Sham Mailankody

Unintended Consequences of Expensive Cancer Therapeutics—The Pursuit of Marginal Indications and a Me-Too Mentality That Stifles Innovation and Creativity: The John Conley Lecture

Cancer is expected to continue as a major health and economic problem worldwide. Several factors are contributing to the increasing economic burden imposed by cancer, with the cost of cancer drugs an undeniably important variable. The use of expensive therapies with marginal benefits for their approved indications and for unproven indications is contributing to the rising cost of cancer care. We believe that expensive therapies are stifling progress by (1) encouraging enormous expenditures of time, money, and resources on marginal therapeutic indications and (2) promoting a me-too mentality that is stifling innovation and creativity. The modest gains of Food and Drug Administration-approved therapies and the limited progress against major cancers is evidence of a lowering of the efficacy bar that, together with high drug prices, has inadvertently incentivized the pursuit of marginal outcomes and a me-too mentality evidenced by the duplication of effort and redundant pharmaceutical pipelines. We discuss the economic realities that are driving this process and provide suggestions for radical changes to reengineer our collective cancer ecosystem to achieve better outcomes for society.

Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues After Approval

Importance A common justification for high cancer drug prices is the sizable research and development (R&D) outlay necessary to bring a drug to the US market. A recent estimate of R&D spending is

Implications of Proposed Medicare Reforms to Counteract High Cancer Drug Prices

2.7 billion (2017 US dollars). However, this analysis lacks transparency and independent replication. Objective To provide a contemporary estimate of R&D spending to develop cancer drugs. Design, Setting, and Participants Analysis of US Securities and Exchange Commission filings for drug companies with no drugs on the US market that received approval by the US Food and Drug Administration for a cancer drug from January 1, 2006, through December 31, 2015. Cumulative R&D spending was estimated from initiation of drug development activity to date of approval. Earnings were also identified from the time of approval to the present. The study was conducted from December 10, 2016, to March 2, 2017. Main Outcomes and Measures Median R&D spending on cancer drug development. Results Ten companies and drugs were included in this analysis. The 10 companies had a median time to develop a drug of 7.3 years (range, 5.8-15.2 years). Five drugs (50%) received accelerated approval from the US Food and Drug Administration, and 5 (50%) received regular approval. The median cost of drug development was

Treatment of multiple myeloma with monoclonal antibodies and the dilemma of false positive M-spikes in peripheral blood

648.0 million (range,

The UK Cancer Drugs Fund Experiment and the US Cancer Drug Cost Problem: Bearing the Cost of Cancer Drugs Until It Is Unbearable

157.3 million to

Prevalence of myeloma precursor state monoclonal gammopathy of undetermined significance in 12372 individuals 10-49 years old: a population-based study from the National Health and Nutrition Examination Survey.

1950.8 million). The median cost was

Overall Survival in Cancer Drug Trials as a New Surrogate End Point for Overall Survival in the Real World

757.4 million (range,

Pharmaceutical Marketing for Rare Diseases: Regulating Drug Company Promotion in an Era of Unprecedented Advertisement

203.6 million to

Frequency and level of evidence used in recommendations by the National Comprehensive Cancer Network guidelines beyond approvals of the US Food and Drug Administration: retrospective observational study

2601.7 million) for a 7% per annum cost of capital (or opportunity costs) and

Controversies in multiple myeloma: Evidence-based update.

793.6 million (range,