January, 2017

Saved by the Bill!
Best of 2016

By Michael J. Katin, MD

It has been a tradition dating back to 2016 for this column to give recognition to the major developments in the field of oncology from the previous year. This time, the year was bracketed by two events that overwhelmed all others.

On January 12, 2016, President Barack Obama, in his State of the Union Address, announced a "Moonshot " program to cure cancer. It was then almost exactly eleven months later, on December 13, that he signed into law the 21st Century Cures Act, supplying additional fuel to the Moonshot. The final product was described as "momentous" and the original sponsor, Fred Upton of Michigan, said this was "a giant leap on the path to cures." The history of the 21st Century Cures Act is somewhat complicated, however.

First, it should be recognized that the 114th Congress had a notable list of accomplishments. These included the Keystone XL Pipeline Authorization Act (vetoed), the National Defense Authorization Act for Fiscal Year 2016 (vetoed), the Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 (vetoed), and a joint resolution indicating disapproval of the Environmental Protection Agency's rule for carbon pollution emission guidelines for existing stationary sources (vetoed). During the time of this series of accomplishments was consideration of bill HR 6, with the stated goal "To accelerate the discovery, development, and delivery of 21st century cures, and other purposes." It is beyond the scope of this column to explain why there would be "other purposes" other than to assume that the nature of all legislation is to include items totally unrelated to the title. HR 6 went through three roll call votes to get to its final version, which was passed by a vote of 344-77 on July 10, 2015. It then stagnated in the Senate, and then retrograded back to the House, where it parasitized HR 34, the Tsunami Warning, Education and Research Act of 2015, whose primary sponsor was Suzanne Bonamici of Oregon. There was then a senate amendment to the bill which went back to the House and was approved on November 30, 2016 by a vote of 392 to 26, and on December 7 a Senate vote to concur with the House amendment to the Senate amendment, which passed by a vote of 94 to 5.

The Representative and Senators who voted against helping cancer patients are astoundingly heterogeneous, to say the least. Voting "Nay" were Jim McDermott, MD, liberal Democrat from Washington (next to Rep. Bonamici's state); Raul Grijalva, liberal Democrat from Arizona and the first member of Congress to endorse Bernie Sanders for President; Rosa DeLauro, very liberal Democrat from Connecticut and founding member of the Congressional Progressive Caucus AND an ovarian cancer survivor; Barbara Lee, extreme liberal Democrat of California, and the only member of either the House or the Senate to vote against authorization of force after the September 11, 2001, terrorist attacks; and conservative Republican Freedom Caucus members Amash, Babin, Bridenstine, Brooks, DesJarlais (MD and also a cancer survivor), Gosar, Huelskamp, Jordan, Labrador, Massie, Meadows, Mulvaney, Sanford, and Weber. The Senate side was even more amazing. Only five Senators voted against this-- Senators Wyden and Merkley, both from Oregon, Rep. Bonamici's state, ultra-conservative Mike Lee from Utah, potential Presidential candidate Elizabeth Warren from Massachusetts, and.........Bernie Sanders.

Had we finally discovered a way to have Mike Lee and Elizabeth Warren and the Freedom Caucus and Barbara Lee come together? Can one analyze the Tsunami/21st Century Cares Act and find out how to put an end to the division that has plagued our government for the past decade. The answer, of course, is, no. As has been said many times, one's enemy's enemy is not necessarily your friend, although your friend's friend is not necessarily your enemy. Although this was called by Senator Lamar Alexander a "Christmas miracle " it was called by Public Citizen a "grab bag of goodies for Big Pharma and medical device companies" due to reducing drug approval and safety testing restrictions. It is anticipated that laetrile, krebiozen and orgone accumulators will be available by prescription in the very near future. The law also creates an NIH Innovation Fund to expedite approaches to other diseases as well as cancer, and provides money for treatment of opioid abuse and addiction. It also encourages sharing of data, probably forgetting that HIPAA regulations made that more complicated in the first place.

The main benefit of the law is to throw more money at cancer research and treatment, and to pay for this we will be selling off part of our Strategic Petroleum Reserve (what?) and also taking money from the Prevention and Public Health Fund which, interestingly, was established under the Affordable Care Act. Fortunately, if everything can be cured, prevention will be unnecessary.

At least now with the Moonshot new ways to treat cancer can be discovered, and with the 21st Century Tsunami Warning Cares Act research can be guaranteed to be funded, even in the case of seismic events.

Oh, yes, other things in 2016. Aspirin and coffee are good, the NCCN decided hypofractionated breast irradiation was ok, and immune checkpoint inhibitors got approved for a whole bunch of indications.

Emanuel Countdown: Dr. Ezekiel Emanuel's biographies list his birth year as 1957 but, interestingly, do not list a birth date. He has expressed that he does not wish to live past his 75th birthday. Giving him every benefit of the doubt, he will have his 75th birthday no later than December 31, 2032. Including January 1, 2017, this leaves 5,844 days to his goal.