Medical research is a huge industry churning out scientific papers at quite a rate. How are doctors supposed to keep up and know what is deemed the ‘appropriate’ treatment for a condition? A supposed helping hand comes for doctors in the form of ‘clinical guidelines’ which can come from a variety of sources including one or more of the relevant professional college or society.
However, a recent article in the British Medical Journal casts considerably doubt on the reliability of these reports. The article, written by medical investigative journalist Jeanne Lenzer, focuses on the drug alteplase, a clot-busting drug given for acute stroke. Earlier this year, three US professional societies recommended use of the drug. However, it turns out that only two of the 12 studies on the drug found any benefit, and five of them had to be stopped early due to the finding of a lack of benefit, increased risk of brain haemorrhage or increased death rates.
So, how come the guidelines are at such variance with the science? Well, according to ms Lenzer: “Proponents of alteplase have launched projects to ensure uptake of the guidelines in the US, such as the development of “stroke certified hospitals,” which require hospitals to commit resources to enable rapid administration of alteplase to eligible stroke patients. Since ambulances divert patients with suggestive symptoms to stroke certified hospitals, the project has substantial financial ramifications. These efforts, and others like the “Brain Attack” campaign, have been actively supported by the American Heart Association and American Stroke Association, which “partnered” with the Joint Commission (a quasi-governmental agency that accredits hospitals) to promote hospital stroke certification. Genentech, Boehringer Ingelheim and Novo Nordisk, which market alteplase, have contributed tens of millions of dollars to the associations.”
There are other potential conflicts of interest too, with regard to the people who sit on the committee and panels that decide what is ‘good medical care’ and what doctors should prescribe. The American Heart Association (one of the bodies which issues pro-alteplase guidelines) states that it “makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of . . . a business interest of a member of the writing panel.” However, 13 of the 15 authors of the AHA guidelines had ties to the manufacturers of products to diagnose and treat acute stroke, with 11 having ties to companies that market alteplase.
This problem is not an isolated one, of course, and we are informed that: “For all guidelines, the overwhelming majority of committee chairs and cochairs have ties to industry, and selection of panellists 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.”
The article refers to other examples of clear conflicts of interest, including recommendations on the use of high-dose steroids for spinal cord injury, the use of erythropoietin (a blood boosting drug) in treatment of anaemia associated with kidney disease, and the treatment guidelines for cholesterol issued in 2004.
The fact is, many clinical guidelines are far from reliable and may not reflect the scientific facts at all. And, it seems, many doctors know this. For example, in one poll, only 49 per cent of doctors believed that the science supported the use of alteplase. Yet, alarmingly, 83 per cent said they would give this drug.
What this disparity probably reflects is the fact that doctors can often be fearful about not acting in according with the guidance they are issued, even if they believe it to be wrong. The author of the article puts it this way: “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.”
The article ends with a quote from one doctor who stated: “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.”
What sort of a system of medicine do we have that means that doctors are happy to recommend and administer treatments are not supported by the evidence, they themselves don’t believe in, are not beneficial, and perhaps do more harm than good, for fear of being out-of-step with their colleagues and profession? I think patients deserve much, much better than this. And I think the BMJ is to be applauded for highlighting this issue and giving the medical profession an opportunity to take a long, hard look at itself.
1. Lenzer J. Why we can’t trust clinical guidelines. BMJ 2013;346:f3830
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