Ben Goldacre's BAD PHARMA

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Richard Lehman

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Sep 23, 2012, 1:08:13 PM9/23/12
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Dear All,

Ben kindly sent me a pre-release copy of his book which I have been reading avidly over the weekend. It is a brilliant tour-de-force and deserves to become both a popular best-seller and the manifesto for a new age of open medicine. We owe him a debt of gratitude. So does everybody.

I would welcome thoughts from all of you about how we move PATH up a gear. Ben has set out many well-argued proposals which will require action within the profession, but much more importantly by legislators in individual countries, the EU and the USA. We need a plan to push these home - no doubt in the face of a big push-back from pharma lobbyists. We may need to press for prosecutions and disciplinary hearings. This may be uncomfortable work but we cannot let the moment pass and allow things to drift on. I hope that Ben's work leads the public to ask some awkward questions about how our profession has been so complict for so long. Doctors need to be leaders in putting things right.

There has been quite a lot of other activity in the leading American medical journals. Here are some extracts from my latest weekly journal reviews on the BMJ website:

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.

Richard



Tom Jefferson

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Sep 23, 2012, 1:50:15 PM9/23/12
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Richard and all pathists, thank you for this. The whole topic area is poorly defined as yet. This is natural and healthy as it's a relatively new area (although reporting bias has been identified decades ago). For example we say "we want access to trial data". This to me has become almost like saying we like motherhood and apple pie or that we should not open fire on the Red Cross.
All the folk I know or I am in contact with would agree, as I do.

The difficulties start when we try to define what we mean by "access" and "data", assuming "trial" is shorthand for RCT.

So all this long splurge to say that I think we'd need a brainstorming session to even throw down an agenda for discussion and perhaps primarily some aims or objectives.

Then we'd have to all discuss the agenda and formulate a plan.

How? Email is good but I think brainstorming needs voice activation - Skype?

The trouble with having lots of folk on Skype is that the system becomes unstable.

Someone else will have a better solution.

Good night from Rome,

Tom.
--
Dr Tom Jefferson
www.attentiallebufale.it

James Heilman

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Sep 23, 2012, 1:54:49 PM9/23/12
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Joined a great webinar hosted by HIFA and PLoS medicine a while ago
that used "Elluminate web conferencing software" Not sure the price
however.

James Heilman
--
James Heilman
MD, CCFP-EM, Wikipedian

The Wikipedia Open Textbook of Medicine
www.opentextbookofmedicine.com

Ben Goldacre

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Sep 23, 2012, 2:34:42 PM9/23/12
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thanks richard, v kind. 

"google hangouts" seem to work pretty well, and do video too.

 (they can also be recorded, or made public, for other projects, in case thats useful to anyone)

Mark Emberton

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Sep 23, 2012, 2:58:01 PM9/23/12
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Richard and others.  I think clarity on the pathway is required so a brain storming is a good idea.  A conference even – I am sure we could get a venue donated.

In terms of developing pressure how about starting a dialogue with the on line pressure group  - 38degrees

I have ben impressed by them so far on the topic selection, their ability to communicate and their impact.

Mark 

www.38degrees.org.uk/





From: Richard Lehman <drricha...@gmail.com>
Reply-To: <pathtodata...@googlegroups.com>
Date: Sunday, 23 September 2012 18:08
To: <pathtodata...@googlegroups.com>
Subject: Ben Goldacre's BAD PHARMA

Dear All,

Ben kindly sent me a pre-release copy of his book which I have been reading avidly over the weekend. It is a brilliant tour-de-force and deserves to become both a popular best-seller and the manifesto for a new age of open medicine. We owe him a debt of gratitude. So does everybody.

I would welcome thoughts from all of you about how we move PATH up a gear. Ben has set out many well-argued proposals which will require action within the profession, but much more importantly by legislators in individual countries, the EU and the USA. We need a plan to push these home - no doubt in the face of a big push-back from pharma lobbyists. We may need to press for prosecutions and disciplinary hearings. This may be uncomfortable work but we cannot let the moment pass and allow things to drift on. I hope that Ben's work leads the public to ask some awkward questions about how our profession has been so complict for so long. Doctors need to be leaders in putting things right.

There has been quite a lot of other activity in the leading American medical journals. Here are some extracts from my latest weekly journal reviews on the BMJ website:

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.

Ben Goldacre

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Sep 23, 2012, 2:59:50 PM9/23/12
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i think, for something like 38degrees, we need a clear simple policy demand. 

in my view this requires the involvement of policy wonks who understand regulation and know how best to achieve single attainable goals through government. 

Eva Vanamee

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Sep 23, 2012, 5:12:10 PM9/23/12
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IMHO the data issue is secondary. The primary issue is having the right incentives for companies to develop good drugs.
We need strong deterrents for bad behavior. We know that fines don't work, they just become part of the cost of business for companies. In the US if a company is fined for fraudulent behavior, they should not be able to participate in Medicare/Medicaid. This is a more meaningful deterrent but companies get around it by identifying a small daughter company as the reliable party, and the parent company can still continue to supply drugs for Medicare/Medicaid. This loophole needs to be closed.  
As recent reports in the NY Times indicate there are serious problems with the regulatory agencies as well. They often look the other way because they depend on licensing fees. 
I think all these problems could have a simple fix by establishing personal liabilities and sending executives who intentionally misrepresent or hide information to jail. Combine that with strong whistleblower protection laws and we might end up with safer drugs on the market. 

- Eva

Jenny Molloy

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Sep 25, 2012, 7:53:02 AM9/25/12
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Dear All

Thanks for all the great discussion on this list, I coordinate the Open Science Working Group volunteers at the Open Knowledge Foundation http://science.okfn.org/ and was invited by Richard after a BioMedCentral post about one of our projects 'Who Needs Access?' gathering stories from those who rely on open access to the scientific literature, including patients. http://whoneedsaccess.org/

I'd like to add our support to moving forward access to trial data and offer practical help. We have a wide network of experts in data wrangling and data policy and OKFN has built open source data repositories and tools for open data such as CKAN, which is behind data.gov.uk. I would second James Heilman's suggestion of considering a community driven repository such as wikidata or CKAN, designed in conjunction with the people who want access to the data.

I'm based at the University of Oxford and run Oxford Open Science group (http://wiki.okfn.org/Working_Groups/Science/Oxford#Upcoming_Meetings_in_2012 ). I was already planning a meeting in late November around the ethics and practicalities of open clinical trial data, given the number of clinial trials units in the area and the discussions I saw on this list. I had been meaning to get in touch with you all about that, but if Mark Emberton's suggestion of a conference/meeting sounds good to you, it would perhaps be possible to turn it into a larger event. I have enthusiastic contacts at the Oxford e-Research Centre, who would probably be able to help set up a virtual meeting environment for remote participants and upgrade the space I've already booked. Just let me know what you think! If it sounds like a good idea, then if anyone has further contacts in Oxford who could help that would be great. However, you may feel that an online webinar is more suitable.

Best wishes

Jenny Molloy

Coordinator, Open Science Working Group
Open Knowledge Foundation

Richard Lehman

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Sep 25, 2012, 11:01:39 AM9/25/12
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Many thanks Jenny - it would be great to have your help in setting up a conference, and to link up with your Open Science Group. But I suspect we are looking at early next year, rather than late November.

By the way, the European Medicines Agency meeting on data sharing is on Nov 22nd in London, and I think most of us who applied have got places in the end.

There is also a meeting at the US Institute of Medicine Oct 4&5 which will have some live web coverage.

Thanks to everyone for your responses. I hope we can soon make some firm plans for a meeting to discuss progress and priorities,

Best wishes,

Richard

ma...@comcast.net

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Sep 25, 2012, 6:35:27 PM9/25/12
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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

ma...@comcast.net

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Sep 29, 2012, 7:06:55 AM9/29/12
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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



 

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