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New York Times vs. Personalized Medicine?PMC President: Times’ Critique of Streamlined Regulatory Approval for Personalized Treatments ‘Ignores Promising Implications’ of Field WASHINGTON (June 13, 2018) — In response to an editorial published on June 9 by the New York Times titled “Easier Drug Approval, at What Price?,” Personalized Medicine Coalition (PMC) President Edward Abrahams today defends a series of decisions by the U.S. Food and Drug Administration (FDA) over the last several years that have streamlined the regulatory review process for personalized medicines. “Unlike FDA, which has been an engine for innovation under the direction of Scott Gottlieb and his predecessors, ‘Easier Drug Approval, at What Price?’ ignores the promising implications of reforms in regulatory science that FDA has put in place to facilitate a new appreciation of how different individuals respond to selected treatments,” Abrahams said. As PMC underlined earlier this year in a report titled Personalized Medicine at FDA: 2017 Progress Report, personalized medicines now account for one of every four drugs the agency approves. The Times’ editorial, which was also published online under the headline “Easier Drug Approval Isn’t Cutting Drug Prices,” contends that “it’s not clear that people, as opposed to drug companies, are feeling much benefit” from the streamlined regulatory review pathways that bring personalized treatments to market faster. Abrahams disagrees, noting that in non-small cell lung cancer, for example, a disease that was nearly untreatable 20 years ago, there are now multiple drugs on the market that target a patient’s particular tumor. As indicated by the U.S. National Cancer Institute (NCI), these treatments “improve the survival of subsets of patients with metastatic disease.” Furthermore, because targeted therapies zero in on specific cancerous mutations, doctors can use diagnostic tests to identify with much greater certainty the patients who will likely benefit from them, sparing expenses and side effects for those will not. That logic underpins FDA’s decision to streamline its regulatory processes, to ensure that patients who will benefit from promising targeted therapies — many of whom have few remaining options — can access those treatments without unnecessary delay. “By putting in place smarter policies to encourage the efficient development of personalized drugs whose safety and efficacy profiles are often higher than one-size-fits-all, trial-and-error treatments, FDA serves the interests not only of patients but also the health system, which spends too much money on ineffective treatments,” Abrahams said. To evaluate the American public’s interest in personalized medicine, PMC and GenomeWeb recently commissioned Public Perspectives on Personalized Medicine: A Survey of U.S. Public Opinion, which was published in May. Two-thirds of Americans indicated in the survey that they appreciate personalized medicine’s potential, and the majority expressed concerns about whether they will have access to personalized tests and treatments in the future. ### About the Personalized Medicine Coalition: |
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From: “Christopher Wells (PMC)” <cwells@personalizedmedicinecoalition.org>
Date: Wednesday, June 13, 2018 at 3:15 PM
To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>
Subject: Re: New York Times vs. Personalized Medicine?
This is very insightful. There is no doubt that there is the bias you refer to. 42 years ago, when I was postdocing in biochemistry/enzymology before completing my residency in pathology, I knew that there were very influential mambers of the faculty, who also had large programs, and attracted exceptional students. My mentor, it was said (although he was a great writer), could draft a project on toilet paper and call the NIH. It can’t be true, but it was a time in our history preceding a great explosion. It is bizarre for me to read now about eNOS and iNOS, and about CaMKII-á, â, ã, ä – isoenzymes. They were overlooked during the search for the genome, so intermediary metabolism took a back seat. But the work on protein conformation, and on the mechanism of action of enzymes and ligand and coenzyme was just out there, and became more important with the research on signaling pathways. The work on the mechanism of pyridine nucleotide isoenzymes preceded the work by Burton Sobel on the MB isoenzyme in heart. The Vietnam War cut into the funding, and it has actually declined linearly since.
A few years later, I was an Associate Professor at a new Medical School and I submitted a proposal that was reviewed by the Chairman of Pharmacology, who was a former Director of NSF. He thought it was good enough. I was a pathologist and it went to a Biochemistry Review Committee. It was approved, but not funded. The verdict was that I would not be able to carry out the studies needed, and they would have approached it differently. A thousand young investigators are out there now with similar letters. I was told that the Department Chairmen have to build up their faculty. It’s harder now than then. So I filed for and received 3 patents based on my work at the suggestion of my brother-in-law. When I took it to Boehringer-Mannheim, they were actually clueless.