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Four percent of healthcare workers MRSA-positive
By Debra Beaulieu
if you want to get sick, go to the hospital
About 4 percent of healthcare workers are infected with some strain of methicillin-resistant Staphylococcus aureus, according to a recent voluntary screening of 3,638 clinical and non-patient-care employees.
The researchers at the Brody School of Medicine at East Carolina University in Greenville, N.C., sought to determine the prevalence and genotypes of MRSA isolates from various groups of healthcare workers, and to evaluate the effectiveness of eradication therapy with nasal mupirocin, reports Medscape Today.
Of the healthcare whose nasal swabs were analyzed, 4.3 percent were MRSA-positive. Among those involved in direct patient care, 4.6 percent were positive, 75 percent of whom were infected with a healthcare-related strain. Among nonclinical staff, 4.2 percent were positive, with 54 percent carrying a healthcare-related strain.
As for combating the bug, Mupirocin eliminated MRSA in 75 percent of the studied carriers for at least three months. Mupirocin susceptibility testing indicated that 8.9 percent of initial isolates had high-level resistance and 10.3 percent had low-level resistance. Development of resistance was detected among 2.6 percent of those previously treated with Mupirocin.
According to the study's principal investigator, Keith M. Ramsey, MD, finding such a low percentage of healthcare workers who were MRSA-positive was encouraging. And the findings were consistent with similar studies of MRSA carriage among healthcare workers, noted Kerri A. Thom, MD, MS, assistant professor of epidemiology and preventive medicine from the University of Maryland in Baltimore.
However, Thom said that percent of nonclinical workers infected with healthcare-related strains indicated that the bacteria were being transmitted into non-patient-care areas. "This would be unusual based on the current literature," she told Medscape Infectious Diseases.
Thom stressed that all healthcare workers should practice Standard Precautions when caring for patients, to protect both themselves and their patients.
For more information:
- here's the screening abstract
- read the full article in Medscape Today (free reg. req.)
Related Articles:
C. diff more common than MRSA, can be contained with bleach wipe, studies find
New, lethal MRSA strain emerges
Read more about: mupirocin, MRSA, healthcare workers
I Agree! 4/11 is also my youngest daughter's birthday!
My son is 16 and my daugter is 20, so I think the stock goes to 36 on the 36th of April
For those of you missing bread on Passover
Two old friends, one, a man 85 and the other 87, were sitting on their usual park bench one morning.
The 87-year old had just finished his morning jog and wasn't even short of breath.
The 85-year old was amazed at his friend's stamina and asked him what he did to have so much energy.
The 87-year old said, "Vell, Chaim, I eat rye bread every day. It keeps mine energy level high and l have great stamina vit de vomen."
So, on the way home, Chaim stops at the bakery. As he was looking around, the assistant asked if he needed any help.
He said, "Zog mir, lady, do you have any rye bread?"
She said, "Yes, there's a whole shelf of it. Would you like one?"
He said, "I vant 5 loafs please.
She said, "My goodness, 5 loaves...by the time you get to the 5th loaf, it will be hard"
He replied, "I can't believe it, everybody in this farkockte velt knows about this EXCEPT ME!!"
Someone rich like Dr. Bio talks about wanting to game the system. Which in turn causes his friends and neighbors to pay more and cover his costs when he opts in based on a near term need. I think it's foul, particularly for those who can best afford it.
I think that ramming this bill through was foul. You cannot allow people with pre existing conditions that were gaming the system in the past, into the healhcare insurance system without making your friends and neighbors pay more now.
I was pointing out that this hole in the system is a disgrace, and who says I'm rich, I am comfortable.
A Two-Pronged Attack on Cancer
A number of dual-action antibodies are in clinical trials for fighting cancer.
By Emily Singer
Last year marked a first for engineered antibodies--the European Commission approved a new cancer drug called Removab (catumaxomab), an antibody specially designed to grab both cancer cells and immune cells in such a way that the immune cell can kill the cancer cell. (The drug is undergoing testing for U.S. Food and Drug Administration approval.)
Now a handful of similarly complex molecules, dubbed "bispecific antibodies" for their ability to target two things at once, are in clinical trials. The two arms of these antibodies work together in different ways to treat cancer or other diseases, by bringing together two types of cells, as with Removab, by targeting two different types of receptors on the surface of a cell, or even using one arm to deliver drugs to specific cells targeted by the other.
Scientists say the two-front attack can make existing cancer therapeutics more powerful and help combat drug resistance, an issue for some targeted cancer therapies. "If you can wrap two treatments into one molecule, you have a potentially more active drug and can take it to the FDA more quickly," says Carlos Barbas, chair of the Skaggs Institute for Chemical Biology at the Scripps Research Institute in La Jolla, CA.
While the concept of bispecific antibodies has been around for decades, the approach has only recently shown clinical success. The field has been driven forward by new ways of designing and making the antibodies, which take advantage of advances in protein engineering, as well as the success of single-target antibodies, such as herceptin, that are already on the market. "The European approval of the Trion antibody provides proof of principle that this technology works," said Tariq Ghayur, senior principle scientist at Abbott Laboratories, in Worcester, MA, at a conference in Boston organized by the Massachusetts Biotechnology Council on Wednesday. "I think in the next few years, we'll see lots of advances in this area."
Herceptin, an antibody used to treat some types of breast and other cancers, has been one of the earliest successful examples of targeted cancer treatment. Given primarily to women whose cancers overexpress a receptor called HER2, the antibody binds to the receptor, encouraging the immune system to attack the cell.
Newer bispecific antibodies also target HER2, but in a different way. Merrimack Pharmaceuticals, a startup in Cambridge, MA, has developed a candidate bispecific antibody called M-111. One arm binds to the HER2 receptor, and the other binds to a related receptor called HERB3. Binding both prevents the two receptors from coming together and activating a signaling pathway important for cell survival. The drug is now in early-stage clinical trials for cancers that overexpress HER2.
One of the problems with herceptin is that tumors can evolve resistance to the drug, an issue that bispecific antibodies may avoid. "Cancers often escape targeted treatments by either down-regulating the target or mutating it," says Barbas. "The chance of escaping a drug that can hit cancer at multiple sites is much lower because the cancer can't mutate two receptors at once."
While M-111 has the same target as Herceptin, it acts differently, using HER2 only as a marker for cancer cells rather than as the target for drug-induced activity. Ulrik Nielsen, chief scientific officer at Merrimack, says that because the antibody works through different mechanisms, M-111 could be delivered along with Herceptin. In fact, he says, it may prove effective in killing cancer cells that have become resistant to Herceptin.
Another bispecific antibody now in clinical testing by Pfizer takes a similar approach. It binds to two molecules that encourage the growth of the blood vessels that feed tumors: VEGF, a protein targeted by the popular drug Avastin, and ANG-2. If the tumor evolves resistance to one, the drug can still target the other.
Combining the action of two antibodies could also prove much cheaper for pharmaceutical companies and patients. Testing two experimental drugs separately and then in combination is prohibitively expensive. And the drugs already on the market are extremely costly. "Combinations of monofunctional drugs will be unaffordable--treatment with herceptin and avastin can cost upwards of $200,000," says Barbas, whose research led to the development of the Pfizer antibody now in clinical testing. "We need to wrap them into a single protein package that can be manufactured and delivered to patients with the cost of a single antibody."
Copyright Technology Review 2010
Transcept Pharmaceuticals Updates Plan for Intermezzo(R) NDA Resubmission Following Teleconference With the FDA
I guess the university in the netherlands has a padded highway so if the patients fall asleep at the wheel they won't get hurt.
Companies:Transcept Pharmaceuticals, Inc.
Press Release Source: Transcept Pharmaceuticals, Inc. On Wednesday March 24, 2010, 9:30 pm EDT
POINT RICHMOND, Calif., March 24 /PRNewswire-FirstCall/ -- Transcept Pharmaceuticals, Inc. (Nasdaq:TSPT - News) has announced its plan for the resubmission for the Intermezzo® New Drug Application (NDA) based on a teleconference with the U.S. Food and Drug Administration (FDA) held earlier today. The key component of the resubmission plan is an Intermezzo® highway driving study to assess next day residual effects, for which Transcept now expects to begin enrollment in the late second quarter of 2010. Based on the teleconference with FDA, and pending a positive highway driving study outcome, Transcept estimates that it will resubmit the Intermezzo® NDA in the late fourth quarter of 2010.
Update on the Intermezzo® NDA resubmission plan
In the October 28, 2009 Intermezzo® Complete Response Letter, the FDA expressed two concerns regarding the possibility of middle of the night patient dosing errors that could lead to next day residual effects, with particular reference to next day driving impairment. Specifically, the FDA asked Transcept to address methods to avoid inadvertent re-dosing in a single night, and inadvertent dosing with less than four hours of bedtime remaining.
A meeting was held on January 20, 2010 to discuss the Intermezzo® Complete Response Letter, during which the FDA indicated that the Transcept proposal to employ a single unit dose package appeared to reduce the potential for inadvertently taking more than one Intermezzo® dose in a single night.
During the March 24, 2010 teleconference, the FDA agreed that the Transcept proposal submitted on February 16, 2010 to conduct a highway driving study is a reasonable way to measure potential next day driving impairment as a result of dosing Intermezzo® in the middle of the night with four hours or less remaining in bed. This study will be conducted at the University of Maastricht in the Netherlands, a leading center of research on the effects of drugs and alcohol on driving performance.
Key elements of the highway driving study include:
Approximately 36 adult subjects
Highway driving over a one-hour period
Single center, double-blind, randomized, placebo-controlled crossover design
Key comparisons:
Intermezzo® 3.5mg vs. placebo, 4 hours post-dose
Intermezzo® 3.5mg vs. placebo, 3 hours post-dose
Zopiclone 7.5mg vs. placebo (positive control)
Primary endpoint: deviation of lateral position as compared to placebo
In earlier interactions, the FDA and Transcept discussed whether a patient use study might help to define patient ability to properly follow instructions under actual conditions of use. During the March 24, 2010 teleconference, the FDA indicated that, during the review of the overall resubmission of the Intermezzo® NDA, it would consider the Transcept position regarding the challenges and limitations of a pre-approval patient use study. Transcept also plans to include data from on-going studies of patient comprehension of label instructions in this resubmission.
abio
sorry I left the symbol out of my previous message.
they recieved a patent and the stock tripled.
Health and Hospitals Corp., prepares to slash 10 percent of its workforce
If everyone dies costs will go down
By Dan Bowman Comment | Forward |
The combination of a $1 billion budget deficit and constant cuts to statewide healthcare subsidies has New York-based Health and Hospitals Corp. (HHC), the largest public hospital system in the country, bracing to slash 3,900 positions--roughly 10 percent of its workforce.
In 2011 alone, HHC's budget gap is expected to grow by 86 percent to a staggering $1.5 billion, according to the Wall Street Journal. A good portion is due to uncompensated care. HHC is the largest provider of uncompensated care in New York City, having served more than 450,000 uninsured patients in 2009, notes a report from the city's Independent Budget Office released today. Those uninsured patients cost HHC an estimated $492 million.
Add to that Gov. David Paterson's plans to cut more than $1 billion in healthcare subsidies throughout the state--$250 million of which would have gone to hospitals--and the fact that employee pensions have increased by more than $280 million since 2004, and it's easy to see the conundrum facing HHC. Health insurance costs for the system's employees also have doubled to $190 since 2004.
"No hospital in the country is exempt from the crushing economics facing the healthcare industry," New York Mayor Michael Bloomberg told the Journal.
Alan Aviles, HHC's president, added that because 70 percent of the system's budget comprises personnel costs, lowering expenses "will simply not be possible" unless jobs are cut.
how does this happen
Last Trade: 7.86
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Gaming the system
Second, coverage is not immediate. Apply today, you'll wait 30 days for it to kick in. You'd be forced to pay for the uncovered bills in the meantime.
If I were an insurance company I would start a new class of thirty day insurance policies.
if insurance doesn't kick in for thirty days a person could be wiped out if they break a hip or have a sudden problem like a heart attack or stroke. An insurance company could probably make a fortune charging 400-500 dollars a month for thirty day policies that would cover these kinds of problems until the person gets a new policy that covers pre existing conditions after thirty days.
It would alleviate the mind of a person like myself that could lose all of their assets for a thirty day hospitalization and surgical expenses.
NEW YORK (AP) -- Canadian drug developer Biovail Corp. said Friday it bought several Ampakine compounds, aimed at treating a breathing disorder, for $9 million upfront, plus future payments.
Biovail said it bought the compounds from Cortex Pharmaceuticals Inc. They include CX717, now in midstage development.
Biovail will pay the upfront fee, along with an additional $1 million upon completion of a transition period. It could also pay up to $15 million in milestones.
this is clear
If there is no provision to prevent this, than the insurance industy in the US will go bankrupt. That has probably been the plan all along.
why aren't those stocks getting killed?
I am currently paying nearly 1800 a month for my medical insurance
I am tying to find out if I can cancel it and pay the penalty. Then if someone in my family gets sick, I can buy the insurance because I will not be denied because of the pre existing condition. Does any one know of a provision that prevents this?
it could be paid off over a period of time
terms would normally say an up front payment of ten million and milestones of 15 million.
this says a purchase price of ten million and milestones of 15 million.
do they get the ten million immediately?
it isn't really that clear
There are probably 5 or six institutions that control sixty percent of the stock.
There is an expression, in for a dime in for a dollar. My feeling is that even if those funds had to put together ten million dollars to extend the runway, that would last a long time given the company's reduced burn.
Most of the biotechs that have gone bankrupt had debt of fifty to sixty million so it didn't make sense in those instances.
This company has two blockbuster ready for phase three drugs and one multihundred million, ready for phase three drugs I think the large holders would want to perserve their interests.
I may be wrong but I doubled my position today at 90 cents.
I can't believe they won't get a buyer of the entire pipeline for what we thought be be just the up front payment on the afib deal
You are correct about Multaq, apples and oranges. Half the patients on afib drugs have chf and patients and multaq is contra indicated in patients with chf.
that is why Sanofi had to do the last trial. In the prior study there were more deaths on the drug than the placebo for patients with chf
Iron Ore Prices -Vale is the second largest mining company in the world, so when Vale speaks, our commodities team listens. Last night Vale sent a document to its customers saying it was raising iron ore prices to $122.20 per tonne, versus $57 per tonne year last year. That is a 114% increase. I don't need a degree from MIT to know that is inflationary.
Incidentally, if you are looking for a market with duopoly pricing power, Vale and its competitor Rio Tinto Group control roughly2/3rds of the global iron ore market. So, yes, they have pricing power. And yes, when they raise price by 114% year-over-year that is inflationary for all things steel.
Something more important than the healthcare debate
did Toni Basil steal the song form the Run Dmc or vice versa
Austrailia is looking better and better to me.
I think you left out a decimal on osir
not 15.00 but 1.50
they have failed every trial except a small open label 30 patient study
FDA Will Review Fosamax, Boniva for Safety
By JENNIFER CORBETT DOOREN
The Food and Drug Administration said Wednesday it's conducting a safety review of certain bone-building drugs like Fosamax and Boniva to see if they increase the risk of femur fractures.
The review involves a class of drugs known as bisphosphonates, which are commonly prescribed to treat osteoporosis and are designed to build bone mass. Drugs in the class include Actonel, marketed by Sanofi Aventis SA and Procter & Gamble Co.; Boniva, marketed by Roche Holding AG and GlaxoSmithKline PLC; and Merck & Co.'s Fosamax.
The agency said it was looking at reports about whether there's an increased risk of atypical subtrochanteric femur fractures—fractures in the bone just below the hip joint—in some patients who've been on the drugs for several years.
However, the FDA said, "the data that FDA has reviewed have not shown a clear connection" between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.
Two studies presented Wednesday at the American Academy of Orthopaedic Surgeons' annual meeting suggest the drugs might adversely affect bone quality and increase risk of atypical fractures of the femur, or the main bone in the thigh, when used for four or more years.
The FDA said it had requested information from drug manufacturers in 2008 after seeing case reports about femur fractures occurring in women with osteoporosis using bisphosphonates.
"FDA's review of these data did not show an increase in this risk in women using these medications," the agency said in a statement posted to its Web site Wednesday. The agency also cited a 2008 study that found similar femur fracture rates among women taking bisphosphonates compared to women not taking the drugs. The study found that the femur fractures had many features in common with osteoporotic hip fractures.
However, the agency said it would work closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research's Subtrochanteric Femoral Fracture Task Force, to gather additional information.
The FDA said people currently taking the medications shouldn't stop taking them but said they should talk to their doctors if they develop new hip or thigh pain. The agency asked doctors to report any side effects seen with bisphosphonates to the agency.
Bisphosphonates are designed to work by slowing or stopping bone loss by partially blocking the body's natural process involved in removing and rebuilding bone tissue. The drugs have been shown to increase bone mass and stop or slow the progression of osteoporosis.
But researchers said Wednesday that while the drugs are effective at increasing the quantity of bone, it's possible they might cause brittle bones over the long term that are more susceptible to fractures.
One study by researchers at Columbia University looked at the bone structure of 111 postmenopausal women with osteoporosis, 61 of whom had been taking bisphosphonates for a minimum of four years, and compared it to 50 people taking calcium and vitamin D supplements.
"In the early treatment period, patients using bisphosphonates experienced improvements in all parameters, including decreased buckling ratio and increased cross-sectional area," Melvin Rosenwasser, an orthopaedic surgeon for Columbia University Medical Center, said in a statement. "However, after four years of use, these trends reversed, revealing an association between prolonged therapy and declining cortical bone structural integrity."
Dr. Rosenwasser said the drugs are still very effective at preventing bone loss and the findings from the study shouldn't change treatment practices. He said additional studies are needed.
Another, separate study, by researchers at the Hospital for Special Surgery in New York, looked at bone samples taken from 21 post-menopausal women who were treated for femoral fractures. Of these, 12 patients had a history of bisphosphonate treatment for an average of 8.5 years, while nine women hadn't been treated with the drugs.
The study found that patients treated with bisphosphonates had a reduction in bone tissue heterogeneity compared with women not receiving the drugs, which researchers said suggests there might be differences in some bone quality parameters.
Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com
The Nothing Cure
Matthew Herper and Robert Langreth 03.29.10, 12:00 AM ET
http://www.forbes.com/forbes/2010/0329/opinions-placebo-harvard-health-medicine-ideas-opinions_print.html
Though recurring tummy aches from irritable bowel syndrome are among patients' most common complaints, drugmakers have had trouble coming up with a safe and effective treatment. But in 2008 Harvard's Ted J. Kaptchuk devised a safe remedy that helps far more people than any designer drug ever did.
His magic cure: fake acupuncture delivered with lots of warm talk from a sympathetic acupuncturist--but no needles. In a trial of 262 patients with severe IBS, 62% of those who received the fake treatment got better, according to results published in the British Medical Journal. By comparison, only 28% of a control group of patients put on a waiting list saw their symptoms improve markedly. A third group who got the fake acupuncture, but without any warm talk, showed in-between results: 44% improved.
The result, says Kaptchuk, shows just how much the expectation of a cure--and the rituals associated with medical treatment--can improve real-world symptoms. "Our own will, imagination and belief can modulate the course of illness," says Kaptchuk.
Kaptchuk is among a small band of researchers studying the mechanisms behind the mysterious placebo effect. They are finding that the mere expectation that a treatment will help produces lasting effects on symptoms of many diseases--and real changes inside patients' brains. Certainly placebos will never cure cancer or heart disease. But believing in a treatment may ease back pain, improve Parkinson's disease symptoms, alleviate depression and lessen nausea.
Mainstream medicine has tended to dismiss or ignore the placebo effect. Drug companies try to minimize it when conducting clinical trials. But Kaptchuk argues that doctors should instead do everything in their power to try enhance it by hyping up the rituals around their treatments. Doing so could help make existing treatments more effective and may reduce the need for expensive pills that have lots of side effects. "The ritual of health care has an important role to play that gets overlooked," says Kaptchuk.
Kaptchuk's research helps explain why doctors often think they have found a breakthrough treatment, only to find to their embarrassment years later that a placebo pill or other sham treatment works just as well. Knee arthroscopy was long thought to be a good treatment for arthritis pain. In 2002 a rigorous clinical trial found that patients got just as much relief from a fake surgery. Last summer two major trials tested vertebroplasty, a procedure to relieve pain from osteoporosis fractures by injecting cement into the back. Doctors had reported a high success rate. But it turned out that a fake surgery with no cement was just as good. It was all in the expectation.
The most recent big brouhaha is over studies in the Journal of the American Medical Association and PLoS Medicine finding that antidepressants barely beat sugar pills for mild and moderate depression. "The question is: Are we all fooling ourselves, telling ourselves that the improvement is caused by a pill when it's actually caused by the nice interaction we've had with our patients?" wonders psychiatrist and blogger Daniel Carlat. "A big part of what gets people better when they take pills is something other than the neurochemical action." Carlat thinks the pills work.
Kaptchuk, 62, has a college degree in religious studies from Columbia University and is one of the few Harvard medical professors without a Western graduate degree. An expert in acupuncture, he became interested in the placebo effect while getting a doctorate in Chinese medicine at the Macau Institute of Chinese Medicine in China in the 1970s (Massachusetts law doesn't allow him to call himself a doctor). He now leads a dozen investigators studying the placebo effect, funded with grants from the National Institutes of Health.
A placebo, he says, is the sum total of all the psychological benefits patients get from seeing their doctors and taking their pills. One theme of his research is that the bigger and more complicated the ritual, the greater the placebo effect. Surgery and medical devices often produce a bigger placebo effect than a pill because expectations for a cure are higher, he says. In a British Medical Journal article in 2006, for example, Kaptchuk and his colleagues reported treating 270 people suffering severe arm pain from repetitive-use injuries with either a placebo pill or fake acupuncture. The people who got the fake acupuncture reported significantly greater reductions in self-reported pain, even though there was no difference in posttreatment grip strength between the groups.
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Certainly doctors and patients routinely underestimate how often symptoms will get better on their own. Back pain, irritable bowel syndrome, depression and anxiety tend to wax and wane over time. People report to the doctor's office when symptoms are worst. They assume the treatment they get is responsible for any improvement, even though they might have got better anyway. Some say this is not a true placebo effect.
But recent brain-imaging studies show that fake treatments can produce real effects deep inside the brain. One of the scientists performing these studies is University of Colorado psychologist Tor Wager, 35. Over the years "there has been tons of skepticism" that the placebo effect really exists, says Wager. He was skeptical himself when he first started doing brain scans of patients on placebos as a grad student at the University of Michigan. But now, he says, "the science has really exploded."
In recent years researchers have proved that the placebos alter the perception of pain inside the brain. The expectation of getting treated turns on the brain's reward system, causing the brain to produce dopamine and natural narcoticlike chemicals. This can trigger pain relief even in the absence of a drug. "The placebo effect is a real thing, and it is tied to an old, hardwired pain-control pathway," says Falk Eippert, a researcher at University Medical Center Hamburg-Eppendorf in Germany. "It is not some kind of elusive phenomenon."
In 2004 Wager and his colleagues applied an inert cream to the arms of 50 volunteers, then pressed a painfully hot ceramic plate against their arms while the subjects were inside a magnetic resonance imaging machine. Half the time the researchers lied to the subjects. "We told them it was a powerful pain-relieving drug," Wager says. The rest of the time they admitted the cream was inert. When volunteers thought they were getting a real drug, they reported 20% less pain. Neuronal activity in regions of the brain that encode pain intensity subsided, the MRI showed.
The next year neuroscientist Jon-Kar Zubieta of the University of Michigan used a different type of brain scan (positron emission tomography) to delve more deeply into what goes on at the molecular level when people receive a placebo. He showed that when patients think they are getting a painkiller--but are getting a placebo--it stimulates some of the same molecular receptors in the brain that the narcotic painkiller morphine hits.
Another ailment where there is mounting evidence for a placebo effect is Parkinson's disease. In this disease dopamine-producing cells in the brain gradually die. A 2001 University of British Columbia study in the journal Science gave six Parkinson's disease patients a placebo and then examined their brains with positron emission tomography. The expectation of relief triggered large amounts of dopamine to be released inside the damaged areas of the brain.
Placebo is Latin for "I shall please," and for two centuries the word has been used to refer to inactive treatments given to make patients happy. The concept of a placebo effect was popularized in a 1955 JAMA article by anesthesiologist Henry Beecher, "The Powerful Placebo." It made a case for performing placebo-controlled trials of new drugs.
Some are still skeptics. Danish epidemiologist Asbjørn Hróbjartsson calls the placebo effect "grossly exaggerated." Hróbjartsson analyzed 202 studies comparing placebo treatments for various diseases with no treatment and found only a clear statistically significant placebo effect for two conditions: pain and nausea. He says a lot of what gets called the placebo effect is really patients getting better on their own or exaggerating symptom improvements to please their doctors.
While drug companies are desperate to get rid of the placebo effect, the opposite is true in clinical practice. A 2008 survey of U.S. internists and rheumatologists found that half of them prescribed placebos, including sugar pills, vitamins and supplements they did not expect to have an effect on anything aside from the patient's own belief. But it may be possible to enhance the placebo effect even when active drugs are being used. "We do a lot to undermine the placebo effect" by making pill-taking mechanical, argues Duke University behavioral economist Dan Ariely. In a 2008 experiment he found that more people get pain relief from a placebo that supposedly costs $2.50 a pill than from a placebo they think costs only 10 cents per pill.
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To enhance patients' expectations, drugs could come in colorful packaging instead of plain white bottles, says Ariely, author of Predictably Irrational. The term "generic drug" should be abandoned because it is associated with cheapness, he says. Ariely became aware of the placebo effect after suffering severe burns in an explosion. At the hospital he was at in Israel, morphine doses were limited to prevent addiction. Sometimes patients exhausted their daily rations and would be crying in agony. "The nurses would give them a placebo injection, and they would go to sleep. It was unbelievable," he says.
Another possibility: It may able be possible to take advantage of the placebo effect to lower the amount of drug needed to treat a patient. This could save money and prevent side effects. Only a handful of small studies have explored this concept. In one trial of 46 psoriasis patients, psychologist Robert Ader from the University of Rochester School of Medicine & Dentistry found it was possible to reduce the amount of steroids needed to treat psoriasis by half, giving patients the full dose of steroids some days and a placebo cream on others. "The brain interacts with the immune system in all sorts of ways--there are communications in both directions," Ader says.
It could take decades for researchers like Kaptchuk and Wager to parse all the psychological and neurobiological mechanisms behind the placebo effect. They may never come up with a clear answer as to what is going on. Meanwhile, the next time your doctor recommends an expensive drug or complicated operation to relieve everyday symptoms, it may pay to ask him a simple question. Will the treatment beat a placebo?
that is true, if you have no cash there aren't many alternatives.
Did you think it was a scam because to the way management presented or did you think the product was useless
around the end of October
http://finance.yahoo.com/news/Fibrocell-Science-Inc-prnews-1592404833.html?x=0&.v=1
They seem to received a complete response letter from the fda and according to their press release they do not seem to have a lot of work to do to, to respond to the letter and get approved.
Dew,
do you remember the former Isologen, I think you followed the company and didn't like to product?
he wouldn't know good science if it bit him on the A$$"...
I believe the ceo that said that is the ceo of nvlt or hdvy. You could probably make that quote about either one of them.
if you found it hard to find, and you follow the company, why didn't the ahole put it in the release
it sounds like neop will probably be ok as far as nda filing
there were sites that diluted the drug too much. I do not know why this wasn't eplained in the press release
Expert witness: Microsoft infringed VirnetX patents, and knew it
An expert witness who looked at Microsoft's source code has determined that the company indeed infringed upon two of VirnetX's patents, knew about the patents, and believed the technology was valuable enough – and not obvious enough – to attempt patenting similar technology itself.
http://blog.seattlepi.com/microsoft/archives/197593.asp
Seattlepi.com combed through 301 pages of court transcripts from Day 2 (on Tuesday) of the VirnetX v. Microsoft patent-infringement trial. Mark T. Jones, an electrical and computer engineering professor at Virginia Tech, testified in his 10th trial as an expert witness that VirnetX's allegations were true.
The Scotts Valley, Calif., company of 12 employees alleges Microsoft infringed two of its patents – Nos. 6,502,135 and 7,188,180 – on technology for secure and automatic virtual private networks, or VPNs. In its defense, Microsoft is arguing that the patents are invalid largely because the technology was obvious – in this sense, a legal term – and that Microsoft's Windows XP, Windows Vista, Office Live Communicator and other products did not infringe.
During the trial in Tyler, Texas, Jones and a VirnetX attorney walked the jury through a lengthy presentation that explained the wording of VirnetX's patents, explained Jones' independent analysis of Microsoft's products, and explained how he believed Microsoft infringed.
BACKGROUND COVERAGE
· VirnetX stock soars as Microsoft patent trial nears
· VirnetX's future depends on Microsoft lawsuit
· Microsoft: VirnetX was created to sue us for $242M
Perhaps more notably, however, VirnetX's legal team showed that Microsoft tried to patent the VPN technology it used in Office Live Communicator, and that the U.S. Patent and Trademark Office rejected the application by citing VirnetX's '135 patent as previously existing technology, or "prior art."
Microsoft's merely applying for a patent suggests that Microsoft didn't believe the technology was obvious to a computer expert. Obviousness is a main element of Microsoft's legal defense.
Let's tackle that first, that Microsoft received a rejection from the USPTO based on the '135 patent VirnetX now owns.
Here, VirnetX council Douglas Cawley, of the McKool Smith law firm, is questioning Jones about the elements of "direct infringement" – whether Microsoft had the knowledge that its products might have been directly infringing VirnetX patents. Edmund Munger and Bob Short are two of the listed inventors.
Accompanying Jones' sworn testimony, in which he referred to evidence documents and Microsoft depositions, was a PowerPoint presentation for the courtroom.
Q. So for the first element, did you find that Microsoft had – did you find evidence that Microsoft had knowledge of the '135 patent?
A. Yes, sir, I did. I'd like to show that to you.
Q. Okay. This is Plaintiff's Exhibit 401. What are we seeing here?
A. This is an information sent from the U.S. Patent & Trademark Office from – well, from there to Microsoft representatives during the – what's called the prosecution of a patent by Microsoft.
Q. So Microsoft was applying for a patent on some technology it wanted to patent?
A. Yes, sir.
Q. And this is correspondence from the United States Patent Office back to Microsoft?
A. Yes, it is, and it's dated September 26th, 2003.
Q. Now, where does Mr. Munger and Dr. Short's '135 patent fit into this document?
A. Well, let me turn to a little bit later part of it. So I've highlighted two portions of this document. The first one says, essentially, that the claims that Microsoft had submitted as part of the patent application were unpatentable in view of Munger. And they mention the '135 patent explicitly. And a little lower down, we see as to Claim 12, Munger teaches the method of Claim 9 wherein the communication device is a proxy server.
Q. So does this mean that the patent claims that Microsoft was trying to get, that in September of 2003, they were rejected because of the Munger '135 patent we've talked about?
A. Yes, sir. And this is the record of the information or the discussion that the Patent Office sent back to Microsoft's representatives.
Before Jones spoke about the USPTO application, he and Cawley went through the specifics of Microsoft's alleged infringement of the '135 patent.
To infringe a patent, somebody must violate only one "claim." VirnetX alleges Microsoft infringed Claims 1, 10 and 12 of the '135 patent. In the excerpt below, Jones and Cawley walk through the three steps to Claim 1.
Not quoted here, they also went through the steps for Claims 10 and 12. Jones said his opinion is that Microsoft infringed all three claims.
Bold sentences were added for clarity.
Q. So I want to start with the preamble of the claim, which says: A method of transparently creating a virtual private network between a client computer and a target computer. Is that what we do in Office Communicator and the remaining Microsoft '135 products?
A. Yes, it is. That's what happens when the remote computer establishes a VPN to the computers back at (example) Acme.com.
Q. Are there words in here that Judge (Leonard) Davis has defined for us?
A. Yes, there are. As we saw earlier and the definition I read was for virtual private network.
Q. And you've already read that definition to us. Did you apply it in analyzing these claims?
A. Yes, sir.
Q. Now, let's move to the first step, which is, generating from the client computer a domain name service request that requests an IP address corresponding to a domain name associated with the target computer. What is happening – I'm sorry. Did Judge Davis provide us definitions for that term?
A. Yes, he did. For two of those terms. The first one is domain name service, and that is a lookup service that returns an IP (Internet protocol) address for a requested domain name. And the second one is the definition of domain name, which is a name corresponding to an IP address.
Q. So did you find that in the Microsoft '135 product?
A. Yes, I did. That is when the – for example, the application is sending that domain name to the RTC interfaces (or, pieces of the Windows application programming interface).
Q. Did you find that element met in all of the Microsoft '135 products?
A. Yes, sir, I did.
Q. Now, Professor Jones, we have check boxes here (on a foam board). What I want to know is, can I check off that element as being met in the Microsoft '135 products?
A. Yes, sir.
Q. The second element of the claim says – the second step, excuse me – says: Determining whether the domain name service, or DNS, request transmitted in Step 1 is requesting access to a secure website. Has Judge Davis provided us definitions of some of the words there?
A. Yes, sir. Secure website, and the definition for that is a website that requires authorization for access and that can communicate in a VPN. For website, it's one or more related web pages at a location on the worldwide web.
Q. Now, in the Microsoft '135 products, did you find that the RTC interfaces determine whether the DNS request is requesting access to a secure site?
A. Yes, I did, as I described for the DNS proxy server with those four questions about available connections.
Q. Does the site require authorization for access?
A. Yes, sir. As discussed, the user has to be an authorized user or the gatekeeper computer will not allow the connection.
Q. Now, more specifically, in the Microsoft '135 products, did you find that the RTC interfaces determine whether the DNS request is requesting access to a secure website?
A. No, sir, I did not.
Q. Okay. Why not?
A. Well, as I mentioned earlier, the Office Communications Server is not literally a website.
Q. Well, Professor Jones, if you found the Microsoft '135 products do not involve requesting access to a secure website, does that mean that this element of the claim is not met by the Microsoft '135 products?
A. No, sir, it doesn't. Just making a small change does not mean that you don't infringe. If – if the product is insubstantially different from the claims, then it still infringes under this Doctrine of Equivalents (a legal term) that we talked about earlier.
Q. Well, Professor Jones, did you determine this Office Communicator features offered over the virtual private network are not substantially different than a secure website?
A. Yes, sir, I did.
Q. For instance, would the virtual private network be triggered any differently, if it were to carry website traffic?
A. No, sir, it wouldn't. The – the triggering mechanism here would still be the same whether it was literally web pages or presence information or instant messaging. It wouldn't work any differently.
(Jumping ahead ....)
Q. So were you able to determine if the Microsoft '135 products perform substantially the same function as a secure website?
A. Yes, sir, they do. They make use of computers to communicate in the VPN to present information to clients, and they require that the clients be authorized to access the servers.
Q. Were you able to determine if the Microsoft '135 products perform in substantially the same way as a secure website?
A. Yes, sir, they do. They make use of computers to communicate in the VPN using protocols. They present information to clients through Windows over the internet, and they do so in a way in which the client's and servers cooperate to ensure that the clients are authorized to connect.
Q. And finally, did you determine whether the Microsoft '135 products achieve substantially the same result as a secure website?
A. Yes, sir, I did. I found that the result achieved was that the client is able to communicate with computers in a VPN. It does so over a public network and in a way in which only clients that are registered are able to communicate in that network with those servers.
Q. And, Professor Jones, did you conclude that the Microsoft '135 products meet the element of determining whether the DNS request in Step 1 is requesting access to a secure website?
A. Yes, sir, I did under the Doctrine of Equivalents.
Q. May I check that element (on the board)?
A. Please do.
Q. Let's look now at the last claim element, which reads: In response to determining that the domain name service request, or DNS request, in Step 2 is requesting access to a secure target website, automatically initiating the VPN between the client computer and the target computer. What is happening in that claim element?
A. In that element, the DNS proxy server is sending a request to – to initiate the VPN. And in the Microsoft products that happens when the RTC interfaces initiate the VPN with the gatekeeper computer.
Q. I think you touched on this earlier, but is that VPN just always going to be to a single Office Communications Server?
A. No, sir. As I mentioned earlier, that's a group of servers as well as other computers that form a network back at the company.
Q. Now, has Judge Davis provided any additional definitions that help us with this claim element?
A. Yes, sir. So for the claim term, automatically initiated in the VPN, we use the definition initiating the VPN without involvement of a user.
Q. In the Microsoft products, after it is determined that the DNS request pertains to a secure site, do the products automatically initiate a VPN between the client computer and the target computer?
A. Yes, sir, they do. They send that request to the gatekeeper computer to – or the RTC interfaces sent that request to the gatekeeper computer to initiate the VPN.
Q. Will that gatekeeper computer make sure that the proper credentials are presented?
A. Yes, sir, it will.
Q. Now, remind us, really, what was the user's involvement here with all this information going back and forth?
A. Well, the user, as we saw in the screen shot, types in that domain name and his log in. And after that, this all happens behind the scenes automatically.
Q. Professor Jones, did you find this last element met in the Microsoft '135 products?
A. Yes, sir, I did under the Doctrine of Equivalents.
Q. May I check that box?
A. Please do.
Q. Well, Professor Jones, we have checked all the boxes on Claim 1. What does that mean?
A. Well, that means that the Microsoft '135 – '135 products infringe Claim 1 of the '135 patent, and, therefore, they infringe the '135 patent.
The following statement from Jones summarizes Tuesday's court proceedings quite well.
It's my opinion that even Microsoft's own knowledge of the way its products operate, as well as their knowledge of the '135 patent, that as one of ordinary skill in the art would have understood, that using those products in the way that Microsoft describes would have resulted in infringing the '135 patent.
Cawley and Jones went on to talk about the '180 patent – the other one VirnetX alleges Microsoft infringed. But at about 5 p.m., Judge Davis sent the court to recess. VirnetX's attorneys did not complete their examination of Jones on Tuesday, and seattlepi.com has not yet been able to obtain transcripts of Wednesday's proceedings.
Ostensibly, Microsoft's attorneys were able to cross-examine Jones. Further proceedings will be reported here when the transcripts become available.
Sources said the proceedings Wednesday and Thursday were "good for VHC," or VirnetX Holding Corp.
Neop press release
if the data was good off the bat, you announce the data and that the trial was successful, then meet with the fda. Since they must have had protocol violators that made the results miss the endpoint, before announcing the data, they met with the fda so they could put out press releases that the nda will eventually be filed because they will have several meetings with the fda.
at each meeting the fda will say do not file the data, it is crap but you will keep playing with the data and having more meetings, extending the defeat until you can sell your stock.
I have never seen a press release like this where the company met with the fda before announcing their data. why didn't they announce the data as soon as they had it, if it met the endpoints
Neoprobe Announces Successful Meeting on Lymphoseek Phase 3 Results
Submission Plan for New Drug Application for Lymphoseek Reviewed With FDA
Conference Call Scheduled for 8:30 a.m. Tomorrow, Friday, March 12, 2010
Companies:Neoprobe Corp.
Press Release Source: Neoprobe Corporation On Thursday March 11, 2010, 4:05 pm EST
DUBLIN, OHIO--(BUSINESS WIRE)--Neoprobe Corporation (OTCBB: NEOP - News), a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that it recently met with the United States Food and Drug Administration (FDA) to review the clinical trial results of a Phase 3 investigational new drug, Lymphoseek®. The Phase 3 clinical study (NEO3-05) was conducted in subjects diagnosed with either breast cancer or melanoma. The FDA review included the efficacy and safety results of the NEO3-05 study and Neoprobe’s plans for the submission of a New Drug Application (NDA) for Lymphoseek. The NDA submission will be based on the clinical results of NEO3-05 and other already completed clinical evaluations of Lymphoseek. FDA encouraged Neoprobe to request a series of pre-NDA meetings in the coming months to review the components of the NDA prior to its formal submission. Neoprobe indicated to FDA that the Company plans to submit the NDA following satisfactory completion of these meetings.
“We are very pleased with our recent discussions with the FDA review team regarding the NEO3-05 Phase 3 clinical results,” said David Bupp, Neoprobe’s President and CEO. “The results from this meeting have clearly confirmed our pathway for the submission of a NDA approximating our previously disclosed target timeline. The potential clearance of the NDA in 2011 would position Lymphoseek to be the first radiopharmaceutical for the preoperative or intraoperative identification of lymphatic tissue. Neoprobe will be working with FDA in the coming months to prepare for a successful review of the Lymphoseek NDA, and to determine additional information that could be provided on a post-marketing basis to extend or expand the labeling from that planned for the initial NDA.”
“The performance of Lymphoseek in the Phase 3 study was excellent,” said Dr. Fred Cope, Neoprobe’s Vice President, Pharmaceutical Research and Clinical Development. “The primary and secondary efficacy endpoints of the study were met and no significant adverse events were reported that were directly attributed to Lymphoseek. The results of the Phase 3 trial have been favorably received by the members of the medical and scientific community. We plan to continue ongoing clinical evaluations of Lymphoseek that will be supportive of the NDA and subsequent amended claims for the product.”
The NEO3-05 Phase 3 study was an open label trial of node-negative subjects with either breast cancer or melanoma. It was designed to evaluate the safety and the accuracy of Lymphoseek while identifying the lymph nodes draining from the subject’s tumor site. To demonstrate the accuracy of Lymphoseek, each subject consenting to participate in the study was injected in proximity to the tumor with Lymphoseek and one of the vital blue dyes that are commonly used in lymphatic mapping procedures. The primary efficacy objective of the study was to identify lymph nodes that contained the vital blue dye and to demonstrate a statistically acceptable concordance rate between the identification of lymph nodes with the vital blue dye and Lymphoseek. To be successful, the study needed to achieve a statistical p-value of at least 0.05.
In this review meeting with FDA, the full analysis of the NEO3-5 clinical data was discussed. The protocol compliant clinical sites that participated in the NEO3-05 study contributed 136 Intent-To-Treat (ITT) subjects who provided 215 lymph nodes that contained the vital blue dye. 210 of the vital blue dye positive lymph nodes contained Lymphoseek for an overall concordance rate of 98% achieving a statistical p-value of 0.0001. In addition to the nodes identified by vital blue dye and Lymphoseek, Lymphoseek was able to identify 85 additional lymph nodes that did not contain the vital blue dye, and 18% of these nodes were found by pathology to contain cancer. There were no significant safety events related to Lymphoseek. The FDA indicated that the clinical data would be supportive of a NDA submission for Lymphoseek.
In future pre-NDA meetings, Neoprobe will continue discussions with the FDA reviewers regarding the pre-clinical and chemistry, manufacturing and control quality data modules that will be part of the NDA submission. Neoprobe will be discussing elements of the statistical analysis plan that would support the NDA, including the design of any prospective clinical evaluations to support the primary indication, and to potentially expand the future indications for Lymphoseek.
Neoprobe’s President and CEO, David Bupp, Vice President, Pharmaceutical Research and Clinical Development, Frederick Cope, Ph.D. and Vice President, Regulatory Affairs and Quality Assurance, Rodger Brown, will discuss the NEO3-05 results and FDA meeting results during a conference call scheduled for 8:30 AM EST, Friday, March 12, 2010.
The conference call can be accessed as follows:
Conference Call Information
TO PARTICIPATE LIVE: TO LISTEN TO A REPLAY:
Date: Mar. 12, 2010 Available until: Mar. 19, 2010
Time: 8:30 AM ET Toll-free (U.S.) Dial in # : (877) 660-6853
International Dial in # : (201) 612-7415
Toll-free (U.S.) Dial in # : (877) 407-8031
International Dial in # : (201) 689-8031 Replay passcode:
Account #: 286
Conference ID #: 346813
About Neoprobe
Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients. Neoprobe currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan™ CR. Neoprobe’s subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT.
Neoprobe’s strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic biomedical markets through continued investment and selective acquisitions. http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.neoprobe.com&esheet=6211758&lan=en_US&anchor=www.neoprobe.com&index=1&md5=94775f501ea148746eaec87c4b9ac854
Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Neoprobe CorporationBrent Larson, Vice President / CFO, 614-822-2330ORThe Shoreham GroupTim Ryan, 212-242-7777
InterMune, Inc. [ITMN]
https://jefferies.bluematrix.com/docs/pdf/361652f8-6d06-472f-8f2b-9ae02c4d8034.pdf
Jefferies has had it wroing the entire time so I guess they feel it is too late to change now. Pirfenidone's patent runs out in 2012, I believe. They do have orphan status but that can be broken if the molecule can be developed with fewer side effects. Pirfenidone does have side effects that can be minimized with changes to the delivery technology. I think the stock is ahead of itself but that doesn't mean some large pharma doesn't grab it without thinking.
FDA AdComm panel voted 9-3 in favor of approving pirfenidone for
treatment of IPF; PDUFA date, May 4th; we continue to view potential
approvability low with current dataset.
AdComm panel voted in favor of pirfenidone approval; ITMN shares will
likely trade up on expectations for highly likely approval (>85%
probability). However, we view FDA risks remain (e.g., delay in PDUFA,
requiring additional data), thus skewing risk/rewards towards
downside. Recommend taking profits, especially on share strength.
Eun K. Yang, Ph.D.,
(212) 284-2264 eyang@Jefferies.com
Kimberly Smith,
(212) 284-2192 kimberly.smith@Jefferies.com
Lunan Ji,
(212) 284-2378 lji@Jefferies.com
Osteoporosis Drugs Like Fosamax May Increase Risk of Broken Bones in Some Women
here is a link with a video. Amgen's drug will do this also because completely shuts down bone resorption
http://abcnews.go.com/WN/WorldNews/osteoporosis-drugs-fosamax-increase-risk-broken-bones-women/story?id=10044066
Osteoporosis Drugs Like Fosamax May Increase Risk of Broken Bones in Some Women
Longterm Use of Popular Class of Osteoporosis Drugs May Have Opposite Effect For Some Women, Experts Say
By CHRISTINE ROMO and LARA SALAHI
Mar. 8, 2010—
Sandy Potter, 59 of Queens, New York, was jumping rope with neighborhood children when she felt her thigh bone snap.
"I went up in the air and I came straight down to the ground," Potter said. "The pain was excruciating."
Potter, who was diagnosed with osteoporosis at age 48, had been taking the popular osteoporosis drug Fosamax for eight years before breaking her femur.
Fosamax, one in a class of drugs called bisphosphonates, is supposed to make bones stronger, and for many woman it is safe and effective. But now there's mounting evidence that for some women, taking these medications for more than five years could cause spontaneous fractures.
"We are seeing people just walking, walking down the steps, patients who are doing low-energy exercise," said Dr. Kenneth Egol, professor of orthopedic surgery at New York University Medical Center. "Very unusual, the femur is one of the strongest bones in the body."
Egol said X-rays of some of his patients look more like injuries from car accidents than from an otherwise-minimal fall.
"Over the last 18 months we are seeing this more frequently," he said.
Sales of the popular drug increased when doctors began prescribing it, not only to women with osteoporosis, but to others who were osteopenic -- with reduced bone density that might lead to the disease. Now some doctors worry that staying on the drug for more than five years can cause some women's bones to become more brittle.
Weighing the Risks
This is not the first time that many doctors have reported an opposite effect for people taking the drug. Fosamax has already been linked to severe musculoskeletal pain, as well as a serious bone-related jaw disease called osteonecrosis.
Also, the Food and Drug Administration asked the manufacturer, Merck, in 2008 to add information about the report of femur fractures.
After 16 months, Merck added patients' reports of femur fractures to the list of possible side effects included in the drug's package insert.
"It took Merck an entire year to respond," said ABC News senior health and medical editor Dr. Richard Besser. In small print on the package insert listing possible side effects from the drug, he said, there are "just six words: 'low energy femoral shaft and subtrochanteric fractures.'"
The FDA has also never made an effort to inform the public or doctors across the country who prescribe biphosphonates of the possible side effect, said Besser.
Both the FDA and Merck declined ABC News' request for interviews. The FDA said it is looking into reports of fractures.
"Nothing is more important to Merck than the safety of its medicines," said a written statement from Merck to ABC News. "A causal association has not been established between long-term bishphosphonate use and subtrochanteric femoral fractures. In clinical studies, FOSAMAX (alendronate sodium) has not been associated with increased fracture risk at any skeletal site. The company currently has several ongoing epidemiological studies to further investigate the issue of subtrochanteric femoral fractures."
data should become available just as the drug becomes generic, what timing
Dr. Joseph Lane, Orthopedic Trauma Surgeon at the Hospital for Special Surgery in New York City, said, "The drug companies have to recognize when there is a problem, they have to be up front with the public. If there's a concern they have to voice it and at least give everybody a fair chance to look at this carefully."
How Much For How Long?
Many studies suggest an overall benefit from taking the medication for women who are at risk for osteoperosis. In fact, biphosphonates can help to prevent hip and spine fractures, which for many women may lead to death.
"Normally your bone is constantly being remade," said Dr. Joseph Lane, Chief of Metabolic Bone Disease at the Hospital for Special Surgery in New York City. "These patients don't remake their bone and they acquire damage, microdamage, the collagen gets altered and we need to rejuvenate the skeleton."
In 2008, biphosphonate sales exceeded $3.5 billion according to data from IMS Health. In 2009, over 37 million prescriptions were written for the osteoporosis medications.
While some physicians use bone density scans to help drive their decisions, doctors generally prescribe them to women who are at an increased risk for either osteoporosis or fractures from osteoporosis they already have. A new tool developed by the World Health Organization can determine risk of having fractures and can help doctors determine which women with osteoporosis should be treated with medications.
Although biphosphonate are generally recommended for postmenopausal women, research does not indicate how long women should be on the drug. Many doctors now recommend a five-year limit.
"When they are on it for five, six, seven or eight years they lost their ability to remodel and regenerate their skeleton," said Lane. "[A subset of women] are very vulnerable and they will then develop problems of brittle bone."
Additional time on the medication depends on doctor's orders, said Besser.
Copyright © 2010 ABC News Internet Ventures
I mentioned Hyseq because I knew him back then.
Further down in my email I mentioned that he made claims about this drug working for stroke, and that I believe he knew that would never happen, because of the issue of delivering the drug properly in the ER.
I believe I made posts about it at the time
Dr. Love,
I remember Dr. Love as CEO of Hyseq speaking about how great their patent estate in genes were going to make the company. At the time they were saying they had IP on about 100,000 genes, five times the number of genes there turns out to be.
With all this great gene discovery and IP they had, they licensed their product from Amgen. Why would Amgen give up this great product?
then he was running his trials and running out of money, and low and behold he is saved by ONXX. Coles was not running ONXX at the time, so they must have become friendly after he joined.
I do not think Love is honest because while he was running his VTE studies he would constantly speak about the drug working in stroke, and that woud be a bigger market. That was never going to happen. The drug has such a short half life that it would have needed to be delivered with a catheter very precisely in the neck. When someone has a stroke, it is hard enough figuring out how long ago they had it, and what to do with them, without having a doctor on staff that would be an expert on delivering this particular drug in the emergency room.
Alnara rises from Altus' ashes
By Maureen Martino
In other words, let Altus go bankrupt and buy the assets back on the cheap and own it all for practically nothing. Great business plan.
Just 16 months after raising $20 million in its first round of funding, Massachusetts-based Alnara Pharmaceuticals says it's preparing an NDA for its cystic fibrosis treatment. It's a drug that was once held by the now-defunct Altus Pharmaceuticals, which was the victim of the economic crisis that started in 2008. During that time the company went into a free-fall that eventually landed it in Fierce's 2009 Biotech Graveyard.
Before its demise, Altus transferred the rights to its CF drug Trizytek (liprotamase) to Cystic Fibrosis Foundation Therapeutics. Alnara Pharmaceuticals president and CEO Alexey Margolin was a veteran of Altus and had worked on the Trizytek program during his time at the company. After leaving Altus, he founded Alnara and bought the exclusive worldwide rights to liprotamase from CFFT. "We never thought we would work on this drug program again, but the CF Foundation felt that our...company was best positioned to move it forward quickly," Alnara CBO and former Altus employee Bob Gallotto tells Mass High Tech.
Margolin's company ramped up quickly, hiring 35 laid-off Altus employees who'd worked on the liprotamase program. The drug will be submitted to the FDA shortly, and the company hopes to have an approval in hand in six to 10 months.
- read the Mass High Tech article
ot vhc
I think someone put in a market order to sell 600 thousand shares.
they needed money and did some warrant deals. probably some guy excersized his warrants and sold the stock
some people have already made a fortune on this
Microsoft Trial on March 8th Will Highlight VirnetX Patented Security Technologies
Posted : Mon, 01 Mar 2010 14:00:33 GMT
Author : PRWeb
Category : Press Release
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http://www.freecourtdockets.com/docketsummaries/VirnetX-Inc-v-Microsoft-Corporation-6-07-cv-00080-Texas-Eastern-Federal-District-Court-Docket-Case-Summary-40283.htm
‘David versus Goliath’ Legal Battle May Impact Patent Reform Issue
Bluffton, SC (PRWEB) March 1, 2010 -- “The March 8th jury trial between VirnetX Holding Corp. (AMEX:VHC; www.virnetx.com) and Microsoft Corp. (NASDAQ: MSFT) will be an opportunity to reveal VirnetX’s patented security technologies and the impact those technologies could have on real-time secure Internet communications,” stated Larry Oakley, editor and publisher of WallStreetCorner.com (www.WallStreetCorner.com). Oakley made the statement in an Investor Alert today which was posted in his “Bold Ventures” column at his WallStreetCorner.com website. The jury trial between VirnetX and Microsoft will commence on March 8th in Tyler, Texas.
VirnetX, a secure real-time communications firm based in Scotts Valley, California, is alleging that Microsoft Corp. has infringed on two of its patents by deeply embedding them into Microsoft core products. The patent issues include technology for building Virtual Private Networks (VPNs), one of the fastest growing segments in communications. These all involve patented methods for establishing secure connections (“immune from eavesdropping”) involving VPNs where security doesn’t, or wouldn’t, exist. Potential eavesdroppers or hackers cannot hack or invade that which they cannot find in the first instance, which results from the use of VirnetX’s patented technology.
According to Oakley, “This is definitely a ‘David’ versus ‘Goliath’ legal battle taking place in Texas on March 8th. It’s possible that if VirnetX succeeds in this patent jury trial that it may be awarded up to three times the compensatory damages sought and could impact the trend in patent reform being debated in Washington, D.C. As recently as a week ago, Microsoft’s market value motion related to not allowing damages to be based on the entire market value of Window’s sales (as much as a base of several hundred billion dollars) was denied by the court. It’s possible that Microsoft could be liable at trial for enhanced (trebled) damages. Thus far, the court has given VirnetX the potential to include all of Microsoft’s Windows revenues for the referenced infringements. It also means, as I understand it, that VirnetX might be awarded three times the compensatory damages sought. In yet another recent ruling, the court limited the main portion of the trial to 12 hours per side, so we should have a result within a reasonable period of time.”
Oakley also stated, “This trial is a unique opportunity for all of us to learn about VirnetX’s patented security technologies. This company’s technologies could be the beginning of a dramatic shift in secure real-time Internet communications. Could it be that once this trial is completed that VirnetX’s patented technologies will be licensed, developed, implemented, and ultimately emerge as the new security tech standard in the global shift to 4G/Long Term Evolution (LTE) wireless networks? We all understand that the mobility market is projected to have over 2.5 billion connected devices by 2014. VirnetX owns the patented security technology solutions for the vast majority of 4G specifications. This alone will, in my opinion, result in a large part of VirnetX’s expansion over the next few years.” About WallStreetCorner.com: Formed 20 years ago by Larry Oakley, known as the "Elder Statesman of Emerging Growth Company Writers," as a venue for his Conservative Speculator newsletter, www.WallStreetCorner.com, including the Research Reports of its clients, and his four editorial columns, is now regularly read by serious investors in 96 countries.
Safe Harbor Statement: This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from forecasted results. These risks and uncertainties include market conditions, regulatory approvals, and other risks. Contact: Larry Oakley, editor, www.WallStreetCorner.com
###
Source : PRWeb
Read more: http://www.earthtimes.org/articles/show/microsoft-trial-on-march-8th,1183625.shtml#ixzz0hGOu0GgF