The pharmaceutical industry is difficult to understand at first glance. It is governed by complex laws and even more complicated trial processes, set to try to regulate the huge money-making industry. However, this lucrative industry seems to spawn perpetrators with enough knowledge and guts to try to get around these ill-equipped safeguards. One of the most recent of these is Pfizer with its drug Bextra.
Introduced in November 2001, Bextra is a drug that was prescribed for the treatment of ailments such as osteoarthritis, rheumatoid arthritis and painful menstruation. The drug was withdrawn from the U.S. and E.U. markets by Pfizer in 2005 due to increasing fears that consumption would lead to cardiovascular complications, but it is still prescribed in other countries.
Bextra, also known as Valdecoxib, is categorized as a non-steroidal anti-inflammatory drug (NSAID). It is a cousin of Rofecoxib, another well known NSAID and one of the most widely used drugs to ever have been withdrawn from the market. At one point in time, more than 80 million people were prescribed Rofecoxib, which traded under the name Vioxx. These drugs are usually given to patients who are suffering from chronic ailments that cause inflammation and pain. However, consumption of this category of drugs tends to result in an increased risk of heart attack and stroke.
Bextra influences the amount of blood- dilating enzyme in the body. COX-1 and COX-2 are enzymes responsible for the dilation and clotting of blood respectively. As Bextra is a type of COX-2 inhibiter, when consumed it reduces the effectiveness of blood dilating agents. Once the balance between the two enzymes is disrupted, the enzyme responsible for the clotting of blood becomes more prominent, making blood clots more likely. A high chance of blood clots forming in arteries would increase the likelihood of a heart attack or stroke. Medical reports have shown that patients taking Bextra while recuperating from heart surgeries are 2.19 times more likely to suffer from stroke or heart attack as compared to those being administered other medications.
Despite the downsides, Bextra was marketed aggressively by Pfizer. The drug was initially targeted solely at patients suffering from osteoarthritis, rheumatoid arthritis and painful menstruation, but the Pfizer marketing team recommended it for numerous other uses. Bextra was administered for a variety of conditions for which the risks outweigh the benefits of consuming the drug. For instance,Bextra was used to treat migraine patients at a dose eight times more than what was approved. Most patients, ill-informed of the downsides of such a drug, took it without question and put themselves at high risk of cardiovascular complications.
By 2003, unsavory reports had surfaced that Bextra’s manufacturer, Pfizer, had overstepped its boundaries in marketing the drug. Pfizer’s marketing team managed to get medical professionals to prescribe Bextra for unapproved ailments. They accomplished this feat via a variety of unethical and illegal tactics. For instance, sales representatives would send hand-written letters to medical professionals extolling the drug beyond FDA (Food and Drug Administration) approved uses. Such blatant off-label promotion is a clear violation of FDA rules and regulations. The prioritization of drug sales over patient health is a blow to the integrity of the US healthcare system, especially when the promoted drug does the patient more harm than good.
In September 2009, Pfizer was found guilty of violating FDA laws and made to pay $2.3 billion, the largest healthcare fraud settlement in history. Pfizer pleaded guilty for misbranding Bextra with intent to defraud or mislead.
In the aftermath, industry players are wondering if fines are an effective deterrent for pharmaceutical companies practicing off-label marketing. Although a $2.3 billion dollar fine may seem like a lot of money, it is actually just a slap on the wrist for a pharmaceutical giant like Pfizer. In the case of Bextra, a $2.3 billion fine is just a fraction of the profits that Pfizer earned from the sale of the drug. For instance, in 2003 and 2004 alone, sales profits from Bextra and Lyrica, another drug also covered in the marketing settlement, amounted to at least $4.6 billion. The profit figure does not include sales from two other drugs, Geodon – an anti-psychotic drug, and Zyvox, an antibiotic also covered in the settlement.
Although off-label promotion of drugs by pharmaceutical companies is illegal, off-label prescription of drugs is legal. This irony is a systematic flaw that perpetuates throughout the entire healthcare system. As long as off-label prescription of drugs remains legal, firms will tout their products as suitable for other uses beyond what is FDA approved, because they are aware that doctors have the freedom to prescribe the medication as they see fit. Being extremely profit motivated, the cases discussed above demonstrate that firms will not hesitate to rake in money at the expense of patients’ health.