Comments on: The Human Injury of Lost Objectivity: An Insider’s Look into the Corruption of Clinical Trials http://brainblogger.com/2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/ Topics from multidimensional biopsychosocial perspectives. Thu, 18 Mar 2010 21:46:47 +0000 http://wordpress.org/?v=2.9.2 hourly 1 By:   The Human Injury of Lost Objectivity: An Insider’s Look into the Corruption of Clinical Trials — An Inconvenient Womanhttp://brainblogger.com/2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comment-535864   The Human Injury of Lost Objectivity: An Insider’s Look into the Corruption of Clinical Trials — An Inconvenient Woman Sun, 17 May 2009 07:33:40 +0000 http://brainblogger.com/?p=883#comment-535864 [...] by Dan Abshear [...] [...] by Dan Abshear [...]

]]> By: A Failed Attempt to Improve Perceived Greatness: The ENHANCE Trial | Brain Bloggerhttp://brainblogger.com/2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comment-170349 A Failed Attempt to Improve Perceived Greatness: The ENHANCE Trial | Brain Blogger Sat, 10 May 2008 14:48:51 +0000 http://brainblogger.com/?p=883#comment-170349 [...] whole situation is another example of the corruption of the scientific method by placing profits over the well-being of patients. Most were shocked by Merck behaving in such a [...] [...] whole situation is another example of the corruption of the scientific method by placing profits over the well-being of patients. Most were shocked by Merck behaving in such a [...]

]]> By: Taniahttp://brainblogger.com/2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comment-157904 Tania Mon, 28 Apr 2008 05:49:47 +0000 http://brainblogger.com/?p=883#comment-157904 Because they did not participate in the creation, design of the study or experiment, or collection of raw data.Several external writers (MD, PhDs) I know are acknowledged, but this is the vast minority. I agree, to not at least acknowledge that someone else helped write the paper is deception and more transparency is required. The pressure is on from both sides, the writers and journals, so it is just up to the damn pharma companies that pay out to agree to it. Because they did not participate in the creation, design of the study or experiment, or collection of raw data.

Several external writers (MD, PhDs) I know are acknowledged, but this is the vast minority. I agree, to not at least acknowledge that someone else helped write the paper is deception and more transparency is required. The pressure is on from both sides, the writers and journals, so it is just up to the damn pharma companies that pay out to agree to it.

]]> By: Casperhttp://brainblogger.com/2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comment-157049 Casper Sun, 27 Apr 2008 13:12:57 +0000 http://brainblogger.com/?p=883#comment-157049 If Ghostwriters are so qualified, then why are thier names not on the papers? Why hire an author to sign off on such studies described in this article? Is this not deception?Think before you pass judgement. If Ghostwriters are so qualified, then why are thier names not on the papers? Why hire an author to sign off on such studies described in this article? Is this not deception?

Think before you pass judgement.

]]> By: Taniahttp://brainblogger.com/2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comment-157028 Tania Sun, 27 Apr 2008 12:45:56 +0000 http://brainblogger.com/?p=883#comment-157028 Yes it is an angry man's rant. I will concede that the entire health industry including the physicians they serve needs transparency and disclosure. But a few bad apples should not make the entire harvest bad.Furthermore, your blanket statements, e.g. "ghostwriters, who are not identified and acknowledged by the sponsor, and are not trained in clinical research overall, as they are simply freelance writers" shows poor thought. 1) many of these CRO / "freelance" writers are trained in clinical research. A large proportion (30-50%) are mobile, highly trained medical doctors,pharmacists, nurses, and PhDs who chose to move and have a family in a country they are not licensed and therefore, need to make a living by writing. I personally know about 30 people who fit in this category. There is a push and mandate by journals and Medical Writer's organizations to require acknowledgment of external writers.Short of having the raw data produced by the pharma/med device industry available to the public, ranters like you will never be satisfied. Going back to the "good old days" of pure academic research will also mean lost time, lost lives. If one needs to compare, we should compare how "good" academic research was in terms of the same metrics. Acquisition of knowledge sure sounds much better than improving human lives. Yes it is an angry man’s rant. I will concede that the entire health industry including the physicians they serve needs transparency and disclosure. But a few bad apples should not make the entire harvest bad.

Furthermore, your blanket statements, e.g. “ghostwriters, who are not identified and acknowledged by the sponsor, and are not trained in clinical research overall, as they are simply freelance writers” shows poor thought. 1) many of these CRO / “freelance” writers are trained in clinical research. A large proportion (30-50%) are mobile, highly trained medical doctors,pharmacists, nurses, and PhDs who chose to move and have a family in a country they are not licensed and therefore, need to make a living by writing. I personally know about 30 people who fit in this category. There is a push and mandate by journals and Medical Writer’s organizations to require acknowledgment of external writers.

Short of having the raw data produced by the pharma/med device industry available to the public, ranters like you will never be satisfied. Going back to the “good old days” of pure academic research will also mean lost time, lost lives. If one needs to compare, we should compare how “good” academic research was in terms of the same metrics. Acquisition of knowledge sure sounds much better than improving human lives.

]]> By: Stuarthttp://brainblogger.com/2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comment-154980 Stuart Fri, 25 Apr 2008 19:50:37 +0000 http://brainblogger.com/?p=883#comment-154980 I don't know where to begin! You're obviously an angry man, but you're also seriously misinformed. Virtually your entire article is incorrect, from your characterization of CROs and the investigators to your misunderstanding of how medical writing and publishing works. But after 20 years in the business, I'm resigned to the misinformation, half-truths, and the ugly rants.I will make one point: the thousands and thousands of people employed in the pharmaceutical industry - from large pharma to CROs to small biotechs - care about science, care about safety, and care about the patients. We do important work, under highly regulated circumstances, and with great attention paid to detail. We're not getting rich, we're not interested in conning anyone, and we're not involved in some great conspiracy to manipulate data for our financial reward. I currently manage a team of 35 people. Do you think I could get all of them to agree to manipulate poor data? I can't even get them to agree on a day when we can all have a teleconference!I suggest the next time you want to vent about how much drugs cost, ask yourself, "Compared to what?" Lost quality of life? Hospitalization? Lost work? Surgery? Death? The 10 cents or so out of your health dollar is the best spend you could make. I don’t know where to begin! You’re obviously an angry man, but you’re also seriously misinformed. Virtually your entire article is incorrect, from your characterization of CROs and the investigators to your misunderstanding of how medical writing and publishing works. But after 20 years in the business, I’m resigned to the misinformation, half-truths, and the ugly rants.

I will make one point: the thousands and thousands of people employed in the pharmaceutical industry – from large pharma to CROs to small biotechs – care about science, care about safety, and care about the patients. We do important work, under highly regulated circumstances, and with great attention paid to detail. We’re not getting rich, we’re not interested in conning anyone, and we’re not involved in some great conspiracy to manipulate data for our financial reward. I currently manage a team of 35 people. Do you think I could get all of them to agree to manipulate poor data? I can’t even get them to agree on a day when we can all have a teleconference!

I suggest the next time you want to vent about how much drugs cost, ask yourself, “Compared to what?” Lost quality of life? Hospitalization? Lost work? Surgery? Death? The 10 cents or so out of your health dollar is the best spend you could make.

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