in using alternative claims."

Mylan's shares fell as much as 15.8 percent after the first Post-Gazette article was published in late July.

About 50.9 million shares changed hands on the first trading day after it appeared, the second-largest trading day in Mylan's history, Mylan said.

The situation took on additional drama when Mylan and the FDA issued initially conflicting statements over whether the agency had cleared the plant, which is on track to produce 16 billion tablets and capsules this year.

Last week, the agency said it had completed its probe into the facility and that it had found no deficiencies.

The FDA found that Mylan had conducted an adequate investigation into issues at the site. Mylan had previously said the issue had no impact on product quality and demonstrated the company's quality systems were working.

Mylan shares were up 0.3 percent at $14.03 in afternoon trading on Nasdaq. (Reporting by Lewis Krauskopf; editing by Ted Kerr)

A Chinese vaccine company said Tuesday that its swine flu vaccine produced a good immune response with only a single dose.

But international health officials, including Dr. Anthony S. Fauci, who is the head of the National Institute for Allergy and Infectious Diseases and is helping oversee vaccine trials in the United States, said it was impossible to evaluate the claim. That was because the company did not give details about how big a dose of the killed virus was in each shot, whether it was whole virus or just viral parts, and whether it used an immune system booster.

The company, Sinovac Biotech, said preliminary results on 1,641 people showed that one shot produced antibodies to the flu, and that side effects were no more serious than those of a typical flu shot.

Vaccine experts have said they expect most patients to need two shots of swine flu vaccine to produce antibody levels similar to those produced in adults by a seasonal flu shot.

Ten Chinese companies are testing flu vaccines, the newspaper China Daily reported. None have licenses to sell vaccine in the United States.

The length of time that it takes for the toxic effects of a common crop pesticide to emerge raises questions about U.S. EPA's standard approach to assessing pesticides' safety, according to a new study.

University of Pittsburgh researchers exposed nine species of tadpoles to endosulfan -- a common pesticide used on cotton, tomatoes, melons, squash and tobacco crops -- for up to eight days at levels EPA says are typically found in nature.

After four days, three species seemed unaffected. But four more days after being moved to clean water, 97 percent of leopard frog tadpoles died, as did up to 50 percent of spring peeper and American toad tadpoles.

Their findings, published in the September issue of Environmental Toxicology and Chemistry, are noteworthy because most scientists and EPA typically use four-day tests to determine whether a pesticide is safe, said Rick Relyea, an associate professor of biological sciences at Pittsburgh.

"For many pesticides, probably four days is a good assumption," Relyea said. "The problem is that it's clearly not good for every pesticide, so now we have to ask, for which pesticide is it a good assumption?"

The study followed earlier work by Relyea that found endosulfan to be 1,000 times more toxic to amphibians than other pesticides.

"We knew it was really deadly to fish, but in the first four days, the leopard frogs were not dying," Relyea said. "Something weird was going on here. We found [the lag effect] was clearly happening in three different members of frogs, so this was clearly something that must be not that rare."

Part of the problem with EPA's risk-assessment model, Relyea said, is that it does not test pesticides on amphibians, even though tadpoles and other amphibians are sensitive to pollutants and many scientists consider them indicator species. Instead, the agency relies on testing four groups -- fish, mammals, birds and crustaceans -- then extrapolates the data.

"This is the standard set of model organisms, and it's there to represent what's out there in an efficient way," Relyea said. "There's no doubt it's efficient. The question is, is it correct?"

EPA said risks to fish are generally assumed to be representative of risks to other aquatic vertebrates, including amphibians. Additionally, the agency said specific tests for amphibians are not sufficiently vetted yet to be used. EPA also said amphibians tend to be less sensitive than fish to pesticides.

Endosulfan is an organochlorine, as is DDT, which EPA banned in 1972. Endosulfan is already banned in other countries, and last month, pesticide manufacturer, Bayer CropScience, announced it would stop selling products containing the pesticide.

EPA said its scientists would evaluate the Pittsburgh research along with other comments the agency receives as it reviews endosulfan's risk assessment. As a part of that review, EPA said it would evaluate the need for longer toxicity studies. It expects to make a final decision on endosulfan by the end of this year.

"If other studies consistently show that post-exposure toxicity estimates differ substantially from those recommended by [the American Society for Testing and Materials] and other global partners, then the agency will consider revisiting the design of aquatic toxicity studies in general," EPA said.

Click here (pdf) to read the report.

Study Says Plastic Decomposes at Sea

Plastic decomposes at sea, releasing potentially dangerous chemicals, report says

TUESDAY, Aug. 18 (HealthDay News) -- Scientists have developed a vaccine for the common viral infection norovirus from a novel source: a tobacco plant.

The new vaccine was "manufactured" in a tobacco plant using a bioengineered plant virus.

This plant biotechnology opens the door to faster, more inexpensive ways to bring vaccines to the public quickly, especially in times when viruses mutate into unpredictable new strains, said Charles Arntzen, who reported on the vaccine at the American Chemical Society annual meeting, in Washingtopn, D.C.

"The recent outbreak of H1N1 influenza virus has once again reminded us of the ability of disease-causing agents to mutate into new and dangerous forms," Arntzen said.

He added that, "for a case like the H1N1 influenza virus, you want to be able to move very rapidly and introduce a commercial vaccine in the shortest possible time. We think we have a major advantage in using engineered plant viruses to scale up vaccine manufacture within weeks instead of months."

The new vaccine for norovirus is a step in that direction. Norovirus is a dreaded cause of diarrhea and vomiting that may be the second most common viral infection in the United States, behind the flu.

Norovirus is sometimes called the "cruise ship virus," because the microbe can spread quickly through passenger liners, schools, offices and military bases. Because noroviruses are always mutating, it is a moving target for vaccine developers.

So Arntzen's team designed a vaccine-manufacturing process quick enough to keep up with shape-shifting viruses.

"With plant-based vaccines, we can generate the first gram quantities of the drug and do clinical tests within eight to 10 weeks. We could easily scale that up for commercial use in a two to four month period," Arntzen said.

Plant-based vaccine production also offers cost advantages. Building greenhouses costs less than the sterilized facilities, manufacturing technology and stainless steel tanks required for the insect or mammalian cell cultures used in most traditional vaccines, he noted.

The swine flu vaccine has been hit by new cancer fears after a German health expert gave a shock warning about its safety.

Lung specialist Wolfgang Wodarg has said that there are many risks associated with the vaccine for the H1N1 virus.

He has grave reservations about the firm Novartis who are developing the vaccine and testing it in Germany. The vaccination is injected “with a very hot needle”, Wodarg said.

The nutrient solution for the vaccine consists of cancerous cells from animals and "we do not know if there could be an allergic reaction".

But more importantly, some people fear that the risk of cancer could be increased by injecting the cells.

The vaccine - as Johannes Löwer, president of the Paul Ehrlich Institute, has pointed out - can also cause worse side effects than the actual swine flu virus.

Wodrag also described people’s fear of the pandemic as an "orchestration": “It is great business for the pharmaceutical industry,” he told the ‘Neuen Presse’.

Swine flu is not very different from normal flu. “On the contrary if you look at the number of cases it is nothing compared to a normal flu outbreak,” he added.

The chairman of the health committee in the European Council has urged for a careful and calm reaction to the virus.

Up until now, the producers of the vaccine did not know how many orders they would have by the autumn, but the German Government is now a guaranteed customer.

Even the pharmaceutical companies are trying to exploit the fear of the swine flu pandemic.