One of the most troubling
lapses — a problem the report labeled “critical” — involved a drug known as
ozanezumab, which was being developed to treat patients with multiple sclerosis
and Lou Gehrig’s disease.
The report revealed that
the drug’s project leader belatedly learned the results of three studies of
ozanezumab in mice. During their investigation, auditors came across six
studies whose results had not been reported, even though early trials in humans
were already under way.
Reporting such information
is crucial, ethicists said, because animal studies can identify safety risks
and are among the main factors drug companies use to decide whether to pursue
human trials.
“If that’s true, it’s a
mortal sin in research requirements,” said Arthur L. Caplan, the head of the
division of medical ethics at NYU
Langone Medical
Center
Avandia:
Looks like GlaxoSmithKline has now settled: NY Times
Published: November 3, 2011
The British drug company GlaxoSmithKline said Thursday that it had agreed to pay $3 billion to settle United States
The settlement would be the largest yet in a wave of federal cases against pharmaceutical companies accused of illegal marketing, surpassing the previous record of $2.3 billion paid by Pfizer in 2009. In recent years, drug companies have been prime targets of federal fraud investigations, which have recovered tens of billions of dollars for Medicaid and Medicare.
The cases against GlaxoSmithKline include illegal marketing of Avandia, a diabetes drug that was severely restricted last year after it was linked to heart risks. Federal prosecutors said the company had paid doctors and manipulated medical research to promote the drug.
It is sad that the warnings came from one of the most respected Clinics and it took so many years and so many deaths before something was done.
In The Cockroach Catcher, Dr Am Ang Zhang had an interesting discussion with his Junior who had just transferred from one of the top London teaching hospitals:
“Do you agree that Leroy has Social Phobia ? Everything fitted in with the criteria in DSM IV.” My junior plucked up courage to ask me during supervision.
It was good to keep oneself on one’s toes with juniors who had just arrived from London
“What’s wrong with shyness?” I joked, “Do you want me to put him on SSRI (Selective serotonin reuptake inhibitors)?”
“It is supposed to work.”
“If he starts taking SSRI at thirteen, what is he going to do for the rest of his life?!”
“The newer short acting ones are supposed to be better.”
“Take one advice from me; think the opposite, the opposite to what the big Pharmas tell you. In pharmacology, shorter acting drugs are more addictive. That was what I learned in Medical School
“A report suggested that GlaxoSmithKline (GSK) knew about safety risks but failed to report them to the medicines safety watchdog for five years.”
The drug concerned is Paroxetine and in the UK marketed as Seroxat and in the US as Paxil.
“GSK submitted data from clinical trials to the MHRA in May 2003 showing that patients under 18 had a six or sevenfold increased risk of suicidal behaviour if they were treated with Seroxat than if they received a placebo. Data also showed that the drug was not effective for treating depression in children and adolescents. Leaked documents suggested that GSK had known about these results as early as 1998.”
Keen eyed bloggers would have noticed Paxil CR in a previous posting of mine about how GlaxoSmithKline had all their Paxil CR and Avandamet seized in the U.S.
Now the story of Ribena has to be one of those sweet (sorry) stories one remembers for a long, long time.
Wagner, it would seem is as up to date as ever.
Four former GlaxoSmithKline employees will share up to $250m (£159m) after their evidence helped US authorities secure a record settlement with the UK
Greg Thorpe, Blair Hamrick, Thomas Gerahty and Matthew Burke are in line to receive the payout under the Federal False Claims Act, a US law dating back to the Civil War that allows whistleblowers to receive a portion of money the government recovers when prosecuting fraud.
The dark side of the gods: (it is sometimes easier if one take GODS in the Ring to mean those in POWER. For the characters read here.) In fact, the gods need not work at all, the Nibelungs work almost all the time.
Disrespectful Wotan is hardly revered unanimously, and even he acknowledges higher authorities. Erda knows things he doesn't; his almost bureaucratic dominance derives solely from treaties engraved in runes on his spear, treaties to which he is subservient.
Born liarsCharacters lie as it suits them. Events are initiated by Wotan's spurious promise to the Giants to pay them by giving them Freia in exchange for building Valhalla , a promise he knows he cannot keep, as she is the indispensable symbol of love whose golden apples keep the gods alive. His shady ally, Loge, is defined as a double-dealing trickster. Brünnhilde breaks her promise to her father to allow Siegmund to be killed in combat. Mime makes dissembling a veritable life's work, ably carried forward by his nephew, Hagen, in Götterdämmerung.
Contemptuous
Brünnhilde disobeys Wotan, and his grandson Siegfried destroys his power. Mime, who raises Siegfried from infancy and even makes him toys, is treated with disturbingly cruel contempt by the bumptious hero. Hagen, whom Alberich sired via gold-empowered lust as a tool to retrieve the Ring for him, mutters that if he succeeds he will keep it, not hand it over to his Nibelung father.
Thieving & Misappropriation
……. misappropriation, of persons or of things, provides much of the plot machinery. First, Alberich plunders the Rhinegold, and afterward, theft of others' possessions, including the Ring, motivates action upon action.
……. misappropriation, of persons or of things, provides much of the plot machinery. First, Alberich plunders the Rhinegold, and afterward, theft of others' possessions, including the Ring, motivates action upon action.
Incest and other illicit sexThe teasing of Alberich by the Rhinemaidens which leads to his abjuring love--love, not lust. The definitive heroine, Brünnhilde, and her Valkyrie sisters are the offspring of an adulterous liaison between Wotan and Erda; Wotan also illegitimately fathers the Wälsung twins by a mortal. Sieglinde's infidelity is excoriated by marriage-goddess Fricka, as is her violation with Siegmund of an even more basic taboo, incest. But Wotan defends the twins ("…those two are in love") and, like most audience members moved by the ardent love music, views both transgressions kindly.
Homicidal
Fafner kills his brother Fasolt, the first victim of Alberich's curse, and we are off to the homicide races. Hunding slays Siegmund, only to be destroyed by Wotan's contempt. Siegfried kills Fafner, the Giant-turned-dragon, and then, after realizing that Mime is trying to poison him, kills him as well. By the time the gods' destiny climaxes, Hagen Valhalla 's proud-standing stronghold") and all the gods die.
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Greed, greed, greed!Finally, "coveting that which is your neighbor's" is pretty much the whole raison d'être for the Ring story, starting with Alberich's desire for the Rhinemaidens, then for the gold they guard. Thereafter everybody seems to want what doesn't belong to him or her: the Ring, a sword, a treasure, someone else's wife, sheer power.
Yet in spite of Wagner's wholesale abandonment of the Decalogue, the bastion of Western morality, Der Ring des Nibelungen generates explosive ethical and metaphysical impact. He started with the absorption, fusion and reinvention of myriad legendary sources, and layered Schopenhauer's philosophy upon Feuerbach's. In Art and Climate Wagner wrote, "there is no true freedom except that which is common to all mankind... The redeemer is therefore love… starting with sexual love, [it] strides forward through love of children, brothers and friends, to universal love of humanity." The emphasis is his. Yet, some years later he wrote to Mathilde Wesendonck, "I can conceive of only one salvation. It is Rest! ...The stilling of every desire!"
Wagner once wrote to Röckel, "I have come now to realize how much there is, owing to the whole weight of my poetic aim, that only becomes clear through the music." He later described the discontinuity between his "rationally formed ideas" and "the exquisite unconsciousness of artistic creation… guided by wholly different, infinitely more profound intuition."
Richard Wagner
Götterdämmerung
www.staatsoper.de
Götterdämmerung
www.staatsoper.de
Intermezzo Update: Just one of those Rings
The world of Götterdämmerung is the 21st century corporation, featuring an anonymous mass of business-suited Gibichungs in a flashy glass and steel edifice.
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