Comments on: The Human Injury of Lost Objectivity: An Insider’s Look into the Corruption of Clinical Trials /2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/ Health and Science Blog Covering Brain Topics Sat, 29 Dec 2018 04:00:22 +0000 hourly 1 https://wordpress.org/?v=5.0.3 By: onergk69 /2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comment-708646 Fri, 17 Aug 2012 18:21:00 +0000 /?p=883#comment-708646 I agree w/ Dan’s essential premise about Big Pharma & the push for profits over patient/client safety. Due to their huge conflict of interests, their studies are more subjective than impirical,& they have experienced record amounts of criminal fines in the past few years due to illegal marketing tactics.

The US is only 1 of 2 core developed countries that allows DTC marketing!

I posses over 40 yrs. of clinical experience in behavioral health, esp. re: psychotropics.

I suggest that any skeptics do a search on Big Pharma placebo washout strategies; and keep in mind that BP is not required to submit studies where the active agent does not beat placebo. And they are only required to submit 2 studies that demonstrate that the active agent is superior to placebo. And BTW, placebo effects can be as high as 35% in double-blind, controlled research.

I’ve seen marketing materials on psychostimulants that are only 3 or 4 weeks in duration!!

Rich

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By: Anonymous /2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comment-619583 Thu, 26 Jan 2012 08:03:22 +0000 /?p=883#comment-619583 If your interested in a recycled rubber playground then you should use this company they’re great.

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By: Duncan /2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comment-600108 Sun, 02 May 2010 03:42:24 +0000 /?p=883#comment-600108 Stuart and Tania take umbrage at the criticism in the article without really acknowledging the seriousness of the issues raised.

I find Tania’s view of “ghostwriting” to be shocking. Any college students would be kicked out of school for such behavior: both the writers and the “authors of signature”.

Stuart’s claim that most of the people in his industry are “good” therefore “don’t criticize” is not a argument, it is simply a complaint. I sympathize to the extent that taking Stuart at his word that he is honorable, it must be quite painful to have a constant stream of well researched criticisms levied against his industry.
(And yes, of course, there are also a lot of off-the-wall critics as well

Stuart may lead an impeccable team solely dedicated to science and truth but even a casual exploration of the flood of criticisms of the pharmaceutical industry by researchers, medical journals and the regulatory agencies and courts opens many doors on questionable activities. Dan Abshear is just one of the many writers exploring this area.

I would suggest that Stuart and Tania get involved in forming groups within the pharma industry to weed out the scoundrels so the reputation of the industry can be improved. The criticisms are not going to stop until the shady practices are corrected.

Tania’s suggestion of providing the raw data to the public is excellent. To have third party access and analysis of the data and research would go a long way to improving everyone’s behavior: industry insiders, regulators and critics alike.

The histories of Vioxx, Celebrex, Avandia, Seroquel, Neurontin etc, etc, are not deniable.

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By:   The Human Injury of Lost Objectivity: An Insider’s Look into the Corruption of Clinical Trials — An Inconvenient Woman /2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comment-535864 Sun, 17 May 2009 07:33:40 +0000 /?p=883#comment-535864 […] by Dan Abshear […]

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By: A Failed Attempt to Improve Perceived Greatness: The ENHANCE Trial | Brain Blogger /2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comment-170349 Sat, 10 May 2008 14:48:51 +0000 /?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 […]

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By: Tania /2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comment-157904 Mon, 28 Apr 2008 05:49:47 +0000 /?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.

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By: Casper /2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comment-157049 Sun, 27 Apr 2008 13:12:57 +0000 /?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.

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By: Tania /2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comment-157028 Sun, 27 Apr 2008 12:45:56 +0000 /?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.

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By: Stuart /2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comment-154980 Fri, 25 Apr 2008 19:50:37 +0000 /?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.

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