The Bells

I Hear the sledges with the bells- Silver bells! What a world of merriment their melody foretells! How they tinkle, tinkle, tinkle, In the icy air of night! While the stars that oversprinkle All the heavens, seem to twinkle With a crystalline delight; Keeping time, time, time, In a sort of Runic rhyme, To the tintinnabulation that so musically wells From the bells, bells, bells, bells, Bells, bells, bells- From the jingling and the tinkling of the bells. II Hear the mellow wedding bells, Golden bells! What a world of happiness their harmony foretells! Through the balmy air of night How they ring out their delight! From the molten-golden notes, And an in tune, What a liquid ditty floats To the turtle-dove that listens, while she gloats On the moon! Oh, from out the sounding cells, What a gush of euphony voluminously wells! How it swells! How it dwells On the Future! how it tells Of the rapture that impels To the swinging and the ringing Of the bells, bells, bells, Of the bells, bells, bells,bells, Bells, bells, bells- To the rhyming and the chiming of the bells! III Hear the loud alarum bells- Brazen bells! What a tale of terror, now, their turbulency tells! In the startled ear of night How they scream out their affright! Too much horrified to speak, They can only shriek, shriek, Out of tune, In a clamorous appealing to the mercy of the fire, In a mad expostulation with the deaf and frantic fire, Leaping higher, higher, higher, With a desperate desire, And a resolute endeavor, Now- now to sit or never, By the side of the pale-faced moon. Oh, the bells, bells, bells! What a tale their terror tells Of Despair! How they clang, and clash, and roar! What a horror they outpour On the bosom of the palpitating air! Yet the ear it fully knows, By the twanging, And the clanging, How the danger ebbs and flows: Yet the ear distinctly tells, In the jangling, And the wrangling, How the danger sinks and swells, By the sinking or the swelling in the anger of the bells- Of the bells- Of the bells, bells, bells,bells, Bells, bells, bells- In the clamor and the clangor of the bells! IV Hear the tolling of the bells- Iron Bells! What a world of solemn thought their monody compels! In the silence of the night, How we shiver with affright At the melancholy menace of their tone! For every sound that floats From the rust within their throats Is a groan. And the people- ah, the people- They that dwell up in the steeple, All Alone And who, tolling, tolling, tolling, In that muffled monotone, Feel a glory in so rolling On the human heart a stone- They are neither man nor woman- They are neither brute nor human- They are Ghouls: And their king it is who tolls; And he rolls, rolls, rolls, Rolls A paean from the bells! And his merry bosom swells With the paean of the bells! And he dances, and he yells; Keeping time, time, time, In a sort of Runic rhyme, To the paean of the bells- Of the bells: Keeping time, time, time, In a sort of Runic rhyme, To the throbbing of the bells- Of the bells, bells, bells- To the sobbing of the bells; Keeping time, time, time, As he knells, knells, knells, In a happy Runic rhyme, To the rolling of the bells- Of the bells, bells, bells: To the tolling of the bells, Of the bells, bells, bells, bells- Bells, bells, bells- To the moaning and the groaning of the bells. by:Edgar Allan Poe

Speechless

i spent all the night watching this album,from United States Holocaust Memorial Museum Photo Archive

This one is taken by Hessisches Hauptstaatsarchi

The following note is tagged: 

"Women and children lost their lives as victims of mass executions. This photograph shows a mother and her two children, as well as several hundred others, just before the mass shooting at Lubny, Ukraine, on October 16, 1941. "

The brutal truth left me speechless;the image will deliver the desperate cry through halls of history.

پیکره های سرد

بیشتر از هر دوستی

در سخت ترین لحظات

بدون هیچ چشمداشتی

کنارم ایستاده اند

پیکره های سرد

...هیچگاه تنها نخواهم بود

تو و ادعای انسانیت.

انها و دست یاریشان

.را به خدا می سپارم

In Pestilence,Burning

Where the silence moves with every beast.
Beneath them sits the wrath of their sickness
No Mercy,
No Pity,
Wind swept sands of the blistering light.
Farewell greenfields and birds of flight...

They dream on banks of summer beyond the beauties of the world.
When jealousy shall shadow thou woeful plague.
Pestilence burning seized with the tears of dying children.
I am nothing in rapturous trance... 


Evoken

Regulatory Action on Rosiglitazone

There have been ongoing concerns about the safety of the diabetes drugs containing rosiglitazone (Avandia, Avandaryl, and Avandamet) — a thiazolidinedione antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

In 2007, a meta-analysis of controlled clinical trials found increases in the risk of myocardial infarction and a near-significant increased risk of death from cardiovascular causes when rosiglitazone was compared with placebo or with standard diabetes drugs. Following an advisory committee meeting held in July 2007, the U.S. Food and Drug Administration (FDA) added information about the possibility of ischemic cardiovascular risk to the drug’s existing boxed warning. At the same time, the FDA also required the sponsors to conduct a head-to-head cardiovascular safety trial of rosiglitazone versus pioglitazone — the other antidiabetic drug in this class available in the United States. After new data became available, the FDA held a second advisory committee meeting on rosiglitazone safety on July 13 and 14, 2010. On September 23, 2010, the FDA announced regulatory actions stemming from these deliberations.

The FDA is restricting access to rosiglitazone by requiring the drug sponsor to submit a Risk Evaluation and Mitigation Strategy, or REMS. Under the Food and Drug Administration Amendments Act of 2007, the FDA can require a drug sponsor to issue a REMS to impose certain restrictions so that the benefits of a drug continue to outweigh its risks. When the REMS for rosiglitazone is implemented, the drug will be available to patients not already taking it only if they are unable to achieve glycemic control using other medications and, in consultation with their health care professional, decide not to take pioglitazone for medical reasons. Current users of rosiglitazone will be able to continue using the medication if they appear to be benefiting from it and they acknowledge that they understand these risks. Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns. The agency anticipates that the REMS will limit use of rosiglitazone significantly.

The FDA is taking this step on the basis of its assessment of all available data on the cardiovascular ischemic risk of rosiglitazone. At the recent advisory committee meeting, FDA scientists and external experts presented new signals of risk from observational studies and meta-analyses. Each of these data sources has its limitations, including the potential for bias in observational studies and the fact that pooling the results of the studies that were not designed to assess cardiovascular risk can lead to invalid conclusions. But there was no reliable evidence to refute these cardiovascular safety concerns.

After considering the data, 18 members of the advisory committee found significant cause for concern about an increase in ischemic cardiovascular events with rosiglitazone relative to other non-thiazolidinedione antidiabetic agents, whereas 6 committee members did not. Twenty-one members believed that the cardiovascular risk with rosiglitazone was significant as compared with pioglitazone. Three members did not reach this conclusion. This 21-to-3 vote also reflected recognition that available evidence on pioglitazone, including the results of a well-designed trial in high-risk patients, does not show a signal of a cardiovascular ischemic risk.

The rosiglitazone controversy is remarkable because there are strongly held, differing positions on how the agency should respond to emerging safety data, both inside the FDA and in the biomedical community. The 2010 advisory committee was split in advising the agency about what to do. Moving from the least to most restrictive options, 3 members voted to allow continued marketing with no changes to the label; 7 voted that the FDA should adjust the label to account for the new concerns but take no additional action; 10 members voted for the FDA to both increase warnings and limit access to rosiglitazone; and 12 voted that the medication should be removed from the market altogether. The FDA decided to increase warnings and limit access to rosiglitazone substantially.

The FDA anticipates questions on whether the agency has gone too far, or not far enough.

Some may note the limitations of available data and argue that the FDA should provide more information to clinicians but not impose additional restrictions. The FDA’s response is that a label change alone does not provide adequate assurance that use of rosiglitazone will be limited to appropriate patients. New label warnings are not always read. The significant questions about the drug’s cardiovascular safety justify stronger measures to support good clinical decision making and protect patients.

Others may argue that rosiglitazone should be removed from the market because there is no predefined patient population for whom it is known that it will be more advantageous than pioglitazone. Our response starts with the fact that rosiglitazone does have benefits in glycemic control. These benefits include reductions in short-term complications of hyperglycemia. There is also a broad range of evidence supporting glycemic control as a reliable surrogate marker for decreasing the rate of progression of the microvascular complications of diabetes, including retinopathy and kidney disease.

Against these benefits, we must assess the evidence of rosiglitazone’s cardiovascular risks. This evidence is concerning, but it is not definitive. There are patients with severe type 2 diabetes whose disease may not be controlled on other medications and either may not tolerate pioglitazone or, in consultation with their health care professional, decide not to take pioglitazone for other medical reasons. If well informed, these patients may be willing to accept the concern about cardiovascular safety in exchange for the known benefits of glycemic control. The FDA recently announced that the agency is investigating further signals of a possible increase in the risk of bladder cancer with long-term use of pioglitazone. Although the absolute risk to all patients appears to be small, some patients with a history of bladder cancer, in consultation with their doctors, may decide not to take pioglitazone. When there are just two drugs in a class, and many outstanding uncertainties, maintaining some flexibility may have value for patient care.

The FDA will continue to review emerging data on rosiglitazone. The agency is requiring an independent readjudication of end points at the patient level of an important trial of rosiglitazone’s safety — the Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes, or RECORD, trial. As published, RECORD demonstrated the noninferiority of rosiglitazone when compared with sulfonylureas and metformin with respect to a composite end point of multiple cardiovascular events and death, but it did not rule out an elevated risk of myocardial infarction. However, during the course of the FDA’s review of the RECORD study, serious questions arose about potential bias in identification of cardiovascular events arising from the study’s open-label design. The FDA is requiring the readjudication of end points to provide additional clarity about the findings.

Other actions taken by the agency include the discontinuation of the trial known as TIDE (Thiazolidinedione Intervention with Vitamin D Evaluation) — the head-to-head cardiovascular safety trial of rosiglitazone versus pioglitazone. Given the current state of the evidence and the FDA’s recent actions, participants would need to be informed of significant concerns that rosiglitazone may cause more cardiovascular disease than pioglitazone, the restrictions on the use of rosiglitazone that will be imposed through the REMS, and that it is unlikely that, outside the study, the patient would receive rosiglitazone. According to recent recommendations from an Institute of Medicine committee, such an informed consent process might be justified if the study’s outcome could realistically yield a significant benefit to public health. At this point, however, the FDA does not consider TIDE such a study. It is possible that additional data, including information from the readjudication of RECORD, could support additional clinical trials of rosiglitazone safety.

How can the FDA prevent such uncertainty about a major risk from happening again? In 2008, the FDA issued draft guidance on the assessment of cardiovascular risk for new antidiabetic drugs. In this guidance, the FDA proposed upper boundaries for the risk of major cardiovascular events in a meta-analysis or a noninferiority study that compares the new drug with standard therapy. The FDA also recommends that the data for these comparisons come from longer-term trials — that is, trials of at least 2 years’ duration. Guidance represents the FDA’s current thinking on how to meet a specific requirement — in this case, demonstration of the safety of a new drug for this indication. Drug sponsors are free to use other methods to show safety, but such methods need to be equally robust. The expectation of longer-term evidence on the cardiovascular risks of new antidiabetic drugs will assure that such evaluations are routinely conducted and that longer-term data on multiple safety parameters are also available.

The case of rosiglitazone underscores the need for a robust evidence base to demonstrate the safety of medicines administered long-term. The FDA is committed to advancing the science of drug safety evaluation, during both drug development and in the postmarketing period.

My New albums

i tried to expand my music circulation by testing some novel prospects.I pursue this purpose in september and the result  was a handful of admirable albums . I think the most immense pleasure of it is due to the dynamism of art,particularly in music. There's a pessimist view to modern music ,considering the facts about financial aspect of record companies and the input/outcome imbalance which i understand. I believe free downloads will  ruin the industry and thats so heart-breaking . Yet  the free music streaming has a produce an unbelievable penetration which perfectly suites some amateur or underground musicians. i agree the current situation is desperate for those who are professionally involved in the context. It reminds me of a porcupine tree song "sound of muzak. Yeah,it's true one of the wonders of the world is going down .
After this preface it's time to introduce my new albums,actually i haven't focused on the new ones yet.My recent adventure mostly follows two distinct directions; slowcore/indie rock and doom metal less recognized subgenres.
1- Low : The Great Destroyer2005 : slowcore/indie trio from Minnesota


2-Land of Talk : Some Are Lakes2008: Indie rock band from Quebec,Canada


3-Soul Whirling Somewhere : Eating The Sea This is probably the most promising among my new album,a beautiful music by a one man project ;it's not easy to describe the sound of SWS it's a prestigious dreamy ambient with wide range of  influence from modern dark-wave to jazz music.


4-Pandors.box : Barriers2009 This is so exciting german rock band Archive.org describes the band :made up of five like-minded, old friends from the sticks of Lower Bavaria. The close ties between the eclectic personalities in this group have given rise to a totally different musical slant – a sound in perpetual search of the perfect equilibrium between a collective consciousness, personal gratification and the expression of higher emotions and ineffable common ideals. Their remarkable, sometimes even evasive space-rock sound has a sober tone which fabricates a feeling of a radically romantic aura that sets pandoras.box apart from the norm in today's indie landscape. It's no wonder that the band currently has a strong underground following of enthusiastic fans. Aggressive, gentle, depressive, sanguine, negative, positive, harmonious, cynical and always with a dash of irony: this band is full of contrasts. pandoras.box expresses a range of different moods and emotions in its chameleonic performances, yet in the end, a compelling, coherent ensemble is created which draws audiences in. 
5-The Fall of Every Season :Neglected's Motif  Norwegian death/doom metal band


6-Thy Sinister Bloom : Excellent doom metal band. i highly enjoyed  1996 EP Serein Falls. alas TSB disbanded in 1998 

John W Henry Seals Liverpool Takeover

New England Sports Ventures’ front man John W. Henry has revealed his delight after completing a £300 million takeover of Liverpool.

The 61-year-old, who also owns the Boston Red Sox baseball team, has reflected on the last week, which was bombarded with legal hurdles after former American owners Tom Hicks and George Gillett attempted to hold on to the Premier League club.

“It has been a dramatic few days, twists and turns, it's been stressful but finally we have it done and that was our goal and our hope," Henry told the club’s official website. "I'm extremely proud of this team that worked on this deal.

“We're incredibly pleased. Talking to all the partners in the States, they're extremely happy.”

The deal finally became official on Friday afternoon, however due to Hicks and Gillett’s legal accusations, Henry conceded he was not completely confident everything would go to plan and he admitted that, during the turmoil, he was worried NESV would be turned away from a sale.

He added: “There were many days where I was wondering whether or not we'd be going home. In fact, even today I wasn't a hundred per cent confident.

“There were days where I was confident but there were a lot of twists and turns here. It was a terrific team [Broughton, Ayre, Purslow] who did a tremendous job of managing this process and I'm just happy it ended successfully.”

The Illinois-born businessman revealed that similarities between the Boston Red Sox and Liverpool are what drew him into taking over the historic club.

“There are a lot of similarities and that was something we've been discussing as we started doing our due diligence. We found more and more similarities between Liverpool 2010 and the Red Sox of 2001.

“For instance the stadium issue was a big issue in Boston in 2001 and we went in there not knowing what we should do, whether we should build a new ball park or refurbish Fenway. We have the same issue here.

“We have to listen, learn, talk to the community, talk to the council, talk with the supporters, but the biggest issue of all is really what makes the most sense for Liverpool long term.”

The position of the club, on and off the field, has been dismal and Henry is under no illusion that it will be easy to bring back winning ways for the Reds.

He continued: “There's a lot of work to be done to get this club to where it needs to be in the grand scheme of things. We really, through all the work we've done over the last two months, saw the challenges and problems which exist and we've got to work to address those.

 “There is a great nucleus here off the field and on the field and we think we can build from that, but it's not going to be easy. We've got real challenges.”

While Liverpool fans have been welcome to the new owners, they have also expressed caution and uncertainty over another tenure of American ownership.

When Hicks and Gillet bought the Anfield outfit in 2007, promises were made by the duo that never came into fruition.

“It's been a tough three years and there were a lot of expectations created, so one thing I'm going to try not to do is to create a lot of expectations,” Henry admitted.

“I'm going to hopefully rather than make promises, deliver. When I say I, I mean New England Sports Ventures.

“We've got a very strong organisation, financially and otherwise, we have some terrific strategic thinkers and we're going to be attacking this head on starting tomorrow.”

“All I can say at this point is we're going to work as hard for you [Liverpool fans] as we possibly can and there's no doubt about it, you deserve it,” Henry continued.

“You have supported this club through the worst of times now and we're going to do everything in our power to make the supporters proud of their club and of us. It's a big challenge but I think we're up for that challenge.”


@GOAL.COM

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