FDA clears safety test to screen Tysabri patients

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WASHINGTON (AP) — The Food and Drug Administration on Friday approved a new diagnostic test to help identify patients who have an increased risk of developing a rare brain infection while taking Biogen Idec's multiple sclerosis drug Tysabri.

Tysabri is one of a handful of drugs used to control multiple sclerosis, a debilitating disease in which the body attacks its own nervous system. Prescribing of the drug has been tightly controlled by the FDA because of a rare infection that causes inflammation of the brain, known as multifocal leukoencephalopathy, or PML. Currently there is no treatment or cure for PML, which usually causes death or severe disability.

The newly approved Stratify JCV test is designed to detect a common virus that increases the likelihood of developing the brain infection. The John Cunningham virus is harmless in most people, but can become dangerous in patients taking immune system-suppressing drugs like Tysabri.

Doctors can use the results of the blood-based test, combined with facts about the patient's medical history, to determine whether they are at risk of developing the brain infection. Other factors that influence a patient's risk include how long they've been taking Tysabri and whether they've previously taken other medications that weaken the immune system.

The test was developed by Quest Diagnostics.

The FDA also updated Tysabri's label to specify that patients who test positive for the virus have a higher risk of developing PML.

"This label change marks an important advance in assisting people with MS and their physicians to make better-informed decisions concerning the challenges of balancing effectiveness with safety," said Dr. Nicholas LaRocca, vice president of the National MS Society.

Tysabri was temporarily pulled from the market shortly after its launch in 2005 after three patients taking the drug developed PML. FDA allowed the drug back on the market the following year but under a restricted distribution program. Only doctors and pharmacies registered with the company's distribution program are permitted to prescribe and dispense the drug.

Biogen, based in Weston, Mass., sells Tysabri through a partnership with Elan Corp., an Irish drugmaker.

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New device uses light to screen for melanoma

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WASHINGTON (AP) — Dermatologists will soon get some high-tech help deciding which suspicious-looking moles should be removed and checked for melanoma, the deadliest form of skin cancer.

The Food and Drug Administration on Wednesday approved a first-of-its-kind device, called MelaFind, that makes detailed, digital images of skin growths and uses a computer to analyze them for signs of cancer, offering a sort of second opinion to doctors. The device is approved only for dermatologists and only for use on growths that don't have obvious signs of cancer but still have one or two worrisome traits.

The hope is to find more melanomas sooner. Nearly all patients diagnosed with early-stage melanoma can be treated and cured, but 85 percent of patients with late-stage melanoma die from it within five years.

More than 70,000 people in the U.S. will be diagnosed with melanoma this year, and 16 percent are diagnosed only after the disease has spread to other parts of the body, according to estimates from the National Institutes of Health.

To diagnose the disease, doctors decide which moles to remove and biopsy using an entirely visual set of guidelines involving size, shape and color. Most dermatologists easily spot late-stage lesions that have obvious signs of cancer, including irregular edges, uneven color and a width greater than 6 millimeters. But many others are tough calls.

"Every day patients come in with 20 moles on their back and the dilemma is, which ones are suspicious and need to be biopsied?" said Dr. David Pariser, former president of the American Academy of Dermatology. "The diagnosis of melanoma is the most serious one a dermatologist makes, and we have sleepless nights worrying about it," said Pariser, who consulted for the device's maker, Mela Sciences Inc. of Irvington, N.Y., on its presentation to FDA.

The device's handheld attachment, about the size of a blow dryer, emits light that penetrates below the surface of the skin, taking multicolored images that reflect the depth and shape of skin growths. A computer compares these to a database of 10,000 archived images and recommends whether a biopsy should be done.

In a company-sponsored study published last year involving around 1,300 patients, some with multiple growths, doctors reported that MelaFind correctly suggested biopsies on 125 of 127 melanomas that doctors had removed. MelaFind correctly identified about 10 percent of non-cancerous growths, which was better than doctors in the study who were correct less than 4 percent of the time, on average. The study was published in the Archives of Dermatology.

The company's study was not intended to show that screening with the device saves lives, only that it can help improve a doctor's ability to spot melanoma.

For now, experts say MelaFind will help dermatologists make better decisions on which moles to remove.

"There is no such thing as 100 percent certainty in medicine," said Dr. George Elias, a melanoma expert at Georgetown's Lombardi Comprehensive Cancer Center who had no ties to the company or the device. "Ultimately it's the responsibility of the dermatologist to use his clinical judgment to make the best decision. This machine is there to help him, not replace him."

Elias voted with the majority of an FDA panel that narrowly endorsed the device last year.

Dermatologists say it's too early to tell whether MelaFind will lead to fewer unnecessary biopsies.

"A biopsy takes a few minutes in my hands, so if there's an issue with any lesion we will always biopsy, whether we have a MelaFind picture or not," said Dr. Leonard Goldberg, a dermatologist at the Texas Medical Center and vice president of the Skin Cancer Foundation, a disease awareness group that accepts donations from makers of sunscreen.

MelaFind underwent a contentious, years-long review by the Food and Drug Administration, which initially rejected the device and concluded it could "potentially cause more harm than good."

Regulators worried that the device could give physicians a false sense of certainty, leading to fewer biopsies. Another concern was that doctors could misinterpret the device's feedback, particularly error messages when a mole cannot be scanned. About 8 percent of growths scanned in the company study came back as "unevaluable."

At a meeting last fall, FDA scientists said Mela Sciences had not shown how its device would influence day-to-day decisions by doctors. The agency also worried about its use by general doctors not accustomed to identifying suspicious skin moles. Despite these concerns, the panel of advisers narrowly backed the overall safety and efficacy of the device in a 8-7 vote.

Regulators said this week that they ultimately approved the device after Mela Sciences agreed to limit its use to board-certified dermatologists who undergo a specialized training course.

"The device is only good for certain lesions, and that's why you have to be a dermatologist to be able to classify and categorize those lesions appropriately," said Christy Foreman, director of FDA's Office of Device Evaluation.

Foreman said an FDA-required follow-up study would help determine how much of a benefit MelaFind represents for patients.

"This device represents new technology. At the end of the day I don't know that this will be the best technology out there, but it is a step forward to allow continued innovation in this area," Foreman said.

Don't expect to see a MelaFind machine at your next doctor's appointment. The company plans to bring them next year to just 200 dermatologists on the East coast, all of whom must undergo company training before they can begin using the device.

Doctors will pay a one-time fee of $7,500 to lease and receive training on the device. Patients will pay $150 out of pocket for a MelaFind scan, which analysts say may limit use to more affluent patients who are willing to pay extra for the latest medical care. Mela Sciences does not plan to ask insurers to cover the device until several years from now, after it is more widely used.

Shares of the company fell 4 cents to $5.35 in afternoon trading.

Mela Sciences originally developed the technology to guide military weapons systems. But the company changed course in the mid-90s after consulting with dermatologists, adapting its technology for melanoma detection.

___

AP Chief Medical Writer Marilynn Marchione contributed to this report.

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Two - Question screen can help doctors Spot teen alcohol problems

Two questions during regular visit to the pediatrician may help identify youth drinking problems, according to a group of national experts organized by the National Institute on alcohol and the alcohol abuse (NIAAA), which has just released the guidelines for the screening of alcohol and treatment.

Despite the national drinking age 21, approximately 7% of Americans 12 - years have been more odd sip of drink alcoholic. According to the age of 18, that proportion rises to 70%. Children who begin drinking before age 15 - outside the parameters adapted as the religious ceremonies or family meals in cultures of drinkers of wine - are four times more likely to develop alcoholism than those who begin later.

Then that drinking deviants beginning is not necessarily to alcoholism, it indicates that the young person may be at high risk for alcohol problems and other psychiatric disorders and may benefit from early treatment.

More: Status: drunk. Can help Facebook ID problem drinkers?

Questions pediatricians should ask according to the NIAAA are as follows, with text amended to be age-appropriate:

You have friends who drank beer, wine or drink containing alcohol in the last year?

You - the last year, had you on how many days have more than a few sips of beer, wine or any drink containing alcohol?

Screening is obviously better when the parents are not present and after the child was informed of the privacy policy of the doctor. In General, pediatricians keep confidential information unless the child is in immediate danger for alcohol-related harm by engaging in activities as the daily drinking or drinking and driving.

The question to what friends drinking tends to predict future alcohol consumption. If the child responds Yes but not in the second, the doctor may welcome the child to avoid alcohol, discuss the risks of alcohol ways they can avoid drinking if their friends continue to do so.

If the child admits to drinking, the NIAAA guide provides physicians of information on the level of risk associated with various amounts of drink at specific ages, as well as advice on the implementation of what is called a "brief motivational intervention" helps people smoking or levels at least cut at least risky drinking.

Brief interventions involve "meet people when they are in," rather than requiring immediate abstinence or entry into an intensive treatment. In a brief intervention - which literally takes 15 minutes or less - the doctor discussed to reduce or eliminate risk behaviour and the means, this objective can be achieved.

More: How Teen Dating Influences Teen drinking

More importantly, however, the focus is on the objectives and the wishes of the patient. The doctor tries to help patients find their own reasons to choose of more healthy behaviour change and then support them, instead demanding or "refusal." Follow-up appointments are made to discuss the progress, sometimes combined with another follow-up medical appointments if the child does not want to disclose a problem at low altitude to parents.

Not surprising, given how short these interventions are, they have been shown to be as effective as more intensive treatment to reduce the consumption of alcohol to teens. They carry low cost and no risk of exposure of adolescents to more deviant peers that can come with the treatment of group for the substance use problems.

If adolescents are found to have ongoing problems or have engaged in threatening behavior such as drinking and driving, the NIAAA guide offers parents and physicians policy advice to find the best care, including treatment more intensive.

More:
Guide for the Parents"href="http://healthland.time.com/2011/02/17/how-to-find-the-best-drug-treatment-for-teens-a-guide-for-parents/">How to find the best treatment of drug abuse for Teens: a Guide for Parents

"We know that alcohol is by far the drug of choice among young people," said NIAAA acting Director Kenneth Warren in a statement. "Minor drinking is also a marker for other unhealthy behaviors and it often goes unnoticed." "This new tool was designed for busy professionals who manage the health and well-being of children and adolescents to conduct fast, screens of the entry into force of the alcohol and brief interventions".

Unfortunately, actually getting physicians to integrate testing into their practice can be difficult, given their time. A 4 000 adult patients NIAAA study revealed that, while 49% were questioned on their consumption of alcohol, only 14% of those with alcohol use has exceeded healthy levels advised this subject by their physicians in their most recent visit.

The guide NIAAA alcohol screening and intervention for youth are located here.

More: Teen Drug Rehab cure drug addiction or create it?

Maia Szalavitz, is a writer of health at TIME.com. Find him on Twitter at @ maiasz. You can also continue the discussion on the time Facebook page Healthland and on Twitter at @ TIMEHealthland.

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'Contagion' spreads to big screen

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Kate Winslet stars as a young detective in the virus-out-of-control movie "Contagion." Teaching advanced math and science isn't usually part of a big Hollywood thriller"Contagion" cast includes Kate Winslet, Gwyneth Paltrow, Matt Damon, Jude LawIdea for movie planted in writer Scott Burns when he saw online TED talk by Larry Brilliant

(CNN) -- At a critical moment in the newly released action-thriller movie "Contagion," the young disease detective, played by Kate Winslet, is using a dry-erase board to drive home the danger of the new virus that has wiped out thousands of people, including Gwyneth Paltrow.

Winslet's character uses a concept known as "R0" -- pronounced "R-naught"--- to explain to skeptical public health officials that the new virus could be much more contagious than influenza or polio.

"I wanted people to understand R0," explains Scott Z. Burns, who wrote the film, which was No. 1 at the box office this weekend. Here it is: R0 is the number of new cases that a single infected person will cause, on average. In most seasons, R0 for influenza is just below 2. In the devastating 1918 pandemic, it was likely above 3. With an R0 that high, the number of cases will grow exponentially, unless patients remain isolated or quickly receive effective treatment.

"Kate Winslet did an amazing job with it," says Burns. "That one scene is really a science and math lesson, but people seem to get it."

Advanced math and science aren't usually a part of a big Hollywood thriller, particularly one with "Contagion's" cast: not just Winslet and Paltrow but Matt Damon, Jude Law, Laurence Fishburne and Marion Cotillard, along with a cameo by CNN's Dr. Sanjay Gupta. But Burns and director Steven Soderbergh approached the project in an unusually dedicated way.

The germ of the idea was planted in Burns when he saw an online TED talk by Larry Brilliant, who was one of the doctors and scientists who finally eradicated the smallpox virus in the 1970s. By the time he gave the talk in 2006, he was working with Google to try and leverage the reach of the Internet to find early warning signs of a flu pandemic or other outbreak of deadly disease.

Burns reached out to Brilliant, who introduced him to Dr. W. Ian Lipkin, a scientist and disease detective at the Center for Infection and Immunity at Columbia University.

Lipkin describes himself as an experimental pathologist -- "I figure out what went wrong." As a big part of his research, he examines tissue samples from around the world, looking for new and dangerous viruses. He began to hold one-on-one seminars with Burns at his office and his lab at Columbia, which evolved into a major role as a consultant on the film.

Lipkin says the science in "Contagion" is strong enough that the film could have a long life as a teaching tool for students, politicians and even public health officials.

Soon, Burns found himself poring through the daily reports of ProMedMail.com, a sort of listserv for scientists and infectious disease specialists, flagging unusual cases or findings anywhere in the world.

"You'd see three unexplained deaths in Africa, or two people with an unusual virus in India. I'd call Ian, and frequently he'd have been sent blood and tissue, to see what it was," Burns recalls.

For the right killer for "Contagion," "I wanted to find a virus that would be especially nefarious in that it wouldn't show up in an unusual way, that could be misinterpreted in an emergency room 5,000 miles away from where a person originally caught it."

Burns and Lipkin eventually focused on a pair of deadly, closely related viruses that primarily live in bats but occasionally infect people: Nipah, found in Southeast Asia, and Hendra, from Australia. With a screenwriter's glee, they genetically modified the fictional virus to let it spread readily through bodily fluids or coughing. Voila! A global killer.

By then, Brilliant had left Google to work at the Skoll Global Threats Fund, a foundation created by eBay co-founder Jeff Skoll to conduct research on large-scale dangers, including viruses. Another Skoll venture, Participant Media, founded with a mission to support films with important social messages, agreed to underwrite the development of the script. Ricky Strauss, Participant's president, served as an executive producer of "Contagion."

Meanwhile, Lipkin was opening more doors to the scientific community, including top officials at the World Health Organization and the Centers for Disease Control and Prevention.

"Some of these places, they wouldn't have gotten the time of day," recalls Lipkin. "But I said, 'look, this is an important film. I wouldn't put my name on it if I didn't think it was going to be solid."

CDC not only allowed filmmakers to spend a day shooting "on campus," but senior scientists spent a day with Winslet to help her prepare for the role. Winslet's main guide at CDC was Dr. Anne Schuchat, who led the agency's response to the H1N1 pandemic.

"In my discussions, the key thing I wanted to get across was the intensity of these investigations, the focus you give and the 24/7 nature of it," says Schuchat. "You're disconnected from your regular life, and totally immersed in what you're doing."

Schuchat herself spent six weeks in China during the SARS outbreak in 2003, barely speaking to her family back home.

As part of its promotional effort, Participant Media also built a multifaced website, showcasing the work of leading virologists and public health experts. One of them is Dr. John Brownstein, an assistant professor of pediatrics at Children's Hospital in Boston, who has worked with Skoll to develop an online tool to flag outbreaks as they happen around the world.

Brownstein called it "a massive challenge" to break down the science of pandemics into a viewer-friendly message.

"In the absence of a vaccine or a therapeutic (medication), you couldn't come up with three things you could do right now to prevent a pandemic."

He says that people could somewhat slow the spread of a pandemic by taking simple measures like isolating themselves if they fall sick, or properly washing their hands. (Burns, incidentally, says he took away one new hand-washing lesson: Don't forget to wash your thumbs.)

Lipkin says the real message of the film is political: Don't slash budgets for disease research and early-warning systems.

In 2009, just a few months into development, it seemed as though real-world developments might hijack the film. That's when Burns put the project on hold and watched to see whether his imaginary scenario would be trumped by the real H1N1 virus. He found himself fascinated by the push and pull of officials struggling to answer questions from the public. He says the pressures are much the same for those officials and for journalists.

"It's tricky," Burns said. "You don't want to be the scientist who cried wolf, or the journalist who cried wolf. The thing is, they move so quickly, and if you don't sound the alarm quickly, you're way behind the curve."

In "Contagion," the CDC director, played by Fishburne, sends his own family into isolation, even as he offers a more reassuring take to the public. He's outed by an investigative blogger, played by Jude Law, who wins a mass following with his scoops on the pandemic -- some accurate, some deliberately misleading.

Brownstein says he loved the subplot.

"That to me is the most interesting part of the film. They have this knowledge, and people are holding it back. It plays with the idea of false reporting, and the viral nature of the Web and how it can lead to mistrust."

Schuchat says the CDC is trying to move toward more openness.

"The more we focus on transparency, the more credibility we have. We shared what we knew as we knew it, although we also were careful to say it might change -- this might not be the last word on it."

Now that his creation is decimating a world filled with some of Hollywood's biggest stars, Burns pauses when asked whether the project left him reassured or alarmed about our vulnerability to a newly emergent killer virus.

"On the one hand, writing it did freak me out. I wanted to be realistic, and I kept asking these scientists, 'Could this or that scenario really happen?' And they always said, 'Sure, it could happen.' On the other hand, I was reading an article two years ago, and it talked about how human DNA is littered with remnants of our battles with retroviruses. There's something poetic about that. So with people and viruses, when you look at in the longevity of the relationship, there's some comfort."

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'Contagion' spreads to big screen

AppId is over the quota
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Kate Winslet stars as a young detective in the virus-out-of-control movie "Contagion." Teaching advanced math and science isn't usually part of a big Hollywood thriller"Contagion" cast includes Kate Winslet, Gwyneth Paltrow, Matt Damon, Jude LawIdea for movie planted in writer Scott Burns when he saw online TED talk by Larry BrilliantTo find out more about the film "Contagion," watch Sanjay Gupta MD, Saturday and Sunday at 7:30 a.m. ET. Warner Bros is owned by Timer Warner Inc., which also owns CNN.

(CNN) -- At a critical moment in the newly released action-thriller movie "Contagion," the young disease detective, played by Kate Winslet, is using a dry-erase board to drive home the danger of the new virus that has wiped out thousands of people, including Gwyneth Paltrow.

Winslet's character uses a concept known as "R0" -- pronounced "R-naught"--- to explain to skeptical public health officials that the new virus could be much more contagious than influenza or polio.

"I wanted people to understand R0," explains Scott Z. Burns, who wrote the film, which was No. 1 at the box office this weekend. Here it is: R0 is the number of new cases that a single infected person will cause, on average. In most seasons, R0 for influenza is just below 2. In the devastating 1918 pandemic, it was likely above 3. With an R0 that high, the number of cases will grow exponentially, unless patients remain isolated or quickly receive effective treatment.

"Kate Winslet did an amazing job with it," says Burns. "That one scene is really a science and math lesson, but people seem to get it."

Advanced math and science aren't usually a part of a big Hollywood thriller, particularly one with "Contagion's" cast: not just Winslet and Paltrow but Matt Damon, Jude Law, Laurence Fishburne and Marion Cotillard, along with a cameo by CNN's Dr. Sanjay Gupta. But Burns and director Steven Soderbergh approached the project in an unusually dedicated way.

The germ of the idea was planted in Burns when he saw an online TED talk by Larry Brilliant, who was one of the doctors and scientists who finally eradicated the smallpox virus in the 1970s. By the time he gave the talk in 2006, he was working with Google to try and leverage the reach of the Internet to find early warning signs of a flu pandemic or other outbreak of deadly disease.

Burns reached out to Brilliant, who introduced him to Dr. W. Ian Lipkin, a scientist and disease detective at the Center for Infection and Immunity at Columbia University.

Lipkin describes himself as an experimental pathologist -- "I figure out what went wrong." As a big part of his research, he examines tissue samples from around the world, looking for new and dangerous viruses. He began to hold one-on-one seminars with Burns at his office and his lab at Columbia, which evolved into a major role as a consultant on the film.

Lipkin says the science in "Contagion" is strong enough that the film could have a long life as a teaching tool for students, politicians and even public health officials.

Soon, Burns found himself poring through the daily reports of ProMedMail.com, a sort of listserv for scientists and infectious disease specialists, flagging unusual cases or findings anywhere in the world.

"You'd see three unexplained deaths in Africa, or two people with an unusual virus in India. I'd call Ian, and frequently he'd have been sent blood and tissue, to see what it was," Burns recalls.

For the right killer for "Contagion," "I wanted to find a virus that would be especially nefarious in that it wouldn't show up in an unusual way, that could be misinterpreted in an emergency room 5,000 miles away from where a person originally caught it."

Burns and Lipkin eventually focused on a pair of deadly, closely related viruses that primarily live in bats but occasionally infect people: Nipah, found in Southeast Asia, and Hendra, from Australia. With a screenwriter's glee, they genetically modified the fictional virus to let it spread readily through bodily fluids or coughing. Voila! A global killer.

By then, Brilliant had left Google to work at the Skoll Global Threats Fund, a foundation created by eBay co-founder Jeff Skoll to conduct research on large-scale dangers, including viruses. Another Skoll venture, Participant Media, founded with a mission to support films with important social messages, agreed to underwrite the development of the script. Ricky Strauss, Participant's president, served as an executive producer of "Contagion."

Meanwhile, Lipkin was opening more doors to the scientific community, including top officials at the World Health Organization and the Centers for Disease Control and Prevention.

"Some of these places, they wouldn't have gotten the time of day," recalls Lipkin. "But I said, 'look, this is an important film. I wouldn't put my name on it if I didn't think it was going to be solid."

CDC not only allowed filmmakers to spend a day shooting "on campus," but senior scientists spent a day with Winslet to help her prepare for the role. Winslet's main guide at CDC was Dr. Anne Schuchat, who led the agency's response to the H1N1 pandemic.

"In my discussions, the key thing I wanted to get across was the intensity of these investigations, the focus you give and the 24/7 nature of it," says Schuchat. "You're disconnected from your regular life, and totally immersed in what you're doing."

Schuchat herself spent six weeks in China during the SARS outbreak in 2003, barely speaking to her family back home.

As part of its promotional effort, Participant Media also built a multifaced website, showcasing the work of leading virologists and public health experts. One of them is Dr. John Brownstein, an assistant professor of pediatrics at Children's Hospital in Boston, who has worked with Skoll to develop an online tool to flag outbreaks as they happen around the world.

Brownstein called it "a massive challenge" to break down the science of pandemics into a viewer-friendly message.

"In the absence of a vaccine or a therapeutic (medication), you couldn't come up with three things you could do right now to prevent a pandemic."

He says that people could somewhat slow the spread of a pandemic by taking simple measures like isolating themselves if they fall sick, or properly washing their hands. (Burns, incidentally, says he took away one new hand-washing lesson: Don't forget to wash your thumbs.)

Lipkin says the real message of the film is political: Don't slash budgets for disease research and early-warning systems.

In 2009, just a few months into development, it seemed as though real-world developments might hijack the film. That's when Burns put the project on hold and watched to see whether his imaginary scenario would be trumped by the real H1N1 virus. He found himself fascinated by the push and pull of officials struggling to answer questions from the public. He says the pressures are much the same for those officials and for journalists.

"It's tricky," Burns said. "You don't want to be the scientist who cried wolf, or the journalist who cried wolf. The thing is, they move so quickly, and if you don't sound the alarm quickly, you're way behind the curve."

In "Contagion," the CDC director, played by Fishburne, sends his own family into isolation, even as he offers a more reassuring take to the public. He's outed by an investigative blogger, played by Jude Law, who wins a mass following with his scoops on the pandemic -- some accurate, some deliberately misleading.

Brownstein says he loved the subplot.

"That to me is the most interesting part of the film. They have this knowledge, and people are holding it back. It plays with the idea of false reporting, and the viral nature of the Web and how it can lead to mistrust."

Schuchat says the CDC is trying to move toward more openness.

"The more we focus on transparency, the more credibility we have. We shared what we knew as we knew it, although we also were careful to say it might change -- this might not be the last word on it."

Now that his creation is decimating a world filled with some of Hollywood's biggest stars, Burns pauses when asked whether the project left him reassured or alarmed about our vulnerability to a newly emergent killer virus.

"On the one hand, writing it did freak me out. I wanted to be realistic, and I kept asking these scientists, 'Could this or that scenario really happen?' And they always said, 'Sure, it could happen.' On the other hand, I was reading an article two years ago, and it talked about how human DNA is littered with remnants of our battles with retroviruses. There's something poetic about that. So with people and viruses, when you look at in the longevity of the relationship, there's some comfort."

View the original article here

Peliculas Online

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