The Big Picture

‘Fail First’ No More: Pennsylvania Moves to Expand Coverage of Treatments for Advanced Cancers Bookmark

Article from The Philadelphia Inquirer curated by Editor in Chief George Lundberg, MD, who notes: 

A new Pennsylvania law requires insurance coverage for use of FDA-approved best drugs first, rather than only after failing with a cheaper alternative.

Go to full article published by The Philadelphia Inquirer.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.

The Evolutionary History of 2,658 Cancers Bookmark

Research paper from Nature curated by Editor in Chief George Lundberg, MD, who notes: 

A massive study of thousands of cancers that explores the genomic basis for cancer is being reported simultaneously in dozens of journals. Nature has published this summary article.

Go to full paper published in Nature.

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Estimating the Magnitude of Cancer Overdiagnosis in Australia Bookmark

Research paper from the Medical Journal of Australia curated by Editor in Chief George Lundberg, MD, who notes: 

For five types of cancer, the rate of overdiagnosis in Australia is roughly one in five. Many of these diagnoses are “indolentomas” or “incidentalomas.”

Go to full paper published in the Medical Journal of Australia.

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Cancer Data Provide Insights into Occurrence, Overdiagnosis, and Treatment Advances Bookmark

Article from ScienceDaily curated by Editor in Chief George Lundberg, MD, who notes: 

Go to full article published by ScienceDaily.

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Machine vs Man for Cancer Detection in Barrett’s Esophagus Bookmark

Article from MedPage Today curated by Editor in Chief George Lundberg, MD, who notes: 

A deep-learning Artificial Intelligence imaging system shows promise for enabling earlier endoscopic detection of esophageal cancer precursors.

Go to full article published by MedPage Today.

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Follow-Up Strategies Following Completion of Primary Cancer Treatment in Adult Cancer Survivors Bookmark

Research paper from Cochrane Systematic Review – Intervention curated by Editor in Chief George Lundberg, MD, who notes: 

How to follow a patient who has completed cure-intended treatment? This Cochrane review of dozens of clinical trials is a guide to confusion.

Go to full paper published in Cochrane Systematic Review – Intervention.

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Weathering the Perfect Storm of the Vaping Threat Bookmark

A Q&A with Alan Blum, MD, who founded the Center for the Study of Tobacco and Society in 1999 at The University of Alabama, where he serves as Professor and Gerald Leon Wallace, MD, Endowed Chair in Family Medicine. Email: ablum@ua.edu

Q: Inhalation of carcinogens and other harmful chemicals in tobacco smoke is responsible for more American deaths—especially from cancer—than any other one factor. Nicotine addiction is central to that pathologic process. The relatively recent invention of the e-cigarette seemed to offer great hope as an alternative nicotine-delivery device that most likely did not cause cancer, and could prevent nicotine addicts from having to smoke. Yet, the “unintended” consequence of masses of new young nicotine addicts produced by unregulated for-profit vaping companies has created a new public health disaster. How might the U.S. Congress and the U.S. Food and Drug Administration (FDA) have better managed this threat?

A: In 2009, Congress passed a bill giving the FDA the authority to regulate tobacco products. When the treacly named Family Smoking Prevention and Tobacco Control Act was signed by President Obama, the bill’s proponents—notably, the Washington lobbying group Campaign for Tobacco-Free Kids—touted it as a long-awaited defeat for Big Tobacco. When it was revealed that the Campaign had secretly co-written the bill with Altria, maker of the top-selling cigarette Marlboro, we realized that the brand’s iconic cowboy wouldn’t be riding off into the sunset just yet.

But few could have predicted that the efforts to protect Americans from the harmfulness of tobacco would become more confused and convoluted by adding it to the FDA’s portfolio.

Because the FDA is the nation’s watchdog over medications and medical devices, a provision in the 2009 bill distinguishes drugs and devices from tobacco products, in order to prevent duplicative regulation by different centers within the FDA. And therein lies the origin of the unfettered explosion of vaping—the inhaling of a heated, flavored nicotine solution from an e-cigarette or other device: in their eagerness to get the FDA bill passed, Senate Democrats rejected a Republican amendment to regulate e-cigarettes as tobacco products and deliberately left them out of the bill. After all, proponents reasoned, e-cigarettes were new and expensive, and they were manufactured by just a handful of companies. The proponents also counted on using a provision of the bill in which the FDA could “deem” as tobacco products both e-cigarettes as well as future nicotine-containing products that regulators couldn’t yet envision.

But a not-so-funny thing happened. While the FDA hemmed and hawed about these new-fangled electronic nicotine delivery systems (now called ENDS), hundreds of manufacturers entered the market, costs dramatically dropped, and e-cigarettes could be purchased at any convenience store for the price of a pack of Marlboros.

Finally, in 2016, the FDA issued its deeming rule that included e-cigarettes as tobacco products subject to the agency’s regulatory authority. In July 2019, a U.S. District Court in Maryland upheld the FDA’s rule. Meanwhile, products such as the Juul e-cigarette, craftily designed to resemble a USB drive and promoted through social media to the wired generation, became an essential accoutrement of high school and college students. That Juul was also engineered to deliver nicotine more rapidly than any previous e-cigarette—and came in appealing flavors such as mango and mint—contributed to its capturing 75% of the e-cigarette market just three years after it was introduced in 2014.

In December 2018, Altria paid $12.8 billion for a 35% stake in Juul Labs, Inc. At the same time, the vape shop industry burgeoned, as did online sellers of e-liquids and paraphernalia aimed at a counter-culture that rejected commercial products. The legalization and commercialization of marijuana by several states also led to the proliferation of e-cannabis with THC-containing e-liquids. This in turn has resulted in an outbreak of vaping-related pulmonary illness in 2019, causing more than 40 deaths and sickening more than 2100 users of electronic vaping devices.

Thus, the FDA lost a full decade in which it could have required manufacturer registration and ingredient-reporting, inspected e-liquid-making facilities, and acted against adulterated or misbranded products. Lost, too, was the opportunity to slow the introduction of e-cigarettes, to temper so-called harm reduction health claims about these products compared to cigarettes, to verify their value in smoking cessation, and to thwart their marketing to young people.

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Copyright: This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Cancer Biology as Revealed by the Research Autopsy Bookmark

Research paper from Nature Reviews Cancer curated by Editor in Chief George Lundberg, MD, who notes: 

The New York-based authors of this study have rediscovered the vital use of the autopsy to learn more about how cancer works.

Go to full paper published in Nature Reviews Cancer.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.