Excerpta Medica

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Excerpta Medica is a 'strategic medical communications agency'. It 'partners' with its clients in the pharmaceutical and biotech industry to 'educate the global health care community'.[1] It was owned by Elsevier until October 2010 when it became a division of pharmaceutical consultancy Adelphi Worldwide.[2]

Screengrab from Excerpta Medica Homepage created on 27 August 2009

Ghostwriting for 'fen-phen' 1996-7

Fen-phen was an anti-obesity combination drug marketed by American Home Products, now Wyeth. It was withdrawn in 1997 after being linked to cases of pulmonary hypertension and heart valve abnormalities. However, PBS reported that American Home Products had turned a profit of $200 million by the time of its voluntary withdrawal of the drug.[3]

According to a 2004 Hastings Center Report - 'Pharma goes to the laundry' - by Carl Elliott:[4]

One of the most ingenious pieces of the Fen-Phen public relations strategy was its ghostwriting scheme. In 1996 Wyeth hired Excerpta Medica Inc, a New Jersey-based medical communications firm, to write ten articles for medical journals promoting obesity treatment. Wyeth paid Excerpta Medica $20,000 per article. In turn, Excerpta Medica paid prominent university researchers $1,000 to $1,500 to edit drafts of their articles and put their names on the published product. Wyeth kept each article under tight control, scrubbing drafts of any material that could damage sales. One draft article included sentences that read: "Individual case reports also suggest a link between dexfenfluramine and primary pulmonary hypertension." Wyeth had Excerpta delete it.[5]
What made Excerpta Medica such an inspired choice is that it is a branch of the academic publisher, Reed Elsevier Plc., which publishes many of the world's most prestigious science journals. Excerpta Medica manages two journals itself: Clinical Therapeutics and Current Therapeutic Research. According to court documents, Excerpta Medica planned to submit most of the articles it produced to Elsevier journals. In the actual event, Excerpta managed to publish only two articles before Fen-Phen was withdrawn from the market in 1997. One appeared in Clinical Therapeutics, the other in the American Journal of Medicine (another Elsevier journal). In neither case did the authors of the articles disclose that they were paid by Excerpta Medica. So clean was the laundering operation, in fact, that many of the authors did not even realize that Wyeth was involved. Richard Atkinson of the University of Wisconsin wrote a letter to Excerpta Medica congratulating them on the thoroughness and clarity of their article. "Perhaps I can get you to write all my papers for me!" he wrote. He did have one reservation about the piece he was signing: "My only general comment is that this piece may make dexfenfluramine sound better than it really is."[6]

In 1999 Excerpta Medica was named in sworn testimony in the first 'fen-phen' 'wrongful death trial'. The drug - Redux - was approved for use in April 1996, and both it and its mirror image Pondimin were removed from the market in September 1997 after the link with pulmonary hypertension and heart valve problems emerged. According to the Houston Chronicle:

The company that developed the fen part of the fen-phen diet drug combination paid for ghost-written scientific papers on the drug and helped edit these papers before publication, testimony showed Tuesday. In a videotaped deposition played in the nation's first fen-phen wrongful death trial, American Home Products medical monitor Jo Alene Dolan acknowledged the company had asked that a sentence be stricken from a paper that suggested a link between the "fen" drug Redux, or Dexfenfluramine, to a rare and often deadly lung disease. The sentence was removed, Dolan said, and the information was "not conveyed" in the paper.
The disease, primary pulmonary hypertension, led to the death of Mary Marisa Smith, 35, of Friends-wood in September 1997. Her family is suing Madison, N.J.-based American Home Products and the prescribing physician, Leo Borrell.

Plaintiffs' attorney Tommy Fibich accused the company of "buying science" to promote sales of the two types of fen drugs it made.

In her deposition, Dolan insisted that the company 'had done nothing wrong', reported the Chronicle. 'She said pharmaceutical companies often hire ghost writers to produce scientific literature targeted to various groups of physicians. She said such papers are scientifically accurate and the company has a right to review them before publica-tion "to have the appropriate areas covered as accurately as possible."'
The authors of such papers do not do original research, she said, but they do review other researchers' findings "so that it could be communicated to the audience." These papers often list as authors leaders in various fields. Dolan said the listed authors had the oppor-tunity to review the papers before publication to make sure they were accurate. She said American Home Products paid $ 20,000 apiece for such papers to Excerpta Medica, a company that researches the findings of others and hires ghost writers to summarize it. She said $ 1,500 of that goes to the listed author as an honorarium. Fibich said the company didn't disclose that it was paying for the papers to be produced.[7]

Dolan acknowledged that an editorial comment about one proposed article, the Chronicle reported, said

"this may make desfen-fluramine sound better than it really is." Her videotaped deposition did not address whether any changes were made to address that concern. Fibich also asked why in one proposed paper a sentence was deleted that explained that long-term us-ers of diet drugs have a 23-fold greater risk of having primary pulmonary hypertension than the general public. Instead, American Home Products said studies estimate that every year 23 to 46 long-term diet drug users out of a million would have the disease. She said the change reflected the scientific literature "more accurately." Smith took Pondimin, a fen drug made by American Home Products approved for use in 1973. Plaintiffs' attorneys are accusing the company of intentionally underreporting the risks of Pondimin and Redux, which are believed to be similar because the two drugs are chemical mirror-images.[8]

Ghostwriting for Johnson & Johnson 2002

According to an article in the Wall Street Journal Excerpta were involved in ghostwriting for Johnson and Johnson's drug Eprex:

Susanna Dodgson, who holds a doctorate in physiology, says she was hired in 2002 by Excerpta Medica, the Elsevier medical-communications firm, to write an article about Johnson & Johnson's anemia drug Eprex. A Johnson & Johnson unit had sponsored a study measuring whether Eprex patients could do well taking the drug only once a week. The company was facing competition from a rival drug sold by Amgen Inc. that could be given once a week or less.
Dr. Dodgson says she was given an instruction sheet directing her to emphasize the "main message of the study" -- that 79.3 percent of people with anemia had done well on a once-a-week Eprex dose. In fact, only 63.2 percent of patients responded well as defined by the original study protocol, according to a report she was provided. That report said the study's goal "could not be reached." Both the instruction sheet and the report were viewed by The Wall Street Journal. The higher figure Dr. Dodgson was asked to highlight used a broader definition of success and excluded patients who dropped out of the trial or didn't adhere to all its rules.
The instructions noted that some patients on large doses didn't seem to do well with the once-weekly administration but warned that this point "has not been discussed with marketing and is not definitive!"
The Eprex study appeared last year in the journal Clinical Nephrology, highlighting the 79.3 percent figure without mentioning the lower one. The article didn't acknowledge Dr. Dodgson or Excerpta Medica. Dr. Dodgson, who now teaches medical writing at the University of the Sciences in Philadelphia, says she didn't like the Eprex assignment "but I had to earn a living."
The listed lead author, Paul Barre of McGill University in Montreal, says Excerpta Medica did "a lot of the scutwork" but he had "complete freedom" to change its drafts. Dr. Barre says he helped design the study and enroll patients in it. In statements, Johnson & Johnson and Excerpta Medica offered similar explanations of the process. Johnson & Johnson says it regularly uses outside firms "to expedite the development of independent, peer-reviewed publications."
A Johnson & Johnson spokesman said he wasn't familiar with the details of the instruction sheet and referred questions about the highlighted data to Dr. Barre, who said he never interacted with Johnson & Johnson's marketing department and doesn't believe the article was biased. He said the higher figure was "more representative" because those patients followed the study's rules. "Without wanting to distort data, you always want to put the spin that's more positive for the article," Dr. Barre says. "You're more likely to get it published."
Hartmut Malluche, an editor of Clinical Nephrology, declined to comment on details of the article. The journal doesn't require authors to disclose the role of medical writers. But after hearing Dr. Dodgson's story, Dr. Malluche said he would suggest changing the policy. "It's not good if the company has control over the article," he says.[9]

Publishing industry-sponsored "fake" journals

In 2009 it emerged that Excerpta was doing more than placing ghostwritten articles but actually produced industry-sponsored or what an article in the life sciences magazine, The Scientist, called "fake" journals ("Elsevier published 6 fake journals", TheScientist.com, 7 May 2009). Bob Grant of The Scientist wrote:

Scientific publishing giant Elsevier put out a total of six publications between 2000 and 2005 that were sponsored by unnamed pharmaceutical companies and looked like peer reviewed medical journals, but did not disclose sponsorship, the company has admitted.
Elsevier is conducting an "internal review" of its publishing practices after allegations came to light that the company produced a pharmaceutical company-funded publication in the early 2000s without disclosing that the "journal" was corporate sponsored.
The allegations involve the Australasian Journal of Bone and Joint Medicine, a publication paid for by pharmaceutical company Merck that amounted to a compendium of reprinted scientific articles and one-source reviews, most of which presented data favorable to Merck's products. The Scientist obtained two 2003 issues of the journal -- which bore the imprint of Elsevier's Excerpta Medica -- neither of which carried a statement obviating Merck's sponsorship of the publication.[10]

Sheldon Krimsky described the scandal in the New Scientist:

even the most hardened cynics were left open-mouthed last month by the news that the Australian affiliate of the global drug giant Merck had signed up with publisher Excerpta Medica, a division of Elsevier (a sister company of New Scientist ) to produce a publication with the look and feel of a peer-reviewed journal, yet which contained only reprints of articles, most of them sympathetic towards Merck products.
The Australasian Journal of Bone and Joint Medicine was sent to up to 20,000 doctors between 2003 and 2005. The publication had no website and, unlike normal journals, was not open for submissions. Neither was there any disclosure that it was funded and controlled by Merck. Elsevier has since revealed that it put out five other industry-sponsored titles between 2000 and 2005 under its Excerpta Medica imprint.[11]

According to the Singapore based Straits Times:

The Elseviergate variety of bogus journals aside, how do outsiders do the actual clinical research that are publishable in the best journals? Basically, it is drug firms that 'ghost manage' the whole process of de-signing and executing clinical drug trials, data analysis, write-up and publishing. These drug firms use for-profit 'clinical research organisations' to do the science itself. They also employ for-profit 'medical educa-tion and communication companies' (MECCs) to tweak the analysis, write up the articles and shepherd these papers through the arduous publication process. Published articles are then used by drug firms to promote their brands to doctors to influence their prescription habits.
Surely this is a fantastical conspiracy theory, you say. Unfortunately, it isn't a fantasy. Documents recovered in a US court case, Motus vs Pfizer (2004), show that drug giant Wyeth hired Excerpta Medica to pro-duce scientific papers at US $15,000 (S $21,700) to US $20,000 each to tout Fen-Phen as the preferred anti-obesity drug. Completed papers with the words 'author to be determined' on them were unearthed. Wyeth told Excerpta to pay prominent clinicians willing to be 'named author' US $1,500 per article.[12]

As of August 2009 the company discloses its policy on Industry sponsorship:

Content for Excerpta Medica’s Industry-Sponsored Publications is developed under the direction of an outside expert (eg, editor-in-chief, guest editor). Consistent with the Uniform Requirements and other generally accepted publication practices, Excerpta Medica distinguishes between authors and contributors. Authors are responsible for each article’s final content and are uniquely authorized to approve an article prior to its release/publication. Contributors are those individuals who helped to create the article, but who did not meet the criteria for authorship. Contributors are acknowledged in a manner that is appropriate for the publication (eg, on a Web site; on a masthead; in an acknowledgements section). Contributors may include, but are not limited to: copy editors; freelance writers; production staff; etc. The identity of the sponsor(s) for these publications is disclosed.[13]

The policy distinguishes between 'authors' and 'contributors' in a way that disguises the role of PR agencies and other ghost writers in process of publication.

Removing case studies from its website

Between 2006 and 2008 Excerpta Medica hosted case study material on its website. In July 2006 the list of case studies included:

  • How did Excerpta Medica extend the life cycle of a mature product in a crowded and evolving market?
  • How did Excerpta Medica create an online solution to strengthen a client's relationship with the medical community?
  • How did Excerpta Medica increase the awareness of an underdiagnosed, life-threatening condition and educate the medical community on the available treatment options?
  • With limited clinical support, how did Excerpta Medica establish a client’s product more prominently within its therapeutic marketplace?[14]

By 2009, with one exception, all of these case studies had been removed. The remaining case study titled 'With limited clinical support, how did Excerpta Medica establish a client’s product more prominently within its therapeutic marketplace?' was, however changed by removing the phrase 'company-sponsored journal' and replacing it with 'company-sponsored publication'. The website includes a foootnote acknowledging that 'In an earlier version of this case study, we stated that a “company-sponsored journal” was created when in fact this was a “company-sponsored publication”.'[15]

List of "fake" journals

Australasian Journal of Bone & Joint Medicine‎ (2002-?), Australasian Journal of Musculoskeletal Medicine (2002), Australasian Journal of General Practice (200?-05), the Australasian Journal of Neurology, the Australasian Journal of Cardiology (2002-?), the Australasian Journal of Clinical Pharmacy, the Australasian Journal of Cardiovascular Medicine (2000-01).[16]

List of current journals (2009)

Other journals published by EM

Clinical Cornerstone | Insulin

People

Mark Flanick, Vice President, Marketing & Business Development (USA) m.flanick@elsevier.com | Edward Roos, Global Managing Director e.roos@elsevier.com | Kathleen Coughlan, Marketing Director, Excerpta Medica Interactive k.coughlan@elsevier.com

Management team members

| David Benson, Business Controller | Amanda Horsford, Managing Director, Excerpta Medica Interactive | Mark Flanick, Vice President, Marketing & Business Development (USA) | Suzanne Hayes, Vice President, Operations | Rosa Real MD, CMPP, Director, Global Medical Communications | Brian O'Connor, US Managing Director | Erika Qualben, Manager Human Resources | Edward Roos, Global Managing Director | Jo-Ann West MSc, Publisher, Rapid Publications and Reprint Services[18]

Subsidiaries

Pracon & HealthIQ a subsidiary 'Founded in 1976, Pracon & HealthIQ provides services to pharmaceutical, biotech, and medical device companies in the areas of reimbursement assistance services, communications, and competitive intelligence.' In 2002 Parexel International Corp. 'announced the acquisition of Pracon & HealthIQ, a provider of specialized sales and marketing services based in Reston, Virginia and Orange, California.'[19]

Contact

Address:
Excerpta Medica USA
685 US-202
Bridgewater, NJ 08807
Telephone +1 908 547 2100
Fax +1 908 547 2200
Excerpta Medica EuropeRadarweg 29
1043 NX Amsterdam
Netherlands
Telephone +31 20 485 3975
Fax +31 20 485 3188 905 King Street West
Excerpta Medica Interactive
4th Floor
Toronto, ON
M6K 3G9 Canada
Telephone +1 416 955 9449
Fax +1 416 955 9666


Website:http://www.excerptamedica.com/

Resources

Statements from Elsevier

Screengrabs of deleted case studies

Further Reading

  • Terry Allen, 'Hello, You've Got Smallpox' In These Times January, 2006, SECTION: HEALTH + SCIENCE; Pg. 45.
  • Bill Hooker More on the "Australasian Journal of..." series. Open Reading Frame Blog, 09 May, 2009, accessed 27 August 2009
  • Ron Nissimov 'Video shows how diet-drug maker paid for, edited scientific papers' The Houston Chronicle June 16, 1999, Wednesday 3 STAR EDITION SECTION: A; Pg. 28
  • Anna Wilde Mathews (The Wall Street Journal) 'At medical journals, paid writers play big role' Pittsburgh Post-Gazette, Tuesday, December 13, 2005

Notes

  1. ↑ Excerpta Medica Home page, accessed 16 August 2009
  2. ↑ Excerpta Medica Joins Adelphi Worldwide ,Excerpta Medica Press Release, 7 October 2010, accessed
  3. ↑ Kate Cohen, Fen Phen Nation, PBS, 13 Nov 2003, accessed 19 Nov 2009
  4. ↑ Carle Elliott 'Pharma goes to the laundry: public relations and the business of medical education' The Hastings Center Report September 1, 2004, SECTION: Pg. 18(6) Vol. 34 No. 5 ISSN: 0093-0334
  5. ↑ C. Ornstein, "Maker of Diet-Drug Combo Accused to Funding Journal Articles," Dallas Morning News, May 23, 1999.
  6. ↑ C. Ornstein, "Maker of Diet-Drug Combo Accused to Funding Journal Articles," Dallas Morning News, May 23, 1999. See also A. Mundy, Dispensing with the Truth (New York: St. Martin's Press, 2001), 164.
  7. ↑ RON NISSIMOV 'Video shows how diet-drug maker paid for, edited scientific papers' The Houston Chronicle June 16, 1999, Wednesday 3 STAR EDITION SECTION: A; Pg. 28
  8. ↑ RON NISSIMOV 'Video shows how diet-drug maker paid for, edited scientific papers' The Houston Chronicle June 16, 1999, Wednesday 3 STAR EDITION SECTION: A; Pg. 28
  9. ↑ Anna Wilde Mathews (The Wall Street Journal) 'At medical journals, paid writers play big role' Pittsburgh Post-Gazette, Tuesday, December 13, 2005
  10. ↑ Bob Grant, Elsevier published 6 fake journals, TheScientist.com, 7 May 2009, accessed 20 Nov 2009
  11. ↑ Sheldon Krimsky. 'Looks like an independently refereed journal? Don't be too sure; In medical publishing, the line between editorial and advertorial has become dangerously blurred', New Scientist, June 6, 2009, Comment and Analysis; Pg. 24-25
  12. ↑ Andy Ho, 'Big Pharma's lab of massaged data', The Straits Times (Singapore), May 23, 2009 Saturday, SECTION: REVIEW - OTHERS
  13. ↑ Excerpta Medica Publication Policy, accessed 26 August 2009
  14. ↑ Excerpta Medica Case Studies, retrieved from the Internet Archive dated 10 July 2006 on 26 August 2009.
  15. ↑ Excerpta Medica Case Studies: With limited clinical support, how did Excerpta Medica establish a client’s product more prominently within its therapeutic marketplace?, accessed 26 August 2009
  16. ↑ Bob Grant Elsevier published 6 fake journals 07 May 2009, The Scientist, accessed 26 August 2009
  17. ↑ Excerpta Medica Publication Policy, accessed 26 August 2009
  18. ↑ Excerpta Medica How to reach us, accessed 26 August 2009
  19. ↑ 'MERGERS AND AQUISITIONS: Parexel acquires Pracon & HealthIQ', Health & Medicine Week, December 23, 2002, SECTION: EXPANDED REPORTING; Pg. 17
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