BMJ analysis reveals widespread publication/selection bias in research

Reporting on a study released by BMJ and characterized as an almost existential threat to the medical research system by Dr. Harlan Krumholz, the Milwaukee Journal Sentinel‘s John Fauber writes that “Drug research, even from clinical trials sponsored by the federal government, routinely is suppressed, harming patients and increasing health care costs.” The emphasis is mine, the strong language Fauber’s.

The conclusions are based on a survey of meta-analyses of individual participant data, which the authors broke down by data source characteristics and publication status. The work is heavy on statistical analysis, but even lay readers can understand the broad strokes of what appears to be a widespread issue.

Steve Nissen, the lead author of the analysis, said 35 of the 42 studies he looked at were unpublished and were obtained only because a court case required the drug’s maker, GlaxoSmithKline, to turn over the data.

And it isn’t just pharmaceutical companies’ financial concerns driving the suppression, Nissen and his coauthors found. At that point, it may more of an issue of confirmation bias and other problems which have always lurked within academic research.

A surprising finding in the BMJ analysis was that serious lapses occurred even in clinical trials funded by the National Institutes of Health.

That research showed that less than half of NIH-funded clinical trials were published in a medical journal within 30 months of the completion of the trial and after 51 months, one-third of trials remained unpublished.

1 thought on “BMJ analysis reveals widespread publication/selection bias in research

  1. Avatar photoMary Schweitzer

    There’s another industry pushing in the other direction – the insurance lobby.

    I share a disease, Myalgic Encephalomyelitis, with one million American adults and countless teenagers and children. For most of us, it is a life sentence. I belong to a clearly defined subgroup – I have an abnormal defective immune system, and when off medication, I have been found to have active cases of EBV, HHV-6 Variant A, cytomegalovirus, HHV-7, and Coxsackie B. I even have active HHV-6 and CMV in my spinal fluid.

    My symptoms include expressive dysphasia, ataxia, disorientation, sensitivity to light and sound, severe headaches, memory loss, massive confusion, constant pain behind my eyes and in the back of my neck, and severe pain in my large muscles. I have had abnormal SPECT scans, abnormal cytokine pattens, very abnormal CPET scores; I have developed Hashimoto’s thyroiditis and I have NMH/POTS (both are known comorbidities). I am bedridden in pain, and can only leave the house accompanied by my husband, in a wheelchair.

    Big Insurance pushed CDc to rename this disease “chronic fatigue syndrome” in 1988 – now that’s a pathetically inept name if I ever heard one. How could a serious drug ( beyond SSRIs) be appropriate to this community if all these patients have is “chronic fatigue.” Chronic fatigue. I had blackouts. It doesn’t match.

    The reason I can write to you at all is that I improve significantly on an experimental drug called Ampligen produced by a small drug company.

    They do not have the influence of the big companies at FDA, and getting the drug approved has been made much more difficult by the CDC’s misleading website, patterned after websites in England created by psychiatrists who hold executive positions with insurance companies.

    I have been on the drug since 1999. It costs $22,000/year – precisely equal to my disability pay, but I am lucky in having a wonderful husband who takes care of me and can pay the rest of the bills wih his income. I have friends who live on less than 2/3,of the cost of the drug – clearly they have no access to it, let alone all the testing I have had.

    Every time I lose it – in one case simply because the head of my practice died, I relapse again. When I get it back, I have to climb back out of the hole, and each time it has been harder. The alternatives are all drugs that have known toxicities this one does not. It does not give me serious side effects – you’ll have to ask me about the long-run effects when I get there. The worst side effect has been due to the vagaries of living within the rules of FDA – every time I go back to being seriously ill, I fear I collect viruses and symptoms like Marley’s ghost collected chains.

    So the degree of corporate interference on available knowledge goes beyond selection bias. Big Pharma fights the approval of venture capital drugs in the hopes of picking up the patent in a fire sale – they don’t care if the drug is completely lost to patients. The Insurance Lobby has enormous influence – in fact, if you can get Big Pharma on your side, they help you fight Big Insurance. During a brief period in the last two years, it appeared a retrovirus was involved (I tested positive for antibodies) – and Big Pharma jumped to attention, anxious to rebrand AIDS drugs for this new market. Now that it has been deemed a “lab contaminant” ( and a strange one at that – a retrovirus created in a lab inadvertently), the interest has died down. I guess Big Pharma hasn’t got much in the way of antivirals (as opposed to anti-retrovirals) for us.

    What truly breaks my heart are that we are now getting a third generation coming down with this disease. How long is it going to take to break through the barriers put up by both Big Pharma and Big Insurance?

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