. 

 



President Bush signs bill
to authorize federal
cord blood funding 




Skin cancer gel to advance
in clinical testing
 
  
January 3, 2006
  
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ASBMT HOME

 BMT Tandem Meetings
Feb. 16-20, 2006
Honolulu, Hawaii

 
Calendar

• January
New Developments in the Epidemiology of Cancer Prognosis: Traditional and Molecular Predictors of Treatment Response and Survival
American Association for Cancer Research (AACR)
Jan. 11-15
Charleston Place
Charleston, South Carolina

Ubiquitin and Cancer: From Molecular Targets and Mechanisms to the Clinic
American Association for Cancer Research (AACR)
Jan. 18-22
Disney’s Contemporary Resort
Lake Buena Vista, Florida

Drugging the Cancer Genome: Developing Rational Combination Therapies for Multigene Cancers
American Association for Cancer Research (AACR)
Jan. 25-29
Marriott Rancho Las Palmas Resort & Spa
Rancho Mirage, California

• February
Conference on Molecular Basis for Targeted Therapy for Leukemia
American Association for Cancer Research (AACR)
and European School of Haematology (ESH)
Feb. 2-6
Cascais, Portugal

BMT Tandem Meetings
(Combined ASBMT and CIBMTR annual meetings)
Feb. 16-20
Hawaii Convention Center
Honolulu, Hawaii

2nd Advances Against Aspergillosis Conference
Feb. 22-25
Hilton Athens
Athens, Greece

• March
Cancer Susceptibility and Cancer Susceptibility Syndromes
American Association for Cancer Research (AACR)
March 1-5
Sheraton Maui
Maui, Hawaii

Frontiers of Immune Suppression
American Society of Transplantation (AST)
10th Annual Winter Symposium
March 16-19
Westin Resort & Spa Cancun
Cancun, Mexico

European Group for Blood and Marrow Transplantation (EBMT)
32nd Annual Meeting
March 19-22
Congress Centrum Hamburg
Hamburg, Germany

• April
American Association for Cancer Research (AACR)
97th Annual Meeting
April 1-5
Washington Convention Center
Washington, D.C.

American Society of Pediatric Hematology/Oncology (ASPH/O)
19th Annual Meeting
April 28-May 1
San Francisco, California

• May
American Society for Apheresis (AAFS)
27th Annual Meeting
May 23-26
Venetian Resort Hotel
Las Vegas, Nevada

• June
Federation of Clinical Immunology Societies (FOCIS)
6th Annual Conference
June 1-5
San Francisco Marriott
San Francisco, California

American Society of Clinical Oncology (ASCO)
42nd Annual Meeting
June 3-6
Georgia World Congress Center
Atlanta, Georgia

International Society for Stem Cell Research (ISSCR)
4th Annual Meetings
June 29-July 1
Metro Toronto Convention Center
Toronto, Ontario

• July
World Transplant Congress 2006
American Society of Transplant Surgeons (ASTS)
and the American Society of Transplantation (AST)
July 22-27
Hynes Convention Center
Boston, Massachusetts

Society for Cryobiology
Cryo 2006: 43nd Meeting

July 24-27
Hamburg Chamber of Commerce
Hamburg, Germany

• September
German Society for Transfusion Medicine and Immunohematology (DGTI)
in collaboration with the International Society for Cellular Therapy-Europe (ISCT-Europe)

39th Annual Congress
Sept. 19-22
Congress Centre Messe
Frankfurt, Germany

10th Biennial National Symposium on Hematopoietic Cell Transplantation
Stanford University School of Medicine
Sept. 28-30
Fairchild Auditorium
Stanford, California

2007
BMT Tandem Meetings
(Combined ASBMT and CIBMTR annual meetings)
Feb. 8-12
Keystone Conference Center
Keystone, Colorado

2008
BMT Tandem Meetings
(Combined ASBMT and CIBMTR annual meetings)
Feb. 13-17
Manchester Grand Hyatt Hotel
San Diego, California

 
  
Top Stories
 
President Bush signs bill to authorize federal cord blood funding
President Bush has signed a bill (HR 2520) that authorizes $79 million in federal funding for the collection and storage of umbilical cord blood. The bill, the Cord Blood Stem Cell Act of 2005, was passed by the House last May, and amended and passed by the Senate on Dec. 16. The law creates an umbilical cord blood bank network to support disease treatment and stem cell research.  
   
All 11 stem cell lines determined to be false
An expert panel investigating South Korean researcher Hwang Woo-suk has determined that none of the 11 embryonic stem cell lines he claimed to have created actually exist. The original 11 stem cell lines were from only two stem cell lines, and the cells could not be matched to patients’ DNA.
   
Test predicts adverse reaction to irinotecan
The Mayo Clinic is offering a new diagnostic test that will allow patients to determine through genetic screening whether they are likely to have a serious reaction to irinotecan hydrochloride, used to treat advanced colon cancer and rectal cancer. The test is based on UGT1A1 technology, which detects a change in the DNA of a gene that encodes for a protein involved in the metabolism of irinotecan. 
   
Hyperbaric oxygen increases stem cell circulation
Hyperbaric oxygen treatment can cause an eight-fold increase in the number of stem cells circulating in a patient’s body, according to a report published in the Nov. 15, 2005, issue of the American Journal of Physiology: Heart and Circulation Physiology. Researchers concluded that hyperbaric oxygen treatment is a safer way to increase stem cell circulation, compared with pharmaceutical options. 
   

A Word from President Nelson Chao, M.D.

Primum non nocere. . . . It is a widely held misconception that the familiar dictum “First, do no harm” comes from the Hippocratic Oath. But the Hippocratic Oath does not, and never did, contain those words.

Many scholars are of the opinion that Hippocrates did, in fact, originate the phrase, but in another of his writings, Epidemics, Bk. I, Sect. XI. One translation reads: “Declare the past, diagnose the present, foretell the future; practice these acts. As to diseases, make a habit of two things — to help, or at least to do no harm."

It is true that “First, do no harm” is expressed Primum non nocere in Latin, but Hippocrates wrote in his native Greek. So Latin cannot be the origin of the phrase. Some sources attribute Primum non nocere to the Roman physician, Galen.

What does this have to do with anything? I am writing to you about a recently introduced Senate bill that addresses two particular needs of terminally ill patients: unnecessary barriers to promising new therapies and ethical concerns about enrolling patients in studies that are placebo-controlled or that have a “no treatment” arm.

Introduced by Sen. Sam Brownback (R-Kan.), the proposed legislation would reform the Food and Drug Administration’s approval system of treatments for patients with cancer and other life-threatening diseases. It would accelerate the availability of cancer drugs, biological products and medical devices for terminally ill patients, creating a three-tiered approval system that may be more responsive to their needs.

The bill also addresses one of the cornerstones of medical research, which also is one of the great ethical dilemmas for studies with terminally ill patients: the random assignment of patients to placebo or to conventional therapy in clinical trials. The bill would relax, when it makes sense to do so, rigid requirements that trials have a placebo or no-treatment arm. It would encourage the FDA to consider modern alternative methodologies that may not involve placebos. The agency already is doing this in its medical devices division for tests of lifesaving products such as defibrillators.

The FDA’s cancer division has, over the years, largely relied on mortality statistics when approving new therapies. The agency has been reluctant to endorse other metrics such as tumor shrinkage and improved quality of life. Recently, though, the FDA has acknowledged “progression-free survival” as a clinical benefit. For example, if a tumor has not grown or a malignancy has not spread and the patient is still alive, the treatment may be considered to have clinical value.

The Wall Street Journal put it more bluntly the other day, saying that “the FDA is no longer insisting that we wait around for people to die to get statistics when a drug is obviously working.”

We all want to help seriously ill patients, but we also want to avoid harm. As stem cell physicians, we understand these issues well, as we deal with them on a daily basis in patients with advanced disease. What we do has the potential for cure, but also the potential for causing harm and suffering.

We absolutely want to avoid the snake oils, coffee enemas and laetrile-like “cures.” Placebo-controlled trials are critical in the early development of a therapy when there’s no other option and effectiveness is highly uncertain. But it is difficult to enroll a seriously ill patient in a study that has a placebo arm or a no-treatment arm when an alternative therapy promises real benefits and an improved outcome.

Sen. Brownback’s bill is S 1956 and is titled Access, Compassion, Care and Ethics for Seriously Ill Patients Act (or the “Access Act” for short). Co-sponsors are Sen. James Inhofe (R-Okla.) and Sen. Johnny Isakson (R-Ga.).

According to Sen. Brownback, the decision for terminally ill patients to participate in an investigational therapy should be between the physician and the patients, not government bureaucrats.

Declaratio ab definio, difficultas discordia. Expressed in those terms, it’s hard to disagree.

– Nelson

 
Clinical Research
 
  EU awards 12 million euro grant for cancer research
The European Union has awarded a 12 million euro ($14.2 million) grant to international researchers to refine gyroscopic technology to detect cancer proteins. The researchers have manufactured discs less than 0.1 millimeter in diameter and coated them with special patterns of DNA or proteins that cause cancer-specific markers to bind to the surface.

  Skin cancer gel to advance in clinical testing
Peplin plans to step up human testing of its PEP005 skin cancer gel, thanks to $10 million in funding raised from institutional investors. This drug is a potential treatment for actinic keratosis, which can develop into skin cancer. The next stage of phase II testing, scheduled to begin in 2006, involves concurrent clinical trials in Australia and the U.S.  

  Holograms could replace biopsies for cancer diagnosis
Welsh scientists are working to develop holographic technology that could provide high-resolution images of suspected tumors, potentially replacing conventional biopsies. During an endoscopic procedure, pictures would be taken of the suspected cancer, which would then be turned into color three-dimensional holograms using computer technology.

  Ultraviolet B increases basal, squamous cell carcinoma risk
Exposure to ultraviolet B radiation in test tubes may cause a decreased ability to repair chromosomal damage, leading to increased risk of basal cell and squamous cell carcinoma but not melanoma. According to a report published in the Dec. 21 issue of the Journal of the National Cancer Institute, UB-V radiation can cause strands of DNA to break, and some people’s systems may be unable to repair this damage.

 
Pharmaceutical News
 
FDA approves Femara to treat early stage breast cancer
The U.S. Food and Drug Administration has approved Femara (letrozole), an aromatase inhibitor from Novartis, to treat early stage breast cancer. Tests in more than 8,000 women show that this drug is free of some of the serious side-effects of tamoxifen, including endometrial cancer and potentially fatal blood clots. 

FDA approves Revlimid for treatment of MDS
The U.S. Food and Drug Administration has approved Revlimid (lenalidomide) from Celegene Corporation, indicated for a subset of transfusion-dependent patients with myelodysplastic syndromes.   
 
Association News
 

  Comments sought for new edition of FACT standards
A new edition of FACT Standards for transplant centers has been completed and is available for public comment through Jan. 31. The Standards are used for accreditation of facilities in the three phases of blood and marrow transplantation: collection, processing and clinical care. Major updates occur at three-year intervals. 

  Review addresses transplants for ALL in adults
A comprehensive evidence-based review of blood and marrow transplantation for acute lymphoblastic leukemia in adults appears in the January Biology of Blood and Marrow Transplantation. A review of ALL in pediatric patients was published in the November 2005 issue. Together they are the latest in the ASBMT series of evidence-based reviews of hematopoietic stem cell transplantation for specific diseases. 

  NMDP provides funding for evidence-based reviews
The National Marrow Donor Program (NMDP) has awarded a $600,000 grant to ASBMT to support the development and dissemination of evidence-based reviews. The funds will be disbursed over a three-year period as work on the reviews progresses. The next review will address acute myelogenous leukemia, and an expert panel is being assembled for the review. 

  2006 version of RFI forms released
The 2006 update of the ASBMT Standardized Request for Information (RFI) has been released, and the interactive forms are available online. The RFI is used for submitting transplant program data and information to third-party payers when they request it. 

  Ballots for officers, directors are in the mail this week
The ballots for the annual election of ASBMT officers and directors are being mailed this week to Society members. Completed ballots must be returned by Tuesday, Jan. 24. 

  Next Monday is housing deadline for Hawaii meeting
The deadline for advance registration and housing is next Monday for the 2006 BMT Tandem Meetings, to be held Feb. 16-20 in Honolulu. Registration and housing are available on the ASBMT Web site, or click the link below. After Jan. 9, registration rates are higher, and housing will be on a “space available” basis. Some categories of housing already are full as pre-registration indicates another year of record attendance. 

  Orrin Hatch to receive Public Service Award
Sen. Orrin G. Hatch (R-Utah), a leading congressional advocate for cancer research, blood and marrow transplantation, and stem cell research, will receive the 2006 ASBMT Public Service Award. The award will be presented at the BMT Tandem Meetings Feb. 18 in Honolulu.

  Nurses, pharmacists, administrators prepare for Honolulu
Program agenda are online for conferences parallel to the BMT Tandem Meetings in February in Honolulu: Transplant Nurses (Feb. 18-20), BMT Pharmacists (Feb. 15-17), BMT Center Administrators (Feb. 17-18), and Clinical Research Professionals Data Management (Feb. 15-17).

  Tours and vacation packages offered for Hawaii
Professional help is available for arranging tours and pre- and post-meeting vacation packages. Scenic and historic island tours, Diamond Head hike, helicopter flights, Atlantis submarine, whale watching and Polynesian shows. Peruse the possibilities online.

  Travel grants awarded to 46 young investigators
The ASBMT Board of Directors has announced 46 travel grants for young clinicians and investigators who will be traveling to the BMT Tandem Meetings in February in Honolulu. Grants of $1,000 each are being awarded to the 23 young investigators who are presenting oral abstracts at the meetings, and grants of $750 are being given to 23 who are presenting posters that earned the highest scores from the Abstract Review Committees.

  Membership jumps 17% to record 1,370
ASBMT membership climbed 17.5% during 2005, well exceeding the 10% goal that was set for the year by the Society’s leaders. Part of the strategy for membership growth was a $50 across-the-board reduction in dues for most membership categories. The largest increase was among In-Training Members, climbing from 114 to 209. Health professionals outside of the United States and Canada comprise 12% of ASBMT members.

  Three new editorial appointments for BBMT
The ASBMT Board of Directors has appointed a new associate editor and two new members to the Editorial Board for Biology of Blood and Marrow Transplantation. Announcing the new appointments was Editor-in-Chief Robert Korngold, Ph.D.

  

Copyright © 2006 American Society for Blood and Marrow Transplantation. All rights reserved.

The editor for ASBMT eNews is Andrew L. Pecora, M.D.

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