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The Genes Battle

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Can genes, which are present in nature, be patented? A US court recently ruled that they cannot. The outcome may be cheaper diagnostic kits, says Hari Pulakkat
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It’s a debate that will continue for a few years, and the dust is unlikely to settle down even after that. Are human genes patentable? While the world slowly seemed to move towards a grudging acceptance of human gene patents, an American judge suddenly springs a surprise, ruling they aren’t valid, providing new hope for those campaigning against them. If the higher courts uphold this judgment, patients around the world could expect cheaper diagnostic tests soon.

To summarise, the American Civil Liberties Union and the Public Patent Foundation, two non-profit organisations, filed a lawsuit against Myriad Genetics, a biotech company based in Salt Lake City, Utah. Myriad, along with the University of Utah Research Foundation, is the holder of several patents on two breast cancer genes, BRCA1 and BRCA2. Myriad has developed tests for breast cancer susceptibility, and no one else can do those tests. Now Judge Robert Sweet of the New York District Court has ruled that some claims of the patents are invalid, thus opening the door for competitors.

The US and Europe have been allowing human gene patents for over two decades, and this is the first time a judge has questioned their validity. In the last two decades, the US Patent Office granted patents to over 4,300 genes, which is about 20 per cent of active human genes.

Diagnostic tests based on these patented genes are expensive, and not within the reach of many. In the US, for example, testing for breast cancer susceptibility can cost as much as $3,000 for a full analysis of both genes. “Many patients will benefit from this judgment,” says Mark Stoler, president of the American Society for Clinical Pathology. The judge himself noted that the tests cost less than $1,000 in Canada, where the genes are not patented.

On the other hand, several biotech companies have built business models around those, and raise money based on their gene patents. “Some biotech companies will now find it more difficult to raise money,” says Lisa Haile, partner of life sciences practice at DLA Piper, a large law firm. In fact, as a way of buttressing this fact, the shares of Myriad fell 9.2 per cent immediately after the judgment. Myriad’s revenues had increased almost 50 per cent last year, mostly owing to BRCA gene testing.

So a fierce battle is on between two factions. On one side are the life sciences industry, venture capitalalists and other investors in life sciences companies. On the other side are a large number of doctors, scientists, patients and non-profit organisations. Each has its arguments and supporting evidence. Although the second faction is unlikely to win in a superior court, its victory will have far-reaching impact on the life sciences industry and the future of medicine. “This is very likely to go to the Supreme Court,” says Haile. That would take at least two to four years, and what happens in the US is also a good pointer to what will happen later in other countries.

Opponents of gene patents have more than one argument against them. One of the first is, of course, the principle itself: genes are present in nature and thus cannot be patented. Myriad and others have argued what is patented is a unique DNA sequence isolated in a lab. Judge Sweet in his judgment says genes are genes, whether inside or outside the body. However, there are even stronger arguments against gene patenting. They push up medical costs, stifle innovation and prevent patients from taking a second opinion. It is not just the patients who have to pay Myriad; even scientists who work on the BRCA gene have to pay the company.

“Myriad is just one example,” says Stoler. “Around 5,000 new tests are likely to be developed in the next 10 years.” These tests will be based on genes, and indiscriminate patenting can make them unaffordable except to a small fraction of the world population. Some of these products will be built by a research foundation funded by the public, and hence won’t be the exclusive property of private companies. For example, the BRCA gene was discovered in the University of California Berkeley by Marie-Claire King, now at the University of Washington. King herself is known to be averse to gene patents.

On the other hand, the life sciences industry argues gene patents are no different from drug patents, and a 20-year exclusivity is a small price to pay for treatments and diagnostics that would not exist otherwise.

Even an unfavourable ruling by the Supreme Court is unlikely to stop innovation or patents, as the industry is trying to tell the world. Many diagnostic tests are on multiple genes, and products based on unique combinations of genes may be patentable, even if single genes themselves are not. In any case, the next four years will see some interesting battles.


Source:
The Telegraph (Kolkata,India)

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Nod Off to Take Off

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Your brain will function better after a good siesta, say researchers.

If you are a teacher and catch students napping in your class, fret not. The youngsters may not learn what you teach, but will certainly grasp the next lecture very well. This was the conclusion of some sleep researchers, unveiled at a recent meeting of the American Association for the Advancement of Science in San Diego. Napping during the day not only consolidates memory but also improves the brain. The activity is necessary not just for babies; it’s important for adults and old people too, say researchers.

Matthew Walker of the University of California in Berkeley investigated the effect of long afternoon naps on students’ learning ability. His team found that the more you remain awake during the day, the more the brain loses its ability to learn.

At the University of Arizona, professor of psychology Lynn Nadel and his team investigated the effect of napping on babies, and came to the same conclusion — babies learn to abstract better when they nap.

At the University of Pennsylvania School of Medicine, Marcos Frank found something more fundamental — the brain reorganises itself during sleep, and this reorganisation is essential to learning.

Together, neuroscientists are learning new facets of this seemingly passive activity. The brain does not switch off during sleep. In fact, it remains active, in a different way from when you are awake.

“Sleep is a far more complex activity than we thought,” says Walker. What his research shows now is that the brain has a limited short-term memory capacity, and it needs sleep to free up this space frequently by sending some facts to long-term memory. And it can perform this activity only during sleep. This much is now clear, but things get a bit murky after that.

Walker experimented with 40 volunteers, half of whom took a 90-minute nap in the afternoon. When the two teams learned things at noon and at 6pm, the team that did not nap performed much worse the second time.

“We chose a 90-minute nap to provide for a full sleep cycle,” says Walker. This cycle includes stages of rapid eye movement (REM) and non-REM sleep. REM is a dream state of sleep, and was long thought to be the most important phase of sleep. Non-REM sleep is in three stages — 1, 2 and deep sleep. Memory consolidation occurs during stage 2 non-REM sleep, which during the night constitutes 50 per cent of our sleep cycle.

You enter stage 2 non-REM sleep within 15 minutes of falling asleep, and the brain remains in this state for another 40-50 minutes. So for a nap to really enhance learning, it needs to last an hour.

“We do not know yet whether shorter naps are enough,” says Walker. The scientist also hints at another fascinating aspect of sleep — many older people are known to sleep less, and this could be one reason why they have poorer memories. We would know this in the future, when scientists investigate the mechanisms behind sleep and learning.

At the University of Arizona, Nadel and his team tried to investigate the effect of naps on 15-month-old babies. They created an artificial language, with nonsense sounds but having a close relationship structurally — like subject-verb agreement — with English. Like in the Berkeley experiment, babies in this exercise learned before and after naps. Those who napped were able to translate their previous learning to understand what they learned after the naps. In other words, they were able to generalise their knowledge of sentence structure to understand new phrases better.

What they found was slightly different from the Berkeley team’s finding but was equally important. If babies nap within a specific period after learning a new task, they learned to abstract better.

This kind of learning, the ability to detect patterns in a piece of information, is vital to learning many things in later life. Napping is effective only if it happens within four hours of learning. Babies thus need to nap to understand what they learn during the day.

While these are significant findings, Marcos Frank found something fundamental — the young brain grows more connections during sleep. Frank’s earlier research had indicated that the brain was fundamentally different during sleep from during wakefulness.

This difference is in aspects: electrochemical activity, proteins synthesised and biochemical activity. In early development, during the first five years of one’s life, this reorganisation during sleep becomes critical to its capabilities in later life. “We have some evidence that what happens during early years cannot be acquired in later life,” says Frank.

What this means is clear enough. Babies who are deprived of sleep can develop brains that are deficient. While this may not happen for healthy babies, many who suffer from sleep apnea — a disease where you wake up periodically — can have poorly-developed brains by adulthood.

However, while the research shows how important sleep is for our brains, we still do not know everything about this vital daily exercise. It still remains a puzzle, and hopefully the next few years will throw more light on it.

Source: The Telegraph (Kolkata, India)

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Health & Fitness

Keep Firm Muscle Tone with the Age

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Scientists have found and manipulated body chemistry linked to the aging of muscles, and were able to restore the ability of old human muscle to repair and rebuild itself.
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Importantly, the research also found evidence that aging muscles need to be kept in shape, because long periods of atrophy are more challenging to overcome. Older muscles do not respond as well to sudden bouts of exercise. And rather than building muscle, older people can instead generate scar tissue if they exercise after long periods of inactivity.

Previous studies have shown that adult muscle stem cells have a receptor called Notch, which triggers growth when activated. An enzyme called mitogen-activated protein kinase (MAPK) regulates Notch activity.

In the lab, the researchers cultured old human muscle and forced the activation of MAPK. The regenerative ability of the old muscle was significantly enhanced.

Resources:
Live Science September 30, 2009
EMBO Molecular Medicine September 30, 2009 [Epub ahead of Print]

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News on Health & Science

Babies Born During Pollen Season More Likely to Wheeze

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Newborns born during the high pollen and mould seasons, linked with the presence of allergens, are more likely to develop early symptoms  of asthma, suggests a new study.
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University of California, Berkeley (UC-B) researchers found that such children born in the high mould season, coinciding with the last quarter of the year, have three times the odds of developing wheezing, often an early sign of asthma, compared with those born at other times of the year.

The study may help shed light on why such babies appear to have a higher risk of eventually developing asthma than children born in the summer.

A 2008 study of birth and medical records found that babies born in autumn are at greater risk of later developing childhood asthma.

That study suggested an influence from early exposure to respiratory viruses, which is more common during the peak of cold and flu season.

“In our study, we took a different tack to understand the link between month of birth and asthma by considering ambient concentrations of fungal spores and pollen, which follow distinct seasonal patterns,” said Kim Harley, associate director at UC-B Centre for Children’s Environmental Health Research and co-author of the study.

The researchers examined 514 children born in 1999 and 2000 in California’s Salinas Valley, a region with mild, rainy winters and dry summers.

They identified 27 spore and 48 pollen groups in the study, recording the average daily concentrations for the groups that accounted for more than 3% of the total during the first three months of life for each child in the study.

The researchers found that babies born in autumn and winter have triple the odds of developing early wheezing, often a precursor to asthma, by 24 months of age, said an UC-B release.

The results were reported online in Thorax.

Sources:The Times Of India

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Positive thinking

Train That Brain

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The negative effect of poverty on the intellectual level of children can be reversed.

It may be a politically incorrect question to ask, but the answer may have profound implications for socio-economic development. How well can children from poor or uneducated families do in life? One could make the question even more incorrect, but at the least, equally relevant: what is the influence of children’s family backgrounds on their subsequent mental development? Research in the last few years has provided partial answers to the question, and they are deeply disturbing.

It now turns out that a child’s brain develops according to the stimulus it receives at home.
If you do not provide complex inputs, you do not get complex brains.

To give one example, the more sophisticated the language used at home, the better the chances of good brain development in the first 10 years of a child’s life.

To put it bluntly, if the parents are uneducated, the children can often end up with deficient brains by the age of 10, compared with children from more educated families. Is this the reason why poverty runs in many families through generations?

Scientists from the University of California, Berkeley, are conducting a set of experiments to understand the real nature of the problem. They put cameras in the dining rooms of families — rich and poor — to monitor dinner time conversation. They got children to their labs and tried to give them tasks and measure the brain response. Their initial finding: the brains of children from poor families often resemble that of stroke victims by the age of 10.

Research in other labs around the world corroborates this finding, while also providing explanations as well as solutions to the problem. Parents in poor families do not talk much to their children. “We hope that parents in poor families will at least talk to their children more than they do,” says Mark Kishiyama, psychologist at the University of California, Berkeley. But even if they do, their language is not complex enough. In fact, Adele Diamond, professor of psychiatry at the University of British Columbia, has shown that children in poor families hear 30 million fewer words by the time they are four years old.

Those with low socio-economic status perform poorly in language tests and long-term memory tests. Martha Farah, director at the Centre for Cognitive Neuroscience at the University of Pennsylvania, showed such differences two years ago. Enrico Mezzacappa at the Children’s Hospital in Boston also showed three years ago that low income children perform poorly in speed and accuracy in some problems when compared with those from higher income families. While common sense can attribute these differences to a lack of education and opportunities, neuroscientists suspected that some of these disparities stemmed from differences in the brain. There is now substantial proof for the differences of brain development in children.

The problem is in an area of the brain called the prefrontal cortex. This area is in the front part of the brain, just behind the forehead. The prefrontal cortex is the seat of problem solving and creativity. A deficient prefrontal cortex makes you poor at complex tasks and problem solving. The experiment now being conducted at the University of California at Berkeley has already shown that poor children have deficient prefrontal cortex, thus substantiating the research of Martha Farah. But we also know the reasons, and other research provides us with a means of solving the problem.

It is not just the lack of intellectual stimulus that interferes with brain development. Poor children are usually under high stress, and it is known that high stress interferes with brain development, by producing chemicals that destroy neurons. Another important factor is pollution: they are exposed to a higher amount of pollutants — lead in water is an example — than children in richer families. All these factors combine to work against the brains of poor children. No wonder, then, that poor children are often not able to measure up to their richer counterparts if they manage to enter institutions of higher learning.

However, science also provides us with a solution to the problem.
“The differences in the brain of children can be reversed with proper training,” says Tom Boyce, a developmental psychobiologist at the University of British Columbia. Neuroscientists are now discovering that the brain remains plastic well into old age. For example, in experiments performed at the University of California, San Francisco, scientists have taken old rats — with only a few weeks to live — and made their brains look young purely by providing more inputs.

There is now a booming industry in the West called the brain improvement industry. Some of their products provide mental exercises with visual and auditory inputs that can improve the brain even in old age. We can thus train young brains to be on a par with those of children from more privileged backgrounds, provided we recognise the problem first.

Sources: The Telegraph (Kolkata, India)

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