OBR Daily Commentary

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This Federal Agency That Aims To Make Health Care More Effective Is On The Chopping Block, Again

(STAT) Mar 30, 2017 - A little-known federal agency responsible for making health care safer and more efficient has survived 20 years in Washington with a target on its back, but its time may be running out.

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William McGivney, PhD (Posted: April 02, 2017)

quotesAs we now rest “comfortably” in the “Valley of Value-Based Policy-Setting and Decision-Making”, it is quite reasonable to evaluate the benefits of providing organizations like AHRQ with half-a-billion dollars a year and compare how such health care dollars might be better (or not) spent. While one is at it, one might as well throw in PCORI to this evaluative and valuation effort. My experiences with AHRQ are based upon my serving as a reviewer for a grant about 12 years ago, a meeting I had with AHRQ folks when I was CEO of a national organization, my experience with the work product of a large contract let by AHRQ, and general tracking of the agency as it changed names through the years. I started to describe those experiences but thought better of heading down that path. In the briefest of my comments (ever), I believe it is a good time to evaluate the products of these agencies and the Value that they might provide. quotes

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Are Right-To-Try Laws A Last Hope For Dying Patients — Or A False Hope?

(Washington Post) Mar 26, 2017 - The battle over access to unapproved treatments moves from the states to Congress.

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William McGivney, PhD (Posted: March 30, 2017)

quotesThe issue of offering access to “investigational” treatments for serious and life-threatening illnesses is a very difficult issue from a clinical perspective, especially with respect to the provision of a treatment with an ill-defined adverse event profile. However we must remind ourselves that we are talking about people with serious and life-threatening illnesses such as ALS, lung cancer etc. There are ways to and examples of how the issue has been addressed. Clearly, the FDA has compassionate use guidelines. Further and even better, during the rise of the AIDS epidemic in the 1980s, the FDA produced and finalized the Treatment-IND regulation that made drugs that had shown some early efficacy and had been granted the Treatment-IND designation available to patients with AIDS before FDA approval. The road to finalization of the Treatment-IND was a controversial and a rocky path; but it happened. In my view the Treatment-IND, pushed by then Commissioner Frank Young, MD, was successful in terms of offering hope to patients, establishing a bridge to possible better drugs, and spurring on innovative research, especially the involvement of smaller biotech companies. The support of the American Medical Association was key and I was fortunate to be the FDA liaison for the AMA at the time and work with Stuart Nightingale, MD Associate Commissioner for Health Affairs at the FDA. I took the lessons from that experience with me to Aetna in 1991. Six days after joining Aetna as VP Clinical and Coverage Policy, Aetna was on “60 Minutes” for the second time for having denied coverage for high dose chemotherapy/bone marrow transplant. I was charged with addressing the issue of the use of investigational treatments in patients with less than a year to live. The bottom line was the establishment in 1991 of the Aetna “Terminal Illness Policy” whereby investigational treatments, especially HDCT/BMT, were evaluated on an individual patient/beneficiary basis for patients with limited life expectancies. The limit of life expectancy was treated with great flexibility. This program was highly successful and well-respected by patient groups, providers, other payers, employer customers, state legislators, etc. A modified version of this policy still exists at Aetna. Through it all, I learned one of the commandments for my decision-making in setting coverage policy and making individual patient medical necessity determinations at Aetna: “The more serious and life-threatening the illness, the lesser degree of certitude about efficacy and the greater risk of harm about treatments that patient, provider and payer should accept.” This real-world commandment came into decision-making play every day and still does. quotes

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From Twitter To Treatment Guidelines, Industry Influence Permeates Medicine

(NPR/ProPublica) Jan 17, 2017 - The long arm of the pharmaceutical industry continues to pervade practically every area of medicine, reaching those who write guidelines that shape doctors' practices, patient advocacy organizations, letter writers to the Centers for Disease Control and Prevention and even oncologists on Twitter, according to a series of papers on money and influence published Tuesday in JAMA Internal Medicine.

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William McGivney, PhD (Posted: January 25, 2017)

quotesSupport received by organizations from various stakeholders for educational programs and other activities at provider or patient not-for-profits is a valid issue, especially when such an organization(s) might have considerable influence over practice norms and coverage policy. However, it is always interesting to note the amblyopic view of researchers and the media who focus their efforts only on one side and the easy target. When I was CEO of a major provider organization, I decided to address my limited curiosity by having each grant request (for mainly educational programs) that was sent to a pharma company be also sent (the same grant request) to major payers. One year at our Annual Conference, I was listening to a Panel discussion addressing this issue and was compelled to make a public comment. The organization had sent over thirty requests for support for educational programs to major payers and we had a uniform answer to all such requests. That answer was “NO”. I suggest that researchers make sure that they understand the entire system and not close the one eye that should hold a field of vision that includes other stakeholders (e.g., payers) in their quest for veracity. quotes

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Meet the Editorial Board

Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

Lung Cancer
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H. Jack West, MD

Medical Director, Thoracic Oncology Program, Swedish Ca...

Gastrointestinal Cancers
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Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

Radiation Oncology
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Howard Sandler, MD, MS, FASTRO

Ronald H. Bloom Chair in Cancer Therapeutics
Pr...

Community Oncology
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Jeff Patton, M.D.

CEO Tennessee Oncology...

Precision Medicine Section Editor
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Jennifer Levin Carter, MD, MPH

Chief Medical Officer and Founder, N-of-One...

Financial Sector
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Michael G. King Jr.

Managing Director and Senior Biotechnology Analyst...

Gastrointestinal Cancers
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Richard Goldberg, MD

Director WVU Cancer Institute Director of Cancer Signa...

Editor-In-Chief
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Robert A. Figlin, MD., FACP

Professor and Director, Division of Hematology Oncology...

Health Policy
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Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Community Oncology
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William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
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William McGivney, PhD

National Health Policy Expert...

Payer
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Winston Wong, PharmD

President, W-Squared Group...