Health and Biotechnology: Year in Review

Cancer Clinical Trials a Tough Sell to Patients

On June 5, results of a survey conducted by the Coalition of Cancer Cooperative Groups and Northwestern University were announced at the American Society of Clinical Oncology annual meeting, showing that “as few as one in 10 cancer survivors report ever being made aware of trial opportunities during treatment.” Just 50,000 of the estimated 200,000 newly diagnosed patients each year who may be eligible for participating in cancer treatment trials actually do so.

Later that month, study results published in a supplement to the Journal of Clinical Oncology stated that “less than 5% of adult cancer patients participate in clinical trials.”

The National Cancer Institute backs these findings, adding that the problem is particularly significant in adolescent and adult patients; whereas 60% of children with cancer participate in cancer clinical trials, only “about 3-5% of the 10.1 million adults with cancer in the U.S. participate” and only 10% of patients age 15-19 years are entered into cancer trials.

Even when patients are referred to a “dedicated phase I clinic with the expressed intent of participating in a phase I trial,” accrual rates, although higher than the norm, were still low (29.5%) in a study reported in the November 8 issue of BMC Cancer. Additionally, 24.7% of patients were deemed ineligible, 14% declined entering a trial, 12.6% before entering the trial were recommended another treatment, and “8.4% were unable to participate due to lack of available trials or open cohorts.”

The lack of awareness of cancer clinical trials has become so pervasive that entire conferences are now dedicated to the issue. On December 11-12, the FDA hosted Clinical Trials: Effective Recruitment and Informed Consent Strategies — An Interactive Workshop to Avoid the Industry’s Biggest Pitfalls, based on the premise that “failure to recruit subject is the number one reason clinical trials do not meet deadlines. Compounded by failure to properly consent patients, 72 percent of all trials run over schedule by more than one month and only 6 percent are completed on time.”

“We are at a real turning point in the development of new cancer treatments with the large number of clinical trials currently underway, but too few patients are aware that these trials even exist,” said Robert L. Comis, MD, president and chairman of the Coalition of Cancer Cooperative Groups. “Serious lag times will continue to occur in completing these studies unless there is an improved dialogue between the physician and patient about trial opportunities.”

Cancer Genome Atlas Starts to Roll in 2006

The official launch of The Cancer Genome Atlas (TCGA) on December 13, 2005 was the first and last major news story regarding TCGA for nine months, until September when the National Institutes of Health (NIH) announced that the genomic changes of lung, brain, and ovarian cancers would be the first to be mapped under the three-year, $100 million TCGA Pilot Project.

These cancers were selected because all are leading types among men and women, and also due to the ready “availability of biospecimen collections that met TCGA’s strict scientific, technical, and ethical requirements.” The chosen biorepositories were the Lung Cancer Tissue Bank of the Cancer and Leukemia Group B clinical trials group, at the Brigham and Women’s Hospital; MD Anderson Cancer Center in Houston, TX (glioblastoma); and the Gynecologic Oncology Group tissue bank at the Children’s Hospital of the Ohio State University.

NCI and the National Human Genome Research Institute (NHGRI) also announced in September that the International Genomics Consortium, in collaboration with the Translational Genomics Research Institute of Phoenix, AZ, will “establish and manage” TCGA’s Biospecimen Core Resource (BCR), one of four “integrated components”—BCR, Cancer Genome Characterization Centers (CGCCs), Genome Sequencing Centers (GSCs), and a Principal Bioinformatics Resource (PBR)—of TCGA.

Shortly thereafter, NCI and NHGRI announced the establishment of the CGCCs seven member institutions located in five states; the CGCCs will be supported by an $11.7 million grant per year from the Pilot Project. The seven members are: Broad Institute of MIT and Harvard; Harvard Medical School and Brigham and Women’s Hospital; Lawrence Berkeley National Laboratory; Memorial Sloan-Kettering Cancer Center; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University; Stanford University School of Medicine; and the University of North Carolina Lineberger Comprehensive Cancer Center.

On November 20, the NHGRI committed its support to three GSCs—Broad Institute Sequencing Platform, The Eli & Edythe L. Broad Institute of the Massachusetts Institute of Technology and Harvard University; Washington University Genome Sequencing Center, Washington University School of Medicine; and Human Genome Sequencing Center, Baylor College of Medicine—leaving only the PBR to be named, which at the current pace of announcements, could come in early 2007.

CCHIT Certifies Electronic Health Record Products

During the last six months, The Certification Commission for Healthcare Information Technology (CCHIT)—tasked with the mission of fostering the “adoption of health information technology to improve US healthcare”—has certified a total of 33 ambulatory electronic health record (EHR) products, each of which comply 100% with the more than 200 required criteria. Twenty were announced on July 18, two on July 31, and 11 on October 23. The established criteria were “designed to ensure that products provide a broad foundation of functionality, will evolve to be interoperable with other systems, and include security features that protect the privacy of personal health information.” HHS Secretary Mike Leavitt said, “This seal of certification removes a significant barrier to wide-spread adoption of electronic health records. It gives healthcare providers peace of mind to know they are purchasing a product that is functional, interoperable and will bring higher quality, safer care to patients.”

Industry reaction to the CCHIT EHR certification process has been mixed. Netsmart Technologies, a software supplier to US state and community mental health centers, is the designer of one of the CCHIT-certified EHR products. According to Kevin Scalia, executive vice president of corporate development, the company is excited about receving certification. “Being the first behavioral health provider to receive certification pushes our industry forward,” he said. On the other hand, some companies are concerned with the cost of the certification process. Not only do companies have to invest funds to develop their products, they also have to pay an initial $28,000 certification fee and foot yearly recertification costs. Vice President of marketing and government affairs at Greenway Medical Technologies, Inc., Justin Barnes, wonders “why more of the some 200 existing EHR companies did not apply for certification,” but surmises “cost is likely a factor.”

A new initiative will be established during the CCHIT EHR certification process to “expand certification criteria for ambulatory electronic medical records software to reflect different specialties and care settings.” The plan will consider adding new specialty areas starting in 2007, with the intention of adding more every year.

Midterm Elections Halt Health IT Legislation

Prior to election season, it seemed as if some health IT legislation might be passed before year's end, but now that control over Congress has changed, further progress might not be made until after the 110th Congress convenes in January. Of more than 50 health IT bills introduced during the 109th session of Congress, only two—The Wired for Health Care Quality Act (S. 1418) and the Health IT Promotion Act of 2006 (H.R. 4157)—seemed likely candidates for approval back in August (the outlook on that front has soured considerably since then). In October, the Healthcare Information and Management Systems Society (HIMSS) and 40 organizations (including the US Chamber of Commerce, the National Association of Manufacturers, IBM, Dell, and Oracle) signed a letter encouraging both the House and Senate to “resolve their differences” regarding the bills passed during the past year. Still, Dave Roberts, Vice President of Government Relations, HIMSS, acknowledges even before the change in leadership, it was not smooth-sailing for HIT legislation. Roberts notes that among the details that still need to be hammered out between S. 1418 and H.R. 4157 are “differences in provisions that would allow hospitals to share health IT systems with doctors,” the final authority on privacy standards, and funding issues. For more, listen to the Special Audio Report “Prospects for Health IT Legislation in 2007 ‘Look Pretty Good,’ Rep. Kennedy Policy Adviser Says.”

More Americans Going Online for Health Information

According to the recently released report Online Health Search 2006 from the Pew Internet & American Life Project, 80% of American Internet users have searched for health-related information, with 10 million looking for such information on a typical day. Further, 53% said their most recent health-information search had an impact on how they cared for themselves or someone else, 58% reported that the information they found affected how they would decide to treat an illness or condition, and 55% said the information “changed their overall approach to maintaining their health or the health of someone they help take care of.” With so many Americans using the Internet to find health information, several health-specific search engines were launched this year, including Healia, launched on September 18; MedStory, released as a public beta version in mid-July; Mamma Health, made available in June; and Kosmix Health, launched in early-February. The additions accompany the already available Yahoo Health, Healthline, Google Directory — Health and LookSmart Health. Although the search engines all aim to help patients in their online search for health information, they differ in regards to quality and quantity of sites returned for a given search. Google Directory — Health offers search categories and Healia provides search filters, allowing users to narrow down the number of sites returned through which they must browse for information, whereas Healthline uses icons displayed next to returns that refer to the quality of the return. With only 15% of people surveyed for Online Health Search 2006 saying “they ‘always’ check the source and date of the health information they find online,” we feel it’s up to healthcare providers to at least explain to patients to check for dates, references, and reputable sources when searching online.

More Reductions in Medicare Reimbursement Rates for Oncologists?

Oncologists awaiting the release of the Medicare Physician Fee Schedule Notice for 2007 on November 1 were greeted with few positives, as nearly all provisions therein affecting them involved a decrease in reimbursement.

The Center for Medicare and Medicaid Services (CMS) will continue to dole out extra payment for “pre-administration services related to [intravenous immune globulin] IVIG” which totals approximately $71.00 per day of IVIG treatment. CMS also followed through on proposed increases in physician relative work values for numerous codes pertaining to evaluation and management, including level 3-5 established patient office visits and office consultations.

CMS reduced the 2007 conversion factor “by 5.0% to $35.98” and “finalized its proposal to revise the methodology for setting practice expense relative values,” which when fully phased in, is expected to decrease oncology payments by 1%. ASCO believes that these cuts, in combination with losses from other Medicare rule changes, “could create treatment access problems for patients” (). CMS also plans to move ahead with implementation of the Deficit Reduction Act provision “capping the payment amount for the technical component of imaging services at the hospital outpatient payment rate,” but will maintain reduction of the payment rate “for the technical component of the second and subsequent imaging procedures in the same family at 25%, rather than further reducing it to 50% as it had proposed in 2005.”

While it “remains under consideration,” the decision that could have the most dramatic effect on oncologists is the possibility that CMS will not continue the “pay for reporting demonstration for oncology services” that it conducted in 2005 and 2006. At the start of 2006, CMS estimated “the demonstration would add $150 million into the cancer care delivery system,” resources which would be lost if the project is not continued.

Un-Coordinated

The position of National Coordinator for Health Information Technology (NCHIT)—with the duty to “execute the actions ordered by President George W. Bush in the Executive Order that he issued on April 27, 2004, which called for widespread deployment of health information technology within 10 years to help realize substantial improvements in safety and efficiency” according to the Department of Health and Human Services (HHS)—has been in a state of flux throughout most of 2006, with relief thus far yet to be seen. On April 20, David J. Brailer, MD, PhD, announced his resignation from the position he had held for two years, citing family reasons and the hassles of commuting weekly from his home in San Francisco to Washington, DC. Although he stated the resignation involved “no drama,” Dr. Brailer did note that “some people will use my leaving to attack the president or to say the program is not going well.” However, he added in an April 20 Financial Times article that the NCHIT office is “mature and moving in the right direction…if anyone expected me to stay to the point where every doctor and patient has an electronic health record, that was a profoundly unrealistic expectation.”Although Dr. Brailer agreed to consult the HHS on health care IT and serve as vice chair of the American Health Information Community, no replacement was named until September 20, when HHS officials announced the appointment of Veterans Health Administration CIO Robert M. Kolodner, MD, as the Interim National Coordinator for Health Information Technology. From day one, it was known that Dr. Kolodner’s tenure would be limited, with a VA spokesperson announcing that he was still serving on a detail from the VA. Although reaction to the appointment was positive—HHS Secretary Mike Leavitt stated, “He joins us at a time when we are making steady progress in advancing the President’s health IT initiative, and his experience in patient care, health IT, and government will be invaluable to those efforts”—and Dr. Kolodner holds strong goals, he stated in late October that he would leave the position in roughly two months, causing the Office of the National Coordinator again to rely on interim executives until a suitable long-term candidate is found; no name has yet been publicly announced.

Check out the January issue of MDNG for more on Dr. Kolodner, his goals as NCHIT, and his thoughts on the future of HIT.

Big Future for Nanotechnology

The National Cancer Institute (NCI) has been the leader in nanotechnology research to find new ways in detecting cancer “at its earliest stages, pinpointing its location within the body, delivering anticancer drugs specifically to malignant cells, and determining if these drugs are killing malignant cells."

Our June 2006 cover story “Nanotechnology: Science Fiction or the Future of Oncology” discussed nanotechnology and the six major areas of research the NCI was planning to emphasize: imaging/early detection, prevention and control, multifunctional therapeutics, in vivo imaging systems, reporters of efficacy, and research enablers.

Throughout 2006, the NCI was actively involved with awarding grants to institutions to pursue nanotechnology research. Recently, it awarded nine five-year Tumor Microenvironment Network grants (worth $2 million) nationwide for researchers to “study tumor ‘microenvironments,’ where tumors interact with surrounding tissues, cells and chemicals in ways that all too often encourage cancer cells to invade other areas of the body in the process known as metastasis.”Recipients were Lawrence Berkeley Laboratory, Stanford University School of Medicine, Memorial Sloan-Kettering Cancer Center, Massachusetts Institute of Technology, Vanderbilt University Medical Center, University of Washington School of Medicine, Baylor College of Medicine, Columbia University, and College of Nanoscale Science and Engineering of the University of Albany and Albert Einstein College of Medicine of Yeshiva University. The focus of the grant is to “develop a next-generation microchip that, when placed in a cancerous mass, can gather information on the presence of metastatic cells that would demand more aggressive cancer therapy.” Grants have also been authorized to help private companies in furthering their research, including for Fairway Medical Technologies, which received a $2.7 million phase II grant and a $1.1 million Small Business Innovation Research Phase II grant both from the NCI to “support Phase II research into breast and prostate cancer using a laser optoacoustic imaging technology.”The hope is that the grants will help prove that this imaging technology “can locate tumors tagged with gold nanorods bound to antibodies against breast cancer-specific receptors.”