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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'.<ref>Excerpta Medica [http://www.excerptamedica.com//index.cfm Home page], accessed 16 August 2009</ref> It is owned by [[Elsevier]], part of [[Reed Elsevier]].
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| − | [[Image:Excerpta_Medica_1251310593362.png|right|thumb|400px|Screengrab from [[Excerpta Medica]] Homepage created on 27 August 2009]]
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| − | ==Ghostwriting for 'fen-phen' 1996-7==
| + | '''Sudler & Hennessey''' is a global healthcare communications firm, developing strategic promotional and educational programmes for a broad array of healthcare brands. <ref>WPP. [http://www.wpp.com/WPP/Companies/CompanyDetail.htm?id=226 Sudler & Hennessey] Accessed 26 November 2009.</ref> It is one of [[WPP Group plc]]'s companies. |
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| − | 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 It was withdrawn in 1997 after being linked to cases of pulmonary hypertension and heart valve abnormalities.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.<ref>Kate Cohen, [http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/fenphen.html Fen Phen Nation], PBS, 13 Nov 2003, accessed 19 Nov 2009</ref>
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| − | According to a 2004 ''Hastings Center Report'' - 'Pharma goes to the laundry' - by [[Carl Elliott]]:<ref>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</ref>
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| − | :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.<ref>C. Ornstein, "Maker of Diet-Drug Combo Accused to Funding Journal Articles," Dallas Morning News, May 23, 1999.</ref>
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| − | :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."<ref>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.</ref>
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| − | 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'':
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| − | :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.
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| − | :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.
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| − | Plaintiffs' attorney Tommy Fibich accused the company of "buying science" to promote sales of the two types of fen drugs it made.
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| − | :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."'
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| − | :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.<ref>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</ref>
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| − | Dolan acknowledged that an editorial comment about one proposed article, the Chronicle reported, said
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| − | :"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.<ref>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</ref>
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| − | ==Ghostwriting for Johnson & Johnson 2002==
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| − | According to an article in the ''Wall Street Journal'' Excerpta were involved in ghostwriting for Johnson and Johnson's drug [[Eprex]]:
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| − | :[[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.
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| − | :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.
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| − | :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!"
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| − | :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."
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| − | :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."
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| − | :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."
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| − | :[[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.<ref>Anna Wilde Mathews (The Wall Street Journal) '[http://www.post-gazette.com/pg/05347/621668-114.stm At medical journals, paid writers play big role]' ''Pittsburgh Post-Gazette'', Tuesday, December 13, 2005
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| − | </ref>
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| − | ==Publishing industry-sponsored "fake" journals==
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| − | 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:
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| − | :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.
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| − | :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.
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| − | :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.<ref>Bob Grant, [http://www.the-scientist.com/blog/display/55679/ Elsevier published 6 fake journals], TheScientist.com, 7 May 2009, accessed 20 Nov 2009</ref>
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| − | Sheldon Krimsky described the scandal in the ''New Scientist'':
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| − | :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.
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| − | :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.<ref>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
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| − | </ref>
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| − | According to the Singapore based ''Straits Times'':
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| − | :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.
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| − | :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.<ref>Andy Ho, 'Big Pharma's lab of massaged data', ''The Straits Times'' (Singapore), May 23, 2009 Saturday, SECTION: REVIEW - OTHERS</ref>
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| − | As of August 2009 the company discloses its policy on Industry sponsorship:
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| − | :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.<ref>Excerpta Medica [http://www.excerptamedica.com//index.cfm?vID=FE9B781C-1422-16B3-78CB5EF0EDCFA983 Publication Policy], accessed 26 August 2009</ref>
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| − | 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.
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| − | ==Removing case studies from its website==
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| − | Between 2006 and 2008 Excerpta Medica hosted case study material on its website. In July 2006 the list of case studies included:
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| − | * How did Excerpta Medica extend the life cycle of a mature product in a crowded and evolving market?
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| − | * How did Excerpta Medica create an online solution to strengthen a client's relationship with the medical community?
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| − | * How did Excerpta Medica increase the awareness of an underdiagnosed, life-threatening condition and educate the medical community on the available treatment options?
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| − | * With limited clinical support, how did Excerpta Medica establish a client’s product more prominently within its therapeutic marketplace?<ref>Excerpta Medica [http://web.archive.org/web/20060710073317/www.excerptamedica.com/index.cfm?vID=FE9A903C-1422-16B3-787CA38ABA6C1C9C Case Studies], retrieved from the Internet Archive dated 10 July 2006 on 26 August 2009.</ref>
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| − | 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”.'<ref>Excerpta Medica [http://www.excerptamedica.com/index.cfm?vID=3CA13C48-1422-16B3-783DC2916631BB46 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</ref>
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| − | ==List of "fake" journals==
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| − | [[Australasian Journal of Bone & Joint Medicine]], [[Australasian Journal of General Practice]], the [[Australasian Journal of Neurology]], the [[Australasian Journal of Cardiology]], the [[Australasian Journal of Clinical Pharmacy]], the [[Australasian Journal of Cardiovascular Medicine]].<ref>Bob Grant [http://www.the-scientist.com/blog/display/55679/ Elsevier published 6 fake journals] 07 May 2009, The Scientist, accessed 26 August 2009</ref> | |
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| − | ==List of current journals (2009)==
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| − | * [[American Journal of Geriatric Pharmacotherapy]] | [[Clinical Therapeutics]] | [[Current Therapeutic Research]] | [[Gender Medicine]]<ref>Excerpta Medica [http://www.excerptamedica.com//index.cfm?vID=FE9B781C-1422-16B3-78CB5EF0EDCFA983 Publication Policy], accessed 26 August 2009</ref>
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| − | ==Other journals published by EM==
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| − | [[Clinical Cornerstone]] | [[Insulin (journal)|Insulin]]
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| | ==People== | | ==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
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| − | ===Management team members===
| + | *[[Jed Beitler]] - Chairman, CEO Worldwide |
| − | | [[David Benson]], Business Controller
| + | *[[Ellen Goldman]] - CFO and COO Worldwide |
| − | | [[Amanda Horsford]], Managing Director, Excerpta Medica Interactive
| + | *[[Louisa Holland]] - Co-CEO, The Americas |
| − | | [[Mark Flanick]], Vice President, Marketing & Business Development (USA)
| + | *[[Rob Rogers]] - Co-CEO, The Americas |
| − | | [[Suzanne Hayes]], Vice President, Operations
| + | *[[Mary Sobiechowski]] - Chief Information Officer |
| − | | [[Rosa Real]] MD, CMPP, Director, Global Medical Communications
| + | *[[Max Jackson]] - President, EMEA |
| − | | [[Brian O'Connor]], US Managing Director
| + | *[[Sarah Dawson]] - Group Managing Director for Education & Training |
| − | | [[Erika Qualben]], Manager Human Resources
| + | *[[Brian Kelly]] - Chief Strategy Officer |
| − | | [[Edward Roos]], Global Managing Director
| + | *[[Lia Treichler]] - Director of Client Procurement |
| − | | [[Jo-Ann West]] MSc, Publisher, Rapid Publications and Reprint Services<ref>Excerpta Medica [http://www.excerptamedica.com//index.cfm?vID=59BC8A5D-C09F-296A-618C4F60004AAAFB How to reach us], accessed 26 August 2009</ref>
| + | *[[David McLean]] - Chairman Asia/Pacific |
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| − | ==Subsidiaries==
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| − | [[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.'<ref>'MERGERS AND AQUISITIONS: Parexel acquires Pracon & HealthIQ', Health & Medicine Week, December 23, 2002, SECTION: EXPANDED REPORTING; Pg. 17</ref> | |
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| | ==Contact== | | ==Contact== |
| | :Address: | | :Address: |
| | + | :230 Park Avenue South |
| | + | :New York |
| | + | :NY |
| | + | :10003-1566 |
| | + | :United States |
| | + | :(T) +1 212 614 4100 |
| | + | :(F) +1 212 598 6907 |
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| − | :Excerpta Medica USA
| + | '''Sudler & Hennessey EMEA, HQ''' |
| − | :685 US-202
| + | :Piazzale Stefano Türr, 5 – 20149 Milan |
| − | :Bridgewater, NJ 08807 | + | :Phone: +39 02 349 721 |
| − | :Telephone +1 908 547 2100
| + | :Fax: +39 02 345 330 57 |
| − | :Fax +1 908 547 2200
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| − | :Excerpta Medica EuropeRadarweg 29
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| − | :1043 NX Amsterdam
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| − | :Netherlands | |
| − | :Telephone +31 20 485 3975 | |
| − | :Fax +31 20 485 3188 905 King Street West | |
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| − | :Excerpta Medica Interactive
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| − | :4th Floor
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| − | :Toronto, ON
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| − | :M6K 3G9 Canada
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| − | :Telephone +1 416 955 9449
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| − | :Fax +1 416 955 9666 | |
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| − | :Website:http://www.excerptamedica.com/
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| − | ==Resources==
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| − | ===Statements from Elsevier===
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| − | * Michael Hansen '[http://www.elsevier.com/wps/find/authored_newsitem.cws_home/companynews05_01203 Statement From Michael Hansen, CEO Of Elsevier's Health Sciences Division, Regarding Australia Based Sponsored Journal Practices Between 2000 And 2005]' Elsevier, Philadelphia, PA, 7 May 2009, accessed 17 September 2009.
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| − | * Elsevier [http://www.elsevier.com/wps/find/authored_newsitem.cws_home/companynews05_01233 Elsevier To Create New Guidelines For Pharmaceutical Article Reprint, Compilation and Custom Publications - Company also updates findings related to Australian sponsored publication practices from 2000-2005] Philadelphia, PA - 4 June 2009 accessed 17 September 2009.
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| − | ===Screengrabs of deleted case studies===
| + | :Website:http://www.sudler.com |
| − | *[http://www.spinprofiles.org/index.php/Image:Product_Life_Extension_1251217323884.png Product Life Extension] Retrieved from the Internet Archive of 14 July 2006 on 26 August 2009 from http://web.archive.org/web/20060714055800/www.excerptamedica.com/index.cfm?vID=3D979BDC-1422-16B3-78CCE1719C66F3B7
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| − | *[http://www.spinprofiles.org/index.php/Image:On-line_Resource_1251217359400.png On-line Resource] Retrieved from the Internet Archive of 14 July 2006 on 26 August 2009 from http://web.archive.org/web/20060714004614/www.excerptamedica.com/index.cfm?vID=3D7EADA8-1422-16B3-7888D9C16F1CCD3B
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| − | *[http://www.spinprofiles.org/index.php/Image:Disease_Management_Education_1251217381745.png Disease Management Education] Retrieved from the Internet Archive of 10 July 2006 on 26 August 2009 from http://web.archive.org/web/20060714004547/www.excerptamedica.com/index.cfm?vID=3C949871-1422-16B3-78BE8E688C560609
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| − | *[http://www.spinprofiles.org/index.php/Image:Filling_a_Clinical_Gap_1251217408125.png Filling a Clinical Gap] Retrieved from the Internet Archive of 10 July 2006 on 26 August 2009 from http://web.archive.org/web/20060714004602/www.excerptamedica.com/index.cfm?vID=3CA13C48-1422-16B3-783DC2916631BB46
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| − | ===Further Reading===
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| − | *Terry Allen, 'Hello, You've Got Smallpox' ''In These Times'' January, 2006, SECTION: HEALTH + SCIENCE; Pg. 45.
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| − | *Bill Hooker [http://www.sennoma.net/main/archives/2009/05/_i_think_elsevier_published_no.php More on the "Australasian Journal of..." series.] Open Reading Frame Blog, 09 May, 2009, accessed 27 August 2009
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| − | *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
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| − | *Anna Wilde Mathews (The Wall Street Journal) '[http://www.post-gazette.com/pg/05347/621668-114.stm At medical journals, paid writers play big role]' ''Pittsburgh Post-Gazette'', Tuesday, December 13, 2005
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| | ==Notes== | | ==Notes== |
