[Ip-health] NY Times Today on DNDI: Escaping Big Pharma's Pricing With Patent-Free Drugs

Fran Quigley fwquigley at gmail.com
Tue Jul 18 08:12:26 PDT 2017

Escaping Big Pharma’s Pricing With Patent-Free Drugs


How’s this for a great deal? The United States government funded research
and development of a new vaccine against Zika. But the Army, which paid a
French pharmaceutical manufacturer for its development, is planning to grant
d-a-bad-zika-deal.html?mcubz=0&_r=0> exclusive rights to the vaccine to the
manufacturer, Sanofi Pasteur, along with paying Sanofi up to $173 million.

Sanofi will be free to charge the United States American health care
providers and patients any price it wishes. Although American tax dollars
funded the vaccine, and the United States took the economic risks, history
suggests that many Americans would not be able to afford it.

This is a negotiating strategy of unconditional surrender. Although
President Trump said before taking office that drug companies were
“getting away with murder” and had campaigned on lowering drug prices, his
administration is doing the opposite. A draft order on drug pricing that
became public in June would grant pharmaceutical companies
es-easing-regulations.html?smid=tw-nytpolitics&smtyp=cur&_r=0> even more
power to charge exorbitantly. For example, it could shrink a federal program
that requires companies to sell at a discount to clinics and hospitals
serving low-income patients.

Exorbitant prices are one thing that’s very wrong with the way we make
medicines. The other is: medicines for what? If a malady has no market in
wealthy countries, it gets no attention. Poor-country diseases, known as
“neglected diseases,” have a ferocious impact: O
<http://www.globalnetwork.org/about> ne of every six people in the world,
including a half-billion children, suffers from neglected diseases. Yet of
the 756 new drugs approved between 2001 and 2011,
dInno_Report_MedInnforNegPatients_ENG_2012.pdf> less than 4 percenttargeted
those diseases. The industry spends far more on lobbying government agencies
to extend monopolies on high-cost drugs — or hand out deals like the Zika
vaccine — than it does on research for a vaccine against dengue fever, which
poses a risk for 40 percent of the world’s population.

But there’s one drug company that behaves differently.

When Bernard Pécoul was a young physician working for Médecins Sans
Frontières/Doctors Without Borders in the 1980s and 1990s, the only
available treatment for Human African Trypanosomiasis, better known as
sleeping sickness, horrified him. 

The protocol called for multiple, extremely painful, injections of
melarsoprol, an arsenic-based compound. People in the Democratic Republic of
Congo called it “fire in the veins.” Children who received it had to first
be forcibly restrained. The treatment was so toxic that it caused fatal
brain swelling in 5 percent of the patients, and it didn’t work for a third
of those who survived it. But sleeping sickness is fatal if not treated, so
there was no choice.

What outraged Pécoul, who is French, was that melarsoprol had been around
since 1949, and nothing better had been developed since. To the physicians
at Doctors Without Borders, it was just one example of the lack of effective
remedies for the diseases of the poor. “We were well aware of the difference
between the quality of treatment we were providing and the care that was
available to patients in high-income countries,” Pécoul said.

In 2014, the Ebola virus spread in epidemic proportions while physicians had
no response. Promising vaccines to prevent Ebola, and drugs to treat it, had
been in early development years before. But those medicines were allowed to
languish without completion to public availability because pharmaceutical
companies saw  <https://www.ncbi.nlm.nih.gov/pubmed/14711361> no prospect of
significant profit to be made from their sale. Ebola claimed 11,000 lives,
demonstrating in stark terms the core limitation of the current medicines
research and development model.

Pécoul and Doctors Without Borders decided to tackle the diseases that were
killing the global poor. Doctors Without Borders dedicated its 1999 Nobel
Peace Prize award money to providing seed funding for the Drugs for
Neglected Disease Initiative, known as D.N.D.I. The aim was to see what
could be accomplished when research priorities ignore questions of
profitability, and the price of medicines is “delinked” from research costs,
which are instead shouldered by public financing or philanthropy.

An immediate challenge was that D.N.D.I. possessed none of the required
hardware for the expensive drug research and development process: It had no
labs, no manufacturing facilities, and no distribution process. It fell to
Pécoul to recruit partners, including private pharmaceutical companies he
persuaded to share drug compounds that had been uncovered but abandoned
because of lack of profitability. Government and grant funding allowed
D.N.D.I. to pay existing labs to test promising drug candidates and
facilities to manufacture the end results. D.N.D.I. itself took on the
difficult task of conducting clinical trials in the rugged, remote areas
where neglected disease are most deadly. Pécoul says the multi-partner
approach is akin to being the “conductor of a virtual orchestra.”

D.N.D.I. has already delivered seven new patent-free, low-cost treatments
for neglected diseases. A partnership with Sanofi (yes, the same company)
led to the distribution of a fast-release oral antimalarial treatment to
nearly 500 million adults and children, at a cost of less than a dollar per
patient. Dr. François Bompart, vice president for access to medicines at
Sanofi, said that Pécoul was not shy about insisting that the company had a
moral obligation to make its products widely available. “Bernard is able to
combine the role of a sometimes aggressive challenger with a personal style
that is likable,” Bompart says. “He is offended by situations that are
unfair, but he has established D.N.D.I. as a credible partner with the
private sector.”

Last month, Tina Rosenberg
tart.html?mcubz=0> wrote about the  <http://www.cepi.net/> Center for
Epidemic Preparedness Innovations, which is raising foundation and public
money to develop vaccines for dangerous pathogens. C.E.P.I. is just for
vaccines. D.N.D.I. also works on treatments. It tries to improve existing
medicines to make them easier to use in the field: for example, administered

And it develops new drugs; the more than 30 projects in its current pipeline
include 15 entirely new chemical entities.

To create seven drugs, with 30 more in testing, D.N.D.I. has spent $290
million to date. For-profit pharmaceutical manufacturers claim that it costs
al-drug-now-exceeds-2-5b/> $2.5 billion to develop a single drug, a figure
often derided by critics as a wild exaggeration.

Another way D.N.D.I. is different is that it makes its research available
for follow-up studies, adhering to an open-source philosophy that is unusual
in patent-focused biomedical circles. It uses the term “public goods” to
describe its products, harkening back to an era when medicines were widely
considered to be off-limits to patenting and the resulting monopoly price
markups. As Jonas Salk famously said when asked why he did not seek to
patent the polio vaccine, “Could you patent the sun?”

D.N.D.I. does not claim it can replace the for-profit pharmaceutical
industry. “Every single drug that the (D.N.D.I.) initiative is developing —
and they’re all worthwhile — piggybacks on other people’s quest for profit,”
a pharmaceutical researcher, Derek Lowe, wrote in a Science magazine
s-a-better-way> blog post last year.

But clearly there’s room for more nonprofit drug companies. “D.N.D.I.’s
success is ample proof that the model of nonprofit, open-source research and
development is a viable alternative to exclusive reliance on patent and data
monopolies,” said Brook Baker, a professor at Northeastern University School
of Law who studies pharmaceutical development issues. Recent reports on the
crisis of access to medicines by the
5e231b2f02cd3d4/1473890031320/UNSG+HLP+Report+FINAL+12+Sept+2016.pdf> United
Nations and the British medical journal
The Lancet single out D.N.D.I. as evidence that different approaches to
research and development can provide improved efficiency and affordability.

Pécoul and his D.N.D.I. colleagues say their biggest challenge now is
securing sustainable funding for research — another illustration of the
limits of a model with no profits to invest in research. But the government
funds research all the time — it’s just often turned over to for-profit
companies. The Zika vaccine is one example. The prostate cancer drug
pacilataxel, the leukemia medicine imatinib and many mental health and
H.I.V. medicines and vaccines can all trace their origins to
government-funded research — only to be handed over to industry to charge
what they want.

“For-profit pharma has depended upon the National Institutes of Health and
other government programs to fund all steps of research and development,”
said James Love, director of Knowledge Ecology International, which is
helping to lead the opposition to the Zika vaccine deal. “Governments should
provide more resources and more opportunities for nonprofit companies to
bring drugs and vaccines to market.” That way their products would be
available and affordable to all.

financed-medicines-research-system/> Some economists have argued that since
Medicare and Medicaid are the leading purchasers of drugs (and Medicare is
forbidden by law from negotiating on price), the money saved by buying from
nonprofit drugmakers could easily replace all privately funded research and
development. The increased public research dollars could then be applied,
D.N.D.I.-like, to develop the medicines that would have the most significant
public health impact.

This would help rich countries as well as poor ones. D.N.D.I. has already
received funds to work on treatments for hepatitis C. Cures exist, but
companies charge as much as $84,000 for a typical 12-week course of
treatment. This means that most people with Hep C
n/> cannot get the drugs.

In the meantime, D.N.D.I. has made progress in tackling the disease that
helped spur its creation. In 2009, it started the first new sleeping
sickness therapy in 25 years, a combination treatment that avoids the
toxicity of melarsoprol and reduces the number of intravenous injections
that made other options impossible to use in remote settings. Since humans
are the main reservoir of the disease, increased treatment has caused
sleeping sickness cases to drop to just a few thousand a year. And
D.N.D.I.’s pipeline of projects under development includes its gold standard
of a single-dose oral medicine for sleeping sickness, a prospect that is
causing health experts to envision the
ulltext?rss=yes> global elimination of the disease.

“I would not say we are the only solution, but we do show a different way
that can work,” Pécoul said. “We cannot depend on a for-profit model to
address the needs of all patients — that has been well-demonstrated.”

Fran Quigley directs the Health and Human Rights Clinic at Indiana
University McKinney School of Law. He is a freelance writer and a former
news editor.

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Fran Quigley

PFAM: People of Faith for Access to Medicines, www.pfamrx.org
<http://www.pfamrx.org/> , (317) 750-4891

Also: Clinical Professor, Health
<http://mckinneylaw.iu.edu/faculty-staff/profile.cfm?Id=440> & Human Rights
Clinic, Indiana University McKinney School of Law



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