New York Times Editorial Advocates for Policies that Could Hurt Patients

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New York Times Editorial Advocates for Policies that Could Hurt Patients

In an editorial published on Friday, June 8, 2018, in The New York Times (Easier Drug Approval Isn’t Cutting Drug Prices), the Times Editorial Board claims that the U.S. Food and Drug Administration (FDA) is lowering standards by working to get treatments to patients more quickly and instituting a less regulation approach to reviewing new drugs and medical devices.

The paper’s Editorial Board also recommended that the FDA require at least two successful clinical trials for any drug.

Unethical
The misguided editorial omits many important pieces, including the need for flexibility in clinical trials, particularly for those with serious illnesses. Additionally, the recommendation that FDA should require two successful clinical trials for any drug is rigid, and in some cases, unethical.

As a patient advocate who lost her sister to cancer at the age of 40, I read this editorial with dismay. This piece is devoid of today’s science and instead advocates for policies that would create an arbitrary barrier for men and women in urgent need of treatment.

Randomized trials
Years ago, in order to determine if a drug had an effect, it was necessary to conduct multiple, randomized trials. While the randomized trial remains an important part of developing a new drug, many of today’s medicines are based on complex biologic processes and yield unprecedented effects that can be observed very early on. When this occurs, especially treatments addressing life-threatening illnesses, multiple trials may not be necessary and every effort should be made to get those treatments to patients quickly and safely.

This is why a pathway like the FDA’s Breakthrough Therapy Designation was created. This pathway helps speed access to lifesaving drugs for the patients that need them most, and it is crucial we do not lose sight of the benefits and positive impact the breakthrough therapy designation has brought to so many patients.

Arcane rules that tether medicine to a bygone era should not grind our drug approval system to a halt. Such rules will not protect anyone and will only deprive patients of their best chance at recovery.


 

Last Editorial Review: June 11, 2018

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Ellen V. Sigal, Ph.D., is the founder and Chairperson of Friends of Cancer Research, a Washington, D.C. based not-for-profit organization dedicated to accelerating the nation's progress toward prevention and treatment of cancer by mobilizing public support for cancer research funding and providing education on key public policy issues. Sigal also holds leadership positions with a broad range of cancer advocacy and public policy organizations, including: Duke University's Comprehensive Cancer Center, the Johns Hopkins Cancer Center Advisory Council, the Foundation for the National Institutes of Health, the American Association for Cancer Research (AACR) and the American Cancer Society. Dr. Sigal serves on the Board of Scientific Advisors for the National Cancer Institute and most recently, Dr. Sigal was named to the National Institute of Health Director's Council of Public Representatives. Prior to her work in cancer research advocacy, Sigal enjoyed a highly successful and influential business career in commercial real estate. Her firm, Sigal Development, financed and developed major projects throughout the Washington and mid-Atlantic region - a portfolio in excess of one billion dollars. For her efforts on behalf of cancer research advocacy, Dr. Sigal received the 1998 American Association for Cancer Research National Leadership Award, the 1999 Sidney Kimmel Cancer Center National Leadership Award, and the 2002 American Society of Clinical Oncology Special Recognition Award. Dr. Sigal received her Ph.D. from Rutgers University in Russian History.

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