Cough medicine ingredient to get safety probe

FDA panel to look at potential risks, benefits of dextromethorphan

WASHINGTON - Health regulators are concerned about the potential for people to abuse a key ingredient in many cough suppressant medications, calling for a public meeting in September to weigh the issue.

The U.S. Food and Drug Administration said on Monday it would call on a panel of outside advisers to look at the potential risks and benefits of the drug dextromethorphan, used in cough medicines made by Pfizer Inc and Procter & Gamble Co, among others.

Cough medicines have been under FDA scrutiny for the last few years, especially their use in children. The agency has said they should not be used in children 2 and younger, while manufacturers have urged against their use in children under 4.

 

Gene map of anti-malaria plant could boost supply

Global supply of a key, plant-based, anti-malaria drug is set to be boosted by a genetic study, scientists say.

Researchers have mapped the genes of Artemisia annua to allow selection of high-yield varieties.

The study, published in the journal Science, aims to make growing the plant more profitable for farmers.

"It's a major milestone for the development of this crop," Professor Ian Graham from the University of York in the UK told BBC News.

Short supply

The research has been welcomed by Dr Chris Drakeley, director of the Malaria Centre at the London School of Hygiene and Tropical Medicine. "Anything that enables an increased yield of product from something like Artemisia annua is a major step.

"This is the first line anti-malarial in nearly all endemic countries at the moment and supplies can be limited."

Artemisinin combination therapies, or ATCs, are used widely to treat malaria and are seen as the best solution to the parasite's increasing resistance to anti-malarial drugs.

Professor Graham, who led the study, hopes that new higher yielding and more robust varieties could increase global supply of the malaria treatment within three years.

"Our aim is to have hybrid seeds that can be released to farmers in the developing world by 2011 or 2012. With a year lag for planting, this would have an impact on supply in 2012 or 2013."

"We have to wait six to eight months from putting the seed in the ground to harvesting the crop and seeing how it has performed."

Dr Drakeley hopes the new varieties will become available quickly.

"This will allow an increase in the basic compound that forms ATC therapies. If they can get these seeds out in the timeframe they're talking about it'll be a major advance," he said.

Professor Graham explains how the project works

To identify the best plants for hybrid seed production, researchers measured characteristics of individual plants, for example, the number of artemisinin producing glands on the leaf. They also performed tests to find the plants with the best genetic make-up.

The resulting seeds are being planted in field trials in China, East Africa, India and Madagascar. "We are expecting to end up with not just one hybrid.

Leaf gland which produces artemisinin

"Ideally we would like good hybrids for east Africa and good hybrids for India etc.," explained Professor Graham.

The study is the culmination of three years work funded by the Bill and Melinda Gates Foundation and the genetic maps and markers the researchers have identified will be made available for free all over the world.

"All the information and tools we've developed in this work are free for people to use for the charitable purpose," Professor Graham told BBC News.

"We're also working with seed producers so they can produce the seeds as cheaply as possible for the developing world."

Window of time

Scientists hope a better supply of the drug might also help with the problem of fake drugs being distributed.

Some treatments being sold have been found to have no drug content or to be substandard in quality. This can make them fatal or they can be more likely to encourage resistance rather than combat the disease.

"Hopefully, if the final product is easier and cheaper to procure after this development, it might lessen the production of counterfeit drugs," said Dr Drakeley.

Professor Graham believes that the development of drug resistance by the malaria parasite has made the work more urgent.

"We have a window of time when we can use artemisinin effectively, and we want to have a stable, reliable supply that can be used in that window," he said.

No such thing as 'safe' cocaine, experts warn

The image of cocaine as a "safe party drug" is a myth that must be dispelled, say UK experts, as a study shows the drug is linked to 3% of sudden deaths.

The British Heart Foundation said the findings, published in the European Heart Journal, were a reminder that the drug can have devastating effects.

Although the data comes from south-west Spain, researchers said the results should apply to Europe in general.

They said anyone could suffer the deadly consequences of taking cocaine.

Fotini Rozakeas of the British Heart Foundation said: "The reality is that there are risks every time you use it.

"Cocaine can have devastating effects on the user including heart attacks, life-threatening heart rhythms, strokes and even sudden death.

"The potential deadly consequences from cocaine use can happen to anyone who takes it, even in previously young healthy people with no history of heart disease."

Deadly cocktail

In the study, 21 out of 668 sudden deaths were related to cocaine use and all of these occurred in men aged between 21 and 45.

Most involved problems with the heart and the majority of the men were also smokers and had been drinking alcohol at the same time as taking cocaine.

Lead researcher Dr Joaquin Lucena, of the Institute of Legal Medicine in Seville, said these habits added up to a lethal cocktail for the heart.

He said: "Our findings show that cocaine use causes adverse changes to the heart and arteries that then lead to sudden death."

His teams looked at post-mortem reports and investigated all the circumstances surrounding sudden deaths in Seville between 2003 and 2006.

Their findings suggested any amount of the drug could be toxic.

"Some patients have poor outcomes with relatively low blood concentrations, whereas others tolerate large quantities without consequences," they told the European Heart Journal.

Death row Briton's daughter says he is 'mentally ill'

The daughter of a British man due to be executed in China for drug smuggling has said her father was "mentally ill" and deserved to be spared.

Leila Horsnell said her father Akmal Shaikh, 53, from London, had always behaved in "extreme" ways.
Mr Shaikh has denied knowledge of the 4kg of heroin found with him in 2007.
Gordon Brown has called for clemency but Mr Shaikh's final appeal was turned down this week and he is due to be executed on 29 December.
His defence team has said Mr Shaikh suffers from bipolar disorder and did not know what he was doing.
They say he was duped by a criminal gang into carrying a suitcase that did not belong to him.

There would be times he would have extravagant ideas. Then there were times when he would be extremely religious Leila Horsnell

His daughter said he was approached by drug smugglers in Poland and they convinced him they would make him a popstar in China.
"They recorded a song, and he can't sing, and the song itself is very very bizarre, but they convinced him that they're going to take him to the clubs in China and make him a huge popstar," said Ms Horsnell.
"He just believed he could do anything, and he could achieve anything, and if somebody had said to him that he could become a popstar, I believe he genuinely thought that."
'Extravagant ideas'
She told BBC Radio 4's Today programme there were "a lot of different sides" to her "charismatic" and "delusional" father.
"There would be times he would have extravagant ideas, he could open an airline," she added. "Then there were times when he would be extremely religious and wanting us to lead a secluded life."

The Chinese law is actually pretty careful about mental health issues Professor Christopher Stone

She insisted her father would never do anything criminal willingly and called on the Chinese authorities to take his mental health problems into account.
Mr Shaikh was arrested in September 2007 in Urumqi, north-west China.
The Chinese foreign ministry said the "grave crime" had been handled in accordance with the law.
China's Supreme People's Court denied his final appeal on Monday. He is set to become the first EU national to be executed in China in 50 years.
'Hugely popular'
Chinese death penalty expert Professor Christopher Stone told the BBC the death sentence was "heavily used" in China but the exact figures were a "state secret".
Prof Stone, of Harvard University, said estimates over the past five years reached a height of about 10,000 death sentences a year, but a "genuine reform process" had brought the figures down.
He said death sentences were handed down for various crimes including murder, corruption and drug trafficking.

China does not react well usually to pressure from outside Jonathan Fenby

The death sentence was "hugely popular" in China and had the support of between 80-95% of the population, he said.
Prof Stone said the authorities would not want to be seen to make an exception for a foreign man but the issue of mental illness was an important consideration in Chinese law.
"The Chinese law is actually pretty careful about mental health issues," he said. "They have special dispensations, special rights, greater right to counsel.
"In this case, the issue of mental illness seems not to have been raised until after the trial was over and the death sentence had been handed down."
'Behave themselves'
Jonathan Fenby, China director at the research service Trusted Sources, said the chances of a reprieve were "small" and there was a "whole pattern at the moment" of China playing "things fairly tough".
"China does not react well usually to pressure from outside," he said. "The Chinese would see this as an interference with their internal affairs, which is the thing they are most resistant to."
Amnesty International counted 1,700 executions last year, he said, but about 6,000 prisoners were actually condemned to death, with many sentences suspended for several years.
"If they are thought to have behaved themselves or ingratiated themselves in various ways with the authorities, the execution is not carried out but that's usually in semi-political cases," he said.
Reprieve, which campaigns for fair trials and promotes human rights, has been working with Mr Shaikh and his legal team.
It has called on the prime minister to "speak directly" to the Chinese president.
A Downing Street spokesman said on Tuesday: "The prime minister and foreign secretary have raised Akmal Shaikh's case with China's leaders on many occasions.
"Yesterday the prime minister wrote to express his dismay that Akmal Shaikh's sentence has been upheld by the Supreme People's Court."