What we must learn from the US opioid epidemic

时间：2017-10-19

发布：Fiona Godlee, editor in chief，The BMJ

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News flash: Donald Trump is doing the right thing. He looks set to declare America’s epidemic of opioid misuse a national emergency.1 But the history of this epidemic is a masterclass in unintended consequences, and the big question now is what Trump and his administration choose to do next.

The scale of the epidemic is not in doubt. The US Centers for Disease Control and Prevention (CDC) reports that prescription and illicit opioid misuse caused more than 52 000 deaths in 2015, a fourfold rise since 1999.2 But the seeds of the epidemic are complex, and the exact contribution of different events and players is disputed.

Most agree that it started in the 1990s, when doctors massively increased their prescribing of opioids for non-cancer pain, encouraged by drug companies’ assurances that addiction was rare. This harmful overprescribing continues, write the pancreatic surgeon Martin Makary and colleagues this week (doi:10.1136/bmj.j4792). One in 16 surgery patients becomes a chronic opioid user, they say, and surgeons are the second highest opioid prescribers in the US after chronic pain specialists.

Surgeons vary widely in their prescribing behaviour and in their understanding of modern approaches to postoperative pain. This has to change, say Makary and colleagues, and so too must default settings on the number of pills prescribed: fewer tablets would limit stockpiling and reduce the risk of subsequent inappropriate use by patients and others, they say.

But we also publish a patient’s plea not to demonise prescription opioids. Attributable deaths have fallen in recent years, says Bob Roehr (doi:10.1136/bmj.j4727), who uses hydrocodone for back and joint pain and who disputes the CDC report’s methodology. While most people who have become addicted began on prescribed opioids, only a tiny proportion progress to misusing them, he says. He blames the epidemic of deaths on the failure to provide addiction treatment for those who need it, driving them to increasingly available and cheap street heroin and, as Eugenia Socías and Evan Wood explained last month (doi:10.1136/bmj.j4355), to even cheaper and more deadly synthetic opioids such as fentanyl. Michael McCarthy reminds us that the well intentioned reformulation of oxycodone played its part, in driving intravenous users to heroin (doi:10.1136/bmj.j4730).

Our commentators agree on one thing: that the prohibitionist “war on drugs” mindset has done huge, perhaps the most, damage. In a time of economic decline and social fragmentation, such moralising and criminalising has blocked public health approaches that could have stemmed the tide of death and human misery (doi:10.1136/bmj.i6067). It is this above all that has to change.

References
01. Jacobs B. Trump says he’ll declare the US opioid crisis a national emergency “next week.” Guardian 16 Oct 2017. https://www.theguardian.com/us-news/2017/oct/16/trump-us-opioid-crisis-national-emergency.
02. Centers for Disease Control and Prevention. Annual surveillance report of drug related risks and outcomes. 2017. www.cdc.gov/drugoverdose/pdf/pubs/2017-cdc-drug-surveillance-report.pdf.

BMJ 2017; 359 doi: https://doi.org/10.1136/bmj.j4828 (Published 19 October 2017)
Cite this as: BMJ 2017;359:j4828

A Big Sister society?

时间：2017-10-12

发布：Fiona Godlee, editor in chief，The BMJ

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When you imagine a surgeon, is that person white and male? The online campaign #ILookLikeASurgeon aims to tackle this stereotype, which campaigners say discourages women and ethnic minorities from entering and flourishing in surgery. The campaign has gained traction, but change of this sort takes time.

Research published in this week’s journal might help. Wallis and colleagues look at whether surgeons’ sex affected how patients fared after surgery (doi:10.1136/bmj.j4366). They found that, in a wide range of common procedures, patients treated by female surgeons had considerably lower 30 day mortality, length of stay, complications, and readmissions than patients treated by men.

This is an observational study with the usual limitations. But the authors went to some lengths to correct for surgeons’ age and experience and for patient case mix. At the very least, their study shows that female surgeons are as good as men. Writing in a linked editorial, the current and recent past presidents of the Royal College of Surgeons cautiously conclude that improving surgical outcomes is complex and that what this study shows is that a surgeon’s sex is unlikely to be relevant (doi:10.1136/bmj.j4580).

The #ILookLikeASurgeon campaigners are more bullish (doi:10.1136/bmj.j4653). Yes, the ultimate aim is to improve patient outcomes. But they emphasise that female surgeons are particularly good at communication, collaboration, and patient centredness, skills that may improve team morale and perioperative care. They write, “Perhaps male surgeons should attempt to be more like their colleagues who have better outcomes, to reclaim parts of themselves that their training and societal expectations may have suppressed.”

All doctors need to be good at being patient centred, so it’s worth asking whether and how such behaviour can be encouraged. Foskett-Tharby and colleagues reflect on the chequered history of using financial incentives to change what doctors do (doi:10.1136/bmj.j4532). All too often, modest benefits are lost when clinicians and administrators game the system or allow incentives to distort priorities in patient care. If we want to use patient reported outcomes to improve care we need better ways to measure and report them, they say.

And, as Stephen Armstrong reports, we must release doctors from the wasteful and energy sapping work of data entry (doi:10.1136/bmj.j4546). Surveys of US doctors find that the electronic patient record serves mainly to separate them from their patients and is one of the most commonly cited causes of burnout. Patients’ trust has been damaged, too, by high profile security breaches. Perhaps, rather than Big Brother, we can find our way towards a Big Sister society.

BMJ 2017; 359 doi: https://doi.org/10.1136/bmj.j4690 (Published 12 October 2017)
Cite this as: BMJ 2017;359:j4690

What you need to know about cancer drugs

时间：2017-10-05

发布：Fiona Godlee, editor in chief，The BMJ

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Last year, writing in The BMJ, Peter Wise told us that cytotoxic chemotherapy had done little to extend life of people with cancer (doi:10.1136/bmj.i5792). Most of the added years were due to earlier diagnosis and treatment, he said, and he called for higher bars to drug approval, accurate and impartial information for patients, and rejigging of our clinical priorities.

This week brings further news in a similar vein. A systematic study of cancer drugs approved by the European Medicines Agency in recent years finds that most had no supporting evidence of better survival or quality of life (doi:10.1136/bmj.j4530). The few drugs with evidence of benefit achieved only marginal gains. As Deborah Cohen explains in her accompanying Feature (doi:10.1136/bmj.j4543), the researchers also found that decisions about which drugs to approve were often based on uncontrolled studies or surrogate endpoints, without firm requirements for postmarketing evaluation. Drugs once rejected by EMA may be approved later—“No one wants to say no to a cancer drug,” said one EMA adviser Cohen spoke to—and are kept out of the market only through the vigilance of bodies such as the UK’s National Institute for Health and Care Excellence. As Vinay Prasad says in a linked editorial (doi:10.1136/bmj.j4528), the result is increased cost, unrealised hopes, and harm to patients, and because the regulators are lax it’s payers who have had to wield the stick.

Jessica Pace and colleagues understand the desire for speed and funding of new treatments (doi:10.1136/bmj.j4494), given that this is underpinned by compassion and concerns about inequity. But media rhetoric and hype are fuelling what they call the “access imperative”: the growing sense that drugs for severe or life threatening illness shouldn’t have to wait for regulatory approval.

Combating these forces will be hard. Researchers will always want to promote their work, manufacturers their products, and the media emotive stories, and desperate patients may want to try even unproved remedies. But Pace and colleagues caution against lowering standards of evidence or disregarding usual cost effectiveness thresholds. Drugs that are rushed through the regulatory process are more likely to gather safety warnings at a later date (doi:10.1136/bmj.j3837). Rather, we should hold research institutions accountable for claims made in their press releases, enforce rules against off-label marketing of drugs, and set media standards for reporting positive and negative outcomes of trials.

Pace and colleagues also suggest increased support for publicly funded clinical trials and drug pricing that is linked to demonstrable evidence of effectiveness. And Prasad adds, I am glad to say, a call for sharing of patient level data.

But while approval and oversight of cancer drugs are so lacking, the cycle of poor evidence generation, wasted resources, and disappointment to patients will continue.

BMJ 2017; 359 doi: https://doi.org/10.1136/bmj.j4585 (Published 05 October 2017)
Cite this as: BMJ 2017;359:j4585