The Big Bad Vioxx
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- And so began the rise of Vioxx, a powerful drug used to relieve symptoms of arthritis.
- Done and dusted! Our clinical trials for the arthritis drug is complete! The results show that Vioxx patients have fewer ulcers and less gastrointestinal bleeding than Naproxen takers!
- The FDA has also approved us. Our drug is FINALLY on the market!!
- During the second data and safety meeting, the study demonstrates that Vioxx and naproxen have similar cardiovascular safety profiles, with a slightly higher incidence of adverse events in the Vioxx group. However, the observed difference is not statistically significant.
- Bad news folks! Results show that 79/4000 Vioxx users have had serious heart problems or have died, compared to 41/4000 Naproxen users.
- Aye!
- The trends are worrying, however the number of events are small. All in favor of continuing the study, say aye.
- During the final data and safety meeting we see selective reporting of data. Merck chose to highlight favorable outcomes while down-playing or not disclosing unfavorable results.
- It's not looking good team, the risk of heart problems and death among Vioxx patients is twice as high as in the Naproxen group.
- It's like we can't tell if Vioxx is the cause of the heart problems. Or what if Naproxen is acting as a low level aspirin and protecting people from the heart problems hence making Vioxx look bad in comparison?!
- We need to come up with a plan to analyze the cardiovascular results before the study ends...
- The head of Merck seems to encourage the misrepresentation of data and allows the company to delay the releasing of these findings. Even with all the negative side effects, the drug was still marketed without adequate warnings.
- Sir, I have an idea! Let's only analyze heart problems reported 1 month before the last patient leaves the study, and nothing more after that.
- That's a little shady but I agree! At least Now the study will exclude the 3 heart attacks that occured after the last patient leaves the study.
- Merck went on to publish their incorrect results and analysis in the New England Journal of Medicine, leaving out the three deaths as it "didn't fall within the prescribed timeline". When NEJM requested that Merck correct their data, Merck refused to.
- Does the NEJM REALLY expect us to correct our data?!
- NOT HAPPENING! Too much time and effort went into this!
- Multiple lawsuits and trials later, Merck was finally punished with a fine of . This incident led to public health heightening their stringency in official drug approvals as well as improved post-market monitoring.
- Your honor. Vioxx has caused 88000 Americans to suffer from heart problems and 38000 of them have died because of it.
- HA! Even with the 4.85 billion dollar fine, we make a profit!
- After all the deaths and lawsuits, Merck finally removed Vioxx from the market voluntarily. The FDA did not get a chance to review Mercks stats and was never able to retract their approval.
- JESSE WE NEED TO COOK! WE NEED TO DOUBLE OUR PRODUCTION!
- Yo Mr. White, chill out! Now that Vioxx has been pulled from the market we don't even gotta compete man.
- In the end, Merck made irreparable mistakes that ultimately led to the downfall of the Vioxx drug. Merck intentionally participated in comparison bias by comparing Vioxx to Naproxen, when they should have compared it to a placebo instead. Had they compared it to a placebo, they would have been able to obtain more accurate results as opposed to the skewed results that they submitted. This would've also prevented them from having purposefully neglecting to report three deaths in order to manipulate their data and skew it into looking better. Their study should have also considered the long term side effects. The analysis of cardiovascular adverse events up until February 2000 suggested a comparable risk between the Vioxx and Naproxen groups. Further long-term studies are essential to assess any potential causal relationship between Vioxx and adverse cardiovascular outcomes. That's all folks!!
- 5. Curfman, G.D., Morrissey, S. and Drazen, J.M. (2005). Expression of Concern: Bombardier et al., ‘Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis,’ N Engl J Med 2000;343:1520-8.. New England Journal of Medicine, 353(26), pp.2813–2814. doi:https://doi.org/10.1056/nejme058314
- 4. Bombardier, C., Laine, L., Reicin, A., Shapiro, D., Burgos-Vargas, R., Davis, B., Day, R., Ferraz, M.B., Hawkey, C.J., Hochberg, M.C., Kvien, T.K. and Schnitzer, T.J. (2000). Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis. New England Journal of Medicine, [online] 343(21), pp.1520–1528. doi:https://doi.org/10.1056/nejm200011233432103
- 2. Couzin, J. (2004). DRUG SAFETY: Withdrawal of Vioxx Casts a Shadow Over COX-2 Inhibitors. Science, 306(5695), pp.384–385. doi:https://doi.org/10.1126/science.306.5695.384
- 3. Response to Expression of Concern Regarding VIGOR Study. (2006). New England Journal of Medicine, 354(11), pp.1196–1199. doi:https://doi.org/10.1056/nejmc066096
- 1. Reuters (2005). A Time Line of Vioxx. The New York Times. [online] 19 Aug. Available at: https://www.nytimes.com/2005/08/19/business/a-time-line-of-vioxx.html
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