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Day 26 of Our 31 Day Series of How Medicine Got It Wrong

Medicine Got It Wrong with Bextra: Pfizer's Billion-Dollar Blunder Costly Lesson in Putting Profits Over Patients

Bextra was a non-steroidal anti-inflammatory drug (NSAID) that was once widely prescribed for the treatment of arthritis and pain. Pfizer, the pharmaceutical company that developed and marketed Bextra, claimed that it was more effective and had fewer side effects than other NSAIDs. However, as it turned out, Bextra was not as safe as Pfizer had claimed, and the company ultimately had to withdraw it from the market.


The story of Bextra is a cautionary tale about the dangers of putting profits before patient safety. In this blog post, we will explore how medicine got it wrong with Bextra and the consequences that followed.


The Rise and Fall of Bextra


Bextra was approved by the U.S. Food and Drug Administration (FDA) in 2001 for the treatment of arthritis and menstrual pain. Pfizer marketed Bextra aggressively, claiming that it was more effective and safer than other NSAIDs. The company spent millions of dollars on advertising, including a campaign featuring Olympic gold medalist Dorothy Hamill.

However, as early as 2002, there were reports of serious side effects associated with Bextra. In particular, the drug was linked to an increased risk of heart attacks and strokes. Despite these reports, Pfizer continued to market the drug aggressively and even sought FDA approval to use it for surgical pain.


In 2004, the FDA required Pfizer to include a warning on the label of Bextra about the increased risk of cardiovascular events. However, this warning was not enough to stop the widespread use of the drug.


In 2005, the FDA requested that Pfizer withdraw Bextra from the market due to concerns about its safety. The FDA also required Pfizer to include a black box warning on the label of another NSAID called Celebrex, which was also marketed by Pfizer and had similar safety concerns.


The Fallout from Bextra


The withdrawal of Bextra from the market was a major blow to Pfizer, which had invested heavily in the development and marketing of the drug. However, the fallout from Bextra was not limited to Pfizer.


In 2008, Pfizer agreed to pay $2.3 billion to settle civil and criminal charges related to the marketing of Bextra and other drugs. The settlement was the largest health care fraud settlement in the history of the Department of Justice. The charges included off-label marketing, which is when a drug is marketed for uses that have not been approved by the FDA.


The settlement also included allegations that Pfizer paid kickbacks to doctors to prescribe its drugs. These allegations were part of a larger trend of pharmaceutical companies using questionable marketing tactics to boost sales of their drugs.


The Lessons of Bextra


The story of Bextra is a reminder of the importance of putting patient safety first. Pharmaceutical companies have a responsibility to thoroughly test their drugs and to be transparent about the risks associated with them. Doctors also have a responsibility to carefully evaluate the risks and benefits of the drugs they prescribe and to keep up to date with the latest research.


The Bextra case also highlights the need for strong regulation and enforcement to ensure that pharmaceutical companies are held accountable for their actions. The FDA plays a critical role in ensuring the safety and efficacy of drugs, and it is important that it has the resources and authority it needs to do its job effectively.


In conclusion, the rise and fall of Bextra is a cautionary tale about the dangers of prioritizing profits over patient safety. It is a reminder that pharmaceutical companies have a responsibility to act ethically and transparently, and that regulators and healthcare providers must work together to ensure that patients receive safe and effective treatments.


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References:


  1. Pfizer to Settle Bextra, Celebrex Lawsuits. Reuters. Retrieved from https://www.reuters.com/article/us-pfizer-bextra/pfizer-to-settle-bextra-celebrex-lawsuits-idUSTRE49G43220081017

  2. Justice Department Announces Largest Health Care Fraud Settlement in its History. U.S. Department of Justice. Retrieved from https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history

  3. List of largest pharmaceutical settlements. Wikipedia. Retrieved from https://en.wikipedia.org/wiki/List_of_largest_pharmaceutical_settlements

  4. Pfizer Inc. Withdrawal of Approval of a New Drug Application for Bextra. Federal Register. Retrieved from https://www.federalregister.gov/documents/2013/08/02/2013-18657/pfizer-inc-withdrawal-of-approval-of-a-new-drug-application-for-bextra

  5. Recalled Drug: Bextra. Drug Injury News. Retrieved from https://www.drug-injury.com/druginjurycom/2005/05/recalled_drug_b.html

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