Genomics And Personalized Medicine Open Policy Forum

Brings Cancer Care Leaders to Cleveland

Newswise — Actress Angelina Jolie’s opinion piece in The New York Times this month highlighted the critical role genetic testing can play in cancer prevention – as well as the obstacles many face in securing that lifesaving knowledge.

The test that determined Jolie’s increased breast cancer risk can cost as much as $3,000, she wrote. “It has got to be a priority to ensure that more women can access gene testing… whatever their means and background, wherever they live.”

The benefits of science’s dramatic growth in genomic knowledge extend well beyond identifying genes that correlate with increased risk. Today oncologists can individualize a patient’s cancer treatment after they identify a genetic mutation in the tumor – one absent from all the patient’s other cells.

Leaders of the Case Comprehensive Cancer Center agree – and not only for women and breast cancer. More, they are taking action to persuade federal officials to support measures that remove barriers to testing – and to treatment as well.

This month the Center hosts dozens of experts in research, public policy and advocacy as part of a five-state effort to develop recommendations to the Food and Drug Administration and the Centers for Medicare and Medicaid Services regarding genetic testing and treatment. In the simplest terms, advances in genomics provide physicians unprecedented opportunities to identify and eliminate cancer in patients. But too often those options are limited because policies haven’t kept pace with science.

“Genomics identify which patients may benefit from a drug,” said Stanton Gerson, MD, Asa and Patricia Shiverick- Jane Shiverick (Tripp) Professor of Hematological Oncology, Director of the Case Comprehensive Cancer Center and Director of the Seidman Cancer Center at UH Case Medical Center. “Once a drug has been shown to be effective against a specific gene, patients may need access and insurance coverage for that drug to treat their cancer.”

The June 10 forum will include representatives from more than a half dozen cancer centers across the Midwest, and marks the first such gathering of its kind.

Gerson and his colleagues do not simply seek blanket expansion of coverage. In many instances, genetic testing can tell whether or not a certain medication will be effective. Ruling out futile options is not only better for the patient, but also cuts overall health care costs.

Given that the human genome includes more than 20,000 genes, traditional approaches to drug approval often are too cumbersome to provide timely aid to patients who need help most. A more effective approach for patients – and efficient one for spending – would be to approve genetically based therapeutics deemed appropriate based the patient’s genetic profile. Similarly, insurance coverage for tests would be based on proof that genetic markers or mutations correlate with high probability of tumor development – and on evidence that specific therapeutics yield desired genetic changes in prevention and cures.

“Genomics identify which patients may benefit from a drug because they have a particular mutation that we did not expect in the tumor,” said Gerson, who also serves as the Forum chair. “We know that not all patients will benefit, but the gene testing allows us for the first time to be precise in our treatment recommendations.”

Conference participants will explore progress in developing genetically based tests and therapeutics, as well as potential approaches to engage federal agencies in increasing patient access to needed interventions. Organizers expect to develop a white paper with recommendations for federal leaders as a result of next month’s discussions.

Participating cancer centers include: Roswell Park Cancer Institute, University of Pittsburgh Cancer Institute, University of Michigan Comprehensive Cancer Center, The Ohio State University Comprehensive Cancer Center, The Barbara Ann Karmanos Cancer Institute and Case Comprehensive Cancer Center – in addition to leaders from other NCI designated cancer centers, representatives from the pharmaceutical and insurance industry, public health, patient advocacy and government organizations.

The forum, entitled the “Impact of Genomics on Cancer Diagnosis and Treatment: Open Drug Policy Forum,” will take place on the health sciences campus at Case Western Reserve School of Medicine, in the Iris S. and Bert L. Wolstein Research Building. For more information and to register, please click here.

About Case Western Reserve University School of Medicine
Founded in 1843, Case Western Reserve University School of Medicine is the largest medical research institution in Ohio and is among the nation’s top medical schools for research funding from the National Institutes of Health. The School of Medicine is recognized throughout the international medical community for outstanding achievements in teaching. The School’s innovative and pioneering Western Reserve2 curriculum interweaves four themes--research and scholarship, clinical mastery, leadership, and civic professionalism--to prepare students for the practice of evidence-based medicine in the rapidly changing health care environment of the 21st century. Nine Nobel Laureates have been affiliated with the School of Medicine.

Annually, the School of Medicine trains more than 800 MD and MD/PhD students and ranks in the top 25 among U.S. research-oriented medical schools as designated by U.S. News & World Report’s “Guide to Graduate Education.”

The School of Medicine’s primary affiliate is University Hospitals Case Medical Center and is additionally affiliated with MetroHealth Medical Center, the Louis Stokes Cleveland Department of Veterans Affairs Medical Center, and the Cleveland Clinic, with which it established the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in 2002. http://casemed.case.edu

About Case Comprehensive Cancer Center
Case Comprehensive Cancer Center is an NCI-designated Comprehensive Cancer Center located at Case Western Reserve University. The center, now in its 25nd year of funding, integrates the cancer research activities of the largest biomedical research and health care institutions in Ohio – Case Western Reserve, University Hospitals (UH) Case Medical Center and the Cleveland Clinic. NCI-designated cancer centers are characterized by scientific excellence and the capability to integrate a diversity of research approaches to focus on the problem of cancer. It is led by Stanton Gerson, MD, Asa and Patricia Shiverick- Jane Shiverick (Tripp) Professor of Hematological Oncology, Director of the National Center for Regenerative Medicine, Case Western Reserve, and director of the Seidman Cancer Center at UH Case Medical Center. http://cancer.cwru.edu/