Merck amassed 8 violations in a 9 month monitoring period and an additional 10 Institutional Animal Care and Use Committee (IACUC) violations in 3 months following this period. One infraction involved an allegedly "illegal surgery", where holes were drilled into an animals skull and penetrated the brain. (Government reports and ranking statistics available upon request.) <ref>Micheal Budkie [http://www.all-creatures.org/saen/press-20070213.html Pharmaceutical/Testing Companies Among Nation’s Leaders for Federal Violations, Says Watchdog Group], SAEN, February 2007</ref>
==Vioxx issues & controversyViox (subsection)==
===Marketing===[[Vioxx]] is the brand name for Merck's anti-inflammatory drug and pain medication, initially marketed as an alternative to analgesics that aggravate stomach ulcers. Merck's marketing of Vioxx was unusually aggressive. In January 2001, ''O'Dwyers PR Daily'' reported that Merck had paid Bruce Jenner and the former Olympic skater Dorothy Hamill for media interviews they gave discussing Vioxx. <ref>"[http://www.odwyerpr.com/members/archived_stories_2001/january/0108drugcompanies.htm Drug companies pushing celebrity message]", ''O'Dwyers PR Daily'', January 8, 2001</ref> A November 2001 study by the ''National Institute for Health Care Management Research and Educational Foundation'' found that Merck spent $160 million to advertise Vioxx in 2000 alone; more than [[Anheuser-Busch]] spent that year promoting Budweiser beer. <ref>[http://www.prwatch.org/node/860 What Happens When Drug Dealers Advertise?], PR Watch, (Advertising Age, November 21, 2001)</ref> ===Recall===Concerns about Vioxx's safety reached the FDA as early as 2000, but the FDA failed to act, in part due to: :"laboratories and network of independent drug safety experts in favor of hiring more people to approve drugs. ...the agency (is) increasingly reliant on and bound by drug company money." <ref>[http://www.prwatch.org/node/3086 FDA, Heal Thyself], PR Watch, (Source: New York Times, December 6, 2004)</ref> It was not until 2004 that strong, publicly available research tied Vioxx (a COX-2 inhibitor), to a significant increase in heart attacks among users. The drug was pulled off the shelves that fall. <ref>[http://www.vioxx.com/rofecoxib/vioxx/consumer/index.jsp Vioxx (rofecoxib) Information Center], Merck, accessed December 2009</ref> Following the Vioxx recall, many faulted Merck's over-the-top [[Direct-to-consumer advertising|direct-to-consumer advertising]]: :"Advertising and promotions played a major role in making people think Vioxx was safer and more effective than it is," said [[Public Citizen]]'s Health Research Group director. "If we see product liability emanating from Merck's decision ... it will ... encourage drug companies to disclose the maximum amount of a drug's risks in their advertising," said former FDA associate commissioner [[Wayne Pines]]." <ref>[http://www.prwatch.org/node/2948 Drug Ads Just Got Harder to Swallow], PR Watch, (source: Wall Street Journal, October 2004)</ref> The New York Times cited Vioxx and other COX-2 drugs as "perhaps the clearest instance yet of how the confluence of medicine and marketing can turn hope into hype - and how difficult it is for the Food and Drug Administration to monitor the safety of drugs after they have been approved for the market." <ref>[http://www.prwatch.org/node/3131 Pushing Pills for Profit], PR Watch, (New York Times, December 2004)</ref> Merck responded to the Vioxx recall by launching a PR campaign to salvage its image and portray its pulling the drug in as positive a light as possible. <ref>''Merck Public Relations'', Yahoo Finance, November 2004</ref> The campaign included "three full-page ads in seven prominent newspapers," "several television appearances," and "testimony before Congress by the company's chief executive." However, leaked emails and other internal documents indicated that the company knew about the side effects long before the drug was withdrawn. According to Merck's media relations director, "the mantra has been openness, integrity and transparency." <ref>[http://www.prwatch.org/node/3055 Merck Toots Its Own Horn], PR Watch, ([[Associated Press]], November 22, 2004)</ref> ===Doctored science and lawsuits===After Merck withdrew Vioxx, evidence surfaced that the company had withheld early evidence of its dangers. In December 2005, the editors of the prestigious [[New England Journal of Medicine]] issued a rare "Expression of Concern" regarding a 2000 Merck report on Vioxx in which "Merck scientists failed to report three nonfatal heart attacks among the Vioxx users. The total number of heart attacks among the drug users was 20 ... not the 17 reported." Merck argued that the heart attacks occurred after the study cut-off date, but the editors maintained that they should have submitted an update, as "the three heart attacks occurred shortly after the study's end." According to the editors, Merck: :"withheld more relevant data about strokes and other heart problems linked to the drug, producing inaccuracies and deletions that 'call into question the integrity of the data'." :"Experts disagreed on how medically significant the three heart attacks were, but agreed that the decision not to include the cases could bolster claims in thousands of lawsuits against Merck and that the company was deliberately withholding data about the drug's health risks," reported the [[Los Angeles Times]]. "The accusations by the prestigious New England Journal of Medicine could hurt Merck's ability to defend itself in the 6,500 lawsuits blaming Vioxx for heart attacks, strokes and deaths. Analysts have estimated that the cases could eventually cost the company $50 billion." <ref>Thomas H. Maugh II and Lisa Girion "[http://www.latimes.com/business/la-fi-vioxx9dec09,0,4538043.story Journal Slams Vioxx Study: Questions about 3 heart attacks not included in data analysis could hurt Merck's legal defense]," [[Los Angeles Times]], December 9, 2005.</ref> In November 2007, it was reported that Merck had "agreed to pay $4.85 billion to settle 27,000 lawsuits by people who claim they or their family members suffered injury or died after taking" Vioxx. The settlement came "after nearly 20 Vioxx civil trials over the last two years." Merck lost the first civil suit, paying $253 million, but won most of the rest. "The settlement will help put Vioxx behind Merck, as well as sharply reduce its Vioxx-related legal defense fees, which are now running at more than $600 million annually," reported the ''New York Times''. :"The deal becomes binding only if 85 percent of all plaintiffs agree to drop their cases and take the deal. ... Based on the fact that the 27,000 suits cover about 47,000 sets of plaintiffs, the average plaintiff will receive just over $100,000 before legal fees and expenses. ... While eye-popping, the settlement payment represents less than one year's profits for the company." <ref>Alex Berenson, "[http://www.nytimes.com/2007/11/09/business/09merck.html Merck Agrees to Settle Vioxx Suits for $4.85 Billion]," ''New York Times'', November 9, 2007.</ref> In April 2008, the [[Journal of the American Medical Association]] (JAMA) published two studies analyzing Merck documents that had surfaced during Vioxx litigation. Collectively, they concluded that the pharmaceutical company had "violated scientific-publishing ethics by [[medical paper ghostwriting|ghostwriting]] dozens of academic articles, and minimized the impact of patient deaths in its analyses of some human trials." One study found that medical papers on Vioxx "were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose financial support." The other study concluded that Merck "neither provided to the [[FDA]] nor made public in a timely fashion" evidence that Vioxx use was linked to increased risk of death. <ref name="2jama">Ron Winslow and Avery Johnson, "[http://online.wsj.com/article/SB120828763322216997.html Merck's Publishing Ethics Are Questioned by Studies]," [[Wall Street Journal]] (sub req'd), April 16, 2008</ref> Five of the six authors of the two JAMA studies had "served as paid consultants to plaintiffs' lawyers in Vioxx lawsuits." A Merck researcher called the findings "false and misleading." <ref name="2jama"/> In August 2008, an analysis of Merck internal documents published by the ''Annals of Internal Medicine'' concluded that Merck carried out a clinical study of Vioxx in 1999, "primarily to support a marketing campaign before the drug's launch." Merck stated that the study was done "to test side effects of the painkiller Vioxx." The 1999 "ADVANTAGE" study compared Vioxx to the widely-used painkiller Naproxen, in order "to accelerate uptake and advocacy for Vioxx," according to the Merck documents, which were disclosed during litigation. <ref>Kevin P. Hill, MD, MHS; Joseph S. Ross, MD, MHS; David S. Egilman, MD, MPH; Harlan M. Krumholz, MD, SM [http://www.annals.org/cgi/content/full/149/4/251 The ADVANTAGE Seeding Trial: A Review of Internal Documents], Annals of Internal Medicine, vol. 149 no. 4 251-258, August 19, 2008</ref> Another document, a nomination of the 1999 study for a marketing award, said the study was "designed and executed in the spirit of Merck marketing principles." Carrying out clinical studies for marketing purposes "would raise ethical and scientific questions, from whether study participants were unknowingly -- and needlessly; put in harm's way, to whether a company's research is reliable," reported the ''Wall Street Journal''. Again, the authors of the Merck document analyses were paid consultants in Vioxx lawsuits against Merck. <ref>Ron Winslow, Jacob Goldstein, "[http://online.wsj.com/article/SB121910517536051499.html Report Says Merck Vioxx Study Aimed at Marketing]," [[Wall Street Journal]], August 19, 2008.</ref> Merck responded to the analysis in an open letter, which claimed that the analysis "contains numerous inaccuracies." For example, the analysis concluded that the 1999 Vioxx "ADVANTAGE" clinical trial was designed by one of Merck's marketing units. However, Merck maintained that the trial was "designed, conducted, analysed, interpreted and published by the scientific department of Merck’s US Human Health organisation." Merck also stressed that there were legitimate scientific reasons to conduct the trial, such as assessing "the gastrointestinal tolerability of VIOXX compared to naproxen." <ref>"[http://www.pmlive.com/index.cfm?showArticle=1&ArticleID=7027 Merck hits out at controversial paper]," ''PM Live'', August 27, 2008</ref> In April 2009, an Australian class action revealed tactics Merck used to intimidate or discredit doctors or researchers who were critical of Vioxx. An internal email was revealed saying "We may need to seek them out and destroy them where they live".<ref name="hitlist">Milanda Rout "[http://www.theaustralian.news.com.au/story/0,25197,25272600-2702,00.html Vioxx maker Merck and Co drew up doctor hit list]", ''The Australian'', April 1, 2009</ref> Merck staff produced a list of people who they wished to "neutralise" or "discredit". ===Merck promotional campaign===In June 2005, the ad agency [[Ogilvy & Mather Worldwide]] launched the first promotional campaign ever for Merck - a $20 million, 6-month campaign with the slogan: :"Merck. Where patients come first." The campaign was planned before the company was forced to withdraw its popular painkiller [[Vioxx]], and before evidence came to light that Merck not only ignored evidence that Vioxx caused heart complications, but also heavily marketed the drug. The major goal of the Merck promotional campaign was "to build emotional ties between Merck and consumers". One television commercial shows cute children reacting in charming confusion to requests to define "measles," "mumps" and "chicken pox": :"Most kids today don't have a clue about diseases adults remember, thanks to Merck's scientists," a female announcer says, adding: "We've invested billions to research heart disease and asthma. Now we're trying to make Alzheimer's, diabetes and cancer history too." Over 40% of the ads in the campaign are devoted to information about what Merck calls "access programs"; or efforts to provide consumers with prescription drugs either free or at reduced prices. According to [[Michael Guarini]], managing director for Ogilvy & Mather's health care practice: :"We want the public to understand a little more who Merck is and raise the awareness of Merck, but we also want to communicate useful information." While the Vioxx scandal had tarnished Merck and public opinion of drug companies in general was low, "It's always good to engage in dialogue, to make sure the public has true, balanced, accurate information." <ref>Stuart Elliott, "[http://www.nytimes.com/2005/06/02/business/media/02adco.html? A Drug Maker's Ads, Hold the Disclaimer]," [[New York Times]], June 2, 2005.</ref> ===Censoring spokesdoctor-turned-critic===In June 2005, U.S. [[National Public Radio]]'s Snigdha Prakash reported: :"New documents obtained by NPR suggest that even as Merck was making Vioxx into a bestseller, the company was putting pressure on independent doctors. The company's apparent aim: to keep them from discussing evidence of Vioxx's potential safety problems. The documents show that Merck exerted pressure not only on individual doctors, but also on several of the nation's top medical schools." Merck's campaigned to recruit physician Gurkirpal Singh of [[Stanford University]] as a Vioxx spokesperson "because he was a senior researcher on a seminal study of arthritis patients." Starting in 1998, Singh became a Vioxx booster and was paid $2,500 per speaking engagement by Merck. However, in 2000, a study suggesting heart problems among Vioxx users worried Dr. Singh and he requested the data: :"I wanted to know how many heart attacks, how many strokes, how many deaths were occurring in each one of the groups, and what were these actual number of patients at risk, and how many ended up having an event," he told NPR. Merck originally promised to share the information with Singh, but never did. Singh began including his concerns in his public presentations on Vioxx. Merck began closely tracking Dr. Singh's activities. According to NPR, almost a dozen Merck executives were involved in tracking Dr. Singh. A senior regional executive who had supervised Singh's scientific handlers sent this Oct. 4, 2000, e-mail: :"I have in excess of 80 e-mails pertaining to interactions with Dr. Singh from March 1999 to present. The following is my best recollection of what has happened. Because of the sensitive nature of the following, I strongly encourage you not to share with anyone unless they clearly have a need to know." As Singh's public criticisms of Vioxx continued (He was now promoting Vioxx's rival, Celebrex," and "being paid by [[Pfizer]]" reported NPR), <ref>Snigdha Prakash "[http://www.npr.org/templates/story/story.php?storyId=4696609 Part 1: Documents Suggest Merck Tried to Censor Vioxx Critics]", ''All Things Considered'', [[National Public Radio]], June 9, 2005.</ref> Merck began calling his superiors at the university. According to Stanford medical professor James Fries, he :"received a call from a medical director at Merck, stating that someone on my staff had been making wild and irresponsible public statements about the cardiovascular side effects of Vioxx." According to Dr. Fries, the representative "hinted there would be repercussions for Fries and Stanford if Singh's statements didn't stop. He was left with the sense that Merck's financial support to Stanford was at risk." <ref>Snigdha Prakash "[http://www.npr.org/templates/story/story.php?storyId=4696711 Part 2: Did Merck Try to Censor Vioxx Critics?]", ''All Things Considered'', NPR, June 9, 2005.</ref> ===Another attempt to rehabilitate Merck's image===:"[[APCO Worldwide]] is supporting Merck's PR efforts for the controversial" -- and deadly -- "arthritis drug Vioxx, which was found to increase heart attack risk in patients. <ref>"[http://www.odwyerpr.com/members/0531apco_merck.htm APCO Tackles Litigation PR For Merck, Vioxx]", ''O'Dwyer's PR Daily'', May 31, 2006.</ref> The PR boost comes as the pharmaceutical company "acknowledged that it misidentified a statistical method used in the study that led it to pull Vioxx from the market." reported the [[Wall Street Journal]]. <ref>John Carreyrou, Ron Winslow, Heather Won Tesoriero, "[http://online.wsj.com/article/SB114903203696566853.html?mod=todays_us_personal_journal Merck Admits Error in Vioxx Study]", [[Wall Street Journal]], May 31, 2006; Page D7.</ref> The admission calls into question Merck's claim that patients were only at risk if they took Vioxx for 18 months or longer. Doctors who oversaw the study "are planning to release new data" that "show risk as soon as four months after taking the drug," according to <i>O'Dwyers</i>. Over 11,000 Vioxx-related lawsuits have been filed against Merck. The company retained [[Burson-Marsteller]] for a $20 million "image campaign," after withdrawing Vioxx in 2004. <ref>"[http://www.odwyerpr.com/members/0531apco_merck.htm APCO Tackles Litigation PR For Merck, Vioxx]", ''O'Dwyer's PR Daily'', May 31, 2006</ref> See also [[Australian class action against Merck over Vioxx safety risks]].
==Other drug issues==
==Personnel & board==
* [[Kenneth C. Frazier]] - President & CEO
* Richard S. Bowles III, Ph.D. - Executive VP & Chief Compliance Officer
* Willie A. Deese - Executive VP & President, Manufacturing
* Mirian M. Graddick-Weir - Executive VP, Human Resources
* Bridgette P. Heller - Executive VP & President, Consumer Care
* Peter N. Kellogg - Executive VP & CFO
* Peter S. Kim, Ph.D. - Executive VP & President, Merck Research Laboratories
* Raul E. Kohan - Executive VP & President, Animal Health
* Bruce N. Kuhlik - Executive VP & General Counsel
* Michael Rosenblatt - Executive VP & Chief medical officer
* J. Chris Scalet - Executive VP, Global Services, Chief Information Officer
* Adam H. Schechter - President, Global Human Health
* Mervyn Turner, Ph.D. - Chief Strategy Officer & Senior VP, Emerging Markets R&D, Merck Research Laboratories<ref>[http://www.merck.com/about/leadership/board-of-directors/home.html Executive Division]Merck, accessed January 2011</ref>
===Key executives & 2006 paysalaries===* [[Richard T. Clark]] (64) - Chairman - $2.23 million <ref>[http://www.forbes1,800,000 * Kenneth Frazier (55) -global.com/lists/2006/12/D493.html Richard T Clark]1, ''Forbes''044, accessed November 2007.</ref>688 * [[Peter N. KelloggKellegg]] (54)- Executive VP & CFO* [[J. Chris Scalet]] - Senior VP & CIO $903,978 <ref>[http://www.merckhoovers.com/aboutcompany/executive_committeeMerck__Co_Inc/homerrytji-1-1njea1.html Merck Executive Committee], Merck, accessed November 2007.</ref> ===Executive Compensation===According to Fierce Pharma, Richard T. Clark was the seventh top wage earner in 2007 among pharmaceutical CEOs. * Total Compensation: $14.5M* 2007 Revenue: $24.2B* 2006 Revenue: $22.6B* Change: 7% :"2007 was a great year for Merck, with the company making significant progress on the five year turnaround plan enacted after the [[Vioxx]] scandal. The company's good fortunes led to an 80 percent hike in compensation for CEO Richard Clark. It included $1.62 million in base pay, 37 percent more than 2006 levels, and $8.23 million in stock and options grants. In addition, Clark got $4& Co.31 million in incentive pay, plus about $360,000 worth of miscellaneous items like retirement-plan matching funds ($10,125), a home security system ($51,024), and commuting costs ($18,686)Inc."<ref>[http://www.fiercepharma.com/special-reports/mercks-richard-clark-ceo-pay Top 17 Paychecks in Big PharmaExecutives], ''Fierce Pharma''Hoovers, May 19, 2008accessed January 2011</ref>
===Former executives===
* [[Raymond V. Gilmartin]], Former CEO, total pay of $37.8 million in 2005.<ref>[http://www.forbes.com/static/pvp2005/LIRE1B2.html Raymond V Gilmartin], ''Forbes'', accessed November 2007.</ref>
===Selected board Board members===* Richard T. Clark - Chairman* Leslie A. Brun * Thomas R. Cech, Ph.D. * Kenneth C. Frazier - President & CEO, Merck; Director [[Exxon Mobil]]* [[Thomas H. Glocer]] - CEO, [[Reuters]], Inc.* Steven F. Goldstone]] - Former Chairman Retired & CEO, RJR Nabisco, Inc.; Non-Executive Chairmanexecutive chairman, [[ConAgra]] Foods, Inc. * [[William B. Harrison, Jr.]] - Former Lead Board Director & Retired Chairman of the Board, [[JPMorgan Chase|J.P. JP Morgan Chase]] & Co.* Harry R. Jacobson, M.D. - Vice chancellor, Health Affairs, Emeritus, Vanderbilt University* William N. Kelley, M.D. - Professor, University of PA Medical School * [[C. Robert Kidder]] - Director, [[Morgan Stanley]]* [[Rochelle B. Lazarus]] - Chairman & CEO, [[Ogilvy & Mather Worldwide]]; Director, [[General Electric]]* [[Carlos E. Represas]] - Chairman, [[Nestle]] (advertising and marketing communicationsMexico)* [[Patricia F. Russo]] - Director, [[Alcoa]], Inc. & [[General ElectricMotors]]* [[Thomas E. Shenk]], Ph.D.* [[Anne M. Tatlock]] - Director, Fortune Brands, Inc.* [[Craig B. Thompson, M.D.]] - President & CEO, [[Memorial Sloan-Kettering Cancer Center]] * Wendell P. Weeks - Director, Corning, Inc.* Peter C. Wendell - Director, Sierra Ventures<ref>[http://www.merck.com/about/corporategovernanceleadership/board_membersboard-of-directors/home.html Board of Directors], Merck, accessed November 2007.January 2011</ref>
==Contact==
1 Merck<br>One Merck Drive<br>
Whitehouse Station, NJ 08889<br>
* [[AIDS industry]]
* [[Animal testing]]
* [[Australian class action against Merck over Vioxx safety risks]]*
* [[Carlos E. Represas]]
* [[Crisis management]]
* [[Ogilvy & Mather Worldwide]]
* [[Pharmaceutical industry]]
* [[Memorial Sloan-Kettering Cancer Center]]
* [[Using celebrities]]
* [[Vioxx]]
* [[War on Cancer]]
* [[Women in Government]]
search_term=Merck</tdo>
[[Category: Tobacco documents organizations]] [[Category: Animal testing]] [[Category: Corporations]] [[Category: Pharmaceutical industry]] [[Category: United States]] [[Category: Health]] [[Category: Huntingdon Life Sciences]] [[Category: Gross Animal Welfare Violations]] [[Category: Animal rights]] [[Category: Human rights abuses]] [[Category: AIDS]] [[Category: Cancer]]