Pay-to-Play Seroquel Research Scheme

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Pay-to-Play Seroquel Research Scheme

Postby seemslikeadream » Mon Jan 24, 2011 12:57 pm

Controversial Pill Now Marketed for Depression

Seroquel's Toll

By MARTHA ROSENBERG

Even though AstraZeneca's antipsychotic Seroquel is the fifth best-selling medication in the US according to drugs.com, exceeded only by Lipitor, Nexium, Plavix and Advair diskus, its safety, effectiveness, clinical trial and promotion records are highly checkered.

An original backer, psychiatrist Richard Borison, was sentenced to a 15-year prison sentence in 1998 for a pay-to-play Seroquel research scheme.

Its US medical director Wayne MacFadden had sexual affairs with two different women involved with Seroquel research, say published reports.

Chicago psychiatrist Michael Reinstein received $500,000 from AstraZenenca and wrote 41,000 prescriptions for Seroquel reports the Chicago Tribune and ProPublica.

Psychiatrist Charles Nemeroff who left Emory University in disgrace after a Congressional investigation for unreported pharma income, promoted Seroquel in continuing medical education courses according to the web site of psychiatrist Daniel Carlat.

Florida child psychiatrist Jorge Armenteros was chairman of the FDA committee responsible for recommending Seroquel approvals while a paid AstraZeneca speaker himself, said the Philadelphia Inquirer in 2009.

Psychiatrist Charles Schulz' high profile pro-Seroquel presentations are suspected of being colored by his AstraZeneca income says the Minneapolis Star Tribune.

And unexplained Iraq and Afghanistan troop deaths are linked to Seroquel reported the Associated Press in August.

Originally approved for schizophrenia in 1997, Seroquel has subsequently been approved for bipolar disorder, for some groups of kids and as an add-drug for depression. This "indications creep" has mostly flown below the public's radar. Seroquel expansion to treat children in late 2009, for example, was noted as a mere "label change" on the FDA web site. Hello?

Even without its depression indication, Seroquel is big business for AstraZeneca, earning $4.9 billion in sales in 2009. It is the drug that North Carolina's Medicaid spends the most on: $29.4 million per year, reports the Charlotte News and Observer.

But now, as AstraZeneca rolls out its "Still Trying to Get Ahead of Your Depression" campaign, there are new questions about Seroquel's safety and effectiveness.

According to an FDA warning letter, an AstraZeneca sales representative during an unsolicited sales call on January 3, 2008 sold Seroquel as a treatment for major depressive disorder to a physician before it was approved for MDD, an infraction which is illegal.

Once Seroquel was approved for depression (as an add-on treatment to an antidepressant for patients with major depressive disorder who not have an adequate response to antidepressant therapy), its leave-behind sheets drew another FDA warning letter.

AstraZeneca implied patients would achieve "remission" from depression with Seroquel XR (extended release) as opposed to with an antidepressant alone, says FDA -- a claim not backed up by clinical experience.

Seroquel's effect on depression has only been demonstrated in two, six-week trials FDA further said and six weeks is "not a long enough time period to adequately assess remission." (It was approved...why?)

Also the case study of "Catherine F." depicted in leave-behind sheets is inaccurate says FDA because it suggests Seroquel alleviates "symptoms of sadness and loss of interest when this has not been demonstrated by substantial evidence or substantial clinical experience." (It was approved...why?)

Even AstraZeneca's own briefing to the FDA committee in 2009 admits a "failed study" in which both Seroquel and Lexapro "failed to differentiate from placebo" which is Clinical Trial for "didn't work."

Nor did AstraZeneca adequately disclose Seroquel risks says FDA which include increased mortality in elderly patients with dementia-related psychosis, suicidality, neuroleptic malignant syndrome, hyperglycemia and diabetes mellitus, hyperlipidemia, weight gain and other serious side effects.

In fact, in addition to risks like cataracts, seizures and increases in blood pressure in children and adolescents, already on the Seroquel label, FDA asked AstraZeneca to add the "risk of EPS and withdrawal syndrome in neonates" a few months ago: movement disorders which can affect mothers' babies if the mothers are taking Seroquel and stop.

But the FDA might also look at what the government's other hand is doing. In May the Office of the Army Surgeon General's final report on the findings of its Pain Management Task Force unabashedly hawks Seroquel for an unapproved use.

"Physicians should consider these medications for sleep disorders," says the 163-page report," listing Ambien and Seroquel (quetiapine) "for nightmares" even though Seroquel has never been approved for insomnia, sleep disorders or "nightmares."

Maybe the government will send itself a warning letter.
Mazars and Deutsche Bank could have ended this nightmare before it started.
They could still get him out of office.
But instead, they want mass death.
Don’t forget that.
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Re: Pay-to-Play Seroquel Research Scheme

Postby 82_28 » Mon Jan 24, 2011 2:23 pm

I can tell you this. From what I was able to gather last week, they're handing Seroquel out in jail like it's candy.

The original is behind a paywall or something now. But I was able to find the text of a report published in the Rio Grande Sun in a forum. Can't find part 2 though.

Jail's Drug Program Spun Out of Control

(SUNfoto by Bryant Furlow) Rio Arriba County Jail Administrator Bidal Candelaria took over management of the jail in Spring 2006 as inmate drug prescriptions were rising sharply. Candelaria has worked at the jail for 27 years.



First of Two Part Series on Rio Arriba County's practice of spending thousands of dollars on powerful, and controversial, anti-psychotic drugs for inmates from 2004 to 2008
By Bryant Furlow
SUN Staff Writer
Published:
Thursday, May 14, 2009 1:02 PM MDT
The Rio Arriba County Jail spent more than $140,000 over five years to keep inmates sedated with dangerous and addictive psychiatric drugs, according to a Rio Grande SUN investigation.

The most commonly prescribed psychiatric drug was Seroquel, a powerful and possibly addictive anti-psychotic tied to increased risks of diabetes, seizures, nerve damage, hypothyroidism and blood clots, Jail Administrator Bidal Candelaria acknowledged and County documents show.

Jail documents, including staff memoranda and hundreds of pages of pharmacy billing records show that between 2004 and 2008, University of New Mexico psychiatrist Richard Barendsen was responsible for prescribing more than 20,000 doses of Seroquel and thousands of doses of Xanax and other psychiatric drugs to the inmates he saw at La Clinica del Pueblo de Rio Arriba in Tierra Amarilla. During those five years, the jail paid Rio Drugs of Chama $146,000 for Seroquel purchases alone, billing records show.

By late November 2007, nearly a third of the jail’s inmates were on Seroquel, Xanax or other psychiatric medications, according to a Jail staff memo.

But Barendsen wasn’t treating an epidemic of severe mental illnesses such as schizophrenia or bipolar disorder, the two brain diseases for which Seroquel is a federally approved treatment.

Instead, Barendsen readily admits, he was using the drug to sedate inmates and help them sleep.

At first, jail officials encouraged inmates to meet with Barendsen, according to former inmates, a former guard and Barendsen. But by late 2007, jail officials were growing concerned over mounting drug costs and “zombied” prisoners who slept for days at a time, according to former jail supervisor Lydia Garcia and a 2007 staff memo.

Costs were not the only concerns. Seroquel is a powerful and potentially dangerous drug. Just last month, a U.S. Food and Drug Administration panel deemed Seroquel too dangerous to approve its use as a first-line treatment for depression. But Barendsen said the clinic did not closely monitor inmates for side-effects (see sidebar).

Barendsen said he did not order blood tests to monitor inmates’ liver enzymes, which can become elevated by Seroquel, for example.

One inmate to whom Barendsen prescribed Seroquel, Lawrence Kaiser, died in February 2007 in a holding cell, of deep vein thrombosis and pulmonary embolism, potential risk factors of the drug, although it is unclear whether Seroquel caused his death. His wife has filed a lawsuit against Barendsen and the County over its alleged negligence in monitoring his medical condition (see story on Kaiser's death under the County tab on this web site).

DRUGMAKER DOWN-PLAYED RISKS

More than 15,400 patients are suing AstraZeneca in state and federal courts, claiming that Seroquel caused diabetes or other serious health problems, according to the firm’s 2008 annual report.

The federal Food and Drug Administration ordered AstraZeneca to more prominently list risks at the top of Seroquel labels in February, instead of burying safety warnings at the bottom of multi-page inserts. Among the risks AstraZeneca acknowledges for Seroquel are hyperglycemia, hypoglycemia, diabetes, seizures, hypothyroidism, suicidal thoughts, irreversible muscle tics, elevated cholesterol and loss of appetite. Seroquel can also cause Neuroleptic Malignant Syndrome, the drug’s warning label states — a potentially fatal disorder that can cause deep vein thrombosis and thromboembolisms, the types of blot clots noted in Lawrence Kaiser’s autopsy.

Despite those risks, the company has aggressively marketed the drug and sought federal Food and Drug Administration approval for its use as a treatment for additional disorders, like depression. But citing safety concerns and insufficient evidence that Seroquel is any more effective than other medications for depression, a panel of Administration scientists ruled against approving the drug as a stand-alone treatment for depression, last month.

First marketed in 1997, Seroquel has been prescribed to more than 22 million patients worldwide, according to AstraZeneca’s web site.

Under Administration regulations, drug companies are supposed to report evidence of side effects in a timely manner.

AstraZeneca did not return a call for comment. Another inmate who overdosed in the jail reported that he had ground up Seroquel pills and snorted them, Garcia said. Yet another developed diabetes while taking Seroquel — one of the drug’s leading known risk factors.

But none of the former inmates who were prescribed Seroquel and other drugs at the jail and who were contacted for this story were warned of potential side effects, they said.

One former inmate admitted that he buys Seroquel on the street in Española, and claimed he was not the only one to do so. Another former inmate, Jerome Abeyta, 45 — who jail records list as having been prescribed Xanax while an inmate — died of a drug overdose just weeks after his April 2008 release. Abeyta died of an overdose involving a lethal mixture of Xanax, alcohol, morphine, codein and methadone, a toxicology report states.

Abeyta’s death was one of four Xanax-involved overdose deaths in the County in 2008. (There have been no confirmed Seroquel overdose deaths in the County, according to data from the state Office of the Medical Investigator, but elsewhere in New Mexico, at least 43 accidental overdose deaths involving Seroquel are listed in an Office database. See sidebar in story on Kaiser's death under the County tab on this web site)

“Jerry said some of the best drugs he ever got were in that Jail,” Abeyta’s brother Jeffrey recalled. “The drugs he was prescribed didn’t help him. They made things worse. It was easy for him to get them and stay high. He didn’t get clean during his time in the Jail.”

Barendsen refused to discuss individual cases, but expressed regret that La Clinica had not more closely monitored his patients.

“I think we could’ve avoided some situations if we did a better job of seeing people,” Barendsen said.

At least some of Barendsen’s patients at the jail didn’t really need Seroquel at all, Barendsen said. Instead, Barendsen believes they were trying to obtain pills for abuse or trade in the jail, he said.

Still, he continued to prescribe powerful anti-psychotics to more patients each year.

The University abruptly ended Barendsen’s work with the jail in August 2008 without explanation. Barendsen would not explain why his work was halted; but Candelaria said the University had become nervous about Kaiser’s lawsuit. The County hired two Santa Fe-based psychiatrists to work with inmates starting in August 2008.

But by Barendsen’s own admission, he continues to prescribe Seroquel to many La Clinica patients through a deal with pharmaceutical giant AstraZeneca. AstraZeneca provides free prescriptions of Seroquel to low-income patients.

The jail’s new psychiatrists, Jonathan Beamer and E.J. Neidhardt “occasionally” prescribe Seroquel to inmates, but only after other medications fail, Beamer said. This is supported by a recorded drop-off in Seroquel purchases since Barendsen’s departure, County documents show.

But Barendsen has an explanation for why he prescribed so many powerful drugs to inmates.

Some are skeptical of that explanation, but it just might deserve serious consideration, a critic conceded, because — if true — Barendsen’s prescriptions represent a damning indictment of Northern New Mexico’s culture of violence.

Worried

On October 26, 2007, Rio Arriba County jail Administrator Bidal Candelaria was worried.

He had just received a memo from Assistant Administrator Larry DeYapp. The cover letter’s subject line read, “Research you requested.”

Of the 112 inmates in the jail that month, 48 were on prescription medications, DeYapp reported in the memo.

Of those, 33 inmates — close to a third of the inmate population — were taking psychiatric medications, in most cases Seroquel or Xanax, the memo states. Fourteen inmates had been prescribed both drugs.

Xanax’s side effects can include suicidal thoughts, aggression and rage, slurred speech and hallucinations, according to the federal Food and Drug Administration.

At least one inmate, Manuel Gutierrez, was prescribed Xanax, Seroquel and Valium — three powerful sedatives, jail documents state.

Three other inmates were prescribed Hydrocodone, an addictive opiate.

Seven former inmates who were prescribed Seroquel and other drugs – and Garcia, whose job included dispensing the pills — said the jail was awash in powerful prescription drugs.

“I kept thinking, the whole jail’s on this stuff,” Garcia said.

Garcia was the target of a state narcotics task force jail raid in September 2007, leading to her firing by Candelaria. No charges were ever brought against Garcia. The raid had resulted from a series of inmate overdoses, including one in which an inmate said he had ground up and snorted Seroquel pills.

“Every hand at the TA jail had Xanax or Seroquel or Valium,” Gutierrez said. “A guard told me if I had problems sleeping or anything to go to Dr. Barendsen.”

Gutierrez refused to say which guard made the comment. But inmates needed little coaxing to seek out Barendsen. Former inmates described Seroquel-induced vivid and colorful dreams.

“It’s definitely very habit-forming,” said one former inmate who was prescribed Seroquel and requested that his name not be used for this story. “In between prescriptions everybody had insomnia and withdrawals.”

One former inmate said he developed diabetes after six months of taking Seroquel. Like all of Barendsen’s patients contacted for this story, the inmate said Barendsen never warned him of Seroquel’s dangers; he only learned that Seroquel can cause diabetes after his release, while surfing the Internet, he said.

Another former inmate readily admitted that he now buys Seroquel on the street in Española.

“Barendsen had me on 60 mg of Valium a day plus 300 mg of Seroquel and 50 mg of Wellbutrin,” Jason Armenta, 28, said. “I gained 20 pounds. He never warned me about any diabetes risks. He just said I’d be hungry and prescribed extra snacks from the kitchen.”

Candelaria acknowledged that Barendsen would prescribe extra meals to inmates taking Seroquel.

“Hey, that happens,” Candelaria said. “As long as there’s a prescription, I don’t have a problem with it.”

Before ending his work for the jail in August, Barendsen slowly weaned the inmates off Seroquel, according to Candelaria.

“The University pulled him out of the jail after they learned they were being sued (over Kaiser’s death),” Candelaria speculated.

Once Barendsen stopped seeing inmates, Seroquel prescriptions fell off sharply. By November 2008 — just a year after DeYapp’s memo — only seven orders for Seroquel were made by the Jail.



Diversion

Standing in the jail’s small pharmacy dispensary, DeYapp showed how prisoners are watched by a guard as they swallow their pills, and then show the guard that both their mouth and the cup in which they were given the pills, are empty.

“We track the pills because they’re highly in demand,” DeYapp said. “Only shift supervisors have a key to the medicine (cabinet). They see ‘em take it.”

DeYapp then pulled his cheeks open using his index fingers, like a child making a face out the school bus window.

“Then mouth, fingers, they show that they swallowed the pills,” DeYapp said.

But the system’s far from perfect, DeYapp admitted.

“Some of these guys are real slick,” DeYapp said. “One guy, I thought he’d swallowed and was good to go, but he’d dropped the pill onto his toe. They’re magicians. We try to get two guards to watch them, but we can’t do everything.”

And the video camera mounted on the ceiling in the dispensary’s ceiling only documents which inmates were given medications, DeYapp and Candelaria said. The videotaping of security cameras cycles through all of the jail’s 44 cameras each second, leaving video images from each individual camera choppy and unlikely to catch a split-second sleight-of-hand that allowed inmates to smuggle medicines out of the dispensary.

Former inmates confirmed that guards were routinely tricked.

“We started fake fights,” Armento said. “All you need is two seconds for the guard to look away and you pocket the pills. Everybody kept them. Kept them in the cup, in your cheek. People would trade for Seroquel.”

Some inmates who are on medication are forced to smuggle pills out to others or face physical abuse, DeYapp said.

“They get punked out for pills when they get back,” DeYapp said.

Asked how frequently pills are discovered in contraband searches known as shakedowns, DeYapp looked to Candelaria, his boss, before answering.

“We tend to find them,” DeYapp said. “A lot of them show up in blankets.”

Not Safe

AstraZeneca reported Seroquel sales of nearly $4.5 billion in 2008, according to Securities and Exchange Commission filings, and tried in April to expand its government-approved uses to include depression. But citing safety concerns, a U.S. Food and Drug Administration panel refused April 10, 2009, to approve Seroquel’s use as a first-line treatment for depression.

Two and a half years after DeYapp delivered his memo, Candelaria was still reluctant to talk about it. Asked about the memo and hundreds of pages of jail pharmacy bills he had disclosed in response to a public records request, Candelaria paused to sigh before answering.

“Listen, I don’t practice law or medicine,” Candelaria said. “I don’t second-guess our doctors. Dr. Barendsen is a great guy, a good doctor. But was I worried? Yes.”

Candelaria is proud of the jail’s substance abuse recovery program. But inmates who are on narcotics couldn’t participate, he said.

And each year, it seemed to Candelaria that more of them were taking powerful – and expensive — psychiatric drugs. That’s why he had asked DeYapp and jail staffers to tally how many inmates had such prescriptions.

“At one point, Seroquel was 80 percent of our pharmacy cost,” Candelaria said.

In 2004, the jail purchased Seroquel from Rio Drugs in Chama just 76 times, jail records show, at a cost of $8,300. But by 2007, there were 899 Seroquel purchases, costing the jail more than $47,000, records show (See graphs).

Calls to Rio Drugs Pharmacist Sandra Abeyta and AstraZeneca were not returned.

When the University told Barendsen to stop seeing inmates during his weekly one-day visits to La Clinica, the doctor began weaning patients off Seroquel, Candelaria said.

“Our costs went way down,” Candelaria said.

Barendsen would neither confirm nor deny that he had weaned patients off the drug.

Asked whether all of those Seroquel prescriptions he prescribed to Rio Arriba County Jail inmates had been for seriously mentally ill individuals with schizophrenia or bipolar disorder — the disorders for which the U.S. Food and Drug Administration has approved Seroquel as a treatment — Barendsen offered a surprising response.



In final part of this series, Barendsen provides a surprising explanation for why he prescribed Seroquel so frequently to County Jail inmates. The second part also takes a look at the use of Seroquel in jails across the state.
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Re: Pay-to-Play Seroquel Research Scheme

Postby Nordic » Mon Jan 24, 2011 10:24 pm

Jesus Christ. Seroquel is nasty business. They have no business giving it to children, and certainly not to treat depression, my God.

Then there's the weight gain. They're trying to tell me that women who take Seroquel aren't gonna be even more depressed when they've gained 100 pounds (or more!)?

Big Pharma is simply out of control. They are amoral, immoral, irresponsible, greedy and sociopathically dishonest. And then there are their bad traits. Somebody needs to reign these assholes in.
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Re: Pay-to-Play Seroquel Research Scheme

Postby Occult Means Hidden » Tue Jan 25, 2011 6:52 am

I hear you Nordic. It's infuriating and grotesque.



Even without its depression indication, Seroquel is big business for AstraZeneca, earning $4.9 billion in sales in 2009. It is the drug that North Carolina's Medicaid spends the most on: $29.4 million per year, reports the Charlotte News and Observer.



Ugh!
Is Exercise a Treatment for Clinical Depression?

Research has shown that exercise is an effective but often underused treatment for mild to moderate depression.



http://www.webmd.com/depression/guide/exercise-depression

A brisk 30-minute walk or jog three times a week may be just as effective in relieving major depression as are standard antidepressant drugs, researchers have found.

In the study, 156 patients diagnosed with major depressive disorder (MDD) were assigned to three groups: exercise, medication, or a combination of medication and exercise. To the surprise of the researchers, after 16 weeks all three groups showed similar--and significant--improvement in measurements of depression.



http://www.hdlighthouse.org/see/diet/triad/exercise/duke.htm

All that wasted money. Not just to fight depression but the oncoming of other health problems. I'm willing to bet a vast majority of people do not exercise as much as they should. I certainly didn't years ago when I was at a major low.
Rage against the ever vicious downward spiral.
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Re: Pay-to-Play Seroquel Research Scheme

Postby Nordic » Tue Jan 25, 2011 10:35 am

Sure! It's no coincidence in my own life that I didn't need antidepressants until I had to give up running every day.

But no, let's give people dangerous drugs instead.

Nobody's even mentioned the danger of getting diabetes from the long-term use of these.
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Re: Pay-to-Play Seroquel Research Scheme

Postby Gnomad » Tue Jan 25, 2011 11:51 am

Yes, it was mentioned in the quoted stories, several times ;)
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Re: Pay-to-Play Seroquel Research Scheme

Postby nathan28 » Tue Jan 25, 2011 2:34 pm

Nordic wrote:Jesus Christ. Seroquel is nasty business. They have no business giving it to children, and certainly not to treat depression, my God.


I don't have a problem with psychiatric medication, in fact, a lot of it is good. But Seroquel is a piece of shit.

Quetiapine is a dopamine, serotonin and adrenergic antagonist and a potent antihistamine with clinically negligible anticholinergic properties.


In laymen's terms, this means you'll be dull-witted, hungry, unmotivated and fat when you aren't asleep. Compare that broad spectrum of impacts to most any other psychiatric drug, almost every other major one on the market targeting a much more specific pathway/function.

My current theory is that Seroquel and Ambien represent intellectual property gone mad. Most of the effective psychiatric drugs are very old now, making them subject to manufacture as generics at half the price. You have the "XR" thing, which uses inactive binding compounds that cost more than the drug itself to make it dissolve slowly in your gut, to triple prices. Not that there isn't value in that, but 3x the $$$ to take one capsule instead of three tablets? Really? You have drugs like Seroquel and Ambien, which are "atypical" and less effective than "typical" (i.e., well-understood) drugs in their class. In fact, Seroquel targets so many pathways you could prescribe it for multiple purposes, i.e., re-brand quetiapine as several different products (see, e.g., Wellbutrin and Zyban).
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Re: Pay-to-Play Seroquel Research Scheme

Postby 82_28 » Tue Jan 25, 2011 3:37 pm

I think you may have meant Abilify, nathan. Not Ambien. Abilify like Seroquel are both atypical antipsychotics.

Last year were all the ads for Abilify that one may want to add to their ssri. This year it's been all Seroquel.

Astro-Zeneca May be Able to Help!
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Re: Pay-to-Play Seroquel Research Scheme

Postby nathan28 » Tue Jan 25, 2011 4:15 pm

82_28 wrote:I think you may have meant Abilify, nathan. Not Ambien. Abilify like Seroquel are both atypical antipsychotics.

Last year were all the ads for Abilify that one may want to add to their ssri. This year it's been all Seroquel.

Astro-Zeneca May be Able to Help!



No, I meant Ambien, too, as another "atypical", but Abilify would have been a better choice.

I have to wonder if most of the time these aren't targeted at GPs rather than psychiatrists, who actually tend to realize that their patients' neurochemistries involve a lot of idiosyncratic treatments and adjustments in a careful, rather than scattershot "get out of my office" manner.
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Re: Pay-to-Play Seroquel Research Scheme

Postby undead » Tue Jan 25, 2011 6:44 pm

Nobody's even mentioned the danger of getting diabetes from the long-term use of these.


That's the whole point of psychiatric drugs, to make the "patient" a fat lump of diabetic cholesterol so that they can increase the market for their diabetes and cholesterol drugs. After spending the rest of your life paying them, they hope you will kill yourself or die an early death and reduce the population.
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Re: Pay-to-Play Seroquel Research Scheme

Postby cptmarginal » Tue Jan 10, 2017 2:01 pm

Biotech Company Moderna Raises $450 Million - January 5, 2015

http://www.forbes.com/sites/matthewherp ... ine/print/

Jan 9, 2017

Mysterious $5 Billion Biotech Firm Moderna Lays Out Drug Pipeline

Matthew Herper, Forbes Staff

Moderna Therapeutics, based in Cambridge, Mass., has raised $1.9 billion at a valuation approaching $5 billion–higher than most publicly traded biotechnology companies. But the company is so secretive that until now the company didn’t even disclose what most of the drugs and vaccines it is developing are meant to do.

Today, at the J.P. Morgan Healthcare Conference in San Francisco, Moderna is unveiling new details about its pipeline and strategy.

The company now has five vaccines in clinical trials. Two are for strains of influenza that could become pandemic, for which governments might want to stockpile vaccines. Another is for Zika virus, and a fourth, being developed with AstraZeneca, would treat heart attacks disease. The goal of a fifth, being developed with Merck, is not being revealed. Another vaccine, for Chikungunya virus, a mosquito-transmitted disease, is ready to start trials.

The flu vaccines are an interesting strategic gambit. Neither is likely to become a product, although governments may want to stockpile them, according to Stéphane Bancel, Moderna’s chief executive officer and a 10% stockholder in the company. But they provide an early chance to prove that Moderna’s basic technology works.

“We picked those two because we were not interested in solving for what’s the biggest [net-present value] product,” Bancel says. “We are solving for how quickly can we learn.”

Influenza vaccines can be approved by the Food and Drug Administration based on whether they lead the body to create antibodies for the virus strain they are meant to inoculate against. Both of these flu viruses are strains that patients have not been exposed to. Therefore, these studies will serve as a test not only of the safety of Moderna’s technology, but of its efficacy.

That’s key, because Moderna is doing something new: making drugs that are made of messenger RNA, a key chemical courier that takes the genetic messages encoded in genes to parts of the cell where they are made into proteins, the building blocks of life and the targets of most drugs. This has led to big collaborations with Merck, AstraZeneca and Alexion.

Other drugs in development look more likely to result in paydays: a personalized cancer vaccine from Merck, an immunotherapy Moderna is developing on its own, and a treatment for heart attacks being developed with AstraZeneca.

One big question raised by a lawsuit covered by FORBES last year: How is Moderna getting this RNA into the body? That can often be a problem, and a lawsuit between Moderna’s partner, Acuitas, and Arbutus Biopharma, a hepatitis C-focused biotech, revealed Moderna was using their tech, called a lipid nanoparticle, to deliver many of its drugs.

Today’s release gives more detail. The five drugs in the clinic use licensed technology, as does the Chikungunya virus vaccine. Four of those are likely to be the Acuitas-Arbutus tech; the fifth, the Merck drug, may well use a Merck lipid nanoparticle. But remember, two of those are not likely to become products. All of Moderna’s future products either don’t use a nanoparticle (the AstraZeneca heart attack drug), or use one of Moderna’s nanoparticles, called N1G3L and V1G3L.

That still leaves the question of why Moderna is using nanoparticles, an old tech. Is there nothing better? RaNA Therapeutics, another Cambridge company doing RNA drugs, says it has a new, undisclosed technology for delivering them in addition to nanoparticles. But, then again, Moderna has something else: the company says that it has $1.3 billion in the bank, enough to fund a great many experiments.


AstraZeneca Makes a Bet on an Untested Technique - MARCH 21, 2013

Other previous references and discussion here:

AstraZeneca site:rigorousintuition.ca

Let’s take a look at the trustees of Jimmy Savile’s charities, namely the Jimmy Savile Charitable Trust and the Jimmy Savile Stoke Mandeville Charitable Trust.

Both charities now have the same group of three trustees, namely:

[...]

Lady Gabrielle Greenbury (replaced James Collier at the JSSMCT in March 2012)

She’s married to Richard Greenbury, who was CEO at Marks and Spencer from 1988 to 1999, chairman of the pharmaceutical company Astrazeneca (giving his wife an obvious conflict of interest in her role as trustee of the said charities), and a director of Lloyds TSB. Gabrielle Greenbury was also a director of the dodgy security company Sabrewatch.
The new way of thinking is precisely delineated by what it is not.
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