The members appointed to the Methodology Committee are:

• Naomi Aronson, PhD, Executive Director, Blue Cross and Blue Shield Association Technology Evaluation Center.
• Ethan Basch, MD, MSc, medical oncologist and health services researcher, Department of Medicine and Department of Epidemiology, Memorial Sloan-Kettering Cancer Center.
• Alfred Berg, MD, MPH, Professor, Department of Family Medicine, University of Washington.
• David Flum, MD, MPH, Professor, Department of Surgery and Adjunct Professor, Department of Health Services, University of Washington Schools of Medicine and Public Health; Attending physician, General Surgery, University of Washington Medical Center.
• Sherine Gabriel, MD, MSc, Professor of Medicine and of Epidemiology, and the William J. and Charles H. Mayo Professor, Mayo Clinic.
• Steven Goodman, MD, PhD, Professor of Oncology, of Pediatrics, of Epidemiology and of Biostatistics, Johns Hopkins School of Medicine and Bloomberg School of Public Health.
• Mark Helfand, MD, MS, MPH, Professor of Medicine and of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University; Staff physician, Portland VA Medical Center.
• John Ioannidis, MD, DSc, the C.F. Rehnborg Professor in Disease Prevention, Professor of Medicine and Director, Stanford Prevention Research Center, Stanford University School of Medicine.
• David Meltzer, MD, PhD,  Director, Center for Health and the Social Sciences, Chief of the Section of Hospital Medicine, and Associate Professor, Department of Medicine, Department of Economics, and Graduate School of Public Policy Studies, University of Chicago.
• Brian Mittman, PhD, Director, VA Center for Implementation Practice and Research Support, Department of Veterans Affairs Greater Los Angeles Healthcare System.
• Robin Newhouse, PhD, RN, Assistant Dean, Doctor of Nursing Practice Program and Associate Professor, Organizational Systems and Adult Health, University of Maryland School of Nursing.
• Sharon-Lise Normand, MSc, PhD, Professor of Health Care Policy, Harvard Medical School and Professor of Biostatistics, Harvard School of Public Health.
• Sebastian Schneeweiss, MD, ScD, Associate Professor, Department of Medicine, Harvard Medical School and Associate Professor, Department of Epidemiology, Harvard School of Public Health;  Vice Chief and Director,  Drug Evaluation and Outcomes Research, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital.
• Mary Tinetti, MD, Professor of Medicine, Epidemiology, and Public Health, Division of Geriatrics, Yale University School of Medicine;  Director, Program on Aging, Yale University School of Medicine.
• Clyde Yancy, MD, MSc, Chief, Cardiology, Northwestern University Feinberg School of Medicine; Associate Director, The Bluhm Cardiovascular Institute, Northwestern Memorial Hospital.

“The Methodology Committee has the responsibility of helping PCORI develop and update methodological standards and guidance for comparative clinical effectiveness research.  The  men and women named today bring impressive credentials and experience to this important task,” Dodaro said.

In addition to the 15 members appointed today, the Director of the Agency for Healthcare Research and Quality and the Director of the National Institutes of Health, or their designees, will also serve on the committee.

Under the provisions of the Affordable Care Act, PCORI is tasked with assisting patients, clinicians, purchasers, and policymakers in making informed health decisions by providing quality, relevant evidence on how best to prevent, diagnose, treat, and monitor diseases and other health conditions.

“Thanks for your comments.”

Words heard over and over in elevators, hallways, and coffee breaks in the last couple of weeks, as Colorectal Cancer Coalition research advocates spoke out during research-focused meetings … appreciation expressed for the reality-based voices of patients as research gets planned and evaluated.

We’ve been busy with three different meetings in the last ten days . . . and a big one coming up.

Colon and Rectal Cancer Clinical Trials Planning Meeting

Pam McAllister and I were in Washington meeting with two of the task forces that provide input to the National Cancer Institute Gastrointestinal Cancers Steering Committee.  Pam serves on the Colon Task Force, and I am part of the Rectal/Anal Task Force.

The GI Steering Committee approves new NCI clinical trial concepts and is key to getting trials prioritized and moving ahead.  Colorectal Cancer Coalition Board Chair Nancy Roach serves on that critical committee.

The task forces met to set clinical trials priorities and goals for the next eighteen months.  There was lots of new thinking and plans for the future.  Among ideas discussed in the Rectal Task Force were:

• The importance of clinical trials to find answers that were clinically meaningful to patients rather than just statistically significant.
• Helping patients to balance survival and side effects as they make decisions about their care.
• Reducing the impact of treatment on long-term side effects, including bowel function and peripheral neuropathy.
• Making sure that the right patient gets the right treatment — chemotherapy, radiation, and surgery.
• Including studies of genomic changes upfront in clinical trials.
• Involving advocates.

Comparative Effectiveness Research and Cancer Genomic Medicine

I was one the stakeholders discussing whether there was enough evidence to move ahead with three different genomic tests or if more research was necessary into their value.

My particular concern was screening all colorectal cancer patients’ tumors for Lynch syndrome in order to test and protect their relatives.

Unusual for many meetings I attend was the involvement of the people who pay for health care — the Centers for Medicare and Medicaid Services (CMS) and insurers including Humana and Blue Cross and Blue Shield.  Agencies that develop guidelines for testing and treating cancer patients were also there:  National Comprehensive Cancer Network (NCCN) and Evaluation of Genomic Applications in Practice and Prevention (EGAPP).

EGAPP has developed a recommendation for Genetic testing strategies in newly diagnosed individuals with colorectal cancer aimed at reducing morbidity and mortality from Lynch syndrome in relatives.

Despite fairly good evidence that testings tumors of newly diagnosed people with colorectal cancer for potential Lynch syndrome benefits both patients and their relatives, the group felt that processes were not in place to notify relatives when Lynch syndrome was found or counsel and test those relatives at risk.

Radiation Therapy Oncology Group (RTOG)

Pam McAllister and I were back together for the RTOG meeting in San Diego where we both are members of the Patient Advocacy Committee.

Emphasis during the meeting was on Patient-Reported Outcomes or PROs as a way of evaluating and reporting treatment side effects and quality of life.

While chemotherapy and radiation toxicity in clinical trials has normally been reported by doctors and nurses conducting the trials, research shows that there is a significant difference in what patients say about their own side effects and how toxicity gets reported.  PROs may be more meaningful and accurate, particularly in helping future patients make treatment decisions.

RTOG is one of the cancer cooperative groups, funded by NCI, to conduct clinical trials.

Stay tuned for reports from the 2011 Gastrointestinal Symposium beginning on Thursday, January 18 in San Francisco.

Catherine Knowles is C3′s new Director of Policy

The health care reform debate continues.  Last week, the Senate Finance Committee discussed Senator Baucus’s proposal and considered hundreds of amendments.  The Committee will hold a final vote on the proposed bill later this week.  This will allow the Congressional Budget Office (CBO) time to complete its analysis of the bill and provide a final cost estimate.  After the Finance Committee has approved the bill, it will be combined with the bill from the Senate Health, Education, Labor and Pensions Committee before it is scheduled for a vote on the floor by the full Senate.

C3 has been closely following the various health reform proposals introduced in Congress, because access to care is critical to preventing, treating and beating colorectal cancer.  Please feel free to share your thoughts with us by leaving comments below.

Continue reading for more information on some of the amendments adopted by the Senate Finance Committee that C3 thinks are important for people living with colorectal cancer.

C3 was pleased to see that the Senate Finance Committee made significant changes to the health reform overhaul package it considered that will make health care more affordable and accessible.

Sen. Cantwell (D-WA) sponsored an amendment that will let states create low-cost health insurance plans for low-income families.  The amendment is designed to encourage states to enact a program mirroring the Washington State Basic Health plan.  It will allow states to put people making more than 133 percent of the federal poverty level (the upper threshold for Medicaid in the mark) and less than 200 percent of the federal poverty level (approximately $44,000 for a family of four) in a state-based government plan.  The amendment provides a federally funded, non-Medicaid, state plan which combines the innovation and quality of private sector competition with the purchasing power of the states.  It passed 12-11.  This amendment would help expand coverage to people who currently cannot afford insurance.  And without insurance, people are less likely to be screened, let alone able to be treated for colorectal cancer.

The committee also adopted along party lines an amendment sponsored by Senate Finance Health Subcommittee Chairman Rockefeller (D-WV) regarding so-called “Cadillac” insurance policies – expensive policies with low deductibles, limited co-pays and extensive benefits.  Senator Baucus proposed taxing the insurers for plans that cost over $8,000 anually ($21,000 for a family) in order to help offset costs of coverage for the uninsured.  In addition, there is an underlying assumption that “Cadillac” policies encourage inappropriate over-use of medical care – and taxing these policies could help make them less attractive.   However, some of the committee were concerned that some consumers – people in high-risk jobs, or older Americans – have to spend that much for “Chevrolet” coverage.  They felt that the costs should be increased.  Under the Rockefeller amendment, the cost of the plans for retirees older than 55 and those in high-risk professions must total $9,850 for individuals and $26,000 for families before they are considered “Cadillac” and therefore taxable.  The threshold tops the amounts in the underlying proposed bill by $1,100 for individuals and $3,000 for families.

Colorectal cancer patients tend to be older – most people are diagnosed over age 50.  And the cost of insurance policies increases significantly as people age.  The Rockefeller amendment will increase affordability to policies for retirees over age 55.

The Rockefeller amendment also guarantees that the independent commission set up to find savings in Medicare cannot propose increases to Medicare premiums.  This will reassure Medicare recipients who are concerned about cuts in benefits accompanied by increases in premiums.

The Committee also addressed comparative effectiveness research.  Comparative effectiveness research (CER) compares treatments – for example, does ibuprofen, aspirin or acetaminophen work better for a headache?  Senator Baucus proposed the formation of a Patient-Centered Outcomes Research Institute (PCORI) which would be responsible for coordinating CER data and communicating results with health care providers and the public.  Comparative effectiveness will help determine what therapies can be used to effectively treat those with colorectal cancer.  Any provisions related to comparative effectiveness research should be conducted through an open and transparent process involving all stakeholders, starting from the research planning stage.  During the Senate Finance Committee markup, Sen. Grassley (R-IA) sponsored an amendment designed to improve the PCORI governance of patient-centered outcomes research institute.  The amendment would not allow the Secretary of Department of Health and Human Services, the National Institutes of Health, and other high-ranking officials, including elected officials and appointees, from being board members of the institute.   It was agreed to by voice vote.  Ensuring that patient voices are represented and that politics is kept out of comparative effectiveness research is extremely important to ensuring that patients continue to have access to innovative and life-saving medical treatments.

You can read the entire text of the Senate Finance Committee bill as amended online.

Finding the best imaging methods to diagnosis and monitor cancer and comparing new colorectal cancer screening technologies to current standards are among recommended priorities for comparative effectiveness research (CER).  The FDA reports new egg safety rules and the recall of a powdered dietary supplement.

Videos of cancer patients are now online discussing the emotional impact of their diagnosis in The Day I Found Out.

Research Reports

• Reduced uptake on FDG/PET after the first chemotherapy treatment may be able to predict how well patients will respond to chemo. In early information from a study of  advanced colorectal cancer patients reported at ASCO 2009, PET scans before initial chemo and  again two weeks later accurately predicted tumor response on later CT scans.   Dr.  Alain Hendlisz said, “Our results show that if tumor metabolism does not respond after 14 days, the patient is not likely to experience tumor shrinkage two or three months later on. Finding this out early on in treatment can help us avoid unnecessary side effects and also allows us to try another type of therapy sooner, if possible, to optimize results for our patients.”
• Chemotherapy before surgery to remove colorectal cancer that has spread to the liver makes CT scan evaluation less accurate. Doctors in France compared whether liver metastases were correctly identified in 92 patients, 30 of whom did not have chemotherapy before surgery.  CT either failed to find lesions or identified tumors that weren’t there in half of the chemotherapy patients but only about a third of those who went directly to surgery.  Other factors making CT scans less accurate were more than three liver tumors and fatty deposits (steatosis) in more than 30 percent of liver tissue.  Benjamin Angliviel and the team from the Hôpital Ambroise Paré in Boulogne report their results in the May, 2009 issue of the Annals of Surgical Oncology.

Other Headlines

• Finding the best imaging strategies for the diagnosis, staging, and monitoring of cancer is among the 25 most important priorities for comparative-effectiveness research (CER) recommended by a new Institute of Medicine report.  Comparing the effectiveness of new colorectal cancer screening methods, including CT colonographyand FIT, to usual care with FOBT and colonoscopy to prevent colorectal cancer is among the second tier of 25.  The IOM report chose 100 priorities from an initial list of 1,300 as important for $1.1 billion in CER funding to help Americans make good health care decisions based on evidence from research.  Said Dr. Harold C. Sox, co-chair of the IOM panel, “Healthcare decisions too often are a matter of guesswork because we lack good evidence to inform them.”
• Cancer survivors share their stories of diagnosis and treatment on video talking about The Day I Found Out. Developed by the Seattle Cancer Care Alliance, the videos include several colon cancer patients including C3 advocate and stage IV survivor Anita Mitchell who talks about her oncologist who gave her hope when he said, “I have a plan for you.”  She says, “All I needed was that hope.”
• The FDA has issued new rules to help reduce Salmonella infections from eggs.   Large egg farmers will have to buy chicks from bacteria safe sources, keep facilities clean and bacteria-free, test their facilities regularly, and refrigerate eggs promptly for storage and shipment.  Salmonella enteritidis causes more than 140,000 illnesses every year, some of which are life-threatening.  FDA tells consumers to buy only refrigerated eggs, check for clean and uncracked shells, refrigerate eggs promptly at home, and cook eggs until yolks are firm.
• FDA: Vital Pharmaceuticals has recalled lots of its powdered dietary supplement Stealth Chocolate and Stealth Vanilla because it may be contaminated with Salmonella. Milk protein concentrate, one of the supplement’s ingredients, was recalled by the supplier.  The dietary supplements were sold nationwide, including at GNC stores.  Consumers with questions may contact Vital Pharmaceutical Inc. at 1-800-954-7904 or 954-641-0570 during the hours of 9 am – 5 pm, Monday through Friday.