Restoring Study 329: Correspondence with BMJ Jul 15 to Jan 16

Editorial Note: The letter from the Study 329 team to BMJ re Dr Loder featured in 50 Shades of Gray and in Conflicts of Interest. The actual letter and related correspondence is all on Study329.org.  The emails below and in the next post tell you what happened next.

From: Jureidini, Jon (Health)
Sent: Wednesday, 8 July 2015 10:32 PM
To: fgodlee@bmj.com
Subject: 329 and COI

Dear Dr Godlee

Please find attached a letter that raises some COI issues.

Thanks

Jon Jureidini

___________________________________

On Wednesday, 30 September 2015, 23:52, “Jureidini, Jon (Health)” <Jon.Jureidini@sa.gov.au> wrote:

Dear Fiona

Thank you for publishing and promoting our paper. We are very pleased that we and you saw this difficult process through.

We have not received a reply to the attached letter we sent you on 8 July, about our concerns about potential conflict of interest on the part of Dr Loder. We still think that the issues we raised are important, so we are seeking a response from you.

Thanks

Jon

___________________________________

From: Fiona Godlee [mailto:fgodlee@bmj.com]
Sent: Thursday, 1 October 2015 6:46 PM
To: Jureidini, Jon (Health)
Subject: Re: Confidential

Dear Jon.

Thank you for your message. My apologies for not replying to your earlier message. I’m not sure how I missed it.

Let me discuss your concerns with Dr Loder. I will get back to you as soon as I have had a chance to do so.

All best wishes. Fiona

Dr Fiona Godlee FRCP

Editor in chief, The BMJ

London WC1H 9JR

http://www.thebmj.com/

fgodlee@bmj.com

44 (0)207 383 6002

___________________________________

—–Original Message—–

From: Jureidini, Jon (Health)
Sent: Wednesday, 4 November 2015 9:37 AM
To: fgodlee@bmj.com
Subject: FW: Confidential

Hi

Have you had a chance to evaluate our concerns?

Cheers

Jon

___________________________________ 

On 14 Dec 2015, at 2:07 am, Jureidini, Jon (Health) <Jon.Jureidini@sa.gov.au> wrote:

Hi

Just tidying things up before Christmas, and wanting to check if I will hear back from about this potential COI issue.

Happy new year

Jon

___________________________________

From: “fgodlee@bmj.com” <fgodlee@bmj.com>
Date: Wednesday, 16 December 2015 4:46 am
To: “Jureidini, Jon (Health)” <Jon.Jureidini@sa.gov.au>
Subject: Re: Confidential

Dear Jon.

So sorry not to have got back to you about this. I referred it to our ethics committee which meets three times a year, but the last meeting was cancelled. They meet tomorrow and I should be able to give you their conclusion shortly afterwards. All best wishes. Fiona Dr Fiona Godlee FRCP

Editor in chief, The BMJ

London WC1H 9JR

http://www.thebmj.com/

fgodlee@bmj.com

44 (0)207 383 6002

___________________________________

From: Fiona Godlee [mailto:fgodlee@bmj.com]
Sent: Sunday, 3 January 2016 11:09 PM
To: Jureidini, Jon (Health)
Subject: Re: Confidential

Dear Jon,

Just to give you an update.

The ethics committee’s agenda was rather full for its December 16 meeting – having missed a meeting earlier in the year, and I am afraid we didn’t get to this item. However, I have asked our chair, Professor Marion McMurdo, to convene an additional meeting, which I hope will take place in the next few weeks, in order that we can get you a response to your concerns. My apologies for this further delay. I will be in touch again as soon as possible.

All best wishes,

Fiona

Dr Fiona Godlee FRCP Editor in Chief, The BMJ BMJ, BMA House, Tavistock Square, London, WC1H 9JR T: 020 7383 6002 E: fgodlee@bmj.com W: bmj.com/company

Personal assistant:

Julia Burrell

T: 020 7383 6102

E: jburrell@bmj.com

___________________________________

From: Fiona Godlee [mailto:fgodlee@bmj.com]
Sent: Monday, 11 January 2016 3:42 AM
To: Jureidini, Jon (Health)
Subject: Fwd: response to the Jureidini allegations

Dear Jon,

I am now able to respond in full to the concerns you raised last year about Elizabeth Loder’s possible conflicts of interest in relation to your reanalysis of the data from Study 329.

The ethics committee convened on Friday 8 January, 2015. It was chaired by the committee chair Professor Marion McMurdo, attended by committee members Julian Sheather, Elizabeth Wager, and Dr Adrian Sutton. Committee members who were unable to attend – Dr Rubin Minhas, John Coggon, and Dr Richard Hain – sent their comments by email. Also attending were myself, the BMJ’s Executive Editor Dr Theo Bloom, and the committee’s secretary Laura Templar who took the minutes.

The committee were in receipt of your letter and a response from Dr Loder, which is appended with attachments below.

The committee reviewed the issues you raised and, by a large majority, concluded that the possible conflicts you have identified are so attenuated by distance from Dr Loder – by virtue of the size and scope of her and her husband’s organisations, as to be highly unlikely to have impacted on her decision making. The committee felt that to require an individual to consider, manage or declare such attenuated links would take declaration of conflicts of interest to an absurd level, since such potential conflicts would be near impossible for an individual to keep track of or to be held responsible for. The committee was satisfied with Dr Loder’s response.

On the basis of this advice I therefore intend to take no further action on this matter.

Thank you again for raising it.

All best wishes, Fiona

Dr Fiona Godlee FRCP Editor in Chief, The BMJ BMJ, BMA House, Tavistock Square, London, WC1H 9JR T: 020 7383 6002 E: fgodlee@bmj.com W: bmj.com/company

Personal assistant:

Julia Burrell

T: 020 7383 6102

E: jburrell@bmj.com

———- Forwarded message ———-

From: Elizabeth Loder <eloder@bmj.com> Date: 16 December 2015 at 11:11 Subject: response to the Jureidini allegations To: Fiona Godlee <FGodlee@bmj.com>

Dear Fiona,

You asked me to respond to Dr. Jureidini’s accusations of conflict of interest regarding connections to GSK. These were 1) that my hospital, Brigham and Women’s, receives research money from GSK; 2) that my husband is a partner in the law firm Ropes & Gray, which has done work for GSK and thus he profits directly from this connection; and 3) that I have made public statements favorable to GSK products.

With regard to the first matter, I don’t keep track of nor do I have any practical way of knowing about the hospital’s many sources of research support. BWH is one of the largest academic medical centers in the US and receives millions of dollars of research support from a vast array of companies and government agencies.

With regard to the second matter, Ropes & Gray is a huge international law firm with thousands of clients. The firm has approximately 1200 lawyers working from 11 different offices around the world and well over $1 billion in annual revenues. I didn’t have any knowledge of their work for GSK. My husband does not work in their healthcare division. He is a securities lawyer. He works exclusively with firms that manage money. He advises the management of these firms or their independent boards of directors and represents them in government enforcement matters.  Ropes & Gray’s work for GSK and the firm’s relationship with GSK accordingly had no influence on the editorial process. It seems entirely unreasonable to expect that any journal would make disclosures of all of their editors’ spouses’ employers’ business relationships. Those relationships are much too attenuated to be likely to have any bearing on the objectivity of the editorial process. Furthermore, there is no practical mechanism for gathering information about such remote relationships.

With regard to the third matter, the examples provided by Dr. Jureidini are taken out of context. They do not illustrate that I have spoken favorably about GSK products. You will note that in the live Q&A with the Washington Post, from which he pulled a quote, I use the generic name sumatriptan, and am answering a question posed by a reader who used the brand name.

http://live.washingtonpost.com/how-serious-are-migraines.html

The question was specifically about sumatriptan so it made sense to speak of that drug. It is a matter of fact not opinion that the injectable version of the drug, and early administration, improve outcome. Furthermore, sumatriptan is the only one of the seven marketed triptans that is available in an injectable formulation. The injectable formulation is produced by a number of generic manufacturers in addition to GSK. GSK makes a branded version of sumatriptan which is called Imitrex or Imigran but I did not use the brand name.  Additionally, you will see in the attached review article I wrote for NEJM that I specifically recommend the use of a generic version of sumatriptan because it is the least expensive treatment.

With regard to the statement about combinations of triptans and NSAIDs being more effective than either drug alone, again this is a matter of fact and not opinion. There are many trials comparing combination treatment to the single drugs — see attached editorial I wrote about the combination of frovatriptan and an NSAID. It is hard to understand how a statement about the effectiveness of combination therapy constitutes an endorsement for a particular fixed dose combination. In practice I do not use the GSK product treximet (sumatriptan + naproxen) because I think aspirin is a better choice than naproxen for use in combination therapy.

I hope these answers are satisfactory. Let me know if you have any other questions.

Elizabeth

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On Thursday, 28 January 2016, 6:08, “Jureidini, Jon (Health)” <Jon.Jureidini@sa.gov.au> wrote:

Hi

Please find attached a response to this email.

Cheers

Jon