American Society of Clinical Oncology

Web site: www.asco.org

bulletAbout ASCO

The American Society of Clinical Oncology (ASCO) is a non-profit organization, founded in 1964, with overarching goals of improving cancer care and prevention and ensuring that all patients with cancer receive care of the highest quality. More than 25,000 oncology practitioners belong to ASCO, representing all oncology disciplines (medical, radiation, and surgical oncology) and subspecialties. Members include physicians and health-care professionals participating in approved oncology training programs, oncology nurses, and other practitioners with a predominant interest in oncology.

bulletNews and Items of Interest

ASCO Action in Brief

ASCO Urges Congress to Pass 13-Month SGR Patch
While ASCO is calling for the development of a new system that pays oncologists directly and fairly for all of the services involved in treating Medicare patients, ASCO is also urging Congress to pass a 13-month patch for the sustainable growth rate formula for Medicare physician payments in the meantime. ASCO has signed on to a joint letter with more than 100 medical societies to House and Senate leadership.

Congress Passes Continuing Resolution
Before adjourning for recess, Congress passed a continuing resolution funding all government agencies at their current levels through December 3, 2010.

Congress Passes Improving Access to Clinical Trials Act
On September 24, Congress sent to President Obama legislation to address financial barriers that may affect Medicaid and Supplemental Security Income recipients ability to participate in a clinical trial.

OHRP Releases Final Guidance on Patient Withdrawal from Research
The Office of Human Research Protections (OHRP) recently released its final guidance document on patient withdrawal from research. The final guidance reflects recommendations made by ASCO when it submitted comments on the initial draft.

Amgen Issues Voluntary Nationwide Recall of Certain Lots Of Epogen® And Procrit® (Epoetin Alfa)
The Food and Drug Administration has issued an announcement that Amgen has issued a voluntary recall for certain lots of EPOGEN® and PROCRIT® (Epoetin alfa) vials. ASCO Urges Congress to Pass 13-Month SGR Patch
On September 29, Congress adjourned for recess without taking any action with the sustainable growth rate formula for Medicare physician payments and the almost 30 percent cut facing physicians in 2011. Rather than fix the SGR formula, Congress has continued to pass short-term patches, with the current one expiring on November 30, 2010, and it is unlikely that Congress will be able to take any long-term action in the brief lame-duck session following the election.

Therefore, ASCO, along with more than 100 medical societies, have sent letters to House and Senate leadership urging Congress to pass a 13-month patch for the SGR. This patch would provide stability and predictability to Medicare physician payments through 2011 and will allow time for the development of a new system that pays oncologists directly and fairly for all of the services involved in treating Medicare patients.

Your members of Congress have just begun an extended work period in your district and state, and will be hosting local events and town halls. If you attend one of these events, please urge them to support this 13-month patch, and ask that they begin work on a permanent repeal immediately. Even if you don’t attend an event, you can still send a message urging action on the issue by visiting ASCO’s Grassroots Action Center.

Congress Passes Continuing Resolution
Congress has passed a continuing resolution funding all government agencies, including the National Institutes of Health, the National Cancer Institute and the Food and Drug Administration, at their current levels through December 3, 2010. Congress went into recess on September 29, but the House and Senate are expected to pass an omnibus appropriations bill when they return for a lame-duck session after the November 2 election. ASCO will continue to advocate for increased funding for cancer research for the remainder of this session of Congress and when the new Congressional session begins in early 2011.

Congress Passes Improving Access to Clinical Trials Act
On September 24, Congress passed the Improving Access to Clinical Trials Act (S.1674), which would allow patients who receive Medicaid or Supplemental Security Income (SSI) to receive payments for enrolling in clinical trials without jeopardizing their Medicaid and SSI eligibility. This legislation, which unanimously passed both the House and Senate, allows trial participants to exclude up to $2000 per year of clinical trial compensation from their income when determining eligibility for Medicaid and SSI.


OHRP Releases Final Guidance on Patient Withdrawal from Research in Line with ASCO’s Recommendations
The Office of Human Research Protections (OHRP) recently released its final guidance document on patient withdrawal from research. The document, Withdrawal of Subjects from Research: Data Retention and Other Related Issues, was initially released in December 2008 and was finalized based on the consideration of 30 comment letters received by OHRP from individuals and organizations, including ASCO.

In alignment with ASCO’s recommendations, the final guidance now includes specific provisions regarding management of various scenarios related to patient withdrawal from participation in a research study. Examples include scenarios in which a patient chooses to withdraw from all components of a study, and scenarios in which a patient chooses to withdraw from the intervention component of a study, but desires to continue participation on secondary research components.

ASCO’s comment letter also expressed concern that the draft guidance was too restrictive regarding the use of human biospeicmens for research purposes and was not consistent with Food and Drug Administration (FDA) requirements. In the recently released final guidance, OHRP removed all content regarding research with biospecimens, stating that this change made the document more harmonious with FDA’s guidance on the topic. In a notice published in the Federal Register, OHRP indicated that a more comprehensive guidance document will be developed in the future to address this, “complex, evolving area of research.”

In regard to patients who withdraw from participation in research, OHRP’s final guidance specifically indicates that investigators are permitted to maintain and use data that was collected prior to the patient’s withdrawal, provided the research is conducted in accordance with the IRB-approved protocol. The final guidance further elaborates on research that is subject to the HIPAA Privacy Rule, indicating that analysis of protected health information (PHI) can only continue if it is necessary in maintaining the integrity of the research study. According to the guidance document, “For FDA-regulated research, retention and analysis of already collected data, including PHI, is always considered necessary to protect the integrity of the research study.”

ASCO applauds OHRP’s commitment to protecting human research participants by developing guidance documents that increase transparency and promote harmony with FDA requirements related to clinical research. Such guidance is important in helping investigators maintain compliance with federal regulations.

Amgen Issues Voluntary Nationwide Recall of Certain Lots Of Epogen® And Procrit® (Epoetin Alfa)
Amgen has issued a voluntary recall for certain lots of EPOGEN® and PROCRIT® (Epoetin alfa) vials from specialty distributors, wholesalers, pharmacies and healthcare providers. The recalled product may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. To determine if the recall affects you, please read the FDA’s announcement of the recall.

News and Notes

Congress Amends Stem Cell Therapeutic and Research Reauthorization Act
Congress has unanimously passed legislation amending the Stem Cell Therapeutic and Research Reauthorization Act. This bill – which applies only to non-embryonic cells – extends the funding for the National Cord Blood Inventory (NCBI) Program for another five years and lifts NCBI’s cap of 150,000 available new units of cord blood. The NCBI was established in the original act to help treat patients who need umbilical cord blood or a bone marrow transplant. The legislation will now be sent to President Barack Obama for his signature.

NIH Clinical Center Offers Sabbatical/Training in Clinical Research Management
The National Institutes of Health Clinical Center is accepting applications for a sabbatical/training program in clinical research management. The sabbatical is intended to help ensure that medical research programs are safe, ethical, and efficient and is open to clinical investigators, health care managers and administrators, and others who oversee clinical trials. There is no fee for participating in the program, and applications are accepted year-round. For more information, please visit clinicalcenter.nih.gov/training/sabbatical/index.html.

NIH Launches Database on Genomic Structural Variations
The National Institutes of Health has launched the Database of Genomic Structural Variation (dbVar) to assist scientists in understanding how DNA differences contribute to health and disease. dbVar will help track variations in DNA discovered in both healthy individuals as well as those living with diseases, such as cancer. The database was developed by the National Center for Biotechnology Information. To access dbVar, please visit www.ncbi.nlm.nih.gov/dbvar.

NIH to Establish Institute on Minority Health and Health Disparities
The National Institutes of Health (NIH) has announced that the National Center on Minority Health and Health Disparities (NCMHD) will transition to become the National Institute on Minority Health and Health Disparities (NIMHD). As an institute, NIMHD will have a more defined role in the NIH's research agenda to address health disparities and will be authorized to plan, coordinate, review and evaluate all minority health and health disparities research activities conducted and supported by the NIH institutes and centers. For more information on NIMHD and its programs, please visit www.ncmhd.nih.gov.

bulletLetters supported by ICAN