Sikh history written with blood

Sikh history

Duchenne muscular dystrophy.

 Duchenne muscular dystrophy. 

'Right-to-try' for the terminally ill

WASHINGTON — Fifteen-year old Austin Leclaire and his brother Max, 12, of Pembroke, Mass., share the deadly degenerative diseaseBut over the course of the past 144 weeks, the boys' physical conditions have progressed in opposite directions.
Max has regained functions — he has abandoned his wheelchair and can now run, tote his own backpack to school and even ride a bike. Austin's capabilities are diminishing. He cannot walk at all, and he's lost the ability to brush his teeth or hold a water bottle. He expects that soon he won't be able to play drums anymore, one of his few remaining physical pleasures.
The difference in their trajectories is that Max has been in a clinical trial for nearly three years, during which he has been given weekly infusions of the experimental drug eteplirsen, manufactured by Sarepta Therapeutics Inc. Austin was deemed unqualified to get the drug because of his more advanced condition.
Withholding experimental drugs from the most gravely ill has fueled several states to pass so-called "right-to-try" legislation that would make these drugs available without Food and Drug Administration approval to terminally ill patients with no other options.
Some critics of the yearslong FDA drug approval process, with its requirement for multiple clinical trials, contend that it is much longer than it should be, thereby keeping some promising drugs from those who might benefit, particularly those, like Austin, with time running out. The Tufts Center for the Study of Drug Development says it normally takes 5 1/2 to 10 1/2 years for a drug to receive FDA approval.
Because of that, Colorado, Missouri and Louisiana all passed right-to-try legislation this year that would enable those with terminal illnesses and no other treatment options to secure investigational drugs after their first phase of clinical trials (there usually are at least three) before final FDA approval if the drug manufacturer is willing to provide them. Arizona voters will decide a similar measure in a referendum in November.
The legislation passed overwhelmingly and with bipartisan support, often after lawmakers heard anguished testimony from terminally ill patients or their families.
The laws would cut the FDA out of the process, at least in terms of an individual terminally ill patient. The decision would be left entirely in the hands of the patient, the doctor and the drug company.
Whether these laws would withstand a court challenge is an open question. Typically, state laws cannot supersede federal statutes. Even if the laws don't withstand a challenge, advocates say, they may serve a valuable service in spotlighting the issue.
"(A lawsuit) wouldn't be all bad news because it would further elevate this issue in the public arena and put pressure on Congress and the FDA to make this change and literally save thousands of lives every year," said Frank Burroughs, head of the Abigail Alliance for Better Access to Developmental Drugs, which he founded 13 years ago after his 21-year-old daughter died of cancer.
So far, only Colorado's law has taken effect, a little over a month ago. The Goldwater Institute, a conservative nonprofit that defends states' rights, created the model legislation for the new laws. While it has received word of interest, no patients have yet formally tried to receive an experimental drug under the new law, the institute said.
Under FDA rules for drug testing, Phase One, the first studies to use human subjects, is quite limited in the number of patient participants (typically 20 to 80, according to the FDA website on the drug approval process). This first step is intended to determine the drug's most frequent side effects and how the drug is metabolized and excreted.
If Phase One doesn't reveal unacceptable toxicity, the drug can be approved for Phase Two trials, where the emphasis is on testing the effectiveness of the drug. This stage can involve a few dozen to 300 patients. If the drug passes muster, it goes onto Phase Three, which gathers additional evidence on safety and effectiveness and involves from several hundred to 3,000 subjects.
In the Leclaire brothers' case, those selected for the trial had to still be ambulatory most of the time, but with the expectation that their walking days would end within a year, said Jenn McNary, the boys' mother. Max fell down occasionally, but he still didn't need the wheelchair most of the time. Austin no longer qualified.
So even as Austin has watched Max get stronger from the drug treatments, he wonders what motor skill he will lose next. And while he hopes s one day to earn degrees in mechanical engineering and zoology, he is aware that those with his condition rarely survive their 20s.
"I'm glad that Max has (the treatments), and he's proving that it does work, and I should have it, too," Austin said by phone from home. "But it's also unfair. ... I'm just really upset that the FDA won't approve the drug, and it's their fault that someone might die."
The FDA has taken no official position on the new laws. "While the agency is supportive of patients' access to experimental new treatments, the FDA believes that the drug approval process represents the best way to assure the development of safe and effective new medicines for patients," an FDA statement said.
Although there are already provisions in place that allow for expedited approval of drugs and to make certain experimental drugs available to individuals prior to final approval, the Goldwater Institute insists that even those procedures take too long for a person whose time is running out. "A lot of patients don't have five or six months" that those procedures take, said Victor Riches, a Goldwater spokesman.
The FDA said it receives about 550 applications a year from drug companies to supply drugs to individuals before final approval and agrees to nearly all of them.
But that doesn't account for patients who have been turned down by manufacturers, such as Holly Singh, a Texas second-grade teacher whose 14-month-old daughter, Harper, has spinal muscular dystrophy, which leaves her incapable of picking her head up, crawling or rolling over. Without help, her life expectancy is quite limited.
Singh applied to Isis Pharmaceuticals, developer of the promising drug, ISIS-SMN-rx, which is soon to enter Phase Three clinical testing, for early access to the drug. In turning down her request, Isis chairman Stan Crooke raised the possibility that granting it could have prolonged the overall testing program and delayed the drug's approval for other patients. He also said that all the safety concerns had not been fully addressed.
Singh's correspondence with Crooke demonstrates her desperation. She wrote, "What kind of mother would I be if I just told my child, 'I'm sorry that there's a drug, but unfortunately you can't have it. You just need to suffer a little while longer.' "
While sympathetic to the situation of individual patients, the pharmaceutical industry has been far from enthusiastic about the right-to-try laws.
"We have serious concerns with any approach to make investigational medicines available that seeks to bypass the oversight of the Food and Drug Administration and clinical trial process, which is not in the best interest of patients and public health," said Sascha Haverfield, vice president of scientific and regulatory affairs for the Pharmaceutical Research and Manufacturers of America. He suggested that medical providers, the pharmaceutical industry and FDA should seek ways to improve access to clinical trials.
Critics of the new laws contend that Phase One trials are too limited to assure that a drug can be safely used. "Safety (in Phase One) is tested in only the crudest way you can imagine, making sure it doesn't kill people," said David Gorski, an associate professor of surgery at Wayne State University and the editor of the Science-Based Medicine blog, which has been critical of right-to-try laws. Even for terminally ill patients, Gorski argues, the risks are too great based solely on Phase One trials.
"They say it couldn't get any worse." Gorski said. "Well, yes, it can get worse. If there's anything worse than dying of a terminal disease, it's added suffering and potentially cutting the time you have left."
According to a January article in the journal Nature Biotechnology, only 16 percent of investigational drugs that complete Phase One clinical trials ultimately gain FDA approval.
Still, patients and families say they feel that they should be free to take the chance given that the alternative is death. "I should be able to take the risk of whether or not it would help," said Austin Leclaire. "It's my life."

Tallest tree (morphanki ) in amritsar

11 years old Tree
Person claiming it the tallest tree of its kind ( morpankhi )
in amrtsar .Height 20.5 ft from ground .N.G.Avenue , Amritsar

Art of young punjab

healthy diet

Fun fun food

Water melon with no loss of vitamins ,

You use this water melon skull for display of salads .

Try Pickles on Dinnig table preserved in the skull covered for at least 1 hour .

Try boiled Pulses and cereals like Grams (black.white ) , Dals , eat Indian Chat in it

Graze thin layers of  white part of the water melon skull ,pour vinegar in the skull to dip the pieces only wait for 15 mins and eat it with breakfast , lunch , dinner . You will like it

Try this at home and Restaurant owners for biz

Chennai Gold Rates

gold rates

Hangover

FIFA WORLD CUP

FIFA WORLD CUP

Brazil Vs Mexico - Wed 18 Jun, 12:30 am

Cameron Vs Brazil Tue 24 Jun, 1:30 am

Domain for sale

Domain for sale 

Domain Fot Sale

This Domain Is for sale

www.quicr.in
For sale $ 15000 
Quality visitors 
Contact : Amritpal singh
Cell No.: 9256049541

Trace of another world on moon

Trace of another world found on Moon

Researchers have found evidence of the world that crashed into the Earth billions of years ago to form the Moon.

Analysis of lunar rock brought back by Apollo astronauts shows traces of the "planet" called Theia.

The researchers claim that their discovery confirms the theory that the Moon was created by just such a cataclysmic collision.

The study has been published in the journal Science.

The accepted theory since the 1980s is that the Moon arose as a result of a collision between the Earth and Theia 4.5bn years ago.

Theia was named after a goddess in Greek mythology who was said to be the mother Selene the goddess of the Moon. It is thought to have disintegrated on impact with the resulting debris mingling with that from the Earth and coalescing into the Moon.

It is the simplest explanation, and fits in well with computer simulations. The main drawback with the theory is that no one had found any evidence of Theia in lunar rock samples.

Earlier analyses had shown Moon rock to have originated entirely from the Earth whereas computer simulations had shown that the Moon ought to have been mostly derived from Theia

Alien origin

Now a more refined analysis of Moon rock has found evidence of material thought to have an alien origin.

According to the lead researcher, Dr Daniel Herwartz, from the University of Goettingen, no one has found definitive evidence for the collision theory, until now.

"It was getting to the stage where some people were suggesting that the collision had not taken place," he told BBC News.
"But we have now discovered small differences between the Earth and the Moon. This confirms the giant impact hypothesis."
But the difference, some say, could be explained by material absorbed by the Earth after the Moon formed.
And Prof Alex Halliday of Oxford University, is among many scientists who are surprised at the difference between the Theian material found in the Moon rock and the Earth is so small.
"What you are looking for is a much bigger difference, because that is what the rest of the Solar System looks like based on meteorite measurements," he said.
Dr Herwartz measured the difference in what is called the isotopic composition of the oxygen contained in rocks on Earth and Moon rock. This is the ratio of different forms of oxygen.
Studies of meteorites from Mars and the outer solar system show that these ratios are markedly different - rather like a fingerprint. So Prof Halliday and others are puzzled by the fact that the fingerprints of Earth and Theia seem almost identical.

Similar composition

One possibility is that Theia was formed very close the Earth and so had a similar composition. If that was the case it raises the possibility that the assumption that each planet in the current Solar System has a markedly different fingerprint that needs to be revisited, according to Prof Halliday.
"It raises the question of how well the meteorites from Mars and the asteroid belt in the outer Solar System is representative of the inner Solar System? We do not have samples from Mercury or Venus.
"They may well be similar to the Earth. If that is the case then all the arguments over the similarities of the Earth and the Moon fall away," he told BBC News.
Dr Mahesh Anand from The Open University described the research as "exciting" but noted that the data was from just three lunar rock samples.
"We have to be cautious about representativeness of these rocks of the entire Moon, and so further analysis of a variety of lunar rocks is required for further confirmation," he said.
Other theories have been proposed to explain why the composition of the Earth and Moon are so similar: one is that the Earth spun much faster before impact, another is that Theia was much larger than current models suggest.
An alternative, controversial, theory proposed by Prof Rob de Meijer of Groningen University in the Netherlands was that the Earth's crust and mantle was blown into space by an accumulation of nuclear material 2,900km (1,800 miles) below the surface. It was this debris that clumped together to form the Moon.
He told BBC News that the new finding - demonstrating that there was a difference in
the composition of the Earth and the Moon - did not change his view.

"The difference is too small," he said. "We don't know how the Moon was formed. What we need are manned missions to the Moon and a search for rocks deeper under the lunar surface, that have not been polluted by meteorite impacts and the solar wind." 

Bhai Amritpal singhji

Missed call to 1800 30 000 press 123

Indian prime minister Narendra Modi is set up for the gear up india to prosperity .