HELENA, Mont. (AP) -- A Montana man will not serve time in prison for his role distributing unapproved, misbranded and counterfeit cancer drugs to U.S. physicians after surrendering an estimated $4.5 million in cash and property purchased from the sale of illegal pharmaceuticals.
U.S. District Judge Dana Christensen on Friday sentenced Paul Daniel Bottomley, 48, to six months of house arrest and five years' probation after he pleaded guilty to misprision of a felony, meaning he failed to report a felony crime to authorities.
Federal prosecutors said Bottomley imported mislabeled and unapproved drugs for years, and was a contact for physicians who bought a fake version of the Roche cancer drug Avastin last year.
Prosecutors had asked for a one-year prison sentence for Bottomley, saying they wanted an example to deter others who might circumvent U.S. pharmaceutical regulations and put at risk patients who are looking for cheap drugs.
"Those like Bottomley, who ignore the law and circumvent the regulatory framework, are playing Russian roulette with the health of the American public," U.S. Attorney for Montana Mike Cotter said in a news conference after the sentencing in Missoula.
The judge sided with Bottomley's attorneys, who had asked for a probation sentence. Christensen cited Bottomley's cooperation with authorities in handing down the sentence.
FDA Office of Criminal Investigations director John Roth said all the fake Avastin has been accounted for and Bottomley's conviction is one of the final cases in an investigation into an underground distribution network of illegal pharmaceuticals.
Bottomley founded Montana Health Care Solutions in 2008 and illegally imported misbranded and unapproved cancer drugs, selling them to doctors in the United States for lower prices, an FDA investigation found.
Bottomley sold his company in 2010 to Rockley Ventures, a division of the Internet pharmaceutical company Canada Drugs Ltd. for $5 million, but he remained as an adviser who was paid $10,000 a month. He made sales calls for the company and worked on shipping matters with a mail-order pharmaceutical shipping company in Gainesboro, Tenn., called Volunteer Distribution.
Under Canada Drugs, Montana Health Care Solutions continued illegal drug imports, Cotter said. Last year, it distributed the counterfeit version of Avastin, prosecutors said.
The Food and Drug Administration issued warnings that the fake chemotherapy drug was sold to U.S. cancer clinics and hospitals, and it is unknown how much was administered to patients.
In January 2012, United Kingdom regulators informed U.S. officials that a shipment of fake Avastin was shipped to Volunteer Distribution. U.S. officials tested the drug, and found it did not contain the active ingredient in the legitimate drug and was little more than saline solution.
Thirty-six packs of the fake drug were distributed in the U.S., while five other packets were returned to the wholesaler in the United Kingdom.
FDA investigators interviewed customers that received the drugs, and most said Bottomley was their main contact. Others said the drugs they received from Volunteer Distribution were from orders placed with Montana Health Care Systems, prosecutors said.
Montana Health Care Systems sold the drug for $1,700 per vial, compared to the normal cost of nearly $2,300 per vial.
Even though Bottomley was only a "cog in the wheel" of Canada Drugs at that point, he should have notified the authorities when he became aware that the company was breaking the law, Cotter said.
"This really is a case about greed, the greed of the individuals like Bottomley, the greed of the physicians who purchased discounted, foreign drugs for distribution to their patients suffering from cancer and other serious ailments," Cotter said.
Calls to Canada Drugs were referred to the company's attorney, Curtis Unfried, who said he could not comment on the case because an investigation is underway.
Cotter declined to discuss whether Canada Drugs or the physicians who purchased the drugs would be charged.
Bottomley wrote Christensen a letter prior to the sentencing hearing, saying that he is a religious man with a wife and two teenage daughters whom he would not be able to support if imprisoned.
"We have surrendered everything we have to the Federal Government except our home and are now in a position of considerable debt," he wrote.
Bottomley forfeited an estimated $4.5 million, which included $1 million in cash, 10 parcels of land valued at $3 million and a 2011 Aston Martin sports car that was sold at auction for $110,000.
Facebook's now out of beta and ready for primetime on Windows Phone 8, Microsoft announced today. It's known as Facebook 5.0 and, aside from exiting beta, the latest version of Facebook for Windows Phone adds a revamped UI, as well as, "improved navigation, support for high-res pictures, post sharing, Facebook Timeline view, and more." Should you wish to continue living just ahead of the rest of Facebook's Windows Phone 8 userbase, a beta version of Facebook will remain in the Windows Phone store -- it promises a look at "pre-release software." We also wouldn't be too surprised if this is a good look into what that upcoming Windows 8 app will look like.
As you might expect, Facebook 5.0 for Windows Phone 8 is free and available right here.
JEDDAH, Saudi Arabia (Reuters) - Saudi Arabia regards the involvement of Iran and Hezbollah in Syria's civil war as dangerous and believes the rebels must be offered military aid to defend themselves, the kingdom's foreign minister said on Tuesday.
Speaking at a news conference with U.S. Secretary John Kerry in Jeddah, Prince Saud al-Faisal added that Saudi Arabia "cannot be silent" about Iranian intervention and called for a resolution to ban arms flows to the Syrian government.
"The kingdom calls for issuing an unequivocal international resolution to halt the provision of arms to the Syrian regime and states the illegitimacy of the regime," Prince Saud said.
Kerry has returned to the Middle East after a two-day visit to India, and will continue efforts to strengthen the Syrian opposition and revive peace talks between Israel and the Palestinians.
In Jeddah, Kerry is holding discussions with Prince Saud and Saudi Arabian intelligence chief Prince Bandar bin Sultan, who coordinates the kingdom's efforts to topple Syrian President Bashar al-Assad.
The discussions include Washington's plans for providing direct military support to General Salim Idriss of the Supreme Military Council, the military wing of Syria's main civilian opposition group.
Prince Saud said the world's top oil exporter "cannot be silent" at the intervention of Iran and Hezbollah in the Syrian conflict and renewed calls to arm the opposition and bar weapons sales to President Bashar al-Assad.
"The most dangerous development is the foreign participation, represented by Hezbollah and other militias supported by the forces of the Iranian Revolutionary Guard," said.
"There is no logic that allows Russia to publicly arm the Syrian regime and the foreign forces that support it," he added.
U.S. President Barack Obama has said he will arm the rebels but has not disclosed what type of assistance he will provide. Kerry is trying to ensure that the aid to the rebels is properly coordinated among the allies, in part out of concern that weapons could end up in the hands of extremist groups.
A meeting between Kerry and European and Arab counterparts in Doha last week agreed to increase support for Syria's rebels although there was no consensus among the foreign ministers over providing arms, with Germany and Italy strongly opposed to the move.
More than 93,000 people have been killed in the Syrian conflict, which began as a popular protest movement against President Bashar al-Assad but has descended into a civil war with sectarian overtones.
Nearly 1.7 million refugees have fled into neighboring countries, including Lebanon, where clashes between armed groups supporting opposing sides in Syria have fuelled fears of a lapse back into sectarian civil war.
Saudi Arabia has become more actively involved in the Syrian crisis in recent months, expanding the flow of weapons to the rebels to include anti-aircraft missiles.
(Reporting By Mahmoud Habboush and Lesley Wroughton, Editing by Angus McDowall and William Maclean)
All the draft picks at this week?s NFL Rookie Symposium are learning about the pitfalls that can come with their new opportunities.
But as the first quarterback taken, and the guy expected to lead the Bills out of a generation of mediocrity-at-best, there?s an extra burden on E.J. Manuel.
Manuel said that the Symposium was an introduction into what he can expect as the guy the Bills expect to become the face of the franchise.
?It?s a great responsibility,? Manuel said, via Tim Graham of the Buffalo News. ?You?re always going to be watched, always going to be evaluated each and every day. You?ve got to take that responsibility and respect it. . . .
?I had high expectations no matter where I went in the draft. I?m a natural competitor. I mean, that?s something I was going to work toward anyway. So I don?t feel any added pressure.?
Of course, the first thing Manuel has to do to reach his goal is to prove more able than Kevin Kolb. While that shouldn?t be the most difficult thing in the world, being in a setting where setting up their future is the main topic of discussion had Manuel thinking about what his legacy as a player would be.
?I?ve always been taught that a good name is more important than great treasure,? Manuel said. ?So just keeping that respect for yourself and keeping your name clean, I think that?s what adds to your legacy.
?Obviously, when you play well you have a football legacy. But at the end of the day, I still want to be known as more than a football player. I want to be remembered as a great man.?
If he can deliver the Bills to the playoffs for the first time since 1999, he?ll have the first half of that taken care of.
U-shaped curve revealed for association between fish consumption and atrial fibrillationPublic release date: 24-Jun-2013 [ | E-mail | Share ]
Contact: Jacqueline Partarrieu press@escardio.org 33-492-947-756 European Society of Cardiology
Moderation seems to be key when it comes to eating fish to prevent atrial fibrillation
Athens, Greece, 24 June 2013. Moderation seems to be key when it comes to eating fish to prevent atrial fibrillation (AF) according to an observational study presented at the EHRA EUROPACE congress held 23 to 26 June in Athens, Greece.
The study found a U-shaped association between consumption of marine n-3 polyunsaturated fatty acids (n-3 PUFA) and the risk of developing AF, with people who have both low and high intakes found to suffer more from AF than those with median intakes. The lowest risk of AF was found in those who consumed around 0.63 g marine n-3 PUFA per day, which corresponds to around two servings of fatty (oily) fish per week.
Earlier studies have reported that regular consumption of fish can exert beneficial effects in preventing the development of AF. Notably, in the Cardiovascular Health study, which included 4,815 participants, a 28% lower risk of AF was observed among people who consumed fish one to four times per week compared with those who ate fish less than once per month. However, such observed associations have not been confirmed in all cohort studies?8.
In the current study, Doctor Thomas Rix and colleagues from Aalborg University Hospital in Denmark, set out to examine the hypothesis that a negative association exists between the development of AF and consumption of n-3 PUFA. "Since AF is present in over six million people in Europe and associated with considerable morbidity, mortality and economic costs, preventing AF by achievable dietary changes would be of major public interest," said Dr. Rix.
The investigators made use of the Danish Diet, Cancer and Health cohort 9, which between 1993 and 1997 enrolled a total of 57,053 Danish participants aged 50 to 64 years. The study, funded by the Danish Cancer society, had been initiated with the primary objective of exploring the role of diet in the development of cancer. Baseline data recorded for the study included a semi quantitative food frequency questionnaire with detailed questions about the consumption of fish and food products containing fish that enabled the calculation of average n-3 PUFA intakes. Levels of N-3 PUFA/day were divided into quintiles: with quintile 1 representing 0.00-0.38g marine n-3 PUFA/ day; quintile 2 representing 0.39-0.53g marine n-3 PUFA/day; quintile 3 representing 0.54 to 0.73 g marine n-3 PUFA/day; quintile 4 0.74 to 0.99 g marine n-3 PUFA/day; and quintile 5 1.00-7.22 g marine n-3 PUFA/day.
Follow-up of AF events in the population was undertaken using the Danish National Patient Registry, which recorded discharge diagnoses from hospital admissions, emergency rooms and outpatient clinics. The registry was facilitated by the Danish practice of identifying every citizen with a unique personal identification number that enables cross links to be made between different national registries.
Altogether a total of 3,425 incident cases of AF were registered during 13.6 years of follow-up. When data was analysed in a multivariate Cox regression model, in comparison to the lowest quintile a 9% lower risk of AF was seen for the second quintile (HR 0.91 95% CI 0.81-1.02); a 13 % lower risk of AF was seen for the third quintile (HR 0.87, 95% CI 0.78-0.98, p=0.02); a 4% lower rate was seen for the fourth quintile (HR 0.96, 95% CI 0.86-1.07) and a 3% increased rate was seen for the 5th quintile (HR 1.03, 95% CI 0.92-1.15).
"The 13% observed lower risk of AF seen at moderate intakes of marine n-3 PUFA compared with low intakes may be related to a reduction in ischemic heart disease and anti-inflammatory effects in addition to direct anti arrhythmic effects," said Dr. Rix. He noted that in one study, treatment with 1.8g n-3PUFA/day in patients with low intakes of fish resulted in prolongation of the atrial effective refractory period and less inducible AF, both in subjects with AF8 and subjects without AF10.
The biological mechanisms behind the higher risk of AF observed for high intakes of n-3 PUFA compared to moderate intakes were more difficult to explain," said Dr. Rix. "We can only speculate that the balance between AF inhibiting and AF promoting effects can change according to co morbidities and intakes of marine n-3PUFA. This is the first time that such an association has been shown and it needs to be explored in further studies. However, it may help explain some of the contradictory results obtained in earlier studies."
###
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AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.
U-shaped curve revealed for association between fish consumption and atrial fibrillationPublic release date: 24-Jun-2013 [ | E-mail | Share ]
Contact: Jacqueline Partarrieu press@escardio.org 33-492-947-756 European Society of Cardiology
Moderation seems to be key when it comes to eating fish to prevent atrial fibrillation
Athens, Greece, 24 June 2013. Moderation seems to be key when it comes to eating fish to prevent atrial fibrillation (AF) according to an observational study presented at the EHRA EUROPACE congress held 23 to 26 June in Athens, Greece.
The study found a U-shaped association between consumption of marine n-3 polyunsaturated fatty acids (n-3 PUFA) and the risk of developing AF, with people who have both low and high intakes found to suffer more from AF than those with median intakes. The lowest risk of AF was found in those who consumed around 0.63 g marine n-3 PUFA per day, which corresponds to around two servings of fatty (oily) fish per week.
Earlier studies have reported that regular consumption of fish can exert beneficial effects in preventing the development of AF. Notably, in the Cardiovascular Health study, which included 4,815 participants, a 28% lower risk of AF was observed among people who consumed fish one to four times per week compared with those who ate fish less than once per month. However, such observed associations have not been confirmed in all cohort studies?8.
In the current study, Doctor Thomas Rix and colleagues from Aalborg University Hospital in Denmark, set out to examine the hypothesis that a negative association exists between the development of AF and consumption of n-3 PUFA. "Since AF is present in over six million people in Europe and associated with considerable morbidity, mortality and economic costs, preventing AF by achievable dietary changes would be of major public interest," said Dr. Rix.
The investigators made use of the Danish Diet, Cancer and Health cohort 9, which between 1993 and 1997 enrolled a total of 57,053 Danish participants aged 50 to 64 years. The study, funded by the Danish Cancer society, had been initiated with the primary objective of exploring the role of diet in the development of cancer. Baseline data recorded for the study included a semi quantitative food frequency questionnaire with detailed questions about the consumption of fish and food products containing fish that enabled the calculation of average n-3 PUFA intakes. Levels of N-3 PUFA/day were divided into quintiles: with quintile 1 representing 0.00-0.38g marine n-3 PUFA/ day; quintile 2 representing 0.39-0.53g marine n-3 PUFA/day; quintile 3 representing 0.54 to 0.73 g marine n-3 PUFA/day; quintile 4 0.74 to 0.99 g marine n-3 PUFA/day; and quintile 5 1.00-7.22 g marine n-3 PUFA/day.
Follow-up of AF events in the population was undertaken using the Danish National Patient Registry, which recorded discharge diagnoses from hospital admissions, emergency rooms and outpatient clinics. The registry was facilitated by the Danish practice of identifying every citizen with a unique personal identification number that enables cross links to be made between different national registries.
Altogether a total of 3,425 incident cases of AF were registered during 13.6 years of follow-up. When data was analysed in a multivariate Cox regression model, in comparison to the lowest quintile a 9% lower risk of AF was seen for the second quintile (HR 0.91 95% CI 0.81-1.02); a 13 % lower risk of AF was seen for the third quintile (HR 0.87, 95% CI 0.78-0.98, p=0.02); a 4% lower rate was seen for the fourth quintile (HR 0.96, 95% CI 0.86-1.07) and a 3% increased rate was seen for the 5th quintile (HR 1.03, 95% CI 0.92-1.15).
"The 13% observed lower risk of AF seen at moderate intakes of marine n-3 PUFA compared with low intakes may be related to a reduction in ischemic heart disease and anti-inflammatory effects in addition to direct anti arrhythmic effects," said Dr. Rix. He noted that in one study, treatment with 1.8g n-3PUFA/day in patients with low intakes of fish resulted in prolongation of the atrial effective refractory period and less inducible AF, both in subjects with AF8 and subjects without AF10.
The biological mechanisms behind the higher risk of AF observed for high intakes of n-3 PUFA compared to moderate intakes were more difficult to explain," said Dr. Rix. "We can only speculate that the balance between AF inhibiting and AF promoting effects can change according to co morbidities and intakes of marine n-3PUFA. This is the first time that such an association has been shown and it needs to be explored in further studies. However, it may help explain some of the contradictory results obtained in earlier studies."
###
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?
AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.
CINCINNATI (AP) ? A budget analyst with a daredevil streak, Jane Wicker knew she was taking a risk when she signed up to entertain thousands of spectators at the Vectren Air Show near Dayton.
She said in a TV interview she felt confident of her ability and said on her website that lots of practice makes her signature stunt a "managed risk." She planned to hang underneath the plane's wing by her feet and sit on the bottom of the airplane while it was upside-down.
It wasn't clear Saturday what went so wrong. The biplane glided through the sky, rolled over, then crashed and exploded into flames, killing the wing walker and the pilot, authorities said. No one else was hurt.
A video posted on WHIO-TV shows the small plane turn upside-down as the performer sits on top of the wing. The plane then tilts and crashes to the ground, erupting into flames as spectators screamed.
Ian Hoyt, an aviation photographer and licensed pilot from Findlay, was at the show with his girlfriend. He told The Associated Press he was taking photos as the plane passed by and had just raised his camera to take another shot.
"Then I realized they were too low and too slow. And before I knew it, they hit the ground," he said.
He couldn't tell exactly what happened, but it appeared that the plane stalled and didn't have enough air speed, he said. He credited the pilot for steering clear of spectators and potentially saving lives.
"Had he drifted more, I don't know what would have happened," Hoyt said. He said he had been excited to see the show because he'd never seen the scheduled performer ? wing walker Jane Wicker ? in action.
The show was canceled for the rest of the day, but organizers said events would resume Sunday and follow the previous schedule and normal operations. The National Transportation Safety Board said it is investigating the crash.
On the video, the announcer narrates as the plane glides through the sky and rolls over while the stuntwoman perches on a wing.
"Now she's still on that far side. Keep an eye on Jane. Keep an eye on Charlie. Watch this! Jane Wicker, sitting on top of the world," the announcer said, right before the plane makes a quick turn and nosedive.
Federal records show the 450 HP Stearmans was registered to Wicker, who lived in Loudon, Va. A man who answered the phone at a number listed for Wicker on her website said he had no comment and hung up.
One of the pilots listed on Wicker's website was named Charlie Schwenker. A post on Jane Wicker Airshows' Facebook page announced the deaths of Wicker and Schwenker, and asked for prayers for their families.
A message left at a phone listing for Charles Schwenker in Oakton, Va., wasn't immediately returned.
Dayton International Airport spokeswoman Linda Hughes and Ohio State Highway Patrol Lt. Anne Ralston confirmed that a pilot and stunt walker had died but declined to give their names. The air show also declined to release their identities.
Another spectator, Shawn Warwick of New Knoxville, told the Dayton Daily News that he was watching the flight through binoculars.
"I noticed it was upside-down really close to the ground. She was sitting on the bottom of the plane," he said. "I saw it just go right into the ground and explode."
Thanh Tran of Fairfield said he could see a look of concern on the wing walker's face just before the plane went down.
"She looked very scared," he said. "Then the airplane crashed on the ground. After that, it was terrible, man ... very terrible."
Wicker's website says she responded to a classified ad from the Flying Circus Airshow in Bealeton, Va., in 1990, for a wing-walking position, thinking it would be fun. She was a contract employee who worked as a Federal Aviation Administration budget analyst, the FAA said.
She talked to WDTN-TV in an interview this week about her signature stunt.
"I'm never nervous or scared because I know if I do everything as I usually do, everything's going to be just fine," she told the station.
Wicker wrote on her website that she had never had any close calls.
"What you see us do out there is after an enormous amount of practice and fine tuning, not to mention the airplane goes through microscopic care. It is a managed risk and that is what keeps us alive," she wrote.
In 2011, wing walker Todd Green fell 200 feet to his death at an air show in Michigan while performing a stunt in which he grabbed the skid of a helicopter.
In 2007, veteran stunt pilot Jim LeRoy was killed at the Dayton show when his biplane slammed into the runway while performing loop-to-loops and caught fire.
Organizers were presenting a trimmed-down show and expected smaller crowds at Dayton after the Air Force Thunderbirds and other military participants pulled out this year because of federal budget cuts.
The air show, one of the country's oldest, usually draws around 70,000 people and has a $3.2 million impact on the local economy. Without military aircraft and support, the show expected attendance to be off 30 percent or more.
___
Thomas reported from Philadelphia. Associated Press writers Kerry Lester in Chicago and Randy Pennell in Philadelphia contributed to this report.
Microsoft reportedly was in talks to buy Nokia's device unit, but talks broke down.
According to the Wall Street Journal, the move, which isn't all that surprising given the companies' tight partnership on Windows Phone, is the second report indicating that Nokia may be on the block. Huawei may also be interested in buying Nokia.
The plan was to combine Microsoft with a device maker with scale and then go after the likes of Apple and Samsung. In theory Nokia would give Microsoft the scale to crank out Windows-based tablets as well phones. What's unclear is whether actually owning Nokia would provide any real benefit to Microsoft's market share.
It's also notable that the Journal story noted that Microsoft walked away due to Nokia's placement in the smartphone pecking order. That reality could indicate that Microsoft thinks it needs a new horse to make a dent in the mobile market. Samsung is closely aligned with Google's Android.
Microsoft is in a battle with BlackBerry to be the No. 3 smartphone platform. Windows Phone is ahead for now, but BlackBerry's Q10 appears to be selling well. In either case, Microsoft and BlackBerry are vying to be a distant third to Apple and Samsung.
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Public release date: 24-Jun-2013
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