Merck

From SourceWatch

Merck is an international pharmaceutical company. It also publishes the industry standard Merck Drug Guide. Top competitors are Bristol-Myers Squibb, Pfizer, and Sanofi-Aventis. In 2006, Merck had sales of US $22.6 billion with profits of US$4.4 billion.^[1]

Contents 1 Vytorin 2 Gardasil 3 Vioxx 3.1 Marketing 3.2 Recall 3.3 Doctored science and lawsuits 4 Promotional campaign 5 Censoring a spokesdoctor-turned-critic 6 Another attempt to rehabilitate Merck's image 7 Animal testing 7.1 Animals by species, numbers & locations 7.2 Biomedical research facilities and copies of USDA reports by state 7.3 Animal cruelty & welfare violations 7.4 Contract testing 8 Merck and tobacco issues 9 Political contributions 10 Lobbying 11 Personnel 11.1 Executive Compensation 12 Merck products 12.1 Case studies 13 Contact info 14 Articles & sources 14.1 SourceWatch articles 14.2 References 14.3 External articles 14.4 External resources

Vytorin

Merck and Schering-Plough, which co-market the cholesterol drug Vytorin, "have gone into damage-control mode, taking out newspaper ads," reported Advertising Age in January 2008. The pharmaceutical companies' PR campaign followed their reluctant publication of a study showing that neither of the drugs present in Vytorin "reduced the buildup of fatty plaque in arteries." The study "was completed in 2006, but Merck and Schering said they didn't release it for nearly 21 months due to the complexity of the data and their own scientific concerns." ^[2]

The drug companies' newspaper ads, which ran in the New York Times and USA Today, referred to the damning study as "a single study that has generated a lot of confusion." The ads stressed that the drugs "have been proven to lower LDL (bad) cholesterol," but what the study showed was that Vytorin is not "any better than generic Zocor in reducing the buildup of fatty plaque." Members of Congress called for an investigation into why the "massive advertisement campaign for Vytorin was allowed to continue," after the study was belatedly made public. Class-action lawsuits were also filed, alleging that Merck and Schering-Plough "misrepresented and withheld significant information" from the Food and Drug Administration and the public. ^[2]

In July 2008, a major European study involving more than 1,800 patients and researchers at 173 hospitals and other sites found that Vytorin "was no better than placebo at lowering the risk of major cardiovascular events -- including heart attack, stroke, heart surgery and death -- in patients with aortic stenosis." Vytorin "did cut cholesterol levels about 60 percent," but that effect was previously known and is also seen when Zocor (one of two drugs that comprise Vytorin) is taken alone. The European study also observed an increase in cancer cases and deaths among patients taking Vytorin, but researchers said this was not likely due to the drug. ^[3]

Gardasil

During 2006, five products received FDA approval, including Gardasil, “the first vaccine for the prevention of cervical cancer and genital warts caused by certain kinds of human papillomavirus.” Gardasil later became a subject of controversy when Gov. Rick Perry of Texas signed an executive order that required all girls entering the 6th grade to receive this vaccination, starting in September 2008. ^[4]

Vioxx

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. ^[5] 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. ^[6]

Recall

Concerns about Vioxx's safety reached the Food and Drug Administration as early as 2000, but the FDA failed to act, in part due to having reduced "its laboratories and network of independent drug safety experts in favor of hiring more people to approve drugs, changes that ... left the agency increasingly reliant on and bound by drug company money." [2] 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, and competing COX-2 inhibitors labelled with warnings of heart attack risks. ^[7]

Following the Vioxx recall, many faulted Merck's over-the-top 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. [3] 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." ^[8]

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. ^[9] The campaign included "three full-page ads in seven prominent newspapers," "several television appearances," and "testimony before Congress by the company's chief executive." While leaked emails and other internal documents indicate "the company knew about the side effects long before the drug was withdrawn," Merck's media relations director claimed, "The mantra has been openness, integrity and transparency." [4] [5]

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 Journal editors maintained that they should have submitted an update, pointing out that "the three heart attacks occurred shortly after the study's end." The Journal editors also said that 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'." ^[10]

"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 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." ^[11]

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." ^[12]

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 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. ^[13]

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." ^[13]

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. 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. ^[14]

Merck responded to the Annals of Internal Medicine 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." ^[15]

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".^[16] Merck staff produced a list of people who they wished to "neutralise" or "discredit".

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": ^[17]

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." ...

Also, more than 40 percent of the ads in the campaign are being devoted to information about what Merck calls its access programs, which are efforts to provide some consumers with prescription drugs either free or at reduced prices.

Michael Guarini, the managing director for Ogilvy & Mather's health care practice, said, "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," said Guarini. ^[18]

Censoring a 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." ^[19]

NPR described Merck's campaign to recruit the physician Gurkirpal Singh of Stanford University as a Vioxx spokesperson. "Merck wanted Singh on board because he was a senior researcher on a seminal study of arthritis patients," reported Prakash. Starting in 1998, Merck cultivated Singh; the physician soon became a Vioxx booster, being paid $2,500 per speaking engagement by Merck.

But in 2000, a study suggesting heart problems among Vioxx users worried Dr. Singh. He asked Merck for 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. ^[20]

Merck began closely tracking Dr. Singh's activities. According to NPR: ^[21]

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 ^[22], Merck decided to start calling his superiors at Stanford. Stanford medical professor James Fries told NPR, "I 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." Fries said the Merck 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." ^[23]

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," reports O'Dwyer's. ^[24] 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," reports the Wall Street Journal. ^[25]

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 O'Dwyer's. More than 11,000 Vioxx-related lawsuits have been filed against Merck. The company had retained Burson-Marsteller for a $20 million "image campaign," after withdrawing Vioxx in 2004. ^[26]

Animal testing

Merck does animal testing.

Animals by species, numbers & locations

• Rahway, New Jersey ^[27]

Biomedical research facilities and copies of USDA reports by state

For links to copies of this facility's U.S. Department of Agriculture reports indicating species, number of animals used and other information visit Stop Animal Experimentation Now Facility Reports and Information, U.S. Department of Agriculture-Animal Plant Health Inspection reports. This Web site lists each of the 50 states; each state's name links to biomedical research facilities in that state, and to PDF copies of government documents where the facilities must report their animal usage.

Animal cruelty & welfare violations

Stop Animal Exploitation Now! (SAEN) is a national research watchdog organization. ^[28] SAEN has included Merck among the worst violators of U.S. laws. According to Executive Director, Micheal Budkie:

"Drug and testing companies are violating federal law on a regular basis and endangering the health of the American People as a result. It should surprise no one that drugs like Vioxx came out of the Merck Corporation, where federal law is broken almost every month." ^[29]

Merck amassed 8 violations in a 9 month monitoring period and an additional 10 Institutional Animal Care and Use Committee (IACUC) ^[30] 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.) ^[31]

Contract testing

Merck contract tests out to Huntingdon Life Sciences (HLS). ^[32] Huntingdon Life Sciences is the 3rd largest Contract Research Organization (CRO) in the world and the largest animal testing facility in all of Europe. Firms hire HLS to conduct animal toxicity tests for agrochemicals, petrochemicals, household products, pharmaceutical drugs and toxins. ^[33] HLS has a long history of gross animal welfare violations. See also Huntingdon Life Sciences, sections 2 & 3.

Merck and tobacco issues

Merck was an early supporter of smoke-free workplaces. In 1988 Merck launched a corporate policy prohibiting smoking in all of their workplaces and that paid the full costs of approved smoking cessation classes for workers and their spouses. The policy covered over 29,000 U.S. workers. Merck CEO Roy Vagelos, M.D. stated before a Congressional hearing on March 17, 1994 that during the first eighteen months of their policy, the number of Merck employees who smoked fell by 25 percent.^[34]

On April 4, 1993, William Ian Campbell, CEO of Philip Morris, wrote to Merck about Merck's nonsmoking workplace policy. Campbell explained why he believed the EPA's rating secondhand tobacco smoke a human carcinogen was flawed, and suggested a meeting to discuss "cost-effective ways to protect and respect the rights of all employees by accommodating non-smokers and smokers at Merck." In his letter, Campbell further cited the "arbitrary and damaging manner in which certain industries are made scapegoats," and suggested that PM and Merck could possibly become allies.^[35]. Noel M. Howard, Director of Executive Communications at Merck wrote back to Campbell on May 14, 1995 and declined the meeting, saying,

Given our strong corporate commitment to a smoke-free workplace, and in light of Philip Morris' understandable interest in promoting the tobacco use, we do not believe that a meeting between representatives of our two companies would be productive." ^[36]

Political contributions

Merck gave $347,693 to federal candidates in the 05/06 election cycle through its political action committee (PAC) - 28% to Democrats, 72% to Republicans. ^[37]

Lobbying

The company spent $4,050,000 for lobbying in 2006. Of this total, $1,430,000 was to 12 outside lobbying firms with the remainder being spent using in-house lobbyists. Some of the lobbying firms used were Akin, Gump, Strauss, Hauer & Feld, Mehlman Vogel Castagnetti, and Alston & Bird. ^[38]

Personnel

Key executives and 2006 pay: ^{[39] [40]}

• Richard T. Clark, Chairman, President, and Chief Executive Officer, US$2.23 million
• Peter N. Kellogg, Chief Financial Officer
• J. Chris Scalet, Senior Vice President and Chief Information Officer

Former executives:

• Raymond V. Gilmartin, Former Chief Executive Officer, total pay of US$37.8 million in 2005.^[41]

Selected members of the Board of Directors: ^[42]

• Steven F. Goldstone, Former Chairman and Chief Executive Officer, RJR Nabisco, Inc. and Non-Executive Chairman, ConAgra Foods
• William B. Harrison, Jr., Former Chairman of the Board, J.P. Morgan Chase & Co.
• Rochelle B. Lazarus, Chairman and Chief Executive Officer, Ogilvy & Mather Worldwide (advertising and marketing communications). Director, General Electric

Executive Compensation

According to Fierce Pharma, Merck's CEO, 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 $4.31 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).^[43]

Merck products

• Erbitux
• Gardasil
• Vioxx

Case studies

• Australian class action against Merck over Vioxx safety risks

Contact info

1 Merck Drive
Whitehouse Station, NJ 08889
Phone: 908-423-1000
Fax: 908-735-1253
Web: http://www.merck.com

Articles & sources

SourceWatch articles

• Animal testing
• Huntingdon Life Sciences
• Medical Industrial Complex
• crisis management
• Merck/stats, details
• Ogilvy & Mather Worldwide
• Pharmaceutical industry
• Using celebrities
• Women in Government
• Medical Industrial Complex
• Carlos E. Represas

References

External articles

• "Drug companies pushing celebrity message", O'Dwyers PR Daily, January 8, 2001. (Sub req'd)
• Merck, Merck Announces Voluntary Worldwide Withdrawal of VIOXX®", Media Release, September 30, 2004.
• Merck, "Merck & Co., Inc. Media Briefing", October 18, 2004.
• Joe Lepper, "MSD in crisis PR mode over Vioxx", PR Week, October 08 2004. (Sub req'd)
• Beth Herskovits, "Merck mulls future launch strategy amid Vioxx fallout", PR Week, October 11 2004. (Sub req'd)
• Beth Herskovits, "Next-generation Vioxx could escape recall fallout, study suggests", PR Week, November 8, 2004. (Sub req'd)
• Beth Herskovits, "Doctors hold firm on Vioxx-type products", PR Week, November 12, 2004.(Sub req'd)
• Darren Rovell, "The burden of pitching pills", ESPN.com, November 19, 2004.
• Theresa Agovino, "Merck Steps Up PR Campaign After Recall", Associated Press, November 21, 2004.
• Henry Waxman, "Merck Documents Show Aggressive Marketing of Vioxx After Studies Indicated Risk", May 5, 2005.
• Henry A. Waxman, "The Marketing of Vioxx to Physicians", May 5, 2005.
• "Rep. Waxman's statement for the hearing "The Roles of the FDA and Pharmaceutical Companies in Ensuring the Safety of Approved Drugs, Like Vioxx", May 5, 2005.
• Henry A. Waxman, "Full Committee Hearing on Vioxx: Documents used in analysis", archive of documents accessed June 2005.
• Stuart Elliott, "A Drug Maker's Ads, Hold the Disclaimer," New York Times, June 2, 2005.
• "Mobic triumphs in Vioxx' wake", PMLive.com, June 7, 2005.
• Snigdha Prakash , "Part 1: Documents Suggest Merck Tried to Censor Vioxx Critics", All Things Considered, National Public Radio, June 9, 2005.
• Snigdha Prakash , "Part 2: Did Merck Try to Censor Vioxx Critics?", All Things Considered, National Public Radio, June 9, 2005.
• Snigdha Prakash , "Part 2: Merck Attempted to Quash Vioxx Criticism", Morning Edition, National Public Radio, June 10, 2005.
• Ed Silverman, "2000 study by Merck showed Vioxx risk: Results not given to FDA", NJ.com, July 03, 2005. (NJ.com is the website of the New Jersey Star-Ledger).
• "Vioxx death trial opens", Pharmaceutical Marketing, July 12, 2005.
• Alex Berenson, "Some Pointed Questioning at the Vioxx Trial in Texas", New York Times, July 19, 2005.
• "Vioxx trial sees marketing attacked", Pharmaceutical Marketing, July 19, 2005.
• Beth Herskovits, 'Merck hires B-M to rebuild image", PR Week, August 19, 2005. (Sub req'd).
• Beth Herskovits, "Hefty Merck verdict spurs firms to rethink DTC efforts", PR Week, August 29 2005. (Sub req'd)
• Paul Holmes, "Merck loss in lawsuit shows that good PR is sometimes a company's best legal defense", PR Week, August 29, 2005. (Sub req'd)
• Thomas H. Maugh II and Lisa Girion, "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.
• Reed Abelson and Stephanis Saul, "Ties to Industry Cloud a Clinic's Mission", New York Times, December 17, 2005.
• "APCO Tackles Litigation PR For Merck, Vioxx", O'Dwyer's PR Daily (sub req'd), May 31, 2006.
• John Carreyrou, Ron Winslow and Heather Won Tesoriero, "Merck Admits Error in Vioxx Study", Wall Street Journal, May 31, 2006; Page D7.
• Andrew Bridges, "Lawmaker Alleges FDA, Merck Collaborated", Newsday, July 19, 2006. (This is an Associated Press story).
• See the Gardasil article for a list of 2007 news stories on Merck's HPV vaccine and the controversy surrounding it.
• Judith Siers-Poisson, The Politics and PR of Cervical Cancer, a four part series, PRWatch.org, July, 2007.
• Alex Berenson, "Merck Agrees to Settle Vioxx Suits for $4.85 Billion," New York Times, November 9, 2007.
• Alex Berenson, "For Widely Used Drug, Question of Usefulness Is Still Lingering ," New York Times, September 1, 2008
• Maria Cheng, "Doctors say Vytorin-cancer link can't be ruled out," Associated Press, September 2, 2008.

External resources

• You-tube Merck recalls 1.2 million doses of childhood vaccine, accessed August 2009
• Insidevaccines.com staph vaccine enters phase II, Sept 2008
• Youtube Huntingdon Life Sciences Merck Office Demo in DC, January 2008
• Youtube [http://www.youtube.com/watch?v=ZJpGpAWrIYo&feature=related Huntingdon Life Sciences Merck Novartis demos DC, January 2008

This article may include information from Tobacco Documents Online.