Also great is this November 2 post that presents a "character study" of investment bankers.
Saturday, November 21, 2009
The Epicurean Dealmaker - Skewering the Bailouts and Bankers
Posts to The Epicurean Dealmaker (TED) blog are infrequent but have been especially wonderful this month. The best is this week's post skewering the government's pre-election decisions on AIG and Goldman. The post was good enough that Paul Krugman cited and quoted it for this recent column that followed up on the SIGTARP report on AIG, Goldman and TARP.
Friday, November 20, 2009
Global Choice of Law Issues for D & O Coverage - Contract Issues
This post at Kevin LaCroix's D & O Diary covers an interesting new decision from Canada on global choice of law issues arising from D & O policies, and identifies contract clauses that might be changed to obtain better outcomes. Here's an excerpt:
"The November 12 Opinion
In his November 12, 2009 decision (here), Justice Walker determined that British Columbia law is the proper law to be applied to the interpretation of the policy.
He began with the determination that the parties intended different laws to apply to different parts of the policy (a choice of law principle known as dépeçage). In reaching this conclusion, Justice Walker referenced several different parts of the policies at issue, including in particular the primary policy’s definition of "Loss," which contained a provision specifying that the policy’s coverage for punitive and exemplary damages would be determined under the law most favorable to the insured. Justice Walker also referenced the policy’s Oregon state amendatory endorsements, which specified that Oregon law would govern any disputes regarding alleged misrepresentations in the insurance application.
Justice Walker determined that given these clause-specific choice of law provisions, and given the absence from the policies of any general choice of law provisions, the "proper law" governing the disputes arising under other policy provisions "is left to be determined by the court hearing the dispute to find based on the application of its own laws, taking into account the directing language in the policies."
Reviewing these circumstances in this light, and discounting the policies’ various connection to jurisdictions in the United States, and applying British Columbia choice of law principles, Justice Walker concluded that "the policies have the closest and most substantial connection with BC," and therefore BC law governs the coverage dispute presented by the receiver.
In substantiating this decision, Justice Walker stated that given the importance of the Canadian subsidiary, "most of the claims could be expected to arise from Canadian operations," and he stressed that the P&T Ltd. employees’ wage claims are "unique to Canadian operations" and have "no equivalent in Oregon," as a result of which Justice Walker concluded that "the proper law of the policies to determine the carriers’ coverage obligations for these claims is BC law."
He added that the parties "would reasonably have expected BC law to apply to determine the insurers’ coverage obligations."
"The November 12 Opinion
In his November 12, 2009 decision (here), Justice Walker determined that British Columbia law is the proper law to be applied to the interpretation of the policy.
He began with the determination that the parties intended different laws to apply to different parts of the policy (a choice of law principle known as dépeçage). In reaching this conclusion, Justice Walker referenced several different parts of the policies at issue, including in particular the primary policy’s definition of "Loss," which contained a provision specifying that the policy’s coverage for punitive and exemplary damages would be determined under the law most favorable to the insured. Justice Walker also referenced the policy’s Oregon state amendatory endorsements, which specified that Oregon law would govern any disputes regarding alleged misrepresentations in the insurance application.
Justice Walker determined that given these clause-specific choice of law provisions, and given the absence from the policies of any general choice of law provisions, the "proper law" governing the disputes arising under other policy provisions "is left to be determined by the court hearing the dispute to find based on the application of its own laws, taking into account the directing language in the policies."
Reviewing these circumstances in this light, and discounting the policies’ various connection to jurisdictions in the United States, and applying British Columbia choice of law principles, Justice Walker concluded that "the policies have the closest and most substantial connection with BC," and therefore BC law governs the coverage dispute presented by the receiver.
In substantiating this decision, Justice Walker stated that given the importance of the Canadian subsidiary, "most of the claims could be expected to arise from Canadian operations," and he stressed that the P&T Ltd. employees’ wage claims are "unique to Canadian operations" and have "no equivalent in Oregon," as a result of which Justice Walker concluded that "the proper law of the policies to determine the carriers’ coverage obligations for these claims is BC law."
He added that the parties "would reasonably have expected BC law to apply to determine the insurers’ coverage obligations."
Thursday, November 19, 2009
State Secrets Privilege - Should The Alleged Victim Be Compensated When the Government Chooses to Exercise the Privilege ?
Here is an interesting NLJ article on the state secrets privilege from a law professor and dean with an impressive background in both public interest litigation and academics. The law professor, Alan B. Morrison, currently is the Lerner Family Associate Dean for Public Interest and Public Service Law at the George Washington University School of Law. In short, he suggests that the price for exercising the privilege should be that the government pays for the harm caused. Here are two key paragraphs:
"The problem to date has been that the arguments have all been about whether the claims of secrecy are actually justified and who should decide that. The best way around that debate is for Congress to pass a law saying to the intelligence community, "You can keep your secrets, but you (the U.S. Treasury) must pay the claimant's damages if you won't allow the case to be tried in the ordinary fashion." That's what the law says will happen if the government wants to take my land to build a military base, and that same principle should apply in these cases as well.
"The problem to date has been that the arguments have all been about whether the claims of secrecy are actually justified and who should decide that. The best way around that debate is for Congress to pass a law saying to the intelligence community, "You can keep your secrets, but you (the U.S. Treasury) must pay the claimant's damages if you won't allow the case to be tried in the ordinary fashion." That's what the law says will happen if the government wants to take my land to build a military base, and that same principle should apply in these cases as well.
Here's how such a law might work. Cases would be filed in the usual way, and if the government contended that state secrets might have to be divulged if the case were tried, it would make whatever efforts it could to dismiss the case on nonstate secrets grounds. But if that failed, the attorney general could formally invoke the state secrets privilege. At that point, the case would be transferred to the Court of Federal Claims, which hears claims against the government that it has taken someone's property without compensation. However, once the government invoked the state secrets defense, it would lose its right to contest its liability: The only issue remaining would be the proper amount of actual, but not punitive, damages."
Toyota's Issues Move Towards Arbitration
Here is an update on the Toyota situation. The claims of the former inside counsel have been sent to arbitration, and RICO claims were dismissed.
Wednesday, November 18, 2009
Daubert Case Law, Alzheimer's and Fundamental Research
Wondering what the Daubert case law will look like in a few years as great new science pushes past epidemiology as new machines and techniques make cause and effect more or less directly observable ? Worried about Alzheimer's perhaps being part of your future and wondering what's ahead? Wondering why nations need to invest more n fundamental science at national laboratories such as Brookhaven and Argonne ? If any of those topics are in mind, consider reading a short article that reports on a new molecular level discovery made by scientists at the storied Cold Springs Harbor Laboratory using the National Synchrotron Light Source at Brookhaven National Laboratory. For the article online, go to ScienceDaily (Nov. 13, 2009). Key excerpts are below:
"A team of scientists at Cold Spring Harbor Laboratory (CSHL) reports on Thursday their success in solving the molecular structure of a key portion of a cellular receptor implicated in Alzheimer's, Parkinson's, and other serious illnesses
***
"Without a highly detailed molecular picture of the ATD, however, efforts to rationally design inhibitors cannot proceed. Hence the importance of Furukawa's achievement: a crystal structure revealed by the powerful light source at Brookhaven National Laboratory, that shows the ATD to have a "clamshell"-like appearance that is important for its function. The results are published in a paper appearing online Thursday ahead of print in The EMBO Journal, the publication of the European Molecular Biology Organization. (emphasis added)
The team obtained structures of the ATD domain with and without zinc binding to it. Zinc is a natural ligand that docks at a spot within the "clamshell" in routine functioning of the NMDA receptor. Of much greater interest is the location and nature of a suspected binding site of a small molecule type that is known to bind the ATD and inhibit the action of the NMDA receptor.
These inhibitor molecules are members of a class of compounds called phenylethanolamines which "have high efficacy and specificity and show some promise as neuroprotective agents without side effects seen in compounds that bind at the extracellular domain of other receptors," Furukawa explains. Now that his team has solved the structure of the ATD domain of the NR2B subunit, it becomes possible to proceed with rational design of a phenylethanolamine-like compound that can precisely bind the ATD within what Furukawa and colleagues call its "clamshell cleft," based on the crystal structure they have obtained."
"A team of scientists at Cold Spring Harbor Laboratory (CSHL) reports on Thursday their success in solving the molecular structure of a key portion of a cellular receptor implicated in Alzheimer's, Parkinson's, and other serious illnesses
***
"Without a highly detailed molecular picture of the ATD, however, efforts to rationally design inhibitors cannot proceed. Hence the importance of Furukawa's achievement: a crystal structure revealed by the powerful light source at Brookhaven National Laboratory, that shows the ATD to have a "clamshell"-like appearance that is important for its function. The results are published in a paper appearing online Thursday ahead of print in The EMBO Journal, the publication of the European Molecular Biology Organization. (emphasis added)
The team obtained structures of the ATD domain with and without zinc binding to it. Zinc is a natural ligand that docks at a spot within the "clamshell" in routine functioning of the NMDA receptor. Of much greater interest is the location and nature of a suspected binding site of a small molecule type that is known to bind the ATD and inhibit the action of the NMDA receptor.
These inhibitor molecules are members of a class of compounds called phenylethanolamines which "have high efficacy and specificity and show some promise as neuroprotective agents without side effects seen in compounds that bind at the extracellular domain of other receptors," Furukawa explains. Now that his team has solved the structure of the ATD domain of the NR2B subunit, it becomes possible to proceed with rational design of a phenylethanolamine-like compound that can precisely bind the ATD within what Furukawa and colleagues call its "clamshell cleft," based on the crystal structure they have obtained."
Tuesday, November 17, 2009
US Chapter 11 Filing Opens the Door To Discovery of Otherwise Unavailable Records - Mass Tort Implications ?
A US bankruptcy court in Delaware ruled that an overseas company that files for chapter 11 in the US will be subject to discovery regardless of the law of its home country. This ruling could be big in some particular mass tort situations since it might make available myriad corporate records that would not otherwise be available.
Here is a Mayer Brown article on the ruling. The key excerpts from the article are as follows:
"In a decision that highlights the uncertain terrain faced by US litigants involved in overseas discovery, the United States Bankruptcy Court for the District of Delaware held on October 28 that the Federal Rules of Civil Procedure trump a French “Blocking Statute” that restricts discovery. The Blocking Statute, French Penal Code Law No. 80-538, imposes criminal penalties on any French national or corporation that engages in discovery under a foreign judicial system without using the procedures of the Hague Evidence Convention—letters rogatory or letters of commission. In In re Global Power Equipment Group, Inc., No. 06-11045, 2009 WL 3464212 (Bankr. D. Del. Oct. 28, 2009), the court ordered a claimant in the Global Power bankruptcy proceeding, Maasvlakte Energie B.V., to produce documents and personnel for depositions from its French affiliate. It ordered production even though Maasvlakte had claimed, belatedly, that this discovery would violate the French Blocking Statute and expose its affiliate to prosecution in France.
In response to the bankruptcy plan administrator’s discovery requests, Maasvlakte initially agreed to produce documents and witnesses, and identified its affiliate’s French documents as likely to be relevant, without mentioning the Blocking Statute. Maasvlakte first raised the French Blocking Statute only three days before it was scheduled to produce documents, arguing that the statute required the administrator to follow Hague Convention procedures to obtain discovery in France. After the administrator moved to compel Maasvlakte to produce the documents and deponents, the court rejected Maasvlakte’s position. It held that the Blocking Statute did not prevent it from applying the Federal Rules, and it ordered Maasvlakte to produce the documents and witnesses.
The court emphasized the fact that when Maasvlakte filed its bankruptcy claim it had submitted to the court’s jurisdiction, and that using the Hague Evidence Convention procedures would slow resolution of the claim. The court held that considerations of comity established by the Supreme Court in Société Nationale Industrielle Aérospatiale v. United States Dist. Court for S.D. Iowa, 482 U.S. 522 (1987), weighed in favor of application of the Federal Rules, particularly in light of the fact that the subject matter of the disputed claim was centered in the Netherlands, rather than in France."
Here is a Mayer Brown article on the ruling. The key excerpts from the article are as follows:
"In a decision that highlights the uncertain terrain faced by US litigants involved in overseas discovery, the United States Bankruptcy Court for the District of Delaware held on October 28 that the Federal Rules of Civil Procedure trump a French “Blocking Statute” that restricts discovery. The Blocking Statute, French Penal Code Law No. 80-538, imposes criminal penalties on any French national or corporation that engages in discovery under a foreign judicial system without using the procedures of the Hague Evidence Convention—letters rogatory or letters of commission. In In re Global Power Equipment Group, Inc., No. 06-11045, 2009 WL 3464212 (Bankr. D. Del. Oct. 28, 2009), the court ordered a claimant in the Global Power bankruptcy proceeding, Maasvlakte Energie B.V., to produce documents and personnel for depositions from its French affiliate. It ordered production even though Maasvlakte had claimed, belatedly, that this discovery would violate the French Blocking Statute and expose its affiliate to prosecution in France.
In response to the bankruptcy plan administrator’s discovery requests, Maasvlakte initially agreed to produce documents and witnesses, and identified its affiliate’s French documents as likely to be relevant, without mentioning the Blocking Statute. Maasvlakte first raised the French Blocking Statute only three days before it was scheduled to produce documents, arguing that the statute required the administrator to follow Hague Convention procedures to obtain discovery in France. After the administrator moved to compel Maasvlakte to produce the documents and deponents, the court rejected Maasvlakte’s position. It held that the Blocking Statute did not prevent it from applying the Federal Rules, and it ordered Maasvlakte to produce the documents and witnesses.
The court emphasized the fact that when Maasvlakte filed its bankruptcy claim it had submitted to the court’s jurisdiction, and that using the Hague Evidence Convention procedures would slow resolution of the claim. The court held that considerations of comity established by the Supreme Court in Société Nationale Industrielle Aérospatiale v. United States Dist. Court for S.D. Iowa, 482 U.S. 522 (1987), weighed in favor of application of the Federal Rules, particularly in light of the fact that the subject matter of the disputed claim was centered in the Netherlands, rather than in France."
Monday, November 16, 2009
New Science from Australia for Persons with Mesothelioma
Courtesy of a friend in Australia, here is a link to a story on new radiotherapy science developed in Australia that is bringing some new hope for perhaps two more years of life for persons suffering from mesothelioma. Key excerpts are as follows:
Breakthrough in fight against mesothelioma
By Lindy Kerin for AM
AM abc.net.au/am
Posted Fri Nov 13, 2009 11:11am AEDT
Updated Fri Nov 13, 2009 11:22am AEDT
A new radiation technique can improve the life expectancy for sufferers.
A new radiation technique can improve the life expectancy for sufferers. (www.sxc.hu: Adam Ciesielski, file photo)
Australian experts are offering new hope to mesothelioma sufferers, claiming a breakthrough in the treatment of the aggressive cancer.
Specialists at the Austin Health Centre in Victoria have discovered a new radiation technique which can improve the life expectancy for sufferers.
Every year, around 700 Australians find out they have mesothelioma. The deadly cancer, which attacks the lungs, is mostly caused by exposure to asbestos.
On average sufferers are given just two years to live after diagnosis.
Dr Malcolm Feigen, a Radiation Oncologist at the Austin Health Centre in Victoria, has for the past seven years been developing new techniques for treating mesothelioma, involving high doses of radiotherapy.
"Gradually with new technologies and better equipment we've been able to increase our doses and look at the results by doing PET scans before they start the radiotherapy and PET scans after they've finished to see what difference we've made," he said.
"And we've been very impressed that in most cases there's a considerable improvement in the activity of the tumour masses that we've given high doses of radiotherapy. And most patients have got through the course of treatment with no major side effects and some have had long-term benefits."
Dr Feigen says patients treated only with chemotherapy mostly have short-term benefits and then the cancer comes back.
"But with radiotherapy it doesn't come back in the same area and if we find patients early enough we may be able to stop any further developments of their disease," he said.
All up, 13 patients were involved in the pilot program.
Breakthrough in fight against mesothelioma
By Lindy Kerin for AM
AM abc.net.au/am
Posted Fri Nov 13, 2009 11:11am AEDT
Updated Fri Nov 13, 2009 11:22am AEDT
A new radiation technique can improve the life expectancy for sufferers.
A new radiation technique can improve the life expectancy for sufferers. (www.sxc.hu: Adam Ciesielski, file photo)
Australian experts are offering new hope to mesothelioma sufferers, claiming a breakthrough in the treatment of the aggressive cancer.
Specialists at the Austin Health Centre in Victoria have discovered a new radiation technique which can improve the life expectancy for sufferers.
Every year, around 700 Australians find out they have mesothelioma. The deadly cancer, which attacks the lungs, is mostly caused by exposure to asbestos.
On average sufferers are given just two years to live after diagnosis.
Dr Malcolm Feigen, a Radiation Oncologist at the Austin Health Centre in Victoria, has for the past seven years been developing new techniques for treating mesothelioma, involving high doses of radiotherapy.
"Gradually with new technologies and better equipment we've been able to increase our doses and look at the results by doing PET scans before they start the radiotherapy and PET scans after they've finished to see what difference we've made," he said.
"And we've been very impressed that in most cases there's a considerable improvement in the activity of the tumour masses that we've given high doses of radiotherapy. And most patients have got through the course of treatment with no major side effects and some have had long-term benefits."
Dr Feigen says patients treated only with chemotherapy mostly have short-term benefits and then the cancer comes back.
"But with radiotherapy it doesn't come back in the same area and if we find patients early enough we may be able to stop any further developments of their disease," he said.
All up, 13 patients were involved in the pilot program.
Sunday, November 15, 2009
Save a Life - Donate Cord Blood - New Science Shows Cord Blood Donations May Cure Leukemias and Other Cancers, Especially for Children
Are cord blood donations important ? You bet ! Great new science documents that children and others with leukemia (and perhaps other lymph cancers) may obtain cures through transplants of two units of cord blood even when there is no perfect match available. This is promising news because today's increasing diversity means that children from diverse marriages have more difficulty in finding perfect matches for marrow stem cell donations. The published medical article is in the journal Blood and can be downloaded here for personal use. Set out below is summary from Science Daily.
University of Minnesota (2009, November 15). Two Units Of Umbilical Cord Blood Reduce Risk Of Leukemia Recurrence. ScienceDaily.
Two Units Of Umbilical Cord Blood Reduce Risk Of Leukemia Recurrence
ScienceDaily (Nov. 15, 2009) — A new study from the Masonic Cancer Center, University of Minnesota shows that patients who have acute leukemia and are transplanted with two units of umbilical cord blood (UCB) have significantly reduced risk of the disease returning. This finding has the potential to change the current medical practice of using one unit of UCB for treatment of patients who are at high risk for recurrence of leukemia and other cancers of the blood and bone marrow.
Michael Verneris, M.D., and John Wagner, M.D., who specialize in research and treatment of children with cancer, led the research team on this breakthrough study. The results are published in the current issue of the scientific medical journal Blood. This study was funded with grants from the National Cancer Institute and the Children's Cancer Research Fund.
Verneris and his colleagues studied 177 patients treated at the University of Minnesota Medical Center, Fairview and the University of Minnesota Amplatz Children's Hospital between 1994 and 2008. The average age of the patients in this study was 16 years. Eighty-eight patients had acute lymphoblastic leukemia (ALL) and 89 had acute myeloid leukemia (AML).
"Our analysis showed that patients in first or second remission from the leukemia had a significantly lower likelihood of leukemia recurrence if they were transplanted with two UCB units than if they were transplanted with one (19 percent vs. 34 percent)," says Verneris.
"We believe our finding provides evidence that using two units of UCB for transplantation may be more effective in preventing leukemia relapse and gives hope to patients with hematological malignancies so that they may live cancer-free," he says.
Blood and marrow stem cell transplantation has been a mainstay treatment for patients with high risk leukemia and other hematological malignancies for the past 30 years. In the last decade, the blood in the placenta and umbilical cord has been collected and banked for public use. Now, UCB is routinely used throughout the world as an alternative to bone marrow transplantation.
However, because of the limited number of cells in UCB, this stem cell source has been reserved for young children and small adults. The practice of using two UCB units (from two different individuals) was pioneered at the University of Minnesota approximately 10 years ago. By using two UCB units, nearly all patients can now use this stem cell source for transplantation.
Previous research studies have also shown that about 25 to 30 percent of patients suffer leukemia relapse after transplant. The relapse or disease recurrence rates are similar regardless of whether the stem cells used for transplantation are from bone marrow, peripheral blood, or umbilical cord blood.
Verneris and his colleagues compared the outcomes of patients who were transplanted with one verses two UCB units. Forty-seven percent of the patients received one unit of UCB; the remaining patients received two units. The choice to receive one versus two units was based on the number of stem cells contained in the UCB. Since the number of stem cells needed for a successful transplant varies with the patient's weight, older patients and those who weigh more need more stem cells than infants and young children.
"Given that adult patients were more likely to receive two UCB units and that they tend to have more aggressive leukemia, we think that the lower relapse rates with two UCB units is remarkable," says Verneris. He notes that while promising, these results will have to lead to a national study comparing one verses two cord blood units in children with leukemia.
"Prior to the research done by my predecessors, the co-infusion of two UCB units had not previously been performed," says Verneris. "We now know that without this double transplantation procedure, the majority of the patients treated would have had no other reasonable treatment option for their leukemia. The fact that they had less leukemia relapse was a wonderful surprise." (emphasis added)
Set out below is the abstract from the medical article.
Relapse risk after umbilical cord blood transplantation: enhanced
graft-versus-leukemia effect in recipients of 2 units
Michael R. Verneris,1,2 Claudio G. Brunstein,2,3 Juliet Barker,2,3 Margaret L. MacMillan,1,2 Todd DeFor,1,2 David H. McKenna,4 Michael J. Burke,1 Bruce R. Blazar,1,2 Jeffrey S. Miller,2,3 Philip B. McGlave,2,3 Daniel J. Weisdorf,2,3 and John E. Wagner1,2
1Department of Pediatrics, 2Blood and Marrow Transplant Program, 3Department of Medicine, and 4Department of Laboratory Medicine and Pathology,
University of Minnesota Medical School, Minneapolis
Umbilical cord blood (UCB) transplantationis potentially curative for acute leukemia. This analysis was performed to identify risk factors associated with leukemia relapse following myeloablative UCB transplantation. Acute leukemia patients (n 177; 88 with acute lymphoblastic leukemia and 89 with acute myeloid leukemia) were treated at a single center. Patients received a UCB graft composed of either 1 (47%) or 2 (53%) partially human leukocyte antigen (HLA)–matched unit(s). Conditioning was with cyclophosphamide and total body irradiation with or
without fludarabine. The incidence of relapse was 26% (95% confidence interval [CI], 19%-33%). In multivariate analysis,relapse was higher in advanced disease patients (> third complete remission [CR3]; relative risk [RR], 3.6; P < .01), with a trend toward less relapse in recipients of 2 UCB units (RR 0.6; P .07). However, relapse was lower for CR1-2 patients who received 2 UCB units (RR 0.5; P < .03). Leukemia-free survival was 40% (95% CI, 30%-51%) and 51% (95% CI, 41%-62%) for single- and double-unit recipients, respectively (P .35). Although it is known that transplantation in CR1 and CR2 is associated with less relapse risk, this analysis reveals an enhanced graft-versus-leukemia effect in acute leukemia patients after transplantation with 2 partially HLA-matched UCB units. This trial was registered at http://clinicaltrials. gov as NCT00309842. (Blood. 2009;114: 4293-4299).
University of Minnesota (2009, November 15). Two Units Of Umbilical Cord Blood Reduce Risk Of Leukemia Recurrence. ScienceDaily.
Two Units Of Umbilical Cord Blood Reduce Risk Of Leukemia Recurrence
ScienceDaily (Nov. 15, 2009) — A new study from the Masonic Cancer Center, University of Minnesota shows that patients who have acute leukemia and are transplanted with two units of umbilical cord blood (UCB) have significantly reduced risk of the disease returning. This finding has the potential to change the current medical practice of using one unit of UCB for treatment of patients who are at high risk for recurrence of leukemia and other cancers of the blood and bone marrow.
Michael Verneris, M.D., and John Wagner, M.D., who specialize in research and treatment of children with cancer, led the research team on this breakthrough study. The results are published in the current issue of the scientific medical journal Blood. This study was funded with grants from the National Cancer Institute and the Children's Cancer Research Fund.
Verneris and his colleagues studied 177 patients treated at the University of Minnesota Medical Center, Fairview and the University of Minnesota Amplatz Children's Hospital between 1994 and 2008. The average age of the patients in this study was 16 years. Eighty-eight patients had acute lymphoblastic leukemia (ALL) and 89 had acute myeloid leukemia (AML).
"Our analysis showed that patients in first or second remission from the leukemia had a significantly lower likelihood of leukemia recurrence if they were transplanted with two UCB units than if they were transplanted with one (19 percent vs. 34 percent)," says Verneris.
"We believe our finding provides evidence that using two units of UCB for transplantation may be more effective in preventing leukemia relapse and gives hope to patients with hematological malignancies so that they may live cancer-free," he says.
Blood and marrow stem cell transplantation has been a mainstay treatment for patients with high risk leukemia and other hematological malignancies for the past 30 years. In the last decade, the blood in the placenta and umbilical cord has been collected and banked for public use. Now, UCB is routinely used throughout the world as an alternative to bone marrow transplantation.
However, because of the limited number of cells in UCB, this stem cell source has been reserved for young children and small adults. The practice of using two UCB units (from two different individuals) was pioneered at the University of Minnesota approximately 10 years ago. By using two UCB units, nearly all patients can now use this stem cell source for transplantation.
Previous research studies have also shown that about 25 to 30 percent of patients suffer leukemia relapse after transplant. The relapse or disease recurrence rates are similar regardless of whether the stem cells used for transplantation are from bone marrow, peripheral blood, or umbilical cord blood.
Verneris and his colleagues compared the outcomes of patients who were transplanted with one verses two UCB units. Forty-seven percent of the patients received one unit of UCB; the remaining patients received two units. The choice to receive one versus two units was based on the number of stem cells contained in the UCB. Since the number of stem cells needed for a successful transplant varies with the patient's weight, older patients and those who weigh more need more stem cells than infants and young children.
"Given that adult patients were more likely to receive two UCB units and that they tend to have more aggressive leukemia, we think that the lower relapse rates with two UCB units is remarkable," says Verneris. He notes that while promising, these results will have to lead to a national study comparing one verses two cord blood units in children with leukemia.
"Prior to the research done by my predecessors, the co-infusion of two UCB units had not previously been performed," says Verneris. "We now know that without this double transplantation procedure, the majority of the patients treated would have had no other reasonable treatment option for their leukemia. The fact that they had less leukemia relapse was a wonderful surprise." (emphasis added)
Set out below is the abstract from the medical article.
Relapse risk after umbilical cord blood transplantation: enhanced
graft-versus-leukemia effect in recipients of 2 units
Michael R. Verneris,1,2 Claudio G. Brunstein,2,3 Juliet Barker,2,3 Margaret L. MacMillan,1,2 Todd DeFor,1,2 David H. McKenna,4 Michael J. Burke,1 Bruce R. Blazar,1,2 Jeffrey S. Miller,2,3 Philip B. McGlave,2,3 Daniel J. Weisdorf,2,3 and John E. Wagner1,2
1Department of Pediatrics, 2Blood and Marrow Transplant Program, 3Department of Medicine, and 4Department of Laboratory Medicine and Pathology,
University of Minnesota Medical School, Minneapolis
Umbilical cord blood (UCB) transplantationis potentially curative for acute leukemia. This analysis was performed to identify risk factors associated with leukemia relapse following myeloablative UCB transplantation. Acute leukemia patients (n 177; 88 with acute lymphoblastic leukemia and 89 with acute myeloid leukemia) were treated at a single center. Patients received a UCB graft composed of either 1 (47%) or 2 (53%) partially human leukocyte antigen (HLA)–matched unit(s). Conditioning was with cyclophosphamide and total body irradiation with or
without fludarabine. The incidence of relapse was 26% (95% confidence interval [CI], 19%-33%). In multivariate analysis,relapse was higher in advanced disease patients (> third complete remission [CR3]; relative risk [RR], 3.6; P < .01), with a trend toward less relapse in recipients of 2 UCB units (RR 0.6; P .07). However, relapse was lower for CR1-2 patients who received 2 UCB units (RR 0.5; P < .03). Leukemia-free survival was 40% (95% CI, 30%-51%) and 51% (95% CI, 41%-62%) for single- and double-unit recipients, respectively (P .35). Although it is known that transplantation in CR1 and CR2 is associated with less relapse risk, this analysis reveals an enhanced graft-versus-leukemia effect in acute leukemia patients after transplantation with 2 partially HLA-matched UCB units. This trial was registered at http://clinicaltrials. gov as NCT00309842. (Blood. 2009;114: 4293-4299).
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