Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
You didn't "make" me cranky - you'll get the same response from me on any stock at any time. I'm the guy who doesn't care wether you make money or lose money in the market. I'm not an apologist for the company either. Need a shoulder to cry on? Hire a nanny.
DNAPrint to Phase Out ANCESTRYbyDNA(TM) 2.0 in Favor of More Advanced Technology
THURSDAY, APRIL 29, 2004 11:32 AM
- PR Newswire
SARASOTA, Fla., Apr 29, 2004 /PRNewswire-FirstCall via COMTEX/ -- DNAPrint genomics (DNAP) of Sarasota, FL (the "Company") announced today that it is discontinuing its ANCESTRYbyDNA(TM) 2.0 (ABD 2.0) testing service commencing June 1, 2004.
The move allows the Company to focus its consumer genomics service resources on its technologically superior ANCESTRYbyDNA(TM) 2.5.
Until the close out date of June 1, 2004, the Company will be offering the ANCESTRYbyDNA 2.0 test for $99. This test will no longer be available through any of the Company's distributors and for a limited time, starting May 1, 2004 can only be ordered directly from the Company at the $99 price. The test is used to help determine a person's genetic heritage such as sub Saharan African, East Asian, Native American and Indo European. Genealogy studies linked to genetic ancestry helps individuals connect to their origins. It is the only test of its kind available to the public.
About DNAPrint genomics, Inc.
DNAPrint genomics, Inc. uses proprietary human genome research methods to develop genomic-based services and products. The Company introduced ANCESTRYbyDNA(TM) in the consumer market and DNA Witness(TM) in the forensic market in 2003. DNAPrint(TM) is developing products in the pharmacogenomic market and has a disease gene discovery program. The Company is traded on the NASDAQ OTC Bulletin Board under the ticker symbol: DNAP. For more information about the company, please visit www.dnaprint.com. ANCESTRYbyDNA(TM) 2.0 or 2.5 can be ordered by linking to www.ancestrybydna.com
All statements in this press release that are not historical are forward- looking statements within the meaning of Section 21E of the Securities Exchange Act as amended. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including, but not limited to, uncertainties relating to technologies, product development, manufacturing, market acceptance, cost and pricing of DNAPrint's products, dependence on collaborations and partners, regulatory approvals, competition, intellectual property of others, and patent protection and litigation. DNAPrint genomics, Inc. expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DNAPrint's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based.
Media and Press Contacts
Richard Gabriel
DNAPrint genomics, Inc.
CEO/President
(941) 366-3400
OT: Old people, golf courses. Typical retirement community. eom.
maybe so. The measurement of "Caribbean" admixture is based on their core science so that's not new (NA, EA, IE, AF). But perhaps they way they are able to categorize admixture has become more refined. Or maybe they're referring to something else.
I put his name in parenthesis because the article is from the sleepy little town of Stuart - a place that we are both familiar with. <g>
In the future don't address those kinds of posts to me. You place your trades according to what you see, not what you'd like to see.
(bag8ger) - from the Stuart News editorials.
http://www.tcpalm.com/tcp/the_news_editorials/article/0,1651,TCP_1033_2841308,00.html
Help lobby today
$5 million for Moffitt Center will benefit local cancer patients
April 28, 2004
Treasure Coast residents — in particular, Martin Memorial Medical Center cancer patients — will be the beneficiary of a unique program being launched by the H. Lee Moffitt Cancer Center and Research Institute, if all goes as planned.
The center, located at the University of South Florida in Tampa, is creating a massive cancer and genetic data base aimed at providing care for every cancer patient in Florida, something that heretofore hasn't been available. But it needs help from the state of Florida, $5 million to be exact, which appropriately could come from the $365 million the state is receiving this year from its tobacco suit settlement.
Research has indicated that cancer acts differently in almost every patient, and that each case responds to a different set of treatment regimens and medications. Study at the Moffitt Center has revealed that the varying reactions are in part based on the combination of genes in a patient. By studying a patient's 32,000 genes, scientists at Moffitt can predict which treatments would be the most effective. The procedure is expensive, not covered by most insurance plans, and thus usually available to only the very wealthy. Moffitt scientists want to change that by creating the data base made available to all physicians.
Total cost of the project is about $25 million. Moffitt will provide $10 million, hopes to get $5 million from the state, and raise the remainder from private sources.
Currently Moffitt has 11 affiliates in Central and South Florida, including Martin Memorial Medical and its cancer clinic. If the Moffitt plan is accomplished, local patients will not have to travel outside the area to receive advanced care, including the now-expensive gene comparison studies, and that will increase the survivability rate of cancer patients.
But there is a problem. In Tallahassee the House and Senate are entering the madhouse period that always occurs at the end of the legislative session. During this time laws are passed or lost in a blur. There is a chance the appropriation for Moffitt, contained in Senate Bill 1116 and House Bill 0497, may be lost in the shuffle or cut in some conference room deals. Voters should let their legislators know today — we're nearly out of time — that passage of the funding program is essential.
Access to proper high-tech medical care is often the key to the recovery of a patient, and as our technology improves, the cost of that access rises, making it less available to the general public. The Moffitt plan seems aimed at opening the door of the best level of care to all patients at a reasonable cost, and Floridians should demand its speedy adoption this week in Tallahassee.
Here's how to contact the pertinent members of legislative delegation. Clip and save:
• Rep. Richard Machek, D-Delray Beach (Dist. 78; parts of Martin, St. Lucie counties) —— 1301 Capitol, 402 S. Monroe St., Tallahassee 32399, phone 850-488-5588; fax 561-279-1634. E-mail: machek.richard@myfloridahouse.com
• Rep. Gayle Harrell, R-Port St. Lucie (Dist. 81; parts of Martin, St. Lucie counties) —— 214 House Office Building, 402 S. Monroe St., Tallahassee 32399, phone 850-488-8749; fax 772-873-6502. E-mail: harrell.gayle@myfloridahouse.com
• Rep. Joe Negron, R-Stuart (Dist. 82; parts of Martin, Palm Beach counties) —— 221 Capitol, 402 S. Monroe St., Tallahassee 32399, phone 850-488-8832; fax 772-221-4906. E-mail: negron.joe@myfloridahouse.com
• Sen. Ken Pruitt, R-Port St. Lucie (District 27, includes parts of Martin, St. Lucie, and Palm Beach counties) — 214 Senate Office Bldg., 404 South Monroe St., Tallahassee 32399-1100, phone 850-487-5088; fax 772-344-4102. E-mail: pruitt.ken.web@flsenate.gov.
Would be nice to know what this part of the PR means:
Ongoing research at DNAPrint(TM) has resulted in a substantial enhancement of the power of DNAWitness(TM) as an investigative tool.
I suppose if it's something that sells more tests we'll get a PR or read about it in the filing.
Bill, man. You always get there first. lol.
Here's yet another article. Some slightly different info.
Net closes on serial rapist
By Rebecca Mowling, Evening Standard Crime Reporter
27 April 2004
http://www.thisislondon.co.uk/news/articles/10451417?source=Evening%20Standard
A ground breaking DNA technique has given police a breakthrough in the hunt for a serial sex attacker who they have been hunting for more than 12 years.
The man is linked to a string of 200 crimes, including more than 30 rapes or assaults on vulnerable elderly women in London and the South-East.
Now a new procedure known as "familial testing" has given detectives their biggest lead in tracing the attacker.
Using DNA recovered from the scene of the assaults, officers have narrowed down his ethnic origin - and believe they are close to finding where he was born.
Detectives say the attacker is a black man originally from the West Indies.
Detective Superintendent Simon Morgan, who is leading the investigation known as Operation Minstead, said: "After 12 years we feel this is a major breakthrough and are confident that the new DNA results should lead us to the suspect or even his relatives.
"We have travelled all over the world comparing DNA samples and databases without success but we believe that the scientific advancements will allow us to discover exactly which island in the West Indies the suspect's ancestors are from and even what town."
He added: " Every offence involves a burglary. His modus operandi is very particular. He targets elderly woman and breaks into their homes late at night and we have had reports of him stalking his potential victims to make sure they are alone."
The assailant has struck in towns across south-east London and Home Counties areas such as Croydon, Warlingham, Forest Hill, East Dulwich and Sidcup since 1992.
He targets the elderly women's homes, usually enters properties through rear windows during the night, wearing a balaclava, and spends time with them before attacking them.
Scotland Yard today revealed he is suspected of 31 rapes or assaults and another 170 robberies or break-ins.
Since 1992 he has assaulted women aged between 68 and 93. His most violent attack was in August 1999 when he raped an 88-year-old woman twice.
The familial testing technique has already enabled police to secure the conviction of a man who killed a lorry driver when he threw a brick through his windscreen.
Surrey Police tracked down Craig Harman after tracing him through a close relative with a criminal record.
It has also been used in the investigation into the murder of the boy known as Adam whose torso was found in the Thames. Using bone samples, scientists were able to pinpoint Adam's home country as Nigeria.
Detective Supt Morgan said the attacker was unusual because he liked to spend several hours talking with his victims and enjoys the contacts with elderly women.
In nearly every case, the attacker usually uses a tool from a nearby shed to break in through a rear window. He then cuts telephone lines, turns off electricity or removes light bulbs.
A number of his victims have been woken up by the intruder appearing in their bedrooms and shining a torch at them.
He wears a balaclava and a black all in one outfit which detectives now believe is likely to be motorbike leathers. He is described as an athletic man aged around 35.
Forensic psychologists have described the attacker as a " gerontophile" - someone who is obsessed with the elderly.
Police are offering a £20,000 reward for anyone with information leading to the arrest and conviction of attacker and
Det Supt Morgan added: "Anyone who thinks they might know the identity of the attacker can call us in the incident room on 0208 217 6536 or Crimestoppers on 0800 555
I think the info is too skimpy to really say. In the past journalists have had some problems getting the facts right with respect to DNAP and DNA testing in general. In this article, it says:
The DNA technique was developed from methods used by Scotland Yard during the 'Adam' torso inquiry.
IMO - there's no clear facts there since many techniques were used in the 'Adam' case. One of the things they did was use mineral deposits in the body to identify a "birthplace" signature. But I don't think that's a DNA technique. It's not clear to me what they're talking about.
Another article - DNA clue in sex attacker manhunt
http://news.bbc.co.uk/2/hi/uk_news/england/london/3663195.stm
DNA evidence was gathered at the scenes of previous attacks
Ground-breaking DNA techniques have traced the geographical roots of the serial sex attacker at the centre of London's biggest manhunt.
Scientists used DNA samples found at some crime scenes in south London to prove his family is from the Caribbean.
They will be compared with swabs from up to 200 police officers with Caribbean origins to try to trace the island the man or his family was from.
He is suspected of at least four rapes and 27 sex assaults over 12 years.
Criminal profiles say he enjoys sex with victims over 50 years old, his youngest victim was 68 and the eldest was 93.
He often breaks into homes and removes light bulbs, cuts telephone wires and turns off the power before attacking them.
One 88-year-old woman was raped twice in August 1999 - her bowel was perforated and she almost died from her injuries.
Detective Superintendent Simon Morgan said it was a miracle no-one had died from fright.
"It's in the dark. He shines a torch in their face - the descriptions that you get are very limited. The victims are petrified by these circumstances."
The DNA technique was developed from methods used by Scotland Yard during the 'Adam' torso inquiry.
With no clues to the identity of the boy who was found in the Thames, samples from his body showed he had strong links to West Africa.
Now detectives hope to narrow the search for the south London sex attacker who is thought to be responsible for more than 80 crimes.
His DNA samples were sent to the DNA Print Genomics in Florida, and found to contain Native American, European and Sub-Saharan strands.
The combination is only found in the Caribbean.
Detectives working on Operation Minstead have also tried familial testing, which successfully traced Craig Harman, who threw a brick through a lorry driver's windscreen.
Now they are working through a list of 100 people with similar DNA to the rapist.
The attacker wears a balaclava and often a black all-in-one suit thought to be a motorcycle outfit.
He is thought to be about 35, black and may have links to Brighton, as he mentioned it during one attack.
They "suspended" offering the DNAP test because they were falling behind on all of their tests and the DNAP test requires more prep work than the mitochondrial tests (the prep is done at FTDNA). At the time, they didn't have an automated system in place to eliminate much of the man-hours involved. I believe they are in the process of automating now but I don't expect them to continue offering the DNAP test anytime in the near future.
For one thing it was published in 2000. DNAP came into existance in the second half of 2000. That list is also out of date. Most of those companies listed have either narrowed their focus or dropped out of the race.
ok - I see what you're saying. To me, those kinds of relationships are secondary. If Taxol is approved and/or clinical genotyping commences, it will be because of who we are and not who's chips we use. You know? I mean, it would be nice, but it's not a critical event. I do remember reading in a patent application that DNAP's test could be suitable for use on waffers like Affymetrix's so you never know....
cosmic - one thing we don't talk much about is the long term - pharmaceuticals. To a certain extent, I don't think it's worth talking about until some of the near term goals come into focus (Taxol and clinical genotyping). But in theory, the ADMIXMAP will be better suited for targeting new therapies than for anything else. Just something to keep in mind
Also, I don't think integrating our approach with other methods diminishes DNAPs technology in any way. In fact, I think this kind of attitude will speed the adoption of new technologies rather than hinder them.
Have a good day,
Doug
I don't think so. Those SNP's come from Perlegen and the public domain. DNAP already has their own maps - and they will remain proprietary. I don't see any symbiosis there. Why would we need them?
Basically, the scenario that I see unfolding begins with Moffitt - they are initiating a very large scale project. DNAP is a role player but an important one.
From the excellent video that Ifida posted, it's clear that Moffitt wants to connect patient treatment and care with research so that each feeds off the other. They're going to do this by establishing a database that creates a patient history and a patient profile. When a cancer patient checks into Moffitt or one of Moffitt's affiliates, they'll be asked to sign a consent form that will allow Moffitt to take a biopsy and track them all the way though the process. That data will then be fed back into the research end of the process to eventually guide physicians in giving a better prognosis and help researchers create new therapies.
Where does DNAP fit in? In the patient profile, there is likely to be several sets of data available as a backdrop to the patient history. After all, how do you know what parts of the patient profile will be pertinent until after a patient history has been established to measure it against? Moffitt will be able to do some of this in-house but genetic profiling will likely be subed out to DNAP. Why? Because the ADMIXMAP is a "compact" test. It would be far cheaper for Moffitt to rely on DNAP as a supplier of genetic profiling as they can already create a profile for relatively cheap but also, the ADMIXMAP already provides a means of analyzing that genetic profile. In other words, I think there is a very likely chance that all the patients that come into Moffitt will have, as part of their overall patient profile, a DNAP supplied genetic profile.
This would be in addition to a gene expression profile (from the biopsy) and maybe a proteomic profile. All of the technologies would be useful in creating new cancer therapies but the DNAP profile would be especially useful for targeting those therapies to "responders" in the future.
The really important thing that I took from the video is that Moffitt and partners will be supplying a framework in which the usefulness of each technology or drug will be categorized. The likely end of all these methods of examining a disease are that researchers are going to have to rely on different methods to achieve a single goal. In order to make these methods complementary they will have to be integrated. Judging from the video, nobody out there has set out to do this as yet - so this is a cutting edge program that DNAP is participating.
ifida/cosmic - I don't see the connection. You guys are talking about gene expression technology. DNAP's bag is in snips technology. They're different animals.
IMO, proteomics, gene expression, and snips are going to end up being *complimentary* technologies - but they aren't the same unless I'm missing something.
There are probably a lot more factors affecting the review process than whether or not the drug is already approved.
How effective is the classifier for its intended use?
Under what conditions is the classifier applied?
How broad is it? (can it be applied to all population or is it better with specific ethnicities, age groups, etc.)
Can it be used to prescribe specific dosages?
If it was used in conjunction with a drug not yet approved, it would probably be packaged as a total solution and, as such, would be subject to a full drug review process.
Let's see what happens with Taxol over the next six months first
w2p - since I started reading about Moffitt and what they do, I've seen a lot of new studies that aim to predict patient response through hybrid approaches. I like this idea. It could really speed things up.
If DNAP could explain, say, only 70% of the variability in patient response and Moffit can explain say, only 70% as well - together they could conceivably explain >95% if they did not completely overlap. But portions of findings that are overlapping or redundant in their predictivity might be able to bolster an FDA application. As long as their independent research is somewhat complimentary it's a win-win situation, IMO.
If new studies are anything like the Ovanome project which already had greater than 95% predictivity in the first screen, they could develop very accurate classifiers and possibly much faster than if DNAP were to do it on their own.
I'm still sceptical of the Affymetrix connection. Some of their technology still seems to be in competition with ours. But we'll see about that
"Scientists at Moffitt now can study all of a patient’s 32,000 genes simultaneously"
That sounds a lot like a pan-genome screen to me.
Project takes aim at cancer
http://www.news-press.com/news/opinion/040411canceredit.html
Published by news-press.com on April 11, 2004
Is there anyone in Florida whose life has not been touched in some way by cancer?
Given the statistics, we doubt it.
It’s Florida’s high population of older people — not the water or the air — that make cancer so prevalent in our state. The incidence of cancer is age-related, although its occurrence is not limited to older people. The prevalence of cancer here puts our state in an unusual position to be a leader in the field of cancer treatment and cure.
And Florida’s legislators have a chance to do something unique about those statistics this session. Our elected officials have a chance to be both pioneers and heroes.
Medical science is making enormous strides, thanks in large part to the U.S. Human Genome Project, and its completion last year of the sequencing of the human genome.
Now, by working with its 11 affiliates — including Lee Memorial Health System — the Moffitt Cancer Center in Tampa wants to start using its new technology to start reaching the 80 percent of Florida cancer patients that cannot be treated at the center through a project called Total Cancer Care.
The project would mean Floridians everywhere would have the best care available where they live — no matter where they live — through creation of a database that can determine what works and why, an expanded network of affiliates (now mostly in Central and South Florida) and enlarged patient access to clinical trials.
Most of each person’s 32,000 genes are identical, but not all. That is why some people respond to certain types of cancer treatments and others do not.
Scientists at Moffitt now can study all of a patient’s 32,000 genes simultaneously and identify which patients are likely to respond to treatment, an expensive procedure. This isn’t covered by health insurance so only the very wealthy — or those participating in clinical trials — are likely to have it done. By building a database that a patient’s doctor can plug into, all patients can benefit from what is learned. Taking such tissue banks into the community, as Moffitt proposes, is unique.
For example, why subject a patient to a standard and rigorous, debilitating procedure if it is not likely to work on that patient?
Moffitt’s first project will be to tackle lung cancer, Florida’s deadliest cancer.
To do this, Moffitt wants $5 million from the Legislature. The center is kicking in $2 million and will seek the remainder needed for the $25 million project from private sources.
This is not much money. Especially for a state that is getting $365 million in 2004-5 from its 1997 tobacco industry settlement.
We can do this and still fully fund the successful teen antismoking campaign that the Legislature seems determined to dump.
Instead of frittering that money away on this and that, why not use some of it as it was intended?
It’s up to you to let your legislators know that this is what you want.
CANCER FACTS
• In Florida this year, more than 97,000 people are estimated to be diagnosed with cancer.
• More than 40,000 in Florida will die of cancer this year.
• In 2002, cancer cost our state $12.3 billion.
• Cancer is the second leading cause of death in Florida.
• Cancer kills more children in Florida than any other disease.
• Floridians are more than 35 percent more likely to be diagnosed with cancer than residents of any other state.
• Lung cancer is Florida’s biggest cancer killer.
• Nearly 14,000 Floridians are estimated to be diagnosed with lung cancer this year.
• This year, an estimated 12,360 Floridians are likely to die from lung cancer.
— SOURCE: American Cancer Society report “Cancer Facts & Figures 2004.”
I think the FDA is eager to get some kind of regulatory protocol in place soon. There needs to be a plan that not only gets reliable tests approved expeditiously, but fairly so that each test and each company are evaluated on an equivalent basis.
There has to be an overarching set of standards in place and, IMHO, DNAP has an interest in making sure that the standard set is not below their own. So far as I know, the Taxol classifier will be the first complex genetic classifier to go to the FDA and one of the first to be paired with an already approved drug. I'm guessing from the last PR that they are looking this as an opportunity to set the curve for their competitors.
That's my best guess. I don't really know.
Bag
I really, really like the Moffit collaboration because it has the potential to benefit every aspect of DNAP's business. The relationship obviously is beginning at the research end but IMO it will probably extend to deployment Taxol as well. All the things that go on in between - the gathering of samples, a well executed clinical trial, inclusion of corroborative/supplementary data - all the things that can expedite an FDA submittal will be that much easier.
But if DNAP can perfect a tool with the aid of a partner that can do the testing for automating the selection of therapies for patients, then IBM, for instance, might just have some interest in it.
Any classifier, drug or research tool that DNAP developed would need to be integrated into a system that gets it to the end user - that much I agree with. But that is not the basis of a partnership. IBM can develop semi-generic solutions that accommodate many different types of tests. Going back to the library analogy - it would not be much of a library if there were only books by one author or if the library only offered mystery novels. Nor would it be much of a library if there were only a couple books.
As far a pharmaceutical companies go (my opinion only) - they've done a good job of raping genomics companies of their intellectual property. I think before we start assuming that it would be in DNAP's best interest to partner with a pharmaceutical company we should take a look at the *quality* of deals that have already taken place and ask ourselves why it is that that path has not already been traversed by DNAP.
Terry,
I'm a lay person in this respect - so my idea of what these deals *should* look like is kind of fuzzy.
If one tries to project how the field of genomics is going to impact medicine as a whole one of the important aspects that we don't talk about much is the analysis and sharing of genetic information. DNAP is one source of that information.
I made an analogy a few days ago of a library system where library users (Moffit researchers and physicians) go to a library (built and indexed by IBM and Affymetrix) to get books (made by DNAP). It's not a perfect analogy (nor original) but it illustrates some of the things that need to happen to make personalized medicine a reality. Everyone has a role to play and those roles are clearly defined.
The idea of a company with deep pockets partnering directly with us for the sole purpose of helping us make discoveries seems less realistic to me. Beckman is a possibility since they have the remaining portion of the option agreement and since they package diagnostic solutions. But the terms of that agreement don't support a future partnership unless they've been modified to incorporate new equipment and technology.
Theo
I don't think Mickey knew what he was talking about <ng> There might be a collaboration in the making but I'm certain it's not what people suppose it is.
ps - Thanks for bringing some of that sunshine to the NW. Much appreciated
the vast majority is the stock based compensation to officers. its in the annual filing.
w2p - I like to think of what IBM, Beckman and Affymetrix are doing as being analogous to a library building with it's own Dewey Decimal system. Its has no medical value of its own - just a building for storing books with its own indexing system - the books will not be provided. That is for others. Moffit may already have their own set of tests and DNAP may have another. DNAP and Moffit together may develop more. Regardless of who's books they are in the library the the probability remains that the more "books" that are added, the more useful and powerful the library becomes. If the library is successful then it becomes the "blueprint" for how future libraries will be built in other hospitals.
Everyone is looking at the projection of 12Billion in the diagnostics market and thinking that they are going to have to start sowing the seeds now. The tests (the books) are whats holding this thing back now, IMO. I think there is going to be a push to get more useful diagnostics to patients so that Beckman, Affx, IBM and everyone else can start establishing themselves as the de facto standard for getting things from the lab to the patient.
As an aside - nobody mentioned the Taxol discussion in the filing. I thought that was on of the most thorough and interesting parts. The only questions remaining are:
1. When will clinicals end?
2. What kind of guidance will the FDA give?
rofl. you're a little bit evil <g>. eom.
c'mon guys. eom.
I think you should discount what NITE does unless the price is moving quickly.
But I'm not an expert.
Validation genotyping? Any guess as to what that means? I'm assuming that Dr. Moskowitz already has a regiment that has been verified to work and now must figure out exactly why it works in order to protect it from future competitors (or to get regulatory approval?)
At any rate, thank you for posting.
Thanks for posting, Ming. Did you notice that dnap is now showing 4-way admixture in bar chart format?
Is that based on horizontal support or are you trying to draw a wedge? Just curious.
Group Wants AstraZeneca Cholesterol Drug Banned
Thu 4 March, 2004 15:29
http://www.reuters.co.uk/newsArticle.jhtml?type=healthNews&storyID=4498532§ion=news
By Lisa Richwine
WASHINGTON (Reuters) - A consumer group on Thursday asked the U.S. government to ban an AstraZeneca cholesterol drug approved only months ago, citing reports of dangerous reactions and one death.
The prescription drug, Crestor, was introduced in Canada in February 2003 and in Europe in March 2003. The drug hit the U.S. market last September.
Since the drug's launch, seven patients who took it developed life-threatening muscle deterioration, and nine experienced kidney failure or damage, consumer group Public Citizen said.
One 39-year-old U.S. woman died from kidney damage and muscle breakdown, a known side effect of drugs such as Crestor called statins, the group said.
The information, detailed in a petition to the Food and Drug Administration, was based on reports submitted to regulators in the United States, Canada and Britain, Public Citizen said.
"For there to have been that many of those problems in basically in less than a year is very worrisome," Dr. Sidney Wolfe, head of Public Citizen's Health Research Group, said in an interview.
Cases of muscle breakdown, known as rhabdomyolysis, led to the 2001 withdrawal of Bayer AG's Baycol, which was linked to more than 100 deaths.
AstraZeneca is relying on Crestor, known generically as rosuvastatin, to drive future profits. Millions of people take statins to lower high cholesterol, a major risk factor for heart disease.
More than 1 million patients have taken Crestor, AstraZeneca spokesman Gary Bruell said. Side effects so far "totally mirror the experience" in the company's clinical trials that supported Crestor's approval, he said.
The drug's risks "are comparable to other statins," he said.
While both the muscle and kidney problems were seen in premarketing trials of Crestor, the FDA concluded the drug's benefits outweighed its risks at doses of five to 40 milligrams. Safety concerns had led AstraZeneca to drop plans to market an 80-milligram dose.
Public Citizen, which had urged the FDA not to approve Crestor in the first place, said the post-marketing information showed serious side effects occurred even in patients taking the lower doses.
We could have done it, no doubt. Many companies could have done it. But how much money could we possibly have made? And why do it if its not part of our future?
I think it's more valuable to GNSC than it is to DNAP because GNSC is trying very hard to establish credibility as a service based company.
Animal testing and traceability? The market exists but it is *highly* competitive because the DNA testing procedure is not new - anyone can do it. Furthermore there are effective (cheaper) means to trace animals like implanting ID chips and soon, retinal scanning. In short, I don't believe GNSC is trying to break into this. They're just trying to establish credibility.
ok. will do. but please don't taunt me anymore with those one sentence excerpts. lol.
appreciate the excerpts but......where the hell are you getting this from?!!!
I looked at the WIPO applications last week and only found one page.