P&G Pharmaceuticals: how to deal with a public relations disaster

Patients get damaged by misrepresented pharmaceutical research. “Ghost-writing” has been repeatedly criticized - but this diverts attention from the more important problem – “ghost science”, of which “ghost-writing” is only a small part. Ghosts work behind the scenes at every level of the pharmaceutical scientific process. Sometimes these ghosts make mistakes and get startled by the headlamps - as Procter and Gamble discovered this week.

The steps P&G have taken to suppress concerns about their research procedures involving the drug Actonel seem to have derived from a Monty Python script. For the backstory read press reports, collated postings on this blog, report in AAAS, or Slate.

Last year, Procter and Gamble released previously hidden raw data underlying one published paper, several meeting abstracts, and two draft publications (with myself as first author). Work by independent statisticians has confirmed that the data does not provide credible support for P&G's reporting of a convenient "plateau" for Actonel in any of the three ghosted publications.

A declaration of Mea Culpa would have served Procter and Gamble far better than the endless attempts to collude with other script writers (like the editors of the Journal of Bone and Mineral Research). Instead P&G have now stepped further into the mud:

1. They refused to allow me to place the data they eventually provided (underlying three publications) into the public domain. This did not serve to enhance their credibility.
2. They refused to allow me as author to submit raw data directly to a journal editor requesting such data.
3. They declined to provide a copy of the consent form patients would have signed upon agreeing to participate in this research. Did patients consent to have the measurements I performed? Did participants realize that data derived from their risk would not be open to scrutiny by authors of the publications, or that it could be misrepresented?
4. But wait .... whatever next .... the Python team would be impressed by P&G's new attempt to act behind the scenes to have a perfectly valid conflict of interest declaration removed from the first of several scientifically correct meeting abstracts submitted about this research.

Read what happened and laugh (or cry):

Step 1: The abstract below (authored by myself and an independent statistician) was submitted on 22 January for presentation at The International Bone and Mineral Society Meeting (to be held in Montreal). The statistical aspects have been redacted pending publication. The electronic submission was accompanied by a declaration of funding leading to the footer as shown - "Study funded by Procter & Gamble Pharmaceuticals".

Control/Tracking: 07-A-464-IBMS Current Date/Time: 1/22/2007 3:53:26PM
Relationship of fracture risk to change in bone resorption with risedronate in the HIP study - is there a plateau response?
Authors: A. Blumsohn(1), J. L. Hutton(2)
1 Sheffield Teaching Hospitals, Sheffield, UNITED KINGDOM,
2 Department of Statistics, University of Warwick, Coventry, UNITED KINGDOM.
Understanding the determinants of bisphosphonate induced change in fracture risk is a prerequisite to rational prescribing and therapeutic monitoring. A previous abstract (Blumsohn, Barton, Chines, Eastell. JBMR 2003;18 S2:S89), and draft publications failed to shed light on the true relationship between change in bone resorption (uNTX/Cr) and fracture risk in the HIP study. The study included 938 women (FN T score <-3, age 74 SD 3) who received Ca and either 5mg risedronate/day, 2.5mg or placebo for 3 years. Randomization and event codes were supplied to authors in 2006. Data did not provide evidence to support previous conclusions.
Previous reports on these data suggested risk of incident vertebral fracture (V#) was non-decreasing when NTX decreases beyond -30% (%?NTX < -30%), and the relationship was "non linear" with "little further improvement in fracture benefit below a decrease of 30 to 35%". It further suggested that another marker (%?PINP) was significantly predictive of V#.
We used several statistical models as well as visual inspection to evaluate a potential "plateau" effect at a putative threshold -30% or -40%.
--- --- -------- ---------- ------ ---- ----, ---- ---------- -- ---- --- ----, --- --- --------------- -- ---: ----- --- ---------- --- -------- --- ------- -- ---- --------- ------ ----- --- ----- --- ---------, --- ---- ------ --- --------- ---------- ----------- ---- ----------- --- ---- --- --- ------, ---- -- ------- --------- -- ---- -- --- ---------- ------- -----
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In conclusion, this study provides no evidence to support a plateau relationship between NTX change and fracture risk with threshold near -30% in patients taking risedronate.
Author Disclosure Block: Study funded by Procter & Gamble Pharmaceuticals.

Step 2: On the 6th of March a fascinating E-mail was sent from the meeting organizers to mysterious Dr C Purple at Procter and Gamble. Unfortunately for Dr Purple the E-mail was also copied to my own E-mail address which had accompanied the abstract submission, together with Dr Purple's earlier secret E-mail to the meeting organizers. Dr Purple had asked for my declaration of interests and funding to be removed from the abstract. The meeting organizers had complied with this request.

Subject: RE: Abstract Change
Date: Mon, 5 Mar 2007 17:33:59 -0500
From: "Paterson, Anne"
To: purple.cr@pg.com
CC: Aubrey Blumsohn

Dear Dr. Purple,

I have adjusted the disclosure so it does not include the below disclosure for P&G. There is currently no disclosure. If there is to be, please let me know and I’ll make the appropriate change.

Thank you for your patience and please do not hesitate to let me know if you have additional questions or concerns.

Kindly,
Anne

Anne Paterson
International Bone and Mineral Society (IBMS)
Washington, DC 20036

From: purple.cr@pg.com [mailto:purple.cr@pg.com]
Sent: Tuesday, February 27, 2007 10:47 AM
To: IBMS - Paterson, Anne
Subject: Abstract Change

Dear Anne:

Last Thursday we spoke about changing an abstract, here are the details;

Please check the abstract submitted by Blumsohn and Hutton (Title: Relationship of fracture risk to change in bone resorption with risedronate in the HIP study - is there a plateau response) for a statement in the disclosure block indicating that the study was funded by Procter & Gamble Pharmaceuticals. Would you please let me know if is this disclosure is still attached to the abstract. If it remains associated with the abstract, please tell me what is the process for having it removed from the abstract?

Thank you for your help with this.

Christopher Purple, Ph.D.
Medical & Technical Affairs
Procter & Gamble Pharmaceuticals
513.622.0516
purple.cr@pg.com

Step 3: Professor Hutton and I responded with some consternation. We were informed that the meeting organizers had been duped (misled) by Procter and Gamble.

From: Aubrey Blumsohn
Sent: Monday, March 05, 2007 5:59 PM
To: Paterson, Anne
Subject: RE: Abstract Change


Dear Ms Paterson

Kindly let me know the basis upon which you altered the abstract submitted by myself (removing the conflicts of interest/disclosure section). Please also state precisely who gave you permission to do so.

This is extremely strange. Dr Purple's rather unusual E-mail below your own appears to have derived from a commercial company.

I would appreciate your urgent response. I would also appreciate it if you would send be a copy of the IBMS conflicts of interest and disclosure policy as it applies to this meeting and to IBMS
activities in general.

The abstract as submitted is attached.

Yours Sincerely

Dr Aubrey Blumsohn
MBBCh, PhD, MSc, BSc(hons), MRCPath

Subject: RE: Abstract Change
Date: Mon, 5 Mar 2007 18:11:17 -0500
From: "IBMS - Paterson, Anne"
To: "Aubrey Blumsohn"

Dear Dr. Blumsohn,

I apologize for this misunderstanding as I was under the impression you knew about the conflict. I have reentered the disclosure in the abstract as indicated in your attached pdf.

Please let me know if you have any further questions. I will contact you if anything else comes up regarding this conflict.

Regards,
Anne

Anne Paterson
International Bone and Mineral Society (IBMS)
2025 M Street NW, Suite 800
Washington, DC 20036

Subject: RE: Abstract Change
Date: Tue, 6 Mar 2007 09:19:10 -0500
From: "IBMS - Paterson, Anne"
To: "Professor Jane Hutton"

Dear Dr. Hutton,

Thank you for your concern. It is not our policy and I take responsibility for the misunderstanding. I was misled and can assure you that as soon as I realized that the authors were not notified, I alerted the submitter and immediately returned it to its original form.

I am not sure how Dr. Purple viewed the abstract.

Please do let me know if you have any additional concerns.

Kind regards,
Anne

Anne Paterson
International Bone and Mineral Society (IBMS)

Well thank you Anne Paterson and the IBMS for behaving properly so far. Award of an oral presentation to to 07-A-464-IBMS may help restore a little of the lost credibility in skeletal pharmaceutical research.

And to Dr Purple of P&G: Please watch the Monty Python Parrot sketch below. Perhaps the PR staff at P&G should assist with research into soap and sanitary products like the Rely Tampon until you get some training from a proper pharmaceutical company - like Eli Lilly or Merck. Please invite me to give a seminar to your staff about the obligations of a doctor and how to deal with ethical problems in a more plausible way. I would be happy to do so any time.



You might also want to read some excellent blogs about pseudoevidence based medicine, a more effective public relations gambit, Conflicts of interest and other troubles with research. You are not alone.

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