The drug is chemically similar to GHB — the “date-rape” drug. Approving the drug for such a large patient population would risk flooding the streets with a [...]]]> A Food and Drug Administration (FDA) advisory panel on Friday significantly rejected the application of Jazz Pharmaceuticals for the approval of Xyrem (sodium oxybate) for the treatment of fibromyalgia.

The drug is chemically similar to GHB — the “date-rape” drug. Approving the drug for such a large patient population would risk flooding the streets with a pharmaceutical-grade version of the highly controlled substance.

“Sodium oxybate and GHB are the same thing,” said Lewis Nelson, MD, of the New York University School of Medicine, one of the FDA panelists. “This is much better than the stuff you get on the street, and that is the problem.”

The drug is only approved for the treatment of narcolepsy. It has been prescribed for 35,000 people since being introduced in 2002.

RISKY BUSINESS

Thomas Kosten, MD, of Baylor University, who loudly opposed approval, cited a lack of convincing evidence by Jazz that the risks involved in releasing the drug to such a large population were balanced by its effectiveness in treating fibromyalgia and narcolepsy, the two conditions for which the drug maker was seeking approvals.

“Without any data to show that this is better than existing medications, I think we are foolish to consider approving this drug,” Kosten said in the discussion immediately preceding the vote.

The panel’s vote contrasted with the FDA’s view of the data provided by Jazz, which included two studies measuring pain relief, and another that tested effectiveness as a sleep aid.

During a public comment period, the majority of speakers supported approval of the drug. Many of them had participated in the studies conducted by Jazz. They explained how much they had benefited from sodium oxybate after failing to respond to any of the three other drugs approved for fibromyalgia.

As many as half of all patients with fibromyalgia do not respond to available medications, according to Jon Russell, MD, director of the University Clinical Research Center at the University of Texas Health Science Center at San Antonio.

CONCERNS

FDA panelists were not convinced that the company had made enough of an effort to prove the drug’s effectiveness, nor did they have confidence in the company’s ability to monitor and manage the potential risks associated with sodium oxybate.

The panel said there was a lack of data concerning drug interactions for patients on multiple medications, as well as risks for people with multiple conditions. They also expressed concerns for the likelihood of misuse, and confusion over what the FDA calls the drug’s “unusual and complex dosing arrangement.”

But it was the link to GHB and the potential for abuse in the difficult-to-monitor market that drove the 20-2 vote.

If a drug needs to get on the market, there needs to be a mechanism in place to mitigate risk, which the panel clearly found lacking.

Via: redorbit.com

The police have also disclosed that [...]]]> HYDERABAD: The arrests on Thursday of two budding actors and a Nigerian national on charges of drug peddling had literally dissolved the sheen of Hyderabad being a drug-free city. In an alarming disclosure, the city police have announced that they had information about drugs being peddled in nine upmarket pubs.

The police have also disclosed that they had compiled a list of 60 people including entrepreneurs, film actors and students who are hooked onto drugs. The names of the drug-addicts have not been released, but Commissioner of Police A.K. Khan said, “We need to have material evidence. We will use decoy teams and nab them. Our aim is to catch them while being in possession of the drugs,” Mr. Khan told a press conference on Friday.

Belief shattered

The Commissioner painted a grim picture of Hyderabad, shattering the belief that the fifth largest metropolitan city in the country did not have an organised crime syndicate and that the drug menace was minimal. “We have information about pubs where drugs are laced with drinks and served to women. We also know of some pubs which lure customers by offering drugs.”

Via: hindu.com

Air New Zealand said earlier this month it was unhappy about the suppression of the names of the airline and pilot because it could unfairly implicate other airlines [...]]]> Pacific Blue has been identified as the employer of a commercial pilot fighting to get back his job after being sacked amid allegations of alcohol and drug abuse.

Air New Zealand said earlier this month it was unhappy about the suppression of the names of the airline and pilot because it could unfairly implicate other airlines and pilots.

Yesterday Employment Court Judge Tony Crouch granted an application by Pacific Blue to overturn an Employment Relations Authority ruling reinstating the pilot before the full hearing of his personal grievance case against the airline in October.

Judge Couch also lifted an ERA suppression order over the airline’s name. The name of the pilot remains suppressed.

The pilot was dismissed by the airline in May, after being suspended on full pay for almost a year. However, the ERA ordered the pilot reinstated in a non-flying capacity pending a hearing to decide whether he was fired unjustifiably.

Pacific Blue this week announced it was pulling out of the New Zealand domestic market.

Via: nzherald.co.nz

DEA will be collecting unused, expired and unwanted prescription drugs at sites around the country on Sept. 25. The pills will later be destroyed.

Steve Derr, special agent in charge of the DEA for New England, said [...]]]> BOSTON—The U.S. Drug Enforcement Administration has announced a nationwide prescription drug “take-back” initiative aimed at preventing pill abuse and theft.

DEA will be collecting unused, expired and unwanted prescription drugs at sites around the country on Sept. 25. The pills will later be destroyed.

Steve Derr, special agent in charge of the DEA for New England, said the free and anonymous program is an opportunity to get rid of unwanted medications before they can be abused, cause an accidental overdose or hurt the environment.

Via: boston.com

It is worth remembering, however, that drugs are not simply the [...]]]> Supporters of drug decriminalisation are mobilising en masse at present, attempting to force a radical overhaul of Britain’s drugs policy. Critics have lambasted current legislation for its role in increasing crime and damaging public health, promoting decriminalisation as the perfect tonic for curing society’s ills.

It is worth remembering, however, that drugs are not simply the scourge of the poor, nor is their usage restricted to estates and inner cities across the country.

Drugs blight lives across the social spectrum, with the class divide meaning little when it comes to the vice-like grip in which addiction holds countless Britons. Growing up in one of London’s most salubrious suburbs, my friends and I were exposed to drugs on a round-the-clock basis at times, despite seemingly having it all in terms of money and privilege.

Likewise, during my days in the Square Mile, a culture of excess and hedonism reigned, thanks to the narcissistic and self-indulgent nature of the City beast at whose altar we all worshipped. Largesse and greed coursed through the veins of market players across the board, and drugs and drink were two easy ways in which to satiate one’s lust for high living.

Drug abuse was a far less prominent phenomenon than excessive alcohol consumption, largely because of the ramifications for any trader or broker caught high during office hours. Three-hour, booze-fuelled lunches were the norm for bosses and subordinates alike, yet coke-connoisseurs such as myself and my friends had to restrict our intake to nocturnal gatherings for fear of the consequences of being caught. As such, our habits didn’t get even more out of control than they already were, and we were forced to self-regulate our consumption.

Grandiose ideas such as withdrawing benefits for drug users who refuse treatment for their addiction will have no impact on such “high-end” users, for whom money is no object when it comes to supporting their illicit habits. Similarly, the price of the product being consumed makes little difference to those with copious amounts of disposable income at hand: we brokers happily paid £50 a gram to satisfy our craving; we’d have just as gladly paid double or triple should market forces have demanded us to do so. Addicts cannot be simply priced or taxed out of their habits; instead, the onus should be on reducing demand via educational and psychological means.

I underwent just such a remedial process, which was wholly effective in getting me off drugs for good. Once I realised that there was far more to life than a perpetual cycle of money worship by day, hard drugs by night, and little to no structure past the next trade I put on or the next gram I scored, I was able to consign coke to my past and move onwards and upwards in terms of living a far more fulfilling life in which drugs played no part.

In an ideal world, both drugs and drink would be unnecessary evils for all citizens, and the issue of their legality neither here nor there. In the real world, however, there should be a concerted effort to keep drugs as far out of reach as possible, if only to prevent their further encroachment into previously safe terrain, whether that be a Bethnal Green council flat or a Bishops Avenue summer palace.

That the global war on drugs is not working is a sad fact of life, but throwing in the towel is not the answer. Moral positions should not get turned on their head just to satisfy short-termist lawmakers and lobbyists; instead, a more concerted effort must be made to stop disaffected citizens running into the welcoming arms of their local drug dealers.

Drug usage can be curtailed by effective education and provision of alternative pastimes – a strategy infinitely preferable to exposing society to an even headier cocktail of substances than are already on offer.

Via: guardian.co.uk

Officers stopped the vehicle on the M5 on Friday afternoon and discovered cannabis and an amount of powder – believed to be controlled drugs.

More suspected drugs were found when they searched an address [...]]]> Two people have been arrested after police stopped a car in Devon and found drugs inside with an estimated street value of £6,000.

Officers stopped the vehicle on the M5 on Friday afternoon and discovered cannabis and an amount of powder – believed to be controlled drugs.

More suspected drugs were found when they searched an address in east Devon.

A man from east Devon and a woman from Bristol, both 45, were arrested and bailed until 6 November.

Via: bbc.co.uk

The firm slashed the price of its hydrocortisone tablets, used to treat kidney patients, by £7.40 – saving the NHS almost £500,000 on [...]]]> A drugs company under scrutiny for increasing the price the NHS pays for lifesaving pills by 1,000 per cent in two years has dramatically cut its charges after a Mail on Sunday investigation.

The firm slashed the price of its hydrocortisone tablets, used to treat kidney patients, by £7.40 – saving the NHS almost £500,000 on its monthly drugs bill.

The company’s boss had claimed the NHS ‘doesn’t care what it costs’ when he was asked to explain the price increases passed on to the taxpayer.

The price cut came as the Department of Health admitted it does not police the cost of everyday medicines supplied to the NHS.
Despite claims of profiteering on some commonly prescribed drugs, civil servants said the department ‘does not regulate generic prices’.

The Mail on Sunday investigation revealed how some pharmaceutical companies were imposing huge price increases while earning massive profits. Drugs firm Auden McKenzie was charging £44.40 for a packet of its 10mg hydrocortisone tablets, but on Monday – the day after our investigation was published – the company wrote to wholesalers cutting the price to £37 with immediate effect.

The firm had increased the price of the tablets for the NHS from £5 in 2008 to a peak of £48 earlier this year – making it about £2.4 million a month.

Company boss Amit Patel, 35, whose personal wealth is said to exceed £40 million, claimed the price rises were needed to pay for his firm’s new multi-million-pound factory production line.

He refused to say where the factory was or give any further details and said the price of the drugs would ‘creep back down’ because the firm had recouped much of its outlay.

In a previous interview with The Mail on Sunday, he said: ‘Joe Public doesn’t know what it takes to . . . revive these old drugs. Quite rightly . . . the Government views medicine as public safety, so they don’t care what it costs.’

He added: ‘To be honest, they don’t care what it costs. You either meet their criteria or you don’t market the product.’

Last week, he issued a statement denying that he had claimed the ‘NHS doesn’t care what drugs cost’ and saying he ‘strenuously denies ever discussing the production costs of the drug’.

Questions to Auden McKenzie’s media advisers asking for the reasons for the reduction in the price of the tablets went unanswered yesterday.

Between 2007 and 2008, the firm’s turnover rose from £5.3 million to £10.6 million and its profits trebled to £6.2 million.

Details of its more recent accounts – which coincide with the increased price of hydrocortisone – are not available and are listed as overdue by Companies House.

Via: dailymail.co.uk

The UK’s breast cancer patients have 50 percent less chance of the drug Herceptin than elsewhere in Europe.

The report, commissioned by the Department of Health will put pressure on the Government [...]]]> London, July 26 (ANI): A new report is set to reveal that thousands of Britons are being denied access to drugs crucial in cancer treatments.

The UK’s breast cancer patients have 50 percent less chance of the drug Herceptin than elsewhere in Europe.

The report, commissioned by the Department of Health will put pressure on the Government to speed up plans for a 200 million pounds cancer fund that would allow patients to get access to new drugs not currently approved for NHS use.

“It is high time we had a review of access to new drugs. However, I doubt that the 200million pound cancer fund would make us as good as the best countries in the report. We would need around £billion to achieve that,” The Daily Express quoted leading cancer specialist Karol Sikora from Cancer Partners UK, as saying.

“Patients in the UK have poorer access to Alzheimer’s drugs, Multiple Sclerosis drugs and Rheumatoid Arthritis drugs too. It all needs to be looked at,” he added.

Allegedly, the National Institute for Health and Clinical Excellence or NICE has blocked a number of medicines, on grounds of cost, that can extend the lives of those battling more unusual forms of cancer.

NICE has restricted access to the bowel cancer drug Avastin, and Nexavar, the only treatment offering any chance of survival for patients with advanced liver cancer.

NICE agrees the drugs can alleviate symptoms but says the NHS cannot afford them.

The outcry against negative decisions has led to a review by NICE into a controversial decision to block one new bone marrow drug called Azacitidine.

One of the groups suffering most are 400 liver cancer patients denied Nexavar to shrink their tumours and give them the chance of potentially life-saving surgery.

Ian Beaumont, of Bowel Cancer UK, said that for some patients even a few months delay “means the difference between life and death.” (ANI)

Via: newstrackindia.com

The goal, he said, is to get users into treatment.

He said he has gotten little feedback from his colleagues, [...]]]> Utah voters have reacted enthusiastically to Sen. Orrin Hatch’s legislation to drug test the unemployed and those receiving other forms of government cash assistance, the Utah Republican told the Huffington Post after introducing his measure last week.

The goal, he said, is to get users into treatment.

He said he has gotten little feedback from his colleagues, however. Sens. Bob Bennett (R-Utah), Bob Corker (R-Tenn.) and Scott Brown (R-Mass.) all told HuffPost they don’t have an opinion yet on Hatch’s measure and will have to study the language.

Sen. Barbara Mikulski (D-Md.), meanwhile, has an opinion. “I think it’s a punitive attitude. Who’s going to pay for the test? What’s the point of the test? You know, why do you want to drug test people who have lost their job?” she wondered.

Hatch said the test would be paid for with money saved by not paying benefits. “Any monies left over would go to help the states with the drug testing and so forth, and if there’s any surplus it goes to pay off the deficit,” he said.

The idea of drug testing those on public assistance is not a new one, though policymakers have generally dismissed it as ineffectual.

Harold Pollack, the Helen Ross Professor of Social Service Administration at the University of Chicago, has studied the issue closely. He notes that the 1996 welfare reform already grants states broad discretion to drug test recipients, though Hatch’s measure would expand that to the unemployed. “Absent specific indications, my own research and work conducted by others suggests that population drug screening is unwise. The likely consequence is to stretch states’ already overburdened screening, assessment, and referral systems with large numbers of casual marijuana users,” he said. “In part, this pattern reflects a technological quirk: Urine tests more readily detect marijuana than they can detect other intoxicating substances. In part this pattern reflects the basic epidemiology of illicit drug use.”

A project in Michigan demonstrated that reality. “A decade ago, Michigan implemented mandatory testing in three welfare offices. Out of 258 new and continuing applicants tested, 21 tested positive for illicit substances. All but three of these women tested positive for marijuana only. In light of such experiences, few states have chosen to pursue similar efforts,” said Pollack.

Medical marijuana, meanwhile, is legal at the state level for nearly half the American population. Drug testing could punish patients who are legally following state law and their doctors’ recommendations.

Via:  huffingtonpost.com