THE THORNIEST QUESTIONS FACING PHARMA, ACCORDING TO A LEADING BIOETHICIST

The thorniest questions facing pharma, according to a leading bioethicist

Bioethics guru Arthur Caplan of NYU gives his outspoken and frank opinion on the industry’s minefield of ethical challenges.

Arthur Caplan, professor of bioethics and founding head of the Division of Medical Ethics, NYU’s Grossman School of MedicinePermission granted by NYU

Editor’s note: This story represents the opinion of a leading bioethicist with regard to the biopharma industry. Views expressed are his own and do not necessarily reflect the views of this publication. PharmaVoice will publish a follow-up article with insight from industry insiders who discuss how they approach ethics in the biopharma realm.

The pharma industry, for all the good it provides in the name of public health and scientific progress, is still an ethical minefield.

When a company like Pfizer develops the first vaccine to address a worldwide health crisis, for example, the conversation quickly turns to massive profits or suspected ulterior motives, regardless of intent and outcome. Reputation and public perception are fleeting wins.

But frank conversations about ethics can better position companies to serve their patients even if the conversations are a little uncomfortable, said Arthur Caplan, professor of bioethics and founding head of the Division of Medical Ethics at NYU’s Grossman School of Medicine.

“I’m not sure we’ve thought about what the term ‘real-world evidence’ really means.”

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Professor of bioethics, founding head of the Division of Medical Ethics at NYU’s Grossman School of Medicine

Caplan, who has consulted with biopharma companies on the subject of ethics, believes that these discussions shouldn’t exist merely in the academic echo chamber but out in the open between researchers, industry insiders, government officials, patients, media and other stakeholders in the healthcare world.

Here are some of what Caplan — one of the leading voices in bioethics who speaks candidly and sometimes fervidly about such issues — sees as the most pressing concerns for the industry in terms of health, reputation and overall principle.

“The biopharmaceutical industry has developed very close relationships with patient advocacy groups, but they’re not very transparent,” Caplan said.



Patient groups do a great job communicating to the industry that a treatment is needed for even the rarest of diseases, and companies have responded in kind, he said. But that’s not the end of the story.

“Biopharmaceutical companies are starting to use patient-driven demand to shape regulatory policy,” Caplan said. For example, Alzheimer’s disease groups backed the Biogen and Eisai drug Aduhelm for an FDA approval when experts considered evidence of the treatment’s efficacy murky. And patient groups need to justify their existence and funding through results — that means convincing drugmakers to develop a treatment and then backing it to the end, Caplan said.

“Most people have the view that patients are separate from the industry and that patients show up and say ‘I want X,’ but that isn’t quite true,” Caplan said. “They’re kind of connected — if a patient showed up and said, ‘I think your drug is bulls---,’ the sponsorship of the patient group would be coming to a rapid end.”

Haste is a double edged sword when it comes to drug development. A quickly made drug or vaccine can save lives by providing access at an earlier date, but potentially compromise safety or efficacy in the long run, Caplan said.