Pharma Strategy Blog

We do believe that we should aim to choose 100% of the benefit. We should not forget that the “benefit” in this situation is reducing deaths from breast cancer. A 30% reduction in saving lives is not acceptable. We also recognize that mammograms are not perfect. We realize that women do have to get additional studies for suspicious lesions. We realize that some women have biopsies that do not show breast cancer. We realize that our predictive tests are not perfect, so that we can’t say with certainty which breast cancers are aggressive and require intensive treatment and which would—if left alone—never cause a problem. We realize that we need better screening tools, and that we must work diligently to improve the quality of screening mammography across the country. Until we have something better, what we have to work with to detect breast cancer early is the screening mammogram. Is it imperfect? Yes. Has it saved lives and reduced deaths from breast cancer? Absolutely.

Key research findings:
● Genetic variation in the core components of the PI3K/ PTEN/AKT/mTOR signaling pathway influences recurrence risk, overall survival, and response to chemoradiotherapy for esophageal cancer patients
● A cumulative effect and higher-order interactions among single nucleotide polymorphisms (SNPs) associated with recurrence risk were identified
● A single SNP in AKT2 — rs892119 — was associated with a poor clinical outcome based on all 3 endpoints

Leaders of the House Ways and Means and Energy and Commerce Committees sent a letter to the Government Accountability Office (GAO) last night requesting an expedited report on recent trends in prescription drug pricing.

Ned Calonge, who chairs the 16-member panel, defended the recommendations and denied that cost or the debate over health-care reform played any role in the decision. "Cost just isn't a consideration when the task force deliberates," said Calonge, who is also the chief medical officer for the Colorado Department of Public Health and Environment. Twelve of the task force members were seated during the Bush administration, and the remaining four were chosen before President George W. Bush left office, he said.

new study which uses modeling to summarize the benefits and harms of breast cancer screening finds that regular mammography screening for women ages 50 to 74 reduces the risk of dying due to breast cancer, with a smaller benefit for women 40 to 49.

National statistics show that about 18 percent of all breast cancers occur in women aged 40-49, and, at Johns Hopkins, more than one in four breast cancer patients are among this age group. We also know that breast cancers occurring in women under 50 tend to grow faster and more aggressively than in older women and arise in denser tissues, making their early detection more difficult.

The U.S. Preventive Services Task Force (USPSTF) recommends screening mammography, with or without clinical breast examination (CBE), every 1-2 years for women aged 40 and older.
Grade: B Recommendation.

Way back in 1997, a committee of a dozen experts convened by the National Institutes of Health heard testimony, reviewed the scientific literature and mulled what to tell doctors and women in their 40s about screening for breast cancer.

After weighing the risks and benefits, they concluded:
[T]he data currently available do not warrant a universal recommendation for mammography for all women in their forties. Each woman should decide for herself whether to undergo mammography.