[Ip-health] Foreign Affairs Article on Insulin Pricing and Diabetes Patient Advocates

Fran Quigley fwquigley at gmail.com
Mon Mar 13 11:18:12 PDT 2017

Article in Foreign Affairs up today on the global insulin pricing crisis and
a type 1 diabetes patient group with a principled (refuses pharma $) and
passionate approach:


ordable?cid=int-lea&pgtype=hpg> &pgtype=hpg 




James Elliott is convinced that the statistics describing the prevalence of
type 1 diabetes are misleading. “People say that there is little or no type
1 diabetes in poor countries,” he says. “But that is because all of the
people who had it are dead.” 


Elliott, a health researcher working with Doctors Without Borders/Médecins
Sans Frontières and other organizations, has type 1 diabetes himself. As a
volunteer advocate with the diabetes patient organization
<https://www.t1international.com/> T1International, he and his colleagues
confront the often-fatal problems caused by the price of insulin and other
diabetes supplies. Elliott’s work recently took him to Cameroon, where a
physician shared the story of a young patient’s father happily delivering
news. “Did you hear?” the father said with a smile. “Isabelle died!” He was
referring to his diabetic daughter (the name here is a pseudonym). The
family had struggled to pay for her insulin and equipment such as syringes
and blood sugar test strips. Uneven access to the medicine had often left
the young girl quite ill, and its cost when it was purchased had plunged the
family into financial distress. “Now we are all able to eat enough,” the
father said. “And the other children can get an education.”


Mbolonzi Mbaluka understands. A Kenyan living with type 1 diabetes, he has
had to skip insulin injections, sometimes because he could not afford the
cost and sometimes because local hospitals ran out of stock. A fellow Kenyan
patient recently died after going two months without insulin, which in many
countries can cost up to 50 percent or more of the average income. For
example, in Brazil, insulin and supplies can cost over 80% of an average
income. “The insulin and the equipment together are just not affordable for
many,” Mbaluka says.


Insulin is a pancreas-created hormone that allows the body to absorb and
deploy sugar from consumed food. For people with type 2 diabetes, the
pancreas struggles to keep up with the body’s insulin demand, either because
the pancreas is not producing enough or because the body has developed
insulin resistance. For persons with type 1 diabetes, their body’s immune
system has damaged or destroyed the insulin-producing cells in the pancreas.
A lack of insulin causes blood sugar levels to rise, damaging the heart,
kidneys, eyes, and nerves. Over 400 million people globally have diabetes.
Lack of widespread testing makes it hard to apportion the percentages
between type 1 and type 2, but the majority of those people have type 2
diabetes,   According to some estimates, half of those who need insulin
cannot reliably get access to it.  People with type 2 diabetes often need to
take insulin shots on a temporary or permanent basis. For people with type 1
diabetes, the equation is much more uniform, and more stark: they must
inject insulin in order to stay alive.


The discovery of insulin in the 1920s by a University of Toronto research
team is one of history’s great pharmaceutical success stories. Orthopedic
surgeon Frederick Banting and medical student Charles Best were able to
extract insulin from an animal pancreas and inject it into a diabetic human,
a groundbreaking advancement that earned Banting the Nobel Prize. Suddenly,
a fatal disease became a survivable, chronic condition—as long as the
insulin was available to the patient. 


The researchers were ideologically opposed to monopoly patenting of
biomedical discoveries, but they were eager to see that wide distribution
begin as soon as possible. And so, the researchers took out a patent for
insulin, which they promptly sold to the university for $1 each. The plan
was for the university to partner with pharmaceutical companies that were
prepared to mass produce and distribute insulin. (A few decades later, Jonas
Salk would famously refuse to patent the polio vaccine.)


For a while, the plan worked. Insulin became widely available and affordably
priced. It was even improved upon.  Innovations reduced the frequency of
needed injections. Soon, the first human insulin and then synthetic insulin,
known as analogues, replaced the original animal-extracted version. Yet
those changes also caused problems. Each improvement allowed for
corporations to take out their own patents on the new versions, and the
price began to increase. The far-cheaper former versions of insulin, which
experts generally agree were not significantly less effective than the
enhanced iterations, disappeared from the market. 


Although the changes in insulin over the years have brought some benefits to
patients, some experts say that the insulin producers’ tactics have
corrupted the original public health vision of the medicine’s inventors. “I
don’t think it takes a cynic such as myself to see most of these (insulin)
drugs are being developed to preserve patent protection,” Harvard Medical
School professor David Nathan told
ave-kept-rising-for-95-years/?utm_term=.7f58b19d9bd8> The Washington Post.
“The truth is they are marginally different, and the clinical benefits of
them over the older drugs are zero.”   


Yet the three main manufacturers of insulin—Eli Lilly, Sanofi Aventis, and
Novo Nordisk—have dramatically raised prices on the newest versions. A 2016
study published in the Journal of the American Medical Association  showed
that the cost of insulin in the U.S. almost tripled between 2002 and 2013,
and prices have continued to climb since. A U.S. patient’s out-of-pocket
cost for a month’s supply of Eli Lilly’s Humalog can be over $400. 


For the drug companies, insulin is a hugely profitable product. Although
manufacturers keep the cost of insulin production a tightly-guarded secret,
U.S. prices are likely hundreds of times higher than the expense of making
the drug. With annual revenues of $31 billion and growing, insulin is one of
the highest-grossing medicines in the global market.


But for patients who are dependent on insulin, its cost is creating a
crisis—and not just in low-income countries but also in the comparatively
wealthy United States. Increasingly, a lack of insurance coverage for the
medicine or high-deductible coverage leaves people with diabetes paying as
much as half their income for insulin.  Patients report skipping doses,
injecting expired insulin, and even starving themselves to control their
blood sugar. Some patients are intentionally allowing themselves to slip
into the life-threatening state of diabetic ketoacidosis just so they can
obtain free insulin samples from emergency rooms. Not surprisingly,
physicians report seeing more patients in distress because they can’t afford
their insulin. 


Americans with type 1 diabetes are particularly anxious over the likely
repeal of the Affordable Care Act, which protects them against coverage
denials because of pre-existing conditions and against lifetime caps on
coverage. Amy Leyendecker, who lives in Elizabethtown, Kentucky, currently
has most of her insulin and equipment costs paid by insurance provided by
her husband’s employer. But she has been without health insurance before,
and is anxious about what may happen when her husband retires in a post-ACA
world. “I have a five-month stash of insulin in my refrigerator that a
friend brought in from outside the U.S.,” she says. “This is life-and-death
for me.” 




Among those fighting for more affordable insulin is T1International. Elliott
and Mbolonzi Mbaluka are active members. T1International’s founder and
director, Elizabeth Rowley, began the organization as a blog, but she
quickly discovered that there was a global population of persons living with
type 1diabetes eager to connect—and to speak out. One core purpose of the
group is to provide a forum for those patient voices. “There are a lot of
difficult challenges people with type 1 struggle with,” Rowley says. “And
number one among those is that the prices for insulin and equipment are just
far too high.”


Rowley and her colleagues try to channel widespread frustration into focused
activism. T1International’s detailed toolkit for advocacy includes global
case studies of successful campaigns for better insulin access, tactical
guidance, and tips on dealing with elected officials—“Sometimes you have to
make the politician think it was their idea.”   They collect data on insulin
and supply costs, publish accounts of patient experiences worldwide, and
even steer U.S. patients toward the attorneys who have filed a class action
suit against the insulin manufacturers. That lawsuit, in the U.S. District
Court in Massachusetts, alleges price collusion among the three major
manufacturers, citing years of remarkably similar price increases by Eli
Lilly, Sanofi, and Novo Nordisk.


T1International’s support of that litigation, and its outspoken criticism of
insulin pricing, put it squarely at odds with the pharmaceutical industry.
That also makes T1 different from most patient advocacy groups. Groups
including cancer patient groups and allergy and asthma patient groups have
come under criticism for not speaking out in response to drug pricing
issues. Most even declinied to weigh in even during the recent high-profile
Epi-Pen and Martin Shkreli “pharma bro” debates, in which triple-digit drug
price increases led to public outcry and Congressional hearings. 


In fact, patient groups often vigorously support the pharma industry agenda,
while at the same time receiving significant pharma funding. A 2016 report
by the U.S. advocacy group Public Citizen revealed that at least
three-quarters of the patient groups who actively opposed an Obama
administration proposal to reduce Medicare drug expenditures received pharma
industry donations. Another study showed that over 90 percent of patient
groups participating in a discussion of FDA drug approval reform were
pharma-funded.  Most patient groups that opposed California’s 2016 ballot
measure to regulate the medicine prices paid by state government proved to
be heavily funded by pharmaceutical corporations. 


Not surprisingly, access to medicines advocates report that patient group
representatives privately admit that they won’t speak out on drug pricing
for fear of losing state funding. That fear is well-founded. The U.S.
National Multiple Sclerosis Society endured push-back from its pharma
funders when it dared to mention concerns over the cost of multiple
sclerosis drugs that average $78,000 annually, a 400 percent increase in
little over a decade


For patient groups, the pharma industry is the best source both for
operational funding and the drug donations that can be shared with desperate
patients. So most groups choose to accept the funding and devote themselves
to patient education and direct aid, muting any criticism. T1International
made the choice to favor advocacy, but it was not an easy one. Elliott
recalls an early board meeting where he argued for a focus on patient
service mission instead. “I am glad I was outvoted,” he says now. “T1 fills
a much-needed need in the diabetes patient community.”


T1International refuses on principle to accept pharma industry donations.
“Even if they don’t force you to take certain positions, it is human nature
not to want to bite the hand that feeds you,” Rowley says. But that choice
has implications. Although pharma-funded organizations such as the
International Diabetes Federation and the American Diabetes Association are
well-staffed, T1International gets by with an all-volunteer workforce,
anchored by Rowley’s 40-plus hours of unpaid labor each week.


She and other volunteers continue to spend those hours ratcheting up the
pressure on lawmakers and companies to address insulin pricing. They push
for congressional hearings on the alleged industry collusion, expose the
limitations of well-publicized corporate drug donation programs, and build a
social media community around the theme of #insulin4all. And they are giving
voice to the argument that essential medicines should be once again a public
good, not a for-profit commodity. “It is a tragedy that a drug like insulin,
invented by people who were motivated by a goal of access to all, is so
clearly unavailable to so many,” Elliott says. “People are dying, and that
is a status quo no one can defend.”   


Fran Quigley is clinical professor and director of the Health and Human
Right Clinic at Indiana University McKinney School of Law and coordinator of
<http://www.pfamrx.org/> People of Faith for Access to Medicines. 



Fran Quigley

PFAM: People of Faith for Access to Medicines www.pfamrx.org

(317) 750-4891


Clinical Professor and Director of Health and Human Rights Clinic

Indiana University McKinney School of Law





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