WHEN THE CRISIS GETS IN THE WAYVioxx and the failure to communicate health risk during the biggest drug recall in history

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• Two million Americans• Withdrawn in 2004 after study showed it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

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

•

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

``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

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

`̀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 PUBLIC AFFAIRS MEMO

VIOXX PRESS RELEASE, NOV 2000

Continued …

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

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

VIOXX PULLED FROM MARKET

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

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.

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

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

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?

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

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

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

WHAT PETER SANDMAN SAYSExpress hopes, regrets, wishes 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

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