British Medical Journal investigation finds that treatment guidelines issues to doctors can be lacking in evidence and riddled with conflicts of interest

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.

References:

1. Lenzer J. Why we can’t trust clinical guidelines. BMJ 2013;346:f3830

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13 Responses to British Medical Journal investigation finds that treatment guidelines issues to doctors can be lacking in evidence and riddled with conflicts of interest

  1. lorraine cleaver 26 June 2013 at 10:06 am #

    This is the problem thyroid patients have. The GPs know many patients remain ill on levothyroxine and yet are pulled in front of GMC if they treat according to symptoms, not RCP policy statement, itself only applicable to a certaiin thyroid group and by no means the majority.

    Doctors want to help their patients yet are stymied by these ‘guidelines’ and accepted wisdom despite all evidence to the contrary. It’s not health care, it’s NHS by numbers, box ticking.

  2. steve 26 June 2013 at 12:02 pm #

    first-class article!

    Excellent end point.

  3. Bill 26 June 2013 at 12:32 pm #

    This is one of the reasons why I am frankly afraid to follow any medical advice I receive without independent investigation and the benefit of multiple opinions.

    But in an emergency (such as a stroke!), what to do? How can one know if it is safer to accept the care they proffer or refuse it? To me, not an obvious decision at all, even (or maybe especially) in a crisis, when extreme interventions may be contemplated.

    And this assumes one is even capable of resisting the standard procedures, not in my experience easy at all in emergency and inpatient settings.

    Best to stay out of the belly of the beast in the first place, of course, and I do my best to keep healthy. But we are all just flesh and blood and things will happen…

  4. JT 26 June 2013 at 12:35 pm #

    When it comes to a patient choosing tools to help address health conditions this certainly complicates matters.

  5. Dr John Briffa 26 June 2013 at 1:06 pm #

    Bill and JT

    You’re both right, and I don’t envy the position of patients in the light of these issues.

    In my opinion, there are certain circumstances (for example, acute medicine) where we really should be able to rely on our doctors to advise us about the best treatment for us, and that this advice should not be sullied by conflicts of interest.

    I’m hoping that by a light being shone on the issue, some progress will be made here.

  6. Galina L. 26 June 2013 at 5:20 pm #

    I asked my doctor to put in to my file the information that I follow a LC diet in order to be sure that information will be available in the case of medical crisis. My doc is very supportive about my diet because my health significantly improved and I didn’t regain the lost weight (he thought was impossible).

  7. Paul C 27 June 2013 at 11:41 am #

    “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.”

    so why the bleep don’t they administer it as a matter of protocol in the ambulance itself for anyone suspect of having a stroke? Does it carry a risk of adverse events in those who are not suffering a stroke?

  8. David Wallace 28 June 2013 at 9:19 am #

    Well at age 72 4 months ago i heard of LCHF eating plan. Just another load of rubbish to sell books etc i thought. But on this occasion after reading one or two books I did give it a try. Well 4 moths later 2 stone lighter 10 points of upper and lower blood pressure readings. I must admit I also gave up all alcohol while reducing weight. I sleep better have more energy, and one of the most staggering facts is I am no longer an compulsive eater. Once taking wheat, pasta rice etc out of diet, something I never thought could be possibly done, I now don’t have the cravings that used to keep putting on weight. Will I go back to the old eating style, no way ever, but maybe the odd red wine or two.
    Thank you, thank you John Briffa and other enlightened medical men.

  9. Paul C 28 June 2013 at 10:51 am #

    OK, I’ve subsequently discovered that alteplase is for busting clots and would be disastrous to administer to someone who is suffering from a bleed in the brain where you actually want a clot to form.

  10. Bill 28 June 2013 at 8:52 pm #

    A friend told me today that he had a stroke a month ago affecting the whole left side of his body. He received tPA (alteplase I imagine) at the hospital.

    He is recovering nicely, but of course he may well have done so regardless of treatment. The research cited above suggests that’s very likely the case.

    One thing isn’t recovering nicely: his bank account.

    The bill for the dose of tPA he was given (just the drug): $16,000.

    I got curious and found a recent review of all the tPA trials (Lancet. 2012 June 23; 379(9834): 2364–2372) that concluded there is clear, though small, absolute benefit of tPA in ischemic stroke that outweighs the increased risk of death from bleeding at 6 months. More people who got the drug wound up alive and independent.

    I do have to wonder how believable that result is given the data aggregation, conflicts of interest, etc., and I don’t have access to the full text of the BMJ article cited above.

  11. Jamie Hayes 4 July 2013 at 7:38 am #

    This conflict of interest is intolerable. What happened to the oath “First do no harm.” Really they are acting on the basis “First do no harm – to my medical practice by stepping outside the consensus.”

    “Evidence-based” is now a dangerous euphemism.

    Having survived a brain haemorrhage my doctor said the cause was bad luck. It took me 6 months to overcome being cross-eyed from the event. Anyway I am lucky enough to be healthy (LCHF diet) and medication and doctor free.

    Thanks John.

  12. Marco Cornejo-Ovalle 1 November 2013 at 11:38 pm #

    Very interesting report. Regarding that, a recent study by Chilean researchers, led by Brignardello R et al, have reported entitled “Positive association between conflicts (COI) of interest and reporting of positive results in randomized clinical trials (RCT) in dentistry report that”.The stusy show that RCTs in which authors have some type of COI are more likely to have results that support the intervention being assessed. Brignardello et al. recommend that when reviewing the results of RCTs, clinicians need to be aware of the association between reporting positive study results and the type of COI disclosure and be even more careful when critically appraising and applying their results. http://www.ncbi.nlm.nih.gov/pubmed/24080933

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