Painkillers not as addictive as feared: study

NEW YORK (Reuters Health) – Fewer than five percent of patients prescribed narcotics to treat chronic pain become addicted to the drugs, according to a new analysis of past research.

The finding suggests that concerns about the risk of becoming addicted to prescription painkillers might be “overblown,” said addiction specialist Dr. Michael Fleming at Northwestern University’s Feinberg School of Medicine.

“If you’re a person that doesn’t have a history of addiction and doesn’t have any major psychiatric problems, narcotics are relatively safe as long as your doctor doesn’t give you too much and uses the right medication,” Fleming, who was not involved in the new study, told Reuters Health.

Some recent research has concluded the same thing, but another expert remained skeptical about the new report because many of the studies it included were not considered the best quality research, and they varied widely in their results.

“I think the jury’s still out” on how worrisome prescription opioid addiction is, said Joseph Boscarino of the Geisinger Clinic in Danville, Pennsylvania, who studies pain and addiction.

Opioid painkillers, which include oxycodone, fentanyl and morphine, have only recently become available for patients with chronic pain, said Boscarino, who was not part of the new study.

In the past, the drugs were almost exclusively reserved for cancer patients and people with short-term pain – on the theory that in the first category of patients the need outweighed the risk, and in the second group, short term use was unlikely to lead to long-term addiction.

“They opened up (to chronic pain patients), and since then there’s been a wave of addiction, especially in the last five years,” Boscarino said.

One recent study found that the number of people diagnosed with a substance abuse problem increased by 70 percent from 2001 to 2009, and doctors suspect the increased popularity of prescription painkillers is a primary driver (see Reuters Health story of October 22, 2012).

Of course, not all these cases reflect patients who are using the drugs as directed – or who even have a prescription to treat chronic pain.

To get a sense of how addictive opioid painkillers are for those patients who do have a prescription, researchers from The Cochrane Collaboration, an independent group that reviews research on medications, collected the results from 17 studies covering more than 88,000 people.

All of the patients had been prescribed opioids to treat chronic pain, and nearly all of them had pain unrelated to cancer.

In 10 of the studies, patients used the painkillers for anywhere from three months to several years, while one study included just short-term use of several days and the others did not report the length of time patients were on the drugs.

Taken together, the studies found that 4.5 percent of people developed a dependency on the painkillers.

“It’s a low percentage,” said Dr. Silvia Minozzi, lead author of the study and a member of the Cochrane Drugs and Alcohol Group in Rome.

Although 4.5 percent was the most common rate of addiction among the studies, Minozzi pointed out there were large differences in the rates each study found – ranging from zero to 31 percent.

For instance, a study by Boscarino and his colleagues that was included in Minozzi’s review found that 25 percent of patients became addicted.

The group of patients Boscarino surveyed had a high rate of alcoholism and illegal drug use, though.

He said the disparities among the various studies could also be a result of how people were surveyed about their behaviors.

“We surveyed the patients about their pain in their homes (where) they were relaxed,” he said. “I think they were more inclined not to try to hide their symptoms.”

Minozzi’s review found that, among the three studies with information on substance abuse, people with a history of drug use were more likely than other patients to develop an addiction to their prescription pain pills.

For most people, addiction “does happen, but it’s not very common,” Fleming told Reuters Health. “But if you give a big bottle of Percocets to someone who has an addiction history, who may or may not be using cocaine and marijuana at the same time, they have pain and maybe they should be treated, but they’re much more likely to get into trouble with that.”

Knowing this can help physicians screen patients to judge who might be the most vulnerable to becoming addicted and get them into the appropriate interventions, he said.

Minozzi noted the fact that her review found a “deficiency of good-quality” studies on this subject, “seems to stand in contrast to the widespread concern of doctors and authorities relating to the prescription of opioids for pain.”

SOURCE: http://bit.ly/U0ye5P Addiction, online October 18, 2012.

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Canada will push to keep bank capital rules on schedule

OTTAWA (Reuters) – Canada will urge all countries to stick to the agreed schedule for implementing tougher bank capital rules at a November 4-5 meeting of finance ministers and central bankers from the Group of 20 nations, a senior finance ministry official said on Thursday.

The so-called Basel III rules are the world’s regulatory response to the financial crisis, forcing banks to triple the amount of basic capital they hold in a bid to avoid future taxpayer bailouts.

They were to be phased in from January 2013 but areas such as the United States and the European Union are not yet ready and U.S. and British supervisors have criticized them as too complex to work.

The Canadian official, who briefed reports ahead of the meeting on condition that he not be named, said it was imperative that the rules, the timelines and the principles behind them be respected and said Finance Minister Jim Flaherty would make that view known to his G20 colleagues.

Canada sees the European debt crisis as the biggest near-term risk to the global economy, and it also expects the U.S. debt crisis to be top of mind at the talks, the official said.

But the meeting takes place just before the U.S. presidential election and U.S. Treasury Secretary Timothy Geithner will be absent, so it remains unclear how much the G20 can pressure Washington on that front.

Some other countries have also scaled back their delegations, raising doubts about how meaningful the meeting will be.

The official dismissed that argument, saying high-level officials substituting for their ministers allowed for extremely important issues to be addressed anyway.

He said holding each country around the table accountable to its past commitments helped keep the momentum going toward resolving global economic problems.

(Reporting by Louise Egan; Writing by David Ljunggren; Editing by M.D. Golan)

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‘Assassin’s Creed’ stumbles on PlayStation Vita

There’s never been a video game heroine quite like Aveline de Grandpre.

The daughter of an African slave and a French shipping magnate in New Orleans at the end of French and Indian War, Aveline is the deadly but charming protagonist of “Assassin’s Creed III: Liberation” (Ubisoft, for the PlayStation Vita, $ 39.99). She seeks to fight injustice in and around the Big Easy as a member of the series’ secret order of assassins.

The hallmarks of the “Assassin’s Creed” franchise are all gloriously present here in hand-held form: traipsing across a jagged cityscape, dispatching foes with stealthy prowess and plotting against the clandestine group known as the Templars. “Liberation” doesn’t feel like a typical PlayStation Vita game — and that’s both its biggest strength and weakness.

Despite its name, there’s only a tenuous connection to “Assassin’s Creed III,” its sweeping console counterpart. That shouldn’t deter die-hard “Assassin’s Creed” fans from embodying Aveline, who’s armed with iconic hidden blades just like forerunners Altair and Ezio, as well as her own original weapons, such as a blowgun and a parasol loaded with poison darts.

Unlike her male predecessors, Aveline assumes different personas to achieve her aims. As an assassin, she can use all weapons and scale buildings; disguised as a slave, she can blend in with crowds and incite riots; and when dressed as a noble lady, she can awkwardly woo men. It’s an inventive touch, but one that frustratingly makes Aveline always feel handicapped.

Most of “Liberation” takes place in New Orleans, beginning in 1768 as a French colony through the American Revolution. For the most part, the game’s story, setting, combat and characters all work remarkably well given the constraints of the platform, and there’s a plethora of side quests, business pursuits and a multiplayer mode to keep things interesting.

With missions focusing on freeing slaves and rioting against Spanish soldiers, “Liberation” doesn’t shy away from the harsh realities of American history in the South. It’s refreshing to see a video game deal with such serious issues while maintaining a sense of adventure. That alone should be enough for Vita owners to give this historical action title a try.

Unfortunately, “Liberation” is too big for its britches. It’s difficult not to wonder how more effective the game could have been if the developers didn’t bend over backward in an effort to replicate the console experience, especially after playing through a smaller section of “Liberation” that’s set outside Louisiana and ultimately proved to be more fun.

The lamest part of “Liberation” is definitely the most unnecessary, namely, using the Vita’s unique control scheme for actions like opening letters by swiping both touchscreens or revealing secret maps by pointing the rear camera toward a bright light. Such novel gimmicks wouldn’t be so disastrous if they consistently worked and weren’t repeated several times.

There are other glitches, too. Some wobbly graphics, disappearing characters, audio dropouts and other assorted bugs mark “Liberation” as a less polished “Assassin’s Creed” experience. Despite the game’s very daring ambitions, Aveline — and “Assassin’s Creed” fans — deserve more than “Liberation” is able to truly deliver on the Vita. Two stars out of four.

___

Online:

http://assassinscreed.ubi.com/

___

Follow AP Entertainment Writer Derrik J. Lang on Twitter at http://www.twitter.com/derrikjlang .

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Judge throws out lawsuit against Britney Spears and parents

LOS ANGELES (Reuters) – A Los Angeles judge on Thursday dismissed a lawsuit by the one-time confidante of pop star Britney Spears, ruling there was insufficient evidence to go forward with the trial on allegations of defamation, assault and breach of contract.

“I really thought long and hard. It’s the right thing to do, so I am going to do it,” Los Angeles Superior Court Judge Suzanne Bruguera said, announcing her decision to throw out the case after hearing two weeks of evidence in the civil trial.

Bruguera’s ruling was a major victory for Spears and her family, despite damaging and sometimes humiliating testimony that lifted the lid on the singer’s controversial career and personal meltdown five years ago.

Sam Lutfi, the self-styled manager of the pop star for a brief period in 2007 and early 2008, had sued Spears’ mother, Lynne Spears, for defaming him in her 2008 book “Through the Storm.” Lynne Spears wrote that Lutfi controlled her daughter, cut her telephone lines and tried to cut the star off from her family.

Bruguera also dismissed claims filed by Lutfi against Spears. He said the singer hired him as her manager after they met in a nightclub in 2007, and he was entitled to a portion of her earnings.

Lutfi case against Spears’ father, Jamie Spears, was also thrown out. Lutfi alleged that Jamie Spears punched him in 2008 while the singer was in a Los Angeles psychiatric ward.

Lutfi, 38, said he would appeal the ruling.

Spears, 30, has since staged a comeback with world tours, hit albums and a new job as judge on Fox’s TV talent show “The X-Factor.” She did not attend the trial.

In testimony last week, Lutfi sobbed on the witness stand, saying he received death threats because of the villainous portrayal of him in the book. He also claimed he tried to get Spears off drugs and protect her from paparazzi photographers who hounded her day and night.

His most sensational claim was that Spears shaved her head in February 2007 because she feared her hair could be tested for drug use in her bitter child custody battle with ex-husband Kevin Federline.

Lutfi also told the court that he brought drug-sniffing dogs to her home and flushed a bag of white powder down the toilet.

Jamie Spears’ attorney told the court that his client was afraid that his daughter would die from drug abuse and believed that Lutfi was making her problems worse.

Lynne Spears testified that Lutfi crushed up drugs and put them into the singer’s food to help her sleep.

Spears’ meltdown led to her father’s conservatorship, which gives him legal control over her finances and health.

(Editing by Jill Serjeant and Stacey Joyce)

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UK cost agency backs melanoma drugs after price cuts

LONDON (Reuters) – Two new drugs for skin cancer have been recommended for use on Britain’s state-run health service after the rival manufacturers – Roche and Bristol-Myers Squibb – agreed to cut their prices.

The move underscores the growing pressure on drug companies to cut deals with austerity-hit European governments in order to prove their expensive new medicines offer value for money.

The National Institute for Health and Clinical Excellence (NICE) said on Friday it had issued final draft guidance recommending both Roche’s Zelboraf and Bristol‘s Yervoy after the companies offered undisclosed discounts.

NICE, which determines if products should be used by the National Health Service (NHS), had initially rejected both medicines, despite acknowledging that they represented a breakthrough in treating melanoma.

The list price for Zelboraf, which is only suitable for patients with a particular genetic profile, is 52,500 pounds ($ 84,600) for an average treatment span of seven months.

The price of a four-dose course of Yervoy, which is recommended only for people who have received prior chemotherapy, is 75,000 pounds.

($ 1 = 0.6207 British pounds)

(Reporting by Ben Hirschler; Editing by Mark Potter)

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New York state asks Washington to cover all storm costs

NEW YORK/WASHINGTON (Reuters) – New York state on Wednesday asked the U.S. federal government to pay all the costs of cleaning up and repairing damage from massive storm Sandy that tore through the Northeast this week and crippled New York City.

Governor Andrew Cuomo said he is asking fellow Democrat, President Barack Obama, to pay 100 percent of the estimated $ 6 billion bill, at a time that state and local government budgets remain constrained by a weak economic recovery.

That would be a significant change from last year when the federal government covered about 75 percent of the $ 1.2 billion cost paid by New York to clean up after storm Irene hit the region.

The two U.S. senators from neighboring New Jersey, the other state hit hardest by the storm, also asked that the federal government cover more than the usual share of the cost, given the size of the disaster and the financially strapped local coffers.

“Recent storms in New Jersey have already placed a significant burden on our state and local governments, which have been forced to pay for disaster response and will need federal assistance for recovery from Hurricane Sandy,” Senator Frank Lautenberg and Senator Robert Menendez, both Democrats, wrote in a letter to Obama.

“While we understand the federal share is typically 75 percent of these total costs, the unprecedented and extraordinary extent of damage Hurricane Sandy has caused to our state merits an adjustment to this cost-share to 90 to 100 percent federal coverage,” the two senators said.

New Jersey Governor Chris Christie, a Republican, did not reply to request of comments.

Obama and Christie toured storm-stricken parts of New Jersey on Wednesday, taking in scenes of flooded roads from the air and telling residents they were moving quickly to get them help.

‘WE CAN’T PRINT MONEY’

New York top finance official, Comptroller Thomas DiNapoli, said Washington should foot the bill, because of lingering financial pressures on state and local governments from the 2007-09 recession.

“I think the focus will have to be on Washington, for obvious reasons,” DiNapoli told Reuters in an interview.

“They have greater resources. They can print money; we can’t do that here. And given the fact this is not just a New York disaster, it’s really a national disaster, it’s probably for the federal government to step up and play a significant role.”

“The problem is the state is limited in its resource capacity. We just put out the mid-year report a week or two ago and it really showed tax revenues are down,” DiNapoli said.

Most U.S. states must balance their budgets, unlike the federal government, and it is up to Obama to decide if federal funds can cover all the costs.

“The president has the discretion to go higher. Seventy-five percent is a floor not a ceiling,” said Matt Mayer, a former senior official at the Department of Homeland Security.

If Obama accepts covering all the costs, this would be announced by Federal Emergency management Agency, Mayer said.

Former President George W. Bush allowed 100 percent reimbursement of costs in some states after Hurricane Katrina struck in 2005, Mayer, who worked at DHS during Bush’s presidency, told Reuters.

Cuomo said in a letter to Obama that “initial estimates project up to $ 6 billion in lost economic revenue in the greater metropolitan area and the state” due to disruption to business in the world’s financial hub.

Cuomo added that “the significant impact from Hurricane Sandy plainly warrants providing this assistance.”

The state, he said, was still battling multi-building fires, tunnel closures, and power outages at hospitals and other vital facilities. Plus there are destroyed homes and people needing shelter.

“Moreover, the cost to restore the complex electrically driven subway and rail transportation systems after total inundation from saltwater flooding will place a tremendous financial burden on New York state,” Cuomo said in the letter.

In New York alone nearly 2 million homes and businesses are still without power.

Cuomo said federal support is key to making sure state and local governments can respond effectively to the disaster.

New York state is rated AA by Standard and Poor’s and Aa2 by Moody’s and its outstanding debt is the second highest among states, after California.

(Additional reporting by Michael Connor in Miami; writing by Tiziana Barghini in New York; Editing by Mary Milliken and Bob Burgdorfer)

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Clinton calls for overhaul of Syrian opposition

ZAGREB (Reuters) – The United States called on Wednesday for an overhaul of Syria‘s opposition leadership, saying it was time to move beyond the Syrian National Council and bring in those “in the front lines fighting and dying”.

Secretary of State Hillary Clinton, signaling a more active stance by Washington in attempts to form a credible political opposition to Syrian President Bashar al-Assad, said a meeting next week in Qatar would be an opportunity to broaden the coalition against him.

“This cannot be an opposition represented by people who have many good attributes but who, in many instances, have not been inside Syria for 20, 30, 40 years,” she said during a visit to Croatia.

“There has to be a representation of those who are in the front lines fighting and dying today to obtain their freedom.”

Clinton’s comments represented a clear break with the Syrian National Council (SNC), a largely foreign-based group which has been among the most vocal proponents of international intervention in the Syrian conflict.

U.S. officials have privately expressed frustration with the SNC’s inability to come together with a coherent plan and with its lack of traction with the disparate internal groups which have waged the 19-month uprising against Assad’s government.

Senior members of the SNC, Free Syrian Army (FSA) and other rebel groups ended a meeting in Turkey on Wednesday and pledged to unite behind a transitional government in coming months.

“It’s been our divisions that have allowed the Assad forces to reach this point,” Ammar al-Wawi, a rebel commander, told Reuters after the talks outside Istanbul.

“We are united on toppling Assad. Everyone, including all the rebels, will gather under the transitional government.”

Mohammad Al-Haj Ali, a senior Syrian military defector, told a news conference after the meeting: “We are still facing some difficulties between the politicians and different opposition groups and the leaders of the Free Syrian Army on the ground.”

Clinton said it was important that the next rulers of Syria were both inclusive and committed to rejecting extremism.

“There needs to be an opposition that can speak to every segment and every geographic part of Syria. And we also need an opposition that will be on record strongly resisting the efforts by extremists to hijack the Syrian revolution,” she said.

Syria’s revolt has killed an estimated 32,000. A bomb near a Shi’ite shrine in a suburb of Damascus killed at least six more people on Wednesday, state media and opposition activists said.

NEW LEADERSHIP

The meeting next week in Qatar’s capital Doha represents a chance to forge a new leadership, Clinton said, adding the United States had helped to “smuggle out” representatives of internal Syrian opposition groups to a meeting in New York last month to argue their case for inclusion.

“We have recommended names and organizations that we believe should be included in any leadership structure,” she told a news conference.

“We’ve made it clear that the SNC can no longer be viewed as the visible leader of the opposition. They can be part of a larger opposition, but that opposition must include people from inside Syria and others who have a legitimate voice which must be heard.”

The United States and its allies have struggled for months to craft a credible opposition coalition.

U.S. President Barack Obama’s administration has said it is not providing arms to internal opponents of Assad and is limiting its aid to non-lethal humanitarian assistance.

It concedes, however, that some of its allies are providing lethal assistance – a fact that Assad’s chief backer Russia says shows western powers are intent on determining Syria’s future.

Russia and China have blocked three U.N. Security Council resolutions aimed at increasing pressure on the Assad government, leading the United States and its allies to say they could move beyond U.N. structures for their next steps.

Clinton said she regretted but was not surprised by the failure of the latest attempted ceasefire, called by international mediator Lakhdar Brahimi last Friday. Each side blamed the other for breaking the truce.

“The Assad regime did not suspend its use of advanced weaponry against the Syrian people for even one day,” she said.

“While we urge Special Envoy Brahimi to do whatever he can in Moscow and Beijing to convince them to change course and support a stronger U.N. action we cannot and will not wait for that.”

Clinton said the United States would continue to work with partners to increase sanctions on the Assad government and provide humanitarian assistance to those hit by the conflict.

(Additional reporting by Ayla Jean Yackley; editing by Andrew Roche)

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What’s New in the New, Slim IMac?

Apple‘s iMac, or all-in-one desktop Mac, has always had a flair for the dramatic. From the “transparent gumdrop” original, to the “Pixar lamp” model, through to today’s enormous flatscreens, it’s been perhaps the most distinctive desktop computer in each of its iterations.

Now, at the event where Apple introduced the new iPad Mini, it also refreshed its mainstream desktop Mac lineups. Both the Mac Mini and iMac got new models, each faster and more powerful than the previous year’s. But while the Mac Mini still looks basically the same, the iMac now cuts an incredibly slim profile, which Apple says is 5 millimeters thin at its edge.

It’s not as thin as it seems — it curves substantially towards the back, not that you’d be able to tell from most of the photos on Apple’s site. But it doesn’t just have its looks going for it.

Improved display

The iMac still doesn’t have a Retina Display; that honor went to the 13-inch MacBook Pro, the second Mac to get a screen so sharp you can’t discern individual pixels with your unaided eye. Apple claims that the iMac’s screen now features 75 percent glare reduction, however, as well as an IPS display for improved viewing angles. Finally, the screen is now flush with the glass, so that it looks like there’s nothing in between you and the picture.

No optical drive

The new iMac has an SDXC card slot, so you can plug in up to 64 GB digital camera memory cards. It also has two high-speed Thunderbolt ports, for attaching external displays and backup hard drives, as well as four USB ports. The slot-loading DVD drive, however, has been removed … so make room in the budget for an external drive, if you still need one.

Dramatically improved performance

It’s a cliche that each new generation of computers is faster, better, and smaller than the last these days. Apple provides concrete numbers and handy benchmarks, however: “up to 60 percent faster graphics,” for instance, and it says that they feature the new third-generation quad-core Intel Core processors. Obviously, how much faster it is than the last iMac will depend on the specs of each, but the high end is now much higher.

Fusion Drive

What about hard disk access speeds — the tightest bottleneck, when it comes to computer performance? One way to get around those is to use a solid-state drive, or SSD, which uses flash memory like on the iPad and is much faster than a magnetic hard disk. SSDs cost more, though, and don’t offer nearly as much storage space.

Apple’s solution to get around this is Fusion Drive, which pairs a smaller SSD with a 1 TB (or larger) hard disk. OS X and its core apps are preloaded on the faster SSD, and Fusion Drive automatically puts your most-used stuff on it as well. Expect this add-on option to be pricey, however; it costs $ 250 extra on the Mac Mini, and isn’t even available on the cheapest Mac Mini model.

Jared Spurbeck is an open-source software enthusiast, who uses an Android phone and an Ubuntu laptop PC. He has been writing about technology and electronics since 2008.

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Evan Rachel Wood marries “Billy Elliot” star Jamie Bell

LOS ANGELES (Reuters) – Hollywood actress Evan Rachel Wood has quietly married Briton Jamie Bell – star of the 2000 “Billy Elliot” dance movie – in a ceremony in California, Wood’s spokeswoman said on Wednesday.

“The bride wore a custom dress by Carolina Herrera. It was a small ceremony with close family and friends,” the spokeswoman said in a statement, adding that the wedding took place on Tuesday.

In a Twitter posting on Wednesday, Wood, best known for her roles in “The Wrestler” and coming of age movie “Thirteen,” said “Words cannot describe the happiness I am feeling. Overwhelming.”

Wood, 25, first began dating Bell about seven years ago. But the pair broke up and Wood went on to have a highly publicized engagement with heavy metal rocker Marilyn Manson, who is almost twice her age.

Wood and Bell, 26, were rumored to have become engaged in January this year, but never confirmed their relationship.

Bell found fame as the teen star of “Billy Elliot” about a ballet dancer growing up in a tough coal mining town in northern England. He won a British BAFTA award for the role and has since appeared in adventure movies like “The Eagle” and “Jumper.”

(Reporting By Jill Serjeant; Editing by Sandra Maler)

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Sanofi draws fire over cost of MS drug Lemtrada

PARIS (Reuters) – Medical journal The Lancet warned that Sanofi‘s experimental multiple sclerosis drug Lemtrada may be too costly for patients and health insurers once it gets approved by regulators.

The journal, which published the encouraging results of two late-stage Lemtrada tests on Thursday, also criticized the drugmaker’s decision to withdraw leukemia therapy Campath, the same drug given at a different dosage, depriving MS patients who had been using it off-label.

In an editorial accompanying the test results, The Lancet voiced concerns that Lemtrada would be priced higher than current MS drugs on the market and said the discontinuation of Campath may mean patients who had used it for MS would not be able to continue their treatment.

The injectable drug, chemically known as alemtuzumab, was sold until September 2012 under the name Campath as treatment for leukemia and given more frequently at a higher dosage.

“There is concern that with a license for multiple sclerosis, the cost of alemtuzumab could rise and might become too expensive for many patients and health systems,” the editorial said.

Although Campath remains available free of charge to leukemia patients, Sanofi’s rare disease unit Genzyme pulled it off the market in September to prevent its unauthorized use as an MS drug.

Analysts said the move would allow the company to adjust the price to match that of rival MS drugs on the market.

A full course of Campath, which in 2011 had sales of $ 76 million, cost around $ 60,000 when given three times a week for up to 12 weeks, according to Genzyme.

Lemtrada, instead, is given at less than half the dose of Campath for 5 consecutive days and then again for 3 days a year later. Since the drug has yet to be approved, it remains unclear how much Sanofi will charge for it.

The drug, which works by resetting a person’s immune system, has shown in late-stage trials to be an effective treatment for MS patients who have failed to respond to other therapies.

It has also shown to benefit people not previously treated for the disease, suggesting it could be used as a first-line MS therapy.

But patients need regular monitoring for serious side effects that can include infections and autoimmune diseases.

“It’s important that the appropriate safety monitoring is in place for patients who are prescribed Lemtrada,” Genzyme’s head of MS, Bill Sibold, told Reuters, responding to questions about the Lancet editorial. “Until an approved risk-management program is established, we believe the use of Lemtrada should only occur in clinical trials.”

Lemtrada remains available to patients who are taking part in clinical tests.

Sibold declined to discuss pricing plans for Lemtrada, but said Genzyme has set up programs to make its approved drugs available to patients who cannot afford them. “With Lemtrada it would be no different,” he said.

DRUG FUNDING

But there are concerns that cash-strapped European governments may balk at funding the drug through their public healthcare systems.

Doug Brown, Head of Biomedical Research at U.K. charity MS Society said that while Lemtrada’s results are great news for patients, the drug would only be useful to them if it were available through the country’s publicly funded National Health Service.

“We urge Genzyme to price the treatment responsibly so that if it’s licensed, it’s deemed cost effective on the NHS,” he said.

The U.K.’s cost-effectiveness body National Institute for Health and Clinical Excellence (NICE), whose opinions are also watched closely in other countries, initially rejected Novartis’ MS pill Gilenya, only to make a U-turn after the company agreed to a discounted price.

Sanofi launched its MS pill Aubagio in the U.S. at a price of $ 45,000 for a year’s treatment, making it cheaper than rivals.

Gilenya – the only other MS pill currently on the market – costs 28 percent more, while injectable treatments such as Biogen Idec Inc’s Avonex and Teva Pharmaceutical Industries Ltd’s Copaxone are 8 and 6.5 percent higher respectively.

(Reporting by Elena Berton; Editing by Tim Dobbyn)

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