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Javelin .....
Defective Medicines Report Centre
Market Towers
1 Nine Elms Lane
London
SW8 5NQ
Telephone: +44 (0)20 7084 2574 Fax: +44 (0)20 7084 2676
MHRA Distribution:
Regional Contacts for NHS Trusts and Provider Units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to Independent Health Care Establishments
Primary Care Trusts (England)
Page 1 of 3
D R U G A L E R T
CLASS 2 MEDICINES RECALL
Action within 48 hours
Hospital, wholesaler and clinic level recall
Date: 21 May 2010 EL (10)A/11 Our Ref: MDR 41-05/10
_________________________________________________________________________
Dear Healthcare Professional,
Therabel Pharma UK Ltd
Dyloject Vials 75mg/2ml
Diclofenac sodium
PL 25053/0001
Product in Javelin Pharmaceuticals UK and Therabel Pharma UK
Liveries
Therabel Pharma UK Ltd are recalling all remaining stock of batches listed in Appendix 1.
The majority of batches are in Javelin Pharmaceuticals UK livery but one batch is in
Therabel Pharma UK livery.
These batches may be contaminated with small amounts of white particles. The particles
are not readily visible and work is ongoing to determine the nature, size and risk posed by
this contamination. In order to minimise risk to patients, all remaining stock is being
recalled.
A review of Pharmacovigilance information, carried out by the Marketing Authorisation
holder, does not appear to indicate any detected safety concerns and these batches have
been in use since 2008. However, as the contamination is not readily visible it could be
missed during normal checks prior to administration.
We understand this product is mainly used in a hospital environment and recipients are
asked to check ward and clinic stocks and withdraw any of the listed batches.
Page 2 of 3
Date: 21 May 2010 EL (10)A/11 Our Ref: MDR 41-05/10
Stock should be returned via the original wholesaler for credit. For stock return and
general enquiries please call Therabel Pharma UK Ltd on 01223 257759.
For medical information enquiries please call Therabel Pharma UK Ltd Medical
Information on 0800 066 5446.
Recipients of this Drug Alert are requested to bring it to the attention of relevant
professionals by copy of this letter. Primary Care Trusts are asked to forward this
document to relevant clinics.
Yours faithfully
Ian Holloway
DMRC Manager
Page 3 of 3
Date: 21 May 2010 EL (10)A/11 Our Ref: MDR 41-05/10
Appendix 1
Dyloject Vials 75mg/2ml for recall – all packs 10 X 2 ml vials
Batch Livery Date of Manufacture Expiry Date Date First Distributed
D7004 Javelin 12/2007 05/2010 14/08/2008
D7005 Javelin 12/2007 05/2010 27/10/2008
D8001 Javelin 02/2008 07/2010 13/02/2009
D8003 Javelin 02/2008 07/2010 12/12/2008
D8006 Javelin 04/2008 09/2010 02/04/2009
D8007 Javelin 04/2008 09/2010 15/06/2009
D8008 Javelin 04/2008 09/2010 12/05/2009
D8009 Javelin 04/2008 09/2010 15/07/2009
D8010 Javelin 04/2008 09/2010 20/10/2008
D8011 Javelin 05/2008 10/2010 19/08/2009
D8012 Javelin 05/2008 10/2010 21/09/2009
D8014 Javelin 07/2008 12/2010 16/11/2009
D8015 Javelin 07/2008 12/2010 19/10/2009
D8016 Javelin 08/2008 01/2011 08/12/2009
D8018 Javelin 08/2008 01/2011 12/01/2010
D8019 Javelin 08/2008 01/2011 09/02/2010
D8020 Javelin 09/2008 02/2011 04/03/2010
D8021 Javelin 09/2008 02/2011 29/03/2010
D8022 Javelin 09/2008 02/2011 26/04/2010
089001 Therabel 09/2009 02/2012 28/04/2010
Additional information
The single Therabel batch number is an all-numeric format.
pgs
I have a friend that is big into accp. There are a lot of people with that get oral mucositis and this drug seems to prevent it before it starts. why wouldn't it be a big drug.
And you are correct I have seen a lot of products in that space, and they always say this one has the advantages, and then they never sell.
I have seen other product that can't be swallowed only gargled. It seems that you can actually drink this one. Would that make a difference?
UPDATE 1-Drug may prevent lung cancer, US study finds
6:54pm EDT
so is the idea to spend 50 thousand a year to everyone that quits smoking for the rest of their lives
* Study involved drug already used for other ailments
* Current smokers did not show significant improvement (Adds details on Tarceva, paragraphs 15-20)
By Maggie Fox, Health and Science Editor
WASHINGTON, May 18 (Reuters) - A drug approved to treat a range of conditions may also work to prevent lung cancer in people who have given up smoking, U.S. researchers reported on Tuesday.
The drug, called iloprost, is approved in inhaled forms to treat pulmonary hypertension, when blood pools near the lungs, a connective tissue disease called scleroderma and a nerve condition called Raynaud's phenomenon.
Dr. Robert Keith of the Denver Veterans Affairs Medical Center and colleagues tested an oral version to see if it might prevent lung cancer in smokers and former smokers.
"Oral iloprost showed promise for preventing lung cancer in former, but not current, smokers in a phase II clinical trial," they wrote in a summary presented to a meeting of the American Thoracic Society in New Orleans.
Iloprost is a version of prostacyclin, a drug in the prostaglandin class that prevents lung cancer in mice.
Keith, who has been testing several drugs to prevent lung cancer, looked at biopsies taken from the lungs of 125 current and former smokers.
They treated half with placebo and half with iloprost, and then performed bronchoscopy examinations to assess precancerous changes in the lungs.
Six months later, "former smokers showed significant improvements on all measures, indicating that treatment with iloprost may reduce the risk of developing lung cancer among former smokers," the researchers said.
"Interestingly, current smokers did not show any significant improvements," they added.
"Oral iloprost significantly improves endobronchial dysplasia in former smokers and deserves further study to determine if it can prevent the development of lung cancer."
ITALIAN RESEARCH
Swiss drug maker Actelion <ATLN.VX> markets inhaled iloprost under the brand name Ventavis.
It is also sold in an intravenous form under the trade name Ilomedin by Schering, acquired by Merck <MRK.N>.
In April, researchers said a natural supplement derived from food, called myo-inositol, seems to stop the precancerous changes that lead to lung cancer.
Cigarette smoke causes 90 percent of all cases of lung cancer, which kills 1.2 million people a year globally. But only about 10 percent of smokers ever develop lung cancer, although they often die of other causes like heart disease, stroke or emphysema.
Separately, Italian researchers reported that advanced lung cancer patients given the targeted therapy drug Tarceva as so-called maintenance treatment -- after they finished a course of standard chemotherapy -- lived a little bit longer.
Federico Cappuzzo from Ospedale Civile di Livorno in Italy and colleagues did a phase 3 trial in 889 patients who had already had chemotherapy and whose tumors had not come back.
They received either Tarceva, a drug sold by Roche <ROG.VX> and OSI Pharmaceuticals <OSIP.O> and known generically as erlotinib, or a placebo until they got worse or died.
The patients who got Tarceva lived a little longer without their tumors growing -- 12 weeks versus 11 weeks on average and they lived a month longer on average -- 12 months versus 11 months.
This was seen even among patients who did not have the EGFR genetic mutation that Tarceva targets, they reported in Lancet Oncology.
Fewer than half of all lung cancer patients who do well after a first course of chemotherapy get more treatment, but the Italian group said their study shows this is worth doing.
(Reporting by Maggie Fox; Editing by Julie Steenhuysen and Cynthia Osterman
I just think there is very little that we (the govt) have been able to do about the spill, and the EPA sticks its noes in places that it doesn't belong that in this case they could acutally serve a purpose and they are saying we will let BP handle that.
The other product has been shown to be better and that is what should be used.
Everything isn't about money. Until this calamity I never heard about this company or was even interested in this subject, but we have a disaster of monumental proportions and anything that can be done to reduce the effects of the disaster should be looked at and a change in the depersion product should be on the top of the list, and something that can be easily done.
Maybe Momenta or Idenix has the answer. That would certainly get the board comments flowing
why is the EPA being so quiet about this.
Toxic Oil Dispersant Used in Gulf Despite Better Alternative
By Brandon Keim May 5, 2010 | 5:18 pm | Categories: Environment, Government
http://www.wired.com/wiredscience/2010/05/gulf-dispersants/
British Petroleum and government disaster-relief agencies are using a toxic chemical to disperse oil in the Gulf of Mexico, even though a better alternative appears to be available.
As the Deepwater Horizon oil spill spreads, BP and the U.S. Coast Guard have conducted tests with Corexit 9500, a chemical designed to break oil slicks into globules that are more quickly consumed by bacteria or sink into the water column before hitting shore.
The decision has been a controversial one. A few scientists think dispersants are mostly useful as public relations strategy, as they make the oil slick invisible, even though oil particles continue to do damage. Others consider Corexit the lesser of two evils: It’s known to be highly toxic, adding to the harm caused by oil, but at least it will concentrate damage at sea, sparing sensitive and highly productive coastal areas. Better to sacrifice the deep sea than the shorelines.
But even as these arguments continue, with 230,000 gallons of Corexit on tap and more commissioned by BP, a superior alternative could be left on the shelf.
Called Dispersit, it’s manufactured by the U.S. Polychemical Corporation and has been approved for use by the Environmental Protection Agency. Both Corexit and Dispersit were tested by the EPA, and according to those results, Corexit was 54.7 percent effective at breaking down crude oil from the Gulf, and Dispersit was 100 percent effective.
Not only did Corexit do a worse job of dispersing oil, but it was three times as lethal to silverfish – used as a benchmark organism in toxicity testing — and more than twice as lethal to shrimp, another benchmark organism and an important part of Gulf fisheries.
As for why Corexit is being used instead of Dispersit, authorities haven’t yet said. According to the Protect the Ocean blog, U.S. Polychemical executive Bruce Gebhardt said the government had used Corexit before, and was sticking with what it already knows. Corexit makes up most dispersant stockpiles in the United States for this reason, though dispersant manufacture can be easily ramped up.
In a 1999 letter, the U.S. Coast Guard told U.S. Polychemical that “product information from planning mode evaluations remain on file to facilitate rapid review in the context of a spill.” In that same year, the EPA added Dispersit to the National Oil and Hazardous Substances Pollution Contingency Plan, which determines what will be considered for use in an oil spill.
Relief agencies were not immediately available for comment about Dispersit. In a Tuesday press conference, Charlie Henry, the scientific support coordinator for the National Oceanic and Atmospheric Administration, said the potential effects of Corexit’s use in the Gulf are unknown. “Those analyses are going on, but right now there’s no consensus,” he said. “And we’re just really getting started. You can imagine it’s something we’ve never thought about.”
Image: Coast Guard workers spray Corexit on oiled rocks in Berkeley, California, in 2007./United States Coast Guard
Read More http://www.wired.com/wiredscience/2010/05/gulf-dispersants/#ixzz0o7wUm0iR
http://www.wired.com/wiredscience/2010/05/gulf-dispersants/
I own some MNTA
but the following should not give you much comfort, Sanofi has come out and said that they expect generic lovenox competition in their 2012-2013 #'s
If mnta doesn't get approval until late 2011 the stock will be a lot lower if there is a correction than it is now. that quote is the last one you should use to defend your position
Less Toxic Dispersants Lose Out in BP Oil Spill Cleanup
By PAUL QUINLAN of Greenwire
The epa is letting thousands of farmers go bankrupt in California to save a fish that looks like a sardine but they aren't forcing BP to use the more effective less toxic disperants. What am I missing here?
BP PLC continues to stockpile and deploy oil-dispersing chemicals manufactured by a company with which it shares close ties, even though other U.S. EPA-approved alternatives have been shown to be far less toxic and, in some cases, nearly twice as effective.
After the Deepwater Horizon rig exploded and a deepwater well began gushing crude in the Gulf of Mexico three weeks ago, BP quickly marshaled a third of the world's available supply of dispersants, chemicals that break surface oil slicks into microscopic droplets that can sink into the sea.
But the benefits of keeping some oil out of beaches and wetlands carry uncertain costs. Scientists warn that the dispersed oil, as well as the dispersants themselves, might cause long-term harm to marine life.
So far, BP has told federal agencies that it has applied more than 400,000 gallons of a dispersant sold under the trade name Corexit and manufactured by Nalco Co., a company that was once part of Exxon Mobil Corp. and whose current leadership includes executives at both BP and Exxon. And another 805,000 gallons of Corexit are on order, the company said, with the possibility that hundreds of thousands of more gallons may be needed if the well continues spewing oil for weeks or months.
But according to EPA data, Corexit ranks far above dispersants made by competitors in toxicity and far below them in effectiveness in handling southern Louisiana crude.
Of 18 dispersants whose use EPA has approved, 12 were found to be more effective on southern Louisiana crude than Corexit, EPA data show. Two of the 12 were found to be 100 percent effective on Gulf of Mexico crude, while the two Corexit products rated 56 percent and 63 percent effective, respectively. The toxicity of the 12 was shown to be either comparable to the Corexit line or, in some cases, 10 or 20 times less, according to EPA.
EPA has not taken a stance on whether one dispersant should be used over another, leaving that up to BP. All the company is required to do is to choose an EPA-approved chemical, EPA Administrator Lisa Jackson told reporters yesterday during a conference call aimed at addressing questions about dispersants being used in efforts to contain the Gulf spill.
"Our regular responsibilities say, if it's on the list and they want to use it, then they are preauthorized to do so," Jackson said.
One explanation for BP's reliance on Nalco's Corexit, which its competitors say dominates the niche market for dispersants because of its industry ties, was its availability in large quantities at the time of the Gulf spill.
"Obviously, logistics and stockpiles and the ability for the responsible party to pull the materials together," Jackson said. "I'm sure that has a lot to do with the ones that they choose."
Nonetheless, experts question BP's sustained commitment to Corexit, given apparently superior alternatives.
"Why wouldn't you go for the lesser toxic formulation?" said Carys Mitchelmore, an assistant professor of environmental chemistry and toxicology at the University of Maryland's Center for Environmental Science. Mitchelmore testified on Capitol Hill this week about dispersants and co-authored a 2005 National Academy of Sciences report on the chemicals.
BP spokesman Jon Pack defended the use of Corexit, which he said was decided in consultation with EPA. He called Corexit "pretty effective" and said the product had been "rigorously tested."
"I'm not sure about the others," Pack said. "This has been used by a number of major companies as an effective, low-toxicity dispersant."
BP is not considering or testing other dispersants because the company's attention is focused on plugging the leak and otherwise containing the spill, Pack said.
"That has to be our primary focus right now," he said.
Nalco spokesman Charlie Pajor said the decision on what to use was out of his company's hands. He also declined to comment on EPA comparison tests, saying only that lab conditions cannot necessarily replicate those in the field. "The decision about what's used is made by others -- not by us," he said.
Nalco's connections
Critics say Nalco, a joint partnership with Exxon Chemical that was spun off in the 1990s, boasts oil-industry insiders on its board of directors and among its executives, including an 11-year board member at BP and a top Exxon executive who spent 43 years with the oil giant.
"It's a chemical that the oil industry makes to sell to itself, basically," said Richard Charter, a senior policy adviser for Defenders of Wildlife.
The older of the two Corexit products that BP has used in the Gulf spill, Corexit 9527, was also sprayed in 1989 on the 11-million-gallon slick created by the Exxon Valdez grounding in Alaska's Prince William Sound.
Cleanup workers suffered health problems afterward, including blood in their urine and assorted kidney and liver disorders. Some health problems were blamed on the chemical 2-butoxyethanol, an ingredient discontinued in the latest version of Corexit, Corexit 9500, whose production Nalco officials say has been ramped up in response to the Gulf of Mexico disaster.
Among Corexit's competitors, a product called Dispersit far outpaced Corexit 9500, EPA test results show, rating nearly twice as effective and between half and a third as toxic, based on two tests performed on fish and shrimp.
Bruce Gebhardt, president of the company that manufactures Dispersit, U.S. Polychemical Corp., said BP asked for samples of his company's product two weeks ago. Later, he said, BP officials told him that EPA had wanted to ensure they had "crossed all their T's and dotted all their I's" before moving forward.
Gebhardt says he could make 60,000 gallons a day of Dispersit to meet the needs of spill-containment efforts. Dispersit was formulated to outperform Corexit and got EPA approval 10 years ago, he said, but the dispersant has failed to grab market share from its larger rival.
"When we came out with a safer product, we thought people would jump on board," he said. "That's not the case. We were never able to move anyone of any size off the Corexit product."
He added, "We're just up against a giant."
Copyright 2010 E&E Publishing. All Rights Reserved.
For more news on energy and the environment, visit www.greenwire.com.
Greenwire is published by Environment & Energy Publishing. Read More »
David Hung took three Dimebon's and remembered that those trials were on going and they should be halted.
the drug was good for something
The solution is not to slow down our markets but to speed up our protections. We need a real-time circuit breaker that, when things go haywire, will automatically halt trading in individual stocks before the damage is done. One approach would be similar to that used in Germany: If a stock drops 5% in less than five minutes, automatically halt trading. After humans examine the situation and figure out when it is safe to resume trading, they would then restart trading as soon as possible with the normal opening auction that is used to open stocks in the morning. Such a system would help to restore fair and orderly markets and prevent the inevitable trading glitches from cascading into monstrous market meltdowns.‹
the above is not the answer either. If someone sees some bad news earlier than anyone else and is fast enough to react to it, he is entitled to bring the stock down 5 percent or more in 5 minutes to avoid a larger loss which is what he would be subject to if the stock were halted for the above reason.
now I do believe that something is neccessary to avoid another meltdown. Maybe there should be a limit on the amount of money that can be used on any single trade, lets say 250 million dollars.
That could totally affect the value of a particular security but it would have a limited effect on the entire market.
any one that would complain about a limit like that would have to be told sorry sir or madame, If you need to sell 2.5 billion dollars worth of assets you will have to make ten 250 million dollar trades.
Genzyme Corporation [GENZ]
I guess Genz is turning into large pharma, when innovation dies, buy back stock.
Update from Analyst Day on May 6th; share buyback and planned
divestiture of low CFROI 'non-core' assets to boost EPS in >2010;
raising PT to $63 from $60.
To improve EPS, GENZ plans $2B share buyback (~14% of outstanding
shares; $1B in 2010) & to divest low ROI assets by YE. While
divestitures reduce top-line revenues, we estimate EPS accretion of
~5-6% in 2011-2015. This move is in line with proposal from R.
Whitworth, newly appointed board member/activist.
I was on the NYSE floor at about 2:00 today and there was a button that said DO NOT TOUCH.
I accidently bumped into it, and I couldn't believe the way the market started tanking. What was really unbelieveble was the people on the floor weren't speaking about the crash, it was just like this board. They were wondering why MNTA was down a point and a half
Who would have known?
maybe they just saw how not having a call didn't do anything to exude confidence in getting something done and they feel they owe it to the shareholders to reiterate the value of the pipeline
dew,
can you explain how the regulatory pathway for biogenerics helps. I think the new regulations hurt companies pursuing bio generics. The fda is asking for safety and efficacy studies. How do you recruit patients on a drug for a trial where the endpoint is that the efficacy is the same.
(I guess my question is why they held the ODAC in the 1st place if they were going to overide it no matter what)
Either their "blind trust" own some osip stock, or OSI used the same consultant as Vanda. He knows what to put in the brown paper bags he brings with him to the FDA lunch meetings
We are only going to get a year or two reprieve. We will catch up.
It will be a job killer and recession extender.
debt goes up so interest needs to go up, so inflation has to go up.
I really hope we do not turn into Zimbabwe, but high inflation is the great equalizer causing income distribution
Why has king been getting pounded, it can't be because of the Acura drug?
Thank you president Obama
The insurance premium from my plan increased from 1700 a month to 2100 a month.
when I first started with self employment I was paying insurance of about 1500 a month, which increased over the next three years by about 200 a month. Now because of healthcare reform it went up by 400 a month in one year.
up until now I figured I would pay a few hundred more for a good plan so I didn't need to worry about deductibles and things like that, because as long as I went in network most things were covered except for a copayment.
With an increase like this I will go for a cheaper policy with a higher deductible. I will probably end up saving money but it will be more of a hassle. I was willing to pay for convenience but not at these prices.
Study finds what many feared; needed savings will be elusive
that is a real shocker to anyone with half a brain
if you have anywhere from three quarters of a brain or more then you knew that healthcare reform was not about saving the system money. It was about government increasing their control over our lives
Rest assured that, if the Blues are lying, Washington is simply crawling with politicians who will jump on it, prove it, and use it as a reason for more legislation and regulation. If they are not lying, I expect the matter to fade away without a lot of media attention.
It will fade away after the insurance companies go bankrupt because their costs are going up and they will not be allowed to raise rates. You will get the one payer system, pretty soon.
from the DARPA website.
Fact Sheet
Defense Advanced Research Projects Agency
3701 North Fairfax Drive
Arlington, VA 22203-1714
http://www.darpa.mil/news/2009/AMPFactSheet17Feb.pdf
February 17, 2010
DARPA and Accelerating Critical Therapeutics
DARPA has a long-standing research program to protect warfighters from infectious diseases
encountered during deployments. Current research activities include development of new, rapid
mechanisms to discover, test and manufacture large quantities of critical therapeutics.
In response to emerging and novel biologic threats, DARPA’s Accelerated Manufacture of
Pharmaceuticals (AMP) program started in 2005. AMP focuses on identifying, developing and
demonstrating new ways to produce large amounts of pharmaceuticals, such as high-quality
vaccine-grade protein within three months of sequencing the pathogen DNA. Inspiration for this
scalable approach is a preparedness strategy that provides capability to respond quickly to
emerging biothreats.
In response to the 2009 H1N1 swine flu pandemic, AMP's plant-based platform redirected its
rapid scale-up processes that were initially developed for avian influenza. After receiving the
H1N1 DNA sequence April 29, a candidate recombinant H1 protein, an essential component of a
vaccine, was produced within four weeks.
AMP’s plant-based system combines three major components to rapidly express vaccine
candidate proteins: non-genetically modified plant seedlings, viral-based protein expression
vectors and vacuum infiltration/viral infection methodologies. Upon receipt of the gene
sequence for a target protein, that sequence is cloned into a viral-based protein expression vector.
This virus vector provides the mechanism for transferring millions of copies of the target gene
sequence into the plant cells. Upon transfer to the plant, the virus replicates the target gene and
stimulates protein expression in those plants.
Essentially, this platform uses the plant's protein synthesis capabilities to produce the specific
recombinant protein material that will be the active component of a vaccine. Scale-up could be
as simple as infiltrating additional non-genetically modified seedlings. Compared to other
vaccine technologies, this platform's production time allows for protein expression, the first step
in vaccine production, in less than five weeks.
DARPA is pursuing this technology development along two, parallel paths:
1) A pilot facility to produce a vaccine-grade recombinant protein under current good
manufacturing practices (cGMP) for formulation, immunogenicity and toxicology
studies. Data along with results from those studies will lead to filing of an
investigational new drug package with the FDA allowing the start of a phase 1
clinical trial. The data generated would be needed to approve this approach for rapid,
flexible vaccine manufacturing under an emergency use authorization scenario.
2) Demonstrate a proof-of-concept capability for cGMP scale up of the plant-based
platform to 10 million doses per month.
Because of the time required to address key FDA regulatory requirements, this program is not
anticipated to deliver H1N1 vaccine for widespread human use during the 2010 flu season.
Protein produced in a facility that meets FDA requirements, is formulated into a vaccine and has
completed phase 1 clinical studies has a higher chance of being authorized by the FDA for use in
a public health emergency under an emergency use authorization.
Fraunhofer Centers in Newark, DE, and at Boston University Develop Plant-Based Vaccine Factory based on Proprietary Expression Technology of iBio, Inc.
Companies:iBio, Inc.
Press Release Source: iBio, Inc. On Thursday April 22, 2010, 8:30 am EDT
NEWARK, Del.--(BUSINESS WIRE)--The Fraunhofer Center for Molecular Biotechnology (“CMB”) in Newark, Delaware, the Fraunhofer Center for Manufacturing Innovation (“CMI”) in Boston, Massachusetts, the Boston University College of Engineering, and the biopharmaceutical company iBio, Inc. (OTCBB: IBPM - News) in Newark, Delaware, announced today that they have developed a fully automated, scalable “factory” that uses natural (non-genetically-modified) green plants to efficiently produce large quantities of vaccines and therapeutics within weeks. Such a rapid vaccine production facility will play a crucial role in addressing and containing future pandemics and emerging biological threats.
This first-of-a-kind, plant-based vaccine factory, takes advantage of plant viral vector technology developed by Fraunhofer CMB for the biopharmaceutical company iBio. The technology has the capability to produce specific proteins within the leaves of rapidly growing plant biomass. The factory’s robotically tended machines, designed by Fraunhofer CMI, plant seeds, nurture the growing plants, introduce a viral vector that directs the plant to produce a target protein and harvest the biomass once the target has accumulated in the plant tissue. “Traditional methods of vaccine production can take many months. Our plant-based technology provides the means for rapid, large scale production of vaccine material in a cost effective manner,” said Dr. Vidadi Yusibov, Executive Director of CMB. "This technology has the potential to revolutionize how biological materials are manufactured. By partnering with CMI and Boston University, we engineered agricultural and molecular biology into scalable automated processes to establish the first cGMP (current Good Manufacturing Practices) facility for plant-based protein production.”
The factory was designed to be time, cost and space efficient. It has the capacity to grow tens of thousands of plants in one batch. The plants are grown in multi-plant trays that are used to handle and transport the plants to the different processing stations. To automate the process, robots glide up and down a track, tending the plants – delivering trays from the lighted, irrigated growth modules to each processing station at the appropriate time. “In order to quickly produce large quantities of vaccine material or other protein-based medicines such as antibodies in compliance with cGMP, it was necessary to develop a consistent, repeatable process. We have taken a biological process and turned it into an industrial process,” said Andre Sharon, a professor of mechanical engineering at Boston University and Director of CMI. “Even though the process of making vaccines from plants includes many aspects of traditional horticulture such as growing, watering and harvesting, we have developed a way to automate those functions to quickly, safely and cost effectively scale up from a few milligrams in a laboratory setting to the many kilograms that would be required in case of a pandemic,” said Sharon. “Everything was designed from the ground up. The process is faster, less expensive, safer, and does not require the sophisticated culturing or fermentation necessary in the current vaccine production processes.”
This unique, plant-based vaccine factory resulted from a three-year collaboration between the Fraunhofer USA Centers in Delaware and Boston, which are affiliated with Fraunhofer-Gesellschaft, Europe’s largest applied research organization, and Boston University. "This is a perfect example of coupling engineering expertise and scientific advancement to cost-effectively meet a societal need," remarked Robert Brown, president of Boston University and a chemical engineer. "It is a model for collaboration that we strongly believe in on our campus, as they do at Fraunhofer as well."
Support from the Defense Advanced Research Projects Agency (DARPA) under the Accerlated Manufacturing of Pharmaceuticals program, along with funding from the state of Delaware were key in facilitating the design and construction of the pilot facility in Newark, Delaware. “I am impressed by Fraunhofer’s innovation and commitment to excellence at the scientific and business levels. I am hopeful that Fraunhofer’s promising discoveries will advance vaccines and pleased that these biological state-of-the-art developments are taking place in Delaware,” said Delaware Governor Jack Markell.
“We believe the new factory in Delaware demonstrates that public health officials will finally have a rapid, high-performance vaccine production technology to use against emergent threats,” said Robert Erwin, President of iBio. “We also expect scalability and efficiency of the expression and manufacturing technology to lead to broad commercial applications.”
About Fraunhofer
Fraunhofer-Gesellschaft is the leading organization for applied research in Europe with 59 research institutes and 17,000 employees. Fraunhofer USA is a wholly-owned subsidiary headquartered in Plymouth, Michigan with research centers that collaborate with major universities throughout the U.S.
Fraunhofer Center for Molecular Biotechnology develops safe, rapid and economical alternatives for vaccine production. The Center conducts research in the area of plant biotechnology, utilizing new, cutting edge technologies to assist the diagnosis, prevention and treatment of human and animal diseases. The Center houses individuals with expertise and excellence in plant virology, pathology, molecular biology, immunology, vaccinology, protein engineering, and biochemistry.
Fraunhofer Center for Manufacturing Innovation is located on the campus of, and partnered with Boston University. The Center was established in 1995 to serve as a bridge between academic research and industrial needs. Working with BU faculty and students, the engineers and scientists in the Center scale up basic research into advanced technologies. The focus of Center is on development of next-generation instruments and high precision automation systems for the biotech/biomedical, photonics and renewable energy sectors.
About Boston University
Founded in 1839, Boston University is an internationally recognized private research university with more than 30,000 students participating in undergraduate, graduate, and professional programs. BU consists of 17 colleges and schools along with a number of multi-disciplinary centers and institutes which are central to the school's research and teaching mission. The BU College of Engineering offers bachelor’s, master’s and doctoral degrees in the departments of Biomedical, Mechanical, and Electrical and Computer Engineering. It also has two interdisciplinary divisions focused on research and graduate education: the Division of Systems Engineering; and the Division of Materials Science & Engineering.
About iBio
iBio, Inc. is a biopharmaceutical company commercializing its proprietary technology, the iBioLaunch™ platform, for the production of biologics including vaccines and therapeutic proteins. The iBioLaunch platform uses transient gene expression in green plants for superior efficiency in protein production. Advantages include significantly lower capital and process costs, and the technology is ideally suited to infectious disease applications where speed, scalability, and surge capacity are important. iBio’s strategy is to utilize its technology for development and manufacture of its own product candidates and work with both corporate and government clients to reduce their costs during product development and meet their needs for low cost, high quality biologics manufacturing systems. iBio owns technology developed at the Fraunhofer USA Center for Molecular Biotechnology, and continues to sponsor development and refinement of the technology for broad applications in human healthcare. Further information is available at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.ibioinc.com&esheet=6260030&lan=en_US&anchor=www.ibioinc.com&index=1&md5=439f4124ae04e3edc4b4eea218535518.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995:
Statements included in this release related to iBio, Inc. may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties such as competitive factors, technological development, market demand, and the Company's ability to obtain new contracts and accurately estimate net revenues due to variability in size, scope and duration of projects. Further information on potential risk factors that could affect the Company's financial results can be found in the company's Reports filed with the Securities and Exchange Commission
I do not believe these stories
Another loyal, paying WellPoint customer who faced this situation was Patricia Reilling of Louisville, Kentucky. Ms. Reilling was an interior designer and art gallery owner who never missed a payment. But that did not stop WellPoint from canceling her insurance in the middle of her fight with breast cancer. WellPoint abandoned her at her weakest moment, forcing her to pay enormous medical bills on her own. This woman, who was once a highly successful business owner, is now subsisting on Social Security and food stamps
I think any sick person that has been paying their policy on a current basis could have gone to their state if the insurance company threw them off and gotten reinstated. I do not see anything in the article about the people trying to fight to keep their insurance.
there is some factual information missing.
The aim of the healthcare bill was to purposely increase healthcare costs by not allowing insurers from denying preexisting conditions and then set up boards to deny increases in rates.
anyone that owns a health insurance company stock should exchange for an ownership percentage in the brooklyn bridge. They have a better chance of making a profit on the bridge.
SuperSonic Imagine Unveils Results of Largest Breast Ultrasound Clinical Trial Ever Undertaken
Does this mean they have undertaken to Ultrasound the largest breasts in a clinical trial?
World Wide Breast Trial Results on ShearWave(TM) Elastography indicate technology could change lesion classification and reduce negative biopsies.
Press Release Source: SuperSonic Imagine On Friday April 23, 2010, 9:54 am EDT
AIX-EN-PROVENCE, France, April 23 /PRNewswire/ -- SuperSonic Imagine, the innovative medical imaging company based in Aix-en-Provence, France has unveiled some of the results of the largest clinical breast study ever undertaken in ultrasound imaging. The worldwide multicenter study, involving top clinicians in the breast radiology community, is assessing the clinical benefits of ShearWave™ Elastography in the ultrasonic evaluation of breast lesions.
(Photo: http://www.newscom.com/cgi-bin/prnh/20100423/CG92138)
The study has two objectives: The first is to demonstrate that images obtained using ShearWave™ Elastography are reproducible. The second is to compare ultrasound alone versus the combination of ultrasound and ShearWave™ Elastography for breast lesion diagnosis. The goal of the latter is to improve lesion classification in categories BI-RADS ® 3 and BI-RADS ® 4(i) in order to better direct patients towards clinical follow-up or biopsy.
"This clinical investigation is the largest trial ever undertaken by an ultrasound imaging company as the recruitment will involve a targeted 2300 breast lesion cases," explains Claude Cohen-Bacrie, co-founder and Scientific Director of SuperSonic Imagine.
"Today it is essential to obtain additional information on breast lesions to improve diagnosis. In an era of healthcare reform, being able to reduce the number of biopsies by correctly classifying lesions could save resources and spare women the anxiety and difficulty that surrounds invasive procedures. Better lesion classification also means improved diagnosis, which can lead to quicker and better treatment."
ShearWave™ Elastography: the technology
Ultrasound imaging plays an important role in breast diagnosis. It is used on palpable masses, as a second intention exam after X-Ray and MRI and as a modality of choice to guide biopsy. ShearWave™ Elastography is a breakthrough technology that gives additional, important information about tissue elasticity. Unlike conventional elastography methods, which rely on manual compression and measure tissue displacement, ShearWave™ Elastography requires no manual compression and computes true tissue elasticity by measuring the velocity of shear waves as they propagate in tissue. Shear wave propagation speed in tissue is directly related to tissue stiffness. This technology relies upon the generation of a shear wave and its subsequent capture. Shear wave propagation speed is then calculated and a color-coded real time ShearWave™ Elastography map is produced showing tissue stiffness. Results are real-time, user-skill independent, reproducible and quantifiable in kilopascals(1). ShearWave™ Elastography is available only on the Aixplorer® MultiWave™ Ultrasound System.
The multicenter clinical trial
A world wide multicenter breast clinical study was launched in April 2008(2) with 17 prestigious American and European sites(ii) including: the Hammersmith Hospital Imperial College (United Kingdom), the Curie Institute of Paris (France), the DKD Wiesbaden and the academic hospitals Schleswig-Holstein and Greifswald (Germany), Yale Medical Center and the Northwestern Memorial Hospital (USA). The study was conducted under the leadership of Professor David Cosgrove (Imperial College, London).
The first phase of the study was to define a scientific model on 1000 cases, to determine if ShearWave™ Elastography information can complement ultrasound information in order to improve a diagnosis. To undertake this, it was necessary to identify the criteria of an elastography image that would, when added to ultrasound criteria, improve lesion characterization (in sensitivity and specificity when compared to ultrasound alone) and eventually improve a BI-RADS® score. The ShearWave™ Elastography criteria or features studied for each lesion were: size, shape, average value of elasticity, homogeneity, orientation and contrast of elasticity between lesion and fatty tissue.
The second phase of the study will consist of testing this scientific model on an independent set of lesions. This phase is currently ongoing.
Clinical Result 1: ShearWave™ Elastography features are reproducible
To determine reproducibility, each clinical investigator was asked to perform and compare features on 3 separate ShearWave™ Elastography image acquisitions of the same lesion. The clinical results clearly showed that ShearWave™ Elastography is reproducible both qualitatively and quantitatively:
Qualitative: 87% of consecutive repeated ShearWave™ Elastography exams were 'similar', 'reasonably similar' or 'very similar' in appearance.
Quantitative: Intra-Observer Reproducibility(3) (IOR) rates for ShearWave™ Elastography measurements are close to perfect at 0.91.
Reproducibility assures the physician of a reliable and precise evaluation of a lesion, both during an elastography examination and over time, which is key for follow up.
Clinical Result 2: ShearWave™ Elastography feature(s) increase diagnostic accuracy and improve lesion classification
Regression models based on 1000 cases were statistically evaluated by Caroline Dore, an independent biostatistician from the Hammersmith Hospital and show that each individual ShearWave elastographic feature, when added to the ultrasound evaluation, improved the classification of the BI-RADS® score of a lesion. The global evaluation is calculated on an analysis of the area under the ROC curve (Receiver Operating Characteristic). The larger the area under the curve, the better the BI-RADS® score classification.
The clinical results demonstrated that when two ShearWave™ Elastography features are added to the ultrasound evaluation, correct breast lesion classification rates soar to 87%, thus leading to more accurate results.
Scientifically evaluated, the results of this clinical study therefore demonstrate that ShearWave™ Elastography features, when added to the BI-RADS® score significantly improve the specificity and sensitivity of the diagnosis of the lesion. Associated with the BI-RADS® score, these features increase the percentage of correctly classified lesions and improve lesion diagnosis.
Historically, ultrasound imaging was considered as an efficient method to differentiate solid lesions from liquid lesions. As a result of research over the last 15 years, ultrasound has become an important technique, with a very high negative predictive value, in the classification of lesions on the BI-RADS® scale: 2(benign) to 5 (highly suggestive of malignancy). Today, the results of this multicenter study show that ShearWave™ Elastography combined with ultrasound, further improves lesion classification by significantly raising the percentage of lesions that are correctly classified and increases the specificity in the diagnosis while keeping a high negative predictive value and sensitivity.
Cohen-Bacrie concluded, "Our clinical objective is to confirm if ShearWave™ Elastography, combined with ultrasound, leads to a more refined lesion classification of BI-RADS® 3 and 4 and in turn leads to better direct patients towards follow-up or biopsy."
(i)
BI-RADS® is the acronym for Breast Imaging-Reporting and Data System, a quality control system developed by the ACR (American College of Radiology) to assess breast lesions according to their degree of malignancy.
The world vaccine congress charges 25,000 to present the data.
That is pretty expensive just to issue a press release
I can't post who wrote this but I thought it should be posted
We are pretty sure that by the end of this week, most analysts will get it that the increasing Medicaid rebate as a result of healthcare reform will have an effect on the current earnings of any company selling drugs in the US. If GILD's stock gets punished today, as it was in the after-hours trading, the moral is when there is an industry-wide issue, don't be the first company to report. Let somebody else be the bearer of bad news. Technically, Gilead isn't the first company to lower guidance. The issue has been discussed since last week: by Roche (ROG.VX), Cubist (CBST), Lilly (LLY), Biogen (BIIB) and others. But, the analysts covering large-cap biotech appear to have just realized the problem. BIIB reported yesterday morning, but BIIB had less exposure to Medicaid, because Avonex and Tysabri are (how should we put it?) expensive for Medicaid. The other moral of the story is to raise prices while you can. HMOs did it. Now they are beating their numbers, despite the fact that they are supposed to be victims of healthcare reform.
• All kidding aside, after all these years, for us to talk about the potential pricing pressure on drugs and biologicals finally is starting to be meaningful -- not only in the US, but from governments around the world. If one is still investing based on what was taught in MBA classes in 1985, it is time to rethink the allure of investing in cash cow companies -- and, most mature drug companies and biotech companies have become cash cows. Let's put it in the language of Graham and Dodd. In an environment of diminishing pricing power and unfavorable regulation, the cash flow goes down and risk premium goes up, which leads to higher discount rate. With generics and biosimilars, the terminal value goes down and duration of the cash flow gets smaller. The end result: NPV is lower. We can't stress enough that in a period when the business environment is less certain (we won't use the term "political instability" because that would make us sound too much like tea partiers), the uncertainty of the cash flow stream is much higher. Even a month ago, we would bet most drug and biotech companies did not realize how much they would have to revise their earnings and cash flow forecast in just a month's time. Combining all of the above, cash cows are much less attractive.
• Lastly, and here we are dead serious, the final moral of the day is that in the biotech and drug universe, the only way to create value is innovation.
No on besides me has anything to say about the clinically insignificant HGSI data that caused a meteoric rise in the market cap to about 15 billion dollars?
Human Genome Sciences and GlaxoSmithKline Announce Topline 76-Week Results of Phase 3 Trial of BENLYSTA in Systemic Lupus Erythematosus
It is difficult to imagine a drug with such weak results to be a multibillion dollar drug. Someone help us. It appears that the primary endpoint of this trial was the composite of 3 endpoints that we have known all along. What I see from this data is the this Selena Sledai score is the endpoint that seemed to change most significantly. The problem is that I think that is the least clinically meaningful endpoint. Can someone confirm or deny that statement? I am curious
Companies:Human Genome Sciences Inc.
Press Release Source: Human Genome Sciences, Inc. On Tuesday April 20, 2010, 7:00 am EDT
ROCKVILLE, Md. & LONDON--(BUSINESS WIRE)--Human Genome Sciences, Inc. (Nasdaq: HGSI - News) and GlaxoSmithKline PLC (GSK) today announced topline secondary endpoints from BLISS-76, the second of two pivotal Phase 3 trials of BENLYSTA™ (belimumab) in seropositive patients with systemic lupus erythematosus (SLE). BENLYSTA 10 mg/kg already met its primary efficacy endpoint at Week 52 in both BLISS-52 and BLISS-76, as announced in July and November 2009.
At Week 76 in the BLISS-76 study, belimumab plus standard of care showed higher response rates compared with placebo plus standard of care as measured by the SLE Responder Index; however, this secondary endpoint did not reach statistical significance. Study results also showed that belimumab continued to be generally well tolerated, as demonstrated by a similar rate of discontinuations due to adverse events across treatment groups, with overall adverse event rates comparable between belimumab and placebo treatment groups.
“A positive overall picture has emerged from our pivotal Phase 3 studies of BENLYSTA, including its achievement of statistical significance on the primary efficacy endpoint at Week 52 with a favorable safety profile in both BLISS-52 and BLISS-76,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “We view the results of these studies as strongly supportive of our view that BENLYSTA has the potential to become the first new approved drug in more than 50 years for people living with systemic lupus.”
Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK, said, “Based on the totality of data in BLISS-52 and BLISS-76, we believe that belimumab could deliver a significant therapeutic option for patients with lupus, a chronic condition which has a devastating effect on the lives of patients living with the disease.”
The data from the BLISS-76 study were previously analyzed after 52 weeks in accord with the study protocol, in support of a potential Biologics License Application in the United States and Marketing Authorization Applications in Europe and other regions. The primary efficacy endpoints in both pivotal Phase 3 studies of belimumab, BLISS-52 and BLISS-76, were the patient response rates at Week 52 as measured by the SLE Responder Index. BLISS-76 then continued for an additional 24 weeks. Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. Belimumab is being developed by HGS and GSK under a co-development and commercialization agreement entered into in 2006.
Key Findings from BLISS-76
“These new data from BLISS-76 provide additional evidence of the beneficial effect of belimumab despite not reaching statistical significance on the secondary endpoint. The results of our Phase 3 trials support a potentially important role for belimumab added to standard of care for the treatment of seropositive patients with systemic lupus,” said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. “We and GSK are working together to complete and submit regulatory applications for belimumab in the United States and Europe in the second quarter of this year. We look forward to the full presentation of BLISS-76 52-week and 76-week results at appropriate scientific meetings later this year.”
Based on an intention-to-treat (ITT) analysis, patient response rates for belimumab plus standard of care versus placebo plus standard of care, as measured by the SLE Responder Index (SRI) at Week 76, were: 38.5% for 10 mg/kg belimumab, 39.1% for 1 mg/kg belimumab, and 32.4% for placebo (p=0.13 and p=0.11 for 10 mg/kg and 1 mg/kg belimumab, respectively vs. placebo). The SRI defines patient response as an improvement in SELENA SLEDAI score of 4 points or greater, with no clinically significant BILAG worsening and no clinically significant worsening in Physician’s Global Assessment.
Topline Week 76 results currently available for secondary endpoints include:
The proportion of patients with a reduction in SELENA SLEDAI score of at least 4 points was 41.4% for belimumab 10 mg/kg, 42.1% for belimumab 1 mg/kg, and 33.8% for placebo (p=0.066 and p=0.049 for belimumab 10 mg/kg and 1 mg/kg, respectively vs. placebo). Who cares about reduction in Selena Sledai score
Mean improvement from baseline in Physician’s Global Assessment (PGA) was 0.51 for belimumab 10 mg/kg, 0.53 for belimumab 1 mg/kg, and 0.49 for placebo (p=0.21 for both belimumab 10 mg/kg and for 1 mg/kg, vs. placebo). this is the important score
At entry into the BLISS-76 study, approximately 46% of patients were receiving steroids at a prednisone-equivalent dose of at least 7.5 mg per day. Among these patients, the percentage of patients who had their average steroid dose reduced by at least 25% from baseline to 7.5 mg per day or less during the last 12 weeks of the study (Week 64 through Week 76) was 24.2% for belimumab 10 mg/kg, 26.9% for belimumab 1 mg/kg, and 17.5%% for placebo (p=0.27 and p=0.07 for belimumab 10 mg/kg and 1 mg/kg, respectively, vs. placebo. Whoopdi do
In BLISS-76 at Week 76, the mean percent reduction in SELENA SLEDAI score was 37.0% for belimumab 10 mg/kg, 36.1% for belimumab 1 mg/kg, and 27.8% for placebo (p=0.01 and p=0.03 for 10mg/kg belimumab and 1 mg/kg belimumab, respectively vs. placebo). At Week 52, the reduction in SELENA SLEDAI was 36.0% for belimumab 10 mg/kg, 33.9% for belimumab 1 mg/kg, and 26% for the placebo (p<0.01 and p=0.04 for 10 mg/kg and 1 mg/kg belimumab, respectively vs. placebo).
Biomarker responses have been studied throughout the program and belimumab consistently demonstrated a beneficial effect on anti double-stranded DNA and complement with both doses.
Additional analyses are ongoing, including post-hoc analyses, to further understand these data.
In BLISS-76 through 76 weeks, belimumab was generally well tolerated, with rates of overall adverse events, serious and/or severe adverse events, all infections, serious and/or severe infections, and discontinuations due to adverse events comparable between treatment groups receiving belimumab plus standard of care and the treatment group receiving placebo plus standard of care. Serious and/or severe adverse events were reported in 29.0% of patients on belimumab and 26.2% of patients on placebo. Infections were reported in 74.3% of patients on belimumab and 69.1% of patients on placebo. Serious and/or severe infections were reported in 4.2% of patients on belimumab and 3.6% of patients on placebo. Serious and/or severe infusion reactions were reported in 1.1% of patients on belimumab and 0.7% of patients on placebo. Discontinuations due to adverse events were 7.5% in the belimumab treatment groups and 8.4% in the placebo treatment group. One new malignancy was reported since the Week 52 data were announced, with a total 2, 4, and 1 subjects in the belimumab 10 mg/kg, belimumab 1 mg/kg and placebo groups, respectively. No additional deaths were reported since the Week 52 data were announced, with a total of three deaths in the study: 1, 2, and 0 reported in the belimumab 10 mg/kg, belimumab 1 mg/kg and placebo groups, respectively. Malignancies and deaths are nothing to sneeze at when you have such a weak effect. I do not get it.About the Belimumab Phase 3 Development Program
The Phase 3 development program for belimumab included two double-blind, placebo-controlled, multi-center Phase 3 superiority trials – BLISS-52 and BLISS-76 – to evaluate the efficacy and safety of belimumab plus standard of care, versus placebo plus standard of care, in seropositive (HEp-2 ANA = 1:80 and/or anti-dsDNA = 30 IU/mL) patients with SLE. Both BLISS-52 and BLISS-76 have now been completed. This is the largest clinical trial program ever conducted in lupus patients. BLISS-52 randomized and treated 865 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe. BLISS-76 randomized and treated 819 patients at 136 clinical sites in 19 countries, primarily in North America and Europe. The design of the two trials was similar, but the duration of therapy in the two studies was different – 52 weeks for BLISS-52 and 76 weeks for BLISS-76. Data from BLISS-76 were analyzed after 52 weeks in support of a potential Biologics License Application in the United States and Marketing Authorization Applications in Europe and other regions. HGS designed the Phase 3 program for belimumab in collaboration with GSK and leading international SLE experts, and the program is being conducted under a Special Protocol Assessment agreement with FDA.
The primary efficacy endpoint of BLISS-52 and BLISS-76 was the patient response rate at Week 52 as measured by the SLE Responder Index, which is defined by: (1) a reduction from baseline of at least 4 points on the SELENA SLEDAI disease activity scale (which indicates a clinically important reduction in SLE disease activity); (2) no worsening of disease as measured by the Physician’s Global Assessment (worsening defined as an increase of 0.30 points or more from baseline); (3) no new BILAG A organ domain score (which indicates a severe flare of lupus disease activity) and no more than one new BILAG B organ domain score (which indicates a moderate flare of disease activity). Analysis for the primary endpoint is based on intention-to-treat and adjusted for baseline stratification factors, including SELENA SLEDAI score, proteinuria and race. The patient response rate at Week 76 as measured by the SLE Responder Index was a protocol-specified major secondary endpoint of the BLISS-76 study.
In each of the two Phase 3 trials, patients were randomized to one of three treatment groups: 10 mg/kg belimumab (BLISS-52, n=290; BLISS-76, n=273), 1 mg/kg belimumab (BLISS-52, n=288; BLISS-76, n=271), or placebo (BLISS-52, n=287; BLISS-76, n=275). Patients were dosed intravenously on Days 0, 14 and 28, then every 28 days thereafter for the duration of the study. All patients received standard of care therapy in addition to the study medication. Safety was reviewed by an independent Data Monitoring Committee throughout both studies.
how do you know it isn't the best of deals?
maybe it will have no activity or be toxic, then it would be a great deal
what is the purpose of posting a fly on the wall comment that is just taking info from the press release?
YM BioSciences announces pivotal preclinical efficacy data for the JAK1/2 inhibitor CYT387 published in Blood, the Journal of the American Society of Hematology
what exactly is pivotal preclinical data, does that mean they file an nda to treat mice.
Companies:YM BIOSCIENCESYM BioSciences Inc.
Press Release Source: YM BioSciences Inc. On Monday April 19, 2010, 7:30 am EDT
MISSISSAUGA, ON, April 19 /PRNewswire-FirstCall/ - YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), announced the pre-publication of pivotal preclinical data for CYT387, the company's highly selective and potent JAK1/2 inhibitor, currently in a Phase I/II trial for myelofibrosis.
The scientific paper, published as a First Edition in the premier hematology journal Blood, describes an extensive body of work demonstrating the potent activity of the compound in in vitro cell assays and in an in vivo model of the myeloproliferative neoplasms (MPNs). (Jeffrey W. Tyner, Michael W. Deininger et al CYT387, a novel JAK2 inhibitor, induces hematologic responses and normalizes inflammatory cytokines in murine myeloproliferative neoplasms Blood First Edition Paper, prepublished online April 12, 2010; DOI 10.1182/blood-2009-05-223727).
The paper describes work conducted in the laboratory of Dr. Michael Deininger at Oregon Health Sciences University Knight Cancer Institute, Portland, Oregon, which demonstrates that orally-administered CYT387 normalizes the hallmark MPN features of elevated blood cell counts and enlarged spleen size in an in vivo model of the disease. Importantly, blood cell production is shown to return to the bone marrow with drug treatment.
CYT387 also significantly reduces circulating levels of inflammatory cytokines such as IL-6 and TNF-alpha, which are common in patients with MPNs, as well as in auto-immune diseases such as rheumatoid arthritis. The data are consistent with data reported for INCB18424 (Incyte/Novartis), the other dual JAK1/2 inhibitor in clinical development. An internal study at YM BioSciences demonstrates that CYT387 possesses similar potency against JAK1/2 enzymes as INCB18424. Moreover, in the same study CYT387 was demonstrated to have improved selectivity over JAK3 and TYK2 than INCB18424, which may result in a superior therapeutic window for CYT387. Results from this comparative study will be submitted for presentation at forthcoming meetings during 2010.
"This extensive study by Dr. Deininger and his team clearly demonstrates that our JAK1/2 inhibitor CYT387, has an exceptional profile for the treatment of MPNs," said David Allan, Chairman and CEO of YM BioSciences. "Our expectation for the clinical success of this compound is reflected in the recent decision by the principal investigator and data safety monitoring board to accelerate the current Phase I/II clinical trial in myelofibrosis through an earlier-than-planned initiation of the Phase II component of the study."
We are maintaining our 2-Equal Weight rating on BIIB following this month's update on Tysabri
from jim birchenoff of Barclays formerly lehman
PML incidence. With 4 new cases of PML this month, with an accelerating rate and with a rate now >1/1000 in patients treated >12 months we see risk to increasing drug holidays, further reduction in new patient starts and further label restrictions if rates in patients >2 years continue to increase.
BIIB & partner Elan provided an update Thursday on PML incidence for Tysabri through April 6. With 4 new cases over the last month and 46 new cases overall incidence of PML has increased in all treatment duration categories. Specifically PML incidence is now 0.67/1000 overall, 1.10/1000 in patients with more than 12 infusions, 1.27/1000 in patients with more than 18 infusions, 1.59/1000 in patients with more than 24 infusions and 1.53/1000 in patients with more than 30 infusions.
While the increasing rate with increasing duration is well-acknowledged and has been reflected in updated Tysabri labelling we believe that the acceleration of cases into April could create still greater tentativeness in prescribing with greater impetus for earlier drug holidays in a greater percent of patients.
Read more:
Biogen Idec: PML Accelerating into April »
Aside from the fact that the company can't talk about any results because they are in a quiet period, what else about the company is real.
they have been speaking about their animal studies for years, do they ever intend on filing an IND and actually going into humans?
what makes a stock like this have a market cap of over 300 million and who even knows if all the warrants are counted in that number?
nnvc. they have no data
Ladies and Gentlemen I present for your reading pleasure, Patrick Cox: Revolutionary Virus Research Expands NanoViricides' Potential Market Further
Part of the reason that I write about NanoViricides Inc. so frequently is that the company is at such an exciting point in its development. Specifically, the NanoViricides team has proven their revolutionary combination of nanotechnology and biotechnology works in animal studies. They've demonstrated that their nano-bio structures can fool human-infecting viruses in animal bloodstreams into harmlessly releasing their DNA.
They did this, as you may remember, in mouse lethality studies that proved their drug, FluCide, vastly superior to the current best flu treatment, Tamiflu. Mouse lethality studies require that no further treatments are given to test animals beyond the initial dosing. So the test mice were allowed to die, but blood work indicated that NanoViricides’ FluCide essentially “cured” the massively infected mice.
Beyond that, the company has made its technology available to important scientists at clearly prestigious institutions, including Department of Defense labs, for investigation and verification. They simply wouldn't have done this if they were not confident that the FluCide results would be replicated on other viruses. Among the tests that have been publicly announced are in vitro dengue virus, in vitro HIV, in vivo Ebola and in vivo rabies.
My fear is that once a number of positive test results are known, it will become obvious that NanoViricides is going to demolish the existing virus medication industry. At that point, the opportunity to own a piece of this transformation technology at bargain-basement prices will be gone.
So how big is that market? Estimates I've seen range from $20-29 billion annually and are growing. As far as I can tell today, NanoViricides will eventually dominate that industry. Even if other unexpected anti-virus technologies are discovered, the head start that the company has now assures that it will do very, very well for a long time.
I had expected, in fact, that we would be getting those results now. Instead, NanoViricides' “quiet period,” due to an S3 finance filing with the FDA, has extended longer than expected. This, I think, is a good thing. It gives you more time to examine the company and add it to your portfolio if you haven't already done so.
One more technical note on this topic: Investors often react negatively when a company brings in additional financing. If, however, this financing accelerates return on investment (ROI), dilution of equity may be counterbalanced by an increase in total present value. I think this is clearly the case with NanoViricides' current financing move, but it might provide some downward movement if you're looking to buy on dips.
So because NanoViricides executives can't talk about ongoing tests at the moment, I took the opportunity to ask CEO Dr. Eugene Seymour about a subject that has fascinated many scientists for the last few years. It is the newly discovered genetic connection between viruses and diseases that we have not traditionally viewed as virus diseases. In the last several weeks, in fact, several papers have been published bearing on this subject.
One, published in PLoS ONE, demonstrates that four HIV drugs also inhibit a retrovirus linked to prostate cancer and chronic fatigue syndrome. This story, about the study, in Science Daily, points out that, “The findings suggest that if XMRV (xenotropic murine leukemia virus-related virus) is proven to be a cause for prostate cancer or chronic fatigue syndrome, those illnesses may be treatable with drugs already approved for treating HIV.”
This is entirely plausible, as it is known that viruses have the ability to impair the host's immune system. This is a simple self-defense function on the part of viruses, but its implications are profound both for medical researchers and investors. Not only is prostate cancer linked to specific viruses, leukemia and other cancers seem to be triggered or driven by viruses.
An article in Medical News Today discusses work done by French researchers in the Retrovirus Endogenes et Elements Retroides des Eucaryotes Superieurs Laboratory. The most important part of this story is in the last paragraph: “The researchers succeeded in locating the domain responsible for this property within the amino acid sequence of the envelope protein. This domain, an authentic virulence factor, is a crucial element in the arsenal that enables retroviruses to invade their host and produce their pathogenic effect. It thus becomes a target of choice for the design of novel antiretroviral therapeutic strategies, including vaccines.”
This is, in fact, what NanoViricides' nanotech structures do. Moreover, the scientist behind NanoViricides' platform, Anil R. Diwan, Ph.D., has an 18-year head start on those who have just figured this out. The implication, now, is that this approach could have far greater application than treating infections by viruses.
For example, a researcher in Glasgow has found that childhood diabetes is associated with the presence of a particular virus. This discovery has been made just as Cambridge University researchers have published a study in the journal Science showing that type 1 diabetes is linked to mutations in a gene involved in the immune response to enteroviruses.
So scientists who wrote the PLoS ONE article are pondering the possibility of treating or preventing prostate cancer and chronic fatigue syndrome with existing HIV drugs. Obviously, NanoViricides' superior therapy would have any greater potential. Similarly, the possibility exists that NanoViricides will have therapies for childhood diabetes as well as other diseases that many scientists believe to be mediated by viruses. This includes, incidentally, obesity and even some mental disorders. As the genome continues to be unraveled, I predict that we will find many other diseases have virus triggers.
There has been speculation to this effect for decades. What is revolutionary is the new tools that scientists are bringing to this research arena. The decoding of the human genome is one of the most important… and one of the most startling.
Listen, for example, to Dr. Phillip A. Sharp of the Center for Cancer Research at MIT. His Nobel Prize is in recognition for his role decoding the genome. He says that “We humans are well over 50% viral.”
That's right. Sharp says that half or our DNA has come from viruses. We're speaking about the so-called “junk DNA” that was initially assumed to have no active role. Today, this belief is being jettisoned. Some researchers, such as Luis P. Villarreal, director of the Center for Virus Research at the University of California, Irvine, believe humans have benefited from DNA viruses in yet unknown ways. (If you're interested in the subject you can find more here and here.)
I realize that this may be seem a bit much to process if the subject is new to you. So I asked NanoViricides CEO Dr. Eugene Seymour to comment on this emerging science and what it means to his company. Following is what he wrote.
Dr. Eugene Seymour Comments
“It's now quite obvious that many of the medical profession's most cherished notions are now being overturned by virtue of new research. My friend Dr. Howard Lipton has maintained that the initiating cascade for MS starts with a viral infection. Dr. Lipton is professor of immunology and neurology at the University of Illinois College of Medicine and previously was chairman of the Neurology Department at the Mount Sinai School of Medicine. One of his former colleagues, an oncologist at that medical school, feels that the initiating cascade for breast cancer comes from a retrovirus, the mouse mammary virus.
“It's interesting to note that XMRV is also a retrovirus. I feel that the intense research interest in HIV/AIDS will lead to further understanding of the links between cancer, the immune system and viruses. The number of virus-associated cancers now stands at eight, but I firmly believe that by the end of this decade, that number will at least quadruple.
“This work started with Dr. Francis Peyton Rous in 1911. The Rous sarcoma virus is named after him. I interviewed him in 1961, 50 years after his groundbreaking discovery that a virus could cause a malignancy. He was almost laughed out of the medical profession. He was awarded the Nobel Prize in Medicine 55 years later for that discovery. This was before the true nature of viruses had been discovered. So little work has been done on interrupting the linkage between a virus infection and the subsequent development of a malignancy. In 1997, Dr. Lawrence Altman, a physician-journalist from The New York Times, wrote, ‘An emerging theory is that most AIDS-related cancers are somehow linked to viral infections. But doctors do not know if HIV enhances the ability of other viruses to produce certain cancers.’
“Since there has never been a nontoxic way to destroy viruses (before the advent of nanoviricides), uncoupling the link has been a difficult task.
“Of the eight verified cancers caused by viruses, I've seen almost all of them... some in the U.S. and some in my travels worldwide. My son, when he was a resident at UCSF, saw a Chinese male with nasopharyngeal carcinoma (ultimately fatal) that was caused by a prior Epstein-Barr infection. I saw a number of these cases in China when I went there to teach the Chinese doctors how to use my AIDS test.
“I'll never forget a patient I had as a medical student on the surgical service. He was a 30-year-old who was an oil field worker in Nigeria. He presented to us with a widely metastatic carcinoma and a strange immune system collapse that we had never before seen. He died of massive overwhelming septicemia. Even though this was in the mid-1960s, 15 years before the first AIDS cases were reported, I feel that he was, in reality, the first AIDS patient I ever saw!
“I like to go back to the story of Dr. Barry Marshall, who completely upset the medical establishment with his suggestion that peptic ulcers were caused by a bacteria. He drank a brew of bacteria and managed to cause a rip-roaring gastroenteritis, which he quickly eradicated with antibiotics. Thus, almost overnight, the long-standing treatment paradigm (often surgical) was overturned.
“So how does NanoViricides Inc. fit into this picture? I'll just focus on herpesviruses and retroviruses for the purpose of this discussion. Epstein-Barr virus is a herpesvirus. We've already tested our nanoviricides against herpesviruses and have reported excellent results! With respect to retroviruses, we've done the same with HIV, which is itself a retrovirus. I feel that as we move forward with additional animal and human studies, others will take the appropriate nanoviricides and use them to evaluate the links to various cancers. I also feel that 100 years after Dr Rous' discovery, we too are poised to make a significant contribution to both the understanding and potential eradication of virus-caused malignancies.
“This is a complex undertaking and is outside the scope of our present R&D plans. Others will have to take our drugs and assume the responsibility of investigating the virus-cancer links. If these researchers can confirm the links and impact the status of a malignancy with treatment with our optimized nanoviricides, then the paradigm for treatment of cancers will have been inexorably altered.
“Incidentally, I have no interest in infecting myself with one of these viruses to see if a malignancy is the outcome. Any volunteers?”
Uh, I doubt it, Dr. Seymour.
But I am enormously excited about the possibility that nanoviricides could play a much larger role in disease prevention and treatment than is currently projected. We'll be following this area closely as it unfolds.
For transformation profits,
Patrick Cox
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The fact that asco feels it would be an important presentation does not mean they have the data.
If they had the data they could put out topline results or even a press release that the trial was successful, as dendreon did last year would be fine.
If they were sitting on material data the SEC would not be too happy, or at least they shouldn't be.. I do not think the result is known
Regulators to Review New Drugs to Curb Appetite .ArticleComments (
By THOMAS GRYTA
http://online.wsj.com/article/SB10001424052702304703104575174373476976674.html?ru=yahoo&mod=yahoo_hs#printMode
A new generation of anti-obesity drugs could hit the market in coming months, the latest attempt in what has proved a difficult medicine to make safe for patients.
Currently, just two anti-obesity drugs are approved for long-term treatment, and medical practitioners say both can cause undesirable side effects in many patients. The three new medications, which have been submitted for approval to the Food and Drug Administration, also can be expected to have side effects for some patients, particularly because treating obesity with drugs involves altering the body's chemistry. But doctors say different weight-loss medications affect people differently, so having more choices should help them match a patient to a therapy that maximizes weight loss while minimizing side effects.
"Obesity has many causes, and ferreting out what is going to work in individuals requires more options," said Charles Billington, a professor of medicine at the University of Minnesota and medical director of the obesity program at the Minneapolis VA Medical Center.
.The FDA will need to review data on the drugs, and approval isn't assured. The agency is aware of past problems with anti-obesity drugs and plans to evaluate the new drugs under the assumption that patients likely would use them indefinitely, an FDA spokeswoman said.
The three new drugs awaiting regulatory approval are lorcaserin, manufactured by Arena Pharmaceuticals Inc., Vivus Inc.'s Qnexa, and Orexigen Therapeutics Inc.'s Contrave. The companies are small drug developers and each has held talks to partner with a larger pharmaceutical concern to help sell the products, although no agreements have been signed.
The three drugs work by affecting the patient's central nervous system to dampen appetite, Dr. Billington said. "To say that you are going to do that without any side effects is just not understanding how things work in real life," he said.
Typically, medications help moderately obese patients lose about 5% to 10% of their body weight. While not a large percentage, even that much weight loss can mean a big reduction in diabetes and cardiovascular risk, said Jeanine Albu, chief of the Metabolic Clinic at the New York Obesity Research Center at St. Luke's-Roosevelt Hospital. "The problem is keeping the weight off over time. A lot of people just gradually gain it back," said Dr. Albu.
Lifestyle Changes First
For most obesity patients, a physician's first line of treatment is to modify the person's lifestyle, including through dieting, exercise and counseling. When this isn't successful, some patients might move on to one of the few anti-obesity drugs currently available. And in cases of dangerous obesity, doctors might recommend bariatric surgery, which makes the stomach smaller. The Centers for Disease Control and Prevention estimates that about two-thirds of U.S. adults are overweight, while a third are considered obese. Obesity is defined as having a body mass index—a measure of weight in relation to height—of 30 or higher.
Some earlier diet drugs have had a mixed history. The so-called fen-phen drug combination manufactured by Wyeth, now owned by Pfizer Inc., was recalled in the 1990s after one of the medication's components was linked to heart-valve damage.
One drug currently in use also has stirred controversy. Meridia, sold by Abbott Laboratories, was pulled from the market in Europe this year after a study indicated that people with certain health problems who took the prescription drug had more heart attacks, strokes and other cardiovascular problems than people getting a placebo. In the U.S., the FDA required Abbott to put a stronger warning on the Meridia label.
Another drug currently on the market, Orlistat, which is sold over the counter as Alli by GlaxoSmithKline Plc and in prescription form as Xenical by Roche Holding AG, can cause undesirable bowel-related problems in some patients. The drugs haven't been blockbusters. Financial firm Cowen and Co. estimates that Alli had U.S. sales of $150 million last year, while Meridia and Xenical had sales of $40 million and $35 million, respectively. Doctors also regularly prescribe phentermine, which is approved for short-term use of, say, a few weeks, to treat obesity.
Arena Pharmaceuticals said its lorcaserin drug works by stimulating a neurotransmitter receptor in the brain that helps control appetite and metabolism. The mechanism is similar to the one used by a component of the recalled fen-phen drug combination, but with an important difference.
While the older medications worked on multiple versions of the body's receptors, including those in the heart, lorcaserin has a very specific target that is mostly in the brain, Arena said. Clinical trials have shown there is no increase in such heart-related side effects with the new drug, it said.
In clinical trials, patients taking lorcaserin lost about 6% of their weight on average, while patients taking a placebo lost between 2% and 3%. The most common side effects of the pill, which would be taken twice a day, were headache and nausea, although both symptoms disappeared after an initial period of use.
Combination Therapies
The two other drugs under FDA review are both combination treatments of compounds that are already on the market, but will be delivered in new dosages and methods. Using two drugs at once can be more effective in treating obesity because the brain has multiple ways of making sure that appetite is preserved, as a survival mechanism. Blocking multiple pathways, therefore, can help ensure that a therapy will work.
Orexigen said its Contrave drug works by stimulating a group of neurons in the brain, known as POMC, which, when activated, seem to result in reduced food intake and increased metabolism. The first drug in the combination, the antidepressant bupropion, turns on POMC. But that action also causes the release of a hormone that subsequently switches POMC back off in order to prevent perpetual weight loss. So the second drug in the combination, addiction-treating naltrexone, blocks that hormone in order to allow weight loss to continue, the company said.
Giving the two together as Contrave, in a sustained-release formulation taken twice a day, led to average weight loss that ranged from 5% to 9.3% of a patient's body weight in four clinical trials. Trial participants who took a placebo lost between 1.2% and 5.1% of their body weight. The medication's most common side effects were nausea, constipation and headache, all of which tended to go away after an initial period.
The third drug, Qnexa from Vivus, was the most effective in clinical trials at taking off pounds. In two separate trials, patients lost an average of 10.4% and 11%, respectively, of their body weight, while those taking a placebo lost 1.8% and 1.6%.
Vivus said Qnexa is a controlled-release formulation that combines low doses of the stimulant phentermine, which leads to the release of the stress hormone norepinephrine to cut the body's appetite, and topiramate, which works in various ways to increase satiety, or the sense of feeling full. Combining the two underlying drugs also seems to counteract some of their individual effects: Topirimate can cause cognitive slowing, which phentermine negates, and topirimate counters the blood-pressure raising of phentermine, the company said.
In clinical trials, the most common side effects of the once-daily Qnexa were constipation and dry mouth, along with mild tingling in the finger tips, all of which eventually went away.
Write to Thomas Gryta((djn, x2169)) at thomas.gryta((djn, x2169)) @wsj.com
Copyright 2009 Dow Jones & Company, Inc. All Rights Reserved
here is a company with a vaccine for type one diabetes that very few people know about because it is located in Sweden
Diamyd US Phase III study well under way
Diamyd Medical announces today that one hundred study participants have been included in the ongoing US Phase III study, DiaPrevent. The global Phase III program with the company's lead drug candidate Diamyd® has thereby enrolled more than 430 children newly diagnosed with type 1 diabetes in Europe and the USA.
One hundred patients are now enrolled in the company's US Phase III study called DiaPrevent at 33 diabetes centers throughout the USA and more sites will be added. The study will include 320 children and adolescents between 10 and 20 years of age, recently diagnosed with type 1 diabetes.
"After FDA's approval to include children down to 10 years of age, which is enabling us to add pediatric sites, the recruitment rate has shown a remarkable increase. Numerous sites have been added with more to come. Last month one new patient per day received their first injection and the recruitment rate is accelerating," says Elisabeth Lindner, CEO and President of Diamyd Medical.
More than 430 children have received Diamyd® or placebo in the global Phase III program. To date, no serious side effects related to the drug have been reported, which supports the strong safety profile seen in previous studies with Diamyd®.
The global Phase III program aims to investigate whether Diamyd® can halt or slow the autoimmune destruction of beta cells in type 1 diabetes, preserving the body's own ability to control blood sugar levels. An improved blood sugar control reduces the risk for both acute and long-term diabetes complications. Diamyd® has been shown, in Phase II studies, to preserve the remaining beta cell function in children and adolescents recently diagnosed with type 1 diabetes.
The DiaPrevent study centers were opened for children as young as 10 years of age during autumn 2009 after previously having included only age 16-20 years. New study sites are added as they receive ethics board approvals.
More information about the DiaPrevent study can be found at www.diaprevent.com and at www.diaprevent.diamyd.com.
The parallel European Phase III study was fully recruited in November 2009 and results are expected during spring 2011.
Instead of another bites the dust, this is an example of:
another one walked the plank
I just for the life of me figure out why they wanted to do something that does so much destruction to the country, on their way out.
When Back Surgeons Are Like Bad ContractorsApril 6, 2010 - 5:27 pmShare
Robert LangrethBio | Email
Robert Langreth is a senior editor at Forbes, in charge of health care coverage
If you wonder why medical costs are surging out of control, there are few better places to look than treatment for back pain. Costs have surged as doctors resort to ever more complex devices and operations despite little evidence that patients are feeling better.
The latest piece of evidence: A new study in the Journal of the American Medical Association finds that rates of complex back surgery surged 15-fold among elderly Medicare patients with pain from narrowed spinal canals between 2002 and 2007. The more complex operation cost three times as much as a simpler operation that could have produced just as good results in many patients. It had also had a far higher rate of life-threatening complications.
“This may be a good example of why health care costs are going up without much discernable improvement in overall patient health,” says lead author Richard Deyo, a back pain researcher at Oregon Health and Science University “The more complex and more expensive operations really took off with little evidence that they actually improved the results.”
Deyo in his colleagues looked at elderly Medicare patients who had pain due to a narrowing of the spinal canal, a condition called spinal stenosis. An old operation to called a laminectomy to widen the narrowed canal works well for this condition. But surgeons in recent years have increasingly turned to far more complex procedures that fuse together spinal vertebrae using cages, screws and other expensive gear. There is little proof that these “instrumented fusion” operations produce more pain relief for the typical patient, Deyo says. But they do cost a lot more.
In 2002, less than 1% of elderly spinal stenosis patients were getting the instrumented fusion operations. By 2007, 14.6% of patients were getting the operations. The complex fusion operation makes sense for spinal stenosis patients who also have deformities such as scoliosis, says Deyo. But he found that in 2007 over half the patients getting the complex fusion operation had no deformities that would justify the more expensive operation, according to Medicare claims data he analyzed.
Among patients who got the instrumented fusion, the rate of life threatening complication was a full 5.6%, versus just a 2.3% rate of life-threatening complications among those who got the simpler operation.
It all makes little sense until you look at the economics. Doctors, hospitals, and medical device makers reap far more revenue make from the fusion operations. Overall hospital charges were $81,000 for instrumented fusion, versus $24,000 for the simple operation, Deyo’s team found. Doctors may like to do the new operation because it makes them feel like they are on the cutting edge.
Another big beneficiary to the trend towards more complex back operations are device makers such as Medtronic and Johnson & Johnson who make gear that can be used during fusion operations. Gear implanted during a fusion surgery alone can be $50,000 or more, an editorial accompanying the study notes. Medical device companies have big incentives to convince doctors to do more of the fusion operations instead of the laminectomy operations, which do not involve implanting medical devices.
“The proliferation of risky and expensive practice beyond reasonable supporting evidence is…a fundamental failing of medical practice in the United States,” writes Stanford University surgeon Eugene Carragee in an editorial accompanying the study.
The Deyo study “demonstrates a definite human cost to this practice in terms of increased risk of surgical mortality, major complications, and prolonged morbidity associated with these more complex approaches,” Carragee writes. He adds: "These devices are aggressively marketed, so much so that their promotion may sometimes cross the line of professional conflict of interest among profession leaders and institutions."
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never really followed it, but I guess you trade it from time to time
aezx
I liked the story. The great thing about it is that they might be able to go to the emea with the design of the kerx US trial and see if the european authority would accept that data if they meet their endpoint.
the problem with aezs is that they have about 40 million in the bank but they are burning it with their German facility. The germans are not allowing them to fire anyone.
The story will be better if they can somehow negotiate with the German government to allow them to cut those expenses otherwise they burn through their cash without running any trials
Socialism is a wonderful thing if you want to destroy capitalism.
they do not mix very well.