Niche focus Spurs Pharma that we aid the antibiotics

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WASHINGTON (AP) - The pharmaceutical industry won approval to market a record number of new drugs for rare diseases last year, as a combination of scientific innovation and business opportunity spurred new treatments for diseases long-ignored by drug companies.

Drug companies are increasingly taking advantage of the extra benefits of developing so-called orphan drugs, which include commercial patent protections, higher pricing and a streamlined review process by FDA. Among the innovative treatments approved in the past year were the first new drug for lupus in 50 years and the first new drug for Hodgkin's lymphoma in 30 years.

But the focus is specialty drugs has put pressure on the U.S. government to ramp up its own spending on vaccines, antibiotics and drugs for more widespread health threats, which are less profitable for companies.

Since 2006, government spending on research for familiar diseases like staph infections, smallpox and botulism has increased more than 660 percent, from $54 million to $415 million last year

"Many of these are everyday, general diseases that we thought we had conquered decades ago, but we've seen some of them pop up again," said Dr. Robin Robinson, director of the Biomedical Advanced Research and Development Authority, which is tasked with acquiring vaccines, drugs and other necessities for public health emergencies.

Since 2005, women has awarded $3.5 trillion to outside companies to encourage research and production of antibiotics, flu vaccines and other products that are seen as less profitable than specialty drugs.

"We have pushed the envelope more toward diminishing the risk for companies so that they'll be more interested in getting involved with us and developing things like vaccines and antivirals," said Dr. Anthony Fauci, infectious diseases chief at the National Institutes of Health, which funds research into bird flu, tuberculosis and other potential pandemics. The government's role in developing new therapies goes beyond awarding contracts and includes offering assistance in designing trials and recruiting test subjects.

The need for such assistance stems in part from a new focus among pharmaceutical companies on drugs for rare diseases or unusual strains of common diseases.

Eleven of the 30 new drugs approved last year, or 37 percent, were for rare medical conditions, the highest percentage on record since the FDA began offering incentives to develop such therapies, known as orphan drugs, about 30 years ago. Additionally, nearly half of the 30 drugs were cleared under FDA's "fast track" program reserved for drugs that fill an unmet medical need.

"The companies are saying 'this is actually a viable model.'" "Whereas back in the nineties they were skeptical, now they seem convinced," said Mark Schoenebaum, an analyst with International Strategy & Investment.

Analysts credit scientific advances and looming patent Expiries with the spate of innovative products. Drugs worth a mammoth $255 billion in global annual sales are set to go off patent before 2016, according to EvaluatePharma Ltd., a London research firm.

The pharmaceutical industry reached its peak of profitability in the 1990s with heavily marketed drugs for common afflictions, like AstraZeneca PLC's Nexium pill for heart burn and Pfizer Inc.'s Lipitor for high cholesterol. In the last decade drugmakers managed to extend the patents on those drugs by tweaking their formulations, resulting in so-called ' follow - on' drugs. But with most of those products on the cusp of losing patent protection, drugmakers have finally been forced to innovate, often turning to hard-to-treat diseases for which there are few existing therapies.

The FDA grants companies seven years of exclusive, competition-free marketing for each newly approved orphan drug, as well as tax breaks on the costs of developing the drugs. Orphan drugs also typically command much higher prices than other drugs. Last year French drugmaker Sanofi paid $20 billion to acquire specialty drugmaker Genzyme, whose products range from $100,000 to $300,000 for one year's supply.

One side effect of the focus on developing drugs for rare diseases is increased investment by the government to spur research into more common public health threats with the potential to cause mass outbreaks of illness. One such threat comes from so-called superbugs, or bacteria that have grown resistant to antibiotic drugs.

Robinson says government support is needed to spur antibiotic development because of how the products are used sparingly in medical practice. After decades of routine use, many first-generation antibiotics like penicillin are no longer effective against common bacterial strains, such as the staphylococcus aureaus, which causes staph infections. Physicians are encouraged to use newer antibiotics only in critical situations so that superbugs have less chance to build a resistance to them. As a result, drugmakers do not see a large commercial market for new antibiotics. Now the federal government is providing an incentive.

BARDA has awarded a series of contracts to encourage development of new antibiotics that can be stockpiled for use in a natural outbreak or during a bioterrorism attack.

-The agency has allocated up to $64 million to Achaogen, a San Francisco startup, for development of a new antibiotic against tularemia, a bacterium that can cause pneumonia and urinary tract infections. Public health officials are especially focused on Tularemia because it could also be used in a potential bioterrorism attack. Robinson says the contract is an example a new strategy of encouraging companies to produce therapies with dual uses: as federal preparatory measures and as commercial medical products.

Achaogen has received $155 million in research contracts and has several antibiotics in early and mid-stage, though none are currently available for sale.

-Under a $38.5 million contract awarded in September, BARDA will help GlaxoSmithKline PLC test an experimental antibiotic against both bioterrorism agents and infections like hospital-acquired pneumonia.

The U.S. government has used a similar pump priming strategy to encourage investment in flu vaccines. The Department of Health and Human Services wants to be able to provide enough vaccine for the entire U.S. population within six months of a flu pandemic. To meet that goal the government has tried to boost vaccine production by encouraging more Americans to get the standard flu vaccine each year. The government's hope is that by making the shots routine for more Americans, companies will invest in larger vaccine that can ramp up production facilities in the event of a pandemic.

Last month Swiss drugmaker Novartis AG opened the first U.S. vaccine facility equipped with cell culture technology, a faster method for producing vaccines than the traditional technique using chicken eggs. The U.S. government provided half of the $1 billion investment for the facility, as part of its preparations for a potential flu pandemic.

Associated Press

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'Baby Joseph,' focus of treatment dispute, dies

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"Baby Joseph" Maraachli died peacefully in his sleep on Tuesday, in Windsor, Ontario, his family said.Joseph Maraachli suffered from a progressive neurological diseaseA hospital in London, Ontario, refused to insert a tracheotomy tubeThe infant received a tracheotomy at a hospital in St. Louis"Baby Joseph" died Tuesday in his sleep

(CNN) -- Joseph Maraachli, the infant who became the center of an international end-of-life debate, died peacefully in his sleep at his Windsor, Ontario, home, a spokesperson for the family said Wednesday.

Widely known in the media as "Baby Joseph," the 20-month-old boy spent the last several months with his family and died Tuesday afternoon.

"Obviously, it's been a very difficult day for the family today," said spokeswoman Emma Fedor. "In some ways, it was a bit of a relief for the family."

Joseph's family had refused to accept a recommendation by a Canadian hospital to remove the boy's breathing tube and allow him to die. In March, the infant received a tracheotomy at a children's hospital in St. Louis, Missouri.

He was able to go home April 21.

"By providing him with this common palliative procedure, we've given Joseph the chance to go home and be with his family after spending so much of his young life in the hospital," said Dr. Robert Wilmott, chief of pediatrics for SSM Cardinal Glennon Children's Medical Center in St. Louis.

A London, Ontario, hospital where Joseph was receiving care for a progressive neurological disease refused to perform a tracheotomy, a surgical procedure in which an opening is made into the airway through an incision in the neck to allow for suction of fluid out of the lungs.

In court papers, doctors in Canada said there was no hope for recovery. They would not perform a tracheotomy because they considered it to be invasive and not recommended for patients who require a long-term breathing machine.

Parents Moe and Sana Maraachli refused to accept the recommendation. The Maraachlis' daughter, Zeina, had died at home in 2002 after a tracheotomy after suffering similar complications, and the family wanted to offer the same care to their son.

"To go through it once is enough for a lifetime, to go through it twice, it's just ... unbelievable," Fedor said.

Joseph was "very peaceful, in no pain whatsoever, no distress," when he died, Fedor said. He was buried Wednesday next to his sister.

The family was thankful for those who helped and prayed for Joseph, she added.

"The heart of the issue would come down to the mix between respecting the parents' rights ... to be in comfort of (their) own home, to die on God's time," said Fedor.

The family countered assertions that Joseph was nonresponsive, blind and deaf, she said. Instead, the boy could hear the parents' voices and look for them, Fedor told CNN. The family believed that, after a tracheotomy, Joseph could be freed from machinery.

The parents said that they, rather than physicians, should make a judgment on quality of life, Fedor said.

The Maraachli case caught the attention of the group Priests for Life, which funded Joseph's transfer and treatment at the SSM Cardinal Glennon Children's Medical Center. That hospital deemed the procedure medically appropriate and Baby Joseph underwent a tracheotomy there on March 21.

In April, Frank Pavone, national director of Priests for Life, said he considered this a "victory over the culture of death." He says "(Joseph) has gained benefit from his tracheotomy, is breathing on his own, and is going home to live with his parents."

Priests for Life is a Catholic pro-life organization that functions as a network to prevent abortion and euthanasia. The group often is noted for the graphic images depicting abortion its members and supporters use to make their case.

The London Health Sciences Centre -- the hospital where Joseph was initially treated -- in March said that "there are clearly differences in the approach of these centres to the management of end-of-life care in this tragic situation" and that "the medical judgments made by LHSC physicians remain unchallenged by any credible medical source."

Nurses helped the family provide 24-hour care for Joseph in his final months. "There was always somebody by his side," Fedor said.

The child was on almost no medication and apparently was in no pain, Fedor said.

"When he was in the arms of his parents, you could tell," she said. "He was settled when he was in their arms."

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Quays Focus 'Weeping Glass' On The Mutter Museum

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A slideshow of objects from the Mutter Museum.

The notion of "beauty" can mean many different things to artists. For the Brothers Quay — identical-twin filmmakers — it often means dimly lit black and white images of animated dolls, screws, cogs — any manner of inanimate object brought to life. They're so good at it that fellow filmmaker Terry Gilliam called the Quays' Street of Crocodiles one of the best animated films of all time.

Enlarge Edward Waisnis/Behind the Scenes with the Quay Brothers

The Quay Brothers, filming Through The Weeping Glass at the Mutter Museum in Philadelphia. The Quays started filming without a script or a storyline.

Edward Waisnis/Behind the Scenes with the Quay Brothers The Quay Brothers, filming Through The Weeping Glass at the Mutter Museum in Philadelphia. The Quays started filming without a script or a storyline.

Timothy and Stephen Quay are American-born stop-motion animators who do most of their work in Europe. Their latest film brought them back to the U.S. — to the Mutter Museum in Philadelphia. The Mutter houses a collection of 19th century medical curiosities. The film brings to life the way medicine used to be, and the stories of the long-dead.

The Quays are lean, fashionable in a comfortable way, with long, graying hair. They're in their 60s but don't look it. It's hard to tell them apart, and they like it that way. To make the film, they turn a museum room into a darkened studio. They fill it ominously with the soundtrack from David Lynch's TV series, Twin Peaks, and they place museum specimens on a table under shimmering lights: a fetus in a jar, or a terrifying sort of metal plunger for removing kidney stones. At the start, they have no script, no storyline.

"What we most like are the accidents," they say. "They," because the brothers usually share sentences, one finishing what the other starts. They prefer to be undifferentiated.

"The accidents bend the direction of the film," they continue, "because the whole thing about this museum is discovering that one little kernel or that one strange event."

'Where Reality And Fiction Tremble With A Nice Favorable Wind'

They rotate and film the objects from different angles, conferring quietly, building mood. The Quays say this museum is both heart-rending and beautiful. Museums figure in their other films. For them, these places contain objects with occluded histories.

What we most like are the accidents. The accidents bend the direction of the film, because the whole thing about this museum is discovering that one little kernel or that one strange event.

- The Quay Brothers

Watching a Quay film is kind of like being in a museum, like looking at a diorama through a peephole. You might call it a dreamscape, but they say no, it's "crepuscular" — it's the slippery moment just after you wake up, between sleep and wakefulness.

"For us," says a brother, "it's always been the in-between world where it's an ambiguous state, and it hovers on, or shimmers in a kind of half-state. Maybe it's a little bit where reality and fiction tremble with a nice ..." He searches for the right word.

"Favorable wind," the other finishes with a laugh.

It's worth noting that the Quays usually keep lots of Belgian beer nearby when filming or doing interviews.

Before the Quays begin filming, they usually decide on the music and let it guide them. They say it "releases and closes down" images. Tim Nelson composed the music for the Mutter film.

"They're looking more for the moments where there might be something that sticks out," Nelson says, "that little sound there that might inspire a reflection off glass, or when a camera angle might change. They find the rhythms within the music."

And the music helps give meaning to the objects.

'Revealing The Hidden'

The Quays grew up near Philadelphia and studied art there before moving to England. They were invited back by Robert Hicks, who came to the Mutter Museum as its director two years ago with a mission — to open its collection to artists. Many came. But it was these painterly animators he really wanted.

"The Quay brothers are so good at revealing the hidden," he says, "at creating stories about the inner lives of overlooked or unusual things. They animate straight pins used in sewing; they animate puppets, screws, dust. They're particularly virtuosos at manipulating dust."

Enlarge Mutter Museum View 1, 1994/Olivia Parker

The bone pathology section of the Mutter Museum shows, in the foreground, the skeleton of a 7-foot-6-inch giant and the skeleton of Mary Ashberry, a 3-foot-6-inch dwarf.

Mutter Museum View 1, 1994/Olivia Parker The bone pathology section of the Mutter Museum shows, in the foreground, the skeleton of a 7-foot-6-inch giant and the skeleton of Mary Ashberry, a 3-foot-6-inch dwarf.

In fact, the brothers had visited the museum in their teens. So they knew about its bizarre offerings.

Anna Dhody, the museum's curator, is also a forensic scientist — she solves criminal mysteries based on bodies or bones. The Mutter's main exhibition hall has plenty of both — like the 139 human skulls on the wall. They're meant to show skeletal diversity among Europeans. Each has an identifying tag.

Dhody reads one tag: "Giza Hermenyi. Reformist herdsman. At age 70 attempted suicide by cutting his throat. Wound not fatal because of ossified larynx. Lived until 80 without melancholy."

In another cabinet, a skeleton stands erect, and looks very melancholy. There's something very wrong with the bones.

"This is Harry Eastlack," Dhody explains. "And Harry has something called fibrodysplasia ossificans progressiva." As Eastlack aged, any bump or injury caused more bone to grow inside him — in places it shouldn't. "If you look at the ribs right here," she says, "you're going to see this sheeting action, almost like dripping down." It looks like icicles of bone. In the end, he could only move his lips. He died at 39 and asked that his skeleton stay at Mutter.

And Eastlack's story is how the Quays start their story. "Harry Eastlack is the one that we're sort of creating kind of a through line [with], but then there's other curves that kind of sweep in and intersect," the Quays say.

'We Never Walk Through The Front Door'

While the Brothers film in their studio, Dhody and director Hicks roam the museum's back rooms, gathering objects that have caught the brothers' fancy. Like a metal sculpture of a head. "It's called an 'eye phantom,' " Hicks explains. It's a 19th century metal sculpture with empty eye sockets. (See the second image in the slideshow above.) Students would place eyeballs in the sockets, and it's Dhody's job to do that for the Quays.

Scalpel in hand and bent over a lab table, she's "trimming" eyeballs. "What we're doing is prepping the eyeballs to get them into the eye phantom. And then I don't know what they are going to be doing." The eyeballs are from a cow, a sheep and a pig.

Enlarge Quay Brothers

A still image from the Quay Brothers' film Through The Weeping Glass, showing a "flap book." Flap books were layered, peel-away anatomy textbooks that progressively revealed deeper structures of the human body.

Quay Brothers A still image from the Quay Brothers' film Through The Weeping Glass, showing a "flap book." Flap books were layered, peel-away anatomy textbooks that progressively revealed deeper structures of the human body.

The eyes finally stay put and she presents the thing to the Quays. They stare for a while, then politely say, "Sorry, it doesn't quite work."

But they are taken with the 139 skulls. There are stories there, they say. "Every one of them had made a journey, and it's true. It's like, 'What would be the five lines that would describe each one of us — the trajectory of life?' "

"Yes, the trajectory of life, and how you end it."

"How you end it in this museum as well."

The filming takes several days. Only after, will the Quays shape the whole film.

"We never walk through the front door," says one. "We insist on coming through the side door or the back door. It's a bit like a plant growing in the sense you just keep it watered. It might grow three limbs on one side and only one on the other, but it will be striking or it will be special."

"Or a perversion," the other jokes.

The film is called Through the Weeping Glass: On the Consolations of Life Everlasting. It opens Sept. 22 in Philadelphia, then moves to the Museum of Modern Art in New York City. Unusually for a Quay film, there is narration, by the Shakespearean actor Sir Derek Jacobi. The first line of the film? "No child ever imagines the unimaginable. That he will end up as a skeleton."

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HEALTH MANAGEMENT. White House childhood obesity task force must focus on the treatment for minority children

The White House task force on childhood obesity, created by the President as part of the first lady "Let's move" campaign, is resolved to be the epidemic of obesity within a generation rising the land at a rate of 5 percent by 2030, what began in the late 1970s the rate before obesity by the year.
A recent U-M study, published online before using print in obesity journal researchers evaluated the balance of prevention and treatment, for the objectives, by the task force may 2010-report ordered.
Is a shared emphasis on the prevention of obesity and treatment strategies required to achieve this goal, according to researchers. Prevention programmes solely deal with according to the epidemic, the children, who are already obese, especially minorities. Obesity treatment strategies have an important part of the equation.
"There are many discussions on the prevention of obesity for children." This is certainly important, but it is not the whole story. "Because so many children are already overweight, it need greater efforts focused on treatment, if we succeed", Joyce M. LEE, MD, mph, Assistant Professor of Pediatrics and communicable diseases at the U-M medical school and a U-M c.s.. clinician says Mott Childrens Hospital.
Rates of obesity in the United States are much higher for minority children, with 20% black and Mexican-American children affected, with only 15 percent for white children childhood. Because the burden of obesity is so high, the study includes prevention strategies alone will not help, the task force, be to achieve objective.
"Effective treatment strategies, in particular targeted minority children, in particular are needed," says Lee, the lead author of the study.
The research suggests that healthy hunger-free kids act of 2010, reverse progress efforts to the obesity epidemic can help recent legislation, including the. The law increased financial support for the national school lunch program, offering free or reduced price meals to students with low income.
However, the researchers say that the law the affected by obesity can have a greater impact on the prevention of obesity in healthy children, instead of reducing obesity in children.
"It is not enough only to develop new, culturally relevant and effective treatment strategies focused on minority children be." "We the financial obstacles to these treatment strategies for children in households with low income, of which there are many racial / ethnic minorities, must reduce", says Lee.
Only ten States include offered obesity nutritional and behavioral therapy by programs such as Medicaid. Given the number of disadvantaged children, which are likely to be more obese, but is it important to say that this scheme for all authors available.
"The health care reform bill passed an important role in the cover for overweight children, can play in 2010 as requires it, new health plans to cover obesity screening and counseling for children," says Lee.
Source: University of Michigan health system
Articles from medical news today adapted from original press release.
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