which you choose to do the trial impact the subsequent therapies of those patients, and therefore impact the outcomes of the trials?” he asked.

Dr. Pazdur also pointed out the need for consistent international regulation of drugs. He noted that the innovative regulation FDA is currently devising in relation to combinations of unapproved drugs and drug-diagnostic combinations has to harmonize with international regulations, especially with the European Medicines Agency. The FDA has regular discussions with this agency about these topics, he said.

Recognizing the rising importance of global health, the NCI is creating a new center for global health that will bring together several existing international programs of NCI and will pave the way to better partnership in research with developing countries, Dr. Varmus reported. “I believe quite strongly that, while it’s difficult to bring sophisticated radiotherapy, complicated surgery, and highly expensive drugs to poor countries, there are many things we can do to lower the burden of cancer in the low- and middle-income populations of poor countries by better prevention practices, especially vaccinations against HPV and HBV (hepatitis B virus), smoking cessation programs, pain management, early detection, and using therapies that are inexpensive because they are off-patent,” Dr. Varmus said.

Dr. Seffrin pointed out that the United Nations (UN) is having its first-ever, high-level meeting on noncommunicable diseases in September 2011. There have only been 28 high-level UN meetings since World War II, he noted, and only one so far has dealt with a health problem (HIV/AIDS). “This is not only our first time to get up to bat, but it’s probably our only time to get up to bat, about what we might be able to do to change the fact that noncommunicable diseases are not on the global health agenda,” he said. He noted that the Millennium Development Goals of the UN are silent about cancer, even though it is the number one cause of death in the world and the single greatest economic burden on the world economy—three times more costly than HIV/AIDS, tuberculosis, and malaria combined (John and Ross, 2010). He added that “if we just were able to provide what we know works today to everyone when they need it and as they need it, by 2030, we could be talking about averting … over 15,000 deaths per day globally.”

HEALTHCARE REFORM—AFFORDABLE CARE ACT

Dr. Horton gave a presentation on the major provisions of the recently passed ACA, which are summarized in Box 2. Dr. Horton noted that much



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