NEJM 20 Sep 2012 Vol 367
1082 In the next few weeks, we can look forward to dignified murmurs of offended innocence from the pharmaceutical industry in response to Ben Goldacre’s brilliant and damning new book, Bad Pharma. But it is difficult to maintain dignity when caught with your pants down, as GlaxoSmithKline has been over the mis-selling of Paxil and Wellbutrin, and the hiding of safety data relating to Avandia. However, all that’s needed is to pay up $3BN and your pants can quickly be raised and adjusted. Nobody need be called to account, and business can go on as usual: after all, $3bn is about half the profit that these three drugs produced every year while they were being mis-marketed. Here’s a swingeing perspective piece titled Punishing Health Care Fraud — Is the GSK Settlement Sufficient? The answer of course is no. There is nothing to stop fraud continuing as a lucrative business plan, and nothing to bring those responsible to court. And is GSK just a bad apple? No way – there are 25 others who are under special measures, including most of the big names in US pharma.
http://www.nejm.org/doi/full/10.1056/NEJMp1209249
1119 Take a look at this study of how US medical interns rate hypothetical studies of new drugs: it’s free to everybody courtesy of Jeff Drazen, who also produces an editorial that you can read in full. Lampytinib, bondaglutaraz, provasinab: what fun to make up drug names like that, and trial designs that varied from a proper large RCT to a footling open-label study with no safety data. Not surprisingly, the interns had little difficulty in grading the quality of these mock-ups. But now comes the interesting bit: they were much less inclined to believe the results if the studies were marked as industry funded. This earns them a lofty reproof from headmaster Drazen: “Patients who put themselves at risk to provide these data earn our respect for their participation; we owe them the courtesy of believing the data produced from their efforts and acting on the findings so as to benefit other patients.” Amen to that – but that’s exactly why we mistrust data that have been gathered and interpreted by people with billions of dollars riding on the result – and who have a track record of deceit. If Drazen wants to show true courtesy to the trial participants, he needs to insist that for every trial published in the NEJM there is a full database of raw, de-identified patient-specific data, with the trial protocol and any variations from it, and all other meta-data required to interpret the study, open to all bona-fide investigators. And let’s not forget that the NEJM itself has a vested interest in putting a positive spin on industry-funded trials, as it gets a substantial (undisclosed) proportion of its income from the sale of reprints to pharma companies. There have been some terrific responses to this editorial, especially from Harlan Krumholz and Joe Ross.
http://www.nejm.org/doi/full/10.1056/NEJMsa1202397
http://www.nejm.org/doi/full/10.1056/NEJMe1207121v
http://www.pharmalot.com/2012/09/the-op-ed-a-suggestion-to-restore-faith-in-pharma-studies/
http://www.cardioexchange.org/voices/why-i-applaud-the-skeptical-physicians/
Good reading everyone.NEJM 20 Sep 2012 Vol 367
1082 In the next few weeks, we can look forward to dignified murmurs of offended innocence from the pharmaceutical industry in response to Ben Goldacre’s brilliant and damning new book, Bad Pharma. But it is difficult to maintain dignity when caught with your pants down, as GlaxoSmithKline has been over the mis-selling of Paxil and Wellbutrin, and the hiding of safety data relating to Avandia. However, all that’s needed is to pay up $3BN and your pants can quickly be raised and adjusted. Nobody need be called to account, and business can go on as usual: after all, $3bn is about half the profit that these three drugs produced every year while they were being mis-marketed. Here’s a swingeing perspective piece titled Punishing Health Care Fraud — Is the GSK Settlement Sufficient? The answer of course is no. There is nothing to stop fraud continuing as a lucrative business plan, and nothing to bring those responsible to court. And is GSK just a bad apple? No way – there are 25 others who are under special measures, including most of the big names in US pharma.
http://www.nejm.org/doi/full/10.1056/NEJMp1209249
1119 Take a look at this study of how US medical interns rate hypothetical studies of new drugs: it’s free to everybody courtesy of Jeff Drazen, who also produces an editorial that you can read in full. Lampytinib, bondaglutaraz, provasinab: what fun to make up drugnames like that, and trial designs that varied from a proper large RCT to afootling open-label study with no safety data. Not surprisingly, the interns had little difficulty in grading the quality of these mock-ups. But now comes the interesting bit: they were much less inclined to believe the results if the studies were marked as industry funded. This earns them a lofty reproof from headmaster Drazen: “Patients who put themselves at risk to provide these data earn our respect for their participation; we owe them the courtesy of believing the data produced from their efforts and acting on the findings so as to benefit other patients.” Amen to that – but that’s exactly why we mistrust data that have been gathered and interpreted by people withbillions of dollars riding on the result – and who have a track record of deceit. If Drazen wants to show true courtesy to the trial participants, heneeds to insist that for every trial published in the NEJM there is a full database of raw, de-identified patient-specific data, with the trial protocol and any variations from it, and all other meta-data required to interpret the study, open to all bona-fide investigators. And let’s not forget that the NEJM itself has a vested interest in putting a positive spin onindustry-funded trials, as it gets a substantial (undisclosed) proportion of its income from the sale of reprints to pharma companies. There have been some terrific responses to this editorial, especially from Harlan Krumholz and Joe Ross.
Hi everyone, the link to sign up to watch the webinar of the IOM workshop on data sharing is here:
http://www.iom.edu/Activities/Research/SharingClinicalResearchData.aspx
Marilyn
From: "Richard Lehman" <drricha...@gmail.com>
To: pathtodata...@googlegroups.com
Sent: Tuesday, September 25, 2012 11:01:39 AM
Subject: Re: Ben Goldacre's BAD PHARMA
There is also a meeting at the US Institute of Medicine Oct 4&5 which will have some live web coverage.
Best wishes,
Richard
The briefing book for the IOM workshop, including an agenda, speakers biographies and background reading materials, is downloadable from this link: http://dl.dropbox.com/u/24104239/Sharing%20Clinical%20Data%20Briefing%20book%20final.pdf
-- Marilyn