Addressing attendees at the opening business program of the National Association of Chain Drug Stores (NACDS) Pharmacy & Technology Conference yesterday, H-E-B chief administrative officer and NACDS chairman of the board Robert D. Loeffler called for even stronger grassroots engagement on public policy priorities that are vital to pharmacy patient care.

Specifically, Loeffler urged attendees to participate in the grassroots advocacy program NACDS RxIMPACT - by attending the Day on Capitol Hill in Washington, D.C. and by weighing in with their federal and state legislators on key legislation throughout the year.

"NACDS has never been stronger, and NACDS needs to confront any threat to the viability of pharmacy patient care services. That said, I need to emphasize an undeniable, unavoidable, and perhaps under-appreciated fact: we need your engagement," Loeffler said.

Loeffler noted that the complexity of pharmacy issues requires true dedication in demonstrating to policymakers the importance of pro-patient policy "that reduces the nation's overall healthcare expenses and maintains patient care at high levels, while keeping the pharmacy industry viable."

"It's not that grassroots engagement is a missing ingredient within pharmacy," he said. "It just needs a lot more muscle. We need your engagement."

Loeffler cited NACDS' success in rallying the involvement of pharmacy in public policy advocacy, "from those just beginning pharmacy school, to those who could write their textbooks." He said that in 2011 NACDS RxIMPACT already has nearly tripled the number of letters written in 2010 by pharmacy advocates to their legislators - from 5,000 to 14,000; that the program has generated 26 pharmacy tours in 2012; and that NACDS RxIMPACT Day on Capitol Hill has grown in participation from 150 advocates in 2009 to 350 this year.

He called on attendees to visit the NACDS RxIMPACT website (www.rximpact.org) and contact lawmakers in support of the Pharmacy Competition and Consumer Choice Act (H.R. 1971 in the House of Representatives and S. 1058 in the Senate).

"This bill includes provisions about transparency, the frequency of updating MAC pricing, networks, audits, use of data, and many of the topics that threaten many in this room, and the patients we serve," Loeffler said.

Loeffler urged participation in the 2012 NACDS RxIMPACT Day on Capitol Hill, scheduled for March 14-15, 2012.

"It is a top priority of NACDS to ensure that the health of patients, and the wellness of the nation's healthcare delivery system, can benefit from pharmacy services that are accessible by every patient and give every patient choices. And we will take that stand with vigor and with resolve," said Loeffler.

Increases in vaccination rates for human papillomavirus (HPV) are trailing increases in rates for two other vaccines recommended for teens and preteens, according to data from the Centers for Disease Control and Prevention.

Coverage rates for the other two vaccines --Tdap, which protects against tetanus, diphtheria and pertussis, and MenACWY, which protects against meningococcal meningitis--are continuing to increase, but vaccination rates for HPV vaccine remain low, the study found. HPV infection can lead to cervical cancer, but vaccination dramatically reduces this risk.

The study in CDC's Morbidity and Mortality Weekly Report drew on data from the 2010 National Immunization Survey-Teen.

"More U.S. teens are being protected against these serious, and sometimes deadly, diseases," said Anne Schuchat, M.D., director of the CDC's National Center for Immunization and Respiratory Diseases.

"However, the HPV results are very concerning. Our progress is stagnating, and if we don't make major changes, far too many girls in this generation will remain vulnerable to cervical cancer later in life. Now that we have the tools to prevent most cervical cancers, it is critical that we use them."

About 6 million people become infected with HPV each year, and the CDC reports that every year, about 12,000 women will be diagnosed with cervical cancer.

CDC recommends HPV vaccine for 11- or 12-year-old girls to protect against the types of HPV that cause cervical cancer and also recommends teenage girls who have not yet been vaccinated with HPV vaccine complete the vaccination series. HPV vaccines are given in three doses (as shots) over six months. To ensure the highest level of protection, girls must complete all three shots.

The CDC NIS-Teen survey found:

• Coverage for the three routine teen vaccines was 49 percent for one dose of HPV vaccine; 63 percent for MenACWY; and 69 percent for Tdap vaccine.

• For girls who received the recommended three doses of HPV vaccine, coverage increased 5.3 points to 32 percent over the previous year.

• Hispanics had higher coverage for one dose of MenACWY and HPV, but third-dose HPV coverage lagged for blacks and Hispanics compared with whites. Girls living in poverty were also less likely to complete the HPV series.

• Coverage increases for HPV were less than half of the increases seen for Tdap (13.3 points) and meningitis (9.1 points) vaccines.

Continued improvements in MenACWY and Tdap are important. With 27,550 cases of pertussis reported in 2010 - 4,858 in 11- to 18-year-olds - it is critical that preteens get their Tdap vaccine. "This one-time dose of Tdap can prevent pertussis infection," said Dr. Schuchat.

"Also, preteens and teens who get vaccinated with MenACWY are protecting themselves from an infection that can lead to lifelong disability - or, in some cases, death in 48 hours or less. Let's make sure all teens are protected."

Dr. Schuchat stressed that any visit to the doctor--such as annual health checkup or physicals for sports, camp, or college--can be a good time for preteens and teens to get the recommended vaccinations. By making sure all recommended vaccines are given at every opportunity, coverage for all the teen vaccines could increase substantially.

Families who may need help paying for vaccines should ask their health care provider about the Vaccines for Children program, which provides vaccines at no cost to uninsured children younger than 19 years. For help in finding a local health care provider who participates in the program, parents can call 800-CDC-INFO or go to www.cdc.gov/vaccines.

The CDC has conducted the National Immunization Survey-Teen since 2006. This survey of more than 19,000 teens aged 13-17, is similar to the standard NIS which began collecting immunization information in 1994 among children 19 through 35 months old. The NIS-Teen is a random telephone survey of parents or caregivers, followed by verification of records with health care providers. The survey estimates the proportion of teens aged 13 through 17 years who have received the three recommended adolescent vaccines, as well as three of the recommended childhood vaccines, by the time they are surveyed.

Amgen today announced that the U.S. Food and Drug Administration (FDA) will target a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2012 for the supplemental Biologics License Application (sBLA) to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases.

Bone is one of the most common places for cancer to spread. If approved in this expanded indication, XGEVA would become the first therapy licensed to prevent or delay the spread of cancer to bone.

XGEVA is the first and only RANK Ligand inhibitor approved by the FDA indicated for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors.

XGEVA was initially approved following a six-month priority review by the FDA. It is not indicated for the prevention of SREs in patients with multiple myeloma. XGEVA is the first novel bone metastases treatment for advanced cancer patients in nearly a decade.

Delivered as an every four week 120 mg subcutaneous injection, XGEVA provides a unique option for urologists and oncologists to prevent SREs in patients with advanced cancer.

XGEVA is a fully human monoclonal antibody that binds to RANK Ligand, a protein essential for the formation, function and survival of osteoclasts (the cells that break down bone). XGEVA prevents RANK Ligand from activating its receptor, RANK, on the surface of osteoclasts, thereby decreasing bone destruction.

XGEVA has been studied in over 7,000 patients with cancer. In clinical trials, XGEVA demonstrated a clinically meaningful improvement compared to the previous standard of care in preventing bone complications. XGEVA is also being investigated for the potential use to delay the onset of bone metastasis in adjuvant breast cancer.

Seattle Genetics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Adcetris (brentuximab vedotin) for two indications:

(1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates.

(2) the treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen.

The indications for Adcetris are based on response rate. There is no data available demonstrating improvement in patient-reported outcomes or survival with Adcetris. Adcetris is the first drug approved by the FDA for Hodgkin lymphoma in more than 30 years, and provides a new therapeutic alternative for Hodgkin lymphoma and systemic ALCL in these settings.

Seattle Genetics expects to make Adcetris available to patients next week. Adcetris is an antibody-drug conjugate (ADC) directed to CD30.

"Bringing a new product to the market is a significant milestone for Seattle Genetics in fulfilling its mission to improve the lives of people with cancer," said Clay B. Siegall, PhD, president and CEO of Seattle Genetics.

"The approval of Adcetris is a result of more than a decade of research and development by talented scientists and physicians. The company has deep appreciation for the hundreds of patients who participated in Adcetris trials, and the passion and determination of the clinicians at sites around the world in investigating this first in a new class of targeted anticancer agents.

"We are committed to continued clinical investigation of Adcetris through a broad development program for CD30-positive malignancies, including confirmatory trials in front-line Hodgkin and T-cell lymphomas that we have planned in consultation with the FDA."

"The marked single agent activity seen with Adcetris, including a high durable complete remission rate, offers an opportunity to improve the treatment paradigm of patients for whom the treatment is indicated," said Owen A. O'Connor, MD, PhD, professor and director, Division of Hematology and Medical Oncology at NYU Cancer Institute. "This approval represents a major advancement in the care of these patients."