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Virgil---They know that. They just want to confuse things
for people. They try to keep all of us off balance. They
know what they say is not the truth. Just let them ramble
on. If a new person comes in here and does not figure out
what the tow of them are up to---well they will just have to learn. I think the whole FUD thing is run by just 3 or 4 people. They drag in bit platers from time to time. Some of the bit players know to much. Somebody is putting words in
their mouths. Hey JMHO
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Goober---only one person has ever called me that.
You boys running this board see this. I would like to see this person removed. We all know who it is.
By Daniel DeNoon
WebMD Medical News Reviewed By Brunilda Nazario, MD
on Monday, December 05, 2005
More From WebMD How Safe is Your Pain Medication?
New Pain Pills: Not Easier to Stomach?
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Those 12 Drugs
The Consumer Reports article lists 12 drugs as examples of safety-system failures.
"These drugs are just examples," Lipman says. "There are bound to be others. Even a perfect safety system could never detect every problem of every drug."
The drugs are:
Celebrex
Estrogen, either alone (Premarin and others) or with progestin (Prempro and others)
Accutane
Ovide
Depo-Provera
Lariam
Crestor
Serevent
Meridia
SSRI antidepressants and other antidepressants
Zelnorm
Topical immunosuppressants such as Elidel and Protopic
Do not stop taking these drugs if you're using them, Consumer Reports warns. The drugs are helpful for people for whom the benefits outweigh the risks.
"These are important drugs. They are very useful drugs," Lipman says. "But in many cases they are not the only drug for the condition. And the patient should know that by taking one of these drugs there is a certain inherent risk, and the patient should be aware of this risk."
Lipman advises patients using these drugs to talk with their doctors about whether there is another drug that can be used with less risk. And all patients taking any drug should be aware of possible side effects and should tell their doctors about any ill effects -- even those not listed on the label.
--------------------------------------------------------------------------------
SOURCES: Consumer Reports, January 2006; pp 34-39. WebMD Feature: "How Safe Are America's Medicines?" FDA web site. IOM web site. PhRMA web site. Marvin M. Lipman, MD, chief medical advisor, Consumers Union; emeritus professor of medicine, New York Medical College, Valhalla. Jeff Trewhitt, spokesman, Pharmaceutical Research and Manufacturers of America (PhRMA). Laurence B. Gardner, MD, vice dean, medical school, and chairman, department of medicine, University of Miami Miller School of Medicine.
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Independent Drug Safety Board Needed?
Currently, the FDA's drug-safety office is one of 12 subgroups reporting to the director of the FDA's Center for Drug Evaluation. It's been lacking a permanent chief for some time.
Lipman says there should be a drug safety office -- with regulatory teeth -- outside the FDA.
"What is really needed, in our opinion, is an independent office of drug safety: nonbiased safety experts not part of either the pharmaceutical industry or the FDA," he says. "The same people can't be responsible for drug approval and drug safety. It just makes it that much harder for a drug to be withdrawn by the people who approved it."
Gardner isn't so sure. He thinks that a drug safety office would be no better than the expert advisory panels that currently advise the FDA. Instead of a new layer of bureaucracy, he would like to see more power given to these panels of experts.
PhRMA's Trewhitt doesn't see the need for any of this. "Simply put, the FDA still has the world's best drug safety record," he says.
Institute of Medicine to the Rescue
Lipman, Gardner, and Trewhitt all praise one thing about the FDA. The agency already has asked for help. Last year, it turned to the independent Institute of Medicine (IOM) for advice. An IOM committee has since been holding hearings. Its recommendations are expected in July 2006.
"The FDA has asked the IOM to thoroughly investigate the drug safety system," Trewhitt says. "It would behoove us to wait to see the results."
Lipman says it's already time for Congress to act.
"We are getting to where this is a problem for our government," he says. "There have to be some bills written that would address some of these problems and that would create a better workforce for the FDA, and that would give them more monetary resources so they don't have to rely on pharmaceutical company fees to process new drugs. Basically the buck passes back to our Congress."
Gardner says the problem goes far beyond the FDA. The real issue, he says, is health care in America.
"Our health care system is in real trouble," Gardner says. "This is an example of a real problem where we don't have the politics yet to create a solution."
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Holes in U.S. Drug Safety Net (continued)
1 | 2 | 3 | 4 | 5
By Daniel DeNoon
WebMD Medical News Reviewed By Brunilda Nazario, MD
on Monday, December 05, 2005
More From WebMD How Safe is Your Pain Medication?
New Pain Pills: Not Easier to Stomach?
Get the Latest Health News Delivered to Your Inbox
After Drug Approval: Patient Beware
When the FDA approves a drug, it sometimes asks the manufacturer to conduct further safety studies. Consumer Reports notes that in February 2005, companies agreed to 1,191 such studies. Yet as of September 2005, more than two-thirds of the studies were still "pending."
The most important drug-safety experiment comes in the years following drug approval. The subjects of this study: consumers who take the drug.
Preapproval studies enroll no more than a few thousand people -- usually healthier people than many of those who will take the drug after approval. And the studies usually last only a few months. Rare side effects, problems for people with multiple conditions taking multiple other drugs, and long-term side effects can only be seen in the years following approval.
And that, Lipman says, is where the U.S. system breaks down. Doctors are supposed to report any side effects that happen. But because there is no reliable system -- and, Gardner says, because these reports aren't easy to file -- only a small fraction of side effects actually get reported.
Compounding this problem, Lipman says, is direct-to-consumer advertising. Ads heavily promote new drugs. Yet there's a drug risk associated with every drug benefit. And the Consumer Reports article states the ads stress benefits but don't adequately identify risks.
"It is impossible to monitor all the ads that are out there," Lipman says. "And more ludicrous, the ad goes into the media, and it takes FDA
three to six months to catch up with the ad. By that time, the damage is done. You need an approval system before, not after the ads hit the media. They should submit copy for vetting by the FDA, and the FDA needs resources for this. They don't have the personnel or the money."
The Consumer Reports article notes that PhRMA in August 2005 announced guiding principles for direct-to-consumer ads, including a wait before advertising new drugs. As of November, the article reports, most of PhRMA's 33 members had signed on.
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By Daniel DeNoon
WebMD Medical News Reviewed By Brunilda Nazario, MD
on Monday, December 05, 2005
More From WebMD How Safe is Your Pain Medication?
New Pain Pills: Not Easier to Stomach?
Get the Latest Health News Delivered to Your Inbox
Drug Industry Reaction
Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA), says PDUFA fees improve drug safety.
"PDUFA has raised hundreds of millions of dollars for FDA in a time when Congress has approved only stagnant funding, even though regulators' duties have expanded dramatically," Trewhitt tells WebMD. "PDUFA money is also being used to increase staffing in the Office of Drug Safety at FDA. It's recently allowed FDA to double the number of safety officers from 100 to 206 officers."
And Trewhitt notes that fewer than 3% of drugs are withdrawn from the market due to safety concerns -- a rate that hasn't changed since PDUFA took effect.
Laurence B. Gardner, MD, chairman of the department of medicine at the University of Miami Miller School of Medicine, agrees with most of the points made by the Consumer Reports article. But he says the FDA's preapproval process isn't the problem.
"Consumer Reports implies that people at the FDA rush approvals through and don't look at safety data," Gardner tells WebMD. "But we are still the safest country in the world when it comes to drug approval. That being said, there are a lot of issues with our health care system. And current regulations don't protect the consumer."
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By Daniel DeNoon
WebMD Medical News Reviewed By Brunilda Nazario, MD
on Monday, December 05, 2005
More From WebMD How Safe is Your Pain Medication?
New Pain Pills: Not Easier to Stomach?
Get the Latest Health News Delivered to Your Inbox
Those 12 Drugs
The Consumer Reports article lists 12 drugs as examples of safety-system failures.
"These drugs are just examples," Lipman says. "There are bound to be others. Even a perfect safety system could never detect every problem of every drug."
The drugs are:
Celebrex
Estrogen, either alone (Premarin and others) or with progestin (Prempro and others)
Accutane
Ovide
Depo-Provera
Lariam
Crestor
Serevent
Meridia
SSRI antidepressants and other antidepressants
Zelnorm
Topical immunosuppressants such as Elidel and Protopic
Do not stop taking these drugs if you're using them, Consumer Reports warns. The drugs are helpful for people for whom the benefits outweigh the risks.
"These are important drugs. They are very useful drugs," Lipman says. "But in many cases they are not the only drug for the condition. And the patient should know that by taking one of these drugs there is a certain inherent risk, and the patient should be aware of this risk."
Lipman advises patients using these drugs to talk with their doctors about whether there is another drug that can be used with less risk. And all patients taking any drug should be aware of possible side effects and should tell their doctors about any ill effects -- even those not listed on the label.
--------------------------------------------------------------------------------
SOURCES: Consumer Reports, January 2006; pp 34-39. WebMD Feature: "How Safe Are America's Medicines?" FDA web site. IOM web site. PhRMA web site. Marvin M. Lipman, MD, chief medical advisor, Consumers Union; emeritus professor of medicine, New York Medical College, Valhalla. Jeff Trewhitt, spokesman, Pharmaceutical Research and Manufacturers of America (PhRMA). Laurence B. Gardner, MD, vice dean, medical school, and chairman, department of medicine, University of Miami Miller School of Medicine.
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See if you all can get in here. If not I will start posting
parts of the story.
http://aolsvc.health.webmd.aol.com/content/Article/115/112007.htm?pagenumber=5
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hope---somebody a lot smarter than you is feeding you
a lot of information---bet I know who it is
stock---speak for yourself.I am not irked
Well now we have this to look forward to.
http://www.marketwire.com/mw/release_html_b1?release_id=103298
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hope---you dont have a clue do you? They dont have to meet with
the FDA to provide Ovanome as a service for people doing research. I have explained this to you before. Guess you are
just a little slow on the uptake---or have a motive to be here
that does not agree with mine.
Gun---Me and you both. I dont know for sure but I dont think
it would cost that much to do. We will just have to wait and
see.
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Then come Wednesday we have this going down. Could be an interesting week.
http://www.marketwire.com/mw/release_html_b1?release_id=103298
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Tomorrow could be interesting.
http://www.marketwire.com/mw/release_html_b1?release_id=103380
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Geo---Like I said I think DNAG is just starting to roll.
With Moffitt all of the work Doc T has done will become
practice. I think we are in better shape than we have ever been. Let all the nay sayers say what they want---the party
is just about to begin. IMHO
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Every body is looking for biomarkers
http://www.medicalnewstoday.com/medicalnews.php?newsid=33626&nfid=rssfeeds
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Then read this from the first of the month---its starting to roll.
News
Total Cancer Care at Moffitt
by Haya Radwan
December 01, 2005
H. Lee Moffitt Cancer Center and Research Institute’s new Total Cancer Care program foresees a new approach on treating cancer patients throughout the state of Florida. The new program plans on helping doctors make better decisions on cancer treatment.
“TCC is a very holistic approach to cancer care delivery that puts the emphasis on the patient, not just the disease. Primarily, it is a system designed to translate new scientific discoveries into clinical benefit and integrate new approaches into the standard of care in such a way as to create evidence for the value of new approaches, and ultimately learn how to properly use newly discovered therapies for cancer care,” said William Dalton, chief executive officer and center director for Moffitt.
The primary component of TCC is the process of gaining molecular signatures from patients to put into the database. With the permission of patients, doctors obtain molecular fingerprints during a clinical trial by extracting RNA to put into a gene ship, creating a molecular fingerprint, said Timothy Yeatman, associate director for translational research and TCC director. A gene ship, he added, is an array that measures thirty thousand genes in an experiment.
“By using these molecular fingerprints and by creating this large central database, we hope to be able to personalize medicine,” Yeatman said.
Typically, when doctors put patients on treatments, it is unsure if the patients will respond to the particular method or drug given to them. By storing data on a large amount of patients and keeping records of which treatment worked on which disease, doctors will be able to research treatments using the TCC database. This will assist doctors in deciding which treatment is appropriate for a disease.
“This, we think, will begin to raise the standard of care across Florida, because if we have new findings based on new evidence, then we will communicate those findings,” said Jan Marshburn, administrative director of TCC.
The second component of TCC is improving and increasing clinical trials. Around 15 percent of Moffitt’s cancer patients participate in clinical trials. The primary reason is because clinical trials are not accessible at all hospitals, and patients have to travel to Moffitt to participate.
“We believe if we can offer that treatmant through our affiliate partners, the patient will more likely consider going on a clinical trial, they can stay home and do it,” Yeatman said. “Clinical trials are the cornerstone of modern cancer care; that’s the way we make our advances.”
Through TCC, Moffitt wants to increase the levels of people taking part in clinical trials and encourage them to participate in trying new drugs and therapies. This will allow doctors to take more blood samples and examine proteins and DNA to record into the database, making it more comprehensive.
TCC is also aiming to homogenize the treatment of cancer patients by doctors, said Yeatman.
Many doctors treat patients differently, even if they have the same disease. Through TCC, Moffitt hopes to have a system where Moffitt and its affiliates use the same treatment for the same disease.
Moffitt plans to enhance clinical trials with technology and touch-screen approaches.
“It’s all about trying to deliver state-of-the-art cancer care and technology to patients throughout the state of Florida, using the community physicians and the community hospitals,” Yeatman said. Moffitt is affiliated with 16 other hospitals in the state of Florida. They will be expanding TCC so their affiliates can participate.
“The concept of Total Cancer Care is that cancer patients can get their treatment in their community with their affiliated physician,” Marshburn said.
Geo---Then read this PR
Published - December, 6, 2005
Area gets new ally in fight against cancer
Baptist Health Care teams up with Tampa's Moffitt Cancer Center
Fredie Carmichael
@PensacolaNewsJournal.com
Baptist Health Care has joined with the H. Lee Moffitt Cancer Center & Research Institute of Tampa in a partnership that is expected to bolster the fight against cancer in the Pensacola Bay Area.
Dr. William S. Dalton, Moffitt's chief executive officer, described the center's affiliation Monday during a luncheon at New World Landing for local doctors and health-care professionals.
"We believe this partnership will help us gain what we need to defeat this disease," Dalton said.
The Florida Legislature established Moffitt 20 years ago to help prevent and cure cancer, which kills 40,000 Floridians each year.
Moffitt is the only cancer center in the state accredited by the National Cancer Institute. It's also among the 19 centers that comprise the National Comprehensive Cancer Network, which touts itself as an authoritative source of information on cancer care.
Moffitt is affiliated with 16 hospitals statewide. The Baptist affiliation is the first locally.
Dr. Allen Patton, an oncologist who has practiced in Pensacola since 1977, said the affiliation will make a wider range of treatment options available to local patients.
"The biggest thing this will do is provide patients here more access to some of the protocols and experimental treatments," Patton said. "The goal is making available in the communities these newer technologies in cancer treatment."
Dr. Jack Lurton, a Pensacola ears, nose and throat specialist, said most surgeries and treatments will continue to be handled in Pensacola, although some patients will have to travel to Tampa. In any case, he said, the latest medications will be available to all patients.
Because of Moffitt's National Cancer Institute designation, it has access to research protocols that aren't generally available, Lurton said.
"The government won't give those drugs to just anybody,'' he said. "Now that we're affiliated with Moffitt, we can have access to those drugs. That's why this is such an important and unique relationship."
Dalton said the Baptist-Moffitt partnership will lead to tailored care locally.
For example, Dalton said, a recently diagnosed cancer patient's tumor could be sent to Tampa after surgery in Pensacola. In Tampa, researchers would conduct a molecular study of the tumor and begin a database on the patient through coordination with the patient's doctors in Pensacola.
Dalton said he's excited about new treatment advances through molecular medicine, which can be tailored to the individual patient.
"Following the patients will allow us to better understand the uniqueness of every individual patient and the disease," he said. "I've never been this excited. And we'll be able to do this all in Pensacola. The last thing a patient needs is to have to leave their family."
Pensacolians Carolyn and Donald Beane were happy to learn of the partnership.
The Beanes have been cancer-free for 10 years. But the couple lost their daughter, Suzi, to cancer in 1994.
That was the year all three were diagnosed: Carolyn with breast cancer, Donald with prostate cancer and Suzi with cervical cancer.
The Beanes know the importance of cancer research as well as cancer treatment.
"This gives us hope and faith that more can and will be done," said Carolyn Beane, 75. "When you've had cancer, you always fear it will come back. You also want to make sure your children and grandchildren have the best care if they get it. This gives me promise for the future."
Bob Murphy, senior vice president and administrator of Baptist Hospital, said Baptist Health Care and its physicians aim to "eliminate cancer from the vocabulary."
"Our message is one of hope," Murphy said. "I like (Moffitt's) slogan, 'The end of cancer begins here.' I believe the end of cancer here begins today."
Geo---I think we are on a roll. When I first bought into
DNAP I knew it was going to be a rough row to hoe. I have bought a lot more after the R/S than I had before. We were just
way to far out in front of the curve. The world is now catching
up to us but we have a lot going with moffitt. IMHO it is going to be hard to catch us. As Doc T said eye color was done
to prove we had the goods. We have done that. The rest is gravy. Hey JMHO
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I like this.
http://www.commondreams.org/news2005/1207-21.htm
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Virgill---I agree with your take on this. It was said long ago
that they could provide the service with or without FDA
approval if it was for research. They could not SELL the service without approval from FDA. I took the word sell to mean
they could not sell it to another company and let them do the
testing. Thats why I have said they did not need FDA aproval for them to start making money off it. Hey JMHO
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Read this with a lot of care.
http://www.pensacolanewsjournal.com/apps/pbcs.dll/article?AID=/20051206/NEWS01/512060322/1006
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550K buy at .0217
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You know what I grow tired of this game. I am a country boy.
Somebody spits in my face I will do what ever I need to. I mean
hurt them big time. I bought in here a long time a go. Now frog
and others say I am doomed. I dont think so. I still like what
I bought into. DNAG might still help me with problems I have had with some drugs I have been given. I know there are people here
who play DNAG just for money. They dont understand where I am
coming from. Bad reactions to drugs are not fun. I would like to make some money here but I am here because I hope they can help
me. So all of you who play here that think this is just a game---
well play on. For me there is a much deeper reason I bought this stock. The lies told here will not scare me off. I want drugs that help me not hurt me.
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Well there is not much else to talk about.
http://www.the-scientist.com/2005/12/5/18/1
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A must read.
http://pubs.acs.org/cen/coverstory/83/8349pharmareview.html
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Dmceng---Try this.
http://ragingbull.lycos.com/mboard/viewclub.cgi?board=CLB01189
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Read this again folks. Its all about the work DNAG is doing there.
http://www.usforacle.com/vnews/display.v/ART/2005/12/01/438ef141c5350
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66---ROTFLMAO
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Virgil---It is even tougher these days. You have the religious
right all fired up to kill anything having to do with DNA.
Its is tough enough to work on new ideas but when the political
people in the country try to use good peoples religion to slow
things down you create REAL problems. Like the old saying goes
dont talk about religion or politics. Now we have people trying
to mix them to get their way. Scares the HELL out of me.
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Geo---anytime you are working in a new area you have to watch to see if the public understands what you are doing.
ANY story like this in the main stream media is good for us.
JMHO
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Looks like it is going main stream.
http://msnbc.msn.com/id/10313002/site/newsweek/
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I mean you got to love this. Check out the folks that
work here. They must see some advantage to joining DNAG.
We are putting together one heck of a team.
http://tampabay.bizjournals.com/tampabay/stories/2005/11/14/daily18.html
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If you want to see what the boss has to say check out this.
http://www.marketwire.com/mw/release_html_b1?release_id=101554
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I sure hope this one goes well. I think we will do well.
http://www.pharmalive.com/News/index.cfm?articleid=294629&categoryid=63
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I still like this. Bio is working in this area just like us.
Trace is covering the cop side of things. We got that little grant to do some work for the government on this stuff. Looks like a plan to me.
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/11-08-2005/0004210483&...
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We should get something out of this by Monday.
http://www.marketwire.com/mw/release_html_b1?release_id=100172
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W2P---The interesting thing about the last few weeks is that
we have picked up a bunch of good people. Now the idiots keep
saying that we got them cheap because they are not worth anything. There is another side of that coin. They have been
shown a business plan that they buy into big time. Well that
is what I think. Hey JMHO Always nice to see you post.
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