Drug Shortages Near an All-Time High, Leading to Rationing
Written by: The New York Times
Original Article
Thousands of patients are facing delays in getting treatments for cancer and
other life-threatening diseases, with drug shortages in the United States
approaching record levels.
Hospitals are scouring shelves for supplies of a drug that reverses lead
poisoning and for a sterile fluid needed to stop the heart for bypass surgery.
Some antibiotics are still scarce following the winter flu season when doctors
and patients frantically chased medicines for ailments like strep throat.
Even children’s Tylenol was hard to find.
Hundreds of drugs are on the list of medications in short supply in the
United States, as officials grapple with an opaque and sometimes
interrupted supply chain, quality and financial issues that are leading to
manufacturing shutdowns.
The shortages are so acute that they are commanding the attention of the
White House and Congress, which are examining the underlying causes of
the faltering generic drug market, which accounts for about 90 percent of
domestic prescriptions.
Story continues below advertisement
The Biden administration has assembled a team to find long-term solutions
for shoring up the pharmaceutical supply chain, at a time when the United
States remains heavily reliant on medicines and drug ingredients from India
and China. And in recent weeks, generic drug makers, supply-chain experts
and patient advocates have appeared before lawmakers to discuss the
problems.
The scarcity of generic forms of chemotherapy to treat lung, breast, bladder
and ovarian cancers has only heightened concerns. “This is, in my opinion, a public health emergency,” said Dr. Amanda Fader, a
professor at the Johns Hopkins School of Medicine and a president-elect of
the Society of Gynecologic Oncology, “because of the breadth of the
individuals it affects and the number of chemotherapy agents that are in
shortage right now.”
The American Cancer Society last week warned that delays caused by the
shortages could result in worse outcomes for patients.
“If these drugs are not available, people are going to get inferior care,” Dr.
William Dahut, the society’s chief medical officer, said. “That’s the bottom
line. These aren’t third- or fourth-line drugs where there are multiple other
agents around. These are used up front for people you are trying to cure.”
Story continues below advertisement
Ryan Dwars beat pancreatic cancer in 2021, but late last year a scan showed
cancerous spots on his liver. Mr. Dwars, 39 and a father of two young
children, had hoped to receive his final four doses of chemotherapy in April.
New Developments in Cancer Research
Progress in the field. In recent years, advancements in research have
changed the way cancer is treated. Here are some recent updates:
Cancer vaccines. A pancreatic cancer vaccine provoked an immune
response in half of the patients treated in a small trial, a finding that experts
described as very promising. The study was a landmark in the movement to
make cancer vaccines tailored to the tumors of individual patients.
Ovarian cancer. Building on evidence that ovarian cancer most often
originates in the fallopian tubes, not the ovaries, the Ovarian Cancer
Research Alliance is urging even women who do not have a genetically-high
risk for ovarian cancer — that is, most women — to have their fallopian tubes
surgically removed if they are finished having children and are planning a gynecologic operation anyway.
Rectal cancer. A small trial that saw 18 rectal cancer patients taking the
same drug, dostarlimab, appears to have produced an astonishing result:
The cancer vanished in every single participant. Experts believe that this
study is the first in history to have achieved such results.
Then his doctor delivered stunning news: He didn’t make the cut of those
given priority for the treatment.
“The light at the end of the tunnel was within sight,” Mr. Dwars, a special
education teacher in Iowa City, said. “It made it even worse to be so close —
and now this.”
Laura Bray, who founded a nonprofit called Angels for Change, works as a
liaison among patients, health systems and drug companies to “micro-
source,” as she calls it, hard-to-find medications.
Dr. Robert Califf, the F.D.A. commissioner, said the agency had prevented a number of drug shortages. “Our
employees can only plug a certain number of holes in a system which has got real problems,” he said.Julia
Nikhinson/Reuters
“Will we have the resolve and sense of urgency to fix this?’’ asked Ms. Bray,
an adjunct business professor who has been providing information to the
White House and Congress. “It’s possible. It can be done. It happens in other
supply chains. But we have to focus on it and we have to think about ending
it — instead of mitigating it. I think the jury’s out on that.”
Story continues below advertisement
For Mr. Dwars, Ms. Bray contacted a maker of cisplatin, the chemo drug he
needed and arranged for a supply to be sent within days and for others at his
hospital. Some in states around the country have not been as fortunate,
encountering frightening gaps between treatments. The White House team working on the broader issue of longstanding drug
supply breakdowns includes national security, economic and health officials,
according to James McKinney, a spokesman for the Food and Drug
Administration. Bloomberg reported earlier on the White House involvement.
Officials have been debating possible measures like tax incentives for
generic drugmakers and greater transparency around generic drug quality.
The current incentives favor drugmakers with the lowest prices, which
includes those that might cut corners — leading to disruptive plant
shutdowns if the F.D.A. demands a fix. (Some shortages, like those of
weight-loss drugs, are the result of sky-high demand, while others have
been attributed to overprescribing, including for antibiotics, or a lack of
investment in potential alternatives.)
The F.D.A., which employs a team of about 10 people who do the day-to-day
work of mitigating and reporting drug shortages, has said it is seeking
authority from Congress to get additional information about the drug
manufacturing and supply chain.
Story continues below advertisement
But the agency has also expressed its concerns to the White House about
severe financial strain in the generic drug industry — an economic problem
that F.D.A. officials say they are not suited to address.
Dr. Robert Califf, the F.D.A. commissioner, highlighted the agency’s views
during recent appearances before Congress, saying officials can only plug
so many holes.
“We have got to fix the core economics if we’re going to get this situation
fixed,” Dr. Califf told a House panel on May 11.
David Gaugh, the interim chief executive of the Association for Accessible
Medicines, which represents generic drugmakers, recalled warning F.D.A. officials in an April meeting that the recent bankruptcy and shutdown of
Akorn Pharmaceuticals would likely be followed by others.
“Shortages are on the rise. We’ve all seen that,” Mr. Gaugh said in an
interview. “And it is likely going to get worse, not better, very soon.”
Story continues below advertisement
Mr. Gaugh cited data underscoring pressure facing the generic industry.
Although the number of generic drugmakers has increased, a review by
IQVIA, a health care analytics company, showed that the market has
consolidated such that three buyers account for about 90 percent of generic
drug purchases. The intermediaries are combined major drug distributors
and retail chains, like Red Oak Sourcing, which includes CVS Health and
Cardinal Health and ClarusONE, which includes Walmart and McKesson.
Walgreens also has distribution agreements with AmerisourceBergen. The
companies did not reply to requests for comment.
The competition for the contracts with those intermediaries pits U.S.
manufacturers against those in India, where labor costs are far lower. When a
generic drug company can’t get a contract for a medication, it tends to stop
making it and might see already-slim profits shrink.
“The opportunity to get it wrong is much narrower if you’re a generic
manufacturer,” Mr. Gaugh said.
Hospital pharmacists and supply-chain experts were stunned in February by
the abrupt shutdown of Akorn, whose products were then recalled since
there was no staff remaining to address potential quality concerns.
That added “insult to injury,” said Eric Tichy, a supply chain division chair at
the Mayo Clinic and the board chairman of the End Drug Shortages Alliance.
Story continues below advertisement Akorn made roughly 100 medications, including cylinders of albuterol that
children’s hospitals had relied on to ease their breathing difficulties. And it
was the only company that made an antidote to lead poisoning, Dr. Tichy
said.
“Health is so foundational to our country functioning well,” Dr. Tichy said.
“And then we have a domestic manufacturer that just goes under and there’s
not a lot of action.”
A respiratory therapist held a nebulizer with albuterol, one of the drugs manufactured by the shuttered
pharmaceutical company Akorn, at a hospital in New Orleans.Erin Schaff/The New York Times
Four Senate bills with bipartisan sponsorship could help get generic drugs to
market more quickly by addressing tactics or loopholes that cause delays.
During a House hearing on the shortages Thursday, Anthony Sardella, a
business research adviser at Washington University in St. Louis, said generic
drug prices had fallen by about 50 percent since 2016.
“But there is a high cost to low prices,” Mr. Sardella said, noting that they
may lead to cost cutting that can result in quality problems.
Story continues below advertisement
A recent case in point was Intas Pharmaceuticals, a company in India that
makes three key chemotherapy drugs that are difficult to find: methotrexate,
carboplatin and cisplatin, the drug Mr. Dwars needed. Intas temporarily
suspended manufacturing of the drugs after the F.D.A. found serious
quality-control violations.
During an unannounced visit to the Intas plant, F.D.A. inspectors discovered
a “truck full of” hundreds of plastic bags filled with torn and shredded
documents, according to a report issued in December. One quality-control
worker poured acid on torn records and stuffed them in a garbage bag, the
report said. F.D.A. inspectors pieced papers together and found quality control records
for products bound for the United States, the report said. The agency cited a
raft of other problems as well.
To ease the supply disruption, the U.S. distributor for Intas, Accord
Pharmaceuticals, said a handful of lots were tested by a third party, certified
and released to the U.S. market. The treatments arranged by Ms. Bray that
reached patients in Iowa were among them.
The companies were working with the F.D.A. to restart manufacturing for
U.S. customers, a statement from Accord said, adding that it found the
shredding to be an “isolated incident.”
Story continues below advertisement
The Society of Gynecologic Oncology sent out a nationwide survey in recent
weeks. In response, doctors in 35 states said they had little to no supply of
key chemotherapy drugs, even at large cancer centers and teaching
hospitals.
Dr. Patrick Timmins, a partner of Women’s Cancer Care Associates in Albany,
N.Y., said his practice ran out of some chemotherapy drugs on May 9, but
still has 25 patients who need them.
“Our patients are in a war, and what we’re doing is we’re taking their
weapons away,” Dr. Timmins said. “It’s completely ridiculous that we can’t
figure out a way, at least in the short run, to get our patients treated, and in
the long run to solve these recurring problems.”
When Ms. Bray met with White House staff members in late April, she said
that she recommended creating an exchange, to get drugs where they were
needed most, and increasing the production of small-batch medicines, often
referred to as compounding.
Dr. Kevin Schulman, a professor at Stanford Medicine who has studied the generic drug industry, said he had urged the White House team to examine
how much power the intermediary companies have in contracting with
generic drug makers. He said they demand rock-bottom prices, but unlike a
customer-facing company like Apple that contracts with suppliers
worldwide, the drug intermediaries face no accountability when shortages
arise.
Story continues below advertisement
Dr. Schulman said he had recommended expanded government contracting
with the nonprofit Civica, which sells generic drugs at slightly inflated prices,
which can help generic makers run a stable business.
“The intermediaries are driving people out of the market,” Dr. Schulman said.
“I think it’s a market problem and we need market-level solutions.”
other life-threatening diseases, with drug shortages in the United States
approaching record levels.
Hospitals are scouring shelves for supplies of a drug that reverses lead
poisoning and for a sterile fluid needed to stop the heart for bypass surgery.
Some antibiotics are still scarce following the winter flu season when doctors
and patients frantically chased medicines for ailments like strep throat.
Even children’s Tylenol was hard to find.
Hundreds of drugs are on the list of medications in short supply in the
United States, as officials grapple with an opaque and sometimes
interrupted supply chain, quality and financial issues that are leading to
manufacturing shutdowns.
The shortages are so acute that they are commanding the attention of the
White House and Congress, which are examining the underlying causes of
the faltering generic drug market, which accounts for about 90 percent of
domestic prescriptions.
Story continues below advertisement
The Biden administration has assembled a team to find long-term solutions
for shoring up the pharmaceutical supply chain, at a time when the United
States remains heavily reliant on medicines and drug ingredients from India
and China. And in recent weeks, generic drug makers, supply-chain experts
and patient advocates have appeared before lawmakers to discuss the
problems.
The scarcity of generic forms of chemotherapy to treat lung, breast, bladder
and ovarian cancers has only heightened concerns.
professor at the Johns Hopkins School of Medicine and a president-elect of
the Society of Gynecologic Oncology, “because of the breadth of the
individuals it affects and the number of chemotherapy agents that are in
shortage right now.”
The American Cancer Society last week warned that delays caused by the
shortages could result in worse outcomes for patients.
“If these drugs are not available, people are going to get inferior care,” Dr.
William Dahut, the society’s chief medical officer, said. “That’s the bottom
line. These aren’t third- or fourth-line drugs where there are multiple other
agents around. These are used up front for people you are trying to cure.”
Story continues below advertisement
Ryan Dwars beat pancreatic cancer in 2021, but late last year a scan showed
cancerous spots on his liver. Mr. Dwars, 39 and a father of two young
children, had hoped to receive his final four doses of chemotherapy in April.
New Developments in Cancer Research
Progress in the field. In recent years, advancements in research have
changed the way cancer is treated. Here are some recent updates:
Cancer vaccines. A pancreatic cancer vaccine provoked an immune
response in half of the patients treated in a small trial, a finding that experts
described as very promising. The study was a landmark in the movement to
make cancer vaccines tailored to the tumors of individual patients.
Ovarian cancer. Building on evidence that ovarian cancer most often
originates in the fallopian tubes, not the ovaries, the Ovarian Cancer
Research Alliance is urging even women who do not have a genetically-high
risk for ovarian cancer — that is, most women — to have their fallopian tubes
surgically removed if they are finished having children and are planning a
Rectal cancer. A small trial that saw 18 rectal cancer patients taking the
same drug, dostarlimab, appears to have produced an astonishing result:
The cancer vanished in every single participant. Experts believe that this
study is the first in history to have achieved such results.
Then his doctor delivered stunning news: He didn’t make the cut of those
given priority for the treatment.
“The light at the end of the tunnel was within sight,” Mr. Dwars, a special
education teacher in Iowa City, said. “It made it even worse to be so close —
and now this.”
Laura Bray, who founded a nonprofit called Angels for Change, works as a
liaison among patients, health systems and drug companies to “micro-
source,” as she calls it, hard-to-find medications.
Dr. Robert Califf, the F.D.A. commissioner, said the agency had prevented a number of drug shortages. “Our
employees can only plug a certain number of holes in a system which has got real problems,” he said.Julia
Nikhinson/Reuters
“Will we have the resolve and sense of urgency to fix this?’’ asked Ms. Bray,
an adjunct business professor who has been providing information to the
White House and Congress. “It’s possible. It can be done. It happens in other
supply chains. But we have to focus on it and we have to think about ending
it — instead of mitigating it. I think the jury’s out on that.”
Story continues below advertisement
For Mr. Dwars, Ms. Bray contacted a maker of cisplatin, the chemo drug he
needed and arranged for a supply to be sent within days and for others at his
hospital. Some in states around the country have not been as fortunate,
encountering frightening gaps between treatments.
supply breakdowns includes national security, economic and health officials,
according to James McKinney, a spokesman for the Food and Drug
Administration. Bloomberg reported earlier on the White House involvement.
Officials have been debating possible measures like tax incentives for
generic drugmakers and greater transparency around generic drug quality.
The current incentives favor drugmakers with the lowest prices, which
includes those that might cut corners — leading to disruptive plant
shutdowns if the F.D.A. demands a fix. (Some shortages, like those of
weight-loss drugs, are the result of sky-high demand, while others have
been attributed to overprescribing, including for antibiotics, or a lack of
investment in potential alternatives.)
The F.D.A., which employs a team of about 10 people who do the day-to-day
work of mitigating and reporting drug shortages, has said it is seeking
authority from Congress to get additional information about the drug
manufacturing and supply chain.
Story continues below advertisement
But the agency has also expressed its concerns to the White House about
severe financial strain in the generic drug industry — an economic problem
that F.D.A. officials say they are not suited to address.
Dr. Robert Califf, the F.D.A. commissioner, highlighted the agency’s views
during recent appearances before Congress, saying officials can only plug
so many holes.
“We have got to fix the core economics if we’re going to get this situation
fixed,” Dr. Califf told a House panel on May 11.
David Gaugh, the interim chief executive of the Association for Accessible
Medicines, which represents generic drugmakers, recalled warning F.D.A.
Akorn Pharmaceuticals would likely be followed by others.
“Shortages are on the rise. We’ve all seen that,” Mr. Gaugh said in an
interview. “And it is likely going to get worse, not better, very soon.”
Story continues below advertisement
Mr. Gaugh cited data underscoring pressure facing the generic industry.
Although the number of generic drugmakers has increased, a review by
IQVIA, a health care analytics company, showed that the market has
consolidated such that three buyers account for about 90 percent of generic
drug purchases. The intermediaries are combined major drug distributors
and retail chains, like Red Oak Sourcing, which includes CVS Health and
Cardinal Health and ClarusONE, which includes Walmart and McKesson.
Walgreens also has distribution agreements with AmerisourceBergen. The
companies did not reply to requests for comment.
The competition for the contracts with those intermediaries pits U.S.
manufacturers against those in India, where labor costs are far lower. When a
generic drug company can’t get a contract for a medication, it tends to stop
making it and might see already-slim profits shrink.
“The opportunity to get it wrong is much narrower if you’re a generic
manufacturer,” Mr. Gaugh said.
Hospital pharmacists and supply-chain experts were stunned in February by
the abrupt shutdown of Akorn, whose products were then recalled since
there was no staff remaining to address potential quality concerns.
That added “insult to injury,” said Eric Tichy, a supply chain division chair at
the Mayo Clinic and the board chairman of the End Drug Shortages Alliance.
Story continues below advertisement
children’s hospitals had relied on to ease their breathing difficulties. And it
was the only company that made an antidote to lead poisoning, Dr. Tichy
said.
“Health is so foundational to our country functioning well,” Dr. Tichy said.
“And then we have a domestic manufacturer that just goes under and there’s
not a lot of action.”
A respiratory therapist held a nebulizer with albuterol, one of the drugs manufactured by the shuttered
pharmaceutical company Akorn, at a hospital in New Orleans.Erin Schaff/The New York Times
Four Senate bills with bipartisan sponsorship could help get generic drugs to
market more quickly by addressing tactics or loopholes that cause delays.
During a House hearing on the shortages Thursday, Anthony Sardella, a
business research adviser at Washington University in St. Louis, said generic
drug prices had fallen by about 50 percent since 2016.
“But there is a high cost to low prices,” Mr. Sardella said, noting that they
may lead to cost cutting that can result in quality problems.
Story continues below advertisement
A recent case in point was Intas Pharmaceuticals, a company in India that
makes three key chemotherapy drugs that are difficult to find: methotrexate,
carboplatin and cisplatin, the drug Mr. Dwars needed. Intas temporarily
suspended manufacturing of the drugs after the F.D.A. found serious
quality-control violations.
During an unannounced visit to the Intas plant, F.D.A. inspectors discovered
a “truck full of” hundreds of plastic bags filled with torn and shredded
documents, according to a report issued in December. One quality-control
worker poured acid on torn records and stuffed them in a garbage bag, the
report said.
for products bound for the United States, the report said. The agency cited a
raft of other problems as well.
To ease the supply disruption, the U.S. distributor for Intas, Accord
Pharmaceuticals, said a handful of lots were tested by a third party, certified
and released to the U.S. market. The treatments arranged by Ms. Bray that
reached patients in Iowa were among them.
The companies were working with the F.D.A. to restart manufacturing for
U.S. customers, a statement from Accord said, adding that it found the
shredding to be an “isolated incident.”
Story continues below advertisement
The Society of Gynecologic Oncology sent out a nationwide survey in recent
weeks. In response, doctors in 35 states said they had little to no supply of
key chemotherapy drugs, even at large cancer centers and teaching
hospitals.
Dr. Patrick Timmins, a partner of Women’s Cancer Care Associates in Albany,
N.Y., said his practice ran out of some chemotherapy drugs on May 9, but
still has 25 patients who need them.
“Our patients are in a war, and what we’re doing is we’re taking their
weapons away,” Dr. Timmins said. “It’s completely ridiculous that we can’t
figure out a way, at least in the short run, to get our patients treated, and in
the long run to solve these recurring problems.”
When Ms. Bray met with White House staff members in late April, she said
that she recommended creating an exchange, to get drugs where they were
needed most, and increasing the production of small-batch medicines, often
referred to as compounding.
Dr. Kevin Schulman, a professor at Stanford Medicine who has studied the
how much power the intermediary companies have in contracting with
generic drug makers. He said they demand rock-bottom prices, but unlike a
customer-facing company like Apple that contracts with suppliers
worldwide, the drug intermediaries face no accountability when shortages
arise.
Story continues below advertisement
Dr. Schulman said he had recommended expanded government contracting
with the nonprofit Civica, which sells generic drugs at slightly inflated prices,
which can help generic makers run a stable business.
“The intermediaries are driving people out of the market,” Dr. Schulman said.
“I think it’s a market problem and we need market-level solutions.”
Written by: The New York Times
Original Article