Preventive migraine treatment

The pharmacologic treatment of migraine may be acute (abortive) or preventive (prophylactic), and patients with frequent severe headaches often require both approaches. Preventive therapy is used to try to reduce the frequency, duration, or severity of attacks. The preventive medications with the best-documented efficacy are amitriptyline, divalproex, topiramate, and the beta-blockers. Choice is made based on a drug’s proven efficacy, the physician’s informed belief about medications not yet evaluated in controlled trials, the drug’s adverse events, the patient’s preferences and headache profile, and the presence or absence of coexisting disorders. Because comorbid medical and psychologic illnesses are prevalent in patients who have migraine, one must consider comorbidity when choosing preventive drugs. Drug therapy may be beneficial for both disorders; however, it is also a potential confounder of optimal treatment of either.

An Interview with Kirk Hammett of Metallica

An Interview with Kirk Hammett of Metallica

Part of our Day With Metallica

By Ryan Cooper, About.com

Kirk Hammett

© Nicole Lucas

Metallica doesn’t do anything halfway, and their visit to SXSW was no exception. From being the most-talked about “secret performers” of SXSW to their performance promoting the release of Guitar Hero Metallica, to the press event, everything they do is a large production.

We arrived at the press event, where we waited for Metallica to arrive from the airport. They rolled in for a brief photo shoot and then disappeared into the 4 Seasons. When it was time for the interview, I was taken to the elevator by an assistant and dropped off on a floor, where I was then greeted by another assistant who escorted me to a room, where I was greeted by yet another assistant, who escorted me into the room, where Metallica guitarist Kirk Hammet was seated, in front of a Guitar Hero backdrop.

This is where our time with Metallica at SXSW begins.

RC: So obviously, the big thing you guys have going right now is promoting the game. What went into the production of the game that would be different from making a record?

KH: It’s a completely different deal all together. The first thing we did in production was a motion capture, or ‘mocap’ as they say. And what they had us do is put on these velour suits with these little balls stuck on them with Velcro, and we would wear these glasses with little balls on them, and the little balls had sensors so that if we waved our hands, the cameras would capture the motion and it would show up on the computer screen.

We would put on these suits with the balls all over our limbs, and we would basically lip sync through the songs, and just pretend that we were playing the songs live. And they would capture the motion of us moving the way we would move while playing.

We did that and then we sat down and discussed settings and locations, and we’d say ‘OK, we want this part of the game set at the Great Western Forum, a venue in L.A., and they would create the venue, or this place that we played in Russia in 1991, they would actually create that and plop us down into that setting.

It was a pretty different experience, because it really had nothing to do with music at all, or playing our instruments. It was all just motion. It was sort of like a Frankenstein monster thing; they were creating us in a virtual world. It was a pretty different experience.

A lot different from making an album, for sure.

RC: Do you like how you look on screen?

KH: Yeah, sure! (Laughs) I mean, it’s kind of weird, looking at a virtual version of yourself, but you get used to it after a while.

RC: Did you get to choose all the ‘extra’ songs on the game? The non-Metallica songs?

KH: Yeah. Totally.

RC: What influenced your choices?

KH: There are a lot of bands on here for various reasons. We’ve toured with a lot of these bands, and a lot are inspirations. It’s what we listen to nowadays. Like Judas Priest, huge inspiration. System of a Down, we think they’re cool, we’ve toured with them. Alice in Chains, the same thing. Lynyrd Skynyrd is a huge inspiration, Mercyful fate is a huge inspiration, and so for us it was a sort of a way to acknowledge their existence in the world of Metallica, so to speak.

RC: But, I saw there’s no Misfits. I saw Samhain, but no Misfits.

KH: Yeah, legal issues. I can’t really get into it, but it’s the same reason there’s no UFO, but there’s Michael Schenker Group. Legal problems.

RC: Yeah there are so many hands in the Misfits thing right now.

KH: Yeah, it’s crazy. But Danzig was a hero of mine.

RC: I saw the game graphics. Is that Pushead graphics in the game?

KH: Yeah.

RC: Just seeing that goes back to old school, and skateboarding.

KH: Yeah, the great thing with that is that we’re trying to make it as much a Metallica experience as possible, and Pushead is a part of the Metallica experience, so it was really cool that he signed on and did some artwork for it.

RC: And we just solicited a couple questions from our readers, if that’s cool.

Have you decided who’ll induct you into the Rock Hall of Fame?

KH: Yes we did. I don’t know if I’m supposed to talk about it or not. F**k it. Flea.

RC: Is Jason Newstead going to be there?

KH: Jason will be there, as a matter of fact. He put 14 years into Metallica, so there’s no reason for him not to be there.

RC: Will you guys play together?

KH: With Jason? Most Likely.

RC: Have you seen the Cliff Burton book yet?

KH: I have not. Is it out?

RC: It’s not out yet; I believe it’s not out until June.

KH: I actually talked to the author a couple of months ago, and he wanted to talk to me about things about Cliff, and my discussion with, I think, is going to be used as the forward.

RC: Everybody loves the way Death Magnetic is reaching for an older sound. Do you guys have plans to work with Rick Rubin again?

KH: You know it’s pretty early still, but I have no qualms about working with him again, but it’s still too early to say. We might be in a totally different headspace by then. It will be a while though; we still have another year and a half of touring to get through, and hopefully we’ll get through that and still have our marbles. Then we’ll start thinking about the new album.

RC: You have worked with a ton of great musicians, collaborating over the years. Is there anyone you haven’t worked with, but would like to?

KH: I would love to work with a lot of different people; the only problem is, some of them are dead. But we’re pretty open to a lot of different things when it comes to collaborations, so who knows?

RC: The video game is pretty cutting edge. What’s the next place, for Metallica to stay on the forefront?

KH: I don’t know. Technology moves so quickly these days, there might be something completely different in two years that everyone is raging about, so it’s hard to say.

RC: And this is my last question, feel free to take the fifth on it.

OK (Laughs)

RC: In retrospect, was Napster really that bad?

KH: It’s one of those situations. You have to ask yourself, ‘would it have been bad if we’d not gotten involved? I don’t know.

We did get involved, did it make it worse, or not? It’s just one of those questions that you just have to take it for what it is, really.

After the interview, I left the hotel, where it was off to Stubb’s, where Metallica’s ‘secret show’ took place…

Reese Witherspoon and Seth Rogen on ‘Monsters vs Aliens’

Reese Witherspoon and her animated counterpart, Ginormica, from ‘Monsters vs Aliens.’

© DreamWorks Animation

 Seth Rogen and Reese Witherspoon provide the voices of two of the monsters in Monsters vs Aliens, DreamWorks Animation’s 3-D animated comedy movie directed by Rob Letterman and Conrad Vernon. Rogen lends his voice to a blue blob known as B.O.B. (short for benzoate-ostylezene-bicarbonate). B.O.B. is an indestructible gelatinous mass with one eye and a tiny brain. Witherspoon tackles her first animated movie with Monsters vs Aliens, providing the voice of Susan, a bride-to-be who is transformed into a 49 foot-11 inches tall creature after an encounter with a meteor on her wedding day. Renamed Ginormica, Susan’s taken to a secret military facility where she meets B.O.B., Dr Cockroach (voiced by Hugh Laurie), and The Missing Link (voiced by Will Arnett). When aliens threaten Earth, it’s up to this bizarre batch of would-be heroes to save the day – and save our planet.

 

Seth Rogen and Reese Witherspoon Monsters vs Aliens Press Conference

Reese, since you’re 5′2″ how was it playing a woman 49 foot tall person for a change?

Reese Witherspoon: [Laughing] “It was an interesting sort of challenge because my character goes from being a regular-size girl to being this giant superhero kind of girl. They wanted me at the end of the movie to kind of talk with an action star voice, which is not a voice I know or have in my repertoire. So they kept trying to coach me to be more like Arnold Schwarzenegger or Sylvester Stallone. ‘I am Ginormica!’ And they were like, ‘No, that sounds like a robot.’ ‘I am Ginormica!’ ‘Can you drink some tea? That doesn’t sound very good.’ So that took me a long time. That was probably the hardest thing for me to do.”

Seth, you’ve proven you’re a very funny guy. Does it change for you when you’re just using your voice?

Seth Rogen: “I think it’s actually a lot easier to be funny when you have like hundreds of geniuses who are paid to animate your every facial expression with painstaking thought and minutiae. I just kind of mosey on set most of the time and spit out the lines and pray something good happened. These guys really put a lot of thought into every second of the movie that winds up in front of you guys, and I think they add a lot of the humor that’s in it. You know, I actually didn’t even know a lot of the stuff that Bob does until I’d seen the movie. I would watch it and say, ‘Man, this is hilarious. I wish I was that funny.’ But no, it’s them.”

What did each of you enjoy most about playing your character and what was the biggest challenge you faced?

Reese Witherspoon: “Well, like Seth was saying, I had no idea that… It was such a different movie when I actually saw it. They put together a rough cut, and I had to go in and animate all the ‘effort’ noises and that kind of stuff, so that is always so disorienting and strange. I guess this was the first movie I ever did that had this much action in it, so I think I was sort of surprised about that and kind of thrilled, because I can’t imagine any other world in which that opportunity will present itself to me. So it was kind of awesome to realize I was creating a female superhero. It feels like a unique opportunity for me and my daughter who was really into this movie. I was with my son and my daughter, we were walking, and I was like, ‘Who’s your favorite superhero?’ And my son was like, ‘Well, there’s Batman, there’s Spider-Man, there’s Robin, there’s…’ And I was like, ‘Well Ava, who’s your favorite superhero?’ ‘I don’t know. The girl who’s in the Justice League? I can’t remember her name.’ So it’s cool to be able to create that kind of character.”

Seth Rogen: “Oh, I just enjoyed the whole thing, you know? It’s fun to see yourself kind of thrown into these worlds and hear your voice coming out of these hilarious creatures. It’s a great movie. I just enjoy watching it. There was nothing really that difficult about it. Some of the effort stuff, like trying to verbalize what it might sound like to get stretched out by a monstrous shoe or something like that, can become — it’s not that difficult. It’s not that bad. It’s a lot of fun, I’ve got to say, and I enjoyed every aspect of it.”

If you could be Ginormica at will, what are some of the things you would do?

Reese Witherspoon: “The first thing I’d do is put on that cat suit and never take it off.”

Seth Rogen: “Me too!”

Reese Witherspoon: “No working out, no dieting. She just looks hot all the time. I was like, ‘I’m into this.’ My girlfriend and I saw the movie together and she brought her kids, and she turned to me halfway through the film and she was like, ‘You look really hot!’ [Whispers] ‘I know. It’s not me! It’s awesome.’ That’s probably the first thing I’d do.”

Your character comes into her own in the movie. What would you hope little girls get from this?

Reese Witherspoon: “I think it’s got an incredible message about finding yourself and your identity. I think everybody – not just girls but guys, too – struggle with who are you. Are you a person who lives in the shadow of another person just so you don’t have to be alone or afraid or find your own strengths? Or are you someone who is willing to take a chance on being a little scared of the unknown and maybe possibly accomplishing great things in your life? [Whispering to Seth:] That was good!”

Seth Rogen: [Laughing] “Really good! I’m going to take a moment from that. I’ve been leading my life all wrong, guys.”

For both of you, what was the best part of making this movie?

Seth Rogen: “Best part of making it… I like watching it. I’ve got to be honest, I’m kind of an end results kind of guy. To me, it’s cool to be able to sit in a movie theater and see the movie in 3-D and have people for once in my life of all ages laughing at the content of the material. To me, that’s the most fun part of it.”

Reese Witherspoon: “Probably getting to take my kids to a movie that I’m in and having them really enjoy it and having them think I’m actually kind of cool, because usually they think I’m a really big dork. They’re like, ‘Mom, stop singing in the car because you’re really annoying me.’ But now they’re like, ‘Hey Mom, can we go see your movie?’ So that’s kind of good.”

Seth Rogen and Reese Witherspoon Monsters vs Aliens Press Conference

Can both of you talk about what are the creative rewards of doing voice work and how important being involved with animated films is career-wise?

Seth Rogen: “I don’t know. It’s fun. It’s a different process entirely. I’m sure you’ve heard the expression that acting is reacting. Well, if you remove other actors from that equation, then the art of reacting becomes quite different, I would say, but it just is kind of a different thing. You kind of go in there and you play around and you have a lot of time to experiment and it’s just a lot of fun, I think. It feels much more like playing than acting. There’s not a lot of technical aspect to it. There’s no lights or cameras or physicality you have to be aware of, or even other actors that you have to be aware of for the most part.”

Reese Witherspoon: “You don’t have to be sensitive about their light.”

Seth Rogen: “Exactly. Nothing. You can just take as much time as you want. You can spend like three hours doing one line if you really, really wanted to, which I would never do on a set with other people whose time I was wasting.”

Reese Witherspoon: “I’d be really annoyed.”

Seth Rogen: “She would kill me. [Laughing] But she wasn’t there. So that was nice. As far as career-wise, there’s no conscious importance to these movies. Personally, I just think they’re cool movies and it’s fun to see yourself in them.”

Reese Witherspoon: “It’s a great opportunity, I think, to reach a wider audience. For me, I just love to travel internationally. This is like the first movie that I’ve done that kind of transcends language because I’m always talking and talking and talking in movies. So it’s nice to actually be able to go to other countries and have them completely understand the concept of the movie and enjoy it in the same kind of way. That’s kind of a good thing for me. That’s the first time I’ve been able to travel and they get when I’m making the movie so that’s great, and also it’s a great opportunity to work with a lot of great comic actors. We’re all so busy doing other kinds of movies that it’s only ever possible to work with this many amazing talented people in this capacity because it doesn’t take up a huge amount of all of our time.”

Reese, you’ve been approached before for animated movies. What made this one so special for you?

Reese Witherspoon: “Yeah, I’ve been offered a lot of animated films. Sometimes they were playing the girlfriend and sometimes the girl who got rescued by a guy. And I just felt like this was the first opportunity that was presented to me where the woman was at the center of the movie. So that’s kind of a unique opportunity for me to create a character that had strength, had a journey, had a whole storyline. So that’s what really appealed to me.”

Has there been talk of a sequel? Also, how do you feel about 3-D?

Reese Witherspoon: “I haven’t heard anything about a sequel. I think we’re just like…”

Seth Rogen: “The movie should come out first probably [laughing]. That would be rad if they just decided to forego that step in the process.”

Reese Witherspoon: “The 3-D is really interesting. I think it’s kind of different than 3-D you’ve seen before where it kind of jumps out at you. This more surrounds you. You feel more immersed in it. I’m excited. My kids have seen the movie, but they haven’t seen it in 3-D. They’re going to see it in 3-D soon. Like as soon as possible. Like my son wakes up every morning and he goes, ‘When do I get to see the movie in 3-D?’ [Laughing] ‘I don’t know. Somebody call somebody and tell them you’re in a hurry!’”

Seth Rogen and B.O.B. from ‘Monsters vs Aliens.’

© DreamWorks Animati

“I’m really excited because I think it’s kind of a new moviegoing experience for them. And with what I hear Mr Katzenberg talking about, it seems like it’s going to be definitely a new cinematic experience that a lot of filmmakers are going to be incorporating in their films.”

Were there any funny or memorable moments from doing the voice work that you’d like to share?

Seth Rogen: “Well apparently when the other actors aren’t there to read with you, there’s a delightful man who’s very talented who does kind of impressions of the other actors, and he’ll read the lines with you. And apparently he does a great impression of me. Reese actually had the bright idea to ask him to impersonate her for me, and he actually does a pretty good you. I actually met him before I met you and then when I met you, I was like, ‘Hey, you’re kind of like the guy I read with.’”

Reese Witherspoon: “I have that weird red Mohawk.”

Seth Rogen: “Exactly. He has kind of a weird faux hawk.”

Reese Witherspoon: “He has a Kramer doo.”

Seth Rogen: “He does have a very Kramer-ish hairdo. My one regret is that I didn’t ever get to hear him do me. I wish I got to hear him do me, but he does you fantastically.”

Reese Witherspoon: “He wouldn’t do my voice in front of me. I don’t know why. He was shy.”

Seth, you’re in two movies opening close together. One is a venture into raunch and the other is family fare. Do you have a preference and do you worry about being locked into the adolescent raunch image? Will Green Hornet be a fusion of both?

Seth Rogen: “Yeah, honestly I’m very thankful that people are allowing me to do this. I’m kind of shocked that I’ve gotten away with it, that I can do a movie like Observe and Report and a movie like Monsters vs Aliens. One which has been described as transgressive, and the other which is a delightful family romp. So I personally am very thankful. I do like both those kinds of movies. I try to do the types of movies that I like to go see, and I genuinely like to go see both those types of movies. Being responsible for the writing of a majority of my movies, I don’t feel typecast. And if I did, I’d probably write myself a different role.”

“As far as Green Hornet goes, yeah, I mean it will be a PG 13 movie. I think it has a lot of the humor that people are used to from us. But obviously in a finessed [way] so that more people can enjoy it. And it’s a big action movie, also, so that helps it round itself off.”

Seth Rogen and Reese Witherspoon Monsters vs Aliens Press Conference

Reese, what do you have coming up next?

Reese Witherspoon: “I’m doing a movie with Jim Brooks next and Paul Rudd and Owen Wilson and Bill Murray. I don’t know what the title is.”

Are you filming it now?

Reese Witherspoon: “Someday. [Laughing] I’ve been making it since September. I’ve been talking about it since September. I’m starting to feel like one of those people that goes to Hollywood parties and goes, ‘Yeah, I’m making movies with Jim Brooks.’”

Seth Rogen: [Laughing] “Exactly. For six years.”

Reese Witherspoon: “I’ve only been making movies with Jim Brooks for about two years now. And one day we’ll start filming and it’s going to be fantastic. Maybe.”

What’s your role?

Reese Witherspoon: “I play a professional athlete. There’s comedy. There’s definitely comedy and drama. All that stuff.”

What sport?

Reese Witherspoon: “Softball.”

Seth Rogen: “It’s awkward when you don’t know how much to reveal. That’s what I always do when people ask me. Look, I have no idea what to say. No one else has said anything.”

Reese Witherspoon: “Am I allowed to? Am I going to get fired? They can still fire me. We haven’t shot the movie yet.”

A scene from ‘Monsters vs Aliens.’

© DreamWorks Animation

Seth, can you bring us up to speed on The Green Hornet?

Seth Rogen: “Michel Gondry is going to direct it. Me and Evan (Goldberg) are in the process of rewriting it with him right now. We should start shooting it in the end of June, around then.”

How is it changing?

Seth Rogen: “You can’t have a guy like Michel around and not get a bunch of new ideas thrown at you. That guy — as soon as he’s in the room, anything seems possible. It’s really exciting to work with a guy like that. We hire directors specifically who we think are smarter than us and who can do things that we can’t do, and he more than fits that criteria.”

Do you each have a favorite superhero?

Reese Witherspoon: “I liked Wonder Woman as a kid. I watched Linda Carter over and over and over again. And I had my golden lasso and my whole costume. I think I wore it for seven Halloweens, so she’d probably be my favorite.”

Seth Rogen: “Oh, I don’t know. Batman.”

Did Monsters vs Aliens inspire you to want to play more superheroes? Maybe Wonder Woman in its new version?

Reese Witherspoon: “I don’t know.”

Would you like to?

Reese Witherspoon: “I don’t know. [Laughing] It seems kind of challenging. Maybe Seth can let me know how Green Hornet goes.”

Seth Rogen: “Physically, it already sucks. I’ll tell you that.”

Reese Witherspoon: “It’s so hard. I’ll be totally honest with you. If I never had to see the inside of a gym again, I’d be a very happy person. The idea of it, there’s people who love it and it’s just their thing and it’s like I can do it, and I can do it for my job because I’m really lucky to get this job and have a job, but it’s not my first choice of morning activity.”

Which of the big summer movies are you looking forward to seeing?

Seth Rogen: “That’s a good question. What have we got? We’ve got Wolverine Origins. That’s coming. I’m in. Transformers I’m in. Star Trek, I’m in.”

Reese Witherspoon: “Oh, I want to see Star Trek.”

Seth Rogen: “Every one. I’ll see every one. [To Reese:] Which ones do you want? All those? Are you going to see them all?”

Reese Witherspoon: “I like J.J. Abrams. I think Star Trek will be very cool. I think that will be interesting.”

Seth Rogen: “That will be good. I’m excited. Good pick. Good pick.”

http://movies.about.com/od/monstersvsaliens/a/rogen-witherspoon_3.htm

The safety and efficacy of clopidogrel versus ticlopidine in Japanese stroke patients: combined results of two Phase III, multicenter, randomized clinical trials

Two Phase III studies comparing the safety and efficacy of clopidogrel with ticlopidine as antiplatelet agents for the secondary prevention of vascular events in patients with prior stroke were performed in Japan. Both studies were randomized, double-blind, double-dummy comparative trials with the primary objective of comparing the clinical safety of treatment with either clopidogrel or ticlopidine for up to 12 months. The secondary objective was to assess the incidence of a combined efficacy endpoint of cerebral infarction, myocardial infarction, and vascular death. Patients with prior stroke were recruited during July 1996-February 1998 and September 2001-November 2003 at centers across Japan. The results of the two studies were combined in this analysis. There were 1,869 patients in the safety population (clopidogrel, 941; ticlopidine, 928). Significantly, fewer patients experienced a safety event in the clopidogrel group than in the ticlopidine group (p<0.001; hazard ratio, 0.610; 95% confidence interval 0.529, 0.703). Almost twice as many patients in the ticlopidine group (25.6%) experienced hepatic dysfunction than in the clopidogrel group (13.4%). There were 1,862 patients evaluable for efficacy (clopidogrel, 939; ticlopidine, 923). There was no significant difference in the incidence of the combined efficacy endpoint between clopidogrel (2.6% of patients) and ticlopidine (2.5%). Clopidogrel was better tolerated than ticlopidine. There was no difference in the efficacy of the two agents with regard to the secondary prevention of vascular events in patients with prior stroke. This was the first combined analysis of direct comparison of clopidogrel with ticlopidine in the clinical setting.

NORUZ (NEW DAY); THE NEW YEAR OF THE IRANIAN PEOPLES

 

 

 

Norooz (Nowruz, Nevruz, Newruz, Navruz) in Persian means “New [-year]-day”.  It is the beginning of the year for the peoples of Iran (Greater Iran, including: Afghanistan, Arran (nowadays the Republic of Azerbaijan) and Central Asian Republics.  

 

Turkey too has decided to declare Norooz a holiday.  It is also celebrated as the New Year by the people of the Iranian stock, particularly the Kurds a, in the neighboring countries of Georgia, Iraq, Syria, and Turkey.

 

 

It begins precisely with the beginning of spring on vernal equinox, on or about March 21. Tradition takes Norooz as far back as 15,000 years–before the last ice age.  King Jamshid (Yima or Yama of the Indo-Iranian lore) symbolizes the transition of the Indo-Iranians from animal hunting to animal husbandry and a more settled life in human history.  Seasons played a vital part then.  Everything depended on the four seasons.  After a sever winter, the beginning of spring was a great occasion with mother nature rising up in a green robe of colorful flowers and the cattle delivering their young.  It was the dawn of abundance.  Jamshid is said to be the person who introduced Norooz celebrations.

 

 

Avestan and later scriptures show that Zarathushtra improved, as early as 1725 BCE., the old Indo-Iranian calendar. The prevailing calendar was luni-solar.  The lunar year is of 354 days.  An intercalation of one month after every thirty months kept the calendar almost in line with the seasons. Zarathushtra, the Founder of the Good Religion, himself an astronomer, founded an observatory and he reformed the calendar by introducing an eleven-day intercalary period to make it into a luni-solar year of 365 days, 5 hours and a fraction. Later the year was made solely a solar year with each month of thirty days.  An intercalation of five days was, and a further addition of one day every four years, was introduced to make the year 365 days, 5 hours, and a fraction. Still later, the calendar was further corrected to be a purely solar year of 365 days 5 hr 48 min 45.5 sec.  The year began precisely with the vernal equinox every time and therefore, there was no particular need of adding one day every four years and there was no need of a leap year. This was [and still is] the best and most correct calendar produced that far.

 

 

Some 12 centuries later, in 487 B.C.E., Darius the Great of the Achaemenian dynasty celebrated the Norooz at his newly built Persepolis in Iran. A recent research shows that it was a very special occasion.  On that day, the first rays of the rising sun fell on the observatory in the great hall of audience at 06-30 a.m., an event which repeats itself once every 1400-1 years.  It also happened to coincide with the Babylonian and Jewish new years.  It was, therefore, a highly auspicious occasion for the ancient peoples. The Persepolis was the place, the Achaemenian king received, on Norooz, his peoples from all over the vast empire.  The walls of the great royal palace depict the scenes of the celebrations.

 

 

We know the Iranian under the Parthian dynasty celebrated the occasion but we do not know the details.  It should have, more or less, followed the Achaemenian pattern.  During the Sasanian time, preparations began at least 25 days before Norooz.  Twelve pillars of mud-bricks, each dedicated to one month of the year, were erected in the royal court.  Various vegetable seeds–wheat, barley, lentils, beans, and others–were sown on top of the pillars.  They grew into luxurious greens by the New Year Day.  The great king held his public audience and the High Priest of the empire was the first to greet him.  Government officials followed next.  Each person offered a gift and received a present.  The audience lasted for five days, each day for the people of a certain profession. Then on the sixth day, called the Greater Norooz, the king held his special audience.  He received members of the Royal family and courtiers.  Also a general amnesty was declared for convicts of minor crimes.  The pillars were removed on the 16th day and the festival came to a close.  The occasion was celebrated, on a lower level, by all peoples throughout the empire.

 

 

Since then, the peoples of the Iranian culture, whether Zartoshtis, Jews, Christians, Muslims, Baha’is, or others, have celebrated Norooz precisely at the time of vernal equinox, the first day of the first month, on about March 21.

 

 

Today, the ceremony has been simplified.  Every house gets a thorough cleaning almost a month before. Wheat, barley, lentils, and other vegetables seeds are soaked to grow on china plates and round earthenware vessels some ten days in advance, so that the sprouts are three to four inches in height by Norooz. A table is laid. It has a copy of the sacred book (the Gathas for Zarathushtrians), picture of Zarathushtra (again for Zarathushtrians), a mirror, candles, incense burner, bowl of water with live gold fish, the plates and vessels with green sprouts, flowers, fruits, coins, bread, sugar cone, various grains, fresh vegetables, colorfully painted boiled eggs like the “Easter eggs,” and above all, seven articles with their names beginning in Persian with the letter s or sh. The usual things with s are vinegar, sumac, garlic, samanu (consistency of germinating wheat), apple, senjed (sorb?), and herbs. Those with sh include wine, sugar, syrup, honey, candy, milk, and rice-pudding. Here in North America, these may be substituted with English words that would alliterate, rhyme, or make mouths water. The seven articles are prominently exhibited in small bowls or plates on the table. The whole table, beautifully laid, symbolizes the Message and the Messenger, light, reflection, warmth, life, love, joy, production, prosperity, and nature. It is, in fact, a very elaborate thanksgiving table for all the good beautifully bestowed by God.

 

 

Family members, all dressed in their best, sit around the table and eagerly await the announcement of the exact time of vernal equinox over radio or television. The head of the family recites the Norooz prayers, and after the time is announced, each member kisses the other and wishes a Happy Norooz. Elders give gifts to younger members. Next the rounds of visits to neighbors, relatives, and friends begin. Each visit is reciprocated. Zarathushtra’s Birthday and Norooz festival are celebrated by Zartoshtis at social centers on about 6 Farvardin (26 March). Singing and dancing is, more or less for the first, a daily routine.  The festivity continues for 12 days, and on the 13th morning, the mass picnic to countryside begins. It is called sizdeh-be-dar, meaning “thirteen-in-the-outdoors.” Cities and villages turn into ghost towns with almost all the inhabitants gone to enjoy the day in woods and mountains along stream and riversides. People sing, dance, and make merry. Girls of marriageable age tie wild grass tops into knots and make a wish that the following Norooz may find them married and carrying their bonny babies.

HIV/AIDS Update – Approval of generic stavudine for oral solution, 1 mg/mL

On March 20, 2009, the Food and Drug Administration (FDA) approved a generic formulation of stavudine for oral solution, 1 mg/mL. Stavudine is a Nucleoside Reverse Transcriptase Inhibitor (NRTI) indicated for used in combination with other antiretroviral agents in the treatment of HIV infection. This child-friendly product, manufactured by Cipla, Limited, of Mumbai, India, is indicated for use in pediatric patients with HIV from birth through adolescence.

A tentative approval was granted on October 29, 2007 for this product.  At that time, existing patent protections prevented full approval for marketing in the United States.

Because patent protection has since expired for the originator product, Zerit® for oral solution, 1 mg/mL, made by Bristol Myers Squibb, the generic product qualifies for approval. Effective patent dates for FDA approved drugs can be found in the agency’s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the “Orange Book.“

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

HIV/AIDS Update – Tentative approval of lamivudine Tablets, 150 m

On March 16, 2009, the Food and Drug Administration granted tentative approval to a generic formulation of lamivudine tablets, 150 mg, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.  The drug is manufactured by Alkem Labs Ltd., of Mumbai, India.

“Tentative approval” means that FDA has concluded that a drug product meets all required quality, safety and efficacy standards, but is not eligible for final approval, and thus cannot be marketed in the U.S., because of existing patent protections for the approved product, Epivir Tablets, 150 mg, made by GlaxoSmithKline.   However, tentative approval does make the product eligible for purchase outside the United States under the President’s Emergency Plan for AIDS Relief (PEPFAR).

The application was reviewed under expedited review provisions for PEPFAR.

Effective patent dates for all approved drugs can be found in the agency’s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the “Orange Book“

As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility, and of the facilities performing the bioequivalence studies, to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application prior to granting approval or tentative approval to these applications.

A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President’s Emergency Plan is available on the FDA website.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Three New Medical Findings

Vestibular migraine: a critical review of treatment trials;

Vestibular migraine (VM), also known as migraine-associated vertigo, is a common cause of dizziness in adults. We performed a comprehensive literature search regarding treatment for VM or migraine-associated vertigo during the period of 1990-2008 and used, individually or in combination, the search terms VM, migraine-associated vertigo, migraine-associated dizziness, migrainous vertigo, migraine and vertigo, migraine and disequilibrium, and headache and vertigo. We found nine publications that address treatment strategies for VM. One small randomized clinical trial found some benefit from the use of zolmitriptan for abortive treatment of VM. The other eight observational studies showed marginal improvement with migraine prophylactic medications such as nortriptyline, verapamil, or metoprolol. Until more specific treatment options become available, patients with VM need to be managed with similar prophylactic and abortive strategies as those used for migraine in adults.

Psychosis secondary to traumatic brain injury;

Background: Traumatic brain injury (TBI) can result in serious and disabling neuropsychiatric disorders. Method: The authors report a case of a 51-year old male, admitted to the psychiatric ward for acute psychosis and suicidal ideation, probably associated with TBI. After a temporal head trauma he initiated auditory/verbal hallucinations and subsequently developed paranoid delusions. The electroencephalography showed slow bilateral temporal activity and the neuropsychological testing showed several impairments. The patient improved with olanzapine at a dosage of 20 mg daily. Results: This case shows the difficulty of differential diagnosis between schizophrenia and psychotic disorder due to traumatic brain injury. Conclusions: The authors conducted a revision of literature about the diagnosis, epidemiology, clinical aspects, laboratory and structural investigations and the treatment of this condition. Based on this revision work, the authors sketch some recommendations about the work-up that should be done when faced with this diagnostic hypothesis.

enetic basis for idiosyncratic reactions to antiepileptic drugs;

PURPOSE OF REVIEW: In recent years, there has been an explosion of genetic research in epilepsy, including a search for genetic markers of adverse reactions to antiepileptic drugs. This article will focus on recent findings concerning genetic factors affecting susceptibility to idiosyncratic reactions to antiepileptic drugs. RECENT FINDINGS: Recent studies have investigated the role of genetic factors in the development of antiepileptic drug-induced cutaneous reactions, carbamazepine and valproate-induced liver toxicity, vigabatrin-induced visual field defects, and antiepileptic drug-induced teratogenicity. The greatest progress has been an improved definition of the role of human leukocyte antigen-related genes as predictors of the risk of serious antiepileptic drug-induced cutaneous reactions. This has led to the recommendation that patients of Asian ancestry be tested for the HLA-B*1502 allele, in order to identify those at high risk of developing Stevens-Johnson syndrome and toxic epidermal necrolysis after administration of carbamazepine and, possibly, phenytoin and other antiepileptic drugs. SUMMARY: Future research will probably lead to discovery of additional genetic predictors of susceptibility to adverse reactions to antiepileptic drugs. Identification of genetic markers should, in turn, allow unravelling of the molecular mechanisms underlying these reactions. Ultimately, these advances should lead not only to improved personalization of therapy but also to development of safer drugs.

New FDA Hepatitis List Serve

The Food and Drug Administration is launching a new hepatitis list serve. This new e-mail list will provide updates on safety and regulatory issues related to hepatitis B and C products as they become available (rather than on a regularly scheduled basis).

The e-mail list is intended to give patients, industry, academia, government agencies, and other interested parties, one source for FDA hepatitis B and C related information on a variety of topics, including:

• product approvals
• significant labeling changes
• safety warnings
• notices of upcoming public meetings
• proposed regulatory guidances and opportunity to comment

You can subscribe to the new hepatitis e-mail list by simply clicking the link below:

http://service.govdelivery.com/service/subscribe.html?code=USFDA_99

or pasting it into your browser.

You will get an e-mail acknowledgment shortly after signing up.

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Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble

Monica Potter Discusses the Psychological Thriller ‘The Last House on the Left’

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Monica Potter as in ‘The Last House on the Left.’

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37 year old Monica Potter hardly looks old enough to play the mother of a teenager, but that’s the role she takes on in the 2009 remake of Wes Craven’s first film, the 1972 shocker The Last House on the Left. This Last House on the Left finds Potter and Tony Goldwyn (American Gun) out for revenge after their beautiful daughter (played by Sara Paxton in a departure from her usual light comedy fare) is kidnapped and tortured by an escaped convict and his crew of merciless thugs.

Potter, the mother of three in real life, believes she’d turn into a real tigress if her child was harmed the way her onscreen daughter is in The Last House on the Left. Asked if she could go as far as her character does, Potter quickly replied, “Oh god, yes, probably further. No, if somebody hurt one of my kids… I watch these shows on CNN sometimes and what’s this channel with all the trials? Court TV? And I’m like, ‘If I were that person’s mom that defendant wouldn’t be sitting there. I would be in jail.’ Do you know what I mean? And someone just said, ‘Well, then you’re no better than the person that is doing the bad.’ I said, ‘Yes, I am, because they started it.’”

Paxton endured a lot of physical punishment in her scenes with her kidnappers, and the way the young actress looked really helped Potter get into character as the protective mom. “[It helped] a lot, a real lot,” said Potter. “You know, when we shot those scenes it was smart how Dennis [Iliadis, the director] did it. You know, we shot that towards the end and we were all pretty tired. We were all missing our families. I was missing my daughter. Sara and I had a relationship now for, you know, a month and a half so when I saw her like that it was like, I’m pretty sensitive anyway to anyone that looks bad or like’s having a bad day – I started to cry, a little emotional. Plus, I had PMS. It was fine and it worked, it totally worked. I didn’t take my Midol and it was fine. Just kidding…”

“Towards the end of the shoot when you get pretty tired and you’re just like, ‘Okay…,’ and you draw from everything that you can possibly draw from to try and do the best job in that scene,” added Potter. “And I had trouble with that scene at first. I was just like, ‘Something’s really false to me about it.’ I talked to Dennis and there was some dialogue in there that I thought was too expositional and I thought, ‘Let’s take this out and not say anything. Why do we have to explain things?’ because to catch the audience up to speed. So I asked him to take out words and he was like, ‘I think you’re the only actress I know that wants to take words out.’ I do that. I like saying not a lot sometimes.”

The Appeal of The Last House on the Left

Potter’s no stranger to the horror/thriller genre having starred in the original Saw, but it was the opportunity to work on a Wes Craven film that drew her to The Last House on the Left. “Wes Craven, and I do like scary movies,” revealed Potter at the film’s LA press day. “I like comedies better, but I read the script and I thought I could relate to the mom a lot, to Emma a lot, because I have children and if somebody were to do that to one of my kids, they would be done for. And I thought it would be cool. And also to shoot in South Africa would be neat, and I liked Tony Goldwyn. It was just a lot of variables.”Potter hadn’t seen the 1972 film before beginning work in this 2009 version. “I didn’t see the original because I didn’t want to have any preconceived notions of who this character was. To me, this felt like a totally different film. You know, it was shot, what, 30-some years ago, so I didn’t want to come in with an inkling at all of what to do or how to do it or to mimic anything because I think it’s different in a sense.”

* * * * *

The Last House on the Left hits theaters on March 13, 2009 and is rated R for sadistic brutal violence including a rape and disturbing images, language, nudity and some drug use.

More on The Last House on the Left

The Last House on the Left PhotosSara Paxton Talks About The Last House on the LeftThe Last House on the Left