Welcome to DU!
The truly grassroots left-of-center political community where regular people, not algorithms, drive the discussions and set the standards.
Join the community:
Create a free account
Support DU (and get rid of ads!):
Become a Star Member
Latest Breaking News
General Discussion
The DU Lounge
All Forums
Issue Forums
Culture Forums
Alliance Forums
Region Forums
Support Forums
Help & Search
Health
Related: About this forumBad pharma: Drug research riddled with half truths, omissions, lies
http://www.salon.com/2013/01/27/bad_pharma_drug_research_riddled_with_half_truths_omissions_lies/One personal example from the author
Reboxetine is a drug I myself have prescribed. Other drugs had done nothing for this particular patient, so we wanted to try something new. Id read the trial data before I wrote the prescription, and I had found only well-designed, fair tests, with overwhelmingly positive results. Reboxetine was better than placebo and as good as any other antidepressant in head-to-head comparisons. Its approved for use by the Medicines and Healthcare products Regulatory Agency (the MHRA), which governs all drugs in the UK. Millions of doses are prescribed every year around the world. Reboxetine was clearly a safe and and effective treatment. The patient and I discussed the evidence briefly, and we agreed it was the right treatment to try next. I signed a prescription saying I wanted my patient to have this drug.
But we had both been misled. In October 2010, a group of researchers were finally able to bring together all the trials that had ever been conducted on reboxetine. Through a long process of investigation searching in academic journals but also arduously requesting data from the manufacturers and gathering documents from regulators they were able to assemble all the data, both from trials that were published and from those that had never appeared in academic papers.
When all this trial data was put together it produced a shocking picture. Seven trials had been conducted comparing reboxetine against placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal for doctors and researchers to read. But six more trials were conducted in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials were published. I had no idea they existed.
It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: Three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs. If all this wasnt bad enough, there was also the side-effects data. The drug looked fine in the trials that appeared in the academic literature. But when we saw the unpublished studies, it turned out that patients were more likely to have side effects, more likely to drop out of taking the drug and more likely to withdraw from the trial because of side effects if they were taking reboxetine rather than one of its competitors.
I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them and I discussed them with the patient. We made a decision together, based on the evidence. In the published data, reboxetine was a safe and effective drug. In reality, it was no better than a sugar pill, and worse, it does more harm than good. As a doctor, I did something which, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished.
But we had both been misled. In October 2010, a group of researchers were finally able to bring together all the trials that had ever been conducted on reboxetine. Through a long process of investigation searching in academic journals but also arduously requesting data from the manufacturers and gathering documents from regulators they were able to assemble all the data, both from trials that were published and from those that had never appeared in academic papers.
When all this trial data was put together it produced a shocking picture. Seven trials had been conducted comparing reboxetine against placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal for doctors and researchers to read. But six more trials were conducted in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials were published. I had no idea they existed.
It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: Three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs. If all this wasnt bad enough, there was also the side-effects data. The drug looked fine in the trials that appeared in the academic literature. But when we saw the unpublished studies, it turned out that patients were more likely to have side effects, more likely to drop out of taking the drug and more likely to withdraw from the trial because of side effects if they were taking reboxetine rather than one of its competitors.
I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them and I discussed them with the patient. We made a decision together, based on the evidence. In the published data, reboxetine was a safe and effective drug. In reality, it was no better than a sugar pill, and worse, it does more harm than good. As a doctor, I did something which, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished.
InfoView thread info, including edit history
TrashPut this thread in your Trash Can (My DU » Trash Can)
BookmarkAdd this thread to your Bookmarks (My DU » Bookmarks)
3 replies, 1444 views
ShareGet links to this post and/or share on social media
AlertAlert this post for a rule violation
PowersThere are no powers you can use on this post
EditCannot edit other people's posts
ReplyReply to this post
EditCannot edit other people's posts
Rec (3)
ReplyReply to this post
3 replies
= new reply since forum marked as read
Highlight:
NoneDon't highlight anything
5 newestHighlight 5 most recent replies
Bad pharma: Drug research riddled with half truths, omissions, lies (Original Post)
Celebration
Feb 2013
OP
Siwsan
(26,268 posts)1. Rx commercials spend more time on the possible side effects, than the potential benefits
I have zero confidence in big pharm. Maybe if they spent the $$ on research, instead of those damn, non-stop commercials, they would have better outcomes with their products.
TM99
(8,352 posts)2. Well, thank the gods
it is not homeopathy.