[Ip-health] Guardian: Scientists on a mission to bring cheap drugs to the world's poorest countries

[Gavin Baker]

Blogged at Essential Medicine News: http://www.emednews.org/
- Gavin

Scientists on a mission to bring cheap drugs to the world's poorest
countries
=B7 Indian trials for low cost hepatitis C treatment
=B7 Researchers pioneer 'ethical pharmaceuticals'

Sarah Boseley, health editor
Tuesday January 2, 2007
The Guardian

Until recently, hepatitis C, a potentially fatal blood-borne infection
that could affect as many as 500,000 people in the UK, was treated with
the antiviral drug ribavirin, together with interferon.

The drugs are old enough to be out of patent and so can be made cheaply,
but the necessary frequent injections of interferon cause serious side
effects.

Then in 2003 scientists working for Roche and Schering Plough developed
a variation on the drug designed to last longer in the blood and so
require fewer injections. The trial results were spectacular - half of
the patients were cured. The drug was patented and is sold to the NHS.

The catch, as so often when it comes to cutting edge pharmaceuticals, is
cost: the =A37,000-a-course price tag is expensive for the NHS and beyond
the budgets of developing countries, where the need is greatest.

Enter Sunil Shaunak, professor of infectious diseases at Imperial
College, and his colleague from the London School of Pharmacy, Steve
Brocchini. Involved in the battle to contain the Aids pandemic from its
outset in 1985, Professor Shaunak was committed to finding ways to
provide cheap medicines for people in the developing world.

In the case of hepatitis C, Professors Shaunak and Brocchini decided to
try to make a different, improved version of the Roche drug which would
be cheap and stable in a hot climate. They redesigned the drug, known as
pegylated interferon, so that it would have the large sugar molecule
which made it last longer in the blood on the inside, rather than the
outside. Then they contacted a company called Shantha in Hyderabad,
which had made the world's first cost-effective hepatitis B vaccine and
was already making the original interferon. Shantha has agreed to make
the new medicine and the Indian government will subsidise the clinical
trials which have to take place before licensing.

"If it works in India, it will eventually come back to the NHS," said
Professor Shaunak. "What we started doing is creating this model of what
we call ethical pharmaceuticals."

Professor Shaunak says they want to make a difference - not just create
new drugs but see them through to become good medicines to treat people
in poor countries. He says the model is not a threat to the
pharmaceutical giants, but "if eventually it became a threat to their
business, I [would] be very flattered". He wants the idea of the model
in the public domain so that other young academic doctors and scientists
can use it.

The pair are now working on a drug for visceral leishmaniasis, also
known as kala-azar - a fatal disease transmitted by the sandfly. Most
cases are in Brazil, Bangladesh, India and the Sudan. The 70- year-old
drug commonly used to treat it kills 10% of patients. A new drug,
Gilead's patented Ambisome, revives patients within hours of the first
injection and has few side effects, but costs $800 (=A3408).

Gilead's medicine is derived from a very toxic drug called amphotericin
B, which, essentially, its scientists inserted into a fat globule,
eliminating the toxicity.

Professors Shaunak and Brocchini came up with the idea of putting it
into sugar-based polymers instead to make a drug that is stable in hot
climates and will cost 2-3% of the price. They have teamed up with the
Drugs for Neglected Diseases Initiative (DNDi), a not-for-profit
organisation which was the brainchild of M=E9decins sans Fronti=E8res, whic=
h
will raise the initial money.

Simon Croft of DNDi said the idea was to repackage the drug, making it
less toxic but just as effective and cheaper. "It has a long way to go,
but it is an exciting concept which is already demonstrated with
hepatitis C. Cost is one of the key issues. If patients and health
services can't afford it, a potentially good formulation can't be used."

Reformulating a drug was a classic way for multinational pharmaceutical
companies to extend the life of a medicine reaching the end of its
patent life, he added.

The multinational drug companies already fight bitter battles over their
patent rights. Lawyers for the drug giants will take a close interest in
any new drug that could potentially damage their profits. The cheap HIV
drugs used in Africa are generic copies which it is illegal to bring
into Europe or the US, but if ethical pharmaceuticals were licensed as
new medicines, they could be sold here.

The Association of the British Pharmaceutical Industry said the key
question was whether the new drug was truly innovative. "The issue is
around whether he [the researcher] has developed a novel compound which
is therefore not covered by the patent on any other product," said Ben
Hayes of the ABPI. "Then he or anybody else has the right to patent it."
They would, however, still face the considerable challenge and expense
of clinical trials before the drug could be licensed first in India and
then in the UK. Only then could the NHS consider whether it was worth
prescribing, he said.

A spokesman for Roche said yesterday: "Roche is committed to ensuring
that as many people as possible can gain access to our medicines, many
of which have transformed once deadly diseases into manageable and or
even curable conditions. One such example is our commitment to supply
HIV drugs to Africa on a not-for-profit basis. It costs the
pharmaceutical industry on average =A3550m to develop a single new
medicine. Patents are in place to ensure we have the resources to
continue to discover cutting edge advances in the future."