The deadly consequences of drug side-effects being ‘neglected, restricted, distorted and silenced’

Last month I wrote a blog post about how the information about the adverse effects of drugs can be neglected, restricted, distorted and silenced. Why is this important? Well, it can harm and kill people, for a start. Some of you may remember that in 2004 the drug company Merck pulled its painkiller Vioxx (rofecoxib) from the market after research revealed it more than doubled risk of heart attack. Subsequently, there were accusations that Merck knew about the problems way before it pulled its money-spinner. This story has resurfaced now, on the publication of a study in the Archives of Internal Medicine [1].

In this study, research (some published, some not) was analysed, to see at what point there was a clear indication that Vioxx was increasing the risk of ‘cardiovascular thrombolic (CVT) events such as heart attack and stroke, as well as death. It turns out that in by 2001, there was clear evidence of harm. This was more than three years before Merck ‘voluntarily withdrew’ Vioxx from the market. In the intervening time, literally thousands of people died and had heart attacks as a result of this drug.

I saw a report of this study on Reuters Health in which one of the study authors, Dr Harlan Krumholz, makes the point that Most of the information we are using in this study was never published, or if it was published, they never included the key safety data. This sounds likes information on critically important adverse effects might have been neglected, restricted, distorted and silenced to me.

Of course Merck denies any wrongdoing, and is sticking with its story that the first time it was aware of any problems was in 2004. I suppose we need to take this stance in context. It has emerged, for instance, that some studies and review articles supportive of Vioxx were ghost-written by employees of Merck. Plus, it has also been revealed that doctors who were not ‘on side’ regarding Vioxx were targeted by Merck for softening-up and if that didn’t work, an attempt was made to discredit them.

Merck happens to manufacture ezetimibe, the cholesterol-reducing drug which I wrote recently about here. Ezetimibe doesn’t appear to do anyone much good, and has also been linked with a statistically significant increased risk of death due to cancer. Never mind, though, because it appears Merck has managed to find some scientists who claim that this association is likely to be due to chance (even though the stats show it’s very unlikely to be due to chance). Let’s hope history isn’t repeating itself.

References:

1. Ross JS, et al. Pooled analysis of rofecoxib placebo-controlled clinical trial data. Archives of Internal Medicine. 2009;169(21):1976-1985

3 Responses to The deadly consequences of drug side-effects being ‘neglected, restricted, distorted and silenced’

  1. Ted Hutchinson 24 November 2009 at 6:05 pm #

    Partly the reluctance of health professionals to speak out against the current consensus of medical opinion is that challenging the system sometimes leads to them being prevented from practicing.

    Here is a Swedish example.
    Annika Dahlqvist Swedish Doctor’s experience of challenging the system

    I’m surprised that Dr. Malcom Kendrick M.D. hasn’t been victimized. I suspect he must have a very thick skin. I wonder what would happen if he received as much public acclaim and press coverage as Dr Dahlqvist does.

    Health professionals need to adopt the kind of safety protocols that the airline industry practices where all errors and potential accidents are declared so every one can learn from them and safety standards can be improved.

    This recent example doesn’t inspire confidence in current practice. Disclosing harmful mammography errors to patients.

  2. Chris 24 November 2009 at 7:41 pm #

    .. profit before people ? Surely not !
    Is there sufficient independent knowledge gathering and sufficiently robust independent regulation to manage these matters?

  3. Joseph 28 November 2009 at 8:18 am #

    I would say we are terrorised by corrupt or ignorant and inept regulators, some doctors and some big pharma operators. Corrupted research aims also complicit as grants often awarded with expectations or direct requests as to what to prove. Patients as well as the better doctors also victimised. The doctor I hired is a young, enthusiastic man to start with, humble enough to allow me to educate him. The short periodical discussions how ever started to became difficult, tension and his discomfort emerging.
    I feel for him. But had to tone down my style as the materials I took to him he requested must came from reputable sources still appeared disturbing to him. I realised it will take much longer and no guarantee I will manage to share my knowledge with him that intended assisting him to be the best doctor he can be. His heart is in the right place but he baulked at some threshold when I pointed out the ethical dilemma of doing harm while thinking doing good. For example prescribing statins, hiding behind the practice guidelines. He told me quite sternly he won’t risk being sued for not prescribing some medications (I provided credible evidence for being harmful and even
    un-necessary as natural alternatives dietary and supplements exist outperforming statins without harm of side effects), he must take notice of peer-reviewed research he said and the practice guidelines his licence is dependent on to practice with the expectations he follow them. I am not sure I find the language that conveys the information while does not ignite his anxiety and increase defensiveness. But I persevere. The information in his hands can do much more good to more people then me. Such a fine man and such a shame! I am tempted to write a mini essay as I have a lot to say and a lot to do. But I stop now. I must compliment Dr Briffa for his courage and dedication!
    Be well! joseph

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