News (Updated June 12, 2011)

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Gilead receives Justice Department subpoena

Jun 10, 2011

(Reuters) - Gilead Sciences Inc, the leading maker of HIV drugs, said it received a subpoena for documents related to its manufacture, quality and distribution practices.

News of the subpoena, from the United States Attorney's Office for the Northern District of California, sent the drugmaker's shares down 2 percent to $39.39 in after-hours trading. The shares dipped 2.3 percent during the regular session.

The request applies to AIDS drugs Atripla, Emtriva, Truvada and Viread, hepatitis drug Hepsera, pulmonary hypertension drug Leitairis and an experimental fixed-dose combination of Truvada and Edurant.

Foster City, California-based Gilead , which brought in revenue of $7.95 billion in 2010, said it is cooperating in the civil and criminal investigation.

Company spokeswoman Cara Miller declined to provide further comment. Gilead said in September it received a warning from the U.S. Food and Drug Administration about manufacturing problems at the San Dimas , California , plant where many of its drugs are made.

The U.S. Attorney's Office did not respond to requests for comment.

Gilead has received two similar subpoenas --in December 2006 and August 2009 -- and both were resolved without penalty, said ISI Group analyst Mark Schoenebaum.

"It will likely take years for full resolution ... The worst-case outcome is likely a fine (which could be substantial, depending on the outcome)," he wrote in a note to investors.

(Reporting by Deena Beasley; editing by Robert MacMillan, Matthew Lewis and Andre Grenon)

 

Global move needed to battle cancer in poor countries

(AFP) – 7 June, 2011

CHICAGO — A broad international effort is needed to halt the rapid spread of cancer in poor and middle-income countries, leaders from world cancer organizations said at a meeting in Chicago .

The call for action came at the 47th annual conference of the American Society of Clinical Oncology (ASCO) held in Chicago . More than 30,000 researchers and representatives of pharmaceutical companies participated in the forum.

The officials called on President Barack Obama and other world leaders to take concrete action at a September meeting at the United Nations scheduled to focus on non-communicable diseases.

The September UN meeting "presents a monumental opportunity to put cancer on the global agenda," said Allen Lichter, the ASCO's chief executive officer.

"We urge world leaders to help save and improve the lives of millions of people living with cancer or at risk for the disease," Lichter said at a press conference.

The only previous UN meeting of this type was held in 2001 and focused on the spread of HIV/AIDS.

Lichter said that ASCO sent a letter co-signed by nearly 300,000 health care professionals to the White House on Monday asking Obama to participate in the UN meeting.

Cancer kills 7.6 million people worldwide each year, more than HIV/AIDS, malaria and tuberculosis combined, according to World Health Organization (WHO) figures.

A UN report concluded that the cancer rate will continue and rise and reach more than 20 million annual cases in 2030. Most of these new cases are expected to occur in low and middle-income countries.

As people in developing countries increasingly flock to polluted cities, smoke, and eat rich foods like those available in wealthy countries, their cancer rate has risen and is now similar to those in rich countries.

At the current rate, the number of cancer cases in these countries will surpass the number of cancer cases in developed countries by about 2015.

However there is a dearth of oncologists in poor and developing countries -- Ethiopia for example, population 80 million, has just one oncologist -- and those who do work there have limited access to the latest cancer treatments and early-detection tools.

The oncologists at the Chicago meeting were also trying to mobilize public attention for their their "World Cancer Declaration," which outlined 11 objectives they hope to achieve by 2020.

The goals, aimed at reducing levels of cancer, include sharp reductions in smoking, drinking alcohol, rates of obesity, and improvements in access to health care and universal vaccination programs for hepatitis B and human papillomavirus (HPV) aimed at preventing liver and uterine cancer.

The declaration has 230,000 signatures. Organizers hope they can obtain one million signatures by the time of the UN conference in September.

Copyright © 2011 AFP. All rights reserved.

 

Premature aging seen as issue for AIDS survivors

By LISA LEFF, 11 June, 2011

SAN FRANCISCO (AP) — Having survived the first and worst years of the AIDS epidemic, when he was losing three friends to the disease in a day and undergoing every primitive, toxic treatment that then existed, Peter Greene is grateful to be alive.

But a quarter-century after his own diagnosis, the former Mr. Gay Colorado, now 56, wrestles with vision impairment, bone density loss and other debilitating health problems he once assumed he wouldn't grow old enough to see.

"I survived all the big things, but now there is a new host of things. Liver problems. Kidney disease. It's like you are a 50-year-old in an 80-year-old body," Greene, a San Francisco travel agent, said. "I'm just afraid that this is not, regardless of what my non-HIV positive friends say, the typical aging process."

Even when AIDS still was almost always fatal, researchers predicted that people infected with HIV would be more prone to the cancers, neurological disorders and heart conditions that typically afflict the elderly. Thirty years after the first diagnoses, doctors are seeing these and other unanticipated signs of premature or "accelerated" aging in some long-term survivors.

Government-funded scientists are working to tease apart whether the memory loss, arthritis, renal failure and high blood pressure showing up in patients in their 40s and 50s are consequences of HIV, the drugs used to treat it or a cruel combination of both. With people over 50 expected to make up a majority of U.S. residents infected with the virus by 2015, there's some urgency to unraveling the "complex treatment challenges" HIV poses to older Americans, according to the National Institutes of Health.

"In those with long-term HIV infection, the persistent activation of immune cells by the virus likely increases the susceptibility of these individuals to inflammation-induced diseases and diminishes their capacity to fight certain diseases," the federal health agency's chiefs of infectious diseases, aging and AIDS research wrote, summing up the current state of knowledge on last September's National HIV/AIDS and Aging Awareness Day. "Coupled with the aging process, the extended exposure of these adults to both HIV and antiretroviral drugs appears to increase their risk of illness and death from cardiovascular, bone, kidney, liver and lung disease, as well as many cancers not associated directly with HIV infection."

In San Francisco, where already more than half of the 9,734 AIDS cases are in people 50 and over, University of California, San Francisco AIDS specialists are collaborating with geriatricians, pharmacists and nutritionists to develop treatment guidelines designed to help veterans of the disease cope with getting frail a decade or two ahead of schedule and to remain independent for as long as possible.

"Wouldn't it be helpful to be able to say, are you at high risk, low risk or moderate risk for progressing to dependency in the next five, the next 10 years, being less mobile, less able to be functional in the workplace. Are you going to be safe in your home, are you going to remember to take all those medications? How are they going to interact?" explained Dr. Malcolm John, who directs UCSF's HIV clinic. "All those questions need to be brought into the HIV field at a younger age."

Research so far suggests that HIV is not directly causing conditions that mimic old age, but hastens patients toward ailments to which they may have been genetically or environmentally predisposed. Plus, their immune systems are being weakened over time even when they are being successfully treated for AIDS, John said.

"That's probably true for a lot of these things. We aren't saying HIV's starting the problem, but it's added fuel on top," he said.

Stokes, a patient of John's who goes by only his last name, is a prime example. At 53, HIV-positive since 1985 and in substance abuse recovery for the last 11 years, he says he is happier than he ever has been. Yet the number of ailments for which he is being treated would be more commonly found in someone 30 years his senior: a condition called Ramsay Hunt syndrome that causes facial paralysis, a rare cartilage disorder for which he has undergone four ear surgeries, bone death in the hip and shoulder, deterioration of his heart muscle, osteoporosis and memory loss.

A specialist recently diagnosed a Kaposi's sarcoma spot on Stokes' ankle. Although the cancer is not life-threatening, the sight of young men disfigured by KS lesions was a harbinger of the early AIDS crisis, and its presence on his own body is unsettling.

At his therapy group for men with HIV, aging "comes up frequently," he said. "I say, 'Just think what we have come through to have a life today.'" At the same time, he acknowledges sometimes feeling self-conscious about his physical appearance and worries if "people are not attracted to me and unwilling to go the length of what it means to be with me, no matter how brilliant my mind or my zest for life."

Loneliness, financial worries and concerns about who will care for them and where can weigh on long-term AIDS survivors in the same way as all adults living in a society that values youth, Charles Emlet, a social work professor at the University of Washington, Tacoma, said.

As they get older and sicker, many feel "doubly stigmatized," he said. Some people who have lived with the virus for a long time have been getting by on private disability benefits that will run out when they turn 65, forcing them to move to less expensive locations or to consider turning to estranged family members. Like soldiers from a distant war, many lost partners and their closest friends to AIDS.

Such emotional side effects, combined with the physical toll of managing chronic health problems, put older AIDS patients at risk for depression. At the same time, Emlet has uncovered evidence that a majority of long-term survivors also share another trait that typically comes with advanced age: that is, the ability to draw strength from their difficult experiences.

"The older adults I've interviewed, many of them talk about how much it means to them to give back, to do something positive with the years they never expected to have," he said.

Peter Greene can relate to that. At times, like the days he is so exhausted he can't get out of bed or the pain from his multiple maladies is too intense, he asks himself "the Carrie Bradshaw question--are we really lucky to still be alive?"

As frightening and uncertain as this phase of AIDS is, he thinks he knows the answer.

"I've tried to make the time I have count, and really, now that I have the body of an 80-year-old, I probably have the wisdom of an 80-year-old as well, which counts for a lot," Greene said. "Everything becomes clear at the end of your life and in some ways, thinking you've been dying all these years, you get moments of clarity that I don't think everyone gets."

Copyright © 2011 The Associated Press.

 

Court says university, company co-owners of patent

(AP) – 12 June, 2011

WASHINGTON (AP) — Ownership of a patent for technology to detect HIV levels in patients' blood was correctly split between Stanford University and the pharmaceutical giant Roche, the Supreme Court ruled Monday.

By a 7-2 vote, the high court upheld a lower court's decision making the company and the university co-owners of a patent for technology in HIV test kits.

Stanford asserted it owned the technology because its discoverer worked there. The 1980 Bayh-Dole Act allows universities to retain rights to research funded by federal grants.

But Stanford researcher Mark Holodniy also signed a contract that gave Roche the patent to anything that resulted from their collaboration. The U.S. Circuit Court of Appeals for the Federal Circuit made Roche and Stanford co-owners, and the high court agreed.

"Nowhere in the Act are inventors expressly deprived of their interest in federally funded inventions," said Chief Justice John Roberts, who wrote the majority opinion.

Justices Stephen Breyer and Ruth Bader Ginsberg dissented.

"I cannot so easily accept the majority's conclusion — that the individual inventor can lawfully assign an invention (produced by public funds) to a third party, thereby taking that invention out from under the Bayh-Dole Act's restrictions, conditions and allocation rules," Breyer said.

The case is Stanford University v. Roche, 09-1159.

 


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