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News in perspective Upfront THE practice of using free drug samples to treat some children in the US may be causing more harm than good. In many countries, doctors are allowed to obtain free samples of new drugs from companies so that they can familiarise themselves and their patients with them. Critics argue that this can divert prescribing away from the best clinical practice. A team led by Sarah Cutrona of the Cambridge Health Alliance in Massachusetts has now revealed the extent to which free drug samples are given to children in the US. In 2004, 4.9 per cent of the 10,295 children in a nationally representative survey were given at least one free drug sample (Pediatrics, DOI: 10.1542/ peds.2007-2928). Among the 15 drugs most frequently distributed were some with safety risks. These include stimulants to treat attention- deficit hyperactivity disorder that the US government lists as controlled substances because of their addictive potential. Also on the list are four drugs that have since been given new or revised “black box” warnings – labelling indicating safety concerns – including Elidel, a cream for eczema. Although the cause remains unknown, Elidel received a black box warning in 2006 after some patients developed cancer. Cutrona is concerned that safety issues often emerge only after drugs are put on the market. “Free samples tend to be newer medicines,” she says, so their risks may be poorly understood. In the US, free drugs are also seen as a means of getting needed medication to people who lack health insurance. Cutrona found that uninsured patients were more likely to receive free drugs when they visited their doctor, indicating that doctors were trying to give the free samples to their neediest patients. But because these patients made fewer visits, they were not more likely to receive free samples than insured children. A GRANT of $28 million to combat disease in African farm animals aims to save the livelihoods of some of the world’s poorest farmers. Currently, an estimated one-quarter of all livestock in the developing world die from preventable diseases each year. The grant was given to the Global Alliance for Livestock Veterinary Medicines (GALVmed), a non-profit UK agency, by the Bill and Melinda Gates Foundation and the UK Department for International Development. The first disease to be tackled is East Coast fever, which costs Africa $200 million every year. “African governments used to make a vaccine,” says Steve Sloan of GALVmed, but this stopped when many state veterinary services were dismantled during the 1990s debt crisis. GALVmed hopes to launch vaccines or drugs for six major livestock diseases by 2015. The list includes Rift Valley fever, which killed thousands of animals and hundreds of people in an outbreak in 2007, and is now spreading out of Africa. TOUGH PREP FOR MARS MISSION Astronauts should complete a punishing lunar endurance mission before NASA will dare attempt a human mission to Mars, says the agency’s boss, Mike Griffin. Astronauts would fly to the International Space Station for seven months, then go to the Moon, where they would land and have to survive for nine months to a year using only what they brought with them, says Griffin. Next, they would fly back to the ISS for another six months before coming home. “That’s all got to be done with no extra assistance,” Griffin told delegates at the International Astronautical Congress in Glasgow, UK, last week. “Unless we can do that experiment successfully, the first crew to go to Mars will not come back.” “I fully agree,” says Jean-Jacques Dordain, director general of the European Space Agency. “We need to know much more about how humans can use the resources in situ.” STEM CELLS FROM DOWN BELOW “Free samples tend to be newer medicines so risks may be poorly understood” Men may wince at the thought, but biopsies from human testicles have yielded stem cells that can be turned into virtually any cell in the body. The hope is that tissue created from stem cells derived from a patient’s testicles would not be rejected when implanted elsewhere in the body. What’s more, such cells would avoid the ethical concerns surrounding embryonic stem cells (ESCs), which have the same therapeutic potential. A team led by Thomas Skutella at the University of Tübingen in Germany harvested spermatogonial cells, which normally mature into sperm, from men and used a series of chemicals to turn them into various cell types (Nature, DOI: 10.1038/nature07404). ”We made them into skin, structures of the gut, cartilage, bone, muscle and neurons,” says Skutella. Taking cells from the testicles sounds painful, but Skutella says such biopsies are routine in men undergoing infertility treatment. “Skin biopsies might sound more acceptable, but it hurts just as much as from the testes,” he says. In 2006, it was shown that mouse spermatogonial cells are ESC-like. Skutella’s corresponding feat in humans is “a home run” that “bypasses the ethical and immunological problems associated with ESCs”, says Robert Lanza, a stem-cell specialist at Advanced Cell Technology in Worcester, Massachusetts. Other researchers caution that more work is needed, as Skutella’s cells do not express all the molecular markers associated with ESCs. “They are not identical to embryonic stem cells,” says Austin Smith of the Wellcome Trust Centre for Stem Cell Research at the University of Cambridge. PROFESSOR MIODRAG STOJKOVIC/SPL Who needs embryonic stem cells?Freebie drugs risk Farmyard funding 4 | NewScientist | 11 October 2008 www.newscientist.com

Testicles could replace embryos as stem cells sourcereplaced

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News in perspective

Upfront–

THE practice of using free drug samples to treat some children in the US may be causing more harm than good.

In many countries, doctors are allowed to obtain free samples of new drugs from companies so that they can familiarise themselves and their patients with them. Critics argue that this can divert prescribing away from the best clinical practice.

A team led by Sarah Cutrona of the Cambridge Health Alliance in Massachusetts has now revealed the extent to which free drug samples are given to children in the US. In 2004, 4.9 per cent of

the 10,295 children in a nationally representative survey were given at least one free drug sample (Pediatrics, DOI: 10.1542/peds.2007-2928).

Among the 15 drugs most frequently distributed were some with safety risks. These include

stimulants to treat attention-deficit hyperactivity disorder that the US government lists as controlled substances because of their addictive potential. Also on the list are four drugs that have since been given new or revised “black box” warnings – labelling indicating safety concerns – including Elidel, a cream for eczema. Although the cause remains unknown, Elidel received a black box warning in 2006 after some patients developed cancer.

Cutrona is concerned that safety issues often emerge only after drugs are put on the market. “Free samples tend to be newer medicines,” she says, so their risks may be poorly understood.

In the US, free drugs are also seen as a means of getting needed medication to people who lack health insurance. Cutrona found that uninsured patients were more likely to receive free drugs when they visited their doctor, indicating that doctors were trying to give the free samples to their neediest patients. But because these patients made fewer visits, they were not more likely to receive free samples than insured children.

A GRANT of $28 million to combat disease in African farm animals aims to save the livelihoods of some of the world’s poorest farmers. Currently, an estimated one-quarter of all livestock in the developing world die from preventable diseases each year.

The grant was given to the Global Alliance for Livestock Veterinary Medicines (GALVmed), a non-profit UK agency, by the Bill and Melinda Gates Foundation and the UK Department for International Development.

The first disease to be tackled is East Coast fever, which costs Africa $200 million every year. “African governments used to make a vaccine,” says Steve Sloan of GALVmed, but this stopped when many state veterinary services were dismantled during the 1990s debt crisis.

GALVmed hopes to launch vaccines or drugs for six major livestock diseases by 2015. The list includes Rift Valley fever, which killed thousands of animals and hundreds of people in an outbreak in 2007, and is now spreading out of Africa.

TOUGH PREP FOR MARS MISSION Astronauts should complete a punishing lunar endurance mission before NASA will dare attempt a human mission to Mars, says the agency’s boss, Mike Griffin.

Astronauts would fly to the International Space Station for seven months, then go to the Moon, where they would land and have to survive for nine months to a year using only what they brought with them, says Griffin. Next, they would fly back to the ISS for another six months before coming home.

“That’s all got to be done with no extra assistance,” Griffin told delegates at the International Astronautical Congress in Glasgow, UK, last week. “Unless we can do that experiment successfully, the first crew to go to Mars will not come back.”

“I fully agree,” says Jean-Jacques Dordain, director general of the European Space Agency. “We need to know much more about how humans can use the resources in situ.”

STEM CELLS FROM DOWN BELOW

“Free samples tend to be newer medicines so risks may be poorly understood”

Men may wince at the thought, but biopsies from human testicles have yielded stem cells that can be turned into virtually any cell in the body.

The hope is that tissue created from stem cells derived from a patient’s testicles would not be rejected when implanted elsewhere in the body. What’s more, such cells would avoid the ethical concerns surrounding embryonic stem cells (ESCs), which have the same therapeutic potential.

A team led by Thomas Skutella at the University of Tübingen in Germany harvested spermatogonial cells, which normally mature into sperm, from men and used a series of chemicals to turn them into various cell types (Nature, DOI: 10.1038/nature07404). ”We made them into skin, structures of the gut, cartilage, bone, muscle and neurons,” says Skutella.

Taking cells from the testicles sounds painful, but Skutella says such biopsies are routine in men undergoing infertility treatment. “Skin biopsies might sound more acceptable, but it hurts just as much as from the testes,” he says.

In 2006, it was shown that mouse spermatogonial cells are ESC-like . Skutella’s corresponding feat in humans is “a home run” that “bypasses the ethical and immunological problems associated with ESCs”, says Robert Lanza, a stem-cell specialist at Advanced Cell Technology in Worcester, Massachusetts.

Other researchers caution that more work is needed, as Skutella’s cells do not express all the molecular markers associated with ESCs. “They are not identical to embryonic stem cells,” says Austin Smith of the Wellcome Trust Centre for Stem Cell Research at the University of Cambridge.

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–Who needs embryonic stem cells?–

Freebie drugs risk Farmyard funding

4 | NewScientist | 11 October 2008 www.newscientist.com