that little thing at the top…

Posted on Monday 8 August 2016

After being stationed together in the UK, five couples have been vacationing together for a week every summer all over North America. We got to be sort of a family back in those days, and that continues, honorary aunts and uncles, nieces and nephews – now over 40 years. Back then we were two internists, a flight surgeon, a primary care guy, and an anesthesiologist. We became a gastroenterologist, psychiatrist, two ophtalmologists, and a hospital administrator. We’ve been to all the weddings and funerals, and our kids travel together too. There are a number of replaced joints and other infirmities, so our activities are more muted. All but one are retired. While we never talk politics or religion, there’s a forty year narrative about medicine and life – which is where I’m headed.

The other internist [gastroenterologist] was the the best clinician I’ve ever known – and the others were top of the line. That’s part of the bond. We learned together and set a good standard for each other back in those post-training days. In the catch-up talk this year, they wanted to know about the Study 329 article I was an author on in the intervening year. It was kind of surprising. They didn’t know about ghostwriting, or guest authoring, or Dollars for Docs, or the Sunshine Act, or the academic-industrial complex, or outcome switching, or all the rest of it. Only the gastroenterologist picked up on what I was talking about. But first, he talked about pharmacology and the changes in his specialty [which he labeled as "miraculous"]. He mentioned antibiotics for ulcer disease [Helicobacter pylori] and the amazing endoscopes they have now. But what he was really talking about were the drugs for turning off stomach acid – H2 blockers and proton-pump inhibitors.

He reminded me of those long nights with GI bleeders in my day, and how, not infrequently, we couldn’t get it stopped and had to call the surgeons. It was a regular on-call event for any internist. "That’s a thing of the past," he said. "With the new drugs, we saw a lot fewer bleeds, and when we did – we could stop them with the scopes." "Chronic ulcer disease? Rare to never." "Surgery required? I can’t recall the last case." Parenthetically, throughout the week, the ophthalmologists talked about the advances over their careers – Lasik, cataract lenses, microscopic surgery, etc. – as did the anesthesiologist – both drugs and equipment. But the gastroenterologist did say, "When the acid switch drugs first came out, they performed as advertised. But later, I thought the newer ones were overblown in the journals. I stopped reading and mostly learned about them at meetings, from colleagues." And then came the punch line. "But you know, you don’t have to read the whole article. You can just read that little thing at the top."

He was referring to the abstract at the beginning of journal articles. I’ve thought about that along the way myself. Back in those days, that’s what I did too – read the abstracts. I got four or five journals a month, reprints left at the office, more in the mail, and I worked 10 hour days. I couldn’t possibly have done more than that. I’d look at the graphs and scan the tables sometimes, but I rarely read the whole articles – certainly not drug studies. To read them like I’ve read them on this blog takes a day or two. Then, I expected the abstract to be just that – an accurate abstract. I might deeply study an article for the odd journal club, but not routinely. I would expect that what I did was the norm, or if anything, I was on the conscientious end of the spectrum.

All I had on last week’s trip was a tablet computer [new and more unfamiliar than I’d planned], but I could get my blog, so I thumbed back through articles I had looked at over the years – just reading the abstracts. Thinking back, in my naiveté, there was a time when I might have even thought that the abstracts were something the journal editorial staff wrote. Whatever I thought, my index of suspicion was woefully low. Nowadays, the abstracts are carefully crafted by ghosts. And looking at them as a group, the abstracts are usually inflated over and above the distortions already in the articles. I concluded that the pharmaceutical marketing departments must know that’s what doctors do, read/scan the abstracts – that little thing at the top.

Recently, Dr. Carroll proposed that the FDA extend its oversight to the published studies [CORRUPTION OF CLINICAL TRIALS REPORTS: A PROPOSAL], which makes perfect sense to me. They are the only ones who have direct access to the Protocol and the the Raw Data from these Clinical Trials needed to insure accuracy. And the FDA is built around statistical and analytic prowess. On one of the list-serves, there was a critique of his proposal, arguing that it was unnecessary because all the information is on the FDA approved package insert for doctors to read [also reprinted in the Physician’s Desk Reference]. The argument was that to do the same thing with journal publications would be redundant. I guess the implication was that doctors are too lazy to read the inserts, aren’t keeping up.

Those inserts are summaries that don’t separate out the individual trials. They are reference materials at best and pretty dense – useful for looking up toxicities but not for much else. The journal articles describe the populations, the metrics, the outcomes, the harms, all in the most easily reviewed format – even if one only reads the abstract. It’s remarkable that the editor’s and peer reviewers don’t have access to the raw data itself. But even more remarkable that they don’t even have the a priori Protocol or the FDA’s analysis. For that matter, neither does the reader. I can think of no reason that the FDA shouldn’t publish their findings and review journal publications that come from Clinical Trials for accuracy, including that little thing at the top – the abstract. They’re the only people that can!
  1.  
    1boringyoungman
    August 8, 2016 | 6:52 PM
     

    The academic authors on the paper have often not had access to the data itself, including the initial orientation to the data that the industry statisticians give to the industry authors on the paper. It’s one thing for the reviewers, editors, and readers not to. But what is the key point to me about Wagner et al is that the academic FIRST author on the paper was essentially in no better position to vet the analysis of the trial than a reader of the eventual paper. The implications of this are belied by statements like “Dr. Wagner, who, along with the other named authors, maintained control over the final content of the manuscript.” It is this sleight of hand, the pretense that “control over the final content” trumps “oblivious to the initial analyses” that is key.
    .
    What is also key is that the collapse of this pretense collapses the pretense of authority conferred by the presence of academic authors and the presence of academic reviewers. Will editors ever take their finger out of that dyke? Doed our community want to grapple with the implications of that widespread a failure of academic authorship and academic peer review? With the impacts on authority of all sorts?

  2.  
    James OBrien, M.D.
    August 9, 2016 | 11:47 AM
     

    The abstract isn’t like a trailer of a movie, it’s really the final product for most busy doctors in practice. It’s insulting that these are not properly reviewed and that we have to review the entire article for shenanigans when that’s the editor’s job. It’s come to the point where a doctor (any type) in practice is actually better off not reviewing new literature given how poorly it is conducted and how infrequently it can be replicated.

  3.  
    Bernard Carroll
    August 9, 2016 | 12:03 PM
     

    Yeah… too often, the imprimatur of publication in an academic journal following peer review has become just a fig leaf for shenanigans.

  4.  
    Cate Mullen
    August 9, 2016 | 1:05 PM
     

    Thanks for this commentary.
    I think that all professionals involved in medical service of any kind need to remain mindful of the past,present , and future.TB wards need to be remembered as well as Polio wards.
    If one was involved with medicine circa 1980
    you will always remember oncology patients going down for chemistry and they and you never sure if they would come through the treatment alive
    So pharma does have its place.
    Instead of using its laurels for the betterment of humankind those in the pharma and business side of profit making walked down the path of Col,Kurtz
    May I suggest end of summer reading?
    The Heart of Darkness by
    Joseph Conrad
    The
    Poison wood
    Bible by Barbara
    Kingsolver
    and
    Family Pictures by Sue Miller

  5.  
    James OBrien, M.D.
    August 9, 2016 | 1:57 PM
     

    Hamilton by Ron Chernow

    750 pages and you will be wanting more when you’re done

    Not recommending it, prescribing it

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