A Medical Device Daily

The U.S. House of Representatives unanimously declared lung cancer a public health priority and called for a reduction in mortality "by at least half by 2015."

Lung Cancer Alliance (LCA) president/CEO, Laurie Fenton-Ambrose hailed this week's passage of House Resolution 335 (H.Res.335) as "a highly significant breakthrough, most welcome during November, Lung Cancer Awareness Month."

The U.S. Senate unanimously passed a similar resolution in August of this year.

"By its action today, the House has now joined the Senate in declaring lung cancer research and mortality reduction public health priorities. This is the first time that both houses of Congress have gone on record stating that the under funding, stigma and neglect of lung cancer must end," she said.

Fenton Ambrose highly praised the primary House sponsors on H.Res.335—Representatives Lois Capps (D-CA), Ed Whitfield (R-KY), and Donna Christensen (D-VI).

"LCA and all of our stakeholders are grateful to Representatives Capps, Whitfield and Christensen and to the 78 other members of Congress who joined as sponsors for their leadership in recognizing the need to address lung cancer with a sense of commitment and urgency," commented Fenton-Ambrose.

"LCA also salutes its advocates around the country for their dedication to making the public and their elected Representatives aware of the devastating statistics on lung cancer."

As both the House and Senate resolutions note, lung cancer is the leading cause of cancer death for men and women, taking more lives each year than breast, prostate, colon, kidney, melanoma and liver cancers — combined.

With large commitments over the years for research funding and screening, the five year survival rates for breast cancer have risen to 88%, for prostate cancer to 99% and for colon cancer to 65%.

The least funded of all the major cancers, lung cancer's five year mortality rate has never gone above 15%, leaving few survivors to advocate for more funding for research and early detection.

Patients are often stigmatized and blamed for their disease whether they smoked or not, Fenton-Ambrose pointed out, even though over 50% of new cases are in former smokers and another 15% in people who never smoked.

"These resolutions passed by the House and Senate will help break through decades of neglect and blame and lead to fundamental policy changes in the way we address and fund lung cancer research and early detection," she said.

Genzyme expects Synvisc-One approval delay

Genzyme (Cambridge, Massachusetts) reported that it has received a letter from the FDA requesting additional analyses and data regarding the marketing application for Synvisc-One in the U.S. The company now expects that approval of the next-generation Synvisc(R) (hylan G-F 20) to be delayed in the U.S. until at least 2Q08.

Synvisc-One is a single treatment of Synvisc that is intended to provide up to six months of pain relief from osteoarthritis (OA) of the knee. Genzyme believes that Synvisc-One will simplify osteoarthritis pain management and provide added patient convenience, while reducing the overall cost of therapy and offering a treatment option that will expand the benefits of viscosupplementation to a broader number of patients.

Genzyme has filed for approval of Synvisc-One in Europe and, if granted a CE mark there, will pursue marketing approvals in wider geographies in Asia and Latin America.

The U.S. House Subcommittee on Domestic Policy of the Oversight and Government Reform Committee held a hearing yesterday, to discuss FDA's responsibility to evaluate the harmful environmental impacts of mercury dental fillings and to question why FDA has not finalized a rule proposed in 2002 to classify mercury tooth fillings under the Medical Device regulations.

Dental mercury releases from clinics are the largest contributor of mercury to municipal waste water treatment plants in the U.S. and are a significant contributor of mercury emissions to the environment and the fish Americans eat. According to US EPA, 34 tons of mercury is used in mercury-based dental fillings each year to fill tooth cavities, and the largest current single use of mercury today is in Americans' mouths — over 1,000 tons.

Testimony by one witness, Michael Bender, Director of the Mercury Policy Project, will show that dental mercury air emissions may be more than five times higher than recent EPA estimates.

The role of mercury tooth fillings, often called amalgams, in dentistry has become an issue of increasing concern for lawmakers recently for both environmental and health reasons. According to a recent article in FDA Week, "Subcommittee members Diane Watson (D-CA) and Dan Burton (R-IN) have pushed for hearings on dental amalgams, Burton's spokesperson says. The lawmakers reintroduced legislation May 1 that would phase out such amalgams."

OBP asks CMS to rethink determination

Ortho Biotech Products (OBP; Bridgewater, New Jersey) the company that markets Procrit (Epoetin alfa), will formally request that the Centers for Medicare and Medicaid Services (CMS) reconsider its final National Coverage Determination (NCD) for erythropoiesis-stimulating agents (ESAs).

The company will provide new scientific evidence and highlight specific areas in which it believes that CMS materially misinterpreted existing data in reaching its current NCD. These two conditions are specified by CMS as necessary for reconsideration of an NCD.

"The goal of our reconsideration request is to re-open an evidence-based dialogue with CMS to ensure that Medicare reimbursement for ESAs supports safe and effective treatment of anemia for patients receiving chemotherapy," said Craig Tendler, M.D., VP, Medical Affairs, Oncology/Nephrology, Ortho Biotech Products L.P. "The policy of most concern is the imposition of a coverage limit on ESA treatment once hemoglobin levels reach 10 grams per deciliter of blood (g/dL). We will present CMS with additional scientific data demonstrating the importance of individualizing ESA therapy — particularly when to initiate and stop therapy — based on the medical needs of Medicare patients."