Public distrust of clinical trials: any more to this?


I put FDA news in my newsreader because it is pretty thorough on the headlines, and I can usually find information otherwise behind their subscription wall elsewhere on the webs. However, there is one story I can’t find elsewhere.

It’s on the public’s waning trust in clinical trials. I was wondering what is leading to this phenomenon, if it exists.

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3 Responses

  1. John,

    Love your blog. I have a Masters in Statistics, but am now a stay at home mom. I find your comments on use of statistics in medicine very interesting. I can give you my opinion on why trust in clinical trials is waning.

    1. It is a fact published in many different places including this blog that the drug companies own the results of their studies and they only publish the ones with good results. Therefore, when a study comes out with positive results for a particular new drug, I wonder how many studies were run that did not have postive results.

    2. I’m not even sure how positive the results are since I only get my info from headlines and the accompanying news articles. It has also been published that these journalists do not necessarily read the study only the blurb they get from the drug company. When you do read articles from people who disagree, they site the same paper and evidence to support their point.

    3. As I get older, I come in contact with more and more people who take one drug to fix something and end up with taking more drugs to counteract the side effects of the first drug. These clinical trial never talk about what other medicine had to be prescribed to counteract side effects.

  2. Hi Interested, I’m glad you dropped by. It sound like you’ve your hands full. (I’m assuming you’re the same Interested as has left comments over at Injecting Sense?) For your points:

    1. You have touched on a real problem, and one for which we’re trying to solve. Some journals are requiring that, if a sponsor wishes to publish, that all studies negative and positive be registered. There may be some regulatory action as well, where regulatory agencies — FDA and abroad, would keep a universal registry of clinical trials. There’s even a call to make clinical protocols public. I personally like most of these initiatives. I think we’ll have to understand the consequences of making protocols public, though maybe we can simply require the summary box be made public. Of course there’s the information hog in me that just wants everything to be public 😉

    2. Since you’ve seemed to have read other parts of this blog, you probably know I’ve written an invective or two on the subject as well. These days, I usually try to dig the article up with Google Scholar or some other service. If I can find the abstract, I usually read and link to that. Even better if the full article is available. What I find fascinating is that sometimes the headlines don’t even match the major conclusions of the study! Either Mark Schauss or David Gumpert (eek I should put them on my blogroll) recently listed all the headlines about a particular vitamin study, and they ran the gamut from positive to negative.

    http://www.randomjohn.info/wordpress/2006/04/25/defeat-snatched-out-of-the-jaws-of-victory-study-conclusions-and-media-reporting/

    3. For clinical trials done for the purposes of marketing applications, we have to look carefully at what has to be done to handle adverse drug reactions. This kind of analysis is part of international guidelines (if you’re curious, the guidelines are at http://www.ich.org — especially look at the E3, E9, and E10). The state of the art of the statistics I’m afraid isn’t very good on the matter (since you have a Masters in Stats, think massive multiple comparisons nightmare), so we usually just print counts and pass them onto scientific or medical personnel so they can try to make sense of it. The Bayesians may have found a better way to get a handle on things, and I’m digging further into it. We can also get a little more creative with our statistical graphics, though I have seen some examples that were simply too creative to be useful. At any rate, I guess the trials that get all the attention don’t seem to address the question, at least not in a publically accessible manner.

    I’m very curious. You said that you have tried homeopathy for your children and it seems to have worked? Could you describe how you came to decide this? You can read about my story here:

    http://www.randomjohn.info/wordpress/2005/09/15/ranting-and-raving-again-about-healthcare-and-the-magical-clinical-trial/#comment-47

  3. Well it all started with having an intractable problem. My background is engineering as well as statistics. If I have a problems, I figure out a solution.

    My son has always had developmental delays in academic areas. But he has always been an exceptional athelete. In athletics, he can meet or exceed the performance of his peers. His first love is soccer and he plays on a travel soccer team.

    But last fall, he started having emotional problems at the games. He would freeze on the field or melt down or come off the field without permission. He really wanted to play, but he couldn’t play.

    So we talked to his pediatrician who told us not to worry and not to do anything (medical) about it. We talked to the coach and he looked out for and handled the problem for the rest of the season. But we knew he wasn’t happy. A friend of mine had had very good results treating her son’s ADD with homeopathy. And I found an book in the library that explained it in such a way that it made sense to me.

    In the end, I figured what did I have to lose? It wasn’t toxic and the worst that could happen was nothing.

    I found a homeopath who has an autistic son. She really understood what was going on. She started us on a set of remedies, one constitutional to take care of the overall problem and others to take care of peripheral issues.

    He played the spring season with no freezes, no coming off without permission and only one short melt down off the field. He had a really good time and is looking forward to the fall.

    We notice that his verbal skills and his social skills have improved. And he is much happier.

    We are now addressing the academic delays.

    I should also mention that he also goes to a chiropractor who does energy adjustments recommended by the homeopath.

    As for my daughter, she has allergies and asthma. She always had phlegm sitting in her throat and she was always clearing her throat. In the winter, this phlegm would give her breathing problems. We were always giving her breathing treatments. Finally, the allergist recommended Advair for use everyday. Additionally, she had exercise induced asthma. When she had gym outside in the nice weather, she had to use her inhaler. I mentioned this to the homeopath. Since she is in the same family, she needed the same constitional remedy. I gave her the recommended remedy. Her ‘phlegm’ cleared up, she no longer needs breathing treatments, and she no longer needs her inhaler.

    This last result has really floored me. My son’s problem was very subtle to everyone but us and his improvement has been also. But my daughter’s has been astounding. Her post nasal drip that was causing all that phlegm was gone within 48 hrs. She never had to take her inhaler out in school after that. This coming winter will tell the full story. If she gets through a winter without inhaler or breathing treatments, she will effectively be allergy free.

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