For
years, hospital executives have expressed frustration when essential
drugs like heart medicines have become scarce, or when prices have
skyrocketed because investors manipulated the market.
Now,
some of the country’s largest hospital systems are taking an aggressive
step to combat the problem: They plan to go into the drug business
themselves, in a move that appears to be the first on this scale.
“This
is a shot across the bow of the bad guys,” said Dr. Marc Harrison, the
chief executive of Intermountain Healthcare, the nonprofit Salt Lake
City hospital group that is spearheading the effort. “We are not going
to lay down. We are going to go ahead and try and fix it.”
While
Intermountain executives would not name the drugs they intend to make,
hospitals have long experienced shortages of drugs like morphine or
encountered sudden price increases for old, off-patent products like the
heart medicine Nitropress. Hospitals have also come under criticism for
overcharging for their services, including for some drugs.
Several
major hospital systems, including Ascension, a Catholic system that is
the nation’s largest nonprofit hospital group, plan to form a new
nonprofit company, that will provide a number of generic drugs to the
hospitals. The Department of Veterans Affairs is also expressing
interest in participating.
In all, about 300 hospitals are now included in the group. Other hospitals are expected to join.
Dr.
Harrison said they planned to focus only on certain drugs. “There are
individual places where there are problems,” he said. “We are not
indicting an entire industry.”
Dr.
Kevin A. Schulman, a professor of medicine at the Duke University
School of Medicine who has studied the generic drug market and is
advising the effort, said: “If they all agree to buy enough to sustain
this effort, you will have a huge threat to people that are trying to
manipulate the generic drug market. They will want to think twice.”
The
idea is to directly challenge the host of industry players who have
capitalized on certain markets, buying up monopolies of old, off-patent
drugs and then sharply raising prices, stoking public outrage and
prompting a series of Congressional hearings and federal investigations.
The most notorious example is of Martin Shkreli, the former hedge fund
manager who raised the price of a decades-old drug, Daraprim, to $750 a tablet in 2015, from $13.50.
Hospitals have also struggled to deal with shortages of hundreds of vital drugs over the past decade, ranging from injectable morphine to sodium bicarbonate (the medical form of baking soda), shortfalls that are exacerbated when only one or two manufacturers make the product.
“We’re
seeing an acceleration of both shortages and escalation of prices,”
said Dr. Richard Gilfillan, the chief executive of Trinity Health, a
large Catholic system that operates in nearly two dozen states and is
part of the group. “There’s not been any effective push back on either
of these.”
Intermountain
executives would not discuss many details of the project, citing fears
that competitors could shut them out of the market by quickly dropping
the price of the drugs in question, then raising them again later. They
said they would focus on drugs whose prices have risen sharply or that
have been in short supply.
“We’re
going to have to hold that very close to our vest,” Dr. Harrison said.
The company will either rely on third-party manufacturers or decide to
make the drugs themselves.
The
new company will initially focus on selling to hospitals, but officials
said they may eventually expand to offer the products more broadly.
Dr.
Carolyn Clancy, the executive in charge of the Veterans Health
Administration, said its pharmacy experts have consulted with the other
systems about the project and is now working out the details of its
possible involvement. “Our strong interest here is minimizing the impact
of any shortages of generic drugs,” she said. While she said the agency
is able to negotiate good prices for veterans, “we don’t necessarily
control supply” and have experienced many of the same shortages,
including the recent lack of saline fluids, as the other health groups.
“We are constantly scanning the horizon and constantly attentive to interruptions of supply chains of medicines,” she said.
In
addition to Daraprim, several old, off-patent drugs have seen sharp
price increases over the past several years. In 2015, Valeant
Pharmaceuticals International became a Wall Street darling after it sold
investors on its business model of buying up old drugs,
then raising the prices precipitously. That year, it sharply raised the
prices of two heart drugs, Nitropress and Isuprel, adding millions to
hospitals’ drug bills almost overnight. Valeant’s practices led to a
series of investigations and Congressional hearings as well as a shake-up of the company’s leadership.
Representatives
for the generic drug industry have noted that many of the most
high-profile cases have involved old, off-patent drugs for which there
has been no generic competition.
The
trade group for generic manufacturers, the Association for Accessible
Medicines, said its members generally welcome competition. “The whole
generic industry is premised on competition, and that competition brings
dramatic savings for patients,” said Allen Goldberg, a spokesman for
the group.
But generic drug makers have also come under scrutiny.
The hike in the price of doxycycline hyclate,
an antibiotic, which increased to $3.65 a pill in 2013 from 5.6 cents
in 2012, led to a congressional investigation as well as state and federal price-fixing inquiries into some of the industry’s biggest players. Last fall, a coalition of state attorneys general broadened a lawsuit over price fixing, accusing 18 companies of engaging in illegal practices involving 15 drugs.
Anthony
R. Tersigni, the chief executive of Ascension, said he and other
hospital executives felt they had little choice but to try to solve the
problem themselves. “We took the position collectively rather than
waiting and hoping for the generic drug companies to address it,” he
said. “We have to address it head on.”
Intermountain executives said that they would seek approval to manufacture the products from the Food and Drug Administration, which has vowed to give priority to companies that want to make generics in markets for which there is little competition.
The
project boasts a high-profile list of advisers, ranging from Bob
Kerrey, the former Democratic senator of Nebraska, to Dr. Donald
Berwick, a former administrator for the Centers of Medicare and Medicaid
Services, as well as two former executives with Amgen, the drug
manufacturer.
Erin
Fox, a drug shortage expert at the University of Utah, said the idea of
creating a nonprofit drug company is promising. “I think anything that
increases the number of suppliers will help,” she said. She added that
the trick will be in selecting the right third-party manufacturer to
ensure good quality.
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