Episode 155 – 28th September 2012

We speak to Ben Goldacre about his new book, Bad Pharma, find out what we can do now anti-choice activists are protesting again, hear what Dawkins had to say at the NSS conference, and discover the vaccine for whooping cough.

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Ben Goldacre Interview (2:10) by Liz Lutgendorff (ft Ben Goldacre!)
40 Days For Life Are Back (21:30) by James O’Malley (ft Lucy Porter & Kerry J)
Dawkins at the NSS Conference (26:12) by James O’Malley (ft Richard Dawkins)
Nature Deficit Disorder (34:13) by Martin Saban-Smith
Whooping Cough Vaccine (42:26) by Peter English
Rbutr (53:08) by Kylie Sturgess (ft Shane Greenup)

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8 thoughts on “Episode 155 – 28th September 2012

  1. Little bit disappointed by the normally excellent Liz’s interview with Ben Goldacre. A bit a of a skeptic fail, IMHO.

    Being a good skeptic means questioning all claims, right? Even from people whom you might consider to be basically on your side. Just because Goldacre is someone who is usually right about most things doesn’t mean that we should all just assume he’s always right about everything.

    And yet Liz’s interview seemed to take the claims presented in his book as fact, with no attempt at critically evaluating them. This is disappointing. Now, Goldacre certainly makes some good and important points (for example, I couldn’t agree more when he says that the secrecy surrounding EMA evaluations of drugs is scandalous), but other points are, shall we say, a little “embellished”. Challenging him on some of those points would have made for a better interview.

    I haven’t finished reading the book yet, but one example from the interview is Goldacre’s claim that Roche has “withheld” reports of trials of Tamiflu. Now, it’s true that not all the trials have been published in peer-reviewed journals, and that’s undoubtedly a failure on the part of Roche. However, I suspect anyone listening to this interview would be left with the impression that the trials are completely hidden, which is simply not true, as the results are made available on Roche’s website.

    There’s other stuff in the book that doesn’t actually stand up to critical evaluation (I’m pretty sure I’ll be blogging about this once I’ve finished reading the book). I do hope those who consider themselves skeptics will read this book with a critical eye, and not just think “Oh, this book is written by someone I respect, so I don’t have to bother with this skepticism stuff today”.

  2. “Goldacre’s claim that Roche has “withheld” reports of trials of Tamiflu. Now, it’s true that not all the trials have been published in peer-reviewed journals, and that’s undoubtedly a failure on the part of Roche. However, I suspect anyone listening to this interview would be left with the impression that the trials are completely hidden, which is simply not true, as the results are made available on Roche’s website.”

    Actually Ben Goldacre talks about Clinical Study Reports, he talks about these specifically because these are what the Cochrane researchers wanted. What you have found on the Roch website are not the Clinical Study Reports.

    The researchers wrote all about this themselves in PLOSmedicine:-

    “In 2010, we began our Cochrane review update using clinical study reports rather than published papers [16]. We obtained some sections of these clinical study reports for the ten trials appearing in the Kaiser 2003 meta-analysis from Tamiflu’s manufacturer, Roche—around 3,200 pages in total. In 2011, we obtained additional sections of clinical study reports for Tamiflu through a Freedom of Information request to the EMA, amounting to tens of thousands of pages. While extensive and detailed, it is important to note that what we have obtained is just a subset of the full clinical study reports in Roche’s possession. Nonetheless, Box 1 provides a list of details we have already discovered—and would have never discovered without access to these documents. This information has turned our understanding of the drug’s effects on its head. Other drugs for which previously unpublished, detailed clinical trial data have radically changed public knowledge of safety and efficacy include Avandia, Neurontin, and Vioxx (Table 1).

    Box 1. What Is Missed without Access to Tamiflu Clinical Study Reports
    Knowledge of the total denominator. (How many trials were conducted on this drug that might fit the systematic review inclusion criteria?) [13]
    Realization that serious adverse events (SAEs) occurred in trials for which SAEs were not reported in published papers [13].
    Understanding what happened in some trials that were published 10 years after completion [43].
    Vital details of trials (content and toxicity profile of placebos, mode of action of drug, description and temporality of adverse events) [11].
    Authorship is not consistent with published papers [44] (although, if a review’s inclusion criteria include clinical study reports, authorship is not an issue, as the responsibility is clearly the manufacturer’s).
    Rationale for alternatively classifying outcomes such as pneumonia as a complication or an adverse event [16].
    Ability to know whether key subgroup analysis (influenza-infected subjects) is valid [11].
    Assessment of validity of previously released information on the drug (articles, reviews, conferences, media, etc.).
    Realization that Roche’s claim of Tamiflu’s mode of action [45] appears inconsistent with the evidence from trials [11],[46].”


  3. Yes, there have been problems with access to the full reports, but that’s not what Goldacre said in the podcast, was it? He said that the trials were hidden, which is misleading.

    Many of the problems Goldacre identifies are real enough. I just don’t understand the need to “sex them up” in this way by trying to make them sound worse than they are.

  4. They are hidden, the clinical study reports show inconsistencies between what has been published publicly by Roche compared to what was written up in the CSR. Goldacre begins to explain this at the start of page 86 of Bad Pharma.
    In short he states that a CSR is inbetween the raw data and the published study, and can be thousands of pages long.
    What is on the Roche website is, to my eyes at least, much less comprehensive than most peer reviewed published studies.

    Regardless, we know that data from the CSRs already released disagrees with what is said in the published studies. The authors write about this themselves on PLOS medicine in the link I posted above.

    There are real problems with the Tamiflu research and that haven’t really been sexed up. Though it is a pop science book so it has been given a nice and easy narrative to follow.

    I agree with the principle that we shouldn’t accept what a skeptic says just because they are a skeptic. If you want to fact check Ben Goldacre’s book then that’s interesting…but that means you are going to get fact checked as well.
    I’ve just checked the references and seen that Goldacre references to what I linked to plus several other sources, I recommend reading those before saying the Tamiflu story is sexed up and then explaining exactly how, where and why it is sexed up.

    I assume Goldacre anticipated skepticism, hence including 33 pages (mostly) of references at the back.

  5. Vince, everything you say about Tamiflu is correct, but that’s not the point. Clearly you have looked into this in some detail and know what’s going on.

    My point is that none of this would be clear from listening to the interview. You only know this stuff because you have read about it in more detail than you listened to in the interview. The interview said that the trials were hidden, which is misleading. It would be accurate to say some details were hidden, but that’s not what Goldacre said in the interview. He said the trials were hidden.

  6. That was a great bit about the Pro-Choice Alliance. I would, however, point out, after James’ “women of childbearing age” quip, that it’s because of many women who *aren’t* now of childbearing age, who worked so hard in the 1980s against initiatives such as David Alton’s, that we still have any decent provision for abortion at all. You don’t need to have functioning ovaries to think a woman’s body is her own, and to characterise the division between pro-choice and anti-choice one being a division also based on age, even as a joke, is to do us all a disservice. (I agree about the dyed-hair-and-nerd-glasses division, though…)

  7. Couldn’t agree more, Hive – after all, I’m mercifully unable to grow a child inside of me.

    Though I think optics-wise it’s useful to have the people you’re most directly supporting visibly on side!

  8. I saw a little write up in the Radio Times about this podcast and came to check it out. I immediately saw you describing NHS protesters as being ‘anti-choice’. I’m outta here!

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