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Vioxx

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Vioxx is a subsection of the main SourceWatch article Merck.

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. [1] 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. [2]

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." [3]

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. [4] Following the Vioxx recall, many faulted Merck's over-the-top direct-to-consumer advertising. According to Public Citizen's Health Research Group director, "Advertising and promotions played a major role in making people think Vioxx was safer and more effective than it is." According to former Food and Drug Administration (FDA) associate commissioner Wayne Pines:

"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." [5]

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." [6]

Merck responded to the Vioxx recall by launching a public relations campaign to salvage its image and portray its pulling the drug in as positive a light as possible. [7] The campaign included three full page ads in seven prominent newspapers; several television appearances and testimony before Congress by the company's CEO. 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." [8]

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." [9]

In November 2007, it was reported that Merck had agreed to pay $4.85 billion to settle 27,000 lawsuits in death and injury claims from victims and their relatives. The settlement came after nearly 20 Vioxx civil trials over two years. Merck lost the first civil suit, paying $253 million, but won most of the rest. According to Alex Berenson of the New York Times in November of 2007:

"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. 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." [10]

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 Merk had violated scientific publishing ethics by ghostwriting dozens of academic articles and minimized the impact of patient deaths in its analyses of clinical trials.

According to one study, medical papers on Vioxx were often prepared by ghostwriters and subsequently attributed academic investigators who often did not disclose financial support. Another study concluded that Merck did not provide to the FDA, nor make public the evidence that Vioxx was linked to increased risk of death. [11] 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." [11]

In August of 2008, an analysis of Merck's internal documents were published in the Annals of Internal Medicine. They concluded that Merck carried out a clinical study of Vioxx in 1999, primarily to support their marketing campaign before launching the drug. According to Merck, 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 disclosed during litigation. [12] According to another document, (a nomination of the 1999 study for a marketing award), the study was, "designed and executed in the spirit of Merck marketing principles." According to the Wall Street Journal, 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."

Again, the authors of the Merck document analyses were paid consultants in Vioxx lawsuits against Merck. [13] Merck responded to the analysis in an open letter, claiming 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 U.S. Human Health organization." Merck also stressed that there were legitimate, scientific reasons for conductin the trial; such as assessing the "gastrointestinal tolerability of VIOXX compared to naproxen." [14]

In April 2009, an Australian class action revealed tactics used by Merck to intimidate or discredit doctors or researchers who were critical of Vioxx. According to an internal email, "We may need to seek them out and destroy them where they live".[15] Merck staff produced a list of people who they wished to "neutralize" 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 Vioxx and 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 promotional campaign was "to build emotional ties between Merck and consumers". One television commercial shows 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." The female announcer adds, "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 "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." [16]

Censoring spokes doctor-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. According to Dr. Singh in an interview with NPR:

"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."

Merck originally promised to share the information with Dr. Singh, but never did. When Dr. Singh began including his concerns in his public presentations on Vioxx, Merck began closely tracking his activities. According to NPR, almost a dozen Merck executives were involved in tracking Dr. Singh. According to an October 4, 2000 email sent by a senior, regional executive who had supervised his scientific handlers:

"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 by this time, promoting Vioxx's rival, Celebrex, while being paid by Pfizer), [17] Merck began calling his superiors at the university. According to Stanford medical professor James Fries:

"(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." 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." [18]

Another attempt to rehabilitate Merck's image

According to the PR firm APCO Worldwide in May of 2006:

"APCO Worldwide is supporting Merck's PR efforts for the controversial arthritis drug Vioxx, which was found to increase heart attack risk in patients." [19]

APCO was founded by Arnold & Porter, one of Washington D.C.'s largest law firms, also well known as a tobacco industry law firm. According to the Wall Street Journal, the PR boost came as Merck:

"acknowledged that it misidentified a statistical method used in the study that led it to pull Vioxx from the market." [20]

The admission calls into question Merck's claim that patients were only at risk if they took Vioxx for 18 months or longer. According to doctors who oversaw the study, risks associated with Vioxx were evident as soon as four months into taking the drug. As of May of 2006, there were over 11,000 Vioxx related lawsuits filed against Merck. The company retained Burson-Marsteller for a $20 million "image campaign," after withdrawing Vioxx in 2004. [21]

See also Australian class action against Merck over Vioxx safety risks.

References

  1. "Drug companies pushing celebrity message", O'Dwyers PR Daily, January 8, 2001
  2. What Happens When Drug Dealers Advertise?, PR Watch, (Advertising Age, November 21, 2001)
  3. FDA, Heal Thyself, PR Watch, (Source: New York Times, December 6, 2004)
  4. Vioxx (rofecoxib) Information Center, Merck, accessed December 2009
  5. Drug Ads Just Got Harder to Swallow, PR Watch, Wall Street Journal, October 2004)
  6. Pushing Pills for Profit, PR Watch, New York Times, December 2004
  7. Merck Public Relations, Yahoo Finance, November 2004
  8. Merck Toots Its Own Horn, PR Watch, Associated Press, November 22, 200)
  9. Thomas H. Maugh II, 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
  10. Alex Berenson, "Merck Agrees to Settle Vioxx Suits for $4.85 Billion," New York Times, November 9, 2007.
  11. 11.0 11.1 Ron Winslow, Avery Johnson "Merck's Publishing Ethics Are Questioned by Studies," Wall Street Journal (sub req'd), April 16, 2008
  12. Kevin P. Hill, MD, MHS; Joseph S. Ross, MD, MHS; David S. Egilman, MD, MPH; Harlan M. Krumholz, MD, SM The ADVANTAGE Seeding Trial: A Review of Internal Documents, Annals of Internal Medicine, vol. 149 no. 4 251-258, August 19, 2008
  13. Ron Winslow, Jacob Goldstein, "Report Says Merck Vioxx Study Aimed at Marketing," Wall Street Journal, August 19, 2008.
  14. Merck hits out at controversial paper, PM Live, August 27, 2008
  15. Milanda Rout "Vioxx maker Merck and Co drew up doctor hit list", The Australian, April 1, 2009
  16. Stuart Elliott, "A Drug Maker's Ads, Hold the Disclaimer," New York Times, June 2, 2005.
  17. Snigdha Prakash "Part 1: Documents Suggest Merck Tried to Censor Vioxx Critics", All Things Considered, National Public Radio, June 9, 2005.
  18. Snigdha Prakash "Part 2: Did Merck Try to Censor Vioxx Critics?", All Things Considered, NPR, June 9, 2005.
  19. "APCO Tackles Litigation PR For Merck, Vioxx", O'Dwyer's PR Daily, May 31, 2006
  20. John Carreyrou, Ron Winslow, Heather Won Tesoriero, "Merck Admits Error in Vioxx Study", Wall Street Journal, May 31, 2006; Page D7.
  21. "APCO Tackles Litigation PR For Merck, Vioxx", O'Dwyer's PR Daily, May 31, 2006