Merck failed to properly communicate health risks of its drug Vioxx before and after recall. Studies in 2000 showed increased heart attack risks but Merck downplayed this. In 2004, a trial showed double heart attack risk with long term use, leading to recall. Merck's communication was ineffective - doctors learned from patients and hotlines were jammed. While Merck withdrew the drug swiftly, it did not express regret or prioritize health communication over legal and financial concerns. This case shows the challenges of balancing priorities during a drug recall crisis.

1. WHEN THE CRISIS
GETS IN THE WAY
Vioxx and the failure to communicate health
risk during the biggest drug recall in history

2. INTRODUCTION
• Vioxx a prescription painkiller made by drug
giant Merck
• Osteoarthritis, acute pain, period pain
• ``Blockbuster’’ drug with all the pain relief of
aspirin and no stomach side effects such as
ulcers
• Very successful thanks to aggressive
marketing, ads
• Two million Americans
• Withdrawn in 2004 after study showed it
increased risk of heart attack, stroke
• Direct link to 27,000 deaths – FDA
• Soon emerges Merck knew of potential
risks for years

3. THIS CASE STUDY
• Based on paper ``Merck and Co. Inc:
communication lessons from the
withdrawal of Vioxx,‘’ James
O’Rourke, Journal of Business
Strategy, and other sources
• How Merck communicated health risk
to patients, doctors before and after
recall
•

4. HEALTH RISK COMMUNICATION
BEFORE THE RECALL
•Previous studies published in
medical journals
•Aggressive marketing to doctors.
3500 sales reps in 2004. $500
million in ads for doctors in 2003
•Direct to consumer advertising.
$500 million in six years.
• Press releases defending Vioxx’s
safety

5. ``Just one
small pill let me
resume my life.
I could get up
in the morning
without pain. I
could take my
daughter to the
park, lace up
my skates and
perform again.
It was a
miracle.’’
DOROTHY
HAMILL, OLYMPIC
ICESKATING
CHAMPION, IN A TV
AD FOR VIOXX

6. THE VIGOR STUDY, 2000
• Compares Vioxx with naproxen, an older, cheaper drug
• Found fourfold increase in heart attacks (.4% vs .1%)
• Merck says difference due to naproxen protecting the heart, not
Vioxx damaging it
• Press release on March 27 and 28, May and November
2000, defending Vioxx’s safety.
• FDA get box labelling changes warning of heart risk

7. ``We successfully managed discussion of
the heart attack data. Dow Jones and the
Los Angeles Times … did not mention
cardiovascular events, and other outlets
discussed the MI (myocardial infarction)
rate with appropriate perspective.’’ MERCK
PUBLICAFFAIRS MEMO

8. VIOXX PRESS RELEASE, NOV 2000

9. Continued …

10. THE APPROVe TRIAL, 2004
• Tests if Vioxx prevents growth of colon polyps associated
with bowel cancer
• Instead, study shows double the risk of a heart attack if
Vioxx is used for 18 months or more, compared to
placebo (sugar pill)
• Ethics committee stops trial because of health risks

11. ``We are taking this action because it serves the best
interests of patients.’’ RAY GILMARTIN, CEO.
VIOXX PULLED FROM MARKET

12. MAIN RISKS
• Legal risk – class
actions, fraud
• Reputational risk
• Financial risk – shares
fell 27 per cent, or $26
billion, from $45 to
$33
• Health risk to
consumers.
KEY PUBLICS
• Doctors
• Consumers
• concerned patients
• potential litigants
• arthritis patients
angry pain relief
withdrawn
• Investors, SEC
• Federal
regulators, fraud
prosecutors

13. MERCK’S KEY MESSAGES
• We recalled the drug voluntarily
• We had no reason to believe Vioxx harmed
the heart until Sept 24, 2004
• The instant we did, we pulled Vioxx from
the market
• We were putting patients first, as we
always do.

14. COMMUNICATING THE HEALTH RISK
• Website hits rise from 4000 on Sept 2 to 234,000 by
October 1, the day after the announcement.
• Two million hits by early December
• But more than a month after recall, the front page of vioxx.com
consisted of one document - the press release – and links to pdf
files for patients and doctors
• Toll-free numbers for doctors and patients. 120,000 calls
in the first six days.
• Full-page advertisements in 25 ``elite’’ newspapers in
the form of a letter to patients.
• 65 per cent of the public aware of withdrawal within three
days

15. THE RESULT? BOTTLENECK
• ``So sudden and unexpected was the Merck
announcement that most physicians learned about the
event only after they had received phone calls from
distraught patients.’’ POISON PILL, THE UNTOLD STORY OF
THE VIOXX DRUG SCANDAL, THOMAS NESI
• ``Merck information hotlines were jammed for days as
doctors tried to get more information … the world’s
doctors were as much in the dark as anyone
else, including their panicked patients. Only a handful of
researchers knew the details of the APPROVe
study, which were a closely guarded secret.’’ POISON
PILL, THE UNTOLD STORY OF THE VIOXX DRUG
SCANDAL, THOMAS NESI

16. WHAT MERCK DID RIGHT
• They withdrew the drug, put matters right
• They had a crisis plan – but not a risk management plan
• War room of 25 people working full time
• Once they decided, they acted swiftly
• Chose the right spokespeople – the CEO and chief
scientist. Demonstrates accountability
• CEO made himself available for interviews
• Had a health risk comms plan – but was it effective?

17. WHAT MERCK DID WRONG
• They never said sorry, no expression of regret, no
compassion – clash with legal.
• ``I’m sorry that I didn’t know four years ago what I know now, but
the data didn’t lead us there four years ago.’’ Dr Alice Reicin, Merck
researcher.
• They should have communicated its health risks more
carefully in the first place
• Ignored internal and external studies warning of health risk
• One-way communication style was ineffective
• Ads in 25 elite newspapers in America on Sunday only
advertisements.
• Two websites for information – with only the press release on it and
links to pdfs.
• Merck hotline – jammed

18. WHAT CONSTRAINED MERCK IN
COMMUNICATING HEALTH RISK?
• Legally prevented from informing
doctors before public announcement
• Conflicting communication needs
meant others given priority
• Legal fears
• Financial fears
• Image restoration

19. CONCLUSIONS
• Merck’s health risk communication before the recall was
unethical
• By making the recall crisis worse, it meant health
communication was given a lower priority than other risks
such as legal.
• Highlights difficulty of competing communications
priorities in the real world
• Circumstances have changed. We live in world of internet
forums, social media and online journals

20. WHAT PETER SANDMAN SAYSExpress
hopes, regrets, w
ishes and
worries
Don’t let the
lawyers stop
you from being
empathetic
Acknowledge
uncertainty
Start talking
early, even if
you are
uncertain about
the details.
Don’t let the
information
vacuum be filled
by critics

21. WHERE IS THE HEALTH RISK MESSAGE?
• ``We found that if people understood the
facts about Merck’s actions with regard to
Vioxx, they had more favourable opinions
of the company. We developed
messaging around three major points that
were frequently misunderstood by the
public. Our strategy was to educate the
public solely about the facts – the
messages included no spin, no emotion.’’
JOAN WAINWRIGHT, VP PUBLIC AFFAIRS, MERCK