“Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit,” the manufacturer said in a statement. “As alternative suppliers have been approved in the United States, Pfizer is undertaking this precautionary measure.”
“Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication,” the statement continued. “The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.”
“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables,” the statement rationalized. “Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”
Toxicity, of course, is a matter of dosage. And as anyone who has stopped smoking without Chantix knows, the drug is not indispensable to quitting cigarettes or other tobacco products.
The timing of the admission that Pfizer’s Chantix drug is tied to increased risk of cancer couldn’t be more convenient for the FDA or for Pfizer. On August 23, the FDA gave its theoretical ‘full approval’ to Pfizer-BioNTech’s Covid vaccine, which is being manufactured under a differerent label not currently on the market: Comirnaty. Less than a month later, the same pharmaceutical manufacturer concedes cancer risk with one of its drugs and is pulling it off the market.
So, is the Big Pharma company doing this because they care about patients who were taking the drug? Or is it because they are set for a government-driven windfall that is exceeding all expectations? Let’s examine its 2021 “profits” (if you can call it that amid government and employer mandates forcing millions of people to take the vaccine).
“Biotech giant Pfizer expects to generate $33.5 billion in Covid-19 vaccine sales in 2021, up from previous estimates of $26 billion, according to its second quarter earnings reports,” Forbes reported in late July. “These projections are based on the 2.1 billion doses of the Pfizer/BioNTech vaccine which the company expects to manufacture and deliver by the end of the year.”
Futhermore, Pfizer suddenly has a competitor on the market: Par Pharmaceuticals’ Endo, which received FDA approval in August. Pfizer’s track record, far from suggesting they care about people quitting smoking, shows instead a profit-hungry company that seems to put patients’ interests second.
“Chantix, first approved in 2006, drew in $1.1 billion in global sales back in 2019,” Fierce Pharma notes. “The number fell 17% last year as the pandemic shuttered doctors offices. Most of Pfizer’s blockbuster sales can be attributed to its numerous price hikes over the years, according to GoodRx. In a 2018 report, the group found that Chantix’s price had more than doubled over 5 years.”
“For months, people trying to wean off smoking have faced short Chantix supplies after Pfizer halted worldwide distribution in late June,” Fierce Pharma’s report continues. “That came after the drugmaker detected unacceptable levels of potential carcinogens, known as nitrosamines, in a number of Chantix lots. Weeks later, the company recalled certain batches in the U.S.”
The FDA-Pfizer pipeline has been well-established. The former FDA head Dr. Scott Gottlieb, who ran the government agency from 2017 to 2019, now sits on Pfizer’s board of directors. Pfizer has been pushing hard for booster shots to be offered to patients as young as 5 years old, which is a plan that has received Biden administration backing.
However, on Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee delivered the booster shots plan a stinging defeat of 16-2. A final FDA vote is forthcoming, but the agency generally follows the advice of the committee. A departure from the resounding vote would be tantamount to a ‘smoking gun’ that it caved to political pressure.
“Over several hours of discussion, members of the Food and Drug Administration panel of outside experts voiced frustration that Pfizer had provided little data on safety of extra doses,” the Associated Press reported. “And they complained that data provided by Israeli researchers about their booster campaign might not be suitable for predicting the U.S. experience.”
“It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” Michael Kurilla, a committee member with the National Institutes of Health, said. A rare bit of common sense from the FDA.
“Pfizer has repeatedly argued that a third dose will be needed, while many experts have said that more data is necessary to support the use of a booster shot,” the report noted. “Meanwhile, the World Health Organization has called for a moratorium on administering booster doses through 2021 to try to give low-income countries a chance to catch up on vaccination coverage.”
The FDA is thus “revolting” against the political pressure being put on the agency, whose sole imperative is scientific integrity and medical ethics. It remains to be seen if the rebellion will be a temporary hiccup or an ongoing thorn in the side of the Biden administration.