Top 2 Instructive Cases
I will let Thomas J. Watson, former CEO of IBM, tell the story. “Recently, I was asked if I was going to fire an employee who made a mistake that cost the company $600,000. No, I replied, I just spent $600,000 training him. Why would I want somebody to hire his experience?”
Well, IBM could withstand a loss of that magnitude, most of us can’t. But we all make mistakes and try to learn from them. However, it is better to learn from other people’s mistakes for two reasons. First, you avoid putting yourself in a precarious situation financially, and second, it is a big world out there. People make all kinds of mistakes. I cannot make all these mistakes to learn from, even if I tried.
Pharmaceutical, medical device, and diagnostic companies have, at times, committed significant marketing blunders that have not only hurt their reputation but also cost them billions in fines, lawsuits, and lost consumer trust. These hit close to home because I was a pharma rep for six years and personally saw some of these things happen to various degrees. I will discuss two instructive cases:
1. Vioxx (rofecoxib, Merck)
On November 23, 2000, the results of the Vioxx Gastrointestinal Outcomes Research study, known as VIGOR, were published in NEJM. This randomized, controlled trial showed that Vioxx, an inhibitor of cyclooxygenase-2, on the market since May 1999, was associated with fewer GI complications than naproxen, a standard NSAID. Unexpectedly, the VIGOR study also showed that Vioxx patients had four times as many myocardial infarctions (MI). However, Merck argued to the FDA that the increased rate of MI was due to a protective effect of naproxen and not an inherent risk posed by its drug – a dubious explanation that fell on deaf ears.
What happened in the aftermath was troubling and culpable. Merck instructed its sales force of more than 3,000 representatives, “DO NOT INITIATE DISCUSSIONS ON THE FDA ARTHRITIS ADVISORY COMMITTEE . . . OR THE RESULTS OF THE . . . VIGOR STUDY.” If a physician inquired about VIGOR, they should respond that the study showed a GI benefit and then say, “I cannot discuss the study with you.”
Merck further instructed its reps to show doctors, “The Cardiovascular Card”, prepared by Merck’s marketing team indicating that Vioxx was associated with 1/8 the mortality from cardiovascular causes compared to other NSAIDs. It ignored the VIGOR data and presented a pooled analysis of preapproval studies with low doses of rofecoxib taken for a short time without adequate power to assess cardiovascular safety.
These hand-picked approved studies provided “solid evidence as to why [doctors] should prescribe Merck products for their appropriate patients.”
On a personal note, I was part of the Celebrex, second approved COX-2 inhibitor, marketing team during this period at Searle. Fortunately, Celebrex did not show such a signal.
Consequences
Merck’s deceptive marketing practices led to the withdrawal of Vioxx from the market in 2004. The company faced accusations of downplaying the risks in its advertising and not fully disclosing the dangers of the drug. Merck paid over $4.85 billion to settle lawsuits and faced a major blow to its brand image. In addition to the legal and financial consequences, it had to rebuild its credibility with both physicians and patients.
Lessons
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- There is a need to enhance the FDA’s resources, authority, and oversight of new drugs.
- The agency does not review all industry promotional material (such as the Cardiovascular Card) quickly; it should have the resources and the authority to review marketing collateral before dissemination.
- The FDA should ensure that key safety information is promptly incorporated into drug labels and warn doctors about potential risks. Advertising should be restricted until safety concerns are adequately addressed.
- Vigilance is needed from hospitals and doctors’ offices. Merck documents were available on investigating committee’s website and prompt review by providers might have kept promotional efforts from distorting clinical profile.
2. OxyContin (Purdue Pharma)
When Purdue Pharma introduced OxyContin in 1996, it was aggressively marketed. Sales grew from $48 million in 1996 to almost $1.1 billion in 2000. Unfortunately, the high availability of the drug correlated with increased abuse, diversion, and addiction, and by 2004, OxyContin had become a leading drug of abuse in the U.S.
OxyContin’s commercial success was not merit-based. Randomized double-blind studies comparing OxyContin given every 12 hours with immediate-release oxycodone given 4 times or daily controlled-release morphine showed comparable efficacy and safety for chronic back and cancer-related pain. The only advantage was a reduction in frequency of dosing but drug abusers quickly learned how to simply crush the controlled-release tablet and swallow, inhale, or inject the high-potency opioid for an intense morphine-like high.
Promotion of OxyContin
Purdue pursued an aggressive marketing campaign to promote the use of opioids, in general, and OxyContin in particular spending $200 million in 2001 alone. From 1996 to 2001, Purdue conducted more than 40 all-expense-paid national pain-management and speaker-training conferences where more than 5000 physicians and pharmacists were recruited and trained for Purdue’s national speaker bureau.
Purdue utilized data for physicians’ prescribing patterns targeting the highest prescribers for opioids across the country. Salesforce was doubled and bonuses were aligned. Primary care physicians were prime targets because they are not sufficiently trained in pain management or addiction issues.
The company promoted the use of opioids in the much larger non-malignant pain market which resulted in nearly tenfold increase in prescriptions even though the cost-benefit for such use is controversial at best.
In literature and audiotapes for physicians, brochures and videotapes for patients, and its “Partners Against Pain” website, reps were trained to claim that the risk of addiction from OxyContin was “less than one percent.” This is erroneous. Several studies demonstrated that in the treatment of chronic non–cancer pain the risks are much higher, e.g., Fishbain et al. (3%–18%), Hoffman et al. (23%), Kouyanou et al. (12%), Chabal et al. (34%), Katz et al. (43%), Reid et al. (24%–31%),58 and Michna et al. (45%).
Consequences
The opioid epidemic in the U.S can, in part, be attributed to this misleading marketing. Purdue Pharma faced thousands of lawsuits and ultimately filed for bankruptcy. The company also agreed to a multi-billion-dollar settlement with states, local governments, and individuals. Its reputation is now permanently tarnished.
Lessons
It is important to understand that, in many ways, Purdue did what most Pharma companies do to increase drug sales. Speakers are groomed, company-sponsored studies are discussed and distributed, free lunches and dinners are provided, pens and pads and magnets are left behind. But some ethical lines were crossed here, and common sense became a casualty. The issue here is absence of guardrails, greed, and failure to appreciate the consequences of inadequate regulatory oversight of addictive chemicals. It should be abundantly clear that controlled substances be on a shorter promotional leash. Marketing rules should be different because of the enormous potential for abuse and harm.
Under current regulations, FDA is limited in its oversight of the marketing and promotion of controlled drugs. However, fundamental changes in the promotion of controlled drugs and an enhanced capacity of the FDA to regulate and monitor such promotion, can positively affect public health.
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- Carefully crafted limits on the promotion of controlled drugs by the sales force and enhanced FDA oversight of their training and performance would realign drugs’ actual use with the principles of evidence-based medicine.
- Free starter coupons for controlled drugs should be restricted or eliminated.
- The use of prescriber profiling data to influence prescribing is imbedded in pharmaceutical detailing. One report indicated that profiling improved profit margins by as much as 3% and the initial uptake of new drugs by 30%. Regulations eliminating this marketing tool might decrease some overprescribing of controlled drugs.
- The public health would be better protected if the FDA reviewed all promotional and educational materials—for their truthfulness, accuracy, balance, and scientific validity—before dissemination.
- From 1996 through 2002, Purdue funded more than 20,000 pain-related educational programs through direct sponsorship or financial grants, For controlled drugs, public health would best be served by severing the industry’s direct role and influence in medical education.
Conclusion
Merck survived, Purdue did not. Lives were lost. Financial and reputational damage was immense. The lessons to regulatory agencies and marketing teams should be indelible. Marketers need to be transparent with data when inherent risks surface about their products. If a drug significantly increases risks of life-threatening events, it will become apparent fairly quickly. It is unwise to try to hide adverse information. The consequences to public health and damage to the brand could be catastrophic and existential.
BTS Consulting is a full-service strategy and marketing consulting company. With our background as laboratory researchers developing diagnostic tests and discovering drug candidates, senior product managers, and pharmaceutical sales professionals, we have proven to be a valuable resource to develop content for pharmaceutical, medical device, diagnostics, and health service providers. We look forward to collaborating with you.
