Big Pharma May Pose an Obstacle to Vaccine Development
Concerns
about profits and liability have often kept them from moving quickly enough.
By Gerald Posner
Mr.
Posner is the author of the forthcoming “Pharma: Greed, Lies and the Poisoning
of America.”
·
March 2, 2020
·
As the danger of the coronavirus grew
worldwide, threatening to spread in the United States, the Centers for Disease
Control and Prevention warned on
Tuesday that, “It’s not so much a question of if this will happen anymore but
rather more a question of exactly when this will happen and how many people in
this country will have severe illness.”
Crash efforts are underway for a
vaccine. Anthony Fauci, the National Institutes of Health’s director for
infectious diseases, said that if
one is ready to be deployed in a year, it “would be the world’s record.” Faster
than that would mean, says Dr. Fauci, “cutting dangerous corners.”
Dr. Fauci and officials at other
government and international health organizations know that any vaccine
developed in a lab will ultimately be manufactured by large pharmaceutical
firms. At this critical juncture with coronavirus, no health expert would
publicly criticize drug companies, but privately they complain that pharma is a
major speed bump in developing lifesaving vaccines.
Pharmaceutical
industry concerns about profits, as well as potential liability for adverse
reactions to the inoculation, often keep them from moving quickly enough to
develop or distribute effective vaccines when there emerges a novel virus, like
the one that has set off the Covid-19 outbreak.
That was undoubtedly the case the last
time Congress approved a national vaccination program in 1976 for swine flu,
when 45 million Americans were
inoculated. For several months, four drug firms — Merck’s Sharp &
Dohme, Merrell, Wyeth, and Parke-Davis — refused to sell to the government the
100 million doses they had manufactured until they got full liability indemnity
and a guaranteed profit.
The federal government feared the
consequences of delaying the inoculations for a pathogen that was a close
variant of the one responsible for history’s most deadly pandemic in 1918. It
finally assumed full responsibility in case the vaccine caused any injuries or
deaths. It also authorized the drug firms to earn a “reasonable profit.”
While the four pharmaceutical companies
got millions, the Department of Justice ultimately had to assign 10 attorneys
to defend full time more than 4,000 legal claims for damages from
Guillain-Barré, a rare but serious disorder in which the immune system assaults
healthy nerve cells. Taxpayer-funded settlements and judgments eventually
topped $100 million.
The chilling effect of that tsunami of
litigation inhibited the federal government from underwriting any mass
immunizations in subsequent decades. There was no national program in 2009
when a novel influenza-A virus became
a pandemic and infected an estimated 60
million Americans and killed 12,469. Instead, the Food and Drug
Administration approved four vaccines that were biological cousins of existing
flu inoculations. They were widely distributed to those groups most at risk,
but were less effective for adults than for children.
Since
then, the United States and its European allies have relied on an array of
public and private entities, including nongovernmental organizations, academia,
philanthropies, and the drug industry to respond to outbreaks of dangerous
pathogens. When Ebola emerged in West Africa in 2014-15, the slow response and
wasted resources were attributed to a lack of international coordination.
In 2017, a new organization was started to
change the way the world researched and developed vaccines to combat new
infectious diseases. It is the Coalition of Epidemic Preparedness Innovations
(CEPI), a Norway-based public-private partnership whose slogan is “New Vaccines
for a Safer World.” The World Health Organization had a list of pathogens for
which it wanted vaccines developed, but pharmaceutical companies had
shown little interest since the outbreaks were in Africa and
Asia, where they had concluded the financial returns were too small to justify
any investment.
Before Covid-19 was identified last
December, CEPI had raised three-fourths of the $1 billion it determined was
necessary to fund the innovative research for expedited development of vaccines
to treat new epidemics. Japan, Germany, Canada, Australia and Norway, as well
as the Wellcome Trust and the Bill & Melinda Gates Foundation, had given $460 million. In the last two years, CEPI has used that
money to provide grants for some leading edge biotechnologies that
could revolutionize vaccine research and production.
But what has played mostly out of
public view over that same time was the organization’s failed effort to get
large pharmaceutical firms to agree to be partners without insisting on
substantial profits or proprietary rights to research that CEPI helped to
finance and produce. That did not surprise many industry observers who knew
that since the 1930s, the National Institutes of Health had spent over $900
billion on grants that drug firms relied on to patent brand-name medications.
Médecins Sans Frontières (Doctors
Without Borders) encouraged a policy by which all countries would have equal and affordable access to
CEPI-funded vaccines. The organization initially embraced those
principles in a detailed policy paper in which it agreed to set prices to
insure “equitable access” during a pandemic. Drug firms would have to share all
vaccine research data. Contracts for manufacturing vaccines would be submitted
first to a public review board. And CEPI retained the right to access
intellectual property that companies developed with CEPI funding, even if they
left the program.
Drug companies on CEPI’s scientific
advisory panel, including Johnson & Johnson, Pfizer, and Japan’s Takeda,
pushed back. CEPI mostly capitulated in a December 2018 two-page declaration in
which it jettisoned specifics but gave lip service to its founding mission of
“equitable access to these vaccines for affected populations during outbreaks.”
Last March, Doctors Without Borders
wrote an open letter expressing
its “concern and disappointment” about CEPI’s “vague, toothless and weak new
policy.” It also concluded that CEPI had taken “an alarming step backwards.
…the revised policy marks a concerning pivot away from CEPI’s early commitments
to access, transparency and openness, and to breaking new grounds in terms of
public responsibility. It betrays the interests of everyone who invested in
CEPI because they wanted to change the deadly status quo.”
Covid-19
is the ultimate test case for whether drug firms might at last become full
partners in a public-private partnership to develop as quickly as possible a
vaccine that could save an untold number of lives.
“What matters more to the drug
companies?” an infectious disease researcher involved in vaccine development
said to me last week. “Keeping trade secrets and boosting the bottom line or
taking a leading role in stemming the Covid-19 outbreak?”
How that is answered in the coming
weeks might well determine how science and medicine deal not only with the
looming pandemic but with future supergerm and viral pandemics that
scientists consider inevitable.
Mr. Posner (@geraldposner) is the author of the forthcoming
“Pharma: Greed, Lies and the Poisoning of America.”