New Haven Register (New Haven, CT)
Should vaccine makers promote their products?
Medical ethics experts weigh in
Experts in medical ethics have expressed concern over the way Pfizer has promoted its COVID-19 vaccine.
“There's a few things that really bothered me. One is, a few months ago, you got the Pfizer CEO going out and saying, ‘We're going to need boosters,’” said Rick Martinello, head of infection prevention at Yale New Haven Health. “You know, that's inappropriate. That taints the situation.”
Pfizer, though, said part of the company’s job is to remain transparent, particularly in the midst of a global pandemic.
“We have to take into consideration that over the last year and a half everything is unprecedented,” said Jerica Pitts, Pfizer’s director of global communication.
In April, Pfizer CEO
Albert Bourla said people could need a booster shot of the vaccine within a year.
“A likely scenario is that there will be likely be a need for a third dose, somewhere between six and 12 months and then from there, there will be an annual re-vaccination, but all of that needs to be confirmed. And again, the variants will play a key role,” Bourla told CNBC.
That was months before the FDA fully approved the vaccine in August, and long before the FDA decided this month against authorizing population-wide boosters. The FDA did approve boosters under limited circumstances and on Friday in Connecticut, people older than 65 and health care workers began getting boosters. More than 20,000 immunocompromised individuals had already received addition shots of the Pfizer vaccine in the state.
The process for booster approval typically is that research is published in a medical journal, peer-reviewed and supplied to regulators for analysis, according to Audrey Chapman, who holds the Healey chair on medical ethics and humanities at UConn. Pfizer, she said, “is not behaving in an ethical manner.”
“The (Centers for Disease Control) makes the determination about whether it should be distributed,” Chapman said. “But usually they only make that decision after the FDA has decided that it approves something and then it goes to an advisory committee at CDC, their Advisory Committee on Immunization Practices, which makes the recommendation to CDC about whether or not it should be authorized for us.”
In the case of booster shots for the COVID-19 vaccine, the process has been different.
“Many companies issue press releases all the time about the success of studies concerning their drug. It happens all the time,” said Art Caplan, founding head of the Division of Medical Ethics at NYU Grossman School of Medicine and a Ridgefield resident. “But, what happens is the media transforms an announcement into a press release for them that touts the drug.”
“That leads to some problems,” he said.
Pitts said the decision of whether or not to approve the vaccine for use is left to regulators.
“We have never said, ‘We’re telling parents to get vaccinated,’” she said. “Even though we’re sharing results, that’s not making a recommendation from Pfizer that children should be vaccinated.”
“We have never said that our role is to make the decision,” she said.
There is a practical difference between a press release sharing data, Caplan said, and an advertisement for a drug.
“These announcements are all just saying the research looks good,” Caplan said. “The TV ads are saying use this drug, pester your doctor to prescribe it to you.”
Pitts agreed. She said Pfizer has never advertised the vaccine, only shared results from clinical trials.
“We don’t advertise this,” she said. “This is a different form of communication.”
The purpose of Pfizer sharing data on its vaccines before FDA approval, Caplan suggested, might be to drive investment in the company or to generate “pressure from the public to get the drug approved more quickly.”
“Morally, you want to make sure that hype and buzz does not drive the decision,” he said.
Pitts said she “can’t speak to what the FDA feels has an impact on them.”
But Martinello called it “the tail wagging the dog.”
“The academic work comes out first,” he said. “With the pandemic, it has changed how we do things, and out of necessity.”
From an ethical standpoint, Caplan said, “it makes a difference to the ethics” if they are “boosters” or simply the third in a series of three-shot vaccines.
“Many vaccines, to work, require three shots,” he said. “It may be that what we’re talking about is, if you want to get vaccinated against COVID you need three shots.”
Both Caplan and Martinello expressed concern that pharmaceutical companies will use public opinion to pressure regulators in the future. When asked if that was likely, Caplan said “I hope not, but I worry that we may.”
Caplan said similar tactics were used when patient advocate groups pressured the FDA to approve Aduhelm, used to treat Alzheimer’s disease, earlier this year.
“This tests the waters for them,” Martinello said. “Granted, when we're no longer in a public health emergency, some things will revert back to our pre-COVID normals. But we know our lives are always going to be different and impacted by this, and this is no different. It does test the waters to an extent it sets that precedent. And I wouldn't be surprised if we see him see more of it.”
Martinello said he believes Pfizer has both public health and “a responsibility to their shareholders,” though he said “they're not mutually exclusive intents.”
“They can have both intents and it kind of makes sense,” he said.
Chapman noted that Pfizer, “unlike any of the other major vaccine manufacturers, did not accept money from the U.S. government to help develop their vaccine.”
“It has therefore left them free to charge whatever they want to charge,” she said. “Apparently, in the first quarter of the year, they had U.S. sales of $2 billion and global sales of $5.8 billion. So they're making, already, a huge amount of money from their vaccine.”
Money made from sales of the vaccine, she said, would likely increase.
“They've announced that after the pandemic is over, and not specifying how that would be determined, that they're going to increase the price of their vaccine,” she said. “It's already been increased, at least in Europe, to $23.15 per dose, which is a lot of money.”