Investigate Pfizer for disregarding FDA advice
Investigate Pfizer for disregarding FDA advice
In the 21st century, medical science is advancing at an accelerated pace. There is no doubt that many of these developments have facilitated an improved quality of life and health-related outcomes for countless individuals, families and communities throughout the globe. There are occasions, however, when pharmaceutical companies have pursued convenience and profit at the expense of the well-being of their consumers. When it comes to Pfizer’s Chantix recall, their failure to take responsibility for and admit accountability for their actions means that consumers were knowingly exposed to possible carcinogens for a prolonged period of time. This is incredibly problematic, because not only does it put the well-being of patients at risk but it also excuses large pharmaceutical companies from much-needed oversight, accountability and responsibility. It’s time to change that.
My name is Nesha Schinhofen, and I have started a petition in order to have Pfizer investigated for its insufficient handling of the latest Chantix recall. Multiple lots of Chantix have been recalled due to the presence of high levels of a nitrosamine, N-nitroso-varenicline, which exceeds the Acceptable Daily Intake (ADI) level that has been established by Pfizer. Unfortunately, Pfizer was aware of the excessive amounts of the nitrosamine present in the recalled lots of Chantix long before they had started recalling them. As a matter of fact, this medication, under the trade name Champix, was also recalled in Canada for the same issue in June 2021. Chantix and Champix are trade names for varenicline, a prescription anti-smoking medication, and the reason for this most recent nationwide recall is because the impurities contained within these drugs have been identified as potential carcinogens.
In early July, nine lots of the drug were recalled by Pfizer, but these recalls were issued only to warehouses rather than consumers. On July 2 2021, the FDA published the following statement on their website, “Pfizer is recalling the varenicline lots currently stored in warehouses. FDA recommended Pfizer revise its recall to the consumer level in order to take into account the product currently on the market, but the company has not yet done so.” Moreover, the FDA determined that the recalled varenicline medications pose an ‘unnecessary risk’ to consumers. Health professionals were therefore advised to consider alternative therapeutic options for their patients.
It would be weeks later that Pfizer would expand their recall of Chantix to the consumer level, whilst simultaneously including three more lots of the medication to their recall. This means that there were twelve lots of drugs containing unacceptable levels of carcinogenic compounds, all of which had been in circulation even after Pfizer had found out that they were contaminated. During this time I was also taking Chantix, and my lot was #ET1600. This was one of the three lots which were later added to the recall list, several weeks after Pfizer had first recalled the original nine lots from warehouses. It’s my understanding that Pfizer knowingly exposed me, and other patients, to worryingly higher levels of potentially cancer-causing compounds. What is particularly concerning is that Pfizer did not heed the advice of the FDA, even when the FDA published a statement calling upon the company to extend the recall from a warehouse level to a consumer level.
Ultimately, I feel that Pfizer prioritised profits and sales over the health of its consumers. At the very least, they chose to overlook their ethical and moral responsibilities in the pursuit of increased revenue. It’s also important to note that the consumers of medications such as Chantix are patients who are trying to improve the quality of their lives by quitting smoking. I realise that I may not understand the finer details of the entire situation, or what was going on behind the scenes, and I’m willing to admit that the company may have had a legitimate reason for how they handled the recall.
What I do know, however, is that as consumers we reserve the right to ask questions. For example, why were these lots released when they contained potential carcinogens? Why was there such a prolonged delay between the warehouse recall and the consumer recall? More importantly, why weren’t consumers promptly informed so that they could understand the risks and make a decision for themselves based on what was acceptable to them? In order to receive an answer to these questions, I have reached out to Pfizer by writing an email to them, and I’m still waiting for a response.
It is for this reason that I decided to start this petition, so that we can push Pfizer to investigate and give us some answers as to why they disregarded the FDA when it advised them to launch a consumer recall. When they did finally act upon this advice, a significant period of time had passed during which multiple consumers such as myself had continued to consume the medication. This petition is incredibly important, because I know that when we are given the opportunity to have our voices heard and our questions finally answered, then we can shed some light on what has happened and why it has happened.