Tuesday, April 1, 2014

Pfizer: Defense of Bextra & Celebrex (2013)

Pfizer logo
Starting in 2006 Pfizer has been under fire from stockholders and consumers over concerns about its painkillers Bextra and Celebrex.  Both drugs are anti-inflammatory drugs most notably prescribed for arthritis relief.  In 2004 the pharmaceutical company Merck pulled their similar drug, Vioxx, from the market due to concerns over increased chances of stroke and heart attack in consumers using Vioxx.  This began to stir up concerns over Pfizer's Bextra and Celebrex due to their similar purpose and chemical make-up.  Bextra would eventually be pulled from the market and, in 2008, Pfizer would spend almost $900 million to settle all lawsuits related to Bextra.  Then in 2009 Pfizer would settle a whistle-blower case against them over Bextra for close to $2 billion.  That same year a shareholder lawsuit would be brought against Pfizer for misrepresenting the dangers of Celebrex and for cherry-picking data from clinical trials to help promote Celebrex.  This lawsuit from 2010 is still going on despite Pfizer's attempts to dismiss the case in March 2013.  This case is the most significant because of the allegations against Pfizer: that Celebrex was wrongly advertised to be easier on the heart and stomach than other arthritis drugs.  Evidence presented for this lawsuit has shown that Pfizer willingly took the data from the first half of their clinical trials to show that Celebrex was better at preventing gastrointestinal injuries.  The entire trial showed that this was not the case and so the marketing of Celebrex was intentionally misleading, both to investors and consumers.  The stakeholders for this case is Pfizer (along with its partner Pharamcia), the investors (involved in the lawsuit(s)), and consumers that were prescribed Celebrex and Bextra in the early 2000s.  Pfizer's intent and actions will be analyzed using four ethical theories: Individualist Theory, Utilitarianism, Kantianism, and Virtue Theory. 

Individualist theory states that the primary goal for a business is to generate profit for its employees and investors. However profit must be gained while still respecting laws and human rights. Pfizer chose to make the most profit by advertising a "safer" arthritis drug with Celebrex and Bextra. The first half of their year-long study of Celebrex showed a possible decrease in gastrointestinal injury. Pfizer chose to use this data set to help promote Celebrex to consumers and investors. But the rest of the clinical trial showed that this decrease was no better than other COX-2 inhibitors on the market, yet Pfizer chose to say otherwise. This shows that while Pfizer was using misinformation to promote Celebrex, the Food and Drug Administration (FDA) had approved the use of Celebrex and its inclusion in the market. Pfizer intentionally misled the public in the safety of Celebrex and Bextra. This misinformation eventually led to Bextra being pulled from the market but Celebrex is still available today. When held up to Individualist virtues, Pfizer has acted unethically by misleading the people in their right to know. 

10mg bottle of Bextra

Utilitarianism states that happiness is the most important aspect of ethics. In other words, if an action brings happiness then it is ethical. At first Pfizer may have wanted to help arthritis sufferers but the dangers of the drug outweigh the benefits. Consumers have an increased risk of stroke, heart attacks, and other heart and stomach complications from taking Celebrex and Bextra. While these two drugs may have benefited people at first, if complications arise then their quality of life drastically changes (if they do not contribute to killing them first). For a Utilitarianist this is unacceptable. The multitude of lawsuits against Pfizer for Bextra -- and their tremendous settlement payouts -- show how unhappy investors and consumers are with Pfizer for how they presented the drug.

100mg and 200mg boxes of Celebrex
Kantianism states that companies should intrinsically want to help consumers and allow them to make informed decisions. It also states that companies should always work within the boundaries and never feel exempt from rules and regulations. Pfizer did not intrinsically want to help consumers; if they did they would have waited for the entirety of their clinical trial before marketing the drugs. Pfizer was not going to allow consumers to make well-informed decisions by withholding the dangers of the drugs and by having an apparently superior anti-inflammatory drug compared to others on the market. Their deception prevented consumers from looking at other similar drugs if those drugs could not promote a decreased risk in abdominal health. Pfizer also was not playing by the rules in their advertising. Other than the cherry-picked data from their trial run, documents show that marketers and advertisers for Pfizer were trying to come up with ways to explain away the rest of the trial run. Investors were being brought in on the credentials of Celebrex despite it being no better than other arthritis drugs. Pfizer fails under these Kantian principles.

Virtue Theory
Ian C. Read, CEO of Pfizer
Virtue Theory has four main virtues: courage, honesty, self-control, and fairness. A company is courageous if it takes chances and stands up for what is right. A company is honest if it is transparent with its business actions. A company shows self-control if they create reasonable expectations and lives up to those expectations. A company is fair if it works hard and follows fair practices. Pfizer certainly took a chance in using unconfirmed data to promote their drugs but in doing so they did not stand up for what is right. Their own actions were shrouded from investors. They were hardly transparent by hiding the fact they were using wrong information in advertising. Pfizer, as a company, had created reasonable expectations that the drugs they sold would be safe but failed to live up to those expectations with the complications that arise from using Bextra and Celebrex. Pfizer was hardly fair in how they promoted the drugs by allowing wrong information to be used. Pfizer has gone against all of these virtues in how they marketed Bextra and Celebrex.

Pfizer has certainly shown how they value ethics in how they promoted Celebrex and Bextra. They failed to follow the four virtues in Virtue Theory, they deceived consumers under Kantianism, they brought unhappiness to consumers and investors under Utilitarianism, and failed to operate within rules and regulations under Individualism. It is interesting to note that Bextra has been removed from the market but Celebrex has not. Pfizer may just be trying to stay competitive by having at least one arthritis drug on the market and are thus aggressively protecting it. This can cause Pfizer to plummet even further down on their ethical principles if they cannot end up settling things and ensuring a better, safer drug.

Bratulic, Anna. "Pfizer Loses Bid to Dismiss Shareholder Lawsuit over Celebrex, Bextra Safetyclaims." - FirstWord Pharma. First World Pharma, 29 Mar. 2013. Web. 28 Mar. 2014.

Mercola. "Pfizer 'Cherry-Picked' Celebrex Data, Memos Say." Mercola.com. N.p., 9 July 2012. Web. 28 Mar. 2014.

Phillips & Cohen LLP. "Bextra Whistleblower Case Leads to Record-setting Pfizer Settlement." Phillips & Cohen LLP. N.p., 2 Sept. 2009. Web. 28 Mar. 2014.

Raymond, Nate, and Ransdell Pierson. "Pfizer to Pay $164 Million in Investor Lawsuit over Celebrex." Reuters. Thomson Reuters, 09 Oct. 2012. Web. 28 Mar. 2014.

Saul, Stephanie. "Pfizer in $894 Million Drug Settlement." The New York Times. The New York Times, 17 Oct. 2008. Web. 28 Mar. 2014.

Stempel, Jonathan. "Pfizer Fails to End Lawsuit over Bextra, Celebrex Safety." Reuters. Thomson Reuters, 28 Mar. 2013. Web. 28 Mar. 2014.

Thomas, Katie. "In Documents on Pain Drug, Signs of Doubt and Deception." The New York Times. The New York Times, 24 June 2012. Web. 28 Mar. 2014.

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