Drug Information Update – Public Health Advisory: Availability of Tamiflu for Oral Suspension
The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and consumers that additional quantities of the commercially prepared Tamiflu for Oral Suspension are being shipped to wholesalers and pharmacies. This new supply should address the current overall product shortage, although it will not immediately resolve shortages in all areas and availability may be variable for some time.
Pharmacists may still be required to prepare a compounded version of Tamiflu oral suspension from the 75 mg capsules, as directed in the drug label, until adequate supplies are available.
FDA is also reminding healthcare professionals and consumers of additional important safety information regarding the safe and effective use of Tamiflu suspension.
For more information, please visit: Tamiflu
Latin Christmas Albums – The Best of 2009
1. ‘Lo Mejor de Gilberto Santa Rosa’ (Gilberto Santa Rosa)
Gilberto Santa Rosa released his popular Christmas album Una Navidad Con Gilberto in 2008, but this 2009 release is a collection of songs from Una Navidad, Asi Es Nuestra Navidad (with El Gran Combo) and other songs you’ll find on various compilations. Santa Rosa fans will be pleased to have these numbers together on one album.
2. ‘Mi Navidad’ (Andrea Bocelli)
Christmas music never really gets old and Mi Navidad, a collection of traditional Christmas music sung by the popular Andrea Bocelli, is an album that will be treasured by the entire family.
3. ‘Me Regalo en Navidad’ (Moncho Rivera)
Moncho Rivera (nephew of Ismael) is on a roll this year with his 2009 album Yo Tengo Lo Mio; he actually dropped this Christmas album at the end of 2008 although I’ve only come across it recently so I’m adding it to the list. A great Christmas salsa album with lots of help on vocals from Gilberto Santa Rosa, Henry Santiago and Charlie Donato.
4. ‘En Esta Navidad al Estilo Norteno y Banda’ (Various)
With Mexican norteno and banda music leading the list of most popular Latin music sold in the U.S., this album of Christmas songs performed in these styles should be a welcome addition to holiday fare. Performers include Banda 3030, Adolfo Urias, Los Marineros del Norte, Dinastia Nortena and more.
5. ‘Volvio La Navidad” (Johnny Ventura)
If merengue is your passion, who better to spend an holiday evening with than merengue royalty? Johnny Ventura can easily be named the once and future king of merengue and, in his new Christmas album, he adds that infectious beat to both familiar and less familiar numbers.
6. ‘Bossa Nova Christmas’ (Jack Jezzro)
Guitarist Jack Jezzro takes those Christmas carols you love to sing, adds a talented group of musicians to the mix and arranges these tunes in a bossa nova style that makes for a cool, jazzy, easy listening holiday. Actually, the only thing ‘Brazilian’ about the album is the style of music, but who cares?
7. ‘La Trulla del Pam Pam Pam’ (Various)
This album of tropical Christmas songs is blessed with a wonderful cast of vocalists that includes NG2, Victor Manuelle, Rey Ruiz, Celia Cruz, Luis Enrique, Ismael Miranda and more.
8. ‘Lo Especial en Esta Navidad’ (Various)
Mariachi Max, Noemy, Yesenia Flores, Los Dinnosaurios and other Mexican artists bring a taste of Christmas south of the border.
9. ‘Celebrando Navidad y Ano Nuevo’ (Various)
This album is a mix of traditional and newer composed songs by Mexican artists including Tres Razones, Relampago Norteno, Tamborazo Kampenisno, Los Giros del Norte and more
10. ‘An Esperanza Family Christmas Album’ (Various)
Here’s a collection of 16 traditional Christmas classics, each sung by a different artist including Santana, Alejandro Sanz, Jose Carreras and Marcos Witt. All of the album proceeds go to Esperanza, a national network of 16,000 Hispanic faith-based and community organizations.
Umcka – Natural Cold Remedies
What Is Umcka?
Umcka (Pelargonium sidoides) is a geranium plant native to South Africa. Long used in traditional African medicine, umcka (short for “umckaloabo”) has recently become popular in other parts of the world, particularly in treatment of respiratory problems.
Uses for Umcka
Umcka is typically used to treat these respiratory issues:
Benefits of Umcka
To date, few studies have explored umcka’s efficacy in treatment of health problems. Existing research suggests that umcka may help manage the following conditions:
1) Rhinosinusitis
For a study published in 2009, researchers assigned 103 people with acute rhinosinusitis to take either an extract of umcka root or a placebofor a maximum of 22 days. (Usually caused by a viral or bacterial infection, acute rhinosinusitis is marked by inflammation of the mucosa of the nasal passages and at least one of the paranasal sinuses.) Study results showed that umcka was more effective than placebo in treatment of the condition.
In a research review published the previous year, scientists concluded that doubt exists as to whether umcka is effective in alleviating symptoms of acute rhinosinusitis.
2) Bronchitis
Umcka appears to be more effective than placebo for patients with acute bronchitis, according to a systematic review and meta-analysis published in 2008. Researchers sized up four placebo-controlled clinical trials, finding that umcka significantly reduced bronchitis symptoms by day 7 of treatment.
3) The Common Cold
A 2007 study indicates that umcka may decrease the severity of cold symptoms and shorten the cold’s duration. Focusing on 103 adults with cold symptoms, researchers found that 78.8 percent of those who took umcka were clinically cured after 10 days (compared to 31.4 percent assigned to a placebo).
How to Use Umcka
Available in syrup, liquid extract, and capsule form, umcka can be found in most health food stories and pharmacies that carry herbal products.
Umcka has been found to produce few adverse effects, but may trigger allergic reactions of gastrointestinal upset in some cases.
Sources:
Agbabiaka TB, Guo R, Ernst E. ” Pelargonium sidoides for acute bronchitis: a systematic review and meta-analysis.” Phytomedicine. 2008 15(5):378-85.
Bachert C, Schapowal A, Funk P, Kieser M. “Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7630: a randomized, double-blind, placebo-controlled trial.” Rhinology. 2009 47(1):51-8.
Lizogub VG, Riley DS, Heger M. “Efficacy of a pelargonium sidoides preparation in patients with the common cold: a randomized, double blind, placebo-controlled clinical trial.” Explore (NY). 2007 3(6):573-84.
Timmer A, Günther J, Rücker G, Motschall E, Antes G, Kern WV. “Pelargonium sidoides extract for acute respiratory tract infections.” Cochrane Database Syst Rev. 2008 16;(3):CD006323.
Matt Damon and Morgan Freeman Talk About ‘Invictus’
Morgan Freeman and Matt Damon in ‘Invictus.’
© Warner Bros Pictures
Morgan Freeman reunites with Clint Eastwood (Unforgiven, Million Dollar Baby) to bring the true story of how Nelson Mandela used sports to help unite South Africa by getting behind the country’s rugby team and cheering it through to the 1995 World Cup Championship. Freeman, who has long wanted to bring Mandela’s story to the big screen, stars in Invictus as the universally respected leader. Matt Damon co-stars as Francois Pienaar, the captain of the 1995 South African rugby team.
Matt Damon and Morgan Freeman Invictus Press Conference
Morgan, I understand since 1993 you felt you were the perfect person to play Nelson Mandela and it’s taken this long to find the right way to do it. Can you talk about that journey?
Morgan Freeman: “Nobody else is gonna get a chance to talk. This started out with Madiba naming me as his heir apparent, so to speak, when he was asked during the press conference at the publication of his book, Long Walk to Freedom. ‘Mr. Mandela, if your book becomes a movie, who would you like to play you?’ He said, ‘Morgan Freeman.’ So, from then on, it’s like, ‘Okay, so Morgan Freeman is going to be Mandela somewhere down the line.’”
”We spent a lot of time, Lori (McCreary) and I, my producing partner at Revelations. We were trying all this time to develop Long Walk to Freedom into a script. Couldn’t happen. Then, in ’06 I believe, we got this book proposal from John Carlin and it was perfect. We bought it. We got a script written. And, this was the role to play to give the world an insight into who Mandela is and how he operates. It was perfect.”
Matt, can you talk about having a real life sports hero who’s unknown maybe outside of South Africa – at least in America – and taking on the challenge of doing that role?
Matt Damon: “Well, the first thing I did when I read the script was I called Clint and I said, ‘I can’t believe this happened. I can’t believe this is true.’ And he said, ‘I couldn’t either, but this is true.’ So, I went immediately and looked up Francois [Pienaar] online and I said, ‘Clint, this guy is huge. We’ve never met, but I’m 5’10.’ I told him on the phone and he started laughing and he said, ‘Oh hell, don’t worry about that.’ I said, ‘All right.’ He said, ‘You go worry about everything else.’ And I said, ‘All right, I’ll worry about everything else. You worry about the fact that I need to grow 6 inches to play the guy.’”
“I had about six months to get ready. I worked hard on the accent and on training physically to build myself up to try to pull off the illusion of being the captain of a South African rugby team. Ultimately, I just try to look at every possible pitfall. When I’m way, way out, say six months away, I look at what could possibly blow this illusion? What are the things? And then, I start thinking about ways to solve those problems before I really get into it. So, I kind of made my little checklist of things I had to do and just planned it out and then I got to South Africa. The very first day, Francois invited me over to his house for a gourmet dinner that he was cooking. He invited me to meet his wife and two boys. Morgan and I went. I just remember I rang the doorbell and he opened the door and I looked up at him, and the first thing I ever said to Francois Pienaar in my life was, ‘I look much bigger on film.’ And he laughed and laughed, and he gave me a big hug and then took me into his house and that was it. We were off and running.”
“He was just an invaluable resource for me the whole time. I was constantly asking him questions – everything from what color is your mouth piece to what’s your philosophy on the captaincy and on leading a team and life in general. He just was incredibly available and a very articulate guy, and he was incredibly helpful to me.”
In doing your research for it, did that include the accent?
Matt Damon: “Yeah, well Francois’ accent has changed quite a bit because he went and played in England for so many years. Everybody – all of his closest friends and his wife – everybody says, ‘Well, you know, his accent has changed quite a bit.’ And, listening to any existing interviews from that day, you can hear how it’s changed. But there was a good key to that. Tim and I, the dialect coach, talked a lot about [how] a lot of people, when they do a South African accent, really overdo it and end up making somebody sound like Frankenstein. It’s actually a quite beautiful accent. We talked about smoothing it out, because Francois speaks quite smoothly, and borrowing some of that and trying to make it so that it’s subtle, so that it’s not so over the top where you’re just like, ‘Wait a minute. That’s a little big.’”
You’ve always described acting as playing, which is nice to hear. When you play Nelson Mandela, does it become more than that?
Morgan Freeman: “No. It might have become more than that were I…was I…?”
Matt Damon: “…were I.”
Morgan Freeman: “…were I?”
Matt Damon: “I think.”
Morgan Freeman: “Were I is plural. I never could figure that one out… Were I playing or working with someone other than Clint Eastwood. He is so enabling. He is so out of your way as an actor and he likes to watch actors play. I don’t think I do anything other than that when I’m working. I’m just playing. Work is something else. Work is maybe what you do.”
Matt Damon and the real Francois Pienaar.
© Warner Bros Pictures
Matt Damon: “Sure. I was not that young. I was 19. I was in college.”
What do you remember about him coming to Boston? And what was it about the character of Francois and his upbringing that you think would have allowed him to even become Mandela’s partner in this unique time in their history?
Matt Damon: “Well, that second question is probably better for Francois. Yeah, I remember the Boston visit. I remember the whole world tour. I remember he just went all over the place. In fact, in my high school, we had the Free Nelson Mandela ribbons. Remember the black ribbon with the writing? Kids were wearing those before they knew who he was. In fact, I have an old scrapbook that I was looking through. This is the photo album that my mother put together for me to go to college. She gave me a photo album of pictures from my whole childhood that progressed. And, I saw recently that the Free Nelson Mandela ribbon was in there from 1986 or 1988, probably 1988 when I graduated high school and all the kids were wearing those ribbons. So I remember. It was very big. My freshman year at Harvard in Fall of ’88, I remember the Divest Now marches and everything that was going on. College campuses are usually the places where a lot of that stuff is cooking and people are talking about that stuff. So yeah, it was a very, very big deal, the Boston visit, and really that whole kind of coming out tour that he did.”
Matt, you became good friends with Francois. What did you pay attention to and incorporate into your performance from your observations of him?
Matt Damon: “There are the more obvious physical things that I have to do to try to pull off that magic trick, and then, just talking to him philosophically about certain things, you know, leadership. That’s really, if you look at the structure of the script, it’s the greatest world leader of our time appealing to this other type of leader and forging a bond with him and basically saying, ‘I need to use you to do this,’ and the guy saying, ‘I understand exactly why,’ and his team exceeding its expectations. They’ve been asked to exceed their expectations, and it’s a metaphor for what the country needs to do because everybody is expecting them to not be able to heal. Those were the things. It was Francois’ integrity and leadership. But those were the kind of things that I needed to get across with the role, and then the obvious kind of attendant physical things – lifting weights and stuff.”
At The Bourne Ultimatum junket you talked about that fight scene. If you compare that to the rugby scenes in Invictus, how did you go into that knowing what you had just gone through? Were you in better condition?
Matt Damon: “Oh no, I was in better shape for this movie. I mean, I was in the gym every day and with Francois who came with me to the gym a few times. This is his life. I don’t want to embarrass him. I can’t. If Jason Bourne looks a little flabby, that’s on me. (Laughing) This is the fictionalization of somebody’s actual life. I didn’t want to let him down. It wasn’t going to be for any lack of effort, which really was what that team was famous for, actually. They were known for going the extra mile and for knowing themselves well enough to say, ‘Okay, we might not be the most talented team…,’ and the line is even in the movie. The coach says, ‘We might not be the most talented team, but we’re going to be the fittest.’”
“Francois talked me through their training regimen. It was just unbelievable what those guys did, all of them, every single guy. It’s that great thing about a great team. It’s like when every single person commits to something and sublimates their own personality for the greater good of the whole team. And that’s basically, again, the metaphor for that whole country.”
Was this before or after The Informant!?
Matt Damon: “After. So, I had a good time putting the weight on and then a tough time reshaping the weight.”
How much did each of you know about the sport of rugby and do you still know the rules?
Morgan Freeman: “Nothing. I know American football. I know just a little bit about soccer. I know baseball. I know basketball. But rugby is a foreign language.”
Matt Damon: “And you know golf.”
Morgan Freeman: “I know golf.”
Matt Damon: “Same. I’m with Morgan. I knew a little bit about rugby but very, very little. But I do think it helps, in terms of an American audience, the game is enough like football in the sense that it’s a battle for field position and you score by running across, running into what looks like an end zone and putting the ball down. I think in terms of the nuance of the game, obviously Americans won’t get that stuff, but in terms of the peanut butter and jelly version of what you need to know, I think it’s pretty clear.”
Matt, will you explain to us why this is an important film?
Matt Damon: “I’d say the film is telling a story that I think is a wonderful thing to remind everybody of, in South Africa and all over the world. If we listen to the better angels of our nature, there are creative and good solutions to serious problems. It’s just an incredibly uplifting movie, and from the moment I read it, I was excited about just being a part of the ensemble that told this story. I think it’s a good thing to put out there, particularly now. There’s not a lot of good news, so this is a nice thing to put out for the holidays.”
Matt Damon and Morgan Freeman in ‘Invictus.’
© Warner Bros Pictures
Morgan Freeman: “When he said that he would prefer that I be the one to play him in 1990 or whenever that was, I had to start then preparing myself to do it. So, I met him not long after that and I said to him, ‘If I’m going to play you, I’m going to have to have access to you. I’m going to have to be close enough to hold your hand.’ And, over the years, while we were trying to develop Long Walk to Freedom, that is what happened. Whenever we were in proximity, like a city away for instance, I would know about it and I would go to him and have lunch, have dinner, or sit with him while he’s waiting to go on stage for whatever. And during that time, I would sit and hold Madiba’s hand. Now, that’s not for camaraderie. I find that if I hold your hand, I get your energy. It transfers, and I have a sense of how you feel. That’s important to me trying to become another person.”
“I have a lot of pressure to bring a character like that to life in any kind of real sense. The danger, of course, is always at caricature, sort of indicating what the person is like. [Singing] ‘I’m Superman!’ The biggest challenge I had, of course, was to sound like him. Everything else is kind of easy to do – to walk like him. He has a few tics and things that I noticed and I picked those up. I didn’t have any agenda, as it were, in playing the role other than to bring it as close to reality as I possibly could. The agenda is incorporated in the script and all I had to do was learn my lines.”
Back during Unforgiven you said that Clint Eastwood ran a very good set, a comfortable set. Can you can amplify on that? And Matt, how was your experience working on an Eastwood film?
Matt Damon: “Morgan and I were saying yesterday maybe if we sit out like for the next few years and let Clint get some more experience, he’s really going to be a good director. (Laughing) We’re going to let him get some more films under his belt.”
Morgan Freeman: “I think about three more.”
Matt Damon: “Three more, he’ll be solid. It’s incredible. Both of us having been on, between us, probably 100 different film sets, it doesn’t get any better than the way that he runs it. As Morgan was saying earlier about him enabling and allowing things to happen, Clint says, ‘Look, I hire the best people I can and I put them in a position to do their best work and I get out of the way and take credit for all their stuff.’ (Laughing) He’s got this crew that just is the top flight crew, and every key and every person working under that key for every department.”
“You walk on some movie sets and it’s like walking into an emergency room and you’re like, ‘We’re just making a movie here.’ But that tension bleeds into the performances and into the film itself. Clint just runs an incredibly tight ship. It’s very laid back but everybody, because we all have experience working on other movie sets, everyone is aware that they’ve been given enough space to do everything they need to do. And if you need something, it’s given to you. If the key of a department says, ‘I need this,’ or the camera department says, ‘I’d like a jib arm for this or a little techno crane,’ it shows up.”
“It’s just very easy. We’ve been entrusted to do our jobs. And then, he’ll come over occasionally and give a little bit of direction. But it’s not a lot of chatter. It’s just a suggestion, a little suggestion here, a little suggestion there, and anybody who doesn’t want to hear a swear word cover their ears for a second. Clint’s favorite saying is, after you do a take he goes, ‘Well let’s move on and let’s not f–k this up by thinking about it to much.’ You hear it every day on a set with him.”
Morgan Freeman: “You don’t really want to go to Clint and say, ‘I’d just like to talk a little bit about the character.’ [Mimicking Clint’s voice] ‘Why?’ He expects you to know what you’re doing and he’s going to take two giant steps back and let you do it. I just have such deep appreciation for that part of him. And, the other part is – Matt says it’s a tight ship, I think it’s a well oiled machine. Try to imagine yourself as the captain of a ship that really runs well. You don’t do anything. You just get credit for the fact that it runs well. The engine room does their job, the steering does their job, the deck crew do their job. It’s all done and done well. ‘Well Captain, you run a very nice ship.’ ‘Thank you very much.’ So that’s what Clint says he does, and it’s wonderful. And everybody who works with him has this very same reaction to him. ‘Can I stay with you?’”
Morgan Freeman as Nelson Mandela in ‘Invictus.’
© Warner Bros Pictures
Matt, you do a number of films that have some kind of social consciousness to them such as this film and Green Zone that’s coming up and you also have The People Speak on TV next week. Can you talk about doing films that have some kind of social value and what that means to you? Also, can you talk about The People Speak and your involvement in that?
Matt Damon: “Sure. I think actors, we react to the material that’s out there and I probably just react more strongly to things that I feel will have some social value. I think this movie is a great example. I think this is a really wonderful message to put out. It’s a completely non-partisan message, incidentally. This is about healing and coming together and it’s an incredibly uplifting story. I think that’s why it appealed to me. It wasn’t that I went and said, ‘I want to make a movie that’s about this.’ It’s that I read this terrific script and it was about the greatest world leader of the past 50 years and he was being played by Morgan Freeman and Clint Eastwood was directing. It was a pretty easy decision for me.”
“And The People Speak, I’m really proud of. It came out really well. It’s going to air on The History Channel on the 13th, and that we just stumbled on a way to tell history that I think is great because it’s factual. It’s just the actual documents. It’s the speeches and diaries and journal entries, all of these great speeches. In fact, there was the anniversary of John Brown’s execution I saw a couple days ago and The Times did a whole thing. We have that David Strathairn reading John Brown in The People Speak, the last thing he said on the public record before they executed him. He was just 150 years ahead of his time. It’s just incredible to read his words. There’s a whole movement to pardon him that I saw in the paper the other day.”
Morgan Freeman: “Not too late, they say.”
Matt Damon: “Yeah, exactly. It’s never too late. Because look, I mean, he ends up getting arrested by Robert E. Lee who leads the Secession force two years later over this issue of slavery, and John Brown predicted [it]. He said, ‘This is only going to be solved with blood. This is the only way. This is a slave nation and we can’t permit it anymore.’ So there are these great inspirational speeches and we hope to turn them into – you know, have a website where teachers are going to be able to access them. If you’re teaching about Frederick Douglass and you can bring a reading by Morgan Freeman into your classroom, I have a feeling high school kids are going to be much more interested and be able to connect to these voices. And that was the thing, looking at all of these readings, you connect to them much more than when you read them on the page, when you see these actors speaking the words. There’s just something very powerful about it.”
6 Points About Pain
That new symptom is troubling: the inexplicable swelling in your calf or the blood in your urine. Could it be serious or even life-threatening?
“Your body flashes signals — symptoms and signs — that warn you of potential problems,” say Neil Shulman, MD, Jack Birge, MD, and Joon Ahn, MD. The three Georgia-based doctors are the authors of the recently revised book Your Body’s Red Light Warning Signals.
Fortunately, many symptoms turn out not to be serious. For example, the majority of headaches stem from stress, eyestrain, lack of sleep, dehydration, caffeine withdrawal, and other mundane causes.
But a sudden, agonizing “thunderclap” headache — the worst of your life — could mean bleeding in the brain. Being able to recognize this serious symptom and calling 911 may save your life.
Here are six important flashing signals.
1. Paralysis of the arms or legs, tingling, numbness, confusion, dizziness, double vision, slurred speech, trouble finding words, or weakness, especially on one side of the face or body.
These are signs of stroke – or a “brain attack” — in which arteries that supply oxygen to the brain become blocked or rupture, causing brain tissue to die.
Symptoms depend on which area of the brain is involved. If a large blood vessel is blocked, a wide area may be affected, so a person may have paralysis on one side of the body and lose other functions, such as speech and understanding. If a smaller vessel is blocked, paralysis may remain limited to an arm or leg.
If you have symptoms, call 911 right away and get to an emergency room that offers clot-busting therapy for strokes due to blocked vessels. Such treatment, which dissolves clots in blocked vessels, needs to be given within the first three hours after symptoms begin, but newer treatments may work within a longer time frame, says Birge, who is medical director at the Tanner Medical Center in Carrollton, Ga.
Timing is urgent; fast treatment can potentially stop brain tissue death before permanent brain injury happens. “There is a time clock ticking as to when you might totally recover,” Birge tells WebMD.
2. Chest pain or discomfort; pain in the arm, jaw, or neck; breaking out in a cold sweat; extreme weakness; nausea; vomiting; feeling faint; or being short of breath.
These are signs of heart attack. If you get some of these symptoms, call 911 immediately and go to the emergency room by ambulance. Shulman and Birge also recommend that patients chew one regular, full-strength aspirin (unless they’re allergic to aspirin) to help prevent damage to the heart muscle during a heart attack.
Not everyone who has a heart attack feels chest pain or pressure or a sense of indigestion. Some people, especially women, the elderly, and people with diabetes, get “painless” heart attacks, the doctors say. Being aware of “painless” heart attack signs is crucial: a very weak feeling, sudden dizziness, a pounding heart, shortness of breath, heavy sweating, a feeling of impending doom, nausea, and vomiting.
Drug Information Update – Final Regulation on Positron Emission Tomography (PET) Drugs
The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
Today, FDA published a final regulation and a related guidance document on positron emission tomography (PET) drugs. These drugs are given to patients to allow a special camera called a PET scanner to take images of internal organs and tissues. The images help physicians diagnose disease and assess specific health concerns.
Because PET drugs have a unique method of manufacture and unique conditions of use, FDA’s final regulations establish Current Good Manufacturing Practices (CGMP) specific to PET drugs. CGMPs are minimum standards that manufacturers should follow to ensure that drugs are safe and effective.
Unlike X-rays or magnetic resonance imaging (MRI) which show only body structure, PET images show the chemical functioning within an organ or tissue. This is useful in people with certain types of cancer or with other conditions. PET drugs contain a very small amount of radioactive material, and one of the distinctive properties is that the drugs must be given to patients within a few hours after being produced. Because these drugs are radioactive and have very short half-lives, they must generally be manufactured at or near the clinical sites where they will be given to patients.
FDA’s final regulation will help make sure that PET drugs meet requirements regarding safety, identity, strength, quality, and purity. The companion guidance document details FDA’s current thinking on CGMP for PET drugs and will guide PET producers in applying the final regulation.
For more information, please visit: PET
Cough Relief – Natural Treatment for Cough Relief
What is Cough?
A cough is a reflex that helps clear foreign substances from your lungs and airways.
What Causes Coughing?
In many cases, coughing occurs as a symptom of a short-term illness, such as the common cold, bronchitis, or the flu.
Chronic coughs, on the other hand, may be caused by one of the following conditions:
- asthma
- allergies
- chronic obstructive pulmonary disease
- gastroesophageal reflux disease
Chronic cough may also result from smoking or from use of some medications.
If your cough lasts longer than two to three weeks, consult your physician to check for an underlying health problem.
Natural Cough Remedies
Although they won’t cure the condition causing your cough, the following may provide natural cough relief:
1) Honey
In a 2009 study, researchers found that honey may decrease the frequency and severity of cough more effectively than the over-the-counter cough-suppressing drug dextromethorphan. Try adding honey to tea, or taking a spoonful on its own.
2) Marshmallow
Compounds extracted from marshmallow (an herb said to soothe irritated tissue) may provide significant cough-suppressing benefits, according to an animal study published in 2007. Marshmallow can be taken in tea form.
3) Mullein
Available in lozenge, powder, and supplement form, mullein is a common weed that contains compounds said to act as demulcents (substances that relieve irritation or inflammation in the throat) and expectorants (agents for loosening mucus and making it easier to cough up). Although mullein hasn’t been specifically studied for its effects on cough, it has long been used to treat coughs in herbal medicine.
Home Remedies for Cough
Drinking plenty of water or warm tea can help loosen mucus and treat throat irritation resulting from cough.
If your cough is the result of a cold or flu, consider performing a eucalyptus steam inhalation to help relieve nasal congestion and sinus congestion.
Sources:
Dealleaume L, Tweed B, Neher JO. “Do OTC remedies relieve cough in acute upper respiratory infections?” J Fam Pract. 2009 58(10):559a-c.
Sutovska M, Nosalova G, Franova S, Kardosova A. “The antitussive activity of polysaccharides from Althaea officinalis l., var. Robusta, Arctium lappa L., var. Herkules, and Prunus persica L., Batsch.” Bratisl Lek Listy. 2007;108(2):93-9.
Hanukkah Music for Kids
Rachel Buchman – ‘Shine Little Candles: Chanukah Songs for Children’
Courtesy Rounder Records
The Jewish Wedding Band – ‘A Child’s Hanukkah’
Courtesy Music For Little People
David Grover & The Big Bear Band – ‘Chanukah at Grover’s Corner’
Courtesy Koch Records
The Klezmatics – ‘Woody Guthrie’s Happy Joyous Hanukkah’
Courtesy Jewish Music Group
Judy Caplan Ginsburgh – ‘Chanukah Favorites’
Courtesy Judy Caplan Ginsburgh
Various Artists – ‘Chanukah at Home’
Courtesy Rounder Records
Julie Silver – ‘It’s Chanukah Time’
Courtesy HyLo Entertainment/Barnes & Noble
Mama Doni – ‘I Love Chanukah!’
Courtesy Mama Doni Productions
Rabbi Joe Black with the Maxwell Street Klezmer Band – ‘Eight Nights of Joy’
Courtesy Klezmer Music Foundation
It’s A Blues Christmas!
1. ‘Alligator Records Christmas Collection’ (Alligator Records)
Photo courtesy Alligator Records
Photo courtesy Price Grabber
3. ‘Best Of B.B. King: The Christmas Collection’ (MCA Records/Universal)
Photo courtesy MCA Records
4. ‘Best Of The Blues: The Christmas Collection’ (Hip-O Records/Universal)
Photo courtesy Universal Music
5. ‘Blue Yule: Christmas Blues and R&B Classics’ (Rhino Records)
Photo courtesy Price Grabber
6. Canned Heat’s ‘Christmas Album’ (Fuel 2000 Records)
Photo courtesy Price Grabber
7. ‘Genuine Houserockin’ Christmas’ (Alligator Records)
Photo courtesy Alligator Records
8. ‘Merry Blue Christmas’ (Varese Sarabande)
Photo courtesy Price Grabber
9. ‘Santa’s Got Mojo’ (Electro-Fi Records)
Photo courtesy Price Grabber
10. ‘Stony Plain Christmas Blues’ (Stony Plain Records)
Photo courtesy Stony Plain Records
Colin Firth Talks About ‘A Single Man’
Colin Firth and Julianne Moore in ‘A Single Man.’
© The Weinstein Company
Colin Firth put himself on the short-list of possible Best Actor Oscar contenders with his starring role in A Single Man. The touching story of a man who’s just going through the motions following the death of his partner, Jim (played by Matthew Goode), is co-written and directed by first-time feature newcomer, fashion designer Tom Ford. Set in Los Angeles in 1962, we meet British college professor George Falconer (Firth) at a difficult time in his life when just the act of getting out of bed takes every single bit of his energy. Although it’s been months since Jim was killed in a car accident, the loss hits him each morning as though his death had occurred just the day before.
A Single Man was adapted from the book by Christopher Isherwood, which was loosely based on his relationship with artist Don Bachardy. Prior to taking on the role of George, Firth watched the 2007 documentary Chris and Don. A Love Story twice. “I don’t know that it helped me with the role,” said Firth. “It was interesting. Whenever I embark on a project, it’s an opportunity to plunge into a particular world, or a different perception, to learn about a time or a place I don’t know as much about. Love is love. I don’t feel there’s anything different to play because the partner happens to be male. The person I’ll be playing opposite is unlikely to be my lover anyway. It’s the job description; you find these emotions from somewhere.”
“I think one of the things I appreciate greatly about Isherwood’s writing is that he doesn’t make the sexuality an assailing feature. I mean, sexual love is part of it. He was writing at a time when other writers were covering that up,” offered Firth. “Isherwood didn’t feel a need to do that. His characters just happened to be gay. I don’t really define myself by my sexuality, either. George struggles with many things, but one of those things is not his sexuality. I think he’s fairly happy with who he is in that respect.”
Firth’s been working steady in films since the mid-1980s, but this is Ford’s first venture into the tricky world of directing. Asked how it was working with a rookie, Firth replied, “He has a great gift. He’s never made a film before, but it didn’t feel like working with a man who was a novice. There were a couple of pieces of film parlance he was unfamiliar with, but it didn’t seem to matter. He would just add them to his vocabulary and carry on. People treated him with the most enormous respect. There was such a strong sense that he could be trusted, in terms of his taste and his judgment. It actually relaxed people.”
Firth said Ford handled himself like a seasoned veteran, chalking his ability to control the set up to what Ford has learned while working in the fashion industry. “A film set can be a neurotic place, and can be rampant in security. People are frightened of falling short, of failure, of miscommunication, all kinds of complications. A good director smoothes that out, unites the set, and creates a unity of vision, which everybody wants to fulfill. He has that gift, and I think he’s learned that over many, many years working in fashion. He’s always felt that fashion has something to say. It may not be a popular thing to hear. But even as Tom said, ‘I must make this woman wear this dress,’ or ‘This woman must feel that she has to wear this dress. I have to get that across in a few seconds on the runway.’ You’re still using your creativity, still having to get a group of people to share a vision, and still working toward an impact. This time it was narrative drama, and it was something very different for him, and it was very clear to me that this was not a vanity project.”
The costumes of A Single Man are gorgeous and completely in line with the clothing of the 1960s. But just because Ford comes from the fashion world doesn’t mean he took the opportunity to show off the costumes to the detriment of the actors or the story. “Just his choice of material indicated to me that this was not just a chance for him to show off his spring collection: ‘Lonely college professor in 1960′. Yes, the clothes look beautiful, and yes, it’s wonderfully designed, but it’s very much at the service of the story, as far as I was concerned,” said Firth. “The way George dresses, so fastidiously, is a sign of his desperation. It’s very clear at the beginning of the film, when he says it takes a long time to become George, you get the feeling that if he took off his cufflinks, he’d fall apart. That he’s actually getting his body armor on, and he’s hanging on by his fingernails. It’s only his exterior world that he has any control over, that is ordered, because inside it’s all a mess. To me, that was the purpose of the costumes.”
Continued Firth, “It was the same with everything else. The house told me about him, the bedroom, the way everything was designed. When I walk into Charley’s house, you understand a lot about her the minute you walk into all that pink and orange and gold. He didn’t give us a lot of verbal instructions, so a lot of the film really was things being explained to us through the senses.”
Firth’s character isn’t much of a talker, and much of what we learn about this man we discover just through Firth’s body language. Actors often ask for more dialogue to help them explain their character’s motivations, but that’s just not Firth. He was perfectly fine with letting the audience discover George for themselves.
“I love a scene without dialogue,” admitted Firth. “When you first get a script – a blank page is a blank page, so you’re not really sure what that’s going to be. You know that’s going to come from the sensibility of your director, or whatever he’s going to allow you to do. One of the most depressing things that I think can happen for an actor is when the material is incredibly coherent and elegant and you feel inspired by it. You don’t want to go through a series of hugely demonstrative gestures, particularly when you believe in the power of just thinking things onto the screen. I love that kind of cinema.”
Colin Firth in ‘A Single Man.’
© The Weinstein Company
Look at people like Bergman, who can spend a very long time on someone’s face,” said A Single Man star Colin Firth. “To me, the most interesting thing you can find in cinema is the human face. There’s a lot of beauty in cinema, but that’s the thing that interests me most. That’s what’s always inspired me. One of the most dispiriting things is to see the possibilities of all that, in a quiet scene, and you get there and you’ve got a wonderfully imaginative director that’s saying, ‘Stare at the doorknob. Pan across the floor, and then there’s going to be a shot of the tape recorder light flashing. Then we’re going to get a close-up of your right eye, and I want a lot of orange in the shot, and I want a silhouette of you, but way, way, way in the corner over there.’ And that may look great, actually, that may be wonderful, but I feel it’s a waste. And that happens quite a bit.”
“On the other hand, you might get a director that does put the camera on your face, but he decides he wants to interfere and control it, and provoke it out of you and say, ‘Think about the time your dog died and you were little,’ and I was fine before the dog thing. They don’t just let you do things. The script was clear to me. By the time I saw the way he set things up, it was eloquent already, and so we were free.”
In addition to heaping praise on co-writer/director Ford, Firth also had nothing but compliments for his co-stars. “Everybody in the film seems to be at the top of their game. When I close my eyes and think of the film, I tend to see Nick Hoult’s face looking back at me. It’s very hard to forget the eyes. There’s something very truthful and very in the moment about what everybody was doing, the people I was watching. I never had such an easy time as when I worked with Julianne [Moore]. That relationship felt real to me. I wasn’t sure about it on the page, but the minute I met her, it was there. I think it’s exactly the same with Matthew [Goode]. Like that scene on the sofa, there’s moments of familiarity. If all of those things are happening, it’s got to be something to do with your director. He’s cultivated an atmosphere where he’s not going to fuss around. He’s going to let people connect with each other. Or, if there’s nobody else around, and there wasn’t in my case, let your imagination take hold and just go. He would roll out a whole magazine of film. You’d be sitting there by yourself, and if he was interested in what you were doing, he wouldn’t say cut just because the scene’s done. You’d just stay there until you heard the sound of the magazine stopping and then he’d say, ‘Okay, we’ll do another one of those. Reload.’ He rolled out three times, in one case.”
A Single Man and Homosexuality
Firth believes that A Simple Man doesn’t make an issue of its characters’ sexual preference. Their choices are not what defines them and instead are simply part of who they are. “The sexuality’s there because part of the love that he experiences is sexual. There’s sex running through the whole movie, which I think is strengthened by the fact that we don’t see anybody humping,” said Firth. “It’s great, we don’t need to go through all the body functions. What’s interesting about sex is its implications, the barriers that are broken down on the way to it. I mean, all these sorts of things are there in the film. The possibilities of it, the ambiguity, the relationship with Kenny [played by Nicholas Hoult]… How sexual is it? Does Kenny have sexual feelings? The fact that it’s forbidden, the fact that George is homosexual in 1960 might add to his isolation. The speech on fear to his students definitely references that, although I don’t think it’s dependent on it. Because the character’s not taking this on as an issue, it’s not his war with his sexuality, or the war with prejudice, or it’s not the assailing feature of the film. I think the fact that he is comfortably open about the fact that he is gay is definitely significant, otherwise, why bother to feature it at all?”
“Tom [Ford] said at a press conference recently that he doesn’t define himself by his sexuality, particularly. It’s there, and if he were asked to say 10 things to describe himself, he’d tell you he’s from Texas, give you his name, tell you something about his life. Probably by the time he got to 10, he’d mention he’s a gay man. In my 10 things, I don’t know that I’d think to tell you I was heterosexual or not. The homosexuality is not irrelevant. I just think the film is about love, regret, and gaining or losing your love of life. What I like about it is it’s absolutely, unashamedly, and unassumedly there. This movie is homosexuality simply as sexuality, as any other sexuality.”
Handling the Oscar Buzz
As for the awards recognition this performance may earn him, Firth’s taking a very level-headed approach to the whole thing. Although actors always love the attention, when all the focus actually shifts to them they express confusion on how to handle it. So, how’s Firth dealing with the awards buzz? “It’s confusing,” laughed Firth. “It’s hard to judge an actor who’s having his insane and insatiable need for attention fulfilled, because he’d probably be at his best… It’s that Tom Waits line: ‘I don’t have a drinking problem, except when I can’t get a drink.’ Check in with me when I’m not getting attention.”
“Acting is my day job, and I do have a life. I think I invest more in my personal life than I do in my professional life. My wife is spectacularly good at keeping my feet on the ground. I have a home to go to at the end of the day, so all the rigors, the ups and downs, disappointments, and expectations, they come and go constantly. Disappointments don’t last unless you cling to them, and neither do expectations. Even if you get rewarded, you can’t cling to that moment. I do find that the sanest actors I know have a fairly strong home life and have friends outside the business.”
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