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Thank God for that! :)
Your post started to worry me when I read the subject line from the main page...
And like neuro, you don't provide examples and specifics of my ignorance. You just project your inability to reason your/my argument, by putting me down. Pretty lame. But not as lame as the God punishing Texas jazz. Maybe if you sleep on what you said, you'll realize it was really stupid.
Ps. Putting yourself in the neuro camp doesn't exactly prove your point--you're better off leaving his name out of it and discussing the matter in your own voice and on your own merits. What 'ignorance' do you speak of?
Pss. Why do you think that I believe God doesn't exist?
Yes, and taking the Twin Towers down on 9/11 was a preemptive attack to retaliate for the recently passed laws on gay marriage:
From Wikipedia:
How did you know I have IBS? Anyway, it's apparent that I have what you need, because you are full of shit.
If you had any capacity to be critical of this mgmt team, your words would mean more to me, and your analysis might carry some weight.
Howard Stern: Stock picker. Funny, sexy, unique, and somewhat offensive. I like it. I looked through a few and saw one poster with this favorite quote:
"It takes 20 years to build a reputation and five minutes to ruin it. If you think about that, you'll do things differently." - Warren Buffett
So true. This seems to be where we are with modern technology, yet people don't seem to be getting it. They will...and that's a good thing.
From everything I've read, zero tolerance doesn't work. On the positive side though, ignore does (which is what I thought you meant by zero tolerance anyway, hence I was disappointingly wrong). It's funny, and kind of sad, that your attacks seems to be cut and pastes from old posts. I guess that's what happens when you lose your way...
Oxycodone painkiller deaths in Florida keep climbing
State officials predict progress this year
By Bob LaMendola, Sun Sentinel
6:48 p.m. EDT, August 15, 2011
Overdose deaths from the narcotic painkiller oxycodone and other prescription drugs marched higher last year throughout the state, but showed signs of peaking in South Florida.
Gov. Rick Scott, at a news conference on Monday, predicted that law enforcement crackdowns and legislative actions would help dry up Florida's oxycodone supply and prevent deaths this year.
Click here to sign-up for our free health report
Others cautioned against expecting fast progress in the illegal trade and abuse of addictive pain drugs in Florida, which has been an epicenter for rogue pain clinics for a decade.
"I'm not even that hopeful we'll see much improvement in the first half of 2011 but I am optimistic that we'll see some kind of a response by the end of the year," said Jim Hall, director of the Center for the Study & Prevention of Substance Abuse at Nova Southeastern University in Davie.
The new report Monday from the Florida Medical Examiners Commission showed that almost 2,300 people died from overdoses caused by prescription drugs last year, up by 7.9 percent from 2009.
Deaths caused by oxycodone alone or in combination with other drugs shot up 28 percent, as abuse of the heroin-like drug spread from South Florida into other parts of the state.
Oxycodone deaths rose especially fast the Orlando area. But in South Florida officials noted deaths from the drug rose only by a small amount, and deaths from the second leading prescription drug killer – the anti-anxiety drug alprazolam, commonly sold as Xanax – fell by double digits.
The governor said a statewide strike force formed in March has arrested 937 people, including 17 doctors, and seized 252,410 pills and $1.7 million.
Also, the number of oxy pills sold in the first five months of this year was down 17 percent compared to the same period last year, a result of the state banning pain clinics from selling pills and federal drug agents scrutinizing pharmacies selling high volumes of pain pills.
But Hall said Florida health officials will need until October to start a statewide database to combat doctor shopping by pill dealers and abusers.
"We may be cutting back supply but we're not ending addiction. The real challenge ahead is what are we going to do with all these addicts? What treatment options? It's going to be rehab or heroin."
Also on Monday, state officials incinerated some of the 357,000 pain pills they confiscated from doctors and clinics. That was a response to a new law banning them from selling pain drugs.
Drug deaths: At a glance
Here are totals of 2010 deaths in which one or more prescription drugs caused a fatal overdose (oxycodone and alprazolam were the top two fatal drugs):
Florida
All prescription drugs -- 2,284 deaths in 2010, up 7.9 percent
Oxycodone – 1,516 deaths in 2010, up 27.9 percent
Alprazolam (Xanax) – 981 deaths in 2010, up 19.3 percent
Breathe Deep—Nighttime Oxygen Loss Linked to Dementia
http://www.alzforum.org/new/detail.asp?id=2874
15 August 2011. In older women, brief suspensions of respiration during sleep (apnea) may cause more than daytime drowsiness, increased cardiovascular risk, and insulin resistance—it may also lead to mild cognitive impairment (MCI) or dementia. Results published in last week’s Journal of the American Medical Association showed that women with sleep-disordered breathing (SDB)—pauses in breathing or reduced ventilation quality during sleep—are more likely to develop cognitive impairment five years later. Hypoxia seems to be the culprit, the authors concluded.
"Given the high prevalence of both sleep-disordered breathing and cognitive impairment among older adults, the possibility of an association between the two conditions, even a modest one, has the potential for a large public health impact," wrote the authors led by Kristine Yaffe of the University of California, San Francisco, and Katie Stone of the California Pacific Medical Center Research Institute in San Francisco.
The researchers longitudinally observed a subset of women enrolled in the large Study of Osteoporotic Fractures—a multicenter analysis of more than 10,000 community-dwelling women. First author Yaffe and colleagues wanted to see if older women with SDB had a higher chance of developing MCI or dementia. Previous cross-sectional studies were conflicted about the link, and no one had done a prospective study to see if older, dementia-free individuals with SDB later developed cognitive problems.
Between 2002 and 2004, the researchers conducted behavioral tests—including the Mini-Mental State Examination and a modified version of Trails B—and an at-home sleep study of 461 women (mean age 82.3 years) from Minneapolis, Minnesota, and the Monongahela Valley, near Pittsburgh, Pennsylvania. None of these women had dementia at baseline, or used SDB therapy, such as continuous positive airway pressure (CPAP) devices or supplemental oxygen therapy. During sleep testing, a team overseen by Susan Redline of Harvard Medical School measured variables such as the number of arousals per hour and the number of airflow cessations (apnea) or reductions (hypopnea) lasting 10 seconds or longer with an associated dip in blood oxygen saturation of 3 percent or more per hour. Among the 298 women who met the criteria for inclusion in the final sample, 35.2 percent were classified as having SDB.
At the time of follow-up about five years later, the women underwent more extensive cognitive tests than they did at baseline. Of the women who did not have SDB at baseline, 31.1 developed MCI or dementia. Of the women who did have SDB, 44.8 percent received one of the diagnoses. After adjusting for demographic and physiological factors, as well as disease and medication use, the researchers found that the odds of developing MCI or dementia were 85 percent higher for women with SDB. Adjusting for baseline cognitive test scores increased the odds ratio to 2.36.
"This suggests that women who have sleep-disordered breathing are at greater risk of subsequent cognitive impairment," said coauthor Adam Spira of The Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland. "It's possible that there is a causal link there."
Intermittent oxygen deprivation could be responsible, the authors suggested. Increased hypoxia—a higher percentage of total sleep time in hypopnea or apnea and greater oxygen desaturations per hour, rather than total sleep time or sleep fragmentation—was associated with MCI or dementia. If that's the case, CPAP or supplemental oxygen therapy could mitigate sleep apnea's harmful effects, the authors wrote. "No medications are known to prevent the progression of mild cognitive impairment to Alzheimer's disease or dementia, so treating at-risk patients with CPAP for sleep-disordered breathing is a prevention strategy that may be worth testing," wrote Nicola Canessa and Luigi Ferini-Strambi of the San Raffaele Scientific Institute in Milan, Italy, in an accompanying JAMA editorial.
For patients whose apnea results from venous insufficiency, a recent paper suggests that compression stockings can decrease nightly apneas and hypopneas by reducing the daily accumulation of fluid in the legs that redistributes in the neck during sleep. Researchers led by Stefania Redolfi published their results online last week in the American Journal for Respiratory Care and Critical Medicine.
Yaffe's study "does indicate that certain populations might be more severely affected by sleep apnea," said Clete A. Kushida, medical director of the Stanford Sleep Medicine Center in California. Kushida directs the NIH-sponsored Apnea Positive Pressure Long-Term Efficacy Study (APPLES), which aims to determine the effects of CPAP therapy on neurocognitive function. So far, the study has found that the severity of apnea in middle-aged adults is mildly associated with worsened neurocognitive performance (see Quan et al., 2011).
Previous research has shown that CPAP treatment slows or improves cognitive impairment in patients with Alzheimer's disease (see Ancoli-Israel et al., 2008 and Cooke et al., 2009), and increases gray matter volume in the hippocampus and frontal area (see Canessa et al., 2011). And other studies have pointed to a role for hypoxia in amyloid-ß deposition. In cultured cells and mouse AD models, hypoxia increases the expression and activity of the APP-processing enzyme ß-secretase (BACE1), which cleaves APP to generate the amyloid-ß peptide that deposits in the brain (see ARF related news story on Sun et al., 2006). The hypoxia inducible factor 1a binds to the BACE1 promoter and increases the BACE1 mRNA and protein levels (see ARF related news story on Mehta et al. 2009 and Zhang et al., 2007).
But further research is needed to establish causation, as Yaffe and colleagues point out in their paper. Randomized control trials with larger sample sizes that include men and more ethnically diverse participants could test whether CPAP or supplemental oxygen therapy prevents cognitive decline. "Also, it would be helpful to determine what brain pathology is associated with the dementia developed by older women with sleep-disordered breathing compared to older women without," said Raj C. Shah, assistant professor at the Rush University Medical Center in Chicago, Illinois. "It could be that sleep-disordered breathing is more likely to be linked to [brain] infarcts rather that AD pathology." Brain infarcts, or mini-strokes, are more common in those with sleep-disordered breathing (see Minoguchi et al., 2007), and increased white matter hyperintensities (a measure of those strokes) have been linked to dementia (see Carmichael et al., 2010).—Gwyneth Dickey Zakaib.
References:
Yaffe K, Laffan AM, Harrison SL, Redline S, Spira AP, Ensrud KE, Ancoli-Israel S, Stone KL. Sleep-disordered breathing, hypoxia, and risk of mild cognitive impairment and dementia in older women. JAMA. 2011 Aug 10. Abstract
Canessa N, Ferini-Strambi L. Sleep-Disordered Breathing and Cognitive Decline in Older Adults. JAMA. 2011 Aug 10. Abstract
Redolfi S, Arnulf I, Pottier M, Lajou J, Koskas I, Bradley TD and Similowski T. Attenuation of obstructive sleep apnea by compression stockings in subjects with venous insufficiency. Am J Resp Crit Care Med. 2011. Abstract
What better to match your 'zero tolerance' policy on Cortex with, sire. Six cents and counting, sir. Shall we consider a 'below zero' valuation as a possibility, just in case? We 'eagerly' await your announcement, Your Royal Highness.
Some appreciation in shareholder return would/could warrant a premium with an acquisition. In this case, we are talking an industry standard practice with a super sub-standard stock and performance.
Throw in the BOD, and you made yourself a pack of sloths.
They are like squatters and thieves--sitting on the land and waiting for someone to pay them--so the lessee can find value in the land, be it digging for gold or drilling for oil. They've been sitting so long on the IP, they have a permanent slouch in their posture. So they maintain an existence (lavishly on a personal level, mind you), hide from their people, and hope and pray, like ombow, for a miracle. I'm embarrassed to pray with this congregation for the same goal, but here I am, not willing to give up :(
Cowards come in all forms. Slithering along all this time and leaving toxic entrails with each wind and twist; never accepting that you're not man enough for the job at nearly each maneuver--with each ignored lesson compounding the evidence of failed leadership; bleeding your lifeline; enriching yourself with minor accomplishments like keeping your company solvent--only to continue on the same dismal and jagged course. There came a time when conceding failure would have been a Grand statement--heroic. We are caught in an ugly Catch 22, but one in which we hopefully all learned significantly from...
Milking failure is cowardly, but not as cowardly as committing suicide, so either they haven't hit rock bottom, or they never will...
That's about as positive as this situation has allowed me to realistically be.
Their executing has dried up like the I-Hub pumping and damage control contributors. But what's the point, it's summer time, and that is the premier reason there is nothing to say, and nothing is going on worth mentioning. Can't wait till the action picks up in the fall, we are sure to be rewarded! Think about it: A dime is a double. LOL.
Frankly, at this point, I hope Stoll, Varney and Messier get what they deserve with Cortex shares and options: Nothing. I'm willing to sacrifice my own meager investment for a little justice to be served.
Please! He is collecting Harry Potter memorabilia and considering writing his own book. I'd like to know what lies beneath the Varney Stone myself? Whatever it is, seeing it would probably render us speechless (a fitting contrast to the Blarney Stone).
Re: Fcoff
Perhaps his statements are a complete fabrication (actually, looking back, they were just provocative questions/insinuations). Maybe the poster's identity itself is fictitious. Or, no less far-fetched, maybe this anonymous poster is a virtual whistle blower? Could be almost anything. One thing it is not: a figment of my imagination. It would serve no purpose for me to create aliases and make shit up. I have nothing to prove, and no alternate agenda. I thought I've made that clear, but you would have to take my word for it :)
Search for AD Drugs Turns to a Hypertension Medicine
http://www.alzforum.org/new/detail.asp?id=2838
12 July 2011. A research consortium led by an Irish group is gearing up to conduct a multicenter Phase 3 clinical trial of the blood pressure medication nilvadipine in Alzheimer’s disease (AD) patients. The study’s go-ahead is subject to successful completion of ongoing negotiations with the granting body, the European Commission (EC) Seventh Framework Programme. But if all goes according to plan, the study is slated to start in January 2012 with funding to the tune of €6 million (US$8.4 million).
Preliminary clinical data have hinted that nilvadipine might be beneficial to patients with AD, but how the drug will fare in a large, randomized trial is hard to predict based on those earlier studies. “I think there is sufficient justification for moving forward with the trial, because until we have effective treatments, we need to explore all plausible strategies, and this is one of them,” said Paul Aisen, at University of California, San Diego School of Medicine, who is not involved in this work. “At this point, we really don’t have any evidence of clinical efficacy for nilvadipine in AD, so we need a substantially large, randomized trial to see if there is an effect.”
One factor that plays in nilvadipine’s favor is that the drug has been prescribed in parts of Europe and Japan (but not the U.S.) for more than a decade. “There is a wealth of experience with the drug to suggest that it is well tolerated and unlikely to raise safety concerns,” said John Breitner, at McGill University in Montreal, Canada, who is also independent of the nilvadipine trial. The approach of looking at existing medicines to see if they have an effect on Alzheimer’s is a valuable one for academic investigators to take, according to Brian Lawlor at Trinity College Dublin and St. James's Hospital, who will be heading the nilvadipine trial. For one thing, pharma tends to have limited interest in such drugs, and the time from clinical trials to market is likely to be shorter than for new drugs.
Although nilvadipine has never been sold in the U.S., it is manufactured by Astellas Pharma US, the U.S. affiliate of Astellas Pharma Inc., Japan’s second-largest pharmaceutical company. Astellas is not pursuing nilvadipine for AD treatment. The patent on the original composition of the drug expired a few years back, and Archer Pharmaceuticals, a commercial spinoff of the Roskamp Institute in Sarasota, Florida, now owns intellectual property rights to developing the drug as a treatment for AD.
There have been no new drug treatments approved for AD since 2003, and the field has been plagued by failed Phase 3 trials. “We have broken our teeth with vast and very expensive efforts for the treatment of Alzheimer’s for more than 20 years. There have been some successes, but they have been modest,” said Breitner. “Many people are fairly pessimistic about our ability to change the course of the disease once the symptoms are present.” But that is no reason not to persevere. “If you have an agent with some promise, as they do here, they should try to see if it will be effective,” he added.
Nilvadipine appears to work by a different mechanism than other drugs that have been tested for treating AD, which typically target the amyloid-ß peptide, the main component of the plaques found in the brains of AD patients. “Nilvadipine has some effects on amyloid-ß, but also other effects,” said Brian Lawlor. “Putting so much focus on one target has not proven to be effective.”
Some single-target drugs have failed in Phase 3 (e.g., Lilly’s semagacestat; see ARF related news story), as have so-called dirty drugs that hit several targets, some suspected of affecting amyloid pathways and some not (e.g., Medivation’s Dimebon; see ARF related news story).
The proposed trial will bring together academic institutions and not-for-profit organizations in countries across Europe, including Italy, Germany, Greece, The Netherlands, Sweden, the U.K., and Luxembourg, as well as the pharmaceutical companies Penn Pharmaceuticals (U.K.) and Archer Pharmaceuticals. It will enroll 500 patients and last about 18 months. “It is extremely positive that the EC is funding a clinical trial like this one because there isn’t a tradition for public money funding clinical trials in Europe,” said Cristina Sampaio of the Institute of Molecular Medicine at the Santa Maria Hospital in Lisbon, Portugal, and the European Medicines Agency. “We will gain a lot of valuable information from studying these patients.”
Nilvadipine belongs to a class of blood pressure-lowering medications that block calcium channels on cells (see ARF related news story). Researchers have long been studying the connection between blood pressure (and blood pressure medications) and AD (see ARF related news story), but that relationship remains “complex,” said Deborah Blacker at Harvard School of Public Health. Blacker headed a curation team for the AlzRisk database, where she compiled a synopsis of the hypertension literature (see ARF related news story).
“In general, the results of studies of anti-hypertensive medicines in people with AD have been mixed,” said Breitner. “We have snippets of evidence that suggest certain kinds of anti-hypertensive drugs, or specific drugs appear in some studies to be beneficial.” Nilvadipine appears to be one such drug. A small study had shown that nilvadipine in hypertensive patients with mild cognitive impairment prevented further cognitive decline for up to 20 months (Hanyu et al., 2007) and improved cerebral blood flow.
In 2010, a team from the Roskamp Institute, led by Michael Mullan, provided experimental results to explain the potential benefit of nilvadipine in AD (Paris et al., 2010). Those data suggest that any such benefit is not related to the drug’s blood pressure-lowering function.
The Roskamp group tested a battery of calcium channel blockers in cells overexpressing a version of the human amyloid precursor protein (APP), and they found that only two such agents, nilvadipine and amlodipine, decreased the production of amyloid-ß from APP. The authors concluded the mechanism responsible for this reduction is unlikely to be related to the calcium channel blocking function, as none of the other drugs tested reduced amyloid-ß. Using an in-vitro model of the blood-brain barrier, they also showed that nilvadipine increased the passage of amyloid-ß through the barrier. “So this drug is interesting because it has a dual mechanism of action in that it stops amyloid-ß production and also increases movement of the peptide across the blood-brain barrier,” said lead author Daniel Paris at the Roskamp. Paris and colleagues validated the in-vitro findings in two transgenic mouse models of AD to show that intraperitoneal injections of 2 mg/kg of nilvadipine reduced amyloid-ß levels in the brain and increased levels in the blood.
One limitation of the in-vitro work is that, to see the effects on amyloid-ß production and secretion, the researchers had to use drug amounts ranging from 1 to 10 micromolar concentrations—much higher than would be present in the body. When used at high concentration, many compounds affect APP processing. In addition, the study did not identify a specific molecular target for nilvadipine’s effects. “There are many studies that report an effect at high micromolar concentrations, but that can be misleading,” said Ilya Bezprozvanny at UT Southwestern Medical Center in Dallas. “First, you want to know what the target is, and then you need to be hitting the target at a concentration in the 100-nanomolar range or less, which is physiologically relevant.” Nilvadipine binds to L-type calcium channels with 1-nanomolar affinity (Cho et al., 1989).
Ongoing studies by Paris and colleagues are addressing these concerns, but those data are unpublished. “We are in the process of identifying the molecular targets of nilvadipine responsible for its amyloid-ß-lowering properties and have several promising candidates,” said Paris. “By blocking those potential targets, we have already shown we can mimic the effects of nilvadipine.”
To move forward on the preclinical data, Mullan and colleagues at Roskamp approached researchers at Trinity College Dublin to conduct an open-label safety trial of nilvadipine in AD patients. The Phase 1 trial, funded by Archer Pharmaceuticals, involved giving a daily dose of 8 mg nilvadipine to 55 AD patients for six weeks. Usually, early-stage clinical AD trials test several doses to establish dose-response, and frequently longer than six weeks; however, in this case, the trial used an old drug for which a standard anti-hypertensive dose is established.
The drug was well tolerated by the patients and had no dangerous blood pressure-lowering effects (Kennelly et al., 2010). “In general, we found that, for AD patients with high blood pressure who took nilvadipine, their blood pressure was reduced as a result of taking the drug. On the other hand, patients with normal or low blood pressure had no change in blood pressure after taking the drug,” said Sean Kennelly at Trinity College, lead author of the safety trial.
The authors conducted some basic tests of cognitive function in the patients, which suggested that nilvadipine stabilized cognition and improved executive function in treated individuals (Kennelly et al., 2011). The trial used the MMSE and an executive function test called EXIT25. The latter is not a standard outcome measure used in AD trials designed to determine the efficacy of a drug, such as the ADAS-cog, CDR Sum of Boxes, or Activities of Daily Living scales. “It is open label, so the conclusions you can draw are limited,” Kennelly said. “But we were giving blood pressure medication to people who did not have high blood pressure, so we did not want to go straight to a large, randomized study.”
In addition, an increasing number of studies of AD, including Phase 1 and 2 trials, are moving toward using surrogate and diagnostic markers of AD in place of cognitive tests, said Barbara Tate at Satori Pharmaceuticals in Boston (see ARF related news story). “Those markers, developed thanks to the Alzheimer’s Disease Neuroimaging Initiative, give us tools to measure endpoints early on in a trial to tell us if we are going in the right direction,” she said. “Clinical batteries are so poor they end up with false positives, but biomarkers are hopefully pretty clean.”
Such biomarkers are expected to be part of the upcoming Phase 3 trial of nilvadipine. Although final details need to be ironed out, investigators plan to measure amyloid-ß plasma levels in patients to see whether the drug has a similar effect as in the animal models. “We also plan to look at novel markers as part of a yet-to-be-agreed substudy,” said Lawlor.
“We will wait and see for the Phase 3 results. Even if it does not work as expected, it is a safe drug and I would not think something dangerous will occur, so that is a good reason to try,” said Sampaio. The trial consortium, she added, will also develop an infrastructure and establish processes that will enable many more trials of different drugs to be carried out.—Laura Bonetta.
Yes, congrats! Judging by the reaction of Wall Street though, something is amiss. Any ideas?
Rexall Sundown, Act III:
FTC Settlement Prohibits Marketers of Children's Vitamins from Making Deceptive Health Claims about Brain and Eye Development
As part of its ongoing efforts to stop bogus health claims, the Federal Trade Commission has reached a settlement requiring major marketers of children’s vitamins to stop making false and unproven claims that their supplements promote healthy brain and eye development in children. The companies have agreed to pay $2.1 million to provide refunds to consumers who purchased certain multivitamins in their Disney and Marvel Heroes line.
The FTC charged NBTY, Inc. and two subsidiaries, NatureSmart LLC and Rexall Sundown, Inc., with making deceptive claims about the amount of DHA – an Omega-3 fatty acid – used in their line of Disney- and Marvel Heroes-licensed children’s multivitamin gummies and tablets. The companies also made unsupported claims that a daily serving of the products promotes healthy brain and eye development in children, according to the FTC administrative complaint.
Sold by major retailers such as CVS Pharmacy, Wal-Mart, Target, Walgreens, Kroger, Kmart, Meijer, and Rite Aid, as well as online, the multivitamins featured characters such as the Disney Princesses, Winnie the Pooh, Finding Nemo, and Spider-Man. Product packaging and print ads promoting the vitamins had bold graphics highlighting that the products contained DHA, but in reality, the products allegedly had only a trace amount of DHA. While the vitamins’ packaging touted the purported health benefits of 100 milligrams of DHA, a daily serving of the Disney and Marvel multivitamins for children ages four years and older contained only one thousandth of that amount (0.1 mg or 100 mcg), according to the FTC’s complaint.
The FTC alleged that the packaging and ads for the Disney and Marvel multivitamins misrepresented that they contained a significant amount of DHA, and that NBTY, NatureSmart, and Rexall Sundown made unsubstantiated claims that the amount of DHA provided by the multivitamins promotes healthy brain and eye development in children.
The settlement:
bars NBTY, NatureSmart, and Rexall Sundown from misrepresenting the amount of any ingredient contained in any product.
bars them from misrepresenting that any ingredient, including DHA, promotes brain or eye health or provides any other health benefit, unless the claim is true and backed by competent and reliable scientific evidence.
specifies that any violations could subject the NBTY, NatureSmart, and Rexall Sundown to civil penalties.
A refund program to distribute the $2.1 million to purchasers of the Disney and Marvel multivitamins will be administered by the FTC. The agency will reach out to affected consumers in the coming months.
Rexall Sundown, Act II:
Rexall Sundown to Pay up to $12 Million to Settle Charges Regarding Cellulite Treatment Product
Company Allegedly Made False and Unsubstantiated Claims for "Cellasene"
Rexall Sundown, Inc. (Rexall) will pay up to $12 million to resolve Federal Trade Commission charges regarding its marketing of the dietary supplement, "Cellasene," a purported cellulite treatment product. The settlement is contingent on approval by the federal district court in Miami and approval of related settlements in class action lawsuits currently pending against Rexall in California and Florida. If approved, the FTC and class action settlements together will provide up to $12 million in redress for consumers throughout the United States who purchased Cellasene.
"Hundreds of thousands of consumers were misled by the claims for this product," said Howard Beales, Director of the FTC's Bureau of Consumer Protection. "This case should alert advertisers to the fact that their chances of getting away with making unsubstantiated claims are slim to none."
Rexall is a Florida-based subsidiary of Royal Numico, N.V. that manufactures and markets a variety of nutritional supplements and consumer health products. In 1999, Rexall launched a national public relations campaign that heralded the introduction of Cellasene as a major news event, and hired an agency to distribute widely a "video news release" that described the Cellasene clinical studies as "impressive." News stories on Cellasene appeared throughout the country. Shortly thereafter, Rexall advertised Cellasene in major newspapers including The Washington Post and USA Today. The company also advertised Cellasene in magazines, on the Internet, on television and radio, and through free-standing inserts in newspapers. Sales of Cellasene exceeded $40 million in the United States. The eight-week Cellasene regimen cost consumers almost $200.
In July 2000, the FTC sued Rexall in the U.S. District Court for the Southern District of Florida, alleging that the company violated the FTC Act by making unsubstantiated claims about the ability of Cellasene to eliminate or substantially reduce cellulite and false claims that it had clinical evidence establishing Cellasene's efficacy. In its promotional materials, Rexall had stated that "clinically researched" Cellasene was "The One That Works," and that, "Unlike massages and creams, Cellasene works from within, nutritionally, to help eliminate cellulite at its source."
In addition to its consumer redress provisions, the stipulated final order prohibits Rexall from making any unsubstantiated cellulite reduction or elimination claim for Cellasene. It also prohibits the defendant from making unsubstantiated claims regarding cellulite, body fat or weight loss for drugs or dietary supplements and from misrepresenting test or study results in connection with the sale of any dietary supplement or drug.
The settlement will become final when the class action settlements are approved in final form by the California and Florida State courts, a process that may take several months. After these approvals are obtained, the FTC will administer a redress fund of up to $12 million for consumers who were dissatisfied with Cellasene. Consumers who purchased Cellasene and want to participate in the redress program should call the Commission's settlement hotline at: 202-326-3793.
The Commission vote authorizing staff to file the stipulated final order was 5-0. It was filed in the U.S. District Court, Southern District of Florida, in Miami, on March 11, 2003.
Media Contact:
Brenda Mack,
Office of Public Affairs
202-326-2182
Staff Contact:
Heather Hippsley or Daniel Kaufman,
Bureau of Consumer Protection
202-326-3285 or 202-326-2675
From your article:
Does anyone else ruminate over the days we envisioned Ampakine IV's being SOC on every crash cart in the country? We've fallen a long way back since those days...and that's with drug study success! And on the cultural battlefront, the problem worsens, but there is a light...:
RX drug overdoses in Florida up 61 percent in 6 years
By Bob LaMendola, Sun Sentinel
8:24 p.m. EDT, July 7, 2011
Fatal prescription drug overdoses jumped by 61 percent in Florida from 2003 to 2009 and claimed 16,650 lives, federal health officials said in a new analysis Thursday.
The report by the Centers for Disease Control and Prevention documents a trend that state officials have noted for years. It led to new laws over the past three years, most recently July 1, to control excessive prescriptions by pain doctors and clinics. Among the CDC's findings:
Prescription drug overdose deaths: Up 61 percent. There were 2,905 in 2009, compared with 1,804 in 2003. Each victim took a lethal dose of at least one prescription drug.
Prescription drug death rate: Up 84.2 percent. For every 100,000 Floridians, there were 13.4 deaths in 2009 vs. 7.3 in 2003.
Oxycodone death rate: Up 265 percent. There were 6.4 deaths per 100,000 Floridians in 2009 vs. 1.7 per 100,000 in 2003.
Alprazolam (Xanax) death rate: Up 234 percent. There were 4.4 deaths per 100,000 Floridians in 2009 vs. 1.3 per 100,000 in 2003.
Illegal drugs death rate: Down 21 percent. There were 3.4 deaths per 100,000 Floridians in 2009, compared with 4.3 per 100,000 in 2003. This includes cocaine, heroin and others.
Also Thursday, Florida's surgeon general gave doctors 60 more days to start using new counterfeit-proof prescription pads that were required to be used for addictive drugs as of July 1.
Dr. H. Frank Farmer said he had heard complaints that pharmacies were refusing to fill patients' prescriptions of pain pills because doctors had used the old forms. Doctors initially may have had trouble finding the forms, but he said they are widely available.
It's true then--the future does stink! This is a Dupont paper addressing that very issue (it was presented at the 10th Biennial Sulfur Market Symposium 5 years ago in Beijing):
http://www2.dupont.com/Sulfur_Technologies/en_US/assets/downloads/Meeting_environmental_challenges_through_alternative_sulfur_management_solutions.pdf
Ombow-It appears to be similar to Pfizer's Chantix, which is a full a7-receptor agonist. Pulling up Chantix on Wikipedia will provide you with the info you are looking for.
Dow Chemical?
After much thought, I disagree. The conventional wisdom is becoming quite questionable. The demonization of tobacco and the manipulation of its ingredients (in addition to the heavy taxation, which coincides with the demonizing, ie., the sin tax) are the true crimes with tobacco. With Chiantix, I believe the risk is greater then the reward. The problem with tobacco is not the ingestion of it per se, it is the amount we have grown accustomed to smoking (as well as the quality of course). The induced and ingrained negative perception of smoking has grown more dangerous then smoking itself. Like most everything else in life that is dose dependent, moderation is key.
Disclosure: For 25 years, I have successfully and unsuccessfully controlled my tobacco usage. Currently, on average, I smoke a pack per week (don't tell my wife, although she probably knows). As with other substances, there is a therapeutic and medicinal value in the leaf. Denying any such benefit, or valuing newer, scientifically engineered (ie., synthesized) creations over traditional centuries old 'medications,' appears a little ignorant and arrogant. We have amazing minds in the world indeed, but this knowledge seems to be inflating our heads and undermining our species...
Freedom is a beautiful thing. Happy 235th! I hope it felt good to get that off your chest and out of your system. Even though you sound absolutely ridiculous, it is still your right, and I respect and encourage that type of transparency.
Hope you saved some fireworks for this evening :)
p.s. Don't take yourself too seriously, in fact, none of us should (although some have to more than others). Peace.
Maybe, unless another study comes out to negate it, or speculation and debt spending ceases :)
State targets pill mills
By Nadege Green, The Miami Herald
8:47 a.m. EDT, July 3, 2011
Call it one more nail in the coffins of the "pill mills" that once proliferated in South Florida.
The state surgeon general, Frank Farmer, has ordered doctors who are no longer authorized to dispense addictive pain medication such as oxycodone to dispose of their remaining inventories. They get a choice: Return the drugs to your distributor, or hand the inventory over to local law enforcers.
Starting Tuesday, the Department of Health will also crack down on pain clinics that purchased more than an average of 2,000 pills a month this year and clinics that pose the greatest threat to the public health.
"Florida is taking a proactive step to combat the illegal distribution of prescription drugs," Farmer said in a statement announcing the initiative on Friday.
Of all the oxycodone dispensed by physicians in the United States, 85 percent is dispensed by Florida doctors, earning the state the title of "pill mill capital."
It's the latest step in a crackdown that began in October when Florida's "Pill Mill Bill" went on the books. The bill allows authorities to conduct inspections and impose stricter penalties on pain clinics. It also prevents pain clinics from advertising.
Cal Deal, one of Fort Lauderdale's biggest foes of the phenomenon said Saturday, "Anything they can do to crack down on the mills is a good thing. You have people traveling thousand of miles to buy pills. Someone had to do something."
In February, drug agents raided Broward Urgent Care, a pill mill near Deal's home. The operation, along with six other clinics owned by ex-felon Vincent Colangelo, sold more than 660,000 doses of oxycodone in just two years.
Colangelo has been charged with drug trafficking conspiracy and money laundering and his clinics are shuttered.
"It was an unbelievably terrible situation for the neighborhood," Deal said. "You had all sorts of questionable people walking around; it's just a bad scene. It's time to put an end to all of them."
Aged and AD Mice Get Antsy at Aurora’s Arrival
1 July 2011. As Nox, Roman goddess of the night, sweeps the sky, some elderly people and those who have Alzheimer’s disease often become hyperactive, agitated, even delirious. A similar thing happens in mice, according to a paper published in the June 27 Proceedings of the National Academy of Sciences USA online. Given that mice are nocturnal, it is the incipient arrival of Aurora, the goddess of dawn, which makes them jumpy.
Aging and dementia are typically associated with off-kilter circadian rhythms, with more than 80 percent of the 65-plus age bracket suffering sleep problems (Foley et al., 1995). Behavioral symptoms such as insomnia and agitation are two of the main reasons caregivers cite when they place their loved ones in institutions (Pollak et al., 1990; Pollak et al., 1991).
But the existence of “sundowning syndrome,” as the late-day anxiety is called, has been controversial. It could be that people who have trouble communicating release a day’s worth of pent-up frustration as night approaches. Or, caretakers and nurses might perceive their charges as more disruptive when the carers themselves are tired and cranky at the end of the day. Finding evidence of “sunupping” in mice nearing night’s end suggests sundowning is a real, biological phenomenon, said first author Tracy Bedrosian, who led the study with senior author Randy Nelson at the Ohio State University Medical Center in Columbus.
To examine sunupping in mice, Bedrosian had to become somewhat nocturnal herself, observing the mice as their lights-on time—2:00 a.m.—approached. She used two tests to measure activity and anxiety. For activity, the animals’ cages were equipped with light beams; the machinery counted every time a mouse crossed a beam. For anxiety, Bedrosian put the mice in a maze with covered and open sections; mice that did not mind being out in the open were, presumably, less anxious than those hiding.
In one group of experiments, the researchers compared seven-month-old, middle-aged mice with 29-month-old seniors (comparable to an 80-year-old person). Early in their nighttime, between 5:00 and 6:00 p.m., the different age groups were similarly active in their cages and equivalently anxious in the maze. But as the end of darkness neared, between 11:00 p.m. and midnight, the older animals moved about more, and spent less time in the open areas of the maze, than their younger counterparts.
Next, the scientists looked for a biological basis for the altered activity. Disruption of the cholinergic system is associated with dementia and circadian changes, and blocking acetylcholine receptors causes anxiety in rodents (Smythe et al., 1998). Bedrosian fixed brain samples and compared acetylcholinesterase staining in the nucleus basis of Meynert, the site of maximal cholinergic neuron degeneration in people with AD. In the middle-aged mice, the amount of staining was similar between the early and late time points. In the older animals, acetylcholinesterase staining nearly doubled between the early and late times. Since acetylcholinesterases degrade acetylcholine, this would result in less of the transmitter, leading to amped-up anxiety.
Finally, Bedrosian repeated her experiments with nine-month-old AD model mice expressing mutant human amyloid precursor protein. These mice were more active throughout the night, and more anxious late, than wild-type nine-month-olds.
There are no standard treatments for sundowning, Bedrosian said, because scientists do not comprehend what happens in the brain as bedtime nears. “This paper provides a mechanistic insight,” said Phyllis Zee of the Northwestern University Feinberg School of Medicine in Chicago, Illinois. “Work like this could lead to more targeted strategies.” Zee added that circadian alterations might contribute not only to sundowning, but also to cognitive and memory problems.
Cholinesterase inhibitors are already approved as a treatment for Alzheimer’s. “Our data suggest it might have an effect on sundowning as well,” Bedrosian said. The researchers also tried melatonin treatment in the mice, with little effect. The addition of light and dark therapy might be more effective, Zee suggested. In people with AD, melatonin and light therapy seem to work best in tandem (see ARF related news story on Riemersma-van der Lek et al., 2008; Dowling et al., 2008).—Amber Dance.
Reference:
Bedrosian TA, Harring KL, Weil ZM, Nelson RJ. Altered temporal patterns of anxiety in aged and amyloid precursor protein (APP) transgenic mice. Proc Natl Acad Sci U S A. 2011 Jun 27. Abstract
OT-Andy-This story made me think of you (the owner is a day trader and horse lover). You have to click on the link to get a visual appreciation of the home:
http://realestate.yahoo.com/promo/the-half-there-house.html
The Half-There House
By Ellen Gamerman, WSJ.com
Jun 29, 2011
This 6,400-square foot home is half-buried in a grassy slope in East Hampton, NY.
Photo: Adam Friedberg
When Bob Stansel and Tammy Marek were planning their new luxury home here, they didn't want to overwhelm the neighbors. So they buried half of it.
Except for its arching corrugated metal roof, the unadorned modern structure built of concrete and glass barely rises higher than the grassy slope into which it's built. More than 3,200 of the four-bedroom home's roughly 6,400 square feet are located in a lower level, making the house appear more than twice as big from the side as it does from the front.
Using subterranean construction to avoid restrictive building codes is a popular option in places like California's Napa Valley, where home owners burrow underground for more space. But the couple here said their decision wasn't driven by regulations; instead it was their own desire for a pared-down aesthetic.
"I don't think I'd want people thinking that was my dream of retirement, to build some monster," said Mr. Stansel, a 65-year-old former mortgage banker who moved into the East Hampton home with his wife this winter. "We didn't want a bunch of expensive decorations on the outside."
On the property, Japanese maple and copper beech trees sit near a planted flat-roofed garage and grass driveway whose wide-set cobblestones look like part of the landscaping. Mr. Stansel took a 1,200-pound glacial rock, which he bought for $2,000 after becoming intrigued by its Alaska history, and trucked it from storage in Portland, Ore. to use outside as a garden feature.
The interior is simple, reflecting the desires of Ms. Marek, a 52-year-old day trader and horse lover—the couple has four horses that are boarded away from home in Connecticut and Holland. "It's more like a loft," she said. The front door leads to an open plan living area with flooring made of Oregon black walnut and white Bulgarian limestone. A concrete slab marks the staircase, which is held up with a harpsichord-like row of steel cables. Arched glass walls surround the modern living room and lacquered wood kitchen, hugging the curve of the roof.
Downstairs, a sitting area and den are lit by three pairs of 9-foot tall glass French doors around a lower courtyard. Mr. Stansel's study and a general storage area, however, are in rooms without any direct light.
Architects are seeing more houses with unassuming façades that explode in size when viewed from the back, or homes split into multiple buildings so they'll look less massive, or even homes that New York architect Lee Skolnick calls "McRanchions"—1950s ranch houses given luxury makeovers. "There's a trend we're seeing—it's called 'perceived thrift,'" said Chris Rose, an architect based in Charleston, S.C. "It's kind of like the ladies going to Bergdorf's and still buying stuff, but putting it in a brown bag."
Mr. Stansel had his fill when it came to towering properties: In 2009, he and Ms. Marek bought Canterbury Castle, a 1930s landmark in Portland, Ore. with a moat, drawbridge and turret, for about $290,000. They were already living in the house next door and bought the site as an investment. The city had deemed the crumbling edifice structurally unsound, clearing the way for the couple to raze it. Some locals were opposed, but the couple considered it unsafe and an eye sore.
At the same time, Mr. Stansel and Ms. Marek were beginning construction on the Long Island house. East Hampton-based architect Maziar Behrooz had come up with a design for the land's previous owner, who was inspired by a photo of an F-16 fighter jet nosing out of an airplane hangar for the building's shape. Mr. Behrooz dubbed it the Arc House, after the curve of the galvanized aluminum roof. Mr. Stansel was drawn to the home's low-slung profile.
The couple paid $1.25 million for the property down a long road lined with tall pines, and another $2.2 million for the building, Mr. Stansel said. Nearby, in a subdivision with meadows and fields for polo matches, a home is on the market for $2.9 million.
The couple moved to New York because they thought it would make it easier to travel to Europe in their retirement, though they are considering spending the winters in Portland if they don't find a buyer for their property there.
Outside their Long Island home, a memento from their Portland past is now set into the ground. Two heavy stones serve as steps to a soon-to-be-built Zen garden—pieces of the castle they once owned.
Is 'The Beast' a movement?:
FBI: Anti-gay group participated in training
By PETE YOST - Associated Press | AP – 14 hrs ago
WASHINGTON (AP) — The FBI said Wednesday that members of an anti-gay fundamentalist group participated in the bureau's training of police officers and FBI agents — a move the bureau says it will take steps to remedy in the future.
The bureau extended the invitations to Westboro Baptist Church of Topeka, Kan., for training this spring at two bureau facilities in Virginia: Quantico and Manassas.
Westboro has stirred widespread outrage with raucous demonstrations at the funerals of U.S. military service members. The group contends God is punishing the military for the nation's tolerance of homosexuality.
National Public Radio first reported the FBI's involvement with Westboro.
At FBI headquarters in Washington, bureau spokesman Paul Bresson acknowledged that Westboro was invited to the training sessions.
An FBI official, who spoke on condition of anonymity because of the sensitivity of the matter, said that in retrospect, the bureau underestimated how the involvement of the outside organization would be perceived.
As a result, said the official, there will be additional layers of review or approval on outside speakers.
The official added that bureau personnel organizing training courses were trying to bring in a variety of views they thought would be helpful to investigators.
Bresson, the bureau spokesman, said that the invitation to Westboro "was done in an effort to establish open dialogue in an academic setting to train law enforcement on how to more effectively engage with the activist community."
The training, Bresson said, was not only for FBI agents but for police executives from around the country — for whom an open line of communication becomes important at critical times during rallies or protests around the country where there might be a potential for violence and police officers might be called on to respond.
Fuck! It really is Glenn Beck! Beware the Beck Beast! No wonder he is leaving Fox (btw, so is MySpace, at a loss of about a 1/2 billion dollars to NewsCorp), he has a bigger beast to build. Beck could easily have taken Myspace (what's he worth, about $300m?) and turned it into his portal of perpetration (MyFaith, MyBeast, for example). But I guess his very own brand name trumps that of the present day MySpace anyway, so why bother. Well, at least Murdoch has his newspapers, lol. I wonder how charging online subscriptions is working for them? In all honesty, I considered buying News Corp. in the $6 pps range a few years ago, but didn't get enough financial stats on them (Yahoo didn't have much data), and then just moved on. Unfortunately, so did the stock, which has settled in the $18-$19 range. They are certainly smart enough to balance out their programming with shows like Family Guy, The Simpsons, even Married With Children back in the day.
So what were we talking about? The devil and gays? Oh yes, let the satanspeak fly.