posted by AndrewW on Feb 19
Story By: Talk of the Nation
Military bases in the California desert could host seven gigawatts of solar power installations—roughly equivalent to the output of seven nuclear plants—according to a study commissioned by the Department of Defense. Study director Robert Kwartin discusses the report.
posted by AndrewW on Feb 17
Story By: by Richard Knox
Many hospitals are perilously close to running out of a form of methotrexate that’s necessary to inject in high doses to treat certain forms of cancer.
It’s a new kind of brinksmanship for U.S. doctors: caring for patients with life-threatening diseases when the supply of critical drugs threatens to disappear.
The latest crisis concerns the old standby cancer drug methotrexate. For six decades, it has made the difference between rapid death and lifelong cure for thousands of children with acute lymphoblastic leukemia, or ALL, and a type of bone cancer called osteogenic sarcoma.
Many hospitals around the nation are perilously close to running out of a form of methotrexate that is necessary to inject in high doses to treat these forms of cancer.
For ALL and osteogenic sarcoma, “there’s really no known curative therapy without methotrexate,” says Dr. Howard Weinstein of Massachusetts General Hospital. “Based on our current outlook, if we don’t get any supply, we’re going to be out of methotrexate in the next couple of weeks.”
It’s the same situation at Children’s Hospital and Clinics of Minnesota.
“We’re probably good for a few weeks, but if we don’t get any, we’ll have to do some substitution or delays of therapy and give the high-dose methotrexate later when it’s available,” says Dr. Bruce Bostrom.
He says doctors just don’t know how that’s going to affect patients’ chance of a cure â which is at least 90 percent with the right treatment.
Brenda Carr’s 4-year-old daughter, Rowen, is a patient at Bostrom’s hospital.
“What I just couldn’t believe was that there was nothing really to prevent this from happening,” Carr says. “It gets really frustrating. I try to stay logical about it, but, unfortunately, I’m a mom.”
Doctors inject methotrexate directly into the spines of patients with ALL. For those with the bone cancer, they must use very high doses of the drug. In such cases, the methotrexate must be free of an alcohol-based preservative that is highly toxic at high doses. Otherwise, it could result in paralysis.
It’s this type of preservative-free methotrexate that is suddenly running out.
The reason for this particular shortage is that a principal supplier of injectable methotrexate, Ben Venue Laboratories of Bedford, Ohio, shut down in November after it flunked an inspection by the Food and Drug Administration.
Erin Fox, an expert on drug shortages at the University of Utah, says the FDA inspectors found a long list of serious problems.
“If you want to read something to give you nightmares, you can look at the FDA 483 inspection form,” Fox says. “You can read about mold on the walls and rust from machinery falling into the vials. It really provides a very grim picture of a crumbling factory.”
Fox says most people don’t realize how decrepit many U.S. drug plants are, especially those that make generic drugs.
Ben Venue Laboratories says it has invested more than $250 million over the past three years to upgrade its facilities, “and continues to invest millions more in order to restore production as quickly as possible.”
The FDA says the methotrexate crisis may be narrowly averted.
Valerie Jensen of the FDA’s office of drug shortages says three other manufacturers have been persuaded to ramp up production of preservative-free methotrexate.
“We’re hearing good news from them this week, that they will be having additional supplies,” Jensen told NPR. “From what the companies are telling us, we do see that meeting patients needs over the coming weeks.”
The same lab is responsible for another recent and far-reaching drug shortage involving Doxil, a drug relied on by thousands of patients with ovarian and breast cancer. Ben Venue Laboratories was the sole worldwide supplier of Doxil, which is now unobtainable.
Jensen said the FDA expects to have good news about Doxil. She says the agency is exploring the possibility of licensing a foreign company to make the drug, something the FDA has done eight times in the past year with other drugs in critical shortage.
“We do hope to have some very good news soon” on Doxil, Jensen told NPR, “hopefully within the next couple of weeks.”
Meanwhile, doctors who learned from NPR that new methotrexate supplies may be on the way were pleased but guarded. “That’s very good news,” Bostrom says. “But this is not the last shortage we’ll have to cope with.”
Carr, the Minneapolis mom, says she has her fingers crossed. But she’s skeptical.
“This isn’t the first time we’ve been on the brink of drug shortages, especially in cancer treatments,” Carr says. “I don’t want another mom to have to be thinking about whether or not their child is going to get the medication they need.”
Experts say there certainly will be other parents who will have to worry about other shortages, because the root causes will not be easily resolved.
posted by AndrewW on Feb 10
Story By: by Nancy Shute
A baby is inoculated against rotavirus in Honduras in early 2009.
When a vaccine for rotavirus debuted in 1998, it was hailed as a huge plus for children’s health. Before that, rotavirus killed more than 400,000 young children a year worldwide by causing severe diarrhea. Problem solved? Not quite.
Shortly after the Rotashield vaccine was introduced, doctors noticed an increase in cases of a serious intestinal problem called intussusception, when the intestine doubles back into itself. It is fatal if not treated, sometimes with emergency surgery.
Investigations determined that Rotashield, made by Wyeth (now part of Pfizer), increased a baby’s risk of intussusception up to 30 times. As a result, the vaccine was yanked off the market in 1999.
The scientists never did figure out why the vaccine increased the risk of the intestinal problem. Newer rotavirus vaccines were developed, tested and licensed in 2006 and 2008. (Here’s an NPR story on efforts to develop a safer vaccine.)
But concerns persist, fueled by two recent studies that found a fivefold increased risk of intussusception in babies in Australia and Mexico during the first week after they were given the vaccine.
So researchers looked at a big database of American children who had been given the new RotaTeq vaccine (made by Merck) between 2006 and 2010. They looked at 786,725 doses, of which 309,844 were first doses. They found no increase in intussusception. The results were published in JAMA, the Journal of the American Medical Association.
“The benefits of rotavirus vaccine do outweigh risks,” says Irene Shui, an epidemiologist at Harvard Medical School and Harvard-Pilgrim Health Care Institute who is the lead author of the study. This study was funded in part by a contract with the Centers Disease Control and Prevention.
But she told Shots that that doesn’t mean that these new vaccines are completely risk-free. “It’s important for the public to realize that every treatment or intervention does have some risk.” This study, she says, will help parents get a better grasp on those risks.
If you’re interested in more details, there’s a JAMA video with Shui.
posted by AndrewW on Feb 10
Story By: by Richard Harris
Natural gas is much cleaner than coal. But some energy analysts say an overabundance of the fuel could depress development in even cleaner energy sources like wind and solar power. Above, a rig in Washington, Pa., drills into shale rock to extract natural gas.
Wind power advocates say that even if wind is slightly more expensive than natural gas, utilities will still want it in their mix. Windmills aren’t subject to variable fuel prices, so the cost of production is predictable, something that’s not true for natural gas.
“You’ll see very low numbers” for new wind installations if the federal production tax credit expires,” Bode says. “In fact, I think EIA [the U.S. Energy Information Administration] projects almost zero for 2013.”
The solar industry’s subsidies run for several more years, so they are not in that bind, at least not yet. But Trevor Houser, an energy analyst at the Rhodium Group, says these tax credits and other incentives like state renewable standards are key if renewables are to grow and mature during the natural-gas glut.
“Long-term renewable deployment in the U.S. is going to depend primarily on policy,” Houser says. “Is there enough concern about environmental consequences to put in place incentives for renewable energy?”
That partly depends on how much of a premium people and companies will be willing to pay for cleaner energy. Right now, with natural gas so cheap, that premium is fairly substantial.
“If those prices hang around for another three or four years, then I think you’ll definitely see reduced political will for renewable energy deployment, ” Houser says. “But we don’t expect prices that low to hang around that long, because low prices are in many ways self-correcting.”
Gas is so cheap now that companies that produce it are struggling to make a profit. So Houser expects prices to move up. That will help close the price gap between gas and renewable energy.
Even so, there’s still a huge way to go before prices and government policies do enough to significantly reduce emissions of the gases that contribute to global warming.
posted by AndrewW on Feb 2
Story By: Talk of the Nation
In a new book, surgeon Paul Ruggieri reveals the “good, the bad, and the complicated” about being a surgeon, and operating on patients. From cutting into a man who just killed his wife, to the headaches of running a small business, Ruggieri candidly discusses his career.
posted by AndrewW on Sep 25
NEW YORK |
NEW YORK (Reuters Health) – Adding talk therapy to medication helps some kids and teens with obsessive-compulsive disorder, according to a new study.
Medications such as fluoxetine (Prozac) or sertraline (Zoloft) are often the first-line treatment for kids who have OCD.
However, “Most kids on medication still have symptoms,” said John Piacentini, head of the Child OCD, Anxiety and Tic Disorders Program at the Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles.
The new findings show that, “If you try medications and you don’t get the benefits that you would like, if you can find quality (cognitive behavioral therapy) it should make a big difference,” Piacentini, who was not involved in the study, told Reuters Health.
About one in every 100 kids has OCD, researchers estimate. It often shows up as repeated hand-washing until hands are raw and chapped or checking homework so many times that it can’t get done, said lead study author Martin Franklin, from the University of Pennsylvania School of Medicine in Philadelphia.
While many kids (and adults) have obsessions and behaviors they do repeatedly, what defines OCD, he added, is when kids feel like they have to do those behaviors to calm themselves down or make sure everything will be okay — the compulsive part.
Franklin said that for many youngsters who don’t get better on one drug, doctors will typically try adding a second or switch to a new medication. But because of worries about possible side effects, his team was interested in whether a kind of talk therapy called cognitive behavioral therapy (CBT) could help those kids.
In CBT, therapists help patients recognize and change the problematic thoughts behind their behaviors.
The new study involved 124 kids aged seven to 17 with OCD. All of them had been taking at least one OCD drug — most for more than a year — but still had some symptoms.
The kids stayed on their current medication during the study. In addition, researchers split them randomly into three groups: one that didn’t get any extra treatment, one that had hour-long CBT sessions about once a week and a third that talked with doctors briefly about CBT during their regular medication check-ins.
After three months, kids who had gotten the full CBT therapy — and not just talked about it — were better off, on average, than the other participants. Close to 70 percent of them saw an improvement in their OCD symptoms, compared to 35 percent who had gotten quick instructions about doing CBT and 30 percent of kids who didn’t have any extra treatment.
Those results, the researchers report in the Journal of the American Medical Association this week, mean in effect that three kids would have to get CBT for one to see a positive response, compared to just taking medication alone.
Jonathan Abramowitz, an OCD researcher at the University of North Carolina at Chapel Hill, said that “all things being equal,” CBT is the best choice for OCD treatment. “CBT is a relatively short-term treatment and you learn skills that no one can ever take away from you,” he told Reuters Health.
But, he added, good CBT can be hard to find, and in the short term is more expensive than medication. “Medicines are easy to take. They’re more available,” said Abramowitz, who was not involved in the new research.
Franklin said that the talk-therapy sessions might cost about $100 to $200 per hour. The generic versions of some OCD medications may cost $10 per month or less.
“The results of this study really underscore the importance of making CBT more accessible,” he told Reuters Health. “We know we have a therapy that works for these kids. It’s not perfect… but it works really well.”
The new study didn’t test talk therapy alone in kids who weren’t on medication. Still, Franklin said that if CBT was readily available, he would start most kids with OCD on therapy before prescribing drugs — except those with very high anxiety.
“Before we put chemicals into kids it’s important that we get them CBT,” Abramowitz agreed. Parents “should seek out that CBT first.”
SOURCE: bit.ly/rnslfz Journal of the American Medical Association, online September 20, 2011.
posted by AndrewW on Sep 24
Teenagers who watch films showing actors smoking are more likely to take it up, new UK research suggests.
Adolescents who saw the most films depicting smoking were 73% more likely to have tried a cigarette than those exposed to the least. And they were 50% more likely to be a current smoker.
Both U (universal) and PG (parental guidance) film ratings proscribe "potentially dangerous behaviour which young children are likely to copy". This includes drug misuse but not cigarette smoking.
David Cooke, director of the BBFC, said: "Smoking is a major public health issue and we consulted the public very extensively on it in 2005 and 2009. Their clear expectation is that we should be vigilant, sensible and proportionate in how we deal with the issue.
"Glamorising smoking has therefore been included as a classification issue in our published classification guidelines and we frequently use our extended classification information to draw the attention of parents and others to depictions of smoking in films.
"There is, however, no public support for automatically classifying, for instance, a PG film at 18 just because it happens to contain a scene of smoking. We always look carefully at all research on this and related subjects drawn to our attention.
"Experience suggests, with media effects research generally, that attempts to claim a causal link between a particular depiction and a particular behaviour are often disputed and seldom conclusive."
Simon Clark, director of the smokers' group Forest, said: "The idea that films need to be reclassified in order to create a utopian, smoke-free world for older children is not only patronising, it is completely unnecessary.
"Today you would be hard-pressed to find a leading character who smokes in any top 10 box office movie.
"What next? Should government reclassify films that feature fat people as well in case they are bad role models?
"We go to the cinema to escape from the nanny state. The tobacco control industry should butt out and take its authoritarian agenda elsewhere."
posted by AndrewW on Sep 23
The UK's first brain tumour tissue bank is being launched in Glasgow.
The bank will provide access to samples of brain tumours for anyone conducting research – with the aim of helping scientists find new treatments.
Until now individual universities, hospitals and commercial organisations had their own tissue banks which may or may not have allowed access to others.
Glasgow was chosen as the home for the new bank because it is a leading centre for brain tumour research.
Prof Anthony Chalmers, from the University of Glasgow, who led the project, said: "By making this resource available to other researchers, not only here but also around the world, we increase the likelihood that some valuable piece of information will come out of it.
"The more people who are using the resource, the more likely it is that people will benefit."
The tissue bank will sit alongside an existing bio-depository.
More effective treatments for brain tumours are desperately needed as they kill more children than any other cancer.
Anita Smith from Hampshire lost her 16-year-old daughter Charlotte to a brain tumour. Her fundraising has raised the £30,000 needed to staff the tissue bank, and the bank will be called 'Charlotte's Bank of Hope' in her memory.
"I'm very proud and I think Charlotte would have been proud of us too, " she said.
"It is something I know that she would have done for others because she was a very kind and thoughtful girl.
"Charlotte had the worst prognosis for her cancer. We knew at the time when they were giving us treatment options for Charlotte that it was a guess. Was this going to work? Was this particular drug going to have an effect?
"Hopefully now they will find a cure through this research."
Prof Chalmers said finding treatments for brain tumours was particularly difficult because of the large variety of cancer types.
He said: "Treatment is not as good as it could be, or should be, and one of the reasons for that is that everyone's brain tumour is different. And we are beginning to understand that and the ways that those tumours differ from each other."
It is hoped the large number of samples available to researchers through the new tissue bank will speed up progress towards better treatments and help scientists understand how to tackle a wide variety of brain tumours.
posted by AndrewW on Sep 19
BOSTON |
BOSTON (Reuters) – Over the past year, Biogen Idec Inc has given investors little to complain about. The biotechnology company, operating under new management, has restructured its operations, reported promising clinical trial data and seen its shares rise 72 percent.
The question is: can it hang onto its gains?
Much depends on the results, to be released within weeks, of a second, late-stage clinical trial of its experimental multiple sclerosis drug, BG-12.
Results from the first trial, known as DEFINE, were unexpectedly strong. If data from the second trial, known as CONFIRM, are similarly positive, Biogen’s shares could rise as much as 10 percent, analysts say. If it falls short of expectations, they could fall as much as 20 percent, according to some estimates.
Multiple sclerosis is a chronic, often disabling disease that attacks the central nervous system and can lead to numbness, loss of vision and paralysis. BG-12 is designed to treat relapsing-remitting MS, in which flare-ups are followed by periods of remission. About 85 percent of people with MS are initially diagnosed with this form of the disease.
Results of the DEFINE trial showed BG-12 cut the annualized relapse rate by 53 percent at two years versus those treated with a placebo. That compares favorably with the efficacy of a drug made by Novartis AG, Gilenya, that has shown a reduction in annualized relapse rates of about 54 percent.
Unlike most MS drugs, which are given by injection or infusion. Gilenya and BG-12 are both taken orally. Gilenya, given once a day, was approved in 2010. BG-12 will probably be given twice a day, but may have a more benign safety profile. That could help it gain an edge in the market if approved.
“Gilenya has the advantage of first-arrival and once-daily administration, but there is still some anxiety about the possibility of safety issues yet to emerge,” said Harry Tracy, a pharmaceutical industry consultant and publisher of NeuroPerspective, a monthly publication focusing on central nervous system disorders.
“Neurologists are going to be reluctant to switch people off injectables, but over the next few years, I expect Gilenya and BG-12 to become the preferred first drug options to be tried with newly diagnosed patients,” he said.
Some analysts expect BG-12 to generate more than $1 billion in annual sales.
“In our view, the biggest threat to BG-12 becoming a blockbuster is an unforeseen safety issue,” said Eric Schmidt, an analyst at Cowen and Company in a recent research note. He expects, however, that the CONFIRM safety profile will “remain essentially clean.”
TRIAL DESIGN
The design of the CONFIRM trial is similar to that of DEFINE. DEFINE had 1,200 patients while CONFIRM has 1,400. The studies were run more or less contemporaneously and were conducted in similar geographies with the same entry criteria.
The main difference is that CONFIRM has a third arm — a group of patients taking Copaxone, a drug made by Teva Pharmaceutical Industries. In a pivotal trial, Copaxone, which was approved in the United States 15 ago, was shown to reduce the annualized relapse rate by 29 percent. Analysts expect that rate to have improved over the years, potentially confounding results from CONFIRM.
“We expect comparator Copaxone to perform better than expected,” said Jim Birchenough, an analyst at BMO Capital Markets, who advised clients in a recent research note to sell Biogen shares in advance of the results.
“We believe commercial expectations for Biogen Idec’s multiple sclerosis franchise, in particular for BG-12, have been overestimated and that risk to upcoming CONFIRM data has been underestimated.”
Weston, Massachusetts-based Biogen also makes the multiple sclerosis drugs Avonex and Tysabri.
Biogen’s shares have risen 72 percent over the past 12 months and have roughly doubled since George Scangos took over as chief executive in July last year. By April this year, shortly before news emerged that results of the BG-12 trial were positive, they had risen to about $73, helped in part by a restructuring program. By the end of June they touched$109.52.
The stock has fallen back since then and was trading at about $99.40 on Thursday. The decline partly reflects concerns among some investors that CONFIRM may not live up to the promise of DEFINE.
Michael Yee, an analyst at RBC Capital Markets, said most analysts are expecting “generally good data” from CONFIRM though perhaps not as strong the 53 percent relapse rate reduction reported in DEFINE.”
“People expect a mid-40s percent reduction in annualized relapse rate,” he said. “If the number comes in above that consensus, the stock could go $10 higher.”
The best case scenario, to which he assigns a 20 percent probability, would be for the drug to show a relapse rate of 50 percent or higher versus placebo, and for Copaxone to show a relapse rate of 30 to 35 percent.
The most likely scenario, he says, and one to which he ascribes a 60-70 percent probability, is for BG-12 to show a relapse rate of between 40 and 49 percent versus placebo and for Copaxone to show a relapse reduction of 35 to 40 percent.
Yee assigns a 10 percent probability of BG-12 showing surprisingly negative data, but if it did, the stock could drop to below BG-12 levels, he said.
Douglas Williams, Biogen’s head of research and development, feels “confident going into the study, or as confident as you can feel without the data in your back pocket.”
Options traders are sounding an optimistic note too.
Traders have been purchasing Biogen calls — which give investors the right to buy stock at a fixed price up to a certain date — at a greater pace than puts, which give investors the right to sell at a preset price.
“This suggests there are some bullish bets coming in on Biogen ahead of the event,” said Ryan Detrick, senior technical analyst at Schaeffer’s Investment Research.
Over the past 10 trading days, investors have bought 1.94 calls for every put as a new position on three U.S. options exchanges, according to Schaeffer’s. That ratio is greater than 72 percent of the readings over the past year. (For a related graphic click on r.reuters.com/pus73s)
Biogen hopes to file for approval of BG-12 early next year.
(Additional reporting by Doris Frankel in Chicago, editing by Dave Zimmerman)
posted by AndrewW on Sep 17
A bacterium found in soil is a showing promise as a way of delivering cancer drugs into tumours.
The scientists from the University of Nottingham and Maastricht University were able to genetically engineer an improved version of an enzyme into C.sporogenes.
In animal tests, a drug was also injected into the bloodstream which becomes active only when it is triggered by this enzyme.
It then destroys only the cells in its vicinity – the tumour cells.
Professor Nigel Minton, who led the research, said: "Clostridia are an ancient group of bacteria that evolved on the planet before it had an oxygen-rich atmosphere and so they thrive in low oxygen conditions.
"When Clostridia spores are injected into a cancer patient, they will only grow in oxygen-depleted environments, ie the centre of solid tumours.
"This is a totally natural phenomenon, which requires no fundamental alterations and is exquisitely specific.
"We can exploit this specificity to kill tumour cells but leave healthy tissue unscathed."
The team are now planning to work with other researchers on patient trials, due to start in 2013.
Nell Barrie, senior science information officer at Cancer Research UK, said: "Finding ways to target treatments to cancer cells while leaving healthy cells unharmed is a key aim of researchers around the world.
"But it's a difficult problem to solve, especially because every cancer is different. This particular approach hasn't yet been tested in patients so it will be some time before researchers know whether it will offer real benefits."