The Politics and Policy page provides a concise and timely round-up of key government-related oncology and biotechnology news. Content is focused upon the public sector activities that are most likely to impact the evolving oncology and biotech industries.
POLITICS & POLICY FED FOCUS
National Human Genome Research Institute Announces Genome Sequencing Centers for The Cancer Genome Atlas Pilot Project
he announcement of the fourth and final component of The Cancer Genome Atlas (TCGA) Pilot Project came on November 20, when the National Human Genome Research Institute (NHGRI) designated three leading research and cancer centers as TCGA Genome Sequencing Centers. The Genome Sequencing Centers (GSC) form one of four integrated components of the TCGA Pilot Project. The others, seven Cancer Genome Characterization Centers, the Data Coordinating Center, and the Biospecimen Core Resource were announced earlier. (see the last issue of Oncology & Biotechnology News for more at http://www.nxtbook.com/nxtbooks/intellisphere/obn1106/.)
The NHGRI and the National Cancer Institute announced that the three sequencing centers will devote a significant part of their DNA sequencing efforts to the TCGA project, strengthening the project’s endeavors to identify the genomic changes involved in three types of tumors: brain (glioblastoma), lung, and ovarian.
The three GSCs are the Broad Institute of MIT and Harvard University, the Genome Sequencing Center at the Washington University School of Medicine in St. Louis, and the Human Genome Sequencing Center at Baylor College or Medicine. These research centers were selected from more than 20 organizations and institutes that have contributed to the Human Genome Project. For fiscal year 2007, the NHGRI has awarded these centers funds of $48 million, $41 million and $27.6 million respectively.
The centers will be responsible for sequencing several genes and selected genomic targets that are identified by two separate approaches. The first will be “genes of interest” such as tumor repressors or oncogenes that are identified from scientific literature and by consultation with oncology experts. The other will be genes and genomic regions that the TCGA’s Cancer Genome Characterization Centers identify as candidates. To conduct these sequencing activities, the centers will receive quality-controlled samples of tumor specimens from the Human Cancer Biospecimen Core Resource.
The GSCs are also expected to test and implement a number of new technologies to increase the speed and bring down the cost of DNA sequencing. The long-term goal is to sequence the entire genome of individual tumor samples.
The centers “will play a pivotal role in our systematic effort to assess the range of genomic changes associated with malignancy,” said Mark Guyer, director of NHGRI’s Division of Extramural Research. “This genomic information will provide the research community with a powerful tool for uncovering new therapeutic targets and developing better strategies for diagnosing, treating and preventing cancer.”
Visit the TCGA website’s page on Genome Sequencing Centers at http://cancergenome. nih.gov/components/gsc.asp.
POLITICS & POLICY THE STATE HOUSE
Several States and Washington, DC Taking Lead in Promoting Cervical Cancer Vaccination
ore than half a dozen states and Washington, DC have introduced legislation that would mandate middle-school age girls to receive a vaccine against the human papilloma virus (HPV), a known cause of cervical cancer. Some states have announced plans to make Merck’s Gardasil vaccine available at no cost—the full regimen of three shots over six months costs $360. Many states offer parents and guardians the choice to opt out of the requirement.
In clinical trials on more than 11,000 girls and women worldwide, Gardasil has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. It also protects against vaginal and vulvar cancers, which are linked to HPV, according to the American Society of Clinical Oncology. Gardasil received its first validation in July 2006 when the FDA approved the vaccine for sale to girls and women ages nine to 26. The CDC followed close on the heels of the FDA’s decision when its Advisory Committee on Immunization Practices recommended that girls ages 11 and 12 receive the vaccine. Then came yet another reinforcement, this time from the American Cancer Society, which published its guidelines for the vaccine in the January 19, 2007 issue of its journal CA: A Cancer Journal for Clinicians.
But even as proponents are commending efforts by US states as a critical step in the fight against cervical cancer, the initiative has drawn fire from critics. Groups who oppose government vaccine requirements as well as many social conservatives are saying that giving Gardasil to young girls could encourage sexual promiscuity. The issue is further complicated because of social and racial issues—a disproportionately high number of cases are found to occur in minority and low-income women.
Whether or not the above states pass their respective bills, many health experts and advocates support the idea and see this as the right step towards combating the deadliest cancer to afflict women. According to the ACS, more than 11,000 women will be diagnosed with cervical cancer in 2007 and about a third of those women will die from the disease. The new vaccines, combined with information about the viral causes of cervical cancer, “present and unprecedented opportunity for global cervical cancer prevention,” the ACS guidelines say.
In the seven months since the FDA approved Gardasil sales, there has been a flurry of HPV vaccine-related legislative actions at the state level. Here is a recap of these actions:
In December, the California Assembly Speaker introduced a bill that would require all girls in the state entering sixth grade to receive a HPV vaccine. The bill would allow girls to be exempted if their parents file a letter saying that participation is against their beliefs.
A bill recently presented in the state legislature would require girls 12 and older to either show proof that they received Gardasil or that their parents have declined the immunization.
The new year for Kentucky started with a newly introduced bill that would require girls in public and private middle schools to receive an HPV vaccination. Kentucky law states that immunizations are not required for “any child whose parents are opposed to medical immunization against disease and who object by a written sworn statement to the immunization of such child on religious grounds.”
In early January, the state planned to begin distributing Gardasil to doctors as part of its plan to provide the vaccine at no cost to female minors between 11 and 18 years of age. The state health department estimates that about 17,000 girls will receive Gardasil over the year. Some doctors will offer the vaccine on a first-come, first-serve basis while others will use waiting lists.
The state Governor announced on January 8 that the state will provide Gardasil at no cost to girls ages 11 to 18, making it the second state after New Hampshire to provide the vaccine for free. About 44,000 girls in the state are eligible for the vaccine, and the state had plans to distribute enough vaccines to physician offices and health department clinics by January 22. In the future, the state health department plans to focus on girls ages 11 and 12.
On January 9, 2007, two DC city council members proposed a bill that would require girls entering the sixth grade to receive Gardasil. They would have to show proof of vaccination before enrolling in DC public schools, unless their parents or guardians opted out of the requirement. At 13.5 cases per 100,000 females, the cervical cancer rate in DC is much higher than the national average of 8.8. The Maryland senate and the Virginia General Assembly saw similar bills the week following the DC bill introduction.
The state has the second highest cervical cancer mortality rate, after Washington, DC, with four women in 100,000 dying of the disease every year. On January 17, a state delegate announced that she would be introducing a bill that would mandate all girls to receive Gardasil by sixth grade. Georgia, New Jersey and Texas are now considering similar initiatives.
Cervical Cancer Vaccine Sparks Scientific, Social Debate
Scientists and society disagree over routine HPV vaccination of girls and women
either leading cancer authorities nor the general public completely agree over whether and when girls and women should receive a new vaccine thought to prevent the most common forms of human papillomavirus (HPV). Left untreated, the sexually transmitted virus can develop, over time, into cervical cancer, considered one of the more preventable and curable of all cancers.
The latest wrinkle in the vaccine debate came from the American Cancer Society, which recently said that, while it agrees with other cancer researchers that the vaccine is most effective when administered to girls as young as age nine, it does not agree the vaccine, Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) from Merck & Co., is effective in protecting women between the ages of 19 and 26 years old.
“There are currently insufficient data to recommend for or against universal vaccination of females age 19 to 26 years in the general population,” according to the January/February 2007 issue of CA: A Cancer Journal for Clinicians. The ACS cited the article in their Jan. 19th position statement on the vaccine. “A decision about whether a woman age 19 to 26 years should receive the vaccine should be based on an informed discussion between the woman and her health care provider regarding
her risk of previous HPV exposure and potential benefit from vaccination.”
The ACS position is in conflict with several other recognized health authorities. The Food and Drug Administration approved the vaccine for use in girls and women ages nine through 26 years of age in early June. Later the same month, a US Centers for Disease Control Advisory Committee on Immunization Practices (ACIP) agreed with the FDA, saying women up to 26 years of age would still benefit from getting the vaccine. The Society of Gynecologic Oncologists concurred, supporting the ACIP’s recommendation for vaccinating women up to age 26, ideally before the onset of sexual activity. The American College of Obstetricians and Gynecologists also agreed with the ACIP recommendations.
In addition to the scientific debate, there is societal debate over routine administration of the vaccine. Twenty-one states and the District of Columbia have reportedly already introduced legislation that would make the HPV vaccine mandatory for school-age girls, adding it to the list of other vaccines mandatory for school attendance. While most of these bills include a parental “opt-out” provision for the HPV vaccine, some parents resist the bill on principle. Several conservative religious groups, while supporting the availability of the vaccine for older women, say making the vaccine mandatory for school-aged children undermines what they feel is the only way to avoid contracting HPV—abstinence. Some women’s health advocates say the vaccine may unintentionally cause women to skip routine PAP screenings, which they should continue to receive with or without the vaccine. Finally, the cost of the vaccine also concerns some groups. Gardasil must be administered three times over a six-month period at a cost of $120.00 per dose, which advocates for poor and uninsured women and children say puts it out of their reach.
Cancer Deaths Drop, But So Do Mammography Screenings
Finding Puzzles, Disturbs Researchers
t the same time they were cautiously celebrating a dramatic and historic drop in death rates from breast and other cancers in the United States, cancer researchers found themselves scratching their heads over the decline in the number of women getting annual mammography screenings in recent years.
The percentage of women over 40 who received an annual mammogram, considered a key component in detecting breast cancer in its earliest, treatable stages, dropped from 76.4 percent in 2000 to 74.6 percent in 2005, according to a US Centers for Disease Control report issued at the end of January. The data was gathered during a national telephone survey conducted from 2000 to 2005.
The finding deeply disturbs cancer experts.
“Although a 1.8% decline in mammography screening from 2000 to 2005 may not seem like much, it means that in 2005, about 1.5 million fewer women took advantage of getting this proven life-saving test,” Len Lichtenfeld, MD, deputy chief medical officer of the American Cancer Society said in a Jan. 26th statement in reaction to the CDC’s findings. Mammogram screening rates actually rose during the 1990s, according to the CDC, but dropped again between 1999 and 2002. This latest study, researchers say, shows the downward trend in mammography screening continuing.
Yet just days before the CDC reported the decline in mammography screenings, the ACS said their were 3,014 less cancer deaths in the United States from 2003 to 2004, compared to 369 fewer deaths reported between 2002 and 2003. The report marked the first decline in actual number of cancer deaths in the more than 70 years since nationwide data began to be compiled. The decline was observed in all four major cancers in men and women (lung, breast, prostate, and colorectal) in 2004, except for lung cancer among women. Colorectal cancer showed the largest decrease in deaths from the disease.
While the CDC could not explain the reason for the decline in mammography screenings, researchers ventured some guesses. “Certainly lack of access to health care and lack of health insurance play a key role in screening rates for all cancers, including breast cancer,” Dr. Litchenfeld says. A shortage of radiologists and facilities to perform mammography could be another factor contributing to the decrease in screening or women may simply be getting less concerned about getting their mammograms on schedule.
Whatever the reason, Dr. Litchenfeld says the ACS must now “redouble efforts to be certain that every woman in this country is aware of the life-saving benefits from this procedure and has access to high quality mammogram services. If this downward trend continues, it is inevitable that deaths from breast cancer will eventually increase.”