I heard on NPR last week that the U.S. government has spent $50 billion dollars on this new science of protecting us from biological terror attacks. The below AP story details the new science of “microbial forensics” that came from such expenditures. While that is a whole lot of money in contrast to what we spend on health, it was a small portion of what we spend on defense. So the money gets thrown at this “threat”. It seems if we can call a health threat a war on something, then the politics of terror allow us to spend money without any focus or justification.
But how ridiculous is it for us to allocate so much of the U.S. treasury to stopping one supposedly lone killer, when our drug companies are allowed to import raw material to be put intravenously in our most vulnerable people, without any serious attempt to monitor the bio/genetic makeup of such drugs? That is exactly what we did in the heparin disaster. Baxter was practically encouraged to ship those U.S. jobs overseas, to China, a place there was no realistic chance to make sure the raw materials were pure. Then, it didn’t even demand a sophisticated test when the product got to the U.S. to make sure it was pure. Counterfeiting drugs is the single biggest biological risk factor facing the American consumers. Maybe it isn’t a “war on terror” issue, but the drug companies that profit from shipping American jobs to China, ought to know that they have to go to the lengths the government is going to stop terrorism, to keep us safe.
Attorney Gordon Johnson
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©Attorney Gordon S. Johnson, Jr. 2008
Date: 8/8/2008 3:33 PM
By LAURAN NEERGAARD
AP Medical Writer
WASHINGTON (AP) _ The anthrax killer spurred a whole new branch of science that could give the nation a head start in the next emergency — whether it’s investigating more bioterrorism or even a food poisoning outbreak.
It’s called microbial forensics, a way of using a germ’s genetics to help exonerate or incriminate much as human DNA can today.
Microbes — whether bacteria like salmonella and E. coli, or viruses like HIV — have unique genetic signatures that can allow scientists to tell even the most closely related strains apart. The forensics side comes from adding crime-investigation techniques to this advanced microbiology used by disease detectives. Think CSI meets CDC.
With anthrax, that science led to a single flask of bacteria deemed the genetic parent of the spores grown for the 2001 attacks. It then took traditional gumshoe detective work for the FBI to finger the flask’s owner, Dr. Bruce Ivins, as the alleged attacker while ruling out others who shared his Fort Detrick laboratory where that flask was stored.
If tracing a single vial of germs sounds impressive, consider: Research under way now might one day allow tracing where someone has recently traveled by the DNA of bacteria in the dirt on their shoes.
But microbial forensics is a fledgling field, apparently used in court only once before — in the attempted-murder conviction of a Louisiana doctor who injected a former lover with HIV taken from one of his patients.
The far more complicated anthrax case could prove pivotal in establishing the credibility of microbial forensics, even though Ivins’ suicide means it won’t go to court. Thus, scientists are clamoring to see the full evidence. The FBI hasn’t yet released the actual genetic test results, although bits of the work have been published in scientific journals.
“Science is a wonderful thing but it is, at the end of the day, a tool,” said Dr. Gigi Gronvall of the University of Pittsburgh’s Center for Biosecurity. “The question is how that was used.”
Microbial forensics is “still a field very much in its infancy,” said prominent gene researcher Dr. Claire Fraser-Liggett, whose former laboratory, the Institute for Human Genome Research, was tapped by the FBI to perform extensive anthrax testing. “There was always the lingering question as to whether you would ever really be able to find differences that would be useful in terms of doing attribution.”
While the FBI prohibited Fraser-Liggett from disclosing specifics, the investigation ultimately compared DNA from more than 1,000 anthrax samples, “finding that you could really apply many of the same parallels with human forensics to microbial forensics,” she said.
The implications, she added, “go very far beyond just this one case.”
Unlike in 2001, today the genetic makeup of many bacteria and viruses has been fully sequenced, or decoded, and advanced machinery makes it possible to sequence more samples in a day or two, for under $1,000 each.
So Fraser-Liggett urges development of a database of multiple samples of pathogens collected from around the world, so the next such investigation won’t have to start from scratch.
“My recommendation would clearly be to not wait until something happens again, because it may not be with anthrax,” she said. Bioterrorism aside, such testing could trace culprits in food poisonings and other outbreaks more precisely than today’s more limited genetic fingerprinting, she added.
But legally, microbial forensics raises enough issues that in 2004, the FBI created an elite committee of specialists in genetics and law enforcement to develop the first guidelines on how to handle and preserve bacteria or viruses that may be part of a crime.
In the anthrax case, simpler testing rapidly showed the attack bacteria was the so-called Ames strain, widely used in laboratory research. Summaries released by the FBI this week said fuller gene sequencing uncovered four specific mutations that gave the anthrax a unique signature. When compared to 1,000 Ames samples from 16 laboratories, only the germs in Ivins’ flask matched.
Scientists’ top question: Were enough samples tested to be sure another source wasn’t missed?
“Frankly, I have some level of skepticism,” said Dr. Philip Russell, the U.S. Department of Health and Human Services emergency preparedness chief in 2001. He suggested an outside panel such as the National Academy of Sciences review the evidence. “They’ve got a heavy lift to convince the scientific world they’ve nailed it.”
Dr. Francis Collins, former genetics chief at the National Institutes of Health, wants to see complete sequences for each sample — from the first victim, the four letters, the flask, and the ruled-out supplies — and would check testing quality. Labs that repeat the sequencing multiple times can reduce the chance of error to one in a million or less, he said.
More information about the apparently unique mutations is a key, added Dr. Michael Stebbins, who directs the Federation of American Scientists’ biosecurity project. Did they arise naturally when Ivins first grew his anthrax supply in 1997, or did he engineer them?
“If they were engineered by Dr. Ivins, it’s highly unlikely that they would pop up anywhere else,” Stebbins said. “Their case hinges on the fact that these strains came out of this particular flask.”
___
Associated Press Writer Ricardo Alonso-Zaldivar contributed to this report.
Copyright 2008 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
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Army creates team to review security at biolab
We could have filled this and other blogs this week with all of the news and commentary about Anthrax. But what does that have to do with the Heparin Catastrophe. It just drives home even harder, the point we have been making on this blog since February that any firm in the pharmaceutical industry had to do the utmost to insure absolute purity of its drugs. Not only has there been on the front burner of the FDA agenda the risk of counterfeit drugs, but more seriously, the risk of intentional tampering, with malicious intent. Any company that makes drugs, must make them with such utmost security, that no opportunity to infect large numbers of people could exist.
That reality is even more important with a product like Heparin, that is designed to be taken, not only intravenously, but also given to our sickest individuals, those on kidney dialysis. Nothing less than an absolute guarantee of purity is required, and exporting the manufacture of raw materials and expecting a federal agency that has a 30 year backlog, is not the way to do it.
Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
http://waiting.com
http://vestibulardisorder.com
http://youtube.com/profile?user=braininjuryattorney
g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2008
Date: 8/8/2008 7:53 PM
By LOLITA C. BALDOR
Associated Press Writer
WASHINGTON (AP) _ The Army has created a team of medical and other military experts to review security measures at the research laboratory where the scientist linked to the anthrax mailings worked.
Army Secretary Pete Geren has asked at least a dozen military and civilian officials to scrutinize safety procedures, quality controls and other policies and practices at the biodefense lab at Fort Detrick, Md., Army spokesman Paul Boyce said Friday.
To date, the Army has offered no explanation for how its biosecurity system, which is set up to catch mentally troubled workers, failed to flag scientist Bruce Ivins for years. Ivins, the microbiologist accused of sending anthrax-laced letters in 2001 that killed five people, committed suicide last week as the FBI began closing in on him.
Boyce said Friday that Geren met with military officials on Thursday night, then traveled to the high-security Army Medical Research Institute of Infectious Diseases, known as USAMRIID, at Fort Detrick on Friday morning to talk with leaders there.
Boyce said the team, which is only now being formed, is not targeting individuals but instead will be reviewing documents, procedures and other safety measures to ensure security at the military biodefense lab. He added that as yet there are no deadlines for reports from the team.
The facility has come under intense public scrutiny as more details have spilled out about therapists’ concerns that in recent years Ivins had become paranoid, delusional and bent on violence.
Investigators said that between 2000 and 2006, Ivins had been prescribed antidepressants, antipsychotics and anti-anxiety drugs. By 2005, the government had matched anthrax in his lab to the strain that killed five people.
It wasn’t until November 2007, after the FBI raided his home, that Fort Detrick revoked Ivins laboratory access.
Army officials have declined to discuss any other efforts to either watch Ivins more closely or put other restriction on him prior to the November action.
Instead, they have stressed that safety procedures at the lab have included ongoing personnel evaluations, which rely largely on employee self-reporting medical or criminal problems and observations by other workers and supervisors.
Boyce said the impending review will be headed by a two-star general, and will include representatives from the medical research command, the Army’s surgeon general, and Army operations.
While the lab has strict security measures meant to weed out troubled scientists, there are lingering questions about why it took so long for supervisors to restrict Ivins access to the deadly toxins.
Ivins’ attorney, Paul F. Kemp, says the government’s evidence was too weak to trigger any action.
But members of Congress have questioned whether adequate action was taken, and they have pledged to investigate the case and lab security as a whole.
Overall, there are nearly 1,400 biological defense labs, with an estimated 14,000 scientists working with the world’s deadliest pathogens.
In 2005, the Pentagon ordered new “biosurety” safeguards requiring workers such as Ivins to be “mentally alert, mentally and emotionally stable.” The program was meant to ferret out workers with mental problems and those who attempted or threatened suicide.
Colleagues have differed in their observations of Ivins, with some saying they never say signs of mental illness, and others describing him as a “manic basket case” or saying they’d seen him openly weeping at his desk.
Ivins himself wrote in a July 2000 e-mail that he might be suffering from a paranoid disorder.
“I get incredible paranoid, delusional thoughts at times, and there’s nothing I can do until they go away, either by themselves or with drugs,” he wrote that August, in an e-mail included in government documents released Wednesday.
Copyright 2008 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
That reality is even more important with a product like Heparin, that is designed to be taken, not only intravenously, but also given to our sickest individuals, those on kidney dialysis. Nothing less than an absolute guarantee of purity is required, and exporting the manufacture of raw materials and expecting a federal agency that has a 30 year backlog, is not the way to do it.
Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
http://waiting.com
http://vestibulardisorder.com
http://youtube.com/profile?user=braininjuryattorney
g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2008
Date: 8/8/2008 7:53 PM
By LOLITA C. BALDOR
Associated Press Writer
WASHINGTON (AP) _ The Army has created a team of medical and other military experts to review security measures at the research laboratory where the scientist linked to the anthrax mailings worked.
Army Secretary Pete Geren has asked at least a dozen military and civilian officials to scrutinize safety procedures, quality controls and other policies and practices at the biodefense lab at Fort Detrick, Md., Army spokesman Paul Boyce said Friday.
To date, the Army has offered no explanation for how its biosecurity system, which is set up to catch mentally troubled workers, failed to flag scientist Bruce Ivins for years. Ivins, the microbiologist accused of sending anthrax-laced letters in 2001 that killed five people, committed suicide last week as the FBI began closing in on him.
Boyce said Friday that Geren met with military officials on Thursday night, then traveled to the high-security Army Medical Research Institute of Infectious Diseases, known as USAMRIID, at Fort Detrick on Friday morning to talk with leaders there.
Boyce said the team, which is only now being formed, is not targeting individuals but instead will be reviewing documents, procedures and other safety measures to ensure security at the military biodefense lab. He added that as yet there are no deadlines for reports from the team.
The facility has come under intense public scrutiny as more details have spilled out about therapists’ concerns that in recent years Ivins had become paranoid, delusional and bent on violence.
Investigators said that between 2000 and 2006, Ivins had been prescribed antidepressants, antipsychotics and anti-anxiety drugs. By 2005, the government had matched anthrax in his lab to the strain that killed five people.
It wasn’t until November 2007, after the FBI raided his home, that Fort Detrick revoked Ivins laboratory access.
Army officials have declined to discuss any other efforts to either watch Ivins more closely or put other restriction on him prior to the November action.
Instead, they have stressed that safety procedures at the lab have included ongoing personnel evaluations, which rely largely on employee self-reporting medical or criminal problems and observations by other workers and supervisors.
Boyce said the impending review will be headed by a two-star general, and will include representatives from the medical research command, the Army’s surgeon general, and Army operations.
While the lab has strict security measures meant to weed out troubled scientists, there are lingering questions about why it took so long for supervisors to restrict Ivins access to the deadly toxins.
Ivins’ attorney, Paul F. Kemp, says the government’s evidence was too weak to trigger any action.
But members of Congress have questioned whether adequate action was taken, and they have pledged to investigate the case and lab security as a whole.
Overall, there are nearly 1,400 biological defense labs, with an estimated 14,000 scientists working with the world’s deadliest pathogens.
In 2005, the Pentagon ordered new “biosurety” safeguards requiring workers such as Ivins to be “mentally alert, mentally and emotionally stable.” The program was meant to ferret out workers with mental problems and those who attempted or threatened suicide.
Colleagues have differed in their observations of Ivins, with some saying they never say signs of mental illness, and others describing him as a “manic basket case” or saying they’d seen him openly weeping at his desk.
Ivins himself wrote in a July 2000 e-mail that he might be suffering from a paranoid disorder.
“I get incredible paranoid, delusional thoughts at times, and there’s nothing I can do until they go away, either by themselves or with drugs,” he wrote that August, in an e-mail included in government documents released Wednesday.
Copyright 2008 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
Company asks pharmacists, hospitals to return drug
Date: 8/1/2008 8:47 PM
WASHINGTON (AP) _ A New Jersey company is asking pharmacists and hospitals to return all prescription drug products made at one of its facilities because it did not pass health authorities’ standards.
A Food and Drug Administration inspection at the Little Falls, N.J., facility of Actavis Totowa LLC “revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices,” according to a company statement issued Friday.
The recall, only on the pharmacy and retail level, includes about 65 different prescription drugs, such as pain killers, antidepressants, diet medication and drugs for blood pressure and hypertension.
Only pharmacies and hospitals should return the prescription drugs. Patients who may have the drug should continue to take them in accordance with their prescriptions, the Morristown, N.J. company said in a release. The company said that suddenly stopping needed medication before obtaining replacement drugs may place patients at risk.
For more information on the recall, consumers can visit http://www.actavis.us/en/media+center/newsroom/articles/RecallFAQ.htm
Copyright 2008 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
WASHINGTON (AP) _ A New Jersey company is asking pharmacists and hospitals to return all prescription drug products made at one of its facilities because it did not pass health authorities’ standards.
A Food and Drug Administration inspection at the Little Falls, N.J., facility of Actavis Totowa LLC “revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices,” according to a company statement issued Friday.
The recall, only on the pharmacy and retail level, includes about 65 different prescription drugs, such as pain killers, antidepressants, diet medication and drugs for blood pressure and hypertension.
Only pharmacies and hospitals should return the prescription drugs. Patients who may have the drug should continue to take them in accordance with their prescriptions, the Morristown, N.J. company said in a release. The company said that suddenly stopping needed medication before obtaining replacement drugs may place patients at risk.
For more information on the recall, consumers can visit http://www.actavis.us/en/media+center/newsroom/articles/RecallFAQ.htm
Copyright 2008 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney