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Experts debate urgency of better flu shot, drug prices, nonprofit R&D models


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Experts debate urgency of better flu shot, drug prices, nonprofit R&D models

It is time to stop talking about making a better flu vaccine and just do it, said Margaret Hamburg, former commissioner of the U.S. Food and Drug Administration.

"We can't just keep talking," Hamburg said at the 2019 Milken Institute's Future of Health Summit in Washington, which ran Oct. 28-30. "We do need to have some accountability."

SNL ImageFrom left, The New Yorker's Michael Specter, BARDA's Rick Bright, NIH's Anthony Fauci, Sabin Vaccine Institute's Bruce Gellin, former FDA Commissioner Margaret Hamburg and Flu Lab's Casey Wright
Source: The Milken Institute

The ongoing discussions about getting to a more effective flu shot has taken the place of action, said Hamburg, who served at the FDA during the Obama administration and is now the foreign secretary for the U.S. National Academy of Medicine and board chair for the American Association for the Advancement of Science.

Seasonal influenza kills as many as 650,000 people worldwide, yet the virus is not viewed by many people as a serious disease and therefore industry has lacked the sense of urgency to pursue a better vaccine, Hamburg said.

"We are not mobilizing," she said, adding that industry has gotten complacent and too comfortable with relying on the 70-year-old antiquated egg-based process to make flu vaccines, whose effectiveness varies from year to year.

It is unlikely that flu vaccine makers will "spontaneously change" their processes, since they have been able to make a profit year over year on the egg-based vaccine, said Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases.

Rick Bright, director of the U.S. Biomedical Advanced Research and Development Authority, suggested the poorest performing vaccines on market should be uncloaked, so that Americans know which products are working better than others.

"We're afraid of the truth," Bright said at the Milken summit.

For those who have complained that the costs of developing a more effective flu vaccine could run into the billions, Bright noted that the U.S. could ultimately spend trillions to address the next influenza pandemic.

One of the biggest reasons scientists and industry lack interest in flu vaccine research and development is because "it's just not sexy anymore," Bright said.

The easiest way to generate interest in a research area, Fauci said, is to "put a gown on it," meaning allotting more funding.

"HIV was galvanized when we put a lot of money into it," Fauci said.

The greatest dilemma is that there is no clear global owner of the problem, making progress difficult, said Casey Wright, CEO of the philanthropy Flu Lab.

Drug price debate

The various Capitol Hill proposals aimed at reining in the high prices Americans pay for prescription drugs was another issue panelists at the Milken summit debated.

SNL ImageSen. Bill Cassidy
Source: AP Photo

Sen. Bill Cassidy, R-La., gave drug pricing legislation a 60% chance of being adopted by Congress by the end of the year, though he said he opposed House Speaker Nancy Pelosi's package.

He acknowledged, however, that Senate Majority Leader Mitch McConnell, R-Ky., has made no commitments to bring any of the three bills adopted by the finance, health and judiciary panels to the chamber's floor for a vote.

"The leader is never going to be effusive about very much except Louisville football," Cassidy said.

Dan Leonard, CEO of the National Pharmaceutical Council, argued the sky would not fall if Congress failed to move on drug pricing legislation this year.

But Centers for Medicare and Medicaid Services Administrator Seema Verma said reform on drug pricing was needed now, particularly for the Medicare Part B program, which covers injectable medicines administered in a doctor's office or clinic.

The way the program is set up encourages high-cost drugs, Verma said, adding that reforms would bring more competition to Medicare Part B.

While she said the Trump administration supports negotiations on drug prices, she objected to giving the government the authority to engage in those activities directly with drugmakers, even if that power was granted to her boss, Health and Human Services Secretary Alex Azar.

Verma said she liked the idea of experimenting with paying for medicines based on their outcomes, but she also warned that value-based payments may lead to higher launch prices for new drugs.

Philanthropic drug discovery

Among the other issues discussed at the Milken summit was how philanthropic organizations drive drug discovery for specific diseases.

Nonprofits can look at the ecosystem and see where investment is needed, said Kathy Giusti, founder and chief mission officer of the Multiple Myeloma Research Foundation.

Philanthropic organizations have the ability to take more risk than biopharmaceutical manufacturers because nonprofits are not beholden to shareholders, said Todd Sherer, CEO of the Michael J. Fox Foundation for Parkinson's Research.

One of the unique roles foundations play is being a source of information for the patient community and a galvanizing force for it, Sherer said.

He stressed the importance of "learning about the disease from people with the disease."

The biopharmaceutical industry, Sherer said, cannot engage with the patient community the same way a charity can.