Failing FDA, Warning to Novartis and Greensboro's Involvement

The Associated Press through Yahoo reports that a pharmaceutical giant has been issued a warning letter by the FDA. The letter involves a drug called Deramaxx, 14 dead cats, FDA regulations and an animal testing facility in Greensboro, NC. Read more about it at:
http://news.yahoo.com/news?tmpl=story&u=/ap/20041230/ap_on_go_ot/fda_warning

Deramaxx is a COX-2 inhibitor and is in the same family of drugs as Celebrex and Vioxx. COX-2 inhibitor pain killers have come under fire lately as many have died due to complications from the drugs.

What happened to a doctors visit where you are prescribed drugs that have been tested to the Nth degree? I have a couple of pretty good inside sources that tell me that the drug companies hand out kickbacks to doctors and pharmaceutical outlets to push their drugs. That's right, push our drugs and we'll send you and your family to Hawaii or give you cash rewards. I have had this happen to me personally. I was taking Prilosec for some ulcers I had problems with. The drug was working wonderfully. When I moved back to Greensboro from NJ, I switched doctors and when my Prilosec ran out, had to go to the doctor to get checked for a new prescription. The doctor at Eagle Family Practice(Quaker Village) refused to give me a prescription for Prilosec and made me take Aciphex or nothing at all. The same doctor also made me go home with a severe hive outbreak, seeing if it would just pass. From my vast experience with this problem, I knew that would not be the case. I expressed that the only thing that has ever worked for my hive problem is a Epipen(epinephrine or adrenaline) shot and a shot of a common corticosteroid called Prednisone. He said no and sent me home. A few hours later, I had to go back and was finally given the shots that work. I was also billed for 2 level III office visits for this doctors incompetence. By the way, the Aciphex never worked. It actually made me sicker. I now see a different doctor.

Drug companies are forcing the FDA to push through drugs that are not thoroughly tested or ready to go to market. There is full coverage on this at Yahoo UK. Check out this interesting story:
http://uk.biz.yahoo.com/041229/323/f9dm0.html

In the article they say there "was testimony in November of a leading FDA drug reviewer, David Graham. Graham charged the agency repeatedly dismissed employees who questioned the safety of certain drugs on the market, particularly Vioxx."

The article also says, "The FDA says it supports a separate drug surveillance entity, whether it resides within or without the formal structure of the FDA.'This country does not have a system to monitor drugs after they're approved,' FDA's Woodcock said. 'Right now it's more of a passive system.' Few resources Woodcock notes the FDA has a small budget of around $5 million a year to monitor the performance of drugs. The Kaiser study that it ran to determine whether Vioxx posed cardiac risks was paid for under that budget, she said. A more powerful surveillance entity to monitor drugs and medical devices out on the market likely will cost taxpayers $150 million a year, says Woodcock. She cited numbers used recently in a bill on the matter sponsored by Sen. James Jeffords, I-Vermont."

Just yesterday there was a law suit filed against Johnson and Johnson by the parents of a 7 year old girl, who has come down with Stevens-Johnson Syndrome after taking the Motrin. She is now blind because Johnson and Johnson failed to warn of the possibility of the condition, something the company did include in the warnings before the drug went over the counter. This is the second lawsuit involving children's Motrin in two years.

All we as American citizens can ask for is safety in drug testing. We can try to rebuild the trust between drug companies and doctors and patients, but I feel it may be too far gone. I always read the small print on any info given to me, as well as, go to the internet and look up the drug companies website and drug info listed. Check out the side effects that these drugs can cause. A good resource for potentially harmful drugs is adrugrecall.com Weigh the risk and talk to other medical professionals if you feel you don't want to take those risks. We have to protect ourselves, because once again our government won't do it for us (which is their job at the FDA).

15 Million to Aide Tsunami Victims

The US government has initially stated they would give 15 million dollars to aide the victims of the tsunami/earthquake catastrophe according to a report from Reuters.

Some may say that I am not compassionate for what I am about to say, others may agree. I disagree with the aide we are sending to Asia for the aftermath of this tragedy. How can we come up with 15 million when we can not afford to put armor on the vehicles our soldiers are driving in to combat? How can we afford 15 million when we have people in our own country that are homeless and starving? How can we afford 15 million when these same countries in Asia did not extend a hand during our time of need(9/11)? Some will say that they are poor countries and could not help us and need our help. I say there are poor people here that are legal citizens that could sure use a hand. Instead they get the back of one from big brother. Oh, I almost forgot the fact that we have a 4 trillion dollar deficit. Where are we getting this 15 million? Where is the compassion for our own people?

Cool link of the day

Mark Glaser from the Online Journalism Review with a great piece on bloggers and the little people's rise to power in 2004. http://www.ojr.org/ojr/stories/041221Glaser/

The Local Blogisphere

There has been a lot of interesting (and I hope friendly) discussion going on over the past couple of weeks about the local blogisphere. I have not weighed in a lot to date. I will share with you all where I stand on this friendly debate.

I got into blogging a few months ago when I talked to my friend Ed Cone. I was looking for a new direction in life, having given up on a life long dream of playing music on the big stage for big money. I have played the big stage, no big money though. This blogging adventure is a creative outlet for me, as well as, an embarkment of my secondary dream. Even at a young age I made the papers in a debate about smoking and school rules. I appeared before the Paramus, NJ school board and aired my grievance. I was in two local papers the following day. AAH...The power of the media realized for the first time. I have always been outspoken and ideal based. What better tool to use to get my voice out then blogging.

I have never had any intention of blogging taking over the responsibility of paying my bills or affording vacations. If it was to ever happen that would be great, but it is probably not likely. If I could make a little money for what I write, I would feel monitarily appreciated. Where the real payoff is for me is the fact that you people out there in the blogisphere read my work, and comment, and debate, and interact. Someone's personal appreciation is what I strive for. It cost you nothing extra then the time you put into posting. It cost me nothing to set up a blog page on Blogger. It cost me nothing to do research on the net or to write my stories. It cost you nothing to read them and comment. I have not made a dime doing any of this. I have not spent one either.

There is some great talent on the local blog express. The people I read, and the people that read me are intelligent and well educated. I learn a lot from all of you and hope you learn from me. What The Shu has done at his site with a comprehensive blogroll is impressive. The local press coverage and trials of a family going through cancer is priceless at Dave Hoggards site. Roch Smith has started Greensboro101.com as a local news aggregator. Laughs are provided daily at Mr Sun's site, where he combines news and comedy in a way that makes my belly ache in a good way. The Greensboro News and Record has jumped aboard the blog express with many good blogs, as well as, plans to unleash more in the new year. I read a lot of local blogs. We are getting attention on the national level with Jay Rosen's piece on Greensboro and blogging. Local politics changed when Tara Sue Grubb blogged for office and Jeff Thigpen won the Register of Deeds job with the aid of his blog. There is so much talent here and all we need to do is find a way to pool it so it works for everyone.

I am calling for another Piedmont Bloggers Conference in the near future so we can all sit and talk with each other and bounce our ideas around. I think every idea I have heard so far is great, they may all work or they may not. Our job as the local blogging community is to figure this out in a civil way and remain united with each other for the greater good of all of us. I feel this whole community has come a long way since the first conference and I am personally proud to know all of you. Lets get the one thing we all have in common with each other together..... our intelligence and come up with something that will blow away the rest of the blogisphere, maybe change blogging as we know it. If there is a group of people who can do this, it is the Guilford County North Carolina Blogging Community.

I will now take Ed Cone's advice from his column last Sunday and wish you all a Happy Holiday. May you all be healthy and happy. (I am not religious so a Happy Holiday back would be more then enough.)

I Feel Like I Lost A Friend

On December 8th, 2004, I feel like I lost a friend. In Columbus, Ohio, "Dimebag" Darrell Abbott, guitarist for Damageplan, was shot and killed at point blank range during the first song of his bands performance. "Dimebag" was a founding member of the superstar rock band "Pantera". He was 38 years old. According to various reports, disgruntled fan Nathan Gale ran up on stage yelling something about breaking up Pantera and then unloaded two clips of ammo. Five shots at point blank range hit "Dimebag", and he was killed. Also killed were a club employee, a fan, and one of the bands bodyguards. Gale was shot and killed by a police officer.

This turn of events is shocking. What has this world come to? I am especially hurt by this occurrence, because of the fact that I devoted 24 years of my life to playing music in clubs much like the one Damageplan played on December 8th. Some people are going to blame the music, saying stuff like, "Because of the violent nature of the music, this is not surprising". I will give everyone an inside tip on the world of metal/hard rock music. This is a very tight knit community. There is little in the way of violent acts encouraged by this music. Some people point to a style of dance called a mosh pit and say that it is a display of violence, but really it is a controlled way to vent anger and aggression with people who feel the same way that you do. There are unwritten rules for being in the pit. If someone falls, you pick them up. There is no punching or kicking people in a way that will hurt anyone. Yes, sometimes accidents happen, but really no more then if you were snowboarding or doing stunts on bicycles or skateboards. The metal community is a force that bands together to fight the system and offer a family of others when your family fails you. I will go so far as saying that, the metal community is a positive community of people looking for an escape, other then anti-depressants, from the negative things that go on around us on a daily basis. It has always been said that force in numbers will be heard, and this community of music lovers is the crux of that force. A lot of people disagree with the content of the music created. It is a group of dark subjects, but no darker then if you watch the evening news or read the daily paper.

"Dimebag" Darrell was an innovator on his instrument. He redefined a style of music and expanded on it. His music was very dissident and aggressive, but it was heartfelt. That is the overwhelming consensus on "Dimebag", he had a big heart. He gave every ounce of energy on stage. He played for the fans. I know, without a doubt, he would have played for free. He loved the music and his fans that much. "Dimebag" was looked up to by other musicians for his talent, as well as the guitar playing community. He won numerous awards for guitar player of the year.

I feel like I lost a friend, even though I never met Darrell Abbott. His music touched me. In times of anger or frustration, I turned to his music to escape and then release what was inside of me. Many times when I was down and out, "Dimebag" picked me up with his melodious chords and ripping solos. He will be missed but not forgotten. I watched a special tribute to "Dimebag" on Fuse TV the other night and I welled up with emotion.

Darrell's brother, Vinnie Paul, plays drums for Damageplan, as well as Pantera. I can not imagine what he is going through as he got to witness the assassination of his brother on the very stage that they were playing on. I know from experience, if you spend a lot of time with a fellow band member, you get very close. I can only imagine it is a hundred times worse if that band member is a member of your blood family. I really feel for Vinnie and wish him a speedy recovery in dealing with this tragedy.

This unfortunate event is going to spark debate on venue security. A lot of the clubs I played didn't have metal detectors. The only one, in fact, that had metal detectors was The House of Blues in Myrtle Beach, SC. Local clubs here, that have national touring acts, do not have any detectors. Ziggy's(Winston-Salem, NC), Tremont Music Hall(Charlotte, NC), and many more have large acts come play and you rarely, if ever, get so much as patted down by security. I think this will change in the near future. I also think the fans will welcome new security measures. They, of course, are for their own protection anyway.

Nathan Gale was killed by police officer that night to stop his rampage. I could only hope that he suffered, for what he did was tragic and as horrid as you get. December 8th was the 24th anniversary of John Lennon's tragic assassination in NYC. There is no motive for the shooting as of yet, but I do think he carefully planned this out. I was no coincidence that it occurred on Lennons anniversary.

The following statement was issued today by Vinnie Paul Abbott:

"With all his greatness and accomplishments on the guitar, Dime will be missed more for his giving personality, charisma, caring for others, love and most of all his HEART!! Twice as big as the state of TEXAS!!!!!!!!!!!! Dime gave it all every day to each and every one of us and our lives have forever been hollowed without him...Thanks to all of you for reaching out to us in this time of our immeasurable loss. REST IN PEACE BROTHER DIME!!!!!!"

"Dimebag", your fans love you and will always. Your music was innovative, touching and loved. You offered and incredible amount of your life to music and it's fans. I thank you for what you gave me and others. You will be missed dearly. Rest in Peace.

Steroids and hemorrhoids

The Balco grand jury leak , this week, is the beginning of the end for America's past time.

Baseball, by far, is my favorite sport to watch and follow. I grew up in the NYC area, hence my undying allegiance to the New York Yankees. I have watched the Yankees through thick and thin, for 26 years. At five years old, I witnessed the Bucky Dent home run at Fenway. I lived through the 1980's teams that were, well horrible. I got the 90's run with Joe Torre at the helm. Diehard is an understatement for my allegiance. Just check out the inside of my right forearm next time you see me. It is tattooed with the interlocking NY and blue pinstripes.

This week, the Balco grand jury hearings were broke publicly by the San Francisco Chronicle. The first bombshell, Jason Giambi. The New York Yankee slugger, or lack of slugging Yankees first baseman, had his testimony brought public. In the testimony, Giambi admitted to using steroids that he received from Barry Bond's personal trainer. Steroids, Bond's trainer got from a company called Balco. He went into detail about what steroids he used and how he used them. Up until now, Giambi has denied the use of steroids adimitly. Last season, he was noticeably underweight and his body frame was much smaller. Giambi said, "I was only 4 pounds lighter going into camp. I just concentrated on my diet and got leaner so I could play first base every day." Giambi came down with a rare, and might I add, weird parasite this past season. He also was diagnosed with a tumor on his pituitary gland that he was mum about all season. Can you link steroids and his health problems? I would ask a medical professional, but if I had to have an educated guess, I would say yes. The health ridden, smaller, Giambi only appeared in 80 games for the Yankees this past season, batting a mere .208. This for a guy who usually hits 40 to 50 homers a season and bats around .300.

Barry Bonds has come out and said he didn't know the "clear" and the "cream", as they are being referred to, were steroids. The "clear" is a liquid, put under the tongue, and has been identified as the designer steroid THG. Balco VP, James Valente has been quoted as saying, "Bonds didn't like how the clear made him feel." The "cream" is a testosterone based balm applied to the body. Both the "clear" and the "cream" are undetectable in drug test's performed by Major League Baseball.

The New York Yankees are now discussing the termination of Jason Giambi's contract.

Baseball fans have endured a lot. Pete Rose was banned from baseball, and the strike year. Baseball had finally recovered fully from the strike, and fans and TV ratings were on the upward again. Now, steroids will unravel all that work. As a fan, it makes you feel cheated. Did McGwire really hit all those home runs naturally? Did Bonds break McGwire's home run record with sheer talent? Who else is marring the game with illegal steroids? Can the owners get past the union agreement on drug testing to punish these players. One ESPN.com analyst said, "Under the current agreement, Giambi could have gone to the center of Yankee stadium and shot up steroids in front of a sellout crowd, and faced no repercussions." Giambi was signed to a 120 million dollar contract, of which 82 million remains. Should the Yankees have to pay him? What if Giambi, off steroids, is a .208 hitter like last season?

Bud Selig, MLB's Commissioner, has his hands full. I am guessing this will be a wait and see game on the issue of steroids. I can only hope that MLB weeds out the offenders and we can get back to playing baseball. I tend to believe that the Players Union will have some heavy input on the issue, defending the players involved.

I am the kind of fan who watch's all 162 games the Yankees play. I endure the games naturally, and all I get out of it, is the enjoyment of my beloved Yankees winning a game. They do steroids, we get hemorrhoids. They make millions and we fans pay that millions. We want our moneys worth. Get this game back to an even playing field. Why do millionaire baseball players feel the need to cheat? Padding your stats, and achieving stardom should be done through hard work and natural talent. When you cheat, by taking performance enhancing steroids, the only people getting cheated are the fans who pay your salary. You should be ashamed of yourselves. If I was in your shoes, for the integrity of the game, I would retire. Save the league the embarrassment of this steroid scandal and restore the past time of this country to it's natural state. It is not like you haven't made enough money for your lifetime already. So, step down and save Bud Selig and MLB the trouble of having to win back the fans again. From the fans point of view, this is getting old. I wonder what all the past greats are thinking at that diamond in the sky, where they are playing baseball and showing off their natural talents? I am sure they are rosey cheeked and greatly ired with this situation.