As Merck takes its first foray into the COVID-19 cash cow that its competitors Pfizer, Moderna, and Johnson & Johnson have dominated thus far, it's doing so by taking a different path. While the aforementioned vaccine consortium was able to take in billions of taxpayer dollars thanks to their inclusion in Operation Warp Speed, Merck is predicating its success off of pioneering a therapeutic option to treat the disease instead of a prophylactic one. Molnupiravir, the oral antiviral prodrug developed by Merck in tandem with Ridgeback Biotherapeutics is touted as a godsend for those who have already been infected with SARS-CoV-2. Initially, Ridgeback Biotherapeutics developed the mediciation to treat influenza before Merck's involvement arose in order to adapt the antiviral for use against COVID-19. $1.2 billion has been earmarked for its purchase by the Department of Health and Human Services if it gets an EUA from the FDA. Now, Molnupiravir is on a collision course with the regulator as Merck has requested that approval.
According to its preliminary clinical trial results, treatment with the experimental antiviral reduced the risk of hospitalization and death in high-risk patient groups by as much as 50%. For those who have fallen under the spell cast by the pharmaceutical industry, the auspices of these claims bring hope that the threat COVID-19 poses can be mitigated in the most dire of straits. For those with a healthy sense of skepticism, the claims sound too good to be true. For those without a short memory, the path charted forward by the advancement of Molnupiravir is a redux of one of the most controversial drugs in history: Merck's now-recalled arthritis drug Vioxx.
When it was first approved by the FDA in 1999, Vioxx was touted as an answer for treating the chronic and acute symptoms of arthritis. Over the course of its administration, over 80 million people were prescribed the drug throughout the world. Yet, despite its commercial success, the drug would be completely off of the market about 5 years following its introduction. Like Molnupiravir, questions surrounded the safety profile of Vioxx preceding its FDA approval as well. Namely, concerns about Vioxx surrounded whether or not the arthritis drug presented an increased risk of heart attacks in patients. The basis of this risk assessment was linked to a study which compared the efficacy and adverse effects of the Merck-pioneered medication against patients who were treated with Naproxen, a nonsteroidal anti-inflammatory drug ("NSAID") sold over the counter under the brand name Aleve. Data resulting from this study conveyed that the risk of a heart attack increased by 400% in patients treated with Vioxx as opposed to those whose treatment relied upon the well-established NSAID Aleve. This profound adverse effect was observed to take effect 2 months into the 9-month observation period conducted by the study.
Despite this eye opening concerning, Merck was able to carefully craft a response to diminish the risk assessment. Under the methodology of the study that revealed these concerns, this increased cardiovascular risk was only observed in patients who had a pre-existing risk of heart attacks who would already be on a prophylactic regiment which used a low-dose aspirin like Aleve. As such, Merck's scientists categorized the increased risk in heart attacks attributed to this group as the byproduct of the prophylactic effect of the aspirin regiment. Simply put, Merck claimed that 400% disparity was more indicative of the preventative impact of a drug like Aleve than it was emblematic of any increased risk attributed to Vioxx.
Supporting this claim was central to Merck's campaign to have the FDA approve Vioxx. In order to assure that it would earn that approval, Merck resorted to a public relations campaign that aggressively marketed the drug with the help of celebrity endorsements from the likes of Bruce Jenner before it was even approved, a standard of scientific review that revolved around obfuscating the intent of its studies, funding ghostwritten studies that painted the drug in a positive light, creating fake medical journals to laud the drug, and even working in tandem with the FDA to suppress scientific dissent by intimidating doctors who questioned the safety of the drug.
Ultimately, the nefarious campaign behind getting Vioxx approved by the FDA would succeed. However, not even a full year after the drug got its green light to hit the market, cracks began forming at its foundation. Following a study published in the Journal of the American Medical Association in 2001, an FDA advisory panel recommended that Vioxx include a label warning doctors and their patients of the link between the drug and the increased risk of heath attacks. By then, the New England Journal of Medicine had published the initial Merck-sponsored study which revealed this correlation, causing the FDA to put Vioxx under increased scrutiny and to examine whether Merck had intentionally withheld critical data from the regulatory body with all of the available information they had at the time they applied for the drug's approval.
Research undertaken by FDA scientist in the wake of the revelations regarding Merck's conduct leading up to the approval of Vioxx would prove to be the last straw for the drug. Despite the FDA deeming that the medication was safe enough to be approved for public consumption in 1999, by 2004 its own independent research determined that patients using Vioxx were undoubtedly more likely to suffer a heart attack or fatal cardiac episode than those taking a NSAID. These findings showed that the increased risk of a cardiac episode was due to the consumption of the prescription as opposed to the claim that it was a measure more indicative of the prophylactic effect of NSAID use as Merck previously claimed. Still, the company stood by Vioxx issuing a press release stating "Merck stands behind the efficacy, overall safety and cardiovascular safety" of the drug. Yet, just one month after the FDA study published the findings which Merck refuted, the company revealed that its own post-approval studies conveyed that patients taking Vioxx were twice as likely to suffer a cardiac episode than patients in a control group given a placebo.
Ultimately, Merck being pushed to abandon its selective practices during clinical trials become the drug's undoing. Once they were put in a position to compare the cardiovascular impact of Vioxx against a placebo group without any pre-existing medical conditions putting them at risk of heart attacks, the adverse effect of the drug became apparent. On September 30th, 2004, Merck voluntarily withdrew Vioxx from a market including more than 80 different countries where the medication was sold. Merck's decision to withdraw Vioxx from the market was the largest prescription drug recall in history at the time.
In the following years, the Vioxx scandal resulted in scathing examination of the company's clinical practices and thousand of lawsuits from patients detrimentally effected by the drug. In 2005, The New England Journal of Medicine Published a damning "Expression of Concern" which demanded Merck submit a correction to the data published in its initial studies of the drug. In 2006, the medical journal Lancet estimated that the use of Vioxx caused 88,000 instances of heart attacks, 38,000 of which proved to be fatal, in Americans prescribed the drug. The downfall reached its low point in 2007 when Merck announced it would pay out $4.85 billion into a settlement fund to end the remaining lawsuits it faced. This payout amounted to the largest single drug settlement in history.
The fallout from the Vioxx scandal would linger into 2020, when a former employee of the company's was found dead. Brandy Vaughan, a self-described big pharma whistleblower was once a sales rep for Merck. Her experience selling Vioxx inspired her to change the trajectory of her career. In 2015, Vaughan founded Learn The Risk, a 501(c)(3) non-profit organization that was designed to draw upon her experience in the pharmaceutical industry to expose the wrong doings of companies like her former employer. Vaughan's advocacy aimed to inform prospective patients of the risks of drugs and vaccines. Her role founding Learn The Risk put Vaughan at odds with the giants of big pharmaceutical enterprises to the point where she proclaimed that she was in fear of her life in which she expressly conveyed that she would never commit suicide. Vaughan was found dead in 2020 as the result of a heart attack caused by an arterial blood clot in a cruel, ironic twist of fate. A coroner determined that the cause of death was due to natural causes. Vaughan's tragic death leaves Learn The Risk in a position where its future is in doubt as it is devoid of any current leadership. Still, it serves as a testament to the change in public perception of pharmaceutical industry that was accelerate by Merck's reckless push to sell Vioxx.
Even amidst the increased visibility of Merck's sordid history with obscuring the safety of its drugs and with the safety concerns that scientists have over its COVID-19 antiviral, the company has asked for an emergency use authorization for Molnupiravir. Ironically, it was Merck who had worked to first make Ivermectin available for human use in 1987. Now that the patent has expired on that anti-viral, the company finds itself slandering the medicine it offers to countries in dire need of antiviral medication. In a profound testament to the contradictory position Merck has taken on Ivermectin, the pharmaceutical company literally dedicates a portion of its website to its 30-year running program donating the antiviral that it writes off for using against COVID-19. Despite the red flags raised by Merck's about-face on Ivermectin, and wanton abandonment for its patients in seeking the approval of Vioxx, the company's track record of putting profits before patients, distorting science, and infiltrating regulatory bodies tasked with oversight are little more than an omen of the inevitable approval for its latest drug to draw ire in the public eye.