Colossal Wrongdoings by Big Pharma – Vioxx – Asrar Qureshi’s Blog Post #1089

Colossal Wrongdoings by Big Pharma – Vioxx – Asrar Qureshi’s Blog Post #1089

Dear Colleagues! This is Asrar Qureshi’s Blog Post #1089 for Pharma Veterans. Pharma Veterans Blogs are published by Asrar Qureshi on its dedicated site https://pharmaveterans.com. Please email to pharmaveterans2017@gmail.com  for publishing your contributions here.

Vioxx Pack

Credit: Anna Shvets

Credit: Engin Akyurt

Preamble

Pharmaceutical business is like any other business where profit comes first. If businesses were left unchecked to do as they desired, which is still the case for many businesses worldwide, and for most businesses in badly managed countries like ours, they would do indescribable things, including but not limited to killing people.

Pharma industry is ruled by Big Pharma internationally. There are Big Pharma companies locally also, but they are so small as compared to the real Big Pharma. 

Big Pharma has been involved in criminal concealment of evidence and facts about their products and has caused huge damage to people. Thalidomide was the first recorded case in 1950-60 which caused the birth of thousands of deformed, limbless babies; the scrutiny started from that point. 

I had described it in a blog post a while ago. I also wrote a series of posts on the opioid crisis started by Oxycontin from Purdue Pharma. The cases are still in courts. I am now going to describe several other major cases where Big Pharma knew and concealed information deliberately thereby causing colossal damage to people. True, that they finally paid millions/ billions of dollars to settle suits, but it did not bring back lost lives or years. Here is the first one about the antirheumatic drug Rofecoxib, launched internationally by the brand name VIOXX. Its generic versions were launched in Pakistan also and several companies made huge money out of it. What happened internationally is here; nothing happened in Pakistan to settle the damages.

The Vioxx Scandal: How a Blockbuster Drug Became One of Big Pharma’s Biggest Disasters

In the world of pharmaceuticals, few cases highlight the dangers of corporate greed and regulatory lapses as dramatically as the Vioxx scandal. This case is a textbook example of how a promising blockbuster drug turned into a global health disaster due to concealed risks and unethical business practices.

The Rise of Vioxx: A Miracle Painkiller?

In 1999, Merck, one of the largest pharmaceutical companies in the world, introduced Vioxx (rofecoxib) as a revolutionary new painkiller. Designed to treat arthritis and acute pain, Vioxx was a COX-2 inhibitor that promised to be as effective as traditional nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen but with fewer gastrointestinal side effects. The drug quickly became a blockbuster, generating billions of dollars in sales and being prescribed to millions of patients worldwide.

The Hidden Danger: Increased Risk of Heart Attacks and Strokes

While Vioxx was widely embraced by doctors and patients, concerns about its cardiovascular safety emerged early. As early as 2000, internal studies and independent research suggested that patients taking Vioxx faced a higher risk of heart attacks and strokes compared to those taking other painkillers. Instead of acting on this critical safety data, Merck actively worked to suppress unfavorable findings and downplay the risks.

The Cover-Up: How Merck Misled the Public and Regulators

Merck’s handling of Vioxx’s safety concerns is one of the most infamous examples of corporate malfeasance in the pharmaceutical industry. The company:

• Manipulated Clinical Trial Data: Evidence suggests that Merck selectively reported favorable results while hiding data that showed the cardiovascular risks associated with Vioxx.

• Aggressively Marketed Vioxx: Even as safety concerns mounted, Merck continued to promote Vioxx aggressively, making it one of the most heavily advertised drugs of its time.

• Pressured Scientists and Doctors: Reports indicate that Merck attempted to silence critics by intimidating scientists who questioned the drug’s safety and even ghostwriting favorable research articles.

• Delayed Regulatory Action: By failing to provide full transparency to the U.S. Food and Drug Administration (FDA), Merck delayed the withdrawal of Vioxx and prolonged patient exposure to serious health risks.

The Public Health Fallout

By the time Vioxx was withdrawn from the market in September 2004, an estimated 88,000 to 139,000 people in the United States alone had suffered heart attacks and strokes due to the drug. Thousands of deaths were linked to its use. The scale of the disaster prompted widespread outrage and multiple investigations into Merck’s conduct.

Legal Repercussions: One of the Largest Pharma Settlements in History

In the aftermath of the scandal, Merck faced thousands of lawsuits from patients and families who suffered harm. In 2007, the company agreed to pay $4.85 billion to settle around 27,000 lawsuits. Additionally, Merck paid hundreds of millions in fines and legal fees. Despite these penalties, no top executives were criminally charged, raising concerns about corporate accountability in the pharmaceutical industry.

Lessons Learned from the Vioxx Scandal

The Vioxx case serves as a cautionary tale for the pharmaceutical industry, regulators, and consumers. Key takeaways include:

1. The Importance of Transparency: Pharmaceutical companies must disclose safety risks fully and honestly to protect public health.

2. Regulatory Oversight Must Be Stronger: The FDA and other agencies must have the power and resources to detect and act on safety concerns faster.

3. Ethical Marketing Matters: Aggressive promotion of drugs without adequate safety data can have deadly consequences.

4. Holding Corporations Accountable: Stronger legal consequences are needed to deter corporate misconduct in the pharmaceutical sector.

Sum Up – Vioxx Case

The Vioxx scandal remains one of the most shocking examples of pharmaceutical negligence in history. While Merck eventually paid billions in settlements, the damage to public trust in the industry was immeasurable. This case underscores the need for stronger ethical practices, regulatory vigilance, and corporate accountability to ensure that patient safety always comes before profits.

Pakistan market also saw several branded generics of Rofecoxib on the market. The patents application was still soft and though the drug was still in patent, its generic versions were marketed in Pakistan. After Vioxx was withdrawn from the US market, our own Ministry of Health (DRAP came much later) also got up to ask companies to withdraw the drug. The companies complied reluctantly. No one has any data on the number of deaths and heart attacks or strokes linked to use of rofecoxib in Pakistan. Of course, there is no question of any compensation whatsoever.

Concluded.

Disclaimers: Pictures in these blogs are taken from free resources at Pexels, Pixabay, Unsplash, and Google. Credit is given where available. If a copyright claim is lodged, we shall remove the picture with appropriate regrets.

For most blogs, I research from several sources which are open to public. Their links are mentioned under references. There is no intent to infringe upon anyone’s copyrights. If, however, it happens unintentionally, I offer my sincere regrets.