Opioids and a failure to declare competing interests

Regular readers of The BMJ will have noticed that we published no print issue this week. Many of you will have been on holiday and, if you’re lucky, switched off from medical reading for a week or two. So we are using this opportunity to highlight some recent online articles that you may have missed.

On 26 August, a judge in Oklahoma ordered the drug company Johnson and Johnson to pay the state $572m (£467m; €516m) for its role in the state’s opioid crisis (doi:10.1136/bmj.l5319). This is the first time that a company has been ordered by a US court to pay out over its involvement in the opioid epidemic. The judge ruled that Johnson and Johnson’s marketing campaigns were “false and dangerous,” and had resulted in “increasing rates of addiction [and] overdose deaths” (https://www.theguardian.com/us-news/ng-interactive/2019/aug/26/johnson-johnson-opioid-ruling-explained-the-key-points). Johnson and Johnson intends to appeal. But this case could set a precedent in thousands of other opioid related lawsuits pending across the US.

The judge emphasised Johnson and Johnson’s attempts to influence medical practice, saying that the company developed and carried out a plan to directly influence and convince doctors to prescribe more and more opioids and marketed a narrative that “chronic pain was under-treated and increased opioid prescribing was the solution.”

The opioid epidemic, responsible for 50 000 US deaths a year, shows the real harms that can come from competing interests in healthcare, which, as an investigation published in The BMJ this week shows, continue to be undeclared (doi:10.1136/bmj.l5167).

The investigation found that the National Academies of Sciences, Engineering, and Medicine (NASEM), a scientific body currently advising the US government’s Food and Drug Administration (FDA) on opioid policies, had not disclosed that one of its presidents had recent links to industry. Victor Dzau, president of the National Academy of Medicine since 2014, had financial ties to Medtronic, a company that sells an implantable device to deliver pain medicine, until last year.

The investigation found further conflicting interests in a NASEM panel to advise the FDA on opioid prescribing guidelines. Seven of 15 academics had recent ties to the drug or healthcare industry. NASEM has also received at least $14m from the Sackler family, owners of Purdue Pharma, which makes the opioid painkiller OxyContin. Members of the Sackler family are facing lawsuits for allegedly playing down the risks of addiction to OxyContin. Purdue and the Sacklers have offered to settle for up to $12bn.

NASEM responded to The BMJ's investigation to say that it was reviewing its conflict of interest policies and its funding from the Sacklers (www.bmj.com/content/366/bmj.l5167/rr). It said that it considers only “current” financial ties; but past ties, particularly if recent, substantial, or longstanding, are also conflicts of interest, which is why journals like The BMJ ask authors for disclosures going back three years. NASEM said that Dzau had complied with its policies; but requiring the public disclosure of all competing interests is essential if policy makers, practitioners, and patients are to be fully informed of how NASEM drafts its guidance. NASEM said that the $1m of shares Dzau held for previous Medtronic board membership while president of the National Academy of Medicine were managed by his bank without his involvement; but still they constituted a substantial and undeclared conflict of interest because Dzau stood to gain if their worth rose. NASEM implied that conflicts of interest are sometimes unavoidable, but it has a choice: it could enforce a policy of not appointing staff or advisers who are conflicted by having had financial ties to industry.

Elsewhere in The BMJ, a recent systematic review of randomised controlled trials compared mortality in adults taking vitamin D supplementation, placebo, or no treatment (doi:10.1136/bmj.l4673). Supplementation alone was not associated with all cause mortality compared with placebo or no treatment. It did, however, reduce the risk of cancer death by 16%. The paper has sparked a lively discussion in rapid responses.

In our education section, a new clinical review on Clostridioides difficile infection reports considerable underdiagnosis and misdiagnosis (doi:10.1136/bmj.l4609). The review uses the most recent data to help clinicians understand and stratify their choices in the diagnosis and treatment of C difficile infections.

A recent editorial discusses post-finasteride syndrome (doi:10.1136/bmj.l5047), which some reports have associated with sexual, physical, and psychological symptoms that develop after exposure to finasteride, a drug used to treat benign prostatic hyperplasia and, at a lower dosage, male pattern baldness. Efforts to explain persistent symptoms are undermined by low quality long term data on harms, say the authors. They call for placebo controlled trials using validated questionnaires and long term follow-up after treatment to examine the persistence of symptoms.

Our next print issue will be published next week.