Oversulfated chondroitin sulfate (OSCS) in Heparin Kills

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Posted on 12th September 2009 by gjohnson in Uncategorized

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What is OSCS? Frankly, it is poison. It politely is called a “contaminant.” It is part of what was in the Heparin (that Baxter and Scientific Protein Labs distributed) that killed people. Almost all of the controversy in the Heparin litigation has swirled around OSCS. OSCS is oversulfated chondroitin sulfate. Here is some of what the FDA has said about OSCS at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm112606.htm:

13. What is the contaminant? (new question and answer added 6/18/2008)
Oversulfated chondroitin sulfate (OSCS), a substance that mimics the biological activity of heparin, was identified as the contaminant.
14. Where is the contaminant found? (new question and answer added 6/18/2008)
The contaminant was found in samples of heparin crude materials, heparin active pharmaceutical ingredients (API), and finished heparin drug products.
15. Is oversulfated chondroitin sulfate unsafe by itself or in combination with heparin? (new question and answer added 6/18/2008)

The adverse events were reported in patients who received heparin contaminated with oversulfated chondroitin sulfate. The lab studies suggest that when oversulfated chondroitin sulfate is given alone or in combination to animals, similar adverse events occur (N Engl J Med 358;23 June 5, 2008 p2457) .

For a catastrophe the potential magnitude of the swine flu, that is pretty polite language. What the FDA doesn’t say about OSCS above is that OSCS got in Heparin by the intentional actions of some Chinese individuals trying to make an extra profit by cutting Heparin, like a street drug might be cut with sugar. OSCS was used to cut the drug because it chemically looked enough like Heparin that it would pass the crude testing that Baxter and SPL were doing to determine the purity of this drug.

What the FDA also doesn’t say is that OSCS got into Heparin because some American corporate executives also were motivated by greed. More on that tomorrow.


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
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FDA Drug Chief Woodcock Accused of Conflict of Interest

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Posted on 4th September 2009 by gjohnson in Uncategorized

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The name Janet Woodcock, M.D. is one that anyone who has followed the Heparin Catastrophe is familiar with. It was Dr. Woodcock who stood in front of Congress in 2008, trying to explain how the FDA could possibly have allowed the import of drugs into the United States from facilities that the FDA would not get around to inspecting for nearly 30 years.

It was clear in those hearings that the Congressmen and Dr. Woodcock were well acquainted, with many references to her previous testimony. It now appears that Dr. Woodcock was the pure Washington insider, well acquainted not only with those who were in charge of oversight of her job, but also with those who she was supposed to be regulating.

The Wall Street Journal reported last month that Dr. Woodcock has been accused of conflict of interest, not just on any old drug, but with a heparin based blood thinner, Lovenox. http://online.wsj.com/article/SB125003545637224263.html

According to the Wall Street Journal:

“The investigation of Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, stems from an ethics complaint filed by Amphastar Pharmaceuticals Inc., a California company that says it has been delayed in its six-year effort to win approval for a generic version of Lovenox, a multi-billion-dollar blood thinner.

“In its complaint, Amphastar alleges that its competitor had special access to Dr. Woodcock at critical times in the prolonged approval process, which is ongoing. Amphastar points out that Dr. Woodcock co-authored a scientific paper with scientists at Momenta Pharmaceuticals Inc. while both companies were battling to win FDA approval of their generic blood thinners.”

It is an old cliché, but it may be time to throw out those bums. Change we can believe in must come to Washington. The debate over healthcare reform has shown just how deep the health industries ties are to our government. If we can’t return our government to the people, not corporate lobbyists, government for the people, by the people, may perish.


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
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Heparin – FDA’s SPL Inspection – No One in Charge

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Posted on 6th April 2009 by gjohnson in Uncategorized

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Today we discuss what has to be the most staggering aspect of the manufacturing situation at the Changzhou SPL plant in China, Baxter’s source of the API which made up the contaminated Heparin: No one with specialized knowledge of Heparin, was working for SPL in China.

These quotes are taken from the April 29, 2008 hearings before the House Subcommittee on Oversight and Investigations hearings, see: The Heparin Disaster: Chinese Counterfeits and American Failures
For more, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml

Regina Brown of the FDA was questioned in those hearings by U.S. Representative, Jan Schakowsky:

Question by Schakowsky: There was no person with special knowledge of Heparin at the firm to guide decisions made by the quality unit. So Ms. Brown, I would assume that if a plant was making Heparin API, it would want to have a person with “special knowledge” of that product, in case deviations from any manufacturing process were observed, wouldn’t you agree?

Answer by Brown: They had a quality unit there, which consisted of four people, they were trying to track what was going on with the firm. The person with the special knowledge I mentioned, because when I arrived, management was aware that there were Baxter recalls, and that there were adverse drug events and deaths in the United States. It was middle of February, the general manager of the firm, Mr. Wong, was the one who described the process to me and how he thought that impure materials were removed from the crude heparin to make it into the heparin API and he said he wasn’t a heparin expert. And so, he was really the person who gave me my fullest extent of knowledge during the inspection.

Q: So, neither he nor the others had any special knowledge, he had the most knowledge?

A: I believe so, yes.
Unbelievable. SPL is manufacturing a drug that is going to be put in to the veins of our sickest people and they don’t have anyone on site with specialized knowledge as to how to make Heparin? How could Baxter have allowed this? Any superficial investigation would have determined that Changzhou SPL didn’t know what it was doing. Such a breakdown in the process of making an intravenous pharmaceutical is outrageous and is an institutional catastrophe.


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
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Baxter’s Heparin Contamination – More on SPL Inspection

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Posted on 29th March 2009 by gjohnson in Uncategorized

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In our previous blogs, we discussed the first of the four essential problems with the manufacture of Heparin API at the Changzhou SPL plant in China. Today, we discuss the second, which is non-sterile equipment found during the FDA’s inspection of Changzhou SPL plant in China. Changzhou SPL was the supplier of the contaminated Heparin to Baxter.

Again, these quotes are from the April 29, 2008, House Subcommittee on Oversight and Investigations hearings, see: The Heparin Disaster: Chinese Counterfeits and American Failures
For more, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml

Regina T. Brown, FDA Consumer Safety Officer was the FDA Officer at the Changzhou SPL plant. U.S. Representative, Jan Schakowsky’s, questioning of Brown included the following with respect to the substandard equipment:
Question by Rep. Schakowsky: You found that the equipment SPL used to manufacture heparin may not have been suitable for its intended use, isn’t that correct?

Answer by Brown: Yes.

Q: And how was it unsuitable and why is this important?

A. There were three different pieces of equipment that I found unsuitable for use.

The first was these big polyethylene tanks that they dissolved heparin up in, just prior to the last manufacturing step, which was a liofolization, a freeze drying step. And these PE tanks were scratched on the bottom, very scratched, as if somebody had been chopping stuff out of them with plastic. I ran my fingernail along it and it was like playing an accordion. And there also was stuff adhering to the bottom of these tanks.

Q: This was inside?

A: On the inside of the tanks where crude heparin would be right before it became heparin API. So I scratched stuff off the inside of the tank. And this was tank that was marked clean.

A second PE tank I turned over and liquid fell out of the handle, the molded, PE comes from a mold polyethylene, and stuff, a liquid fell out of the handles into the bottom of the tank. And it was marked cleaned. So it wasn’t a clean tank.

Q: Stuff. Do we know what stuff was in there?

A: The stuff I scratched off? No I don’t know what it was. It was a little gray colored, it wasn’t white. That is all I know.
If Brown was describing the conditions of a commercial kitchen, this would be a serious area of concern. But that such non-sterile conditions could occur in the manufacture of an intravenous medicine to be given to ill people, is simply outrageous. Baxter claims to have inspected this plant in the months before word of this calamity reached the U.S. market. It is hard to imagine how an honest inspection could have been done by Baxter, in light of what the FDA inspection showed.


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
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Heparin Frequently Asked Questions Continued

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Posted on 22nd March 2009 by gjohnson in Uncategorized

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More Frequently Asked Questions on the Baxter Heparin Catastrophe:

8. What if there was a death or a serious injury consequence from HIT?

HIT is short for heparin induced thrombocytopenia. See http://en.wikipedia.org/wiki/Heparin-induced_thrombocytopenia HIT is a condition where the body reacts to heparin causing the blood to clot. This clotting can result in death, serious injury such as gangrene and may leave survivors with severe consequences, such as amputations. The evidence is beginning to mount that OSCS may cause or exaggerate a HIT response or reaction. Thus, all cases of HIT after 2007. and up to this date, should be investigated.

We also are concerned that OSCS may cause a cumulative sensitization phenomenon, similar to what often happens with a bee sting. Most people experience little more than local pain and brief swelling with repeated stings by bees. Some people, however, become increasingly more sensitive until the person reaches the point of a severe allergic reaction or even death. In the case of OSCS, a second or later exposure may cause the catastrophic consequence. Thus, we are not ruling out a case where heparin was given during the presumptive contamination period – September 13, 2007 through April 30, 2008 – and then a catastrophic reaction to heparin occurred, even if the second dosage of heparin was not contaminated.


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
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Heparin Frequently Asked Questions Part III

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Posted on 15th March 2009 by gjohnson in Uncategorized

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For the last few days, we have been discussing Frequently Asked Questions. On previous days we have addressed:
  • 1. When did the Baxter Heparin contamination begin?
  • 2. When did Heparin return to being Safe?
  • 3. How severe of a reaction should we have before calling?
Today, we continue with:

4. What Happens when I Call?

All Heparin calls are answered by my paralegal, Jayne Zabrowski, jayne@tbilaw.com If Jayne misses your call she will call you back if you leave a message. Jayne carefully listens to the details of how the death or serious injury occurred and will ask appropriate follow-up questions. Jayne cares and will sincerely listen to those who can benefit by our representation. If you have the type of case that we handle, you will then hear from the nurse paralegal who will assist in obtaining medical records and additional information.

Jayne has talked to every potential Heparin client, since our first client told us about a Heparin death in February of 2008. Melissa Scott had a severe reaction and died shortly after being administered Heparin during home dialysis. Jayne’s hours of talking to victims makes her uniquely qualified to understand the pain that this poison has caused and is experienced at prioritizing the cases for investigation.

Jayne is one of the country’s best paralegals and comes to the Heparin claims after a decade of work with the debilitating complexities of representing brain injured people in the bulk of the Johnson Law Office’s case load. She annually attends the national trial lawyers convention (AAJ) each year and is very knowledgeable and experienced in forensic medical issues.


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

FDA Use of Private Inspectors Raises Doubts

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Posted on 6th March 2009 by gjohnson in Uncategorized

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As if they had been reading this blog, the New York Times and the Rachel Maddow Show today blasted the FDA’s “chicken guarding the hen house” choice of inspectors. The FDA has allowed industries being inspected to be the ones who hired the FDA inspectors. For the Rachel Maddow video, see http://www.msnbc.msn.com/id/26315908/#29561173

The New York Times, at http://www.nytimes.com/2009/03/06/business/06food.html?_r=1 said:

“With government inspectors overwhelmed by the task of guarding the nation’s food supply, the job of monitoring food plants has in large part fallen to an army of private auditors like Mr. Hatfield. And the problems go well beyond peanuts.”

The total abrogation of its responsibility to regulate has left both of the FDA’s mandates – food and drugs – vulnerable. The NY Times article highlights peanuts and salmonella. The Heparin Catastrophe is the poster child for what is wrong with the FDA’s drug inspections. But the spirit of deregulation has harmed Americans in virtually all aspects of their lives.

One must ask, what was the SEC doing all those years, giving Bernie Madoff and Citibank, clean bills of health? What was the Justice Department doing worrying about Martha Steward and not Wall Street?

Ronald Reagan’s infamous quote: “government is not the solution to our problem; government is the problem” has left a legacy of a broken economic system, grossly disproportionate income distribution, corruption, and now, disease. We must allow government to go back to monitoring business. We must stop the absurd out cry outcry against a mild return to a progressive tax system. And we must use the Justice Department to prosecute crimes, not curry politic favor. For those who have been killed or made sick by Baxter’s greed, there must be justice.


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

Misdiagnosis of HIT

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Posted on 21st October 2008 by gjohnson in Uncategorized

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One issue that we have been blogging about since the beginning of the heparin catastrophe, is the presumption that doctors have misdiagnosed an overwhelming number of cases of adverse reaction to OSCS contamination, as normal disease processes.  The default diagnosis for most heparin related deaths prior to the onset of this crisis is HIT (heparin-induced thrombocytopenia).  Initially it was thought that anyone with a HIT diagnosis would clearly not be considered a potential adverse reaction to OSCS.  But the more that we have gotten into these files, the more suspicious we are of a HIT diagnosis.  Since HIT is the default diagnosis, it may simply mean that the doctors didn’t know what else to call it.

A good example of what we are saying about the overuse of the HIT diagnosis, is the case study below:

In late 2007 after receiving Heparin during cardiac surgery, Mrs. B, age 44, suffered from a severe reaction that caused extremely low blood pressure and required her to be on a breathing ventilator for 15 days. Tests for heparin-induced thrombocytopenia (HIT) came back negative initially, but one week later an additional test came back positive for HIT.  

This September, in response to an article published in the New England Journal of Medicine, several medical doctors pointed out that the contaminant recently discovered in the nation’s supply of Heparin manufactured by Baxter International, Inc., may cause symptoms that are indistinguishable from HIT.

After more than three weeks in intensive care, Mrs. B. was discharged, but today suffers from heavy audible wheezing and shortness of breath, severe memory loss, extreme fatigue, and tingling in her extremities.


This information about the heparin catastrophe is provided by Attorney Gordon Johnson, in conjunction with the Nolan Law Group of Chicago, IL. The Johnson Law Office is affiliated with The Nolan Law Group on Heparin litigation. The Nolan Law Group is presently involved in the litigation on behalf of those affected by the distribution of contaminated heparin.
www.heparin-law.com
www.thelegaltimes.net
www.tbilaw.com
http://youtube.com/profile?user=braininjuryattorney


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

Heparin-bonded Catheters

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Posted on 17th October 2008 by gjohnson in Uncategorized

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Heparin-bonded catheters are used to prolong the patency of central venous catheters in children. According to The Cochrane Collaboration (a database of systematic reviews of world healthcare),

“Central venous catheters are used for prolonged intravenous therapy in the management of critically ill children, for parenteral nutrition, medication and monitoring. Having these catheters in place can cause blood clots in or around the end of the catheter as well as infection, either local or a blood stream infection. As a result, the catheter becomes blocked, eventually to the point that it is occluded and can no longer be used to give fluids. Anticoagulant drugs such as heparin can be given to prolong the usefulness of the catheter or the catheters coated with heparin (heparin-bonded catheters). Heparin can cause side effects such as bleeding, allergic reactions, induced thrombocytopenia (an abnormal drop in the number of platelets in the blood) and osteoporosis with long-term use.”

It is not clearly established how much heparin increases the patency of catheters, “There was a trend towards the heparin-bonded catheter reducing the risk of catheter-related thrombosis over the time the catheter was in and a trend towards reduction in the risk of catheter occlusion in the first week after catheter placement.”

Heparin is intended to reduce the risks of catheter-related infections and other problems. Clearly, studies are not based on the incidence of contaminated lots of heparin which introduce risks and risk factors not included in clinical trials. The advantage of using a heparin-bonded catheter over a standard catheter is not a clear advantage, but exposing children to contaminated heparin would not be seen as preferable on any level.

– Baby O. was born March 9, 2007 with choroid plexus carcinoma (brain tumor).  He underwent surgery to remove the entire tumor and began chemotherapy in April.  To administer his treatment, doctors inserted a broviac catheter that was flushed with heparin twice daily to prevent the catheter from clogging.  Until September 2007, Baby O. was responding positively to chemotherapy and was showing signs of improvement. Late that month, however, he suddenly began suffering from respiratory distress, went into renal failure and ultimately passed away on November 19, 2007.  Baby O.’s physicians were baffled by the sudden unexplained deterioration in his condition.  

On August 26, 2008, Nolan Law Group filed a wrongful death case in the Circuit Court of Cook County, Illinois, located in Chicago, against Baxter International, Inc. and Baxter Healthcare Corporation.  

– In January of this year, Little Girl B was diagnosed with a subdural empyema (pus on the brain sometimes caused by sinusitis).  Little Girl B underwent surgery with no complications that successfully removed the pus.  After the procedure, physicians inserted a Peripherally Inserted Central Catheter (PICC line) for antibiotic medication to prevent post-surgery infection.  The PICC line was flushed with heparin to keep the antibiotics free-flowing.  Doctors expected Little Girl B to fully recover, but soon after they began administering heparin flushes, Little Girl B. developed a high fever and was re-hospitalized.  Blood tests came back negative for infection despite Little Girl B.’s increasing symptoms which included a rash, very low blood pressures, nausea, vomiting and seizures.   Little Girl B. passed away on February 9, 2008.

Nolan Law Group filed suit in the Circuit Court of Cook County, Illinois against Baxter International, Inc. and Baxter Healthcare Corporation on October 7, 2008.  

Heparin-bonded catheters, on theory, were meant to give a promising edge to children in high risk situations. The results were far less than hoped for when contamination entered into the picture, and tragically, fatal for Baby O and Little Girl B.


This information about the heparin catastrophe is provided by Attorney Gordon Johnson, in conjunction with the Nolan Law Group of Chicago, IL. The Johnson Law Office is affiliated with The Nolan Law Group on Heparin litigation. The Nolan Law Group is presently involved in the litigation on behalf of those affected by the distribution of contaminated heparin.

www.heparin-law.com


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

Anthrax case spurred field of germ-gene sleuthin

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Posted on 11th August 2008 by gjohnson in Uncategorized

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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.

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