Fortune Article

Good afternoon and happy Tuesday, readers—This is Sy.

For years now, the extent of the heroin and prescription opioid painkiller addiction scourge ravaging the United States has become increasingly clear. It’s a crisis that afflicts communities both rich and poor, which reverberates through social and economic life alike.

That reality has led, understandably, to a flurry of public health measures aimed at containing this ever-growing opioid epidemic, which kills tens of thousands of people every year (and may actually be getting worse). But, as a Food and Drug Administration (FDA) meeting held Monday highlights, the issue is extremely complicated—especially for the millions of Americans who legitimately suffer from chronic pain and feel that recent public health efforts are in effect cutting off a vital resource that helps them lead more bearable lives.

One patient attending the meeting laid out the reality in dark, stark terms: “Suicide is always an option for us,” said Mariann Farrell, who reportedly suffers from conditions like fibromyalgia and other chronic pain-inducing diseases, according to NBC.

Several other attendees highlighted what, for them, amounted to harmful unintended consequences of the national crackdown on opioids, including the increasing stigma of prescribing powerful painkillers and stricter drug monitoring programs. Several said they could no longer find doctors willing to prescribe the treatments they desperately need.

Federal health authorities, including the Food and Drug Administration (FDA) chief, took a cautious approach in responding to the concerns.

“Unfortunately, the fact remains that there are still too many prescriptions being written for opioids, and too many prescriptions written for long durations of use that aren’t appropriate for the medical need for which the opioid is being prescribed,” said FDA commissioner Scott Gottlieb in a statement. “This presents a difficult challenge both for the FDA and for providers. We don’t want to perpetuate practices that led to the misuse of these drugs, and the addiction crisis. At the same time, we don’t want to act in ways that are poorly targeted, and end up disadvantaging legitimate patients.”

Balancing those delicate needs is a difficult task, indeed—one that major medical groups like the cancer outfit American Society of Clinical Oncology (ASCO) have noted in their own proposed guidelines. “ASCO believes that cancer patients should be largely exempt from regulations restricting access to or limiting doses of prescription opioids in recognition of the unique nature of their disease, its treatment, and potentially life-long adverse health effects from having had cancer,” wrote the group in a 2016 position paper.

Millions of Americans suffer from pain. Millions suffer from addiction. Both can be deadly—the question is how to best produce the best outcomes for all involved parties.

Read on for the day’s news.

Sy Mukherjee

@the_sy_guy

sayak.mukherjee@fortune.com

DIGITAL HEALTH

Gene editing your way to lower cholesterol. Back in 2014, several new cholesterol treatments that significantly lowered levels of "bad" LDL cholesterol hit the market. These drugs work by inhibiting something called "PCSK9", a protein associated with the creation of this unfortunate cholesterol. But University of Pennsylvania researchers may have found a way to achieve the same effect with a more high-tech process (at least in monkeys)—via gene-editing. (Endpoints)

Sid Mukherjee takes on diet and its effect on cancer drugs. Renowned oncologist and Pulitzer Prize winner Sid Mukherjee (no, Brainstorm Health readers, no relation to yours truly) is getting into the microbiome-drug development game. The microbiome, simply put, is the makeup of the organisms that reside in your gut/body. Small-time researchers and pharmaceutical giants alike have been trying to figure out if these organisms influence the effectiveness of drugs. Now, Mukherjee and his team at Columbia University will examine, at least indirectly, a key aspect of this research: Whether or not diet can boost the effectiveness of cancer drugs for lymphoma and endometrial cancer patients. (The Guardian)

INDICATIONS

Will all the drug pricing tough talk ever amount to anything? President Trump issued a threat to drug makers about the rising cost of medicines following Pfizer's latest round of drug price hikes, vowing retaliation. Health and Human Services (HHS) Secretary Alex Azar quickly followed suit, specifically calling out the 340B drug discount program for hospitals (for more on what that entails, here's an interesting and provocative look from STAT). But for all of the administration's tough talk on drug pricing, a growing number of stakeholders (including drug companies themselves) appear to be skeptical that any meaningful action will arise anytime soon (just take a gander at how biotech indices are performing in the past year). For one thing, the administration's own recently announced proposals don't suggest broad, unilateral actions that can be taken by the government, and the prospect of anti-pharma Congressional action may be murky. (BioPharma Dive)

THE BIG PICTURE

Burned out docs. A new national survey highlights just how harmful physician burnout can be for patients; doctors who are too stressed and tired tend to make twice as many errors. And half of surveyed physicians said they were feeling the burn. How do you fix such a problem in a naturally high-stress job? Here's at least one possible solution: "A 2015 Mayo Clinic study found that doctors who rated their leaders favorably were less likely to report burnout. And medicine is already borrowing from business, with some institutions bringing in executive coaches and offering doctors sessions on mindfulness and positive psychology." (Fortune)