Yesterday I read an interesting piece by Oliver Obst, “Trust no guideline that you did not fake yourself.” (Journal of EAHIL. 2013. v9 (4) p25) Obst references the German newspaper Frankfurter Allgemeine Zeitung, which reported several cases of fake practice guidelines. I don’t read German and it appears you must pay to access FAZ’s article archive, but if you read German and have access to the archive, the link to the article is here. According Obst’s summation of the article and Google Translate’s translated version of the abstract, the newspaper attributes thousands of deaths in Europe due to guidelines from the European Society of Cardiology and scientific misconduct.
Unfortunately this is not a single incident, Obst reports “many more examples can be found in a disturbing report by Jeanne Lenzer in the British Medical Journal, ‘Why we cannot trust clinical guidelines.” Lenzer’s article reports that doctors with ties to pharma companies are writing the guidelines. Since most guidelines are written by a large group of doctors you would think it would be difficult to have financial bias make any sort of impact on the guidelines. However, Lenzer discovered a survey showing that it is entirely possible.
“A recent survey found that 71% of chairs of clinical policy committees and 90.5% of co-chairs had financial conflicts.12 Such conflicts can have a strong impact: FDA advisers reviewing the safety record of the progestogen drospirenone voted that the drug’s benefits outweighed any risks. However, a substantial number of the advisers had ties to the manufacturer and if their votes had been excluded the decision would have been reversed.13“
The Cochrane Collection is not immune either according to Lenza.
Early 1990’s-Reinforced by a Cochrane review, high dose steroids became the standard of care for acute spinal cord injury. The Cochrane Collaboration, permitted Michael Bracken, “who declared he was an occasional consultant to steroid manufacturers Pharmacia and Upjohn, to serve as the sole reviewer.”
The standard was just reversed in March 2013 with the Congress of Neurological Surgeons new guidelines. They found, “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.”11
Lenza believes another example of biased guidelines is beginning to emerge regarding stroke and the use of alteplase.
“American College of Emergency Physicians with the American Academy of Neurology (jointly)18 and the American Heart Association,19 separately, issued grade A level of evidence guidelines for alteplase in acute stroke. The simultaneous recommendation by three respected professional societies would seem to indicate overwhelming support for the treatment and consistent evidence. However, an online poll of 548 emergency physicians showed that only 16% support the new guidelines.20“
Lenza points out that “claims of benefit rest on science that is contested. Sceptics say that baseline imbalances, the use of subset analyses, and chance alone could account for the claimed benefit.24 26 31 32 33 They also note that only two of 12 randomised controlled trials of thrombolytics have shown benefit and five had to be terminated early because of lack of benefit, higher mortality, and significant increases in brain haemorrhage.”33 Lenza also notes that “13 of the 15 authors had ties to the manufacturers of products to diagnose and treat acute stroke; 11 had ties to companies that market alteplase.”19
So what does this mean for librarians as we try and find the best research out there for our doctors, nurses and patients? This is a problem. Even if you take out the pharma bias, bio-medical scientific literature rarely publishes work on failures. Add the pressure from pharma wanting and promoting positive outcome research to published, we have even fewer examples of “what didn’t work” research articles and quite possibly what we thought was good evidence isn’t as good as we thought.
As Obst notes, librarians must be aware of this issue and to keep our patrons informed. Unfortunately this may be the only thing we can do and even then it might not be enough. Lenza ends her article by saying;
“Yet these and other guidelines continue to be followed despite concerns about bias, because as one lecturer told a meeting on geriatric care in the Virgin Islands earlier this year, ‘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.”