by Judith Curry
Yet these and other guidelines continue to be followed despite concerns about bias, because “We like to stick within the standard of care, because when the shit hits the fan we all want to be able to say we were just doing what everyone else is doing—even if what everyone else is doing isn’t very good.” – Jeanne Lenzer
On 13 April 1990, in an unprecedented action, the US National Institutes of Health faxed a letter to every physician in the US on how to correctly prescribe a breakthrough treatment for acute spinal cord injury. Many neurosurgeons were sceptical of the evidence that lay behind the new recommendation to give high dose steroids, yet when two respected organisations released a review and a guideline recommending the treatment, they felt obliged to give it. Now, over two decades later, new guidelines warn against the serious harms of high dose steroids. This case and others like it point to the ethical difficulties that doctors face when biased guidelines are promoted and raise the question: why do processes intended to prevent or reduce bias fail?
Doctors who are sceptical about the scientific basis of clinical guidelines have two choices: they can follow guidelines even though they suspect doing so will cause harm, or they can ignore them and do what they believe is right for their patients, thereby risking professional censure and possibly jeopardising their careers. This is no mere theoretical dilemma; there is evidence that even when doctors believe a guideline is likely to be harmful and compromised by bias, a substantial number follow it.
A poll of over 1000 neurosurgeons showed that only 11% believed the treatment was safe and effective. Only 6% thought it should be a standard of care. Yet when asked if they would continue prescribing the treatment, 60% said that they would. Many cited a fear of malpractice if they failed to follow “a standard of care.”
That standard was reversed this March, when the Congress of Neurological Surgeons issued new guidelines. The congress found that, “There is no Class I or Class II medicine evidence supporting the benefit of [steroids] in the treatment of acute [spinal cord injury]. However, Class I, II, and III evidence exists that high-dose steroids are associated with harmful side effects including death.”
Guidelines are usually issued by large panels of authors representing specialty and other professional organisations. While it might seem difficult to bias a guideline with so many experts participating under the sponsorship of large professional bodies, a worrying number of cases suggests that it may be common.
Biased guidelines can have powerful and wide ranging effects. Thousands of guidelines have been issued, and, when promulgated by highly respected professional societies, they sometimes serve as de facto “standards of care” that may be used to devise institutional protocols, to develop measures of physician performance, and for insurance coverage decisions.
Guidelines may influence the medicines selected for inclusion on drug formularies and may be used as a “reliable authority” to support expert testimony in malpractice suits. Eighty four per cent of doctors say they are concerned about industry influence over clinical guidelines, yet the fear of malpractice suits puts many in an untenable position of following guidelines they believe are flawed or dangerous to patients.
Despite repeated calls to prohibit or limit conflicts of interests among guideline authors and their sponsors, most guideline panellists have conflicts, making the guidelines they issue less than reliable.
For all guidelines, the overwhelming majority of committee chairs and cochairs have ties to industry, and selection of panelists with desired viewpoints can make a wished for outcome a foregone conclusion. Committee stacking may be one of the most powerful and important tools to achieve a desired outcome. In response to a question about whether any known sceptics were invited to be on the committee, a spokesperson for the American Academy of Neurology said, “A potential panel member’s opinion on a topic does not determine eligibility for participation on an American Academy of Neurology guideline author panel. The guideline development process is evidence based.”
JC comments: For the past several years, I have been following the topic of consensus clinical guidelines and the conflict of interest issue in pharmacology and clinical medicine. There are some interesting parallels and differences with the climate science-policy interface. The issues are much starker in the context of clinical guidelines: life and death situations vs malpractice lawsuits. Common themes are cherry picking of data, stacking of committees, conflicts of interest and other sources of bias.
While the medical community has been grappling with these issues for decades (arguably with mixed success), the climate community has only begun grappling with these issues in the wake of climategate. Conflict of interest recommendations made by the InterAcademy Council are being addressed by the IPCC in a minimal way.
The lesson for climate scientists is that the consensus can be wrong, and many scientists will go along with it to avoid censure by their peers. The conflict of interest issues for climate science are far more complex and less easily identified than the financial conflicts existing in the medical field. Regardless of the presence or not of formally defined conflicts of interest, scientists need to continually challenge their assumptions to avoid bias.