american hospitals have been living with
serious drug shortages for more than a
decade most days nearly 300 essential
drugs can be in short supply
after months of investigation we found
it's not a matter of supply and demand
the drugs are needed and the ingredients
are easy to make
it's that pharmaceutical companies have
stopped producing many life-saving
generic drugs because they make too
little profit
yet year after year the government stays
on the sidelines as companies take drug
production offline and doctors worry the
shortages are compromising patient care
the story will continue in a moment
just normal things that should be
available
but they're not
neonatologist dr mitch goldstein treats
the most vulnerable patients at loma
linda university children's hospital in
california most of these babies would
fit comfortably
in the palm of your hand
struggling to hold on to life they
really are
many of these premature and sick babies
have undeveloped digestive systems so dr
goldstein keeps them alive with
intravenous nutrients many of which are
in short supply it can be certain
minerals it can be certain salts
things that you would ordinarily find
in a college chemistry lab
we can't get
but these are basic these are basic
things
glucose sugar it's not hard to make
but the point is
we can't get it
so then what are your options you don't
have any
you do the best you can
and then if it's something that's an iv
that needs to be compounded anthony
gobin heads the pharmacy at loma linda
hospital
he told us shortages of basic drugs are
a constant worry
help me understand how often
do you face drug shortages every day is
this just another
casualty of kovid
no so we were dealing with shortages
long before kovit they're all
very old fundamental drugs that every
hospital in the country
needs and uses
drug shortages can kill
in 2011 when nor epinephrine an old low
profit drug used to treat septic shock
was in short supply hundreds of people
around the country died
yeah that one's also still a backboard
we can't get it just about every
hospital in the u.s has weekly drug
shortage meetings like this one at loma
linda it's like dextrose dextrose vials
still completely out of the vials we're
using these syringes for everything
during a drug shortage hospitals may be
forced to switch patients to less safe
or effective alternative drugs
they retrieve leftovers from single-dose
drug vials to share with other patients
and avoid wasting a single drop that's
the pharmacist maybe further
concentrating to try to conserve some of
these 100 ml bags you would think to
yourself how hard is it to manufacture
some of these simple meds like dextrose
or sterile water but some of these are
low margin drugs and then because of
that smaller margin you don't have a ton
of manufacturers making the product
sarah carney and cindy valenta were
facing the same wrenching ordeal at loma
linda hospital
both had children undergoing
chemotherapy for aggressive leukemia
just so many different chemos sarah's
son micah was in pre-kindergarten when
he began the painful treatment
he wasn't the same kid several times he
looked at us and said why is this
happening to me what did i do wrong
so much is being thrown at you knew back
then i didn't understand i thought there
was one type of chemo that people took
when they had cancer
i didn't realize there was this whole
road map this regimen we had to follow
they give you a schedule and they
tell you you must stick to that schedule
every function of your life went on this
road map so
if chemo was supposed to be given on day
one and day five whether that was the
holiday or not we had to take john in to
get his infusions
cindy's 13 year old son john gave up
baseball to beat his leukemia
in late 2019 he settled into his usual
chemo chair and got some bad news the
chemo drug vin kristen he'd been using
for more than two years was suddenly
unavailable this was after
the doctors had insisted with you that
you
keep to this schedule
what was john's reaction scared
vincent an essential drug for childhood
leukemia was in short supply nationwide
it's a chief ingredient of a chemo
cocktail that has an 80 to 90 percent
cure rate when sarah learned micah
wouldn't get his treatment she was on
the phone for days calling anyone who
might know how to get the life-saving
drug
other cancer moms the hospital pfizer
the drug maker i honestly didn't even
know who to believe because the
pharmaceutical company is telling me
they have it
and the hospital is telling me we've we
call them every day and they're telling
us they don't have it so
i didn't know what to say
as a cancer mom we shouldn't be fighting
for our children to get a drug that is
needed you know we are fighting every
day to keep their spirits up to
change our whole life to make sure that
they're getting this treatment there's
no other alternative it's just a
gut-wrenching feeling of
just fear and anger
sarah and cindy raised all kinds of
alarms on social media a week later drug
maker pfizer shipped scarce doses of
incristin to loma linda enough for micah
and john to continue their treatments
hi how are you milwaukee pediatric
oncologist cindy schwartz is a committee
chair of the children's oncology group
students it stings yeah a consortium of
cancer researchers and bioethicists from
across the country
these recent shortages have become very
very serious and really hit drugs like
vin kristen that are in every regiment
vin kristen was one of 16 chemo drugs in
short supply last year dr schwartz told
us the shortages are forcing doctors to
ration scarce drugs
does that present you with
some ethical dilemmas
of course it does who wants to be
picking
how you
prioritize one
person over another one child over and
over one child over another
i'm just trying to come up with some
explanation for why a drug that is known
to save lives
is not
valued why it should be a top value
unlike newer brand name drugs that cost
as much as six figures per dose
vincristin a low margin generic drug
around since the 1960s costs about five
dollars per dose
months before the shortage one of the
two remaining vin christian
manufacturers teva pharmaceuticals
announced it would stop making vin
christian for u.s hospitals they
indicated that it was a business
decision they could make more money on
more profitable drugs
than than christine ross day is a former
director of visiant the country's
largest group purchasing organization or
gpo a health services company that
negotiates contracts between hospitals
drug makers and medical suppliers i
don't understand why companies in good
conscience can make those kinds of
decisions none of these companies are
poor companies they have the opportunity
to not make as much on one drug and
still make plenty of margin and profit
on other drugs those kinds of economic
decisions made not because that person
running that business is malicious in
their intent and they are trying to keep
that plan operating we also met with
bill simmons a former high-ranking
generic drug executive you have to keep
in mind that
corporations aren't charities so how
does this work the two former executives
once negotiated drug contracts across
the table from one another they still
have disagreements you've got the
generic drug manufacturers we asked them
to spell out the economics of generic
drug shortages from the manufacturers on
the left here distributor or wholesaler
to the hospitals and patients on the
right then you've got the patient over
here we were hoping a diagram would help
there's a gatekeeper here i'm putting
gpo in it's called a group purchasing
organization and that organization
negotiates prices for the hospital
collectively in an effort to get lower
pricing on products at least that's the
way it's supposed to work and you've got
money going this way they pay it and
then they sell it to the hospital and
then it comes back this way contract
price concept of fee for service a cost
minus why is all of that part of the
process the honest answer to that is
this private label fee for service cost
minus these are things
to create lack of transparency to
pricing but this confusion is
on purpose yeah i want to charge
different prices and not have clarity
around
what people are really paying so far
this is clear as mud but i'm not sure
there are more efficient
ways to administer this supply chain at
least i've not been presented one
there's nothing more efficient than this
but all the arrows and acronyms point to
one thing
a broken system which our investigation
found is a root cause of drug shortages
take the five dollar cancer drug vin
kristen the middlemen the group
purchasing organizations and drug
distributors take their cut for
administrative marketing and other fees
and hospital incentives the drug
manufacturers end up with just a small
fraction of what the patient pays
many have simply stopped making the
least profitable drugs
we are systematically shutting down all
of our us manufacturing because we do
not pay enough money for the drugs to
the manufacturers and not enough money
is paid because of the middlemen i
guarantee you the patients over here
would say i would pay more
if i could be guaranteed i would get
these drugs when i need them bill i
think this person over here might be
willing to pay another 20 bucks but
these people
will absorb a lot of that 20 dollars
before it gets over here group
purchasing organizations control more
than 250 billion dollars in hospital
purchases annually the biggest three
account for about 90 percent of the
business
they typically award the contract to the
manufacturer with the lowest price drug
add in all the complex fees and the
group purchasing organizations grow
wealthier while losing manufacturers are
squeezed out if you refuse to sell
through group purchasing organization or
through drug wholesalers
you will not exist you're out you are
out it's not a gpo's best interest at
all to drive anybody out of the market
i've attributed more of the drug
shortage problem to some decisions by
fda to start evaluating
manufacturers differently than they had
in the past the fda to improve patient
safety raised the bar on quality
controls at drug plants several were
shut down the fda wants higher quality
products that cost more money to make
and the gpos want to drive the price
down to whoever will supply them the
lowest price which is usually people who
are not investing in equipment not
investing in quality and those two
things don't go together
in july 2019 when teva pharmaceuticals
stopped making vin christian for lack of
profit pfizer's generic division haspira
became the sole supplier
in a letter to the fda we obtained
pfizer called the situation untenable
two months later a quality control issue
forced pfizer to suspend production for
six weeks which is not uncommon in drug
manufacturing when you're down to just a
couple of manufacturers and one
is found to have
quality control problems
where do you go there's no plan b there
is no plan b
forty percent of generic drugs now have
just one manufacturer
i think the government could play a role
in keeping some of these drug
manufacturers viable
because this is just as much of an
emergency in my mind
as the pandemic is but i'm not ready to
say the current model is ready to blow
up
maybe tweak
back at loma linda i think about the
babies i take care of
dr mitch goldstein like doctors all
across the country is bracing for more
shortages it's horrible and it's like
being in a siege and you're you're
running out of ammunition
sometimes we look at it and it's just
how are we going to survive this next
day
the day after
and what is the new problem
what's on the horizon what's going to
happen next week