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The thorniest questions facing pharma, according to a leading bioethicist

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.”

Arthur Caplan

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.

Ties to patient groups

“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.”

Speed of drug development

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.

“There’s a lot of pressure to do faster development post-COVID,” Caplan said. “Everybody saw emergency use authorizations and using real-world evidence as a substitute for a full clinical trial, and speed is becoming something the industry can push for.”

As with all ethical quandaries, there’s more to faster drug development lurking beneath the surface.

“I’m not sure we’ve thought about what the term ‘real-world evidence’ really means or what the cost is when speed means rolling out things that still may fail,” Caplan said.

Post-market approvals

Conditional approval of a drug falls into a similar category as a speedier development — a regulator will grant the go-ahead to a treatment based on unmet medical need with the requirement that a company conduct a post-market study to confirm the drug’s efficacy.

“I don’t think the industry does a good job on phase 4 post-market approvals,” Caplan said. “We don’t know what the hell’s going on half the time to answer questions about whether something is working or not.”

The post-market approval process is ripe for conflicts of interest, he said.

“Sometimes it’s in the industry’s best interest to get it approved, get paid for a couple years and then withdraw it,” Caplan said. “The FDA is under extreme pressure to speed things up from a Congress that has many members who don’t like regulation — I don’t think it serves the public well.”

Price control

No bioethics conversation is complete without bringing drug pricing to the table. A topic that has been discussed widely and to the benefit of politicians campaigning for office, drug pricing remains a thorn in the industry’s side as new policies threaten profits.

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